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NEW JERSEY REGISTER
VOLUME 36, NUMBER 7
MONDAY, APRIL 5, 2004
RULE PROPOSAL

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
BOARD OF MEDICAL EXAMINERS
PERFUSIONISTS ADVISORY COMMITTEE

Proposed New Rules: N.J.A.C. 13:35-13

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

Authority: N.J.S.A. 45:9-37.94 et seq.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2004-139.

Submit written comments by June 4, 2004 to:

William V. Roeder

Executive Director

New Jersey State Board of Medical Examiners

PO Box 183

Trenton, New Jersey 08625-0183

The agency proposal follows:

Summary

The Perfusionist Licensing Act (Act), N.J.S.A. 45:9-37.94 et seq., became effective on June 24, 1999. The new law provides for the regulation of the practice of perfusion and for the establishment of licensure standards for perfusionists. The Act created within the Division of Consumer Affairs in the Department of Law and Public Safety, under the State Board of Medical Examiners, a Perfusionists Advisory Committee. In order to implement the provisions of the Act, the Board proposes a new subchapter of rules, N.J.A.C. 13:35-13.

Proposed new rule N.J.A.C. 13:35-13.1 sets forth the purpose and scope of the rules, which are to apply to all applicants seeking licensure as a perfusionist and all perfusionists licensed in the State. The rule identifies certain individuals who are not subject to the regulatory requirements, which include individuals licensed to practice under other laws who are engaging in the practice for which they are licensed and students enrolled in bona fide perfusion programs recognized by the committee.

Proposed new N.J.A.C. 13:35-13.2 defines a number of key words and phrases as they are used in the subchapter. Among key words and phrases defined are "Board," "Committee," "licensee," "perfusionist," and "perfusion." "Board" is defined as the State Board of Medical Examiners. "Committee" means the Perfusionists Advisory Committee established pursuant to the Act. "Licensee" is defined as an individual holding a license issued by the Perfusionists Advisory Committee under the State Board of Medical Examiners. "Perfusionist" is defined as a person who is licensed to practice perfusion pursuant to the provisions of the Act. "Perfusion" is defined generally to mean the functions necessary for the support, treatment, measurement or supplementation of the cardiovascular, circulatory or respiratory system or other organs, or a combination of those activities, and to ensure the safe management of physiologic functions by monitoring and analyzing the parameters of the systems under an order and under the supervision of a licensed physician.

Proposed new rule N.J.A.C. 13:35-13.3 sets forth the physical and mailing address of the office of the Committee.

Proposed new rule N.J.A.C. 13:35-13.4 requires licensees to notify the Committee in writing of any change of the licensee's address of record within 30 days of the date the address of record is changed. Failure to do so may result in disciplinary action. Service at the licensee's address of record is deemed sufficient notice for the commencement of disciplinary proceedings.

Proposed new rule N.J.A.C. 13:35-13.5 provides the standards under which a person can apply for licensure as a perfusionist under grandfathering. The application for licensure under grandfathering must be submitted within 180 days of this section taking effect.

Proposed new N.J.A.C. 13:35-13.6 provides the licensing requirements for a perfusionist. To be eligible for licensure, an applicant must be at least 18 years of age, be of good moral character, and have successfully completed an approved perfusion education program and a certification examination.

Proposed new N.J.A.C. 13:35-13.7 would allow any person who submits an application for perfusionist licensure within six months of the effective date of these rules to continue to practice as a perfusionist until the application is approved or denied by the Committee. Any person who engages in the practice of perfusion six months after the effective date of these rules without submitting an application for licensure as a perfusionist shall be deemed to be engaged in the unlicensed practice of perfusion.

Proposed new rule N.J.A.C. 13:35-13.8 provides for licensure by reciprocity. A perfusionist with a valid license, registration or certification issued by another state or possession of the United States, or the District of Columbia, may, upon application and payment of a fee, be issued a perfusionist license without examination provided that the education, training and examination requirements in the other jurisdiction are substantially equivalent to those required in New Jersey and that the license in the other jurisdiction is current, active and in good standing.

Proposed new rule N.J.A.C. 13:35-13.9 prohibits a person from engaging or offering to engage in the practice of perfusion in the State of New Jersey unless the person holds a New Jersey license. The section also prohibits any person from using the title "perfusionist" or the abbreviation "LP" or any other title, designation, words, letters, abbreviations or insignia indicating the practice of perfusion, unless the person holds a New Jersey license to practice perfusion.

Proposed new rule N.J.A.C. 13:35-13.10 provides for temporary licensure and contains the application requirements for a temporary license. A person who is at least 18 years of age, is of good moral character who has successfully completed an approved education program but has not yet passed the certificate examination may apply for a temporary license. A perfusionist with a temporary license shall practice perfusion only under the direct supervision of a licensed perfusionist. The rule defines the term "direct supervision," establishes standards for individuals who may supervise a temporary licensee, and sets forth provisions detailing activities a temporary licensee may render in the event of an emergency situation which potentially threatens the life or well being of a patient during an unanticipated absence of a supervising licensed perfusionist.

Proposed new rule N.J.A.C. 13:35-13.11 concerns license renewal. Licenses to practice perfusion will be valid for two years. Renewal applications along with the license renewal fee shall be submitted prior to the expiration of the current license, along with a certification that the applicant has successfully completed any required continuing education. This section also provides for inactive status and late renewals.

Proposed new rule N.J.A.C. 13:35-13.12 sets forth the showings a licensee must make to return to active status after a licensee has elected inactive status. In order to return to active status, the applicant shall make application to the Committee, pay the renewal fee, present proof of completion of the continuing education credits which would have been required for license renewal at the time the licensee elected inactive status, and an additional 15 continuing education credits for each year the licensee was on inactive status. Additional requirements for a licensee seeking to return to active status after being on inactive status for more than one year are also set forth in this section.

Proposed new rule N.J.A.C. 13:35-13.13 contains the requirements for reinstatement after the suspension of a license for non-renewal of a biennial license. The applicant for reinstatement must submit to the Committee a completed reinstatement application, pay all past delinquent renewal fees, pay a reinstatement fee, submit an affidavit on a form provided by the Committee that states whether or not the applicant has been practicing perfusion in this or any other state, an affidavit verifying completion of the continuing education credits required for the renewal of an active license, and, if the applicant has been practicing perfusion, affidavit(s) from all the applicant's employer(s) on a form provided by the Committee. Additional requirements for a licensee seeking to reactivate a license suspended for more than one year are set forth in this section.

Proposed new rule N.J.A.C. 13:35-13.14 requires a licensee to report any change in status at each licensed health care facility with which the licensee is affiliated. This section further requires licensees to notify the Committee in writing of any changes in circumstances which would alter the licensee's answer to questions on the biennial renewal form eliciting information pertaining to pending or finalized actions. This section lists actions to be reported, to include actions by law enforcement authorities for statutory or regulatory violations, actions by the Department of Health and Senior Services, and entry of judgment or settlements in any malpractice actions. Proposed N.J.A.C. 13:35-13.14 also provides that a licensee is to notify the Committee of any changes in circumstances which would alter the licensee's responses to questions on the last biennial renewal pertaining to medical conditions and the use of chemical substances which would impair the licensee's ability to practice. Failure by the licensee to provide the Committee with the information required by this section may be deemed professional conduct.

Proposed new rule N.J.A.C. 13:35-13.15 lists acts which may be a basis for the Board may refuse to grant or to suspend or revoke a license to practice perfusion. These include using procedures and/or acting in a manner inconsistent with the practice of perfusion, engaging in repeated acts of negligence, malpractice or incompetence, having authority to engage in the practice of perfusion revoked or suspended by any other state, agency or authority for reasons consistent with this subchapter, and engaging in present drug or alcohol use that is likely to impair the licensee's ability to practice.

Proposed new rule N.J.A.C. 13:35-13.16 addresses the requirement for continuing education credit. This section requires licensees applying for biennial license renewal to have completed during the proceeding biennial period 30 continuing education credits as specified under this section. The proposed rule provides that the Committee may direct a licensee to complete continuing education credits to correct a deficiency in their continuing education requirements. The proposed rule lists where licensees may obtain continuing education credits. These sources include: programs, courses or seminars approved by the Committee; courses approved by the American Board of Cardiovascular Perfusion (ABCP); professional presentations consisting of new courses specifically related to perfusion; and authorship of peer reviewed textbooks, articles or manuals specifically related to perfusion. The proposed rule states how credit for continuing education shall be granted and how the licensee is to report continuing education credit hours. The proposed rule also delineates how sponsors of continuing education courses may seek Committee approval.

Proposed new rule N.J.A.C. 13:35-13.17 sets forth the schedule of fees which may be assessed by the Committee.

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.

Social Impact

The proposed rules will promote the health and welfare of the citizens of New Jersey by identifying individuals qualified and legally authorized to engage in the practice of perfusion.

Adoption of the subchapter is essential for the Committee to identify those individuals who are qualified to render perfusion services.

Economic Impact

The rules will have a direct economic impact upon all licensees by imposing fees for application, licensure, renewal, late renewal, reinstatement, endorsement, duplicate wall certificate, change of address, and verification of licensure, certification, and continuing education credits.

The rules will have an indirect economic impact on continuing education providers in the minor administrative costs they will incur in order to submit their courses, programs, or services for approval by the Committee.

Federal Standards Statement

A Federal standards analysis is not necessary as there are no Federal standards or requirements applicable to the proposed new rules. The Board proposes these rules pursuant to the rulemaking authority set forth in N.J.S.A. 45:9-37.94.

Jobs Impact

The Board believes that the proposed new rules will not result in the generation or loss of jobs.

Agriculture Industry Impact

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

Regulatory Flexibility Analysis

The Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq., requires the Board to give a description of the types and an estimate of the number of small businesses to which the new rules will apply. If perfusionists are considered "small businesses" for the purposes of the Act, 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 necessary to comply with the requirements. The Act further requires the Board to estimate the initial and annual compliance costs of the proposed rules with an indication of the varying impact on small businesses of differing types and sizes. In addition, the Act requires the Board to outline the manner in which it designed the rules to minimize any adverse economic impact upon small businesses.

Proposed N.J.A.C. 13:35-13.4 requires that a perfusionist must report an address change to the Committee.

Proposed N.J.A.C. 13:35-13.14 imposes ongoing reporting requirements. A licensee must keep the Committee appraised of any change in status at a licensed health care facility that they are affiliated with and of any changes in circumstances which would alter the response last provided by to license to questions on the biennial renewal form eliciting information pertaining to pending or finalized actions and of any changes in circumstances which would alter the response last provided by the licensee to questions on the biennial renewal form pertaining to medical conditions and the use of chemical substances which may limit or impair the licensee's ability to practice.

Proposed N.J.A.C. 13:35-13.5 contains the requirements for licensure under the grandfather clause.

To comply with proposed N.J.A.C. 13:35-13.6, each applicant for licensure must supply the Committee with certain information in order to be eligible for licensure.

A perfusionist seeking licensure by reciprocity must comply with proposed N.J.A.C. 13:35-13.8.

All licensees must adhere to the biennial renewal standards contained in proposed N.J.A.C. 13:35-13.11. All applicants for renewal must also satisfy the continuing education requirements contained at proposed N.J.A.C. 13:35- 13.16.

The standards for returning to active status for a licensee who has elected inactive status are at proposed N.J.A.C. 13:35-13.12.

A perfusionist seeking reinstatement of a license suspended for nonrenewal of a biennial license must comply with N.J.A.C. 13:35-13.13.

Finally, all licensees, certificate holders and applicants must continue to forward the appropriate fees to the Board pursuant to the proposed fee schedule set forth in N.J.A.C. 13:44G-14.1.

No additional professional services will be necessary for perfusionists to comply with the proposed new rules.

The Committee has designed the rules to minimize adverse economic impact upon perfusionists by imposing only that level of professional fees necessary to defray its expenses. Because the Committee has designed the rules to further the health, welfare, and safety of all persons who receive perfusionists services, the rules must be applied uniformly to all practitioners.

Smart Growth Impact

The proposed new rules will have no impact on the achievement of smart growth or the implementation of the State Development and Redevelopment Plan.

Full text of the proposed new rules follows:

SUBCHAPTER 13. PERFUSIONISTS ADVISORY COMMITTEE

<< NJ ADC 13:35-13.1 >>

13:35-13.1 Purpose and scope

(a) This subchapter implements the Perfusionist Licensing Act, N.J.S.A. 45:9-37.94 et seq., and shall apply to all applicants seeking licensure as a perfusionist and all perfusionists licensed in the State of New Jersey.

(b) This subchapter shall not apply to any person:

1. Licensed to practice under any other law and who is engaging in the practice for which he or she is licensed, registered or certified;

2. Enrolled as a student in a bona fide perfusion training program recognized by the Committee in performing those duties which are necessary for the student's course of study, provided the duties are performed under the supervision and direction of a licensed perfusionist;

3. Practicing perfusion within the scope of his or her official duties when employed by an agency, bureau or division of the Federal government, serving in the Armed Forces or the Public Health Service of the United States, or employed by the Veterans Administration; or

4. Performing autotransfusion or blood conservation techniques under the supervision of a licensed physician.

<< NJ ADC 13:35-13.2 >>

13:35-13.2 Definitions

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

"Act" means the Perfusionist Licensing Act, N.J.S.A. 45:9-37.94 et seq.

"Address of record" means an address designated by a licensee which is part of the public record and which may be disclosed upon request made to the Committee. "Address of record" may be a licensee's home, business, mailing address, or a post office box.

"Board" means the State Board of Medical Examiners.

"Committee" means the Perfusionists Advisory Committee established pursuant to section 4 of P.L. 1999, c.126 (N.J.S.A. 45:9-37.97 et seq.)

"Licensee" means an individual holding a license issued by the Perfusionist Advisory Committee under the State Board of Medical Examiners.

"Extracorporeal circulation" means the diversion of a patient's blood through a heart-lung machine or a similar device that assumes the functions of the patient's heart, lungs, kidney, liver or other organs.

"Perfusionist" means a person who is licensed to practice perfusion pursuant to the provisions of P.L. 1999, c.126 (N.J.S.A. 45:9-37.94 et seq.).

"Perfusion" means the functions necessary for the support, treatment, measurement or supplementation of the cardiovascular, circulatory or respiratory system or other organs, or a combination of those activities, and to ensure the safe management of physiologic functions by monitoring and analyzing the parameters of the systems under an order and under the supervision of a licensed physician, including:

1. The use of extracorporeal circulation, long-term cardiopulmonary support techniques including extracorporeal carbon-dioxide removal and extracorporeal membrane oxygenation, and associated therapeutic and diagnostic technologies;

2. Counterpulsation, ventricular assistance, autotransfusion, blood conservation techniques, myocardial and organ preservation, extracorporeal life support and isolated limb perfusion;

3. The use of techniques involving blood management, advanced life support and other related functions;

4. In the performance of the activities described above, the administration of:

i. Pharmacological and therapeutic agents;

ii. Blood products or anesthetic agents through the extracorporeal circuit or through an intravenous line as ordered by a physician;

5. In the performance of the activities described above, the performance and use of:

i. Anticoagulation monitoring and analysis;

ii. Physiologic monitoring and analysis;

iii. Blood gas and chemistry monitoring and analysis;

iv. Hematologic monitoring and analysis;

v. Hypothermia;

vi. Hyperthermia;

vii. Hemoconcentration and hemodilution;

viii. Modified extracorporeal circulatory hemodialysis; and

6. The observation of signs and symptoms related to perfusion services, the determination of whether the signs and symptoms exhibit abnormal characteristics and the implementation of appropriate reporting, perfusion protocols, or changes in or the initiation of emergency procedures.

<< NJ ADC 13:35-13.3 >>

13:35-13.3 Office of the Committee

The office of the Committee shall be maintained at 124 Halsey Street, Newark, New Jersey. The mailing address of the Committee is PO Box 45049, Newark, New Jersey 07101.

<< NJ ADC 13:35-13.4 >>

13:35-13.4 Notification of change of address and record

(a) Licensees shall notify the Committee in writing of any change of the licensee's address of record from the address filed with the Committee and shown on the most recently issued certificate. Such notice shall be sent to the Committee no later than 30 days following the date on which the address of record is changed. If a PO Box is used as the address of record, the licensee must also provide the committee with another address which includes a street, city, state and zip code.

(b) Failure to notify the Committee of any change of the address of record pursuant to (a) above may result in disciplinary action in accordance with N.J.S.A. 45:1-21(h).

(c) Service of an administrative complaint or other Board or Committee- initiated process at the licensee's address of record on file with the Committee shall be deemed adequate notice for the purposes of N.J.A.C. 1:1- 7.1 and the commencement of any disciplinary proceedings.

<< NJ ADC 13:35-13.5 >>

13:35-13.5 Licensure under grandfathering

(a) Upon submission of an application provided by the Committee for licensure as a perfusionist and payment of the application fee set forth at N.J.A.C. 13:35-13.17, the Committee shall issue a license to any person who applies for licensure within 180 days from (effective date of this section) and submits documentation demonstrating that the applicant has at least five years experience immediately preceding the submission of the application for licensure, operating cardiopulmonary bypass systems for cardiac surgical patients as the applicant's primary function in a licensed health care facility.

1. An applicant who is certified by the American Board of Cardiovascular Perfusion (the "ABCP") shall be deemed to have demonstrated that he or she has the requisite experience operating cardiopulmonary bypass systems for cardiac surgical patients as his or her primary function in a health care facility provided that the applicant submits evidence that he or she has performed not less than 40 perfusion procedures per calendar year.

2. An applicant who is not ABCP certified shall be deemed to have demonstrated that he or she has the requisite experience operating cardiopulmonary bypass systems for cardiac surgical patients as his or her primary function in a health care facility provided that the applicant submits evidence that he or she has performed not less than 75 perfusion procedures per calendar year.

(b) An applicant for licensure under (a) above shall complete a clinical activity report form provided by the Committee. The applicant shall list on the clinical activity report each perfusion procedure he or she performed for which experience credit is claimed, within the five years preceding the date of application and shall, for each procedure listed, provided information to include:

1. The date on which the procedure was performed;

2. The medical record number of the procedure performed;

3. A description of the procedure performed;

4. The name of the surgeon who performed the procedure; and

5. The health care facility at which the procedure was performed.

(c) All application materials and fees required under this section shall be received by the Committee or bear a postmark dated prior to (180 days from the effective date of this section) in order to be considered timely filed.

<< NJ ADC 13:35-13.6 >>

13:35-13.6 Licensing requirements for perfusionist

(a) To be eligible for licensure as a perfusionist, an applicant shall fulfill the following requirements:

1. Be at least 18 years of age;

2. Be of good moral character;

3. Have successfully completed:

i. A perfusion education program which complies with standards established by the Accreditation Committee for Perfusion Education, approved by the Commission on Accreditation of Allied Health Education Programs (CAAHEP), or its successors; or a foreign program that has been approved by an entity with substantially equivalent standards as CAAHEP or the Conjoint Committee under the Canadian Medical Association; or a program with substantially equivalent standards; and

ii. The two-part certification examination composed of the Clinical Applications in Perfusion Examination and the Perfusion Basic Science Examination offered by the American Board of Cardiovascular Perfusion (ABCP), or its successor, or the Canadian Certification Examination.

<< NJ ADC 13:35-13.7 >>

13:35-13.7 Grace period for practicing without licensure pending application

(a) Any person who submits an application for perfusionist licensure, whether by grandfathering pursuant to N.J.A.C. 13:35-13.5 or pursuant to the licensing requirements of N.J.A.C. 13:35-13.6, within six months of (the effective date of this subchapter), may continue to practice as a perfusionist until the application is approved or denied by the Committee. During this six- month time period, such person shall not hold himself or herself out as being licensed or certified as a perfusionist by the Committee.

(b) Any person who engages in the practice of perfusion after six months from (the effective date of this subchapter) who has not submitted an application for licensure within the time period set forth in (a) above, shall be deemed to be engaged in the unlicensed practice of perfusion.

<< NJ ADC 13:35-13.8 >>

13:35-13.8 Licensure by reciprocity

(a) A perfusionist with a valid license, registration or certification issued by another state or possession of the United States, or the District of Columbia shall, upon the submission of an application provided by the Committee, and payment of a fee as set forth in N.J.A.C. 13:35-13.17, be issued a perfusionist license without examination, provided that:

1. The education, training and examination requirements in such other jurisdiction are substantially equivalent to those required by New Jersey at the time application; and

2. All licenses, in such other jurisdiction, are current, active and in good standing.

<< NJ ADC 13:35-13.9 >>

13:35-13.9 License required for designation as perfusionist

(a) No person shall engage or offer to engage in the practice of perfusion in the State of New Jersey unless that person holds a New Jersey license issued pursuant to N.J.S.A. 45:9-37.94 et seq., and this subchapter.

(b) No person shall use the title "perfusionist" or the abbreviation "LP" or any other title, designation, words, letters, abbreviations or insignia indicating the practice of perfusion, unless licensed to practice perfusion under the provisions of P.L. 1999, c.126 (N.J.S.A. 45:9-37.94 et seq.) and the rules of this subchapter.

<< NJ ADC 13:35-13.10 >>

13:35-13.10 Temporary license; supervision

(a) The Committee shall issue a temporary license to practice perfusion to a graduate perfusionist who:

1. Is at least 18 years of age;

2. Is of good moral character;

3. Has successfully completed a perfusion education program which complies with standards established by the Accreditation Committee for Perfusion Education, approved by the Commission on Accreditation of Allied Health Education Programs (CAAHEP), or its successors; or a foreign program that has been approved by an entity with substantially equivalent standards as CAAHEP or the Conjoint Committee under the Canadian Medical Association; or a program with substantially equivalent standards; and

4. Has not yet passed the certification examination required by N.J.A.C. 13:35-13.6(a)3ii.

(b) An applicant for temporary licensure shall submit to the Committee:

1. A completed application form;

2. A transcript sent directly from the perfusion program;

3. A letter from the medical director of the perfusion program stating that the applicant has successfully completed the perfusion program; and

4. The required fee as set forth in N.J.A.C. 13:35-13.17.

(c) A temporary perfusionist license shall expire one year from its date of issuance. A temporarily licensed perfusionist whose license expires may apply for renewal of the temporary license for one additional one-year period.

(d) The temporary license shall be surrendered to the Committee upon expiration or upon the issuance of the initial license.

(e) The temporarily licensed perfusionist shall practice only under the direct supervision of a licensed perfusionist. For purposes of this subsection, "direct supervision" means:

1. Immediate, constant oversight of a temporarily licensed perfusionist by a supervising licensed perfusionist for a minimum of the first 50 cases; and

2. After a minimum of the first 50 cases, the supervising licensed perfusionist shall be immediately available within the operating room suite in order to render any physical assistance to the temporarily licensed perfusionist, if required.

(f) At no time shall a supervising licensed perfusionist supervise more than one temporarily licensed perfusionist.

(g) A supervising licensed perfusionist shall not perform perfusion at the same time as supervising a temporarily licensed perfusionist.

(h) The supervising licensed perfusionist shall be certified by the American Board of Cardiovascular Perfusion for a minimum of three years and be license by the Committee.

(i) The supervising licensed perfusionist shall be responsible for the care of the patient while under extracorporeal support administered by the temporarily licensed perfusionist.

(j) A temporarily licensed perfusionist shall be supervised at all times. In the event that a supervising licensed perfusionist is no longer available to supervise, the temporarily licensed perfusionist may not practice until a new supervisor is available, who shall assume responsibility for the ongoing supervision of any temporarily licensed perfusionist providing care to the patient.

(k) Notwithstanding (j) above, if an emergency situation arises which potentially threatens the life or well-being of a patient, a temporarily licensed perfusionist may render perfusion services during the unanticipated absence of the supervising licensed perfusionist.

(l) Every effort shall be made by the supervising licensed perfusionist and/or the temporarily licensed perfusionist to obtain direct supervision in any emergent situation as described in (k) above.

<< NJ ADC 13:35-13.11 >>

13:35-13.11 License renewal

(a) The Committee shall send a notice of renewal to all licensees at least 60 days prior to the date of license expiration. If the notice to renew is not sent at least 60 days prior to the license expiration date, no monetary penalties or fines shall apply to a licensee for failure to renew.

(b) A license to practice perfusion shall be issued for a period of two years. A licensee who seeks renewal of his or her license shall submit a license renewal application and the license renewal fee as set forth in N.J.A.C. 13:35-13.17 to the Committee prior to the expiration of the current license. The applicant shall also certify successful completion of the continuing education requirements prescribed in N.J.A.C. 13:35-13.16.

(c) Renewal applications shall provide the applicant with the option of either active or inactive status. Licensees electing inactive status shall pay the inactive license fee as set forth in N.J.A.C. 13:35-13.17 and shall not engage in the practice of perfusion.

(d) If a licensee does not renew his or her license prior to its expiration, the licensee may renew the license within 30 days of its expiration by submitting a renewal application, a license renewal fee and a late fee, as set forth in N.J.A.C. 13:35-13.17.

(e) A license that is not renewed within 30 days of its expiration shall be automatically suspended. An individual who continues to practice with a suspended license shall be deemed to be engaged in unlicensed practice.

(f) Falsification of any information submitted with a renewal application may result in penalties and/or suspension of the license pursuant to N.J.S.A. 45:1-21, 45:1-22 and 45:1-25 and N.J.A.C. 13:35-13.15.

<< NJ ADC 13:35-13.12 >>

13:35-13.12 Change of license status: inactive to active

(a) A licensee who has placed his or her license in inactive status pursuant to N.J.A.C. 13:35-13.11(b) may, upon application to the Committee and payment of the renewal fee as set forth in N.J.A.C. 13:35-13.17, return to active status.

(b) Upon application to the Committee, the licensee shall present proof of completion of the continuing education credits which would have been required for license renewal at the time the licensee elected inactive status.

(c) A licensee who has been on inactive status shall complete 15 continuing education credits for each year the licensee is on inactive status.

(d) A licensee who has been on inactive status for one year or more shall complete all continuing education credits as required in (b) and (c) above and shall also demonstrate:

1. That the licensee has maintained certification by the American Board of Cardiovascular Perfusion (ABCP) continuously for the entire time period that the license has been inactive;

2. If the licensee has not maintained certification by the ABCP and has been inactive for more than one year but less than three years, the licensee shall take and pass the Clinical Applications in Perfusion Examination administered by the ABCP; or

3. If the licensee has not maintained certification by the ABCP and has been inactive for more than three years, the licensee shall take and pass the certification examination required in N.J.A.C. 13:35-13.6(a)3ii.

<< NJ ADC 13:35-13.13 >>

13:35-13.13 Reinstatement of suspended license

(a) A person seeking reinstatement following the suspension of a license, pursuant to N.J.A.C. 13:35-13.11(d) for nonrenewal of a biennial license, may be reinstated by the Committee, provided the applicant otherwise qualifies for licensure pursuant to N.J.A.C. 13:35-13.6 and submits to the Committee the following information and materials:

1. A completed reinstatement application;

2. Payment of all past delinquent renewal fees as set forth in N.J.A.C. 13:35-13.17;

3. Payment of a reinstatement fee as set forth in N.J.A.C. 13:35-13.17;

4. An affidavit, on a form provided by the Committee and submitted by the applicant, that states whether or not the applicant has been practicing perfusion in this or any other state;

5. An affidavit verifying completion of the continuing education credits required for the renewal of an active license; and

6. If the applicant has been practicing perfusion, the applicant shall obtain an affidavit(s), on a form provided by the Committee, from all of the applicant's employers, documenting the dates of employment from the date that the New Jersey license was suspended to the date of application for reinstatement and the name, address and telephone number of each employer.

(b) An applicant whose license has been suspended for nonrenewal of a biennial license shall meet the following requirements as a condition of reinstatement:

1. Maintenance of certification by the American Board of Cardiovascular Perfusion (ABCP) continuously for the entire time period that the license has been suspended in this State;

2. If the applicant has not maintained certification by the ABCP and the license has been suspended for more than one year but less than three years, the applicant shall take and pass the Clinical Applications in Perfusion Examination administered by the ABCP; or

3. If the license has been suspended for a period of three years or more, even if the applicant has maintained certification by the ABCP, the licensee shall take and pass the certification examination required in N.J.A.C. 13:35-13.6(a)3ii.

<< NJ ADC 13:35-13.14 >>

13:35-13.14 Duty to report change in status

(a) A licensee shall notify the Committee in writing, within 30 days, of any change in status at each licensed health care facility with which the licensee has an affiliation. The licensee shall further indicate the effective date of the change in status and provide an explanation therefor.

(b) A licensee shall notify the Committee, in writing, of any changes in circumstances which would alter the response last provided by the licensee to questions on the biennial renewal form eliciting information pertaining to pending or finalized actions, including those predicated on a no contest or nolo contendere plea or other consensual or voluntary agreement, or a surrender or resignation of license or of privileges or a consent to limitations on practice which occurred as a result of an investigation or of pending action. The following actions shall be reported:

1. Actions by law enforcement authorities for statutory or regulatory violations;

2. Actions by a New Jersey health care facility which condition, curtail, limit, suspend or revoke privileges;

3. Disciplinary actions by New Jersey or out-of-State licensing authorities;

4. Actions by the Department of Health and Senior Services;

5. Actions by professional review organizations or utilization review organizations;

6. Actions by a medical malpractice insurance carrier which decline coverage or decline continuation of coverage, assess a surcharge based on claims experience, impose new limitations or restrictions on practice, or require remedial education or monitoring; and

7. Entry of judgment in any malpractice actions or settlements.

(c) A licensee shall notify the Committee, in writing, of any changes in circumstances which would alter the response last provided by the licensee to questions on the biennial renewal form pertaining to medical conditions and use of chemical substances which in any way impair or limit the licensee's ability to practice with reasonable skill and safety.

(d) Failure by a licensee to provide the Committee with notice of any information required pursuant to this section within 30 days of the change or the event necessitating the filing of the notice may be deemed professional misconduct within the meaning of N.J.S.A. 45:1-21(e).

<< NJ ADC 13:35-13.15 >>

13:35-13.15 Suspension, revocation or refusal to renew license

(a) The Board may refuse to grant or may suspend or revoke a license to practice perfusion upon proof that the licensee:

1. Has permitted an unlicensed person or entity to perform an act for which a license is required by the Committee, or aided and abetted an unlicensed person or entity in performing such an act;

2. Used procedures and/or acted in a manner inconsistent with the standards of the practice of perfusion;

3. Has obtained a license or authorization to sit for an examination, as the case may be, through fraud, deception or misrepresentation;

4. Has engaged in the use or employment of dishonesty, fraud, deception, misrepresentation, false promise or false pretense;

5. Has engaged in gross negligence, gross malpractice or gross incompetence which damaged or endangered the life, health, welfare, safety or property of any person;

6. Has engaged in repeated acts of negligence, malpractice or incompetence;

7. Has engaged in professional or occupational misconduct as may be determined by the Board or Committee;

8. Has been convicted of, or engaged in acts constituting any crime or offense involving moral turpitude or relating adversely to the activity regulated by the Committee. For the purpose of this subchapter, a judgment of conviction or a plea of guilty, non vult, nolo contendere or any other such disposition of alleged criminal activity shall be deemed a conviction;

9. Has had his or her authority to engage in the practice of perfusion revoked or suspended by any other state, agency or authority for reasons consistent with this subchapter;

10. Has violated or failed to comply with the provisions of any Act or regulation administered by the Committee;

11. Is incapable, for medical or any other good cause, of discharging the functions of a licensee in a manner consistent with the public's health, safety and welfare;

12. Has violated any provision of P.L. 1983, c.320 (N.J.S.A. 17:33A-1 et seq.) or any insurance fraud prevention law or Act of another jurisdiction or has been adjudicated, in civil or administrative proceedings, of a violation of P.L. 1983, c.320 (N.J.S.A. 17:33A-1 et seq.) or has been subject to a final order, entered in civil or administrative proceedings, that imposed civil penalties;

13. Is presently engaged in drug or alcohol use that is likely to impair the ability to practice the profession or occupation with reasonable skill and safety. For purposes of this subchapter, the term "presently" means at any time within the previous 365 days; or

14. Advertised the practice of perfusion so as to disseminate false, deceptive or misleading information, whether as an individual, through a professional service corporation or through a third party.

(b) In addition to the consequences listed in (a) above, the Board may impose additional or alternative penalties pursuant to N.J.S.A. 45:1-22 and 45:1-25 for violations of any provision of N.J.S.A. 45:9-37.94 et seq., and this subchapter.

(c) The Board may order a refusal to renew license, suspension of license, temporary suspension of license or revocation of license, and/or the issuance of a civil penalty under this section, provided that the licensee has an opportunity to be heard by the Board pursuant to the Administrative Procedure Act, N.J.S.A. 52:14B-1 et seq., and the Uniform Administrative Procedure Rules, N.J.A.C. 1:1.

<< NJ ADC 13:35-13.16 >>

13:35-13.16 Continuing education

(a) A licensee applying for biennial license renewal shall complete, during the preceding biennial period, 30 continuing education (CE) credits as specified under this section. Applicants for initial licensure are exempt from the continuing education requirements of this section for the initial biennial period of licensure.

(b) Each licensee shall confirm on the application for biennial licensure renewal that he or she has completed 30 continuing education credits. The Committee may conduct random audits to determine licensee compliance with continuing education requirements.

(c) A licensee who completes credit hours in excess of the 30 credits required may apply no more than 15 of those credits to the continuing education requirement for the following biennial period only.

(d) A licensee who is required to complete remedial continuing education pursuant to Board or Committee action shall not receive credit for such imposed continuing education toward the mandatory 30 credits of biennial licensure period.

(e) The Committee may direct a licensee to complete continuing education credits to correct a deficiency in the licensee's continuing education requirement.

(f) A licensee may obtain continuing education credits from the following:

1. Successful completion of programs, courses or seminars approved by the Committee, pursuant to (j) below. The Committee shall approve only such continuing education programs as are available to all perfusionists in this State on a reasonable, non-discriminatory basis. The Committee shall maintain a list of all approved programs, courses and lectures at the Committee office and shall furnish this information to licensees upon request;

2. Courses approved by the American Board of Cardiovascular Perfusion (ABCP);

3. Post-graduate courses at Commission on Accreditation of Allied Health Education Programs (CAAHEP) approved perfusion schools;

4. Courses offered in Pediatric Advanced Cardiac Life Support (PALS) and/or Advanced Cardiac Life Support (ACLS) and courses offered by the American Heart Association (AHA), the Society of Thoracic Surgeons, the American Association for Thoracic Surgery, the American College of Cardiology (ACC), the American Academy of Cardiovascular Perfusion (AACP), the American Society of Extracorporeal Technology (AmSect), the American Society of Anesthesiology (ASA), the Society of Cardiovascular Anesthesiologists (SCA), the American Society of Blood Banks, the American College of Chest Physicians, the Joint Commission on Accreditation of Healthcare Organizations, the National Heart, Lung and Blood Institute, the New England Journal of Medicine, the New Jersey State Perfusion Society and the American College of Surgeons (ACS) and the Cardiovascular Research Education Foundation (CREF);

5. Medical science courses relevant to the scope of practice of perfusion, as defined in N.J.A.C. 13:35-13.2;

6. Professional presentations consisting of new courses specifically related to perfusion. For purposes of this paragraph, "new" means a course which the licensee has never taught before in an educational setting;

7. Authorship of peer reviewed textbooks, articles or manuals specifically related to perfusion; and

8. Videotaped, teleconference and Internet courses related to the practice of perfusion, with verification by the course provider that the course was monitored and successfully completed by the licensee.

(g) Credit for continuing education shall be granted for each biennial licensure period as follows:

1. A licensee shall receive one continuing education credit for each hour of attendance at programs, courses or seminars approved by the Committee pursuant to (j) below. Credit shall not be granted for courses that are less than one instructional hour long. For purposes of this subchapter, an "instructional hour" represents a 60-minute clock hour with no less than 50 minutes of content within the hour. Programs may include one 10-minute break for each instructional hour;

2. Successful completion of courses approved by the ABCP pursuant to (f)2 above: one continuing education credit for each course credit awarded;

3. Successful completion of post-graduate courses pursuant to (f)3 above: one continuing education credit for each course credit awarded;

4. Successful completion of perfusion related courses pursuant to (f)4 and/or (f)5 above: one continuing education credit for each course credit awarded and a maximum of 15 credits per biennial licensure period;

5. Professional presentations pursuant to (f)6 above: three credits per new course presentation with a maximum of six credits per biennial licensure period;

6. Publication in a peer-reviewed professional journal of an article related to the practice of perfusion pursuant to (f)7 above: three credits per article with a maximum of six credits per biennial licensure period;

7. Authorship of a peer-reviewed textbook or manual related to the practice of perfusion pursuant to (f)7 above: five credits for each textbook or manual with a maximum of 10 credits per biennial licensure period; and

8. Videotaped, teleconference and Internet courses related to the practice of perfusion pursuant to (f)8 above: one credit for each course with a maximum of 10 credits per biennial licensure period.

(h) To report continuing education credit hours, a licensee shall:

1. Certify on the application for biennial renewal, completion of the required number of continuing education credits. Falsification of any information submitted on the renewal application shall provide cause for penalties and/or license suspension;

2. Maintain all evidence of verification of continuing education requirements for a period of four years after completion of the credits and submit such documentation to the Committee upon request; and

3. Provide to the Committee upon request, documentation of continuing education requirements as follows:

i. For programs, courses, seminars and conferences approved by the Committee: the course provider's written verification of attendance;

ii. For post-graduate courses: an official transcript;

iii. For articles published in a peer-reviewed professional journal: the published article;

iv. For professional presentations: brochure, announcement or written evidence of presentation;

v. For authored textbooks or manuals: the textbook or manual; and

vi. Videotaped, teleconference and Internet courses: written verification from the course provider.

(i) The Committee may extend and/or waive the time period for completion of continuing education requirements on an individual basis for reasons of hardship, such as severe illness, disability or military service.

1. A licensee seeking an extension and/or waiver of the continuing education requirements shall apply to the Committee in writing and set forth in specific detail the reasons for requesting the extension and/or waiver. The licensee shall submit to the Committee all documentation in support of the request for extension and/or waiver.

2. A licensee shall apply for an extension and/or waiver within 60 days of the expiration of the biennial renewal period. All requests shall be sent to the Office of the Committee, as defined in N.J.A.C. 13:35-13.3, by certified mail, return receipt requested.

(j) All sponsors of continuing education seeking approval under (f)1 above shall:

1. Submit for each course, program or seminar offered, for evaluation by the Committee:

i. A detailed description of course content and estimated hours of instruction;

ii. The curriculum vitae of each lecturer, including the specific background which qualifies the individual as a lecturer in the area of instruction; and

iii. A form of verification of attendance that will be provided to attendees.

2. Obtain Committee approval prior to representing that any course, seminar or program fulfills the requirements of this section;

3. Monitor the attendance at each approved course, program or seminar and furnish to each enrollee a verification of attendance, which shall include at least the following information:

i. The title, date and location of the course, program or seminar;

ii. The name of the attendee;

iii. The number of credits awarded; and

iv. The name and signature of the sponsor and the official documentation of the organization.

4. Submit course evaluations. The sponsor shall conduct post-course evaluations. Evaluations shall be solicited from both the participants and instructors. Courses shall be evaluated to determine whether:

i. Objectives have been met;

ii. Prerequisites were necessary or desirable;

iii. Facilities were satisfactory;

iv. The instructor was effective;

v. Advanced preparation materials were satisfactory; and

vi. The course content was timely and effective; and

5. Submit a fee pursuant to N.J.A.C. 13:35-13.17 for each new course, program or seminar reviewed by the Committee.

(k) Failure of a sponsor to comply with the content requirements for continuing education courses and the responsibilities of course sponsors as specified in (j) above may result in the suspension of the pre-approved status for courses offered by the sponsor. The Committee may rescind course approval based on the content of the post-course evaluations.

<< NJ ADC 13:35-13.17 >>

13:35-13.17 Fee schedule

(a) The fee schedule for the Committee shall be as follows:

1. Application fee: (non-refundable) ................................. $20.00
2. Temporary license ................................................. $75.00
i. Extension of temporary license .................................... $75.00
3. Initial registration fee:
i. If paid during the first year of a biennial renewal period ....... $150.00
ii. If paid during the second year of a biennial renewal period ....... $75.00
4. Biennial registration renewal .................................... $150.00
5. Application for reciprocal license ............................... $150.00
plus the applicable initial certification fee set forth in (a)3 above
6. Inactive license fee ......... (to be established by rule by the Director)
7. Reinstatement fee ............ (to be established by rule by the Director)
8. Sponsor course approval fee ...................................... $100.00
9. Late fee .......................................................... $25.00
10. Duplicate or replacement of biennial registration certificate ..... $25.00
11. Preparation of certification papers for applicants to other
states .......................................................... $25.00

 

  

  

  

  

  

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