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