Authority: IC 16-21-13-5

Affected: IC 16-21-13

Sec. 4. (a) A Neonatal Level IV facility is a Neonatal Level III facility plus the ability to provide comprehensive subspecialty neonatal care services, including acute neonatal intensive care for infants of all birth weights and gestational ages, and neonatologists who assist in the management of fetuses who are extremely premature or have complex problems that render significant risk of preterm delivery and postnatal complications. In addition to the requirements of a Neonatal Level III facility, a Neonatal Level IV facility shall meet the requirements set forth in this section.

(b) A Neonatal Level IV facility shall demonstrate as follows its capability of providing neonatal care through written standards, protocols, guidelines, and training, including (Neonatal Level III plus the following):

1. (1) Each Neonatal Level IV facility shall have the following facility capabilities:

   1. (A) Located within an institution with the capability to provide surgical repair of complex congenital or acquired conditions.
   2. (B) Facilitate transport and provide outreach education.
   3. (C) Managing all neonatal patients including those requiring advanced modes of neonatal ventilation and life support.
   4. (D) Pediatric medical subspecialty services.
   5. (E) Pediatric subspecialty surgical services such as pediatric cardio-thoracic open-heart surgery and pediatric neurosurgery within the institution.
   6. (F) A neurodevelopmental follow-up clinic or practice.

2. (2) Each Neonatal Level IV facility shall have all equipment required to provide advanced modes of neonatal ventilation and life support, including, but not limited to, the following:

   1. (A) High frequency ventilation.
   2. (B) Inhaled nitric oxide.
   3. (C) Extracorporeal membrane oxygenation (ECMO).
3. (3) The medication requirements for Neonatal Level IV are the same as Neonatal Level III.
4. (4) The policies and procedures requirements for Neonatal Level IV are the same as Neonatal Level III.

(c) Each Neonatal Level IV facility shall ensure the following staffing requirements are met, including (Neonatal Level III plus the following):

1. (1) Physician services, as follows:

   1. (A) Maintain a full range of pediatric medical subspecialists, including pediatric cardio-thoracic open-heart surgery and pediatric neurosurgery, and pediatric anesthesiologists at the site.
   2. (B) Pediatric medical and pediatric surgical specialty consultants readily available at all times.

2. (2) Nursing services, as follows:

   1. (A) Adequate numbers of registered nurses (RNs) who have experience in the care of newborns with complex medical illnesses, including competence in Neonatal Level IV care criteria, readily available at all times.
   2. (B) An advanced practice RN shall be available to the staff for consultation, education, and support on nursing care issues.
3. (3) A pediatric cardiac catheterization laboratory and appropriate staff.

(Indiana Department of Health; 410 IAC 39-5-4; filed Aug 14, 2019, 3:32 p.m.: 20190911-IR-410180416FRA; readopted filed Nov 14, 2025, 11:18 a.m.: 20251210-IR-410240588RFA)