Section 640.10  Scope (Repealed)

(Source:  Repealed at 35 Ill. Reg. 2583, effective January 31, 2011)

Section 640.20  Definitions

"Act" means the Developmental Disability Prevention Act [410 ILCS 250].

"Active Candidate" means having completed a residency in the appropriate medical discipline in a program approved by the Residency Review Committee or a program approved by  the Council on Postdoctoral Training (COPT) for the American Osteopathic Association (AOA). Active candidates shall become board certified within five years after completion of an approved program.

"Administrative Perinatal Center" or "APC" means a referral facility intended to care for the high-risk patient before, during, or after labor and delivery and characterized by sophistication and availability of personnel, equipment, laboratory, transportation techniques, consultation and other support services. (Section 2(e) of the Act) An APC is a university or university-affiliated hospital designated by the Department as a Level III hospital, that receives financial support from the Department to provide leadership and oversight of the Regionalized Perinatal Healthcare Program.

"Advanced Practice Nurse" or "APN"  means  a person who has met the qualifications for a certified nurse midwife (CNM); certified nurse practitioner (CNP); certified registered nurse anesthetist (CRNA); or a clinical nurse specialist (CNS) and has been licensed by the Department of Financial and Professional Regulation.

"Affiliated Hospital" means an institution that has a letter of agreement with a specific APC.

"Apgar" means the score devised in 1952 by Virginia Apgar to assess the health of newborn children immediately after birth. The five criteria are Activity (Muscle Tone), Pulse, Grimace (Reflex Irritability), Appearance (Skin Color), and Respiration.

"Assisted Ventilation" means the movement of gas into and out of the lung by an external source connected directly to the patient.  The external source may be a resuscitation bag, a continuous distending pressure device, or a mechanical ventilator.  Attachment to the patient can be by way of a face mask, a head box, an endotracheal tube, nasal prongs, a tracheostomy, or a negative-pressure apparatus surrounding the thorax.

"Certified Local Health Department" means a local health department that receives program approval from the Department for all ten required basic health programs during required program and performance review.

"Congenital" means those intrauterine factors which influence the growth, development and function of the fetus.  (Section 2(b) of the Act)

"Consultation" means a health care provider obtaining information from an obstetrician, a maternal-fetal medicine physician or neonatology specialist via the telephone, in writing, or in person for the purpose of making patient care decisions and developing a care plan.

"Continuous Quality Improvement" or "CQI" means a structured organizational process for involving personnel in planning and executing a continuous flow of improvements to provide quality health care that meets or exceeds expectations.

"Department" means the Department of Public Health.  (Section 2(h) of the Act)

"Designation" means official recognition of a hospital by the Department as having met the standards contained in Section 640.40 and Section 640.50 for the level of care that the hospital will provide as a part of a regional perinatal network for all levels of perinatal care.

"Developmental Disability" means mental retardation, cerebral palsy, epilepsy, or other neurological handicapping conditions of an individual found to be closely related to mental retardation or to require treatment similar to that required by mentally retarded individuals, and the disability originates before such individual attains age 18, and has continued, or can be expected to continue indefinitely, and constitutes a substantial handicap of such individuals.  (Section 2(f) of the Act)

"Dietitian" means a person who is licensed as a dietitian in accordance with the Dietetic and Nutrition Services Practice Act [225 ILCS 30].

"Disability" means a condition characterized by temporary or permanent, partial or complete impairment of physical, mental or psychological function.  (Section 2(g) of the Act)

"Environmental" means those extrauterine factors which influence the adaptation, well being or life of the newborn and may lead to disability.  (Section 2(c) of the Act)

"Essential Resource" means a component, such as medical or nursing medical staff; a service, such as heat, water, or electrical power, or equipment that is necessary to maintain the designated level of care.

"Full-time" means on duty a minimum of 36 hours, four days per week.

"Handicapping Condition" means a medically recognized birth defect that threatens life or has a potential for a developmental disability in accordance with Subpart C of the Illinois Health and Hazardous Substances Registry (77 Ill. Adm. Code 840.210).

"Health Care Provider" means an individual who provides medical services or treatments to patients within his or her scope of practice. This may include, but is not limited to, physician, nurse, dietitian, social worker and respiratory care provider.

"High-Risk" means an increased level of risk of harm or mortality to the woman of childbearing age, fetus or newborn from congenital and/or environmental factors.  (Section 2(d) of the Act)

"High-Risk Infant" means a live-born infant fitting the Adverse Pregnancy Outcomes Reporting System (APORS) case definition.  (See 77 Ill. Adm. Code 840.200.)

"Hospital" means a facility defined as a hospital in Section 3 of the Hospital Licensing Act [210 ILCS 85].

"Intermediate Care Nursery" or "ICN" means a nursery that provides nursing care to those infants convalescing or those sick infants not requiring intensive care.

"Joint Morbidity and Mortality Review" means the required review of maternal and neonatal cases attended by the APC's maternal-fetal medicine physician, neonatologist and the Perinatal Center administrator and/or obstetric and neonatal educators. The review is a quality improvement initiative under the Medical Studies Act [735 ILCS 5/8-2101] and consists of cases presented by the attending physician at the Regional Network Hospital. The review includes all maternal, fetal and neonatal deaths, as well as selected morbidities as determined by the APC's Regional Quality Council or defined in the Regional Network Hospital's letter of agreement. The review provides evaluation and disposition of outcomes to guide educational program needs and quality improvement initiatives.

"Letter of Agreement" means a document executed between the APC and the hospital, which includes responsibilities of each party in regard to the hospital's level of designation and the services to be provided.

"Maternity or Neonatal Complications" means those medically determined high-risk conditions, including, but not limited to, those explained in the Guidelines for Perinatal Care, American Academy of Pediatrics and American College of Obstetricians and Gynecologists.

"Maternity and Neonatal Service Plan" means the description required under Subpart O of the Hospital Licensing Requirements (77 Ill. Adm. Code 250) of the hospital's services for care of maternity and neonatal patients, and the way in which the services are part of an integrated system of perinatal care provided by designated perinatal facilities.

"Morbidity" means an undesired result or complication associated with a pregnancy, whether naturally occurring or as the result of treatment rendered or omitted.

"Neonatal Intensive Care Unit" or "NICU" means an intensive care unit for high risk neonates, directed by a board-certified pediatrician with subspecialty certification in neonatal/perinatal medicine.

"Neonate" means an infant less than 28 days of age.

"Nurse" means a registered nurse or a licensed practical nurse as defined in the Nurse Practice Act [225 ILCS 65].

"Nurse Midwife, Certified" or "Certified Nurse Midwife" or "CNM" means an individual educated in the two disciplines of nursing and midwifery who possesses evidence of certification according to the requirements of the American College of Nurse-Midwives (ACNM).

"Perinatal" means the period of time between the conception of an infant and the end of the first month of life.  (Section 2(a) of the Act)

"Perinatal Advisory Committee" or "PAC" means the advisory and planning committee established by the Department, which is referred to in Section 3 of the Act.

"Pharmacist, Registered" or "Registered Pharmacist" means a person who holds a certificate of registration as a registered pharmacist, a local registered pharmacist or a registered assistant pharmacist under the Pharmacy Practice Act of 1987 [225 ILCS 85].

"Physician" means any person licensed to practice medicine in all its branches as defined in the Medical Practice Act of 1987 [225 ILCS 60].

"Preventive Services" means a medical intervention provided to a high risk mother and/or neonate in an effort to reduce morbidity and mortality.

"Refer" means to send or direct for treatment.

"Regional Perinatal Network" means any number and combination of hospitals providing maternity and newborn services at a designated level of perinatal care.

"Regional Quality Council" or "RQC" means an organization of representatives of perinatal services, providers and service-related agencies and organizations within a regional perinatal network that is responsible for the planning, development, evaluation and operation of the network and the establishment of regional priorities and policies for system support activities and staff.

"Registered Nurse" means a person licensed as a registered professional nurse under the Nurse Practice Act.

"Respiratory Care Practitioner" means a person licensed as a respiratory care practitioner under the Respiratory Care Practice Act [225 ILCS 106].

"Social Worker" means a person who is a licensed social worker or a licensed clinical social worker under the Clinical Social Work and Social Work Practice Act [225 ILCS 20].

"Special Care Nursery" or "SCN" means a nursery that provides intermediate intensive care, directed by a board-certified pediatrician with subspecialty certification in neonatal/perinatal medicine, to infants who weigh more than 1250 grams.

"State Perinatal Reporting System" means any system that requires data collection and submission of data to the Department. These systems include, but are not limited to, birth certificate submission, metabolic newborn screening, newborn hearing screening, perinatal HIV testing, and the Adverse Pregnancy Outcomes Reporting System (APORS) (see 77 Ill. Adm. Code 840).

"Statewide Quality Council" means the standing subcommittee established by the Perinatal Advisory Committee that is responsible for monitoring the quality of care and implementing recommendations for improving the quality of care being provided in the perinatal care system.

"Substantial Compliance" means meeting requirements, except for variance from the strict and literal performance that results in unimportant omissions or defects, given the particular circumstances involved.

"Substantial Failure" means the failure to meet requirements, other than unimportant omissions or defects, given the particular circumstances involved.

"Support Services" means the provision of current information regarding the identified handicapping conditions, referrals and counseling services, and the availability of additional consultative services.

(Source:  Amended at 35 Ill. Reg. 2583, effective January 31, 2011)

Section 640.25  Incorporated and Referenced Materials

The following regulations, standards, statutes and rules are incorporated or referenced in this Part.

a)         State of Illinois Statutes:

1)         Developmental Disability Prevention Act [410 ILCS 250]

2)         Freedom of Information Act [5 ILCS 140]

3)         Illinois Health Statistics Act [410 ILCS 520]

4)         Hospital Licensing Act [210 ILCS 85]

5)         Section 8-2101 of the Code of Civil Procedure (Medical Studies Act) [735 ILCS 5/8-2101]

6)         State Records Act [5 ILCS 160]

7)         Illinois Health and Hazardous Substances Registry Act [410 ILCS 525]

8)         Vital Records Act [410 ILCS 535]

9)         Respiratory Care Practice Act [225 ILCS 106]

10)         Dietetic and Nutrition Services Practice Act [225 ILCS 30]

11)         Illinois Administrative Procedure Act [5 ILCS 100]

12)         Nurse Practice Act [225 ILCS 65]

13)         Pharmacy Practice Act of 1987 [225 ILCS 85]

14)         Medical Practice Act of 1987 [225 ILCS 60]

15)         Clinical Social Work and Social Work Practice Act [225 ILCS 20]

b)         State of Illinois Rules

1)         Department of Public Health – Illinois Health and Hazardous Substances Registry (77 Ill. Adm. Code 840)

2)         Department of Public Health − Hospital Licensing Requirements (77 Ill. Adm. Code 250)

3)         Department of Public Health − Practice and Procedure in Administrative Hearings (77 Ill. Adm. Code 100)

4)         Department of Human Services − Maternal and Child Health Services Code (77 Ill. Adm. Code 630)

5)         Department of Public Health − Access to Public Records of the Department of Public Health (2 Ill. Adm. Code 1127)

c)         Standards or Guidelines

1)         Guidelines for Perinatal Care, American Academy of Pediatrics and American College of Obstetricians and Gynecologists (2007) (which may be obtained from the American Academy of Pediatrics, 141 Northwest Point Road, P.O. 927, Elk Grove Village, Illinois 60009-0927)

2)         Vermont Oxford Network:  VLBW (Very Low Birth Weight) Summary for Birth Years 2006-2008 (which may be obtained from the Vermont Oxford Network, 33 Kilburn Street, Burlington, Vermont 05401; www.vtoxford.org)

d)         All incorporations by reference of the standards of nationally recognized organizations refer to the standards on the date specified and do not include any amendments or editions subsequent to the date specified.

(Source:  Amended at 35 Ill. Reg. 2583, effective January 31, 2011)

Section 640.30  Perinatal Advisory Committee

a)         The Perinatal Advisory Committee (PAC) is an advisory body to the Department in matters pertaining to the regionalization of perinatal health care.  The purpose is to advise the Department on the establishment and implementation of policy.

b)         The duties of the PAC shall be to advise the Department on and make recommendations concerning:

1)         Health policies and quality of care issues affecting perinatal health care services and implementation of the State's perinatal health care plan;

2)         The needs of perinatal health care consumers and providers;

3)         Methods to seek a better understanding and wider support of regionalized perinatal health care within the local community;

4)         Coordinating and organizing regional networks or systems of perinatal health care;

5)         Policies relating to planning, operating and maintaining regional networks or systems of perinatal health care;

6)         All proposals for rulemaking affecting the provision of perinatal health care services under the Act; and

7)         Hospitals seeking designation or redesignation as described in Sections 640.40 through 640.70.

c)         The PAC shall consist of 22 members appointed by the Director of the Department and six ex-officio members as follows:

1)         Members

A)        10 physicians;

B)        Three hospital administrators;

C)        Two registered nurses;

D)        One social worker;

E)        One dietitian;

F)         One respiratory care practitioner;

G)        One health planner;

H)        Two consumers or representatives of the general public interested in perinatal health care; and

I)         One representative of a certified local health department;

2)         Ex-Officio Members

A)        One representative of the Illinois Department of Healthcare and Family Services;

B)        One representative of the Illinois Department of Human Services;

C)        One representative of the Consortium of Perinatal Network Administrators;

D)        One representative of the Chicago Department of Public Health;

E)        One representative of the Chicago Maternal and Child Health Advisory Committee of the Chicago Department of Public Health; and

F)         One representative of the Genetic and Metabolic Diseases Advisory Committee of the Department.

d)         Physician membership on the PAC shall consist of four obstetrician-gynecologists, to include a subspecialist in maternal/fetal medicine, four pediatricians, to include a subspecialist in neonatal/perinatal medicine and two family practice physicians.

e)         Recommendations for physicians shall be solicited from the Illinois State Medical Society, the Illinois Section of the American College of Obstetricians and Gynecologists, the Illinois Chapter of the American Academy of Pediatrics, and the Illinois Chapter of the American Academy of Family Practice.  Recommendations for hospital administrators and a health planner shall be solicited from the Illinois Hospital Association.  Recommendations for nurses shall be solicited from the Illinois Nurses Association; the Illinois Section, Association of Women's Health, Obstetric and Neonatal Nursing (AWHONN); the National Association of Neonatal Nurses; and the American College of Nurse-Midwives.  Recommendations for a social worker, a dietitian and a respiratory care practitioner shall be solicited from the Illinois Perinatal Social Work Association, the Illinois Dietetics Association and the Illinois Society of Respiratory Care.  Recommendations for a representative of a certified local health department shall be solicited from the Illinois Association of Public Health Administrators.

f)         Membership of the PAC shall be selected to be representative of the levels of perinatal care described in Section 640.40, as well as of the different settings in which perinatal care is provided, both geographic and institutional.

g)         Members of the PAC shall serve four-year terms. Ex-officio members shall have no set term of service.  Both members and ex-officio members shall have full voting privileges.

(Source:  Amended at 35 Ill. Reg. 2583, effective January 31, 2011)

Section 640.40  Standards for Perinatal Care

a)         Levels of Perinatal Care

            Hospital licensing requirements for all  levels of care are described in Subpart O of the Hospital Licensing Requirements.  All hospitals shall be designated in accordance with this Part and have a letter of agreement with a designated APC. (Section 640.70 describes the minimum components for the letter of agreement.)

1)         Non-Birthing Center hospitals do not provide perinatal services, but have a functioning emergency department. All licensed general hospitals that operate an emergency department shall have a letter of agreement with an APC for referral of perinatal patients, regardless of whether the hospital provides maternity or newborn services.  The letter of agreement shall delineate, but is not limited to, guidelines for transfer/transport of perinatal patients to an appropriate perinatal care hospital; telephone numbers for consultation and transfer/transport of perinatal patients;  educational needs assessment for emergency department staff, and provision of education programs to maintain necessary perinatal skills.

2)         Level I hospitals provide care to low-risk pregnant women and newborns, operate general care nurseries and do not operate an NICU or an SCN;

3)         Level II hospitals provide care to women and newborns at moderate risk, operate intermediate care nurseries and do not operate an NICU or an SCN.

4)         Level II with Extended Neonatal Capabilities hospitals provide care to women and newborns at moderate risk and do operate an SCN but do not operate an NICU.

5)         Level III hospitals care for patients requiring increasingly complex care and do operate an NICU.

b)         Perinatal Network

            Non-Birthing Center, Level I, Level II, Level II with Extended Neonatal Capabilities and Level III hospitals shall function within the framework of a regionally integrated system of services, under the leadership of an APC, designed to maximize outcomes and to promote appropriate use of expertise and resources.  Prenatal consultations, referrals, or transfers and recognition of high risk conditions are important to improve outcomes. Regional consultant relationships in maternal-fetal medicine and neonatology referred to in this Part shall be detailed in the letter of agreement.  The hospital shall ensure that staff physicians and consultants are familiar with the letter of agreement.

c)         All hospitals shall inform the Department of any change in or loss of essential resources required by this Part within 30 days after the change and/or loss. The hospital shall then replace the required resource within 90 days. Failure to comply shall result in a review by the Department, with a potential loss of designation.

(Source:  Amended at 35 Ill. Reg. 2583, effective January 31, 2011)

Section 640.41  Level I – Standards for Perinatal Care

To be designated as Level I, a hospital shall apply to the Department as described in Section 640.60; shall comply with all the conditions described in Subpart O of the Hospital Licensing Requirements that are applicable to the level of care necessary for the patients served; and shall comply with the following provisions:

a)         Level I − General Provisions

1)         The Maternity and Neonatal Service Plan shall include:

A)        A letter of agreement between the hospital and its APC establishing criteria for maternal and neonatal consultation; criteria for maternal and neonatal transports; standards of care of mothers and neonates; and support services to be provided.  (Section 640.70 establishes the minimum components for the letter of agreement.);

B)        Continuing education of staff in perinatal care; and 

C)        Participation in the CQI program implemented by the APC.

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); 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 hospital are the stabilization of patients with unexpected problems, initiation of neonatal and maternal transports, patient and community education, and data collection and evaluation.

3)         The Level I hospital shall provide 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.

4)         The Level I hospital shall maintain a system of recording patient admissions, discharges, birth weight, outcome, complications, and transports to meet the requirement to support network CQI activities described in the hospital's letter of agreement with the APC.  The hospital shall comply with the reporting requirements of the State Perinatal Reporting System.

b)         Level I – Standards for Maternal Care

1)         The maternal patient with an uncomplicated current pregnancy and no previous history that suggests potential difficulties is considered appropriate for Level I hospitals; however, the hospital's letter of agreement shall establish the specific conditions for the Level I hospital.

2)         Other than those maternal patients identified in subsection (b)(1), pregnancies of fewer than 36 weeks gestation constitute potentially high-risk conditions for which the attending health care provider shall consult with a board-certified obstetrician or maternal-fetal medicine subspecialist to determine whether a transport or transfer to a higher level of care is needed. The letter of agreement shall specify policies for consultation and the hospital's obstetric policies and procedures for each of, but not limited to, the pregnancy conditions listed in Section 640.Appendix H. Exhibit A.

3)         Hospitals shall have the capability for continuous electronic maternal-fetal monitoring for patients identified at risk, with staff available 24 hours a day, including physician and nursing, who are knowledgeable of electronic fetal monitoring use and interpretation. Physicians and nurses shall complete a competence assessment in electronic maternal-fetal monitoring every two years.

4)         Hospitals shall provide caesarean section decision-to-incision capabilities within 30 minutes.

c)         Level I – Standards for Neonatal Care

1)         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 hospitals; however, the hospital's letter of agreement shall establish the specific conditions for Level I hospitals.

2)         For all neonatal patients other than those identified in subsection (c)(1), consultation with a neonatologist is required to determine whether a transport to a higher level of care is needed. Consultation shall be specified in the letter of agreement and outlined in the hospital's pediatric policies and procedures for conditions including, but not limited to:

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

B)        Documented sepsis

C)        Seizures

D)        Congenital heart disease

E)        Multiple congenital anomalies

F)         Apnea

G)        Respiratory distress

H         Neonatal asphyxia

I)         Handicapping conditions or developmental disabilities that threaten life or subsequent development

J)         Severe anemia

K)        Hyperbilirubinemia, not due to physiologic cause

L)        Polycythemia

d)                  Level I – Resource Requirements

            The following support services shall be available:

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

2)         General anesthesia services shall be on call and available within 30 minutes to initiate caesarean sections.

3)         Radiology services shall be available within 30 minutes.

4)         Clinical laboratory services shall include microtechnique for hematocrit, blood gases, and routine urinalysis within 15 minutes; glucose, blood urea nitrogen (BUN), creatinine,  complete blood count (CBC), routine blood chemistries, type, cross, Coombs' test and bacterial smear within one hour; and capability for bacterial culture and sensitivity and viral culture.

5)         A physician for the program shall be designated to assume primary responsibility for initiating, supervising and reviewing the plan for management of distressed infants.  Policies and procedures shall assign responsibility for identification and resuscitation of distressed neonates to individuals who have completed a nationally recognized neonatal resuscitation program and are 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 respiratory care practitioner.

e)         Application for Designation, Redesignation or Change in Network

1)         To be designated or to retain designation, a hospital shall submit the required application documents to the Department. For information needed to complete any of the processes, see Section 640.50 (Designation and Redesignation of Non-Birthing Center, Level I, Level II, Level II with Extended Neonatal Capabilities, Level III Perinatal Hospitals, and Administrative Perinatal Centers) and Section 640.60 (Application for Hospital Designation and Redesignation as Non-Birthing Center, Level I, Level II, Level II with Extended Neonatal Capabilities, Level III Perinatal Hospital, and Administrative Perinatal Center, and Assurances Required of Applicants).

2)         The following information shall be submitted to the Department to facilitate the review of the hospital's application for designation or redesignation:

A)        Appendix A (fully completed);

B)        Resource Checklist (fully completed);

C)        A proposed letter of agreement between the hospital and the APC (unsigned);

D)        The curriculum vitae for all directors of patient care, i.e., obstetrics, neonatal,  ancillary medical and nursing.

3)         When the information described in subsection (e)(2) is submitted, the Department will review the material for compliance with this Part. This documentation will be the basis for a recommendation for approval or disapproval of the applicant hospital's application for designation.

4)         The medical co-directors of the APC (or their designees), the medical directors of obstetrics and maternal and newborn care, and a representative of hospital administration from the applicant hospital shall be present during the PAC's review of the application for designation.

5)         The Department will make the final decision and inform the hospital of the official determination regarding designation. The Department's decision will be based upon the recommendation of the PAC and the hospital's compliance with this Part, and may be appealed in accordance with Section 640.45. The Department will consider the following criteria to determine if a hospital is in compliance with this Part:

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

B)        Proposed letter of agreement between the applicant hospital and its APC in accordance with Section 640.70;

C)        Appropriate outcome information contained in Appendix A and the Resource Checklist (Appendices L, M, N and O);

D)        Other documentation that substantiates a hospital's compliance with particular provisions or standards of perinatal care; and

E)        Recommendation of Department program staff.

(Source:  Amended at 35 Ill. Reg. 2583, effective January 31, 2011)

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

To be designated as Level II or Level II with Extended Neonatal Capabilities, a hospital shall apply to the Department as described in Section 640.60 of this Part; shall comply with all of the conditions described in Subpart O of the Hospital Licensing Requirements that are applicable to the level of care necessary for the patients served; and 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 APC):

a)         Level II and Level II with Extended Neonatal Capabilities − General Provisions

A Level II or Level II with Extended Neonatal Capabilities hospital shall:

1)         Provide all services outlined for Level I (Section 640.41(a));

2)         Provide diagnosis and treatment of selected high-risk pregnancies and neonatal problems;

3)         Accept selected neonatal transports from Level I or other Level II hospitals as identified in the letter of agreement with the APC; and

4)         Maintain a system for recording patient admissions, discharges, birth weight, outcome, complications and transports to support network CQI activities described in the hospital's letter of agreement with the APC.  The hospital shall comply with the reporting requirements of the State Perinatal Reporting System.

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 hospitals without requirement for a maternal-fetal medicine consultation; however, the hospital's letter of agreement shall establish the specific conditions for the Level II hospital:

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

B)        Normal current pregnancy although obstetric history may suggest 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)         The attending health care provider shall consult a maternal-fetal medicine subspecialist, as detailed in the letter of agreement with the APC and outlined in the hospital's obstetric department policies and procedures, for each of, but not limited to, the current pregnancy conditions listed in Section 640.Appendix H.Exhibit B.  Subsequent patient management and site of delivery shall be determined by mutual collaboration between the patient's physician and the maternal-fetal medicine subspecialist.

3)         Hospitals shall have the capability for continuous electronic maternal-fetal monitoring for patients identified at risk, 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.

c)         Level II – Standards for Neonatal Care

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

A)        Those listed for Level I (see Section 640.41(c));

B)        Premature infants at 32 or more weeks gestation who are otherwise well;

C)        Infants with mild to moderate respiratory distress (not requiring assisted ventilation in excess of six hours);

D)        Infants with suspected neonatal sepsis, hypoglycemia responsive to glucose infusion, and asymptomatic neonates of diabetic mothers; and

E)        Infants with a birth weight greater than 1500 grams who are otherwise well.

2)         The attending physician shall consult a neonatologist for the following neonatal conditions.  Consultation shall be specified in the letter of agreement with the APC and outlined in the hospital's pediatric department policies and procedures for conditions including, but not limited to:

A)        Birth weight less than 1500 grams;

B)        10 minute Apgar scores of 5 or less;

C)        Handicapping conditions or developmental disabilities that threaten subsequent development in an otherwise stable infant.

3)         Minimum conditions for transport shall be specified in the letter of agreement and outlined in the hospital's pediatric department policies and procedures for conditions including, but not limited to:

A)        Premature birth that is less than 32 weeks gestation;

B)        Birth weight less than 1500 grams;

C)        Assisted ventilation beyond the initial stabilization period of six hours;

D)        Congenital heart disease associated with cyanosis, congestive heart failure or impaired peripheral blood flow;

E)        Major congenital malformations requiring immediate comprehensive  evaluation or neonatal surgery;

F)         Neonatal surgery requiring general anesthesia;

G)        Sepsis, unresponsive to therapy, associated with persistent shock or other organ system failure;

H)        Uncontrolled seizures;

I)         Stupor, coma, hypoxic ischemic encephalopathy Stage II or greater;

J)         Double-volume exchange transfusion;

K)        Metabolic derangement persisting after initial correction therapy;

L)        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 shall be immediately available in the hospital for blood banking procedures and identification of irregular antibodies. Blood component therapy shall be readily available.

2)         Experienced radiology technicians shall be immediately available in the hospital with professional interpretation available 24 hours a day. Ultrasound capability shall be 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 services shall include microtechnique blood gases in 15 minutes and electrolytes and coagulation studies within one hour. 

4)         Personnel skilled in phlebotomy and intravenous (IV) placement in the newborn shall be available 24 hours a day.

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

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

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

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

9)         Capability to provide neonatal resuscitation in the delivery room shall be satisfied by current completion of a nationally recognized neonatal resuscitation program by medical, nursing and respiratory care staff or a hospital rapid response team.

e)         Application for Designation, Redesignation or Change in Network

1)         To be designated or to retain designation, a hospital shall submit the required application documents to the Department. For information needed to complete any of the processes, see Section 640.50 and Section 640.60.

2)         The following information shall be submitted to the Department to facilitate the review of the hospital's application for designation or redesignation:

A)        Appendix A (fully completed);

B)        Resource Checklist (fully completed) (Appendices L, M, N and O);

C)        A proposed letter of agreement between the hospital and the APC (unsigned); and

D)        The curriculum vitae for all directors of patient care, i.e., obstetrics,  neonatal, ancillary medical care and nursing (both obstetrics  and neonatal).

3)         When the information described in subsection (e)(2) is submitted, the Department will review the material for compliance with this Part. This documentation will be the basis for a recommendation for approval or disapproval of the applicant hospital's application for designation.

4)         The medical co-directors of the APC (or their designees), the medical directors of obstetrics and maternal and newborn care, and a representative of hospital administration from the applicant hospital shall be present during the PAC's review of the application for designation.

5)         The Department will make the final decision and inform the hospital of the official determination regarding designation. The Department's decision will be based upon the recommendation of the PAC and the hospital's compliance with this Part and may be appealed in accordance with Section 640.45. The Department will consider the following criteria or standards to determine if a hospital is in compliance with this Part:

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

B)        Proposed letter of agreement between the applicant hospital and its APC, in accordance with Section 640.70;

C)        Appropriate outcome information contained in Appendix A and the Resource Checklist;

D)        Other documentation that substantiates a hospital's compliance with particular provisions or standards of perinatal care set forth in this Part; and

E)        Recommendation of Department program staff.

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

1)         The following patients are considered appropriate for Level II with Extended Neonatal Capabilities hospitals with SCN services:

A)        Those listed in subsection (c) of this Section;

B)        Infants with low birth weight greater than 1250 grams;

C)        Premature infants of 30 or more weeks gestation;

D)        Infants on assisted ventilation.

2)         For each of the following neonatal conditions, consultation between the Level II with Extended Neonatal Capabilities attending physician and the APC or Level III neonatologist is required. The attending neonatologist at the Level II with Extended Neonatal Capabilities hospital and the attending neonatologist at the APC or Level III hospital shall determine, by mutual collaboration, the most appropriate hospital to continue patient care. The Level II hospital with Extended Neonatal Capabilities shall develop a prospective plan for patient care for those infants who remain at the hospital.  Both the letter of agreement with the APC and the hospital's department of pediatrics' policies and procedures shall identify conditions that might require transfer to a Level III hospital, including, but not limited to::

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

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

C)        Conditions listed in subsections (c)(3)(C) through (L) of this Section.

g)         Level II with Extended Neonatal 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 full-time obstetrician certified by the American Board of Obstetrics and Gynecology or a licensed osteopathic physician with equivalent training and experience and certification by the American Osteopathic Board of Obstetrics and Gynecology.

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 certification 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 respiratory care practitioner with at least three years experience in all aspects of pediatric and neonatal respiratory therapy, with a bachelor's degree and completion of the neonatal/pediatric specialty examination of the National Board for Respiratory Care.

F)         Preventive services shall be 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 person shall be designated 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 Illinois Department of Human Services will identify and update referral resources for the area served by the unit.

H)        Each Level II hospital with Extended Neonatal Capabilities shall develop, with the help of the APC, a referral agreement with a neonatal follow-up clinic to provide neuro-developmental assessment and outcome data on the neonatal population.  Hospital policies and procedures shall describe the at-risk population and referral procedure to be followed. 

I)         If the Level II hospital with Extended Neonatal Capabilities transports neonatal patients, the hospital shall comply with Guidelines for Perinatal Care, American Academy of Pediatrics and American College of Obstetricians and Gynecologists.

2)         To provide for assisted ventilation of newborn infants beyond immediate stabilization, the Level II hospital with Extended Neonatal Capabilities shall also provide the following:

A)        Effective July 1, 2011, a pediatrician or advanced practice nurse whose professional staff privileges granted by the hospital specifically include the management of critically ill infants and newborns receiving assisted ventilation; or an active candidate or board-certified neonatologist shall be in the hospital the entire time the infant is receiving assisted ventilation. If infants are receiving on-site assisted ventilation care from an advanced practice nurse or a physician who is not a neonatologist, an active candidate or board-certified neonatologist shall be available on call to assist in the care of those infants as needed.

B)        Suitable backup systems and plans shall be in place to prevent and respond appropriately to sudden power outage, oxygen system failure, and interruption of medical grade compressed air delivery.

C)        Nurses caring for infants who are receiving assisted ventilation shall have documented competence and experience in the care of those infants.

D)        A respiratory care practitioner with documented competence and experience in the care of infants who are receiving assisted ventilation shall also be available to the nursery during the entire time that the infant receives assisted ventilation.

h)         Application for Designation, Redesignation or Change in Network

1)         To be designated or to retain designation, a hospital shall submit the required application documents to the Department. For information needed to complete any of the processes, see Section 640.50 and Section 640.60.

2)         The following information shall be submitted to the Department to facilitate the review of the hospital's application for designation or redesignation:

A)        Appendix A (fully completed);

B)        Resource Checklist (fully completed) (Appendices L, M, N and O);

C)        A proposed letter of agreement between the hospital and the APC (unsigned); and

D)        The curriculum vitae for all directors of patient care, i.e., obstetrics, neonatal, ancillary medical, and nursing (both obstetrics  and neonatal).

3)         When the information described in subsection (h)(2) is submitted, the Department will review the material for compliance with this Part. This documentation will be the basis for a recommendation for approval or disapproval of the applicant hospital's application for designation.

4)         The medical co-directors of the APC (or their designees), the medical directors of obstetrics and maternal and newborn care, and a representative of hospital administration from the applicant hospital shall be present during the PAC's review of the application for designation.

5)         The Department will make the final decision and inform the hospital of the official determination regarding designation. The Department's decision will be based upon the recommendation of the PAC and the hospital's compliance with this Part, and may be appealed in accordance with Section 640.45. The Department shall consider the following criteria or standards to determine if a hospital is in compliance with this Part:

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

B)        Proposed letter of agreement between the applicant hospital and its APC in accordance with Section 640.70;

C)        Appropriate outcome information contained in Appendix A and the Resource Checklist;

D)        Other documentation that substantiates a hospital's compliance with particular provisions or standards of perinatal care set forth in this Part; and

E)        Recommendation of Department program staff.

(Source:  Amended at 41 Ill. Reg. 3477, effective March 9, 2017)

Section 640.43  Level III – Standards for Perinatal Care

To be designated as Level III, a hospital shall apply to the Department for designation; shall comply with all of the conditions prescribed in this Part for intensive (Level III) perinatal care; shall comply with all of the conditions prescribed in Subpart O of the Hospital Licensing Requirements applicable to the level of care necessary for the patients served; and 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 APC):

a)         Level III − General Provisions

1)         A Level III hospital shall provide all services outlined for Level I and II (Sections 640.41(a) and 640.42(a)), general, intermediate and special care, as well as diagnosis and treatment of high-risk pregnancy and neonatal problems. Both the obstetrical and neonatal services shall achieve Level III capability for Level III designation.  The hospital shall provide for the education of allied health professionals and shall accept selected maternal and neonatal transports from Level I, Level II and Level II with Extended Neonatal Capabilities hospitals.

2)         The Level III hospital shall make available a range of technical and subspecialty consultative support such as pediatric anesthesiology, ophthalmology, pediatric surgery, genetic services, intensive cardiac services and intensive neurosurgical services.

3)         To qualify as a Level III hospital, these standards and resource requirements are necessary to ensure adequate competence in the management of certain high-risk patients. These criteria will be assessed by reviewing the resources and outcomes of each hospital's admissions, and which admissions include patients who are subsequently transferred, for the three most recent calendar years, combined, for which data are available. 

4)         A Level III hospital that elects not to provide all of the advanced level services shall have established policies and procedures for transfer of these mothers and infants to a hospital that can provide the service needed.

5)         The Level III hospital shall maintain a system for recording patient admissions, discharges, birth weight, outcome, complications, and transports to meet requirements to support network CQI activities described in the hospital's letter of agreement with the APC.  The hospital shall comply with the reporting requirements of the State Perinatal Reporting System.

b)         Level III – Standards of Care

1)         The Level III hospital shall have a policy requiring general obstetricians and newborn care physicians to obtain consultations from or transfer care to the appropriate subspecialists as outlined in the standards for Level II.

2)         The Level III hospital shall accept all medically eligible Illinois residents. Medical eligibility is to be determined by the obstetric or neonatal director or his/her designee based on the Criteria for High-Risk Identification (Guidelines for Perinatal Care, American Academy of Pediatrics and American College of Obstetricians and Gynecologists).

3)         The Level III hospital shall provide or facilitate emergency transportation of patients referred to the hospital in accordance with guidelines for inter-hospital care of the perinatal patient (Guidelines for Perinatal Care)). If the Level III hospital is unable to accept the patient referred, the APC Level III hospital shall arrange for placement at another Level III hospital or appropriate Level II or Level II hospital with Extended Neonatal Capabilities.

4)         The Level III hospital shall have a clearly identifiable telephone number, facsimile number or other electronic communication, either a special number or a specific extension answered by unit personnel, for receiving consultation requests and requests for admissions. This number shall be kept current with the Department and with the Regional  Perinatal Network.

5)         The Level III hospital shall provide and document continuing education for medical, nursing, respiratory therapy, and other staff providing general, intermediate and intensive care perinatal services.

6)         The Level III hospital shall provide caesarean section decision-to-incision capabilities within 30 minutes.

7)         The Level III hospital shall provide data relating to its activities and shall comply with the requirements of the State Perinatal Reporting System.

8)         The medical co-directors of the Level III hospital shall be responsible for developing a system ensuring adequate physician-to-physician communication. Communication with referring physicians of patients admitted shall be sufficient to report patient progress before and at the time of discharge.

9)         Hospitals shall have the capability for continuous electronic maternal-fetal monitoring for patients identified at risk, 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.

10)         The Level III hospital, in collaboration with the APC, shall establish policies and procedures for the return transfer of high-risk mothers and infants to the referring hospital when they no longer require the specialized care and services of the Level III hospital.

11)         The Level III hospital shall provide backup systems and plans shall be in place to prevent and respond to sudden power outage, oxygen system failure and interruption of medical grade compressed air delivery.

12)         The Level III hospital shall provide or develop a referral agreement with a developmental follow-up clinic to provide neuro-developmental services for the neonatal population.  Hospital policies and procedures shall describe the at-risk population and the referral procedure to be followed for enrolling the infant in developmental follow-up.  Infants shall be scheduled for assessments at regular intervals.  Neuro-developmental assessments shall be communicated to the primary care physicians. Referrals shall be made for interventional care in order to minimize neurologic sequelae. A system shall be established to track, record and report neuro-developmental outcome data for the population, as required to support network CQI activities.

13)         Neonatal surgical services shall be available 24 hours a day.

c)         Level III – Resource Requirements

1)         Obstetric activities shall be directed and supervised by a full-time subspecialty obstetrician certified by the American Board of Obstetrics and Gynecology in the subspecialty of Maternal and Fetal Medicine, or an  osteopathic physician with equivalent training and experience and certification by the American Osteopathic Board of Obstetricians and Gynecologists. The director of the obstetric services shall ensure the backup supervision of his or her services by a physician with equivalent credentials.

2)         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 certification by the American Osteopathic Board of Pediatricians/Neonatal-Perinatal Medicine. The director of the neonatal services shall ensure the backup supervision of his or her services by a physician with equivalent credentials.

3)         An administrator/manager with a master's degree shall direct, in collaboration with the medical directors, the planning, development and operation of the non-medical aspects of the Level III hospital and its programs and services.

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

B)        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 NICU 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. All nursing staff working in the NICU shall have yearly competence assessment in neonatal intensive care nursing.

4)         Obstetric anesthesia services under the direct supervision of a board- certified anesthesiologist with training in maternal, fetal and neonatal anesthesia shall be available 24 hours a day. The directors of obstetric anesthesia services shall ensure the backup supervision of their services when they are unavailable.

5)         Pediatric-neonatal respiratory care services shall be directed by a full-time  respiratory care practitioner with a bachelor's degree.

A)        The respiratory care practitioner responsible for the NICU shall have at least three years of experience in all aspects of pediatric and neonatal respiratory care at a Level III NICU and completion of the neonatal/pediatrics specialty examination of the National Board for Respiratory Care.

B)        Respiratory care practitioners with experience in neonatal ventilatory care shall staff the NICU according to the respiratory care requirements of the patient population, with a minimum of one dedicated neonatal respiratory care practitioner for newborns on assisted ventilation, and with additional staff provided as necessary to perform other neonatal respiratory care procedures.

6)         A physician for the program shall assume primary responsibility for initiating, supervising and reviewing the plan for management of distressed infants in the delivery room. Hospital policies and procedures shall assign responsibility for identification and resuscitation of distressed neonates to individuals who are both specifically trained and immediately available in the hospital at all times. Capability to provide neonatal resuscitation in the delivery room may be satisfied by current completion of a neonatal resuscitation program by medical, nursing and respiratory care staff or a rapid response team.

7)         A board-certified or active candidate obstetrician shall be present and available in the hospital 24 hours a day. Maternal-fetal medicine consultation shall be available 24 hours a day. 

8)         Medical director-neonatal: to direct the neonatal portion of the program.  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/Neonatal-Perinatal Medicine.  The directors of the neonatal services shall ensure the back-up supervision of their services when they are unavailable.

9)         Neonatal surgical services shall be supervised by a board-certified surgeon or active candidate in pediatric surgery appropriate for the procedures performed at the Level III hospital.

10)       Neonatal surgical anesthesia services under the direct supervision of a board-certified anesthesiologist with extensive training or experience in pediatric anesthesiology shall be available 24 hours a day.

11)       Neonatal neurology services under the direct supervision of a board-certified or active candidate pediatric neurologist shall be available for consultation in the NICU 24 hours a day.

12)       Neonatal radiology services under the direct supervision of a radiologist with extensive training or experience in neonatal radiographic and ultrasound interpretation shall be available 24 hours a day.

13)       Neonatal cardiology services under the direct supervision of a pediatric board-certified or active candidate by the American Board of Pediatrics sub-board of pediatric cardiology shall be available for consultation 24 hours a day.  In addition, cardiac ultrasound services and pediatric cardiac catheterization services by staff with specific training and experience shall be available 24 hours a day.

14)       A board-certified or active candidate ophthalmologist with experience in the diagnosis and treatment of the visual problems of high-risk newborns (e.g., retinopathy of prematurity) shall be available for appropriate examinations, treatment and follow-up care of high-risk newborns.

15)       Pediatric sub-specialists with specific training and extensive experience or subspecialty board certification or active candidacy (where applicable) shall be available 24 hours a day, including, but not limited to, pediatric urology, pediatric otolaryngology, neurosurgery, pediatric cardiothoracic surgery and pediatric orthopedics appropriate for the procedures performed at the Level III hospital.

16)       Genetic counseling services shall be available for inpatients and outpatients, and the hospital shall provide for genetic laboratory testing, including, but not limited to, chromosomal analysis and banding, fluorescence in situ hybridization (FISH), and selected allele detection.

17)       The Level III hospital shall designate at least one person to coordinate the community nursing follow-up referral process, to direct discharge planning, to make home care arrangements, to track discharged patients, and to ensure appropriate enrollment in a developmental follow-up program.  The community nursing referral process shall consist of notifying the follow-up nurse in whose jurisdiction the patient resides of discharge information on all patients. The Illinois Department of Human Services will identify and update referral resources for the area served by the unit. The hospital shall establish a protocol that defines the educational criteria necessary for commonly required home care modalities, including, but not limited to, continuous oxygen therapy, electronic cardio-respiratory monitoring, technologically assisted feeding and intravenous therapy.

18)       One or more full-time  social workers with perinatal/neonatal experience shall be available to the Level III hospital.

19)       One registered pharmacist with experience in perinatal pharmacology shall be available for consultation on therapeutic pharmacology issues 24 hours a day.

20)       One dietitian with experience in perinatal nutrition shall be available to plan diets and education to meet the special needs of high-risk mothers and neonates in both inpatient and outpatient settings.

d)         Application for Hospital Designation,  Redesignation or Change in Network

1)         To be designated or to retain designation, a hospital shall submit the required application documents to the Department. For information needed to complete any of the processes, see Section 640.50 and Section 640.60.

2)         The following information shall be submitted to the Department to facilitate the review of the hospital's application for designation or redesignation:

A)        Appendix A (fully completed);

B)        Resource Checklist (fully completed) (Appendices L, M, N and O);

C)        A proposed letter of agreement between the hospital and the APC (unsigned); and

D)        The curriculum vitae for all directors of patient care, i.e., obstetrics, neonatal, ancillary medical, and  nursing (both obstetrics and neonatal).

3)         When the information described in subsection (d)(2) is submitted, the Department will review the material for compliance with this Part. This documentation will be the basis for a recommendation for approval or disapproval of the applicant hospital's application for designation.

4)         The medical co-directors of the APC (or their designees), the medical directors of obstetrics and maternal and newborn care, and a representative of hospital administration from the applicant hospital shall be present during the PAC's review of the application for designation.

5)         The Department will make the final decision and inform the hospital of the official determination regarding designation. The Department's decision will be based upon the recommendation of the PAC and the hospital's compliance with this Part, and may be appealed in accordance with Section 640.45. The Department will consider the following criteria to determine if a hospital is in compliance with this Part:

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

B)        Proposed letter of agreement between the applicant hospital and its APC in accordance with Section 640.70;

C)        Appropriate outcome information contained in Appendix A and the Resource Checklist;

D)        Other documentation that substantiates a hospital's compliance with particular provisions or standards of perinatal care set forth in this Part; and

E)        Recommendation of Department program staff.

(Source:  Amended at 35 Ill. Reg. 2583, effective January 31, 2011)

Section 640.44  Administrative Perinatal Center

To be designated as an APC, a hospital shall submit an application to the Department for a grant to provide financial support to assist the Department in the implementation and oversight of the Regionalized Perinatal Health Care Program;and shall comply with all of the conditions described for intensive (Level III) perinatal care in Section 640.43; and shall comply with all of the conditions described in Subpart O of the Hospital Licensing Requirements.  The APC shall comply with the following:

a)         Administrative Perinatal Center − General Provisions

1)         An APC shall be a university or university-affiliated hospital, having Level III hospital designation.  An APC may be composed of one or more institutions.  The APC shall be responsible for the administration and implementation of the Department's regionalized perinatal health care program, including but not limited to:

A)        Continuing education for health care professionals;

B)        Leadership and implementation of CQI projects, including morbidity and mortality reviews at regional network hospitals;

C)        Maternal and neonatal transport services;

D)        Consultation services for high-risk perinatal patients;

E)        Follow-up developmental assessment programs; and

F)         Laboratory facilities and services available to regional network hospitals.

2)         An APC shall be capable of providing the highest level of care within a regional network appropriate to maternal and neonatal high-risk patients.  The following services shall be available:

A)        Consultants in the various medical-pediatric-surgical subspecialties including, but not limited to, cardiac, neurosurgery, genetics, and other support services;

B)        Follow-up developmental assessment program;

C)        Maternal and neonatal transport services; and

D)        Laboratory facilities available to the hospitals within the regional perinatal network.

b)         The Department will designate an APC within each regional perinatal network to be responsible for the administration and implementation of the Department's Regionalized Perinatal Health Care Program.

c)         The APC will be responsible for providing leadership in the design and implementation of the Department's CQI Program, including the establishment and regularly scheduled meetings of a regional quality improvement structure (Regional Quality Council).

d)         The APC shall establish a Joint Mortality and Morbidity Review Committee with the affiliated regional network hospitals. The Committee shall review all perinatal deaths and selected morbidity, including, but not limited to, transports of neonates born with handicapping conditions, or developmental disabilities, or unique medical conditions. This review shall also include a periodic comparison of total perinatal mortality and the numbers attributable to categories of complications. Membership on the Committee shall include, but not be limited to, pediatricians, obstetricians, family practice physicians, nurses, quality assurance, pathology, and hospital administration staff and representatives from the hospital's APC. The network administrator shall prepare a yearly synopsis of the Regional Perinatal Network's perinatal deaths. This synopsis shall include statistical information, as well as an identification of the factors contributing to deaths that are identified as potentially avoidable.  The synopsis shall be shared with the Regional Quality Council. The Council shall develop, for the Network, an action plan to address issues of preventability. The Council's action plan shall be forwarded to the Department. The membership of the Council shall include representatives from all levels and disciplines of perinatal health care providers.

e)         Perinatal Program Oversight

1)         The Department shall work in conjunction with the APCs to conduct site visits at network hospitals to assure compliance with this Part on a periodic basis not to exceed three years.

2)         The requirements of this Part do not apply to infants who, after having completed initial therapy, are transferred back to the referring hospital for continuing care.  The capability of the hospital to provide necessary services for these infants shall be determined by mutual consent with the APC and addressed in the letter of agreement.

3)         APCs shall provide information to the Department no less frequently than quarterly. These reports shall include,  but not be limited to, network education activities; network meetings; overview of CQI activities; schedule of mortality and morbidity review meetings; and schedule of proposed and completed network hospital site visits.

(Source:  Amended at 35 Ill. Reg. 2583, effective January 31, 2011)

Section 640.45  Department of Public Health Action

a)         Department Review

1)         The Department will develop a plan for determining the degree of compliance with this Part on a periodic basis not to exceed three years.

2)         During the site visit, the hospital will receive a determination of substantial compliance or substantial failure.

b)         Department Oversight

The Department may deny designation or redesignation or revoke designation of any hospital that fails to achieve substantial compliance with the requirements for designation or redesignation set forth in this Part.  The Department will consider the following factors in deciding whether to deny designation or redesignation or to revoke designation:

1)         Failure to complete the letter of agreement within 90 days after receipt of the official site visit report;

2)         Failure to have and to comply with an approved Maternity and Neonatal Service Plan;

3)         Failure to complete the site visit and accompanying site visit report documentation;

4)         Failure to comply with all of the requirements of this Part for the level of designation.

5)         Failure to participate in and comply with CQI programs, including the Regional Quality Council or other programs designed or implemented by the APC or the Department;

6)         Failure to notify the Department of the loss of, or change in, an essential resource required for its level of designation;

c)         The Department will notify the hospital within 30 days after the site visit as to whether the hospital has achieved substantial compliance with this Part. The notification will include specific requirements with which substantial compliance has not been achieved. If the hospital has not achieved substantial compliance within 90 days after having received the notice, the Department will deny or revoke the designation. If progress toward substantial compliance is being made, per written documentation of the APC, the Department will continue to work with the hospital and its APC to achieve designation.

d)         The Illinois Administrative Procedure Act  and the Department's Practice and Procedure in Administrative Hearings  shall apply to all hearings challenging Department decisions, including those related to designation, redesignation, and denial or revocation of designation.

(Source:  Amended at 35 Ill. Reg. 2583, effective January 31, 2011)

Section 640.50  Designation and Redesignation of Non-Birthing Center, Level I, Level II, Level II with Extended Neonatal Capabilities, Level III Perinatal Hospitals and Administrative Perinatal Centers

a)         The hospital shall declare by means of a letter of intent to the Department and the affiliated APC that it seeks designation as a hospital with no OB services, or as a Level I, Level II, Level II with Extended Neonatal Capabilities, or Level III in a Regional Perinatal Network.

b)         The Department will acknowledge the letter of intent.

c)         The APC shall arrange a site visit to the applicant hospital. The hospital shall prepare the designation/redesignation documents in accordance with Section 640.60.  The site visit team for Level I, II, II with Extended Neonatal Capabilities, and III perinatal hospitals shall consist of six members: three from the APC of the hospital's Regional Perinatal Network, including the Directors of Neonatology and Maternal-Fetal Medicine or their designees and the Perinatal Network Administrator; a representative of nursing; one representative from the PAC; and one representative of the Department. When travel is not feasible, regardless of the reason, the PAC representative shall be permitted to participate in the site visit from a remote location via telephone, Voice over Internet Protocol (VoIP), or video conferencing.  The site visit team shall review the capabilities of the applicant hospital based on the requirements outlined in the letter of agreement between the applicant hospital and the APC. The site visit team shall complete the Standardized Perinatal Site Visit Protocol (see Appendix A) and submit these materials to the medical directors of the hospital visited for their review and comment within 30 days after the date of the site visit. The APC shall collaborate with the Department to develop a summary site visit report within 60 days after the site visit. This report shall be sent to the hospital within 90 days after the site visit.

d)         The Department will coordinate the site visit for APCs. The team shall consist of five members: one Director of Neonatology, one Director of Maternal-Fetal Medicine and one Perinatal Network Administrator from a non-contiguous Center; one representative from the PAC; and one representative of the Department. When travel is not feasible, regardless of the reason, the PAC representative shall be permitted to participate in the site visit from a remote location via telephone, Voice over Internet Protocol (VoIP), or video conferencing.  The Department shall collaborate with the site visit team to develop a summary site visit report within 60 days after the site visit. This report shall be forwarded to the hospital within 90 days after the site visit.

e)         The Department will review the submitted materials, any other documentation that clearly substantiates a hospital's compliance with particular provisions or standards for perinatal care, and the recommendation of the PAC.

f)         The Department will make the final decision and inform the hospital of the official determination regarding designation. The Department's decision will be based upon the recommendation of the PAC and the hospital's compliance with this Part, and may be appealed in accordance with Section 640.45. A 12-month to 18-month follow-up review will be scheduled for any increase in hospital designation to assess compliance with the requirements of this Part that are applicable to the new level of designation.  The Department shall consider the following criteria to determine if a hospital is in compliance with this Part:

1)         Maternity and Neonatal Service Plan (Subpart O of the Hospital Licensing Requirements);

2)         Proposed letter of agreement between the applicant hospital and its APC in accordance with Section 640.70;

3)         Appropriate outcome information contained in Appendix A and the Resource Checklist (Appendices L, M, N and O); 

4)         Other documentation that substantiates a hospital's compliance with particular provisions or standards of perinatal care set forth in this Part; and

5)         Recommendation of Department program staff.

g)         The Department will review all designations at least every three years to assure that the designated hospitals continue to comply with the requirements of the perinatal plan. Circumstances that may influence the Department to review a hospital's designation more frequently than every three years could include:

1)         A hospital's desire to expand or reduce services;

2)         Poor perinatal outcomes;

3)         Change in APC or Network affiliation;

4)         Change in resources that would have an impact on the hospital's ability to comply with the required resources for the level of designation; or

5)         An APC finds and the Department concurs or determines that a hospital is not appropriately participating in and complying with CQI programs.

h)         Existing designations shall be effective until redesignation is accomplished.

(Source:  Amended at 41 Ill. Reg. 3477, effective March 9, 2017)

Section 640.60  Application for Hospital Designation or Redesignation as a Non-Birthing Center, Level I, Level II, Level II with Extended Neonatal Capabilities, Level III Perinatal Hospital and Administrative Perinatal Center, and Assurances Required of Applicants

a)         Applicant hospitals shall provide the Department with information based on standards and resources for the applicable level of designation. The information shall include, but not be limited to the following (see Appendix A):

1)         A definition of the geographic area the hospital currently serves or plans to serve.

2)         A physical description of the hospital, compliance with Subpart O of the Hospital Licensing Requirements, and a description of the maternity and nursery units currently in place or in preparation for operation should the hospital be designated.

3)         A physical description of the hospital's staffing in accordance with this Part as follows:

A)        Social work and nutrition services shall be available through a hospital department for Level II and Level III designation.

B)        Names, titles and contact numbers shall be provided for the Director or Chairman of Maternal-Fetal Medicine, Neonatology, Obstetrics, Pediatrics and Neonatal Services, Chief Nursing Supervisor, Nursing Supervisor of Maternity Unit; names and contact numbers of medical staff members in maternal-fetal medicine, obstetrics and gynecology, neonatology, obstetric anesthesiology, family practice, anesthesiology; listing of anesthetists, staff for respiratory therapy, nurse-midwives, and involved house staff.

C)        A description of the current nurse/patient ratios in the nursery, delivery room, postpartum floor and intermediate or intensive care newborn nurseries for all shifts.

D)        A description of the qualifications of nursing personnel involved in the newborn nursery, delivery room and postpartum area.

E)        A description of the staff plans to assure that maternity/nursery staff are trained and prepared to stabilize infants prior to transfer, and are available 24 hours a day.

4)         A description giving evidence that the hospital's laboratory, X-ray and respiratory therapy equipment and capabilities meet all of the conditions described in Subpart O of the Hospital Licensing Requirements and are available 24 hours a day in-house.

A)        Continuous electronic maternal-fetal monitoring shall be available, and staff with knowledge in its use and interpretation shall be available 24 hours a day for Level I, Level II, Level II with Extended Neonatal Capabilities, and Level III designation applicants.

B)        Level III and APCs shall provide Level II ultrasound available on the obstetric floor.

C)        Level I ultrasound and staff knowledgeable in its use and interpretation shall be available at Level II hospitals on a 24-hour-a-day basis.

5)         A description of the capabilities for or capabilities planned for (giving the start-up time) emergency neonatology surgery, listing specialists such as surgeons, trained or support staff for neonates, and a description of the capabilities for caesarean section and start-up time.

6)         A description of the present plan for identification of high-risk maternity and neonatal patients and agreements for consultation with the APC in cases of maternity and neonatal complications and neonates with handicapping conditions. This description shall include plans and agreements for providing:

A)        Management of acute surgical or cardiac difficulties;

B)        Genetic counseling if a genetically related condition is diagnosed in the neonate, or if a parent or a known carrier requests the services;

C)        Information, counseling and referral to another health care provider for parents of neonates with handicapping conditions or developmental disabilities to ensure informed consent for treatment;

D)        Counseling and referral services to another health care provider to assist these patients in obtaining habilitation and rehabilitation services;

E)        A description of the types of patients the hospital will care for and the types of patients it will refer to the APC.

7)         A description of the history and current level of involvement with CQI activities as designed and implemented by the APC.

8)         All of the information required for hospital designation or redesignation to the APC with which it is seeking affiliation.

b)         The following procedures shall govern the review of perinatal hospitals applying for designation or redesignation:

1)         Hospitals applying for perinatal designation or redesignation shall provide all of the information contained in the Standardized Perinatal Site Visit Protocol (Appendix A) and the Resource Checklist  (see Appendices L, M, N and O).

2)         The completed written documentation shall be submitted to the Department three weeks in advance of the scheduled site visit.

3)         The Department will send the completed site visit documentation to the PAC no less than two weeks in advance of the PAC meeting, to facilitate PAC review of the applicant hospital.

4)         A representative of the APC and representatives of the hospital for which the application is being considered shall be present at the PAC meeting to respond to questions or concerns of PAC members regarding the hospital's application for designation or redesignation. The representative may also be asked to present an oral summary of the applicant hospital's and the APC'sreasons for recommending/not recommending designation or redesignation to the PAC. A 12- to 18- month follow-up will be scheduled for any increase in designation to assess compliance with the new level of designation.

5)         The Department will request that the APCconduct a follow-up site visit to the hospital for review for designation or redesignation if the initial site visit is more than six months prior to submission to the PAC. Approval shall be contingent upon receiving the findings of the follow-up site visit.

c)         The following procedure shall be followed to change network affiliation for an individual hospital:

1)         The hospital requesting a change in affiliation shall submit a written request to the Department. The existing APC shall provide information for the site visit and review, as requested.  The receiving APC shall conduct the site visit in preparation for a change in network.

2)         Representatives from the hospital and receiving APC shall appear before the PAC and shall present appropriate documentation as described in Appendix A.

(Source:  Amended at 35 Ill. Reg. 2583, effective January 31, 2011)

Section 640.70  Minimum Components for Letters of Agreement Between Non-Birthing Center, Level I, Level II, Level II with Extended Neonatal Capabilities, or Level III Perinatal Hospitals and Their Administrative Perinatal Center

The following components, at a minimum, shall be addressed in a letter of agreement between the applicant hospital and its APC:

a)         A description of how maternal and neonatal patients with potential complications, including handicapping conditions or developmental disabilities, will be identified.

b)         A description of the types of maternal and neonatal cases in which consultation from the APC or Level III hospital shall be sought and from which patients shall be selected for transfer.  This description shall address those high-risk mothers or neonates with handicapping conditions, developmental disabilities, or medical conditions that may require additional medical and surgical treatment and support services, but would not, however, require transport to an APC or Level III hospital.

c)         A description of how the APC or Level III hospital will report a patient's progress to the referring physicians, and the criteria for return of the patient from the APC or Level III hospital to an affiliated hospital closer to the patient's home.

d)         A description of the methods for transporting high-risk mothers and neonates with physiological support in transit.

e)         A description of the information, counseling and referral services available within the local community and the regional network for parents or potential parents of neonates with handicapping conditions or developmental disabilities.

f)         A description of the professional educational outreach program for the regional network, including how efforts will be coordinated.

g)         A description of the regional perinatal network's program for medical and home nursing follow-up, describing systems of liaisons, with a letter of agreement from the agency providing the home nursing follow-up services.

h)         A description of the methodologies used to monitor, evaluate and improve the quality of health care services provided by the applicant hospital, including  expectations of both the APC and applicant hospital on joint participation in CQI activities.

i)          A requirement that the hospital shall provide information, counseling and referral services to another health care provider to parents or potential parents of neonates with handicapping conditions or developmental disabilities upon the identification of the handicapping conditions and developmental disabilities, to assist in obtaining habilitation, rehabilitation and special education services.

j)          A requirement for evaluation and consultation with the APC or Level III hospital and referral to the APC or Level III hospital, when determined appropriate by the perinatal conditions or developmental disabilities, within 24 hours after the identification of the conditions (specific conditions shall be defined in the letter of agreement).

k)         A requirement that procedures for referral to appropriate state and local education service agencies of children having an identified handicapping condition or developmental disability requiring evaluation and assessment under such agencies shall be established.  The procedures shall include obtaining parental consent prior to release of information to the appropriate state and local educational service agencies.

(Source:  Amended at 35 Ill. Reg. 2583, effective January 31, 2011)

Section 640.80  Regional Perinatal Networks – Composition and Funding

a)         Regional Perinatal Networks, as defined in Section 640.20, may include any number and combination of hospitals providing maternity and newborn services at one of the  levels of perinatal care, according to policies and practices described in their letters of agreement.  Where more than one Level III hospital provides services within a Regional Perinatal Network, a letter of agreement with the APC shall describe how each will participate in the provision of services included in Section 640.40 of this Part.  Regional Perinatal Networks may also include other agencies, institutions and individuals providing a complete range of perinatal health services, including preconceptional, prenatal, perinatal and family follow-up care services, as part of the regional network.

b)         The Department will allocate funds for perinatal health services provided through Regional Perinatal Networks.

1)         Funds will be awarded to Regional Perinatal Networks under the following mechanisms:

A)        The Department will provide grants to designated APCs responsible for the administration and implementation of the Department's regionalized perinatal health care program.  Under this option, the APC is the applicant for Maternal and Child Health (MCH) Project funds and will apply as specified in the Department of Human Services’ Maternal and Child Health Services Code (77 Ill. Adm. Code 630.30 through 630.70).

B)        Grant applications by regional perinatal networks may include services and responsibilities assigned to APCs and Level III hospitals in Section 640.40(c) of this Part in addition to the perinatal care services included in 77 Ill. Adm. Code 630.30 through 630.70.

2)         Preventive Services

A portion of funds available to the Department for funding regional perinatal networks shall be targeted for preventive services.

(Source:  Amended at 35 Ill. Reg. 2583, effective January 31, 2011)

Section 640.85  Exceptions to Part 640

a)         A hospital may request an exception to the standards of care set forth in this Part in accordance with this Section. Exceptions are not intended to circumvent Level designations.  The hospital or the APC may seek the advice and consultation of the Department, as well as the PAC, in regard to the requirements for an exception.

b)         Exceptions to the standards of care set forth in this Part may be granted when the hospital requesting an exception demonstrates that the resources and quality of care (outcomes) are substantially equivalent to the resources and quality of care for a facility at the next highest level of designation, as indicated by the resource requirements set forth in this Part.  If the hospital and its APC agree on the proposed exception, a proposed letter of agreement shall be submitted to the Department for review and approval. The Department's review will be based on compliance with this Part, patient care needs, current practice, outcomes, and geography in the regional perinatal network. 

c)         If the hospital and its APC do not agree on any aspect of the proposed exception, the hospital or the APC shall consult the Subcommittee on Facility Designation (SFD) of the PAC. 

d)         The following information shall be submitted to the SFD:

1)         A proposed letter of agreement (unsigned);

2)         The curriculum vitae for all directors of patient care, i.e., obstetrics, neonatal, nursing (obstetrics and neonatal);

3)         Appendix A of this Part (fully completed);  and

4)         A letter from the APC that includes the following information:

A)        The exceptions being requested;

B)        Information demonstrating that the quality of care (outcomes) of the hospital is substantially equivalent to the standards of this Part for the next highest level of designation for the proposed exceptions;

C)        A description of the monitoring system used when consultation  between the attending physician at the hospital and the physician consultant at a higher level hospital determines that a mother or newborn infant should remain in the hospital rather than being transferred to the higher level hospital;

D)        A description of any arrangements made between the hospital and the APC to seek or ensure quality improvement;

E)        A copy of the hospital's Maternity and Neonatal Service Plan (Subpart O of the Illinois Hospital Licensing Requirements); and

F)         The PAC's recommendation concerning the exception.

e)         The medical co-directors of the APC (or their designees) and the medical directors of obstetrics and maternal and newborn care and a representative of hospital administration from the applicant hospital shall participate (either in person or electronically) in the SFD's review of the application.

f)         Exceptions agreed to between hospital and the SFD shall be defined in a proposed letter of agreement and submitted to the Department for review and  approval. The Department's review will be based on compliance with this Part, patient care needs, current practice, outcomes, and geography in the regional perinatal network. 

g)         If the SFD is not able to make a decision on the exception, the SFD shall submit the request for an exception to the Department, including all of the information submitted to the SFD in accordance with subsection (d) and the SFD's recommendation concerning the exception.

h)         The Director of Public Health shall make the final decision regarding approval of the exception and the letter of agreement.  The Director's decision shall be based upon the recommendations of the APC and the SFD and the documentation required in subsection (d) to determine the facility's compliance with this Part.  The Director's decision may be appealed in accordance with Section 640.45.  The Department shall inform the hospital, the APC and the SFD of the decision.

(Source:  Added at 35 Ill. Reg. 2583, effective January 31, 2011)

Section 640.90  State Perinatal Reporting System

a)         Purpose

            The Department will maintain a State Perinatal Reporting System to follow selected high-risk perinatal patients to ensure that those patients are assessed at appropriate intervals, receive intervention as needed, and are referred for needed support services.

b)         Identification and Referral of High-Risk Maternal Patients

1)         Each designated APC and Level III hospital that provides obstetrical care shall establish criteria and procedures for identifying high-risk pregnant and postpartum patients. A statement describing the criteria and procedures shall be on file and shall be provided to the Department on request.

2)         The hospital's Perinatal Review Committee, or other committee established for the purpose of internal quality control or medical study for the purpose of reducing morbidity or mortality or improving patient care, shall collect and submit the information required in subsection (b)(1) to the Department. These data will be considered confidential under Section 8-2101 of the Code of Civil Procedure.

c)         Identification of Perinatal Patients

1)         All Illinois hospitals licensed to provide obstetrical and newborn services shall report information on all perinatal patients. The Department requests, but does not require, reports on perinatal patients from hospitals outside Illinois.(The Department does request reports from the St. Louis APCs or hospitals maintained by the federal government or other governmental agencies within the United States.)

2)         Each hospital shall prepare a Perinatal Report record (see Appendix I), to be provided by the Department, for patients meeting one of the following conditions:

A)        Live-birth; or

B)        Diagnosed prior to discharge from newborn hospitalization as a perinatal or neonatal death.

3)         Women who present with spontaneous abortion, ectopic pregnancy or hydatidiform mole are perinatal patients and shall be reported. The products of induced abortions shall not be reported to the State Perinatal Reporting System.

4)         Fetal death (gestation greater than 20 weeks) is considered a reportable perinatal outcome. These fetal deaths do not have to be reported through the State Perinatal Reporting System, because they are already reported and compiled in the Department's  Vital Records database.

5)         Every hospital shall provide representatives of the Department with access to information from all medical, pathological, and other records and logs related to reportable registry information. The mode of access and the time during which this access will be provided shall be by mutual agreement between the hospital and the Department.

6)         The State Perinatal Reporting System also will be complemented with information from the Department's Vital Records live birth database under the Vital Records Act, the Adverse Pregnancy Outcomes Reporting System under the Illinois Health and Hazardous Substances Registry Act  and other Maternal and Child Health Reports and submissions.

7)         The State Perinatal Reporting System consists of two forms of reporting. This reporting shall be on the forms provided by the Department or through electronic means that meets the exact specifications of the Department's data processing system. Complete perinatal reporting information shall be reported to the Department within 14 days after infant discharge, regardless of the method of reporting.

d)         Availability of Information

1)         The patient and hospital-identifying information submitted to the Department or certified local health department under the Act and this Part shall be privileged and confidential and shall not be available for disclosure, inspection or copying under the Freedom of Information Act or the State Records Act, except as described in this Section. These data shall also be considered confidential under Section 8-2101 of the Code of Civil Procedure.

2)         Aggregate summaries and reports of follow-up activities may be provided upon request to hospitals, to APCs, and to the certified local health department designated by the Department to provide follow-up services to the patients. These reports may contain information provided by the referring hospital and information provided by the follow-up certified local health department. Patient or hospital specific data provided to the appropriate designee under this Section are confidential and shall be handled in accordance with  the Illinois Health Statistics Act  and Section 9 of the Hospital Licensing Act. These data shall also be considered confidential under Section 8-2101 of the Code of Civil Procedure.

3)         All reports issued by the Department in which the data are aggregated so that no patient or reporting hospital may be identified shall be available to the public pursuant to Access to Public Records of the Department of Public Health and the Freedom of Information Act.

e)         Quality Assurance and Continuous Quality Improvement

1)         Reporting entities (i.e., hospitals, certified local health departments and managed care entities (MCEs) shall be subject to review by the Department to assess the timeliness, correctness and completeness of the reports submitted by the entity.

2)         Reporting entities (i.e., hospitals, certified local health departments and MCEs shall supply additional information to the Department at the Department's request when additional information is needed to confirm the accuracy of reports previously submitted, or to clarify information previously submitted. The Department will not request data that are more than two years old.

(Source:  Amended at 35 Ill. Reg. 2583, effective January 31, 2011)

Section 640.100  High-Risk Follow-up Program

The Illinois Department of Human Services manages the high-risk follow-up program in accordance with the Maternal and Child Health Services Code (77 Ill. Adm. Code 630).

(Source:  Amended at 35 Ill. Reg. 2583, effective January 31, 2011)

Section 640.APPENDIX A   Standardized Perinatal Site Visit Protocol

Standardized Perinatal Site Visit Protocol

Components of site visit tool − information to be completed by applicant hospital prior to site visit and reviewed and approved at time of site visit by site visit team.

HOSPITAL:                                                                CITY:                                            , Illinois

Level of Designation Applied for:      Level I ____  Level II _____  Level II with Extended Neonatal Capabilities ____  Level III ____  Administrative Perinatal Center

I.          HOSPITAL DATA

Please use data from most recent three calendar years

A.        MATERNAL DATA

*    Use final delivery modality

+    Augmentation – stimulation of contractions when spontaneous contractions have failed to progress dilation or descent

B.        NEONATAL DATA

*    Provide explanation of how average daily census in Special Care Nursery was calculated.

C.        LIVE BIRTH DATA

1.         Birth Weight Specific Data – indicate # born & died in each category (example 10/2)

(Use Electronic Birth Certificate data for live births) (add percent for LBW and VLBW in shaded areas)

2.         Incidence of Neonatal complications (Occurrences at hospital of birth)

*   If in expanded VON, use VON data for "all babies" categories

D.        FETAL DEATHS

Birth weight Specific Data − # per weight category

E.        MORTALITY DATA

*  Question #3, only for Level III institutions

F.         TRANSPORT DATA

3.   Provide maternal and neonatal transport information for the most current calendar year (for Perinatal Centers, provide transport information by hospital, by gestational age and by year for 3 years).

II.        OB HEMORRHAGE DOCUMENTATION

List OB Hemorrhage cases from the previous calendar year (patients sent to ICU or received 3 or greater units of blood products).

III.       RESOURCE REQUIREMENTS

Complete attached Resource Checklist for the appropriate level of care − current level and level being applied for if different.

IV.       ADMINISTRATIVE PERINATAL CENTERS

A.        Provide documentation of educational activities sponsored by the Administrative Perinatal Center for network hospitals and local health departments.

B.        Provide evidence of morbidity and mortality reviews with network hospitals.

C.        Provide written documentation of Regional Perinatal Network CQI Activities.

(Source:  Amended at 35 Ill. Reg. 2583, effective January 31, 2011)