Delaware · Through 2026-10-01 (85 Del. Laws, c. 550)

16 Del. C. § 1016: Standards for levels of neonatal care.

(a) For the purposes of this section:
(1) “American Academy of Pediatrics” or “AAP” means the largest professional association of pediatricians in the United States.
(2) “American Academy of Pediatrics Standards for Levels of Neonatal Care” or “AAP Standards for Levels of Neonatal Care” means risk-appropriate care standards established by the American Academy for Pediatrics for newborns that ensure facilities provide the necessary personnel and resources based on the infant’s condition.
(3) “American College of Surgeons” means the scientific and educational association of surgeons whose primary goal is to improve the quality of care for surgical patients.
(4) “Children’s surgical verification” or “CSV” means the program by the American College of Surgeons that aims to improve surgical care for infants and children.
(5) “Health-care facility” or “facility” means a “health-care facility” as defined in § 1740 of Title 24.
(6) “Level IV neonatal intensive care services” or “Level IV NICU services” means surgical and nonsurgical subspecialty care provided to critically ill or medically complex neonates, who require continuous complex care beyond the scope and resources of lower level nurseries and NICUs.
(7) “Neonatal intensive care unit” or “NICU” means a specialized hospital unit dedicated to providing critical care to newborns, particularly premature infants or those with severe medical conditions.
(8) “Neonatal nursery” means a unit dedicated to specialized care for newborns.
(b) A licensed facility under this title operating a NICU or neonatal nursery must demonstrate compliance with the American Academy of Pediatrics’ standards for levels of neonatal care and subsequent revisions, including staffing, equipment, facility capabilities, and patient care protocols.
(c) Neonatal nurseries’ and NICUs’ levels of care must be designated by the Secretary of Health and Social Services or the Secretary’s designee in accordance with subsection (b) or subsections (d), and (e) of this section.
(d) A facility providing Level IV NICU services must meet the following criteria:
(1) Have a CSV from the American College of Surgeons.
(2) Be directed by a Delaware licensed, full-time, board certified or board eligible neonatologist.
(3) Have a Delaware licensed, board certified or board eligible neonatologist on-site at all times.
(e) A Level IV NICU must do all of the following:
(1) Have a Delaware licensed, board certified or board eligible pediatric anesthesiologist on-site at all times.
(2) Have the following pediatric medical subspecialties available on-site:
a. Anesthesiology.
b. Orthopedics.
c. Otolaryngology.
d. Palliative care.
e. Urology.
(3) Have the following pediatric surgical subspecialties available at all times:
a. Cardiothoracic.
b. Orthopedic.
c. General surgery.
d. Neurosurgery.
(4) Provide pediatric serices on-site, including the following:
a. Echocardiogram.
b. Electroencephalogram.
c. Extracorporeal membrane oxygenation.
d. Radiology.
(f) A facility designated under this section must submit an annual attestation of compliance with this section and any updates adopted by the Department.
(g) A facility designated under this section must provide written notice to the Secretary within 30 days of determining that it is unable to meet a provision of subsections (b) or subsections (d) through (f) of this section and must be given the opportunity to demonstrate just cause for noncompliance or evidence that the facility is actively implementing a corrective action plan.
(h) A facility may request a voluntary downgrade in designation status.
(i) A facility has the right to appeal any decision of the Department regarding the initial or subsequent designation or change in the designation status. The appeal process must be consistent with the Administrative Procedures Act, Chapter 101 of Title 29.
(j) The Department shall adopt rules to implement this section by June 30, 2027, including procedures for verification of compliance with this section, and must seek input and review from the Delaware Perinatal Quality Collaborative and existing facilities operating neonatal intensive care units.

Where this section sits in the code

Title 16. Health and Safety
Part II. Regulatory Provisions Concerning Public Health
Chapter 10. Hospitals
Subchapter I. General Provisions

(a) For the purposes of this section:

(1) “American Academy of Pediatrics” or “AAP” means the largest professional association of pediatricians in the United States.

(2) “American Academy of Pediatrics Standards for Levels of Neonatal Care” or “AAP Standards for Levels of Neonatal Care” means risk-appropriate care standards established by the American Academy for Pediatrics for newborns that ensure facilities provide the necessary personnel and resources based on the infant’s condition.

(3) “American College of Surgeons” means the scientific and educational association of surgeons whose primary goal is to improve the quality of care for surgical patients.

(4) “Children’s surgical verification” or “CSV” means the program by the American College of Surgeons that aims to improve surgical care for infants and children.

(5) “Health-care facility” or “facility” means a “health-care facility” as defined in § 1740 of Title 24.

(6) “Level IV neonatal intensive care services” or “Level IV NICU services” means surgical and nonsurgical subspecialty care provided to critically ill or medically complex neonates, who require continuous complex care beyond the scope and resources of lower level nurseries and NICUs.

(7) “Neonatal intensive care unit” or “NICU” means a specialized hospital unit dedicated to providing critical care to newborns, particularly premature infants or those with severe medical conditions.

(8) “Neonatal nursery” means a unit dedicated to specialized care for newborns.

(b) A licensed facility under this title operating a NICU or neonatal nursery must demonstrate compliance with the American Academy of Pediatrics’ standards for levels of neonatal care and subsequent revisions, including staffing, equipment, facility capabilities, and patient care protocols.

(c) Neonatal nurseries’ and NICUs’ levels of care must be designated by the Secretary of Health and Social Services or the Secretary’s designee in accordance with subsection (b) or subsections (d), and (e) of this section.

(d) A facility providing Level IV NICU services must meet the following criteria:

(1) Have a CSV from the American College of Surgeons.

(2) Be directed by a Delaware licensed, full-time, board certified or board eligible neonatologist.

(3) Have a Delaware licensed, board certified or board eligible neonatologist on-site at all times.

(e) A Level IV NICU must do all of the following:

(1) Have a Delaware licensed, board certified or board eligible pediatric anesthesiologist on-site at all times.

(2) Have the following pediatric medical subspecialties available on-site:

a. Anesthesiology.

b. Orthopedics.

c. Otolaryngology.

d. Palliative care.

e. Urology.

(3) Have the following pediatric surgical subspecialties available at all times:

a. Cardiothoracic.

b. Orthopedic.

c. General surgery.

d. Neurosurgery.

(4) Provide pediatric serices on-site, including the following:

a. Echocardiogram.

b. Electroencephalogram.

c. Extracorporeal membrane oxygenation.

d. Radiology.

(f) A facility designated under this section must submit an annual attestation of compliance with this section and any updates adopted by the Department.

(g) A facility designated under this section must provide written notice to the Secretary within 30 days of determining that it is unable to meet a provision of subsections (b) or subsections (d) through (f) of this section and must be given the opportunity to demonstrate just cause for noncompliance or evidence that the facility is actively implementing a corrective action plan.

(h) A facility may request a voluntary downgrade in designation status.

(i) A facility has the right to appeal any decision of the Department regarding the initial or subsequent designation or change in the designation status. The appeal process must be consistent with the Administrative Procedures Act, Chapter 101 of Title 29.

(j) The Department shall adopt rules to implement this section by June 30, 2027, including procedures for verification of compliance with this section, and must seek input and review from the Delaware Perinatal Quality Collaborative and existing facilities operating neonatal intensive care units.

Collected 2026-10-21T05:49:39Z. Source file · JSON

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