Section 250.210  The Governing Board

 

a)         Each hospital shall have a governing authority, called the board, responsible for the organization, management, control and operation of the hospital, including the appointment of the medical staff.  For two or more hospitals within a health care system, the system board may serve as the single governing authority of each hospital (which shall be referred to as the "system board").  When this option is exercised, the system board shall be responsible for compliance with the medical staff requirements in the Act and its regulations.

 

b)         The board shall be organized in accordance with a written constitution and bylaws that clearly set forth organization, duties, responsibilities and relationships.  The Department may require a copy for its files.

 

c)         The board shall meet regularly.  Monthly meetings are recommended.  Written reports of all meetings shall be maintained.

 

d)         The board shall employ a competent executive officer or administrator and vest him or her with authority and responsibility to carry out its policies.  A qualified individual shall be responsible to the administrator in matters of administration and shall represent him or her during the administrator's absence.

 

e)         The board shall ensure the availability of competent, well qualified personnel for all hospital departments in order to efficiently carry out the functions of the hospital and meet patient care needs. The board shall also provide a mechanism for assisting employees in addressing physical and mental health problems.

 

f)         The board shall be responsible for the maintenance of standards of professional work in the hospital and shall require that the medical staff function competently.  Clinical audits shall be performed by the medical staff and reviewed by a committee of the governing authority and the medical staff. The board shall consult directly with the individual who is responsible for the organization and conduct of the hospital's medical staff.  The direct consultation shall occur at least twice per year and shall include discussion of matters related to the quality of medical care provided to the patients of the hospital.  For a hospital system using a system board, the system board shall consult directly with the individual responsible for the organized medical staff (or his or her designee) of each hospital within the system.  Direct consultation occurs when the governing body, or a subcommittee of the governing body, meets with the leaders of the medical staffs, or their designee, either face-to-face or via a telecommunications system that permits immediate, synchronous communication.

 

g)         The board shall establish a policy providing for the investigation of unusual incidents that may occur.  (Refer to Section 250.990.)

 

h)         Two or more separately licensed hospitals that are part of a hospital system with a system board may elect to use the option of a unified medical staff, conditioned upon acceptance by a majority vote of  the medical staff members of the participating hospitals.  Members who hold privileges to practice at the hospital  shall vote in accordance with the medical staff bylaws.  Nothing in this Section shall be construed to require a unified medical staff for any hospital.

 

1)         The system board shall be responsible for the decisions of the unified medical staff and may direct the unified medical staff to consider any matter or reconsider any decision.  The system board shall take final action on all medical staff matters, on behalf of the hospitals within the system that share a unified medical staff, including, but not limited to:

 

A)        The appointment, reappointment and delineation of clinical privileges of the medical staff;

 

B)        The denial or revocation of a medical staff appointment and the denial, revocation, suspension, restriction or reduction of clinical privileges;

 

C)        The approval of bylaws and policies; and

 

D)        The maintenance of standards for professional work in the hospital and the review of clinical audits, pursuant to subsection (f).

 

2)         The unified medical staff shall be considered a committee of a licensed hospital for purposes of Section 8-2101 of the Code of Civil Procedure.

 

3)         All of the activities of the system board shall be in compliance with the medical staff provisions of the Act and this Part.

 

4)         If two or more hospitals within a hospital system designate a system board, each hospital in the hospital system shall still individually comply with the Act and this Part.

 

(Source:  Amended at 41 Ill. Reg. 7154, effective June 12, 2017)

 

Section 250.220  Accounting

 

Accounting procedures shall be carried out in accordance with a recognized system of hospital accounting and should be adequate to permit satisfactory auditing.  It is recommended that an audit be performed at least annually by a qualified auditor independent of the hospital.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.230  Planning

 

a)         Occupancy Control

 

1)         Every hospital shall develop occupancy control measures and participate in inter-hospital and community planning to meet medical and hospital needs.  Such planning shall include a continuing evaluation of the hospital's facilities and services to make effective use of existing hospital, nursing home and public health facilities and services, including community home care services, and of developing new and/or additional services.

 

2)         Every hospital shall enforce its occupancy control measures in an effort to avoid over utilization of its facilities and services. Hospitals experiencing a high level occupancy should, if other measures are inadequate, develop hospital expansion plans in conjunction with recognized health facility planning organizations within its area or region.  Expansion programs must also comply with Public Act 78-1156, the Illinois Health Facilities Planning Act, as administered by the Health Facilities Planning Board.  (Refer to Section 250.310 (a)(14))

 

b)         Admission – Discharge

            The hospital shall control its admission and discharge of patients so that occupancy does not at any time exceed capacity, except in the event of unusual emergency and then only as a temporary measure.

 

c)         Admission – Discharge Control Committee

 

1)         The hospital shall, if high-level occupancy is expected or being experienced on any of its services or nursing units, activate a standing committee which shall further scrutinize existing activities of utilization review, admission, discharge, elective surgery and assure that patient census will not exceed bed capacity.

 

2)         The Medical staff, Hospital administration and the Nursing service shall be represented on this committee.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.240  Admission and Discharge

 

a)         Principle

The hospital shall have written policies for the admission, discharge, and referral of all patients who present themselves for care.  Procedures shall assure appropriate utilization of hospital resources such as preadmission testing, ambulatory care programs, and short-term procedure units.

 

b)         Referrals

A hospital licensed under the Hospital Licensing Act may not refer a patient or the family of a patient, or have an entity on a resource reference list for a patient or the family of a patient, to a home health, home services, or home nursing agency unless the agency is licensed under the Home Health, Home Services, and Home Nursing Agency Licensing Act.  (Section 3.8 of the Home Health, Home Services, and Home Nursing Agency Licensing Act)  A hospital shall verify that an agency is currently on the Department's list of licensed home health, home services, and home nursing agencies posted on the Department's website or obtain a copy of an agency's license prior to making a referral to that agency.

 

c)         Access

 

1)         All persons shall be admitted to the hospital, whether as inpatients or under observation by a member of the medical staff with admitting privileges, an advanced practice registered nurse, or a physician assistant with clinical privileges recommended by the medical staff and granted by the hospital governing board. All persons admitted to the hospital shall be under the professional care of a member of the medical staff.

 

2)         Insofar as possible, the hospital shall assign patients to accommodations with regard to gender, age, and medical requirement.

 

3)         The hospital shall provide basic and effective care to each patient.  No person seeking necessary medical care from the hospital shall be denied care for reasons not based on sound medical practice or the hospital's charter, and, particularly, no person shall be denied care on account of race, creed, color, religion, gender, or sexual orientation.

 

4)         When the hospital does not provide the services required by a patient or a person seeking necessary medical care, an appropriate referral shall be made.

 

d)         Required Testing for All Admissions

 

1)         The laboratory examinations required on all admissions shall be determined by the medical staff and shall be consistent with the scope and nature of the hospital.  The required list or lists of tests shall be in written form and shall be available to all members of the medical staff.  The required examinations shall be consistent with the requirements of this subsection (d).

 

2)         Uterine Cytologic Examination for Cancer

 

A)        Every hospital shall offer a uterine cytologic examination for cancer to every female inpatient 20 years of age or over, unless one of the following conditions exists:

 

i)          The examination is considered contra-indicated by the attending physician; or

 

ii)         The patient has had a uterine cytologic examination for cancer performed within the previous year prior to the admission to the hospital.

 

B)        Every woman for whom the test is applicable shall have the right to refuse such test on the counsel of the attending physician or on her own judgment.

 

C)        Patient records for all female inpatients 20 years of age or older shall indicate one of the following:

 

i)          The results of the test;

 

ii)         The reasons that the test offer requirement was not applicable as provided under subsection (d)(2)(A); or

 

iii)        A statement that it was refused by the patient. (Section 2310-540 of the Civil Administrative Code).

 

3)         Testing for Infection with Human Immunodeficiency Virus (HIV)

 

A)        The hospital shall offer testing for infection with human immunodeficiency virus (HIV) to patients upon request.

 

B)        The hospital shall ensure that pre-test and post-test counseling is provided to the patient in accordance with the provisions of the AIDS Confidentiality Act and the HIV/AIDS Confidentiality and Testing Code.

 

C)        Testing that is performed under the Act and this Part shall be subject to the provisions of the AIDS Confidentiality Act and the HIV/AIDS Confidentiality and Testing Code. (Section 6.10 of the Act)

 

e)         Discharge Notification

 

1)         The hospital shall develop a discharge plan of care for all patients who present themselves to the hospital for care.

 

2)         The discharge plan shall be based on an assessment of the patient's needs by various disciplines responsible for the patient's care.

 

3)         When a patient is discharged to another level of care, the hospital shall ensure that the patient is being transferred to a facility that is capable of meeting the patient's assessed needs.

 

4)         A hospital’s discharge procedures shall include prohibitions against discharging or referring a patient to any facility for further health care services that is unlicensed, uncertified, or unregistered.

 

5)         Whenever a patient who qualifies for the federal Medicare program is hospitalized, the patient shall be notified of discharge at least 24 hours prior to discharge from the hospital.  The notification shall be provided by, or at the direction of, a physician with medical staff privileges at the hospital or any appropriate medical staff member.  The notification shall include:

 

A)        The anticipated date and time of discharge.

 

B)        Written information concerning the patient's right to appeal the discharge pursuant to the federal Medicare program, including the steps to follow to appeal the discharge and the appropriate telephone number to call if the patient intends to appeal the discharge.  This written information does not need to be included in the notification, if it has already been provided to the patient. (Section 6.09 of the Act)

 

6)         Every hospital shall develop and implement policies and procedures to provide the discharge notice required in subsection (e)(5).  The policies and procedures may also include a waiver of the notification requirement in either or both of the following cases:

 

A)        When a discharge notice is not feasible due to a short length of stay in the hospital by the patient.  The hospital policy shall specify the length of stay when discharge notification will not be considered feasible.

 

B)        When the patient voluntarily desires to leave the hospital before the expiration of the 24 hour period. (Section 6.09 of the Act)

 

7)         When a facility-provided medication is ordered at least 24 hours in advance for surgical procedures and is administered to a patient at a hospital, any unused portion of the facility-provided medication shall be offered to the patient upon discharge when it is required for continuous treatment. 

 

A)        A facility-provided medication shall be labeled consistent with labeling requirements under Section 22 of the Pharmacy Practice Act.

 

B)        If the facility-provided medication is used in an operating room or emergency department setting, the prescriber is responsible for counseling the patient on its proper use and administration and the requirement of pharmacist counseling is waived.  (Section 6.28 of the Act)

 

C)        For the purposes of this Section, “facility-provided medication” means any topical antibiotic, anti-inflammatory, dilation, or glaucoma drop or ointment (Section 15.10 of the Pharmacy Practice Act)

 

f)         Patient Notice of Observation Status.  Within 24 hours after a patient's placement into observation status by a hospital, the hospital shall provide that patient with an oral and written notice that the patient is not admitted to the hospital and is under observation status. The written notice shall be signed by the patient or the patient's legal representative to acknowledge receipt of the written notice and shall include, but not be limited to, the following information:

 

1)         A statement that observation status may affect coverage under the federal Medicare program, the medical assistance program under Article V of the Illinois Public Aid Code, or the patient's insurance policy for the current hospital services, including medications and other pharmaceutical supplies, as well as coverage for any subsequent discharge to a skilled nursing facility or for home and community based care; and

 

2)         A statement that the patient should contact his or her insurance provider to better understand the implications of being placed into observation status.  (Section 6.09b of the Act)

 

g)         The hospital shall develop a written policy for cases in which a patient in observation status is incapacitated and attempts to contact the patient's legal representative within 24 hours pursuant to subsection (f) have been unsuccessful.  The hospital shall document all attempts to contact the patient's legal representative.

 

h)         Background Checks for Patients Transferring to a Long-Term Care Facility

 

1)         Before transfer of a patient to a long term care facility licensed under the Nursing Home Care Act where elderly persons reside, a hospital shall as soon as practicable initiate a name-based criminal history background check by electronic submission to the Department of State Police for all persons between the ages of 18 and 70 years; provided, however, that a hospital shall be required to initiate such a background check only with respect to patients who:

 

A)        are transferring to a long term care facility for the first time;

 

B)        have been in the hospital more than 5 days;

 

C)        are reasonably expected to remain at the long term care facility for more than 30 days;

 

D)        have a known history of serious mental illness or substance abuse; and

 

E)        are independently ambulatory or mobile for more than a temporary period of time.

 

2)         A hospital may also request a criminal history background check for a patient who does not meet any of the criteria set forth in subsections (h)(1)(A) through (E).

 

3)         A hospital shall notify a long term care facility if the hospital has initiated a criminal history background check on a patient being discharged to that facility.  In all circumstances in which the hospital is required by this subsection (h) to initiate the criminal history background check, the transfer to the long term care facility may proceed regardless of the availability of criminal history results.

 

4)         Upon receipt of the results, the hospital shall promptly forward the results to the appropriate long term care facility.  If the results of the background check are inconclusive, the hospital shall have no additional duty or obligation to seek additional information from, or about, the patient. (Section 6.09(d) of the Act)

 

(Source:  Amended at 47 Ill. Reg. 14455, effective September 26, 2023)

 

Section 250.245  Failure to Initiate Criminal Background Checks

 

The Department may impose fines on hospitals, not to exceed $500 per occurrence, for failing to initiate a criminal background check on a patient that meets the criteria for hospital-initiated background checks.  In assessing whether to impose such a fine, the Department shall consider various factors including, but not limited to, whether the hospital has engaged in a pattern or practice of failing to initiate criminal background checks.  Money from fines will be deposited into the Long Term Care Provider Fund. (Section 7(a) of the Act)

 

(Source:  Added at 35 Ill. Reg. 13875, effective August 1, 2011)

 

Section 250.250  Visiting Rules

 

a)         Each hospital shall establish, in the interest of the patient, policies regarding visitation on the various services and departments of the hospital.  It is recommended that visitors be limited to two per patient at any one time.

 

b)         In times of increased incidence of communicable disease in the community, the hospital should consult with the local health officer regarding further restriction of visitors.

 

c)         Hospitals shall implement and comply with Section 3.2 of the Medical Patient Rights Act regarding visitation rights, policies, and procedures. Hospitals shall develop policies and procedures to address visitation when a disaster exists or in the event of an outbreak or epidemic of communicable disease.

 

d)         No visitor shall knowingly be admitted who has a known infectious disease, who has recently recovered from such a disease, or who has recently had contact with such a disease.

 

e)         Children

 

1)         Children under 12 years of age should not be admitted as visitors to the hospital except in the company of a responsible adult.

 

2)         Children under six years of age should be admitted as visitors only when the hospital has a special family visiting program or when requested in writing by the attending physician or chief executive officer of the hospital.  Visiting facilities other than the patient's room shall be used for children under six years of age, unless that room is a private room.

 

f)         No lay visitor shall be given access to the operating rooms during surgery, except as provided in Section 250.1305 or Section 250.1860(a).

 

g)         See Section 250.1830(k) for visiting regulations applicable to maternity departments and newborn nurseries.

 

h)         Smoking by visitors shall be prohibited except in specially designated outside areas.

 

i)          No visitors shall be permitted in the postoperative recovery room.

 

j)          No birds, turtles, dogs, cats, or other animals (exclusive of those required for laboratory purposes or for animal-assisted therapy in accordance with Section 250.890) shall be allowed in a medical facility, except as provided in this subsection (j).  Guide dogs may accompany sightless persons.  When animals are allowed in the hospital, the hospital shall have policies for infection control, sanitation, care of the animals, and any necessary patient screening.  The policies shall be followed and shall comply with the requirements concerning animals in the Department's Food Code.

 

(Source:  Amended at 47 Ill. Reg. 6477, effective April 27, 2023)

 

Section 250.260  Patients' Rights

 

a)         Policy on Patients' Rights

 

1)         Hospitals shall adopt a written policy on patients' rights.

 

2)         This policy shall be available to all patients and personnel upon request.

 

b)         Patient Morale

 

1)         Emotional and Attitudinal Support

Hospitals shall have a written plan for the provision of those components of total patient care that relate to the spiritual, emotional and attitudinal health of the patient, patients' families and hospital personnel.

 

2)         Social Services

Hospitals shall have a written plan for providing social services.  This service may be provided through:

 

A)        An organized social service within the hospital; or

 

B)        A social worker employed on a part-time basis; or

 

C)        Social work consultant services from a community agency.

 

c)         Patient Protection from Abuse

 

1)         For purposes of this subsection (c):

 

Abuse – means any physical or mental injury or sexual abuse intentionally inflicted by a hospital employee, agent, or medical staff member on a patient of the hospital and does not include any hospital, medical, health care, or other personal care services done in good faith in the interest of the patient according to established medical and clinical standards of care.

 

Mental Injury – means intentionally caused emotional distress in a patient from words or gestures that would be considered by a reasonable person to be humiliating, harassing, or threatening and which causes observable and substantial impairment.

 

Sexual Abuse – means any intentional act of sexual contact or sexual penetration of a patient in the hospital.

 

Substantiated – with respect to a report of abuse, means that a preponderance of the evidence indicates that abuse occurred.

 

2)         No administrator, agent, or employee of a hospital or a member of its medical staff may abuse a patient in the hospital.

 

3)         Any hospital administrator, agent, employee, or medical staff member who has reasonable cause to believe that any patient with whom he or she has direct contact has been subjected to abuse in the hospital shall promptly report or cause a report to be made to a designated hospital administrator responsible for providing such reports to the Department as required by this subsection (c).

 

4)         Retaliation against a person who lawfully and in good faith makes a report under this subsection (c) is prohibited.

 

5)         Upon receiving a report under subsection (c)(3), the hospital shall submit the report to the Department within 24 hours after obtaining such report.  In the event that the hospital receives multiple reports involving a single alleged instance of abuse, the hospital shall submit one report to the Department.

 

6)         Upon receiving a report under this subsection (c), the hospital shall promptly conduct an internal review to ensure the alleged victim's safety.  Measures to protect the alleged victim shall be taken as deemed necessary by the hospital's administrator and shall include, but are not limited to, removing suspected violators from further patient contact during the hospital's internal review.  If the alleged victim lacks decision-making capacity under the Health Care Surrogate Act and no health care surrogate is available, the hospital may contact the Illinois Guardianship and Advocacy Commission to determine the need for a temporary guardian of that person.

 

7)         All internal hospital reviews shall be conducted by a designated hospital employee or agent who is qualified to detect abuse and is not involved in the alleged victim's treatment.  All internal review findings shall be documented and filed according to hospital procedures and shall be made available to the Department upon request.

 

8)         Any other person may make a report of patient abuse to the Department if that person has reasonable cause to believe that a patient has been abused in the hospital.

 

9)         The report required under this subsection (c) shall include:

 

A)        The name of the patient;

 

B)        The name and address of the hospital treating the patient;

 

C)        The age of the patient;

 

D)        The nature of the patient's condition, including any evidence of previous injuries or disabilities; and

 

E)        Any other information that the reporter believes might be helpful in establishing the cause of the reported abuse and the identity of the person believed to have caused the abuse.

 

10)         Except for willful or wanton misconduct, any individual, person, institution, or agency participating in good faith in making a report or in making a disclosure of information concerning reports of abuse under this subsection (c), shall have immunity from any liability, whether civil, professional, or criminal, that otherwise might result by reason of such actions.  For the purpose of any proceedings, whether civil, professional, or criminal, the good faith of any persons required to report cases of suspected abuse under this subsection (c) or who disclose information concerning reports of abuse in compliance with this subsection (c) shall be presumed.

 

11)         No administrator, agent, or employee of a hospital shall adopt or employ practices or procedures designed to discourage or having the effect of discouraging good faith reporting of patient abuse under this subsection (c).

 

12)         Every hospital shall ensure that all new and existing employees are trained in the detection and reporting of abuse of patients and retrained at least every 2 years thereafter.

 

13)         The Department shall investigate each report of patient abuse made under this subsection (c) according to the procedures of the Department, except that a report of abuse which indicates that a patient's life or safety is in imminent danger shall be investigated within 24 hours after such report.  Under no circumstances may a hospital's internal review of an allegation of abuse replace an investigation of the allegation by the Department.

 

14)         The Department shall keep a continuing record of all reports made pursuant to this subsection (c), including indications of the final determination of any investigation and the final disposition of all reports.  The Department will inform the investigated hospital and any other person making a report under subsection (c)(7) of this Section of its final determination or disposition in writing.

 

15)         All patient identifiable information in any report or investigation under this subsection (c) shall be confidential and shall not be disclosed except as authorized by the Act or other applicable law.

 

16)         Nothing in this subsection (c) relieves a hospital administrator, employee, agent, or medical staff member from contacting appropriate law enforcement authorities as required by law.

 

17)         Nothing in this subsection (c) shall be construed to mean that a patient is a victim of abuse because of health care services provided or not provided by health care professionals.

 

18)         Nothing in this subsection (c) shall require a hospital, including its employees, agents, and medical staff members, to provide any services to a patient in contravention of his or her stated or implied objection thereto upon grounds that such services conflict with his or her religious beliefs or practices, nor shall such a patient be considered abused under this Section for the exercise of such beliefs or practices. (Section 9.6 of the Act)

 

d)         Patient Discrimination

 

1)         Discrimination Grievance Procedures. Upon receipt of a grievance alleging unlawful discrimination on the basis of race, color, or national origin, the hospital must investigate the claim and work with the patient to address valid or proven concerns in accordance with the hospital's grievance process. At the conclusion of the hospital's grievance process, the hospital shall inform the patient that such grievances may be reported to the Department if not resolved to the patient's satisfaction at the hospital level. (Section 5.1 of the Medical Patient Rights Act)

 

2)         Emergency Room Anti-discrimination Notice. Every hospital shall post, either by physical or electronic means, a sign next to or in close proximity of its sign required by 42 CFR 489.20(q)(1) stating the following: "You have the right not to be discriminated against by the hospital due to your race, color, or national origin if these characteristics are unrelated to your diagnosis or treatment. If you believe this right has been violated, please call the Illinois Department of Public Health Central Complaint Registry, 1-800-252-4343." (Section 5.2 of the Medical Patient Rights Act)

 

e)         In compliance with Section 3.4 of the Medical Patient Rights Act, every hospital shall post information about the rights listed in Section 3.4 of the Medical Patient Rights Act in a prominent place (physical or electronic) and on their websites. The postings in the hospital and on the hospital’s website shall include the web address of the Department’s posting of this information, http://www.dph.illinois.gov/topics-services/health-care-regulation/facilities/hospitals.  (Section 3.4(b) of the Medical Patient Rights Act)

 

(Source:  Amended at 46 Ill. Reg. 15597, effective September 1, 2022)

 

Section 250.265  Language Assistance Services

 

The hospital shall comply with the Language Assistance Services Act [210 ILCS 87] and the Language Assistance Services Code (77 Ill. Adm. Code 940).

 

(Source:  Amended at 29 Ill. Reg. 12489, effective July 27, 2005)

 

Section 250.270  Manuals of Procedure

 

a)         It is recommended that the hospital administrator, in cooperation with the medical staff and the respective department heads, formulate manuals of procedure so that technics and departmental relationships may be systematized and standardized.

 

b)         Where appropriate these manuals shall contain a statement of policy and procedure regarding routine laboratory and x-ray examinations.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.280  Agreement with Designated Organ Procurement Agencies

 

a)         Each hospital shall have an agreement with its federally designated organ procurement agency providing for notification of the organ procurement agency when potential organ donors become available, as required in Section 2 of the Organ Donation Request Act [755 ILCS 60].  (Section 6.16 of the Act)

 

b)         Each hospital shall provide its federally designated organ procurement agency and any tissue bank with which it has an agreement with access to the medical records of deceased patients for the following purposes:

 

1)         estimating the hospital's organ and tissue donation potential;

 

2)         identifying the educational needs of the hospital with respect to organ and tissue donation; and

 

3)         identifying the number of organ and tissue donations and referrals to potential organ and tissue donors.  (Section 6.17(a) of the Act)

 

c)         All hospital and patient information, interviews, reports, statements, memoranda, and other data obtained or created by a tissue bank or federally designated organ procurement agency from the medical records review in subsection (b) of this Section shall be privileged, strictly confidential, and used only for the purpose put forth in subsection (b) of this Section and shall not be admissible as evidence nor discoverable in an action of any kind of court or before a tribunal, board, agency, or person.  (Section 6.17(b) of the Act)

 

d)         Any person who, in good faith, acts in accordance with the terms of this Section shall not be subject to any type of civil or criminal liability or discipline for unprofessional conduct for those actions.  (Section 6.17(c) of the Act)

 

(Source:  Added at 20 Ill. Reg. 10009, effective July 15, 1996)

 

Section 250.285  Smoking Restrictions

 

The hospital shall comply with the Smoke Free Illinois Act [410 ILCS 82].

 

(Source:  Added at 34 Ill. Reg. 19031, effective November 17, 2010)

 

Section 250.290  Safety Alert Notifications

 

a)         Each hospital shall subscribe to the free e-mail notification services of the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention.

 

1)         FDA:  MedWatch E-List , which can be accessed at www.fda.gov/Safety/MedWatch/default.htm; and

 

2)         CDC:  Clinician Outreach and Communication Activity (COCA), which can be accessed at http://emergency.cdc.gov/coca/.   COCA updates and clinical reminders may be requested by sending an email to coca@cdc.gov.

 

b)         Actions in response to these notifications shall be taken promptly.

 

(Source:  Amended at 39 Ill. Reg. 13041, effective September 3, 2015)

 

Section 250.295  Notification and Posting Requirements

 

Hospitals shall comply with all hospital notification and posting requirements, by physical or electronic means, of the following Acts:

 

a)         Section 6.14(c) of the Hospital Licensing Act, related to the hospital's license, complaint procedures, Department or court orders, and other materials available for public inspection under Section 6.14(d) of the Act;

 

b)         Section 4-4 of the Illinois Health Finance Reform Act, related to established charges for services;

 

c)         Section 15 of the Fair Patient Billing Act, related to patient financial assistance;

 

d)         Section 3.4 of the Medical Patient Rights Act, related to the rights of women with regard to pregnancy and childbirth;

 

e)         Section 5.1(a) of the Crime Victims Compensation Act, related to posters, provided by the Attorney General, regarding the existence of the Crime Victims Compensation Act and its provisions;

 

f)         Sections 5 and 10 of the Human Trafficking Resource Center Notice Act, related to the requirements of the Human Trafficking Resource Center Notice Act as provided in the model notice; and

 

g)         Section 22 of the Abandoned Newborn Infant Protect Act, related to relinquishing a newborn infant.

 

(Source:  Added at 46 Ill. Reg. 15597, effective September 1, 2022)

 

Section 250.300  At-Home Patient Care Waivers

 

a)         To adequately respond to COVID-19, a hospital may apply to the Centers for Medicare and Medicaid Services (CMMS) for an Acute Hospital Care at Home waiver from the requirements of 42 CFR 482.23(b) and (b)(1) to provide limited inpatient services directly in a patient’s home. The waiver application may be found at https://qualitynet.cms.gov/acute-hospital-care-at-home.

 

b)         A participating hospital with an approved waiver from the Centers for Medicare and Medicaid Services (CMMS) shall provide the Department with the following:

 

1)         A copy of the CMMS-approved Medicare waiver;

 

2)         A copy of the participating hospital’s screening protocol to determine patient eligibility for the at-home, inpatient services; and

 

3)         A copy of the participating hospital's policy and procedures for clinical management of inpatients at home.

 

c)         The Department will conduct any complaint investigation, survey, or inspection of the participating hospital, request any documentation, and require corrective action pursuant to its State licensure authority under the Hospital Licensing Act and this Part.

 

d)         A participating hospital also shall meet the following requirements:

 

1)         Provide safe and quality care to each patient in the patient's home;

 

2)         Prohibit all abuse of a patient by an administrator, agent, employee, or member of its medical staff and, in addition, comply with the abuse and neglect reporting requirements of Section 250.260 for suspected occurrences;

 

3)         Ensure access to health care information and services for limited English-speaking or non-English speaking patients, in compliance with Section 250.265;

 

4)         Administer no medication, treatment, or diagnostic test to a patient except on a written or verbal order, if necessary, by a licensed medical professional acting within the professional's scope of practice;

 

5)         Ensure nursing services are under the direction of a registered nurse who has qualifications in nursing administration;

 

6)         Maintain an adequate, timely, and complete medical record for each patient receiving at-home care in compliance with Section 250.1510;

 

7)         Comply with incident reporting requirements in Section 250.1520(f);

 

8)         Ensure all drugs and medicines are stored and dispensed in compliance with Section 250.2110(f) and (g); and

 

9)         Comply with State law or rule related to COVID-19 diagnosis and treatment from the Department or other State agencies.

 

(Source:  Added at 48 Ill. Reg. 2516, effective January 30, 2024)

SUBPART C: THE MEDICAL STAFF

 

Section 250.310  Organization

 

a)         For the purposes of this Section only:

 

1)         Adverse Decision − means a decision reducing, restricting, suspending, revoking, denying, or not renewing medical staff membership or clinical privileges.  (Section 10.4(b) of the Act)

 

2)         A Distant-site Hospital − means an Illinois licensed hospital or a Medicare participating hospital.

 

3)         A Distant-site Telemedicine Entity – means an entity consisting of a group of licensed physicians that:

 

A)        Provides telemedicine services;

 

B)        Is not a Medicare-participating hospital; and

 

C)        Provides contracted services in a manner that enables a hospital using its services to meet all applicable Medicare conditions of participation, particularly those requirements related to the credentialing and privileging of practitioners providing telemedicine services to the patients of a hospital. A distant-site telemedicine entity would include a distant-site hospital that does not participate in the Medicare program that is providing telemedicine services to a Medicare-participating hospital.

 

4)         Economic Factor − means any information or reasons for decisions unrelated to quality of care or professional competency.  (Section 10.4(b) of the Act)

 

5)         Non-simultaneously − means that, while the telemedicine physician or practitioner still provides clinical services to the patient upon a formal request from the patient's attending physician, these services may, for example, involve after-the-fact interpretation of diagnostic tests, consultations between a physician or practitioner and a person outside the State of Illinois, or second opinions provided to an Illinois-licensed physician or practitioner in order to provide an assessment of the patient's condition and do not necessarily require the telemedicine practitioner to directly assess the patient in real time or establish a provider-to-patient relationship or interaction.  An example of after-the-fact interpretation of diagnostic tests would be similar to the services provided by an on-site radiologist who interprets a patient's x-ray or CT scan and then communicates the assessment to the patient's attending physician who then bases a diagnosis and treatment plan on these findings.

 

6)         Privilege − means permission to provide medical or other patient care services and permission to use hospital resources, including equipment, facilities and personnel that are necessary to effectively provide medical or other patient care services.  This definition shall not be construed to require a hospital to acquire additional equipment, facilities, or personnel to accommodate the granting of privileges. (Section 10.4(b) of the Act)

 

7)         Simultaneously − means that the clinical services (for example, assessment of the patient with a clinical plan for treatment, including any medical orders needed) are provided to the patient in real time by the telemedicine physician or practitioner, similar to the actions of an on-site physician or practitioner.

 

8)         Telemedicine − means the provision of clinical services to patients by physicians or practitioners remotely via electronic communications. The distant-site telemedicine physician or practitioner provides clinical services to the hospital patient either simultaneously, as is often the case with teleICU services, for example, or non-simultaneously, as may be the case with many teleradiology services.  Telemedicine may also include provider-to-provider consultations between Illinois-licensed physicians or practitioners and physicians or practitioners licensed in the United States.

 

b)         The medical staff shall be organized in accordance with written bylaws, rules and regulations approved by the governing board.  The bylaws, rules and regulations shall specifically provide, but are not limited to:

 

1)         establishing written procedures relating to the acceptance and processing of initial applications for medical staff membership, granting and denying of medical staff reappointment, and medical staff membership or clinical privileges disciplinary matters in accordance with subsection (e) for county hospitals as defined in Section 15-1(c) of the Illinois Public Aid Code, or subsection (f) for all other hospitals.  The procedures for initial applicants at any particular hospital may differ from those for current medical staff members.  However, the procedures at any particular hospital shall be applied equally to each practitioner eligible for medical staff membership as defined in Section 250.100.  The procedures shall provide that, prior to the granting of any medical staff privileges to an applicant, or renewing a current medical staff member's privileges, the hospital shall request of the Director of the Department of Financial and Professional Regulation information concerning the licensure status, proper credentials, required certificates, and any disciplinary action taken against the applicant's or medical staff member's license.  This provision shall not apply to medical personnel who enter a hospital to obtain organs and tissues for transplant from a deceased donor in accordance with the Illinois Anatomical Gift Act.  This provision shall not apply to medical personnel who have been granted disaster privileges pursuant to the procedures and requirements established in this Section.  (Section 10.4(a) of the Act);

 

2)         identifying divisions and departments as are warranted (as a minimum, active and consulting divisions are required);

 

3)         identifying officers as are warranted;

 

4)         establishing committees as are warranted to assure the responsibility for functions such as pharmacy and therapeutics, infection control, utilization review, patient care evaluation, and the maintenance of complete medical records;

 

5)         assuring that active medical staff meetings are held regularly, and that written minutes of all meetings are kept;

 

6)         reviewing and analyzing the clinical experience of the hospital at regular intervals − the medical records of patients to be the basis for review and analysis;

 

7)         identifying conditions or situations that require consultation, including consultation between medical staff members in complicated cases;

 

8)         examining tissue removed during operations by a qualified pathologist and requiring that the findings are made a part of the patient's medical record;

 

9)         keeping completed medical records;

 

10)         maintaining a Utilization Review Plan, which shall be in accordance with the Conditions of Participation for Hospitals;

 

11)         establishing Medical Care Evaluation Studies;

 

12)         establishing policies requiring a physician as first assistant to major or hazardous surgery, including written criteria to determine when an assistant is necessary;

 

13)         assuring, through credentialing by the medical staff, that a qualified surgical assistant, whether a physician or non-physician, assists the operating surgeon in the operating room;

 

14)         determining additional privileges that may be granted a staff member for the use of the staff member's employed allied health personnel in the hospital in accordance with policies and procedures recommended by the medical staff and approved by the governing body.  The policies and procedures shall include, at least, requirements that the staff member requesting this additional privilege shall submit the following for review and approval by the medical staff and the governing body of the hospital:

 

A)        a curriculum vitae of the identified allied health personnel, and

 

B)        a written protocol with a description of the duties, assignments and functions, including a description of the manner of performance within the hospital by the allied health personnel in relationship with other hospital staff;

 

15)         establishing a mechanism for assisting medical staff members in addressing physical and mental health problems;

 

16)         implementing a procedure for preserving medical staff credentialing files in the event of the closure of the hospital;

 

17)         establishing a procedure for granting telemedicine privileges, based upon the privileging decisions of a distant-site hospital or telemedicine entity that has a written agreement that meets Medicare requirements; and

 

18)         establishing a procedure for granting disaster privileges.

 

A)        When the emergency management plan has been activated and the hospital is unable to handle patients' immediate needs, it shall:

 

i)          identify in writing the individuals responsible for granting disaster privileges;

 

ii)         describe in writing the responsibilities of the individuals granting disaster privileges.  The responsible individual is not required to grant privileges to any individual and is expected to make decisions on a case-by-case basis at his or her discretion;

 

iii)        describe in writing a mechanism to manage individuals who receive disaster privileges;

 

iv)        include a mechanism to allow staff to readily identify individuals who receive disaster privileges;

 

v)         require that medical staff address the verification process as a high priority and begin the verification process of the credentials and privileges of individuals who receive disaster privileges as soon as the immediate situation is under control.

 

B)        The individual responsible for granting disaster privileges may grant disaster privileges upon presentation of any of the following:

 

i)          a current picture hospital ID card;

 

ii)         a current license to practice and a valid picture ID issued by a state, federal or regulatory agency;

 

iii)        identification indicating that the individual is a member of a Disaster Medical Assistance Team (DMAT) or an Illinois Medical Emergency Response Team (IMERT);

 

iv)        identification indicating that the individual has been granted authority to render patient care, treatment and services in disaster circumstances (authority having been granted by a federal, state or municipal entity); or

 

v)         presentation by current hospital or medical staff members with personal knowledge regarding practitioner's identity.

 

C)        Any hospital and any employees of the hospital or others involved in granting privileges who, in good faith, grant disaster privileges, pursuant to Section 10.4 of the Act, to respond to an emergency shall not, as a result of their acts or omissions, be liable for civil damages for granting or denying disaster privileges except in the event of willful and wanton misconduct, as that term is defined in Section 10.2 of the Act.

 

D)        Individuals granted privileges who provide care in an emergency situation, in good faith and without direct compensation, shall not, as a result of their acts or omissions, except for acts or omissions involving willful and wanton misconduct, as that term is defined in Section 10.2 of the Act, on the part of the person, be liable for civil damages.  (Section 10.4 of the Act)

 

c)         General Acute or Critical Access Hospitals without a licensed pediatric unit or board certified or board eligible pediatrician in the hospital or on call 24 hours a day, 7 days a week that provide limited inpatient or observation services to pediatric patients (neonate (less than 28 days of age) to 14 years old):

 

1)         Shall have a written agreement with a children’s hospital or hospital with a licensed pediatric unit. The agreement shall include provider-to-patient and/or provider-to-provider consultations that meet the telemedicine requirements provided in subsections (a)(2) through (a)(8) remotely via electronic communications, whether synchronous or asynchronous, and specify other information including communication frequency, equipment, education, transfers, case reviews, and critical criteria for emergency transfers;

 

2)         Must have an agreement with one primary hospital, for the purposes of continuing education and consultation, but are encouraged to have agreements with multiple hospitals, in order to ensure options when a transfer is warranted but restricted from accommodation due to primary hospital census or family preference;

 

3)         May have agreements with out-of-state hospitals who have agreements with the Department under the Regionalized Perinatal Health Care Code (77 Ill. Adm. Code 640) and designated as a trauma center by the Department in accordance with Section 3.90 of the Emergency Medical Services (EMS) Systems Act;

 

4)         May include a fee for provider-to-patient and/or provider-to-provider consultations with the consulting hospital in the written agreement, but the fee may not be transferred to the patient;

 

5)         Shall have until June 1, 2024 to enter into an agreement, or amend an existing agreement, as required in this subsection (c);

 

6)         Shall consult with the children’s hospital or hospital with licensed pediatric unit prior to the patient being moved to a medical/surgical unit from either the emergency department or post-operative procedure unit.  In cases where the consultation cannot occur prior to the move, the consultation must occur within one hour after the patient has been placed on the medical/surgical unit as an inpatient or in observation status.  The frequency of the consultations during the pediatric patient’s stay shall be determined by the health care provider and shall continue until the patient is discharged or transferred;

 

7)         Shall maintain a record of the consultation in the pediatric patient’s medical file;

 

8)         Shall report pediatric services provided pursuant to the requirements of this subsection (c) to the Department quarterly as required by Section 250.1520(i); and

 

9)         Shall not require providers who give provider-to-provider consultations to be privileged at the hospital where the patient is receiving treatment.

 

d)         If a hospital is part of a hospital system consisting of two or more separately licensed hospitals, and the system elects to have a unified, integrated medical staff for its separately licensed member hospitals, each separately licensed hospital shall permit the medical staff members of each separately licensed hospital in the system (in other words, all medical staff members who hold specific privileges to practice at that hospital) to vote, in accordance with medical staff bylaws, whether to accept a unified, integrated medical staff structure or to maintain a separate and distinct medical staff for their respective licensed hospital.

 

1)         If the medical staffs of the separately licensed hospitals vote to accept an integrated, unified medical staff structure, they shall meet the following conditions:

 

A)        Adopt written bylaws, rules and requirements that describe the processes for self-governance, appointment, credentialing, privileging and oversight, as well as peer review policies and due process rights guarantees, including a process for the members of the medical staff of each separately licensed hospital to be advised of their rights to opt out of the unified and integrated medical staff structure after a majority vote by the members to maintain a separate and distinct medical staff for their hospital;

 

B)        Take into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital; and

 

C)        Establish and implement written policies and procedures, including meetings that shall occur at least twice per fiscal or calendar year, to ensure that the needs and concerns expressed by members of the medical staffs at each separately licensed hospital, regardless of practice or location, are given due consideration, and that the unified, integrated medical staff has mechanisms in place to ensure that issues localized to particular hospitals are considered and addressed.

 

2)         The unified, integrated medical staff shall be organized in accordance with the Conditions of Participation for Hospitals related to medical staff.

 

3)         Medical staffs may vote, no more than every two years, whether to remain or discontinue as an integrated, unified medical staff.

 

4)         This subsection (d) shall not apply to hospitals that are required to have a unified, integrated medical staff under 42 CFR 413.65(d) and (e) as being a multi-campus hospital under one Medicare certification number.

 

e)         The medical staff bylaws for county hospitals as defined in Section 15-1(c) of the Illinois Public Aid Code shall include at least the following:

 

1)         The procedures relating to evaluating individuals for staff membership, whether the practitioners are or are not currently members of the medical staff, shall include procedures for determining qualifications and privileges; criteria for evaluating qualifications; and procedures requiring information about current health status, current license status in Illinois, and biennial review of renewed license.

 

2)         Written procedures that allow the medical staff to rely upon the credentialing and privileging decisions of a distant-site hospital or telemedicine entity as an option for recommending the privileging of telemedicine physicians.

 

3)         The procedure shall grant to current medical staff members at least: written notice of an adverse decision by the governing board; an explanation and reasons for an adverse decision; the right to examine and/or present copies of relevant information, if any, related to an adverse decision; an opportunity to appeal an adverse decision; and written notice of the decision resulting from the appeal.  The procedures for providing written notice shall include timeframes for giving notice.

 

f)         The medical staff bylaws for all hospitals except county hospitals shall include at least the following provisions for granting, limiting, renewing, or denying medical staff membership and clinical staff privileges:

 

1)         Minimum procedures for pre-applicants or applicants for medical staff membership, including the following:

 

A)        Written procedures relating to the acceptance and processing of pre-applicants or applicants for medical staff membership.

 

B)        Written procedures to be followed in determining a pre-applicant's or an applicant's qualifications for being granted medical staff membership and privileges.

 

C)        Written criteria to be followed in evaluating a pre-applicant's or an applicant's qualifications.

 

D)        An evaluation of a pre-applicant's or an applicant's current health status and current license status in Illinois.

 

E)        A written response to each pre-applicant or applicant that explains the reason or reasons for any adverse decision (including all reasons based in whole or in part on the applicant's medical qualifications or any other basis, including economic factors).

 

F)         Written procedures that allow the medical staff to rely upon the credentialing and privileging decisions of a distant-site hospital or telemedicine entity as an option for recommending the privileging of telemedicine physicians.

 

2)         Minimum procedures with respect to medical staff and clinical privilege determinations concerning current members of the medical staff shall include the following:

 

A)        A written notice of an adverse decision and explanation of the reasons for an adverse decision including all reasons based on the quality of medical care or any other basis, including economic factors.

 

B)        A statement of the medical staff member's right to request a fair hearing on the adverse decision before a hearing panel whose membership is mutually agreed upon by the medical staff and the hospital governing board. The hearing panel shall have independent authority to recommend action to the hospital governing board.  Upon the request of the medical staff member or the hospital governing board, the hearing panel shall make findings concerning the nature of each basis for any adverse decision recommended to and accepted by the hospital governing board.

 

i)          Nothing in this subsection (f)(2)(B) limits a hospital's or medical staff's right to summarily suspend, without a prior hearing, a person's medical staff membership or clinical privileges if the continuation of practice of a medical staff member constitutes an immediate danger to the public, including patients, visitors, and hospital employees and staff.

 

ii)         In the event that a hospital or the medical staff imposes a summary suspension, the Medical Executive Committee, or other comparable governance committee of the medical staff as specified in the bylaws, must meet as soon as is reasonably possible to review the suspension and to recommend whether it should be affirmed, lifted, expunged, or modified if the suspended medical staff member requests a review.

 

iii)        A summary suspension may not be implemented unless there is actual documentation or other reliable information that an immediate danger exists.  This documentation or information must be available at the time the summary suspension decision is made and when the decision is reviewed by the Medical Executive Committee.

 

iv)        If the Medical Executive Committee recommends that the summary suspension should be lifted, expunged, or modified, this recommendation must be reviewed and considered by the hospital governing board, or a committee of the board, on an expedited basis.

 

v)         Nothing in this subsection (f)(2)(B) shall affect the requirement that any requested hearing must be commenced within 15 days after the summary suspension and completed without delay unless otherwise agreed to by the parties.

 

vi)        A fair hearing shall be commenced within 15 days after the suspension and completed without delay, except that, when the medical staff member's license to practice has been suspended or revoked by the Department of Financial and Professional Regulation, no hearing shall be necessary. (Section 10.4(b)(2)(C)(i) of the Act)

 

vii)       Nothing in this subsection (f)(2)(B) limits a medical staff's right to permit, in the medical staff bylaws, summary suspension of membership or clinical privileges in designated administrative circumstances as specifically approved by the medical staff.  This bylaw provision must specifically describe both the administrative circumstance that can result in a summary suspension and the length of the summary suspension. The opportunity for a fair hearing is required for any administrative summary suspension.  Any requested hearing must be commenced within 15 days after the summary suspension and completed without delay.  Adverse decisions other than suspension or other restrictions on the treatment or admission of patients may be imposed summarily and without a hearing under designated administrative circumstances as specifically provided for in the medical staff bylaws as approved by the medical staff. (Section 10.4(b)(2)(C)(ii) of the Act)

 

viii)      If a hospital exercises its option to enter into an exclusive contract and that contract results in the total or partial termination or reduction of medical staff membership or clinical privileges of a current medical staff member, the hospital shall provide the affected medical staff member 60 days prior notice of the effect on his or her medical staff membership or privileges.  An affected medical staff member desiring a hearing under this subsection (f)(2)(B) must request the hearing within 14 days after the date he or she is so notified.  The requested hearing shall be commenced and completed (with a report and recommendation to the affected medical staff member, hospital governing board, and medical staff) within 30 days after the date of the medical staff member's request.  If agreed upon by both the medical staff and the hospital governing board, the medical staff bylaws may provide for longer time periods. (Section 10.4(b)(2)(C)(iii) of the Act)

 

C)        A statement of the member's right to inspect all pertinent information in the hospital's possession with respect to the decision.

 

D)        A statement of the member's right to present witnesses and other evidence at the hearing on the decision.

 

E)        The right to be represented by a personal attorney.

 

F)         A written notice and written explanation of the decision resulting from the hearing.

 

G)        A written notice of a final adverse decision by the hospital governing board.

 

H)        Notice given 15 days before implementation of an adverse medical staff membership or clinical privileges decision based substantially on economic factors.  This notice shall be given after the medical staff member exhausts all applicable procedures under subsection (f)(2)(B)(viii), and under the medical staff bylaws in order to allow sufficient time for the orderly provision of patient care. (Section 10.4(b)(2)(D) through (G) of the Act)

 

3)         Nothing in subsection (f)(2) limits a medical staff member's right to waive, in writing, the rights provided in subsection (f)(2)(A) through (H) upon being granted privileges to provide telemedicine services or the written exclusive right to provide particular services at a hospital, either individually or as a member of a group.  If an exclusive contract is signed by a representative of a group of physicians, a waiver contained in the contract shall apply to all members of the group unless stated otherwise in the contract.  (Section 10.4(b)(2)(H) of the Act)

 

4)         All peer review used for the purpose of credentialing, privileging, disciplinary action, or other recommendations affecting medical staff membership or exercise of clinical privileges, whether relying in whole or in part on internal or external reviews, shall be conducted in accordance with the medical staff bylaws and applicable rules, regulations, or policies of the medical staff.  If external review is obtained, any adverse report utilized shall be in writing and shall be made part of the internal peer review process under the bylaws.  The report shall also be shared with a medical staff peer review committee and the individual under review.  If the medical staff peer review committee or the individual under review prepares a written response to the report of the external peer review within 30 days after receiving the report, the governing board shall consider the response prior to the implementation of any final actions by the governing board which may affect the individual's medical staff membership or clinical privileges.  Any peer review that involves willful or wanton misconduct shall be subject to civil damages as provided for under Section 10.2 of the Act. (Section 10.4(b)(2)(C-5) of the Act)

 

5)         Every adverse medical staff membership and clinical privilege decision based substantially on economic factors shall be reported to the Hospital Licensing Board before the decision takes effect.  The reports shall not be disclosed in any form that reveals the identity of any hospital or physician.  These reports shall be utilized to study the effects that hospital medical staff membership and clinical privilege decisions based upon economic factors have on access to care and the availability of physician services. (Section 10.4(b)(3) of the Act)

 

g)         If a hospital enters into agreement for telemedicine services with a distant-site hospital or distant-site entity, the governing body of the hospital whose patients are receiving the telemedicine services may choose, in lieu of the hospital performing the credentialing and privileging requirements, to rely upon the credentialing and privileging decisions made by the distant-site hospital when making recommendations on privileges for the individual distant-site physicians and practitioners providing the services.  The hospital's governing body ensures, through its written agreement with the distant-site hospital, that the distant-site hospital meets the Conditions of Participation for Hospitals for credentialing and privileging of physicians and practitioners.  The agreement shall be in writing and shall verify:

 

1)         That the distant-site hospital providing the telemedicine services is an Illinois licensed hospital or a Medicare participating hospital;

 

2)         That the individual distant-site physician or practitioner is privileged at the distant-site hospital that provides the telemedicine services and provides to the hospital a current list of the distant-site physician's privileges;

 

3)         That the individual distant-site physician or practitioner holds a license issued or recognized by the State of Illinois; and

 

4)         That, if the hospital conducts an internal review of the distant-site physician's or practitioner's performance, it provides the distant-site hospital with the performance information for use in the distant-site hospital's periodic appraisal of the distant-site physician or practitioner. At a minimum, this information shall include all adverse events that result from the telemedicine services provided by the distant-site physician or practitioner to the hospital's patients and all complaints the hospital has received about the distant-site physician or practitioner.

 

h)         The hospital's governing body shall grant privileges to each telemedicine physician or practitioner providing services at the hospital under an agreement with a distant-site hospital or telemedicine entity before the telemedicine physician or practitioner may provide telemedicine services. The scope of the privileges granted to the telemedicine physician or practitioner shall reflect the provision of the services offered via a telecommunications system.

 

i)          When the hospital's governing body exercises the option to grant privileges based on its medical staff recommendations, which rely upon the privileging decisions of a distant-site telemedicine hospital or entity, the governing body may, but is not required to, maintain a separate file on each telemedicine physician or practitioner. In lieu of maintaining a separate file on each telemedicine physician or practitioner, the hospital may have a file on all telemedicine physicians or practitioners providing services at the hospital under each agreement with a distant-site hospital or telemedicine entity, indicating which telemedicine services privileges the hospital has granted to each physician or practitioner on the list. The file or files may be kept in a format determined by the hospital.

 

j)          Regardless of any other categories (divisions of the medical staff) having privileges in the hospital, the hospital shall have an active staff, which shall include physicians and may also include podiatrists and dentists, properly organized, who perform all the organizational duties pertaining to the medical staff.  These duties include:

 

1)         Maintaining the proper quality of all medical care and treatment of inpatients and outpatients in the hospital.  Proper quality of medical care and treatment includes:

 

A)        availability and use of accurate diagnostic testing for the types of patients admitted;

 

B)        availability and use of medical, surgical, and psychiatric treatment for patients admitted;

 

C)        availability and use of consultation, diagnostic tools and treatment modalities for the care of patients admitted, including the care needed for complications that may be expected to occur; and

 

D)        availability and performance of auxiliary and associate staff with documented training and experience in diagnostic and treatment modalities in use by the medical staff and documented training and experience in managing complications that may be expected to occur.

 

2)         Organizing the medical staff, including adoption of rules and regulations for its government (which require the approval of the governing body), election of its officers or recommendations to the governing body for appointment of the officers, and recommendations to the governing body upon all appointments to the staff and grants of hospital privileges.

 

3)         Making other recommendations to the governing body regarding matters within the purview of the medical staff.

 

k)         The medical staff may include one or more divisions in addition to the active staff, but this in no way modifies the duties and responsibilities of the active staff.

 

(Source:  Amended at 48 Ill. Reg. 450, effective December 20, 2023; expedited correction at 48 Ill. Reg. 5807, effective December 20, 2023)

 

Section 250.315  House Staff Members

 

a)         In hospitals participating in professional graduate training programs, the policies of the hospital, which shall be approved by the Board, must specify the duty hour requirements for house staff members and the mechanisms by which house staff members are supervised by members of the medical staff in carrying out their patient care responsibilities.

 

b)         These policies shall comply with the Accreditation Council for Graduate Medical Education, Common Program Requirements (Residency).

 

(Source:  Amended at 47 Ill. Reg. 6477, effective April 27, 2023)

 

Section 250.320  Admission and Supervision of Patients

 

a)         All persons admitted to the hospital shall be under the professional care of a member of the medical staff.  Patients admitted by a podiatrist or a dentist shall be under the care of both the admitting medical staff member and a physician who is also a medical staff member.  The podiatrist or the dentist shall be responsible for all care within the limits of the privileges granted to them; the physician shall be responsible for all aspects of general medical care. Patients admitted by a dentist or a podiatrist may have their histories and physical examinations performed by the admitting dentist or podiatrist, provided that the dentist or podiatrist is a member of the hospital medical staff, that the dentist or podiatrist has been approved to perform histories and physical examinations by the hospital governing board and that the history and physical examination are directly related or incident to the dental or podiatrist service, operation, or surgery for which the patient is being admitted.

 

b)         Patients admitted by an advanced practice registered nurse or physician assistant shall be under the care of both the advanced practice provider and a physician who also is a medical staff member. The advanced practice provider shall be responsible for care within the limits of the privileges granted to him or her.

 

(Source:  Amended at 43 Ill. Reg. 3889, effective March 18, 2019)

 

Section 250.330  Orders for Medications and Treatments

 

a)         No medication, treatment or diagnostic test shall be administered to a patient except on the written order of a member of the medical staff, a house staff member under the supervision of a member of the medical staff, or allied health personnel with clinical privileges recommended by the hospital medical staff and granted by the hospital governing board, with the exception of influenza and pneumococcal polysaccharide vaccines, which may be administered per medical staff-approved hospital policy that includes an assessment for contraindications, and medications and treatments provided to patients in a hospital outpatient setting as set forth in a policy approved by the hospital medical staff and governing board.

 

1)         The staff-approved influenza and pneumococcal immunization policy shall include, but not be limited to, the following:

 

A)        Procedures for identifying patients age 65 or older and, at the discretion of the hospital, other patients at risk;

 

B)        Procedures for offering immunization against influenza virus when available between September 1 and April 1, and against pneumococcal disease upon admission or discharge, to patients in accordance with the recommendations of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention that are most recent to the time of vaccination, unless contraindicated; and

 

C)        Procedures for ensuring that patients offered immunization, or their guardians, receive information regarding the risks and benefits of vaccination.

 

2)         The hospital shall provide a copy of its influenza and pneumococcal immunization policy to the Department upon request. (Section 6.26 of the Act)

 

3)         The outpatient medication and treatment administration policy shall include, but not be limited to, the following:

 

A)        Procedures for verifying the credentials and scope of practice of non-medical staff members providing written orders for medications and treatment for patients under their care and management.

 

B)        Identifying what, if any, medications or treatments should not be included in this exception.

 

C)        A process for tracking non-medical staff members providing written orders for medication and treatments and the medications and/or treatments ordered.

 

4)         The hospital shall provide a copy of its outpatient medication and treatment policy to the Department upon request.

 

b)         Verbal orders shall be signed before the member of the medical staff, the house staff member or allied health personnel with clinical privileges recommended by the hospital medical staff and granted by the hospital governing board leaves the area.  Telephone orders shall be used sparingly and countersigned by the ordering practitioner or another practitioner who is responsible for the care of the patient as soon as practicable pursuant to a hospital policy approved by the medical staff, but no later than 72 hours after the order was given.

 

c)         Members of the medical staff, house staff members or allied health personnel with clinical privileges recommended by the hospital medical staff and granted by the hospital governing board shall give orders for medication and treatment only to the licensed, registered or certified professional persons who are authorized by law to administer or dispense the medication or treatment in the course of practicing their identified specific discipline.

 

d)         The medical directors of the laboratory, radiology or other diagnostic services may respectively authorize the performance of diagnostic tests and procedures at the request of other than members of the medical staff in accordance with policies approved by the medical staff and governing board.

 

e)         The medical director of the physical therapy or rehabilitation department may authorize the provision of physical therapy or rehabilitation services or treatments at the request of other than members of the medical staff in accordance with policies approved by the medical staff and governing board.

 

(Source:  Amended at 46 Ill. Reg. 15597, effective September 1, 2022)

 

Section 250.340  Availability for Emergencies

 

The governing board shall provide that one or more physicians shall be available at all times for emergencies.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

SUBPART D: PERSONNEL SERVICE

 

Section 250.410  Organization

 

a)         Personnel department organization

 

1)         There shall be an organized personnel department or service designed to meet the needs of the personnel.

 

2)         The chief executive officer shall designate an individual as department or service chief.

 

3)         The chief executive officer (administrator) shall ensure that personnel policies and practices that adequately support hospital services and quality of patient care are established and maintained.

 

4)         There shall be sufficient qualified personnel to properly operate the various departments and the adjunct services requiring technical skill, such as laboratory, x-ray, physical therapy, pharmacy, nursing, surgery, respiratory therapy, etc.

 

5)         There shall be sufficient service personnel to properly operate service departments.

 

6)         Qualified personnel shall mean those persons who hold necessary licenses for the activities they perform.  If no license is required, qualified personnel shall mean those persons who are registered or certified by the Department, the Illinois Department of Financial and Professional Regulation, the Council on Medical Education of the American Medical Association or Agencies or Committees established in collaboration with the Council, other accrediting agencies approved by the Department, or an acceptable experience equivalent to the above.

 

b)         Personnel policies shall be written and available to all personnel.

 

c)         Personnel policies shall be reviewed and/or revised periodically, but no less than once every two years.  The date of review or revision shall be indicated on the personnel policies.

 

d)         The hospital's governing body, through its chief executive officer, shall identify functions for the management of personnel and place responsibility for implementation and actions related to established policies and procedures.

 

e)         Under the direction of the hospital's administration, the personnel department shall have available organizational charts that identify all departments and/or services.

 

f)         All positions shall be authorized by the governing authority, either directly or through delegation to the administrator.

 

g)         There shall be a written job description including minimum qualifications for each position in the hospital.

 

h)         Prior to employing any individual in a position that requires a State license, the hospital shall contact the Illinois Department of Financial and Professional Regulation to verify that the individual's license is active.  A copy of the license shall be placed in the individual's personnel file.

 

i)          The hospital shall check the status of all applicants with the Health Care Worker Registry prior to hiring.

 

j)          Hospitals shall ensure that employees of the hospital are made aware of employee assistance programs or other like programs available for the physical and mental well-being of the employees.  Hospitals shall provide information on these programs, no less than at the time of employment and during any benefit open enrollment period.  A hospital may provide this information to employees electronically.  (Section 6.33 of the Act)

 

(Source:  Amended at 47 Ill. Reg. 6477, effective April 27, 2023)

 

Section 250.420  Personnel Records

 

a)         Accurate, current and complete personnel records shall be maintained for each hospital employee during his term of employment and for the years thereafter as may be necessary to satisfy other State Agency or Federal requirements.

 

b)         There shall be an established standard of content for personnel records, which shall contain at least the following:

 

1)         Application form and/or resume with current and background information sufficient to justify the initial and continuing employment of the individual.

 

2)         Verification of license, if the applicants for the positions require a license.  A licensed person should be employed only after obtaining verification of their license.

 

3)         A record regarding the employee's specialized education, training, and experience.

 

4)         Verification of identity.

 

5)         Employment health examination and subsequent health services rendered to the employees as are necessary to ensure that all hospital employees are physically able to perform their duties.

 

6)         Record of orientation to the job.

 

7)         Continuance of education.

 

8)         Current information relative to periodic work performance evaluations.

 

(Source:  Added at 4 Ill. Reg. 25, p. 138, effective June 6, 1980)

 

Section 250.430  Duty Assignments

 

Employees shall not be assigned duties which exceed their education training, experience, and qualifications.

 

(Source:  Added at 4 Ill. Reg. 25, p. 138, effective June 6, 1980)

 

Section 250.435  Health Care Worker Background Check

 

A hospital shall comply with the Health Care Worker Background Check Act [225 ILCS 46] and the Health Care Worker Background Check Code (77 Ill. Adm. Code 955).

 

(Source:  Amended at 31 Ill. Reg. 4245, effective February 20, 2007)

 

Section 250.440  Education Programs

 

Orientation and in-service training programs shall be provided in order that personnel may maintain their skills and learn new developments.

 

(Source:  Added at 4 Ill. Reg. 25, p. 138, effective June 6, 1980)

 

Section 250.445  Workplace Violence Prevention Program

 

a)         A hospital licensed under the Act shall comply with the Health Care Violence Prevention Act.  (Section 9.8 of the Act)

 

b)         Each hospital shall display, either by physical or electronic means, a notice stating that verbal aggression will not be tolerated and physical assault will be reported to law enforcement.  (Section 15(c) of the Health Care Violence Prevention Act)

 

c)         Each hospital shall create a workplace violence prevention program that complies with the Occupational Safety and Health Administration (OSHA) Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers.  In addition, the workplace violence prevention program shall include:

 

1)         the following classification of workplace violence as one of 4 possible types:

 

A)        "Type 1 violence" – workplace violence committed by a person who has no legitimate business at the work site and includes violent acts by anyone who enters the workplace with the intent to commit a crime;

 

B)        "Type 2 violence" – workplace violence directed at employees by customers, clients, patients, students, inmates, visitors, or other individuals accompanying a patient;

 

C)        "Type 3 violence" – workplace violence against an employee by a present or former employee, supervisor, or manager; or

 

D)        "Type 4 violence" – workplace violence committed in the workplace by someone who does not work there, but has or is known to have had a personal relationship with an employee.

 

2)         management commitment and worker participation, including, but not limited to nurses;

 

3)         worksite analysis and identification of potential hazards;

 

4)         hazard prevention and control;

 

5)         safety and health training that includes annual completion of one of the following online courses:

 

A)        Preventing Workplace Violence in Healthcare (OSHA); or 

 

B)        Workplace Violence Prevention for Nurses (CDC); and

 

6)         recordkeeping and evaluation of the violence prevention program.  (Section 20 of the Health Care Violence Prevention Act)

 

d)         A hospital's workplace violence prevention program shall also include:

 

1)         An overview of the incidence and prevalence of sexual assault and sexual violence;

 

2)         Strategies and approaches to prevent sexual violence;

 

3)         Intervention procedures to report sexual violence;

 

4)         Contact information for local programs and services to assist victims of sexual violence; and

 

5)         Additional training and education resources regarding the prevention and reporting of sexual violence, including, but not limited to, the Centers for Disease Control and Prevention's STOP SV: A Technical Package to Prevent Sexual Violence.

 

(Source:  Amended at 46 Ill. Reg. 15597, effective September 1, 2022)

 

Section 250.450  Personnel Health Requirements

 

a)         Each hospital shall establish an employee health program that includes the following:

 

1)         An assessment of the employee's health and immunization status at the time of employment;

 

2)         Policies regarding required immunizations; and

 

3)         Policies and procedures for the periodic health assessment of all personnel.  These policies shall specify the content of the health assessment and the interval between assessments, and shall comply with the Control of Tuberculosis Code).

 

b)         Personnel absent from duty because of any communicable disease shall not return to duty until examined for freedom from any condition that might endanger the health of patients or employees.

 

(Source:  Amended at 38 Ill. Reg. 13280, effective June 10, 2014)

 

Section 250.460  Benefits

 

Policies shall be established concerning pay days, sick leave, vacations, holidays, overtime, hospitalization, retirement plan, leaves of absence and other benefits or related conditions of employment, and a statement of all such policies should be furnished all personnel upon commencing work.

SUBPART E: LABORATORY

 

Section 250.510  Laboratory Services

 

The hospital shall have a clinical laboratory, certified in accordance with 42 CFR 493, to perform services commensurate with the hospital's needs for its patients. Anatomical pathology services and blood bank services shall be available either in the hospital or by arrangement with other facilities.

 

a)         Adequacy of Laboratory Services.  Clinical laboratory services adequate for the individual hospital shall be maintained in the hospital, as determined by the following:

 

1)         The extent and complexity of services are commensurate with size, scope and nature of the hospital, and the demands of the medical staff upon the laboratory.

 

2)         Basic laboratory services, necessary for routine examinations as defined in subsection (b), are provided in the hospital.

 

b)         Clinical Laboratory Examinations.  Provisions shall be made to carry out basic clinical laboratory examinations including chemistry, microbiology, hematology, serology, and clinical microscopy in such depth as required by the medical staff.

 

1)         Other laboratory examinations may be provided under arrangements by the hospital with another laboratory which is certified under CLIA regulations.

 

2)         In the case of work performed by an outside laboratory, the original report from this laboratory shall be contained in the medical record as specified in subsection (f).

 

c)         Availability of Facilities and Services

 

1)         Facilities and services shall be available at all times.  Adequate provision shall be made for assuring the availability of emergency laboratory services, either in the hospital or under arrangements with a laboratory which meets the requirements of subsection (b).

 

2)         Such services shall be available 24 hours a day, 7 days a week, including holidays.  Coverage of the service is permissible by having arrangements with personnel for "on call duty."

 

3)         Where services are provided by an outside laboratory, the conditions, procedures, and availability of examinations performed are to be in writing and available in the hospital.

 

d)         Required Examinations.  The laboratory examinations required on all admissions shall be determined by the medical staff as provided in Section 250.240(c).

 

e)         Laboratory Report.

Signed or otherwise authenticated reports shall be filed with the patient's medical record and duplicate copies are maintained in the laboratory.

 

1)         The laboratory director shall be responsible for the laboratory reports.

 

2)         There shall be a policy for assuring that all tests and procedures are ordered by a member of the medical staff or by others in accordance with approved policies.  (See Section 250.330)

 

f)         Pathologist Services.  Services of a pathologist shall be provided as indicated by the needs of the hospital.

 

1)         Services are to be under the supervision of a pathologist certified by the American Board of Pathology or who possesses training and experience acceptable to the Department and equivalent to such certification, and licensed to practice medicine in all its branches in Illinois, on a full-time, regular part-time or regular consultive basis.  If the latter pertains, the hospital shall provide for, at a minimum, semimonthly consultive visits by a pathologist.

 

2)         The pathologist shall participate in staff, departmental and clinicopathologic conferences.

 

g)         Tissue Examination.  All tissues removed at operation are to be submitted for examination. The extent of examination is determined by the pathologist.

 

1)         All tissues removed from patients at surgery shall be macroscopically, and if necessary, microscopically examined by the pathologist, with the exception of the following tissues and materials, which do not need to be examined by a pathologist:

 

A)        Foreskin, fingernails, toenails, and teeth that are removed during surgery;

 

B)        Bone, cartilage, normal skin and scar tissue that are coincidentally removed during the course of cosmetic or corrective surgery;

 

C)        Cataract lenses that are removed during the course of eye surgery;

 

D)        Foreign substances (e.g., wood, glass, pieces of metal including previously inserted surgical hardware) that are removed during surgery; and

 

E)        Placenta and placental tissue, unless requested by the delivering physician or practitioner.

 

2)         The pathologist is responsible for verifying the receipt of tissues for examinations.

 

3)         A list of tissues which routinely require microscopic examination shall be developed in writing by the pathologist with the approval of the medical staff.

 

4)         A tissue file shall be maintained and include, as a minimum, reports, slides and cross-index.

 

5)         In the absence of a pathologist, there shall be an established plan for sending to a pathologist outside the hospital all tissues requiring examination.  The pathologist may refer tissues to another pathologist for consultation when he deems necessary.

 

h)         Reports of Tissue Examination.  Signed reports of tissue examinations are to be filed with the patient's medical record and duplicate copies are to be maintained.

 

1)         All reports of macro and microscopic examinations performed shall be signed by the pathologist.

 

2)         Provisions are to be made for the prompt filing of examination results in the patient's medical record and notification of the physician requesting the examination.

 

3)         Duplicate copies of the examination reports are to be maintained in a manner which permits ready identification and accessibility.

 

(Source:  Amended at 48 Ill. Reg. 450, effective December 20, 2023)

 

Section 250.520  Blood and Blood Components

 

Facilities for procurement, safekeeping and necessary pretransfusion procedures for blood and blood components shall be provided or readily available.

 

a)         The hospital shall maintain, as a minimum, blood storage facilities under adequate control and supervision of the pathologist or other authorized physician.

 

b)         For emergency situations the hospital maintains at least a minimum blood supply in the hospital or can obtain blood quickly from community blood banks or institutions, or has an up-to-date list of donors and equipment necessary to bleed them.

 

c)         Where the hospital depends on outside blood banks, there shall be an agreement governing the procurement, transfer and availability of blood which is reviewed and approved by the medical staff, administration and governing body.

 

d)         There shall be provision for prompt blood typing and cross-matching, and for laboratory investigation of transfusion reactions, either through the hospital or by arrangements with others on a continuous basis, under the supervision of a physician licensed to practice medicine in all its branches in Illinois.

 

e)         A committee of the medical staff or its equivalent shall review all transfusions of blood or blood components and make recommendations concerning policies governing such practices.

 

f)         The review committee shall investigate all transfusion reactions occurring in the hospital and make recommendations to the medical staff.

 

(Source:  Amended at 18 Ill. Reg. 11945, effective July 22, 1994)

 

Section 250.525  Designated Blood Donor Program

 

a)         Each hospital shall establish and operate a designated blood donor program which allows a recipient of blood to designate a donor of his choice for purpose of receiving red blood cells. Policies and procedures which are followed in the operation of the program must be approved and reviewed at least annually by the medical staff or its designated subcommittee. The program must be consistent with the requirements of this Section.

 

b)         The program shall allow designated blood donations when at least the following conditions are met:

 

1)         The recipient, or a representative of the recipient, has solicited the donor or donors;

 

2)         The designated donor or donors have consented to the donation;

 

3)         The designated donor or donors meet the qualifications for donor selection adopted by the Department of Public Health under the Blood Labeling Act (See 77 Ill. Adm. 460.130);

 

4)         The blood of the designated donor or donors is compatible with the medical needs of the recipient (See 77 Ill. Adm. Code 460.140); and

 

5)         The blood of the designated donor or donors can be obtained in sufficient time to meet the medical needs of the recipient.

 

c)         The hospital shall insure that designated blood donations are properly labeled, stored, screened and reserved for the designated recipient (See 77 Ill. Adm. Code 460). Designated blood donations which are not used for the designated recipient within seven days of donation may be used for any other medically appropriate purpose.

 

(Source:  Amended at 15 Ill. Reg. 5328, effective May 1, 1991)

 

Section 250.530  Proficiency Survey Program (Repealed)

 

(Source:  Repealed at 18 Ill. Reg. 11945, effective July 22, 1994)

 

Section 250.540  Laboratory Personnel (Repealed)

 

(Source:  Repealed at 18 Ill. Reg. 11945, effective July 22, 1994)

 

Section 250.550  Western Blot Assay Testing Procedures (Repealed)

 

(Source:  Repealed at 18 Ill. Reg. 11945, effective July 22, 1994)

SUBPART F: RADIOLOGICAL SERVICES

 

Section 250.610  General Diagnostic Procedures and Treatments

 

a)         The hospital shall maintain and provide radiological services sufficient to perform and interpret the radiological examinations necessary for the diagnosis and treatment of the various types of patients, to the extent that the complexity of services are commensurate with the size, scope and nature of the hospital. Additional required services shall be provided by shared services or referral of patients.

 

b)         The physician responsible for the direction of a radiological department or service shall be board certified or eligible for certification by the American Board of Radiology or equivalent.  The physician shall have a written agreement with the hospital to direct the radiological services on a full-time, part-time or consulting basis and be an approved member of the medical staff.  The responsibilities of the physician shall be identified in the hospital's Policy and Procedure Manual or other document.

 

c)         Radiological facilities shall comply with Sections 250.2440(c)(3) or 250.2630(c)(3).

 

d)         Technicians employed in the radiological services shall be accredited pursuant to 32 Ill. Adm. Code 401 as appropriate and have had sufficient training and experience to carry out the procedures safely and efficiently commensurate with the size, scope and nature of the service.  A procedure and means for evaluating qualifications shall be established and used.  (Refer to Section 250.410 and 32 Ill. Adm. Code 401.)

 

e)         Each general hospital shall provide for emergency radiological services at all times.  (Refer to Section 250.710.)

 

f)         Complete signed reports of the radiological examinations shall be made part of the patient's record and duplicate copies kept in the radiological department for a period of time established by the hospital.

 

g)         Written reports of each radiological interpretation, consultation and treatment shall be signed by the physician responsible for conducting the procedure and shall be a part of the patient's medical record.  Maintenance and filing of records shall be coordinated with direction and supervision by the medical record administrator. (Refer to Section 250.1510.)

 

h)         Hospital X-ray or Roentgen Photographs shall be retained in accordance with the X-Ray Retention Act, which requires retention for five years and longer when notification of litigation is received.

 

i)          X-ray or roentgen photographs or treatments of therapy shall be given only on an order for treatment in accordance with Section 250.330.

 

j)          Radiological facilities operated by a hospital constitute a "radiation installation" within the meaning of the Radiation Protection Act of 1990 and are required to be registered with the Illinois Emergency Management Agency, Division of Nuclear Safety.

 

k)         Every radiation therapy service shall be integrated into a comprehensive program for total cancer care.  Radiation therapy service shall be available in coordination with other institutions or agencies for the necessary supportive services.

 

(Source:  Amended at 47 Ill. Reg. 6477, effective April 27, 2023)

 

Section 250.620  Radioactive Material

 

Radioactive material, whether for diagnostic or therapeutic purposes, shall be received, handled, used, and disposed of pursuant to the Radiation Protection Act of 1990 and the regulations promulgated thereunder.

 

(Source:  Amended at 47 Ill. Reg. 6477, effective April 27, 2023)

 

Section 250.630  General Policies and Procedures Manual

 

Each radiological department or department in charge of an identified distinct radiological service shall prepare and maintain a policies and procedures manual.  It shall be reviewed and updated annually.  It shall include but not be limited to provisions for the following identified requirements:

 

a)         The hospital shall establish and enforce safety policies that will protect both patient and radiological worker from excessive or stray radiation in accordance with the Radiation Protection Act of 1990 and the regulations promulgated thereunder.

 

b)         Personnel Monitoring shall be performed pursuant to 32 Ill. Adm. Code 340.210 and 340.520.

 

1)         Procedures for personnel monitoring shall be maintained for each individual working in the area of radiation where there is a reasonable possibility an individual will exceed 10% of annual limit.

 

2)         Personnel monitoring records resulting from the use of film badges or dosimeters must be maintained. Readings must be on at least a quarterly basis.

 

3)         Upon termination of employment, each worker shall be provided with a summary of the worker's exposure record.

 

4)         Permanent records of exposure on all monitored personnel shall be maintained for review by surveyors for licensing.

 

c)         Monthly and yearly reports shall be maintained on the number of examinations done and kinds of treatment given.

 

d)         The use of all radiological apparatus shall be limited to personnel designated as qualified by the physician responsible for the direction and supervision of the department or service.  Qualified personnel shall comply with the Radiation Protection Act of 1990 and the regulations promulgated thereunder, specifically 32 Ill. Adm. Code 401.  The use of fluoroscopes shall be limited to persons licensed under the Medical Practice Act of 1987, the Illinois Dental Practice Act, or the Podiatric Medical Practice Act of 1987, and to personnel who meet the requirements in 32 Ill. Adm. Code 360.50(n)(1) through (4).

 

e)         Radiological personnel accredited pursuant to 32 Ill. Adm. Code 401 shall participate in continuing education pursuant to 32 Ill. Adm. Code 401.140.  Physicians shall participate in training pursuant to Subpart J of 32 Ill. Adm. Code 335 as applicable.  The continuing education shall be documented.

 

f)         At all times, there shall be reasonable privacy for the radiological patient relative to dressing, evacuation, and the study being performed.

 

g)         The hospital must develop and maintain written safety policies for the radiological services to protect patients and personnel.  These policies must relate to radiation pursuant to the Radiation Protection Act and the regulations promulgated thereunder, electrical and mechanical hazards, prevention and containment of fire and explosion, and prevention and treatment of any untoward reaction to contrast media.

 

h)         The hospital must enforce written policies and procedures for the radiological services that relate to the management of critically ill patients and to the administration of diagnostic agents by nonphysicians.

 

i)          When qualified personnel are permitted to administer diagnostic agents intravenously for radiological evaluations, the hospital shall develop and enforce written safety guidelines specifying which individuals have this authority and whether a physician shall be physically present or immediately available, in accordance with 32 Ill. Adm. Code 360.50(n)(1) through (4).  If radioactive materials are being administered, accreditation and supervision rules apply.  Refer to 32 Ill. Adm. Code 335.1050.

 

j)          There must always be an emergency drug tray in the room or immediately available where parenteral diagnostic agents for radiologic evaluations are being administered.  The hospital must maintain a system for maintaining an emergency drug tray with no outdated medications or missing items, and to ensure that the tray's content is appropriate.  Oxygen, airways, syringes and needles, intravenous administration sets, and appropriate parenteral solutions shall be available at all times.

 

k)         Policies and procedures for the administration of radiological drugs shall be coordinated with and approved by the Pharmacy and Therapeutics Committee.  (Refer to Subpart R Section 250.2140).

 

l)          Written safety policies must provide for the steps to be followed in the event of a spill of radioactive material pursuant to Subpart M of 32 Ill. Adm. Code 340; for specific authority for any nonphysician qualified personnel who administer radioactive material intravenously pursuant to 32 Ill. Adm. Code 335.1050; for the recording of cumulative radiation exposure of all personnel pursuant to 32 Ill. Adm. Code 340.1160 and 340.520; a requirement for protective security from all radioactive areas for all unauthorized personnel pursuant to Subpart G of 32 Ill. Adm. Code 340 and 32 Ill. Adm. Code 340.810; and the establishment of a radiation protection survey at least once per week pursuant to 32 Ill. Adm. Code 335.2080 if applicable.

 

m)        Instrument logbooks maintained by radiological services must include calibration records of equipment and monitors, maintenance and repair records, and the findings of outside evaluators (if used), with the corrective action taken pursuant to 32 Ill. Adm. Code 340.1130.

 

n)         Requests by attending members of the medical staff for radiological examinations must contain a concise statement of the reason for the examination.

 

(Source:  Amended at 47 Ill. Reg. 6477, effective April 27, 2023)

SUBPART G: EMERGENCY SERVICES

 

Section 250.710  Classification of Emergency Services

 

a)         Each hospital, except long-term acute care hospitals and rehabilitation hospitals identified in Section 1.3 of the Hospital Emergency Service Act and in subsection (c) of this Section (Section 1 of the Hospital Emergency Service Act), shall provide emergency services according to one of the following categories:

 

1)         Comprehensive Emergency Treatment Services

 

A)        At least one licensed physician shall be in the emergency department at all times.

 

B)        Physician specialists who represent the major specialties and sub-specialties, such as plastic surgery, dermatology and ophthalmology, shall be available within minutes.

 

C)        Ancillary services, including laboratory and x-ray, shall be staffed at all times.  The pharmacy shall be staffed or on call at all times.

 

2)         Basic Emergency Treatment Services

 

A)        At least one licensed physician shall be in the emergency department at all times.

 

B)        Physician specialists who represent the specialties of medicine, surgery, pediatrics and obstetrics shall be available within minutes.

 

C)        Ancillary services, including laboratory, x-ray and pharmacy, shall be staffed or on call at all times.

 

3)         Standby Emergency Treatment Services

 

A)        A registered nurse on duty in the hospital shall be available for emergency services at all times.

 

B)        A licensed physician shall be on call to the emergency department at all times.

 

b)         All hospitals, irrespective of the category of services provided, shall provide immediate first aid and emergency care to persons requiring first aid emergency treatment on arrival at the hospital.

 

c)         General acute care hospitals designated by Medicare as long-term acute care hospitals and rehabilitation hospitals are not required to provide hospital emergency services described in this Section or Section 1 of the Hospital Emergency Service Act. Hospitals defined in this subsection (c) may provide hospital emergency services at their option.

 

1)         Any hospital defined in this subsection (c) that opts to discontinue or otherwise not provide emergency services shall:

 

A)        Comply with all provisions of the federal Emergency Medical Treatment and Labor Act (EMTALA);

 

B)        Comply with all provisions required under the Social Security Act;

 

C)        Provide annual notice to communities in the hospital's service area about available emergency medical services; and

 

D)        Make educational materials available to individuals who are present at the hospital concerning the availability of medical services within the hospital's service area.

 

2)         Long-term acute care hospitals that operate standby emergency services as of January 1, 2011 may discontinue hospital emergency services by notifying the Department. Long-term acute care hospitals that operate basic or comprehensive emergency services must notify the Health Facilities and Services Review Board and follow the appropriate procedures. (Section 1.3 of the Hospital Emergency Service Act)

 

3)         Any rehabilitation hospital that opts to discontinue or otherwise not provide emergency services shall comply with subsection (c)(1), shall not use the term "hospital" in its name or on any signage, and shall notify in writing the Department, the Health Facilities and Services Review Board, and the Division of Emergency Medical Services and Highway Safety of the discontinuation. (Section 1.3 of the Hospital Emergency Service Act)

 

A)        "Signage" means any signs or system of signs affixed to, adjacent to, or directing the public to the hospital, including but not limited to informational road signs.

 

B)        Signage does not include materials for advertising, licensure, certification or patient referral materials.

 

(Source:  Amended at 39 Ill. Reg. 13041, effective September 3, 2015)

 

Section 250.720  General Requirements

 

a)         Each hospital shall provide adequate facilities for the provision of immediate life saving measures.

 

b)         Policies and procedures governing the acceptance and care of emergency patients shall be established.  These shall be in accordance with the category of emergency services established in the hospital.  Specific policies shall be adopted and implemented in regard to rendering emergency care in the hospital's emergency department, in the hospital but away from the emergency department, and within proximity to the hospital.  In developing these policies, the hospital shall take into consideration any available national or state guidelines on the standard of practice in this area.  These policies shall be included as a part of any initial employee orientation/training and shall be reviewed annually with staff.

 

c)         An appropriate record shall be maintained on each patient who presents for emergency services.

 

d)         Appropriate supplies and equipment shall be available and ready for use.

 

e)         This Section shall not be construed to affect hospital-patient arrangements regarding payment for care.

 

f)         Hospitals providing obstetric services shall have a written policy and conduct continuing education yearly (calendar) for providers and staff of obstetric medicine, and of the emergency department, and other staff that may care for pregnant or postpartum women.  The written policy and continuing education shall include yearly educational modules regarding management of severe maternal hypertension and obstetric hemorrhage and other leading causes of maternal mortality for units that care for pregnant or postpartum women.  Hospitals providing obstetric services shall demonstrate compliance with these written policy, education, and training requirements. (Section 2310-222(b) of the Department of Public Health Powers and Duties Law)  (See also Section 250.1830(n) and (o)).

 

g)         A REH shall have an agreement with at least one licensed and Medicare-certified hospital that is a level I or level II trauma center for the referral and transfer of patients requiring emergency medical care beyond the capabilities of the REH.

 

(Source:  Amended at 47 Ill. Reg. 14455, effective September 26, 2023)

 

Section 250.725  Notification of Emergency Personnel

 

a)         For purposes of this Section:

 

1)         "Emergency Services Provider Agency" means any entity which used vehicles, personnel and equipment for the prehospital or interhospital transportation and care of patients requiring emergency care of life support services in conformance with the provisions of the Emergency Medical Services (EMS) Systems Act (Ill. Rev. Stat. 1987, ch. 111˝, pars. 5501 et seq., as amended ).

 

2)         "Paramedic" means an emergency medical technician-paramedic certified by the Department pursuant to Section 4.13 of the Emergency Medical Services (EMS) Systems Act (Ill. Rev. Stat. 1987, ch. 111˝, par. 5504.13, as amended ).

 

3)         "Ambulance Personnel" means any person employed by an emergency services provider agency who is or was involved in the prehospital or interhospital transportation and care of a patient requiring emergency care or life support services as an ambulance crew member, including the vehicle driver.

 

b)         Each hospital shall establish procedures for notifying police officers, paramedics and ambulance personnel who have provided, or are about to provide, emergency care or life support services to a patient who has been diagnosed as having a dangerous communicable or infectious disease. The procedures shall include at a minimum the requirements of this Section.

 

c)         Notification shall be required for the following diseases:

 

1)         Rubella (including congenital rubella syndrome)

 

2)         Measles

 

3)         Tuberculosis

 

4)         Invasive meningococcal infections (meningitis or meningococcemia)

 

5)         Mumps

 

6)         Chickenpox

 

7)         Herpes Simplex

 

8)         Diphtheria

 

9)         Rabies (human rabies)

 

10)         Anthrax

 

11)         Cholera

 

12)         Plague

 

13)         Polio (Poliomyelitis)

 

14)         Hepatitis B

 

15)         Typhus (louse-borne)

 

16)         Smallpox

 

17)         Hepatitis non-A, non-B

 

18)         Acquired Immunodeficiency Syndrome (AIDS)

 

19)         AIDS-related complex (ARC)

 

20)         Human Immunodeficiency Virus (HIV) Infection

 

d)         The hospital shall send a letter notification to the emergency services provider agency within 72 hours after the hospital receives actual knowledge of a confirmed diagnosis of any of the diseases listed in subsection (c) of this Section, other than AIDS, ARC or HIC infection, of any patient who has been transported to the hospital by police officers, paramedics or ambulance personnel.

 

e)         In the case of a confirmed diagnosis of AIDS, ARC, or HIV infection, the hospital shall send a letter of notification to the emergency services provider agency within 72 hours only if one or both of the following conditions exist:

 

1)         The police officers, paramedics or ambulance personnel have indicated on the ambulance run sheet that a reasonable possibility exists that they have had blood or body fluid contact with the patient.

 

2)         The hospital has reason to know of a possible exposure of the police officers, paramedics or ambulance personnel to the blood or body fluids of the patient.

 

f)         Letters of notification shall be sent to the designated contact at the emergency services provider agency listed on the ambulance run sheet and shall include at least the following information. Such notification letters shall not include the name of the patient or any patient-identifying information.

 

1)         The names of the police officers, paramedics, ambulance personnel, and other crew members listed on the ambulance run sheet,

 

2)         The patient's diagnosed disease,

 

3)         The date the patient was transported,

 

4)         A statement that this information shall be maintained as a confidential medical record (See 77 Ill. Adm. Code 697.140), and

 

5)         A statement that upon receipt of the notification letter, the provider agency shall contact all personnel involved in the prehospital or interhospital care and transport of the patient.

 

g)         Upon discharge of a patient with a communicable disease listed in subsection (c) of this Section or below to ambulance personnel, the hospital shall notify the ambulance personnel of appropriate precautions against the communicable disease, but shall not identify the name of the disease.

 

1)         Typhoid fever

 

2)         Amebiasis

 

3)         Shigellosis

 

4)         Salmonellosis

 

5)         Giardiasis

 

6)         Hepatitis A

 

h)         The hospital may take any additional measures which it considers necessary or useful to notify police officers, paramedics or ambulance personnel of possible exposure to any communicable disease. However, such measures shall not violate the confidentiality of the medical record of the patient, or conflict with the provisions of this Section. (Section 6.08 of the Act)

 

(Source:  Amended at 15 Ill. Reg. 5328, effective May 1, 1991)

 

Section 250.730  Community or Areawide Planning

 

a)         Hospitals may participate in a community or areawide plan which provides for hospital emergency services.

 

b)         The primary participating hospital in any community or areawide plan for hospital emergency services must meet the requirements of either Comprehensive Emergency Treatment Services or Basic Emergency Treatment Services.

 

c)         The community or areawide plan for providing hospital emergency services shall be approved by this Department prior to being placed in operation.  Such approval shall be based on compliance with the following requirements:

 

1)         A precise definition of the geographical area to be served shall be incorporated in the plan.

 

2)         A written agreement endorsed by all hospitals participating in the plan shall be signed by the authorized officer(s) of the respective Boards, Medical Staffs and Administrative Officials of all hospitals participating in the plan.

 

3)         Review comments on the value of the plan shall be obtained from all existing local and/or areawide health facilities' planning agencies recognized by the Department and they shall be requested to submit their comments to the Department.  A review of the plan and appropriate comments shall also be obtained from local public authorities and groups involved in emergency services, including Fire Departments, Police Departments, providers of ambulance service, medical societies, local Public Health Departments and other appropriate organizations.

 

4)         There shall be established an areawide hospital emergency services' committee that accepts responsibility for implementation of the plan and the formulation of policies that affect the plan.  This Committee shall perform an annual review of the plan, but shall also be available for more frequent review and consultation of the overall plan when indicated.  The committee shall include representatives from Medical Staffs, Nursing Departments and Hospital Administrations from the hospitals included in the plan. All participating hospitals shall have an administrative representative as a member of this committee if not otherwise represented.

 

5)         The plan shall state which hospital emergency services will be provided, the category of the primary participating hospital and the services to be provided in each participating hospital covered by the plan.  The plan shall include a commitment to provide twenty-four hour Hospital Emergency Services to all people in the service area in need of emergency treatment regardless of economic and ethnic status.

 

6)         A call list of physicians, both generalists and specialists, available to give care in any type of emergencies, shall be established and maintained.  The list shall be consistent with the requirements of the category of the primary participating hospital.

 

7)         The plan shall provide for inter-hospital transfer of patients for both specialized and routine emergencies.  The arrangements shall include the necessary transfer of patients' records and treatment information.

 

8)         Pre-transfer communication between the referring and receiving hospitals and physicians shall be provided.  The plan shall make provisions for immediate communication with fire, police, ambulance and other involved local public authorities.

 

9)         Provisions for transportation of the sick and injured shall be made.

 

10)         An ongoing plan of information to the public of available hospital emergency services and how they can most quickly be obtained shall be established.  The statement should specify clearly where (at what hospital) and how routine and specialized services can be obtained within the service area, seven days a week, twenty-four hours a day.

 

11)         Provisions shall be made for the specialized training and in-service education needed by all personnel involved in providing hospital emergency services under the plan. Consideration shall be given as to how to provide the training and education.

 

(Source:  Amended at 12 Ill. Reg. 15080, effective October 1, 1988)

 

Section 250.740  Disaster and Mass Casualty Program

 

a)         Each hospital shall, through joint effort of governing board, administrator, medical staff, and hospital personnel, have and maintain a disaster and mass casualty program.  Such program shall, in all instances, be worked out in cooperation with the other hospitals of the area and with official and non-official agencies concerned.  This program shall include the possibility of disaster involving loss of the hospital or serious impairment of its facilities.

 

b)         In instances where hospitals are participating in an areawide plan for hospital emergency services, the plan shall include responsibilities to be shared for a disaster and mass casualty program.

 

Section 250.750  Medical Forensic Services for Sexual Assault Survivors

 

a)         All hospitals providing emergency services shall render care to victims of sexual assault.  The care shall be in accordance with 77 Ill. Adm. Code 545.55 (Treatment and Transfer of Pediatric Sexual Assault Survivors), 77 Ill. Adm. Code 545.60 (Treatment of Sexual Assault Survivors), 77 Ill. Adm. Code 545.63 (Treatment Hospital with Pediatric Transfer), and 77 Ill. Adm. Code 545.65 (Transfer of Sexual Assault Survivors).

 

b)         A hospital may fulfill its obligation to provide medical forensic services to sexual assault victims by participating in an areawide plan for emergency service in accordance with 77 Ill. Adm. Code 545.50 (Areawide Sexual Assault Treatment Plans).

 

c)         Pursuant to, but not limited to, Sections 7 and 7.5 of the Sexual Assault Survivors Emergency Treatment Act, a hospital shall not seek payment from a sexual assault survivor who presents at a hospital for medical forensic services.  If the Department becomes aware that a sexual assault survivor has been billed for treatment, the Department will refer the matter to the Office of the Attorney General for enforcement.

 

d)         The hospital shall provide a sexual assault survivor with a sexual assault services voucher.  For the purposes of this Section, a sexual assault services voucher is a document generated by a hospital at the time the sexual assault survivor receives outpatient medical forensic services that may be used to seek payment for any ambulance services, medical forensic services, laboratory services, pharmacy services, and follow-up healthcare provided as a result of the sexual assault.  (Section 1a of the Sexual Assault Survivors Emergency Treatment Act)

 

(Source:  Amended at 44 Ill. Reg. 18379, effective October 29, 2020)

SUBPART H: RESTORATIVE AND REHABILITATION SERVICES

 

Section 250.810  Applicability of Other Parts of These Requirements

 

All other Parts of these requirements are applicable with the exception of Subparts O, Q and S and as otherwise amended and modified by this Part.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.820  General

 

In setting forth the regulations for Restorative and Rehabilitation Services, it is recognized that there are several "levels," or degrees of comprehensiveness, that can be provided by a facility.  Just what level is to be provided should be a function of such factors as: perceived need; hospital size and location; financial feasibility; and services available elsewhere within the community.  It is important that each hospital select in writing the level of restorative or rehabilitation services which it will provide in accord with license.  Those levels not provided directly by the hospital must be made accessible to every patient through formal referral mechanisms or contractual arrangements.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.830  Classifications of Restorative and Rehabilitation Services

 

a)         Basic rehabilitation (restorative) services – This level must be provided by all hospitals and includes at least restorative nursing, medical management and administrative services;

 

b)         Physical rehabilitation services – In addition to basic restorative services, this level must include the provision for at least physical therapy and social services. It is recommended that occupational therapy and speech therapy be available.

 

c)         Comprehensive physical rehabilitation services – This level of services must be provided in a distinct, clearly defined, special unit, of an acute care hospital, or in a special referral hospital.  This scope of services provided must include, but is not limited to, the services of members of the medical staff, rehabilitation nursing, physical therapy, occupational therapy, speech therapy, social services, psychology, vocational counseling and nutritional counseling.  It is recommended that correctional therapy be available.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.840  General Requirements for all Classifications

 

Regardless of the selected level of services to be provided by each hospital, every hospital shall provide an identifiable, active restorative or rehabilitation program with written goals of assisting each patient to achieve and maintain their optimal level of self-care and independence.  The program shall include coordinated health services utilizing the team approach.  It shall meet the following requirements:

 

a)         Effective written policies and procedures relating to the program organization, function, casefinding, follow-up and appropriate referral mechanisms.  These policies and procedures shall be developed by representatives of all health professions participating in the program, particularly as they relate to their specialties.

 

b)         A clear indication of physical, philosophical and economic support of the program through:

 

1)         An identifiable program of quality assurance involving action by a patient care and/or utilization review committee to assist in implementing program services as needed, including provision of the time required to achieve restorative or rehabilitation goals. The committee shall include physicians and representatives of allied health professions within the hospital.

 

2)         Access to restorative and rehabilitation services for all patients requiring such care regardless of the service to which the patient is assigned.  If needed levels of rehabilitation service are not available in-house, formal referral mechanisms or contractual arrangements to obtain appropriate services must be in evidence.

 

3)         A budget that is adequate for necessary program personnel, equipment and facilities.

 

c)         Physician direction of coordinated individual patient care through written orders and assistance in establishing and attaining treatment objectives.

 

d)         Involvement of all appropriate health care professionals in the development and implementation of each patient's care plan.  This shall be accomplished through formal patient-care conferences, or other established methods of interaction between the physicians and allied health professionals.

 

e)         Documentation of the patient's response to treatment by all health-care professionals involved in carrying out the patient's care plan.  This shall be part of the ongoing medical record.

 

f)         Restorative nursing provided on a 24-hour, seven-day-a-week basis.

 

g)         Adequate space and equipment to provide treatment offered through the program.

 

h)         Regularly scheduled departmental and interdisciplinary in-service education, embracing program orientation, skill-training and continuing education regarding the restorative and rehabilitation process. Representatives of all professions involved in the program should be given the opportunity of performing the "teaching" function.

 

i)          Establishment of safety policies in the selection, use and maintenance of patient-care equipment.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.850  Specific Requirements for Comprehensive Physical Rehabilitation Services

 

a)         Treatment shall be multidisciplinary, intensive, time-limited, goal-oriented, integrated and coordinated.

 

b)         The multidisciplinary treatment team shall function under the direction of a physiatrist for each patient.  The team shall meet on a scheduled basis to review evaluations, to set treatment plans and objectives, to review patient response to treatment and to plan discharge and follow-up.  A physician qualified by education and experience in physical rehabilitation may act as team leader until a physiatrist is available.

 

c)         The patient, and wherever possible, the family or significant others, should be actively involved in planning and goal-setting.  The patient is actively involved in treatment.

 

d)         Evaluation and treatment planning should be geared to the "whole person," with the primary objectives of reducing disability and dependence in activities of daily living, concurrent with the promotion of optimal personal adjustment in psychological, social, emotional, spiritual and economic dimensions.

 

e)         Extensive pre-admission screening must be conducted to assess the patient's need for this level of service.

 

f)         In addition to restorative nursing, rehabilitation nursing must be provided on a daily basis.

 

g)         Program shall include at least access to vocational assessment, training and placement.  This is often done in conjunction with state-operated vocational rehabilitation services.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.860  Medical Direction

 

a)         Basic rehabilitation (restorative) services – The attending medical staff member shall provide written orders for care, including treatment objectives.

 

b)         Physical Rehabilitation

 

1)         Facilities identifying themselves under this category shall regularly provide medical participation through:

 

A)        A qualified physiatrist

 

B)        A physician qualified by training and/or experience in physical rehabilitation; or

 

C)        A formally designated group of physicians from various specialties usually associated with physical rehabilitation (e.g. orthopedics, neurology, neurosurgery, etc.).

 

2)         The physician(s) shall meet on a regular basis with representatives of the professions involved in patient-care to discuss patient evaluations, set objectives, report patient response to treatment and to plan discharges and follow-up care where appropriate.

 

c)         Comprehensive Physical Rehabilitation Unit or Hospital –

            Facilities identifying themselves under this category shall provide patient-care under the direction of a physiatrist.  A physician fully qualified by education and experience in physical rehabilitation may provide patient care direction until a physiatrist is available.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.870  Nursing Care

 

a)         Facilities providing basic rehabilitation (restorative) care shall include rehabilitation concepts in their orientation program.  Basic restorative care shall be evidenced in the patient care plan.  (Refer to Subpart I.)

 

b)        

1)         Facilities providing physical rehabilitation services shall have available a person who by education or training may provide consulting services in rehabilitation nursing.

 

2)         The consultant shall meet on a regular basis with representatives of the nursing staff and document staff participation.

 

c)        

1)         Facilities providing comprehensive physical rehabilitation services shall have clinical specialists available on the staff.

 

2)         It is recommended that all nursing staff receive adequate training in rehabilitation nursing through initial orientation training, on-going in-service education and by attending accredited workshops, seminars and training programs.

 

3)         Patient care plans should include appropriate inputs from other allied health professionals.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.880  Additional Allied Health Services

 

a)         Restorative and physical rehabilitation programs may include, but are not limited to, any or all of the following specialty services:

 

1)         Diagnostic and/or treatment services of physicians

 

2)         Nursing services

 

3)         Physical Therapy services

 

4)         Occupational Therapy services

 

5)         Speech Therapy Services

 

6)         Social services

 

7)         Psychology services

 

8)         Vocational services

 

9)         Audiology services

 

10)         Prosthetic services (including biomedical engineering services)

 

11)         Orthotic services (including biomedical engineering services)

 

12)         Religious/spiritual services

 

13)         Recreational Therapy services

 

14)         Podiatric services

 

15)         Nutritional Counseling services

 

16)         Education services

 

17)         Dental services

 

18)         Optometric services

 

19)         Inhalation Therapy services

 

20)         Corrective Therapy

 

b)         These services shall be provided under the supervision of professionals, fully qualified by education and experience, and holding a state license, or state or national certification or registration where applicable.

 

c)         Each allied health service shall have documented in the medical chart patient assessment, care plans, objectives and follow-up plans, and shall provide evaluative, therapeutic and follow-up programs, working in coordination with other services, under the overall direction of an appropriately qualified physician, for the purpose of maximizing patient self-care and independence.

 

d)         It is recommended that hospitals provide appropriate, current and accessible reference materials as guides for the specific restoration services offered.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.890  Animal-Assisted Therapy

 

a)         Animal-assisted therapy programs may be established in hospitals if the boarding and grooming location of the animals is separate and distinct from patient care units and the presence of the animals is part of a special program established in accordance with this Section.

 

b)         The hospital's Medical Staff and Infection Control Committee shall approve an animal-assisted therapy program prior to operation of the program.

 

c)         The Infection Control Committee and Medical Staff shall develop written policies and procedures for operation of the animal-assisted therapy program, including, but not limited to, the following.  All policies and procedures shall be developed in accordance with the Guidelines of the Centers for Disease Control and Prevention titled "Guidelines for Environmental Infection Control in Health-Care Facilities:  Recommendations – Animals in Health Care Facilities" (see Section 250.160). 

 

1)         Designation of a department within the hospital that will be responsible for operation and establishment of the animal-assisted therapy program (e.g., Volunteer Services).

 

2)         Development of written goals and objectives for the program.

 

3)         Policies governing sanitation, infection control and care and grooming of animals, including veterinary care.

 

4)         Certification and training requirements for animals, animal handlers and hospital staff.

 

5)         Policies for patient screening and assessment for participation in animal-assisted therapy.

 

6)         Policies governing areas in the hospital where animals are permitted and prohibited, including whether therapy will be held in a public area of the hospital or in the patients' rooms.

 

7)         Policies for determining the length of therapy sessions.

 

8)         Policies governing the types of animals that will be permitted to participate in the program.

 

9)         Policies governing patient safety and incidents of biting, scratching or other behavior, and including reporting requirements and patient care.

 

10)         Policies governing patient consent requirements for participation in the program, for both adult and child patients.

 

d)         Records shall be kept for each patient who participates in the program and shall be available for review by Department staff.

 

e)         All animal-assisted therapy sessions shall be prescheduled and approved in advance by the patient's physician and hospital staff who are responsible for the program.

 

f)         If a therapy animal is to be boarded overnight in the hospital, the hospital shall establish, in addition to the infection control requirements of this Section, policies governing the location in the hospital where the animal will board.  A hospital staff member who has had training for this responsibility shall be responsible for the care and management of the animal during the time that the animal is boarding.

 

g)         Therapy animals shall be accompanied at all times that the animal is in the hospital by a volunteer or staff member who is familiar with and capable of controlling the animal's behavior.

 

h)         The animal-assisted therapy program shall be evaluated annually in a written report to the Infection Control Committee.

 

(Source:  Added at 32 Ill. Reg. 14336, effective August 12, 2008)

SUBPART I: NURSING SERVICE AND ADMINISTRATION

 

Section 250.910  Nursing Services

 

The hospital shall provide an organized nursing service.

 

a)         Nursing Services – General Provisions

 

b)         The hospital shall maintain a staff of nursing personnel organized to provide the nursing care for its patients commensurate with the size, scope and nature of the hospital.

 

c)         Director of Nursing Administration

 

1)         The nursing service shall be under the direction of a registered professional nurse who has qualifications in nursing administration and who has the ability to organize, coordinate, and evaluate the service.

 

2)         The Nursing Administrator (Director of Nursing) shall be a registered professional nurse who holds a degree in nursing or has documented experience and relevant continuing education.  He/She shall be employed full-time within the hospital as director of the nursing administration.

 

3)         The Nursing Administrator shall be accountable to the Chief Executive Officer or designate for developing and implementing policies and procedures of the service and for the nursing practice.

 

4)         The Nursing Administrator should have authority over the selection, promotion and retention of nursing personnel based on established job descriptions.

 

d)         Assistants to the Nursing Administrator.

            A qualified registered nurse shall be designated and authorized to act in the absence of the nursing administrator on a 24 hour basis.

 

e)         Nursing Staff.

 

1)         A sufficient number of registered professional nurses shall be on duty at all times to assess, plan, assign, supervise, and evaluate nursing care and provide patients such nursing care for which the judgement and specialized skills of a registered nurse is required.

 

2)         Licensed practical nurses and other nursing personnel shall be qualified through training, education, and experience, and shall have demonstrated abilities to give nursing care that does not require the skill and judgement of a registered professional nurse.  Auxiliary nursing personnel shall be assigned and supervised by a professional nurse and shall be given only those duties for which they are trained.

 

3)         The number of registered professional nurses, licensed practical nurses and other nursing personnel assigned to each patient care unit shall be consistent with the types of nursing care needed by the patients and the capabilities of the staff.  Patients on each unit shall be evaluated near the end of each change of shift by criteria developed by the nursing service.

 

4)         Specific staffing requirements for particular units shall be followed as stated in other sections of this Part.

 

f)         Staffing Standards.

 

1)         There shall be staffing schedules reflecting actual nursing personnel required for the hospital and for each patient unit.  Staffing patterns shall reflect consideration of nursing goals, standards of nursing practice, and the needs of the patients.

 

2)         Staffing schedules shall accomplish the following:

 

A)        Identification of the nurse in charge of the patient care unit.

 

B)        Assignment of personnel in a manner which gives consideration to patient care plans and minimizes the risk of cross-infections.

 

C)        Projection of future time schedules indicating assignment of personnel by name, status, date and duty tour.

 

D)        Time schedules shall be kept in detail, indicating the assignment of nursing personnel by name, status, date, patient care unit, and duty tour.  Actual time reports shall be kept verifying personnel attendance by name date, patient care unit, and time of actual attendance.

 

(Source:  Added at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.920  Organizational Plan

 

a)         A written organizational plan of nursing services shall be an integral part of the overall hospital organizational plan and shall be available to all nursing personnel.

 

b)         The nursing service organizational plan shall:

 

1)         be reviewed annually, revised as necessary and dated to indicate the time of last review;

 

2)         indicate the lines of communication within and between nursing services;

 

3)         define the relationship of nursing services to other services and departments of the hospital, both administrative and professional;

 

4)         include a written statement which defines the role and responsibility of both the nursing service and the education program if the hospital provides clinical facilities for the education and training of nursing students.

 

c)         Nursing service goals shall be identified, reviewed annually and made available to all nursing personnel.

 

(Source:  Added at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.930  Role in hospital planning

 

Planning, decision making, and formulation of policies that affects the operation of the nursing service, the care of patients, or the environment of patients shall include nursing service representatives, and their recommendations shall be considered.

 

(Source:  Added at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.940  Job descriptions

 

Job descriptions shall be written for each position classification in the nursing services and shall delineate the functions, responsibilities, and qualification for each classification.  Copies of job descriptions shall be available to nursing personnel.

 

(Source:  Added at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.950  Nursing committees

 

Nursing committee(s) shall be formally organized within the nursing department to facilitate the establishment and attainment of the goals and objectives of the nursing service.  The purpose and function of each standing committee shall be defined in the nursing service organizational plan.

 

(Source:  Added at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.960  Specialized nursing services

 

If specialized nursing services are provided for separate clinical departments or patient care units, those services shall be subject to the policies and procedures established pursuant to this Part.

 

(Source:  Added at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.970  Nursing Care Plans

 

a)         There shall be evidence that the nursing service provides safe, efficient, and therapeutically effective nursing care through the planning of the care of each inpatient, and patient in observation, and the effective implementation of nursing care plans.

 

b)         In any case where it is determined that a nursing care plan is not necessary, that decision shall be documented in the patient's record.

 

c)         The nursing care plan for each patient shall be coordinated with their medical management plan and the patient's representative.

 

d)         Each nursing care plan shall, at minimum, indicate:

 

1)         The patient’s problems as identified by the nursing staff and what nursing care is needed;

 

2)         How it can best be accomplished;

 

3)         What methods and approaches are believed likely to be most successful; and

 

4)         What modifications are necessary to ensure the best results.

 

e)         Each nursing care plan shall be initiated upon the admission of the patient to the hospital and shall include a discharge plan.

 

f)         The nursing care plans shall be available to all nursing personnel and shall be reviewed and revised as necessary.

 

g)         Nursing care plans may be considered as a part of and filed with the patient's record.

 

(Source:  Amended at 47 Ill. Reg. 14455, effective September 26, 2023)

 

Section 250.980  Nursing Records and Reports

 

a)         Nursing records and reports which reflect the progress of each patient and the nursing care planned shall be maintained.

 

b)         They shall be pertinent, accurate, and concise so that they contribute to the continuity of patient care.

 

c)         Nursing records and reports shall become part of each patient's medical record.

 

(Source:  Added at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.990  Unusual Incidents

 

a)         A procedure shall be established to investigate any unusual incidents which occur at any time on a patient care unit. (Refer to Subpart B Section 250.210 (g)).

 

b)         The procedure shall include the making and disposition of incident reports.  Notation of incidents having a direct medical effect on a specific patient shall be entered in the medical record of that patient.  (Refer to Subpart R, Section 250.2140 (c)(5).)

 

c)         Each report shall be analyzed and summarized, and corrective action shall be taken if necessary.  Summarized reports shall be available to the Department of Public Health and shall be confidential in accordance with Section 9 of the Licensing Act.

 

d)         Pursuant to Section 3.2(a) of the Criminal Identification Act, if a patient is not accompanied by a law enforcement officer, as soon as treatment allows, a hospital, physician, or nurse shall notify the local law enforcement agency that serves the hospital when it appears that the patient has any injury sustained as a victim of an alleged sexual assault or sustained an injury as a victim of a criminal offense. 

 

1)         In instances of alleged sexual assault, the hospital shall obtain the patient's consent prior to disclosure of the patient's identity to law enforcement and prior to any interview with law enforcement.

 

2)         A hospital, physician, or nurse shall be forever held harmless from any civil liability for their reasonable compliance with the provisions of this Section. (Section 3.2(a)(2) of the Criminal Identification Act)

 

(Source:  Amended at 47 Ill. Reg. 6477, effective April 27, 2023)

 

Section 250.1000  Meetings

 

a)         Meetings of the nursing staff shall be held on a regular basis and proceedings of the meetings shall be recorded.

 

b)         Meetings may be organized consistent with the organizational plan of the nursing service.

 

(Source:  Added at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.1010  Education Programs

 

a)         In an attempt to provide the patient with competent nursing personnel, there shall be continuing education programs and educational opportunities for nursing personnel.

 

b)         The Nursing Service Administrator or designee shall design and implement an educational program to orient new employees and to keep the nursing staff up-to-date on new and expanding programs, techniques, equipment, and concepts of care.  The program shall be planned, scheduled, documented by a written outline of its contents, and evaluated at least annually.

 

c)         The scope and duration of the educational program shall be such as to effectively prepare new and existing personnel.  An orientation program shall be provided for each new nursing service employee.

 

d)         The educational program shall be conducted using resources internal or external to the hospital.  Teaching material and suitable reference shall be supplied as needed for each patient care unit.

 

e)         There shall be documented evidence of the attendance at each meeting.

 

(Source:  Added at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.1020  Licensure

 

a)         A procedure shall be maintained to ensure that nursing personnel for whom licensure is required have valid and current licenses in the State of Illinois.  There shall be a procedure to verify licensure status.

 

b)         The current license and credentials of private duty and agency nurses shall be verified prior to assignment.  The nursing service shall maintain adequate supervision of private duty and agency nurses and shall require that they abide by the appropriate policies, procedures and maintain standards of the hospital and the nursing service.

 

(Source:  Added at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.1030  Policies and Procedures

 

a)         For the purposes of this Section:

 

Health Care Worker means an individual providing direct patient care services who may be required to lift, transfer, reposition, or move a patient. A direct patient care provider is the same as a health care worker.

 

Safe Lifting Equipment and Accessories means mechanical equipment designed to lift, move, reposition, and transfer patients, including, but not limited to, fixed and portable ceiling lifts, sit-to-stand lifts, slide sheets and boards, slings, and repositioning and turning sheets.

 

Safe Lifting Team means at least 2 individuals who are trained in the use of both safe lifting techniques and safe lifting equipment and accessories, including the responsibility for knowing the location and condition of such equipment and accessories. (Section 6.25 of the Act)

 

b)         Nursing policies and procedures shall be developed, reviewed periodically but at least once a year, and revised as necessary by nursing representatives in cooperation with appropriate representatives from administration, the medical staff, and other concerned hospital services or departments.

 

c)         The nursing policies and procedures shall be dated to indicate the time of the most recent review or revision.

 

d)         Written policies shall include, but not be limited to, the following:

 

1)         Criteria pertaining to the performance of special procedures and the circumstances and supervision under which these may be performed by nursing personnel;

 

2)         Communication and implementation of diagnostic and therapeutic orders, including verbal orders, and the responsibility and mechanism for nursing service to obtain clarification of orders when indicated;

 

3)         Administration of medication;

 

4)         Assignments for providing nursing care to patients;

 

5)         Documentation in patients' records by nursing personnel;

 

6)         Infection control, pursuant to Section 250.1100;

 

7)     A policy to identify, assess, and develop strategies to control risk of injury to patients and nurses and other health care workers, associated with the lifting, transferring, repositioning, or movement of a patient. The policy shall establish a process that, at a minimum, includes all of the following:

 

A)        Analysis of the risk of injury to patients and nurses and other health care workers posted by the patient handling needs of the patient populations served by the hospital and the physical environment in which the patient handling and movement occurs;

 

B)        Education and training of nurses and other direct patient care providers in the identification, assessment, and control of risks of injury to patients and nurses and other health care workers during patient handling and on safe lifting policies and techniques and current lifting equipment;

 

C)        Evaluation of alternative ways to reduce risks associated with patient handling, including evaluation of equipment and the environment;

 

D)        Restriction, to the extent feasible with existing equipment and aids, of manual patient handling or movement of all or most of a patient's weight except for emergency, life-threatening, or otherwise exceptional circumstances;

 

E)        Collaboration with, and an annual report to, the nurse staffing committee;

 

F)         Procedures for a nurse to refuse to perform or be involved in patient handling or movement that the nurse in good faith believes will expose a patient or nurse or other health care worker to an unacceptable risk of injury;

 

G)        Submission of an annual report to the hospital's governing body or quality assurance committee on activities related to the identification, assessment, and development of strategies to control risk of injury to patients and nurses and other health care workers associated with the lifting, transferring, repositioning, or movement of a patient;

 

H)        In developing architectural plans for construction or remodeling of a hospital or unit of a hospital in which patient handling and movement occurs, consideration of the feasibility of incorporating patient handling equipment or the physical space and construction design needed to incorporate that equipment;

 

I)         Fostering and maintaining patient safety, dignity, self-determination, and choice, including the following policies, strategies, and procedures:

 

i)          The existence and availability of a trained safe lifting team;

 

ii)         A policy of advising patients of a range of transfer and lift options, including adjustable diagnostic and treatment equipment, mechanical lifts, and provision of a trained safe lifting team;

 

iii)        The right of a competent patient, or guardian of a patient adjudicated incompetent, to choose among the range of transfer and lift options, subject to the provisions of subsection (d)(7)(I)(v);

 

iv)        Procedures for documenting, upon admission and as status changes, a mobility assessment and plan for lifting, transferring, repositioning, or movement of a patient, including the choice of the patient or patient's guardian among the range of transfer and lift options; and

 

v)         Incorporation of such safe lifting procedures, techniques, and equipment as are consistent with applicable federal law; (Section 6.25(b) of the Act)

 

8)         Nursing role in other hospital services, including but not limited to services such as dietary, pharmacy and housekeeping; and

 

9)         Emotional and attitudinal support. (Refer to Section 250.260(b)(1).)

 

e)         A nursing procedure manual shall be developed to provide a ready reference on nursing procedures and a basis for standardization of procedures and equipment in the hospital.

 

f)         Copies of the nursing procedure manual shall be available on the patient care units, to the nursing staff and to other services and departments of the hospital, including members of the medical staff and students.

 

(Source:  Amended at 38 Ill. Reg. 13280, effective June 10, 2014)

 

Section 250.1035  Domestic Violence Standards

 

A hospital licensed under the Act shall comply with the following standards relating to domestic violence (Section 6.01 of the Act) (see Hospital Accreditation Standards (HAS) of the Joint Commission on Accreditation of Healthcare Organizations, Section 250.160):

 

a)         Hospitals shall have policies regarding the identification of possible victims of

 

            abuse.

 

b)         Hospital policies regarding possible victims of alleged or suspected abuse or

 

            neglect shall address patients' special needs relative to the patient assessment

 

process, including consent, evidence collection, notification and release of information to authorities, and referrals to community agencies.

c)         Nothing in this Section requires hospitals to adopt new policies regarding domestic violence if their existing hospital policies meet the requirements of this Section.

 

(Source:  Added at 27 Ill. Reg. 1547, effective January 15, 2003)

 

Section 250.1040  Patient Care Units

 

a)         Facilities

            Patient care units in existence shall comply with patient care unit requirements and recommendations as stated under Subpart U.  When major remodeling is undertaken on such patient care units the requirements of Subpart T shall be met.

 

b)         Patient's Rooms

            All patient rooms shall be in compliance with Subpart T or U of this Part.

 

c)         Isolation Room

            At least one isolation room shall be provided for each hospital in compliance with Subparts T or U of this Part.

 

d)         Special Care Room for Disturbed Patients

            Every hospital shall provide facilities for emergency retention of patients with acute mental illness.  Emergency retention is a temporary measure, usually for less than seventy-two hour duration, and is concerned with the immediate protection of the patient or other persons, or with the prevention of conduct on the part of disturbed persons that appear to be dangerous.  Emergency retention may be provided in a Special Care Room.  The Special Care Room may be used for multiple purposes and may be located in the Emergency Department or in a private room on a patient care nursing unit.  (See Subpart S, Section 250.2220 (c).)

 

e)         Room Furnishings

 

1)         Room furnishings shall be arranged to facilitate nursing care and to avoid the transmission of infection.

 

2)         For spacing see Subparts T or U of this Part.

 

f)         Bed and Bedding

            A hospital-type bed with suitable mattress, pillow, and necessary coverings shall be provided for each patient.  Side rails shall be readily available for each bed.  It is recommended that replacement bed purchases have side rails integral with the bed.

 

g)         Bedside Furniture

            There shall be a bedside table and chair for each patient except infants.  Such furnishings may be removed if clinically indicated.

 

h)         Storage Space

            There shall be sufficient and satisfactory storage space for clothing, toilet articles, and other personal belongings of patients.

 

i)          Signals

            Audio and/or visual means for signaling nurses shall be provided within easy reach of patients confined to bed.

 

j)          Patients' Screens

            Screens or cubicle curtains shall be available for multibed rooms to assure privacy for each patient.

 

(Source:  Amended at 11 Ill. Reg. 10642, effective July 1, 1987)

 

Section 250.1050  Equipment for Bedside Care

 

a)         There shall be sufficient equipment for patient care according to the types of patients accepted by the hospital and for emergency needs.

 

b)         Equipment used near patients and staff shall be adequately supported or secured and protected to avoid accident and injury.

 

c)         Precautions shall be taken in the use of equipment.  Policies and procedures shall be established accordingly.

 

d)         Specific Equipment

 

1)         Utensils:  There shall be a sufficient number of patient care utensils, wash basins, mouth wash cups, bedpans, emesis basins, urinals, and soap dishes.  Reusable utensils must be sterilized before reissue to another patient.  Disposable equipment shall be used for one patient.  There shall be no resterilization of disposable utensils.

 

2)         Thermometers:   

 

A)        There shall be a sufficient number of clinical thermometers to permit an individual thermometer for each patient.  An effective procedure for cleaning thermometers shall be followed.  (A laboratory tested procedure is recommended.)  When electronic thermometers are utilized there shall be a sufficient supply of probe cots for each patient to have their own.  After use, the probe cot shall be discarded.  The probe and cord shall be cleansed at intervals with an effective agent.

 

B)        A sufficient number of hypothermic or electronic thermometers capable of aiding in the diagnosis of hypothermia shall be available. The actual number of these types of thermometers for each hospital will depend on the numbers and needs of the patients of the hospital. (Ill. Rev. Stat. 1985, ch. 111˝, par. 147.07)

 

3)         Hot Water Bags:  When hot water bags are used, they shall be tested for leakage and covered before being placed in beds.  The temperature of the water should not exceed 110ş F (55ş C).

 

4)         Electrical Appliances and Equipment: Electrical equipment shall be inspected before use.  It shall be maintained in good repair under the provisions of a preventive maintenance program of the Engineering and Maintenance Services.  (Refer Subpart O.)

 

5)         Restraints:  Restraints shall be available and policies shall be established for their use.  (Policy shall reflect use of cloth and leather restraints.)  (See Section 250.2280(c).)

 

6)         Oxygen Equipment:  

 

A)        Oxygen apparatus shall be provided and maintained in good repair. Definite marked storage space shall be provided for oxygen equipment.

 

B)        Oxygen tanks in use at patient's bedside, or wherever located, shall be adequately secured to prevent movement or falling.

 

(Source:  Amended at 11 Ill. Reg. 10642, effective July 1, 1987)

 

Section 250.1060  Drug Services on Patient Unit

 

Refer to Subpart R – Pharmacy or Drug and Medicine Service and Subpart C – Medical Staff Section 250.330(a).

 

Section 250.1070  Care of Patients

 

a)         All persons shall be admitted to the hospital, by a member of the medical staff with admitting privileges, an advanced practice registered nurse, or a physician assistant with clinical privileges recommended by the medical staff and granted by the governing board. All persons admitted to the hospital, whether as inpatients or outpatients, shall be under the professional care of a member of the medical staff.  (See Section 250.240(b)(1).)

 

b)         The hospital shall provide basic and effective care to each patient.  Insofar as possible, the hospital shall assign patients to accommodations that will provide for adequate segregation with regard to sex, age, and medical management.  (See Section 250.240(b)(2).)

 

(Source:  Amended at 43 Ill. Reg. 3889, effective March 18, 2019)

 

Section 250.1075  Use of Restraints and Seclusion

 

a)         Each hospital licensed under the Act and this Part shall have a written policy to address the use of restraints and seclusion in the hospital.  Each hospital policy shall include periodic review of the use of restraints and seclusion in the hospital. (Section 6.20 of the Act)

b)         The hospital's policy governing the use of restraints and seclusion shall be

            consistent with 42 CFR 482.213(e) and (f).  (Section 6.20 of the Act)

c)         In hospitals, restraints or seclusion may only be ordered by a physician licensed to practice medicine in all its branches or a registered nurse with supervisory responsibilities as authorized by the medical staff.  The medical staff of a hospital may adopt a policy specifying the requirements for the use of restraints or seclusion and identifying whether a registered nurse with supervisory responsibilities may order restraints or seclusion in the hospital when the patient's treating physician is not available.  (Section 6.20 of the Act)

d)        Registered nurses authorized to order restraints or seclusion shall have appropriate training and experience as determined by medical staff policy.  The treating physician shall be notified when restraints or seclusion is ordered by a registered nurse.  Nothing in this Section requires that a medical staff authorize a registered nurse with supervisory responsibilities to order restraints or seclusion.  (Section 6.20 of the Act)

e)         When hard restraints are employed, all nursing and patient care staff assigned to that unit must have a restraint key in their possession for the duration of their shift.

 

(Source:  Amended at 27 Ill. Reg. 13467, effective July 25, 2003)

 

Section 250.1080  Admission Procedures Affecting Care

 

a)         Written policies and procedures for the routine admission of patients shall be established.

 

b)         Patients having communicable disease need not be denied admission.  If admitted, proper isolation procedures shall be initiated and enforced.

 

c)         A policy for the admission and treatment of patients with communicable disease shall be established by the Infection Control Committee of the hospital.  The policy shall indicate conditions for transfer of those cases which cannot be properly cared for at the institution.

 

d)         A policy shall be established for the treatment of patients with infectious or communicable diseases requiring intensive care or other ancillary service.

 

e)         On admission, the admitting member of the medical staff shall provide an admission or tentative diagnosis which shall become a part of the patient's medical record.

 

f)         The admitting member of the medical staff shall provide initial orders for the care of each patient upon admission.

 

g)         At all times there shall be used as a reliable method of patient identification affixed to the patient in an acceptable manner.  Particular attention shall be given to the identification of infants and young children and others unable to identify themselves.

 

Section 250.1090  Sterilization and Processing of Supplies

 

a)         All sterilization and processing of all sterile supplies and equipment shall be under competent, qualified supervision.

 

1)         The director or person responsible for central services shall be responsible to the chief executive officer either directly or through a designated department head.  The director of the central sterile supply shall be qualified for the position by education, training, and experience and shall be a member of the Infection Control Committee. (See Section 250.1100(a).)

 

2)         The number of supervisory and support personnel shall be related to the scope of the services provided.  New employees shall receive initial orientation and on-the-job training, and all employees shall participate in a continuing in-service education program, which shall be documented.

 

3)         Educational efforts, though directed primarily at sterile-supply processing and handling techniques, shall also include management concepts, safety, personal hygiene, health requirements, and work attire.

 

b)         There shall be written policies and procedures for the decontamination and sterilization activities performed in central services and elsewhere in the hospital.  The hospital shall comply with the Centers for Disease Control and Prevention Guidelines for Disinfection and Sterilization in Healthcare Facilities.  These policies and procedures shall include, but are not limited to, the following:

 

1)         The receiving, decontaminating, cleaning, preparing, disinfecting and sterilizing of reusable items.

 

2)         The assembly, wrapping, storage, distribution, and quality control of sterile equipment and medical supplies.  Load control numbers shall be used to designate the hospital sterilization equipment used for each item, including the sterilization date and cycle.

 

3)         The use of sterilization process monitors, including temperature and pressure recordings, and the use and frequency of appropriate chemical indicator and bacteriological spore tests for all sterilizers.

 

4)         Designation of the shelf life for each hospital-wrapped and -sterilized medical item and, to the maximum degree possible, for each commercially prepared item.

 

A)        Designation of a shelf life may be a specific expiration date, i.e., 30 days, six months, etc., based on manufacturer's recommendation, a nationally recognized authority, or other standard approved by the facility's Infection Control Committee.

 

B)        Designation of shelf life may be event related if policies and procedures, approved by the Infection Control Committee, address at least the following:

 

i)          requirements for wrapping, storage and rotation of sterile supplies;

 

ii)         definition of an event that may cause a sterile item to be or be suspected of being compromised, such as the package being wet or torn, or the seal being broken or tampered with;

 

iii)        clear direction that the final inspection of the package and the ultimate decision to use the contents of the package rest with the clinician; and

 

iv)        orientation, in-service and other follow-up training to assure that all necessary staff understand and implement the policies and procedures.

 

C)        A facility may choose to use both a specific expiration date and event-related shelf life designation specific for certain wrappings, areas of the hospital, etc., as long as the policies and procedures, as approved by the Infection Control Committee, and the training of staff define this practice.

 

5)         Acquisition of supplies after normal working hours or any time the central service or sterile supply unit is considered "closed" or unstaffed.

 

6)         Preventive maintenance of all central supply service equipment, including performance verification records and reports.

 

7)         The recall and disposal or reprocessing of expired or inadequately sterilized supplies.

 

8)         The emergency collection and disposition of supplies when special warnings have been issued by the manufacturer.  The attending physician shall be notified when patient exposure is known.

 

9)         Specific aeration requirements for each category of gas-sterilized items to eliminate the hazard of toxic residues.

 

10)         The cleaning and sanitizing of work surfaces, floors, utensils, and equipment used in central service functions.

 

c)         Space shall be provided for the efficient operation of all central service functions. Functional design and work flow patterns shall provide for the separation of soiled and contaminated supplies from those that are clean and sterile.  Equipment of adequate design, size, and type shall be provided for the effective decontaminating, disinfecting, cleaning, packaging, sterilizing, storing, and distributing of medical instruments, supplies, and equipment used in patient care.

 

d)         Equipment and procedures

 

1)         The facilities, equipment, and procedures for clean-up, preparation, and sterilization shall be adequate to allow proper cleaning, processing, and sterilizing of patient care supplies and equipment.

 

2)         When clean-up, preparation, and sterilization functions are carried out in the same room or unit (as in a central sterilizing department) the physical facilities and equipment and the policies and procedures for their use shall be such as to effectively separate soiled or contaminated supplies and equipment from the clean or sterilized supplies and equipment.

 

3)         Sterilization equipment shall be maintained in good repair and under the provisions of a preventive maintenance program of the Engineering and Maintenance Services. (Refer to Subpart P.)

 

4)         All pressure steam autoclaves shall have recording thermometers, and the sterilization performance shall be otherwise checked.

 

e)         Sterilization of instruments and utensils

 

1)         All surgical instruments not adversely affected by high temperature shall be sterilized by pressure steam sterilization.

 

2)         The steam method of sterilization is the preferred method for sterilizing medical and surgical instruments that are not damaged by heat, steam, pressure, or moisture.  Low-temperature sterilization technologies (e.g., Ethylene Oxide (EtO), hydrogen peroxide gas plasma) may be used for reprocessing patient care equipment that is heat or moisture sensitive.  In addition, a peracetic acid immersion system of sterilization may be used to sterilize heat-sensitive immersible medical and surgical items, and dry-heat sterilization may be used to sterilize items (e.g., powders, oils) that can sustain high temperatures.  Operating parameters and guidelines for each method or system of sterilization shall be followed for whichever method is used.

 

3)         All instruments shall be thoroughly cleaned before sterilization. 

 

4)         Boiling is not an approved method of sterilization.

 

f)         Water sterilization

 

1)         When non-commercial sterile water is utilized, water sterilization equipment shall be maintained and operated in a manner that will protect the sterilized water from contamination.

 

2)         An acceptable method for checking the sterility of the water shall be utilized. Water may be sterilized either in approved water sterilizers or autoclaved in approved flasks.

 

g)         Sterilization and storage of supplies and equipment

 

1)         Supplies and equipment shall be properly wrapped and labeled before sterilization.

 

2)         The effectiveness of hospital sterilization shall be checked.  Mechanical, chemical, and biologic monitors shall be used to ensure the effectiveness of the sterilization process.   Indicators shall be used to show that the items have been sterilized.  A procedure shall be established for the recall of expired or inadequately sterilized goods for both in-house and commercially sterilized supplies and equipment.  Refer to Section 250.1100(a).

 

3)         Supplies and equipment commercially prepared so as to retain sterility indefinitely are acceptable.  The hospital shall satisfy itself of the sterility of such materials.

 

4)         Sterile equipment and supplies shall be stored properly in clean cabinets, cupboards or other suitable enclosed spaces.  An orderly system of rotation of supplies is recommended so that supplies stored first will be used first.

 

h)         Transmissible spongiform encephalopathies (TSEs)

 

1)         Records shall be maintained for at least 20 years regarding quarantine, disposal, decontamination, and sterilization of surgical instruments used for patients with a confirmed or suspected TSE.

 

2)         For the purposes of this Section, TSEs are a group of rapidly progressive, invariably fatal neurodegenerative diseases that affect both humans and animals.  TSEs in humans include Creutzfeldt-Jakob disease (CJD), kuru, Gerstmann-Straussler-Scheinker syndrome (GSS), fatal familial insomnia (FFI), and variant CJD (vCJD). 

 

(Source:  Amended at 34 Ill. Reg. 19031, effective November 17, 2010)

 

Section 250.1100  Infection Control

 

a)         A hospital shall designate a person or persons as Infection Prevention and Control Professionals to develop and implement policies governing control of infections, communicable diseases, and Antibiotic Stewardship Programs.  The Infection Prevention and Control Professionals shall be qualified through education, training, experience, or certification. The qualifications shall be documented.

 

b)         A multidisciplinary Infection Control Committee, composed at least of members of the medical staff and nursing staff, the Infection Prevention and Control Professionals, and the supervisor of Central Sterile Supply and administration, shall be responsible for investigations and recommendations for the prevention and control of infections within the hospital. This Committee shall perform an annual facility-wide infection control risk assessment.  (Section 6.23 of the Act)

 

c)         Policies and procedures for reporting cases of communicable diseases and for the care of patients with communicable diseases shall be in accordance with the Control of Communicable Diseases Code, the Control of Sexually Transmissible Infections Code and the Control of Tuberculosis Code.

 

d)         When patients having a communicable disease, or presenting signs and symptoms suggestive of that diagnosis, are admitted, proper precautionary measures shall be taken to avoid cross-infection to personnel, other patients, or the public.

 

e)         The hospital shall provide facilities and equipment for the isolation of known or suspected cases of infectious disease.

 

f)         Policies and procedures for handling infectious cases shall include orders for nursing and non-professional staffs providing for proper isolation technique.

 

g)         A hospital shall develop a policy for testing its water supply for Legionella pneumophila bacteria.  The policy shall be based on the ASHRAE publications "Managing the Risk of Legionellosis Associated with Building Water Systems" and "Legionellosis:  Risk Management for Building Water Systems", and the Centers for Disease Prevention and Control's "Toolkit for Controlling Legionella in Common Sources of Exposure".  The policy shall include the frequency with which testing is conducted.  The policy and the results of any tests and corrective actions taken shall be made available to the Department upon request.  (Section 6.29 of the Act)  The policy shall include, at a minimum:

 

1)         A procedure to conduct a facility risk assessment to identify potential Legionella and other waterborne pathogens in the facility water system;

 

2)         A water management program that identifies specific testing protocols and acceptable ranges for control measures; and

 

3)         A system to document the results of testing and corrective actions taken.

 

h)         All persons who care for patients with, or suspected of having, a communicable disease, or whose work brings them in contact with materials that are potential conveyors of communicable disease, shall take appropriate safeguards to avoid transmission of the disease agent.

 

i)          The hospital shall develop and implement comprehensive interventions to prevent and control multidrug-resistant organisms (MDROs), including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and certain gram-negative bacilli (GNB), that take into consideration guidelines of the Centers for Disease Control and Prevention for the management of MDROs in health care settings, including the "Guidelines for Isolation Precautions:  Preventing Transmission of Infectious Agents in Healthcare Settings" and "Guidelines for Hand Hygiene in Health-Care Settings".  (Section 6.23 of the Act)

 

j)          All hospitals shall comply with the Centers for Disease Control and Prevention publication "Guidelines for Infection Control in Health Care Personnel".

 

k)         The multidisciplinary Infection Control Committee shall be responsible for developing, implementing, monitoring, and enforcing a hand hygiene program in the hospital.  For the purposes of this Section, "hand hygiene" is a general term that applies to hand washing with plain soap and water; antiseptic hand wash using soap containing antiseptic agents and water; antiseptic hand rub using a waterless antiseptic product, most often alcohol based, rubbed on the surface of the hands; or surgical hand antiseptic.

 

1)         The Committee shall assess the current practices and compliance, assess hand hygiene products that are currently being used, solicit input from clinical staff, and develop a hand hygiene program for all staff.

 

2)         All staff (including contractual and medical) shall be educated in the hand hygiene program during initial orientation and at least annually.  This education shall be documented.

 

3)         The program shall have clear written goals that require quantitative, time-specific improvement targets.

 

4)         The Committee shall develop and implement measurement tools to be used to assure ongoing compliance with the program.

 

5)         The program shall incorporate the requirements for hand hygiene in educational materials presented to all staff on an ongoing basis; engage patients and families in the hand hygiene efforts; monitor compliance of all staff with recommended measurement tools for hand hygiene, including immediate feedback to personnel; and track compliance over time.

 

6)         The results of the monitoring shall be incorporated in the Quality Assurance/Quality Improvement Program.

 

l)          Contaminated material shall be handled and disposed of in a manner designed to prevent the transmission of the infectious agent.

 

m)        Thorough hand hygiene shall be required after touching any contaminated or infected material.

 

n)         Whenever the Control of Communicable Diseases Code and the Control of Tuberculosis Code require the submission of laboratory specimens for the release of a patient from isolation or quarantine and the hospital laboratory is not approved by the Department for the performance of the specific tests, the specimens shall be submitted to the laboratories of the Illinois Department of Public Health or other laboratory licensed by the Department for the specific tests required.

 

o)         The hospital shall establish a systematic plan of checking and recording cases of infection, known or suspected, that develop in the institution; these cases shall be reported to the Infection Control Committee and hospital administration.  The Committee shall be empowered and directed to investigate health care-associated infections to determine the causative organism and its possible sources.  The findings and recommendations of the Infection Control Committee shall be reported to the medical staff and administration for corrective action.

 

p)         Policies and procedures related to this Section and to the following items shall be developed:

 

1)         The admission and isolation of patients with specific or suspected infectious diseases, and protective isolation of appropriate patients.

 

2)         In-service education programs on the control of infectious diseases.

 

3)         Policies and procedures for isolation techniques appropriate to the working diagnosis of the patient, and protective routines for personnel and visitors.

 

4)         The recording and reporting of all infections of clean surgical cases to the Infection Control Committee, and procedures for the investigation of those cases.

 

q)         In order to improve the prevention of hospital-associated bloodstream infections due to methicillin-resistant Staphylococcus aureaus (MRSA), every hospital shall establish an MRSA control program that requires:

 

1)         Identification of all MRSA-colonized patients in all intensive care units, and other at-risk patients identified by the hospital, through active surveillance testing.

 

2)         Isolation of identified MRSA-colonized or MRSA-infected patients in an appropriate manner.

 

3)         Monitoring and strict enforcement of hand hygiene requirements.

 

4)         Maintenance of records and reporting of cases under Section 10 of the Act.  (Section 5 of the MRSA Screening and Reporting Act)

 

r)          Each hospital shall adopt, implement, and update no less than every three years evidence-based protocols for the early recognition and treatment of patients with sepsis, severe sepsis, or septic shock (sepsis protocols) that are based on generally accepted standards of care. Sepsis protocols shall include components specific to the identification, care, and treatment of adults and of children, and shall clearly identify where and when components will differ for adults and for children seeking treatment in the emergency department or as an inpatient. These protocols shall also include the following components:

 

1)         A process for the screening and early recognition of patients with sepsis, severe sepsis, or septic shock;

 

2)         A process to identify and document individuals appropriate for treatment through sepsis protocols, including explicit criteria defining those patients who should be excluded from the protocols, such as patients with certain clinical conditions or who have elected palliative care;

 

3)         Guidelines for hemodynamic support with explicit physiologic and treatment goals, methodology for invasive or non-invasive hemodynamic monitoring, and timeframe goals;

 

4)         For infants and children, guidelines for fluid resuscitation consistent with current, evidence-based guidelines for severe sepsis and septic shock with defined therapeutic goals for children;

 

5)         Identification of the infectious source and delivery of early broad spectrum antibiotics with timely re-evaluation to adjust to narrow spectrum antibiotics targeted to identified infectious sources; and

 

6)         Criteria for use, based on accepted evidence of vasoactive agents.

 

s)         Each hospital shall ensure that professional staff with direct patient care responsibilities and, as appropriate, staff with indirect patient care responsibilities, including, but not limited to, laboratory and pharmacy staff, are periodically trained to implement the sepsis protocols required under subsection (r). The hospital shall ensure updated training of staff if the hospital initiates substantive changes to the sepsis protocols.

 

t)          Each hospital shall be responsible for the collection and utilization of quality measures related to the recognition and treatment of severe sepsis for purposes of internal quality improvement.

 

u)         The evidence-based protocols adopted by the hospital under Section 6.23a of the Act shall be provided to the Department upon the Department's request.

 

v)         Hospitals submitting sepsis data as required by the Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting Program are presumed to meet the sepsis protocol requirements outlined in this Section.  (Section 6.23a of the Act)

 

(Source:  Amended at 46 Ill. Reg. 15597, effective September 1, 2022)

 

Section 250.1110  Mandatory Overtime Prohibition

 

a)         As used in this Section, the following definitions apply:

 

"Agreed-to, predetermined shift" – nursing hours of work, provided in advance to staff, in a prospective nurse staffing schedule for each patient care unit.  Any work hours in addition to the predetermined shifts or prospective work schedule must be agreed to between the nurse employee and the employer.  The agreed-to, predetermined shift may include "on call" but does not include other overtime staffing mechanisms in which a nurse employee's work, or availability to work additional hours, is at the sole discretion of the employer.

 

"Mandated overtime" – work that is required by the hospital in excess of an agreed-to, predetermined work shift.  Time spent by nurses required to be available as a condition of employment in specialized units, such as surgical nursing services, shall not be counted or considered in calculating the amount of time worked for the purpose of applying the prohibition against mandated overtime.  (Section 10.9(a) of the Act)

 

"Nurse" – any advanced practice registered nurse, registered professional nurse, or licensed practical nurse, as defined in the Nursing and Advanced Practice Nursing Act, who receives an hourly wage and has direct responsibility to oversee or carry out nursing care.  For the purposes of this Section, "advanced practice registered nurse" does not include a certified registered nurse anesthetist who is primarily engaged in performing the duties of a nurse anesthetist.  (Section 10.9(a) of the Act)

 

"On-call/available" – the voluntary agreement by any nurse to be assigned specific agreed-to, predetermined hours of availability for work as a condition of employment.  Additional hours of on-call in excess of the nurse's predetermined hours of work shall be strictly voluntary.

 

"Overtime" – the hours of work in excess of an agreed-to predetermined regularly scheduled shift, not to exceed 40 hours of work in a seven-day workweek.

 

"Retaliation" – disciplining, discharging, suspending, demoting, harassing, denying employment or promotion, laying off, or taking any adverse action against a nurse.

 

"Specialized unit" – a unit, such as surgical nursing services.

 

"Substantially affect" – affecting a situation, except for deviations that result in unimportant changes, given the particular situation involved.

 

"Unforeseen emergent circumstances" –

 

Any declared national, State or municipal disaster or other catastrophic event, or implementation of a hospital's disaster plan, that will substantially affect or increase the need for health care services; or

 

Any circumstances in which patient care needs require specialized nursing skills through the completion of a procedure.

 

An "unforeseen emergent circumstance" does not include situations in which the hospital fails to have enough nursing staff to meet the usual and reasonably predictable nursing needs of its patient.  (Section 10.9(a) of the Act)

 

b)         Mandated overtime is prohibited.  No nurse shall be required to work mandated overtime except in the case of an unforeseen emergent circumstance when such overtime is required only as a last resort.

 

1)         Such mandated overtime shall not exceed 4 hours beyond an agreed-to, predetermined work shift.  (Section 10.9(b) of the Act)

 

2)         Time spent by nurses required to be available as a condition of employment in specialized units, such as surgical nursing services, shall not be counted or considered in calculating the amount of time worked for the purpose of applying the prohibition against mandating overtime.  (Section 10.9(a) of the Act)

 

3)         For any nurse who does not agree to employment requiring on-call hours, the refusal of a nurse employee to agree to such on-call availability shall not constitute grounds for retaliation, discrimination, dismissal, discharge, or any other penalty, threat of reports for discipline, or employment decisions adverse to the nurse employee.

 

4)         The hospital's written staffing plan shall include an on-call policy for those units where on-call is required as a condition of employment.

 

5)         On-call is not to be used to fill vacancies resulting from chronic or foreseeable staff shortages.

 

c)         When a nurse is mandated to work up to 12 consecutive hours, the nurse shall be allowed at least 8 consecutive hours of off-duty time immediately following the completion of a shift.  (Section 10.9(c) of the Act)

 

d)         No hospital shall discipline, discharge, or take any other adverse employment action against a nurse solely because the nurse refused to work mandated overtime as prohibited under subsection (b).  (Section 10.9(d) of the Act)

 

e)         Violations

 

1)         Any employee of a hospital that is subject to the Act and this Part may file a complaint with the Department of Public Health regarding an alleged violation of the Act.  (Section 10.9(e) of the Act)

 

A)        A complaint shall be submitted to the Department in writing, by telephone, or by personal visit.

 

B)        An oral complaint will be reduced to writing by the Department.

 

2)         The complaint shall be filed within 45 days following the occurrence of the incident giving rise to the alleged violation.  The Department will forward notification of the alleged violation to the hospital in question within 3 business days after the complaint is filed.  (Section 10.9(e) of the Act)

 

3)         Upon receiving a complaint of a violation of this Section, the Department may take any action authorized under Section 7 or 9 of the Act.  (Section 10.9(e) of the Act)

 

f)         Any violation of this Section shall be proved by clear and convincing evidence that a nurse was required to work overtime against his or her will.  The hospital may defeat the claim of a violation by presenting clear and convincing evidence that an unforeseen emergent circumstance, which required overtime work, existed at the time the employee was required or compelled to work.  (Section 10.9(f) of the Act) Hearings shall be conducted in accordance with Section 250.140.

 

(Source:  Amended at 43 Ill. Reg. 3889, effective March 18, 2019)

 

Section 250.1120  Staffing Levels

 

a)         As used in this Section, the following definitions apply:

 

"Nursing care" – care that falls within the scope of practice set forth in the Nursing and Advanced Practice Nursing Act or is otherwise encompassed within recognized professional standards of nursing practice, including assessment, nursing diagnosis, planning, intervention, evaluation, and patient advocacy. (Section 10 of the Hospital Report Card Act [210 ILCS 86])

 

"Staffing levels" – the numerical nurse to patient ratio by licensed nurse classification within a nursing department or unit. (Section 10 of the Hospital Report Card Act)

 

"Unit" – a functional division or area of a hospital in which nursing care is provided.  (Section 10 of the Hospital Report Card Act)

 

b)         The number of registered professional nurses, licensed practical nurses, and other nursing personnel assigned to each patient care unit shall be consistent with the types of nursing care needed by the patients and the capabilities of the staff.  Patients on each unit shall be evaluated near the end of each change of shift by criteria developed by the nursing service.  There shall be staffing schedules reflecting actual nursing personnel required for the hospital and for each patient unit.  Staffing patterns shall reflect consideration of nursing goals, standards of nursing practice, and the needs of the patients. (Section 15 of the Hospital Report Card Act)

 

c)         Current nursing staff schedules shall be available upon request at each patient care unit.  Each schedule shall list the daily assigned nursing personnel and average daily census for the unit.  The actual nurse staffing assignment roster for each patient care unit shall be available upon request at the patient care unit for the effective date of that roster.  Upon the roster's expiration, the hospital shall retain the roster for 5 years from the date of its expiration.  (Section 15 of the Hospital Report Card Act)

 

d)         All records required under this Section and Section 15 of the Hospital Report Card Act, including anticipated staffing schedules and the methods to determine and adjust staffing levels, shall be made available to the public upon request.  (Section 15 of the Hospital Report Card Act)

 

e)         All records required under this Section and Section 15 of the Hospital Report Card Act shall be maintained by the facility for no less than 5 years.  (Section 15 of the Hospital Report Card Act)

 

f)         A hospital covered by the Hospital Report Card Act shall not penalize, discriminate, or retaliate in any manner against an employee with respect to compensation or the terms, conditions, or privileges of employment who in good faith, individually or in conjunction with another person or persons, reports violations of the Hospital Licensing Act or the Hospital Report Card Act pursuant to Sections 35 and 40 of the Hospital Report Card Act.  (Section 35 of the Hospital Report Card Act)

 

(Source:  Added at 31 Ill. Reg. 14530, effective October 3, 2007)

 

Section 250.1130  Nurse Staffing by Patient Acuity

 

a)         As used in this Section, the following definitions apply:

 

"Acuity Model" – means assessment tool selected and implemented by a hospital, as recommended by a nursing care committee, that assesses the complexity of patient care needs requiring professional nursing care and skills and aligns patient care needs and nursing skills consistent with professional nursing standards.

 

"Direct Patient Care" – means care provided by a registered professional nurse with direct responsibility to oversee or carry out medical regimens or nursing care for one or more patients.

 

"Nursing-sensitive Care Performance Measure" – means data that examine nursing contributions to inpatient hospital care, including, but not limited to, the data collected and analyzed under the Hospital Report Card Act, the Illinois Adverse Health Care Events Reporting Law of 2005, and the National Database for Nursing Quality Indicators.  The National Database for Nursing Quality Indicators may be accessed at https://www.pressganey.com/products/clinical-excellence/national-database-nursing-quality-indicators.  Hospitals are not required to subscribe to the database.

 

"Nursing Care Committee" − means a hospital-wide committee or committees of nurses whose functions, in part or in whole, contribute to the development, recommendation, and review of the hospital's nurse staffing plan established pursuant to subsection (b). (Section 10.10(b) of the Act)

 

"Patient Acuity" − means the complexity of patient care needs requiring the skill and care of a nurse, which is addressed when aligning nursing resources and professional practice standards as part of the patient's treatment plan.

 

"Registered Professional Nurse" – means a person licensed as a Registered Nurse under the Nurse Practice Act.

 

"Written Staffing Plan for Nursing Care Services" – means a written plan for the assignment of patient care nursing staff based on multiple nurse and patient considerations that yield minimum staffing levels for inpatient care units and the adopted acuity model aligning patient care needs with nursing skills required for quality patient care consistent with professional nursing standards.  (Section 10.10(b) of the Act)

 

b)         Written Staffing Plan

 

1)         Every hospital shall implement a written hospital-wide staffing plan, prepared by a nursing care committee or committees, that provides for minimum direct care professional registered nurse-to-patient staffing needs for each inpatient care unit, including inpatient emergency departments.

 

2)         If the staffing plan prepared by the nursing care committee is not adopted by the hospital, or if substantial changes are proposed, the chief nursing officer shall either provide a written explanation to the committee of the reasons the plan was not adopted or provide a written explanation of any substantial changes made to the proposed plan prior to it being adopted by the hospital. 

 

3)         The written hospital-wide staffing plan shall include, but need not be limited to, the following considerations:

 

A)        The complexity of complete care, assessment on patient admission, volume of patient admissions, discharges and transfers, evaluation of the progress of a patient's problems, ongoing physical assessments, planning for a patient's discharge, assessment after a change in patient condition, and assessment of the need for patient referrals;

 

B)        The complexity of clinical professional nursing judgment needed to design and implement a patient's nursing care plan, the need for specialized equipment and technology, the skill mix of other personnel providing or supporting direct patient care, and involvement in quality improvement activities, professional preparation (credentials), and experience;

 

C)        Patient acuity and the number of patients for whom care is being provided;

 

D)        The ongoing assessments of a unit's patient acuity levels and nursing staff needed, routinely made by the unit nurse manager or his or her designee; and

 

E)        The identification of additional registered nurses available for direct patient care when patients' unexpected needs exceed the planned workload for direct care staff and the process to add additional staff.  (Section 10.10(c) of the Act)

 

F)         The process for submitting the nursing care committee's recommendations to hospital; and

 

G)        The process for providing feedback to the nursing care committee from the hospital administration regarding unresolved or ongoing issues.

 

4)         A written staffing plan shall consider the time required for nursing staff documentation of patient care.

 

5)         In order to provide staffing flexibility to meet patient needs, every hospital shall identify an acuity model for adjusting the staffing plan for each inpatient care unit.

 

6)         Each hospital shall implement the staffing plan and assign nursing personnel to each inpatient care unit, including inpatient emergency departments, in accordance with the staffing plan.

 

A)        A registered nurse may report to the nursing care committee any variations where the nurse personnel assignment in an inpatient care unit is not in accordance with the adopted staffing plan and may make a written report to the nursing care committee based on the variations.

 

B)        Shift-to-shift adjustments in staffing levels required by the staffing plan may be made by the appropriate hospital personnel overseeing inpatient care operations.  If a registered nurse in an inpatient care unit objects to a shift-to-shift adjustment, the registered nurse may submit a written report to the nursing care committee.

 

C)        The nursing care committee shall develop a process to examine and respond to written reports submitted under subsections (6)(A) and (6)(B), including the ability to determine if a specific written report is resolved or should be dismissed. (Section 10.10(c)(2.5) of the Act)

 

7)         The written staffing plan shall be posted, either by physical or electronic means, in a conspicuous and accessible location for both patients and direct care staff, as required under the Hospital Report Card Act.  A copy of the written staffing plan shall be provided to any member of the general public upon request. (Section 10.10(c)(3) of the Act)

 

8)         In addition to the hospital providing a copy of the written staffing plan per subsection (b)(6), the hospital shall allow members of the public to schedule an appointment with the Chief Nursing Officer or their designee to review the staffing plan and address any questions.

 

c)         Nursing Care Committee

 

1)         Every hospital shall have a nursing care committee that meets at least 6 times per year.  A hospital shall appoint members of a committee of which at least 55% of the members are registered professional nurses providing direct inpatient care, one of whom shall be selected annually by the direct inpatient care nurses to serve as co-chair of the committee.  (Section 10.10(d)(1) of the Act)

 

A)        The registered professional nurses on the nursing care committee shall be as broadly representative of the clinical service areas as practically reasonable; e.g., surgery, critical care, medical surgical, obstetrics, emergency department and pediatrics.

 

B)        When committee or nurse staff volume is not practically reasonable to include representatives from each clinical service area at any one time, the hospital may schedule for rotating representation of the hospital's clinical service areas over a defined timeframe to achieve input from all clinical service areas every three years.

 

C)        Minutes for the nursing care committee meetings, summarizing key issues, discussions and recommendations, shall be recorded and maintained for five years.

 

2)         A nursing care committee shall prepare and recommend to hospital administration the hospital's written hospital-wide staffing plan.  If the staffing plan is not adopted by the hospital, the chief nursing officer shall provide a written statement to the committee prior to a staffing plan being adopted by the hospital that:

 

A)        Explains the reasons the committee's proposed staffing plan was not adopted; and

 

B)        Describes the changes to the committee's proposed staffing or any alternative to the committee's proposed staffing plan. (Section 10.10(d)(2.5) of the Act)

 

3)         A nursing care committee's or committees' written staffing plan for the hospital shall be based on the principles from the staffing components set forth in subsection (b).  In particular, a committee or committees shall provide input and feedback on the following:

 

A)        Selection, implementation, and evaluation of minimum staffing levels for inpatient care units.

 

B)        Selection, implementation, and evaluation of an acuity model to provide staffing flexibility that aligns changing patient acuity with nursing skills required.

 

C)        Selection, implementation, and evaluation of a written staffing plan incorporating the items described in subsections (b)(1) through (b)(5).  (Section 10.10(d)(3) of the Act)

 

i)          The process for review and evaluation of the written staffing plan shall take into consideration nursing-sensitive care performance measures.

 

ii)         The process for review and evaluation of the written staffing plan shall consider the National Quality Forum's Safe Practices for Better Healthcare.

 

4)         The committee or committees shall review the nurse staffing plans for all inpatient areas and current acuity tools and measures in use.  The nursing care committee's review shall consider:

 

A)        Patient outcomes;

 

B)        Complaints regarding staffing, including complaints about a delay in direct care nursing or an absence of direct care nursing;

 

C)        The number of hours of nursing care provided through an inpatient hospital unit compared with the number of inpatients served by the hospital unit during a 24-hour period;

 

D)        The aggregate hours of overtime worked by the nursing staff;

 

E)        The extent to which actual nurse staffing for each hospital inpatient unit differs from the staffing specified by the staffing plan; and

 

F)         Any other matter or change to the staffing plan determined by the committee to ensure that the hospital is staffed to meet the health care needs of patients. (Section 10.10(d)(3)(D) of the Act)

 

5)         System-related or clinical service area nurse staffing or patient issues identified between meetings shall be shared, reviewed and addressed at the next nurse care committee meeting.

 

6)         A nursing care committee must issue a written report addressing the items described in subsections (c)(3) and (c)(4) semi-annually. A written copy of this report shall be made available to direct inpatient care nurses by making available a paper copy of the report, distributing it electronically, or posting it on the hospital's website.  (Section 10.10(d)(4) of the Act)

 

7)         A nursing care committee must issue a written report at least annually to the hospital governing board that addresses items including, but not limited to:

 

A)        The items described in subsections (b)(1) through (b)(5);

 

B)        Changes made based on committee recommendations and the impact of these changes;

 

C)        Recommendations for future changes related to nurse staffing (Section 10.10(d)(5) of the Act);

 

D)        The composition of the nursing units represented by members of the nursing care committee;

 

E)        Goals and accomplishments of the nursing care committee;

 

F)         Outline of the current acuity tools in each inpatient and emergency department;

 

G)        Personnel data including annual registered nurse turnover rate, current registered nurse vacancy rate, current and posted full-time or full-time equivalent registered nurse positions, and annual certified nurse aid/tech turnover and vacancy rate;

 

H)        Number of registered nurse injuries related to patient lifting and handling as per Section 250.1030(d)(7); and

 

I)         Number of hospital inpatient acquired pressure injuries.

 

d)         Nothing in this Section shall be construed to limit, alter, or modify any of the terms, conditions, or provisions of a collective bargaining agreement entered into by the hospital.  (Section 10.10(e) of the Act)

 

e)         No hospital may discipline, discharge, or take any other adverse employment action against an employee solely because the employee expresses a concern or complaint regarding an alleged violation of this Section or concerns related to nurse staffing. (Section 10.10(f) of the Act)

 

f)         Any employee of a hospital may file a complaint with the Department regarding an alleged violation of this Section.  The Department will forward notification of the alleged violation to the hospital in question within 10 business days after the complaint is filed. Upon receiving a complaint of a violation of this Section, the Department may take any action authorized under Section 7 or 9 of the Act. (Section 10.10(g) of the Act)

 

g)         If a hospital demonstrates a pattern or practice of failing to substantially comply with the requirements of Section 10.10 of the Act or the hospital's written staffing plan, the hospital shall provide a plan of correction to the Department within 60 days after receiving notice of noncompliance.  The Department may impose fine as follows:

 

1)         If a hospital fails to implement a written staffing plan for nursing services, a fine not to exceed $500 per occurrence may be imposed;

 

2)         If a hospital demonstrates a pattern or practice of failing to substantially comply with a plan of correction within 60 days after the plan takes effect, a fine not to exceed $500 per occurrence may be imposed; and

 

3)         If a hospital demonstrates for a second or subsequent time a pattern or practice of failing to substantially comply with a plan of correction with 60 days after the plan takes effect, a fine not to exceed $1,000 per occurrence may be imposed. (Section 7(a-5) of the Act)

 

(Source:  Amended at 46 Ill. Reg. 15597, effective September 1, 2022)

SUBPART J: SURGICAL AND RECOVERY ROOM SERVICES

 

Section 250.1210  Surgery

 

a)         Where a hospital provides surgical services, the service shall be provided in a manner sufficient to meet surgical needs of the patients.  The surgical department/service shall have a defined organization and shall be integrated with other departments and services of the hospital and shall be governed by written policies and procedures.

 

b)         The Director of Surgical Services or his designee shall design and implement an education program to orient new physicians, residents, physician assistants, and other employees and shall collaborate with the nursing administrator or his/her designee to establish orientation and continuing education programs for the nursing staff. The programs shall be planned, scheduled, documented by a written outline of its contents, and evaluated at least annually.

 

c)         The education program may be conducted using resources internal or external to the hospital.  Teaching material and suitable reference shall be supplied as needed for each patient care unit.

 

d)         The surgical services shall be directed by a member of the medical staff who is qualified by training and experience preferably certified by the American Board of Surgery and approved by the medical staff and board of the hospital.

 

(Source:  Amended at 5 ill. Reg. 507, effective December 29, 1980)

 

Section 250.1220  Surgery Staff

 

a)         A current roster of physicians, dentists, and podiatrists shall be maintained in the surgical suite and be available to the surgical nursing and medical staff.

 

b)         The supervisory nurse of direct patient care shall be a registered professional nurse, knowledgeable in invasive and diagnostic as well as operating room procedures.

 

c)         A registered nurse, qualified by training and experience in operating room nursing, shall be present in the operating room and function as the circulating nurse during all invasive or operative procedures.  As used in this subsection, "circulating nurse" means a registered nurse who is responsible for coordinating all nursing care, patient safety needs, and the needs of the surgical team in the operating room during an invasive or operative procedure.  (Section 10.7(2.5) of the Act)

 

(Source:  Amended at 33 Ill. Reg. 8306, effective June 2, 2009)

 

Section 250.1230  Policies & Procedures

 

The department of surgery shall have effective policies and procedures regarding surgical privileges, maintenance of the operating rooms, and evaluation of the surgical patient.  These shall be available within the department.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.1240  Surgical Privileges

 

a)         Surgical privileges shall be delineated for each member of the medical staff (i.e., a Doctor of Medicine, M.D.; Doctor of Osteopathy, D.O.; Doctor of Podiatric Medicine, D.P.M.; or Doctor of Dental Surgery, D.D.S.) who has been granted surgical privileges in accordance with the competence of each such member of the medical staff.  A file specifying the surgical privileges of each of these members shall be available in the operating room and in the files of the Hospital Administration Department.

 

b)         Policies and procedures shall identify which surgical procedures necessitate a second hospital-credentialed physician to assist in the surgical procedure.

 

(Source:  Amended at 23 Ill. Reg. 13913, effective November 15, 1999)

 

Section 250.1250  Surgical Emergency Care

 

a)         An on-call schedule of physicians shall be established and posted at each patient care unit or other area where surgical patients are admitted or the communications center of the hospital to ensure that there is 24-hour emergency care.

 

b)         An emergency surgical case is defined as any case in which, in the opinion of the attending physician or surgeon, the risk of a delay endangers the patient's life, limb or organs.  The declaration of an emergency shall be appropriately noted in the patient's chart.

 

c)         In the event of the declaration of an emergency case, any of the requirements regarding the preoperative assessment of the patient and informed consents may be waived by the attending physician or surgeon and noted in the medical record.

 

(Source:  Amended at 23 Ill. Reg. 13913, effective November 15, 1999)

 

Section 250.1260  Operating Room Register and Records

 

a)         An operating room log or register, including those created by electronic means, shall be provided and maintained on a current basis. If the register is created by electronic means, then safeguards to protect the integrity and confidentiality of these records must be in place. The operating room log or register shall contain the date of the operation, name and number of patient, names of surgeons and surgical assistants, name of anesthetist, type of anesthesia given and pre- and post-operative diagnosis, type of surgical procedure, operating room number and the presence or absence of complications in surgery.

 

b)         The medical staff shall establish procedures to ensure that preoperative and postoperative medical records are completed in a timely and accurate manner.  A properly executed consent for the proposed surgical or diagnostic procedure, including a consent for anesthesia services, shall be in the patient's chart prior to surgery. Except in an emergency, a complete history and physical work-up shall be recorded in the chart of every patient prior to surgery.

 

c)         The medical record of the patient shall be available in the operating suite and post-anesthesia area.

 

d)         An operative report describing techniques and findings shall be written or dictated immediately following surgery and signed by the surgeon as soon after transcription as possible.

 

(Source:  Amended at 23 Ill. Reg. 13913, effective November 15, 1999)

 

Section 250.1270  Surgical Patients

 

a)         Patients undergoing major surgical procedures shall be observed both pre-operatively and post-operatively by a competent nurse specifically assigned to the duty.  Such observations shall be documented in the patient's record.

 

b)         The chart of the patient shall accompany the patient to the operating suite, to the recovery area and be returned with the patient to the patient care unit.

 

c)         All tissue/specimens removed at surgery, except those exempted by Section 250.510(g)(1), shall be placed in a container properly labeled and submitted for pathological examination.

 

d)         An operative report describing techniques and findings shall be written or dictated immediately following surgery and signed by the surgeon.

 

e)         All infections of clean surgical cases shall be recorded and reported to administration and to the hospital's Infection Control Committee.  The Infection Control Committee shall determine a procedure for the surveillance of such cases.

 

(Source:  Amended at 48 Ill. Reg. 450, effective December 20, 2023)

 

Section 250.1280  Equipment

 

a)         The operating suite is to be equipped with the appropriate and necessary equipment and instruments for the surgical or diagnostic procedures performed.

 

b)         The surgical suite shall have appropriate resuscitation equipment immediately available at all times.

 

c)         A dedicated emergency call system must be present in each operating room for the purpose of alerting operating suite personnel to an emergency or life-saving situation.

 

(Source:  Amended at 23 Ill. Reg. 13913, effective November 15, 1999)

 

Section 250.1290  Safety

 

a)         Policies and procedures shall be established concerning the safety and welfare of patients treated in the surgical suite, and safety training shall be provided to personnel.

 

b)         Policies and procedures shall be established for the control, storage, and safe use of anesthetics, oxygen and other medicinal gases.  Refer: Section 250.1410(e).

 

c)         Suitable facilities must be provided for the safe and convenient preparation of drugs and medications, including ample light, running water, sufficient work area, refrigeration and a secure and locked cabinet for the storage of schedule drugs.

 

d)         Policies and procedures shall be established addressing principles of sterility and asepsis in the surgical suite.

 

e)         Rigid adherence to accepted standards of sterility and asepsis is mandatory in the Surgical Department.

 

(Source:  Amended at 23 Ill. Reg. 13913, effective November 15, 1999)

 

Section 250.1300  Operating Room

 

a)         The surgical area shall be a controlled traffic area.  A control point shall be established to monitor the flow of patients, personnel, and materials.

 

b)         The surgical area is composed of restricted, semi-restricted, monitored unrestricted, and transition areas.

 

1)         Restricted area:  Traffic shall be restricted to authorized personnel and patients.  No street clothing shall be worn in the restricted area.  Health care workers shall wear hospital laundered scrub attire.  Head and facial hair shall be contained within protective covering.  Cloth head coverings shall be laundered by the hospital.  Additional garments shall be completely contained or covered within the scrub attire.  Masks shall be worn in restricted areas where open sterile supplies and equipment are present or scrubbed persons are located.  Patients shall wear attire appropriate for their surgical procedure and shall wear hair covering.

 

2)         Semi-restricted area:  Traffic shall be restricted to authorized personnel and patients.  No street clothing shall be worn in the semi-restricted area.  Health care workers shall wear hospital laundered scrub attire.  Head and facial hair shall be contained within protective covering.  Cloth head coverings shall be laundered by the hospital.  Additional garments shall be completely contained or covered within the scrub attire.  Masks are not required in this area.  Patients shall wear attire appropriate for their surgical procedure and shall wear hair covering.

 

3)         Transition area:  Traffic shall be permitted to allow movement of personnel from unrestricted to semi-restricted areas or restricted areas.  Personnel may enter in street clothing and shall exit into the semi-restricted or restricted area in surgical attire.

 

4)         Monitored unrestricted area:  Permitted traffic includes authorized personnel, patients, and their families.  Health care workers in scrub attire may use this area as a transition area for the purpose of patient management and hospital business.

 

c)         Signage shall clearly define the traffic flow and surgical attire requirements.

 

d)         Movement of clean and sterile items shall be separated from contaminated or dirty items by space, time, or traffic patterns.  The handling of clean and soiled linen shall meet the requirements set forth in Sections 250.1750 and 250.1760.

 

e)         All jewelry shall be removed prior to the surgical scrub.  Jewelry shall not be worn in the operating room, except that anesthesia personnel may wear a watch.

 

f)         Additional personal protective equipment shall be worn when exposure to blood or other potentially infectious material is anticipated.

 

g)         Whenever scrub attire or personal protective equipment is soiled, it shall be removed promptly and placed in an appropriately designated container.

 

h)         The sterile gown and gloves used when participating in surgical procedures shall be removed and discarded prior to leaving the operating room.

 

i)          The gloves used when participating in surgical procedures shall be removed and discarded prior to leaving the operating room.

 

j)          The use of single-use coverall suits shall be determined by hospital policy.

 

k)         Shoe covers shall be worn when it can reasonably be anticipated that splashes or spills may occur.  If shoe covers are worn, they shall be changed whenever they become torn, wet, or soiled.  They shall be removed and discarded before leaving the surgical area.

 

l)          The use of cover gowns for covering the scrub attire when outside of the surgical area shall be determined by hospital policy.  Scrub attire worn into the institution from outside shall be changed before entering the semi-restricted or restricted areas.  Persons exiting the hospital shall don hospital laundered scrub attire on return to the surgical area.

 

m)        Personnel suffering from communicable diseases shall be excluded from the surgical area.

 

(Source:  Amended at 34 Ill. Reg. 19031, effective November 17, 2010)

 

Section 250.1305  Visitors in Operating Room

 

a)         No lay visitor shall be given access to the operating rooms during surgery.

 

b)         Only individuals in the categories authorized herein and individuals authorized in accordance with hospital policy shall be allowed access to the operating rooms during surgery. Individuals authorized herein shall be members of the medical staff, persons covered by Section 250.310(a)(14), persons employed by the hospital and assigned to the operating room, and persons participating in residency or clinical training programs approved by the Department of Financial and Professional Regulation under the Medical Practice Act of 1987.

 

c)         Where hospital policy approved by the Governing Board permits other persons to be in attendance in the operating room during surgery, the policy shall provide for the screening of such persons to ensure the necessity of their presence, such as documentation that they have appropriate licensure, qualifications or competence and that the person performing the procedure, the patient's attending physician and the chairman of the department of surgery in departmentalized hospitals have agreed to allow such access. These individuals shall follow the requirements set forth in Section 250.1300.

 

d)         The presence of a parent or guardian, or other designated individual selected by a child's parent or guardian, may be allowed in the operating room during the induction of anesthesia on an individual who is 12 years of age or younger and for a mentally disabled adult, at the discretion of the hospital if the hospital has first adopted a policy on the matter, approved by the Governing Board. The policy shall include, but not be limited to, the following conditions:

 

1)         Written consent of the parent, guardian or other designated individual, the anesthesia provider, and the physician performing the surgery;

 

2)         Notation in the patient's medical record of the presence of the additional person in the operating room during the induction of anesthesia;

 

3)         Application of safeguards against the introduction of infection or other hazards by the parent, guardian or other designated individual, including orientation, education and training of the person prior to performance of the procedure; this shall include, at a minimum, specifics regarding the procedure and what can be expected, basic infection control practices expected of the person, and instruction that the person must leave the operating room after the induction of anesthesia is completed;

 

4)         Requirements that the parent, guardian, or other designated individual wear a mask, cover all head and facial hair and don hospital laundered scrub attire or a single-use coverall suit designed to totally cover outside apparel;

 

5)         Provision of at least one additional staff person in the operating room assigned to oversee, supervise and assist the parent, guardian or other designated individual for the period of time the parent, guardian or other designated individual is present; and

 

6)         If, at any point during the induction of the anesthesia, the physician performing the surgery or the attending anesthesia provider determines that the parent, guardian or other designated individual poses a threat to the safe completion of the induction of the anesthesia, he or she may require the parent, guardian or other designated individual to leave the operating room.

 

(Source:  Amended at 34 Ill. Reg. 19031, effective November 17, 2010)

 

Section 250.1310  Cleaning

 

a)         Procedures for cleaning the operating rooms after each case may be more but not less stringent than the following:

 

1)         The operating room and its contents shall be thoroughly cleaned after each case.

 

2)         Furniture and equipment shall be washed with an approved disinfecting solution.   Gloves, syringes, instruments, and all wastes shall be soaked in an approved disinfecting solution.

 

3)         Specimen material for laboratory examination or research shall be placed in a closed container and the exterior of the container shall then be washed with an approved disinfecting solution.

 

4)         Nurses, surgeons, and anesthetists shall remove gowns and gloves at the door immediately before leaving the room.

 

5)         All linen shall be bagged in the operating room.  There shall be specific procedures for the identification and handling of surgery linen.

 

b)         The Infection Control Committee, in cooperation with the surgery service, shall develop guidelines and specific requirements for cleaning the operating room following the contaminated or infected case.

 

(Source:  Amended at 11 Ill. Reg. 10642, effective July 1, 1987)

 

Section 250.1320  Postanesthesia Care Units

 

a)         Provision and use of Phase 1 Postanesthesia Care Unit (Phase 1 PACU)

 

1)         For the purposes of this Section, Phase 1 of postanesthesia care is the phase immediately following surgery, usually in a recovery room, after which the patient is returned to his or her room.

 

2)         Postanesthesia care units shall be provided by all hospitals in which surgery is performed.  They shall be in a separate room where patients who have undergone surgical procedures can be immediately observed and receive specialized care by selected and trained personnel and where, when necessary, prompt emergency care can be initiated.

 

3)         The services of the Phase 1 PACU may be used for postpartum care if the delivery room or place of delivery is in proximity to the Phase 1 PACU.  Only clean (non-infected or non-infectious) postpartum patients may be admitted to the Phase 1 PACU and may, after appropriate observation, be returned to the maternity department.

 

b)         Personnel

 

1)         Physician

            A physician shall be responsible for the conduct of the Phase 1 PACU, for the training of Phase 1 PACU personnel, and for the establishment of admission, discharge, and emergency policies and procedures.

 

2)         Nurse

 

A)        A registered nurse who has education and experience in Phase 1 postanesthesia care shall supervise all personnel performing nursing service functions.

 

B)        A registered nurse shall be in attendance at all times when patients are in the Phase 1 PACU.

 

C)        There shall be sufficient nursing personnel to provide the specialized care required for the postsurgical patient.  It is recommended that a ratio of one nursing personnel to two patients be maintained at all times.

 

D)        Nursing personnel shall be assigned permanently to the Phase 1 PACU when patients are present.

 

c)         Practices for operation of the Phase 1 PACU

 

1)         Only clean surgical cases shall be admitted to the Phase 1 PACU.

 

2)         Contaminated cases shall be returned to the isolation room or a private room.  Contaminated cases may be admitted to the Phase 1 PACU when a separate isolation facility is within or adjacent to the Phase 1 PACU.

 

3)         A member of the medical staff shall provide initial orders for the care of each patient upon admission.

 

4)         A member of the medical staff shall be responsible for the patient's discharge from the Phase 1 PACU.

 

5)         Anesthetized patients shall be constantly attended.  Side rails shall be attached to movable carts and beds and raised above mattress level when occupied by anesthetized patients. Cribs shall be provided for the anesthetized or postsurgical child.

 

6)         Written policies and procedures, which shall be reviewed regularly and revised as necessary, shall be established.

 

7)         A complete orientation program and continuing in-service education program shall be provided for all personnel assigned to the Phase 1 PACU.

 

8)         Personnel with communicable diseases shall be excluded from the Phase 1 PACU.

 

9)         Visitors shall be permitted in the Phase 1 PACU if a hospital has adopted a policy, approved through the Governing Board, that allows for visitation in the Phase 1 PACU while the patient is recovering from a surgical procedure. Before allowing individuals to be present in the Phase 1 PACU, the hospital shall have a policy in place that includes at least the following:

 

A)        Written consent of an adult patient; the parent, guardian, or legal representative of a minor or a mentally disabled adult; or the physician performing the surgery;

 

B)        Notation in the patient's medical record of the presence of additional visitors in the Phase 1 PACU during recovery of the patient from a surgical procedure;

 

C)        Application of safeguards against the introduction of infection or other hazards by the visitor, including orientation, education and training of the person, preferably prior to the performance of the procedure but at least prior to visitation; this shall include, at minimum, specifics regarding  recovery, what can be expected, and basic infection control practices expected of the visitor;

 

D)        Provision of at least one additional staff person in the Phase 1 PACU assigned to oversee, supervise and assist the visitors for the period of time the visitors are present;

 

E)        Provision of safeguards to ensure the privacy of other patients who may be recovering from surgical procedures, which may include separate rooms or some other type of separation for recovery of patients who would have a visitor present.  Privacy safeguards shall allow Phase 1 PACU staff to provide constant attention to anesthetized patients; and

 

F)         If, at any point during the recovery of the patient, Phase 1 PACU personnel determine that the visitor poses a threat to the safe, therapeutic recovery of the patient, personnel may require the visitor to leave the Phase 1 PACU.

 

d)         Drugs, supplies and equipment

            Drugs, supplies and equipment shall be immediately and continually accessible in the Phase 1 PACU, including emergencies.  These shall include cardiac-respiratory monitoring and resuscitation materials.

 

e)         The Phase 1 PACU shall contain and provide for a drug distribution station, including a secure area, adequate hand-washing facilities, charting and dictating area, soiled utility area with bedpan flushing device, and adequate storage space for supplies and equipment.

 

(Source:  Amended at 35 Ill. Reg. 4556, effective March 4, 2011)

 

Section 250.1325  Surgical Smoke Plume Evacuation System Equipment and Policies

 

a)         To protect patients and health care workers from the hazards of surgical smoke plume, hospitals shall adopt policies to ensure the elimination of surgical smoke plume by use of a surgical smoke plume evacuation system for each procedure that generates surgical smoke plume from the use of energy-based devices, including, but not limited to, electrosurgery and lasers. (Section 6.32(b) of the Act)

 

1)         The facility's surgical department shall perform a risk assessment to identify all procedures that are performed with energy-based surgical devices (e.g. lasers, electrosurgical instruments, and ultrasonic devices) that generate a surgical smoke plume and will require the use of a surgical smoke plume evacuation system.

 

2)         All surgical team members shall be trained on the methods for mitigating the hazards and minimizing exposure to surgical smoke plume, positioning and operating surgical smoke plume evacuation pursuant to the manufacturer's instructions, and the requirements in facility policies and procedures for management of surgical smoke plume.

 

3)         Staff shall wear appropriate respiratory protection when needed as secondary protection against residual smoke in accordance with the hospital's respiratory protection plan.

 

4)         To protect against potential smoke hazards, the facility’s policy and procedure shall minimally include:

 

A)        During utilization of the smoke evacuator, the suction nozzle inlet shall be positioned as close to the surgical site as possible to maximize capture of airborne contaminants.

 

B)        The smoke evacuator shall be “ON” (activated) at all times when airborne particles are produced during all surgical or other procedures

 

C)        New tubing shall be used before each procedure and the smoke evacuator filter shall be replaced as recommended by the manufacturer. Consider all tubing, filters and absorbers as infectious waste and dispose of appropriately in accordance with OSHA bloodborne pathogens standards.

 

D)        Inspection of smoke evacuator systems regularly, including inspection immediately prior to use, to ensure proper functioning.

 

b)         The hospital shall report to the Department that policies required under subsection (a) have been adopted.  The hospital shall provide the Department a letter identifying the date of the adoption of the facility's policy for utilization of smoke evacuation system. (Section 6.32(c) of the Act)

 

(Source:  Added at 46 Ill. Reg. 15597, effective September 1, 2022)

SUBPART K: ANESTHESIA SERVICES

 

Section 250.1410  Anesthesia Service

 

a)         The Anesthesia Service shall be organized under written policies and procedures regarding staff privileges, the administration of anesthetics, and the maintenance of strict safety controls. In hospitals where there is no organized Anesthesia Service, the Surgery Service shall assume the responsibility for establishing general policies and supervising the administration of anesthetics.  The Anesthesia Service is responsible for all anesthetics administered in the hospital.

 

b)         The Anesthesia Service shall be under the direction of a physician who has had specialized preparation and experience in the area or who has completed a residency in anesthesiology.  An anesthesiologist shall be Board certified or a candidate for Board certification in the American Board of Anesthesiology examination system.

 

c)         A physician or registered professional nurse shall supervise the work of all nonmedical personnel working in the Anesthesia Service.

 

d)         The hospital shall establish procedures for regular inspection, maintenance, and repair of anesthesia equipment and supplies.

 

e)         The Anesthesia Service, hospital administration, and medical staff shall collaborate to establish policies and procedures for the control, storage, and safe use of combustible anesthetics, oxygen, and other medicinal gases; types of anesthesia to be administered and procedures for each; personnel permitted to administer anesthesia; infection control, and safety regulations to be followed.

 

f)         The hospital shall recognize the dangers of accidental ignition of anesthetic gases to patients and others, and shall establish procedures to minimize this hazard in accordance with NFPA 99.

 

g)         The hospital shall provide policies and procedures to all personnel and ensure the enforcement of the policies and procedures.

 

h)         Anesthetic agents and medicinal gases shall be administered only on the order of a member of the medical staff and shall be administered only by persons qualified in the management of these materials. See subsection (e).

 

i)          The use and storage of anesthetic gases shall be in accordance with NFPA 99. Areas for cleaning, testing, and storing anesthesia equipment shall be provided.

 

j)          An anesthetic record on special forms shall be made a part of the patient's chart.  Drugs used, vital signs and other relevant information shall be recorded at regular intervals during anesthesia.

 

1)         There shall be a history and physical examination by a physician no more than 30 days prior to nonemergency surgery or a procedure requiring anesthesia services, or within 24 hours after admission or registration for a surgery or procedure requiring anesthesia services.  Findings must be recorded in the patient's record prior to surgery or a procedure requiring anesthesia services.  For dental surgery, the history and physical examination may be performed by a dentist who has been granted privileges by the hospital medical staff.

 

2)         Except in an emergency, no anesthetic shall be administered until the patient has had a history and physical examination, and a record made of the findings.

 

k)         Patients under or recovering from anesthesia and those who have received sedatives or analgesic shall remain under continuous, direct nursing supervision until vital signs have become stabilized.  Any nurse performing this duty shall have been instructed in the management of post-anesthetic patients, shall have no other clinical duties while supervising these patients, and shall have immediate recourse to the attending surgeon, anesthesiologist, or qualified substitute present in the hospital.

 

l)          Post-anesthetic follow-up visits shall be made within 48 hours after the operation by the anesthesiologist, nurse anesthetist, or responsible physician, who shall note and record any postoperative abnormalities or complications from anesthesia.

 

(Source:  Amended at 43 Ill. Reg. 12990, effective October 22, 2019)

SUBPART L: RECORDS AND REPORTS

 

Section 250.1510  Medical Records

 

a)         Facilities

 

1)         The hospital shall maintain medical record facilities with adequate supplies and equipment.

 

2)         Medical records shall be stored safely.  Medical records shall be handled so as to assure safety from water seepage or fire damage and are to be safeguarded from unauthorized use.

 

b)         Organization

 

1)         Responsible Personnel

 

A)        A qualified health information practitioner (registered health information administrator or accredited health information technician) shall be employed or contracted as the director of the medical records department.

 

B)        The director of the medical records department shall participate in educational programs relative to health information activities, on-the-job training and orientation of other medical record personnel, and in-service health information educational programs.  Professional consultation services shall be provided for the health information practitioner.

 

2)         An adequate, accurate, timely, and complete medical record shall be maintained for each patient.  Minimum requirements for medical record content are:

 

A)        Patient identification and admission information;

 

B)        The history of the patient as to chief complaints, present illness and pertinent medical history, family history, and social history;

 

C)        A physical examination report;

 

D)        Provisional diagnosis;

 

E)        Diagnostic and therapeutic reports on laboratory test results, x-ray findings, any surgical procedure performed, any pathological examination, any consultation, and any other diagnostic or therapeutic procedure performed;

 

F)         Orders and progress notes made by the attending physician and, when applicable, by other members of the medical staff and allied health personnel;

 

G)        Observations notes and vital sign charting made by nursing personnel; and

 

H)        Conclusions as to the primary and any associated diagnoses; brief clinical resume; disposition at discharge, including instructions and medications; and any autopsy findings on a hospital death.

 

3)         For record requirements pertaining to obstetric patients and newborn infants, see Section 250.1830(h).

 

4)         A committee of the organized medical staff shall be responsible for reviewing medical records to ensure adequate documentation, completeness, promptness, and clinical pertinence.

 

5)         The hospital shall establish requirements for the completion of medical records and for the retention period for medical records.  The hospital shall issue policies and procedures pertaining to the use of medical records and the release of medical record information.  Discharge  diagnoses shall be expressed in terminology of a recognized disease nomenclature.

 

6)         When a hospital provides a sexual assault survivor with a voucher in compliance with Section 250.750(d), the hospital shall make a copy of the voucher and place it in the medical record of the sexual assault survivor. The hospital shall provide a copy of the voucher to the sexual assault survivor after discharge upon request. (Section 5(b-5) of the Sexual Assault Survivors Emergency Treatment Act)

 

c)         Authentication of Medical Record Entries

 

1)         All entries into the medical record shall be authenticated by the individual who made or authorized the entry.  "Authentication," for purposes of this Section, means identification of the author of a medical record entry by that author, and confirmation that the contents are what the author intended, except that telephone orders may be authenticated by the ordering practitioner or another practitioner who is responsible for the care of the patient and who is authorized to write orders pursuant to Section 250.330.

 

2)         Medical record entries shall include all notes, orders or observations made by direct patient care providers and any other individuals required to make the entries in the medical record, and written interpretive reports of diagnostic tests or specific treatments, including, but not limited to, radiologic or electrocardiographic reports, operative reports, reports of pathologic examination of tissue and other similar reports. The medical record may include entries that are transmitted by facsimile machine, provided that the faxed copies are on non-thermal paper and that the faxed copies are dated and authenticated pursuant to hospital policy approved by the medical staff.

 

3)         Written signatures or initials and electronic signatures or computer-generated signature codes are acceptable as authentication.  All signatures or initials, whether written, electronic, or computer-generated, shall include the initials of the signer's credentials.

 

4)         If a hospital uses electronic signatures or computer-generated signature codes for authentication purposes, the hospital's medical staff and governing board shall adopt a policy that permits authentication by electronic or computer-generated signature.  The policy shall identify those categories of the medical staff, allied health staff or other personnel within the hospital who are authorized to authenticate patient records using electronic or computer-generated signatures.

 

5)         At a minimum, the policy shall include adequate safeguards to ensure confidentiality, including, but not limited to, the following:

 

A)        Each user shall be assigned a unique identifier that is generated through a confidential access code.

 

B)        The hospital shall certify in writing that each identifier is kept strictly confidential.  This certification shall include a commitment to terminate a user's use of a particular identifier if it is found that the identifier has been misused.  "Misused" shall mean that the user has allowed another person or persons to use his or her personally assigned identifier, or that the identifier has otherwise been inappropriately used.

 

C)        The user shall certify in writing that he or she is the only person with user access to the identifier and the only person authorized to use the signature code.

 

D)        The hospital shall monitor the use of identifiers periodically and take corrective action as needed.  The process by which the hospital will conduct the monitoring shall be described in the policy.

 

6)         A system employing the use of electronic signatures or computer-generated signature codes for authentication shall include a verification process to ensure that the content of authenticated entries is accurate.  The verification process shall include, at a minimum, the following provisions:

 

A)        The system shall require completion of certain designated fields for each type of document before the document may be authenticated, with no blanks, gaps or obvious contradictory statements appearing within those designated fields.  The system shall also require that previously authenticated entries are corrected or supplemented by additional entries, separately authenticated and made after the original entry.

 

B)        The system shall allow the user to verify that the document is accurate and that the signature has been properly recorded.

 

C)        The hospital shall, as part of its quality assurance activities, periodically sample records generated by the system to verify the accuracy and integrity of the system.

 

7)         A user may terminate authorization for use of electronic or computer-generated signature upon written notice to the Director of Medical Records or other person designated by the hospital's policy.

 

8)         Each report generated by a user shall be separately authenticated.

 

d)         Indexing

 

1)         A patient index that serves as a key to the location of the medical record of each person who is or has been an inpatient shall be maintained as a perpetual master index.  A daily register of patients admitted to the hospital and babies born in the hospital shall be maintained.

 

2)         Medical records shall be classified and indexed according to diagnoses, surgical procedures, and physician, and other indices shall be developed as deemed necessary for the advancement of medical care.

 

3)         The International Classification of Diseases shall be used as the statistical classification for purposes of uniformity and compatibility of data between and among hospitals.

 

e)         Preservation

 

1)         All original medical records or photographs of records shall be preserved in accordance with Section 6.17 of the Act.

 

2)         The hospital shall have a policy for the preservation of patient medical records if the hospital closes.

 

3)         Prior to completing a change of ownership pursuant to Section 250.120(g) and (h), the buyer and seller shall inform the Department which party is responsible for record preservation.  If one single party is not responsible for complete record preservation, then the parties shall provide the Department with a list identifying the records each party is responsible for preserving.  No new license will be issued to the new person, legal entity, or partnership until the plan for record preservation is submitted to the Department.

 

(Source:  Amended at 43 Ill. Reg. 12990, effective October 22, 2019)

 

Section 250.1520  Reports

 

a)         Each hospital shall submit reports containing such pertinent data as may reasonably be required by the Department to fulfill its responsibilities under the Act and this Part.

 

b)         In the reporting of communicable disease cases, the hospital shall comply with the Control of Communicable Diseases Code.

 

c)         See Sections 250.1830 and 250.1840 regarding reports pertaining to mothers and infants, and regarding children to be discharged to a person other than a biological parent.

 

d)         See Section 250.1830 regarding birth, fetal death and death reports.

 

e)         The death of a pregnant person or the death of a person within one year following the termination of that person's pregnancy shall be reported to the Department as required by the Department's rules titled Maternal Death Review and in Section 250.1830(i)(2).  This is required regardless of the type of hospital or the reason for the patient's admission.

 

f)         Any incident or occurrence in a hospital that could be considered a catastrophe or creates a potential immediate jeopardy or dangerous threat that requires the transfer of patients to other parts of the facility or other facilities, including but not limited to fire, flood, or power failure, shall be reported to the Department within 24 hours after the occurrence.  Reports shall be made to the Department via email at:  DPH.HospitalReports@illinois.gov.

 

g)         Reporting Opioid Overdoses

 

1)         As used in this Section, the following definitions apply:

 

"Overdose" – has the same meaning as provided in Section 414 of the Illinois Controlled Substances Act.

 

"Health care professional" – a physician licensed to practice medicine in all its branches, a physician assistant, or an advanced practice registered nurse licensed in Illinois.

 

2)         When treatment is provided in a hospital's emergency department, a health care professional who treats a drug overdose, hospital administrator, or the designee of either shall report the case to the Department of Public Health within 48 hours after providing treatment for the drug overdose or at such time the drug overdose is confirmed.

 

3)         The hospital shall report to the Department the following information electronically or on forms provided by the Department:

 

A)        Whether an opioid antagonist was administered and, if yes, the name of the antagonist;

 

B)        The cause of the overdose, including, but not limited to, whether the overdose was caused by an opioid or heroin; and

 

C)        The demographic information of the person treated.  The demographic information shall include, but is not limited to, the patient's:

 

i)          Age;

 

ii)         Sex;

 

iii)        Federal Information Process Standards county code;

 

iv)        Zip code;

 

v)         Race, using the Centers for Disease Control and Prevention (CDC) race category; and

 

vi)        Ethnicity, using the CDC ethnicity group.

 

4)         The person completing the form shall not disclose the name, address, or any other personal information of the individual experiencing the overdose.

 

5)         The identity of the person and hospital reporting under this subsection (g) shall not be disclosed to the subject of the report. For the purposes of this subsection (g), the health care professional, hospital administrator, or designee making the report, and his or her employer, shall not be held criminally, civilly, or professionally liable for reporting under this subsection (g)(5), except for willful or wanton misconduct.  (Section 6.14g of the Act)

 

h)         Each hospital shall notify the Department within 24 hours after receiving a notice of impending strike of staff providing direct care.  The hospital shall submit a strike contingency plan to the Department no later than three calendar days prior to the impending strike.

 

i)          Hospitals without a licensed pediatric unit that provide limited inpatient or observation services to pediatric patients (neonate (less than 28 days of age) to 14 years old) shall report the following information to the Department quarterly on the form available at: https://dph.illinois.gov/topics-services/health-care-regulation/hospitals.html:

 

1)         The number of pediatric patients admitted or under observation;

 

2)         The number of pediatric mortalities;

 

3)         The number of pediatric patients admitted and ultimately transferred; and

 

4)         A breakdown of those pediatric patients that were transferred via the emergency department, post-procedure, or from an in-patient or observation status setting.

 

j)          Consulting hospitals shall report the following information to the Department quarterly, on the form available at: https://dph.illinois.gov/topics-services/health-care-regulation/hospitals.html:

 

1)         The number of pediatric consultations provided; and

 

2)         The costs incurred for providing the pediatric consultations.

 

(Source:  Amended at 48 Ill. Reg. 450, effective December 20, 2023; expedited correction at 48 Ill. Reg. 5807, effective December 20, 2023)

SUBPART M: FOOD SERVICE

 

Section 250.1610  Dietary Department Administration

 

a)         Organization

            There shall be an organized department of dietetics, and a well defined plan of operation designed to meet the needs of the patients whether the services are centralized, decentralized or provided under contractual agreement.

 

b)         Staffing:  Dietetic Service Director

            The dietetic department shall be directed by a full-time person who is qualified by dietetic and food service management training and experience, preferably a registered dietitian, whose responsibilities shall include, but are not limited to, the following:

 

1)         developing written policies and procedures to include but not necessarily be limited to:

 

A)        responsibilities and authority for the operation;

 

B)        standards of nutritional care for all regular and therapeutic diets including supplemental feedings;

 

C)        medically prescribed diet orders and alterations in diets or diet schedules such as holding trays, late trays, and times for accepting diet changes;

 

D)        patient tray identification;

 

E)        food preparation, storage and service;

 

F)         personal hygiene;

 

G)        sanitation and safety;

 

H)        ancillary dietetic services including food storage preparation and service in kitchens and dining areas on patient care units; formula supply; vending operation; and ice making;

 

I)         conferences--departmental and interdepartmental, clinical, executive and/or administrative;

 

J)         training programs for personnel; and

 

K)        patient education programs.

 

2)         planning menus for all general and therapeutic diets in accordance with the current recommended Daily Dietary Allowances of the Food and Nutrition Board, National Research Council, and in accordance with the principles of good dietetic management;

 

3)         planning, organizing, directing, controlling and evaluating all management aspects of the dietetic services including such things as budget and/or interpretations of financial reports; purchasing and/or requisitioning food, dietetic supplies and equipment, food costs, food storage; food preparation; food service; safety; sanitation; record keeping; personnel scheduling and evaluating;

 

4)         planning, implementing and/or conducting education programs for orientation, on-the job training, in-service and continuing education on a regular, routinely scheduled basis for all dietary and other appropriate personnel, and staff development sessions for all professional staff;

 

5)         administering all the nutritional aspects of patient care including, but not necessarily limited to:

 

A)        taking nutrition histories and recording in patients' medical charts;

 

B)        interviewing patients regarding food habits;

 

C)        giving diet counseling to patients and their families; encouraging patient participation in planning their own diets;

 

D)        participating in appropriate ward rounds and conferences, or by other methods; sharing specialized knowledge with medical and nursing staffs and other appropriate interdisciplinary team members involved in the care of the patient;

 

E)        consulting with patient care team(s).

 

c)         Consultation

 

1)         When the full-time dietetic service director, for legitimate, documented reasons, is not a qualified registered dietitian or qualified nutritionist, the hospital shall employ a qualified registered dietitian on a part-time (minimum of 20 hours per week) or on a consulting basis. The hours of consultation in the hospital shall be dependent upon the size, needs and complexity of the hospital and dietetic service but in no case shall there be less than a minimum of eight hours of consultation per month.

 

2)         If consultant dietetic services are used, the consultant's visits are to be at appropriate times and of sufficient duration and frequency to provide continuing liaison with medical, nursing and patient care teams; to advise the administrator; to give patient counseling; to give guidance to the director and staff of the dietetic service; to approve all menus and administrative nutritional aspects of patient care; to participate in development and/or revisions of dietetic policies and procedures; and to assist with planning and conducting orientation, in-service and continuing education programs for dietary and other appropriate personnel.

 

d)         Staff

 

1)         There shall be sufficient number of properly trained and supervised dietary personnel, including a clinical dietitian(s) where warranted, competent to carry out all the functions of the dietetic service in an efficient, effective manner.

 

2)         Dietary personnel shall be so scheduled on duty that the dietary department is open, and in service, a minimum of 12 hours a day.

 

e)         Health and Hygiene

 

1)         Personnel shall be in good health; free of infections or communicable disease; and free of boils, infected wounds, sores or lesions.  Persons suspected of having a communicable, contagious or infectious disease shall be subject to the measures outlined in the Department's current Regulations for the Control of Communicable Diseases (77 Ill. Adm. Code 690)" and the Department's current "Food Service Sanitation Rules and Regulations".

 

2)         The outer clothing of all employees shall be clean and street clothing shall not be worn as outer clothing by employees while engaged in the preparation and serving of food.

 

3)         Employees shall wear hair nets, headbands or other effective hair restraints to prevent the contamination of food or food-contact surfaces.

 

4)         Employees shall thoroughly wash their hands and exposed portions of their arms with soap and warm water before starting work; during work as is necessary to keep them clean; and after smoking, eating, drinking or using toilet.  Employees shall keep their fingernails clean and trimmed.

 

5)         Except where tasting food is part of the job, employees shall consume food only in designated dining areas.  An area shall not be designated as a dining area if consuming food there might result in contamination of other food, equipment, utensils, or other items needed protection.

 

6)         Employees shall not use tobacco in any form while engaged in food preparation or service, nor while in equipment or utensil washing or food preparation areas. Employees shall use tobacco in any form only in designated areas.  An area shall not be designated for that purpose if the use of tobacco there might result in contamination of food, equipment, utensils, or other items needing protection.

 

7)         Employees shall handle soiled tableware in a way that avoids contamination of their hands.

 

8)         In the event food service employees are assigned duties outside the dietetic service, these duties do not interfere with the sanitation, safety, or time required for dietetic work assignments.

 

9)         Employees shall maintain a high degree of personal cleanliness and shall conform to good hygienic practices.

 

Section 250.1620  Facilities

 

a)         Appropriate facilities shall be provided for receiving; food storage; food preparation; tray make-up; food portioning; dining; utensils and dishwashing; record keeping and other necessary administrative and clinical functions of the service.

 

b)         Dietary areas shall be appropriately located, adequate in size, well lighted, properly ventilated, and equipped with the proper kinds, sizes and amounts of equipment required to carry out the sanitation and safety objectives of the dietetic service program.  (See the Department's current rule, "Food Service Sanitation" (77 Ill. Adm. Code 750) for specific details.)

 

c)         Regulations for the construction and maintenance of the physical facilities shall be governed by the Department's current rules on "Food Service Sanitation (77 Ill. Adm. Code 750).

 

Section 250.1630  Menus and Nutritional Adequacy

 

a)         Menus shall be prepared at least one week in advance.  Menus for the current week shall be dated and posted.  Menus shall be kept on file no less than 30 days.

 

b)         Menus shall be planned, and followed, to meet the nutritional needs of patients in accordance with physicians' orders and, to the extent medically possible, in accordance with the current recommended Dietary Allowances established by the Food and Nutrition Board, National Research Council.  When changes in the current day's menu are necessary, substitutions shall provide equal nutritive value and shall be recorded on the original menu.

 

c)         Menus shall be different for the same day of consecutive weeks.

 

d)         Supplies of staple foods for a minimum of a one week period and supplies of perishable foods for a minimum of a two day period shall be maintained on the premises.  Supplies shall be appropriate to meet the requirements of the menu.

 

e)         Records of all food purchased shall be kept on file for less than 30 days.

 

Section 250.1640  Diet Orders

 

a)         All diets shall be ordered by the patient's attending physician and/or a registered dietitian with the attending physician's confirmation. Diet orders shall be recorded in the patient's medical chart.

 

b)         All diet orders shall be sent to the dietetic service department in writing.  Each diet order shall have sufficient pertinent information to enable the dietetic service to serve the diet as prescribed by the physician.

 

c)         Appropriate records for patients shall be maintained in the dietetic service department. These records shall contain pertinent information that will be helpful to the patient's nutritional care.

 

Section 250.1650  Frequency of Meals

 

a)         To the extent medically possible, a minimum of three or their equivalent, shall be served daily, at regular hours with no more than a 14 hour span between a substantial evening meal and breakfast.

 

b)         To the extent medically possible, bedtime nourishment shall be offered to all patients.

 

Section 250.1660  Therapeutic (Modified) Diets

 

a)         Diets shall be medically prescribed and recorded in the patient's medical chart.

 

b)         Therapeutic (modified) diet menus shall be planned in writing and served as ordered with supervision or consultation from the dietitian.

 

c)         A current diet manual approved by the dietitian and medical staff shall be available for use in the dietetic service department and a copy shall be conveniently located at each patient care unit for use by physicians, nurses and other appropriate staff.  Nutritional deficiencies for each type of diet shall be included in the diet manual.  Diet manuals should be reviewed and updated at least every five years or more frequently if necessary.

 

Section 250.1670  Food Preparation and Service

 

a)         Food shall be prepared in sufficient quantities and by appropriate methods that conserve the nutritive value, flavor and appearance.  They shall be prepared according to standardized recipes and a file of such recipes shall be available for use by cooks and other appropriate personnel.

 

b)         Foods shall be attractively served at the proper temperatures and in a form to meet individual needs.

 

c)         Where appropriate, patients shall be encouraged to eat in a dining room that is attractive, well lighted, and appropriately equipped.  In said dining rooms there shall be tables available of sufficient height to accommodate wheelchairs, stryker frames and/or other similar equipment. Over-bed tables shall be provided for patients who eat their meals in bed or in their rooms.

 

d)         Special assistive eating devices shall be available and provided as ordered by the physician or his designee.

 

e)         If a patient refuses the food served, appropriate substitutes of similar nutritive value shall be offered or other appropriate action shall be taken upon the advice of the dietitian.

 

Section 250.1680  Sanitation

 

The hospital shall comply with the Department's current rule "Food Service Sanitation" (77 Ill. Adm. Code 750), a copy of which shall be available in the dietary department.  All dietary employees shall be familiar with and abide by these rules and regulations.

SUBPART N: HOUSEKEEPING AND LAUNDRY SERVICES

 

Section 250.1710  Housekeeping

 

a)         There shall be an organized housekeeping department, under competent supervision.

 

b)         The director of housekeeping services shall be responsible to the chief executive officer either directly or through a designated department head.  The director shall be qualified for the position by education, training, and experience.

 

1)         The number of supervisory and support personnel shall be related to the size and complexity of the facility and to the scope of the services provided.

 

2)         In order to guide personnel in providing a hygienic environment for patients and staff, specific housekeeping procedures shall be developed and available for all departments and services.  They shall identify techniques and product used and shall include, but not be limited to the following:

 

A)        the use, cleaning, and care of equipment;

 

B)        the cleaning of specialized areas, such as the surgical suite, obstetrical suite, newborn nursery, central service, and isolation rooms.

 

            It is recommended that high risk areas be assigned to the same personnel on a routine basis.

 

C)        the selection, measurement, and proper use of housekeeping and cleaning supplies, their storage, and transportation.

 

D)        the maintenance of cleaning schedules;

 

E)        techniques for evaluation of cleaning effectiveness;

 

F)         maintaining liaison with the infection control committee in order to determine appropriate action based on the results of any microbiological evaluations performed; and

 

G)        personal hygiene.

 

c)         There shall be documentation of participation by housekeeping personnel in a relevant continuing education program.

 

d)         The entire facility, including but not limited to the floors, walls, windows, doors, ceilings, fixtures, equipment, and furnishings, shall be maintained in good repair, clean and free of insects, rodents and trash.

 

1)         Dusting, mopping, and vacuum cleaning shall be done in a manner which will not spread dust or other particulate matter.

 

2)         Adequate supplies and equipment for housekeeping functions shall be provided with cleaning compounds and hazardous substances properly labeled and stored.

 

3)         Hazardous cleaning solutions, compounds, and substances shall be labeled, stored in a safe place, and kept in an enclosed section separate from other cleaning materials.

 

4)         Exhaust ducts from kitchens and other cooking areas shall be equipped with proper filters and cleaned at regular intervals. The ducts shall be cleaned and inspected no less than twice a year or more often if necessary.

 

5)         The storage of paints and oils in patient areas shall not be permitted.

 

6)         Venetian blinds, decorative curtains and draperies shall be of fire resistant materials and shall be kept clean at all times.  Venetian blinds, decorative curtains and draperies shall be prohibited in delivery rooms, high risk or critical care nurseries, emergency rooms, and in major and minor surgeries.  When control of excessive sunlight is necessary, washable pull shades (to be damp dusted daily) may be used. Curtains, draperies, and venetian blinds, if used elsewhere in the hospital, shall be kept clean.  For flame spread ratings, see Subpart T of these requirements.

 

7)         After the discharge of a patient, the bed, bedding, and room furnishings used by such patient shall be thoroughly cleaned.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.1720  Garbage, Refuse and Solid Waste Handling and Disposal

 

a)         All garbage and refuse shall be collected, stored, and disposed of in a manner that will not permit the transmission of a contagious disease, create a nuisance or fire hazard, or provide a breeding place for vermin or rodents.

 

b)         Solid waste shall be handled in a safe and sanitary manner within the facility. Garbage and refuse receptacles within the facility shall be made of metal or other appropriate material provided with disposable liners or shall be cleaned and disinfected after each emptying. Receptacles in areas where wet or hazardous wastes are generated shall have tight fitting lids and shall be kept closed except during use.  Carts used for transport shall be of easily cleanable construction, and shall be kept in a sanitary condition. Trash chutes shall comply with Subpart T or Subpart U, and shall be kept clean and sanitary. Pulping-transport systems, if installed, shall be operated and maintained in a safe and sanitary manner.  All refuse shall be in impervious bags during transport within the facility.  Potentially infectious material shall be identified and bagged in durable bags resistant to puncture and tears. Waste may be single-bagged if it can be put in the bag without contaminating the outside, otherwise double-bagging is required. Wastes capable of producing injury, such as needles and scalpel blades, shall be stored and transported in rigid containers.  Blood specimens shall be disposed of pursuant to 29 CFR 1910.1030.  For handling of radioactive wastes, see Subpart F.

 

c)         Collected garbage and refuse shall be stored in stable, durable, watertight, vermin and rodent proof containers, with tight fitting lids.  Lids shall be kept closed except during use.  Containers shall be emptied at frequent intervals, and shall be kept clean and sanitary.  Garbage storage areas shall be kept in a clean and nuisance-free condition.

 

d)         Final disposal of general hospital solid waste may be by incineration (see Subpart T or Subpart U), grinding and flushing to the municipal sewerage system, or removal to a sanitary landfill.  Incinerators shall be approved by the Illinois Environmental Protection Agency, for the types of wastes being generated.  Sanitary landfills shall be approved by the Illinois Environmental Protection Agency.  Surgical, obstetrical, and other tissue wastes shall be disposed of by grinding and flushing, incineration, or burial.  Other potentially infectious wastes shall be rendered safe by grinding and flushing, incineration or steam autoclaving.

 

e)         Alternative systems will be permitted when approved in writing by the Department.

 

f)         Any potentially infectious medical waste such as blood, blood components, organs, semen, or other human tissue, and any other materials or paraphernalia exposed to, or contaminated by, blood, blood components, organs, semen, or other human tissue shall be completely incinerated, sterilized, or sealed in order to render the materials innocuous before disposal or removal from the premises.

 

1)         The incineration of materials shall be done in accordance with the requirements of the Pollution Control Board concerning the operation of an incinerator (35 Ill. Adm. Code 724).

 

2)         The sterilization of materials shall be done by autoclaving the materials in accordance with the recommendations of the manufacturer of the autoclave. The effectiveness of the autoclave shall be verified and documented at least weekly with a biological spore assay containing B. stearothermophilus.

 

3)         Incinerated or sterilized materials shall be disposed of through routine waste disposal methods without precautions against possible contamination.

 

4)         Materials that have not been incinerated or sterilized shall be disposed of by a waste hauler with a permit from the Illinois Environmental Protection Agency under the rules of the Pollution Control Board (35 Ill. Adm. Code 809). These materials shall be sealed, transported, and stored in biohazard containers. These containers shall be marked "Biohazard," shall bear the universal biohazard symbol, and shall be orange, orange and black, or red. The containers shall be rigid and puncture-resistant, such as a secondary metal or plastic can with a lid that can be opened by a step-on pedal. These containers shall be lined with one or two high density polyethylene or polypropylene plastic bags with a total thickness of at least 2.5 mil. or equivalent material. The containers that are marked "Biohazard" shall be sealed before being removed from the hospital.

 

(Source:  Amended at 39 Ill. Reg. 13041, effective September 3, 2015)

 

Section 250.1730  Insect and Rodent Control

 

Any condition on the hospital site conducive to the harborage or breeding of insects, rodents, or other vermin shall be prohibited.

 

a)         All outside doors, windows, and other openings except in air-conditioned buildings where doors and windows are normally kept closed and opened for minimal use, automatically operated doors or infrequently used fire exits shall be effectively screened during the entire fly season. Screens shall be kept in good repair and shall have not less than sixteen meshes per inch.  All screen doors shall open outward where building design permits and be equipped with self-closing devices.  Fire and panic laws shall be considered in screen installation and maintenance.

 

b)         Other methods of preventing the entrance of insects, such as blast-fans, electrocution screens, fly traps, sprays, etc., may be used but only as a supplement to the use of screens.  Fly strips, paper, swatters, insecticide sprays and powders, fly traps, etc., shall be used only in such a manner and place that dead, injured, or affected insects, or the spray or powder itself, cannot fall on or otherwise come in contact with any food or food product.

 

c)         All rooms, particularly those where food is stored, prepared, cooked, or served, and those used for washing and/or storage of dishes and utensils shall be free from insects, rodents, or other vermin.

 

d)         Any chemical substance of a poisonous nature used to control or eliminate various types of vermin shall be properly colored or labeled to identify it as a poison. Identification and storage shall be in accordance with local, state, and federal regulations.  Such substances shall not be stored with or near any food or food preparation utensils or equipment.  Extreme care shall be taken during use to prevent any such poisons from contaminating any food or food product or patient contact material.

 

e)         If pest control services are contracted with an outside firm, that firm must be licensed by the Department as a Pest Control Business.  If services are provided by hospital personnel, and restricted-use pesticides are applied, the person responsible for the application must be certified by the Department as an Institutional-multi-housing pest control operator.

 

f)         There shall be an up-to-date list of all pest control products used in the facility, areas where they are used, and areas where specific formulations must not be used. This document must be readily available, in case of accidental poisoning.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.1740  Laundry Service

 

a)         Laundry Service shall be provided by an organized laundry service under competent supervision or by contract with another entity.

 

1)         If laundry services are provided by an outside firm or another hospital, a written contract shall be available.  It shall specify that the laundry meets the same standards required for an in-hospital unit. The linens must be transported in sanitary vehicles.  Clean and soiled linens must not be transported in the same vehicle at the same time.

 

2)         Equipment and construction shall be as required in Subpart T and Subpart U.

 

b)         The hospital laundry shall be:

 

1)         Located in such relationship to other areas that steam, odors, lint and objectionable noises do not reach patient or personnel areas.

 

2)         Well-lighted, ventilated and adequate in size for the needs of the hospital and for the protection of employees.

 

3)         Maintained in a safe, sanitary, lint free condition and kept in good repair.

 

4)         Not part of a storage area.

 

c)         An adequate supply of clean linen shall be provided for at least three complete bed changes for the hospital's licensed bed capacity.

 

d)         There shall be written procedures developed and maintained pertaining to the handling, storage, transportation and processing of linens in such manner that will prevent the spread of infection and will assure the maintenance of clean linen.

 

e)         All linens shall be mechanically washed using soap or detergent and warm or hot water. Linens shall be disinfected by using one of the following procedures:

 

1)         Thermal Disinfection:  Linen must be exposed to water with a minimum of hot water at least 160 degrees Farenheit for a cumulative time of at least 25 minutes.

 

2)         Chemical and Thermal Disinfection:  Linen must be exposed to wash and bleach bath water at least 140 degrees Farenheit. The bleach bath must be at least 10 minutes long and have a starting bleach concentration of 100 ppm. This bleach concentration should be measured by titration on a periodic basis.

 

3)         Other:  A step-wise wash process which has been previously documented by microbiological study published in a scientific journal. The results must indicate no surviving pathogenic microorganisms and a low level of other organisms. Low level is defined as nine out of ten samples with less than two colonies per ten square centimeters of test surface.

 

f)         All washed linens shall be thoroughly rinsed. A neutralizing rinse is recommended.

 

g)         Separate areas shall be maintained in the hospital for storage of clean linen and for storage of soiled linen.  Linen storage areas shall be adequate in size for the needs of the hospital and shall not be used for any other purpose.  Storage shall not be permitted in areas or rooms where plenums of air conditioning or ventilating systems are located.

 

h)         Handwashing and toilet facilities for laundry personnel shall be provided at locations convenient to the laundry.

 

i)          Soiled and clean linen carts shall be so labeled and provided with covers made of washable materials which shall be laundered or suitably cleaned daily.

 

(Source:  Amended at 15 Ill. Reg. 13811, effective October 1, 1991)

 

Section 250.1750  Soiled Linen

 

a)         Each of the following classes of laundry shall be separately transported, stored and washed:

 

1)         Soiled diapers.

 

2)         Newborn nursery linen.

 

3)         All radioactive contaminated linen.

 

4)         Linen from pathology.

 

b)         Isolation and other potentially infectious linens shall be bagged at the location where they are used in durable, leak-proof bags resistant to puncture and tears and shall be labeled or identified as infectious at the site of use.

 

c)         Soiled linen shall not be sorted or pre-rinsed in patient care areas. Soiled linen may be sorted in a separate enclosed room by a person instructed in methods of infection control.  These personnel shall not have responsibility for immediately handling clean linen.

 

d)         Soiled linen shall be stored and transported in a manner which does not permit contamination of clean linen, corridors and areas occupied by patients.

 

e)         All carts and other containers used to store or to transport clean or soiled linen shall be identified for soiled linen only or for clean linen only and shall be kept covered when not in use.

 

f)         If laundry chutes are used for transporting soiled linen, all soiled linen shall be bagged.  The chutes shall be designed to maintain a negative air pressure within the chute and shall be kept in a clean and sanitary condition.

 

(Source:  Amended at 15 Ill. Reg. 13811, effective October 1, 1991)

 

Section 250.1760  Clean Linen

 

a)         Clean linen shall be sorted, handled and transported in such a manner as to prevent cross contamination.

 

b)         Clean linen carts shall be used only for the purpose of transportation or storage of clean linen.

 

c)         Persons processing clean linen shall be dressed in clean garments at all times while on duty. They shall not handle soiled linen.

 

d)         Clean linen received from a commercial laundry shall be completely wrapped in convenient size bundles or otherwise protected and be delivered to a designated clean area of the hospital.

 

e)         Clean linens shall be adequately protected from contamination.  Clean linen in patient care units shall be stored in clean, ventilated closets, rooms or alcoves, used for that purpose only. Corridors shall not be used for storage of linen.

 

f)         If clean linen is stored in the laundry area, it shall be stored in a room separate from the sorting room, laundry room or soiled linen room.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

SUBPART O: OBSTETRIC AND NEONATAL SERVICE

 

Section 250.1810  Applicability of Other Provisions of this Part

 

The requirements set forth elsewhere in this Part (excluding Subpart P and Subpart Q), shall apply to the operation of obstetric hospitals and to obstetric and neonatal departments of general hospitals.

 

(Source:  Amended at 36 Ill. Reg. 17413, effective December 3, 2012)

 

Section 250.1820  Obstetric and Neonatal Service (Perinatal Service)

 

a)         Provision of Care

 

1)         All hospitals licensed as general hospitals by the Department shall provide for the admission, medical care, transfer or discharge of obstetric and neonatal patients.

 

2)         No hospital shall fail to provide obstetric or neonatal care without the written consent of the Director or the Director's designee.

 

3)         Each hospital providing perinatal services shall comply with the perinatal care standards in the Regionalized Perinatal Health Care Code.

 

4)         Every hospital shall ensure that it has the proper instruments available for taking a pregnant women’s blood pressure.  (Section 11.1a of the Act)

 

b)         Location

 

1)         Obstetric and neonatal services shall be located and arranged to provide maximum protection for obstetric and neonatal patients from infection and cross-infection from one another, patients in other services of the hospital and staff and visitors.

 

2)         Obstetric and neonatal facilities shall be located in an area of the hospital that prevents through-traffic to any other part of the hospital.

 

c)         Adequacy of Services

 

The hospital shall have well-organized obstetric and neonatal services that are adequately supervised by qualified personnel and with the necessary space, facilities, equipment, and personnel to provide obstetric and neonatal services in compliance with the hospital's designated level of care pursuant to the Regionalized Perinatal Health Care Code.

 

d)         Obstetric and Neonatal Service Plan

 

1)         Hospitals providing obstetric and neonatal services shall develop a plan for the management of the obstetric and neonatal patients that meets the requirements of this Subpart and the requirements of the Regionalized Perinatal Health Care Code applicable to the hospital's level of care, as designated by the Department.  The plan shall be developed by the nursing department and medical staff and shall be approved by the governing authority of the hospital.

 

2)         The hospital's written Obstetric and Neonatal Service Plan and level of care shall be known to medical staff and nursing personnel to obstetric and nursery personnel.  A copy of the Plan shall be available in each obstetric and nursery unit and in every relevant hospital service area; the Plan shall be reviewed at least every three years and revised as indicated by the review.

 

e)         Levels of Care

 

1)         Care shall be provided to obstetric and neonatal patients according to the following levels level of specialized care as defined in the Regionalized Perinatal Health Care Code:

 

A)        Non-Birthing Center hospitals do not provide perinatal services, but have a functioning emergency department.  A letter of agreement shall delineate, but is not limited to, guidelines for transfer/transport of perinatal patients who are transferred to an appropriate perinatal care hospital in accordance with the non-birthing center hospital's letter of agreement with an Administrative Perinatal Center.

 

B)        Level I hospitals provide care to low-risk pregnant women and newborns, operate general care nurseries and do not operate a Neonatal Intensive Care Unit (NICU) or a Special Care Nursery (SCN).

 

C)        Level II hospitals provide care to women and newborns at moderate risk, operate intermediate care nurseries and do not operate a NICU or an SCN.

 

D)        Level II hospitals with Extended Neonatal Capabilities (IIE) provide care to women and newborns at moderate risk and do operate an SCN but do not operate a NICU.

 

E)        Level III hospitals care for patients requiring increasingly complex care, operate a NICU, and provide multidisciplinary consultation and supervision for those patients with medical and surgical problems that require highly specialized treatment and highly trained personnel.

 

2)         Service Management Plan

 

A)        A service management plan shall be provided for all levels of care for all patients.  The plan shall provide for consultation services and shall establish the services for early diagnosis of obstetric, fetal and neonatal problems.  The plan shall include an infection control risk assessment and policy and procedures if the hospital allows water births.  Hospitals that are not designated to provide all levels of care shall maintain plans for the safe transfer of patients who require a higher level of care to hospitals with more specialized facilities, services and personnel, pursuant to the Regionalized Perinatal Health Care Code.

 

B)        When the condition permits, a patient may be transferred from the Level III facility to a Level II facility that is nearest the family residence or another facility that can provide the appropriate level of care, in accordance with the Regionalized Perinatal Health Care Code.

 

f)         Infection Control

 

1)         The hospital shall follow procedures approved by the hospital's infection control committee, including procedures for the isolation of known or suspected cases of infectious disease in the obstetric and neonatal departments.

 

2)         The hospital shall establish policies and procedures for infection control in the obstetric and neonatal departments that are consistent with the Guidelines for Perinatal Care;  Section 250.1100 of this Part; the Control of Tuberculosis Code; and the recommendations in the American Academy of Pediatrics Red Book, Report of the Committee on Infectious Diseases.

 

3)         The policy for infection control in the obstetric and neonatal departments shall include, but not be limited to, the following:

 

A)        Health personnel shall:

 

i)          Show evidence of prior rubella infection or rubella vaccination and comply with the health assessment and immunization requirements of Section 250.450 (Personnel Health Requirements).  Health care personnel in obstetric and neonatal services shall comply with any additional requirements for health and immunizations, pursuant to the hospital's policies and procedures for infection control in the obstetric department;

 

ii)         Wash hands to the elbows with an antiseptic agent using a procedure developed and posted by the infection control committee before entering the nursery at the beginning of a shift, and before handling infants for the first time. Hands shall be washed before and after touching each infant and after touching any object. Fingernails shall be kept short.  Artificial fingernails or anything other than clear polish is not acceptable;

 

iii)        Remove all rings, watches and bracelets before hand washing and entering the nursery.

 

B)        The hospital's infection control committee shall establish a dress code for employees and visitors in compliance with the Guidelines for Perinatal Care.

 

C)        An infected newborn shall be placed in an isolation room with separate scrub facilities if the following conditions are not met in the newborn nursery (see Section 250.2440(h) for additional requirements):

 

i)          Adequate nursing and medical staff for unhurried movement between patients;

 

ii)         Adequate time for thorough hand washing between patients and gowning;

 

iii)        Sufficient space (4 to 6 feet) for easy movement between patients so that staff will not move from one patient to another without hand washing;

 

iv)        A continuing program of instruction for all nursery personnel on the mode of spread of infections; and

 

v)         At least two sinks for each nursery room.

 

D)        The hospital shall develop infection control guidelines consistent with the Guidelines for Perinatal Care for infants born outside the hospital, other than transfers, or under conditions not aseptic, or born of mothers with membranes ruptured 24 hours or more, or born of mothers suspected of harboring infectious disease, with careful attention to proper aseptic technique of attending personnel and to conditions described in subsection (f)(3)(C) of this Section.

 

E)        Infection control for the obstetric department shall include procedures for disinfection of patient areas consistent with Guidelines for Perinatal Care and the unit's procedures manual.

 

F)         Policies and procedures for water births shall include an infection control risk assessment by the hospital's infection control committee to identify potential sources of infection for the mother and infant and recommendations for mitigating infections during water deliveries.  The policies and procedures shall be provided to the Department, upon request.

 

g)         Combined Facilities

 

1)         Obstetric and clean gynecologic service facilities may be combined in accordance with a plan that complies with the requirements of this Subpart.  The combined service program, its functional operations and detailed requirements shall be approved by the hospital obstetric and newborn service, medical staff, and governing authority.

 

2)         In combined programs, caesarean section and obstetrically related surgery, other than vaginal delivery, shall be carried out in a designated and approved operating or delivery room.  In combined programs, vaginal deliveries shall be carried out only in designated and approved delivery rooms or designated and approved operating rooms used solely for obstetric and clean gynecologic procedures.

 

3)         Gynecologic service and obstetric service may be provided in a combined Obstetric and Gynecologic Service, or clean gynecologic cases may be admitted to the postpartum nursing unit of an obstetric service in accordance with the hospital's Obstetric and Neonatal Service Plan.

 

4)         Only members of the medical staff with appropriate privileges may admit and care for patients in combined service areas.  Admission shall be strictly controlled and be subject to the final authority delineated in the medical staff bylaws and approved by the hospital governing authority.  The hospital's infection control committee shall provide close surveillance of the services.

 

5)         Patients admitted to combined service facilities of hospitals with approved programs shall be limited to:

 

A)        Obstetric patients admitted for delivery;

 

B)        Clean obstetric complications (regardless of month of gestation); and

 

C)        Selected clean gynecologic patients.

 

6)         A gynecologic and obstetric patient's eligibility for admission shall comply with the hospital's infection control policy.

 

7)         On a daily basis, unoccupied reserve beds in the combined facilities shall be ready for use by obstetric patients, pursuant to hospital policy.

 

8)         Patients admitted to the combined services may be taken to x-ray or other hospital facilities for diagnostic procedures, if the procedures do not pose an infection risk or other hazard to the patient or to other patients on the combined service.

 

9)         Patients may receive postpartum or immediate postoperative care in the general recovery room prior to being returned to the combined service floor if the following conditions exist (refer to Section 250.1320(a)):

 

A)        The recovery room or intensive care unit is a separate unit adjacent to or part of the general surgical operating suite and delivery suite;

 

B)        The recovery room or intensive care unit contains no patients with known or suspected infectious or communicable disease or other adverse conditions;

 

C)        The recovery room is under the direct supervision of the anesthesia service (see Section 250.1410); and

 

D)        Health care professionals providing care to post-surgical obstetric or gynecologic patients in a separate recovery room have training consistent with that required for health care professionals providing care in the general recovery room.

 

10)        Nursing care of all patients shall be supervised by a registered nurse qualified to provide supervision.

 

11)        Nursing care of all patients may be provided by the same personnel.

 

12)        Visiting regulations for obstetric patients shall apply to all patients admitted to the combined facilities (refer to Section 250.1830(k)).

 

h)         Activity Records

 

1)         The hospital shall establish and keep daily records, including a Patient Log and the Obstetric Services Daily Census Report, from which required reports can be prepared.

 

2)         The Patient Log shall contain, at a minimum, the following data on each patient admitted to the department other than obstetric patients:

 

A)        Name of patient or hospital patient number;

 

B)        Age;

 

C)        Attending physician's name;

 

D)        Date of admission;

 

E)        Admitting diagnosis;

 

F)         Operative procedure;

 

G)        Discharge diagnosis;

 

H)        Date of discharge;

 

I)         Days stay;

 

J)         Transferred off floor

 

Yes        Date                           ; No        ; and

 

K)        Reason for transfer.

 

3)         An Obstetric Service Daily Census Report shall be kept that, for each day of the month, gives the patient census (at the census-taking hour) of:

 

A)        obstetric patients, including patients with clean obstetric complications;

 

B)        gynecologic patients;

 

C)        empty beds in the department; and

 

D)        total patients.

 

4)         The hospital shall submit required reports pursuant to the Regionalized Perinatal Health Care Code.

 

(Source:  Amended at 46 Ill. Reg. 8914, effective May 12, 2022)

 

Section 250.1830  General Requirements for All Obstetric Departments

 

a)         The temperature and humidity in the nurseries and in the delivery suite shall be maintained at a level best suited for the protection of mothers and infants as recommended by the Guidelines for Perinatal Care.  Chilling of the neonate shall be avoided; a non-stable neonate shall, immediately after birth, be placed in a radiant heat source that is ready to receive the infant and that allows access for resuscitation efforts.  The radiant heat source shall comply with the recommendations of the Guidelines for Perinatal Care.  When the neonate has been stabilized, if the mother wishes to hold her newborn, a radiant heater or pre-warmed blankets shall be available to keep the neonate warm.  Stable infants shall be placed, and remain, in direct skin-to-skin contact with their mother immediately after delivery to optimally support infant breastfeeding and to promote mother/infant bonding.  Personnel shall be available who are trained to use the equipment to maintain a neutral thermal environment for the neonate.  For general temperature and humidity requirements, see Section 250.2480(d)(1).  In general, a temperature between 72 degrees and 76 degrees and relative humidity between 35% and 60% are acceptable.

 

b)         Linens and Laundry:  Linens shall be cleaned and disinfected in compliance with the Guidelines for Perinatal Care.

 

1)         Nursery linens shall be washed separately from other hospital linens.

 

2)         No new unlaundered garments shall be used in the nursery.

 

c)         Sterilizing equipment, as required in Section 250.1090, shall be available.  Sterilizing equipment may be provided in the obstetric department or in a central sterilizing unit, provided that flash sterilizing equipment or adequate sterile supplies and instruments are provided in the obstetric department.

 

d)         Accommodations and Facilities for Obstetric Patients

 

1)         The hospital shall identify specific rooms and beds, adjacent when possible to other obstetric facilities, as obstetric rooms and beds.  These rooms and beds shall be used exclusively for obstetric patients or for combined obstetric and clean gynecological service beds in accordance with Section 250.1820(g).

 

2)         Patient rooms and beds that are adjacent to another nursing unit may be used for clean cases as part of the adjacent nursing unit.  A corridor partition with doors is recommended to provide a separation between the obstetric beds and facilities and the non-obstetric rooms.  The doors shall be kept closed except when in active use as a passageway.

 

3)         Facilities shall be available for the immediate isolation of all patients in whom an infectious condition inimical to the safety of other obstetric and neonatal patients exist.

 

4)         Labor rooms shall be convenient to the delivery rooms and shall have facilities for examination and preparation of patients.  Each room used for labor, delivery and postpartum (see Section 250.1870) shall include a bathroom equipped with a toilet and a shower. The bathroom also shall include a sink, unless a sink is located in the patient room. The bathroom shall be directly accessible from the patient room without going through the corridor.

 

5)         Delivery rooms shall be equipped and staffed to provide emergency resuscitation for infants pursuant to the recommendation of the American Academy of Pediatrics and ACOG and shall comply with the American Academy of Pediatrics/American Health Association's American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC) of Pediatric and Neonatal Patients:  Neonatal Resuscitation Guidelines.

 

6)         If only one delivery room is available and in use, one labor room shall be arranged as an emergency delivery room and shall have a minimum clear floor area of 180 square feet.

 

7)         The patient shall be kept under close observation until the patient's condition is stabilized following delivery.  Observations at established time intervals shall be recorded in the patient's medical record.  A recovery area shall be provided. Emergency equipment and supplies shall be available for use in the recovery area.

 

e)         Accommodations and Facilities for Infants

 

1)         Level I nurseries:

 

A)        A clean nursery or nurseries shall be provided, near the mothers' rooms, with adequate lighting and ventilation.  A minimum of 30 square feet of floor area for each bassinet and 3 feet between bassinets shall be provided.  Equipment shall be provided to prevent direct draft on the infants.  Individual nursery rooms shall have a capacity of six to eight neonates or 12 to 16 neonates.  The normal newborn infant care area in a smaller hospital shall limit room size to eight neonates, with a minimum of two rooms available to permit cohorting in the presence of infection.

 

B)        Bassinets equipped to provide for the medical examination of the newborn infant and for the storage of necessary supplies and equipment shall be provided in a number to exceed obstetric beds by at least 20% to accommodate multiple births, extended stay, and fluctuating patient loads.  Bassinets shall be separated by a minimum of 3 feet, measuring from the edge of one bassinet to the edge of the adjacent one.

 

C)        A glass observation window shall be provided through which infants may be viewed.

 

D)        Resuscitation equipment as described in subsection (e)(1)(E)(iii), and personnel trained to use it, shall be available in the nursery at all times.

 

E)        Each nursery shall have necessary equipment immediately available to stabilize the sick infant prior to transfer.  Equipment shall consist of:

 

i)          A heat source capable of maintaining the core temperature of even the smallest infant at 98 degrees (an incubator, or preferably a radiant heat source);

 

ii)         Equipment with the ability to monitor bedside blood sugar;

 

iii)        A resuscitation tray containing equipment pursuant to the American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC) of Pediatric and Neonatal Patients: Neonatal Resuscitation Guidelines; and

 

iv)        Equipment for delivery of 100% oxygen concentration, and the ability to measure delivered oxygen in fractional inspired concentrations (FI O₂) pursuant to AAP recommendations.  The oxygen analyzer shall be calibrated and serviced according to the manufacturer's instructions at least monthly by the hospital's respiratory therapy department or other responsible personnel trained to perform the task.

 

F)         Consultation and Referral Protocols shall comply with the Regionalized Perinatal Health Care Code.

 

2)         Level II and Level III nurseries shall comply with the Regionalized Perinatal Health Care Code.  Cribs shall be separated by 4 to 6 feet to allow for ease of movement of additional personnel, and to allow space for additional equipment used in care of infants in these areas.  New buildings or additions or material alterations to existing buildings that affect the Level II with Extended Neonatal Capabilities nursery shall provide at least 70 square feet of space for each infant.

 

3)         A Level III nursery shall provide 80 to 100 square feet of space for each infant.

 

4)         Facilities shall be available for the immediate isolation of all newborn infants who have or are suspected of having an infectious disease.

 

5)         When an infectious condition exists or is suspected of existing, the infant shall be isolated in accordance with policies and procedures established and approved by the hospital and consistent with recommended procedures of the Guidelines for Perinatal Care and the Control of Communicable Diseases Code.

 

f)         The personnel requirements and recommendations set forth in Subpart D apply to the operation of the obstetric department, in addition to the following:

 

1)         Each hospital shall have a staffing plan for nursing personnel providing care for obstetric and neonatal patients.  The registered nursing components of the plan shall comply with Section 250.1130 of this Part, with requirements for the level of perinatal care, as designated in accordance with the Regionalized Perinatal Health Care Code, the Guidelines for Perinatal Care, the National Association of Neonatal Nurses' (NANN) Position Statement #3074 RN Staffing in the NICU, and the following parameters:

 

A)        Nursing supervision by a registered nurse shall be provided for the entire 24-hour period for each occupied unit of the obstetric and neonatal services.  This nurse shall have education and experience in obstetric and neonatal nursing.

 

B)        At least one registered nurse trained in obstetric and nursery care shall be assigned to the care of mothers and infants at all times.  To prepare for an unexpected delivery, at least one registered nurse or LPN trained to give care to newborn infants shall be assigned at all times to the nursery with duties restricted to the care of the infants.  Infants shall never be left unattended.

 

C)        A registered nurse shall be in attendance at all deliveries and shall be available to monitor the mother's general condition and that of the fetus during labor, for at least two hours after delivery, and longer if complications occur.

 

D)        Nursing personnel providing care for obstetric and other patients shall be instructed on a continuing basis in the proper technique to prevent cross-infection.  When it is necessary for the same nurse to care for both obstetric and non-obstetric patients in the gynecologic unit, proper technique shall be followed.

 

E)        Obstetric and neonatal department nurses providing input to the hospital's nursing care committee pursuant to Section 250.1130 shall, prior to proposing their recommendations for the hospital's written staffing plan, consider the staffing standards listed in subsection (f)(1).

 

F)         Temporary relief from outside the obstetric and neonatal division by qualified personnel shall be permitted as necessary according to appropriate infection control policy.

 

G)        For each shift in the obstetric department, at least one of the registered nurses or LPNs shall also have certification or experience in lactation training, pursuant to the requirements of subsection (k).

 

2)         Nursing staff – Level I requirements for occupied units.  These units shall meet the following requirements in addition to General Care Requirements in Section 250.1830(f)(1).

 

A)        At least two nursing personnel shall be assigned per shift.  One shall be a registered nurse and one shall be a registered nurse or an LPN.

 

B)        The capability to provide neonatal resuscitation in the delivery room shall be demonstrated by the current completion of a nationally recognized neonatal resuscitation program by medical, nursing and respiratory care staff or a hospital rapid response team, in accordance with the requirements of the Regionalized Perinatal Health Care Code.

 

C)        Hospitals shall have the capability for continuous electronic maternal-fetal monitoring for patients, with staff available 24 hours a day, including physician and nursing, who are knowledgeable of electronic maternal-fetal monitoring use and interpretation.  Physicians and nurses shall complete a competence assessment in electronic maternal-fetal monitoring every two years, in accordance with the Regionalized Perinatal Health Care Code.

 

3)         Nursing staff – Level II requirements for occupied units.  These units shall meet the requirements for Level I in subsection (f)(2).  Nursery personnel may be shared with the Level I nursery as needed.

 

4)         Nursing staff – Level II with Extended Neonatal Capabilities requirements for occupied units.  In addition to the requirements in subsection (f)(3), the obstetric-newborn nursing services shall be directed by a full-time registered nurse experienced in perinatal nursing. Preference shall be given to registered nurses with a master's degree.

 

5)         Nursing staff – Level III requirements for occupied units.  These units shall meet the following requirements in addition to requirements in subsection (f)(3).  Half of all neonatal intensive care direct nursing care hours shall be provided by registered nurses who have two years or more of nursing experience in a Level III NICU.  All neonatal intensive care direct nursing care hours shall be provided or supervised by registered nurses who have advanced neonatal intensive care training and documented competence in neonatal pathophysiology and care technologies used in the NICU.

 

6)         Medical personnel

 

A)        Each hospital providing obstetric services shall have an organized obstetric staff with a chief of obstetric service.  The chief's level of qualification and expertise shall be appropriate to the hospital's designated level of care.  The responsibilities of the chief of obstetric services shall include the following requirements, as they relate to the care of obstetric patients:

 

i)          General supervision of the care of the perinatal patients assigned to the unit;

 

ii)         Establishment of criteria for admissions;

 

iii)        Adherence to licensing requirements;

 

iv)        Adoption, by the medical staff, of standards of practice and privileges;

 

v)         Identification of clinical conditions and procedures requiring consultation;

 

vi)        Arrangement of conferences, held at least quarterly, to review operations, complications and mortality;

 

vii)       Assurance that the clinical records, consultations and reports are properly completed and analyzed; and

 

viii)      Provision for exchange of information between medical, administrative and nursing staffs.

 

B)        Each hospital providing pediatric services shall have an organized pediatric staff with a chief of pediatric service.  The chief's level of qualification and expertise shall be appropriate to the hospital's designated level of care.  The responsibilities of the chief of pediatric services shall include those listed in subsection (f)(6)(A), as they relate to the care of newborn infants.

 

C)        Level I shall comply with the Regionalized Perinatal Health Care Code:

 

i)          One physician shall be Chief of Obstetrical Care.  The Chief of Obstetrical Care shall be a board certified or board qualified obstetrician.  If this is not possible, a physician with experience and regular practice may be the Chief and be responsible for obstetrical care and available on a 24-hour basis, and a source of obstetric or maternal fetal medicine consultation shall be documented when indicated.

 

ii)         One physician shall be Chief of Pediatric Service.  The Chief of Pediatric Service shall be a board certified or board qualified pediatrician.  If this is not possible, a physician with experience and regular practice may be the Chief and be responsible for pediatric care and available on a 24-hour basis, and a source of neonatology consultation shall be documented when indicated.

 

D)        Level II shall comply with the Regionalized Perinatal Health Care Code:

 

A board certified obstetrician shall be Chief of Obstetrical Care.  A board certified pediatrician shall be Chief of Neonatal Care.  Obstetrical anesthesia shall be directed by a board certified anesthesiologist with experience and competence in obstetrical anesthesia.  Hospital staff shall also include a pathologist and an on call radiologist 24 hours a day.  Specialized medical and surgical consultation shall be readily available.

 

E)        Level II With Extended Neonatal Capabilities:  Staffing shall comply with the Regionalized Perinatal Health Care Code.

 

F)         Level III:  Staffing shall comply with the Regionalized Perinatal Health Care Code.

 

g)         Practices and procedures for care of mothers and infants:

 

1)         The hospital shall follow procedures approved by the infection control committee for the isolation of known or suspected cases of infectious disease in the obstetric department.

 

2)         Patients with clean obstetric complications (regardless of month of gestation), such as pregnancy-induced hypertension for observation and treatment, placenta previa for observation or delivery, ectopic pregnancy, and hypertensive heart disease in a pregnant patient, may be admitted to the obstetric department and be subject to the same requirements as any other obstetric case.  (See Section 250.1820(g)(6).)

 

3)         The physician shall determine whether a prenatal serological test for syphilis and a test for HIV have been done on each mother and the results recorded. If no tests have been done before the admission of the patients, the tests shall be performed as soon as possible pursuant to the Perinatal HIV Prevention Act.  Specimens for a syphilis test may be submitted in appropriate containers to an Illinois Department of Public Health laboratory for testing without charge.  Mothers shall be tested for Group B streptococcus prior to delivery and for Hepatitis B prior to discharge of either mother or infant, pursuant to AAP recommendations.

 

4)         No obstetric patient under the effect of an analgesic or an anesthetic, in the second stage of labor or delivery, shall be left unattended at any time.

 

5)         Fetal lung maturity shall be established and documented prior to elective inductions and caesarean sections if the infant is at less than 39 weeks of gestation, or 38 weeks of gestation for twins.  The hospital shall establish a written policy and procedure concerning the administration of oxytocic drugs.

 

A)        Oxytocin shall be used for the contraction stress test only when qualified personnel, determined by the hospital staff and administration, can attend the patient closely.  Written policies and procedures shall be available to the team members assuming this responsibility.

 

B)        The oxytocin solution shall be administered intravenously via a controlled infusion device, using both a primary intravenous solution and a secondary oxytocin solution.

 

C)        Oxytocin shall be used for medical induction or stimulation of labor only when qualified personnel, determined by the hospital staff and administration, can attend the patient closely.  Written policies and procedures shall be available to the team members assuming this responsibility.  The following shall be included in these policies:

 

i)          An attending physician shall evaluate the patient for induction or stimulation, especially with regard to indications.

 

ii)         The physician or other individuals starting the oxytocin shall be familiar with its effect and complications and be qualified to identify both maternal and fetal complications.

 

iii)        A qualified physician shall be immediately available as is necessary to manage any complication effectively.

 

iv)        During oxytocin administration, the fetal heart rate; the resting uterine tone; and the frequency, duration and intensity of contractions shall be monitored electronically and recorded.  Maternal blood pressure and pulse shall be monitored and recorded at intervals comparable to the dosage regimen; that is, at 30 to 60 minute intervals, when the dosage is evaluated for maintenance, increase or decrease.  Evidence of maternal and fetal surveillance shall be documented.

 

6)         Identification of infants:

 

A)        While the neonate is still in the delivery room, the nurse in the delivery room shall prepare identical identification bands for both the mother and the neonate, as outlined in the hospital's policy.  Wrist bands alone may be used; however, it is recommended that both wrist and ankle bands be used on the neonate.  The hospital shall not use foot-printing and fingerprinting alone as methods of patient identification.  The bands shall indicate the mother's admission number, the neonate's sex, the date and time of birth, and any other information required by hospital policy.  Delivery room personnel shall review the bands prior to securing them on the mother and the neonate to ensure that the information on the bands is identical.  The nurse in the delivery room shall securely fasten the bands on the neonate and the mother without delay as soon as the nurse has verified the information on the identification bands.  The birth records and identification bands shall be checked again before the neonate leaves the delivery room.

 

B)        If the condition of the neonate does not allow the placement of identification bands, the identification bands shall accompany the neonate and shall be attached as soon as possible, as outlined in the hospital's policy.  Identification bands shall not be left unattached and unattended in the nursery.

 

C)        When the neonate is taken to the nursery, both the delivery room nurse and the admitting nursery nurse shall check the neonate's identification bands and birth records, verify the sex of the neonate, and sign the neonate's medical record.  The admitting nurse shall complete the bassinet card and attach it to the bassinet.

 

D)        When the neonate is taken to the mother, the nurse shall check the mother's and the neonate's identification bands, verify the sex of the neonate and verify that the information on the bands is identical.

 

E)        The umbilical cord (cords, with multiple births) shall be identified according to hospital policy (e.g., by the use of a different number of clamps) so that umbilical cord blood specimens are correctly labeled.  All umbilical cord blood samples shall be labeled correctly with an indication that these are a sample of the neonate's umbilical cord blood and not the blood of the mother.

 

F)         The hospital shall develop a newborn infant security system.  This system shall include instructions to the mother regarding safety precautions designed to avoid abduction.  Electronic sensor devices may be included as well.

 

7)         Within one hour after delivery, ophthalmic ointment or drops containing tetracycline or erythromycin shall be instilled into the eyes of the newborn infant as a preventive against ophthalmia neonatorum.  The eyes shall not be irrigated. 

 

8)         A single parenteral dose of vitamin K-1, water soluble to 0.5-1.0 milligrams, shall be given to the infant, shortly after birth, but usually within the first hour after delivery, as a prophylaxis against hemorrhagic disorder in the first days of life.

 

9)         Mandatory Hearing Screening

 

A)        Each hospital shall conduct bilateral hearing screening of each newborn infant prior to discharge unless medically contraindicated or the infant is transferred to another hospital before the hearing screening can be completed. (Section 5(a) of the Early Hearing Detection and Intervention Act)

 

B)        The hospital performing the hearing screening shall report the results of the hearing screening to the Department within 7 days after screening.

 

i)          If there is no hearing screening result or an infant does not pass the hearing screening in both ears at the same time, the hospital shall refer the infant's parents or guardians to a health care practitioner for follow-up, and document and report the referral, including the name of the health care practitioner, to the Department in a format determined by the Department.

 

ii)         For infants born outside a hospital, the newborn's primary care provider shall refer the patient to a hospital for the hearing screening to be done in compliance with the Act and this Section within 30 days after birth, unless a different time period is medically indicated. (Section 5(b) of the Early Hearing Detection and Intervention Act)

 

10)        Each infant shall be given complete individual crib-side care.  The use of a common bath table is prohibited.  Scales shall be adequately protected to prevent cross-infection.

 

11)        Artificial feedings and formula changes shall not be instituted except by written order of the attending physician, pursuant to the requirements of the Hospital Infant Feeding Act.

 

12)        Facilities for drug services.  See Section 250.2130(a).

 

13)        Newborn infants shall be transported from the delivery room to the nursery in a safe manner.  Adequate support systems (heating, oxygen, suction) shall be incorporated into the transport units for infants (e.g., to x-ray).  Chilling of the newborn and cross-infection shall be avoided. If travel is excessive and through other areas, special transport incubators may be required.  The method of transporting infants from the nursery to the mothers shall be individual, safe and free from cross-infection hazards.

 

14)        The stay of the mother and the infant in the hospital after delivery shall be planned to allow the identification of problems and to reinforce instructions in preparation for the infant's care at home.  The mother and infant shall be carefully observed for a sufficient period of time and assessed prior to discharge to ensure that their conditions are stable.  Healthy infants shall be discharged from the hospital simultaneously with the mother, or to other persons authorized by the mother, if the mother remains in the hospital for an extended stay.  Follow-up shall be provided for mothers and infants discharged within 48 hours after delivery, including a face-to-face encounter with a health care provider who will assess the condition of mother and infant and arrange for intervention if problems are identified.

 

15)        When a patient's condition permits, an infant may be transferred from an intensive care nursery to the referring nursery or to another nursery that is nearest the home and at which an appropriate level of care may be provided.  Transfers shall be conducted pursuant to the Regionalized Perinatal Health Care Code.

 

16)        The hospital shall have a policy regarding circumcisions performed by a Mohel.

 

17)        Circumcisions shall not be performed in the delivery room or within the first six hours after birth.  A physician may order and perform a circumcision when the infant is over the age of six hours and, in the physician's professional judgment, is healthy and stable.

 

18)        The hospital shall comply with the Guidelines for Perinatal Care and Guidelines for Women's Health Care (see Section 250.160).

 

h)         Medical Records

 

1)         Obstetric records:

 

A)        Adequate, accurate, and complete medical records shall be maintained for each patient.  The medical records shall include findings during the prenatal period, which shall be available in the obstetric department prior to the patient's admission and shall include medical and obstetric history, observations and proceedings during labor, delivery and the postpartum period, and laboratory and x-ray findings.

 

B)        Records shall be maintained in accordance with hospital medical records policies and procedures, including the applicable requirements of the Health Insurance Portability and Accountability Act and the minimum observations and laboratory tests outlined in Guidelines for Perinatal Care and Guidelines for Women's Health Care.  The physician director of the obstetric department shall require all physicians delivering obstetric care to send copies of the prenatal records, including laboratory reports, to the obstetric unit at or before 37 weeks of gestation, including updates from that time until admission.

 

2)         Infant records.  Accurate and complete medical records shall be maintained for each infant.  The medical records shall include:

 

A)        History of maternal health and prenatal course, including mother's HIV status, if known.

 

B)        Description of labor, including drugs administered, method of delivery, complications of labor and delivery, and description of placenta and amniotic fluid.

 

C)        Time of birth and condition of infant at birth, including the Apgar score at one and five minutes, the age at which respiration became spontaneous and sustained, a description of resuscitation if required, and a description of abnormalities and problems occurring from birth until transfer from the delivery room.

 

D)        Report of a complete and detailed physical examination within 24 hours following birth; report of a physical examination within 24 hours before discharge and daily during any remaining hospital stay.

 

E)        Physical measurements, including length, weight and head circumference at birth, and weight every day; temperature twice daily.

 

F)         Documentation of infant feeding: intake, content, and amount if by formula.

 

G)        Clinical course during hospital stay, including treatment rendered and patient response; clinical note of status at discharge.

 

3)         The hospital shall keep a record of births that contains data sufficient to duplicate the birth certificate.  The requirement may be met by:

 

A)        Retaining the yellow "hospital copy" of the birth certificate properly bound in chronological order, or

 

B)        Retaining this copy with the individual medical record.

 

i)          Reports

 

1)         Each hospital that provides obstetric and neonatal services shall submit a monthly perinatal activities report to its affiliated Administrative Perinatal Center.

 

2)         Maternal death report

 

A)        The hospital shall submit an immediate report of the occurrence of a maternal death to the Department, in accordance with the Department's Maternal Death Review rules (77 Ill. Adm. Code 657).  Maternal death is the death of any woman dying of any cause whatsoever while pregnant or within one year after termination of the pregnancy, irrespective of the duration of the pregnancy at the time of the termination or the method by which it was terminated.  A death shall be reported regardless of whether the death occurred in the obstetric department or any other section of the hospital, or whether the patient was delivered in the hospital where death occurred, or elsewhere. 

 

B)        The filing of this report shall in no way preclude the necessity of filing a death certificate or of including the death on the Perinatal Activities Report.

 

3)         The hospital shall comply with the laws of the State and the rules of the Department in the preparation and filing of birth, death and fetal death certificates.

 

4)         Epidemic and communicable disease reporting

 

A)        The hospital shall develop a protocol for the management and reporting of infections consistent with the Control of Communicable Diseases Code, the Perinatal HIV Prevention Act, Guidelines for Perinatal Care and Guidelines for Women's Health Care, and as approved by the infection control committee.  These policies shall be known to obstetric and nursery personnel.

 

B)        The hospital shall particularly address those infections specifically related to mothers and infants, including but not limited to, methicillin-resistant Staphylococcus Aureus occurring in infants under 61 days of age, ophthalmia neonatorum, and perinatal hepatitis B infection.

 

j)          Infant Feeding Policy

 

1)         For the purposes of this subsection (j): 

 

A)        Baby-Friendly Hospital Initiative means the voluntary program sponsored by the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) that recognizes hospitals that meet certain evaluation criteria regarding the promotion of breastfeeding.

 

B)        Infant Nutrition Resource means breastfeeding education and infant formula safety and preparation.

 

2)         Infant Feeding Policy Required

 

A)        Every hospital that provides birthing services must adopt an infant feeding policy that promotes breastfeeding. In developing the policy, a hospital shall consider guidance provided by the Baby-Friendly Hospital Initiative.

 

B)        An infant feeding policy adopted under this Section shall include guidance on the use of formula for medically necessary supplementation, if preferred by the mother, or when exclusive breastfeeding is contraindicated for the mother or for the infant.

 

3)         Communication of Policy. A hospital shall routinely communicate the infant feeding policy to staff in the hospital's obstetric and neonatal areas, beginning with hospital staff orientation. The hospital shall also ensure that the policy and infant nutrition resources are posted in a conspicuous place in the hospital's obstetric or neonatal area or on the hospital's Internet or Intranet web site or on the Internet or Intranet web site of the health system of which the hospital is a part. The hospital shall make copies of the policy available to the Department upon request.

 

4)         Application of Policy. A hospital's infant feeding policy adopted under the Hospital Infant Feeding Act must apply to all mother-infant couplets in the hospital's obstetric and neonatal areas. (Sections 5 through 20 of the Hospital Infant Feeding Act)

 

k)         Breast Milk and Formula

 

1)         Pursuant to the requirements of subsection (j), the hospital shall provide the mother with information regarding lactation, the nutritional benefits of breast milk, and lactation support organizations within the area. The hospital staff shall include, at a minimum, lactation support staff with certification or experience in lactation training. The lactation support staff shall attend continuing education in relation to lactation counseling and training, consistent with hospital policy. At least one lactation support staff shall be on duty at all times in the obstetric department.

 

2)         Pursuant to the requirements of subsection (j), the hospital shall have a policy for the preparation of formula by hospital staff when hospital-prepared formula is needed in place of commercially prepared formula. Adequate space, equipment and procedures for processing, handling and storing commercially-prepared formula shall be provided.

 

A)        All hospitals providing obstetric or pediatric services that prepare their own formula shall provide a well-ventilated and well-lighted formula room, which shall be adequately supervised and used exclusively for the preparation of formulas.

 

B)        Equipment shall include hand-washing facilities with hot and cold running water with knee, foot or elbow controlled valves; a double-section sink for washing and rinsing bottles; facilities for storing cleaning equipment, refrigeration facilities; utensils in good condition for preparation of formulas; cupboard and work space and a work table; an autoclave and a supply of individual formula bottles, nipples and protecting caps, adequate to prepare a 24-hour supply of formula and water for each infant.  Procedures shall be established by the hospital and enforced.

 

l)          Visiting Policy

 

1)         The visiting requirements set forth in Subpart B shall apply to obstetric departments, except as modified in this subsection (l).

 

2)         Each obstetric department shall have a visiting policy that complies with the Guidelines for Perinatal Care and is approved by the hospital's infection control committee. 

 

3)         The visiting policy shall cover all programs in the obstetric department.

 

4)         The visiting policy shall comply with the hospital's infection control policy and shall include signage instructing visitors to wash their hands.

 

m)        Infant Abduction Policies

Every hospital shall demonstrate to the Department that the following have been adopted:

 

1)         Procedures designed to reduce the likelihood that an infant patient will be abducted from the hospital.  The procedures may include, but need not be limited to, architectural plans to control access to infant care areas, video camera observation of infant care areas, and procedures for identifying hospital staff and visitors.

 

2)         Procedures designed to aid in identifying allegedly abducted infants who are recovered.  The procedures may include, but need not be limited to, foot-printing infants by staff who have been trained in that procedure, photographing infants, and obtaining and retaining blood samples for genetic testing. (Section 6.15 of the Act)

 

n)         Staff Continuing Education Policies and Requirements.

 

1)         Hospitals shall have a written policy and conduct continuing education yearly (calendar) for providers and staff of obstetric medicine and of the emergency department and other staff that may care for pregnant or postpartum women.  The written policy and continuing education shall include yearly educational modules regarding management of severe maternal hypertension and obstetric hemorrhage and other leading causes of maternal mortality for units that care for pregnant or postpartum women.

 

2)         Hospitals shall demonstrate compliance by annually submitting a copy of the facility's written policy, education, and training requirements to the hospital's Administrative Perinatal Center. (Section 2310-222(b) of the Department of Public Health Powers and Duties Law)

 

o)         Hospitals shall incorporate best practices for timely identification and assessment of all pregnant and postpartum women for common pregnancy or postpartum complications in the emergency department and for care provided by the hospital throughout the pregnancy and postpartum period, to be provided to the hospital by the Department, in consultation with the Illinois Perinatal Quality Collaborative, into the written policy required in subsection (n). (Section 2310-222(d) of the Department of Public Health Powers and Duties Law)

 

(Source:  Amended at 46 Ill. Reg. 15597, effective September 1, 2022)

 

Section 250.1840  Discharge of Newborn Infants from Hospital

 

a)         No hospital, nor anyone connected with any hospital, shall place a child for adoption or for foster family care unless the hospital is licensed as a child welfare agency.

 

b)         A hospital shall discharge a newborn infant only to the following:

 

1)         The biological parent;

 

2)         An intended mother, pursuant to the Gestational Surrogacy Act;

 

3)         An intended father, pursuant to the Gestational Surrogacy Act;

 

4)         An adult relative (parent, brother, sister, uncle or aunt) or friend of the mother or father;

 

5)         An officer of a court of competent jurisdiction or other named person, upon presentation of an order from a court that the child be discharged to the officer's custody; or

 

6)         A representative of an Illinois licensed child welfare agency, or the Illinois Department of Children and Family Services, or the Illinois Youth Commission, upon presentation of written authorization by the agency to have the child discharged to the representative's custody; or a representative of any other social agency who presents written authorization by the Department of Children and Family Services to have the child discharged to the representative's custody.

 

c)         If the newborn is to be discharged to an adult relative or friend as provided in subsection (b)(4), the hospital shall obtain the mother's written consent, naming and identifying the relative or friend.

 

d)         When a newborn is discharged to any person other than the biological mother, which is confirmed via identification bands, the hospital shall require proof of the person’s identity, per a government-issued photo ID, and signature of receipt for the newborn.  The hospital shall require proof of identity of the biological mother before discharging the newborn if the newborn is discharged separately from the biological mother.

 

e)         Education on Sudden Infant Death Syndrome Prior to Discharge

 

1)         A hospital shall provide, free of charge, information and instructional materials regarding sudden infant death syndrome (SIDS), explaining the medical effects upon infants and young children and emphasizing measures that may reduce the risk. The materials shall include information concerning safe sleep environments developed by the American Academy of Pediatrics or a statewide or nationally recognized SIDS or medical association.

 

2)         The information and materials described in subsection (e)(1) shall be provided to parents or legal guardians of each newborn, upon discharge from the hospital. Prior to discharge, a nurse or appropriate staff person shall review the proffered materials with the infant's parents or legal guardian and shall discuss best practices to reduce the incidence of SIDS as recommended by the American Academy of Pediatrics.

 

3)         Nothing in this subsection (e) prohibits a hospital from obtaining free and suitable information from a public or private agency. (Section 11.7 of the Act)

 

(Source:  Amended at 46 Ill. Reg. 8914, effective May 12, 2022)

 

Section 250.1845  Caesarean Birth

 

a)         A hospital may permit the father or a support person to be present at a delivery by caesarean birth if the program is part of the hospital's Obstetric and Neonatal Service Plan.  Nothing in this Part shall be construed to require a hospital to permit the father or a support person to attend caesarean births.  This Part does not vest any right upon any lay person to attend a caesarean birth.  The operating physician shall always have the right to exclude a father or support person from a caesarean birth for any reason.  For the purposes of this Section, a support person is the husband of the mother, the father of the infant, or any other person selected by the mother, who is acceptable to the physician and meets the requirements of the hospital's policies.

 

b)         The hospital's Obstetric and Neonatal Service Plan shall include:

 

1)         Criteria for admitting the father or other support person to the delivery by caesarean birth;

 

2)         Education, counseling or other preparation furnished to the mother and father or to the support person attending a caesarean birth; and

 

            3)         Operating room procedures and assignments for caesarean birth.

 

(Source:  Added at 36 Ill. Reg. 17413, effective December 3, 2012)

 

Section 250.1850  Single Room Postpartum Care of Mother and Infant

 

The following requirements apply when postpartum care is provided to a mother and her infant in the same room:

 

a)         The patient's room shall be of sufficient size and arrangement for the bedside care of the mother and infant.

 

b)         The patient's room shall be equipped with a toilet, a hand-washing lavatory and a supply of clean towels.

 

c)         Equipment and supplies shall include:

 

1)         Separate equipment and supplies for the mother and the infant;

 

2)         Separate enclosed storage space for the infant's clean linen, equipment and supplies; and

 

3)         Adequate covered containers for the infant's soiled linen.

 

d)         Single room postpartum care for the mother and infant shall meet the following requirements:

 

1)         The hospital's obstetric and neonatal service plan shall establish the conditions of the mother and infant that are appropriate for mother and infant postpartum care in the same room.

 

2)         All nursing care of the mother and infant shall be given by the same nurse on each shift.

 

3)         Adequate observation and nursing care shall be assured.

 

4)         The care of mothers and infants shall include procedures to prevent cross-infection, emphasizing conscientious hand washing by parents, visitors and personnel, and the careful handling of soiled linen.

 

5)         Adequate nursery facilities shall be provided for periods when infants are not with their mothers.

 

(Source:  Amended at 36 Ill. Reg. 17413, effective December 3, 2012)

 

Section 250.1860  Special Programs (Repealed)

 

(Source:  Repealed at 36 Ill. Reg. 17413, effective December 3, 2012)

 

Section 250.1870  Labor, Delivery, Recovery and Postpartum Care

 

a)         Hospitals may establish a labor, delivery, recovery and postpartum care program in compliance with this Section.  The labor, delivery, recovery and postpartum care program may include the hospital's entire obstetric service or a specific portion of the hospital's obstetric service.

 

b)         General Description

 

1)         A labor, delivery, recovery and postpartum care program provides labor, delivery, recovery and postpartum care for a mother in one room.  The combination of functions in one room is designed to reduce the movement of the mother within the hospital.

 

2)         The labor, delivery, recovery and postpartum care program shall be coordinated with other obstetric services of the hospital.  Facilities for emergency caesarean deliveries shall be available.  Labor, delivery, recovery and postpartum rooms may be used in hospitals at all Level designations, except for caesarean deliveries, based on the hospital's program.

 

3)         Rooms used for labor, delivery, recovery and postpartum care shall include facilities for care of the infant during delivery and after birth.

 

c)         Program Operation

 

1)         The labor, delivery, recovery and postpartum obstetric service program shall be part of the hospital's maternity and neonatal services plan and shall include all of the policies and procedures that are required by this Section.

 

2)         The hospital shall have policies and procedures for assessing the level of risk for each patient, for determining which patients may not qualify for labor, delivery, recovery and postpartum care, and for referring patients to another hospital.

                       

3)         Any increases or decreases in the number of beds in the hospital's obstetric service that occur as a result of the establishment of a labor, delivery, recovery and postpartum care program may also require the approval of the Illinois Health Facilities and Services Review Board.  (See 77 Ill. Adm. Code 1100 and 1110.)

 

d)         Designation of Rooms.  The labor, delivery, recovery and postpartum  care program shall designate the specific rooms that will be used for labor, delivery, recovery and postpartum care.  These rooms may be used as patient rooms for other obstetric patients in the obstetric department at times when they are not being used for labor, delivery, recovery and postpartum care.

 

e)         Staffing Requirements

 

1)         The program shall include a staffing plan that meets the nursing needs of the patients.

 

2)         The program shall include provisions for specialized orientation and training for nurses and other health care personnel in the operation of the labor, delivery, recovery and postpartum care program, including the care of both mothers and infants.

 

f)         Physical Plant Requirements

 

1)         Each room used for labor, delivery, recovery and postpartum care shall be considered a private room.  Occupancy by two patients, the mother and the infant, shall be permitted.  Rooms for multiple patients are not otherwise permitted for labor, delivery, recovery and postpartum care.

 

2)    Architectural plans for new construction or remodeling that are required for the establishment or continued operation of a labor, delivery, recovery and postpartum care program shall be submitted to the Department for review and approval pursuant to the requirements of this Section and Section 250.2420.  The hospital shall not implement the program prior to the Department's approval of the program and of the architectural plans. 

 

3)          Each room used for labor, delivery, recovery and postpartum care shall include a minimum dimension of 12 feet and a minimum clear area of 250 square feet except as provided in subsection (f)(4) or (f)(6) of this Section.

 

4)         Rooms that were approved for use as "birthing rooms" by the Department prior to September 1, 1990 may continue to be used for labor, delivery, recovery and postpartum. The hospital shall continue to comply with the requirement of this Part.

 

5)         At least one delivery room with a minimum clear area of not less than 300 square feet shall be available for more complex deliveries and unanticipated risks. The delivery room shall be in the obstetric unit, on the same level as the rooms in which labor, delivery, recovery and postpartum care is provided, and accessible without passing through any areas used for functions other than labor, delivery, recovery and postpartum care, and without traversing any obstacles. In determining the accessibility of the delivery room, the Department will consider factors including, but not limited to, traffic patterns, corridor width, corridor width changes and the number of turns.

 

6)         The Department will approve rooms that contain a minimum dimension of 10 feet and a minimum clear area of 180 square feet  for labor, delivery, recovery and postpartum care, when the hospital demonstrates that all of the following conditions are met:

 

A)       Policies and procedures for assessing the level of risk for each patient, for determining which patients may not  qualify for labor, delivery, recovery and postpartum care, and for referring patients to other hospitals have been established and are being followed.

 

B)        The hospital participates in a Regional Perinatal Network and has been approved for Level I, Level II, or Level II extended neonatal care. The hospital does not provide Level III care as described in the Regionalized Perinatal Health Care Code.

 

C)        The medical staff of the hospital has approved the use of the rooms for labor, delivery, recovery and postpartum care based on the medical staff's judgment that this care can be provided safely within the rooms.

 

7)         For the purposes of this subsection (f), clear area shall include only useable space within the patient room and shall not include entry or vestibule areas  or space for fixed, immovable furniture.  The bathroom shall not be included in calculating the clear area of the patient room.

 

8)         Staff hand-washing sink

 

A)        Each room used for labor, delivery, recovery and postpartum care shall have direct access to a hand-washing sink for the exclusive purpose of staff hand washing prior to and during the delivery process.  The sink may be used for other purposes at other times.

 

B)        The staff hand-washing sink shall be adequate in size and appropriately equipped to allow thorough hand washing.

 

C)        The staff hand-washing sink may be located in the room, in the adjacent bathroom (if the bathroom is not shared with another patient room), or directly outside the room.

 

9)         Bathroom

 

A)        Each room used for labor, delivery, recovery and postpartum care shall include a bathroom equipped with a toilet and a shower or bathtub.  The bathroom shall also include a sink, unless a sink is located in the patient room.

 

B)        The bathroom shall be directly accessible from the patient room without going through the corridor.

 

10)       An area for gowning by staff and visitors prior to delivery shall be provided within or immediately adjacent to each room used for labor, delivery, recovery and postpartum care.

 

11)       Rooms used for postpartum care of the mother shall also comply with the patient room requirements of Section 250.2630(d)(1) or Section 250.2440(d)(1), as applicable.

 

12)       Adequate nursery facilities shall be provided for periods when infants are not with their mothers.

 

13)       Each room used for labor, delivery, recovery and postpartum care shall also comply with the following requirements:

 

A)        The mechanical requirements for patient rooms in Section 250.2480(e)(8) or Section 250.2660.

 

B)        The electrical requirements for patient rooms in Section 250.2500 or Section 250.2680.

 

14)       Wall, floor, and ceiling finishes shall be cleanable.  All finishes shall be able to withstand cleaning and treatment with chemicals and disinfectants.

 

g)         Equipment Requirements

 

1)         All equipment necessary for delivery, for emergency care of the mother, for infant care, and for infant resuscitation shall be available to each room used for labor, delivery, recovery and postpartum care.

 

2)         A complete set of delivery and infant care equipment shall be provided for every four or fewer rooms used for labor, delivery, recovery and postpartum care. For example:  if four rooms are used, one complete set of equipment shall be provided;  if five to eight rooms are used, two sets of equipment shall be provided; if nine to twelve rooms are used, three sets of equipment shall be provided.

 

3)         Equipment may be stored in an equipment alcove or closet in the room, or in a separate equipment storage room.  The equipment shall be accessible for use without passing through another patient room.  Each equipment storage area shall be located on the same floor and not more than 75 feet from each of the rooms served by the equipment storage area.

 

(Source:  Amended at 36 Ill. Reg. 17413, effective December 3, 2012)

SUBPART P: ENGINEERING AND MAINTENANCE OF THE PHYSICAL PLANT, SITE, EQUIPMENT, AND SYSTEMS – HEATING, COOLING, ELECTRICAL, VENTILATION, PLUMBING, WATER, SEWER, AND SOLID WASTE DISPOSAL

 

Section 250.1910  Maintenance

 

The hospital shall have an organized engineering and/or maintenance department under competent supervision.  The requirements of NFPA 99, Health Care Facilities Code, shall apply in addition to the following:

 

a)         The administrator shall be responsible for maintenance of the physical plant site, equipment and systems and may delegate responsibility to the proper employees. Maintenance services shall be under the supervision of a qualified engineer or persons who have had commensurate experience in the maintenance of public or private plants, preferably hospitals.

 

b)         Personnel engaged in maintenance activities shall receive orientation and follow-up training, including training in principles of asepsis, cross-infection control, and safe practices.

 

c)         The hospital shall have an effective, organized, detailed preventive maintenance program.  Written instructions for operating and maintaining equipment and the various mechanical, electrical, and other systems contained in the hospital shall be available to maintenance personnel.

 

d)         Maintenance and repairs shall be carried out in accordance with applicable codes, rules, regulations, standards and requirements of local jurisdictions, the State Fire Marshal, and the Department of Public Health.

 

e)         Space and equipment shall be provided for the managerial activities of the supervisor of maintenance for repair work and for storage of maintenance materials.  Paints and oils shall not be stored in patient areas.

 

f)         The hospital structure and its component parts and facilities shall be kept in good repair and maintained with consideration for the safety and comfort of the occupants of the building. Mechanical and electrical equipment shall be maintained in good repair and operating condition at all times.

 

g)         Roads, walks, and parking areas shall be properly maintained.  (Refer to Subpart T and Subpart U of this Part.)

 

(Source:  Amended at 35 Ill. Reg. 6386, effective March 31, 2011)

 

Section 250.1920  Emergency electric service

 

a)        

 

1)         It is required that existing hospitals provide emergency electric service as detailed under Section 250.2500(h) and Section 250.2680(h).

 

2)         Inspections and testing of emergency generators shall be weekly, with monthly testing under load.

 

b)         There shall be a biomedical electronics maintenance and safety program, under the supervision of a qualified individual.  This may be by contract with an outside firm or another hospital.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.1930  Water Supply

 

The Rules, of "Sanitary Practice for Drinking Water, Sewage Disposal and Rest Room Facilities" (77 Ill. Adm. Code 895) shall apply, except where those regulations and these requirements differ.  For differences and installation requirements, see Subpart T and Subpart U.

 

a)         Water supplies of medical facilities shall be operated in conformance with the following requirements:

 

1)         All water used in operation shall be provided from a public water supply or from an alternate source.  The source of water supply shall be approved by the department.

 

2)         The construction, maintenance, and operation of any treatment process which might change the physical, chemical, or bacterial characteristics of the water shall be approved by the Department.

 

3)         Hot water shall be available at sinks and lavatories at all times.  Water shall be adequate in volume and pressure for all medical purposes.

 

4)         The water system shall be operated with a hot water system adequate for all medical purposes.

 

5)         The hot water supply shall be regulated by thermostatic or other control devices which shall be either locked or located in places not accessible to patients or the general public so that the hot water used by patients and by the public is maintained at an even temperature which cannot cause personal injury.

 

6)         For installation requirements, see Subpart T and Subpart U of these requirements.

 

b)         As part of the disaster and mass casualty program, a plan for the emergency supply of water must be available.  This plan shall be approved by the Department, and shall include at least written contracts with any outside firms, a listing of procedures to be followed, the amounts of water needed by different departments, the means of dispensing water within the facility, and procedures for sanitizing in the case of contamination.  Plans utilizing existing piping are recommended.

 

Section 250.1940  Ventilation, Heating, Air Conditioning, and Air Changing Systems

 

Ventilation, heating, air conditioning, and air changing systems shall be provided, comply with Subpart T or Subpart U, and shall:

 

a)         be maintained in good repair and shall be operated in a manner which will prevent the spread of infection and provide for patient comfort;

 

b)         be maintained and operated in such manner that air shall not be circulated from operating rooms, patient isolation rooms, laboratories in which work is done in pathology, virology or bacteriology, autopsy rooms, kitchen and dishwashing areas, toilet and bathrooms, janitors' closets, storage rooms, shop areas and soiled linen to any other part of the facility;

 

c)         be provided, as needed, with acceptable air filtration equipment that is cleaned and serviced at adequate intervals; and

 

d)         assure that the relative humidity is maintained at a minimum of 50 percent in those areas where conductive floors are required.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.1950  Grounds and Buildings Shall be Maintained

 

a)        

 

1)         in a clean condition free of safety hazards;

 

2)         in such manner as will prevent standing water, flooding or leakage; and

 

3)         free of excessive noise, odors, pollens, dusts, or other environmental pollutants and such nuisances as may adversely affect the health or welfare of patients.

 

b)         Insect and Rodent Control (refer to Section 250.1730).

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.1960  Sewage, Garbage, Solid Waste Handling and Disposal

 

a)         All sewage and liquid wastes shall be disposed of in a municipal sewerage system where such facilities are available.  When a municipal sewerage system is not available, sewage and liquid wastes shall be collected, treated, and disposed of in an independent plant, the construction, maintenance, and operation of which are approved by the Department or by the Illinois Environmental Protection Agency.  For installation requirements, see Subpart T and Subpart U of these requirements.

 

b)         Garbage and Solid Wastes Handling and Disposal (refer to Section 250.1720.)

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.1970  Plumbing

 

All plumbing shall be designed, installed, and maintained in accordance with the requirements of the Illinois Plumbing Code (77 Ill. Adm. Code 890) except where that Code and these requirements differ.  For areas of difference, see Subpart T and Subpart U.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.1980  Fire and Safety

 

a)         Buildings and equipment shall be maintained so as to prevent fire and other hazards to personal safety.

 

b)         Exits, stairways, doors, and corridors shall be kept free of obstructions.

 

c)         Flammable and combustible liquids shall be labeled, stored, handled and used in compliance with the requirements of NFPA 30, Flammable and Combustible Liquids Code.

 

d)         Flammable and non-flammable gases shall be labeled, handled, and used in compliance with the requirements of NFPA 99, Health Care Facilities Code.  Separate storage for flammable and oxidizing gases shall be provided.

 

e)         A master fire plan, developed to suit the needs of the facility, and acceptable to the Department, shall be maintained.

 

f)         Fire regulations listing the fire stations, procedures, and staff emergency duties by title or position shall be posted conspicuously on each floor at appropriate locations, and shall be available in each unit, section, and department.

 

g)         Employees shall be trained in procedures to be followed in the master fire plan.

 

h)         Fire drills shall be conducted at irregular intervals at least l2 times per year.  A record shall be kept of the staff performance and results, and indicated corrective measures shall be made.

 

i)          Portable fire extinguishers, provided in accordance with NFPA l0, Installation of Portable Fire Extinguishers, shall be inspected at least annually, recharged or repaired as needed, and labeled with the dates of the last inspection.

 

j)          Sprinkler systems, fire hoses, fire detection and alarm devices, and other equipment for use in the fire safety program shall be connected and maintained in a fully functional condition at all times.

 

k)         Fire detection and protection systems shall be inspected no less than twice a year by a recognized competent authority.  A written report of the inspection shall be kept on file at the hospital for at least three years following the date of inspection.

 

l)          The hospital shall maintain a procedure for reporting all accidents to patients, employees, or visitors to a designated administrative officer on a standard form adopted for that purpose.  The report shall include all pertinent information and shall be kept on file for not less than six years after the occurrence reported.

 

m)        The hospital shall maintain a procedure to investigate fires.  A written report of the investigation containing all pertinent information shall be made.  The report shall remain on file for not less than six years.

 

(Source:  Amended at 35 Ill. Reg. 6386, effective March 31, 2011)

SUBPART Q: CHRONIC DISEASE HOSPITALS

 

Section 250.2010  Definition

 

a)         The chronic disease hospital shall be a "hospital" as defined in Section 3 (A) of the Act.

 

b)         Its primary purpose, as demonstrated by its stated program, its facilities, equipment, and staff, and its patient care as reflected in its medical records, shall be the diagnosis, treatment and care of persons admitted for overnight stay or longer in order to obtain medical care of chronic disease.

 

c)         It is not a "hospital," whatever called, if its primary purpose as reflected in either its stated program, its facilities, equipment, staff, or patient care as reflected in its medical records is to provide chiefly skilled nursing care under medical direction, other nursing care, or maintenance and personal care.  Such places are "nursing homes," homes for the aged, or sheltered care homes and subject to appropriate licensing.

 

d)         The chronic disease hospital shall further be defined as a facility for the medical diagnosis and treatment of chronic illness, including the degenerative diseases, and in which is provided an organized medical staff and the definitive diagnostic and treatment procedures normally available in the general hospital, including surgery, and including continuing care services and such additional services as physical therapy, occupational therapy, social services, recreational activities, and rehabilitation services.

 

e)        

 

1)         Chronic diseases include long-term illnesses and permanent impairments including: arthritis and rheumatism, cancer, diseases of the heart and circulation, diseases of the nervous system, nephritis and other kidney diseases, tuberculosis, diabetes mellitus, and the like.

 

2)         The chronic disease hospital shall function primarily for definitive diagnosis and care and treatment for acute phases of long-term illness. Such hospitals may also operate or affiliate with nursing homes for those requiring chiefly skilled nursing care under medical supervision or other facilities for those requiring chiefly custodial or domiciliary facilities.  Affiliation agreements are recommended to promote coordination and continuity of patient care.

 

Section 250.2020  Requirements

 

a)         Chronic disease hospitals are in many respects similar to general hospitals and the same fundamental principles of organization and operation apply.  The regulations stated in other Parts of this publication therefore shall apply to chronic disease hospitals except as modified and amended by this Part.

 

b)         Subpart O, Maternity and Newborn Services, shall not apply.  Maternity and newborn service shall not be approved.

 

c)         Design and Construction Standards

 

1)         The standards of Subpart T or Subpart U shall apply.

 

2)         In the case of chronic disease hospitals, excepting as specifically treated herein, the standards for general hospitals shall apply, with due consideration being made for the specialized requirements of the chronic disease hospital.

 

3)         Surgical department facilities as required in Section 250.2440(i) shall be required of chronic disease hospitals.

SUBPART R: PHARMACY OR DRUG AND MEDICINE SERVICE

 

Section 250.2110  Service Requirements

 

a)         The Hospital shall provide a Pharmacy or Drug and Medicine Service (system) acceptable to the Department for the care and treatment of patients.

 

b)         A Pharmacy or Drug and Medicine Service Policy and Procedure Manual, developed by the Pharmacy and Therapeutics Committee, shall identify the Service (system) and manner of operation.

 

c)         The service shall be under the direction of a registered pharmacist employed by the hospital on a full-time, a part-time or consulting basis. Responsibilities of the pharmacist must be identified in the Policy and Procedure Manual or other document.

 

d)         A pharmacy shall be staffed at all times by a registered pharmacist during open hours.  At all other times, the pharmacy shall be locked. Provisions must be made for a pharmacist or pharmaceutical service on call during times when the pharmacy is not open.

 

e)         When a pharmacist is absent from the hospital, a registered professional nurse may have access to the pharmacy.  The nurse may obtain a single dose, manufacturer's original package, or container prepackaged under the supervision of a pharmacist of a drug or medication, necessary to administer to a patient in carrying out treatment and medication orders of a prescriber.  A signed receipt for the drugs and medicines removed shall be left for the pharmacist.

 

f)         Vending machines for the storage and supply of drugs, used in the facility, shall be stocked only under the supervision of a pharmacist.  They shall be securely locked, shall provide a record of what was supplied and to whom.  The drugs contained therein may be released from such machines only by a registered professional nurse, physician or pharmacist.

 

g)         All drugs and medicines shall be stored and dispensed in accordance with applicable State and Federal laws and regulations.

 

Section 250.2120  Personnel Required

 

Every hospital shall have a pharmacist registered under the Pharmacy Practice Act (Ill. Rev. Stat. 1983, ch. 111 pars. 4001 et seq.) available or on call at all times.

 

a)         An adequate number of registered pharmacists and other supportive personnel shall be provided, consistent with the size and activity of the Service.

 

b)         Pharmacy apprentices, when utilized, must be under the direct and personal supervision of a registered pharmacist.

 

Section 250.2130  Facilities for Services

 

a)         A pharmacy shall be in an identified area or room which complies with the requirements of the Pharmacy Practice Act.  (See Subpart T, Design and Construction Standards.)

 

b)         Whatever drugs and medicines are available, they shall be plainly labeled which shall include the name of the manufacturer, lot and control number, and stored in specifically identified and well illuminated medicine cabinets, closets, refrigerators, or other location provided with proper lighting, ventilation and temperature control and fully protected from access by unauthorized persons.

 

Section 250.2140  Pharmacy and Therapeutics Committee

 

a)         In accordance with the bylaws, rules and regulations of the medical staff, an interdisciplinary committee acceptable to the Board shall be appointed to assure the responsibility for the functions of the service.

 

b)         The committee shall meet not less than quarterly and record minutes of their meetings, which shall reflect their activities.

 

c)         The functions of the committee shall include but not be limited to the following:

 

1)         formulate rules and regulations relating to the selection, evaluation, distribution, and administration of drugs and medicines in the hospital;

 

2)         establish control and reporting procedures for the use of investigational (experimental, trial use) drugs and medicines;

 

3)         promote educational programs on drugs and drug therapy for the medical and nursing staffs and other appropriate personnel;

 

4)         develop and update the Service Policy and Procedure Manual, the Hospital Formulary or Drug List;

 

5)         review and act on recommendations, drug usage reports, medication error and/or other incident reports, storage, distribution and administration of drugs;

 

6)         to develop policies and procedures (which shall be approved by the Medical Staff and Board) to provide for the administration of identified drugs and medicines by qualified professional persons who are authorized by law to administer such drugs and medicines in the course of practicing their professions; and

 

7)         establish the guidelines for the education, in-service training and supervision of all personnel administering drugs and medications.

 

(Source:  Amended at 23 Ill. Reg. 13913, effective November 15, 1999)

SUBPART S: PSYCHIATRIC SERVICES

 

Section 250.2210  Applicability of other Parts of these Regulations

 

a)         The Hospital Licensing Requirements contained in Subpart A – General, Subpart B – Administration and Planning, Subpart E – Laboratory, Subpart F – Radiological Services, Subpart L – Records and Reports, Subpart M – Food Service, Subpart N – Housekeeping and Laundry Service, Subpart P – Engineering and Maintenance of Physical Plant, Site, Equipment and Systems, Subpart R – Pharmacy or Drug and Medicine Service, shall apply in the organization and operation of psychiatric hospitals and psychiatric services of general hospitals.

 

b)         The regulations and standards stated in Subpart C – The Medical Staff, Subpart D – Personnel, Subpart H – Restorative and Rehabilitation Services, Subpart I – Nursing Service and Administration, Subpart T – Design and Construction Standards, Subpart U – Construction Standards for Existing Hospitals, Subpart V – Special Care and/or Special Service Units of the Hospital Licensing Act and Requirements are also applicable except as otherwise amended and modified in this Part.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.2220  Establishment of a Psychiatric Service

 

a)         No hospital shall purport to provide psychiatric services unless such psychiatric service has been approved by the Department of Public Health.

 

b)         Any facility which provides or purports to provide psychiatric in-patient diagnosis and/or treatment on other than an emergency basis is required to comply with the requirements set forth in Subpart S (Psychiatric Services) of this Part.

 

c)         In licensed general hospitals without an approved psychiatric service, psychiatric care to patients with a primary diagnosis of mental illness may be rendered on an emergency basis by appropriate members of the medical staff as determined by the hospital. Psychiatric consultation shall be available and utilized appropriately as determined by the hospital. Adequate and acceptable sources for transfer of psychiatric patients shall be documented and arranged within 72 hours unless the determination by a psychiatrist is such that the patient's condition no longer requires transfer to a licensed psychiatric unit or hospital. (Refer to Section 250.910(e)(1) and Section 250.2630(d)(5).)

 

d)         If, in the course of the inspection of a general hospital, the Department finds from a review of the psychiatric treatment rendered and the adequacy of the consultation and referral resources that the hospital practice and staffing warrants the establishment of a psychiatric service, the Department shall recommend the establishment of such service and assist the governing board, administration and medical staff in organizing and providing such service.

 

(Source:  Amended at 11 Ill. Reg. 10642, effective July 1, 1987)

 

Section 250.2230  The Medical Staff

 

a)         Organization

            The organization and responsibilities of the medical staff shall be in accordance with Subpart C of these Requirements, except as amended and modified in this Part.

 

b)         Clinical Director, Clinical Services Chief, or Equivalent

 

1)         The physician in charge of the psychiatric service shall be a psychiatrist and responsible for supervision of psychiatric services within the institution.

 

2)         The psychiatrist responsible for the supervision of psychiatric services within the psychiatric hospital or of the psychiatric service in a general hospital shall be certified in psychiatry by the American Board of Psychiatry and Neurology, or possess training and experience acceptable to the Department and equivalent to such certification, and licensed to practice medicine in all its branches in Illinois.

 

c)         Psychiatric Staff

            The psychiatrists on the staff of the psychiatric hospital and/or psychiatric unit of a general hospital will be required to have as minimum qualifications at least three years approved residency training in psychiatry or equivalent training and experience acceptable to the Department. Where primary physicians are authorized to treat patients in a psychiatric hospital or in a psychiatric unit of a hospital there must be timely evidence of psychiatric consultation after the patient is admitted, and ongoing consultation with a psychiatrist who is a member of the psychiatric staff, as needed.  The primary physician is expected to abide by the policies of the psychiatric service.

 

d)         Consulting Staff – Psychiatric Hospital

 

1)         There shall be a consulting medical staff, composed of qualified physicians in appropriate specialties, available at all times to the psychiatric staff.

 

2)         The consulting staff shall be appointed by the governing board upon recommendation of the medical staff.

            See requirements Section 250.2250(a)(b)(c).

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.2240  Nursing Service

 

a)         The organization and staffing of the nursing service shall be in accordance with Subpart I – Nursing Service and Administration, except as amended and modified in this Part.

 

b)         The registered professional nurse supervising the nursing program of the psychiatric service shall be required to have had a minimum of three years experience in a recognized psychiatric facility and demonstrated competency in psychiatric nursing acceptable to the Department, and to have completed an advanced degree program in psychiatric nursing or be otherwise qualified by education acceptable to the Department.

 

c)         The nursing personnel of the psychiatric unit in the general hospital shall be a separate staff whose line assignment is limited to the psychiatric service or psychiatric unit. Qualified nurses should be available for consultation with nursing staff on nonpsychiatric services and units.

 

d)         There shall be at least one registered nurse qualified in psychiatric nursing on duty at all times on each psychiatric nursing unit. The number of registered professional nurses and other nursing personnel shall be adequate to provide the individual patient care required in carrying out the nursing plan for each patient.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.2250  Allied Health Personnel

 

a)         For the full development of a psychiatric program, the following services or consultative resources are required: Clinical psychological services; social work services; and occupation and recreational therapy services.  These services shall be under the direction of the physician in charge of the psychiatric unit or service in a general hospital or the psychiatric diagnosis or treatment units in a psychiatric hospital.  They shall function as a multidisciplinary team.

 

b)         The staff used to support these services shall be adequate in number and be qualified by professional education, experience and demonstrated ability.  Where registration or licensing is required by statute or regulation, the registration number shall be on file and available upon request.

 

c)         There shall be a consulting allied health personnel staff composed of persons qualified in appropriate specialties available at all times to the psychiatric staff.

 

            The consulting staff shall be appointed by the hospital administration upon recommendation of the medical staff.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.2260  Staff and Personnel Development and Training

 

a)         There shall be written evidence of basic pre-service training for nonprofessional staff and ongoing, planned and scheduled in-service training for professional and nonprofessional staff.

 

b)         Interdisciplinary staff conferences of such frequency shall be held to insure and provide for communication, coordination, and participation of all professional staff and personnel involved in the care of patients.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.2270  Admission, Transfer and Discharge Procedures

 

All admissions to and discharges from psychiatric hospitals and the psychiatric department or service of a general hospital shall be in accordance with the Mental Health and Developmental Disabilities Code (Ill. Rev. Stat. 1983, ch. 91˝, pars. 1-100 et seq.), effective January l, 1979, as hereafter amended – Public Act 80-1414.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

 

Section 250.2280  Care of Patients

 

a)         The Mental Health and Developmental Disabilities Code shall apply to the care of patients.

 

b)         Accommodations for Patients

 

1)         Each psychiatric unit shall have available recreational and occupational therapy and other appropriate facilities adequate in size in relation to patient population, number of beds and program.

 

2)         Section 250.1040(f) regarding beds and bedding and Section 250.1040(i) regarding signals do not necessarily apply to bed accommodations in psychiatric units of general hospitals and psychiatric specialty hospitals where clinically contraindicated.

 

c)         Restraints and Seclusion

Restraints and seclusion facilities shall be available and written policies shall be established for their use.  Mechanical restraints and/or seclusion may be used only on the written order of a physician.  This written order shall be valid for specific periods of time.  In an emergency, the person in charge may order restraints.  Confirmation of the order by a physician shall be secured.  Policies and procedures regarding use of restraints and seclusion will be reviewed annually.  A log showing patient identification, justification for restraint, time applied and released and other pertinent information shall be maintained.  (Sections 2-108 and 2-109 of the Mental Health and Developmental Disabilities Code.)

 

d)         Policies and Procedures

A policy and procedure manual shall be maintained for the psychiatric services.  The manual shall include the following:

 

1)         Policies and procedures for the care and treatment of psychiatric patients, including specific procedures for the care of suicidal and assaultive patients;

 

2)         Policies and procedures for the assessment of patients for sexual safety (i.e., the identification of vulnerable patients and patients with the potential to display sexual behavior that places other patients at risk).  The policies and procedures shall be applicable to the age of the patient population served in the clinical unit and include measures to assess the risk of sexual harassment, abuse or assault, the management and oversight of the physical environment, requirements for internal reporting, investigation of allegations and incidents, and notification of law enforcement;

 

3)         Policies and procedures describing the relationships between the hospital and State agencies and community organizations providing psychiatric services; and

 

4)         Policies and procedures relating to the evaluation and disposition of psychiatric emergencies.

 

e)         Physical Facilities

 

1)         Requirements contained in Subpart T – Design and Construction Standards regarding general hospitals shall apply to psychiatric specialty hospitals unless otherwise noted.

 

2)         The following additional requirements for psychiatric units in general hospitals and psychiatric specialty hospitals shall be provided for patient care units:

 

A)        Adequate office space for psychiatrists, psychologists, nurses, social workers, and other professional staff.

 

B)        Conference room, day room and dining room.  These rooms may be set up as multipurpose rooms.

 

C)        Patient's laundry room.

 

3)         The design of facilities and the selection of equipment and furnishings shall be conducive to the psychiatric program being carried out and shall minimize hazards to psychiatric patients.

 

(Source:  Amended at 47 Ill. Reg. 6477, effective April 27, 2023)

 

Section 250.2290  Special Medical Record Requirements for Psychiatric Hospitals and Psychiatric Units of General Hospitals or General Hospitals Providing Psychiatric Care.

 

Medical records must stress the psychiatric components of the patient's condition and care including history of findings and treatment rendered for the psychiatric condition for which the patient is hospitalized.

 

a)         Identification data must include the patient's legal status.

 

b)         A provisional or admitting diagnosis must be made on every patient at the time of admission and include the diagnoses of intercurrent diseases as well as the psychiatric diagnoses.

 

c)         Data from all pertinent sources must be included in addition to data obtained from the patient.

 

d)         The psychiatric evaluation, including a medical history must contain a record of mental status and note the onset of illness, the circumstances leading to admission, attitudes, behavior, estimate of intellectual functions, memory functioning, orientation, and an inventory of the patient's assets in descriptive, not interpretive, fashion.

 

e)         A complete neurological examination must be recorded at the time of the admission physical examination, when indicated.

 

f)         The social service records, including reports of interviews with patients, family members and others, must provide an assessment of home plans and family attitudes, and community resource contacts with appropriate recommendations for family and/or community resource involvement, as well as a social history.

 

g)         Reports of consultations, reports of electroencephalograms and other pertinent reports of special studies must be included in the record.

 

h)         The patient's comprehensive treatment plan must be recorded, based on an inventory of the patient's strengths as well as his disabilities, and must include a substantiated diagnosis in the terminology of the American Psychiatric Association's Diagnostic and Statistical Manual, (DSM-3), short-term and long range goals, and the specific treatment modalities utilized as well as the responsibilities of each member of the treatment team in such a manner that it provides adequate justification and documentation for the diagnoses and for the treatment and rehabilitation activities carried out.

 

i)          The treatment received by the patient must be documented in such a manner and with such frequency as to assure that all active therapeutic efforts such as individual and group psychotherapy, drug therapy, milieu therapy, occupational therapy, recreational therapy, industrial or work therapy, nursing care and other therapeutic interventions are included.

 

j)          Progress notes must be recorded by the physician, clinical psychologist, nurse, social worker and by others significantly involved in active treatment modalities.  The notes must contain recommendations for revisions in the treatment plan as indicated as well as precise assessment of the patient's progress in accordance with the original or revised treatment plan.

 

k)         The discharge summary must include a recapitulation of the patient's hospitalization and recommendations from appropriate services concerning follow-up or aftercare as well as a brief summary of the patient's condition on discharge.

 

l)          It is recommended that the unique confidentiality requirements of a psychiatric record be recognized and safeguarded in any unitized record keeping system of a general hospital.

 

(Source:  Amended at 11 Ill. Reg. 10642, effective July 1, 1987)

 

Section 250.2300  Diagnostic, Treatment and Physical Facilities and Services

 

a)         Diagnostic and treatment facilities and services as provided for in Subpart E – Laboratory, and Subpart F – Radiology, shall be provided by the psychiatric hospital either on its premises or by written affiliation arrangement, or contractual agreement with a general hospital or by a licensed independent clinical laboratory.

 

b)         Rooms for Disturbed Patients and Psychiatric Nursing Units.  Section 250.2440(d)(5); Section 250.2440(g); Section 250.2630(d)(5) and Section 250.2630(g).

 

c)         Psychiatric Facilities shall provide a safe and secure environment for patients needing close supervision.  Consideration should be given to shatter-proof glazing, closed circuit T.V., the elimination of sharp edges, use of rounded faucets, safe hot water temperatures, insulation of hot water pipes, plastic coat hanger, etc. in order to minimize patient injury, suicide, or escape.

 

(Source:  Amended at 5 Ill. Reg. 507, effective December 29, 1980)

SUBPART T: DESIGN AND CONSTRUCTION STANDARDS

 

Section 250.2410  Applicability of these Standards

 

a)         These standards shall apply to all new hospitals and major alterations and additions to existing hospitals.  (Major alterations are those that are not defined as minor alterations in Section 250.2420(b).)  Hospitals shall refer to the Health Facilities and Services Review  Board for appropriate action.

 

b)         In the case of types of hospitals not specifically treated in this Part, the standards for general hospitals shall apply, with allowance being made for the specialized or unusual requirements of the particular hospital involved.

 

c)         If a hospital operates a hospital-based outpatient surgery program in a building that does not meet the requirements of Subpart T, that building shall comply with Subparts I, J, K and L of the Ambulatory Surgical Treatment Center Licensing Requirements.  The building housing the hospital's outpatient surgery program shall be located on the hospital's campus or within 250 yards of the hospital.

 

(Source:  Amended at 39 Ill. Reg. 13041, effective September 3, 2015)

 

Section 250.2420  Submission of Plans for New Construction, Alterations or Additions to Existing Facility

 

a)         New Construction, Addition or Major Alteration

 

1)         For all construction of either new buildings or additions or alterations to existing buildings coming within the scope of this Part, design development drawings and outline specifications shall be submitted to the Department for review.  Approval of design development drawings and specifications shall be obtained from the Department prior to starting final working drawings and specifications. Comments or approval shall be provided within 30 days after receipt by the Department.

 

2)         Final Drawings

 

A)        The final working drawings and specifications shall be submitted to the Department for review and approval prior to the beginning of construction. Alternative methods of design development and construction may be acceptable subject to the approval of the Department.  Department approval is void if construction contracts are not executed and construction is not started within one year after the plan approval date.  Comments by the Department shall be provided within 60 days after the day on which the submission is deemed complete.

 

B)        The Department shall be notified of the award of construction contracts.

 

3)         Any contract modifications that affect or change the function, design, or purpose of a facility shall be submitted to the Department for approval prior to proceeding with modifications.  Comments or approval shall be provided within 30 days after receipt by the Department.

 

4)         The Department will conduct an on-site inspection of the completed project no later than 15 business days after notification from the applicant that the project has been completed and all certifications required by the Department have been received and accepted by the Department.  The Department may extend this deadline only if a federally mandated survey time frame takes precedence.  The Department will provide written approval for occupancy to the applicant within 5 working days after the Department's final inspection, provided the applicant has demonstrated substantial compliance.  Occupancy of new major construction is prohibited until Department approval is received, unless the Department has not acted within the time frames provided in Section 8(g) of the Act and this subsection (a)(4), in which case the construction shall be deemed approved.  Occupancy will be authorized after any required health inspection by the Department has been conducted. (Section 8(g) of the Act)

 

5)         As-built drawings shall be maintained by the hospital. For the purposes of this Section, "as-built drawings" are the original design drawings revised to reflect any changes made in the field, including, but not limited to, design changes issued by change order, component relocations required for coordination, or rerouting of distribution systems.

 

b)         Minor Alterations and Remodeling. Minor alterations or remodeling changes that do not affect the structural integrity of the building, that do not change functional operation, that do not affect fire safety, and that do not add beds or facilities over those for which the hospital is licensed do not need to be submitted for approval.

 

c)         Alterations of Water Supply, Plumbing and Drainage. No system of water supply, plumbing, sewage, garbage or refuse disposal shall be installed, nor shall any existing system be altered or extended, until complete plans and specifications for the installation, alteration or extension have been submitted to the Department and have been reviewed and approved.

 

d)         Codes and Standards

 

1)         Nothing in this Part shall relieve the sponsor from compliance with building codes, ordinances, and regulations that are enforced by city or county jurisdictions.

 

2)         The recommendations of the International Building Code shall apply insofar as the recommendations are not in conflict with this Part or with the NFPA 101.  For construction of new buildings or additions, renovations, or alterations to existing buildings coming within the scope of this Part in municipalities with no building code of their own, the hospital may comply with the International Building Code.

 

3)         The codes and standards referenced in this Part may be ordered from the various agencies at the addresses listed in Section 250.105 and are effective on the dates cited in that Section.

 

(Source:  Amended at 41 Ill. Reg. 14945, effective November 27, 2017)

 

Section 250.2430  Preparation of Drawings and Specifications--Submission Requirements

 

Drawings and specifications shall be executed by or be under the immediate supervision of an architect licensed in the State of Illinois.  Structural drawings and specifications for these systems may be executed by or be under the immediate supervision of a Structural Engineer licensed in the State of Illinois.  Mechanical and electrical drawings and specifications for these systems may be executed by or be under the immediate supervision of a Professional Engineer licensed in the State of Illinois. The requirements contained herein have been established for the guidance of the hospital and the architect to provide a standard method of preparation of drawings and specifications.

 

a)         First Stage Submission--Design Development Drawings and Outline Specifications

 

1)         Development of the preliminary sketch plans indicating in detail the assignment of all spaces and size of areas and rooms, and indicating in outline the fixed and movable equipment and furniture.

 

A)        The plans shall be drawn at a scale sufficiently large to clearly present the proposed design.

 

B)        The drawings shall include:

 

i)          A plan of each floor including the basement or ground floor;

 

ii)         A roof plan;

 

iii)        A plan showing roads, parking areas, sidewalks, etc.; four elevations of all facades;

 

iv)        Sections through the building;

 

v)         All adjacent areas clearly labeled if addition or alteration; and

 

vi)        Fire and smoke separation diagrams.

 

2)         Outline specifications shall provide a general description of the construction including finishes; acoustical materials, their extent and type; the extent of the conductive floor covering; heating and ventilating systems; and the type of elevators.

 

3)         The total gross floor area and bed count shall be shown on the drawings.

 

4)         A brief narrative of the proposed program shall be provided.

 

b)         Second Stage Submission--Working Drawings and Specifications

            All working drawings shall be well prepared so that clean and distinct prints may be obtained, and shall be accurately dimensioned and include all necessary explanatory notes, schedules and legends.  Working drawings shall be complete and adequate for contract purposes.  Separate drawings shall be prepared for each of the following branches of work:  Architectural, Structural, Mechanical, Electrical. They shall include or contain the following:

 

1)         Architectural Drawings

 

A)        Site plan showing all new topography; newly established levels and grades; existing structures on the site (if any); new buildings and structures; roadways; walks; and the extent of the areas to be landscaped.  All structures and improvements that are to be removed under the construction contract shall be shown.

 

B)        Plan of each floor and roof.

 

C)        Elevations of each facade.

 

D)        Sections through the building.

 

E)        Elevators and dumbwaiters. Drawings delineating shaft details and dimensions, sizes of cab platforms and doors, travel distances including elevation height of landings, pit sizes, and machine rooms.

 

F)         Kitchens, laundry, laboratories, special care areas, and similar areas shall be detailed at a scale to show the location, type, size and connection of all fixed and movable equipment.

 

G)        Scale details as necessary; scale details to one and one-half inches to the foot may be necessary to properly indicate portions of the work.

 

H)        Schedule of finishes.

 

2)         Structural Drawings

 

A)        Plans of foundations, floors, roofs and all intermediate levels shall show a complete design with sizes, sections, and the relative location of the various members. Schedule of beams, girders and columns.

 

B)        Floor levels, column centers, and off-sets shall be dimensioned.

 

C)        Special openings and pipe sleeves shall be dimensioned or otherwise noted for easy reference.

 

D)        Details of all special connections, assemblies and expansion joints shall be given.

 

E)        Notes on design data shall include the name of the governing building code, values of allowable unit stresses, assumed live loads, wind loads, earthquake load, and soil-bearing pressures.

 

F)         For special structures, a stress sheet shall be incorporated in the drawings showing:

 

i)          Outline of structure;

 

ii)         All load assumptions used;

 

iii)        Stresses and bending moments separately for each kind of loading;

 

iv)        Maximum stress and/or bending moment for which each member is designed, when not readily apparent from the mechanical drawings; and

 

v)         Horizontal and vertical reactions at column bases.

 

3)         Mechanical Drawings.  These drawings with specifications shall show the complete heating, cooling and ventilation systems; plumbing, drainage, stand pipe, and sprinkler systems.

 

A)        Heating, Cooling and Ventilation

 

i)          Radiators, coils and steam-heated equipment such as sterilizers, warmers and steam tables;

 

ii)         Heating and steam mains and branches with pipe sizes;

 

iii)        Diagram of heating and steam risers with pipe sizes;

 

iv)        Sizes, types and heating surfaces of boilers, furnaces with stokers and oil burners, if any;

 

v)         Pumps, tanks, boiler breeching and piping and boiler room accessories;

 

vi)        Air conditioning systems with required equipment, water and refrigerant piping, and ducts;

 

vii)       Supply and exhaust ventilating systems with connections and piping; and

 

viii)      Air quantities for all room supply and exhaust ventilating duct openings.

 

B)        Plumbing, Drainage and Stand Pipe Systems

 

i)          Size and elevation of: street sewer, house sewer, house drains, street water main and water service into the building;

 

ii)         Location and size of soil, waste, and vent stacks with connections to house drains, cleanouts, fixtures and equipment;

 

iii)        Size and location of hot, cold and circulating mains, branches, and risers from the service entrance, and tanks;

 

iv)        Riser diagram of all plumbing stacks with vents, water risers and fixture connections;

 

v)                     Gas, oxygen and similar piped systems;

 

vi)        Standpipe and sprinkler systems; and

 

vii)       All fixtures and equipment that require water and drain connections.

 

4)         Electrical Drawings.  Drawings shall show all electrical wiring, outlets, and equipment that require electrical connections.

 

A)        Electrical service entrance with switches and feeders to the public service feeders, characteristics of the light and power current, transformers and their connections if located in the building.

 

B)        Location of main switchboard, power panels, light panels and equipment.  Feeder and conduit sizes shall be shown with schedule of feeder breakers or switches.

 

C)        Light outlets, receptacles, switches, power outlets, and circuits.

 

D)        Telephone layout showing service entrance, telephone switchboard, strip boxes, telephone outlets and branch conduits as approved by the telephone company.  Where public telephones are used for inter-communication, a separate room and conduits for racks and automatic switching equipment shall be provided as required by the telephone company.

 

E)        Nurses' call systems with outlets for beds, duty stations, corridor signal lights, annunciators and wiring diagrams.

 

F)         Doctors' call and doctors' in-and-out systems with all equipment wiring, if provided.

 

G)        Fire alarm system with stations, signal devices, control board and wiring diagrams.

 

H)        Emergency electrical system with outlets, transfer switch, source of supply, feeders, and circuits.

 

I)         All other electrically operated systems and equipment.

 

5)         Additions to Existing Structures

 

A)        Procedures and requirements for working drawings and specifications are to be followed (see Section 250.2420); in addition, the following information shall be submitted:

 

i)          Type of activities within the existing building and distribution of existing beds, etc.;

 

ii)         Type of construction of existing building and number of stories in height;

 

iii)        Plans and details showing attachment of new construction to the existing structure;

 

iv)        Mechanical and Electrical systems tying into the existing system.

 

B)        The Department may require submission of architectural drawings of all or any part of the existing structure.

 

6)         Specifications.  Specifications shall supplement the drawings and shall comply with the following:

 

A)        The specifications shall fully describe, except where fully indicated and described on the drawings, the materials, workmanship, kind, sizes, capacities, finishes, and other characteristics of all materials, products, articles and devices.

 

B)        The specifications shall include:

 

i)          Cover or tile sheet;

 

ii)         Index;

 

iii)        Invitation for bids;

 

iv)        General conditions;

 

v)         General requirements;

 

vi)        Sections describing material and workmanship in detail for each class of work; and

 

vii)       Bid form.

 

(Source:  Amended at 25 Ill. Reg. 3241, effective February 15, 2001)

 

Section 250.2440  General Hospital Standards

 

Minimum Requirements in the General Hospital

 

a)         Administration and Public Areas

 

1)         Main Entrance:  Designed to accommodate persons with physical disabilities;

 

2)         Lobby:  A reception and information counter or desk, waiting space, public toilet facilities, public telephones and drinking fountain;

 

3)         Interview Space:  Space for private interviews relating to social service, credit or admissions;

 

4)         General or Individual Office:  Office for business transactions, medical and financial records, and administrative and professional staffs.

 

5)         Multipurpose Room:  For conferences, meetings and education purposes including provision for the use of visual aids;

 

6)         Medical Library Facilities; and

 

7)         Storage Areas.

 

b)         Medical Records Unit.  Adequate space for the reviewing, dictating, sorting, recording and storage of medical records shall be provided.

 

c)         Adjunct Diagnostic and Treatment

 

1)         Laboratory Suite.  Laboratory facilities shall be provided to meet the work load described in the program narrative.  These may be provided within the hospital or through an effective contract arrangement with a nearby laboratory service.  If laboratory services are provided by contractual arrangement, then at least the following minimum services shall be available within the hospital (for additional requirements, see Subpart E of this Part):

 

A)        A laboratory work counter with appropriate services;

 

B)        A lavatory or counter sink equipped for hand-washing;

 

C)        A storage cabinet or closet;

 

D)        Blood storage facilities; and

 

E)        Specimen and sample collection facilities, urine collection rooms equipped with a water closet and lavatory, and blood collection facilities with space for a chair and work counter.

 

2)         Morgue and Autopsy Suite

 

A)        The morgue and autopsy suite shall be accessible to an outside entrance and shall be located to avoid movement of bodies through public areas.

 

B)        The following shall be provided when autopsies are performed within the hospital:

 

i)          Refrigerated facilities for body holding; and

 

ii)         An autopsy room.  This room shall contain a work counter with sink equipped for hand-washing; storage space for supplies, equipment and specimens; and an autopsy table.

 

C)        If no autopsies are performed in the hospital, a well-ventilated body-holding room shall be provided.

 

3)         Radiology Suite

 

A)        Facilities shall be provided for radiology purposes as required by the program narrative.  (For additional requirements see Subpart F of this Part.)

 

B)        The suite shall contain the following elements:

 

i)          A radiographic room;

 

ii)         Film processing facilities, if necessary;

 

iii)        A viewing and administration area;

 

iv)        Film storage facilities, if necessary;

 

v)         A toilet room with hand-washing facilities, directly accessible from each fluoroscopy room without entering the general corridor area;

 

vi)        A dressing area with access to toilets and facilities for patients' belongings; and

 

vii)       A waiting room or alcove.

 

C)        Radiation protection requirements for X-ray and gamma ray installations shall conform with National Council on Radiation Protection and Measurements (NCRP), Report 49: Structural Shielding Design and Evaluation for Medical Use of X-rays and Gamma Rays of Energies up to 10 MeV and Report 102: Medical X-Ray, Electron Beam and Gamma-Ray Protection for Energies Up to 50 MeV (Equipment Design, Performance and Use). Provisions shall be made for testing the completed installation and correcting defects before use.

 

D)        X-ray installations for fixed and mobile X-ray equipment: shall conform to Article 660, X-ray Equipment, of NFPA 70.

 

4)         Pharmacy Suite.  The size and type of services to be provided in the pharmacy will depend upon the type of drug distribution system to be used in the hospital and whether the hospital proposes to provide, purchase, or share pharmacy services with other hospitals or other medical facilities. This shall be explained in the program narrative.  (For additional requirements see Subpart R.) Provisions shall be made for the following:

 

A)        Administrative functions, including requisitioning, recording and reporting, receiving, storage (including refrigeration), and accounting;

 

B)        A quality control area  (if bulk compounding or packaging functions are performed);

 

C)        Locked storage for drugs and biologicals;

 

D)        A dispensing area; and

 

E)        Hand-washing facilities.  If required by the program, provisions shall be made for the following:

 

i)          A drug information area for reference materials and personnel; and

 

ii)         A sterile products area for compounding I.V.  admixtures and other sterile dosage forms.  A separate sink for hand-washing shall be provided in this area.

 

5)         Physical Therapy Suite

 

A)        Appropriate services may be planned and arranged for shared use by occupational therapy patients and staff.

 

B)        If a physical therapy suite is required by the program narrative, the following shall be provided:

 

i)          Office space;

 

ii)         Waiting space;

 

iii)        A treatment area for modalities such as thermotherapy, diathermy, ultrasonics and hydrotherapy.  Cubicle curtains shall be provided around each individual treatment area.  Hand-washing facilities shall be provided. One lavatory or sink may serve more than one cubicle;

 

iv)        Facilities for the collection of wet and soiled linen and other material;

 

v)         An exercise area;

 

vi)        Storage space for clean linen, supplies and equipment;

 

vii)       Patients' dressing areas and toilet rooms, for both men and women;

 

viii)      Wheelchair and stretcher storage; and

 

ix)        Showers, lockers and service sinks, as required by the program narrative.

 

6)         Occupational Therapy Suite

 

A)        Appropriate elements may be planned and arranged for shared use by physical therapy patients and staff.

 

B)        If an occupational therapy suite is required by the program narrative, the following elements shall be provided:

 

i)          Office space;

 

ii)         An activities area equipped with a sink or lavatory;

 

iii)        Storage space for supplies and equipment; and

 

iv)        Patients' toilet rooms.

 

d)         Nursing Unit. The requirements in this subsection (d) do not apply to special care areas such as recovery rooms, intensive care areas and newborn care areas.

 

1)         Patient Rooms

 

A)        Each patient room shall be an outside room.  Windows shall be provided for each patient room and shall be of a size not less than 7.5% of the square footage of the floor of the room.

 

B)        Minimum room areas shall be 100 square feet clear in one-bed rooms and 80 square feet clear per bed in multi-bed rooms (no rooms shall have more than four beds).  Clear is defined as the usable dimensions of the room, excluding the vestibule, toilet areas, and closets.

 

C)        A minimum of 3 feet clear at the foot and sides of each bed shall be provided.

 

D)        Each patient room shall have access to a toilet room without entering the corridor.

 

E)        One toilet room shall serve not more than four beds and not more than two patient rooms.

 

F)         The toilet room shall contain a water closet and a lavatory. The lavatory may be omitted from a toilet room that serves not more than two single bedrooms if each such single bedroom contains a lavatory.

 

G)        Each patient shall have a wardrobe, locker, or closet that is suitable for hanging and storing personal effects.

 

H)        Visual privacy shall be provided each patient bed in multi-bed rooms.

 

2)         Nurses' Service Center. The requirements in this subsection (d)(2) shall be provided either as part of a centralized cluster serving more than one nursing unit or shall be used as supportive areas within a self-contained nursing unit.

 

A)        A nurses' station with a work counter, storage areas, and communications equipment shall be provided.

 

B)        A nurses' office shall be provided.

 

C)        Hand-washing facilities convenient to both the nurses' station and the drug distribution station shall be provided.

 

D)        Charting facilities shall be provided for nurses and doctors, including a work counter and charting racks.

 

E)        A lounge and men's and women's toilet rooms for staff shall be provided.

 

F)         Closets or compartments for the safekeeping of coats and personal effects of nursing personnel.

 

G)        A multipurpose room shall be provided for conferences, demonstrations, and consultation. This room may be located outside the nursing unit, but within the hospital.

 

H)        Accessibility to a room for the examination and treatment of patients shall be provided.  This room may be omitted if all patient rooms are single bedrooms.  This room shall have a minimum floor area of 100 square feet excluding spaces for vestibules, toilet rooms (if provided), and work counters.  The room shall contain a lavatory, a work counter, storage facilities, and a writing space.

 

I)         At least one tub or shower shall be provided for each 12 beds that do not have bathing facilities within the patients' rooms. Each tub or shower shall be in an individual room or enclosure that provides space for the private use of the bathing fixture and for drying and dressing.

 

J)         A nourishment station with a sink equipped for hand-washing, equipment for serving nourishment between scheduled meals, a refrigerator, storage cabinets, and units to provide ice for patient's service and treatment shall be provided.

 

K)        A drug distribution station shall be provided for convenient and prompt 24-hour distribution of medicine to patients.  This may be from a medicine preparation room or unit, a self-contained medicine dispensing unit, or by another approved system.  If a medicine preparation room or unit is used, it shall be under the nursing staff's visual control and contain a work counter, refrigerator, and locked storage for biologicals and drugs.  A medicine dispensing unit may be located in an alcove under direct control of the nursing or pharmacy staff.

 

3)         Service Area

 

A)        A clean work room or a clean holding room shall be provided in each nursing unit.  The clean work room shall contain a work counter, hand-washing facilities, a nurse signal, and storage facilities.  The clean holding room shall be part of a system for storage and distribution of clean and sterile supplies and materials.

 

B)        A separate designated area within the clean work room shall be provided for clean linen storage.  If a cart system is used, the storage of the cart may be in an adjacent alcove.

 

C)        Parking shall be provided for stretchers and wheelchairs out of the path of normal traffic.

 

D)        A soiled work room or soiled holding room shall be provided. The soiled work room shall contain a clinical sink or equivalent flushing rim fixture, a nurse signal, a hand-washing sink, a waste receptacle, and a linen receptacle.  The soiled holding room shall be part of a system for the collection and disposal of soiled materials.  If bed pan flushing attachments are used on every patient room toilet, a clinical sink is not required in the soiled work room.

 

E)        Room for the storage of equipment such as I.V. stands, inhalators, mattresses and walkers shall be provided.

 

F)         Space shall be provided for the storage of required emergency equipment, such as a crash cart.  This equipment shall be under the direct control of the nursing staff.

 

G)        Sitz baths shall be provided when required by the program narrative.

 

4)         Isolation Room.  There shall be a room or rooms as required by the program narrative for the isolation of patients with known or suspected communicable diseases.  Each isolation room shall have an individual toilet equipped with a bedpan flushing attachment and a lavatory. Isolation rooms shall be provided with an anteroom equipped with a hand-washing sink, trimmed with valves that can be operated without the use of hands, storage spaces for clean and soiled materials, and a space for gowning.  There shall be only one patient per room.  All isolation rooms shall be otherwise planned as required for a standard patient room.

 

5)         Rooms for Disturbed Patients.  Every hospital that does not have a psychiatric nursing unit shall provide facilities for the care of disturbed patients, usually for a duration of less than 24 hours. The design shall provide for close observation and shall minimize the dangers of patient escape, suicide or injury.  This may be provided in a special care room used for multiple purposes.  This room shall be located either in the emergency unit or in a private room in a medical nursing unit, or as otherwise provided by the program narrative.

 

e)         Intensive Care Units

 

1)         A means of controlling unnecessary noise shall be provided.  A means of providing temporary privacy for each patient shall be provided. Windows shall be provided so that each patient may observe the outdoor environment.  Beds may be arranged so that one window may serve more than one patient.

 

2)         Intensive Care Units shall provide the following:

 

A)        Patient Rooms.  Cardiac intensive care, medical intensive care, and surgical intensive care patients may be housed in either single bedrooms or multi-bed rooms; however, at least one single bedroom shall be provided.  All beds shall be arranged to permit visual observation by nursing staff. Patient rooms shall meet the following requirements:

 

i)          Clearance between beds shall be not less than 6 feet.  Single bedrooms shall have a minimum area of 120 square feet and a minimum dimension of 10 feet.

 

ii)         Viewing panels shall be provided for nursing staff observation of patients.  Curtains or other means shall be provided to cover the viewing panels when the patient requires visual privacy.  Glazing in viewing panels shall be safety glass, wire glass, or clear plastic to reduce the hazard from accidental breakage, except that wire glass is required in glazed openings to corridors or passageways used as means of egress for fire safety purposes.

 

iii)        An I.V.  solution support shall be provided for each patient so that the solution is not suspended directly over the patient.

 

iv)        A lavatory equipped for hand-washing shall be provided in each private patient room.  In multi-bed rooms, no fewer than one lavatory for each six beds shall be provided.

 

v)         A nurses' call system shall be provided. (See Section 250.2500(g).)

 

vi)        Each cardiac intensive care patient shall be provided with a toilet facility that is directly accessible from the bed area. The water closet shall have sufficient clearance around it to facilitate its use by patients needing assistance.  Portable water closet units are permitted within patient rooms.  If portable units are used, facilities for servicing and storing them shall be conveniently located to the cardiac care unit.

 

B)        Service Areas.  The following service areas shall be located in or readily available to each Intensive Care Unit.  One area may serve two or more adjacent Intensive Care Units.  The size and location of each service area shall depend upon the number of beds to be served.

 

i)          A nurses' station shall be located to permit monitoring or visual observation of each patient served.

 

ii)         Hand-washing facilities shall be convenient to the nurses' station and drug distribution station.

 

iii)        Charting facilities shall be furnished with work counters and charting racks.

 

iv)        A staff toilet room shall contain a water closet and a lavatory equipped for hand-washing.

 

v)         Closets or compartments for the safekeeping of coats and personal effects of nursing personnel shall be provided at or near the nurses' station.

 

vi)        A clean work room (or a system for storage and distribution of clean and sterile supply materials) shall contain a work counter, a hand-washing facility, and storage facilities.

 

vii)       The soiled work room or soiled holding room shall contain a clinical sink or equivalent flushing rim fixture, sink equipped for hand-washing, work counter, waste receptacle, and linen receptacle.  A soiled holding room shall be part of a system for collection and disposal of soiled materials and shall be similar to the soiled work room except that the clinical sink and work counter may be omitted.

 

viii)      Facilities for washing or flushing bedpans shall be provided within the unit.

 

ix)        A drug distribution station shall be provided for convenient and prompt 24-hour distribution of medicine to patients either from a medicine preparation room or unit, a self-contained medicine dispensing unit, or by another approved system.  If used, a medicine preparation room or unit shall be under the nursing staff's visual control and shall contain a work counter, a sink, refrigerator, and locked storage for biologicals and drugs.  A medicine dispensing unit may be located at the nurses' station, in the clean work room, or in an alcove or other space under direct control of the nursing or pharmacy staff.

 

x)         Clean Linen Storage.  A storage closet or a designated area within the clean work room shall be provided.  If a closed cart system is used, storage may be in an alcove.

 

xi)        A nourishment station shall contain a sink equipped for hand-washing, equipment for serving nourishment between scheduled meals, refrigerator, storage cabinets, and units to provide ice for patients' service and treatment.

 

xii)       Emergency Equipment Storage.  Space shall be provided for a "crash cart" and similar emergency equipment.

 

xiii)      Equipment Storage Room.  Space for necessary equipment shall be provided.

 

xiv)      Patients' storage facilities shall be provided for the storage of patients' personal effects.  These may be located outside the intensive care unit.

 

C)        A waiting room shall be provided for family members and others who may be permitted to visit the intensive care patients.  A toilet room, public telephone, and seating accommodations for long waiting periods shall be provided.

 

f)         Pediatric Nursing Unit. Young children and adolescents shall be housed in a nursing unit separate from adults unless special allowance has been made in the program narrative.  This unit shall meet the following requirements:

 

1)         General Unit Requirements Including Patient Rooms.  The requirements noted in subsection (d) of this Section shall be applied to a pediatric and adolescent nursing unit containing hospital beds, youth beds or cribs.

 

2)         Nursery as Specified in the Program Narrative.  Each nursery serving pediatric patients shall contain no more than eight bassinets. The minimum clear floor area per bassinet shall be 40 square feet. Each room shall contain a lavatory equipped for hand-washing, a nurses' emergency calling system as provided in Section 250.2500(g), and glazed viewing windows for observing infants from public areas and the work room.

 

3)         Nursery Work Rooms as Specified in the Program Narrative.  Each nursery shall be served by a connecting work room.  One work room may serve more than one nursery.  It shall contain gowning facilities for staff and housekeeping personnel.

 

4)         Examination and Treatment Room.  The examination and treatment room shall contain a work counter, storage facilities, and a lavatory equipped for hand-washing.

 

5)         Service Areas. The service areas in the pediatric and adolescent nursing unit shall conform to the conditions listed in subsection (d)(3) and shall meet the following additional conditions:

 

A)        Multipurpose or individual areas shall be provided for dining, educational, and play, or other patient care purposes.

 

B)        Space for preparation or storage of infant formula shall be provided in the unit or in a convenient location nearby.

 

C)        Patients' toilet rooms shall be provided convenient to multipurpose areas and central bathing facilities.

 

D)        Storage closets or cabinets for toys and for educational and recreational equipment shall be provided.

 

E)        Storage space shall be provided for replacement of youth and adult beds to provide flexibility for interchange of patient accommodations.

 

6)         Fixtures and Accessories

 

A)        Attention shall be given to other details affecting small children as required by the program.

 

B)        Switches and plugs for critical equipment shall be designed to preclude shock and located for inaccessibility by small children.

 

C)        Toilets and washbasins shall be suitable for use by small children as described in the program narrative.

 

g)         Psychiatric Nursing Unit

 

1)         Units intended for psychiatric or other types of disturbed patient nursing care shall provide a safe and secure facility for patients needing close supervision to minimize hiding, escape, injury, or suicide.  The unit shall be designed to facilitate care of ambulatory inpatients, to permit flexibility in arranging various types of therapy, and to present as non-institutional an atmosphere as possible.

 

2)         Each nursing unit shall provide the following:

 

A)        Patient Rooms and Nurses' Service Center.  The requirements noted in subsection (d) shall be applied to patient rooms and nurses' service center in psychiatric nursing units except as follows:

 

i)          A nurses' calling system is not required.  Other types of communications systems may be utilized.

 

ii)         Provision for visual privacy is not required.

 

B)        Service Areas. The service areas noted in subsection (d)(3) shall be provided or made available to each Psychiatric Nursing Unit except that space for stretchers and wheelchairs is not required and clinical sinks or equivalent may be installed but are not required. The following elements shall be provided within and for the exclusive use of the unit:

 

i)          Consultation room.

 

ii)         Space for dining, recreation, and occupational therapy. The total area for these purposes shall not be less than 40 square feet per patient.

 

iii)        Storage closets or cabinets for recreational and occupational therapy equipment.

 

iv)        Storage for patients' clothing.

 

C)        Additional Services.  Appropriate additional services shall be provided as determined by the program narrative.

 

h)         Newborn Care Unit.  Newborn infants shall be housed in nurseries that are conveniently located to the postpartum nursing unit and obstetrical facilities.  The nurseries shall be located and arranged to preclude unrelated traffic.  No nursery shall open directly into another nursery.  Subpart O shall apply.  Additionally:

 

1)         Each nursery shall contain:

 

A)        Lavatory trimmed with valves that are aseptically operated (for example, knee or foot controls) at the rate of one for each eight bassinets.

 

B)        A nurses' emergency calling system.

 

C)        Bassinets in a number at least equal to the number of postpartum beds.

 

D)        Glazed observation windows to permit the viewing of infants from public areas and from work rooms.

 

2)         Full-Term Nursery.  The full-term nursery shall contain no more than 12 bassinets; however, this number may be increased to 16 if the extra bassinets are of the isolation type.  The minimum floor area shall be 30 square feet for each regular bassinet and 40 square feet for each isolation type bassinet.  When a "rooming-in" program is used, the total number of bassinets provided in these units may be reduced by no more than 50%, but the full-term nursery shall not be omitted.

 

3)         Special Care and Observation Nursery

 

A)        A hospital shall make available a nursery to provide special care for infants in distress if the hospital has 25 or more maternity beds, unless equivalent facilities for these infants are conveniently available elsewhere. The floor area per bassinet shall be as determined by the program narrative but shall not be not less than 40 square feet.  Additional area shall be provided to accommodate work room functions if these are located within the nursery area.

 

B)        When a separate special care nursery is provided, it shall have its own work room areas.

 

4)         Work Room.  Each nursery shall be served by a connecting work room. It shall contain gowning facilities at the entrance for staff and housekeeping personnel, work space with counter, refrigerator, and lavatory or sink equipped for hand-washing, and storage. One work room may serve more than one nursery.  The work room that serves the special care nursery may be omitted if equivalent work area and facilities are provided within the nursery, in which case the gowning facilities shall be located near the entrance to the nursery and shall be separated from the work area.

 

5)         Examination and Treatment Room or Space for Infants.  The examination and treatment room or space for infants shall contain a work counter, storage, and lavatory equipped for hand-washing trimmed with valves that are aseptically operated (for example, knee or foot controls), and shall be located so that doctors need not enter nurseries. It may serve more than one nursery and may be located in the work room. If the examination and treatment of infants will take place in the individual bassinets, space for physicians' and nurses' gowning shall be provided as well as a conveniently accessible hand-washing sink trimmed with valves that are aseptically operated (for example, knee or foot controls).

 

6)         Infant Formula Facilities.  When the program narrative requires it, the hospital shall provide the following:

 

A)        On-site Formula Preparation

 

i)          Clean-up facilities for washing and sterilizing supplies. These shall consist of a lavatory or sink equipped for hand-washing, a bottle washer, work counter space, and an equipment sterilizer.

 

ii)         A separate room for preparing infant formula.  It shall contain a lavatory or sink equipped for hand-washing, refrigerator, work counter, formula sterilizer, and storage facilities.  It may be located near the nurseries or at another appropriate place within the hospital. Direct access from the formula room to a nursery or to a nursery work room shall not be permitted.

 

B)        Commercially Prepared Formula.  If a commercial infant formula is used, the storage and handling may be done in the nursery work room or in another appropriate room that has a work counter, a sink equipped for hand-washing, and storage facilities.

 

7)         Janitors' Closet.  A closet for exclusive use of the housekeeping staff in maintaining the nursery unit shall be provided. It shall contain a floor receptor or service sink and storage space for housekeeping equipment and supplies.

 

8)         Gowning and Scrubbing Areas. Gowning and scrub areas shall be equipped with lockers for doctors' and nurses' belongings, cabinets for clean gowning, receptacles for used gowns, and hand-washing sinks aseptically operated without the use of hands.

 

9)         Clean Utility Area. Clean utility area with work counter and hand-washing sink shall be provided.

 

10)         Soiled Utility Area. Soiled utility area with work counter, hand-washing sink, clinical service sink or equivalent flushing rim fixture, and space for storage hamper (one for diapers and one for soiled linen provided at a ratio of one for each four bassinets or fraction thereof) shall be provided.

 

11)         Storage Areas. Storage space for replacement bassinets, phototherapy units, and other large items shall be provided.  These storage areas may be located either within the unit or in the central supplies storage.

 

i)          Surgical Suite.  The number of operating rooms and recovery beds and the sizes of the service areas shall be based on the expected surgical work load.  The surgical suite shall be located and arranged to preclude unrelated traffic through the suite.  The requirements of Section 250.1300 shall be used for the surgical suite wherever applicable.  The suite shall provide the following elements:

 

1)         General Operating Rooms.  Each room shall have a minimum clear area of 360 square feet exclusive of fixed cabinets and shelves.  The minimum dimension shall be 18 feet.  A communications system shall be provided connecting with the surgical suite control station.  At least two x-ray film illuminators shall be provided in each room.

 

2)         Rooms for Surgical Cystoscopic and Other Endoscopic Procedures. These rooms shall have a minimum clear area of 250 square feet exclusive of fixed cabinets and shelves.  If necessary to accommodate special functions in one or more of these rooms, additional clear space shall be required by the program narrative.  A communications system connecting with the surgical suite control station shall be provided.  Facilities for the disposal of liquid wastes shall be provided.

 

3)         Fracture Rooms.  Fracture rooms shall be provided with an adjacent splint room.  The fracture room may be located in the emergency department, the surgical suite, or as indicated in the program narrative.

 

4)         Recovery Room.  The recovery room may be part of an approved combined surgical/obstetrical program as provided in Section 250.1300.

 

A)        The postoperative recovery room shall be located within or adjacent to the surgical suite.  A separate entrance and exit doors remote from each other shall be provided to facilitate a one-way traffic flow within the recovery room.

 

B)        A minimum of one recovery room bed shall be provided for each operating room.

 

C)        A minimum of 70 square feet per bed shall be provided in open units. This area shall exclude the nursing station, work space, and storage area.  In addition, a minimum of 4 feet shall be maintained between the sides of the beds, at least 3 feet between the side of any bed and any wall or other fixed device, and at least six feet between the foot end of any bed and any other equipment or fixed device.

 

D)        The recovery room shall have adequate lighting to allow accurate observation of the patients.

 

E)        A lavatory trimmed with valves operated without the use of hands, and a clinical sink, shall be provided.

 

F)         A soiled holding area shall be provided.

 

G)        A nursing station shall be provided within the postoperative recovery room. Facilities for medical storage and preparation shall be provided.

 

H)        Adequate storage and work space within or adjacent to the recovery room shall be available for necessary supplies and equipment.

 

I)         Each bed site shall be adequately equipped with oxygen, suction and at least two duplex electrical outlets.

 

5)         Stage II Recovery Room.  If outpatient surgery services are provided in the surgical suite, a Stage II recovery room shall be provided for outpatient observation prior to discharge.  The Stage II recovery area may be combined with an outpatient receiving and preparation area and may be located at a site remote from the recovery room.  Additionally, it shall contain the following elements:

 

A)        A minimum of four recovery stations per operating room;

 

B)        Lounge chairs at each recovery station with a minimum clear area of 50 square feet and a minimum clearance around three sides of the chairs of 4 feet;

 

C)        A nurses' station with a work counter and space for communications equipment and charting;

 

D)        A drug distribution station with a work counter, locked storage for narcotics, refrigerator, and hand-washing sink;

 

E)        A toilet space for the exclusive use of the Stage II recovery area.  The toilet shall be equipped with a gray diverter valve; and

 

F)         Clean and soiled utility rooms.

 

6)         Service Areas.  Individual rooms shall be provided, or alcoves or other open spaces that will not interfere with traffic may be used.  Services may be shared with, and organized as part of, the obstetrical facilities, if the approved program narrative reflects this sharing concept.  Cross-circulation between the surgical and delivery suites when using shared service areas shall not be permitted.  The following services shall be provided:

 

A)        A control station located to permit direct visual surveillance of all traffic that enters the operating suite;

 

B)        A supervisor's office or station;

 

C)        Sterilizing facilities with high speed autoclaves conveniently located to serve all operating rooms.  When the program narrative indicates that adequate provisions have been made for replacement of sterile instruments during surgery, sterilizing facilities in the surgical suite will not be required;

 

D)        A drug distribution station.  An area shall be provided for preparation of medication to be administered to patients;

 

E)        Two scrub stations, conveniently located near each operating room.  Scrub facilities shall be arranged to minimize any incidental splatter on nearby personnel or supply carts.  A scrub sink or sinks shall be provided that shall be aseptically operated without the use of hands (wrist blades are not acceptable);

 

F)         A soiled work room for the exclusive use of the surgical suite staff (or a soiled holding room that is part of a system for the collection and disposal of soiled materials).  The soiled work room shall contain a clinical sink or equivalent flushing type fixture, work counter, sink equipped for hand-washing, waste receptacle, and linen receptacle. A soiled holding room shall be similar to the soiled work room except that the clinical sink and work counter may be omitted;

 

G)        Fluid waste disposal facilities.  These shall be conveniently located with respect to the general operating rooms.  A clinical sink or equivalent equipment in a soiled work room or in a soiled holding room meets this requirement;

 

H)        A clean work room or a clean supply room.  A clean work room is required when clean materials are assembled within the surgical suite prior to use.  A clean work room shall contain a work counter, a sink equipped for hand-washing, and space for clean and sterile supplies.  A clean supply room shall be provided when the program narrative defines a system for the storage and distribution of clean and sterile supplies that would not require the use of a clean work room;

 

I)         Anesthesia storage facilities.  The use and storage of anesthetic gases shall be in accordance with NFPA 99.  Areas for cleaning, testing and storing anesthesia equipment shall be provided;

 

J)         An anesthesia work room for cleaning, testing and storing anesthesia equipment.  It shall contain a work counter and sink;

 

K)        Medical gas storage.  Space for reserve storage of nitrous oxide and oxygen cylinders shall be provided;

 

L)        Storage space for splints and traction equipment for operating rooms equipped for orthopedic surgery;

 

M)       Equipment storage rooms for equipment and supplies used in the surgical suite;

 

N)        Staff clothing change areas, including appropriate areas for male and female personnel (orderlies, technicians, nurses and doctors) working within the surgical suite.  The areas shall contain lockers, showers, toilets, lavatories and space for donning scrub suits and boots.  These areas shall be arranged to provide a one-way traffic pattern so that personnel entering from outside the surgical suite can change, shower, gown and move directly into the surgical suite. Space for removal of scrub suits and boots shall be designed so that personnel using it will avoid physical contact with clean personnel;

 

O)        Outpatient surgery change areas.  If the program requires outpatient surgery, a separate area shall be provided where outpatients change from street clothing into hospital gowns and are prepared for surgery. This shall include a waiting room, lockers, toilets, and clothing change or gowning area with a traffic pattern similar to that of the staff clothing change area;

 

P)         Patients' holding area.  In facilities with two or more operating rooms, a room or alcove shall be provided to accommodate stretcher patients waiting for surgery.  This waiting area shall be under control of the surgical suite control station;

 

Q)        Stretcher storage area.  This area shall be out of the direct line of traffic;

 

R)        Lounge and toilet facilities for surgical staff.  These facilities shall be provided in hospitals having three or more operating rooms and shall be located to permit use without leaving the surgical suite.  A nurses' toilet room shall be provided near the recovery room; and

 

S)         Janitors' closet.  A closet containing a floor receptor or service sink and storage space for housekeeping supplies and equipment shall be provided exclusively for the surgical suite.

 

7)         Central Sterilizing and Supply Room.  The central sterile supplies shall be located either within the surgical suite or provided as a separate department within the hospital.  The following shall be provided:

 

A)        A receiving and clean-up room containing work space and equipment for cleaning medical and surgical equipment, and for disposal or processing of unclean material.  Hand-washing facilities operated without the use of hands shall be provided;

 

B)        A clean work room containing work space and equipment for sterilizing medical and surgical equipment and supplies;

 

C)        Storage areas for clean supplies and for sterile supplies (these may be in the clean work room);

 

D)        Unsterile supplies storage room (this may be located in another department);

 

E)        Separate storage area for soiled or contaminated supplies and equipment, separate from the clean or sterilized supplies and equipment; and

 

F)         Cart storage areas.  Cart storage areas and facilities for cleaning and sanitizing carts may be centralized or departmentalized.

 

j)          Obstetrics and Neonatal Suite.  The number of delivery rooms, labor rooms and recovery beds, and the sizes of the service areas shall depend upon the estimated obstetrical work load and the program narrative.  The obstetrical and neonatal suite shall be located and arranged to preclude unrelated traffic through the suite.  The requirements of Subpart O shall apply.

 

1)         Delivery Rooms.  Each delivery room shall have a minimum clear area of 300 square feet exclusive of fixed and movable cabinets and shelves.  The minimum dimension shall be 16 feet clear.  The communications system shall be connected with the obstetrical suite control station. Separate resuscitation facilities (electrical outlets, oxygen, suction, and compressed air) shall be provided for newborn infants.

 

2)         Labor Rooms.  These rooms shall be single or two-bed rooms with a minimum clear area of 80 square feet per bed.  Labor beds shall be provided at the rate of two for each delivery room.  In facilities having only one delivery room, two labor rooms shall be provided, one of which shall be large enough to function as an emergency delivery room.  Each labor room shall contain a lavatory equipped for hand-washing. Labor rooms shall be arranged so that they are accessible from a nurses' work station and shall also be accessible to facilities for medication, hand-washing, charting, and storage for supplies and equipment.

 

3)         Recovery Room.  The recovery room may be part of an approved combined surgical/obstetrical program as provided in Section 250.1820(g).

 

A)        The postpartum recovery room shall be located within or adjacent to the obstetrics and neonatal suite.  A separate entrance and exit doors remote from each other shall be provided to facilitate a one-way traffic flow within the recovery room.

 

B)        A minimum of 70 square feet per bed shall be provided.  This area shall exclude the nurses' station, work space and storage area.  In addition, a minimum of 4 feet shall be maintained between the sides of the beds, at least 3 feet between the side of any bed and any wall or other fixed device, and at least 6 feet between the foot end of any bed and any other equipment or fixed device.

 

C)        The recovery room shall have adequate lighting of the type to allow accurate observation of the patients.

 

D)        A lavatory operable without the use of hands, and a clinical sink shall be provided.

 

E)        A soiled holding area shall be provided.

 

F)         A nurses' station shall be provided within the postoperative recovery room. Facilities for medical storage and preparation shall be provided.

 

G)        Adequate storage and work space within or adjacent to the recovery room shall be available for necessary supplies and equipment.

 

H)        Each bed site shall be adequately equipped with oxygen, suction and at least two duplex electrical outlets.

 

4)         Service Areas.  Individual rooms shall be provided, or alcoves or other open spaces that will not interfere with traffic may be used.  Services may be shared with and organized as part of the surgical facilities if the approved program narrative reflects this sharing concept.  Service areas shall be arranged to avoid direct traffic between the operating and the delivery rooms.  The following services shall be provided:

 

A)        Control station, located to permit direct visual surveillance of all traffic that enters the obstetrics suite;

 

B)        Supervisor's office or station;

 

C)        Sterilizing facilities with high speed autoclaves conveniently located to serve all delivery rooms.  When the program narrative indicates that adequate provisions have been made for replacement of sterile instruments during delivery, sterilizing facilities in the delivery suite will not be required;

 

D)        Drug distribution station.  An area shall be provided for preparation of medication to be administered to patients;

 

E)        Two scrub stations, which shall be conveniently located near each delivery room.  Scrub facilities shall be arranged to minimize any incidental splatter on nearby personnel or supply carts.  Scrub sinks, aseptically operated without the use of hands, shall be provided (wrist blades are not acceptable);

 

F)         Soiled work room for the exclusive use of the obstetrical suite staff (or a soiled room that is part of a system for the collection and disposal of soiled materials).  The soiled work room shall contain a clinical sink or equivalent flushing rim fixture, work counter, sink equipped for hand-washing, waste receptacle and linen receptacle. A soiled holding room shall be similar to the soiled work room except that the clinical sink and work counter may be omitted;

 

G)        Fluid waste disposal facilities.  These shall be conveniently located with respect to the delivery rooms.  A clinical sink or equivalent flushing rim equipment in a soiled work room or in a soiled holding room would meet this requirement;

 

H)        Clean work room or a clean supply room.  A clean work room is required when clean materials are assembled within the obstetrical suite prior to use.  A clean work room shall contain a work counter, a sink equipped for hand-washing, and space for clean and sterile supplies.  A clean supply room shall be provided when the program narrative defines a system for the storage and distribution of clean and sterile supplies that would not require the use of a clean work room;

 

I)         Anesthesia storage facilities.  The use and storage of anesthetic gases shall be in accordance with NFPA 99.  Areas for cleaning, testing and storing anesthesia equipment shall be provided;

 

J)         Anesthesia work room for cleaning, testing and storing anesthesia equipment, containing a work counter and sink;

 

K)        Medical gas storage.  Space for reserve storage of nitrous oxide and oxygen cylinders shall be provided;

 

L)        Equipment storage rooms for equipment and supplies used in the obstetrical suite;

 

M)       Staff clothing change areas.  Appropriate areas shall be provided for male and female personnel (orderlies, technicians, nurses, and doctors) working within the obstetrical suite.  The areas shall contain lockers, showers, toilets, lavatories equipped for hand-washing and space for donning scrub suits and boots.  These areas shall be arranged to provide a one-way traffic pattern so that personnel entering from outside the obstetrical suite can change, shower, gown, and move directly into the obstetrical suite.  Space for removal of scrub suits and boots shall be designed so that personnel will avoid physical contact with clean personnel;

 

N)        Stretcher storage area.  This area shall be out of the direct line of traffic;

 

O)        Lounge and toilet facilities for obstetrics staff.  These facilities shall be provided in hospitals having three or more delivery rooms and shall be located to permit use without leaving the obstetrics suite. A nurses' toilet room shall be provided near the recovery rooms; and

 

P)         Janitors' closet.  A closet containing a floor receptor or service sink and storage space for housekeeping supplies and equipment shall be provided exclusively for the obstetrical suite.

 

k)         Emergency Suite.  Facilities for emergency care shall be provided in each hospital.  The extent of the emergency services to be provided in the hospital will depend upon community needs and availability of other organized programs for emergency services within the community.  Hospitals having a program narrative calling for a minimum level of emergency services shall provide at least the facilities indicated in subsections (k)(1), (k)(4) and (k)(10) with back-up facilities within the hospital capable of furnishing the necessary support for facilities not provided in the emergency suite.  Other hospitals shall provide all of the following to the degree called for in the program narrative:

 

1)         An entrance at grade level, sheltered from the weather with provision for ambulance and pedestrian access;

 

2)         A reception and control area conveniently located near the entrance, waiting area and treatment rooms;

 

3)         Public waiting space with men's and women's toilet facilities, public telephone and drinking fountain;

 

4)         Treatment area.  The treatment area shall contain hand-washing facilities trimmed with valves that are aseptically operated (for example, knee or foot controls), general storage cabinets, medication cabinets, work counters, medical suction outlets, x-ray film illuminators as necessary, and space for storage of emergency equipment such as defibrillators, cardiac monitors and resuscitators;

 

5)         A holding area adjacent to the treatment rooms, as required by the program narrative;

 

6)         A storage area, out of the line of traffic, for stretchers and wheelchairs;

 

7)         Staff work and charting areas.  This may be combined with the reception and control area or located within the treatment area;

 

8)         Clean supply storage, which may be separate or located within the treatment area;

 

9)         Soiled work room or area containing a clinical sink, work counter and sink equipped for hand-washing, waste receptacle and linen receptacle; and

 

10)         Toilet facilities convenient to the treatment area.

 

l)          Outpatient Department

 

1)         The outpatient department, if provided, should be located on an easily accessible floor convenient to the radiology, pharmacy and laboratory departments.

 

2)         Size will vary in different locations with the availability of other examination and diagnostic facilities, and is not necessarily proportionate to the size of the hospital.  The estimated patient load shall determine the number, size and scope of individual facilities in the outpatient department.

 

3)         Required facilities include:

 

A)        Waiting room with men's and women's public toilets;

 

B)        Information, appointments and records;

 

C)        Medical social services;

 

D)        Examination rooms;

 

E)        Dressing booths;

 

F)         Utility rooms;

 

G)        Storage room; and

 

H)        Janitors' closet.

 

m)        Service Departments

 

1)         Dietary Facilities

 

A)        General. Construction, equipment and installation shall comply with the standards specified in the Department's Food Service Sanitation Code and the Food Service Sanitation Manual, P.H.S. 93.  Food service facilities shall be designed and equipped to meet the requirements of the program narrative.  These may consist of an on-site conventional food preparing system, a convenience food service system, or an appropriate combination of the two.

 

B)        Functional Elements.  The following facilities shall be provided as required to implement the type of food service selected:

 

i)          Control Station.  For receiving food supplies;

 

ii)         Storage Space.  Adequate to provide normal and emergency supply needs, including food requiring cold storage and day storage;

 

iii)        Food Preparation Facilities.  Conventional food preparation systems require space and equipment for preparing, cooking and baking. Convenience food service systems, such as frozen prepared meals, bulk packaged entrees, and individual packaged portions, or systems using contractual commissary service, require space and equipment for thawing, portioning, heating, cooking and baking;

 

iv)        Hand-washing Facilities.  Located in the food preparation area;

 

v)         Patients' Meal Service Facilities.  Examples are those required for tray assembly and distribution;

 

vi)        Dining Space.  For ambulatory patients, staff and visitors;

 

vii)       Ware-Washing Space.  Located in a room or an alcove separate from food preparation and serving areas.  Commercial-type dishwashing equipment shall be provided.  Space shall also be provided for receiving, scraping, sorting, and stacking soiled tableware and for transferring clean tableware to the using areas.  A hand-washing lavatory shall be conveniently available;

 

viii)      Pot-Washing Facilities;

 

ix)        Storage Areas.  For cans, carts and mobile tray conveyors;

 

x)         Waste Storage Facilities.  Located in a separate room easily accessible to the outside for direct pickup or disposal;

 

xi)        Offices or Desk Spaces.  For dieticians and the dietary service manager;

 

xii)       Men's and Women's Toilets Accessible to the Dietary Staff.  Hand-washing facilities shall be immediately available;

 

xiii)      Janitors' Closet.  Located within the dietary department. It shall contain a floor receptor or service sink and storage space for housekeeping equipment and supplies;

 

xiv)      Self-dispensing Ice-making Facilities; and

 

xv)       Adequate Can, Cart and Mobile Tray Washing Facilities.

 

2)         Central Stores.  The following shall be provided:

 

A)        Off-street unloading facilities;

 

B)        Receiving area;

 

C)        General storage rooms.  These facilities shall have storage spaces adequate to meet the needs of the hospital.  They shall be concentrated in one area, but in a multiple building complex, they may be in separate concentrated areas in more than one individual building; and

 

D)        Office space.

 

3)         Linen Services

 

A)        On-site Processing.  If linen is to be processed at the hospital site, the following shall be provided:

 

i)          Soiled linen receiving, holding and sorting room with hand-washing facilities;

 

ii)         A laundry processing room, including hand-washing facilities, with commercial-type equipment that can process seven days' needs within a regularly scheduled work week;

 

iii)        A separate clean linen storage and issuing room or area;

 

iv)        A clean linen inspection and mending room or area;

 

v)         Storage for laundry supplies;

 

vi)        A janitors' closet containing a floor receptor or service sink and storage space for housekeeping equipment and supplies;

 

vii)       Cart storage; and

 

viii)      Office space.

 

B)        Off-site Processing.  If linen is processed off the hospital site, the following shall be provided:

 

i)          A soiled linen holding room with facilities for hand-washing;

 

ii)         Clean linen, receiving, inspection and storage rooms;

 

iii)        Cart storage; and

 

iv)        Office space.

 

4)         Facilities for Cleaning and Sanitizing Carts.  Facilities shall be provided to clean and sanitize carts serving the central medical and surgical supply department, dietary facilities, and linen services. These may be centralized or departmentalized.

 

5)         Employees' Facilities.  In addition to the employees' facilities such as locker rooms, lounges, toilets, or shower facilities called for in certain departments, a sufficient number of these facilities as required to accommodate the needs of all personnel and volunteers shall be provided.

 

6)         Janitors' Closets.  In addition to the janitors' closets called for in certain departments, sufficient janitors' closets shall be provided throughout the facility as required to maintain a clean and sanitary environment.  Each shall contain a floor receptor or service sink and storage space for housekeeping equipment and supplies.  Space for large housekeeping equipment and for back-up supplies may be located in other areas.

 

7)         Engineering Service and Equipment Areas.  The following shall be provided:

 

A)        Rooms or separate buildings for boilers, mechanical equipment, and electrical equipment;

 

B)        Engineer's space;

 

C)        A maintenance shop;

 

D)        A storage room or rooms for building maintenance supplies; and

 

E)        Yard equipment storage.  Yard maintenance equipment and supplies may be stored in a separate room or building.

 

8)         Waste Processing Services

 

A)        Storage and Disposal.  Space and facilities shall be provided for the sanitary storage and disposal of waste by incineration, mechanical destruction, compaction, containerization, removal, or by a combination of these techniques.  Proper handling and disposal of radioactive waste substances shall be provided.

 

B)        Incineration.  A gas, electric or oil-fired incinerator shall be provided for the complete destruction of pathological and infectious waste.  Infectious waste shall include, but shall not be limited to, dressings and material from open wounds, laboratory specimens, and all waste material from isolation rooms.

 

i)          The incinerator shall be in a separate room or placed outdoors.

 

ii)         Design and construction of incinerators and trash chutes shall be in accordance with NFPA 82, Standard on Incinerators and Waste and Linen Handling Systems and Equipment.

 

iii)        Incinerators shall be designed and equipped to conform to requirements prescribed by air pollution regulations in the area.

 

9)         Storage.  In addition to the storage areas called for in certain departments of the hospital, suitable additional storage shall be provided.

 

(Source:  Amended at 41 Ill. Reg. 7154, effective June 12, 2017)

 

Section 250.2442  Fees

 

a)         Before commencing construction of new facilities or specified types of alteration or additions to an existing hospital involving major construction with an estimated cost greater than $100,000, architectural plans and specifications therefor shall be submitted to the Department for review and approval.  A hospital may submit architectural drawings and specifications for other construction projects for Department review according to subsection (b) that shall not be subject to fees under subsection (d).  Review of drawings and specifications shall be conducted by an employee of the Department meeting the qualifications established by the Department of Central Management Services class specifications for such an individual's position or by a person contracting with the Department who meets those class specifications.  Final approval of the plans and specifications for compliance with design and construction standards shall be obtained from the Department before the alteration, addition, or new construction is begun.  (Section 8(a) of the Act) For the purposes of this Section, "major construction" means changes that affect the structural integrity of the building, that change functional operations, that affect fire and life safety, and that add beds or facilities over those for which the hospital is licensed.

 

b)         The Department shall inform an applicant in writing within 10 working days after receiving drawings and specifications and the required fee, if any, from the applicant whether the applicant's submission is complete or incomplete.  Failure to provide the applicant with this notice within 10 working days shall result in the submission being deemed complete for purposes of initiating the 60 day review period under this Section.  If the submission is incomplete, the Department shall inform the applicant of the deficiencies with the submission in writing.  If the submission is complete and the required fee, if any, has been paid, the Department shall approve or disapprove drawings and specifications submitted to the Department no later than 60 days following receipt by the Department.  The drawings and specifications shall be of sufficient detail to enable the Department to render a determination of compliance with design and construction standards under the Act.  If the Department finds that the drawings are not of sufficient detail for it to render a determination of compliance, the plans shall be determined to be incomplete and shall not be considered for purposes of initiating the 60 day review period.  If a submission of drawings and specifications is incomplete, the applicant may submit additional information.  The 60 day review period shall not commence until the Department determines that a submission of drawings and specifications is complete or the submission is deemed complete.  If the Department has not approved or disapproved the drawings and specifications within 60 days, the construction, major alteration, or addition shall be deemed approved.  If the drawings and specifications are disapproved, the Department shall state in writing, with specificity, the reasons for the disapproval.  The entity submitting the drawings and specifications may submit additional information in response to the written comments from the Department or request a reconsideration of the disapproval.  A final decision of approval or disapproval shall be made within 45 days after the receipt of the additional information or reconsideration request.  If denied, the Department shall state the specific reasons for the denial.  The applicant may elect to seek informal dispute resolution through the Department's Advisory Committee (see Section 250.2443).  If the issue is not resolved, the applicant may elect to seek dispute resolution pursuant to Section 25 of the Illinois Building Commission Act [20 ILCS 3918/28], in which the Department must participate.  (Section 8(b) of the Act)

 

c)         The Department shall provide written approval for occupancy pursuant to Section 8(g) of the Act and shall not issue a violation to a facility as a result of a licensure or complaint survey based upon the facility's physical structure if:

 

1)         The Department reviewed and approved or deemed approved the drawings and specifications for compliance with design and construction standards;

 

2)         The construction, major alteration, or addition was built as submitted;

 

3)         The Act or this Part has not been amended since the original approval; and

 

4)         The conditions at the facility indicate that there is a reasonable degree of safety provided for the patients.  (Section 8(c) of the Act)

 

d)         The Department shall charge the following fees in connection with its review conducted before June 30, 2004 under this Section:

 

1)         If the estimated dollar value of the project is $99,999.99 or less, no fee is required.

 

2)         If the estimated dollar value of the project is between $100,000 and $499,999.99, no fee is required.

 

3)         If the estimated dollar value of the project is between $500,000 and $999,999.99 the fee shall be the greater of $6,000 or 0.96% of that value.

 

4)         If the estimated dollar value of the project is between $1,000,000 and $4,999,999.99 the fee shall be the greater of $9,600 or 0.22% of that value.

 

5)         If the estimated dollar value of the project is $5,000,000 or more, the fee shall be the greater of $11,000 or 0.11% of that value, but shall not exceed $40,000.

 

6)         The fees provided in this subsection shall not apply to major construction projects involving facility changes that are required by Department rule amendments or to projects deemed by the Department to be related to homeland security.  (Section 8(d) of the Act)

 

e)         The fees provided in this Section shall also not apply to major construction projects if 51% or more of the estimated cost of the project is attributed to capital equipment.  For major construction projects where 51% or more of the estimated cost of the project is attributed to capital equipment, the Department shall have the cost of the capital equipment in the project reduced by 20% in the fee calculation line for capital equipment.  (Section 8(d) of the Act)

 

f)         Disproportionate share hospitals and rural hospitals shall pay only one-half of the fees required in this Section.  For the purposes of this subsection, "disproportionate share hospitals" means a hospital described in items (1) through (5) of subsection (b) of Section 5-5.02 of the Illinois Public Aid Code.  "Rural hospital" means a hospital that is located outside a metropolitan statistical area or located 15 miles or less from a county that is outside a metropolitan statistical area and is licensed to perform medical/surgical or obstetrical services and has a combined total bed capacity of 75 or fewer beds in these 2 service categories as of July 14, 1993, as determined by the Department.  (Section 8(d) of the Act)

 

g)         The Department shall not commence the facility plan review process under this Section until the applicable fee has been paid.  (Section 8(d) of the Act)

 

h)         All fees received by the Department under this Section shall be deposited into the Health Facility Plan Review Fund, and shall be used only to cover the direct and reasonable costs relating to the Department's review of hospital projects under this Section.  (Section 8(e) of the Act)

 

(Source:  Added at 27 Ill. Reg. 6579, effective April 15, 2004)

 

Section 250.2443  Advisory Committee

 

a)         The Director shall appoint an advisory committee to advise the Department and to conduct informal dispute resolution concerning the application of building codes for new and existing construction and related Department rules and standards under the Act, including without limitation rules and standards for design and construction, engineering and maintenance of the physical plant, site, equipment, and systems (heating, cooling, electrical, ventilation, plumbing, water, sewer, and solid waste disposal), and fire and safety.  (Section 2310-560(b) of the Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois)

 

b)         The advisory committee shall be composed of all of the following members:

 

1)         The chairperson or an elected representative from the Hospital Licensing Board under the Act;

 

2)         Two health care architects with a minimum of 10 years of experience in institutional design and building code analysis;

 

3)         Two engineering professionals (one mechanical and one electrical) with a minimum of 10 years of experience in institutional design and building code analysis;

 

4)         One commercial interior design professional with a minimum of 10 years of experience in institutional design and building code analysis;

 

5)         Two representatives from provider associations; and

 

6)         The Director or his/her designee, who shall serve as the committee moderator.  (Section 2310-560(b) of the Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois)

 

c)         Appointments shall be made with the concurrence of the Hospital Licensing Board.  (Section 2310-560(b) of the Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois)

 

d)         Appointments shall be made for a three year term.

 

e)         The committee shall submit recommendations concerning the application of building codes and related Department rules and standards to the Hospital Licensing Board for review and comment prior to submission to the Department.  The committee shall submit the recommendations concerning informal dispute resolution to the Director.  The Department shall provide per diem and travel expenses to the committee members based on the rules of the Department of Central Management Services in 80 Ill. Adm. Code 2800 (Travel).  (Section 2310-560(b) of the Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois) Payment shall be made through the Health Facility Plan Review Fund.

 

f)         The Department shall review the construction requirements contained in this Part every three years and shall update the requirements as necessary, considering the recommendations of the advisory committee.

 

(Source:  Added at 27 Ill. Reg. 6579, effective April 15, 2004)

 

Section 250.2450  Details

 

a)         Compartmentation, exits, automatic extinguishing systems, and other details relating to fire prevention and fire protection shall comply with requirements listed in the appropriate sections of NFPA 101, Life Safety Code.

 

b)         Items such as drinking fountains, telephone booths, vending machines, and portable equipment shall be located so as not to restrict corridor traffic or reduce the corridor width below the required minimum.

 

c)         Doors

 

1)         Doors to patient rooms shall not be lockable from inside the room.  Hospitals shall have policies and procedures for readily gaining access to a locked bathroom in a patient's room.  (Section 11.6 of the Act)

 

2)         Special Locking Arrangements: Electronic locking devices may be installed at specific locations to restrict egress or ingress for patient/staff safety or security, provided that each of the following is complied with and after receiving approval from the Department:

 

A)        The facility shall submit a narrative to the Department providing a rationale for having a locked door in a required means of egress.  The rationale shall relate to security issues.

 

B)        The building shall be protected by a sprinkler or fire detection system approved by the Department.

 

C)        All locking system components shall be U.L. listed.

 

D)        Cross corridor, smoke, or control doors that are located in a required means of egress may be secured only with electronic locks and automatic release devices.  The use of only manual keys or tools to unlock the door is not permitted.

 

E)        Locked doors shall have continuous staff supervision (direct or electronic remote).

 

F)         No other type of locking arrangement may be used in a required means of egress.

 

G)        All locked doors shall release automatically with actuation of the fire alarm system.

 

H)        All doors shall release automatically with loss of electrical power to the locking device.

 

I)         All delayed egress locks shall initiate an irreversible process that will release the lock within 15 seconds whenever a force of not more than 15 pounds is continuously applied to the release device (lever type handle or panic bar) for a period of not more than three seconds.  Relocking of such doors shall be by manual means only. Operation of the release device activates a sign in the vicinity of the door to assure those attempting to exit that the system is functional.  Delays of up to 30 seconds may be acceptable based on the program narrative.

 

J)         Permanent signs shall be posted on electronic locked doors that state the action required to open the door.  Electronic delayed egress type doors shall state:  "Push until alarm sounds.  Door will be opened in 15 seconds." Sign letters shall be at least 1 inch high with 1/8-inch stroke.  Signs may be omitted for security reasons based on the Department's review of the hospital's written rationale.

 

K)        Emergency lighting shall be provided at all locked door locations.

 

L)        The local fire department shall be fully apprised of locked doors or units and all related details of the system.

 

M)       Any discharge exit door may be locked against entry.

 

N)        Additional electronic release of locked doors initiated from a 24/7 staff duty station or an ADA compliant release device located within 5 feet of the door shall be provided.  The duty station shall be located within the locked unit and staff shall be able to observe the door directly to by remote video.

 

O)        No more than two electronic locking devices may be installed in any path of travel to exit discharge, one of which may be delayed egress.

 

P)         Complete smoke detection shall be provided throughout the entire secured unit.

 

d)         The minimum width of all doors to rooms needing access for beds or stretchers shall be 3 feet, 8 inches.  Doors to rooms needing access for wheelchairs shall have a minimum width of 2 feet, 10 inches.

 

e)         Doors on all openings between corridors and rooms or spaces subject to occupancy, except elevator doors, shall be swing type. Openings to showers, baths, patient toilets, and other small wet-type areas not subject to fire hazard are exempt from this requirement.  Sliding doors with a break and swing feature are acceptable.

 

f)         Doors, except those to spaces such as small closets that are not subject to occupancy, shall not swing into corridors in a manner that might obstruct traffic flow or reduce the required corridor width.  (Large walk-in type closets are considered as occupiable spaces.)

 

g)         Windows shall be designed so that persons cannot accidentally fall out of them when they are open, or shall be provided with guards.

 

h)         Glazing

 

1)         Doors, sidelights, borrowed lights, and windows in which the glazing extends down to within 18 inches of the floor (thereby creating possibility of accidental breakage by pedestrian traffic) shall be glazed with safety glass or plastic glazing material that will resist breaking and will not create dangerous cutting edges when broken.  Similar materials shall be used in wall openings or recreation rooms and exercise rooms.  Safety glass or plastic glazing materials shall be used for shower doors and bath enclosures.  Fire-rated glass shall be used where required for fire safety.

 

2)         Safety glass or plastic glazing materials as noted above shall be used in windows and doors in patient areas of psychiatric facilities, if required by the program.  See the Safety Glazing Materials Act  for other requirements.

 

i)          Where labeled fire doors are required, these shall be certified by an independent testing laboratory as meeting the construction requirements equal to those for fire doors in NFPA  80, Standard for Fire Doors and Fire Windows.  Reference to a labeled door includes labeled frame and hardware.

 

j)          Elevator shaft openings shall be Class B 1˝-hour-labeled fire doors.

 

k)         Linen and refuse chutes shall meet or exceed the following requirements:

 

1)         Service openings to chutes shall not be located in corridors or passageways but shall be located in a room of construction having a fire-resistance of not less than one hour.  Doors to such rooms shall be not less than Class C ľ-hour-labeled doors.

 

2)         Service openings to chutes shall have approved self-closing Class B 1˝-hour-labeled fire doors.

 

3)         The minimum cross-sectional dimension of gravity chutes shall be not less than 2 feet.

 

4)         Chutes shall discharge directly into collection rooms separated from incinerator, laundry, or other services.  Separate collection rooms shall be provided for trash and for linen.  The enclosure construction for such rooms shall have a fire-resistance rating of not less than two hours, and the doors thereto shall be not less than Class B 1˝-hour-labeled fire doors. External discharge containers need not be enclosed.

 

5)         Gravity chutes shall extend through the roof with provisions for continuous ventilation as well as for fire and smoke ventilation.  Openings for fire and smoke ventilation shall have an effective area of not less than that of the chute cross-section and shall be not less than 4 feet above the roof and not less than 6 feet clear of other vertical surfaces.  Fire and smoke ventilating openings may be covered with single strength sheet glass or stronger.

 

6)         See NFPA 82, Standard on Incinerators and Waste and Linen Handling System and Equipment for other requirements.

 

l)          Dumbwaiters, conveyors, and material-handling systems shall not open directly into a corridor or exitway but shall open into a room enclosed by construction having a fire-resistance rating of not less than one hour and provided with Class C ľ-hour-labeled fire doors.  Service entrance doors to vertical shafts containing dumbwaiters, conveyors, and material-handling systems shall be not less than Class B 1˝-hour-labeled fire doors.  Where horizontal conveyors and material-handling systems penetrate fire-rated walls or smoke partitions, such openings shall be provided with Class B 1˝-hour-labeled fire doors for two-hour walls and Class C ľ-hour-labeled fire doors for one-hour walls or partitions.

 

m)        Thresholds and expansion joint covers shall be flush with the floor surface to facilitate use of wheelchairs and carts.

 

n)         Grab bars shall be provided at all patients' toilets, showers, tubs, and sitz baths.  The bars shall have 1˝-inch clearance to walls and shall have sufficient strength and anchorage to sustain a concentrated load of 250 pounds.

 

o)         Recessed soap dishes shall be provided at showers and bathtubs.

 

p)         Location and arrangement of hand-washing facilities shall permit their proper use and operation.  Particular care shall be given to the clearances required for blade-type operating handles.

 

q)         Mirrors shall not be installed at hand-washing fixtures in food preparation areas or in sensitive areas such as nurseries, clean and sterile supplies, and scrub sinks.

 

r)          Paper towel dispensers and waste receptacles (or electric hand dryers) shall be provided at all hand-washing facilities except scrub sinks.

 

s)         Lavatories and hand-washing facilities shall be securely anchored to withstand an applied vertical load of not less than 250 pounds on the front of the fixture.

 

t)          Radiation protection requirements of X-ray and gamma ray installations shall conform with the National Council on Radiation Protection and Measurements (NCRP), Report 49:   Structural Shielding Design and Evaluation for Medical Use of X-rays and Gamma Rays of Energies up to 10 MeV and NCRP Report 102: Medical X-Ray, Electron Beam and Gamma-Ray Protection for Energies Up to 50 MeV (Equipment Design, Performance and Use).  Provision shall be made for testing the completed installation.  All defects shall be corrected before use.

 

u)         Ceiling heights shall be as follows:

 

1)         Boiler rooms shall have ceiling clearances not less than 2 feet, 6 inches above the main boiler header and connecting piping.

 

2)         Radiographic, operating, and delivery rooms, and other rooms containing ceiling-mounted equipment or ceiling-mounted surgical light fixtures, shall have height required to accommodate the equipment or fixtures.

 

3)         All other rooms shall have not less than 8-foot ceilings, except that ceilings in corridors, storage rooms, toilet rooms, and other minor rooms shall be not less than 7 feet, 8 inches.  Suspended tracks, rails, and pipes located in the path of normal traffic shall be not less than 6 feet, 8 inches above the floor.

 

v)         Recreation rooms, exercise rooms, and similar spaces where impact noises may be generated shall not be located directly over patient bed areas, or delivery or operating suites, unless special provisions are made to minimize such noise.

 

w)        Rooms containing heat-producing equipment (such as boiler or heater rooms and laundries) shall be insulated and ventilated to prevent any floor surface above from exceeding a temperature of 10°F (6°C) above the ambient room temperature.

 

x)         Noise reduction criteria shown in Table B shall apply to partition, floor, and ceiling construction in patient areas.  (See Table B for sound transmission limitations in general hospitals.)  (Table B is not applicable to existing hospitals.)

 

y)         Elevators. All hospitals having patients' facilities (such as bedrooms, dining rooms, or recreation areas) or critical services (such as operating, delivery, diagnostic, or therapy) located on other than the main entrance floor shall have electric or electrohydraulic elevators.

 

1)         Number of Elevators

 

A)        At least one hospital-type elevator shall be installed where 1 to 59 patient beds are located on any floor other than the main entrance floor.

 

B)        At least two hospital-type elevators shall be installed where 60 to 200 patient beds are located on floors other than the main entrance floor, or where the inpatient services are located on a floor other than those containing patient beds. (Elevator service may be reduced for other floors.)

 

C)        At least three hospital-type elevators shall be installed where 201 to 350 patient beds are located on floors other than the main entrance floor, or where the major inpatient services are located on a floor other than those containing patient beds. (Elevator service may be reduced for those floors which provide only partial inpatient services.)

 

D)        For hospitals with more than 350 beds, the number of elevators shall be determined from a study of the hospital plan and the estimated vertical transportation requirements.

 

2)         Cars and Platforms.  Cars of hospital-type elevators shall have dimensions that will accommodate a patient bed and attendants and shall be at least 5 feet, 8 inches by 7 feet, 6 inches.  The car door shall have a clear opening of not less than 3 feet, 8 inches.

 

3)         Leveling.  Elevators shall be equipped with an automatic leveling device of the two-way automatic maintaining type with an accuracy of +˝ inch.

 

4)         Operation.  Elevators, except freight elevators, shall be equipped with a two-way special service key-operated switch to permit cars to bypass all landing button calls and be dispatched directly to any floor.

 

5)         Elevator controls, alarm buttons, and telephones shall be accessible to physically handicapped.

 

6)         Elevator call buttons, controls, and door safety stops shall be of a type that will not be activated by heat or smoke.

 

7)         Inspections and tests shall be made and written certification shall be furnished that the installation meets the requirements set forth in this Section and all applicable NFPA and local codes.

 

z)         Provisions for Natural Disasters

 

1)         General Requirements.  An emergency radio communication system is desirable in each facility.  If installed, this system shall be self-sufficient in a time of emergency and shall also be linked with the available community system and state emergency medical network system, including connections with police, fire, and civil defense systems.

 

2)         Earthquakes.  In regions where local experience shows that earthquakes have caused loss of life or extensive property damage, buildings and structures shall be designed to withstand the force assumptions specified in the International Building Code.  Seismic zones are identified on the map shown in Illustration A.

 

3)         Tornadoes and Floods. Special provisions shall be made in the design of buildings in regions where local experience shows loss of life or damage to buildings resulting from tornadoes or floods.

 

(Source:  Amended at 35 Ill. Reg. 6386, effective March 31, 2011)

 

Section 250.2460  Finishes

 

a)         Cubicle and window curtains and draperies shall be noncombustible or rendered flame retardant and shall pass both the large and small scale tests of NFPA 701, Standard Methods of Fire Tests for Flame Propagation of Textiles and Films.

 

b)         Flame spread and smoke developed ratings of finishes shall be in accordance with NFPA 101, Life Safety Code.

 

c)         Floors in areas and rooms in which flammable anesthetic agents are stored or administered to patients shall comply with NFPA 99, Standard for Health Care Facilities. Conductive flooring may be omitted from emergency treatment, operating, and delivery rooms provided that a written resolution is signed by the hospital governing board stating that no flammable anesthetic agents will be used in these areas, and provided that appropriate notices are permanently and conspicuously affixed to the wall in each such area and room.

 

d)         Floor materials shall be easily cleanable and have wear resistance appropriate for the location involved. Floors in areas used for food preparation or food assembly shall be water resistant and greaseproof. Joints in tile and similar material in such areas shall be resistant to food acids.  Floors in toilets, baths, janitor's closets, and similar areas shall be water resistant.  In all areas frequently subject to wet cleaning methods, floor materials shall not be physically affected by germicidal and cleaning solutions.

 

e)         Wall bases in kitchens, operating and delivery rooms, soiled work rooms, and other areas that are frequently subject to wet cleaning methods shall be made integral and coved with the floor, tightly sealed to the wall, and constructed without surface voids that can harbor vermin.

 

f)         All wall finishes shall be washable and, in the immediate area of plumbing fixtures, shall be smooth and moisture resistant.  Walls in surgery, delivery, kitchens and in other spaces subject to frequent cleaning shall have finishes that are smooth, sanitary, washable, and capable of withstanding treatment with harsh chemicals.  The finishes shall be capable of being thoroughly cleaned, including concealed spaces.

 

g)         Floor and wall penetrations by pipes, ducts, and conduits shall be tightly sealed to minimize entry of vermin, smoke, and fire.  Joints of structural elements shall be similarly sealed.

 

h)         Ceilings shall be cleanable and shall meet the following criteria:

 

1)         Unrestricted general access areas such as patient rooms, corridors, offices, and waiting areas  may have non-restricted acoustical ceilings installed.

 

2)         Ceilings in wet areas subject to frequent cleaning such as shower rooms, toilet rooms, and dietary units shall have finishes that are smooth, sanitary, washable, and capable of withstanding treatment with harsh chemicals. The finishes shall be capable of being thoroughly cleaned, including any concealed spaces that may be present.

 

3)         Food preparation areas subject to frequent cleaning shall have ceiling finishes that are smooth, sanitary, washable, and capable of withstanding treatment with harsh chemicals.

 

4)         Ceiling finishes in areas such as clean corridors, central sterile supply spaces, specialized radiographic rooms, and minor surgical procedure rooms shall be smooth, scrubbable, non-absorptive, non-perforated, capable of withstanding cleaning with harsh chemicals, and without crevices that can harbor mold and bacterial growth.  If a lay-in ceiling is provided, it shall be designed to prevent the passage of particles from the cavity above the ceiling plane into the semi-restricted environment.  Perforated, tegular, serrated, cut, or highly textured tiles are not acceptable.

 

5)         Ceiling finishes in areas such as operating rooms and other rooms where open wounds are present shall be monolithic, scrubbable, and capable of withstanding harsh chemicals.  Cracks or perforations in these ceilings are not allowed.

 

i)          The following areas shall have acoustical ceilings:

 

1)         Corridors in patient areas;

 

2)         Nurses' stations;

 

3)         Labor rooms;

 

4)         Day rooms;

 

5)         Recreation rooms;

 

6)         Dining areas; and

 

7)         Waiting areas.

 

(Source:  Amended at 35 Ill. Reg. 6386, effective March 31, 2011)

 

Section 250.2470  Structural

 

a)         In addition to compliance with this Subpart, all applicable local or State building codes and regulations shall be observed.

 

b)         The buildings and all parts thereof shall be of sufficient strength to support all dead, live, and lateral loads without exceeding the working stresses permitted for the materials of their construction in generally accepted good engineering practice.

 

c)         Special provision shall be made for machines or apparatus loads that would cause a greater load than the specified minimum live load.

 

d)         Consideration shall be given to structural members and connections of structures that may be subject to earthquakes or tornadoes. (See Section 250.2450(z).)  Floor areas where partition locations are subject to change shall be designed to support, for the partition, a uniformly distributed load of 25 p.s.f.

 

e)         Construction.  Construction shall be in accordance with the requirements of NFPA 101, Life Safety Code, and the minimum requirements contained in this subsection (e).

 

1)         Foundations shall rest on natural solid ground and shall be carried to a depth of not less than 1 foot below the estimated frost line or shall rest on leveled rock or load-bearing piles or caissons when solid ground is not encountered.  Footings, piers, and foundation walls shall be adequately protected against deterioration from the action of ground water.  Test borings shall be taken to establish proper soil-bearing values for the soil at the building site.

 

2)         Assumed live loads shall be in accordance with the International Building Code.

 

3)         All hospitals of any height shall be of Type I or Type II construction as established by NFPA 101, Life Safety Code,  and NFPA 220, Standard on Types of Building Construction.

 

(Source:  Amended at 35 Ill. Reg. 6386, effective March 31, 2011)

 

Section 250.2480  Mechanical

 

a)         General

 

1)         Mechanical systems shall be tested, balanced, and operated to demonstrate that the installation and performance of these systems conform to the requirements of the plans and specifications.

 

2)         Upon completion of the contract, the owner shall obtain a complete set of manufacturer's installation, operating, maintenance, and preventive maintenance instructions and a parts list with numbers and a description for each piece of equipment.  The owner shall also obtain instruction in the operational use of the systems and equipment as required.

 

b)         Thermal and Acoustical Insulation

 

1)         Insulation shall be provided for the following that are located within the building:

 

A)        Boilers, smoke breeching, and stacks.

 

B)        Steam supply and condensate return piping.

 

C)        Hot water piping above 120° F and all hot water heaters, generators, and converters.  Exposed hot water supplies to fixtures need not be insulated except where exposed to contact by the physically handicapped.

 

D)        Chilled water, refrigerant, other process piping, and equipment operating with fluid temperatures below ambient dew point.

 

E)        Water supply, storm, and drainage piping on which condensation may occur.

 

F)         Air ducts and casings with outside surface temperature below ambient dew point.

 

G)        Other piping, ducts, and equipment as necessary to maintain the efficiency of the system.

 

2)         Insulation on cold surfaces shall include an exterior vapor barrier.

 

3)         Insulation, including finishes and adhesives on exterior surfaces of ducts and equipment, shall have a flame spread rating of 25 or less and a smoke developed rating of 50 or less as determined by an independent testing laboratory in accordance with NFPA 255, Standard Method of Test of Surface Burning Characteristics of Building Materials.  

 

A)        Pipe insulation shall have a flame spread rating of 25 or less and a smoke developed rating of 150 or less.

 

B)        All construction exposed to air flow in air distribution plenums shall have a flame spread rating of 25 or less and a smoke developed rating of 50 or less.

 

4)         No duct linings shall be permitted downstream of the 90% filters serving areas requiring 90% filtration.

 

c)         Steam and Hot Water Systems

 

1)         Boilers shall have the capacity to supply the normal requirements of all systems and equipment.  The number and arrangement of boilers shall be such that when one boiler breaks down or is temporarily taken out of service, the capacity of the remaining boilers shall be sufficient to provide hot water service for clinical, dietary, and patient use; steam for sterilization and dietary purposes; heating for surgery, delivery, labor, recovery, intensive care, nursery, and general patient rooms.

 

2)         Boiler feed pumps, heating circulating pumps, condensate return pumps and fuel oil pumps shall be connected and installed to provide normal and standby service.

 

3)         Supply and return mains and risers of cooling, heating, and process steam systems shall be valved to isolate the various sections of each system.  Each piece of equipment shall be valved at supply and return ends.

 

4)         Humidifiers used in conjunction with air handling systems shall be of the direct steam injection type.

 

d)         Air Conditioning, Heating and Ventilating Systems

 

1)         This Part is intended to provide a comfortable, clean, controlled environment for the hospital by employing the most economical and energy efficient systems consistent with these minimum requirements.

 

A)        The minimum requirements as set forth in this Part in no way relieve the designer from providing system capacities and components as required to maintain control of air quality, odor, ventilation rates, space temperatures, and space humidity as set forth in this Part.

 

B)        The design of air conditioning, heating and ventilation systems shall be based on no less than the recommended outdoor design conditions listed in the ASHRAE Handbook of Fundamentals  for 99% occurrence (winter) and 1% occurrence (summer).

 

2)         Ventilation Systems

 

A)        Air handling systems shall conform to NFPA 90A, Standard for Installation of Air Conditioning and Ventilating Systems.

 

B)        Fire dampers, smoke dampers, and smoke control systems shall be constructed, located, and installed in accordance with the requirements of NFPA 90A, Standard for Installation of Air Conditioning and Ventilating Systems.

 

C)        Ducts that penetrate construction intended for x-ray or other ray protection shall preserve the effectiveness of the protection.

 

D)        Outdoor air intakes shall be located at least 15 feet from exhaust outlets of ventilation systems, combustion equipment stacks, medical/surgical vacuum systems, or plumbing vents, or from areas that may collect vehicular exhaust or other noxious fumes unless other provisions are made to minimize recirculation of exhaust into outdoor air intakes.  Plumbing and vacuum vents that terminate above the level of the top of the air intake shall be located no closer than 10 feet.  The bottom of outdoor air intakes serving central systems shall be located as high as practical but at least 6feet above ground level, or if installed above the roof, 3 feet above the roof level.

 

E)        Exhaust outlets from areas that may be contaminated by dangerous or noxious dust, fumes, mists, gases, odors, infectious material, or other contaminants harmful to people shall be above the roof level. The discharge to the atmosphere shall be located as far as possible but not less than 25 feet from any operable window, door, and/or outdoor intake for a fan that discharges air to an occupied space.

 

F)         The ventilation systems shall be designed and balanced to provide the ventilation and pressure relationships specified in this Section.

 

G)        If the ventilation rates required (as specified in this Section) do not provide sufficient make-up air for use by hoods, safety cabinets, and exhaust fans, the additional make-up air shall be provided to maintain required pressure balance.

 

H)        An all-outdoor air system may be used where required by local codes, provided that some form of air-to-air or air-to-water heat recovery system will be included to reclaim the energy otherwise discharged with the air exhausted to the outside.

 

I)         To provide maximum energy conservation, air supplied to patient care areas not required as make-up air for 100% exhaust systems shall be recirculated.  Any air within the hospital that is circulated between patient rooms, or patient rooms and other areas of the hospital, shall pass through filters having an efficiency of 90% (see subsection (d)(3) on filters).

 

J)         To provide maximum energy conservation, air supplied to housekeeping, administration and other nonsensitive areas not required as make-up air for 100% exhaust systems shall be recirculated.  These areas require filters having a minimum efficiency of 30% on the inlet side of the air handling unit.

 

K)        When a central system serves areas with different filtration requirements, the most stringent filtration requirement shall be provided for the complete system.

 

L)        All outside air supplied to patient care areas shall pass through 90% filters (see subsection (d)(3) on filters).

 

M)       Minimum air circulation requirements indicated in this Section are applicable to occupied spaces.  During unoccupied periods, minimum air circulation may be provided as required to maintain space design temperature conditions.

 

N)        Where fan coil or terminal room unit systems are provided in areas to be occupied by patients, through-the-wall outside air ventilation is not acceptable.  A separate central ventilation system, with final filters having a minimum efficiency of 90%, shall supply the required outdoor air ventilation.

 

3)         Filters

 

A)        All central ventilation or air conditioning systems shall be equipped with filters having efficiencies no less than those specified in the area requirements.

 

B)        Where two filter beds are required, filter bed No. 1 shall be located upstream of the conditioning equipment and filter bed No. 2 shall be located downstream of the supply fan and conditioning equipment.

 

C)        Where only one filter bed is required, it shall be located upstream of the air conditioning equipment.

 

D)        All filter efficiencies shall be average atmospheric dust spot efficiencies tested in accordance with ASHRAE Handbook of Fundamentals.

 

E)        Filter frames shall be durable and shall provide an airtight fit with the enclosing duct work.  All joints between filter segments and enclosing duct work shall be gasketed or sealed to provide a positive seal against air leakage.

 

F)         A local indicating device shall be installed across each filter bed serving central air systems to measure the static pressure drop across the bed.

 

e)         Area Requirements  

 

1)         Administration, Public Area, Medical Records, and Housekeeping Offices.

 

A)        Filters:

 

i)	Central ventilation systems shall be provided with prefilters having a minimum efficiency of...............	30%
ii)	Units that recirculate air within a room shall be provided with filters having a minimum efficiency of...............................................................................	10%

 

B)        Space Design Conditions:

 

i)	Temperature, dry bulb..............................................	75°
ii)	Relative Humidity, winter, minimum......................	30%
iii)	Relative Humidity, summer, maximum...................	60%

 

C)        Air Circulation:

 

i)         Total air supplied to each space shall be as required to maintain space design conditions.

 

ii)        Outdoor air supplied shall be no less than 20% of the total air supplied.

 

D)       Space Pressurization:

	Ventilation system shall be designed and balanced so that space pressure, in relation to surrounding areas of the building, is...................................................................	neutral
E)	Recirculation of air within room permitted.......................	yes

 

2)         Laboratories

 

A)        Filters:

 

i)	Central ventilation systems shall be provided with prefilters having a minimum efficiency of...............	30%
	and final filters having a minimum efficiency of.....	90%
ii)	Units that recirculate air within a room shall be provided with filters having a minimum
	efficiency of..............................................................	30%

 

B)        Space Design Conditions:

 

i)	Temperature, dry bulb..............................................	75°
ii)	Relative Humidity, winter, minimum......................	30%
iii)	Relative Humidity, summer, maximum...................	60%

 

C)        Air Circulation:

 

i)         Total air supplied to each space shall be as required to maintain space design conditions.

 

ii)        Outdoor air supplied shall be no less than 20% of the total air supplied.

 

D)        Space Pressurization:

	Ventilation system shall be designed and balanced so that space pressure, in relation to surrounding areas of the building, is...................................................................	negative
E)	Recirculation of air within room permitted except in areas, as listed below, where all air must be exhausted directly to the outdoors.....................................................	yes

 

F)         Air from the following areas shall be exhausted directly to the outdoors:

 

i)          All fume hoods

 

ii)         Histology

 

iii)        Bacteriology

 

iv)        Glass-washing areas

 

G)        All air exhausted from fume hoods shall be made up with outside air.

 

H)        Laboratory hoods shall meet the following general requirements:

 

i)          Have an average face velocity of not less than 75 feet per minute;

 

ii)         Be connected to an exhaust system that is separate from the building exhaust system;

 

iii)        Have an exhaust duct system of noncombustible, corrosion-resistant material consistent with the usage of the hood; and

 

iv)        Have the exhaust fan located at the discharge end of the duct system unless provided with welded stainless steel duct from fan outlet to termination.

 

I)         Laboratory hoods shall meet the following special requirements:

 

i)          Each hood that processes infectious or radioactive materials shall have a minimum face velocity of 100 feet per minute, shall be connected to an independent exhaust system, shall be provided with filters with 99.97 percent efficiency (based on the DOD, dioctylphthalate test method as described in DOD Penetration Test Method MIL STD  282:  Filtered Units, Protective Clothing, Gas-Mask Components and Related Products:  Performance Test Methods) in the exhaust system, and shall be designed and equipped to permit the safe removal, disposal and replacement of contaminated filters.

 

ii)         Duct systems serving hoods in which radioactive and/or strong oxidizing agents such as prechloric or nitric acid are used shall be constructed of stainless steel and shall be equipped with wash-down facilities.

 

3)         Morgue and Autopsy Suite

 

A)        Filters:

 

Central ventilation systems shall be provided with prefilters having a minimum efficiency of....................................	30%
and final filters having a minimum efficiency of...........	90%

 

B)        Space Design Conditions:

 

i)	Temperature, dry bulb...............................................	75°
ii)	Relative Humidity, winter, minimum......................	30%
iii)	Relative Humidity, summer, maximum...................	60%

 

C)        Air Circulation:

 

i)         Total air supplied to each space shall be as required to maintain space design conditions.

 

ii)        Outdoor air supplied shall be no less than 20% of the total air supplied.

 

D)        Space Pressurization: 

	Ventilation system shall be designed and balanced so that space pressure, in relation to surrounding areas of the building, is...............................................................	negative
E)	Recirculation of air within room permitted...................	no

 

F)         Air from the following areas shall be exhausted directly to the outdoors:

 

i)         Autopsy

 

ii)        Non-refrigerated body holding rooms

 

4)         Radiology Suite; X-Ray Diagnostic, Fluoroscopy, and Special Procedures

 

A)        Filters:

 

i)	Central ventilation systems shall be provided with prefilters having a minimum efficiency of...	30%
	and final filters having a minimum efficiency of......	90%
ii)	Units that recirculate air within a room shall be provided with filters having a minimum efficiency of .........................................................	30%
iii)	The exhaust from isotope storage shall be provided with filters with 99.97% efficiency (based on the DOD, dioctylphthalatetest method as described in DOD Penetration Test Method MIL STD  282:  Filter Units, Protective Clothing, Gas-Mask Components and Related Products:  Performance Test Methods).

 

B)        Space Design Conditions:

 

i)	Temperature, dry bulb..............................................	75°
ii)	Relative Humidity, winter, minimum......................	30%
iii)	Relative Humidity, summer, maximum...................	60%

 

C)        Air Circulation:

 

i)         Total air supplied to each space shall be as required to maintain space design conditions.

 

ii)        Outdoor air supplied shall be no less than 20% of the total air supplied.

 

D)        Space Pressurization:

	Ventilation system shall be designed and balanced so that space pressure, in relation to surrounding areas of the building, is...................................................................	neutral
E)	Recirculation of air within room permitted......................	yes

 

F)         Air from the following areas shall be exhausted directly to the outdoors:

 

Nuclear medicine and isotope storage.

 

5)         Pharmacy Suite

 

A)        Filters:

 

i)	Central ventilation systems shall be provided with prefilters having a minimum efficiency of...............	30%
	and final filters having a minimum efficiency of.....	90%
ii)	Units which recirculate air within a room shall be provided with filters having a minimum efficiency of ..............................................................................	30%

 

B)        Space Design Conditions:

 

i)	Temperature, dry bulb..............................................	75°
ii)	Relative Humidity, winter, minimum......................	30%
iii)	Relative Humidity, summer, maximum...................	60%

 

C)        Air Circulation:

 

i)         Total air supplied to each space shall be as required to maintain space design conditions.

 

ii)        Outdoor air supplied shall be no less than 20% of the total air supplied.

 

D)        Space Pressurization:

	Ventilation system shall be designed and balanced so that space pressure, in relation to surrounding areas of the building, is............................................................................	neutral
E)	Recirculation of air within room permitted.........................	yes

 

6)         Physical Therapy Suite and Hydrotherapy

 

A)        Filters:

 

i)	Central ventilation systems shall be provided with prefilters having a minimum efficiency of...............	30%
	and final filters having a minimum efficiency of.....	90%
ii)	Units that recirculate air within a room shall be provided with filters having a minimum efficiency of ..............................................................................	30%

 

B)        Space Design Conditions:

 

i)	Temperature, dry bulb..............................................	75°
ii)	Relative Humidity, winter, minimum......................	30%
iii)	Relative Humidity, summer, maximum...................	60%

 

C)        Air Circulation:

 

i)         Total air supplied to each space shall be as required to maintain space design conditions.

 

ii)        Outdoor air supplied shall be no less than 20% of the total air supplied.

 

D)         Space Pressurization: 

	Ventilation system shall be designed and balanced so that space pressure, in relation to surrounding areas of the building, is................................................................	negative
E)	Recirculation of air within room permitted....................	yes

 

7)         Occupational Therapy Suite

 

A)        Filters:

 

i)	Central ventilation systems shall be provided with prefilters having a minimum efficiency of...............	30%
	and final filters having a minimum efficiency of.....	90%
ii)	Units that recirculate air within a room shall be provided with filters having a minimum efficiency of ..............................................................................	30%

 

B)        Space Design Conditions:

 

i)	Temperature, dry bulb..............................................	75°
ii)	Relative Humidity, winter, minimum......................	30%
iii)	Relative Humidity, summer, maximum...................	60%

 

C)        Air Circulation:

 

i)         Total air supplied to each space shall be as required to maintain space design conditions.

 

ii)        Outdoor air supplied shall be no less than 20% of the total air supplied.

 

D)        Space Pressurization:

	Ventilation system shall be designed and balanced so that space pressure, in relation to surrounding areas of the building, is.................................................................	neutral
E)	Recirculation of air within room permitted.....................	yes

 

8)         Nursing Units (including units such as medical, surgical, intensive care, pediatric, psychiatric, obstetric)

 

A)        Filters:

 

i)	Central ventilation systems shall be provided with prefilters having a minimum efficiency of...............	30%
	and final filters having a minimum efficiency of.....	90%
ii)	Units that recirculate air within a room shall be provided with filters having a minimum efficiency of ..............................................................................	10%

 

B)        Space Design Conditions:

 

i)	Temperature, dry bulb..........................................	75°
ii)	Relative Humidity, winter, minimum...................	30%
iii)	Relative Humidity, summer, maximum................	60%

 

C)        Air Circulation (Patient Rooms):

 

i)	Total air supplied, cfm per bed.............................	15
ii)	Outdoor air supplied, cfm per bed........................	10

 

D)        Air Circulation:

 

i)         Total air supplied to each space shall be as required to maintain space design conditions.

 

ii)        Outdoor air supplied shall be no less than 20% of the total air supplied.

 

E)        Space Pressurization:

	Ventilation system shall be designed and balanced so that space pressure, in relation to surrounding areas of the building, is...................................................................	neutral
F)	Recirculation of air within room permitted.......................	yes

 

G)        Isolation Rooms:  These rooms may be used two ways:  to protect the patient from the hospital environment or to protect the hospital environment from the patient.  Isolation rooms shall have the same conditions as other patient rooms, except that air flow shall be capable of being either into the room or out of the room. When the hospital is being protected (communicable disease), all air shall be exhausted directly to the outdoors.

 

9)         Newborn Care Unit

 

A)        Filters:

 

i)	Central ventilation systems shall be provided with prefilters having a minimum efficiency of...............	30%
	and final filters having a minimum efficiency of.....	90%
ii)	Units that recirculate air within a room shall be provided with filters having a minimum efficiency of ..............................................................................	30%

 

B)        Space Design Conditions:

 

i)	Temperature, dry bulb..............................................	75°
ii)	Relative Humidity, winter, minimum......................	30%
iii)	Relative Humidity, summer, maximum...................	60%

 

C)        Air Circulation (Patient Rooms):

 

i)	Total air supplied, cfm per bed................................	15
ii)	Outdoor air supplied, cfm per bed............................	10

 

D)        Air Circulation:

 

i)         Total air supplied to each space shall be as required to maintain space design conditions.

 

ii)        Outdoor air supplied shall be no less than 20% of the total air supplied.

 

E)        Space Pressurization:

	Ventilation system shall be designed and balanced so that space pressure, in relation to surrounding areas of the building, is............................................................................	neutral
F)	Recirculation of air within room permitted.........................	yes

 

10)         Surgical Suite-Operating Rooms

 

A)        Filters:

 

i)	Central ventilation systems shall be provided with prefilters having a minimum efficiency of...............	30%
	and final filters having a minimum efficiency of.....	90%
ii)	Units that recirculate air within a room shall be provided with filters having a minimum efficiency of ..............................................................................	30%

 

B)        Space Design Conditions:

 

i)	Temperature, dry bulb (adjusted range)............	70°F-76°F
ii)	Relative Humidity, winter, minimum..............................		40%
iii)	Relative Humidity, summer, maximum.........................		60%

 

C)        Air Circulation:

 

i)	Total air supplied, air changes per hour........................	15
ii)	Outdoor air supplied shall be no less than 20% of the total air supplied.

 

D)        Space Pressurization:

	Ventilation system shall be designed and balanced so that space pressure, in relation to surrounding areas of the building, is..........................................................................	positive
E)	Recirculation of air within room permitted........................	yes

 

F)         Minimum requirements for all other spaces within the surgical suite shall be the same as required for Nursing Units.

 

G)        The minimum circulation rate for operating rooms shall be based on the lowest 9 feet of room height.  Air quantity shall be increased as required to meet greater loads and still maintain the desired space conditions.

 

H)        All operating rooms shall have scavenger systems for removing spent anesthetic gases as per NFPA  99, Standard for Health Care Facilities.

 

I)         Operating rooms' air supply shall be from ceiling outlets near the center of the work area to effectively control air movement.  Return air shall be not less than 3 inches nor more than 12 inches from the floor.  Each operating room shall have at least two return air inlets located as remotely from each other as practical.

 

11)       Obstetrics Suite

 

A)        Filters:

 

i)	Central ventilation systems shall be provided with prefilters having a minimum efficiency of...............	30%
	and final filters having a minimum efficiency of.....	90%
ii)	Units that recirculate air within a room shall be provided with filters having a minimum efficiency of ..............................................................................	30%

 

B)        Space Design Conditions:

 

i)	Temperature, dry bulb (adjusted. range)...........	70°F-76°F
ii)	Relative Humidity, winter, minimum...........................		30%
iii)	Relative Humidity, summer, maximum........................		60%

 

C)        Air Circulation:

 

i)         Total air supplied to each space shall be as required to maintain space design conditions.

 

ii)....... Outdoor air supplied shall be no less than 20% of the total air supplied.

 

iii)       Space Pressurization:

 

iv)

Ventilation system shall be designed and balanced so that space pressure, in relation to surrounding areas of the building, is.....................

neutral

 

D)

Recirculation of air within room permitted.........................

yes

 

E)        Delivery rooms' air supply shall be from ceiling outlets near the center of the work area to effectively control air movement.  Return air shall be not less than 3 inches nor more than 12 inches from the floor.  Each delivery room shall have at least two return air inlets located as remotely from each other as practical.

 

F)         Where anesthetic gases are used, scavenger systems for removing spent anesthetics gases as per NFPA  99, Standard for Health Care Facilities, shall be provided.

 

G)        Delivery rooms where caesarean section is performed shall meet the heating, ventilation, and air conditioning (HVAC) requirements for operating rooms.

 

12)       Emergency Suite

 

A)        Filters:

 

i)	Central ventilation systems shall be provided with prefilters having a minimum efficiency of...............	30%
	and final filters having a minimum efficiency of.....	90%
ii)	Units that recirculate air within a room shall be provided with filters having a minimum efficiency of ..............................................................................	10%

 

B)        Space Design Conditions:

 

i)	Temperature, dry bulb..............................................	75°
ii)	Relative Humidity, winter, minimum......................	30%
iii)	Relative Humidity, summer, maximum...................	60%

 

C)        Air Circulation:

 

i)         Total air supplied to each space shall be as required to maintain space design conditions.

 

ii)        Outdoor air supplied shall be no less than 20% of the total air supplied.

 

D)        Space Pressurization:

	Ventilation system shall be designed and balanced so that space pressure, in relation to surrounding areas of the building, is............................................................................	neutral
E)	Recirculation of air within room permitted.........................	yes

 

13)       Outpatient Suite

 

A)        Filters:

 

i)	Central ventilation systems shall be provided with prefilters having a minimum efficiency of...............	30%
	and final filters having a minimum efficiency of.....	90%
ii)	Units that recirculate air within a room shall be provided with filters having a minimum efficiency of ..............................................................................	10%

 

B)        Space Design Conditions:

 

i)	Temperature, dry bulb..............................................	75°
ii)	Relative Humidity, winter, minimum......................	30%
iii)	Relative Humidity, summer, maximum...................	60%

 

C)        Air Circulation:

 

i)         Total air supplied to each space shall be as required to maintain space design conditions.

 

ii)        Outdoor air supplied shall be no less than 20% of the total air supplied.

 

D)        Space Pressurization:

	Ventilation system shall be designed and balanced so that space pressure, in relation to surrounding areas of the building, is............................................................................	neutral
E)	Recirculation of air within room permitted.........................	yes

 

14)       Food Preparation Area

 

A)        Filters:

 

	Central ventilation systems shall be provided with prefilters having a minimum efficiency of.....................	30%
	and final filters having a minimum efficiency of...........	90%

 

B)        Space Design Conditions:

Temperature, dry bulb.........................................................

75°

 

C)        Air Circulation:

 

i)         Total air supplied to each space shall be as required to maintain space design conditions.

 

ii)        Outdoor air supplied shall be no less than 20% of the total air supplied.

 

D)        Space Pressurization:

	Ventilation system shall be designed and balanced so that space pressure, in relation to surrounding areas of the building, is............................................................................	negative
E)	Recirculation of air within room permitted.........................	no

 

F)         Dining areas adjacent to the food preparation area shall meet the requirements for Public Areas.

 

G)        If direct make-up hoods (short cycle) are used, all outside air to the hood shall be filtered by 30% minimum efficiency filters and shall not cause cold cooking surfaces, condensation problems, or grease build-up due to cold temperature.

 

H)        Kitchen air exhausted from the space through hoods shall be made up with outside air.  Air shall flow into the kitchen to prevent cooking odors from migrating throughout the hospital.  Recirculation of air is permissible if a central system is used that serves only the kitchen, cafeteria, and ware-washing area.

 

I)         A dishwasher  shall have a separate exhaust that is interlocked with the dishwasher to operate only when the dishwasher operates.

 

J)         Air supply quantity must equal or exceed air exhaust quantity or meet the loads encountered, whichever is greater.

 

K)        During the unoccupied cycle, kitchen temperature shall be maintained at 75şF plus or minus 10şF.

 

L)        The hood and duct system for cooking equipment used in processes producing smoke or grease-laden vapors shall comply with NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooling Operations.  That portion of the fire extinguishment system required for protection of the duct system may be omitted when all cooking equipment is served by U.L. listed grease extractors.

 

i)          Other exhaust hoods in food preparation centers shall have an exhaust rate of not less than 50 cubic feet per minute per square foot of face area. The face area is the open area from exposed perimeter of hood to the open perimeter of the cooking surface.

 

ii)         Clean-out openings shall be provided at each change in direction and in horizontal sections no more than 20 feet apart in the duct system serving kitchen and food preparation areas.

 

15)       Central Sterile Supply

 

A)        Filters:

 

	Central ventilation systems shall be provided with prefilters having a minimum efficiency of...............	30%
	and final filters having a minimum efficiency of.....	90%

 

B)        Space Design Conditions:

 

i)	Temperature, dry bulb (adjusted range)...................	75°
ii)	Relative Humidity, winter, minimum......................	30%
iii)	Relative Humidity, summer, maximum...................	60%

 

C)        Air Circulation:

 

i)         Total air supplied to each space shall be as required to maintain space design conditions.

 

ii)        Outdoor air supplied shall be no less than 20% of the total air supplied.

 

D)        Air flow shall be from the clean area toward the soiled or decontamination area.

 

E)        Sterilization Room:

 

i)          Where only steam autoclaves are installed, the air exhausted from the sterilizer area for heat control may be recirculated through a central system that is provided with filters having a minimum efficiency of 90%.

 

ii)         Where ethylene oxide sterilizers are used, all air contaminated with ethylene oxide above 1 part per million  shall be exhausted directly outdoors. No air shall be recirculated that has more than 1 part per million of ethylene oxide present.

 

16)       Linen Services; Laundry

 

A)        Filters:

 

Central ventilation systems shall be provided with prefilters having a minimum efficiency of....................	30%
and final filters having a minimum efficiency of..........	80%

 

B)        Space Design Conditions:

Temperature, dry bulb (winter).............................................

75°

 

C)        All air from the soiled storage and sorting area shall be exhausted directly to outdoors.

 

D)        Air flow shall be from the clean area to the soiled area. Air from the clean area may be used to make up air exhausted from the soiled area.

 

E)        Air from the clean area may be recirculated within the laundry complex, but shall pass through a lint screen or trap before returning to the air handling unit.

 

F)         The entire laundry ventilation system shall be controlled so that air flow is into the laundry from the hospital.

 

G)        Circulation and ventilation rates may be variable, but sufficient outside air shall be supplied to make up for exhaust.  Minimum circulation of unconditioned air at summer design conditions shall be 2 cubic feet per minute per square foot² or 12 air changes per hour, whichever is larger.

 

17)       Miscellaneous Supporting Areas

 

A)        Space temperatures shall be maintained for occupant comfort.

 

B)        Ventilation systems shall be designed and balanced so that air flows into these spaces from adjacent areas.

 

C)        Anesthesia Storage Rooms:

 

i)          All air shall be exhausted directly to the outdoors.

 

ii)         Minimum exhaust ventilation rates shall be six air changes per hour.

 

iii)        The ventilation system shall conform to the requirements of NFPA 99, Standard for Health Care Facilities , including the option to provide a gravity (non-mechanical) ventilation system.

 

iv)        Supply air makeup for exhaust requirements may be provided from a mechanical ventilation system or by transfer from adjacent areas.

 

D)        Soiled Holding and Work Rooms:

 

i)          All air shall be exhausted directly to the outdoors.

 

ii)         Minimum exhaust ventilation rates shall be 10 air changes per hour.

 

iii)        Supply air makeup for exhaust requirements may be provided from a mechanical ventilation system or by transfer from adjacent areas.

 

E)        Toilet Rooms and Bathrooms:

 

i)          Exhaust air may be recirculated through a central ventilation system that is provided with final filters having a minimum efficiency of 90%.  Otherwise, all air shall be exhausted directly to the outdoors.

 

ii)         Minimum exhaust ventilation rate shall be 1.5 cubic feet per minute per square foot of floor area, but no less than 50 cubic feet per minute.

 

iii)        Supply air makeup for exhaust requirements may be provided from a mechanical ventilation system or by transfer from adjacent areas.

 

F)         Janitor Closets, Linen, and Trash Chute Rooms:

 

i)          All air shall be exhausted directly to the outdoors.

 

ii)         Minimum exhaust ventilation rate shall be 1.5 cubic feet per minute per square foot of floor area, but no less than 50 cubic feet per minute.

 

iii)        Supply air makeup for exhaust requirements may be provided from a mechanical ventilation system or by transfer from adjacent areas.

 

G)        Boiler rooms shall be provided with sufficient outdoor air to maintain combustion rates of equipment and limit temperatures in working stations to 97°F effective temperature (97°F and 50% relative humidity or its equivalent) as defined by ASHRAE Handbook of Fundamentals.

 

H)        Rooms containing heat-producing equipment, such as boiler rooms, heater rooms, food preparation centers, laundries, sterilizer rooms, or mechanical equipment rooms, shall be insulated and ventilated to prevent any floor surface above from exceeding a temperature of 100°F.

 

(Source:  Amended at 35 Ill. Reg. 6386, effective March 31, 2011)

 

Section 250.2490  Plumbing and Other Piping Systems

 

a)         General

            All plumbing systems shall be designed and installed in accordance with the requirements of the Illinois Plumbing Code, except that the number of waterclosets, urinals, lavatories, bathtubs, showers, drinking fountains, and other fixtures shall be as required by this Part and the hospital programs.

 

b)         Plumbing Fixtures

 

1)         Plumbing fixtures shall be of nonabsorptive acid-resistant materials.

 

2)         The water supply spout for lavatories and sinks required for filling pitchers and for medical and nursing staff and food handlers' hand-washing, shall be mounted so that its discharge point has a minimum perpendicular distance of 5 inches above the rim of the fixture.

 

3)         Hand-washing lavatories used by medical and nursing staff and food handlers shall be trimmed with valves that can be operated without the use of hands where specifically required in this Part.

 

A)        When blade handles are used, the blade handles shall not exceed 4˝ inches in length, except that the handles on clinical sinks shall not be less than 6 inches in length.

 

B)        The hand-washing and/or scrub sinks, for operating, emergency treatment, nursery, and delivery rooms shall be trimmed with valves that are aseptically operated (i.e., knee or foot controls) without the use of hands.  Wrist blades are not acceptable.

 

4)         Clinical rim flush sinks shall have an integral trap in which the upper portion of a visible trap seal provides a water surface.

 

5)         Shower bases and tubs shall be provided with nonslip surfaces.

 

c)         Water Supply Systems

 

1)         Systems shall be designed to supply water at sufficient pressure to operate all fixtures and equipment during maximum demand periods.

 

2)         Each water service main, branch main, riser and branch to a group of fixtures shall be valved.  Stop valves shall be provided at each fixture.

 

3)         Flush valves installed on plumbing fixtures shall be of a quiet operating type, equipped with silencers.

 

4)         Bedpan-flushing devices shall be provided on each patient toilet unless a clinical service sink is centrally located in each nursing unit.  This requirement does not apply to psychiatric units.

 

5)         Water distribution systems shall be arranged to provide hot water at each hot water outlet at all times.  Hot water at shower, bathing, and hand-washing facilities shall not exceed 110ş F (43ş C).  If the program requires, in psychiatric units, plumbing fixtures that require hot water and are accessible to patients shall be supplied with hot water not to exceed 100ş F (38ş C).

 

d)         Hot Water Heaters and Tanks

 

1)         The hot water heating equipment shall have sufficient capacity to supply water at the temperatures and quantities in the following areas:

 

	Clinical	Dietary	Laundry
gallons/hour/bed	6˝	4	4˝
liters/second/bed	.007	.004	.005
temperature şF	100	180	180
temperature şC	43	82	82

 

Water temperatures are to be taken at the hot water point of use or at the inlet to the processing equipment.

 

2)         Storage tanks shall be fabricated of corrosion-resistant metal or lined with non-corrosive material.

 

e)         Drainage Systems

 

1)         Drain lines from sinks in which acid wastes may be poured shall be constructed of acid-resistant material.

 

2)         Insofar as possible, drain piping shall not be installed over operating and delivery rooms; nurseries; food preparation, serving, and storage areas; and similar critical areas.  Special precautions shall be taken to protect these areas from possible leakage or condensation from overhead piping systems.

 

3)         Floor drains shall not be installed in operating rooms.  Flushing rim type drains may be installed in cytoscopic operating rooms.

 

4)         Building sewers shall discharge into a public sewer system.

 

5)         When a public sewer system is not available, plans for any private sewage disposal system shall be submitted to the Environmental Protection Agency for review for approval before hospital construction is started.

 

f)         Nonflammable medical gas systems shall be installed in accordance with NFPA 99, Standard for Health Care Facilities.

 

g)         Clinical vacuum (suction) systems shall be installed in accordance with NFPA 99, Standard for Health Care Facilities.

 

h)         Medical compressed air systems shall be installed in accordance with NFPA 99, Standard for Health Care Facilities.

 

i)          Oxygen, vacuum, and medical compressed air shall be piped to the locations indicated in Table E with the required station outlets.

 

j)          Service outlets for central housekeeping vacuum systems, if used, shall not be located within operating rooms.

 

k)         Fire Extinguishing Systems

 

1)         All fire extinguishing systems shall be designed, installed, and maintained in accordance with NFPA 101, Life Safety Code, NFPA  13, Standards for the Installation of Sprinkler Systems, and NFPA 25A, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems.

 

2)         Class III, Type 1 inside standpipe systems shall be provided in all buildings more than four stories or 55 feet in height.  Such standpipe systems shall comply with NFPA 14, Standard for the Installation of Standpipe, Private Hydrants and Hose Systems.

 

(Source:  Amended at 35 Ill. Reg. 6386, effective March 31, 2011)

 

Section 250.2500  Electrical Requirements

 

a)         General

 

1)         All materials, including equipment, conductors, controls, and signaling devices, shall be installed in compliance with applicable sections of the NFPA 70, National Electric Code, including Article 517, and as necessary to provide a complete electrical system.

 

2)         All electrical installations, including alarm, nurses' call, and communication systems, shall be tested to demonstrate that the equipment installation and operation conform to these requirements.

 

b)         Switchboards and Power Panels

            These items shall comply with NFPA 70, National Electrical Code. The main switchboard shall be located in an area separate from plumbing and mechanical equipment and be accessible only to authorized persons.

 

c)         Panelboards.  Panelboards serving lighting and appliance circuits shall be located on the same floor as the circuits they serve.  This requirement does not apply to the life safety system.

 

d)         Lighting

 

1)         All spaces occupied by people, machinery, and equipment within buildings, approaches to and through exits from buildings, and parking lots shall have lighting.

 

2)         Patients' rooms shall be equipped with general lighting and night lighting.  A reading light shall be provided for each patient.  At least one light fixture for night lighting shall be switched at the entrance to each patient room.  All switches for control of lighting in patient areas shall be of the quiet operating type.

 

3)         Operating and delivery rooms shall have general lighting in addition to local lighting provided by special lighting units at the surgical and obstetrical tables.  The general lighting shall provide a minimum of 100 footcandles at the procedure tables.  Each fixed special lighting unit at the tables shall be connected to an independent circuit.

 

e)         Receptacles (Convenience Outlets)

 

1)         Each operating and delivery room shall have at least two receptacles installed on each wall or eight receptacles in diversified locations per room.

 

2)         Each patient room shall have duplex grounding type receptacles as specified in Article 517-83 and Article 517-84 of the National Electrical Code.  The mounting height of these receptacles shall be 22 to 42 inches above the finished floor.

 

3)         Duplex receptacles for general use shall be installed approximately 50 feet apart in all corridors and within 25 feet of the ends of corridors.  These receptacles shall be circuited to the emergency system.  Single polarized receptacles marked for use of X-ray only shall be located in corridors of patient areas so that mobile equipment may be used in any location within a patient room without exceeding a cord length of 50 feet attached to the equipment.  If the same mobile X-ray unit is used in operating rooms and in nursing areas, all receptacles for X-ray use shall be of a configuration that one plug will fit the receptacles in all locations.  Where capacitive discharge or battery-powered X-ray units are used, these polarized receptacles are not required.

 

f)         At least two X-ray film illuminators shall be installed in each operating, delivery, and recovery room, emergency treatment areas, and in the X-ray Viewing Room of the radiology department. More than two units shall be installed as needed.

 

g)         Nurses' Calling System

 

1)         Each patient room shall be served by at least one calling station and each bed shall be provided with a call button.  Two call buttons serving adjacent beds may be served by one calling station. Calls shall register with nursing staff and shall actuate a visible signal in the corridor at the patients' door.  In multicorridor nursing units, additional visible signals shall be installed at corridor intersections. In rooms containing two or more calling stations, indicating lights shall be provided at each station.  Nurses' calling systems that provide two-way voice communications shall be equipped with an indicating light at each calling station, which will remain lighted as long as the voice circuit is operating.

 

2)         Nurse call duty stations shall be installed in the clean work room, soiled work room, medicine preparation room, nourishment station, and nurses' lounge of the unit.

 

3)         A nurses' call emergency station shall be provided for patients' use at each patient's toilet, bath, sitz bath, and shower.  These stations are to be the pull-cord type with the cord reaching within 6 inches of the floor.  The cords shall be located within reach of a patient.

 

4)         In areas such as intensive care, cardiac care, recovery and similar patient care areas where patients are under constant surveillance, the nurses' calling system may be limited to a bedside station that will actuate a signal that can be readily seen by the other nurses.

 

5)         A communications system that may be used by nurses to summon assistance shall be provided in each operating, delivery, special procedure, birthing, recovery, emergency treatment, and critical care room; in nurseries; and in nursing units for psychiatric patients.

 

h)         Communication System

 

1)         A loudspeaker- type sound system shall be provided throughout the facility to allow for announcements, such as the paging of personnel and other necessary audio functions.

 

2)         Speakers shall be located in all departments to allow hospital personnel to adequately hear all audio outputs from the system.

 

3)         The system shall be used as the communication link for emergency announcements, i.e., code blue, impending disasters and others.  The audio line at the last speaker in the audio circuits shall be electrically supervised against opens and grounds.  The supervision shall be indicated at a building location that is staffed 24 hours a day.

 

i)          Emergency Electric Service

 

1)         To provide electricity during an interruption of the normal electric supply, an emergency source of electricity shall be provided and connected to the life safety branch, the critical branch, and the equipment branch for lighting and power as established in NFPA 70, National Electrical Code.

 

2)         The source of this emergency electric service shall be as follows:

 

A)        An emergency generating set when the normal service is supplied by one or more central station transmission lines.

 

B)        An emergency generating set or a central station transmission line when the normal electric supply is generated on the premises.

 

3)         Emergency Generating Set

 

A)        The required emergency generating set, including the prime mover and generator, shall be located on the premises.  Where stored fuel is required for the emergency generator operations, the storage capacity shall be sufficient for not less than 24-hours of continuous operation.

 

B)        The emergency generator set may be used during periods of high energy demands on local utilities.  In the event of an outage of the normal power source, the normal loads shall immediately be removed from the emergency generating set, and the life safety branch, the critical branch, and the equipment branch shall be connected to the generator.

 

(Source:  Amended at 35 Ill. Reg. 6386, effective March 31, 2011)