VOLUME 46, ISSUE 13
ISSUE DATE: JULY 7, 2014
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF RESPIRATORY CARE
Proposed Amendment: N.J.A.C. 13:44F-3.3
Delegation by a Respiratory Care Practitioner to Unlicensed Persons
Authorized By: State Board of Respiratory Care, Dorcas K. O'Neal, Executive Director.
Authority: N.J.S.A. 45:14E-7 and 45:1-15.1.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2014-120.
Submit comments by September 5, 2014, to:
Dorcas K. O'Neal, Executive Director
State Board of Respiratory Care
Post Office Box 45031
Newark, New Jersey 07101
Or electronically at www.NJConsumerAffairs.gov/proposal/comment/.
The agency proposal follows:
The State Board of Respiratory Care (the Board) is reproposing amendments to N.J.A.C. 13:44F-3.3, concerning the delegation of certain respiratory care services by its licensees to unlicensed assistants. The Board originally proposed amendments to N.J.A.C. 13:44F-3.3(d) and (e) in 2010, in conjunction with proposed amendments to the continuing education requirements in Subchapter 10. The notice of proposal appeared in the New Jersey Register on July 6, 2010, at 42 N.J.R. 1331(a) (2010 proposal). During the public comment period on the 2010 proposal, the Board received numerous comments expressing concern that the proposed amendments would have a negative impact on patients receiving respiratory care services in a home care setting. The Board declined to adopt the amendments to N.J.A.C. 13:44F-3.3 in order to more fully consider the commenters' concerns. The notice of adoption was published in the New Jersey Register on August 15, 2011, at 43 N.J.R. 2188(a).
Existing N.J.A.C. 13:44F-3.3(d) provides that a licensed respiratory care practitioner may delegate the following tasks to an unlicensed assistant: processing, cleaning, and sterilizing basic respiratory equipment under N.J.A.C. 13:44F-3.3(d)1; maintaining and handling oxygen, specialty gas cylinders, and oxygen concentrators under N.J.A.C. 13:44F-3.3(d)2; and setting up, testing, exchanging, and demonstrating equipment related to basic respiratory delivery systems under N.J.A.C. 13:44F-3.3(d)3. Unlicensed persons, however, are not permitted to set up, test, exchange, or demonstrate mechanical ventilators and positive pressure equipment under N.J.A.C. 13:44F-3.3(d)3i. Existing N.J.A.C. 13:44F-3.3(e) provides that a licensed respiratory care practitioner is responsible for any activities that are delegated to an unlicensed assistant under subsection (d).
The 2010 proposed amendments to N.J.A.C. 13:44F-3.3(d)1 and 2 would have authorized unlicensed persons to disassemble, disinfect, sterilize, assemble, and deliver all respiratory equipment, and to maintain and handle oxygen, specialty gas cylinders, and oxygen concentrators, including the performance of oxygen checks and charges. The Board did not receive any negative comments with respect to these proposed amendments. The 2010 proposed amendments also included the proposed deletion of N.J.A.C. 13:44F-3.3(d)3 and (d)3i, and amendments to N.J.A.C. 13:44F-3.3(e), which required a licensee to assess and document assembly and operation of all respiratory equipment set up by an unlicensed assistant prior to use on a patient. The 2010 amendments to N.J.A.C. 13:44F-3.3(d)1, 2, and 3, when read together, would authorize unlicensed assistants to set up, test, and exchange basic respiratory equipment, but would prohibit unlicensed assistants from demonstrating such equipment. The proposed deletion of the prohibition against unlicensed assistants performing any activities in connection with mechanical or positive pressure equipment, contained N.J.A.C. 13:44F-3.3(d)3i, was proposed in light of the new requirement proposed in subsection (e), mandating an assessment of all equipment by the licensee prior to patient use.
The commenters to the 2010 proposal noted that prohibiting unlicensed assistants from demonstrating respiratory equipment, under the proposed amendments to N.J.A.C. 13:44F-3.3(d)3, and requiring respiratory care practitioners to assess all equipment assembled by unlicensed assistants prior to patient use, under the proposed amendments to N.J.A.C. 13:44F-3.3(e), would cause significant delays in the provision of respiratory care services to patients receiving care in their homes. The commenters noted that such delays would have a negative impact on patient health and wellbeing. The commenters believed that requiring patients in home care settings to wait for a licensed respiratory care practitioner to demonstrate equipment prior to use is unreasonable given the fact that assistants are appropriately trained in demonstration of the equipment in order to ensure that patients arriving home may continue their respiratory therapy without undue delay. The commenters also noted that the existing requirement in N.J.A.C. 13:44F-3.3(f) that a licensed respiratory care practitioner visit the patient within 24 hours of equipment delivery in order to document and assess the patient is sufficient to ensure patient safety. Several commenters also noted that the proposed amendments would impose a significant financial hardship on all home medical equipment companies operating in New Jersey by requiring them to employ additional respiratory care therapists in order to ensure no interruption of patient care.
The Board is reproposing amendments to N.J.A.C. 13:44F-3.3(d) at this time because it continues to believe that amendments are necessary to help clarify those tasks that may be delegated to unlicensed persons, and to clarify a licensee's continuing obligation to ensure that such tasks have been properly performed. On reproposal, however, the Board has changed the list of permissible tasks that may be performed by unlicensed assistants in subsection (d) to reflect the practical difference inherent in the delegation of respiratory care services in out-patient, as compared to in-patient, treatment settings. Specifically, the Board believes that prohibiting a licensee from delegating to an unlicensed assistant the demonstration of respiratory care equipment in an out-patient treatment setting may have the unintended consequence of delaying patient access to vital respiratory care services. The Board does not believe that the same concerns exist with respect to in-patient treatment settings, defined in N.J.A.C. 13:44F-3.3(a) to mean, residential care facilities, hospitals, subacute care facilities, and skilled nursing facilities. In such treatment settings, respiratory care practitioners, as well as other licensed healthcare providers, are available on-site to provide equipment demonstration in a timely manner.
In light of such concerns, the reproposed amendments to N.J.A.C. 13:44F-3.3(d) will permit an unlicensed assistant, in both an in-patient and out-patient setting, to disassemble, clean, disinfect, sterilize, assembly, and deliver all respiratory equipment, to maintain and handle oxygen, specialty gas cylinders, and oxygen concentrators, and to perform oxygen checks and charges. The reproposed amendments provide further that in an out-patient setting only, an unlicensed assistant may demonstrate basic respiratory, non-assistive ventilation and oxygen equipment. Demonstration of equipment, however, is further defined to exclude the administration of medication. The Board believes that medication administration constitutes direct patient care and, therefore, may only be performed by a licensed respiratory care practitioner under the existing requirements of N.J.A.C. 13:44F-3.3(c).
The Board is also reproposing the deletion of N.J.A.C. 13:44F-3.3(d)3i, which precludes an unlicensed assistant from setting up, testing, exchanging, or demonstrating mechanical ventilators or positive pressure [page=1549] equipment. Under the reproposed amendments, these activities may be delegated to an unlicensed assistant consistent with the requirements set forth in the proposed amendments to paragraphs (d)1 through 3. The Board is not reproposing any amendments to N.J.A.C. 13:44F-3.3(e) at this time. The rule continues to require a licensed respiratory care practitioner to be responsible for all activities performed by an unlicensed assistant under subsection (d).
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.
The Board believes that the proposed amendments to N.J.A.C. 13:44F-3.3 may have a positive impact upon licensees and their unlicensed assistants by clarifying those tasks that may be delegated to unlicensed persons and the obligations delegating licensees must comply with in order to ensure the health, safety, and welfare of patients receiving respiratory care services.
The Board does not believe that the proposed amendments to N.J.A.C. 13:44F-3.3(d) will have any economic impact upon licensed respiratory care practitioners. In addition, the Board does not believe that the proposed amendments will have no economic impact on providers of respiratory equipment.
Federal Standards Statement
A Federal standards analysis is not required because the proposed amendments are governed by N.J.S.A. 45:14E-1 et seq., and are not subject to any Federal standards or requirements.
The Board does not believe that the proposed amendments will result in an increase or decrease in the number of jobs in the State.
Agriculture Industry Impact
The proposed amendments will have no impact on the agriculture industry in the State.
Regulatory Flexibility Statement
Currently, the Board licenses approximately 3,352 respiratory care practitioners. If Board licensees are considered "small businesses," within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies. The proposed amendments will not impose any reporting or recordkeeping requirements, but will impose compliance requirements on licensed respiratory care practitioners who delegate certain tasks to unlicensed assistants in both an in-patient and an out-patient treatment setting. Those requirements are discussed in the Summary above.
No professional services will be needed to comply with the proposed amendments. The costs of compliance with the proposed amendments are discussed in the Economic Impact above. The Board believes that the proposed amendments should be uniformly applied to all licensed respiratory care practitioners providing services in in-patient and out-patient treatment settings in order to ensure the health, safety, and welfare of the general public receiving such services. Therefore, no differing compliance requirements for any businesses are provided based upon size.
Housing Affordability Impact Analysis
The proposed amendments will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the amendments would evoke a change in the average costs associated with housing because the proposed amendments concern activities that licensed respiratory care practitioners may delegate to unlicensed 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 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 activities that licensed respiratory care practitioners may delegate to unlicensed assistants.
Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
SUBCHAPTER 3. AUTHORIZED PRACTICE
13:44F-3.3 Delegation by a respiratory care practitioner to unlicensed persons
(a)-(c) (No change.)
(d) Activities that a licensed respiratory care practitioner may delegate to assistants are limited to the following routine tasks:
1. [Processing,] In an in-patient and out-patient setting: disassembling, cleaning, [and] disinfecting, sterilizing [basic], assembling, and delivery of all respiratory equipment;
2. In an out-patient setting only: demonstrating basic respiratory, non-assisted ventilation and oxygen equipment. Demonstrating such equipment shall not include administration of medication, which would constitute direct patient care; and
[2.] 3. [Maintaining] In an in-patient and out-patient setting: maintaining and safe handling of oxygen and specialty gas cylinders and oxygen concentrators, including the performance of oxygen checks and charges[; and].
[3. Setting up, testing, exchanging and demonstrating equipment relating to basic respiratory delivery systems.
i. An assistant shall not be permitted to set up, test, exchange or demonstrate mechanical ventilators or positive pressure equipment, such as continuous positive airway pressure and bi-level positive airway pressure devices, with or without artificial airways, in use continuously or intermittently. For purposes of this section, the term "exchange" does not mean delivery, and this section shall not preclude an unlicensed assistant from delivering such equipment to a patient's home.]
(e)-(f) (No change.)