PRINTER'S NO. 651
No. 623 Session of 2001
INTRODUCED BY CORMAN, MOWERY, COSTA, HELFRICK, LAVALLE, PUNT,
TARTAGLIONE, THOMPSON, TOMLINSON AND WAUGH, MARCH 12, 2001
REFERRED TO PUBLIC HEALTH AND WELFARE, MARCH 12, 2001
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
14 pathogens include, but are not limited to, hepatitis B virus
15 (HBV), hepatitis C virus (HCV) and human immunodeficiency virus
16 (HIV).
17 "Department." The Department of Health of the Commonwealth.
1 "Employer." Each employer having public employees with
2 occupational exposure to blood or other material potentially
3 containing bloodborne pathogens.
4 "Engineered sharps injury protection." Either:
5 (1) a physical attribute built into a needle device used
6 for withdrawing body fluids, accessing a vein or artery or
7 administering medications or other fluids, which effectively
8 reduces the risk of an exposure incident by a mechanism such
9 as barrier creation, blunting, encapsulation, withdrawal,
10 retraction, destruction or other effective mechanisms; or
11 (2) a physical attribute built into any other type of
12 needle device or into a nonneedle sharp, which effectively
13 reduces the risk of an exposure incident.
14 "Front-line health care worker." A nonmanagerial employee
15 responsible for direct patient care with potential occupational
16 exposure to sharps-related injuries.
17 "Needleless system." A device that does not utilize needles
18 for:
19 (1) The withdrawal of body fluids after initial venous
20 or arterial access is established.
21 (2) The administration of medication or fluids.
22 (3) Any other procedure involving the potential for an
23 exposure incident.
24 "Public employee." An employee of the State or a local
25 governmental unit or agency thereof employed in a health care
26 facility, home health care organization or other facility
27 providing health care-related services. The term does not apply
28 to a licensed person who provides only intra-oral care.
29 "Sharp." Any object used or encountered in a health care
30 setting that can be reasonably anticipated to penetrate the skin
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1 or any other part of the body and to result in an exposure
2 incident, including, but not limited to, needle devices,
3 scalpels, lancets, broken glass or broken capillary tubes.
4 "Sharps injury." Any injury caused by a sharp, including,
5 but not limited to, cuts, abrasions or needlesticks.
6 "Sharps injury log." A written or electronic record
7 satisfying the requirements of this act.
8 Section 3. Department of Health.
9 (a) Adoption of standard.--The department shall adopt a
10 bloodborne pathogen standard governing public employees to be
11 developed no later than six months from the date of enactment of
12 this act.
13 (b) Standards.--The standard shall be at least as
14 prescriptive as the standard promulgated by the Federal
15 Occupational Safety and Health Review Commission and shall
16 include, but not be limited to, the following:
17 (1) A requirement that needleless systems and sharps
18 with engineered sharps injury protection be included as
19 engineering and work practice controls. However, such
20 engineering controls shall not be required if:
21 (i) none is available in the marketplace; or
22 (ii) an evaluation committee, as described in
23 paragraph (2)(v) determines by means of objective product
24 evaluation criteria that use of such devices will
25 jeopardize patient or employee safety with regard to a
26 specific medical procedure.
27 (2) A requirement that each employer develop and
28 implement an effective written exposure control plan that
29 includes, but is not limited to, procedures for:
30 (i) identifying and selecting needleless systems and
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1 sharps with engineered sharps injury protection through
2 the evaluation committee described in subparagraph (v);
3 (ii) updating the written exposure control plan when
4 necessary to reflect progress in implementing needleless
5 systems and sharps with engineered sharps injury
6 protection as determined by the evaluation committee
7 described in subparagraph (v), but in no event less than
8 once every year;
9 (iii) recording information concerning exposure
10 incidents in a sharps injury log, including, but not
11 limited to:
12 (A) Date and time of the exposure incident.
13 (B) Type and brand of sharp involved in the
14 exposure incident.
15 (C) Description of the exposure incident that
16 shall include:
17 (I) Job classification of the exposed
18 employee.
19 (II) Department or work area where the
20 exposure incident occurred.
21 (III) The procedure that the exposed
22 employee was performing at the time of the
23 incident.
24 (IV) How the incident occurred.
25 (V) The body part involved in the exposure
26 incident.
27 (VI) If the sharp had engineered sharps
28 injury protection, whether the protective
29 mechanism was activated and whether the injury
30 occurred before the protective mechanism was
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1 activated, during activation of the mechanism or
2 after activation of the mechanism.
3 (VII) If the sharp had no engineered sharps
4 injury protection, whether and how such a
5 mechanism could have prevented the injury, as
6 well as the basis for the assessment.
7 (VIII) An assessment of whether any other
8 engineering, administrative or work practice
9 control could have prevented the injury, as well
10 as the basis for the assessment;
11 (iv) ensuring that all front-line health care
12 workers are trained on the use of all engineering
13 controls before they are introduced into the clinical
14 setting; and
15 (v) establishing an evaluation committee, at least
16 half the members of which are frontline health care
17 workers from a variety of occupational classifications
18 and departments, including, but not limited to, nurses,
19 nurse aides, technicians, phlebotomists and physicians,
20 to advise the employer on the implementation of the
21 requirements of this act. Members of the committee shall
22 be trained in the proper method of utilizing product
23 evaluation criteria prior to the commencement of any
24 product evaluation.
25 (c) Additional measures.--The department shall consider
26 additional measures to prevent sharps injuries or exposure
27 incidents, including, but not limited to, training and
28 educational requirements, increased use of vaccinations,
29 strategic placement of sharps containers as close to the work
30 area as practical and increased use of personal protective
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1 equipment.
2 (d) Transitional period for certain drugs and biologics.--
3 The use of a drug or biologic that is prepackaged with an
4 administration system or used in a prefilled syringe and is
5 approved for commercial distribution or investigational use by
6 the Federal Food and Drug Administration shall be exempt for any
7 standard adopted under subsection (b) or additional measures
8 adopted under subsection (c) for a period of three years from
9 the effective date of this act.
10 (e) Compilation and maintenance of list.--The department
11 shall compile and maintain a list of needleless systems and
12 sharps with engineered sharps injury protection, which shall be
13 available to assist employers in complying with the requirements
14 of the bloodborne pathogen standard adopted pursuant to this
15 section. The list may be developed from existing sources of
16 information, including, but not limited to, the Federal Food and
17 Drug Administration, the Federal Centers for Disease Control,
18 the National Institute of Occupational Safety and Health and the
19 United States Department of Veterans Affairs.
20 Section 4. Effective date.
21 This act shall take effect in 120 days.
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