On appeal from the Department of Health and Senior Services.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Before Judges Graves, Espinosa, and Guadagno.
This appeal challenges the validity of regulations promulgated by the New Jersey Department of Health and Senior Services (DHSS or Department) requiring the physical presence of a collaborating anesthesiologist (CA) during induction, emergence and critical change in status when an Advanced Practice Nurse/Anesthesia (APN/A) administers general or major regional anesthesia, conscious sedation or minor regional blocks in a hospital. Appellant New Jersey Association of Nurse Anesthetists (NJANA) challenges the physical presence requirement, claiming DHSS exceeded its statutory authority; violated the Administrative Procedure Act (APA), N.J.S.A. 52:14B-1 to -15; and violated express and implied legislative intent. Because we conclude that DHSS was authorized to promulgate the challenged rule and appellant has failed to overcome the presumption of validity of the regulation, we affirm.
The Advance Practice Nurse (APN) was first recognized in this State in 1992 when the Legislature enacted the Advanced Practice Nurse Certification Act (APN Act), subsequently codified at N.J.S.A. 45:11-45 to -52. The APN Act permitted a wider range of functions for APNs than those previously performed by registered nurses. Some of these functions were done independently and others pursuant to joint protocols established with a collaborating physician. N.J.S.A. 45:11-49.
Amendments in 2004 further expanded the scope of practice for APNs, authorizing them to "manage preventive care services, and diagnose and manage deviations from wellness and long-term illnesses, consistent with the needs of the patient and within the scope of practice of the advanced practice nurse." Ibid.
A certified registered nurse anesthetist (CRNA) is a registered nurse who is certified to administer anesthesia under certain circumstances. In 2008, the New Jersey Board of Nursing (BON) promulgated rules codified at N.J.A.C. 13:37-7.1 to 7.2, that required CRNAs who wished to continue to administer anesthesia to meet requirements to be certified as an APN.
Those CRNAs who became certified as APNs became known as APN/As and the CRNA designation was no longer recognized.
At the time, respondent's licensure regulations for hospitals and ambulatory care facilities permitted CRNAs to administer and monitor general or major regional anesthesia under the supervision of an anesthesiologist and to administer minor regional blocks or anesthetic agents for conscious sedation under the supervision of an immediately available physician pursuant to medical staff bylaws. Adopted Amendments: N.J.A.C. 8:43G-6, 34 & 35, 35 N.J.R. 865, 870-71 (Feb. 3, 2003).
On November 13, 2009, appellant filed a petition for rulemaking with
DHSS, seeking to amend the hospital and ambulatory care facility
licensure regulations to allow APN/As "to provide anesthesia services
without anesthesiologist supervision." DHSS scheduled the matter for a
hearing before the Health Care Administration Board (HCAB).*fn2
Respondent proposed to delete the "requirement that a
certified registered nurse anesthetist administer and monitor general
or major regional anesthesia only under the supervision of a
privileged physician" and replace it with a provision that would include APN/As
"within the list of professionals authorized to administer general,
major regional anesthesia, conscious sedation or minor regional
blocks, provided that this is done in accordance with a joint protocol
established in accordance with N.J.A.C. 13:37-6.3." Memorandum of
Agenda from John A. Calabria to Health Care Admin. Bd. Members, p.4
(undated) (on file w/ DHSS).
Following a hearing, HCAB published a notice of proposed regulation to amend N.J.A.C. 8:43G-6.3 as follows:
The Department proposes to add new N.J.A.C. 8:43G-6.3(e)3 to include APNs/anesthesia within the list of professionals authorized to administer general or major regional anesthesia, provided that this is done in accordance with a joint protocol established in accordance with N.J.A.C. 13:37-6.3, Standards for joint protocols between advanced practice nurses and collaborating anesthesiologists. This protocol would need to include sections governing the availability of an anesthesiologist to consult with the APN/anesthesia on site, on-call or by electronic means. [Proposed Readoption with Amendments: N.J.A.C. 8:43G, 42 N.J.R. 1774, 1776 (Aug. 16, 2010).]
Over four hundred comments were received regarding the required level of supervision for APN/As, prompting respondent to extend the public comment period to November 15, ...