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NEW JERSEY REGISTER
VOLUME 39, ISSUE 21
ISSUE DATE: NOVEMBER 5, 2007
RULE PROPOSALS

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF RESPIRATORY CARE
Rules

Proposed Readoption with Amendments: N.J.A.C. 13:44F

State Board of Respiratory Care Rules

Authorized By: State Board of Respiratory Care, Dorcas K. O'Neal, Executive Director.
Authority: N.J.S.A. 45:1-15.1 and 45:14E-7.

Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2007-329.

Submit comments by January 4, 2008 to:
Dorcas K. O'Neal, Executive Director

State Board of Respiratory Care
Post Office Box 45031
Newark, New Jersey 07101

The agency proposal follows:

Summary

The Board of Respiratory Care (the Board) is proposing to readopt N.J.A.C. 13:44F with amendments. These rules are scheduled to expire on November 14, 2007, pursuant to Executive Order No. 66 (1978) and N.J.S.A. 52:14B-5.1. Because this notice of readoption has been filed prior to November 14, 2007, the expiration date of the rules in Chapter 44F is extended by 180 days, to May 12, 2008 pursuant to N.J.S.A. 52:14B-5.1c.

In compliance with the Executive Order, the Board undertook a thorough review of the existing provisions of N.J.A.C. 13:44F in order to delete unnecessary or unreasonable rules, if any, and to clarify existing provisions, where appropriate. The Board believes that the rules proposed for readoption, as amended, are necessary, reasonable, understandable and responsive to the purposes for which they were promulgated.

The following is a summary of the existing rules of Chapter 44F which the Board proposes to readopt with amendments. The Board is proposing to readopt N.J.A.C. 13:44F-1.1, which sets forth the purpose and scope of the chapter, without amendment. N.J.A.C. 13:44F-1.2 contains definitions of words and terms used throughout the chapter. The Board is proposing to delete the phrase "cardiopulmonary system" within the definition of "respiratory care" in N.J.A.C. 13:44F-1.2 and replace it with the phrase "cardiac and pulmonary system," and to amend the term "management" within the definition to refer to "disease management" in order to make the definition of "respiratory care" consistent with the definition set forth in the Respiratory Care Act (the Act) at N.J.S.A. 45:14E-3. The remaining definitions in N.J.A.C. 13:44F-1.2 are proposed to be readopted without amendment. Subchapter 2, which is currently reserved, is proposed to be readopted without amendment.

Subchapter 3 sets forth requirements concerning authorized practice. The Board is proposing several amendments to N.J.A.C. 13:44F-3.1, which sets forth a licensee's scope of practice, in order to track the statutory language set forth at N.J.S.A. 45:14E-3. The phrases "cardio-respiratory system" and "cardio-respiratory support" are proposed to be deleted and replaced with the phrases "cardiac and pulmonary system" and "cardiopulmonary support," respectively, in order to ensure consistency with the Act. In addition, N.J.A.C. 13:44F-3.1(a)11, which provides that a licensee may perform the insertion and maintenance of artificial airways, is proposed to be amended to also allow a licensee to perform the insertion and maintenance of peripheral arterial and peripheral venous catheters, consistent with the provisions of the Act. In light of this proposed amendment, the Board is proposing that existing subparagraph (a)12iii of N.J.A.C. 13:44F-3.1, which refers to the establishment and maintenance of arterial lines, be deleted to avoid redundancy.

N.J.A.C. 13:44F-3.2 concerns the practice of respiratory care by trainees. Trainees are students enrolled in accredited respiratory care training programs. Currently, N.J.A.C. 13:44F-3.2(a) authorizes a trainee to perform clinical services under the direction or supervision of a physician or under the direct supervision of a licensed respiratory care practitioner. The Board is proposing to amend N.J.A.C. 13:44F-3.2(a) to provide that trainees may be supervised by both a physician and a licensed respiratory care therapist, and not one or the other as is currently provided. The Board is proposing this amendment because it is aware that a trainee may, in fact, be supervised by both professionals.

The Board is proposing various amendments to N.J.A.C. 13:44F-3.3, concerning the delegation of respiratory care services by licensed practitioners to unlicensed assistants. The Board is proposing to reorder several of the existing subsections of the rule for clarification purposes. Existing subsection (c), which concerns the training unlicensed assistants must receive before being allowed to perform delegated tasks, is proposed to be recodified as subsection (b), with minor amendments. The Board is proposing a new paragraph 2 in recodified subsection (b), which will require a licensed respiratory care practitioner to reevaluate unlicensed assistants on an annual basis to ensure continued competency to perform delegated tasks. Documentation related to this reevaluation must be retained as part of the unlicensed assistant's employment file. Existing subsection (d), which prohibits unlicensed assistants from engaging in direct patient care, is proposed to be recodified as subsection (c), with a technical amendment. Existing subsection (b) of N.J.A.C. 13:44F-3.3, which delineates those tasks that may be delegated to unlicensed assistants, is proposed to be deleted and the substantive provisions of the rule are proposed to be recodified with amendments in new subsection (d). Paragraph 1 of proposed new subsection (d) provides that processing, cleaning and sterilizing basic respiratory equipment are delegatable tasks. Paragraph 2 of the new subsection provides that the maintenance and safe handling of oxygen and specialty gas cylinders and oxygen concentrators are also delegatable tasks. Paragraph 3 of the new subsection authorizes the setting up, testing, exchanging and demonstrating of equipment relating to basic respiratory delivery systems, as a delegatable task. Paragraph 3 provides further that 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 pressure airway devices. Existing subsection (e), which provides that the licensed respiratory care practitioner shall be responsible for any activities performed by the assistant, is proposed to be readopted with a technical amendment to reflect the recodification. Existing subsection (f), which requires a licensed respiratory care practitioner who has delegated certain tasks to unlicensed assistants in an inpatient setting to conduct an in-person assessment of the equipment prior to patient use, is proposed to be deleted because this check is often performed by other licensed healthcare practitioners in an inpatient setting. Existing subsection (g) is proposed to be recodified as subsection (f), with a technical amendment.

Subchapter 4 sets forth the rules concerning qualifications for licensure. N.J.A.C. 13:44F-4.1, which delineates applicant qualifications, is proposed to be amended to require, as part of paragraph (b)2, that an applicant for licensure applying more than three years following the completion of the required educational training program must complete a refresher course approved by the Board. The proposed amendment provides that this refresher course shall not be required if the applicant submits proof that he or she was practicing respiratory care in another state or jurisdiction since completing the training program. The Board believes that the proposed amendment is necessary to ensure that applicants granted a license are clinically competent to practice. N.J.A.C. 13:44F-4.2, which sets forth requirements for the licensing examination, and N.J.A.C. 13:44F-4.3, which authorizes the Board to refuse to issue or to suspend or revoke any license after an opportunity for a hearing, are proposed to be readopted without amendment. Subchapter 5 details the requirements for temporary licensure. N.J.A.C. 13:44F-5.1, which outlines the requirements for obtaining a temporary license and imposes requirements upon temporary license holders, is proposed to be readopted without amendment. The Board notes that it recently proposed amendments to N.J.A.C. 13:44F-5.1. The proposal appeared in the May 7, 2007 New Jersey Register at 39 N.J.R. 1639(a). The Board is currently in the process of adopting the proposed amendments to N.J.A.C. 13:44F-5.1, and anticipates that those amendments will become effective prior to the adoption of this proposed readoption. N.J.A.C 13:44F-5.2 is currently reserved and is proposed to be readopted without amendment. Subchapter 6 concerns licensure by endorsement. The Board is proposing that N.J.A.C. 13:44F-6.1 and 6.2, which set forth eligibility and application requirements for licensure by endorsement, respectively, be readopted without amendment.

Subchapter 7 sets forth requirements for licensure renewals. The Board is proposing that N.J.A.C. 13:44F-7.1, which details requirements for biennial license renewal and the election of inactive status, and provides for licensure suspension for failure to renew, be readopted without amendment. The Board is also proposing that N.J.A.C. 13:44F-7.2, which outlines requirements for returning to active status after a licensee has chosen to have his or her license renewed as inactive, and N.J.A.C. 13:44F-7.3, which imposes requirements for the reinstatement of a suspended license, be readopted without amendment.

Subchapter 8 contains general provisions. The Board is proposing to readopt N.J.A.C. 13:44F-8.1, which sets forth its fee schedule, without amendment. The Board notes that amendments have been proposed to N.J.A.C. 13:44F-8.1 as part of the proposed amendments to the temporary licensure rule which appeared in the New Jersey Register at 39 N.J.R. 1639(a). As noted above, the Board anticipates that the amendments proposed as part of that rulemaking will be adopted prior to the adoption of this proposal. N.J.A.C. 13:44F-8.2, which imposes requirements for the maintenance of patient records, and N.J.A.C. 13:44F-8.3, which delineates activities deemed to constitute sexual misconduct by licensees, are proposed to be readopted without amendment. The Board is making a technical amendment to N.J.A.C. 13:44F-8.4, which sets forth the mailing address for the Board office, and is also amending the rule to provide licensees with the Board website, in order to facilitate licensee access to relevant Board information. N.J.A.C. 13:44F-8.5 and 8.6, which outline notification requirements for a change of address and a change of name, respectively, and N.J.A.C. 13:44F-8.7, which details the procedure for obtaining a duplicate license, are proposed to be readopted without amendment.

Subchapter 9 addresses unlicensed practice. N.J.A.C. 13:44F-9.1, which delineates those acts deemed to constitute unlicensed practice, is proposed to be readopted without amendment. The Board is proposing to amend N.J.A.C. 13:44F-9.2, which makes it unlawful for a licensee to aid or assist any person engaged in the acts set forth in N.J.A.C. 13:44F-9.1, to provide that a licensee who supervises or manages the provision of respiratory care services by a licensed respiratory care practitioner shall ensure that all persons providing these services hold a valid and current license issued by the Board. Failure on the part of a licensee to ensure that a respiratory care practitioner working under his or her supervisory or management capacity holds a valid, current license to practice respiratory care will be deemed the aiding and abetting of unlicensed respiratory care practice.

The rules in Subchapter 10 set forth requirements for continuing education. N.J.A.C. 13:44F-10.1, which delineates the continuing education requirements with which licensees must comply for biennial license renewal, and N.J.A.C. 13:44F-10.2, which concerns the approval of continuing education courses and programs and the determination of credit, are proposed to be readopted without amendment. N.J.A.C. 13:44F-10.3, which outlines continuing education recordkeeping requirements for licensees and the Board's authority to conduct continuing education audits, and N.J.A.C. 13:44F-10.4, which outlines requirements for obtaining a waiver or a modification of continuing education requirements from the Board, are proposed to be readopted without amendment.

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 the existing rules, which have been in effect for the past five years, have protected the health, safety and welfare of the citizens of New Jersey by identifying those individuals who are qualified and legally authorized to provide respiratory care services. These rules establish the requisite standards of licensure in the State and positively affect the regulated community by clarifying the varied aspects of the practice of respiratory care for the benefit of all licensed practitioners of respiratory care and applicants for licensure. The readoption of N.J.A.C. 13:44F is essential in order for the Board to continue to regulate the practice of respiratory care, to identify those individuals who are qualified to engage in the practice, and to ensure that every licensee and applicant for licensure is aware of the procedures involved in the issuance of a license.

The readoption of N.J.A.C. 13:44F continues the accepted practice standards for licensed respiratory care practitioners established by the Board, and by so doing, provides licensees and applicants for licensure with a clear and comprehensive set of rules to guide them in their professional work. Applicants for licensure will benefit by having a set of rules which govern the manner in which they may qualify for licensure. The Board also believes that licensees will benefit from the rules proposed for readoption with amendments as a result of the uniform standards that will be applied throughout the field of respiratory care.

The Board believes that the rules proposed for readoption with amendments will have a positive impact upon the general public by continuing to safeguard the public health, safety and welfare by ensuring the maintenance of appropriate practice standards, which will enable licensees to provide the highest quality care in the performance of respiratory care services. The Board believes that the proposed amendments to N.J.A.C. 13:44F-3.2 may have an impact upon persons training to become respiratory care practitioners by allowing them to be supervised by a physician and a licensed respiratory care practitioner at the same time, thereby possibly enhancing the level of supervision they receive. The proposed amendments to N.J.A.C. 13:44F-3.3 may have an impact upon licensees and the unlicensed assistants to whom licensees delegate respiratory care tasks. The proposed amendments will clarify what tasks may be delegated and the obligations imposed upon delegating licensees with respect to training and follow up monitoring of such unlicensed assistants.

The proposed amendment to N.J.A.C. 13:44F-4.1 may have an impact upon applicants for licensure who apply for initial licensure more than three years following completion of the mandatory training program, to the extent that such applicants will be required to take a refresher course to ensure their clinical competency prior to being granted a license. The proposed amendment will positively impact consumers by ensuring that those applicants granted a license to provide respiratory care services in the State have the clinical skills necessary to competently render such services.

The proposed amendment to N.J.A.C. 13:44F-8.4 may have an impact upon licensees to the extent that the inclusion of the Board's website in the rule may provide licensees who were previously unaware of the website's existence with an avenue by which to obtain relevant information about the Board and its operations. The Board also believes that the proposed amendment to N.J.A.C. 13:44F-9.2 may have an impact upon licensees who act as supervisors or managers of respiratory care practitioners to the extent that these supervising or managing licensees may now be deemed to be aiding and abetting unlicensed practice if licensees working for them practice with an expired or suspended license.

Economic Impact

The Board anticipates that the proposed readoption with amendments of the rules in chapter 44F will not impose any new or additional significant costs upon applicants for licensure, licensees, or consumers. The proposed readoption of the existing rules will continue the economic impact that the rules have had on such persons for the past five years. Specifically, N.J.A.C. 13:44F-3.1 will continue to have an economic impact upon licensees to the extent that a licensee may perform only those activities that fall within the scope of practice outlined in the rule. In addition, N.J.A.C. 13:44F-3.3, as proposed to be amended, may have an economic impact upon licensees to the extent that the delegation of respiratory care services outlined in the rule may provide a licensee with greater flexibility in his or her practice. The proposed amendment in N.J.A.C. 13:44F-3.3, which will require licensees who choose to delegate tasks to unlicensed assistants to ensure that such assistants are re-evaluated on an annual basis, may economically impact licensees to the extent that they incur costs associated with this training and re-evaluation.

The proposed readoption of N.J.A.C. 13:44F-4.1 and 4.2 will continue to have an economic impact upon applicants for licensure to the extent that they will incur costs in submitting the documentation required for licensure and with taking the required licensure examination. The proposed amendment to N.J.A.C. 13:44F-4.1 may have an economic impact upon applicants for licensure applying to the Board more than three years following the completion of their required training. Such applicants will now be required to take a refresher course. The proposed readoption of N.J.A.C. 13:44F-5.1 may have an economic impact upon applicants for temporary licensure to the extent that they incur costs associated with submitting the documentation required for this license. Such applicants will also still be required to remit a fee in order to obtain a temporary license.

The proposed readoption of the rules in Subchapter 6 will continue to have an economic impact upon applicants for licensure by endorsement to the extent such applicants incur costs in satisfying the eligibility requirements outlined in N.J.A.C. 13:44F-6.1, and the application requirements outlined in N.J.A.C. 13:44F-6.2.

The proposed readoption of N.J.A.C. 13:44F-7.1, concerning licensure renewal and suspension, may have an economic impact upon licensees, to the extent that licensees who submit their renewal applications within 30 days of their license expiration date must submit a late fee, in addition to the standard license renewal fee charged by the Board. In addition, licensees who have had their licenses suspended for failure to renew within 30 days of the license expiration date may incur additional costs if they wish to have their license reinstated. N.J.A.C. 13:44F-7.2, concerning inactive licensure status, may also have an economic impact upon licensees who choose to renew their licenses with the designation of inactive status, to the extent that such persons who wish to resume the active practice of respiratory care may experience the economic costs associated with filing the required application and with completing the continuing education requirements specified in the rule prior to resumption of practice. In addition, N.J.A.C. 13:44F-7.3 requires a licensee seeking reinstatement from a license suspension to submit a reinstatement application, a reinstatement fee, all past due renewal fees, and if applying more than five years following the expiration of the license, evidence of having re-passed the Board's licensing examination. Applicants for reinstatement must also have completed all applicable continuing professional education requirements prior to reinstatement. N.J.A.C. 13:44F-8.1, which sets forth the Board's fee schedule, will continue to have an economic impact upon licensees and applicants for licensure to the extent that such persons will be required to remit to the Board the fees specified in the rule. The proposed readoption of N.J.A.C. 13:44F-8.2 may have an economic impact upon licensees to the extent that they incur administrative costs associated with creating, maintaining and releasing patient records as outlined in the rule. The proposed readoption of N.J.A.C. 13:44F-8.5 and 8.6, which require notification be given to the Board of a change of address or name, respectively, may have an economic impact upon licensees to the extent that such licensees may incur costs associated with notifying the Board of such changes. The proposed readoption of N.J.A.C. 13:44F-8.7 may have an economic impact upon licensees seeking duplicate licenses to the extent that such licensees will be required to submit the documentation and fees outlined in the rule prior to obtaining a duplicate license.

The proposed amendment to N.J.A.C. 13:44F-9.2, which requires a licensee who supervises or manages the provision of respiratory care services by other Board licensees to ensure that Board licensees working under his or her direction hold valid licenses, may have an economic impact upon supervising or managing licensees because the rule makes failure to do so the aiding and abetting of unlicensed practice. Such a finding could result in the imposition of monetary penalties upon the supervising or managing licensee.

N.J.A.C. 13:44F-10.1, concerning continuing education requirements, will continue to impose economic costs upon licensed respiratory care practitioners to the extent that licensees must satisfy the continuing education requirements outlined in the rule during each biennial renewal period. The proposed readoption of N.J.A.C. 13:44F-10.3 may have an economic impact upon licensees to the extent that licensees incur costs associated with maintaining continuing education records as outlined in the rule. In addition, licensees may incur costs associated with submitting requests for waivers or modifications of continuing education requirements, which must include substantiating documentation, as required pursuant to N.J.A.C. 13:44F-10.4.

Federal Standards Statement

A Federal standards analysis is not required because the rules proposed for readoption with amendments are governed by N.J.S.A. 45:14E-1 et seq., and are not subject to any Federal standards or requirements.

Jobs Impact

The Board does not anticipate that the rules proposed for readoption with amendments will affect the number of applicants for licensure as respiratory care practitioners in the State. Therefore, the Board does not anticipate that the rules proposed for readoption with amendments will result in an increase or decrease in the number of jobs in the State.

Agriculture Industry Impact

The Board does not anticipate that the rules proposed for readoption with amendments will have any impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

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 readoption with amendments of the rules in Subchapter 3 will continue to impose recordkeeping and compliance requirements upon licensed respiratory care practitioners. N.J.A.C. 13:44F-3.1 requires all licensees to provide services consistent with the scope of practice set forth in the rule. N.J.A.C. 13:44F-3.2 requires a licensee supervising a respiratory care trainee who is providing patient care to inform the patient that the person rendering care is a trainee. N.J.A.C. 13:44F-3.3 prohibits a licensee from delegating any tasks not enumerated in the rule to an unlicensed assistant. In addition, N.J.A.C. 13:44F-3.3 requires a licensee who chooses to delegate tasks to unlicensed assistants to keep detailed training records for such persons. As proposed to be amended, N.J.A.C. 13:44F-3.3 also requires the licensee to re-evaluate the training of such persons on an annual basis and to retain documentation of this retraining in the assistants' files. N.J.A.C. 13:44F-3.3 continues to require a licensee who delegates respiratory care tasks in an outpatient setting to provide a follow-up visit within 24 hours of the delivery of equipment in order to conduct an in-person assessment of the equipment. The follow-up visit must be documented in writing and must be maintained for one year following the termination of respiratory care services. Such documentation must also be made available to the Board for inspection within 12 hours of the Board's request.

N.J.A.C. 13:44F-4.1 imposes various compliance requirements upon applicants for initial licensure as respiratory care practitioners. Pursuant to the rule, an applicant for initial licensure must submit proof to the Board that he or she holds a high school diploma or its educational equivalent, has successfully completed a training program accredited by the Committee on Accreditation for Respiratory Care or its successor, and has passed the Board's licensure examination within five years of the date of application. As proposed to be amended, N.J.A.C. 13:44F-4.1 will also require an applicant for licensure applying more than three years following the completion of the training program to take a refresher course if the applicant has not been engaged in the practice of respiratory care in another state or jurisdiction. N.J.A.C. 13:44F-5.1 will continue to impose various compliance requirements upon persons applying for temporary licensure. A person granted a temporary license is required to work under the direct supervision of a physician or licensed respiratory care practitioner. The temporary license holder must advise the Board, in writing, of the name and permanent license number of the licensee under whose direct supervision the temporary licensee will be working, and must advise the Board, in writing, of any subsequent change in the supervising licensee. A temporary licensee is required to take the licensing examination within six months of being issued a temporary license unless he or she can demonstrate hardship to the Board. A temporary licensee is also required to have his or her licensing examination results forwarded to the Board. A temporary licensee must submit an initial license fee within 10 days of being notified that he or she has passed the licensing examination.

N.J.A.C. 13:44F-6.2 continues to impose compliance requirements upon applicants for licensure by endorsement. Such applicants must submit an application, the required fee, proof which establishes that the applicant holds a license in good standing from another state or possession of the United States or the District Columbia, and an affidavit that the applicant has not failed the Board-approved licensing examination.

The rules in Subchapter 7 will continue to impose various compliance requirements upon licensed respiratory care practitioners. N.J.A.C. 13:44F-7.1 requires licensees to remit their renewal applications to the Board, along with the specified renewal fee, prior to the date of their license expiration. If a licensee submits the renewal application within 30 days following the date of his or her license expiration, he or she must also submit a late fee with the application. If a licensee fails to submit the renewal application within 30 days of the license expiration date, he or she must cease engaging in the practice of respiratory care because his or her license is considered suspended. A licensee electing to renew his or her license as inactive is required to pay the inactive renewal fee and is prohibited from engaging in the practice of respiratory care for that biennial licensing period. Pursuant to N.J.A.C. 13:44F-7.2, a licensee who elected inactive status and wishes to resume the active practice of respiratory care must submit a reinstatement application, a reinstatement fee and evidence of compliance with the continuing education or examination requirements outlined in the rule. N.J.A.C. 13:44F-7.3 requires a licensee applying for reinstatement within five years of a suspension for failure to renew to submit a reinstatement application, a reinstatement fee, all past delinquent renewal fees, an affidavit of employment, and evidence of having completed all relevant continuing education requirements. A licensee applying for reinstatement more than five years after license suspension for failure to renew must also retake and pass the Board's licensing examination. The rules in Subchapter 8 will continue to impose reporting and compliance requirements upon Board licensees. N.J.A.C. 13:44F-8.2 requires licensees to prepare and maintain patient treatment records as outlined in the rule. Licensees are required to make such treatment records available to patients. N.J.A.C. 13:44F-8.2 also requires a licensee employed in a setting regulated by the Department of Health and Senior Services to comply with all applicable Department of Health and Senior Services regulations. N.J.A.C. 13:44F-8.3 prohibits a licensee from engaging in or soliciting sexual contact, or from engaging in any of the other activities outlined in the rule, with a patient with whom the licensee has a patient-respiratory care practitioner relationship. The rule also requires a licensee to provide examination conditions which safeguard a patient's privacy. N.J.A.C. 13:44F-8.5 requires a licensee to notify the Board in writing, by certified mail, of any change in the licensee's address. This notification must be submitted to the Board within 30 days of the change of address. N.J.A.C. 13:44F-8.6 requires any licensee whose name has been legally changed to send to the Board legal evidence of the name change, a copy of the licensee's original license, and a duplicate license fee. This submission must be sent to the Board by certified mail no later than 30 days following the name change. N.J.A.C. 13:44F-8.7 requires a licensee seeking a duplicate license to submit a notarized statement to the Board that the license has been lost, along with the duplicate license fee. N.J.A.C. 13:44F-9.2 continues to impose compliance requirements upon licensees. Under the rule, it is unlawful for a licensee to aid or assist any person in engaging in the activities or practices set forth in N.J.A.C. 13:44F-9.1. In addition, the proposed amendment to N.J.A.C. 13:44F-9.2 will impose compliance requirements upon a licensee who supervises or manages the provision of respiratory care services by other Board licensees. As proposed to be amended, N.J.A.C. 13:44F-9.2 requires the supervising or managing licensee to ensure that all persons providing respiratory services under his or her supervision or management holds a valid and current license issued by the Board. Failure on the part of the licensee to ensure that a respiratory care practitioner working under his or her supervisory or management capacity holds a valid, current license to practice respiratory care will be deemed the aiding and abetting of unlicensed respiratory care practice.

The rules in Subchapter 10 will continue to impose recordkeeping and compliance requirements upon licensees. N.J.A.C. 13:44F-10.1 continues to require all licensees to complete 30 continuing education credits, as set forth in the rule. N.J.A.C. 13:44F-10.3 requires a licensee to certify to the completion of the required continuing education credits on his or her application for license renewal. A licensee is also required to maintain documentation to verify completion of the continuing education requirements for two full biennial renewal periods after the completion of the credits. Such documentation must be submitted to the Board upon request. N.J.A.C. 13:44F-10.4 requires a licensee seeking an extension, waiver or other modification of the continuing education requirements to apply to the Board in writing, by certified mail, and to submit documentation to substantiate the request. Such requests must be filed no later than 60 days prior to the end of the biennial licensing period.

No additional professional services will be needed to comply with the rules proposed for readoption with amendments. In addition, the Board does not believe that there will be any significant, additional economic impact upon licensees as a result of the rules proposed for readoption with amendments. The costs of compliance with the rules proposed for readoption with amendments are discussed in the Economic Impact statement above. The Board believes that the rules proposed for readoption with amendments should be uniformly applied to all licensees in order to ensure the health, safety and welfare of the general public in the provision of respiratory care services and, therefore, no differing compliance requirements for any licensee are provided based upon the size of the business.

Smart Growth Impact

The Board does not believe that the rules proposed for readoption with amendments 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 readoption may be found in the New Jersey Administrative Code at N.J.A.C. 13:44F.

Full text of the proposed amendments follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):

13:44F-1.2 Definitions

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

"Respiratory care" means the health specialty involving the treatment, disease management, control, and care of patients with deficiencies and abnormalities of the [cardiopulmonary] cardiac and pulmonary system, as further defined in N.J.S.A. 45:14E-3(c).

13:44F-3.1 Scope of practice

(a) For the purposes of treating, managing, controlling and caring for patients with deficiencies and abnormalities of the [cardio-respiratory] cardiac and pulmonary system, a respiratory care practitioner may perform the following duties under the direction or supervision of a physician:

1.-4. (No change.)

5. Use of apparatus for [cardio-respiratory] cardiopulmonary support and control;

6.-10. (No change.)

11. Insertion and maintenance of artificial airways[;] and insertion and maintenance of peripheral arterial and peripheral venous catheters;

12. Testing techniques to assist in diagnosis, monitoring, treatment and research including, but not limited to:

i. Measurement of [cardio-respiratory] cardiopulmonary volumes, pressure and flow; and

ii. (No change.)

[iii. Establishment and maintenance of arterial lines, provided the licensee is appropriately trained in this procedure; and]

13. (No change.)

(b)-(d) (No change.)

13:44F-3.2 Practice by trainees

(a) A trainee may perform those duties essential for completion of his or her clinical service, without having to obtain a license, provided the duties are performed under the direction of a physician, as defined in N.J.A.C. 13:44F-3.1(b)1 and 2, and the supervision of a physician as defined in N.J.A.C. 13:44F-3.1(d), and/or under the direct supervision of a licensed respiratory care practitioner, as defined in N.J.A.C. 13:44F-5.1.

(b) (No change.)

13:44F-3.3 Delegation by a respiratory care practitioner to unlicensed persons

(a) For the purposes of this section, the following words shall have the following meanings unless the context clearly indicates otherwise and except as otherwise expressly provided:

"Assistant" means a respiratory assistant, respiratory aide, equipment technician or any other unlicensed person to whom a licensed respiratory care practitioner delegates tasks as set forth in [(b)] (d) below.

[(b) Activities which a licensed respiratory care practitioner may delegate to individuals employed as assistants are limited to the following routine tasks which relate to the cleanliness and maintenance of equipment:

1. Disassembling equipment;

2. Cleaning equipment;

3. Preparing equipment for sterilization;

4. Maintaining oxygen cylinder and other specialty gas cylinders; and

5. Making oxygen checks and charges.

i. An assistant who has received a level of training to ensure that the assistant can satisfactorily complete activities set forth in (b) above may set up, test, exchange and demonstrate equipment relating to oxygen delivery systems, except that a licensed respiratory care practitioner shall not permit an assistant to set up, test, exchange or demonstrate the equipment when oxygen is to be used on any life support system. This includes mechanical ventilation, either positive or negative pressure, with or without artificial airways, in use continuously or intermittently.

ii. In performance of the tasks enumerated in (b)5i above, the assistant is limited to basic oxygen delivery devices and shall not perform these duties in conjunction with any other respiratory therapy equipment.]

[(c)] (b) A licensed respiratory care practitioner [shall ensure that an assistant who performs the activities set forth in (b) above shall first receive] may delegate the tasks set forth in (d) below to an individual employed as an assistant, provided the assistant has received a level of training necessary to ensure that the assistant can satisfactorily complete the outlined activities.

1. The licensed respiratory care practitioner shall ensure that training records are completed and kept in the [employee's] assistant's file. The training records shall include the following:

i.-iii. (No change.)

iv. Whether the [employee] assistant demonstrated satisfactory skill in each task.

2. The licensed respiratory care practitioner shall ensure that an assistant to whom the tasks set forth in (d) below are delegated is reevaluated on an annual basis to ensure continued competency to perform the outlined activities. Documentation related to such reevaluation shall be included in the assistant's file.

[(d)] (c) A licensed respiratory care practitioner shall not authorize or permit an [unlicensed person] assistant to engage in direct patient care.

(d) Activities which a licensed respiratory care practitioner may delegate to assistants are limited to the following routine tasks:

1. Processing, cleaning and sterilizing basic respiratory equipment;

2. Maintaining and safe handling of oxygen and specialty gas cylinders and oxygen concentrators; 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.

(e) A licensed respiratory care practitioner shall be responsible for any activities which an assistant performs pursuant to [(b)] (d) above.

[(f) The licensed respiratory care practitioner who delegates tasks as set forth in (b) above in an inpatient setting shall, prior to patient use, conduct an in-person assessment of the equipment and its application to the patient to ensure that the assistant has performed the delegated setup tasks such that the equipment and other devices are safe for patient care.]

[(g)] (f) The licensed respiratory care practitioner who delegates tasks set forth in [(b)] (d) above in an outpatient setting shall ensure that a follow-up visit from a licensee or a person exempt from respiratory care licensure pursuant to N.J.S.A. 45:14E-9(c) takes place within 24 hours of the delivery of the equipment to the patient for the purpose of conducting an in-person assessment of the equipment. The follow-up visit shall be documented in writing.

1.-2. (No change.)

13:44F-4.1 Eligibility for licensure

(a) (No change.)

(b) An applicant shall submit, with the completed application form and the required fee, satisfactory proof that the applicant:

1. (No change.)

2. Has successfully completed a training program accredited by the Committee on Accreditation for Respiratory Care (CoARC) or its successor;[and]

i. If an applicant for licensure is applying more than three years following completion of the training program, the applicant shall submit proof of having completed a refresher course approved by the Board. The refresher course shall not be required if the applicant submits proof that he or she has been engaged in the practice of respiratory care in another state or jurisdiction since the completion of the training program; and

3. (No change.)

13:44F-8.4 Office location; Board information

(a) The offices of the Board are located at 124 Halsey Street, PO Box [45301] 45031, Newark, New Jersey 07102.

(b) Information related to Board operations may be obtained at the following website: www.state.nj.us/lps/ca/medical/respcare.htm.

13:44F-9.2 Aiding and abetting unlicensed practice

(a) It shall be unlawful for a licensee to aid or assist any person engaging in any of the practices identified at N.J.A.C. 13:44F-9.1.

(b) A licensee who supervises or manages the provision of services by licensed respiratory care practitioners shall ensure that all persons providing such services hold a valid, current license issued by the Board. Failure on the part of a licensee to ensure that a respiratory care practitioner working under his or her supervisory or management capacity holds a valid, current license to practice respiratory care shall be considered the aiding and abetting of unlicensed respiratory care practice.



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