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Office Anesthesia Update

By now, everyone should have received a mailing with a fact sheet regarding the Supreme Court hearing and information about the APN proposed regulations.  Below is the information you should have received in the mail.  If you have not been receiving mailings, please be sure to contact one of the board members.  If you are not an AANA member, we do not have your mailing information.

Many people have asked questions regarding 'privileges' for the administration or supervision of conscious sedation.  To briefly summarize:  

A physician who is administering or supervising the administration of conscious sedation must obtain either hospital privileges or alternative privileges from the Board of Medical Examiners ("BME").   If a physician is applying for conscious sedation privileges from the BME, then he must complete then BME's application and indicate which anesthetic agents he wants to be privileged to administer.

August 15, 2005

RE: Supreme Court Upholds New Jersey State Board of Medical Examiners ("BME")

Anesthesia Supervision Regulations and Board of Nursing Proposes Regulations Recognizing CRNAs as Advanced Practice Nurses

Dear CRNAs:

On June 29, 2005 the New Jersey Supreme Court issued its decision upholding the Board of Medical Examiners ("BME") anesthesiologist supervision regulations. We were extremely disappointed with the Court's ruling. For the past seven years, the New Jersey Association of Nurse Anesthetists ("NJANA") has worked to invalidate the BME's in office anesthesia regulations, which mandate that a certified registered nurse anesthetist ("CRNA") must be supervised by an anesthesiologist or a physician with anesthesia privileges. The BME's regulations eliminate the last New Jersey anesthesia practice setting where a CRNA could work in collaboration with any physician. The attached Fact Sheet describes the Court's decision and outlines the BME's alternative privileging regulation.

We know that the Supreme Court's decision is a blow to all CRNAs and we are asking you to contact us with your comments or questions. The support of the State's CRNAs kept this challenge alive for many years and as a result of the Court ordered Stays, the BME's anesthesiologist supervision requirements were never implemented. At this point, the BME's regulations will be implemented and we would appreciate hearing from you if you have been (or may be) adversely affected by the supervision requirements.

The NJANA Board of Directors requested that our counsel, Alma L. Saravia, Esq. compare the alternative privileges regulation with the BME's application for alternative privileges in conscious sedation. We were surprised to learn that the application for conscious sedation does not include Propofol as one of the listed anesthetic agents, particularly since Propofol was included in previous versions of the application. If Propofol can not be used when conscious sedation is administered, then even fewer procedures will be performed with conscious sedation and more with "general anesthesia." The impact will be even fewer office positions for CRNAs.

Ms. Saravia prepared a letter to the Board of Directors analyzing whether the list of anesthetic agents should have been adopted as a regulation, rather than simply added to and later deleted from the application form. We have enclosed a copy of the letter for your review and you may give it to any physician you know who is seeking alternative privileges in conscious sedation. As you will see, Ms. Saravia makes a very convincing argument that the list of drugs should have been published as a regulation. The NJANA Board of Directors has decided that it more appropriate for physicians to be the ones asserting why the deletion of Propofol was unlawful or otherwise improper.

In addition, we have included a new Fact Sheet updating you on the Board of Nursing's ("BN") decision to recognize all CRNAs as advanced practice nurses ("APNs"). The Board of Directors is still reviewing the draft of the proposed regulations and we will keep you posted on any developments. NJANA is requesting that the BN consider our latest comments. We do not anticipate action on the proposed regulations before the end of the year.

Finally, please be assured that the Board of Directors continues to support the right of all CRNAs to work with any physician. The BN's nurse anesthetist practice regulation allows CRNAs to work at a location which has established written policies and procedures including "under what conditions and/or supervision." Thus, the BN does not mandate physician supervision. We are exploring possible options to reinstate a CRNA's right to work with any physician.

MEMBERSHIP SURVEY

If you have administered anesthesia in a physician's office during the past year, please contact one of us with the type of anesthesia you provided and whether you anticipate any changes in your employment because of the anesthesiologist supervision requirements. This membership survey will provide us with valuable information.

Antonio Luciano
732-513-2233
ias2001@hotmail.com

Angela Richman, Executive Director
856-881-4054
angelarichman@comcast.net

PHYSICIANS OR PODIATRISTS MUST OBTAIN PRIVILEGES FROM A HOSPITAL OR THE BME TO "SUPERVISE" CRNAs PERFORMING IN OFFICE ANESTHESIA FOLLOWING SUPREME COURT DECISION UPHOLDING REGULATIONS

The New Jersey Association of Nurse Anesthetists ("NJANA") represents New Jersey 's more than 400 Certified Registered Nurse Anesthetists ("CRNA"). In 1998, the BME adopted regulations governing the surgery, special procedures and anesthesia services performed in an office setting by a practitioner. The BME defines a practitioner as either a physician or a podiatrist, although the term physician is used throughout this fact sheet.

During the past seven years, NJANA has worked tirelessly to prevent the supervision requirements from being implemented. During this time, the supervision regulations have never gone into effect as a result of a series of Court ordered Stays and the BME's decision to not implement the requirements until the adoption of the alternative privileging regulation, which occurred in 2002.

BACKGROUND OF THE RESTRICTIVE SUPERVISION REQUIREMENT

NJANA supported the majority of the regulations' provisions. However, NJANA strongly opposed the adoption of the requirement that a CRNA may not perform anesthesia in an office setting except under the "supervision" of an anesthesiologist or a physician with anesthesia privileges. The supervision requirement may result in CRNAs losing their employment since the BME mandates that there must be two physicians present when general or regional anesthesia is provided. In a one room operating suite it is not cost effective to have two anesthesia providers.

These regulations are similar to the Department of Health and Senior Services' ("DHSS") hospital and ambulatory care facility licensure standards regulations, which require that a CRNA must be supervised by an anesthesiologist or by a physician privileged in anesthesia.

Therefore, NJANA filed a challenge to the regulations, which ultimately resulted in the New Jersey Supreme Court hearing the appeal. Prior to that petition, the Appellate Division issued an opinion upholding the supervision requirements on November 1, 2004 . The Court held that the BME had the authority to adopt the regulations.

SUPREME COURT DECISION

NJANA appealed to the New Jersey Supreme Court and filed extensive briefs arguing that the requirement was "arbitrary and capricious" because it was not supported by substantial credible evidence and that it conflicted with the authority of the Board of Nursing ("BN") to regulate CRNAs. The Supreme Court continued to Stay the implementation of the regulations while it reviewed the BME's briefs as well as the numerous friend of the court briefs submitted by State and national nursing organizations and unions representing nurses.

On May 3, 2005 the Supreme Court conducted oral argument. NJANA argued that the anesthesiologist "supervision" requirement will not protect patients, as there is no empirical evidence that there is a difference in patient outcomes between anesthesia provided by CRNAs and anesthesia provided by anesthesiologists. Over-regulating CRNAs in a manner that is wholly inconsistent with the practice in the rest of the country will not lead to improved patient health and limits a physician's ability to employ the staff he or she deems appropriate. In addition, NJANA argued that CRNAs are regulated by the BN not the BME.

However, on June 29, 2005 , the Supreme Court issued an opinion upholding the Appellate Division decision. The Supreme Court stated that its decision was based upon its narrow role and that it was not commenting on the "wisdom of the agency's decision, but only its legality." In other words, the Supreme Court did not endorse the regulations. It stated that the regulations will have "a significant effect on the autonomy and economic life of CRNAs."

The Supreme Court held that the BME had enough evidence when it adopted the regulations. It did not address NJANA's argument about the jurisdiction of the BN. The Supreme Court acknowledged that it is debatable whether the goals underlying the BME regulations outweigh the consequences. The ruling is legally binding only in New Jersey . It is not a national precedent.

NJANA argued that the administration of anesthesia is both the practice of medicine and the practice of nursing. When a CRNA provides anesthesia, it is the practice of nursing and it is regulated by the BN, not the BME. The Supreme Court ignored both this fundamental fact and the BN's regulation governing CRNAs. Those regulations do not require anesthesiologist or physician supervision of CRNAs. The Supreme Court instead focused on the BME's role in regulating the practice of medicine and physicians who offer anesthesia in an office setting. The BME regulations, however, directly conflict with the BN regulations.

In fact, the national trend is to remove physician supervision requirements. Evidence of this trend is the growing number of states (now 14) that have opted out of physician supervision requirements in Medicare and Medicaid reimbursement rules for hospital and ambulatory surgical centers. These states are Iowa , Nebraska , Idaho , Minnesota , New Hampshire , New Mexico , Kansas , North Dakota , Washington , Alaska , Oregon , Montana , South Dakota , and Wisconsin .

Moreover, the majority of states do not require CRNAs to be physician supervised in state laws and regulations. Thirty-nine states do not have a physician "supervision" requirement for CRNAs in nursing or medical laws or regulations. In addition, a majority of states do not require physician supervision in hospital, ambulatory surgical center, or office laws and regulations.

STAY LIFTED AND SUPERVISION REQUIREMENTS TO BE IMPLEMENTED

Prior to the Supreme Court's opinion, a Stay was issued in early 2005. Effective with the publication of the decision, the Stay was lifted, thereby allowing the BME to implement the regulations. As of August 15, 2005 , t he BME's web site contains a statement that the implementation schedule will be forthcoming. The applications for alternative privileges and other information may be obtained at bme@dca.lps.state.nj.us or by telephone at 609-826-7100.

The BME has contracted with MRAC, Inc. to review the alternative privileging applications. Physicians have begun receiving letters from Laurence Downs, J.D., the President of MRAC, Inc., informing them that "effective September 1, 2005, to be in compliance with the Board's regulation, physicians seeking to provide these surgical services or provide (or supervise the provision of) anesthesia services within an office setting must have current hospital privileges to provide those same services or must be 'engaged in the alternative privileging application process.'"

SUMMARY OF THE MAJOR PROVISIONS

The BME defines anesthesia services as including conscious sedation, regional or general anesthesia as follows:

"Conscious sedation" means the administration of a drug or drugs in order to induce that state of consciousness in a patient which allows the patient to tolerate unpleasant medical procedures without losing defensive reflexes, adequate cardio-respiratory function and the ability to respond purposefully to verbal command or to tactile stimulation if verbal response is not possible as, for example, in the case of a small child or deaf person. For the purposes of this subchapter, conscious sedation does not include an oral dose of pain medication or minimal pre-procedure oral dose of benzodiazepine designed to calm the patient. With the context of this subchapter, "conscious sedation" shall by synonymous with the term "sedation/analgesia" as used by the American Society of Anesthesiologists.

"Regional anesthesia" means the administration of anesthetic agents to a patient to interrupt nerve impulses without loss of consciousness and includes epidural, caudal, spinal and brachial plexus anesthesia. Regional anesthesia does not include minor conduction blocks as defined in this section.

"General anesthesia" means the administration of a drug or drugs which cause loss of consciousness as the result of which the patient is unable to make meaningful responses but may still display reflex withdrawal from a painful stimulus.

N.J.A.C. 13:35-4A.3.

NJANA recognizes that these definitions may be somewhat different than the terms commonly used in practice for various levels of sedation. Since the BME's regulations govern physicians, a physician must order one of these three types of anesthesia. The physician should chart which type of anesthesia he or she ordered the anesthesia provider to administer.

In addition, the BME's regulations define the terms "supervision," "monitoring," and "complications" as follows:

"Supervision" means responsibility by a credentialed physician who is immediately available to oversee the administration and monitoring of anesthesia by health care personnel authorized by this rule to render anesthesia services in an office.

"Monitoring" means continuous visual observation of a patient and continuous observation of the patient using instruments to measure, display and record the values of certain physiologic variables such as pulse, oxygen saturation, blood pressure and respiration.

"Complications" means an untoward event occurring at any time within 48 hours of any surgery, special procedure or the administration of anesthesia services which was performed in an office setting including, but not limited to, any of the following events: paralysis, nerve injury, malignant hyperthermia, seizures, myocardial infarction, renal failure, significant cardiac events, respiratory arrest, aspiration of gastric contents, cerebral vascular accident, transfusion reaction, pneumothorax, allergic reaction to anesthesia, wound infections requiring intravenous antibiotic treatment or hospitalization, unintended return to an operating room or hospitalization, death or temporary or permanent loss of function not considered to be a likely or usual outcomes of the procedure.

N.J.A.C. 13:35-4A.3.

If there are questions about the meaning of these terms it is the physician's responsibility to clarify the BME's intent.

"SUPERVISION" REQUIREMENTS

The regulations provide that a physician "who administers or supervises the administration and monitoring of anesthesia services in an office shall be credentialed by a hospital to provide the particular anesthesia service." If the physician does not have hospital privileges in anesthesia he or she must apply to the BME for alternative privileges.

N.J.A.C. 13:35-4A.7(a).

The BME regulations limit the administration and monitoring of general anesthesia to the following personnel:

1. A physician privileged by a hospital or the Board pursuant to N.J.A.C. 13:35-4A.12 to provide general anesthesia services and who, during every consecutive three-year period beginning July 1, 2004, completes at least 60 Category I hours of continuing medical education in anesthesia which either meet the criteria for credit towards the Physician Recognition Award of the American Medical Association or have been approved by the American Osteopathic Association; or

2. A certified registered nurse anesthetist (CRNA), under the supervision of a physician qualified under (a)1 above.

N.J.A.C. 13:35-4A.8(a).

There is an exception in this subsection allowing "the conversion of conscious sedation to general anesthesia in an emergency to protect the health of the patient, even if there is no physician present who would be qualified to administer and monitor general anesthesia . . ." Thus, a CRNA could convert a patient to general anesthesia.

N.J.A.C. 13:35-48.8(b).

The BME regulations limit the administration and monitoring of regional anesthesia to the following personnel:

1. A physician privileged by a hospital or the Board pursuant to N.J.A.C. 13:35-4A.12 to provide regional anesthesia and who, during every consecutive three-year period beginning July 1, 2004, completes at least eight Category I hours of continuing medical education in anesthesia exclusively, or in anesthesia as it relates to the physician's field of practice, which either meet the criteria for credit

towards the Physician Recognition Award of the American Medical Association or have been approved by the American Osteopathic Association; or

2. A certified registered nurse anesthetist (CRNA), under the supervision of a physician qualified under (a)1 above.

N.J.A.C. 13:35-4A.9(a).

In addition, the BME regulations for general and regional anesthesia share the following additional requirements:

(b) The administration and monitoring of general [regional] anesthesia shall be provided by an individual who meets the requirements of (a) above and who is at all times present in the anesthetizing location and who is not the practitioner performing the surgery or special procedure.

(c) When the administration and monitoring of general [regional] anesthesia is being performed by a CRNA, the supervising physician shall be physically present and available to immediately diagnose and treat the patient in an emergency, without concurrent responsibilities to administer anesthesia or perform surgery, other than minor surgery.

(d) An advanced cardiac life support-trained physician, registered professional nurse or physician assistant shall remain with the patient at all times that the patient is receiving or recovering from general [regional] anesthesia.

N.J.A.C. 13:35-4A.8(b)-(d); N.J.A.C. 13:35 -4A.9(b)-(d).

From a practical standpoint, under the BME regulations, the only physicians who are eligible to meet the BME's educational requirements are anesthesiologists. Even if the physician performing the surgery or special procedure chooses to apply and receives alternative privileging by the BME, the BME regulations will not allow that same physician to also "supervise" the administration and monitoring of general or regional anesthesia.

The physician must choose to either perform the surgery or special procedure or "supervise" the administration and monitoring of general or regional anesthesia. Thus, there will no longer be a need for a CRNA's services for procedures performed in the office using general or regional anesthesia.

The BME regulations limit the administration of conscious sedation in an office to the following individuals:

1. A practitioner privileged by a hospital or the Board pursuant to N.J.A.C. 13:35-4A-12 to provide conscious sedation and who, during every consecutive three-year period beginning July 1, 2004, completes at least eight Category I or II hours of continuing medical education in any anesthesia services, including conscious sedation exclusively, or in anesthesia as it relates to the physician's field of practice, which either meet the criteria for credit towards the Physician Recognition Award of the American Medical Association or have been approved by the American Osteopathic Association; or

2. A certified registered nurse anesthetist (CRNA), under the supervision of a physician qualified under (a)1 above; or

3. A registered professional nurse or physician assistant, who is trained and has experience in the use and monitoring of anesthetic agents, at the specific direction of a physician qualified under (a)1 above, but only for the purpose of administering through an established intravenous line, a specifically prescribed supplemental dose of conscious sedation which was selected and initially administered by the physician who remains continuously present in the procedure room. "Continuously present in the procedure room" does not require that a practitioner remain in the procedure room in violation of human exposure safety standards regularly employed during radiological procedures.

N.J.A.C. 13:35-4A.10(a).

(b) A patient under conscious sedation shall be monitored in an office by a physician, CRNA or a registered professional nurse or physician assistant who has training and experience in the use of monitoring devices, under the supervision of a physician eligible under (a)1 above, to administer conscious sedation.

(c) The monitoring of the patient under conscious sedation shall be provided by an individual who meets the requirements of (b) above and who is at all times present and who is not the practitioner who is performing the surgery or special procedure.

(d) When the administration and monitoring of conscious sedation is being performed by a CRNA, or when the monitoring is being performed by a registered professional nurse or physician assistant, the supervising physician shall be physically present, but may be concurrently responsible for patient care.

(e) An advanced cardiac life support-training physician, registered nurse or physician assistant shall be present at all times when a patient is receiving or recovering from the administration of conscious sedation.

N.J.A.C. 13:35-4A.10(b)-(e).

The physician performing the surgery or special procedure may choose to apply for, and ultimately receive, alternative privileging in conscious sedation by the BME, however, the additional educational requirements required by the physician to remain privileged may create a disincentive to use a CRNA's services for procedures in the office using conscious sedation.

NOTE : The BME web site specifies that physicians do not have to complete the continuing education requirements cited above until July 1, 2007 .

SUMMARY OF ALTERNATIVE PRIVILEGING REQUIREMENTS

The alternative privileging regulation was adopted on December 16, 2002 and the BME provided that a physician had until December 16, 2003 to comply with the requirement. With the lifting of the Stay, all physicians who do not have hospital privileges in the specialty they are performing in the office must apply for BME alternative privileges.

The BME requires that all physicians complete an application form as well as a form for one of the seventeen specialty areas, such as conscious sedation.

The alternative privileges regulation is comprised of subsections governing the administration and monitoring of general or regional anesthesia as well as conscious sedation. Another subsection concerns the performance of surgery or a special procedure by a physician who does not hold privileges at a licensed hospital to perform those procedures.

The BME or the entity designed to review the applications may require that the physician participate in a personal interview, submit a representative sample of patient records substantiating the experience of the applicant, submit patient records related to an identified complication, allow the inspection of his or her office and submit additional information to determine the applicant's clinical competence.

The BME may grant or deny some or all of the privileges requested. The alternative privileges must be renewed every two years.

N.J.A.C. 13:35-4A.12

There is extensive information on the BME's web site about the application process. Physicians, who do not currently hold clinical privileges at a licensed hospital and who seek to administer or supervise the administration and monitoring of only conscious sedation in an office, must submit an application to the BME showing their fulfillment of certain criteria. The application on the BME website requires that each applicant:

1. Provide a statement under oath as to the number of procedures for which he or she has provided conscious sedation in the past two years. The attestation form states that patients must have had "acceptable results."

2. Provide proof of one of the following:

--current certification in anesthesiology; or

--current board certification in Critical Care Medicine or Emergency Medicine; or

--Advanced Cardiac Life Support training and either proof of a home study program or of a course in conscious sedation.

3. Provide three names of physicians who will directly submit letters of reference addressing his or her "current competence" to administer conscious sedation based on their "personal knowledge" obtained either during a residency training completed during the past two years or through "personal observation" during the two years preceding the date of the application.

4. Submit a log of patients who have experienced complications related to the provision of conscious sedation in an office setting and the resulting outcomes of the complications.

In addition, the application requires the applicant to delineate the agents he or she wishes to administer in the office setting. Five specific drugs are listed as follows: Diazepam, Versed, Barbiturates, Meperidine, Ketamine.

NOTE: Earlier versions of the BME's alternative privileges application for conscious sedation included the use of Propofol. At some point, the BME decided to delete Propofol from the list of drugs that a physician applying for conscious sedation privileges may administer. If the physician wishes to administer other agents, (e.g., Propofol), he or she must provide separate documentation concerning his or her training and clinical experience in administering that agent.

The BME regulations do not specify the types of drugs that may be administered for each of the levels of anesthesia. The list of drugs is only contained in the conscious sedation application.

COMPLIANCE AND ENFORCEMENT

A physician who submits an application for alternative privileges "may continue to offer services for which privileges have been requested until such time as the Board acts upon that application." Therefore, if a physician applies for conscious sedation alternative privileges, he or she may continue to employ a CRNA until the BME grants or denies the application.

N.J.A.C. 13:35-4A.17(a).

If a physician violates any of the regulations' requirements, he or she is subject to discipline for "professional misconduct." The BME has broad discretion to determine what constitutes "professional misconduct" and a physician who is found liable for "professional misconduct" may be subject to a range for penalties such as the suspension of his or her license and the imposition of a fine.

N.J.A.C. 13:35-4A.18

____________________________________________________________________________________

ACTION BY NJANA MEMBERS NEEDED

NJANA needs your assistance. We are requesting that all CRNAs contact one of the following individuals to let them know if you have been terminated from your office position because of the implementation of the regulations. Your comments or questions on any aspect of the regulations' implementation are of great interest to NJANA. Throughout the past seven years, the BME has stated that very few CRNAs will lose their positions because of the regulations. However, based upon the initial telephone calls and other communications to NJANA Board members, many CRNAs are effected by the regulations. The impact of the regulations may be greater than anticipated because of the limitations on the types of drugs that may be administered by a physician seeking alternative privileges in conscious sedation.

You may contact any one of the following individuals:

Angela Richman, CRNA, Executive Director
angelarichman@comcast.net
856-881-4054

Legal Counsel for NJANA

Alma L. Saravia, Esquire
Flaster/Greenberg P.C.
alma.saravia@flastergreenberg.com
856-661-2290

© Prepared by the New Jersey Association of Nurse Anesthetists on August 15, 2005

In 1991, DHSS adopted regulations establishing standards for the performance of anesthesia in an ambulatory care facility or hospital which were recently readopted. N.J.A.C. 8:43G-6 et. seq. and N.J.A.C. 8:43A-12.1, et. seq., respectively.

NURSE PRACTICE ACT ("Act")

The Act governs the practice of nursing and grants the Board of Nursing ("BN") the authority to adopt regulations. It defines the practice of registered professional nursing as "diagnosing and treating human responses to actual or potential physical and emotional health problems, through such services as case finding, health teaching, health counseling, and provision of care supportive to or restorative of life and well-being, and executing medical regimens as prescribed by a licensed or otherwise legally authorized physician or dentist." The Act is similar to the laws in other states.

The Act does not specify that a registered professional nurse must work under the "supervision" of a physician. Nothing in the Act can be construed to mandate that a CRNA must be "supervised" by an anesthesiologist or by a physician with anesthesia privileges.

N.J.S.A. 45:11-23 et seq.

NURSE ANESTHETIST REGULATIONS

The BN's nurse anesthetist regulations require that CRNAs who wish to practice shall:

1. Hold current licensure as a registered professional nurse in this State;

2. Have graduated from a program in nurse anesthesia accredited by the Council on Accreditation of Nurse Anesthesia Educational Programs of the American Association of Nurse Anesthetists;

3. Pass the certifying examination administered by the Council on Certification of Nurse Anesthetists of the American Association of Nurse Anesthetists; and

4. Recertify biennially with the Council on Recertification of Nurse Anesthetists of the American Association of Nurse Anesthetists.

The main provision governing a CRNA's practice mandates that he or she shall:

[o]nly practice at a location which has established written policies and procedures which meet minimum accepted standards of nurse anesthesia practice and the standards of the American Association of Nurse Anesthetists. A nurse anesthetist shall comply with said policies and procedures and shall ensure that they are reviewed annually, revised as necessary and that they address at least the following areas:

verification of qualifications;

continuing education;

delineation of the responsibilities of all personnel;

anesthetic agents which may be administered and under what conditions and/or supervision ;

pre-anesthesia evaluation;

patient preparation;

intra-operative monitoring;

post-operative monitoring;

peri-operative documentation (pre/intra/post-operative);

administration and documentation of medications;

responsibilities of all personnel for assuring that anesthesia supplies and equipment are available and in working order; and

patient emergencies.

N.J.A.C. 13:37-13.1

ADVANCED PRACTICE NURSE LAW

The BN also regulates advanced practice nurses ("APNs"). Nurse Practitioners/Clinical Nurse Specialists ("NPs/CNSs") have worked in an advanced nursing role since the 1970s. Many states began to pass laws in the 1980s that recognized the advanced scope of practice of these providers.

On January 15, 1992 , the Governor signed into law the NP/CNS Certification Act, P.L. 1991, c. 377, which officially recognized the jobs performed by NPs/CNSs. This law allowed advanced nurses to perform all tasks within the scope of practice of a registered professional nurse and to manage common deviations from wellness and stabilized long term care by initiating laboratory and other diagnostic tests and prescribing medications under joint protocols. Approximately 25 states now recognize CRNAs as APNs.

In order to be certified as an APN, the applicant must meet certain requirements including successful completion of an educational program, complete pharmacology courses and pass a written examination. An APN must also complete six continuing professional educational pharmacology hours related to controlled substances.

The current New Jersey statute governing the practice of APNs concerns the authority of an APN to perform tasks, prescribe or order all medications (including controlled dangerous substances ), and also discusses the standards of joint protocols.

The statute provides that an APN may "manage preventative care services, and diagnose and manage deviations from wellness and long-term illnesses" by initiating laboratory and diagnostic tests, prescribing or ordering medications and devices, and prescribing or ordering treatments.

An APN will "order" medications in in-patient settings, and "prescribe" in all other settings. In in-patient settings, an "order" for medication must be written in accordance with a standing order, a joint protocol with a collaborating physician, or pursuant to specific physician direction. In addition, the statute provides that a physician must be "present or readily available through electronic communications." The joint protocol must address whether prior consultation with the collaborating physician is required to initiate an order for a controlled dangerous substance.

In all other patient settings, an APN must "prescribe" by writing a written prescription on a New Jersey Prescription Blank in accordance with standing orders, joint protocols, or pursuant to specific physician direction. The physician must be "present or readily available through electronic communications."

The statute does not include the administration of medications because that is implicit within the scope of practice of a registered nurse.

To implement the above statute, the Division of Consumer Affairs is mandated to adopt the joint protocol regulation in consultation with the BN and the Board of Medical Examiners ("BME"). Both boards have jointly adopted the same joint protocol regulations.

N.J.S.A. 45:11-49 and 45:11-51.

JOINT PROTOCOL REGULATION

This regulation establishes the following requirements for a joint protocol between the APN and a collaborating physician:

· The joint protocol must be in writing;

· The joint protocol must be signed by the APN and the physician, with an acknowledgement that any inappropriate behavior or violation of the joint protocol will be reported the practitioner's licensing board;

· The joint protocol must be maintained on the premises of all offices in which APNs practice;

· The joint protocol must be updated regularly to reflect changes in the practice, office personnel, APN skills, record review, and must contain reference materials with practice guidelines and/or accepted standards or practice;

· The joint protocol must be reviewed at least annually;

· The joint protocol must describe the "nature of the practice, the patient population . . . and settings . . .";

· The joint protocol must describe the circumstances in which an examination must be performed before a "definitive diagnosis" is made;

· The joint protocol must discuss the recordkeeping methodology used in the practice;

· The joint protocol must provide a list of "categories of medications appropriate to the practice";

· The joint protocol must indicate specific medications and the specific number of refills appropriate to that medication, to be prescribed under physician direction;

· The joint protocol must provide specific recording requirements with respect to the patient record and/or a separate recording of "medications prescribed or dispensed, dosages, frequency, duration, instructions for use and authorizations for refills";

· The joint protocol must describe medical conditions in the "nature of the practice" which require "direct consultation prior to the prescribing or ordering of medications or devices";

· The joint protocol must provide a system for the review of patient records, including a standard for frequency and methodology;

· The joint protocol must identify how the APN and collaborating physician can be in "direct communication", and must also detail arrangements to ensure that "collaborating physician or peer coverage is accessible and available";

· The joint protocol must provide procedures "for the use of medications in emergency situations"; and

· The joint protocol must identify "reference materials containing practice guidelines or accepted standards of practice."

N.J.A.C. 13:37-6.3

PETITION FOR CRNAs TO BE APNs

NJANA petitioned the BN on April 9, 2003 for CRNAs to be recognized as APN/CRNAs. CRNAs meet the educational requirements and other credentials required by the APN regulations for certification as APNs. The BN considered the Petition at several meetings and it first voted to adopt amendments recognizing CRNAs as APNs in October 2003.

Subsequently, NJANA communicated its concerns about the proposed language to the BN and on April 13, 2004 , Angela Richman, CRNA, NJANA Executive Director and Alma L. Saravia, Esq., NJANA's legal counsel, met with the BN's Practice Committee. The Practice Committee recommended several revisions to the APN regulations it had previously adopted and at the May 18, 2004 , BN meeting it voted to revise the proposed regulations, however, that version of the proposed regulations did not "grandfather in" all CRNAs as APNs.

On March 15, 2005 , the BN voted to recognize all CRNAs as APNs following two years of deliberations. The BN recognized that CRNAs, who must obtain an advanced degree (as of 1998 all CRNAs obtained a master's degree) in nurse anesthesia in order to practice, are qualified to be APNs.

In addition, since more than 180 CRNAs out of the approximately 400 CRNAs in New Jersey are either a BSN or diploma registered nurse who graduated from a nurse anesthesia program, the BN voted to "grandfather in" those CRNAs. The BN will repeal the current nurse anesthesia regulations. NJANA appreciates the BN's efforts to recognize all CRNAs as APNs and it is continuing its review of the proposed regulations.

The proposed regulations are currently being reviewed by the Attorney General's Office and it's anticipated publication in the New Jersey Register will not occur until late fall.

NJANA'S MAJOR COMMENTS ON PROPOSED APN REGULATIONS

The practice of nurse anesthesia has been extensively debated in New Jersey and NJANA is concerned that any provision in the proposed regulations not be used against CRNAs. Under the BN's March 2005 regulations, those CRNAs must demonstrate that they have graduated from an approved program, are certified by the national organization, they have practiced for at least sixteen hundred hours in the past twenty four months and they have completed the pharmacological requirements.

One of the issues NJANA is reviewing in the proposed regulations concerns the joint protocol regulations' provisions concerning the "prescribing or ordering" of anesthesia. The current regulation does not mandate that the practice of nurse anesthesia be considered "prescribing or ordering." In the Petition for Rulemaking, NJANA requested that the BN include the following specific language stating that the provision of anesthesia is distinct from the prescribing or ordering of medication.

"Nothing in this section shall be construed as requiring a Certified Registered Nurse Anesthetist /Advanced Practice Nurse to exercise prescriptive authority in order to administer anesthesia care. The provision of anesthesia care by a Certified Registered Nurse Anesthetist /Advanced Practice Nurse including, but not limited to, the administration of drugs, medications and anesthetics shall not be considered ordering, prescribing or an exercise of prescriptive authority as set forth in P.L. 1991, c. 377."

The BN did not include the requested provision in the proposed regulations. Other states have grappled with this issue and have resolved it in a manner that protects traditional nurse anesthesia practice.

CRNAs do not "prescribe" or "order" when they select, order and administer controlled substances preoperatively, intraoperatively and postoperatively. The customary practices of CRNAs have never been considered an exercise of "prescriptive authority."

A CRNA "administers" anesthesia that has been prescribed or ordered by a physician. The tasks that CRNAs perform are considered the administration of anesthesia because the standard of practice is to keep all anesthesia drugs available, allow the anesthesia provider to choose the most appropriate drug, and then chart what was given to the patient. The current BN nurse anesthesia regulations allow the CRNA to administer and document the medications.

If the BN repeals the current nurse anesthesia regulations, an APN/CRNA could be required to "prescribe" anesthesia. A prescription for medication must be written in accordance with standing orders, joint protocols, or pursuant to specific physician direction according to the statute. In addition, the statute provides that a physician must be "present or readily available through electronic communications."

NJANA is continuing its efforts to clarify this provision. NJANA is requesting that the BN reconsider the issue of including the above language in the regulations concerning the administration of anesthesia because it believes that the CRNA method of practice is outside the scope of "ordering or prescribing." The legislative history of the APN law indicates that the Legislature clearly intended for the BN to distinguish between those tasks that may be performed by a registered professional nurse and an APN.

The law provides that "In addition to all other tasks which a registered professional nurse, may by law, perform, a nurse practitioner may . . . ." Therefore, the BN is authorized by law to propose a regulation specifying that the administration of drugs, medications and anesthetics shall not be considered ordering or prescribing.

In the approximately twenty-five other state statutes and regulations that recognize CRNAs as APNs, they do no require an APN/CRNA to prescribe anesthetics. The other states that already recognize CRNAs as APNs do not consider the "administration of anesthesia" to be included within the scope of the term "prescription." In fact, some of those states do contain the language stating that an APN/CRNA may select, order and administer drugs and medications.

In addition, the proposed regulations grandfather in currently practicing CRNAs without master's degrees, whether currently practicing in New Jersey or another state. The proposed regulations state that a CRNA would have 180-days to apply for certification.

The proposed regulations also require that the pharmacology requirements documenting the completion of at least 39 hours of pharmacology be completed when the applicant submits the application. The proposed regulations mandate that if a CRNA cannot document 39 hours of pharmacology, the alternative is the completion of three credits of "graduate level coursework."

Finally, the current BN nurse anesthesia regulations would expire "one year from the effective date of these rules." Thus, CRNAs who have not become APNs by that date would be prohibited from practicing in New Jersey .

For further information regarding these areas, you can follow the links to The Board of Medical Examiners, The Board of Nursing and AANA.  You are also welcome to contact any of the board members.