N.J. Admin. Code § 8:33C-3.4

Current through Register Vol. 56, No. 23, December 2, 2024

Section 8:33C-3.4 - Designation-specific certificate of need documentation

(a) In addition to the requirements specified at N.J.A.C. 8:33C-3.2(a) and 3.3(b), certificate of need applicants seeking designation as Regional Perinatal Centers shall provide the following additional information:

1. Documentation that the following minimum volume requirements shall be met within two years of initiation of the service:

i. Annual acceptance of over 80 maternal-fetal referrals or transports; and

ii. Provision of full neonatal case management to over 40 very low birth weight infants annually;

2. Demonstration of the need for intensive care bassinets, in accordance with the methodology set forth at 8:33C-2.8(a) and in accordance with the regional perinatal and pediatric plan in effect at the time of the certificate of need application submission;

3. Documentation of the capability to provide, on a continuous basis, care for high risk mothers who have a broad spectrum of conditions, including preexisting maternal disorders, such as significant heart, renal or metabolic diseases, chronic infectious diseases, substance abuse, as well as major complications of pregnancy;

4. Documentation of the ability to care for high risk newborns of very low birth weight, in need of complex neonatal respiratory and metabolic support, or other infants in need of major medical or surgical intervention in accordance with N.J.A.C. 8:43G-19;

5. Documentation of the capability to provide the full range of antenatal testing, prenatal, postpartum and infant and pediatric health services to families in the region. The applicant shall document the existence of a distinct prenatal clinic service in accordance with the requirements as set forth in N.J.A.C. 8:43G-19;

6. Documentation of the existence of, or capability to initiate, a high risk prenatal clinic which is, or shall be staffed, at a minimum, by the following:

i. A perinatologist who shall be responsible for the direction of care provided to patients of the clinic and available to provide consultation to the attending physicians;

ii. An advanced practice nurse on site; and

iii. A risk reduction specialist;

7. Documentation that high risk infant follow-up services shall be provided. Guidelines, compliance with which is not mandatory, are available from the Department of Health, Regional Services Program, PO Box 364, Trenton, New Jersey 08625-0364, telephone (609) 2925616;

8. Documentation of 24 hour availability of a perinatologist to provide consultation to the attending physicians at Community Perinatal Centers. Consultation shall be provided through referral, co-management, transfer or transport;

9. Documentation of a regional transport system established in accordance with 8:33C-5.1(c) and with N.J.A.C. 8:43G-19, and the letters of agreement with the Community Perinatal Centers in the region; and

10. Documentation that a full range of risk reduction services shall be provided. Guidelines, compliance with which is not mandatory, are available from the Department of Health, Regional Services Program, PO Box 364, Trenton, New Jersey 08625-0364, telephone (609) 292-5616.

(b) In addition to the requirements specified at N.J.A.C. 8:33C-3.2(a) and 3.3(b), certificate of need applicants seeking designation as a Community Perinatal Center-Intensive shall provide the following additional information:

1. Demonstration of the need for intensive care bassinets, in accordance with the methodology set forth at 8:33C-2.8(a) and in accordance with the regional perinatal and pediatric plan in effect at the time of the certificate of need application submission;

2. A description of the process for assuring that maternal-fetal transports of patients with needs exceeding the facility's capabilities shall be made as soon as possible, to a facility designated and licensed to provide the appropriate level of care, in accordance with the approved regional transport system, the letters of agreement, and N.J.A.C. 8:43G-19;

3. A description of the process for assuring that any high risk infant delivered at the Community Perinatal Center-Intensive, in need of specialized services or services which exceed the facility's capabilities, shall be transported as soon as possible to a facility designated and licensed to provide the appropriate level of care as specified in the terms of the approved regional transport system, the letters of agreement, and N.J.A.C. 8:43G-19;

4. Documentation of a mechanism for providing or assuring access to high risk infant follow-up services. Guidelines, compliance with which is not mandatory, are available from the Department of Health, Regional Services Program, PO Box 364, Trenton, New Jersey 08625-0364, telephone (609) 292-5616.

(c) In addition to the requirements specified in 8:33C-3.2(a) and 3.3(b), certificate of need applicants seeking designation as a Community Perinatal Center-Intermediate shall provide the following additional information:

1. Demonstration of the need for intermediate care bassinets utilizing the methodology set forth at 8:33C-2.8(b) and in accordance with the most recent regional perinatal and pediatric plan in effect at the time of the certificate of need application submission;

2. A description of the process for assuring that maternal-fetal and/or neonatal transports for patients whose needs exceed the facility's capabilities shall be made, as soon as possible to a facility designated and licensed to provide the appropriate level of care in accordance with the approved regional transport system, the letters of agreement, and N.J.A.C. 8:43G-19;

3. A description of the process for assuring that any high risk infant anticipated to require ventilatory support longer than 48 hours (cumulative or otherwise), with needs exceeding the facility's capabilities shall be transported as soon as possible after delivery to a facility designated and licensed to provide the appropriate level of care in accordance with the approved regional transport system, the letters of agreement, and N.J.A.C. 8:43G-19;

(d) In addition to the criteria at 8:33C-3.2(b), certificate of need applicants seeking designation as a Community Perinatal Center-Basic shall provide all of the following additional information in their certificate of need applications:

1. Documentation that the applicant shall provide care to patients expected to deliver neonates of a weight greater than 2,499 grams and at least 36 weeks gestational age;

2. Documentation that the applicant shall provide supportive care for infants returned from Regional or Community Perinatal Center-Intensive facilities;

3. That the hospital and the MCHC will enter into a letter of agreement stating that the hospital shall be a member of the MCHC for no less than five years. A draft copy of the letter of agreement shall be submitted with the certificate of need application;

4. Letters of agreement valid for at least five years specific to coordination of services, transports and referrals shall be developed and adopted between a Community Perinatal Center-Basic and a designated and licensed Community Perinatal Center-Intensive or Regional Perinatal Center. These letters of agreement shall be facilitated by the MCHC and comply with the regional transport system, as described in this chapter and N.J.A.C. 8:43G-19; and

5. The number of maternal-fetal and neonatal referrals and transports the applicant has made to a facility designated and licensed for advanced capabilities for the preceding two years and a projection of the needs for the next four years.

(e) In addition to the criteria specified at 8:33C-3.2(c), certificate of need applicants seeking designation as a Community Perinatal Center-Birth Center shall provide all of the following additional information in their certificate of need applications:

1. Documentation that the applicant shall provide care to patients expected to deliver neonates of a weight greater than 2,499 grams and at least 37 weeks gestational age and who require a stay of less than 24 hours after birth;

2. That the hospital and the MCHC will enter into a letter of agreement stating that the hospital shall be a member of the MCHC for no less than five years. A draft copy of the letter of agreement shall be submitted with the certificate of need application; and

3. Letters of agreement valid for at least five years specific to coordination of services, transports and referrals shall be developed and adopted between Community Perinatal Center-Birth Center and at a minimum, a designated and licensed Community Perinatal Center-Intermediate, located within 20 minutes transport time for medical care of a woman or an infant when complications arise during the antepartum, intrapartum, postpartum or newborn period.

(f) Designated specialty acute care children's hospitals, as specified in 26:2H-18a, 18c, 18d and 18e, shall provide highly specialized regional neonatal care. Certificate of need applicants shall document in their certificate of need applications:

1. The ability to meet the criteria for the provision of neonatal services required of the Regional Perinatal Center including 24 hour a day, seven days a week, in-hospital coverage by a neonatologist, except that specialty acute care children's hospitals shall not be required to provide obstetric services; and

2. The capability of performing subspecialty surgical procedures, and acting in a leadership role in providing the most recent technology in neonatal medicine and to the medical community throughout the State.

N.J. Admin. Code § 8:33C-3.4

Amended by 53 N.J.R. 2198(a), effective 12/20/2021