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                                 SENATE AMENDED
        PRIOR PRINTER'S NOS. 555, 1845, 1909,         PRINTER'S NO. 3703
        2777, 3216

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 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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