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        PRIOR PRINTER'S NOS. 556, 1846                PRINTER'S NO. 1910

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 SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES,
           JUNE 13, 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
    20070H0501B1910                  - 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)  Two years after the effective date of this section, it
    11  shall be unlawful for any person to hold himself out to the
    12  public as a perfusionist or to practice or offer to practice
    13  perfusion unless the person holds a valid, current license
    14  issued by the board or the State Board of Medicine.
    15     (b)  A perfusionist who holds a valid, current license issued
    16  by either board may use the title perfusionist or licensed
    17  perfusionist, or an appropriate abbreviation of the title, such
    18  as "LP."
    19     (c)  The board is authorized to promulgate regulations to
    20  implement this section.
    21     (d)  A perfusionist may perform perfusion to an individual
    22  being treated by a physician licensed under this act or the act
    23  of act of December 20, 1985 (P.L.457, No.112), known as the
    24  "Medical Practice Act of 1985," under medical supervision and
    25  approval consistent with standing orders or protocols of a
    26  hospital that are promulgated and approved by the physician
    27  designated as the medical director of the cardiovascular surgery
    28  program. These services shall include:
    29         (1)  The use of extracorporeal circulation, long-term
    30     cardiopulmonary support techniques, including extracorporeal
    20070H0501B1910                  - 3 -     

     1     carbon dioxide removal, extracorporeal membrane oxygenation
     2     and associated therapeutic and diagnostic techniques.
     3         (2)  Counterpulsion, ventricular assistance,
     4     autotransfusion, blood and blood component conservation
     5     techniques, myocardial and organ preservation, extracorporeal
     6     life support and isolated limb perfusion.
     7         (3)  Blood and blood component management techniques,
     8     advanced life support and other related functions.
     9         (4)  In the performance of the acts described in
    10     paragraphs (1) through (3):
    11             (i)  The administration of:
    12                 (A)  Pharmacological and therapeutic agents.
    13                 (B)  Blood products or anesthetic agents through
    14             the extracorporeal circuit or through an intravenous
    15             line in conjunction with extracorporeal support,
    16             under the supervision of the treating physician.
    17             (ii)  The performance and use of:
    18                 (A)  Anticoagulation monitoring and analysis.
    19                 (B)  Physiologic monitoring and analysis.
    20                 (C)  Blood gas and chemistry monitoring and
    21             analysis.
    22                 (D)  Hematologic monitoring and analysis.
    23                 (E)  Hypothermia.
    24                 (F)  Hyperthermia.
    25                 (G)  Normothermia.
    26                 (H)  Hemoconcentration and hemodilution.
    27                 (I)  Hemodialysis in conjunction with perfusion
    28             service.
    29             (iii)  The observation of signs and symptoms related
    30         to perfusion services, the determination of whether the
    20070H0501B1910                  - 4 -     

     1         signs and symptoms exhibit abnormal characteristics and
     2         the implementation of appropriate reporting, perfusion
     3         protocols or changes in or the initiation of emergency
     4         procedures.
     5     (e)  The following persons may perform perfusion, as
     6  indicated:
     7         (1)  A person licensed under any other section of this
     8     act or any other law of this Commonwealth, while engaging in
     9     the practice for which the person is licensed.
    10         (2)  A student enrolled in an accredited perfusion
    11     education program if perfusion performed by the student:
    12             (i)  is an integral part of the student's course of
    13         study; and
    14             (ii)  is performed under the direct supervision of a
    15         perfusionist who is assigned to supervise the student and
    16         who is on duty and immediately available in the assigned
    17         patient care area.
    18         (3)  A graduate of an accredited perfusion education
    19     program, if perfusion services:
    20             (i)  are necessary to fulfill the eligibility
    21         requirements for a certification examination; and
    22             (ii)  are performed under the supervision and
    23         responsibility of a perfusionist who is on duty and
    24         assigned to supervise the graduate.
    25         (4)  A legally qualified person employed by the Federal
    26     Government to practice perfusion while in the discharge of
    27     the person's official duties.
    28     (f)  An applicant shall be licensed to practice perfusion
    29  under this act if the applicant meets all of the following
    30  qualifications and has otherwise complied with the provisions of
    20070H0501B1910                  - 5 -     

     1  this act:
     2         (1)  The person is at least 18 years of age.
     3         (2)  The person is of good moral character.
     4         (3)  The person has graduated from an accredited
     5     perfusion program approved by the board.
     6         (4)  The person is certified by a certifying agency
     7     approved by a nationally recognized accrediting agency
     8     approved by the board. The certification shall include an
     9     examination approved by the board.
    10         (5)  The person has completed an application form
    11     provided by the board and paid the appropriate fee.
    12     (g)  Within two years of the effective date of this section,
    13  an applicant who was not a graduate of an accredited program
    14  prior to 1981, but met the then-current eligibility requirements
    15  for certification as a certified clinical perfusionist and
    16  subsequently was certified, shall be licensed as a perfusionist
    17  if the applicant otherwise complies with the provisions of this
    18  act.
    19     (h)  The board may issue a temporary graduate license to
    20  practice perfusion to an individual who has graduated from an
    21  educational program that complies with the education
    22  requirements of this act. The following shall apply:
    23         (1)  The individual has applied for the examination and
    24     is eligible to take the required examination.
    25         (2)  The individual's authorization to practice perfusion
    26     is granted only under the supervision and direction of a
    27     perfusionist licensed under this act.
    28         (3)  The license shall be issued for a period of two
    29     years and shall be nonrenewable.
    30         (4)  The license shall expire immediately upon notice
    20070H0501B1910                  - 6 -     

     1     that the individual has failed the required examination under
     2     this act.
     3     (i)  (1)  The board may issue a temporary provisional license
     4     to practice perfusion if all the following requirements are
     5     met:
     6             (i)  The individual holds a current license which is
     7         in good standing under the laws of another state,
     8         District of Columbia or territory of the United States
     9         which includes certification by a certifying agency
    10         approved by a nationally recognized accrediting agency.
    11             (ii)  The individual meets the requirements as set
    12         forth in subsection (f)(1), (2) and (3).
    13         (2)  The license shall be issued for a period of one year
    14     and shall be nonrenewable.
    15     (J)  (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
    20070H0501B1910                  - 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)  (1)  A licensed perfusionist practicing in this       <--
    28     Commonwealth shall maintain a level of professional liability
    29     insurance coverage as required for a nonparticipating health
    30     care provider under the act of March 20, 2002 (P.L.154,
    20070H0501B1910                  - 8 -     

     1     No.13), known as the Medical Care Availability and Reduction
     2     of Error (Mcare) Act, but shall not be eligible to
     3     participate in the Medical Care Availability and Reduction of
     4     Error (Mcare) Fund.
     5         (2)  A license applicant shall provide proof that the
     6     applicant has obtained professional liability insurance in
     7     accordance with paragraph (1). It is sufficient if the
     8     applicant files with the application a copy of a letter from
     9     the applicant's professional liability insurance carrier
    10     indicating that the applicant will be covered against
    11     professional liability in the required amounts effective upon
    12     the issuance of the applicant's license to practice perfusion
    13     in this Commonwealth. Upon issuance of the license, the
    14     licensee has 30 days to submit to the board the certificate
    15     of insurance or a copy of the policy declaration page.
    16     (k) (L)  All application and licensure fees shall be set by    <--
    17  the board by regulation.
    18     (l) (M)  Disciplinary actions taken by the State Board of      <--
    19  Osteopathic Medicine against a perfusionist licensed by it shall
    20  be enforceable by the State Board of Medicine against the same
    21  individual if such individual holds or seeks a license to
    22  practice as a perfusionist with the State Board of Medicine.
    23     (m) (N)  (1)  The board shall adopt, promulgate and enforce    <--
    24     rules and regulations consistent with the provisions of this
    25     act establishing requirements of continuing education to be
    26     met by individuals licensed as perfusionists under this act
    27     as a condition for renewal of their licenses. The regulations
    28     shall include any fees necessary for the board to carry out
    29     its responsibilities under this section.
    30         (2)  Beginning with the license period designated by
    20070H0501B1910                  - 9 -     

     1     regulation, licensees shall be required to attend and
     2     complete 30 hours of mandatory continuing education during
     3     each two-year license period. Nationally certified education
     4     courses shall be considered as creditable, in addition to any
     5     other courses the board deems creditable toward meeting the
     6     requirements for continuing education.
     7         (3)  An individual applying for the first time for
     8     licensure in this Commonwealth shall be exempted from the
     9     continuing education requirement for the biennial renewal
    10     period following initial licensure.
    11         (4)  (i)  The board may waive all or a portion of the
    12         continuing education requirement for biennial renewal for
    13         a licensee who shows to the satisfaction of the board
    14         that the licensee was unable to complete the requirements
    15         due to serious illness, military service or other
    16         demonstrated hardship.
    17             (ii)  The request shall be made in writing with
    18         appropriate documentation and shall include a description
    19         of circumstances sufficient to show why the licensee is
    20         unable to comply with the continuing education
    21         requirement.
    22         (5)  A licensee seeking to reinstate an inactive or
    23     lapsed license shall show proof of compliance with the
    24     continuing education requirement for the preceding biennium.
    25         (6)  All courses, locations, instructors and providers
    26     shall be approved by the board. No credit shall be given for
    27     any course in office management.
    28     Section 4.  The State Board of Osteopathic Medicine shall
    29  initiate the promulgation of regulations to carry out the
    30  provisions of this act within 18 months of the effective date of
    20070H0501B1910                 - 10 -     

     1  this section.
     2     Section 5.  This act shall take effect in 60 days.



















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