Rule Proposal

VOLUME 49, ISSUE 21
ISSUE DATE: NOVEMBER 6, 2017
RULE PROPOSALS
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF MEDICAL EXAMINERS

Proposed Amendment: N.J.A.C. 13:35-6.4

Click here to view Interested Persons Statement

Delegation of Administration of Subcutaneous and Intramuscular Injections and Performance of Venipuncture to Certified Medical Assistants
 
Authorized By: State Board of Medical Examiners, William Roeder, Executive Director.
 
Authority: N.J.S.A. 45:9-2.
 
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
 
Proposal Number: PRN 2017-258.
 
Submit written comments by January 5, 2018, 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

N.J.A.C. 13:35-6.4 establishes criteria for the education a certified medical assistant must complete in order to be eligible to administer an injection under the direction and supervision of a physician. The rule requires that this education consist of at least 600 clock hours and sets forth the topics that must be covered during these 600 hours of instruction. Recently, the State Board of Medical Examiners (Board) has [page=3482] been presented with the curriculum of a 330-hour long program, which the program's presenters assert adequately prepares a certified medical assistant to administer injections under the direction of a physician. The Board has reviewed this presentation and agrees that this program provides adequate preparation. In keeping with this determination, the Board proposes to amend N.J.A.C. 13:35-6.4 to reduce the required clock hours for certified medical assistant education from 600 to 330. The Board proposes to require that certified medical assistants complete training in the administration of injections. The Board also proposes to amend the definition of "certified medical assistant" to recognize new entities that may certify medical assistants. Proposed amendments to N.J.A.C. 13:35-6.4 recognize that certified medical assistants can perform venipuncture. The proposed amendments to N.J.A.C. 13:35-6.4(c)1i and ii and (e)1 and 2 provide that in order to direct a certified medical assistant to perform venipuncture, a physician has to determine that the assistant has completed education and training in venipuncture and skin puncture for the purpose of withdrawing blood, which includes at least 10 hours on administering injections. The training also must include the performance of at least 10 intramuscular injections, 10 subcutaneous injections, and 10 intradermal injections. When a physician directs a certified medical assistant to perform venipuncture, the physician has to determine that the certified medical assistant has met education requirements, comprehends and has experience in venipuncture, has completed 10 hours of training in venipuncture and skin puncture, and has performed at least 10 venipunctures. The proposed amendments require certified medical assistants to wear an identification badge indicating his or her name and credentials. The Board notes that the proposed amendments will not impact requirements for certified medical assistants who may access the Prescription Monitoring Program (PMP) as delegates for practitioners. Pursuant to the PMP statute, N.J.S.A. 45:1-45 et seq., only certified medical assistants who have completed 600 hours of training may serve as delegates to access the PMP.

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 reducing the required hours of education a certified medical assistant must complete in order to administer medications. This will make it easier for individuals to complete this education and will likely increase the number of individuals who are employed as certified medical assistants.
 
Economic Impact

The proposed amendments may reduce costs for those completing educational programs in administration of medications. It is possible that educational programs that consist of 330 hours would cost less than those that consist of 600 hours. If that is the case, those who complete such programs would incur a reduced cost for completing the required education.
 
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 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 ensure that certified medical assistants are properly prepared to administer injections under the direction of a physician, 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 proposed amendments would evoke a change in the average costs associated with housing because the proposed amendments concern education programs for certified medical assistants.
 
Smart Growth Development Impact Analysis

The proposed amendments will have an insignificant impact on smart growth and there is an extreme unlikelihood that the proposed amendments 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 education programs for certified medical assistants.
 
Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
 
SUBCHAPTER 6.    GENERAL RULES OF PRACTICE
 
13:35-6.4   Delegation of administration of subcutaneous and intramuscular injections and performance of venipuncture to certified medical assistants
 
(a) The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise:
 
1. (No change.)
 
2. "Certified medical assistant" means a graduate of a post-secondary medical assisting education program accredited by the National Healthcare Association (NHA), or its successor, The Committee on Allied Health Education and Accreditation of the American Medical Association (CAHEA), or its successor; Accrediting Bureau of Health Education Schools (ABHES), or its successor; or any accrediting agency recognized by the U.S. Department of Education. The educational program shall include, at a minimum, [600] 330 clock hours of instruction and shall encompass training in the administration of intramuscular and subcutaneous injections and instruction and demonstration in: pertinent anatomy and physiology appropriate to injection procedures; choice of equipment; proper technique, including sterile technique; hazards and complications; and emergency procedures. The medical assistant must also maintain current certification from the Certifying Board of the American Association of Medical Assistants (AAMA), the National Center for Competency Testing (NCCT), the American Medical Certification Association (AMCA), the National Association for Health Professionals (NAHP), the National Certification Medical Association (NCMA), or registration from the American Medical Technologists (AMT), or any other recognized certifying body approved by the Board.
 
(b) A physician may direct a certified medical assistant employed in the medical practice in which the physician practices medicine, to administer to the physician's patients an intradermal, intramuscular or subcutaneous injection, or to perform venipuncture, in the limited circumstances set forth in this section, without being in violation of the pertinent professional practice act implemented by the Board, to the extent such conduct is permissible under any other pertinent law or rule administered by the Board or any other State agency.
 
(c) A physician may direct the administration of an injection by a certified medical assistant only where the following conditions are satisfied:
 
1. The physician has determined and documented that the certified medical assistant has the qualifications set forth in (a)2 above, [and] has attained a satisfactory level of comprehension and experience in the [page=3483] administration of intramuscular and subcutaneous injection techniques[.] and has completed training that demonstrates to the physician proficiency in the procedures to be performed, which shall include at least:
 
i. Ten hours of training in administering injections; and
 
ii. Satisfactory performance of least 10 intramuscular injections, 10 subcutaneous injections, and 10 intradermal injections.
 
2.-5. (No change.)
 
(d) (No change.)
 
(e) A physician may direct a certified medical assistant to perform venipuncture only where the following conditions are satisfied:
 
1. The physician has determined and documented that the certified medical assistant has the qualifications set forth in (a)2 above, has attained a satisfactory level of comprehension and experience in the performance of venipuncture, and has completed training that demonstrates to the physician proficiency in the procedures to be performed, which shall include at least:
 
i. Ten hours of training in venipuncture and skin puncture for the purpose of withdrawing blood; and
 
ii. Satisfactory performance of at least 10 venipunctures.
 
2. The certified medical assistant shall wear a clearly visible identification badge indicating his or her name and credentials.