PRIOR PRINTER'S NO. 489 PRINTER'S NO. 706
No. 454 Session of 2001
INTRODUCED BY O'BRIEN, DAILEY, BELARDI, BENNINGHOFF,
CALTAGIRONE, CAPPABIANCA, CAWLEY, CLARK, CLYMER, CORRIGAN,
CRUZ, DeLUCA, DeWEESE, FAIRCHILD, FLEAGLE, FRANKEL, GEORGE,
GRUCELA, HARHAI, HASAY, HENNESSEY, HERMAN, HORSEY, KENNEY,
LAUGHLIN, LEDERER, MANN, McCALL, McNAUGHTON, MELIO, MICOZZIE,
MUNDY, ORIE, PIPPY, PRESTON, RUBLEY, SATHER, SAYLOR, SHANER,
SOLOBAY, STABACK, STEELMAN, T. STEVENSON, E. Z. TAYLOR,
THOMAS, TIGUE, WALKO, C. WILLIAMS, WILT, WOJNAROSKI, YEWCIC,
YOUNGBLOOD, BROWNE AND YUDICHAK, FEBRUARY 5, 2001
AS REPORTED FROM COMMITTEE ON HEALTH AND HUMAN SERVICES, HOUSE
OF REPRESENTATIVES, AS AMENDED, FEBRUARY 12, 2001
AN ACT
1 Requiring the Department of Health to establish bloodborne
2 pathogen standards for public employees; and establishing the
3 Bloodborne Pathogen Fund.
4 The General Assembly of the Commonwealth of Pennsylvania
5 hereby enacts as follows:
6 Section 1. Short title.
7 This act shall be known and may be cited as the Bloodborne
8 Pathogen Standard Act.
9 Section 2. Definitions.
10 The following words and phrases when used in this act shall
11 have the meanings given to them in this section unless the
12 context clearly indicates otherwise:
13 "Bloodborne pathogen." A pathogenic microorganism which is
14 present in human blood and can cause disease in humans. The term
1 includes hepatitis B virus (HBV), hepatitis C virus (HCV) and
2 human immunodeficiency virus (HIV).
3 "Department." The Department of Health of the Commonwealth.
4 "Employer." An employer having public employees with
5 occupational exposure to blood or other material potentially
6 containing a bloodborne pathogen.
7 "Engineered sharps injury protection." Any of the following:
8 (1) A physical attribute built into a needle device used
9 for withdrawing body fluids, accessing a vein or artery or
10 administering medications or other fluids, which effectively
11 reduces the risk of an exposure incident by a mechanism such
12 as barrier creation, blunting, encapsulation, withdrawal,
13 retraction, destruction or other effective mechanisms.
14 (2) A physical attribute built into any other type of
15 needle device or into a nonneedle sharp which effectively
16 reduces the risk of an exposure incident.
17 "Front-line health care worker." A nonmanagerial employee
18 responsible for direct patient care with potential occupational
19 exposure to a sharps injury.
20 "Fund." The Bloodborne Pathogen Fund established in section
21 4.
22 "Needleless system." A device which 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; or
27 (3) any other procedure involving the potential for an
28 exposure incident.
29 "Public employee." An employee of the Commonwealth or a
30 political subdivision employed in a health care facility, home
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1 health care organization or other facility providing health
2 care-related services. THE TERM DOES NOT INCLUDE A LICENSED <--
3 INDIVIDUAL WHO PROVIDES ONLY INTRAORAL CARE.
4 "Sharp." An object used or encountered in a health care
5 setting which can be reasonably anticipated to penetrate the
6 skin or any other part of the body and to result in an exposure
7 incident. The term includes a needle device, scalpel or lancet;
8 broken glass; or a broken capillary tube.
9 "Sharps injury." An injury caused by a sharp. The term
10 includes any cut, abrasion or needlestick.
11 "Sharps injury log." A written or electronic record of
12 sharps injuries.
13 Section 3. Department.
14 (a) Adoption of standard.--Within six months of the
15 effective date of this act, the department shall promulgate
16 regulations adopting a bloodborne pathogen standard governing
17 public employees. The standard shall be at least as prescriptive
18 as the standard promulgated by the Federal Occupational Safety
19 and Health Review Commission and shall include the following:
20 (1) A requirement that needleless systems and sharps
21 with engineered sharps injury protection be included as
22 engineering and work practice controls. Engineering controls
23 under this paragraph shall not be required if:
24 (i) none is available in the marketplace; or
25 (ii) an evaluation committee, as described in
26 paragraph (2)(iii)(C)(X), determines by means of
27 objective product evaluation criteria that use of such
28 devices will jeopardize patient or employee safety with
29 regard to a specific medical procedure.
30 (2) A requirement that each employer develop and
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1 implement an effective written exposure control plan which
2 includes procedures for all of the following:
3 (i) Identifying and selecting needleless systems and
4 sharps with engineered sharps injury protection through
5 the evaluation committee described in subparagraph
6 (iii)(C)(X).
7 (ii) Updating the written exposure control plan when
8 necessary, but at least once each year, to reflect
9 progress in implementing needleless systems and sharps
10 with engineered sharps injury protection as determined by
11 the evaluation committee under subparagraph (iii)(C)(X).
12 (iii) Recording information concerning exposure
13 incidents in a sharps injury log. This subparagraph
14 includes:
15 (A) Date and time of the exposure incident.
16 (B) Type and brand of sharp involved in the
17 exposure incident.
18 (C) Description of the exposure incident. This
19 clause includes:
20 (I) Job classification of the exposed public
21 employee.
22 (II) Department or work area where the
23 exposure incident occurred.
24 (III) Procedure which the exposed public
25 employee was performing at the time of the
26 incident.
27 (IV) How the incident occurred.
28 (V) Body part involved in the exposure
29 incident.
30 (VI) If the sharp had engineered sharps
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1 injury protection, whether the protective
2 mechanism was activated and whether the injury
3 occurred before the protective mechanism was
4 activated, during activation of the mechanism or
5 after activation of the mechanism.
6 (VII) If the sharp had no engineered sharps
7 injury protection, whether and how such a
8 mechanism could have prevented the injury. This
9 subclause requires statement of the basis for the
10 assessment.
11 (VIII) An assessment of whether any other
12 engineering, administrative or work practice
13 control could have prevented the injury. This
14 subclause requires statement of the basis for the
15 assessment.
16 (IX) Ensuring that all front-line health
17 care workers are trained on the use of all
18 engineering controls before they are introduced
19 into the clinical setting.
20 (X) Establishing an evaluation committee, at
21 least half the members of which are public front-
22 line health care workers from a variety of
23 occupational classifications and departments,
24 including nurses, nurse aides, technicians,
25 phlebotomists and physicians, to advise the
26 employer on the implementation of the
27 requirements of the regulations. Members of the
28 committee shall be trained in the proper method
29 of utilizing product evaluation criteria prior to
30 the commencement of product evaluation.
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1 (b) Additional measures.--The department shall consider
2 additional measures to prevent sharps injuries or exposure
3 incidents. This subsection includes training and educational
4 requirements, increased use of vaccinations, strategic placement
5 of sharps containers as close to the work area as practical and
6 increased use of personal protective equipment.
7 (c) Transitional period for certain drugs and biologics.--
8 The use of a drug or biologic which 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 is exempt for a
12 standard adopted under subsection (a) or additional measures
13 adopted under subsection (b) for a period of three years from
14 the effective date of this act.
15 (d) 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. The list shall
18 be available to assist employers in complying with the
19 requirements of the regulations promulgated under this section.
20 The list may be developed from existing sources of information,
21 including the Federal Food and Drug Administration, the Federal
22 Centers for Disease Control, the National Institute of
23 Occupational Safety and Health and the United States Department
24 of Veterans Affairs.
25 Section 4. Fund.--
26 (a) Establishment.--The Bloodborne Pathogen Fund is
27 established in the State Treasury.
28 (b) Purposes.--The department shall utilize the fund to do
29 all of the following:
30 (1) Implement this act.
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1 (2) In needleless systems and sharps with engineered
2 sharps injury protection, provide for research, development
3 and product evaluation.
4 (c) Source.--The source of the fund is appropriations.
5 (d) Continuous appropriation.--The money in the fund is
6 continuously appropriated to the fund. This appropriation shall
7 not lapse at the end of any fiscal year.
8 Section 5. Effective date.
9 This act shall take effect in 120 days.
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