| (a) The Office of Emergency Medical Services (EMS)/Trauma
Systems Coordination (office) shall recommend to the Executive Commissioner
of the Health and Human Services Commission (executive commissioner)
the designation of an applicant/healthcare facility as a neonatal
facility at the level for each location of a facility, which the office
deems appropriate.
(b) A healthcare facility is defined under this subchapter
as a single location where inpatients receive hospital services or
each location if there are multiple buildings where inpatients receive
hospital services and are covered under a single hospital license.
(c) Each location shall be considered separately for
designation and the office will determine the designation level for
that location, based on, but not limited to, the location's own resources
and level of care capabilities; Perinatal Care Region (PCR) capabilities;
compliance with Chapter 133 of this title, concerning Hospital Licensing.
A stand-alone children's facility that does not provide obstetrical
services is exempt from obstetrical requirements. The final determination
of the level of designation may not be the level requested by the
facility.
(1) Level I (Well Nursery). The Level I neonatal designated
facility will:
(A) provide care for mothers and their infants generally
of ≥35 weeks gestational age who have routine, transient perinatal
problems;
(B) have skilled personnel with documented training,
competencies and continuing education specific for the patient population
served; and
(C) if an infant <35 weeks gestational age is retained,
the facility shall provide the same level of care that the neonate
would receive at a higher level designated neonatal facility and shall,
through the QAPI Program, complete an in depth critical review of
the care provided.
(2) The Level II (Special Care Nursery). The Level
II neonatal designated facility will:
(A) provide care for mothers and their infants of generally ≥32
weeks gestational age and birth weight ≥1500 grams who have physiologic
immaturity or who have problems that are expected to resolve rapidly
and are not anticipated to require subspecialty services on an urgent
basis; and
(B) either provide care, including assisted endotracheal
ventilation for less than 24 hours or nasal continuous positive airway
pressure (NCPAP) until the infant's condition improves, or arrange
for appropriate transfer to a higher level designated facility; and
(C) provide skilled personnel that have documented
training, competencies and annual continuing education specific for
the patient population served.
(3) Level III (Neonatal Intensive Care Unit (ICU)).
The Level III neonatal designated facility will:
(A) provide care for mothers and comprehensive care
of their infants of all gestational ages with mild to critical illnesses
or requiring sustained life support;
(B) provide for consultation to a full range of pediatric
medical subspecialists and pediatric surgical specialists, and the
capability to perform major pediatric surgery on-site or at another
appropriate designated facility;
(C) have skilled medical staff and personnel with documented
training, competencies and continuing education specific for the patient
population served;
(D) facilitate transports; and
(E) provide outreach education to lower level designated
facilities.
(4) Level IV (Advanced Neonatal ICU). The Level IV
neonatal designated facility will:
(A) provide care for mothers and comprehensive care
of their infants of all gestational ages with the most complex and
critically ill neonates/infants and/or requiring sustained life support;
(B) have a comprehensive range of pediatric medical
subspecialists and pediatric surgical subspecialists available to
arrive on-site for face to face consultation and care, and the capability
to perform major pediatric surgery including the surgical repair of
complex conditions;
(C) have skilled personnel with documented training,
competencies and continuing education specific for the patient population
served;
(D) facilitate transports; and
(E) provide outreach education to lower level designated
facilities.
(d) Facilities seeking neonatal facility designation
shall be surveyed through an organization approved by the office to
verify that the facility is meeting office-approved relevant neonatal
facility requirements. The facility shall bear the cost of the survey.
(e) PCRs.
(1) The PCRs are established for descriptive and regional
planning purposes and not for the purpose of restricting patient referral.
(2) The PCR will consider and facilitate transfer agreements
through regional coordination.
(3) A written plan identifies all resources available
in the PCRs for perinatal care including resources for emergency and
disaster preparedness.
(4) The PCRs are geographically divided by counties
and are integrated into the existing 22 TSAs and the applicable Regional
Advisory Council (RAC) of the TSA provided in §157.122 and §157.123
of this title; will be administratively supported by the RAC; and
will have fair and equitable representation on the board of the applicable
RAC.
(5) Multiple PCRs can meet together for the purposes
of mutual collaboration.
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