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        PRIOR PRINTER'S NOS. 555, 1845                PRINTER'S NO. 1909

THE GENERAL ASSEMBLY OF PENNSYLVANIA


HOUSE BILL

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, HOUSE OF REPRESENTATIVES,
           JUNE 13, 2007

                                     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:
    21     * * *

     1     "Extracorporeal circulation."  The diversion of a patient's
     2  blood through a heart-lung machine or similar device that
     3  assumes the functions of the patient's heart, lung, kidney,
     4  liver or other organs.
     5     * * *
     6     "Perfusion."  The functions necessary for the support,
     7  treatment, measurement or supplementation of the cardiovascular
     8  systems or other organs, or a combination of those functions,
     9  and for ensuring the safe management of physiologic functions by
    10  monitoring and analyzing the parameters of the systems under the
    11  supervision of a licensed physician.
    12     "Perfusionist."  An individual who is licensed to practice
    13  perfusion by the State Board of Medicine or the State Board of
    14  Osteopathic Medicine.
    15     * * *
    16     Section 2.  Section 3(a) of the act, amended December 10,
    17  2001 (P.L.859, No.92), is amended to read:
    18  Section 3.  State Board of Medicine.
    19     (a)  Establishment.--The State Board of Medicine shall
    20  consist of the commissioner or his designee, the Secretary of
    21  Health or his designee, two members appointed by the Governor
    22  who shall be persons representing the public at large and seven
    23  members appointed by the Governor, six of whom shall be medical
    24  doctors with unrestricted licenses to practice medicine and
    25  surgery in this Commonwealth for five years immediately
    26  preceding their appointment and one who shall be a nurse
    27  midwife, physician assistant, certified registered nurse
    28  practitioner, respiratory care practitioner [or], certified
    29  athletic trainer or perfusionist licensed or certified under the
    30  laws of this Commonwealth. All professional and public members
    20070H0500B1909                  - 2 -     

     1  of the board shall be appointed by the Governor, with the advice
     2  and consent of a majority of the members elected to the Senate.
     3     * * *
     4     Section 3.  The act is amended by adding a section to read:
     5  Section 13.3.  Perfusionist.
     6     (a)  License required.--Eighteen months TWO YEARS after the    <--
     7  effective date of this section, it shall be unlawful for any
     8  person to hold himself out to the public as a perfusionist or to
     9  practice or offer to practice perfusion unless the person holds
    10  a valid, current license issued by the board or the State Board
    11  of Osteopathic Medicine.
    12     (b)  Use of title.--A perfusionist who holds a valid, current
    13  license issued by either board may use the title perfusionist or
    14  licensed perfusionist, or an appropriate abbreviation of the
    15  title, such as "LP."
    16     (c)  Regulations.--The board is authorized to promulgate
    17  regulations to implement this section.
    18     (d)  Supervision and scope of practice.--A perfusionist may
    19  perform perfusion to an individual being treated by a licensed
    20  physician under medical supervision and approval consistent with
    21  standing orders or protocols of a hospital that are promulgated
    22  and approved by the physician designated as the medical director
    23  of the cardiovascular surgery program. These services shall
    24  include:
    25         (1)  The use of extracorporeal circulation, long-term
    26     cardiopulmonary support techniques, including extracorporeal
    27     carbon dioxide removal, extracorporeal membrane oxygenation
    28     and associated therapeutic and diagnostic techniques.
    29         (2)  Counterpulsion, ventricular assistance,
    30     autotransfusion, blood and blood component conservation
    20070H0500B1909                  - 3 -     

     1     techniques, myocardial and organ preservation, extracorporeal
     2     life support and isolated limb perfusion.
     3         (3)  Blood and blood component management techniques,
     4     advanced life support and other related functions.
     5         (4)  In the performance of the acts described in
     6     paragraphs (1), (2) and (3):
     7             (i)  The administration of:
     8                 (A)  Pharmacological and therapeutic agents.
     9                 (B)  Blood products or anesthetic agents through
    10             the extracorporeal circuit or through an intravenous
    11             line in conjunction with extracorporeal support,
    12             under the supervision of the treating physician.
    13             (ii)  The performance and use of:
    14                 (A)  Anticoagulation monitoring and analysis.
    15                 (B)  Physiologic monitoring and analysis.
    16                 (C)  Blood gas and chemistry monitoring and
    17             analysis.
    18                 (D)  Hematologic monitoring and analysis.
    19                 (E)  Hypothermia.
    20                 (F)  Hyperthermia.
    21                 (G)  Normothermia.
    22                 (H)  Hemoconcentration and hemodilution.
    23                 (I)  Hemodialysis in conjunction with perfusion
    24             service.
    25             (iii)  The observation of signs and symptoms related
    26         to perfusion services, the determination of whether the
    27         signs and symptoms exhibit abnormal characteristics and
    28         the implementation of appropriate reporting, perfusion
    29         protocols or changes in or the initiation of emergency
    30         procedures.
    20070H0500B1909                  - 4 -     

     1     (e)  Exemptions.--The following persons may perform
     2  perfusion, as indicated:
     3         (1)  A person licensed under any other section of this
     4     act or any other law of this Commonwealth, while engaging in
     5     the practice for which the person is licensed.
     6         (2)  A student enrolled in an accredited perfusion
     7     education program if perfusion performed by the student:
     8             (i)  is an integral part of the student's course of
     9         study; and
    10             (ii)  is performed under the direct supervision of a
    11         perfusionist who is assigned to supervise the student and
    12         who is on duty and immediately available in the assigned
    13         patient care area.
    14         (3)  A graduate of an accredited perfusion education
    15     program, if perfusion services:
    16             (i)  are necessary to fulfill the eligibility
    17         requirements for a certification examination; and
    18             (ii)  are performed under the supervision and
    19         responsibility of a perfusionist who is on duty and
    20         assigned to supervise the graduate.
    21         (4)  A legally qualified person employed by the Federal
    22     Government to practice perfusion while in the discharge of
    23     the person's official duties.
    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
    20070H0500B1909                  - 5 -     

     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 following shall apply:
    21             (i)  The individual has applied for the examination
    22         and is eligible to take the required examination.
    23             (ii)  The individual's authorization to practice
    24         perfusion is granted only under the supervision and
    25         direction of a perfusionist licensed under this act.
    26             (iii)  The license shall be issued for a period of
    27         two years and shall be nonrenewable.
    28             (iv)  The license shall expire immediately upon
    29         notice that the individual has failed the required
    30         examination under this act.
    20070H0500B1909                  - 6 -     

     1     (i)  Temporary provisional license to practice perfusion.--
     2         (1)  The board may issue a temporary provisional license
     3     to practice perfusion if all the following requirements are
     4     met:
     5             (i)  The individual holds a current license which is
     6         in good standing under the laws of another state,
     7         District of Columbia or territory of the United States
     8         which includes certification by a certifying agency
     9         approved by a nationally recognized accrediting agency.
    10             (ii)  The individual meets the requirements as set
    11         forth in subsection (f)(1), (2) and (3).
    12         (2)  The license shall be issued for a period of one year
    13     and shall be nonrenewable.
    14     (J)  TEMPORARY EMERGENCY EXEMPTION.--                          <--
    15         (1)  AN INDIVIDUAL WHO HOLDS A CURRENT LICENSE AS A
    16     PERFUSIONIST IN ANOTHER STATE, THE DISTRICT OF COLUMBIA OR A
    17     TERRITORY OF THE UNITED STATES OR HAS OBTAINED NATIONAL
    18     CERTIFICATION MAY PROVIDE A ONE-TIME EMERGENCY PERFUSIONIST
    19     SERVICE IN THIS COMMONWEALTH WITHOUT FIRST OBTAINING A
    20     LICENSE FROM THE BOARD IF:
    21             (I)  PRIOR TO THE OUT-OF-STATE PERFUSIONIST
    22         PERFORMING THE EMERGENCY PERFUSIONIST SERVICES IN THIS
    23         COMMONWEALTH, THE OUT-OF-STATE PERFUSIONIST SUBMITS BY
    24         ELECTRONIC MEANS AND ON FORMS APPROVED BY THE BOARD,
    25         NOTIFICATION OF EMERGENCY PRACTICE WHICH SHALL INCLUDE AN
    26         ACKNOWLEDGMENT THAT THE OUT-OF-STATE PERFUSIONIST IS
    27         SUBJECT TO THE JURISDICTION OF THE BOARD IN THE SAME
    28         MANNER AS IF THE OUT-OF-STATE PERFUSIONIST WERE LICENSED
    29         BY THE BOARD.
    30             (II)  THE HEALTH CARE FACILITY LICENSED BY THE
    20070H0500B1909                  - 7 -     

     1         DEPARTMENT OF HEALTH CERTIFIES TO THE BOARD, BY
     2         ELECTRONIC MEANS AND ON FORMS APPROVED BY THE BOARD,
     3         PRIOR TO THE OUT-OF-STATE PERFUSIONIST PERFORMING THE
     4         EMERGENCY PERFUSIONIST SERVICES IN THIS COMMONWEALTH THAT
     5         ALL OF THE FOLLOWING APPLY:
     6                 (A)  THE EMERGENCY PERFUSIONIST SERVICES WERE
     7             PROVIDED FOR A PATIENT OF THE HEALTH CARE FACILITY.
     8                 (B)  THE PERFUSIONIST LICENSED BY THE BOARD AND
     9             RETAINED BY THE HEALTH CARE FACILITY THAT WOULD
    10             NORMALLY PERFORM THE EMERGENCY PERFUSIONIST SERVICES
    11             WAS NOT AVAILABLE OR INCAPABLE OF PROVIDING THE
    12             PERFUSIONIST SERVICES.
    13                 (C)  NO OTHER PERFUSIONIST LICENSED BY THE BOARD
    14             WAS AVAILABLE TO PROVIDE OR CAPABLE OF PROVIDING THE
    15             EMERGENCY PERFUSION SERVICE.
    16                 (D)  THE OUT-OF-STATE PERFUSIONIST PROVIDED ONLY
    17             THE EMERGENCY PERFUSIONIST SERVICES FOR THE PATIENT
    18             OF THE HEALTH CARE FACILITY AND NO OTHER PERFUSIONIST
    19             SERVICES AT THE HEALTH CARE FACILITY.
    20         (2)  THE OUT-OF-STATE PERFUSIONIST SHALL OBTAIN A LICENSE
    21     FROM THE BOARD IF A HEALTH CARE FACILITY LICENSED BY THE
    22     DEPARTMENT OF HEALTH RETAINS THE PERFUSIONIST OR IF THE
    23     PERFUSIONIST PROVIDES ANY FUTURE PERFUSIONIST SERVICES.
    24         (3)  THE OUT-OF-STATE PERFUSIONIST SHALL NOT PERFORM ANY
    25     OTHER PERFUSIONIST SERVICES OTHER THAN THE EMERGENCY
    26     PERFUSIONIST SERVICES.
    27     (j) (K)  Professional liability.--                             <--
    28         (1)  A licensed perfusionist practicing in this
    29     Commonwealth shall maintain a level of professional liability
    30     insurance coverage as required for a nonparticipating health
    20070H0500B1909                  - 8 -     

     1     care provider under the act of March 20, 2002 (P.L.154,
     2     No.13), known as the Medical Care Availability and Reduction
     3     of Error (Mcare) Act, but shall not be eligible to
     4     participate in the Medical Care Availability and Reduction of
     5     Error Fund.
     6         (2)  A license applicant shall provide proof that the
     7     applicant has obtained professional liability insurance in
     8     accordance with paragraph (1). It is sufficient if the
     9     applicant files with the application a copy of a letter from
    10     the applicant's professional liability insurance carrier
    11     indicating that the applicant will be covered against
    12     professional liability in the required amounts effective upon
    13     the issuance of the applicant's license to practice perfusion
    14     in this Commonwealth. Upon issuance of the license, the
    15     licensee has 30 days to submit to the board the certificate
    16     of insurance or a copy of the policy declaration page.
    17     (k) (L)  Licensure fees.--All application and licensure fees   <--
    18  shall be set by the board by regulation.
    19     (l) (M)  Reciprocal disciplinary action.--Disciplinary action  <--
    20  taken by the State Board of Medicine against a perfusionist
    21  licensed by it shall be enforceable by the State Board of
    22  Osteopathic Medicine against that same individual if the
    23  individual holds or seeks a license to practice as a
    24  perfusionist with the State Board of Osteopathic Medicine.
    25     (m) (N)  Continuing education.--                               <--
    26         (1)  The board shall adopt, promulgate and enforce rules
    27     and regulations consistent with the provisions of this act
    28     establishing requirements of continuing education to be met
    29     by individuals licensed as perfusionists under this act as a
    30     condition for renewal of their licenses. The regulations
    20070H0500B1909                  - 9 -     

     1     shall include any fees necessary for the board to carry out
     2     its responsibilities under this section.
     3         (2)  Beginning with the license period designated by
     4     regulation, licensees shall be required to attend and
     5     complete 30 hours of mandatory continuing education during
     6     each two-year license period. Nationally certified education
     7     courses shall be considered as creditable, in addition to any
     8     other courses the board deems creditable toward meeting the
     9     requirements for continuing education.
    10         (3)  An individual applying for the first time for
    11     licensure in this Commonwealth shall be exempted from the
    12     continuing education requirements for the biennial renewal
    13     period following initial licensure.
    14         (4)  (i)  The board may waive all or a portion of the
    15         continuing education requirement for biennial renewal for
    16         a licensee who shows to the satisfaction of the board
    17         that the licensee was unable to complete the requirements
    18         due to serious illness, military service or other
    19         demonstrated hardship.
    20             (ii)  The request shall be made in writing with
    21         appropriate documentation and shall include a description
    22         of circumstances sufficient to show why the licensee is
    23         unable to comply with the continuing education
    24         requirement.
    25         (5)  A licensee seeking to reinstate an inactive or
    26     lapsed license shall show proof of compliance with the
    27     continuing education requirement for the preceding biennium.
    28         (6)  All courses, locations, instructors and providers
    29     shall be approved by the board. No credit shall be given for
    30     any course in office management.
    20070H0500B1909                 - 10 -     

     1     Section 4.  The State Board of Medicine shall promulgate
     2  regulations to carry out the provisions of this act within 18
     3  months of the effective date of this section.
     4     Section 5.  This act shall take effect in 60 days.


















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