SENATE AMENDED PRIOR PRINTER'S NOS. 555, 1845, 1909, PRINTER'S NO. 3703 2777, 3216
No. 500 Session of 2007
INTRODUCED BY SANTONI, BARRAR, BOYD, CALTAGIRONE, CURRY, FABRIZIO, GERGELY, HENNESSEY, KILLION, KOTIK, MARKOSEK, PALLONE, REICHLEY, WALKO, YOUNGBLOOD, SIPTROTH, JAMES, MURT AND SOLOBAY, FEBRUARY 26, 2007
AS AMENDED ON THIRD CONSIDERATION, IN SENATE, MAY 6, 2008
AN ACT 1 Amending the act of December 20, 1985 (P.L.457, No.112), 2 entitled "An act relating to the right to practice medicine 3 and surgery and the right to practice medically related acts; 4 reestablishing the State Board of Medical Education and 5 Licensure as the State Board of Medicine and providing for 6 its composition, powers and duties; providing for the 7 issuance of licenses and certificates and the suspension and 8 revocation of licenses and certificates; providing penalties; 9 and making repeals," FURTHER PROVIDING FOR DEFINITIONS; <-- 10 providing for perfusionist licensing, qualifications, 11 supervision and scope of practice, regulations and 12 exemptions. 13 The General Assembly of the Commonwealth of Pennsylvania 14 hereby enacts as follows: 15 Section 1. Section 2 of the act of December 20, 1985 16 (P.L.457, No.112), known as the Medical Practice Act of 1985, is 17 amended by adding definitions to read: 18 Section 2. Definitions. 19 The following words and phrases when used in this act shall 20 have the meanings given to them in this section unless the 21 context clearly indicates otherwise:
1 * * * 2 "Extracorporeal circulation." The diversion of a patient's 3 blood through a heart-lung machine or similar device that 4 assumes the functions of the patient's heart, lung, kidney, 5 liver or other organs. 6 * * * 7 "Perfusion." The functions necessary for the support, 8 treatment, measurement or supplementation of the cardiovascular 9 systems or other organs, or a combination of those functions, 10 and for ensuring the safe management of physiologic functions by 11 monitoring and analyzing the parameters of the systems under the 12 supervision of a licensed physician PHYSICIAN LICENSED UNDER <-- 13 THIS ACT OR THE ACT OF OCTOBER 5, 1978 (P.L.1109, NO.261), KNOWN 14 AS THE OSTEOPATHIC MEDICAL PRACTICE ACT. 15 "Perfusionist." An individual who is licensed to practice 16 perfusion by the State Board of Medicine or the State Board of 17 Osteopathic Medicine. 18 * * * 19 "VENTRICULAR ASSIST DEVICE." A MECHANICAL DEVICE USED TO <-- 20 PARTIALLY OR COMPLETELY REPLACE THE FUNCTION OF A FAILING HEART 21 THROUGH CONNECTIONS TO THE HEART AND GREAT VESSELS THAT MAY BE 22 LOCATED INTRACORPOREALLY OR EXTRACORPOREALLY. THE TERM INCLUDES 23 A DEVICE THAT IS PLACED INTRAVASCULARLY OR EXTRAVASCULARLY AND 24 PROVIDES SUPPORT THROUGH DIRECT MEANS OR VIA COUNTERPULSATION. 25 * * * 26 Section 2. Section 3(a) of the act, amended December 10, <-- 27 2001 (P.L.859, No.92), is amended to read: 28 SECTION 2. SECTION 3(A) AND (B) OF THE ACT, AMENDED JULY 2, <-- 29 1993 (P.L.424, NO.60) AND DECEMBER 10, 2001 (P.L.859, NO.92), 30 ARE AMENDED TO READ: 20070H0500B3703 - 2 -
1 Section 3. State Board of Medicine. 2 (a) Establishment.--The State Board of Medicine shall 3 consist of the commissioner or his designee, the Secretary of 4 Health or his designee, two members appointed by the Governor 5 who shall be persons representing the public at large and seven 6 members appointed by the Governor, six of whom shall be medical 7 doctors with unrestricted licenses to practice medicine and 8 surgery in this Commonwealth for five years immediately 9 preceding their appointment and one who shall be a nurse 10 midwife, physician assistant, certified registered nurse 11 practitioner, respiratory care practitioner [or], certified 12 athletic trainer or perfusionist licensed or certified under the 13 laws of this Commonwealth. All professional and public members 14 of the board shall be appointed by the Governor, with the advice 15 and consent of a majority of the members elected to the Senate. 16 (B) TERMS OF OFFICE.--THE TERM OF EACH PROFESSIONAL AND <-- 17 PUBLIC MEMBER OF THE BOARD SHALL BE FOUR YEARS OR UNTIL HIS OR 18 HER SUCCESSOR HAS BEEN APPOINTED AND QUALIFIED, BUT NOT LONGER 19 THAN SIX MONTHS BEYOND THE FOUR-YEAR PERIOD. IN THE EVENT THAT 20 ANY OF SAID MEMBERS SHALL DIE OR RESIGN OR OTHERWISE BECOME 21 DISQUALIFIED DURING HIS OR HER TERM, A SUCCESSOR SHALL BE 22 APPOINTED IN THE SAME WAY AND WITH THE SAME QUALIFICATIONS AND 23 SHALL HOLD OFFICE FOR THE UNEXPIRED TERM. NO MEMBER SHALL BE 24 ELIGIBLE FOR APPOINTMENT TO SERVE MORE THAN TWO CONSECUTIVE 25 TERMS. THE GOVERNOR SHALL ASSURE THAT NURSE MIDWIVES, PHYSICIAN 26 ASSISTANTS, CERTIFIED REGISTERED NURSE PRACTITIONERS, 27 PERFUSIONISTS AND RESPIRATORY CARE PRACTITIONERS ARE APPOINTED 28 TO FOUR-YEAR TERMS ON A ROTATING BASIS SO THAT, OF EVERY FOUR 29 APPOINTMENTS TO A FOUR-YEAR TERM, ONE IS A NURSE MIDWIFE, ONE IS 30 A PHYSICIAN ASSISTANT, ONE IS A CERTIFIED REGISTERED NURSE 20070H0500B3703 - 3 -
1 PRACTITIONER AND ONE IS A RESPIRATORY CARE PRACTITIONER. 2 * * * 3 Section 3. The act is amended by adding a section to read: 4 Section 13.3. Perfusionist. 5 (a) License required.--Two years after the effective date of 6 this section, it shall be unlawful for any person to hold 7 himself out to the public as a perfusionist or to practice or 8 offer to practice perfusion unless the person holds a valid, 9 current license issued by the board or the State Board of 10 Osteopathic Medicine. 11 (b) Use of title.--A perfusionist who holds a valid, current 12 license issued by either board may use the title perfusionist or 13 licensed perfusionist, or an appropriate abbreviation of the 14 title, such as "LP." 15 (c) Regulations.--The board is authorized to promulgate 16 regulations to implement this section. 17 (d) Supervision and scope of practice.--A perfusionist may 18 perform perfusion to ON an individual being treated by a <-- 19 licensed physician PHYSICIAN LICENSED UNDER THIS ACT OR THE ACT <-- 20 OF OCTOBER 5, 1978 (P.L.1109, NO.261), KNOWN AS THE OSTEOPATHIC 21 MEDICAL PRACTICE ACT under medical supervision and approval 22 consistent with standing orders or protocols of a hospital that 23 are promulgated and approved by the physician designated as the 24 medical director of the cardiovascular surgery program. These 25 services shall include: 26 (1) The use of extracorporeal circulation, long-term 27 cardiopulmonary support techniques, including extracorporeal 28 carbon dioxide removal, extracorporeal membrane oxygenation 29 and associated therapeutic and diagnostic techniques. 30 (2) Counterpulsion, ventricular assistance, 20070H0500B3703 - 4 -
1 autotransfusion, blood and blood component conservation 2 techniques, myocardial and organ preservation, extracorporeal 3 life support and isolated limb perfusion. 4 (3) Blood and blood component management techniques, 5 advanced life support and other related functions. 6 (4) In the performance of the acts described in 7 paragraphs (1), (2) and (3): 8 (i) The administration of: 9 (A) Pharmacological and therapeutic agents. 10 (B) Blood products or anesthetic agents through 11 the extracorporeal circuit or through an intravenous 12 line in conjunction with extracorporeal support, 13 under the supervision of the treating physician. 14 (ii) The performance and use of: 15 (A) Anticoagulation monitoring and analysis. 16 (B) Physiologic monitoring and analysis. 17 (C) Blood gas and chemistry monitoring and 18 analysis. 19 (D) Hematologic monitoring and analysis. 20 (E) Hypothermia. 21 (F) Hyperthermia. 22 (G) Normothermia. 23 (H) Hemoconcentration and hemodilution. 24 (I) Hemodialysis in conjunction with perfusion 25 service. 26 (iii) The observation of signs and symptoms related 27 to perfusion services, the determination of whether the 28 signs and symptoms exhibit abnormal characteristics and 29 the implementation of appropriate reporting, perfusion 30 protocols or changes in or the initiation of emergency 20070H0500B3703 - 5 -
1 procedures. 2 (e) Exemptions.--The following persons may perform 3 perfusion, as indicated: 4 (1) A person licensed under any other section of this 5 act or any other law of this Commonwealth, while engaging in 6 the practice for which the person is licensed. 7 (2) A student enrolled in an accredited perfusion 8 education program if perfusion performed by the student: 9 (i) is an integral part of the student's course of 10 study; and 11 (ii) is performed under the direct supervision of a 12 perfusionist who is assigned to supervise the student and 13 who is on duty and immediately available in the assigned 14 patient care area. 15 (3) A graduate of an accredited perfusion education 16 program, if perfusion services: 17 (i) are necessary to fulfill the eligibility 18 requirements for a certification examination; and 19 (ii) are performed under the supervision and 20 responsibility of a perfusionist who is on duty and 21 assigned to supervise the graduate. 22 (4) A legally qualified person employed by the Federal 23 Government to practice perfusion while in the discharge of 24 the person's official duties. 25 (5) FOR A VENTRICULAR ASSIST DEVICE UNDER INVESTIGATIVE <-- 26 TRIALS BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION OR 27 APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION 28 SOLELY AS A VENTRICULAR ASSIST DEVICE, A PERSON WHO: 29 (I) HAS SATISFACTORILY COMPLETED SPECIFIC 30 VENTRICULAR ASSIST DEVICE TRAINING IN A COURSE PROVIDED 20070H0500B3703 - 6 -
1 BY THE VENTRICULAR ASSIST DEVICE MANUFACTURER; AND 2 (II) PROVIDES CARE RELATED TO THE VENTRICULAR ASSIST 3 DEVICE UNDER THE SUPERVISION OF A LICENSED PHYSICIAN. 4 (6) A PERSON WHO PERFORMS AUTOTRANSFUSION OR BLOOD 5 CONSERVATION TECHNIQUES UNDER THE SUPERVISION OF A LICENSED 6 PHYSICIAN. 7 (7) A PERSON WHO: 8 (I) IS TRAINED ACCORDING TO THE EXTRACORPOREAL 9 MEMBRANE OXYGENATION SPECIALIST GUIDELINES OF THE 10 EXTRACORPOREAL LIFE SUPPORT ORGANIZATION; AND 11 (II) OPERATES AN EXTRACORPOREAL MEMBRANE OXYGENATION 12 CIRCUIT UNDER THE SUPERVISION OF A LICENSED PHYSICIAN. 13 (f) Qualifications.--An applicant shall be licensed to 14 practice perfusion under this act if the applicant meets all of 15 the following qualifications and has otherwise complied with the 16 provisions of this act: 17 (1) The person is at least 18 years of age. 18 (2) The person is of good moral character. 19 (3) The person has graduated from an accredited 20 perfusion program approved by the board. 21 (4) The person is certified by a certifying agency 22 approved by a nationally recognized accrediting agency 23 approved by the board. The certification shall include an 24 examination approved by the board. 25 (5) The person has completed an application form 26 provided by the board and paid the appropriate fee. 27 (g) Certain certified persons not graduates of accredited 28 programs.--Within two years of the effective date of this 29 section, an applicant who was not a graduate of an accredited 30 program prior to 1981, but met the then-current eligibility 20070H0500B3703 - 7 -
1 requirements for certification as a certified clinical 2 perfusionist and subsequently was certified, shall be licensed 3 as a perfusionist if the applicant otherwise complies with the 4 provisions of this act. 5 (h) Temporary graduate license to practice perfusion.-- 6 (1) The board may issue a temporary graduate license to 7 practice perfusion to an individual who has graduated from an 8 educational program that complies with the education 9 requirements of this act. The ALL OF THE following shall <-- 10 apply: 11 (i) The individual has applied for the examination 12 and is eligible to take the required examination. 13 (ii) The individual's authorization to practice 14 perfusion is granted only under the supervision and 15 direction of a perfusionist licensed under this act. 16 (iii) The license shall be issued for a period of 17 two years and shall be nonrenewable. 18 (iv) The license shall expire immediately upon 19 notice that the individual has failed the required 20 examination under this act. 21 (2) (RESERVED). <-- 22 (i) Temporary provisional license to practice perfusion.-- 23 (1) The board may issue a temporary provisional license 24 to practice perfusion if all the following requirements are 25 met: 26 (i) The individual holds a current license which is 27 in good standing under the laws of another state, 28 District of Columbia or territory of the United States 29 which includes certification by a certifying agency 30 approved by a nationally recognized accrediting agency. 20070H0500B3703 - 8 -
1 (ii) The individual meets the requirements as set 2 forth in subsection (f)(1), (2) and (3). 3 (2) The license shall be issued for a period of one year 4 and shall be nonrenewable. 5 (j) Temporary emergency exemption.-- 6 (1) An individual who holds a current license as a 7 perfusionist in another state, the District of Columbia or a 8 territory of the United States or has obtained national 9 certification may provide a one-time emergency perfusionist 10 service in this Commonwealth without first obtaining a 11 license from the board if: 12 (i) Prior to the out-of-State perfusionist 13 performing the emergency perfusionist services in this 14 Commonwealth, the out-of-State perfusionist submits by 15 electronic means and on forms approved by the board, 16 notification of emergency practice which shall include an 17 acknowledgment that the out-of-State perfusionist is 18 subject to the jurisdiction of the board in the same 19 manner as if the out-of-State perfusionist were licensed 20 by the board. 21 (ii) The health care facility licensed by the 22 Department of Health certifies to the board, by 23 electronic means and on forms approved by the board, 24 prior to the out-of-state perfusionist performing the 25 emergency perfusionist services in this Commonwealth that 26 all of the following apply: 27 (A) The emergency perfusionist services were 28 provided for a patient of the health care facility. 29 (B) The perfusionist licensed by the board and 30 retained by the health care facility that would 20070H0500B3703 - 9 -
1 normally perform the emergency perfusionist services 2 was not available or incapable of providing the 3 perfusionist services. 4 (C) No other perfusionist licensed by the board 5 was available to provide or capable of providing the 6 emergency perfusion service. 7 (D) The out-of-State perfusionist provided only 8 the emergency perfusionist services for the patient 9 of the health care facility and no other perfusionist 10 services at the health care facility. 11 (2) The out-of-State perfusionist shall obtain a license 12 from the board if a health care facility licensed by the 13 Department of Health retains the perfusionist or if the 14 perfusionist provides any future perfusionist services. 15 (3) The out-of-State perfusionist shall not perform any 16 other perfusionist services other than the emergency 17 perfusionist services. 18 (k) Professional liability.-- 19 (1) A licensed perfusionist practicing in this 20 Commonwealth shall maintain a level of professional liability 21 insurance coverage as required for a nonparticipating health <-- 22 care provider under the act of March 20, 2002 (P.L.154, 23 No.13), known as the Medical Care Availability and Reduction 24 of Error (Mcare) Act, but shall not be eligible to 25 participate in the Medical Care Availability and Reduction of 26 Error Fund. IN THE MINIMUM AMOUNT OF $1,000,000 PER <-- 27 OCCURRENCE OR CLAIMS MADE. FAILURE TO MAINTAIN INSURANCE 28 COVERAGE AS REQUIRED SHALL SUBJECT THE LICENSEE TO 29 DISCIPLINARY PROCEEDINGS. THE BOARD SHALL ACCEPT FROM 30 PERFUSIONISTS AS SATISFACTORY EVIDENCE OF INSURANCE COVERAGE 20070H0500B3703 - 10 -
1 ANY OF THE FOLLOWING: 2 (I) SELF-INSURANCE; 3 (II) PERSONALLY PURCHASED LIABILITY INSURANCE; OR 4 (III) PROFESSIONAL LIABILITY INSURANCE COVERAGE 5 PROVIDED BY THE PERFUSIONIST'S EMPLOYER OR SIMILAR 6 INSURANCE COVERAGE ACCEPTABLE TO THE BOARD. 7 (2) A license applicant shall provide proof that the 8 applicant has obtained professional liability insurance in 9 accordance with paragraph (1). It is sufficient if the 10 applicant files with the application a copy of a letter from 11 the applicant's professional liability insurance carrier 12 indicating that the applicant will be covered against 13 professional liability in the required amounts effective upon 14 the issuance of the applicant's license to practice perfusion 15 in this Commonwealth. Upon issuance of the license, the 16 licensee has 30 days to submit to the board the certificate 17 of insurance or a copy of the policy declaration page. 18 (l) Licensure fees.--All application and licensure fees 19 shall be set by the board by regulation. 20 (m) Reciprocal disciplinary action.--Disciplinary action 21 taken by the State Board of Medicine against a perfusionist 22 licensed by it shall be enforceable by the State Board of 23 Osteopathic Medicine against that same individual if the 24 individual holds or seeks a license to practice as a 25 perfusionist with the State Board of Osteopathic Medicine. 26 (n) Continuing education.-- 27 (1) The board shall adopt, promulgate and enforce rules 28 and regulations consistent with the provisions of this act 29 establishing requirements of continuing education to be met 30 by individuals licensed as perfusionists under this act as a 20070H0500B3703 - 11 -
1 condition for renewal of their licenses. The regulations 2 shall include any fees necessary for the board to carry out 3 its responsibilities under this section. 4 (2) Beginning with the license period designated by 5 regulation, licensees shall be required to attend and 6 complete 30 hours of mandatory continuing education during 7 each two-year license period. Nationally certified education 8 courses shall be considered as creditable, in addition to any 9 other courses the board deems creditable toward meeting the 10 requirements for continuing education. 11 (3) An individual applying for the first time for 12 licensure in this Commonwealth shall be exempted from the 13 continuing education requirements for the biennial renewal 14 period following initial licensure. 15 (4) (i) The board may waive all or a portion of the 16 continuing education requirement for biennial renewal for 17 a licensee who shows to the satisfaction of the board 18 that the licensee was unable to complete the requirements 19 due to serious illness, military service or other 20 demonstrated hardship. 21 (ii) The request shall be made in writing with 22 appropriate documentation and shall include a description 23 of circumstances sufficient to show why the licensee is 24 unable to comply with the continuing education 25 requirement. 26 (5) A licensee seeking to reinstate an inactive or 27 lapsed license shall show proof of compliance with the 28 continuing education requirement for the preceding biennium. 29 (6) All courses, locations, instructors and providers 30 shall be approved by the board. No credit shall be given for 20070H0500B3703 - 12 -
1 any course in office management.
2 Section 4. The State Board of Medicine shall promulgate
3 regulations to carry out the provisions of this act within 18
4 months of the effective date of this section.
5 Section 5. This act shall take effect in 60 days.
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