HBA-NMO C.S.H.B. 1646 76(R)BILL ANALYSIS Office of House Bill AnalysisC.S.H.B. 1646 By: Ehrhardt Public Health 5/7/1999 Committee Report (Substituted) BACKGROUND AND PURPOSE The International Health-Care-Worker Safety Center at the University of Virginia reports that approximately one million accidental needle sticks occur each year nationally. Nurses, physicians, and medical maintenance staff report the highest incidence of these accidents. These accidents can expose persons to bloodborne pathogens such as the hepatitis B virus, hepatitis C virus, and human immunodeficiency virus (HIV), and can also be costly to the health care industry. C.S.H.B. 1646 requires the Texas Department of Health to establish an exposure control plan to minimize exposure of health care industry workers to bloodborne pathogens. The plan includes the establishment, by rule, of minimum standards, needleless systems recommendations, and injury logs. RULEMAKING AUTHORITY It is the opinion of the Office of House Bill Analysis that rulemaking authority is expressly delegated to the Texas Board of Health in SECTION 1 (Sections 81.304, 81.305, and 81.306, Health and Safety Code) of this bill. SECTION BY SECTION ANALYSIS SECTION 1. Amends Chapter 81, Health and Safety Code, by adding Subchapter H, as follows: SUBCHAPTER H. BLOODBORNE PATHOGEN EXPOSURE CONTROL PLAN Sec. 81.301. DEFINITIONS. Defines "bloodborne pathogens" as pathogenic microorganisms that are present in human blood and that can cause diseases in humans, including the hepatitis B virus, hepatitis C virus, and human immunodeficiency virus (HIV). Defines "engineered sharps injury protection" as a physical attribute built into a needle device that reduces the risk of an exposure incident. Defines "governmental unit." Defines "needleless system." Defines "sharp" as an object used or encountered in a health care setting that can be reasonably anticipated to penetrate the body and result in an exposure incident. Defines "sharps injury." Sec. 81.302. APPLICABILITY OF SUBCHAPTER. Provides that this subchapter applies only to a governmental unit that employs those who provide services in a public or private facility providing health care-related services, or otherwise have a risk of exposure to blood or other material potentially containing bloodborne pathogens in connection with exposure to sharps. Sec. 81.303. EXPOSURE CONTROL PLAN. Requires the Texas Department of Health (TDH) to establish an exposure control plan (plan) designed to minimize exposure of employees described by Section 81.302 to bloodborne pathogens. Sets forth considerations that TDH must consider in developing the plan. Sec. 81.304. MINIMUM STANDARDS. Requires the Texas Board of Health (board), by rule, to adopt minimum standards to implement the plan and the other provisions of this subchapter. Requires that the rules be analogous to standards adopted by the federal Occupational Safety and Health Administration. Requires each governmental unit to comply with the minimum. Sec. 81.305. NEEDLELESS SYSTEMS. (a) Requires the board, by rule, to recommend that governmental units implement needleless systems and sharps with engineered sharps injury protection for employees. (b) Provides the recommendation does not apply to the use of a needleless system or sharps with engineered sharps injury protection in circumstances in which an evaluation committee has established that use of needleless systems and sharps with engineered sharps protection will jeopardize patient or employee safety with regard to a specific medical procedure or will be unduly burdensome. Requires that a report of the committee's decision be submitted to TDH annually. (c) Provides that at least half of the members of an evaluation committee established by a governmental unit to implement Subsection (b) must be employees who are health care workers who have contact with patients or provide services on regular basis. (d) Prohibits the rules adopted under Subsection (a) from prohibiting the use of a prefilled syringe that is approved by the federal Food and Drug Administration. Provides that this subsection expires May 1, 2003. Sec. 81.306. SHARPS INJURY LOG. (a) Requires the board, by rule, to require that information concerning exposure incidents be recorded in a written or electronic sharps injury log to be maintained by a governmental unit. Provides that this information must be reported to TDH and provides what the information must include. (b) Requires that information regarding which recommendations under Section 81.305(a) were adopted by the governmental entity be included in the log. (c) Provides that all information and material obtained or compiled by TDH in connection with a report under this section are confidential and not subject to disclosure, discovery, subpoena, or other means of legal compulsion for their release by TDH. Requires TDH to make available, in aggregate form, the information described in Section 81.305(b) and this section, provided that the name and other information identifying the facility is deleted, and the information is provided according to public health regions established by TDH. Sec. 81.307. DEVICE REGISTRATION. (a) Requires TDH, in accordance with rules adopted by the board, to implement a registration program for existing needleless systems and sharps with engineered sharps injury protection. (b) Requires TDH to compile and maintain a list of existing needleless systems and sharps with engineered sharps injury protection that are available in the commercial marketplace and registered with TDH to assist governmental units comply with this subchapter. (c) Requires TDH to charge a fee to register a device in an amount established by the board. Authorizes the appropriation of the fees collected under this section only to TDH to implement this subchapter. SECTION 2. (a) Effective date: September 1, 1999, except as provided by Subsection (e). (b) Requires the board to adopt the plan and the rules required by Subchapter H, Chapter 81, Health and Safety Code, not later than September 1, 2000. (c) Requires a governmental unit, except as provided by Subsection (d), to comply with Subchapter H, Chapter 81, Health and Safety Code, not later than January 1, 2001. (d) Authorizes TDH, in accordance with rules adopted by the board, to waive the application of Subchapter H, Chapter 81, Health and Safety Code, to a rural county if TDH finds that the application of the subchapter to the county would be unduly burdensome. Provides that a waiver granted under this subsection expires December 31, 2001. Defines rural county for the purposes of this subsection. (e) Provides that this Act has no effect if no specific appropriation is provided in H.B. 1, the General Appropriations Act. SECTION 3. Requires the board, in adopting the initial rules establishing the duties of an evaluation committee under Section 81.305(c), to consider the duties of similar committees in existence on the effective date of this Act. SECTION 4. Emergency clause. COMPARISON OF ORIGINAL TO SUBSTITUTE The substitute differs from the original in SECTION 1, as follows: Modifies proposed Section 81.304 (Minimum Standards), Health and Safety Code, by removing language that would have required Texas Board of Health (board) rules relating to minimum standards to implement the plan to minimize the exposure of employees to bloodborne pathogens to be at least as stringent as standards adopted by the federal Occupational Safety and Health Administration (OSHA). Instead, the substitute requires the standards to be analogous to OSHA standards. Further modifies this section by making a conforming change. Modifies proposed Section 81.305 (Needleless Systems) by requiring the board, by rule, to recommend, rather than require, governmental units to implement needleless systems and sharps injury protection for employees. Modifies this section by providing that a recommendation does not apply in circumstances and in a year, rather than circumstances, in which an evaluation committee has established, rather than established, that the use of needleless systems and sharps with engineered sharps injury protection will be unduly burdensome. Modifies this section by requiring that a report of the committee's decision be submitted to the Texas Department of Health (TDH) annually. Modifies this section by creating a Subsection (c) from language in proposed Subsection (b), and by specifying that the members of the evaluation committee that are employees must provide services on a regular basis. Modifies this section by adding Subsection (d). For a complete analysis of this new subsection please see the Section-by-Section Analysis portion of this document. Further modifies this section by making conforming changes. Modifies proposed Section 81.306 (Sharps Injury Log) by providing that information recorded in the sharps injury log must be reported to TDH. Modifies this section to delete the inclusion of employee's opinions in the log. Further modifies this section by adding Subsections (b) and (c). For a complete analysis of these new subsections please see the Section-by-Section Analysis portion of this document. Modifies proposed Section 81.307 (Compilation of Resources) by changing the title to read "Device Registration." Modifies this section by providing a new Subsection (a). Modifies this section by redesignating proposed Subsection (a) as a new Subsection (b), and by requiring TDH to compile and maintain a list of existing needleless systems and sharps with engineered sharps injury protection that are available in the commercial marketplace and registered with TDH to assist governmental units comply with this subchapter, rather than will be available to assist governmental units to comply with this subchapter. Modifies this section by removing proposed Subsection (b) that would have authorized certain sources to be used in developing the list. Further modifies this section by adding Subsection (c). For a complete analysis of the new subsections please see the Section-by-Section Analysis portion of this document. The substitute differs from the original in SECTION 2, as follows: Modifies proposed Subsection (a) by providing that new Subsection (e) is an exception to the effective date of this Act. Modifies proposed Subsection (b) by requiring the board to adopt the plan and the rules required by Subchapter H, Chapter 81, Health and Safety Code, not later than September, rather than February, 1, 2000. Adds Subsections (c), (d), and (e). For a complete analysis of these new subsections please see the Section-by-Section Analysis portion of this document. The substitute adds a new SECTION 3. For a complete analysis of this new section please see the Section-by-Section Analysis portion of this document. The substitute redesignates SECTION 3 of the original (emergency clause) as SECTION 4.