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                                 SENATE AMENDED
        PRIOR PRINTER'S NOS. 556, 1846, 1910,         PRINTER'S NO. 3638
        2778, 3217

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 AMENDED ON THIRD CONSIDERATION, IN SENATE, APRIL 29, 2008

                                     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," FURTHER PROVIDING FOR DEFINITIONS; AND providing     <--
     6     for perfusionist licensing, qualifications, supervision and
     7     scope of practice, 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
    20070H0501B3638                  - 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, PERFUSIONISTS, physician assistants and certified  <--
    14  athletic trainers are appointed to four-year terms on a rotating
    15  basis.
    16     * * *
    17     Section 3.  The act is amended by adding a section to read:
    18  Section 13.3.  Perfusionist.
    19     (a)  Two years after the effective date of this section, it
    20  shall be unlawful for any person to hold himself out to the
    21  public as a perfusionist or to practice or offer to practice
    22  perfusion unless the person holds a valid, current license
    23  issued by the board or the State Board of Medicine.
    24     (b)  A perfusionist who holds a valid, current license issued
    25  by either board may use the title perfusionist or licensed
    26  perfusionist, or an appropriate abbreviation of the title, such
    27  as "LP."
    28     (c)  The board is authorized to promulgate regulations to
    29  implement this section.
    30     (d)  A perfusionist may perform perfusion to ON an individual  <--
    20070H0501B3638                  - 3 -     

     1  being treated by a physician licensed under this act or the act
     2  of act of December 20, 1985 (P.L.457, No.112), known as the
     3  "Medical Practice Act of 1985," under medical supervision and
     4  approval consistent with standing orders or protocols of a
     5  hospital that are promulgated and approved by the physician
     6  designated as the medical director of the cardiovascular surgery
     7  program. These services shall include:
     8         (1)  The use of extracorporeal circulation, long-term
     9     cardiopulmonary support techniques, including extracorporeal
    10     carbon dioxide removal, extracorporeal membrane oxygenation
    11     and associated therapeutic and diagnostic techniques.
    12         (2)  Counterpulsion, ventricular assistance,
    13     autotransfusion, blood and blood component conservation
    14     techniques, myocardial and organ preservation, extracorporeal
    15     life support and isolated limb perfusion.
    16         (3)  Blood and blood component management techniques,
    17     advanced life support and other related functions.
    18         (4)  In the performance of the acts described in
    19     paragraphs (1) through (3):
    20             (i)  The administration of:
    21                 (A)  Pharmacological and therapeutic agents.
    22                 (B)  Blood products or anesthetic agents through
    23             the extracorporeal circuit or through an intravenous
    24             line in conjunction with extracorporeal support,
    25             under the supervision of the treating physician.
    26             (ii)  The performance and use of:
    27                 (A)  Anticoagulation monitoring and analysis.
    28                 (B)  Physiologic monitoring and analysis.
    29                 (C)  Blood gas and chemistry monitoring and
    30             analysis.
    20070H0501B3638                  - 4 -     

     1                 (D)  Hematologic monitoring and analysis.
     2                 (E)  Hypothermia.
     3                 (F)  Hyperthermia.
     4                 (G)  Normothermia.
     5                 (H)  Hemoconcentration and hemodilution.
     6                 (I)  Hemodialysis in conjunction with perfusion
     7             service.
     8             (iii)  The observation of signs and symptoms related
     9         to perfusion services, the determination of whether the
    10         signs and symptoms exhibit abnormal characteristics and
    11         the implementation of appropriate reporting, perfusion
    12         protocols or changes in or the initiation of emergency
    13         procedures.
    14     (e)  The following persons may perform perfusion, as
    15  indicated:
    16         (1)  A person licensed under any other section of this
    17     act or any other law of this Commonwealth, while engaging in
    18     the practice for which the person is licensed.
    19         (2)  A student enrolled in an accredited perfusion
    20     education program if perfusion performed by the student:
    21             (i)  is an integral part of the student's course of
    22         study; and
    23             (ii)  is performed under the direct supervision of a
    24         perfusionist who is assigned to supervise the student and
    25         who is on duty and immediately available in the assigned
    26         patient care area.
    27         (3)  A graduate of an accredited perfusion education
    28     program, if perfusion services:
    29             (i)  are necessary to fulfill the eligibility
    30         requirements for a certification examination; and
    20070H0501B3638                  - 5 -     

     1             (ii)  are performed under the supervision and
     2         responsibility of a perfusionist who is on duty and
     3         assigned to supervise the graduate.
     4         (4)  A legally qualified person employed by the Federal
     5     Government to practice perfusion while in the discharge of
     6     the person's official duties.
     7         (5)  FOR A VENTRICULAR ASSIST DEVICE UNDER INVESTIGATIVE   <--
     8     TRIALS BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION OR
     9     APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION
    10     SOLELY AS A VENTRICULAR ASSIST DEVICE, A PERSON WHO:
    11             (I)  HAS SATISFACTORILY COMPLETED SPECIFIC
    12         VENTRICULAR ASSIST DEVICE TRAINING IN A COURSE PROVIDED
    13         BY THE VENTRICULAR ASSIST DEVICE MANUFACTURER; AND
    14             (II)  PROVIDES CARE RELATED TO THE VENTRICULAR ASSIST
    15         DEVICE UNDER THE SUPERVISION OF A LICENSED PHYSICIAN.
    16         (6)  A PERSON WHO PERFORMS AUTOTRANSFUSION OR BLOOD
    17     CONSERVATION TECHNIQUES UNDER THE SUPERVISION OF A LICENSED
    18     PHYSICIAN.
    19         (7)  A PERSON WHO:
    20             (I)  IS TRAINED ACCORDING TO THE EXTRACORPOREAL
    21         MEMBRANE OXYGENATION SPECIALIST GUIDELINES OF THE
    22         EXTRACORPOREAL LIFE SUPPORT ORGANIZATION; AND
    23             (II)  OPERATES AN EXTRACORPOREAL MEMBRANE OXYGENATION
    24         CIRCUIT UNDER THE SUPERVISION OF A LICENSED PHYSICIAN.
    25     (f)  An applicant shall be licensed to practice perfusion
    26  under this act if the applicant meets all of the following
    27  qualifications and has otherwise complied with the provisions of
    28  this act:
    29         (1)  The person is at least 18 years of age.
    30         (2)  The person is of good moral character.
    20070H0501B3638                  - 6 -     

     1         (3)  The person has graduated from an accredited
     2     perfusion program approved by the board.
     3         (4)  The person is certified by a certifying agency
     4     approved by a nationally recognized accrediting agency
     5     approved by the board. The certification shall include an
     6     examination approved by the board.
     7         (5)  The person has completed an application form
     8     provided by the board and paid the appropriate fee.
     9     (g)  Within two years of the effective date of this section,
    10  an applicant who was not a graduate of an accredited program
    11  prior to 1981, but met the then-current eligibility requirements
    12  for certification as a certified clinical perfusionist and
    13  subsequently was certified, shall be licensed as a perfusionist
    14  if the applicant otherwise complies with the provisions of this
    15  act.
    16     (h)  The board may issue a temporary graduate license to
    17  practice perfusion to an individual who has graduated from an
    18  educational program that complies with the education
    19  requirements of this act. The ALL OF THE following shall apply:   <--
    20         (1)  The individual has applied for the examination and
    21     is eligible to take the required examination.
    22         (2)  The individual's authorization to practice perfusion
    23     is granted only under the supervision and direction of a
    24     perfusionist licensed under this act.
    25         (3)  The license shall be issued for a period of two
    26     years and shall be nonrenewable.
    27         (4)  The license shall expire immediately upon notice
    28     that the individual has failed the required examination under
    29     this act.
    30     (i)  (1)  The board may issue a temporary provisional license
    20070H0501B3638                  - 7 -     

     1     to practice perfusion if all the following requirements are
     2     met:
     3             (i)  The individual holds a current license which is
     4         in good standing under the laws of another state,
     5         District of Columbia or territory of the United States
     6         which includes certification by a certifying agency
     7         approved by a nationally recognized accrediting agency.
     8             (ii)  The individual meets the requirements as set
     9         forth in subsection (f)(1), (2) and (3).
    10         (2)  The license shall be issued for a period of one year
    11     and shall be nonrenewable.
    12     (j)  (1)  An individual who holds a current license as a
    13     perfusionist in another state, the District of Columbia or a
    14     territory of the United States or has obtained national
    15     certification may provide a one-time emergency perfusionist
    16     service in this Commonwealth without first obtaining a
    17     license from the board if:
    18             (i)  Prior to the out-of-State perfusionist
    19         performing the emergency perfusionist services in this
    20         Commonwealth, the out-of-State perfusionist submits by
    21         electronic means and on forms approved by the board,
    22         notification of emergency practice which shall include an
    23         acknowledgment that the out-of-State perfusionist is
    24         subject to the jurisdiction of the board in the same
    25         manner as if the out-of-State perfusionist were licensed
    26         by the board.
    27             (ii)  The health care facility licensed by the
    28         Department of Health certifies to the board, by
    29         electronic means and on forms approved by the board,
    30         prior to the out-of-State perfusionist performing the
    20070H0501B3638                  - 8 -     

     1         emergency perfusionist services in this Commonwealth that
     2         all of the following apply:
     3                 (A)  The emergency perfusionist services were
     4             provided for a patient of the health care facility.
     5                 (B)  The perfusionist licensed by the board and
     6             retained by the health care facility that would
     7             normally perform the emergency perfusionist services
     8             was not available or incapable of providing the
     9             perfusionist services.
    10                 (C)  No other perfusionist licensed by the board
    11             was available to provide or capable of providing the
    12             emergency perfusion service.
    13                 (D)  The out-of-State perfusionist provided only
    14             the emergency perfusionist services for the patient
    15             of the health care facility and no other perfusionist
    16             services at the health care facility.
    17         (2)  The out-of-State perfusionist shall obtain a license
    18     from the board if a health care facility licensed by the
    19     Department of Health retains the perfusionist or if the
    20     perfusionist provides any future perfusionist services.
    21         (3)  The out-of-State perfusionist shall not perform any
    22     other perfusionist services other than the emergency
    23     perfusionist services.
    24     (k)  (1)  A licensed perfusionist practicing in this
    25     Commonwealth shall maintain a level of professional liability
    26     insurance coverage as required for a nonparticipating health   <--
    27     care provider under the act of March 20, 2002 (P.L.154,
    28     No.13), known as the Medical Care Availability and Reduction
    29     of Error (Mcare) Act, but shall not be eligible to
    30     participate in the Medical Care Availability and Reduction of
    20070H0501B3638                  - 9 -     

     1     Error (Mcare) Fund. IN THE MINIMUM AMOUNT OF $1,000,000 PER    <--
     2     OCCURRENCE OR CLAIMS MADE. FAILURE TO MAINTAIN INSURANCE
     3     COVERAGE AS REQUIRED SHALL SUBJECT THE LICENSEE TO
     4     DISCIPLINARY PROCEEDINGS. THE BOARD SHALL ACCEPT FROM
     5     PERFUSIONISTS AS SATISFACTORY EVIDENCE OF INSURANCE COVERAGE
     6     ANY OF THE FOLLOWING: SELF-INSURANCE, PERSONALLY PURCHASED
     7     LIABILITY INSURANCE, PROFESSIONAL LIABILITY INSURANCE
     8     COVERAGE PROVIDED BY THE PERFUSIONIST'S EMPLOYER OR SIMILAR
     9     INSURANCE COVERAGE ACCEPTABLE TO THE BOARD.
    10         (2)  A license applicant shall provide proof that the
    11     applicant has obtained professional liability insurance in
    12     accordance with paragraph (1). It is sufficient if the
    13     applicant files with the application a copy of a letter from
    14     the applicant's professional liability insurance carrier
    15     indicating that the applicant will be covered against
    16     professional liability in the required amounts effective upon
    17     the issuance of the applicant's license to practice perfusion
    18     in this Commonwealth. Upon issuance of the license, the
    19     licensee has 30 days to submit to the board the certificate
    20     of insurance or a copy of the policy declaration page.
    21     (l)  All application and licensure fees shall be set by the
    22  board by regulation.
    23     (m)  Disciplinary actions taken by the State Board of
    24  Osteopathic Medicine against a perfusionist licensed by it shall
    25  be enforceable by the State Board of Medicine against the same
    26  individual if such individual holds or seeks a license to
    27  practice as a perfusionist with the State Board of Medicine.
    28     (n)  (1)  The board shall adopt, promulgate and enforce rules
    29     and regulations consistent with the provisions of this act
    30     establishing requirements of continuing education to be met
    20070H0501B3638                 - 10 -     

     1     by individuals licensed as perfusionists under this act as a
     2     condition for renewal of their licenses. The regulations
     3     shall include any fees necessary for the board to carry out
     4     its responsibilities under this section.
     5         (2)  Beginning with the license period designated by
     6     regulation, licensees shall be required to attend and
     7     complete 30 hours of mandatory continuing education during
     8     each two-year license period. Nationally certified education
     9     courses shall be considered as creditable, in addition to any
    10     other courses the board deems creditable toward meeting the
    11     requirements for continuing education.
    12         (3)  An individual applying for the first time for
    13     licensure in this Commonwealth shall be exempted from the
    14     continuing education requirement for the biennial renewal
    15     period following initial licensure.
    16         (4)  (i)  The board may waive all or a portion of the
    17         continuing education requirement for biennial renewal for
    18         a licensee who shows to the satisfaction of the board
    19         that the licensee was unable to complete the requirements
    20         due to serious illness, military service or other
    21         demonstrated hardship.
    22             (ii)  The request shall be made in writing with
    23         appropriate documentation and shall include a description
    24         of circumstances sufficient to show why the licensee is
    25         unable to comply with the continuing education
    26         requirement.
    27         (5)  A licensee seeking to reinstate an inactive or
    28     lapsed license shall show proof of compliance with the
    29     continuing education requirement for the preceding biennium.
    30         (6)  All courses, locations, instructors and providers
    20070H0501B3638                 - 11 -     

     1     shall be approved by the board. No credit shall be given for
     2     any course in office management.
     3     Section 4.  The State Board of Osteopathic Medicine shall
     4  initiate the promulgation of regulations to carry out the
     5  provisions of this act within 18 months of the effective date of
     6  this section.
     7     Section 5.  This act shall take effect in 60 days.
















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