S0757.02C

SENATE COMMITTEE SUBSTITUTE

FOR

SENATE BILL NO. 253

AN ACT

     Relating to the regulation and licensing of clinical perfusionists, with penalty provisions and an effective date.


BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF MISSOURI, AS FOLLOWS:

     Section 1. Sections 1 to 21 of this act shall be known and may be cited as the "Clinical Perfusionist Licensure Act".

     Section 2. As used in sections 1 to 21 of this act, the following terms mean:

     (1) "Board", the state board of registration for the healing arts in the state of Missouri;

     (2) "Division", the division of professional registration of the department of economic development;

     (3) "Extracorporeal circulation", 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;

     (4) "Licensed clinical perfusionist", a person licensed pursuant to sections 1 to 21 of this act;

     (5) "Perfusion", the functions necessary for the support, treatment, measurement or supplementation of the cardiovascular, circulatory, respiratory systems or other organs, or a combination of such 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:

     (a) 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;

     (b) Counterpulsation, ventricular assistance, autotransfusion, blood conservation techniques, myocardial and organ preservation, extracorporeal life support and isolated limb perfusion;

     (c) The use of techniques involving blood management, advanced life support and other related functions; and

     (d) In the performance of the acts described in this subdivision:

     a. 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;

     b. 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. Hemoconcentration and hemodilution;

     vii. Hemodialysis;

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

     (6) "Perfusion protocols", perfusion related policies and protocols developed or approved by a licensed health care facility or a physician through collaboration with administrators, licensed clinical perfusionists and other health care professionals;

     (7) "Provisional clinical licensed perfusionist", a person provisionally licensed pursuant to sections 1 to 21 of this act.

     Section 3. Notwithstanding the provisions of sections 1 to 21 of this act, a person is eligible to make application to the board and receive a license, if the person is actively engaged in the practice of perfusion consistent with sections 1 to 21 of this act and if the person meets one of the following requirements:

     (1) The person, on the effective date of sections 1 to 21 of this act, was operating cardiopulmonary bypass systems during cardiac surgical cases in a licensed health care facility as the person's primary function and had been operating the system for at least the immediately preceding three years; or

     (2) The person has at least five years' experience, within the last seven years, operating cardiopulmonary bypass systems during cardiac surgical cases in a licensed health care facility as the person's primary function.

     Section 4. The board shall license by examination, or otherwise as provided in sections 1 to 21 of this act, all licensed clinical perfusionist in this state, who meet the requirements of sections 1 to 21.

     Section 5. 1. A candidate for a license to practice as a licensed clinical perfusionist shall submit a sworn application accompanied by the required fees. The board shall prescribe the form of the application and by rule may establish dates by which applications and fees must be received.

     2. To qualify for the licensing examination, the applicant shall have successfully completed a perfusion education program approved by the board. In approving perfusion education programs necessary for qualification for licensing examination, the board shall approve only a program that has educational standards that are at least as stringent as those established by the Accreditation Committee for Perfusion Education and approved by the Commission on Accreditation of Allied Health Education Programs or its successor.

     3. All fees payable pursuant to sections 1 to 21 of this act shall be collected by the division of professional registration and transmitted to the department of revenue for deposit in the state treasury to the credit of the "Licensed Perfusionists Fund", which is hereby created. Notwithstanding the provisions of section 33.080, RSMo, moneys in the fund shall not be transferred and placed to the credit of general revenue until the amount in the fund at the end of a biennium exceeds two times the amount appropriated from the fund in the preceding fiscal year or, if the board requires by rule license renewal less frequently than annually, then three times the appropriation from the fund for the preceding fiscal year. The amount, if any, in the fund which shall lapse is that amount in the fund which exceeds the appropriate multiple of the appropriation from the board's fund for the preceding fiscal year.

     Section 6. 1. To qualify for a license, an applicant shall pass a competency examination. Examinations shall be prepared or approved by the board and administered to qualified applicants at least once each calendar year. An examination prescribed by the board may be, or may include, the complete certification examinations given by the American Board of Cardiovascular Perfusion or its successor or a state testing service in lieu of an examination prepared by the board.

     2. Not later than forty-five days after the date on which a licensing examination is administered pursuant to sections 1 to 21 of this act, the division shall notify each examinee of the results of the examination.

     3. The board by rule shall establish:

     (1) A limit on the number of times an applicant who fails an examination may retake the examination; and

     (2) The requirements for reexamination and the amount of any reexamination fee.

     Section 7. A person licensed pursuant to the provisions of sections 1 to 21 of this act shall display the license certificate issued pursuant to sections 1 to 21 of this act in a prominent place at the site, location or office from which such person practices such person's profession or such license holder shall maintain on file at all times during which the license holder provides services in a health care facility a true and correct copy of the license certificate in the appropriate records of the facility. A license holder shall inform the division of any change of address for the license holder. A license certificate issued by the board is the property of the board and shall be surrendered upon demand.

     Section 8. 1. The board may establish by administrative rule a system which provides that licenses expire on various dates. A person may renew an unexpired license by submitting proof satisfactory to the board of compliance with the continuing professional education requirements prescribed by the board and paying the required renewal fee to the board before the expiration date of the license.

     2. If a person's license has been expired for not more than two years, the person may renew the license by submitting proof, satisfactory to the board, of compliance with the continuing professional education requirements prescribed by the board and any penalty fee prescribed by the board.

     3. If a person's license has been expired two years or more, the person may not renew the license. The person may obtain a new license by submitting to reexamination and complying with the current requirements and procedures for obtaining a license.

     4. The board may renew without reexamination an expired license of a person who was licensed in this state, moved to another state or states, and is currently appropriately licensed or certified and has been in practice in another state or states for two years immediately preceding the person's application to renew a license. The person shall be required to pay the required fee as established by the board.

     5. The board shall notify each license holder in writing of the license expiration date before the thirtieth day before such date by notice to the license holder at the license holder's last known address according to the records of the board.

     Section 9. 1. A license as a provisional licensed clinical perfusionist may be issued by the board to a person who has successfully completed an approved perfusion education program and the filing of an application. Payment of an application fee and the submission of evidence satisfactory to the board of the successful completion of the education requirements as provided in section 5 of this act.

     2. A provisional licensed clinical perfusionist shall be under supervision and direction of a licensed clinical perfusionist at all times during which the provisional licensed clinical perfusionist performs perfusion. The board may adopt rules governing such supervision and direction which do not require the immediate physical presence of the supervising licensed clinical perfusionist.

     3. A provisional license shall be valid for one year from the date it is issued and may be renewed, subject to rules adopted by the board, by the same procedures established for the renewal of licenses pursuant to section 8 of this act, if the application for renewal is signed by a supervising licensed clinical perfusionist.

     4. If the person fails any portion of the licensure examination, such person shall surrender the person's provisional license to the board.

     Section 10. On receipt of an application and application fee, the board may waive the examination and educational requirements for an applicant who at the time of application:

     (1) Is appropriately licensed or certified by another state, territory or possession of the United States, if the requirements of such state, territory or possession for the license or certificate are substantially equivalent to the requirements of sections 1 to 21 of this act as determined by the board; or

     (2) Holds a current certificate as a certified clinical perfusionist issued by the American Board of Cardiovascular Perfusion, or its successor, prior to the effective date of sections 1 to 21 of this act.

     Section 11. 1. A person may not engage or offer to engage in perfusion, as defined in sections 1 to 21 of this act, for compensation or use the title or represent or imply that the person has the title of "licensed clinical perfusionist" or "provisional licensed clinical perfusionist" or use the letters "LCP" or "PLCP" and may not use any facsimile of such titles in any manner to indicate or imply that the person is a licensed perfusionist or provisional licensed perfusionist unless the person holds an appropriate license issued pursuant to sections 1 to 21 of this act.

     2. A person may not use the title or represent or imply that such person has the title of "certified clinical perfusionist" or use the letters "CCP" and may not use any facsimile of such title in any manner to indicate or imply that such person is a certified clinical perfusionist by the American Board of Cardiovascular Perfusion unless the person holds a certificate as a certified clinical perfusionist issued by the American Board of Cardiovascular Perfusion.

     3. Any person who violates the provisions of subsection 1 of this section is guilty of a class B misdemeanor.

     Section 12. The provisions of sections 1 to 21 of this act shall not apply to:

     (1) A person licensed as a health care professional pursuant to the Revised Statutes of Missouri, if:

     (a) The person does not represent to the public, directly or indirectly, that the person is licensed pursuant to sections 1 to 21 of this act, and does not use any name, title or designation indicating that the person is licensed pursuant to sections 1 to 21 of this act; and

     (b) The person limits the person's acts or practice to the scope of practice authorized by the appropriate licensing agency;

     (2) A student enrolled in an accredited perfusion education program, if perfusion services performed by the student:

     (a) Are an integral part of the student's course of study; and

     (b) Are performed under the direct supervision of a licensed clinical perfusionist assigned to supervise the student and who is on duty and immediately available in the assigned patient care area;

     (3) The practice of any legally qualified perfusionist employed by the United States government while in the discharge of the person's official duties.

     Section 13. The board shall:

     (1) Adopt and publish a code of ethics;

     (2) Establish the qualifications and fitness of applicants of licenses, renewal of licenses and reciprocal licenses;

     (3) Revoke, suspend or deny a license, suspend a license or reprimand a license holder for a violation of sections 1 to 21 of this act, the code of ethics or the rules adopted by the commission;

     (4) Provide for the expenditure of funds necessary for the proper administration of its assigned duties;

     (5) Establish reasonable and necessary fees for the administration and implementation of sections 1 to 21 of this act. Fees shall be established at a rate that does not significantly exceed the cost of administering the provisions of sections 1 to 21 of this act;

     (6) Establish continuing professional education requirements for licensed clinical perfusionists and provisional licensed clinical perfusionists, the standards of which shall be at least as stringent as those of the American Commission of Cardiovascular Perfusion or its successor agency;

     (7) Adopt the training and clinical competency requirements established by the department of health through hospital licensing regulations promulgated pursuant to chapter 197, RSMo. The provisions of sections 1 to 21 of this act to the contrary notwithstanding, the board shall not regulate a perfusionist's training, education or fitness to practice except as specifically provided by the hospital licensing regulations of the department of health. In promulgating those regulations, the department of health shall adopt the standards of the American Board of Cardiovascular Perfusion, or its successor organization, or comparable standards for training and experience. The department shall by rule and regulation provide that individuals providing perfusion services who do not meet these standards may continue their employment in accordance with section 3 of this act. The department shall also establish standards for provisional licensed clinical perfusionists pursuant to section 9 of this act.

     Section 14. 1. The board shall keep an information file about each complaint filed with the board. The board's information file shall be kept current and contain a record for each complaint of:

     (1) All persons contacted in relation to the complaint;

     (2) A summary of findings made at each step of the complaint process;

     (3) An explanation of the legal basis and reason for a complaint that is dismissed; and

     (4) Other relevant information.

     2. If a written complaint is filed with the board that the board has authority to resolve, the board, at least as frequently as quarterly and until final disposition of the complaint, shall notify the parties to the complaint of the status of the complaint unless the notice would jeopardize an ongoing investigation.

     3. The board shall adopt by rule a form to standardize information concerning complaints made to the board. The board shall prescribe by rule information to be provided to a person when the person files a complaint with the board.

     4. The board shall provide reasonable assistance to a person who wishes to file a complaint with the board.

     Section 15. 1. The board shall adopt rules concerning the investigation of a complaint filed with the board. The rules adopted pursuant to this subsection shall:

     (1) Distinguish between categories of complaints;

     (2) Ensure that complaints are not dismissed without appropriate consideration;

     (3) Require that the board be advised of a complaint that is dismissed and that a letter be sent to the person who filed the complaint explaining the action taken on the dismissed complaint;

     (4) Ensure that the person who filed the complaint has an opportunity to explain the allegations made in the complaint; and

     (5) Prescribe guidelines concerning the categories of complaints that require the use of a private investigator and the procedures for the board to obtain the services of a private investigator.

     2. The board shall dispose of all complaints in a timely manner. The board shall establish a schedule for conducting each phase of a complaint that is under the control of the board not later than the tenth day after the date the complaint is received by the board. The schedule shall be kept in the information file for the complaint and all parties shall be notified of the protected time requirements for pursuing the complaint. A change in the schedule shall be noted in the complaint information file and all parties to the complaint shall be notified not later than five days after the date the change is made.

     3. The executive director of the board shall notify the board of a complaint that extends beyond the time prescribed by the board for resolving the complaint so that the board may take necessary action on the complaint.

     Section 16. The board shall develop by rule a system for monitoring license holder's compliance with the requirements of sections 1 to 21 of this act. Rules adopted pursuant to this section shall include procedures for monitoring a license holder who is ordered by the board to perform certain acts to ascertain that the license holder performs the required acts and to identify and monitor license holders who represent a risk to the public.

     Section 17. The board shall revoke or suspend a license, place on probation a person whose license has been suspended or reprimand a license holder if there is proof of:

     (1) Any violation of sections 1 to 21 of this act;

     (2) Any violation of a rule or code of ethics adopted by the board; or

     (3) Unprofessional conduct, which includes, but is not limited to, the following:

     (a) Incompetence or gross negligence in carrying out usual perfusion functions;

     (b) A conviction of practicing perfusion without a license or a provisional license;

     (c) The use of advertising relating to perfusion in a way that violates state law;

     (d) Procuring a license or provisional license by fraud, misrepresentation or mistake;

     (e) Making or giving any false statement or information in connection with the application for a license or provisional license;

     (f) Conviction of a felony or of any offense substantially related to the qualifications, functions and duties of a perfusionist, in which event the record of the conviction shall be conclusive evidence of such offense; or

     (g) Impersonating an applicant or acting as proxy for an applicant in any examination required pursuant to sections 1 to 21 of this act for the issuance of a license.

     Section 18. For the purposes of sections 1 to 21 of this act, the board:

     (1) Shall request and receive necessary assistance from state educational institutions or other state agencies;

     (2) Shall prepare a registry of licensed clinical perfusionists and provisional licensed clinical perfusionists and make this information available to the general public, license holders and appropriate state agencies;

     (3) May request the attorney general or an appropriate prosecuting attorney to institute a suit to enjoin a violation of sections 1 to 21 of this act in addition to any other action, proceeding or remedy authorized by law.

     Section 19. 1. There is hereby established an "Advisory Commission for Perfusionist" which shall guide, advise and make recommendations to the board. The commission shall approve the examination required by section and shall assist the board in carrying out the provisions of sections 1 to 21 of this act.

     2. The advisory commission shall consist of five perfusionist members and two public members which shall be appointed by the governor with the advice and consent of the senate. The members of the commission shall be appointed for terms of six years; except those first appointed, of which one shall be appointed for a term of one year, one shall be appointed for a term of two years, one shall be appointed for a term of three years, one shall be appointed for a term of four years, one shall be appointed for a term of five years and one shall be appointed for a term of six years. The nonpublic commission members shall be residents of the state of Missouri for at least one year, shall be a United States citizens and shall meet all the requirements for licensing provided in sections 1 to 21 of this act, shall be licensed pursuant to sections 1 to 21 of this act, except the members of the first commission, who shall be licensed within six months of their appointment and are actively engaged in the practice of perfusion. If a member of the commission shall, during the member's term as a commission member, remove the member's domicile from the state of Missouri, then the commission shall immediately notify the governor and the seat of that commission member shall be declared vacant. All such vacancies shall be filled by appointment as in the same manner as the preceding appointment. The public members shall be at the time of the members' appointment citizens of the United States; residents of the state for a period of at least one year and registered voters; persons who are not and never were members of any profession licensed or regulated pursuant to sections 1 to 21 of this act or the spouse of such person; persons who do not have and never have had a material, financial interest in either the provision of the professional services regulated by sections 1 to 21 of this act, or an activity or organization directly related to any profession licensed or regulated by sections 1 to 21 of this act.

     3. No member of the commission shall be entitled to any compensation for the performance of the member's official duties, but each member shall be reimbursed for necessary and actual expenses incurred in the performance of the member's official duties. All staff for the commission shall be provided by the division of professional registration.

     4. A member of the commission may be removed if, the member:

     (1) Does not have, at the time of appointment, the qualifications required for appointment to the commission;

     (2) Does not maintain during service on the commission the qualifications required for appointment to the commission;

     (3) Violates any provision of sections 1 to 21 of this act;

     (4) Cannot discharge the member's duties for a substantial part of the term for which the member is appointed because of illness or disability; or

     (5) Is absent from more than half of the regularly scheduled commission meetings that the member is eligible to attend during a calendar year, unless the absence is excused by a majority vote of the commission.

     Section 21. 1. Not later than thirty days after the governor appoints the initial members of the commission and annually thereafter, the commission shall meet and elect one of its members as chairperson and one of its members as vice chairperson. The commission shall meet at least quarterly or at any other time if called by the chairperson or a majority of the commission. A majority of the members of the commission shall constitute a quorum.

     Section A. The provisions of sections 1 to 21 of this act shall become effective on January 1, 1998.