Section 640

Section 640.42 Level II and Level II with Extended Capabilities -Standards for Perinatal Care

Level II: To be designated as Level II or Level II with Extended Capabilities, 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) promulgated by the Department 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 resource requirements to be provided shall be defined in the hospital's letter of agreement with its Perinatal Center):

a) General Provisions

1) A Level II or Level II with Extended Capabilities facility is to provide all services outlined for Level I (Section 640.41(a)) as well as diagnosis and treatment of selected high-risk pregnancies and neonatal problems. Both the obstetrical service and the neonatal service must achieve the applicable capability of a Level II or Level II with Extended Capabilities facility for the applicable Level II designation. Further standards for Level II facilities are set out in subsections (b) through (h) with subsections (f) through (h) specifically applying to facilities that are Level II with Extended Capabilities. Included in the functions of this facility are education of allied health professionals and acceptance of selected maternal-fetal and neonatal transports from Level I or other Level II hospitals as identified in the letters of agreement with the Perinatal Center. The letters of agreement should include participation in a Continuous Quality Improvement program as defined by the Department and implemented by the Perinatal Center.

2) A system for recording patient admissions, discharges, birth weight, outcome, complications, and transports must be maintained and must meet requirements to support network Continuous Quality Improvement program activities as developed by the Statewide Quality Council. The hospital must comply with the requirements of the Adverse Pregnancy Outcomes Reporting System (77 Ill. Adm. Code 840). For hospitals designated Level II with Extended Capabilities, participation in the Perinatal Reporting System is also required.

b) Level II – Standards for Maternal Care

1) The following maternal patients are considered to be appropriate for management and delivery by the primary physician at Level II facilities without requirement for a maternal-fetal medicine consultation:

A) Those listed for Level I (See Section 640.41(b)(1));

B) Normal current pregnancy although obstetric history may be suggestive of potential difficulties;

C) Selected medical conditions controlled with medical treatment such as: mild chronic hypertension, thyroid disease, illicit drug use, urinary tract infection, and non-systemic steroid dependent reactive airway disease;

D) Selected obstetric complications that present after 32 weeks gestation, such as: mild pre-eclampsia/pregnancy induced hypertension, placenta previa, abrupto placenta, premature rupture of membranes or premature labor;

E) Other selected obstetric conditions that do not adversely affect maternal health or fetal well-being, such as: normal twin gestation, hyperemesis gravidium, suspected fetal macrosomia, or incompetent cervical os;

F) Gestational diabetes, Class A1 (White's criteria).

2) For the following maternal conditions, consultation with a maternal-fetal medicine subspecialist as detailed in the letters of agreement with subsequent management and delivery at the appropriate facility as determined by mutual collaboration is recommended.

A) Current obstetric history suggestive of potential difficulties such as: intrauterine growth restriction, prior neonatal death, two or more previous preterm deliveries less than 34 weeks, a single previous preterm delivery less than 30 weeks, birth of a neonate with serious complications resulting in a handicapping condition, recurrent spontaneous abortion or fetal demise, family history of genetic disease;

B) Active chronic medical problems with known increase in perinatal mortality, such as: cardiovascular disease Class I and Class II, autoimmune disease, reactive airway disease requiring treatment with systemic corticosteroids, seizure disorder, controlled hyperthyroidism on replacement therapy, hypertension controlled on a single medication, idiopathic thrombocytopenia pupura, thromboembolic disease, malignant disease (especially when active), renal disease with functional impairment, human immunodeficiency viral infection (consultation may be with maternal-fetal medicine or infectious disease subspecialist);

C) Selected obstetric complications that present prior to 34 weeks gestation, such as: suspected intrauterine growth restriction, polyhydramnios, oligohydramnios, pre-eclampsia/pregnancy-induced hypertension, congenital viral disease, maternal surgical conditions, suspected fetal abnormality or anomaly, isoimmunization with antibody titers greater than 1:8, antiphospholipid syndrome;

D) Abnormalities of the reproductive tract known to be associated with an increase in preterm delivery, such as uterine anomalies or diethyl-stilbesterol exposure;

E) Insulin dependent diabetes Class A2 and B or greater (White's criteria).

3) For the following maternal conditions, referral to a maternal-fetal medicine subspecialist for evaluation shall occur. Subsequent patient management and site of delivery shall be determined by mutual collaboration between the patient's physician and the maternal-fetal medicine subspecialist:

A) Selected chronic medical conditions with a known increase in perinatal mortality, such as: cardiovascular disease with functional impairment (Class III or greater), respiratory failure requiring mechanical ventilation, acute coagulopathy, intractable seizures, coma, sepsis, solid organ transplantation, active autoimmune disease requiring corticosteroid treatment, unstable reactive airway disease, renal disease requiring dialysis or with a serum creatinine concentration greater than 1.5 mg%, active hyperthyroidism, hypertension that is unstable or requires more than one medication to control, severe hemoglobinopathy;

B) Selected obstetric complications that present prior to 32 weeks gestation (prior to 30 weeks gestation for Level II with extended capabilities), such as: multiple gestation with more than two fetuses, twin gestation complicated by demise, discordancy, or maldevelopment of one fetus or by fetal-fetal transfusion, premature labor unresponsive to first-line tocolytics, premature rupture of membranes, medical and obstetrical complications of pregnancy possibly requiring induction of labor or non-emergent caesarean section for maternal or fetal indications, such as severe pre-eclampsia;

C) Isoimmunization with possible need for intrauterine transfusion;

D) Insulin-dependent diabetes mellitus Classes C, D, R, F, or H (White's criteria);

E) Suspected congenital anomaly or abnormality requiring an invasive fetal procedure, neonatal surgery or postnatal medical intervention to preserve life, such as: fetal hydrops, pleural effusion, ascites, persistent fetal arrhythmia, major organ system malformation-malfunction, or genetic condition.

c) Level II – Standards for Neonatal Care

1) The following neonatal patients are considered appropriate for Level II facilities without a requirement for neonatology consultation:

A) Those listed for Level I. (see Section 640.41(b)(1).)

B) Mild to moderate respiratory distress (not requiring mechanical ventilation in excess of 6 hours).

C) Suspected neonatal sepsis, hypoglycemia responsive to glucose infusion, and asymptomatic neonates of diabetic mothers.

D) Nursery care of infants with a birth weight greater than 1500 grams who are otherwise well.

E) Nursery care of premature infants at 32 or more weeks gestation who are otherwise well.

2) For the following neonatal conditions, neonatology consultation is recommended, as detailed in the letter of agreement, for each of the following:

A) Premature birth with gestation less than 32 weeks, but greater than or equal to 30 weeks;

B) Infants with a birth weight less than 1500 grams, but greater than 1250 grams;

C) Infants with 10 minute Apgar scores of 5 or less;

D) Stable infants identified as having handicapping conditions or developmental disabilities that threaten subsequent development.

3) Transfer shall occur upon recommendation of the Perinatal Center for each of the following neonatal conditions:

A) Premature birth that is less than 30 weeks gestation;

B) Birthweight less than or equal to 1250 grams;

C) Infants requiring mechanical ventilation beyond the initial stabilization period of 6 hours;

D) Infants who require a sustained inhaled oxygen concentration in excess of 50% in order to maintain a transcutaneous or arterial oxygen saturation greater than or equal to 92%;

E) Infants with significant congenital heart disease associated with cyanosis, congestive heart failure, or impaired peripheral blood flow;

F) Infants with major congenital malformations requiring immediate comprehensive evaluation or neonatal surgery;

G) Infants requiring neonatal surgery with general anesthesia;

H) Infants with sepsis, unresponsive to therapy, associated with persistent shock or other organ system failure;

I) Infants with uncontrolled seizures;

J) Infants with stupor, coma, hypoxic ischemic encephalopathy Stage II or greater;

K) Infants requiring double-volume exchange transfusion;

L) Infants with metabolic derangement persisting after initial correction therapy;

M) Infants identified as having handicapping conditions that threaten life for which transfer can improve outcome.

d) Level II – Resource Requirements

Resources shall include all those listed for Level I (Section 640.41(d)) as well as the following:

1) Experienced blood bank technicians immediately available in hospital for blood banking procedures and identification of irregular antibodies. Blood component therapy readily available.

2) Experienced radiology technicians immediately available in the hospital with professional interpretation available 24 hours a day. Ultrasound capability available 24 hours a day. In addition, Level I ultrasound and staff knowledgeable in its use and interpretation shall be available 24 hours a day.

3) Clinical laboratory shall include microtechnique blood gases in 15 minutes, electrolytes and coagulation studies within an hour. Personnel skilled in phlebotomy and I.V. placement in the newborn shall be available 24 hours a day.

4) Social work services provided by one licensed medical social worker, preferably with relevant experience and responsibility for perinatal patients, shall be available through the hospital social work department.

5) Protocols for discharge planning, routine follow-up care, and developmental follow-up must be established.

6) General anesthesia on call available within 30 minutes to initiate caesarean section.

7) A licensed respiratory care practitioner with experience in neonatal care shall be available.

8) One registered dietitian with experience in perinatal nutrition shall be available to plan diets to meet the needs of mothers and infants.

9) Continuous electronic maternal-fetal monitoring and staff knowledgeable in its use and interpretation, with evidence of completion of a yearly competence assessment in electronic fetal monitoring, shall be available 24 hours a day.

10) The Level II 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.

11) A physician for the program shall be designated to assume primary responsibility for initiating, supervising and reviewing the plan for management of depressed infants in the delivery room. Policies and procedures shall assign responsibility for identification and resuscitation of distressed neonates to an individual who is both specifically trained and available in the hospital at all times, such as another physician, a nurse with training and experience in perinatal care, or respiratory therapist. 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 a neonatal resuscitation course.

e) Exceptions to Level II – 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 with Extended Capabilities 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 with Extended Capabilities. The resource requirements for these exceptions may be found in subsection (d) of this Section for Level II with Extended Capabilities standards. 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 with Extended Capabilities 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 subsection (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 OB and neonatology 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) 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.

f) Level II with Extended Capabilities – Standards for Neonatal Intensive Care Services

1) The following patients are considered appropriate for Level II with Extended Capabilities facilities with neonatal intensive care services:

A) Those listed in subsection (c) for Level II care;

B) Nursery care of low birth weight infants greater than 1250 grams;

C) Nursery care of premature infants 30 or more weeks gestation;

D) Infants on mechanical ventilation.

2) For each of the following neonatal conditions a consultation shall occur between the Level II with Extended Capabilities attending physician and the Perinatal Center or Level III neonatologist. It is expected that the attending neonatologist at the Level II with Extended Capabilities facility and the attending neonatologist at the Perinatal Center or Level III facility shall determine the most appropriate facility to continue patient care by mutual collaboration. The Level II facility with Extended Capabilities shall develop a prospective plan for patient care for those infants who remain at the Level II facility with Extended Capabilities. The plan shall include the following criteria that would trigger subsequent transfer to a Perinatal Center or Level III facility:

A) Premature birth that is less than 30 weeks gestation;

B) Birth weight less than or equal to 1250 grams;

C) Infants with significant congenital heart disease associated with cyanosis, congestive heart failure, or impaired peripheral blood flow;

D) Infants with major congenital malformations requiring immediate comprehensive evaluation or neonatal surgery;

E) Infants requiring neonatal surgery with general anesthesia;

F) Infants with sepsis, unresponsive to therapy, associated with persistent shock or other organ system failure;

G) Infants with uncontrolled seizures;

H) Infants with stupor, coma, hypoxic ischemic encephalopathy Stage II or greater;

I) Infants requiring double-volume exchange transfusion;

J) Infants with metabolic derangement persisting after initial correction therapy;

K) Infants identified as having handicapping conditions that threaten life for which transfer can improve outcome.

g) Level II with Extended Capabilities – Resource Requirements

1) Resources shall include all those listed in Section 640.41(d) for Level I care and in Section 640.42(d) for Level II care as well as the following:

A) Obstetric activities shall be directed and supervised by a board certified obstetrician or a subspecialty obstetrician certified by the American Board of Obstetrics and Gynecology in the subspecialty of maternal and fetal medicine or a licensed osteopathic physician with equivalent training and experience and certified by the American Osteopathic Board of Obstetricians and Gynecologists.

B) Neonatal activities shall be directed and supervised by a full-time pediatrician certified by the American Board of Pediatrics Sub-Board of Neonatal/Perinatal Medicine or a licensed osteopathic physician with equivalent training and experience and certified by the American Osteopathic Board of Pediatricians.

C) The directors of obstetric and neonatal services shall ensure the back-up supervision of their services when they are unavailable.

D) The obstetric-newborn nursing services shall be directed by a full-time nurse experienced in perinatal nursing preferably with a master's degree.

E) The pediatric-neonatal respiratory therapy services shall be directed by a full-time licensed respiratory care practitioner with at least 3 years experience in all aspects of pediatric and neonatal respiratory therapy, preferably with a bachelor's degree and one successful completion of the neonatal/pediatric specialty examination of the National Board for Respiratory Care.

F) Preventive services designated to prevent, detect, diagnose and refer or treat conditions known to occur in the high risk newborn, such as: cerebral hemorrhage, visual defects (retinopathy of prematurity), and hearing loss, and to provide appropriate immunization of high-risk newborns.

G) A designated person to coordinate the local health department community nursing follow-up referral process, to direct discharge planning, to make home care arrangements, to track discharged patients, and to collect outcome information. The community nursing referral process shall consist of notifying the high-risk infant follow-up nurse in whose jurisdiction the patient resides. The Department shall identify and update referral resources for the area served by the unit.

H) Develop a referral agreement with a neonatal follow-up clinic to provide neuro-developmental assessment and outcome data on the neonatal population. Institutional policies and procedures will describe the at-risk population and referral procedure to be followed. Infants will be scheduled to be seen at regular intervals. Neurodevelopmental assessments will be communicated to the primary care physicians. Referrals will be made for interventional care in order to minimize neurologic sequelae. A system shall be established to track, record, and report neurodevelopmental outcome for the population, as required to support network CQI activities as developed by the Statewide Quality Council.

I) If the Level II facility with Extended Capabilities transports patients, they must comply with the Level III transport resource requirements delineated in Section 640.43(c).

2) To provide for mechanical ventilation of newborn infants beyond immediate stabilization, the Level II facility with Extended Capabilities shall also provide:

A) A physician or advanced practice nurse experienced in the management of mechanically ventilated infants present in the hospital during the entire time that the infant receives mechanical ventilation.

B) Suitable back-up systems and planning to prevent and respond appropriately to sudden power outage, oxygen system failure, and interruption of medical grade compressed air delivery.

C) Nurses caring for mechanically ventilated infants shall have documented competence and experience in the care of mechanically ventilated infants.

D) A licensed respiratory care practitioner with documented competence and experience in the care of mechanically ventilated infants must also be available to the nursery during the entire time that the infant receives mechanical ventilation.

h) Exceptions to Level II with Extended Capabilities – 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 III 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) Facilities may request an exception to care for some subgroup of neonates listed in subsection (e)(2). The 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 Perinatal Center or Level III facility. The resource requirements for these exceptions may be found in Section 640.43(c) for Level III. 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) to settle the dispute. 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 Perinatal Center or Level III facility.

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 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.

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

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) 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.

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 under 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)