Section 443. Newborn service requirements; designation of newborn service levels, service levels

A. If a hospital intends to provide newborn services, it shall make application to the department requesting approval for a level of newborn service as specified in subsection B of this section. Application shall be made at least 60 days prior to the desired date of approval. Approval is required to be renewed annually. Newborn service level approval shall be based upon the hospital's certification and the department's verification that the hospital meets the requirements of this section for the level requested.

1. No approval for a general level newborn service designation will be granted without a Certificate of Public Need (COPN) or without documentation by the applicant that it provided general level newborn services prior to July 1, 1992, or that the provision of general level newborn services was found to be exempt from Certificate of Public Need review pursuant to § 32.1-102.11 of the Code of Virginia.

2. No approval for a newborn service level designation higher than general level will be granted without a Certificate of Public Need or without documentation by the applicant that it provided a newborn service level higher than general level prior to July 1, 1992, or that the provision of a newborn service level higher than general level was found to be exempt from Certificate of Public Need review pursuant to § 32.1-102.11 of the Code of Virginia.

B. A hospital's newborn service shall be designated as a general level, intermediate level, specialty level, or subspecialty level newborn service. The newborn service levels are designated as follows:

1. A general level newborn service shall provide care to newborns of low risk as specified within the service's medical protocol. A general level newborn nursery shall have the capability to care for newborns who weigh at least 2000 grams at birth or who have completed 34 weeks gestation. Risk assessment shall be provided to identify all high-risk neonates and ensure appropriate consultation. A general level newborn nursery shall have the equipment and staff capabilities to immediately stabilize a sick newborn prior to transporting the newborn to an appropriate higher level nursery. The equipment and staff to receive convalescing neonates from higher level nurseries shall also be provided.

2. An intermediate level newborn service shall provide care as specified within the service's medical protocol to moderately ill neonates or stable-growing low birthweight neonates who require only a weight increase to be ready for discharge. In addition to the capabilities required of the general level newborn nursery, the intermediate level nursery shall have the equipment and staff capabilities to provide controlled temperature environments for each neonate, the insertion and maintenance of umbilical arterial lines, hood oxygen to 40%, continuous monitoring of blood oxygen, and assisted ventilation of a neonate in preparation for transport utilizing a mechanical ventilator or an ambu bag.

3. A specialty level newborn service shall provide intensive care to high-risk neonates with neonatal illnesses as specified in the service's medical protocol. In addition to the capabilities required of the lower level nurseries, the specialty level nursery shall have the equipment and staff capabilities to provide the following: maintenance of central arterial umbilical catheters or peripheral arterial lines with constant pressure monitoring, insertion and maintenance of chest tubes for drainage, administration of total parenteral nutrition (TPN), the maintenance of pressor medications, the administration of surfactant and respiratory support to include the maintenance of hood oxygen, continuous positive airway pressure (CPAP), and neonatal mechanical ventilation beyond the immediate stabilization period.

4. A subspecialty level newborn service shall provide intensive care for high-risk, critically ill neonates with complex neonatal illnesses. The subspecialty level newborn service shall provide, in-house, a full range of pediatric medical and surgical subspecialists to care for critically ill neonates. The pediatric subspecialists required as members of the hospital's staff are those subspecialists required of a Subspecialty Perinatal Center as referenced within the 1993 edition of Toward Improving the Outcome of Pregnancy, March of Dimes Birth Defects Foundation, Appendix 6, Pages 114 and 115. Rarely, the availability of highly technical expertise and specialized physicians at another subspecialty center will indicate consultation and possibly transfer. The subspecialty level nursery shall have the capability to care for neonates born in its facility as well as those referred from lower level nurseries. The subspecialty level nursery shall have all of the technical capabilities required of the lower level nurseries as well as the equipment and staff capabilities to maintain a neonate on prostaglandin E1 (PgE1) and the ability to perform echocardiography evaluations.

C. The hospital shall establish a written medical protocol, approved by the governing body, that specifies all neonatal conditions routinely managed by the newborn service as well as protocols for those medical conditions which require consultation and may necessitate transfer to a higher level of newborn service.

D. Physician consultation shall occur between physicians at the birth hospital and at the referral hospital to which the newborn may be referred.

E. The physician at the birth hospital shall document in the newborn's medical record any physician's consultation and any agreement to manage the newborn at the birth hospital or to stabilize and then transfer the newborn according to the hospital's collaboration agreement. In the event of disagreement, the attending physician at the birth hospital shall be responsible for the management and care of the newborn and shall document the consultation and results of consultation in the newborn's medical record.

Historical Notes

Former 12VAC5-41-440 D 1 and 2 derived from VR 355-33-500 § 2.28, eff. July 28, 1993; amended, Volume 11, Issue 08, eff. April 1, 1995; Volume 11, Issue 16, eff. June 1, 1995; Volume 11, Issue 21, eff. August 10, 1995; amended and adopted as 12VAC5-410-443, Virginia Register Volume 21, Issue 06, eff. February 14, 2005.

Statutory Authority

§ 32.1-127 of the Code of Virginia.