New Jersey Statewide Navigation Bar
NJ Office of the Attorney General
Division of Consumer Affairs
DCA Highlights Search Licensees Complaint Forms Consumer Information Professional Boards and Advisory Committees DCA News Contact Information
Division of Consumer Affairs A-Z List

NEW JERSEY REGISTER
VOLUME 38, ISSUE 10
ISSUE DATE: MAY 15, 2006
RULE PROPOSALS
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
Board Of Medical Examiners

 

Proposed Repeal and New Rules: N.J.A.C. 13:35-6A

Declarations of Death Upon the Basis of Neurological Criteria

Purpose; Definition of Brain Death; Requirements for Physicians Authorized to Declare Death on the Basis of Neurological Criteria; Standards for Declaration of Brain Death; Organ Donation; Exemption to Accommodate Personal Religious Beliefs; Pronouncement of Death

Authorized By: William Roeder, Executive Director, Board of Medical Examiners.

Authority: N.J.S.A. 26:6A-1, specifically 26:6A-4, and 45:9-2.

Calendar Reference: See Summary below for explanation of exception to calendar requirement.

Proposal Number: PRN 2006-151.

Submit comments by July 14, 2006 to:
William Roeder, Executive Director
Board of Medical Examiners
140 East Front Street, 2nd Floor
P.O. Box 183
Trenton, N.J. 08625

The agency proposal follows:

Summary

The Board of Medical Examiners has reviewed its current rules concerning the declaration of death on the basis of neurological criteria set forth in Subchapter 6A, and promulgated pursuant to the New Jersey Declaration of Death Act (the Act), N.J.S.A. 26:6A-1 et seq., and has determined that the rules should be amended to reflect current clinical practice standards for the declaration of brain death. The Board believes that the amendments are necessary in order to ensure that its licensees are guided in their assessment of brain death by the most up to date and comprehensive clinical criteria available. The current rules were initially promulgated in 1992, and were last amended in 1999. The rules establish both requirements for physicians authorized to declare brain death and acceptable medical standards that must be followed in brain death declarations. The Board notes that its review of the rules in Subchapter 6A was precipitated by correspondence from the New Jersey Trauma Center, the American College of Surgeons Committee on Trauma and the Atlantic Neurosurgical Specialists, requesting that the Board update the clinical standards its licensees must use in the declaration of brain death. The Board has reviewed recent publications on the diagnosis of brain death, including publications from The New England Journal of Medicine, and guidelines issued by the American College of Radiology and the Society of Nuclear Medicine, and has determined that the rules must be updated to reflect new, readily available diagnostic tools that can be used to confirm a brain death determination. The rules must also be updated to reflect the current level of physician expertise in these matters in specialties other than those recognized in the rules.

In order to eliminate any confusion that may be generated when portions of the existing rules are amended or deleted, the Board has decided to repeal the existing rules in Subchapter 6A in their entirety and replace them with the proposed new rules. The Board notes initially that the existing rules and the proposed new rules differ in two key respects. First, under the existing rules, two physicians must be involved in the declaration of brain death. The attending physician's determination of brain death must be confirmed independently by a corroborating physician. In light of the types of diagnostic tests that are now readily available to physicians for confirming brain death determinations, the current standard of practice dictates that a corroborating physician's assessment is no longer necessary for a brain death determination. The scope of the clinical examination, confirmatory tests and/or reexamination outlined in the new rules obviates the need for a corroborating physician.

Second, the current rules and proposed new rules differ with respect to physician qualifications for brain death determinations. Under the current rules, when a determination of brain death is to be made upon an individual above two months of age, the plenary licensed physician involved in the brain death determination must be a neurologist or a neurosurgeon. When such a determination is to be made upon an individual at or below two months of age, the plenary licensed physician involved in the brain death determination must be a neonatologist, a pediatric neurologist or a pediatric neurosurgeon, or a neurologist or neurosurgeon who has been trained in or is experienced in pediatric cases. Under the proposed new rules, brain death determinations on patients under the age of two months must still be made by a neonatologist, a pediatric neurologist or a pediatric neurosurgeon. But under current practice standards, the list of plenary licensed physicians who are qualified to make brain death determinations on patients who are between the ages of two months and 12 months and patients who are above the age of 12 months may be expanded to include other specialists. Advances in both readily available diagnostic testing and in physician training have made the participation of other specialists appropriate. The proposed new rules provide that in the case of patients between the ages of two months and 12 months, the examining physician shall be a specialist in pediatric critical care, pediatric neurology or pediatric neurosurgery. When declarations of brain death are to be made upon patients above 12 months of age, the new rules provide that the examining physician must be a neurologist, neurosurgeon, critical care specialist and/or trauma surgeon. In addition, any physician who has been granted privileges by a hospital to declare brain death may serve as the examining physician for patients in this age category.

The following is a summary of the proposed new rules.

Proposed new rule N.J.A.C. 13:35-6A.1 continues to set forth the purpose and scope of the rules in the subchapter. Proposed new rule N.J.A.C. 13:35-6A.2 continues to contain definitions of the relevant terms used throughout the subchapter. Definitions are provided for the terms "apnea," "brain death," and "examining physician." The Board notes that the definition of "examining physician" reflects the fact that more than one physician may be involved in the clinical brain death examination of a patient. Proposed new rule N.J.A.C. 13:35-6A.3 sets forth qualifications of physicians authorized to perform clinical brain death determinations, depending on the age of the patient. These requirements are discussed above.

Proposed new rule N.J.A.C. 13:35-6A.4 sets forth currently accepted standards for the declaration of brain death. The rule provides that a patient may be pronounced dead if an authorized physician determines, in accordance with the criteria set forth in the rule, that brain death has occurred. The rule sets forth in detail the clinical findings that, if present, are indicative of brain death. Following the clinical examination, the examining physician must confirm the diagnosis of brain death with confirmatory testing. The rule further provides that when confirmatory testing is not available or is clinically precluded, the examining physician must repeat the clinical examination after a period of observation, specified according to the age of the patient.

Proposed new rule N.J.A.C. 13:35-6A.5 continues the prohibition currently contained in the existing rules and in the Act, that if the person to be declared brain dead is or may be an organ donor, the examining physician may not have any responsibility for any contemplated recovery or transplant of that person's organs. Proposed new rule N.J.A.C. 13:35-6A.6 reiterates the religious beliefs exemption contained in the existing rules and in the Act, that death may not be declared on the basis of neurological criteria if the examining physician has reason to believe, on the basis of information in the patient's available medical records, or information provided by a member of the patient's family or any other person knowledgeable about the patient's personal religious beliefs, that such a declaration would violate the personal religious beliefs of the patient. The new rule continues to provide that in these cases, death may be declared only upon the basis of cardio-respiratory criteria.

Proposed new rule N.J.A.C. 13:35-6A.7 requires the examining physician to document in the patient record the results of all tests performed and to sign the patient chart. The rule provides that the examining physician may only authorize the pronouncement of death after a clinical examination and a confirmatory test or repeat clinical examination have been completed and documented on the patient's chart, and the examining physician has been able to make all requisite determinations consistent with N.J.A.C. 13:35-6.5A. The actual pronouncement of death may be made by any plenary licensed physician acting upon the authorization of the examining physician.

The Board has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.

Social Impact

The Board believes that its decision to repeal the current rules in Subchapter 6A and replace them with the proposed new rules that more accurately reflect currently accepted clinical standards for the declaration of brain death will benefit physicians in the State by ensuring that they are guided in their assessment of brain death by the most up to date and comprehensive clinical criteria available. The Board believes that the proposed new rules will also have a positive impact upon members of the general public to the extent that the standards articulated in the new rules will provide physicians with the ability to pronounce death in a more timely manner, thereby minimizing the risk that patients will be kept on life support systems for longer than necessary. The proposed new rules may also have a positive impact on the general public to the extent that the rules may help to facilitate organ transplantation by allowing brain death declarations to be made in a more efficient and timely manner, consistent with appropriate standards of care. The general public will also benefit because the rules continue to include significant safeguards designed to promote the health, safety and welfare of New Jersey citizens. Specifically, the new rules continue to assure that the authority to make brain death determinations is vested in physicians with appropriate expertise. In addition, the continued prohibition against the involvement by an examining physician in the organ donation process ensures physician objectivity, and the continued prohibition against a brain death declaration when the physician has information that such a declaration would violate a patient's religious beliefs ensures that patients' beliefs will be respected.

Economic Impact

The Board does not believe that the proposed new rules will have any negative impact upon licensed physicians, health care facilities or members of the general public. The required clinical examination and confirmatory tests outlined in the proposed new rules represent only minor modifications to the medical standard articulated in the current rules proposed for repeal at this time. The elimination of the collaborating physician requirement, in addition to the expanded list of specialists who may serve as examining physicians for brain death declaration purposes, may, however, have an economic impact upon some health care facilities and the general public. Some facilities may experience a decrease in administrative costs previously incurred in connection with retaining the services of consulting physicians if their facilities did not have staff physicians who where qualified under the rules to corroborate brain death determinations, which may result in a decrease in the hospital fees which must be paid by patients' families.

Federal Standards Statement

A Federal standards analysis is not required because the proposed repeal and new rules are governed by N.J.S.A. 26:6A-1 et seq. The proposed repeal and new rules are not subject to any Federal requirements or standards.

Jobs Impact

The Board does not believe that the proposed repeal and new rules will result in the creation or loss of jobs in the State. It is possible, however, that the elimination of the collaborating physician requirement and the expansion of the list of specialists who may serve as examining physicians for brain death declaration purposes may cause a decrease in the number of consulting positions available for qualified physicians at some health care facilities in the State.

Agriculture Industry Impact

The proposed repeal and new rules will have no impact on the agriculture industry in the State.

Regulatory Flexibility Statement

The proposed new rules, which govern the declarations of death upon the basis of neurological criteria, will be implemented in New Jersey acute care facilities, none of which, the Board believes, employ less than 100 full-time employees. Only these facilities have the equipment necessary to make the determinations required under these rules. Since these facilities would not be considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., a regulatory flexibility analysis is not required. If any of these facilities, however, employ less than 100 full-time employees, the following analysis applies.

The proposed new rules will not impose reporting requirements, but will impose various recordkeeping and compliance requirements upon licensed physicians engaged in the declaration of brain death and upon health care facilities where such determinations are made. These requirements are discussed in the Summary statement above. No additional professional services will be needed to comply with the proposed new rules. The costs of compliance with the proposed new rules are discussed in the Economic Impact statement above. The Board believes that the proposed new rules should be uniformly applied to all physicians and health care facilities involved in the declaration of brain death in order to ensure the health, safety and welfare of the general public in brain death determinations and, therefore, no differing compliance requirements are provided based upon the size of the business.

Smart Growth Impact

The Board does not believe that the proposed repeal and new rules will have any impact upon the achievement of smart growth or upon the implementation of the State Development and Redevelopment Plan.

Full text of the rules proposed for repeal may be found in the New Jersey Administrative Code at N.J.A.C. 13:35-6A.

Full text of the proposed new rules follows:

SUBCHAPTER 6A. DECLARATIONS OF DEATH UPON THE BASIS OF NEUROLOGICAL CRITERIA

13:35-6A.1 Purpose

(a) The rules in this subchapter are established pursuant to N.J.S.A. 26:6A-1 et seq. (P.L. 1991, c. 90), the New Jersey Declaration of Death Act, and set forth:

1. Requirements, by specialty or expertise, for physicians authorized to perform a clinical brain death examination and declare death upon the basis of neurological criteria; and

2. Accepted medical standards, including criteria, tests and procedures, to govern declarations of death upon the basis of neurological criteria.

13:35-6A.2 Definitions

The following words and terms, when used in this subchapter, shall have the following meanings unless the context clearly indicates otherwise.

"Apnea" means the absence of respiration and a terminal PCO2 greater than 60 mmHG or a terminal PCO2 at least 20 mmHg over the initial normal baseline PCO2.

"Brain death" means the irreversible cessation of all functions of the entire brain, including the brainstem.

"Examining physician" means a physician who performs a clinical brain death examination and meets the qualifying criteria set forth at N.J.A.C. 13:35-6A.3. The term "examining physician" may refer to one or more physicians involved in the clinical brain death examination.

13:35-6A.3 Requirements for physicians authorized to declare death on the basis of neurological criteria

(a) A physician performing a clinical brain death examination shall be plenary licensed and shall hold the following qualifications, dependent on the age of the patient upon whom a declaration of brain death is to be made:

1. Age below two months: When declarations of brain death are to be made upon children below two months of age, the examining physician shall be a specialist in neonatology, pediatric neurology or pediatric neurosurgery.

2. Age between two months and 12 months: When declarations of brain death are to be made upon children at or above two months of age, and at or below 12 months of age, the examining physician shall be a specialist in pediatric critical care, pediatric neurology or pediatric neurosurgery.

3. Age greater than 12 months: When declarations of brain death are to be made upon patients above 12 months of age, the examining physician shall be duly qualified by training and experience to declare brain death. For purposes of this section, neurologists, neurosurgeons, critical care specialists and trauma surgeons shall be deemed to be duly qualified physicians. In addition, any physician who has been granted privileges by a hospital to declare brain death may serve as the examining physician pursuant to this subchapter.

13:35-6A.4 Standards for declaration of brain death

(a) Declarations of brain death shall be made in accordance with accepted medical standards. A patient may be pronounced dead if a physician meeting the requirements set forth in N.J.A.C. 13:35-6A.3 determines in accordance with the criteria set forth in this section that brain death has occurred.

(b) The examining physician who is to pronounce brain death shall:

1. Determine a reasonable basis to suspect brain death. Brain death may be declared where the etiology of the insult or injury is sufficient to cause brain death and, in the judgment of the examining physician, is irreversible;

2. Exclude complicating medical conditions that may confound the clinical assessment of brain death, including:

i. Severe hypothermia, defined as core body temperature at or below 92 degrees Fahrenheit in adults, or outside the clinically established age specific range in a child;

ii. The effects of neuromuscular blockade(s). In the event a neuromuscular blockade was used to treat the patient, the examining physician shall establish that the effects of the blockade are reversed prior to performing clinical examinations for brain death;

iii. The effects of CNS depressants. If CNS depressants are present and serum blood level is therapeutic or below the therapeutic range, a clinical examination may be initiated. If serum blood levels are not available, above the therapeutic range or unknown, or there is an overdose or toxic exposure of an unknown agent, a brain death evaluation may proceed without reliance on clinical examination if, in the judgment of the examining physician, the injury or cause of coma is non-survivable. In such event, an objective measure of intracranial circulation shall be used as a confirmatory test;

iv. Severe metabolic imbalances, unless in the judgment of the examining physician any such imbalances do not confound the clinical assessment of brain death; and

v. Mean arterial pressure less than 60 mmHg in an adult or outside the clinically established age specific range in a child;

3. Perform a clinical examination to evaluate the patient for the presence of brain death. The following clinical findings, if present, are indicative of brain death:

i. A determination that supraspinal motor response(s) to pain is absent;

ii. A determination that brainstem reflexes are absent, which determination may be established by ascertaining all of the following:

(1) No pupillary response to light;

(2) No deviation of the eyes to irrigation of each ear with 50 ml of cold water. The tympanic membrane shall be determined to be intact;

(3) No corneal reflex; and

(4) No response to stimulation of the posterior pharynx and/or no cough response to tracheobronchial suctioning; and

iii. The presence of apnea, which shall be established in accordance with the following testing procedure:

(1) Arterial PCO2 is normalized to greater or equal to 40 mmHg;

(2) 100 percent oxygen is delivered via the ventilator for 10 minutes prior to starting the test;

(3) A baseline arterial blood gas is drawn;

(4) A pulse oximeter is connected and the ventilator is disconnected;

(5) 100 percent oxygen is delivered into the trachea via cannula in the ET tube, at six liters/minute;

(6) If tolerated, the patient is left off the ventilator for eight to 10 minutes and the patient is observed carefully for respiratory movements. Another blood gas is drawn at the end of the eight to 10 minutes and the ventilator is reconnected;

(7) The length of the apnea test and the PCO2 at the end of the test are documented in the patient record; and

(8) If the patient does not tolerate the apnea test, as evidenced by significant drops in blood pressure and/or oxygen saturation, or the development of significant arrhythmias, the test shall be discontinued and either repeated or supplanted with a confirmatory test.

iv. When, in the judgment of the examining physician, a clinical examination cannot be performed due to the nature of injuries, intoxication, patient instability, electrolyte imbalances or any other reason, a confirmatory test such as an intracranial blood flow, four vessel cerebral angiography, radionuclide angiography, transcranial Doppler ultrasound, CT angiogram, or MR angiogram shall be substituted for the clinical examination; and

4. Confirm the diagnosis with a confirmatory test or by a repeat clinical examination, consistent with the following:

i. When a clinical examination of a patient shows the absence of all supraspinal and brain stem reflexes as established by the criteria in (b)3 above, the examining physician shall confirm the diagnosis of brain death with an objective confirmatory test measuring intracranial circulation such as an intracranial blood flow, four vessel cerebral angiography, radionuclide angiography, transcranial Doppler ultrasound, CT angiogram or MR angiogram.

ii. In the event confirmatory testing is not available or is clinically precluded, the examining physician shall repeat the clinical examination after a period of observation, which period shall be not less than 48 hours for patients below the age of two months, not less than 24 hours for patients between the ages of two months to one year, and not less than six hours for patients greater than one year of age.

13:35-6A.5 Organ donation

If the person to be declared dead upon the basis of neurological criteria is or may be an organ donor, then the examining physician shall not have any responsibility for any contemplated recovery or transplant of that person's organs, and shall not serve in the capacity of organ transplant surgeon, the attending physician of the organ recipient, or otherwise an individual subject to a potentially significant conflict of interest relating to procedures for organ procurement.

13:35-6A.6 Exemption to accommodate personal religious beliefs

Death shall not be declared on the basis of neurological criteria if the examining physician has reason to believe, on the basis of information in the patient's available medical records, or information provided by a member of the patient's family or any other person knowledgeable about the patient's personal religious beliefs, that such a declaration would violate the personal religious beliefs of the patient. In these cases, death shall be declared, and the time of death fixed, solely upon the basis of cardio-respiratory criteria.

13:35-6A.7 Pronouncement of death

The examining physician shall document within the patient record the results of all tests performed and shall sign the chart. After a clinical examination and a confirmatory test or examination have been completed and documented on the patient's chart, and if the examining physician has been able to make all requisite determinations consistent with N.J.A.C. 13:35-6A.5, then the examining physician may authorize the pronouncement of death. The actual pronouncement of death may thereafter be made by the examining physician or any plenary licensed physician acting upon the authorization of the examining physician.



Contact Us | Privacy Notice | Legal Statement | Accessibility Statement
division: dca home | complaint forms | licensing boards | adoptions | proposals | minutes | consumer protection
departmental: lps home | contact us | news | about us | FAQs | library | employment | programs and units | services a-z
statewide: nj home | my new jersey | people | business | government | departments | search

Page last modified:
New Jersey Home My New Jersey People Business Government Departments