SENATE AMENDED
PRIOR PRINTER'S NOS. 489, 706 PRINTER'S NO. 2967
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, YUDICHAK, JOSEPHS, L. I. COHEN, STETLER,
BELFANTI AND BEBKO-JONES, FEBRUARY 5, 2001
SENATOR THOMPSON, APPROPRIATIONS, IN SENATE, RE-REPORTED AS
AMENDED, DECEMBER 3, 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
1 present in human blood and can cause disease in humans. The term
2 includes hepatitis B virus (HBV), hepatitis C virus (HCV) and
3 human immunodeficiency virus (HIV).
4 "Department." The Department of Health of the Commonwealth.
5 "Employer." An employer having public employees with WHOSE <--
6 DUTIES COULD REASONABLY RESULT IN occupational exposure to blood
7 or other material potentially containing a bloodborne pathogen.
8 "Engineered sharps injury protection." Any of the following:
9 (1) A physical attribute built into a needle device used
10 for withdrawing body fluids, accessing a vein or artery or
11 administering medications or other fluids, which effectively
12 reduces the risk of an exposure incident EXPOSURE TO BODILY <--
13 FLUID by a mechanism such as barrier creation, blunting,
14 encapsulation, withdrawal, retraction, destruction or other
15 effective mechanisms.
16 (2) A physical attribute built into any other type of
17 needle device or into a nonneedle sharp which effectively
18 reduces the risk of an exposure incident EXPOSURE TO BODILY <--
19 FLUID.
20 "Front-line health care worker." A nonmanagerial employee <--
21 responsible for direct patient care with potential occupational
22 exposure to a sharps injury.
23 "Fund." The Bloodborne Pathogen Fund established in section
24 4.
25 "Needleless system." A device which does not utilize needles
26 for:
27 (1) the withdrawal of body fluids after initial venous
28 or arterial access is established;
29 (2) the administration of medication or fluids; or
30 (3) any other procedure involving the potential for an <--
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1 exposure incident EXPOSURE TO BODILY FLUID. <--
2 "Public employee." An employee of the Commonwealth or a
3 political subdivision employed in a health care facility, home
4 health care organization or other facility providing health
5 care-related services. The term does not include a licensed: <--
6 (1) WHOSE ACTIVITIES INVOLVE CONTACT WITH A PATIENT OR
7 WITH BLOOD OR OTHER BODY FLUID FROM A PATIENT IN A HEALTH
8 CARE OR LABORATORY SETTING; OR
9 (2) WHO IS RESPONSIBLE FOR DIRECT PATIENT CARE WITH
10 POTENTIAL OCCUPATIONAL EXPOSURE TO A SHARPS INJURY.
11 THE TERM DOES NOT INCLUDE A LICENSED individual who provides
12 only intraoral care.
13 "Sharp." An object used or encountered in a health care
14 setting which can be reasonably anticipated to penetrate the
15 skin or any other part of the body and to result in an exposure <--
16 incident EXPOSURE TO BODILY FLUID. The term includes a needle <--
17 device, scalpel or lancet; broken glass; or a broken capillary
18 tube.
19 "Sharps injury." An injury caused by a sharp AND RESULTING <--
20 IN EXPOSURE TO BODILY FLUID. The term includes any cut, abrasion
21 or needlestick.
22 "Sharps injury log." A written or electronic record of
23 sharps injuries.
24 Section 3. Department.
25 (a) Adoption of standard.--Within six months of the
26 effective date of this act, the department shall promulgate <--
27 regulations adopting ADOPT a bloodborne pathogen standard <--
28 governing public employees. The standard shall be at least as
29 prescriptive as the standard promulgated by the Federal
30 Occupational Safety and Health Review Commission ADMINISTRATION <--
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1 and shall include the following:
2 (1) A requirement that needleless systems and sharps
3 with engineered sharps injury protection be included as
4 engineering and work practice controls. Engineering controls
5 under this paragraph shall not be required if: <--
6 (i) none is available in the marketplace; or
7 (ii) an evaluation committee, as described in
8 paragraph (2)(iii)(C)(X), determines by means of
9 objective product evaluation criteria that use of such
10 devices will jeopardize patient or employee safety with
11 regard to a specific medical procedure. NONE IS AVAILABLE <--
12 IN THE MARKETPLACE.
13 (2) A REQUIREMENT THAT EACH PUBLIC EMPLOYEE RECEIVE
14 EDUCATION ON THE USE OF AN ENGINEERING CONTROL BEFORE A
15 CONTROL IS INTRODUCED INTO THE CLINICAL SETTING.
16 (2) (3) A requirement that each employer develop and <--
17 implement an effective written exposure control plan which
18 includes procedures for all of the following:
19 (i) Identifying and selecting needleless systems and <--
20 sharps with engineered sharps injury protection through
21 the evaluation committee described in subparagraph
22 (iii)(C)(X).
23 (ii) (I) Updating the written exposure control plan <--
24 when necessary, but at least once each year, to reflect
25 progress in implementing needleless systems and sharps
26 with engineered sharps injury protection. as determined <--
27 by the evaluation committee under subparagraph
28 (iii)(C)(X).
29 (iii) (II) Recording information concerning exposure <--
30 incidents TO BODILY FLUID in a sharps injury log. This <--
20010H0454B2967 - 4 -
1 subparagraph includes:
2 (A) Date and time of the exposure incident. <--
3 (B) Type and brand of sharp involved in the
4 exposure incident. <--
5 (C) Description of the exposure incident. This <--
6 clause includes:
7 (I) Job classification of the exposed public
8 employee.
9 (II) Department or work area where the
10 exposure incident occurred. <--
11 (III) Procedure which the exposed public
12 employee was performing at the time of the
13 incident EXPOSURE. <--
14 (IV) How the incident EXPOSURE occurred. <--
15 (V) Body part involved in the exposure
16 incident. <--
17 (VI) If the sharp had engineered sharps
18 injury protection, whether the protective
19 mechanism was activated and whether the injury
20 occurred before the protective mechanism was
21 activated, during activation of the mechanism or
22 after activation of the mechanism.
23 (VII) If the sharp had no engineered sharps
24 injury protection, whether and how such a
25 mechanism could have prevented the injury. This
26 subclause requires statement of the basis for the
27 assessment.
28 (VIII) An assessment of whether any other
29 engineering, administrative or work practice
30 control could have prevented the injury. This
20010H0454B2967 - 5 -
1 subclause requires statement of the basis for the
2 assessment.
3 (IX) Ensuring that all front-line health <--
4 care workers are trained on the use of all
5 engineering controls before they are introduced
6 into the clinical setting.
7 (X) Establishing an evaluation committee, at
8 least half the members of which are public front-
9 line health care workers from a variety of
10 occupational classifications and departments,
11 including nurses, nurse aides, technicians,
12 phlebotomists and physicians, to advise the
13 employer on the implementation of the
14 requirements of the regulations. Members of the
15 committee shall be trained in the proper method
16 of utilizing product evaluation criteria prior to
17 the commencement of product evaluation.
18 (b) Additional measures.--The department shall consider
19 additional measures to prevent sharps injuries or exposure
20 incidents TO BODILY FLUID. This subsection includes training and <--
21 educational requirements, increased use of vaccinations,
22 strategic placement of sharps containers as close to the work
23 area as practical and increased use of personal protective
24 equipment.
25 (c) Transitional period for certain drugs and biologics.-- <--
26 The use of a drug or biologic which is prepackaged with an
27 administration system or used in a prefilled syringe and is
28 approved for commercial distribution or investigational use by
29 the Federal Food and Drug Administration is exempt for a
30 standard adopted under subsection (a) or additional measures
20010H0454B2967 - 6 -
1 adopted under subsection (b) for a period of three years from
2 the effective date of this act.
3 (d) Compilation and maintenance of list.--The department
4 shall compile and maintain a list of needleless systems and
5 sharps with engineered sharps injury protection. The list shall
6 be available to assist employers in complying with the
7 requirements of the regulations promulgated under this section.
8 The list may be developed from existing sources of information,
9 including the Federal Food and Drug Administration, the Federal
10 Centers for Disease Control, the National Institute of
11 Occupational Safety and Health and the United States Department
12 of Veterans Affairs.
13 (C) REGULATIONS.--THE DEPARTMENT MAY PROMULGATE REGULATIONS <--
14 TO IMPLEMENT THIS ACT.
15 Section 4. Fund.-- <--
16 (a) Establishment.--The Bloodborne Pathogen Fund is
17 established in the State Treasury.
18 (b) Purposes.--The department shall utilize the fund to do
19 all of the following:
20 (1) Implement this act.
21 (2) In needleless systems and sharps with engineered
22 sharps injury protection, provide for research, development
23 and product evaluation.
24 (c) Source.--The source of the fund is appropriations.
25 (d) Continuous appropriation.--The money in the fund is
26 continuously appropriated to the fund. This appropriation shall
27 not lapse at the end of any fiscal year.
28 SECTION 4. EMPLOYERS. <--
29 (A) COMPLAINTS.--EACH EMPLOYER SHALL DEVELOP AND IMPLEMENT
30 COMPLIANCE MONITORING PROCEDURES AND A COMPLAINT PROCESS.
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1 (B) REVIEW.--EACH EMPLOYER SHALL PROVIDE ITS PUBLIC
2 EMPLOYEES AN OPPORTUNITY TO EVALUATE ENGINEERED SHARPS INJURY
3 PREVENTION DEVICES AND NEEDLELESS SYSTEMS IN AN ACCIDENT AND
4 ILLNESS PREVENTION PROGRAM.
5 SECTION 5. IMPLEMENTATION.
6 THE USE OF A DRUG OR BIOLOGIC WHICH IS PREPACKAGED WITH AN
7 ADMINISTRATION SYSTEM OR USED IN A PREFILLED SYRINGE AND IS
8 APPROVED FOR COMMERCIAL DISTRIBUTION OR INVESTIGATIONAL USE BY
9 THE UNITED STATES FOOD AND DRUG ADMINISTRATION IS EXEMPT FROM
10 STANDARDS ADOPTED UNDER THIS ACT FOR A PERIOD OF THREE YEARS
11 FROM THE EFFECTIVE DATE OF THIS ACT.
12 SECTION 6. APPLICABILITY TO CONTRACTORS.
13 NOTHING IN THIS ACT SHALL PROHIBIT AN EMPLOYER FROM APPLYING
14 THE PRINCIPLES OF THIS ACT TO A CONTRACTOR.
15 Section 5 7. Effective date. <--
16 This act shall take effect in 120 days.
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