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NEW JERSEY REGISTER
VOLUME 34, NUMBER 17
TUESDAY, SEPTEMBER 3, 2002
RULE PROPOSAL

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF MEDICAL EXAMINERS
ADDITION OF KINEVAC (CCK) TO LIST OF APPROVED NON-RADIOACTIVE MATERIALS
LICENSED NUCLEAR MEDICINE TECHNOLOGISTS MAY ADMINISTER


Proposed Amendment: N.J.A.C. 13:35-6.20

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

Authority: N.J.S.A. 45:9-2 and 45:1-15.1.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2002-320.

Submit written comments by November 2, 2002 to:

William Roeder, Executive Director

State Board of Medical Examiners

PO Box 183

Trenton, NJ 08625-0183

The agency proposal follows:

Summary

On February 25, 2000, the Board of Medical Examiners (the Board) received a petition for rulemaking from Steven Wozniak, BS, CNMT, RT(N), of Saint Barnabas Ambulatory Care Center, Livingston, New Jersey, requesting that the Board amend N.J.A.C. 13:35-6.20, Physician delegation of tasks to radiologic technologists and nuclear medicine technologists. The petitioner maintains that licensed nuclear medicine technologists (LNMTs) should be permitted to administer Kinevac (CCK) and requests that it be added to the list of approved non-radioactive materials that they are permitted to administer under direct physician supervision. The notice of receipt and action for the petition appeared in the New Jersey Register on June 5, 2000 at 32 N.J.R. 2166(a). Subsequently, on June 17, 2001, the Board voted to approve the petition and propose an amendment to the rule as requested by the petitioner.

Pursuant to its rulemaking authority at N.J.S.A. 45:9-2 and 45:1-15.1, the Board proposes to amend N.J.A.C. 13:35-6.20 by adding Kinevac (CCK) to the list of approved non-radioactive materials that LNMTs are permitted to administer under direct physician supervision. Sincalide (brand name in the United States is Kinevac) belongs to the group of medicines known as diagnostic aids. Sincalide is given by injection before the tests are done to check if the gallbladder and pancreas are working properly and to help diagnose other problems of these organs.

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

Social Impact

The Board believes that the proposed amendment will have a beneficial impact on the public, physicians, nurses and hospitals. The current practice which does not permit LNMTs to administer CCK requires that a physician or nurse must administer the CCK resulting in delays and taking physicians and nurses away from other patients and duties. The Board believes that permitting an LNMT to administer CCK under direct physician supervision will facilitate medical care to patients. The Board notes that the term "under direct physician supervision" is defined in N.J.A.C. 13:35-6.20(a). The Board also believes that LNMTs are well qualified to perform this procedure and the proposed amendment will permit physicians and nurses to perform other tasks which will lead to a more efficient running of the nuclear medicine and radiological departments of hospitals.

Economic Impact

The Board believes that the proposed amendment will not have a direct economic impact but may have a beneficial impact on the public and the regulated community by making the delivery of medical care more efficient in nuclear medicine and radiological departments of hospitals.

Federal Standards Statement

A Federal standards analysis is not required because the proposed amendment does not involve any Federal standards or requirements.

Jobs Impact

The Board does not believe that the proposed amendment will increase or decrease jobs in the State.

Agriculture Industry Impact

The proposed amendment will have no impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

The Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq. (the Act), requires the Board to give a description of the types and an estimate of the number of small businesses to which the proposal will apply. If, for the purposes of the Act, the approximately 33,000 licensed physicians, are considered "small businesses" within the meaning of the Act, then the following analysis applies.

The Act requires the Board to set forth the reporting, recordkeeping, and other compliance requirements of the proposed rules including the kinds of professional services likely to be needed to comply with the requirements. The Act further requires the Board to estimate the initial and annual compliance costs, outline the manner in which it has designed the rules to minimize any adverse economic impact upon small businesses, and to set forth whether the rules establish differing compliance requirements for small businesses.

There are no reporting, recordkeeping or compliance requirements associated with the proposed amendment.

No professional services are needed to comply with the proposed amendment. The Board believes that all LNMTs should be permitted to administer Kinevac (CCK) under direct physician supervision and no restrictions are imposed based on the size of the facility in which they work.

Smart Growth Impact

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

Full text of the proposal follows:

<< NJ ADC 13:35-6.20 >>

13:35-6.20 Physician delegation of tasks to radiologic technologists and nuclear medicine technologists

(a)-(l) (No change.)

(m) A physician may direct the LNMT to administer, under direct physician supervision, nonradioactive pharmaceuticals as follows:

1.-4. (No change.)

5. Vitamin B-12; <<-and->>

6. Intravenous flush solutions such as saline or heparin<<-.->><<+; and+>>

<<+7. Kinevac (CCK).+>>

(n)-(p) (No change.)

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Posted September 3, 2002