| |
|
| |
| THE GENERAL ASSEMBLY OF PENNSYLVANIA |
| |
| HOUSE BILL |
|
| |
| |
| INTRODUCED BY SOLOBAY, BELFANTI, BEYER, BRENNAN, CALTAGIRONE, CARROLL, CREIGHTON, FRANKEL, GRUCELA, MAHONEY, MANN, McILVAINE SMITH, MELIO, M. O'BRIEN, READSHAW, SIPTROTH, STABACK AND VULAKOVICH, JANUARY 30, 2009 |
| |
| |
| REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES, JANUARY 30, 2009 |
| |
| |
| |
| 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 |
18 | human immunodeficiency virus (HIV). |
|
1 | "Department." The Department of Health of the Commonwealth. |
2 | "Emergency medical services." The services utilized in |
3 | responding to the needs of an individual for immediate medical |
4 | care in order to prevent loss of life or the aggravation of |
5 | physiological or psychological illness or injury. |
6 | "Emergency services personnel." A person, including a |
7 | trained volunteer or a member of the armed forces of the United |
8 | States or the National Guard, whose official or assigned |
9 | responsibilities include performing or directly supporting the |
10 | performance of emergency medical or rescue services or |
11 | firefighting. |
12 | "Employer." An employer having emergency services personnel |
13 | or public employees with occupational exposure to blood or other |
14 | material potentially containing a bloodborne pathogen. |
15 | "Engineered sharps injury protection." Any of the following: |
16 | (1) A physical attribute built into a needle device used |
17 | for withdrawing body fluids, accessing a vein or artery or |
18 | administering medications or other fluids, which effectively |
19 | reduces the risk of an exposure incident by a mechanism such |
20 | as barrier creation, blunting, encapsulation, withdrawal, |
21 | retraction, destruction or other effective mechanisms. |
22 | (2) A physical attribute built into any other type of |
23 | needle device or into a nonneedle sharp which effectively |
24 | reduces the risk of an exposure incident. |
25 | "Front-line health care worker." A nonmanagerial employee |
26 | responsible for direct patient care with potential occupational |
27 | exposure to a sharps injury. |
28 | "Fund." The Bloodborne Pathogen Fund established in section |
29 | 6. |
30 | "Needleless system." A device which does not utilize needles |
|
1 | for: |
2 | (1) the withdrawal of body fluids after initial venous |
3 | or arterial access is established; |
4 | (2) the administration of medication or fluids; or |
5 | (3) any other procedure involving the potential for an |
6 | exposure incident. |
7 | "Public employee." An employee of the Commonwealth or a |
8 | political subdivision employed in a health care facility, home |
9 | health care organization or other facility providing health |
10 | care-related services: |
11 | (1) whose activities involve contact with a patient or |
12 | with blood or other body fluid from a patient in a health |
13 | care or laboratory setting; or |
14 | (2) who is responsible for direct patient care with |
15 | potential occupational exposure to a sharps injury. |
16 | The term does not include a licensed individual who provides |
17 | only intraoral care. |
18 | "Rescue." The act of extricating persons from entrapment or |
19 | dangerous situations which pose the imminent threat of death or |
20 | serious bodily injury. |
21 | "Sharp." An object used or encountered in a health care |
22 | setting which can be reasonably anticipated to penetrate the |
23 | skin or any other part of the body and to result in an exposure |
24 | incident. The term includes a needle device, scalpel or lancet; |
25 | broken glass; or a broken capillary tube. |
26 | "Sharps injury." An injury caused by a sharp and resulting |
27 | in exposure to body fluid. The term includes any cut, abrasion |
28 | or needlestick. |
29 | "Sharps injury log." A written or electronic record of |
30 | sharps injuries. |
|
1 | Section 3. Department. |
2 | (a) Adoption of standard.--Within six months of the |
3 | effective date of this act, the department shall promulgate |
4 | regulations adopting a bloodborne pathogen standard governing |
5 | emergency services personnel and public employees. The standard |
6 | shall be at least as prescriptive as the standard promulgated by |
7 | the Federal Occupational Safety and Health Review Commission and |
8 | shall include the following: |
9 | (1) A requirement that needleless systems and sharps |
10 | with engineered sharps injury protection be included as |
11 | engineering and work practice controls. Engineering controls |
12 | under this paragraph shall not be required if: |
13 | (i) none is available in the marketplace; or |
14 | (ii) an evaluation committee, as described in |
15 | paragraph (3)(iii)(C)(X), determines by means of |
16 | objective product evaluation criteria that use of such |
17 | devices will jeopardize patient or employee safety with |
18 | regard to a specific medical procedure. |
19 | (2) A requirement that each emergency service personnel |
20 | and public employee receive education on the use of an |
21 | engineering control before a control is introduced into the |
22 | clinical setting. |
23 | (3) A requirement that each employer develop and |
24 | implement an effective written exposure control plan which |
25 | includes procedures for all of the following: |
26 | (i) Identifying and selecting needleless systems and |
27 | sharps with engineered sharps injury protection through |
28 | the evaluation committee described in subparagraph (iii) |
29 | (C)(X). |
30 | (ii) Updating the written exposure control plan when |
|
1 | necessary, but at least once each year, to reflect |
2 | progress in implementing needleless systems and sharps |
3 | with engineered sharps injury protection as determined by |
4 | the evaluation committee under subparagraph (iii)(C)(X). |
5 | (iii) Recording information concerning exposure |
6 | incidents in a sharps injury log. This subparagraph |
7 | includes: |
8 | (A) Date and time of the exposure incident. |
9 | (B) Type and brand of sharp involved in the |
10 | exposure incident. |
11 | (C) Description of the exposure incident. This |
12 | clause includes: |
13 | (I) Job classification of the exposed |
14 | emergency services personnel or public employee. |
15 | (II) Department or work area where the |
16 | exposure incident occurred. |
17 | (III) Procedure which the exposed emergency |
18 | services personnel or public employee was |
19 | performing at the time of the incident. |
20 | (IV) How the incident occurred. |
21 | (V) Body part involved in the exposure |
22 | incident. |
23 | (VI) If the sharp had engineered sharps |
24 | injury protection, whether the protective |
25 | mechanism was activated and whether the injury |
26 | occurred before the protective mechanism was |
27 | activated, during activation of the mechanism or |
28 | after activation of the mechanism. |
29 | (VII) If the sharp had no engineered sharps |
30 | injury protection, whether and how such a |
|
1 | mechanism could have prevented the injury. This |
2 | subclause requires statement of the basis for the |
3 | assessment. |
4 | (VIII) An assessment of whether any other |
5 | engineering, administrative or work practice |
6 | control could have prevented the injury. This |
7 | subclause requires statement of the basis for the |
8 | assessment. |
9 | (IX) Ensuring that all front-line health |
10 | care workers are trained on the use of all |
11 | engineering controls before they are introduced |
12 | into the clinical setting. |
13 | (X) Establishing an evaluation committee, at |
14 | least half the members of which are public front- |
15 | line health care workers from a variety of |
16 | occupational classifications and departments, |
17 | including nurses, nurse aides, technicians, |
18 | phlebotomists and physicians, to advise the |
19 | employer on the implementation of the |
20 | requirements of the regulations. Members of the |
21 | committee shall be trained in the proper method |
22 | of utilizing product evaluation criteria prior to |
23 | the commencement of product evaluation. |
24 | (b) Additional measures.--The department shall consider |
25 | additional measures to prevent sharps injuries or exposure |
26 | incidents. This subsection includes training and educational |
27 | requirements, increased use of vaccinations, strategic placement |
28 | of sharps containers as close to the work area as practical and |
29 | increased use of personal protective equipment. |
30 | (c) Regulations.--The department may promulgate regulations |
|
1 | to implement this act. |
2 | (d) Transitional period for certain drugs and biologics.-- |
3 | The use of a drug or biologic which 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 is exempt for a |
7 | standard adopted under subsection (a) or additional measures |
8 | adopted under subsection (b) 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. The list shall |
13 | be available to assist employers in complying with the |
14 | requirements of the regulations promulgated under this section. |
15 | The list may be developed from existing sources of information, |
16 | including the Federal Food and Drug Administration, the Federal |
17 | Centers for Disease Control, the National Institute of |
18 | Occupational Safety and Health and the United States Department |
19 | of Veterans Affairs. |
20 | Section 4. Employers. |
21 | (a) Complaints.--Each employer shall develop and implement |
22 | compliance monitoring procedures and a complaint process. |
23 | (b) Review.--Each employer shall provide its emergency |
24 | service personnel and public employees an opportunity to |
25 | evaluate engineered sharps injury prevention devices and |
26 | needleless systems in an accident and illness prevention |
27 | program. |
28 | Section 5. Applicability to contractors. |
29 | Nothing in this act shall prohibit an employer from applying |
30 | the principles of this act to a contractor. |
|
1 | Section 6. Fund. |
2 | (a) Establishment.--The Bloodborne Pathogen Fund is |
3 | established in the State Treasury. |
4 | (b) Purposes.--The department shall utilize the fund to do |
5 | all of the following: |
6 | (1) Implement this act. |
7 | (2) In needleless systems and sharps with engineered |
8 | sharps injury protection, provide for research, development |
9 | and product evaluation. |
10 | (c) Source.--The source of the fund is appropriations. |
11 | (d) Continuous appropriation.--The money in the fund is |
12 | continuously appropriated to the fund. This appropriation shall |
13 | not lapse at the end of any fiscal year. |
14 | Section 7. Repeal. |
15 | (a) Intent.--The General Assembly declares that the repeal |
16 | under subsection (b) is necessary to effectuate the provisions |
17 | of this act. |
18 | (b) Provision.--The act of December 13, 2001 (P.L.873, No. |
19 | 96), known as the Bloodborne Pathogen Standard Act, is repealed. |
20 | Section 8. Effective date. |
21 | This act shall take effect in 120 days. |
|