Rule Proposal

VOLUME 49, ISSUE 1
ISSUE DATE: JANUARY 3, 2017
RULE PROPOSALS
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF MEDICAL EXAMINERS

Proposed Amendments: N.J.A.C. 13:35-6A.2, 6A.3, 6A.4, and 6A.7

Click here to view Interested Persons Statement

Definitions; Standards for Declaration of Brain Death; Pronouncement of Death
 
Authorized By: State Board of Medical Examiners, William Roeder, Executive Director.
 
Authority: N.J.S.A. 45:9-2 and P.L. 2013, c. 185.
 
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
 
Proposal Number: PRN 2017-005.
 
Submit written comments by March 4, 2017, to:
 
   William Roeder, Executive Director
   State Board of Medical Examiners
   PO Box 183
   Trenton, New Jersey 08625-0183
 
or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.
 
The agency proposal follows:
 
Summary

P.L. 2013, c. 185 revised the standards for declaration of death based upon neurological criteria (brain death). The revised standards establish that a physician qualified by specialty or expertise may make a declaration of brain death if such a declaration is in accordance with current medical standards based upon nationally recognized sources of practice guidelines, such as those adopted by the American Academy of Neurology. The Board of Medical Examiners (Board) proposes to amend N.J.A.C. 13:35-6A.4 to conform to P.L. 2013, c. 185. The Board proposes to amend N.J.A.C. 13:35-6A.4 to revise the standards for declaration of brain death to conform to P.L. 2013, c. 185. The amendments require that a declaration of brain death be based on a physician's best medical judgment in accordance with currently accepted medical standards based upon nationally recognized sources of practice guidelines. The amendments also delete the specific criteria for declaring brain death. The Board proposes to amend N.J.A.C. 13:35-6A.2 to delete the definition for the term "apnea." This term is used in the portions of N.J.A.C. 13:35-6A.4 that the Board proposes to delete.

N.J.A.C. 13:35-6A.3 sets forth standards for physicians who are permitted to declare brain death. The Board proposes to amend this rule to permit physicians who specialize in pediatric critical care medicine to declare brain death on children below the age of two months. The Board proposes to amend N.J.A.C. 13:35-6A.7 to remove references to clinical examinations, confirmatory tests, and determinations, consistent with the proposed amendments to N.J.A.C. 13:35-6A.4.

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

The proposed amendments will benefit society by allowing physicians to follow national standards for declaring brain death without the need for the Board to continually revise its rules in order to keep up with evolving standards.
 
Economic Impact

The Board does not believe that the proposed amendments will have any economic impact.
 
Federal Standards Statement

A Federal standards analysis is not required because there are no Federal laws or standards applicable to the proposed amendments.
 
Jobs Impact

The Board does not believe that the proposed amendments will increase or decrease the number of jobs available in New Jersey.
 
Agriculture Industry Impact

The Board believes the proposed amendments will have no impact upon the agricultural industry in New Jersey.
 
Regulatory Flexibility Analysis

Since physicians are individually licensed by the Board, they may be considered "small businesses" under the Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq.

There are no costs imposed on small businesses by the proposed amendments. The Board does not believe that physicians will need to employ any professional services to comply with the requirements of the proposed amendments. The proposed amendments impose no recordkeeping or reporting requirements, but do impose compliance requirements as detailed in the Summary above.

As the compliance requirements contained in the proposed amendments are necessary to provide guidance to physicians when they pronounce brain death, the Board believes that the rules must be uniformly applied to all physicians and no exemptions are provided based on the size of the business.
 
Housing Affordability Impact Analysis

The proposed amendments will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the proposed amendments concern physicians pronouncing brain death.
 
Smart Growth Development Impact Analysis

The proposed amendments will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed amendments concern physicians pronouncing brain death.
 
Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
 
[page=51] SUBCHAPTER 6A.          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.]
 
. . .
 
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, pediatric critical care medicine, or pediatric neurosurgery.
 
2.-3. (No change.)
 
13:35-6A.4 Standards for declaration of brain death
 
[(a)] Declarations of brain death shall be made by a physician, meeting the requirements set forth in N.J.A.C. 13:35-6A.3, based upon the exercise of the physician's best medical judgment and in accordance with currently 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.] that are based upon nationally recognized sources of practice guidelines, including, without limitation, guidelines adopted by the American Academy of Neurology.
 
[(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.7 Pronouncement of death
 
The examining physician shall document [within] the determination of brain death in 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.4, 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.