Current through Register Vol. 48, No. 12, March 22, 2024
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.