La. Admin. Code tit. 48 § I-9521

Current through Register Vol. 50, No. 11, November 20, 2024

Section I-9521 - Neonatal Unit Functions [Formerly LAC 48:I.9513]

A. Level I Neonatal Unit (Well Newborn Nursery)

1. General Provisions

a. This unit shall have the capability for resuscitation and stabilization of all inborn neonates in accordance with Neonatal Resuscitation Program (NRP) guidelines. The unit shall stabilize unexpectedly small or sick neonates before transfer to the appropriate advanced level of care.

b. The unit shall stabilize and provide care for infants born at 35 weeks or greater gestation and who remain physiologically stable. The requirements for maternal transport at lesser gestations for transfer to a higher level of care shall be determined by the medical staff and approved by the hospital governing body.

c. This unit shall have the capability to stabilize newborns born at less than 35 weeks gestational age for transfer to higher level of care.

d. This unit shall maintain consultation and written transfer agreements with an approved level II or III as appropriate.

e. This unit shall have a defined, secured nursery area with limited public access and/or secured rooming-in facilities with supervision of access.

f. Parent and/or sibling visitation/interaction with the neonate shall be provided.

2. Personnel Requirements

a. The unit's chief of service shall be a physician who is board-certified or board-eligible in pediatric or family practice medicine.

b. The nurse manager shall be a registered nurse with specific training and experience in neonatal care. The RN manager shall participate in the development of written policies and procedures for the neonatal care areas, and coordinate staff education and budget preparation with the chief of service. The RN manager shall name qualified substitutes to fulfill duties during absences.

c. Registered nurse to patient ratios may vary in accordance with patient needs. If couplet care or rooming-in is used, a registered nurse who is responsible for the mother shall coordinate and administer neonatal care. If direct assignment of the nurse is also made to the nursery to cover the newborn's care, there shall be double assignment (one nurse for the mother-neonate couplet and one for just the neonate if returned to the nursery). A registered nurse shall be available 24 hours a day, but only one may be necessary as most neonates will not be physically present in the nursery. Direct care of neonates in the nursery may be provided by ancillary personnel under the registered nurse's direct supervision. Adequate staff is needed to respond to acute and emergency situations.

B. Neonatal Level II Unit (Special Care Nursery)

1. General Provisions

a. This unit shall provide care for infants born at more than 32 weeks gestation and weighing more than 1,500 grams.

i. infants who have medical problems that are expected to resolve rapidly and are not anticipated to need emergent subspecialty services from a higher level NICU as determined by the attending medical staff.

b. This unit shall have the capability to provide mechanical ventilation and/or CPAP for a brief duration (less than 24 hours) for infants born at more than 32 weeks and weighing more than 1,500 grams.

c. Neonates requiring greater than 24 hours of continuous ventilator support shall be transferred to a higher-level neonatal intensive care facility.

d. This unit shall have the ability to stabilize infants born before 32 weeks gestation and/or weighing less than 1,500 grams until transfer to a higher level neonatal intensive care facility.

e. Neonates requiring transfer to a higher-level neonatal intensive care facility may be returned to a level II unit for convalescence.

2. Personnel Requirements

a. A board-certified neonatologist shall be the chief of service.

NOTE: This unit shall have continuously available medical staff defined as available 24 hours per day/7 days per week/365 days per year on call for consultation as defined by medical staff bylaws.

b. Registered nurse to patient ratios may vary in accordance with patient needs.

c. This unit shall have at least one full-time social worker to be available as needed to assist with the socioeconomic and psychosocial problems of high-risk mothers, sick neonates, and their families.

d. This unit shall have at least one occupational or physical therapist to be available as needed to assist with the care of the newborn.

e. This unit shall have at least one registered dietitian/nutritionist to be available as needed who can plan diets as required to meet the special needs of mothers and high-risk neonates.

f. This unit shall have staff available 24 hours per day who have the demonstrated knowledge, skills, abilities and training to provide the care and services to infants in this unit, such as but not limited to:

i. nurses;

ii. respiratory therapists;

iii. radiology technicians; and

iv. laboratory technicians.

3. Equipment Requirements

a. This unit shall have hospital based equipment to provide care to infants available 24 hours per day, such as but not limited to:

i. portable x-ray machine;

ii. blood gas analyzer.

C. Level III NICU

1. General Provisions

a. There shall be a written neonatal transport agreement with an approved level III surgical unit or level IV unit.

b. This unit shall have either a neonatologist, a neonatal nurse practitioner, a physician assistant-certified, or a neonatology fellow in-house 24 hours per day.

c. The staffing of this unit shall be based on patient acuity and consistent with the recommended acceptable, nationally recognized standards of practice and/or guidelines of the American Academy of Pediatrics (AAP). For medical sub-specialty requirements, refer to Table 1, Neonatal Medical Subspecialties and Transport Requirements.

NOTE: All provisions of level III NICUs are required of level IIIS and IV NICUs.

2. Personnel Requirements

a. The chief of service of a level III NICU shall be a board-certified neonatologist.

EXCEPTION: In 1995, those physicians in existing units who were designated as the chief of service of the unit and who were not neonatal or perinatal board-certified, were granted a waiver by written application to the Office of the Secretary, Department of Health. This waiver shall be maintained as it applies only to the hospital where that chief of service's position is held. The physician cannot relocate to another hospital nor can the hospital replace the chief of service for whom the exception was granted and retain the exception.

b. This unit shall have at least one full-time social worker available as needed who has experience with the socioeconomic and psychosocial problems of high-risk mothers and fetuses, sick neonates, and their families. For units with greater than 30 patients, the social worker staffing ratios shall be at least one social worker to 30 patients (additional social workers may be required in accordance with hospital staffing guidelines.

c. This unit shall have at least one occupational or physical therapist available as needed with neonatal expertise and at least one individual skilled in evaluation and management of neonatal feeding and swallowing disorders (e.g., speech-language pathologist).

d. This unit shall have at least one registered dietitian/nutritionist available as needed who has training or experience in perinatal nutrition and can plan diets that meet the special needs of high-risk mothers and neonates.

e. Delivery of safe and effective perinatal nursing care requires this unit to have qualified registered nurses in adequate numbers to meet the nursing needs of each patient. To meet the nursing needs of this unit, hospitals shall develop and adhere to an acuity based classification system based on nationally recognized staffing guidelines and have documentation available on such guidelines.

f. This unit shall have the following support personnel immediately available as needed to be on-site in the hospital, including but not limited to:

i. licensed respiratory therapists or registered nurses with specialized training who can supervise the assisted ventilation of neonates with cardiopulmonary disease.

3. Equipment Requirements

a. This unit shall have the following support equipment, in sufficient number, immediately available as needed in the hospital that includes, but is not limited to:

i. advanced imaging with interpretation on an urgent basis (computed tomography, ultrasound (including cranial ultrasound), MRI, echocardiography and electroencephalography); and

ii. respiratory support that allows provision of continuous mechanical ventilation for infants less than 32 weeks gestation and weighing less than 1,500 grams.

4. Transport

a. It is optional for level III NICUs to provide transports. If the unit performs transports, the unit shall have a qualified transport team and provide for and coordinate neonatal transport with level I and level II units throughout the state.

b. Transport shall be in accordance with national standards as published by the American Academy of Pediatrics'section on neonatal and pediatric transport and in accordance with applicable Louisiana statutes.

5. Quality Improvement Collaborative

a. Facilities with level III NICUs and above shall participate in a quality improvement collaborative and a database selected by the Medicaid quality committee, neonatology sub-committee.

b. Proof of current participation by the facility will be available from the LDH website.

D. Level III Surgical NICU

1. General Provisions

a. This unit shall have a transport team and provide for and coordinate neonatal transport with level I, level II units and level III NICUs throughout the state as requested. Transport shall be in accordance with national standards as published by the American Academy of Pediatrics' section on neonatal and pediatric transport and in accordance with applicable Louisiana statutes.

NOTE: All provisions of level III NICUs are required of level IIIS and IV NICUs.

2. Personnel Requirements

a. For medical sub-specialty requirements refer to Table 1-Neonatal Medical Subspecialties and Transport Requirements.

EXCEPTION: Those hospitals which do not have a member of the medical staff who is a board certified/eligible pediatric anesthesiologist but whose anesthesiologist has been granted staff privileges to perform pediatric anesthesiology, such physician(s) may be grandfathered as satisfying the requirement of §9521.2.a when the hospital has documented evidence that the anesthesiologist was granted clinical staff privileges by the hospital prior to the effective date of this Rule. This exception applies only to such physician at the licensed hospital location and is not transferrable.

3. Equipment Requirements

a. This unit shall have the following support equipment, in sufficient number, immediately available as needed in the hospital that includes, but is not limited to:

i. a full range of respiratory support that incudes high frequency ventilation and inhaled nitric oxide.

E. Level IV NICU

1. General Provisions

a. This unit shall be located within an institution with the capability to provide surgical repair of complex conditions (e.g., congenital cardiac malformations that require cardiopulmonary bypass with or without extracorporeal membrane oxygenation).

2. Personnel Requirements

a. for medical sub-specialty requirements, refer to Table 1-Neonatal Medical Subspecialties and Transport Requirements;

NOTE: All provisions of level IIIS NICUs are required of level IV NICUs.

b. Neonatal Medical Subspecialties and Transport Requirements;

Table 1-Neonatal Medical Subspecialties and Transport Requirements
Text denoted with asterisks (*) indicates physician shall be available in person on-site as needed by the facility. Each higher level NICU unit shall meet the requirements of each lower level NICU unit.
Level I (Well Nursery)	Level II	Level III	Level IIIS	Level IV
Board Certified/Eligible Pediatric or Family Practice Physician	Board Certified/Eligible Pediatric or Family Practice Physician	Pediatric Cardiology1	Pediatric Surgery4	Pediatric Surgery4
	Board Certified Neonatologist	Ophthalmology2	Pediatric Anesthesiology5 §9513(2)a-See Exception	Pediatric Anesthesiology5
	Social Worker		Neonatal Transport	Neonatal Transport
	Occupational Therapist	Social Worker Ratio 1:30	Ophthalmology2*	Ophthalmology2*
	Physical Therapist	OT or PT/neonatal expertise	Pediatric Cardiology*	Pediatric Cardiology*
	Respiratory Therapists	RD/training in perinatal nutrition	Pediatric Gastroenterology*	Pediatric Cardiothoracic Surgery*
	Registered dietician/nutritionist	RT/training in neonate ventilation	Pediatric Infectious Disease*	Pediatric Endocrinology*
	Laboratory Technicians	Neonatal feeding/swallowing-SLP/ST	Pediatric Nephrology*	Pediatric Gastroenterology*
	Radiology Technicians		Pediatric Neurology3*	Pediatric Genetics*
			Pediatric Neurosurgery*	Pediatric HematologyOncology*
			Pediatric Orthopedic Surgery*	Pediatric Infectious Disease*
			Pediatric Otolaryngology6*	Pediatric Nephrology*
			Pediatric Pulmonology*	Pediatric Neurology3*
				Pediatric Neurosurgery
				Pediatric Orthopedic Surgery
				Pediatric Otolaryngology7*
				Pediatric Pulmonology*
				Pediatric Radiology*
				Pediatric Urologic Surgery*
			Transport note:
1There shall be at least one board certified or board eligible pediatric cardiologist as a member of medical staff. For Level III facilities, staff using telemedicine shall be continuously available.			Transport shall be in accordance with national standards as published by the American Academy of Pediatrics'Section on neonatal and pediatric transport and in accordance with applicable Louisiana statutes.
2There shall be at least one board certified or board eligible ophthalmologist with sufficient knowledge and experience in retinopathy or prematurity as a member of the medical staff. An organized program for monitoring retinotherapy of prematurity shall be readily available in Level III and for treatment and follow-up of these patients in Level IIIS and IV facilities.
3There shall be at least one board certified or board eligible pediatric neurologist as a member of medical staff.
4For pediatric surgery, the expectation is that there is a board certified or eligible pediatric surgeon who is continuously available to operate at that facility.
5There shall be at least one board certified or board eligible pediatric anesthesiologist as a member of the medical staff.
6Board eligible or certified in Otolaryngology; special interest in Pediatric Otolaryngology or completion of Pediatric Otolaryngology Fellowship.
7Board eligible or certified in Otolaryngology; completion of Pediatric Otolaryngology Fellowship.
For specialties listed above staff shall be board eligible or board certified in their respective fields with the exception of otolaryngology as this field has not yet pursued certification.

La. Admin. Code tit. 48, § I-9521

Promulgated by the Department of Health, Bureau of Health Services Financing, LR 482573 (10/1/2022), Amended by the Department of Health, Health Standards Section, LR 501493 (10/1/2024).

AUTHORITY NOTE: Promulgated in accordance with R.S.36:254 and R.S. 40:2100-2115.