PRIOR PRINTER'S NO. 1914                      PRINTER'S NO. 2309

        INTRODUCED BY O'BRIEN, DAILEY, VAN HORNE, VEON, BEBKO-JONES,
           BELARDI, BELFANTI, BISHOP, BUNT, BUXTON, CALTAGIRONE, CAWLEY,
           CLARK, CLYMER, CORNELL, CORRIGAN, COY, CURRY, DeWEESE,
           EACHUS, FAIRCHILD, FICHTER, FRANKEL, HALUSKA, HARHAI, HASAY,
           HERMAN, JAMES, KIRKLAND, LaGROTTA, LAUGHLIN, McCALL,
           McNAUGHTON, MELIO, R. MILLER, MYERS, ORIE, SATHER, SAYLOR,
           SERAFINI, SEYFERT, SHANER, SOLOBAY, STEELMAN, STERN,
           E. Z. TAYLOR, J. TAYLOR, WALKO, WILLIAMS, WILT, WOJNAROSKI,
           YOUNGBLOOD, YUDICHAK, STURLA, PETRONE, ROONEY, GRUCELA, L. I.
           COHEN, SANTONI, BASTIAN AND MUNDY, JUNE 8, 1999

        AS REPORTED FROM COMMITTEE ON HEALTH AND HUMAN SERVICES, HOUSE
           OF REPRESENTATIVES, AS AMENDED, SEPTEMBER 28, 1999

                                     AN ACT

     1  Relating to bloodborne pathogen standards governing exposure to
     2     certain persons.

     3     The General Assembly of the Commonwealth of Pennsylvania
     4  hereby enacts as follows:
     5  Section 1.  Short title.
     6     This act shall be known and may be cited as the Bloodborne
     7  Pathogen Standard Act.
     8  Section 2.  Definitions.
     9     The following words and phrases when used in this act shall
    10  have the meanings given to them in this section unless the
    11  context clearly indicates otherwise:
    12     "Bloodborne pathogens."  Pathogenic microorganisms that are
    13  present in human blood and can cause disease in humans. These

     1  pathogens include, but are not limited to, hepatitis B virus
     2  (HBV), hepatitis C virus (HCV) and human immunodeficiency virus
     3  (HIV).
     4     "Department."  The Department of Health of the Commonwealth.
     5     "Employer."  Each employer having public employees with
     6  occupational exposure to blood or other material potentially
     7  containing bloodborne pathogens.
     8     "Engineered sharps injury protection."  Either:
     9         (1)  a physical attribute built into OR USED WITH a        <--
    10     needle device used for withdrawing body fluids, accessing a
    11     vein or artery or administering medications or other fluids,
    12     which effectively reduces the risk of an exposure incident by
    13     a mechanism such as barrier creation, blunting,
    14     encapsulation, withdrawal, retraction, destruction or other
    15     effective mechanisms; or
    16         (2)  a physical attribute built into OR USED WITH any      <--
    17     other type of needle device or into a nonneedle sharp, which
    18     effectively reduces the risk of an exposure incident.
    19     "Front-line health care worker."  A nonmanagerial employee
    20  responsible for direct patient care with potential occupational
    21  exposure to sharps-related injuries.
    22     "Needleless system."  A device that does not utilize needles
    23  for:
    24         (1)  The withdrawal of body fluids after initial venous
    25     or arterial access is established.
    26         (2)  The administration of medication or fluids.
    27         (3)  Any other procedure involving the potential for an
    28     exposure incident.
    29     "Public employee."  An employee of the State or a local
    30  governmental unit or agency thereof employed in a health care
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     1  facility, home health care organization or other facility
     2  providing health care-related services.
     3     "Sharp."  Any object used or encountered in a health care
     4  setting that can be reasonably anticipated to penetrate the skin
     5  or any other part of the body and to result in an exposure
     6  incident, including, but not limited to, needle devices,
     7  scalpels, lancets, broken glass or broken capillary tubes.
     8     "Sharps injury."  Any injury caused by a sharp, including,
     9  but not limited to, cuts, abrasions or needlesticks.
    10     "Sharps injury log."  A written or electronic record
    11  satisfying the requirements of this act.
    12  Section 3.  Department of Health.
    13     (a)  Adoption of standard.--The department shall adopt a
    14  bloodborne pathogen standard governing public employees to be
    15  developed no later than six months from the date of enactment of
    16  this act.
    17     (b)  Standards.--The standard shall be at least as
    18  prescriptive as the standard promulgated by the Federal
    19  Occupational Safety and Health Review Commission and shall
    20  include, but not be limited to, the following:
    21         (1)  A requirement that needleless systems and sharps
    22     with engineered sharps injury protection be included as
    23     engineering and work practice controls. However, such
    24     engineering controls shall not be required if:
    25             (i)  none is available in the marketplace; or
    26             (ii)  an evaluation committee, as described in
    27         paragraph (2)(iii)(C)(X) determines by means of objective
    28         product evaluation criteria that use of such devices will
    29         jeopardize patient or employee safety with regard to a
    30         specific medical procedure.
    19990H1570B2309                  - 3 -

     1         (2)  A requirement that each employer develop and
     2     implement an effective written exposure control plan that
     3     includes, but is not limited to, procedures for:
     4             (i)  identifying and selecting needleless systems and
     5         sharps with engineered sharps injury protection through
     6         the evaluation committee described in clause (iii)(C)(X);
     7             (ii)  updating the written exposure control plan when
     8         necessary to reflect progress in implementing needleless
     9         systems and sharps with engineered sharps injury
    10         protection as determined by the evaluation committee
    11         described in clause (iii)(C)(X), but in no event less
    12         than once every year;
    13             (iii)  recording information concerning exposure
    14         incidents in a sharps injury log, including, but not
    15         limited to:
    16                 (A)  Date and time of the exposure incident.
    17                 (B)  Type and brand of sharp involved in the
    18             exposure incident.
    19                 (C)  Description of the exposure incident that
    20             shall include:
    21                     (I)  Job classification of the exposed
    22                 employee.
    23                     (II)  Department or work area where the
    24                 exposure incident occurred.
    25                     (III)  The procedure that the exposed
    26                 employee was performing at the time of the
    27                 incident.
    28                     (IV)  How the incident occurred.
    29                     (V)  The body part involved in the exposure
    30                 incident.
    19990H1570B2309                  - 4 -

     1                     (VI)  If the sharp had engineered sharps
     2                 injury protection, whether the protective
     3                 mechanism was activated and whether the injury
     4                 occurred before the protective mechanism was
     5                 activated, during activation of the mechanism or
     6                 after activation of the mechanism.
     7                     (VII)  If the sharp had no engineered sharps
     8                 injury protection, whether and how such a
     9                 mechanism could have prevented the injury, as
    10                 well as the basis for the assessment.
    11                     (VIII)  An assessment of whether any other
    12                 engineering, administrative or work practice
    13                 control could have prevented the injury, as well
    14                 as the basis for the assessment.
    15                     (IX)  Ensuring that all front-line health
    16                 care workers are trained on the use of all
    17                 engineering controls before they are introduced
    18                 into the clinical setting.
    19                     (X)  Establishing an evaluation committee, at
    20                 least half the members of which are frontline
    21                 health care workers from a variety of
    22                 occupational classifications and departments,
    23                 including, but not limited to, nurses, nurse
    24                 aides, technicians, phlebotomists and physicians,
    25                 to advise the employer on the implementation of
    26                 the requirements of this act. Members of the
    27                 committee shall be trained in the proper method
    28                 of utilizing product evaluation criteria prior to
    29                 the commencement of any product evaluation.
    30     (c)  Additional measures.--The department shall consider
    19990H1570B2309                  - 5 -

     1  additional measures to prevent sharps injuries or exposure
     2  incidents, including, but not limited to, training and
     3  educational requirements, increased use of vaccinations,
     4  strategic placement of sharps containers as close to the work
     5  area as practical and increased use of personal protective
     6  equipment.
     7     (D)  TRANSITIONAL PERIOD FOR CERTAIN DRUGS AND BIOLOGICS.--    <--
     8  THE USE OF A DRUG OR BIOLOGIC THAT IS PREPACKAGED WITH AN
     9  ADMINISTRATION SYSTEM OR USED IN A PREFILLED SYRINGE AND IS
    10  APPROVED FOR COMMERCIAL DISTRIBUTION OR INVESTIGATIONAL USE BY
    11  THE FEDERAL FOOD AND DRUG ADMINISTRATION SHALL BE EXEMPT FOR ANY
    12  STANDARD ADOPTED UNDER SUBSECTION (B) OR ADDITIONAL MEASURES
    13  ADOPTED UNDER SUBSECTION (C) FOR A PERIOD OF THREE YEARS FROM
    14  THE EFFECTIVE DATE OF THIS ACT.
    15     (d) (E)  Compilation and maintenance of list.--The department  <--
    16  shall compile and maintain a list of needleless systems and
    17  sharps with engineered sharps injury protection, which shall be
    18  available to assist employers in complying with the requirements
    19  of the bloodborne pathogen standard adopted pursuant to this
    20  section. The list may be developed from existing sources of
    21  information, including, but not limited to, the Federal Food and
    22  Drug Administration, the Federal Centers for Disease Control,
    23  the National Institute of Occupational Safety and Health and the
    24  United States Department of Veterans Affairs.
    25     (e) (F)  Fund.--A fund is hereby established in the State      <--
    26  Treasury for use of the Department of Health to carry out the
    27  purposes of this act to provide for research and development, as
    28  well as product evaluations, of needleless systems and sharps
    29  with engineered sharps injury protection.
    30  Section 4.  Effective date.
    19990H1570B2309                  - 6 -

     1     This act shall take effect in 60 120 days.                     <--




















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