PRIOR PRINTER'S NO. 1914 PRINTER'S NO. 2309
No. 1570 Session of 1999
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.
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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.
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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
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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.
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1 This act shall take effect in 60 120 days. <--
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