Section 640.41  Level I – Standards for Perinatal Care

 

Level I:  To be designated as Level I, a facility shall apply to the Department as described in Section 640.60 of this Part and comply with all the conditions described in Subpart O of the Hospital Licensing Requirements (77 Ill. Adm. Code 250) which are applicable to the level of care necessary for the patients served, and in addition shall comply with the following provisions (specifics regarding standards of care for both mothers and neonates as well as support services to be provided shall be defined in the hospital's letter of agreement with its Perinatal Center):

 

a)         General Provisions

 

1)         The Maternity and Neonatal Service Plan of the Level I facility shall include a letter of agreement between the facility and its Perinatal Center regarding plans for prompt consultation with a maternal-fetal medicine subspecialist or neonatologist specific to high-risk women and those neonates with conditions or developmental disabilities requiring transfer, such as: acute surgical and cardiac difficulties, neonates born with handicapping conditions, managing high-risk pregnancies, genetic counseling, information, referral and counseling services for families of neonates born with a handicapping condition or for a high-risk mother or her spouse, and continuing education of staff in perinatal care, including family centered care for neonates with handicapping conditions.  (Section 640.70 describes the minimum components for the letter of agreement.) This agreement must include participation in a Continuous Quality Improvement program as defined by the Department and as designed and implemented by the Perinatal Center.

 

2)         The critical considerations in the care of patients anticipating delivery in these hospitals are as follows:

 

A)        the earliest possible detection of the high-risk pregnancy (risk assessment) and consultation with a maternal-fetal medicine subspecialist or neonatologist as specified in the letter of agreement, and transfer to the appropriate level of care; and

 

B)        the availability of trained personnel and facilities to provide competent emergency obstetric and newborn care.  Included in the functions of this facility are the stabilization of patients with unexpected problems, initiation of neonatal and maternal transports, patient and community education, and data collection and evaluation.

 

3)         A system of recording patient admissions, discharges, birth weight, outcome, complications, and transports must be maintained and meet the requirements to support network Continuous Quality Improvement activities as developed by the Statewide Quality Council and must be consistent with that of the Perinatal Center.  The hospital shall comply with the reporting requirements of the Adverse Pregnancy Outcomes Reporting System (77 Ill. Adm. Code 840).

 

b)         Level I – Standards for Maternal Care

 

1)         The maternal patient with an uncomplicated current pregnancy and no previous history suggestive of potential difficulties is considered appropriate for Level I facilities.

 

2)         All maternal patients other than those identified in subsection (b)(1) above constitute potentially high-risk conditions for which consultation with a maternal-fetal medicine subspecialist or neonatologist as specified in the letter of agreement is recommended. Consultation or transfer shall be considered for each of the following conditions:

 

A)        Previous Pregnancy Problems:

 

i)          Premature infant

 

ii)         Perinatal death or mental retardation

 

iii)         Isoimmunization

 

iv)        Difficult deliveries

 

v)         Congenital malformations

 

vi)        Mid-trimester loss

 

B)        Current Pregnancy Problems:

 

i)          Any medical disorder (e.g., diabetes mellitus, hemoglobinopathy, chronic hypertension, heart disease, renal disease)

 

ii)         Drug addiction

 

iii)         Multiple gestation

 

iv)        Intrauterine growth restriction

 

v)         Preterm labor less than or equal to 36 weeks

 

vi)        Postdate greater than or equal to 42 weeks

 

vii)        Third trimester bleeding

 

viii)       Abnormal genetic evaluation

 

ix)        Pregnancy induced hypertension

 

c)         Level I – Standards for Neonatal Care

 

1)         The neonatal patients greater than 36 weeks gestation or greater than 2500 grams without risk factors and infants with physiologic jaundice are generally considered appropriate for Level I facilities; however, the facilities' letter of agreement must establish the specific conditions for Level I facilities.

 

2)         All neonatal patients other than those identified in subsection (c)(1) above constitute neonatal conditions for which a neonatology consultation as specified in the letter of agreement by the attending physician is recommended. Consultation or transfer is recommended for each of the following conditions:

 

A)        Gestational age less than 36 weeks, birth weight less than 2500 grams

 

B)        Small-for-gestational age (less than 10th percentile)

 

C)        Sepsis

 

D)        Seizures

 

E)         Congenital heart disease

 

F)         Multiple congenital anomalies

 

G)        Apnea

 

H)        Respiratory distress

 

I)          Neonatal asphyxia

 

J)         Infants identified as having handicapping conditions or developmental disabilities which threaten life or subsequent development

 

K)        Severe anemia

 

L)         Hyperbilirubinemia, not due to physiologic cause

 

M)       Polycythemia

 

            Specifics regarding consultation or transfer for each of these conditions must be detailed in the letter of agreement.

 

d)         Level I – Resource Requirements

            The following support services shall be available:

 

1)         Capability for continuous electronic maternal-fetal monitoring for patients identified at risk with staff knowledgeable in its use and interpretation available with evidence of completion of a yearly competence assessment in electronic fetal monitoring.

 

2)         Blood bank technicians on call and available within 30 minutes for performance of routine blood banking procedures.

 

3)         General anesthesia on call and available within 30 minutes to initiate caesarean sections.

 

4)         Caesarean section capability within 30 minutes.

 

5)         Radiology service available within 30 minutes notice.

 

6)         Clinical laboratory shall include microtechnique for hematocrit within 15 minutes, glucose, BUN, creatinine, blood gases, routine urinalysis in 1 hour; CBC, routine blood chemistries, type, cross, Coombs' test, and bacterial smear within 6 hours; and capability for bacterial culture and sensitivity and viral culture.

 

7)         A physician for the program shall be designated to assume primary responsibility for initiating, supervising and reviewing the plan for mangagement of depressed infants in the delivery room.  Policies and procedures shall assign responsibility for identification and resuscitation of distressed neonates to at least one individual who is both specifically trained and immediately available in the hospital at all times, such as another physician, a nurse with training and experience in neonatal resuscitation, or a licensed respiratory care practitioner. Individuals assigned to perform neonatal resuscitation shall have documented evidence of current completion of a neonatal resuscitation course.  It is further recommended that physicians and/or advanced practice nurses who care for newborns have documented evidence of completion of a neonatal resuscitation course.

 

8)         The Level I facility shall be responsible for provision of continuing education for medical, nursing, respiratory therapy, and other staff providing general perinatal services with evidence of a yearly competence assessment appropriate to the patient population served.

 

e)         Exceptions to Level I Standards of Care

 

1)         Exceptions to the standards of care set forth in this Part may be necessary based on patient care needs, current practice, outcomes, and geography in the regional perinatal network.  These exceptions are not intended to circumvent the Level II designation.  The applicant facility or the Perinatal Center may seek the advice and consultation of the Department as well as the Perinatal Advisory Committee in regard to the conditions necessary for an exception.

 

2)         Exceptions to the standards of care of this Part may be granted when the facility requesting an exception demonstrates that the resources and quality of care (outcomes) are substantially equivalent to the resources and quality of care for any Level II facility.  The resource requirements for these exceptions may be found in Section 640.42(d) for Level II facilities.  The proposed exceptions shall be determined by the applicant facility and its Perinatal Center based primarily on outcomes.

 

3)         If the applicant facility and its Perinatal Center cannot reach agreement on any aspect of the exceptions to the standards of care of this Part, the applicant facility or Perinatal Center shall seek the advice and consultation of the Perinatal Advisory Committee (i.e., subcommittee on facility designation).  Any exception to the standards of care of this Part shall be clearly defined in the proposed letter of agreement and approved by the Department before implementing the exceptions or patient care services being requested.  The Department shall permit a period of testing or trial (probation) to demonstrate that the applicant facility's resources and quality of care (outcomes) are substantially equivalent to the resources and quality of care for any Level II facility.

 

4)         If a dispute between the applicant facility and its Perinatal Center cannot be resolved after consultation with the Perinatal Advisory Committee (i.e., subcommittee on facility designation), then the applicant facility, the Perinatal Center, or the Perinatal Advisory Committee shall submit the dispute to the Department for settlement.  The Department shall review all of the relevant information and documentation that clearly substantiates the facility's compliance with particular provisions or standards of perinatal care and the recommendations of the Perinatal Advisory Committee in deciding or settling a dispute.  The Department shall inform the applicant facility, the Perinatal Center and the Perinatal Advisory Committee of its decision or judgment.

 

5)         The following information shall be submitted to the Perinatal Advisory  Committee (i.e., subcommittee on facility designation) to facilitate the review of the applicant facility's application for designation with exceptions to the standards of care of this Part:

 

A)        A proposed letter of agreement (unsigned).

 

B)        The curriculum vitae for all directors of patient care, i.e., OB, neonatal, nursing (OB and neonatal).

 

C)        Appendices A and B (fully completed).

 

D)        A letter from the Perinatal Center that includes the following information:

 

i)          List of the exceptions being requested.

 

ii)         Sufficient data/information to demonstrate that the quality of care (outcomes) of the applicant facility are substantially equivalent to the appropriate standards as outlined in subsection (c) of this Section.

 

iii)         A description of the monitoring system used when a consultation occurs between the attending physician at the referring hospital and the physician consultant at the Perinatal Center or Level III facility and it is determined that the mother or newborn infant should stay in the community hospital for care.

 

iv)        A description of any arrangements made between the applicant facility and the Perinatal Center to seek or insure quality improvement.

 

6)         When the information described in Section 640.41(e) is submitted to the Perinatal Advisory Committee, it shall review the material for compliance with the Regionalized Perinatal Health Care Code, and shall make a recommendation for approval or disapproval of the applicant facility's application for designation with exceptions to the Department.

 

7)         The medical co-directors of the Perinatal Center (or their designees) and the medical directors of obstetrics and maternal and newborn care and a representative of hospital administration from the applicant facility shall be present during the Perinatal Advisory Committee's review of the applicant facility's application for designation with exceptions.

 

8)         The Department shall review the submitted materials and any other documentation that clearly substantiates the facility's compliance with particular provisions or standards of perinatal care, including quality of care (outcomes) data/information and the recommendation of the Perinatal Advisory Committee, and shall make a recommendation to the Director of Public Health concerning the approval or disapproval of the applicant facility's application for designation with exceptions.

 

9)         The Director of Public Health shall make the final decision and inform the facility of the official determination regarding designation with exceptions to the standards of care of this Part. The Director's decision shall be based upon the recommendation of the Perinatal Advisory Committee and the facility's compliance with the Regionalized Perinatal Health Care Code, and may be appealed in accordance with Section 640.45. The Director of Public Health shall consider the following criteria or standards to determine if a facility is in compliance with the Code:

 

A)        Maternity and Neonatal Service Plan (Subpart O of the Illinois Hospital Licensing Requirements).

 

B)        Proposed letter of agreement between the applicant facility and its Perinatal Center in accordance with the provisions described in Section 640.70.

 

C)        Appropriate outcome information contained in Appendices A and B.

 

D)        Other documentation that clearly substantiates a facility's compliance with particular provisions or standards of perinatal care.

 

E)         Recommendation of Department program staff.

 

(Source:  Amended at 24 Ill. Reg. 12574, effective August 4, 2000)