SENATE AMENDED PRIOR PRINTER'S NOS. 556, 1846, 1910, PRINTER'S NO. 3638 2778, 3217
No. 501 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, APRIL 29, 2008
AN ACT
1 Amending the act of October 5, 1978 (P.L.1109, No.261), entitled
2 "An act requiring the licensing of practitioners of
3 osteopathic medicine and surgery; regulating their practice;
4 providing for certain funds and penalties for violations and
5 repeals," FURTHER PROVIDING FOR DEFINITIONS; AND providing <--
6 for perfusionist licensing, qualifications, supervision and
7 scope of practice, regulations and exemptions.
8 The General Assembly of the Commonwealth of Pennsylvania
9 hereby enacts as follows:
10 Section 1. Section 2 of the act of October 5, 1978
11 (P.L.1109, No.261), known as the Osteopathic Medical Practice
12 Act, is amended by adding definitions to read:
13 Section 2. Definitions.
14 The following words and phrases when used in this act shall
15 have, unless the context clearly indicates otherwise, the
16 meanings given to them in this section:
17 * * *
18 "Extracorporeal circulation." The diversion of a patient's
1 blood through a heart-lung machine or similar device that 2 assumes the functions of the patient's heart, lung, kidney, 3 liver or other organs. 4 * * * 5 "Perfusion." The functions necessary for the support, 6 treatment, measurement or supplementation of the cardiovascular 7 systems or other organs, or a combination of those functions, 8 and for ensuring the safe management of physiologic functions by 9 monitoring and analyzing the parameters of the systems under the 10 supervision of a physician licensed under this act or the act of 11 December 20, 1985 (P.L.457, No.112), known as the "Medical 12 Practice Act of 1985." 13 "Perfusionist." An individual who is licensed to practice 14 perfusion by the State Board of Osteopathic Medicine or the 15 State Board of Medicine. 16 * * * 17 "VENTRICULAR ASSIST DEVICE." A MECHANICAL DEVICE USED TO <-- 18 PARTIALLY OR COMPLETELY REPLACE THE FUNCTION OF A FAILING HEART 19 THROUGH CONNECTIONS TO THE HEART AND GREAT VESSELS THAT MAY BE 20 LOCATED INTRACORPOREALLY OR EXTRACORPOREALLY. THE TERM INCLUDES 21 A DEVICE THAT IS PLACED INTRAVASCULARLY OR EXTRAVASCULARLY AND 22 PROVIDES SUPPORT THROUGH DIRECT MEANS OR VIA COUNTERPULSATION. 23 * * * 24 Section 2. Section 2.1(a) of the act, amended December 10, 25 2001 (P.L.863, No.93), is amended to read: 26 Section 2.1. State Board of Osteopathic Medicine. 27 (a) The State Board of Osteopathic Medicine shall consist of 28 the Commissioner of Professional and Occupational Affairs or his 29 designee; the Secretary of Health or his designee; two members 30 appointed by the Governor who shall be persons representing the 20070H0501B3638 - 2 -
1 public at large; one member appointed by the Governor who shall 2 be a respiratory care practitioner, a perfusionist, a physician 3 assistant or a certified athletic trainer; and six members 4 appointed by the Governor who shall be graduates of a legally 5 incorporated and reputable college of [osteopathy] osteopathic 6 medicine and shall have been licensed to practice osteopathic 7 medicine under the laws of this Commonwealth and shall have been 8 engaged in the practice of osteopathy in this Commonwealth for a 9 period of at least five years. All professional and public 10 members of the board shall be appointed by the Governor with the 11 advice and consent of a majority of the members elected to the 12 Senate. The Governor shall assure that respiratory care 13 practitioners, PERFUSIONISTS, physician assistants and certified <-- 14 athletic trainers are appointed to four-year terms on a rotating 15 basis. 16 * * * 17 Section 3. The act is amended by adding a section to read: 18 Section 13.3. Perfusionist. 19 (a) Two years after the effective date of this section, it 20 shall be unlawful for any person to hold himself out to the 21 public as a perfusionist or to practice or offer to practice 22 perfusion unless the person holds a valid, current license 23 issued by the board or the State Board of Medicine. 24 (b) A perfusionist who holds a valid, current license issued 25 by either board may use the title perfusionist or licensed 26 perfusionist, or an appropriate abbreviation of the title, such 27 as "LP." 28 (c) The board is authorized to promulgate regulations to 29 implement this section. 30 (d) A perfusionist may perform perfusion to ON an individual <-- 20070H0501B3638 - 3 -
1 being treated by a physician licensed under this act or the act 2 of act of December 20, 1985 (P.L.457, No.112), known as the 3 "Medical Practice Act of 1985," under medical supervision and 4 approval consistent with standing orders or protocols of a 5 hospital that are promulgated and approved by the physician 6 designated as the medical director of the cardiovascular surgery 7 program. These services shall include: 8 (1) The use of extracorporeal circulation, long-term 9 cardiopulmonary support techniques, including extracorporeal 10 carbon dioxide removal, extracorporeal membrane oxygenation 11 and associated therapeutic and diagnostic techniques. 12 (2) Counterpulsion, ventricular assistance, 13 autotransfusion, blood and blood component conservation 14 techniques, myocardial and organ preservation, extracorporeal 15 life support and isolated limb perfusion. 16 (3) Blood and blood component management techniques, 17 advanced life support and other related functions. 18 (4) In the performance of the acts described in 19 paragraphs (1) through (3): 20 (i) The administration of: 21 (A) Pharmacological and therapeutic agents. 22 (B) Blood products or anesthetic agents through 23 the extracorporeal circuit or through an intravenous 24 line in conjunction with extracorporeal support, 25 under the supervision of the treating physician. 26 (ii) The performance and use of: 27 (A) Anticoagulation monitoring and analysis. 28 (B) Physiologic monitoring and analysis. 29 (C) Blood gas and chemistry monitoring and 30 analysis. 20070H0501B3638 - 4 -
1 (D) Hematologic monitoring and analysis. 2 (E) Hypothermia. 3 (F) Hyperthermia. 4 (G) Normothermia. 5 (H) Hemoconcentration and hemodilution. 6 (I) Hemodialysis in conjunction with perfusion 7 service. 8 (iii) The observation of signs and symptoms related 9 to perfusion services, the determination of whether the 10 signs and symptoms exhibit abnormal characteristics and 11 the implementation of appropriate reporting, perfusion 12 protocols or changes in or the initiation of emergency 13 procedures. 14 (e) The following persons may perform perfusion, as 15 indicated: 16 (1) A person licensed under any other section of this 17 act or any other law of this Commonwealth, while engaging in 18 the practice for which the person is licensed. 19 (2) A student enrolled in an accredited perfusion 20 education program if perfusion performed by the student: 21 (i) is an integral part of the student's course of 22 study; and 23 (ii) is performed under the direct supervision of a 24 perfusionist who is assigned to supervise the student and 25 who is on duty and immediately available in the assigned 26 patient care area. 27 (3) A graduate of an accredited perfusion education 28 program, if perfusion services: 29 (i) are necessary to fulfill the eligibility 30 requirements for a certification examination; and 20070H0501B3638 - 5 -
1 (ii) are performed under the supervision and 2 responsibility of a perfusionist who is on duty and 3 assigned to supervise the graduate. 4 (4) A legally qualified person employed by the Federal 5 Government to practice perfusion while in the discharge of 6 the person's official duties. 7 (5) FOR A VENTRICULAR ASSIST DEVICE UNDER INVESTIGATIVE <-- 8 TRIALS BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION OR 9 APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION 10 SOLELY AS A VENTRICULAR ASSIST DEVICE, A PERSON WHO: 11 (I) HAS SATISFACTORILY COMPLETED SPECIFIC 12 VENTRICULAR ASSIST DEVICE TRAINING IN A COURSE PROVIDED 13 BY THE VENTRICULAR ASSIST DEVICE MANUFACTURER; AND 14 (II) PROVIDES CARE RELATED TO THE VENTRICULAR ASSIST 15 DEVICE UNDER THE SUPERVISION OF A LICENSED PHYSICIAN. 16 (6) A PERSON WHO PERFORMS AUTOTRANSFUSION OR BLOOD 17 CONSERVATION TECHNIQUES UNDER THE SUPERVISION OF A LICENSED 18 PHYSICIAN. 19 (7) A PERSON WHO: 20 (I) IS TRAINED ACCORDING TO THE EXTRACORPOREAL 21 MEMBRANE OXYGENATION SPECIALIST GUIDELINES OF THE 22 EXTRACORPOREAL LIFE SUPPORT ORGANIZATION; AND 23 (II) OPERATES AN EXTRACORPOREAL MEMBRANE OXYGENATION 24 CIRCUIT UNDER THE SUPERVISION OF A LICENSED PHYSICIAN. 25 (f) An applicant shall be licensed to practice perfusion 26 under this act if the applicant meets all of the following 27 qualifications and has otherwise complied with the provisions of 28 this act: 29 (1) The person is at least 18 years of age. 30 (2) The person is of good moral character. 20070H0501B3638 - 6 -
1 (3) The person has graduated from an accredited 2 perfusion program approved by the board. 3 (4) The person is certified by a certifying agency 4 approved by a nationally recognized accrediting agency 5 approved by the board. The certification shall include an 6 examination approved by the board. 7 (5) The person has completed an application form 8 provided by the board and paid the appropriate fee. 9 (g) Within two years of the effective date of this section, 10 an applicant who was not a graduate of an accredited program 11 prior to 1981, but met the then-current eligibility requirements 12 for certification as a certified clinical perfusionist and 13 subsequently was certified, shall be licensed as a perfusionist 14 if the applicant otherwise complies with the provisions of this 15 act. 16 (h) The board may issue a temporary graduate license to 17 practice perfusion to an individual who has graduated from an 18 educational program that complies with the education 19 requirements of this act. The ALL OF THE following shall apply: <-- 20 (1) The individual has applied for the examination and 21 is eligible to take the required examination. 22 (2) The individual's authorization to practice perfusion 23 is granted only under the supervision and direction of a 24 perfusionist licensed under this act. 25 (3) The license shall be issued for a period of two 26 years and shall be nonrenewable. 27 (4) The license shall expire immediately upon notice 28 that the individual has failed the required examination under 29 this act. 30 (i) (1) The board may issue a temporary provisional license 20070H0501B3638 - 7 -
1 to practice perfusion if all the following requirements are 2 met: 3 (i) The individual holds a current license which is 4 in good standing under the laws of another state, 5 District of Columbia or territory of the United States 6 which includes certification by a certifying agency 7 approved by a nationally recognized accrediting agency. 8 (ii) The individual meets the requirements as set 9 forth in subsection (f)(1), (2) and (3). 10 (2) The license shall be issued for a period of one year 11 and shall be nonrenewable. 12 (j) (1) An individual who holds a current license as a 13 perfusionist in another state, the District of Columbia or a 14 territory of the United States or has obtained national 15 certification may provide a one-time emergency perfusionist 16 service in this Commonwealth without first obtaining a 17 license from the board if: 18 (i) Prior to the out-of-State perfusionist 19 performing the emergency perfusionist services in this 20 Commonwealth, the out-of-State perfusionist submits by 21 electronic means and on forms approved by the board, 22 notification of emergency practice which shall include an 23 acknowledgment that the out-of-State perfusionist is 24 subject to the jurisdiction of the board in the same 25 manner as if the out-of-State perfusionist were licensed 26 by the board. 27 (ii) The health care facility licensed by the 28 Department of Health certifies to the board, by 29 electronic means and on forms approved by the board, 30 prior to the out-of-State perfusionist performing the 20070H0501B3638 - 8 -
1 emergency perfusionist services in this Commonwealth that 2 all of the following apply: 3 (A) The emergency perfusionist services were 4 provided for a patient of the health care facility. 5 (B) The perfusionist licensed by the board and 6 retained by the health care facility that would 7 normally perform the emergency perfusionist services 8 was not available or incapable of providing the 9 perfusionist services. 10 (C) No other perfusionist licensed by the board 11 was available to provide or capable of providing the 12 emergency perfusion service. 13 (D) The out-of-State perfusionist provided only 14 the emergency perfusionist services for the patient 15 of the health care facility and no other perfusionist 16 services at the health care facility. 17 (2) The out-of-State perfusionist shall obtain a license 18 from the board if a health care facility licensed by the 19 Department of Health retains the perfusionist or if the 20 perfusionist provides any future perfusionist services. 21 (3) The out-of-State perfusionist shall not perform any 22 other perfusionist services other than the emergency 23 perfusionist services. 24 (k) (1) A licensed perfusionist practicing in this 25 Commonwealth shall maintain a level of professional liability 26 insurance coverage as required for a nonparticipating health <-- 27 care provider under the act of March 20, 2002 (P.L.154, 28 No.13), known as the Medical Care Availability and Reduction 29 of Error (Mcare) Act, but shall not be eligible to 30 participate in the Medical Care Availability and Reduction of 20070H0501B3638 - 9 -
1 Error (Mcare) Fund. IN THE MINIMUM AMOUNT OF $1,000,000 PER <-- 2 OCCURRENCE OR CLAIMS MADE. FAILURE TO MAINTAIN INSURANCE 3 COVERAGE AS REQUIRED SHALL SUBJECT THE LICENSEE TO 4 DISCIPLINARY PROCEEDINGS. THE BOARD SHALL ACCEPT FROM 5 PERFUSIONISTS AS SATISFACTORY EVIDENCE OF INSURANCE COVERAGE 6 ANY OF THE FOLLOWING: SELF-INSURANCE, PERSONALLY PURCHASED 7 LIABILITY INSURANCE, PROFESSIONAL LIABILITY INSURANCE 8 COVERAGE PROVIDED BY THE PERFUSIONIST'S EMPLOYER OR SIMILAR 9 INSURANCE COVERAGE ACCEPTABLE TO THE BOARD. 10 (2) A license applicant shall provide proof that the 11 applicant has obtained professional liability insurance in 12 accordance with paragraph (1). It is sufficient if the 13 applicant files with the application a copy of a letter from 14 the applicant's professional liability insurance carrier 15 indicating that the applicant will be covered against 16 professional liability in the required amounts effective upon 17 the issuance of the applicant's license to practice perfusion 18 in this Commonwealth. Upon issuance of the license, the 19 licensee has 30 days to submit to the board the certificate 20 of insurance or a copy of the policy declaration page. 21 (l) All application and licensure fees shall be set by the 22 board by regulation. 23 (m) Disciplinary actions taken by the State Board of 24 Osteopathic Medicine against a perfusionist licensed by it shall 25 be enforceable by the State Board of Medicine against the same 26 individual if such individual holds or seeks a license to 27 practice as a perfusionist with the State Board of Medicine. 28 (n) (1) The board shall adopt, promulgate and enforce rules 29 and regulations consistent with the provisions of this act 30 establishing requirements of continuing education to be met 20070H0501B3638 - 10 -
1 by individuals licensed as perfusionists under this act as a 2 condition for renewal of their licenses. The regulations 3 shall include any fees necessary for the board to carry out 4 its responsibilities under this section. 5 (2) Beginning with the license period designated by 6 regulation, licensees shall be required to attend and 7 complete 30 hours of mandatory continuing education during 8 each two-year license period. Nationally certified education 9 courses shall be considered as creditable, in addition to any 10 other courses the board deems creditable toward meeting the 11 requirements for continuing education. 12 (3) An individual applying for the first time for 13 licensure in this Commonwealth shall be exempted from the 14 continuing education requirement for the biennial renewal 15 period following initial licensure. 16 (4) (i) The board may waive all or a portion of the 17 continuing education requirement for biennial renewal for 18 a licensee who shows to the satisfaction of the board 19 that the licensee was unable to complete the requirements 20 due to serious illness, military service or other 21 demonstrated hardship. 22 (ii) The request shall be made in writing with 23 appropriate documentation and shall include a description 24 of circumstances sufficient to show why the licensee is 25 unable to comply with the continuing education 26 requirement. 27 (5) A licensee seeking to reinstate an inactive or 28 lapsed license shall show proof of compliance with the 29 continuing education requirement for the preceding biennium. 30 (6) All courses, locations, instructors and providers 20070H0501B3638 - 11 -
1 shall be approved by the board. No credit shall be given for 2 any course in office management. 3 Section 4. The State Board of Osteopathic Medicine shall 4 initiate the promulgation of regulations to carry out the 5 provisions of this act within 18 months of the effective date of 6 this section. 7 Section 5. This act shall take effect in 60 days. A19L63JS/20070H0501B3638 - 12 -