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        PRIOR PRINTER'S NO. 556                       PRINTER'S NO. 1846

THE GENERAL ASSEMBLY OF PENNSYLVANIA


HOUSE BILL

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 REPORTED FROM COMMITTEE ON PROFESSIONAL LICENSURE, HOUSE OF
           REPRESENTATIVES, AS AMENDED, JUNE 6, 2007

                                     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," providing for perfusionist licensing,
     6     qualifications, supervision and scope of practice,
     7     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
    19  blood through a heart-lung machine or similar device that

     1  assumes the functions of the patient's heart, lung, kidney,
     2  liver or other organs.
     3     * * *
     4     "Perfusion."  The functions necessary for the support,
     5  treatment, measurement or supplementation of the cardiovascular
     6  systems or other organs, or a combination of those functions,
     7  and for ensuring the safe management of physiologic functions by
     8  monitoring and analyzing the parameters of the systems under the
     9  supervision of a physician licensed under this act or the act of
    10  December 20, 1985 (P.L.457, No.112), known as the "Medical
    11  Practice Act of 1985."
    12     "Perfusionist."  An individual who is licensed to practice
    13  perfusion by the State Board of Osteopathic Medicine or the
    14  State Board of Medicine.
    15     * * *
    16     Section 2.  Section 2.1(a) of the act, amended December 10,
    17  2001 (P.L.863, No.93), is amended to read:
    18  Section 2.1.  State Board of Osteopathic Medicine.
    19     (a)  The State Board of Osteopathic Medicine shall consist of
    20  the Commissioner of Professional and Occupational Affairs or his
    21  designee; the Secretary of Health or his designee; two members
    22  appointed by the Governor who shall be persons representing the
    23  public at large; one member appointed by the Governor who shall
    24  be a respiratory care practitioner, a perfusionist, a physician
    25  assistant or a certified athletic trainer; and six members
    26  appointed by the Governor who shall be graduates of a legally
    27  incorporated and reputable college of [osteopathy] OSTEOPATHIC    <--
    28  MEDICINE and shall have been licensed to practice osteopathic
    29  medicine under the laws of this Commonwealth and shall have been
    30  engaged in the practice of osteopathy in this Commonwealth for a
    20070H0501B1846                  - 2 -     

     1  period of at least five years. All professional and public
     2  members of the board shall be appointed by the Governor with the
     3  advice and consent of a majority of the members elected to the
     4  Senate. The Governor shall assure that respiratory care
     5  practitioners, physician assistants and certified athletic
     6  trainers are appointed to four-year terms on a rotating basis.
     7     * * *
     8     Section 3.  The act is amended by adding a section to read:
     9  Section 13.3.  Perfusionist.
    10     (a)  License required.--Eighteen months TWO YEARS after the    <--
    11  effective date of this section, it shall be unlawful for any
    12  person to hold himself out to the public as a perfusionist or to
    13  practice or offer to practice perfusion unless the person holds
    14  a valid, current license issued by the board or the State Board
    15  of Osteopathic Medicine.                                          <--
    16     (b)  Use of title.--A perfusionist who holds a valid, current  <--
    17  license issued by either board may use the title perfusionist or
    18  licensed perfusionist, or an appropriate abbreviation of the
    19  title, such as "LP."
    20     (c)  Regulations.--The board is authorized to promulgate       <--
    21  regulations to implement this section.
    22     (d)  Supervision and scope of practice.--A perfusionist may    <--
    23  perform perfusion to an individual being treated by a physician
    24  licensed under this act or the act of act of December 20, 1985
    25  (P.L.457, No.112), known as the "Medical Practice Act of 1985,"
    26  under medical supervision and approval consistent with standing
    27  orders or protocols of a hospital THAT ARE PROMULGATED AND        <--
    28  APPROVED BY THE PHYSICIAN DESIGNATED AS THE MEDICAL DIRECTOR OF
    29  THE CARDIOVASCULAR SURGERY PROGRAM. These services shall
    30  include:
    20070H0501B1846                  - 3 -     

     1         (1)  The use of extracorporeal circulation, long-term
     2     cardiopulmonary support techniques, including extracorporeal
     3     carbon dioxide removal, extracorporeal membrane oxygenation
     4     and associated therapeutic and diagnostic techniques.
     5         (2)  Counterpulsion, ventricular assistance,
     6     autotransfusion, blood and blood component conservation
     7     techniques, myocardial and organ preservation, extracorporeal
     8     life support and isolated limb perfusion.
     9         (3)  Blood and blood component management techniques,
    10     advanced life support and other related functions.
    11         (4)  In the performance of the acts described in
    12     paragraphs (1) through (3):
    13             (i)  The administration of:
    14                 (A)  Pharmacological and therapeutic agents.
    15                 (B)  Blood products or anesthetic agents through
    16             the extracorporeal circuit or through an intravenous
    17             line in conjunction with extracorporeal support,
    18             under the supervision of the treating physician.
    19             (ii)  The performance and use of:
    20                 (A)  Anticoagulation monitoring and analysis.
    21                 (B)  Physiologic monitoring and analysis.
    22                 (C)  Blood gas and chemistry monitoring and
    23             analysis.
    24                 (D)  Hematologic monitoring and analysis.
    25                 (E)  Hypothermia.
    26                 (F)  Hyperthermia.
    27                 (G)  Normothermia.
    28                 (H)  Hemoconcentration and hemodilution.
    29                 (I)  Hemodialysis in conjunction with perfusion
    30             service.
    20070H0501B1846                  - 4 -     

     1             (iii)  The observation of signs and symptoms related
     2         to perfusion services, the determination of whether the
     3         signs and symptoms exhibit abnormal characteristics and
     4         the implementation of appropriate reporting, perfusion
     5         protocols or changes in or the initiation of emergency
     6         procedures.
     7     (e)  Exemptions.--The following persons may perform            <--
     8  perfusion, as indicated:
     9         (1)  A person licensed under any other section of this
    10     act or any other law of this Commonwealth, while engaging in
    11     the practice for which the person is licensed.
    12         (2)  A student enrolled in an accredited perfusion
    13     education program if perfusion performed by the student:
    14             (i)  is an integral part of the student's course of
    15         study; and
    16             (ii)  is performed under the direct supervision of a
    17         perfusionist who is assigned to supervise the student and
    18         who is on duty and immediately available in the assigned
    19         patient care area.
    20         (3)  A graduate of an accredited perfusion education
    21     program, if perfusion services:
    22             (i)  are necessary to fulfill the eligibility
    23         requirements for a certification examination; and
    24             (ii)  are performed under the supervision and
    25         responsibility of a perfusionist who is on duty and
    26         assigned to supervise the graduate.
    27         (4)  A legally qualified person employed by the Federal
    28     Government to practice perfusion while in the discharge of
    29     the person's official duties.
    30     (f)  Qualifications.--An applicant shall be licensed to        <--
    20070H0501B1846                  - 5 -     

     1  practice perfusion under this act if the applicant meets all of
     2  the following qualifications and has otherwise complied with the
     3  provisions of this act:
     4         (1)  The person is at least 18 years of age.
     5         (2)  The person is of good moral character.
     6         (3)  THE PERSON HAS GRADUATED FROM AN ACCREDITED           <--
     7     PERFUSION PROGRAM APPROVED BY THE BOARD.
     8         (4)  THE PERSON IS CERTIFIED BY A CERTIFYING AGENCY
     9     APPROVED BY A NATIONALLY RECOGNIZED ACCREDITING AGENCY
    10     APPROVED BY THE BOARD. THE CERTIFICATION SHALL INCLUDE AN
    11     EXAMINATION APPROVED BY THE BOARD.
    12         (3) (5)  The person has completed an application form      <--
    13     provided by the board AND PAID THE APPROPRIATE FEE.            <--
    14         (4)  The person has successfully completed a perfusion     <--
    15     education program approved by the board.
    16         (5)  The person is certified as a certified clinical
    17     perfusionist by a certifying agency approved by the board.
    18     The certification shall include an examination approved by
    19     the board.
    20     (g)  Certain certified persons not graduates of accredited
    21  programs.--Within
    22     (G)  WITHIN two years of the effective date of this section,   <--
    23  an applicant who was not a graduate of an accredited program
    24  prior to 1981, but met the then-current eligibility requirements
    25  for certification as a certified clinical perfusionist and
    26  subsequently was certified, shall be licensed as a perfusionist
    27  if the applicant otherwise complies with the provisions of this
    28  act.
    29     (H)  THE BOARD MAY ISSUE A TEMPORARY GRADUATE LICENSE TO       <--
    30  PRACTICE PERFUSION TO AN INDIVIDUAL WHO HAS GRADUATED FROM AN
    20070H0501B1846                  - 6 -     

     1  EDUCATIONAL PROGRAM THAT COMPLIES WITH THE EDUCATION
     2  REQUIREMENTS OF THIS ACT. THE FOLLOWING SHALL APPLY:
     3         (1)  THE INDIVIDUAL HAS APPLIED FOR THE EXAMINATION AND
     4     IS ELIGIBLE TO TAKE THE REQUIRED EXAMINATION.
     5         (2)  THE INDIVIDUAL'S AUTHORIZATION TO PRACTICE PERFUSION
     6     IS GRANTED ONLY UNDER THE SUPERVISION AND DIRECTION OF A
     7     PERFUSIONIST LICENSED UNDER THIS ACT.
     8         (3)  THE LICENSE SHALL BE ISSUED FOR A PERIOD OF TWO
     9     YEARS AND SHALL BE NONRENEWABLE.
    10         (4)  THE LICENSE SHALL EXPIRE IMMEDIATELY UPON NOTICE
    11     THAT THE INDIVIDUAL HAS FAILED THE REQUIRED EXAMINATION UNDER
    12     THIS ACT.
    13     (I)  (1)  THE BOARD MAY ISSUE A TEMPORARY PROVISIONAL LICENSE
    14     TO PRACTICE PERFUSION IF ALL THE FOLLOWING REQUIREMENTS ARE
    15     MET:
    16             (I)  THE INDIVIDUAL HOLDS A CURRENT LICENSE WHICH IS
    17         IN GOOD STANDING UNDER THE LAWS OF ANOTHER STATE,
    18         DISTRICT OF COLUMBIA OR TERRITORY OF THE UNITED STATES
    19         WHICH INCLUDES CERTIFICATION BY A CERTIFYING AGENCY
    20         APPROVED BY A NATIONALLY RECOGNIZED ACCREDITING AGENCY.
    21             (II)  THE INDIVIDUAL MEETS THE REQUIREMENTS AS SET
    22         FORTH IN SUBSECTION (F)(1), (2) AND (3).
    23         (2)  THE LICENSE SHALL BE ISSUED FOR A PERIOD OF ONE YEAR
    24     AND SHALL BE NONRENEWABLE.
    25     (J)  (1)  A LICENSED PERFUSIONIST PRACTICING IN THIS
    26     COMMONWEALTH SHALL MAINTAIN A LEVEL OF PROFESSIONAL LIABILITY
    27     INSURANCE COVERAGE AS REQUIRED FOR A NONPARTICIPATING HEALTH
    28     CARE PROVIDER UNDER THE ACT OF MARCH 20, 2002 (P.L.154,
    29     NO.13), KNOWN AS THE MEDICAL CARE AVAILABILITY AND REDUCTION
    30     OF ERROR (MCARE) ACT, BUT SHALL NOT BE ELIGIBLE TO
    20070H0501B1846                  - 7 -     

     1     PARTICIPATE IN THE MEDICAL CARE AVAILABILITY AND REDUCTION OF
     2     ERROR (MCARE) FUND.
     3         (2)  A LICENSE APPLICANT SHALL PROVIDE PROOF THAT THE
     4     APPLICANT HAS OBTAINED PROFESSIONAL LIABILITY INSURANCE IN
     5     ACCORDANCE WITH PARAGRAPH (1). IT IS SUFFICIENT IF THE
     6     APPLICANT FILES WITH THE APPLICATION A COPY OF A LETTER FROM
     7     THE APPLICANT'S PROFESSIONAL LIABILITY INSURANCE CARRIER
     8     INDICATING THAT THE APPLICANT WILL BE COVERED AGAINST
     9     PROFESSIONAL LIABILITY IN THE REQUIRED AMOUNTS EFFECTIVE UPON
    10     THE ISSUANCE OF THE APPLICANT'S LICENSE TO PRACTICE PERFUSION
    11     IN THIS COMMONWEALTH. UPON ISSUANCE OF THE LICENSE, THE
    12     LICENSEE HAS 30 DAYS TO SUBMIT TO THE BOARD THE CERTIFICATE
    13     OF INSURANCE OR A COPY OF THE POLICY DECLARATION PAGE.
    14     (K)  ALL APPLICATION AND LICENSURE FEES SHALL BE SET BY THE
    15  BOARD BY REGULATION.
    16     (L)  DISCIPLINARY ACTIONS TAKEN BY THE STATE BOARD OF
    17  OSTEOPATHIC MEDICINE AGAINST A PERFUSIONIST LICENSED BY IT SHALL
    18  BE ENFORCEABLE BY THE STATE BOARD OF MEDICINE AGAINST THE SAME
    19  INDIVIDUAL IF SUCH INDIVIDUAL HOLDS OR SEEKS A LICENSE TO
    20  PRACTICE AS A PERFUSIONIST WITH THE STATE BOARD OF MEDICINE.
    21     (M)  (1)  THE BOARD SHALL ADOPT, PROMULGATE AND ENFORCE RULES
    22     AND REGULATIONS CONSISTENT WITH THE PROVISIONS OF THIS ACT
    23     ESTABLISHING REQUIREMENTS OF CONTINUING EDUCATION TO BE MET
    24     BY INDIVIDUALS LICENSED AS PERFUSIONISTS UNDER THIS ACT AS A
    25     CONDITION FOR RENEWAL OF THEIR LICENSES. THE REGULATIONS
    26     SHALL INCLUDE ANY FEES NECESSARY FOR THE BOARD TO CARRY OUT
    27     ITS RESPONSIBILITIES UNDER THIS SECTION.
    28         (2)  BEGINNING WITH THE LICENSE PERIOD DESIGNATED BY
    29     REGULATION, LICENSEES SHALL BE REQUIRED TO ATTEND AND
    30     COMPLETE 30 HOURS OF MANDATORY CONTINUING EDUCATION DURING
    20070H0501B1846                  - 8 -     

     1     EACH TWO-YEAR LICENSE PERIOD. NATIONALLY CERTIFIED EDUCATION
     2     COURSES SHALL BE CONSIDERED AS CREDITABLE, IN ADDITION TO ANY
     3     OTHER COURSES THE BOARD DEEMS CREDITABLE TOWARD MEETING THE
     4     REQUIREMENTS FOR CONTINUING EDUCATION.
     5         (3)  AN INDIVIDUAL APPLYING FOR THE FIRST TIME FOR
     6     LICENSURE IN THIS COMMONWEALTH SHALL BE EXEMPTED FROM THE
     7     CONTINUING EDUCATION REQUIREMENT FOR THE BIENNIAL RENEWAL
     8     PERIOD FOLLOWING INITIAL LICENSURE.
     9         (4)  (I)  THE BOARD MAY WAIVE ALL OR A PORTION OF THE
    10         CONTINUING EDUCATION REQUIREMENT FOR BIENNIAL RENEWAL FOR
    11         A LICENSEE WHO SHOWS TO THE SATISFACTION OF THE BOARD
    12         THAT THE LICENSEE WAS UNABLE TO COMPLETE THE REQUIREMENTS
    13         DUE TO SERIOUS ILLNESS, MILITARY SERVICE OR OTHER
    14         DEMONSTRATED HARDSHIP.
    15             (II)  THE REQUEST SHALL BE MADE IN WRITING WITH
    16         APPROPRIATE DOCUMENTATION AND SHALL INCLUDE A DESCRIPTION
    17         OF CIRCUMSTANCES SUFFICIENT TO SHOW WHY THE LICENSEE IS
    18         UNABLE TO COMPLY WITH THE CONTINUING EDUCATION
    19         REQUIREMENT.
    20         (5)  A LICENSEE SEEKING TO REINSTATE AN INACTIVE OR
    21     LAPSED LICENSE SHALL SHOW PROOF OF COMPLIANCE WITH THE
    22     CONTINUING EDUCATION REQUIREMENT FOR THE PRECEDING BIENNIUM.
    23         (6)  ALL COURSES, LOCATIONS, INSTRUCTORS AND PROVIDERS
    24     SHALL BE APPROVED BY THE BOARD. NO CREDIT SHALL BE GIVEN FOR
    25     ANY COURSE IN OFFICE MANAGEMENT.
    26     SECTION 4.  THE STATE BOARD OF OSTEOPATHIC MEDICINE SHALL
    27  INITIATE THE PROMULGATION OF REGULATIONS TO CARRY OUT THE
    28  PROVISIONS OF THIS ACT WITHIN 18 MONTHS OF THE EFFECTIVE DATE OF
    29  THIS SECTION.
    30     Section 4 5.  This act shall take effect in 60 days.           <--
    A19L63JS/20070H0501B1846         - 9 -