PRINTER'S NO. 2836
No. 2124 Session of 2001
INTRODUCED BY SOLOBAY, BEBKO-JONES, BELARDI, BELFANTI, CAPPELLI,
COLEMAN, COSTA, COY, CREIGHTON, CRUZ, DALLY, DeLUCA, DERMODY,
DeWEESE, FAIRCHILD, FLEAGLE, FRANKEL, GEORGE, GRUCELA,
HALUSKA, HARHAI, HENNESSEY, HORSEY, HUTCHINSON, JAMES,
JOSEPHS, KELLER, LAUGHLIN, MAHER, MANN, McGEEHAN, MELIO,
MUNDY, PALLONE, PIPPY, PISTELLA, ROONEY, SAINATO, SCRIMENTI,
SHANER, STABACK, TANGRETTI, TIGUE, TRELLO, TURZAI, WALKO,
C. WILLIAMS, J. WILLIAMS, WILT, WOJNAROSKI, G. WRIGHT,
YOUNGBLOOD AND YUDICHAK, NOVEMBER 13, 2001
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES,
NOVEMBER 13, 2001
AN ACT
1 Requiring the Department of Health to establish bloodborne
2 pathogen standards for emergency services personnel and
3 public employees; and establishing the Bloodborne Pathogen
4 Fund.
5 The General Assembly of the Commonwealth of Pennsylvania
6 hereby enacts as follows:
7 Section 1. Short title.
8 This act shall be known and may be cited as the Bloodborne
9 Pathogen Standard Act.
10 Section 2. Definitions.
11 The following words and phrases when used in this act shall
12 have the meanings given to them in this section unless the
13 context clearly indicates otherwise:
14 "Bloodborne pathogen." A pathogenic microorganism which is
15 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 "Emergency medical services." The services utilized in
5 responding to the needs of an individual for immediate medical
6 care in order to prevent loss of life or the aggravation of
7 physiological or psychological illness or injury.
8 "Emergency services personnel." A person, including a
9 trained volunteer or a member of the armed forces of the United
10 States or the National Guard, whose official or assigned
11 responsibilities include performing or directly supporting the
12 performance of emergency medical or rescue services or
13 firefighting.
14 "Employer." An employer having emergency services personnel
15 or public employees with occupational exposure to blood or other
16 material potentially containing a bloodborne pathogen.
17 "Engineered sharps injury protection." Any of the following:
18 (1) A physical attribute built into a needle device used
19 for withdrawing body fluids, accessing a vein or artery or
20 administering medications or other fluids, which effectively
21 reduces the risk of an exposure incident by a mechanism such
22 as barrier creation, blunting, encapsulation, withdrawal,
23 retraction, destruction or other effective mechanisms.
24 (2) A physical attribute built into any other type of
25 needle device or into a nonneedle sharp which effectively
26 reduces the risk of an exposure incident.
27 "Front-line health care worker." A nonmanagerial employee
28 responsible for direct patient care with potential occupational
29 exposure to a sharps injury.
30 "Fund." The Bloodborne Pathogen Fund established in section
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1 4.
2 "Needleless system." A device which does not utilize needles
3 for:
4 (1) the withdrawal of body fluids after initial venous
5 or arterial access is established;
6 (2) the administration of medication or fluids; or
7 (3) any other procedure involving the potential for an
8 exposure incident.
9 "Public employee." An employee of the Commonwealth or a
10 political subdivision employed in a health care facility, home
11 health care organization or other facility providing health
12 care-related services. The term does not include a licensed
13 individual who provides only intraoral care.
14 "Rescue." The act of extricating persons from entrapment or
15 dangerous situations which pose the imminent threat of death or
16 serious bodily injury.
17 "Sharp." An object used or encountered in a health care
18 setting which can be reasonably anticipated to penetrate the
19 skin or any other part of the body and to result in an exposure
20 incident. The term includes a needle device, scalpel or lancet;
21 broken glass; or a broken capillary tube.
22 "Sharps injury." An injury caused by a sharp. The term
23 includes any cut, abrasion or needlestick.
24 "Sharps injury log." A written or electronic record of
25 sharps injuries.
26 Section 3. Department.
27 (a) Adoption of standard.--Within six months of the
28 effective date of this act, the department shall promulgate
29 regulations adopting a bloodborne pathogen standard governing
30 emergency services personnel and public employees. The standard
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1 shall be at least as prescriptive as the standard promulgated by
2 the Federal Occupational Safety and Health Review Commission and
3 shall include the following:
4 (1) A requirement that needleless systems and sharps
5 with engineered sharps injury protection be included as
6 engineering and work practice controls. Engineering controls
7 under this paragraph shall not be required if:
8 (i) none is available in the marketplace; or
9 (ii) an evaluation committee, as described in
10 paragraph (2)(iii)(C)(X), determines by means of
11 objective product evaluation criteria that use of such
12 devices will jeopardize patient or employee safety with
13 regard to a specific medical procedure.
14 (2) A requirement that each employer develop and
15 implement an effective written exposure control plan which
16 includes procedures for all of the following:
17 (i) Identifying and selecting needleless systems and
18 sharps with engineered sharps injury protection through
19 the evaluation committee described in subparagraph
20 (iii)(C)(X).
21 (ii) Updating the written exposure control plan when
22 necessary, but at least once each year, to reflect
23 progress in implementing needleless systems and sharps
24 with engineered sharps injury protection as determined by
25 the evaluation committee under subparagraph (iii)(C)(X).
26 (iii) Recording information concerning exposure
27 incidents in a sharps injury log. This subparagraph
28 includes:
29 (A) Date and time of the exposure incident.
30 (B) Type and brand of sharp involved in the
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1 exposure incident.
2 (C) Description of the exposure incident. This
3 clause includes:
4 (I) Job classification of the exposed
5 emergency services personnel or public employee.
6 (II) Department or work area where the
7 exposure incident occurred.
8 (III) Procedure which the exposed emergency
9 services personnel or public employee was
10 performing at the time of the incident.
11 (IV) How the incident occurred.
12 (V) Body part involved in the exposure
13 incident.
14 (VI) If the sharp had engineered sharps
15 injury protection, whether the protective
16 mechanism was activated and whether the injury
17 occurred before the protective mechanism was
18 activated, during activation of the mechanism or
19 after activation of the mechanism.
20 (VII) If the sharp had no engineered sharps
21 injury protection, whether and how such a
22 mechanism could have prevented the injury. This
23 subclause requires statement of the basis for the
24 assessment.
25 (VIII) An assessment of whether any other
26 engineering, administrative or work practice
27 control could have prevented the injury. This
28 subclause requires statement of the basis for the
29 assessment.
30 (IX) Ensuring that all front-line health
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1 care workers are trained on the use of all
2 engineering controls before they are introduced
3 into the clinical setting.
4 (X) Establishing an evaluation committee, at
5 least half the members of which are public front-
6 line health care workers from a variety of
7 occupational classifications and departments,
8 including nurses, nurse aides, technicians,
9 phlebotomists and physicians, to advise the
10 employer on the implementation of the
11 requirements of the regulations. Members of the
12 committee shall be trained in the proper method
13 of utilizing product evaluation criteria prior to
14 the commencement of product evaluation.
15 (b) Additional measures.--The department shall consider
16 additional measures to prevent sharps injuries or exposure
17 incidents. This subsection includes training and educational
18 requirements, increased use of vaccinations, strategic placement
19 of sharps containers as close to the work area as practical and
20 increased use of personal protective equipment.
21 (c) Transitional period for certain drugs and biologics.--
22 The use of a drug or biologic which is prepackaged with an
23 administration system or used in a prefilled syringe and is
24 approved for commercial distribution or investigational use by
25 the Federal Food and Drug Administration is exempt for a
26 standard adopted under subsection (a) or additional measures
27 adopted under subsection (b) for a period of three years from
28 the effective date of this act.
29 (d) Compilation and maintenance of list.--The department
30 shall compile and maintain a list of needleless systems and
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1 sharps with engineered sharps injury protection. The list shall
2 be available to assist employers in complying with the
3 requirements of the regulations promulgated under this section.
4 The list may be developed from existing sources of information,
5 including the Federal Food and Drug Administration, the Federal
6 Centers for Disease Control, the National Institute of
7 Occupational Safety and Health and the United States Department
8 of Veterans Affairs.
9 Section 4. Fund.--
10 (a) Establishment.--The Bloodborne Pathogen Fund is
11 established in the State Treasury.
12 (b) Purposes.--The department shall utilize the fund to do
13 all of the following:
14 (1) Implement this act.
15 (2) In needleless systems and sharps with engineered
16 sharps injury protection, provide for research, development
17 and product evaluation.
18 (c) Source.--The source of the fund is appropriations.
19 (d) Continuous appropriation.--The money in the fund is
20 continuously appropriated to the fund. This appropriation shall
21 not lapse at the end of any fiscal year.
22 Section 5. Effective date.
23 This act shall take effect in 120 days.
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