PRINTER'S NO. 207
No. 181 Session of 2007
INTRODUCED BY SOLOBAY, BELFANTI, CALTAGIRONE, CAPPELLI, CARROLL,
COHEN, J. EVANS, FABRIZIO, FRANKEL, GALLOWAY, GIBBONS,
GOODMAN, GRUCELA, HORNAMAN, JAMES, JOSEPHS, KOTIK, KULA,
MAHONEY, MANN, MELIO, M. O'BRIEN, O'NEILL, PALLONE, PAYNE,
STABACK, SURRA, TANGRETTI, WALKO AND WOJNAROSKI,
FEBRUARY 1, 2007
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES,
FEBRUARY 1, 2007
AN ACT
1 Requiring the Department of Health to establish bloodborne
2 pathogen standards for emergency services personnel and
3 public employees; establishing the Bloodborne Pathogen Fund;
4 and repealing an act relating to bloodborne pathogen
5 standards.
6 The General Assembly of the Commonwealth of Pennsylvania
7 hereby enacts as follows:
8 Section 1. Short title.
9 This act shall be known and may be cited as the Bloodborne
10 Pathogen Standard Act.
11 Section 2. Definitions.
12 The following words and phrases when used in this act shall
13 have the meanings given to them in this section unless the
14 context clearly indicates otherwise:
15 "Bloodborne pathogen." A pathogenic microorganism which is
16 present in human blood and can cause disease in humans. The term
17 includes hepatitis B virus (HBV), hepatitis C virus (HCV) and
1 human immunodeficiency virus (HIV).
2 "Department." The Department of Health of the Commonwealth.
3 "Emergency medical services." The services utilized in
4 responding to the needs of an individual for immediate medical
5 care in order to prevent loss of life or the aggravation of
6 physiological or psychological illness or injury.
7 "Emergency services personnel." A person, including a
8 trained volunteer or a member of the armed forces of the United
9 States or the National Guard, whose official or assigned
10 responsibilities include performing or directly supporting the
11 performance of emergency medical or rescue services or
12 firefighting.
13 "Employer." An employer having emergency services personnel
14 or public employees with occupational exposure to blood or other
15 material potentially containing a bloodborne pathogen.
16 "Engineered sharps injury protection." Any of the following:
17 (1) A physical attribute built into a needle device used
18 for withdrawing body fluids, accessing a vein or artery or
19 administering medications or other fluids, which effectively
20 reduces the risk of an exposure incident by a mechanism such
21 as barrier creation, blunting, encapsulation, withdrawal,
22 retraction, destruction or other effective mechanisms.
23 (2) A physical attribute built into any other type of
24 needle device or into a nonneedle sharp which effectively
25 reduces the risk of an exposure incident.
26 "Front-line health care worker." A nonmanagerial employee
27 responsible for direct patient care with potential occupational
28 exposure to a sharps injury.
29 "Fund." The Bloodborne Pathogen Fund established in section
30 6.
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1 "Needleless system." A device which does not utilize needles
2 for:
3 (1) the withdrawal of body fluids after initial venous
4 or arterial access is established;
5 (2) the administration of medication or fluids; or
6 (3) any other procedure involving the potential for an
7 exposure incident.
8 "Public employee." An employee of the Commonwealth or a
9 political subdivision employed in a health care facility, home
10 health care organization or other facility providing health
11 care-related services:
12 (1) whose activities involve contact with a patient or
13 with blood or other body fluid from a patient in a health
14 care or laboratory setting; or
15 (2) who is responsible for direct patient care with
16 potential occupational exposure to a sharps injury.
17 The term does not include a licensed individual who provides
18 only intraoral care.
19 "Rescue." The act of extricating persons from entrapment or
20 dangerous situations which pose the imminent threat of death or
21 serious bodily injury.
22 "Sharp." An object used or encountered in a health care
23 setting which can be reasonably anticipated to penetrate the
24 skin or any other part of the body and to result in an exposure
25 incident. The term includes a needle device, scalpel or lancet;
26 broken glass; or a broken capillary tube.
27 "Sharps injury." An injury caused by a sharp and resulting
28 in exposure to body fluid. The term includes any cut, abrasion
29 or needlestick.
30 "Sharps injury log." A written or electronic record of
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1 sharps injuries.
2 Section 3. Department.
3 (a) Adoption of standard.--Within six months of the
4 effective date of this act, the department shall promulgate
5 regulations adopting a bloodborne pathogen standard governing
6 emergency services personnel and public employees. The standard
7 shall be at least as prescriptive as the standard promulgated by
8 the Federal Occupational Safety and Health Review Commission and
9 shall include the following:
10 (1) A requirement that needleless systems and sharps
11 with engineered sharps injury protection be included as
12 engineering and work practice controls. Engineering controls
13 under this paragraph shall not be required if:
14 (i) none is available in the marketplace; or
15 (ii) an evaluation committee, as described in
16 paragraph (3)(iii)(C)(X), determines by means of
17 objective product evaluation criteria that use of such
18 devices will jeopardize patient or employee safety with
19 regard to a specific medical procedure.
20 (2) A requirement that each emergency service personnel
21 and public employee receive education on the use of an
22 engineering control before a control is introduced into the
23 clinical setting.
24 (3) A requirement that each employer develop and
25 implement an effective written exposure control plan which
26 includes procedures for all of the following:
27 (i) Identifying and selecting needleless systems and
28 sharps with engineered sharps injury protection through
29 the evaluation committee described in subparagraph
30 (iii)(C)(X).
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1 (ii) Updating the written exposure control plan when
2 necessary, but at least once each year, to reflect
3 progress in implementing needleless systems and sharps
4 with engineered sharps injury protection as determined by
5 the evaluation committee under subparagraph (iii)(C)(X).
6 (iii) Recording information concerning exposure
7 incidents in a sharps injury log. This subparagraph
8 includes:
9 (A) Date and time of the exposure incident.
10 (B) Type and brand of sharp involved in the
11 exposure incident.
12 (C) Description of the exposure incident. This
13 clause includes:
14 (I) Job classification of the exposed
15 emergency services personnel or public employee.
16 (II) Department or work area where the
17 exposure incident occurred.
18 (III) Procedure which the exposed emergency
19 services personnel or public employee was
20 performing at the time of the incident.
21 (IV) How the incident occurred.
22 (V) Body part involved in the exposure
23 incident.
24 (VI) If the sharp had engineered sharps
25 injury protection, whether the protective
26 mechanism was activated and whether the injury
27 occurred before the protective mechanism was
28 activated, during activation of the mechanism or
29 after activation of the mechanism.
30 (VII) If the sharp had no engineered sharps
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1 injury protection, whether and how such a
2 mechanism could have prevented the injury. This
3 subclause requires statement of the basis for the
4 assessment.
5 (VIII) An assessment of whether any other
6 engineering, administrative or work practice
7 control could have prevented the injury. This
8 subclause requires statement of the basis for the
9 assessment.
10 (IX) Ensuring that all front-line health
11 care workers are trained on the use of all
12 engineering controls before they are introduced
13 into the clinical setting.
14 (X) Establishing an evaluation committee, at
15 least half the members of which are public front-
16 line health care workers from a variety of
17 occupational classifications and departments,
18 including nurses, nurse aides, technicians,
19 phlebotomists and physicians, to advise the
20 employer on the implementation of the
21 requirements of the regulations. Members of the
22 committee shall be trained in the proper method
23 of utilizing product evaluation criteria prior to
24 the commencement of product evaluation.
25 (b) Additional measures.--The department shall consider
26 additional measures to prevent sharps injuries or exposure
27 incidents. This subsection includes training and educational
28 requirements, increased use of vaccinations, strategic placement
29 of sharps containers as close to the work area as practical and
30 increased use of personal protective equipment.
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1 (c) Regulations.--The department may promulgate regulations
2 to implement this act.
3 (d) Transitional period for certain drugs and biologics.--
4 The use of a drug or biologic which is prepackaged with an
5 administration system or used in a prefilled syringe and is
6 approved for commercial distribution or investigational use by
7 the Federal Food and Drug Administration is exempt for a
8 standard adopted under subsection (a) or additional measures
9 adopted under subsection (b) for a period of three years from
10 the effective date of this act.
11 (e) Compilation and maintenance of list.--The department
12 shall compile and maintain a list of needleless systems and
13 sharps with engineered sharps injury protection. The list shall
14 be available to assist employers in complying with the
15 requirements of the regulations promulgated under this section.
16 The list may be developed from existing sources of information,
17 including the Federal Food and Drug Administration, the Federal
18 Centers for Disease Control, the National Institute of
19 Occupational Safety and Health and the United States Department
20 of Veterans Affairs.
21 Section 4. Employers.
22 (a) Complaints.--Each employer shall develop and implement
23 compliance monitoring procedures and a complaint process.
24 (b) Review.--Each employer shall provide its emergency
25 service personnel and public employees an opportunity to
26 evaluate engineered sharps injury prevention devices and
27 needleless systems in an accident and illness prevention
28 program.
29 Section 5. Applicability to contractors.
30 Nothing in this act shall prohibit an employer from applying
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1 the principles of this act to a contractor.
2 Section 6. Fund.
3 (a) Establishment.--The Bloodborne Pathogen Fund is
4 established in the State Treasury.
5 (b) Purposes.--The department shall utilize the fund to do
6 all of the following:
7 (1) Implement this act.
8 (2) In needleless systems and sharps with engineered
9 sharps injury protection, provide for research, development
10 and product evaluation.
11 (c) Source.--The source of the fund is appropriations.
12 (d) Continuous appropriation.--The money in the fund is
13 continuously appropriated to the fund. This appropriation shall
14 not lapse at the end of any fiscal year.
15 Section 7. Repeal.
16 (a) Intent.--The General Assembly declares that the repeal
17 under subsection (b) is necessary to effectuate the provisions
18 of this act.
19 (b) Provision.--The act of December 13, 2001 (P.L.873,
20 No.96), known as the Bloodborne Pathogen Standard Act, is
21 repealed.
22 Section 8. Effective date.
23 This act shall take effect in 120 days.
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