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                                 SENATE AMENDED
        PRIOR PRINTER'S NOS. 556, 1846, 1910          PRINTER'S NO. 2778

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

        SENATOR CORMAN, CONSUMER PROTECTION AND PROFESSIONAL LICENSURE,
           IN SENATE, AS AMENDED, OCTOBER 30, 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


     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
    20070H0501B2778                  - 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, physician assistants and certified athletic
    14  trainers are appointed to four-year terms on a rotating basis.
    15     * * *
    16     Section 3.  The act is amended by adding a section to read:
    17  Section 13.3.  Perfusionist.
    18     (a)  Two years after the effective date of this section, it
    19  shall be unlawful for any person to hold himself out to the
    20  public as a perfusionist or to practice or offer to practice
    21  perfusion unless the person holds a valid, current license
    22  issued by the board or the State Board of Medicine.
    23     (b)  A perfusionist who holds a valid, current license issued
    24  by either board may use the title perfusionist or licensed
    25  perfusionist, or an appropriate abbreviation of the title, such
    26  as "LP."
    27     (c)  The board is authorized to promulgate regulations to
    28  implement this section.
    29     (d)  A perfusionist may perform perfusion to ON an individual  <--
    30  being treated by a physician licensed under this act or the act
    20070H0501B2778                  - 3 -     

     1  of act of December 20, 1985 (P.L.457, No.112), known as the
     2  "Medical Practice Act of 1985," under medical supervision and
     3  approval consistent with standing orders or protocols of a
     4  hospital that are promulgated and approved by the physician
     5  designated as the medical director of the cardiovascular surgery
     6  program. These 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) through (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.
    20070H0501B2778                  - 4 -     

     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)  The following persons may perform perfusion, as
    14  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
    20070H0501B2778                  - 5 -     

     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)  An applicant shall be licensed to practice perfusion
    25  under this act if the applicant meets all of the following
    26  qualifications and has otherwise complied with the provisions of
    27  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
    20070H0501B2778                  - 6 -     

     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)  Within two years of the effective date of this section,
     9  an applicant who was not a graduate of an accredited program
    10  prior to 1981, but met the then-current eligibility requirements
    11  for certification as a certified clinical perfusionist and
    12  subsequently was certified, shall be licensed as a perfusionist
    13  if the applicant otherwise complies with the provisions of this
    14  act.
    15     (h)  The board may issue a temporary graduate license to
    16  practice perfusion to an individual who has graduated from an
    17  educational program that complies with the education
    18  requirements of this act. The following shall apply:
    19         (1)  The individual has applied for the examination and
    20     is eligible to take the required examination.
    21         (2)  The individual's authorization to practice perfusion
    22     is granted only under the supervision and direction of a
    23     perfusionist licensed under this act.
    24         (3)  The license shall be issued for a period of two
    25     years and shall be nonrenewable.
    26         (4)  The license shall expire immediately upon notice
    27     that the individual has failed the required examination under
    28     this act.
    29     (i)  (1)  The board may issue a temporary provisional license
    30     to practice perfusion if all the following requirements are
    20070H0501B2778                  - 7 -     

     1     met:
     2             (i)  The individual holds a current license which is
     3         in good standing under the laws of another state,
     4         District of Columbia or territory of the United States
     5         which includes certification by a certifying agency
     6         approved by a nationally recognized accrediting agency.
     7             (ii)  The individual meets the requirements as set
     8         forth in subsection (f)(1), (2) and (3).
     9         (2)  The license shall be issued for a period of one year
    10     and shall be nonrenewable.
    11     (j)  (1)  An individual who holds a current license as a
    12     perfusionist in another state, the District of Columbia or a
    13     territory of the United States or has obtained national
    14     certification may provide a one-time emergency perfusionist
    15     service in this Commonwealth without first obtaining a
    16     license from the board if:
    17             (i)  Prior to the out-of-State perfusionist
    18         performing the emergency perfusionist services in this
    19         Commonwealth, the out-of-State perfusionist submits by
    20         electronic means and on forms approved by the board,
    21         notification of emergency practice which shall include an
    22         acknowledgment that the out-of-State perfusionist is
    23         subject to the jurisdiction of the board in the same
    24         manner as if the out-of-State perfusionist were licensed
    25         by the board.
    26             (ii)  The health care facility licensed by the
    27         Department of Health certifies to the board, by
    28         electronic means and on forms approved by the board,
    29         prior to the out-of-State perfusionist performing the
    30         emergency perfusionist services in this Commonwealth that
    20070H0501B2778                  - 8 -     

     1         all of the following apply:
     2                 (A)  The emergency perfusionist services were
     3             provided for a patient of the health care facility.
     4                 (B)  The perfusionist licensed by the board and
     5             retained by the health care facility that would
     6             normally perform the emergency perfusionist services
     7             was not available or incapable of providing the
     8             perfusionist services.
     9                 (C)  No other perfusionist licensed by the board
    10             was available to provide or capable of providing the
    11             emergency perfusion service.
    12                 (D)  The out-of-State perfusionist provided only
    13             the emergency perfusionist services for the patient
    14             of the health care facility and no other perfusionist
    15             services at the health care facility.
    16         (2)  The out-of-State perfusionist shall obtain a license
    17     from the board if a health care facility licensed by the
    18     Department of Health retains the perfusionist or if the
    19     perfusionist provides any future perfusionist services.
    20         (3)  The out-of-State perfusionist shall not perform any
    21     other perfusionist services other than the emergency
    22     perfusionist services.
    23     (k)  (1)  A licensed perfusionist practicing in this
    24     Commonwealth shall maintain a level of professional liability
    25     insurance coverage as required for a nonparticipating health   <--
    26     care provider under the act of March 20, 2002 (P.L.154,
    27     No.13), known as the Medical Care Availability and Reduction
    28     of Error (Mcare) Act, but shall not be eligible to
    29     participate in the Medical Care Availability and Reduction of
    30     Error (Mcare) Fund. IN THE MINIMUM AMOUNT OF $1,000,000 PER    <--
    20070H0501B2778                  - 9 -     

     1     OCCURRENCE OR CLAIMS MADE. FAILURE TO MAINTAIN INSURANCE
     2     COVERAGE AS REQUIRED SHALL SUBJECT THE LICENSEE TO
     3     DISCIPLINARY PROCEEDINGS. THE BOARD SHALL ACCEPT FROM
     4     PERFUSIONISTS AS SATISFACTORY EVIDENCE OF INSURANCE COVERAGE
     5     ANY OF THE FOLLOWING: SELF-INSURANCE, PERSONALLY PURCHASED
     6     LIABILITY INSURANCE, PROFESSIONAL LIABILITY INSURANCE
     7     COVERAGE PROVIDED BY THE PERFUSIONIST'S EMPLOYER OR SIMILAR
     8     INSURANCE COVERAGE ACCEPTABLE TO THE BOARD.
     9         (2)  A license applicant shall provide proof that the
    10     applicant has obtained professional liability insurance in
    11     accordance with paragraph (1). It is sufficient if the
    12     applicant files with the application a copy of a letter from
    13     the applicant's professional liability insurance carrier
    14     indicating that the applicant will be covered against
    15     professional liability in the required amounts effective upon
    16     the issuance of the applicant's license to practice perfusion
    17     in this Commonwealth. Upon issuance of the license, the
    18     licensee has 30 days to submit to the board the certificate
    19     of insurance or a copy of the policy declaration page.
    20     (l)  All application and licensure fees shall be set by the
    21  board by regulation.
    22     (m)  Disciplinary actions taken by the State Board of
    23  Osteopathic Medicine against a perfusionist licensed by it shall
    24  be enforceable by the State Board of Medicine against the same
    25  individual if such individual holds or seeks a license to
    26  practice as a perfusionist with the State Board of Medicine.
    27     (n)  (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
    20070H0501B2778                 - 10 -     

     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 requirement 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
    20070H0501B2778                 - 11 -     

     1     any course in office management.
     2     Section 4.  The State Board of Osteopathic Medicine shall
     3  initiate the promulgation of regulations to carry out the
     4  provisions of this act within 18 months of the effective date of
     5  this section.
     6     Section 5.  This act shall take effect in 60 days.
















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