Washington, D.C. - Healthcare workers will gain more protection from blood-borne illnesses under new legislation passed unanimously by the Senate today.
The Senate passed the Needlestick Safety and Prevention Act, which would encourage hospitals and other healthcare facilities to use the best technologies available to help prevent healthcare professionals who work with needles from being exposed to blood-borne pathogens such as HIV and Hepatitis B and C.
The House passed the bill Oct. 3 and President Clinton has been supportive of the legislation and is expected to sign the measure into law.
Senate Employment, Safety and Training Subcommittee Chairman, Mike Enzi, R-Wyo., Sens. Ted Kennedy, D-Mass., Health Education Labor and Pensions Committee Chair James Jeffords, R-Vt. and Harry Reid, D-Nev., sponsored S. 3067.
"This bill has languished in Congress for a number of years, but through cooperation between and within parties we were able to come together to pass this legislation that encourages health care providers to be pro-active in the area of worker safety," said Enzi. "One split-second needle stick can result in a lifetime of heartache. This bill helps people move forward to prevent these tragedies."
The Centers for Disease Control estimated that as many as 800,000 healthcare workers accidentally are stuck with needles each year. The Needlestick Safety and Prevention Act would provide instruction to the Occupational Safety and Health Administration (OSHA) to amend its blood-borne pathogen standard to make certain employers evaluate their workplaces and use medical devices such as needleless systems and retractable needles where appropriate. The bill would change OSHA's standard from an agency directive to a law, giving it more weight. It would be enforced in the same manner as any other safety law enforced by OSHA.
Needlestick Safety and Prevention Act
Statement of Michael B. Enzi
October 26, 2000
Mr. President, I am extremely pleased to speak today at the passage of H.R. 5178, The Needlestick Safety and Prevention Act. By passing this bill, we ensure a safer workplace for the men and women who perform the valuable service of taking care of the people of this country. The bi-partisan nature of this bill is a testament to the importance of the problem we have addressed and the fairness and reasonableness of the solution. I want to commend the hard work of my colleagues Senators Jeffords, Kennedy and Reid and their staff in crafting this solution. I also want to recognize the efforts of my House colleagues, Representatives Ballenger and Owens and their staff. This truly was a bipartisan and bicameral effort and it is a wonderful example of what we can accomplish when we all work together.
We came together over this bill to address the convergence of increased concern over accidental needlestick injuries in health care settings ("needlesticks" is a term used broadly, as health care workers can suffer injuries from a broad array of "sharps" used in health care settings, from needles to IV catheters to lancets) with the technological advancements made over the past decade in the many types of engineering controls that can be used in the workplace to help protect health care workers against sharps injuries. We responded to these two factors by drafting a bill that highlights the importance of using newer safer technologies but also allows healthcare employers the flexibility to choose the technology that provides the best protection under the circumstances. I have further elaborated on my views on the substance of this legislation in the Joint Statement of Legislative Intent, submitted with the legislation.
The passage of this bill today is extremely significant on several levels. First and foremost, this bill will save lives because fewer health care workers will contract deadly diseases from accidental needlesticks. Almost equally as important, it will reduce the number of health care workers who suffer horrible uncertainty after a contaminated needlestick. The healthcare workers on the front lines in hospitals, clinics and other locations are absolutely critical to this country and I hope this bill will provide some peace of mind to these individuals.
Finally, I want to reiterate the significance of the bipartisan and bicameral nature of this legislation. I believe this bill brings employers and employees together to improve safety in the workplace and I hope to be able to work with my co-sponsors and my colleagues in the House on more such measures in the future.
Thank you Mr. President. I yield the floor.
Joint Statement of Legislative Intent on Substitute to S. 3067
The legislation derives from the convergence of two critical circumstances which have a profound effect on the safety of health care workers in the United States. The first circumstance is the increased concern over accidental needlestick injuries in health care settings. "Needlesticks" is a term used broadly, as health care workers can suffer injuries from a broad array of "sharps" used in health care settings, from needles to IV catheters to lancets. The second circumstance is the technological advancements made over the past decade in the many types of engineering controls that can be used in the workplace to help protect health care workers against sharps injuries. Because of the convergence of these two circumstances - and because of increasing concern over the public health issue related to the spread of hepatitis C, it is appropriate to take this action at this time.
Section 1 of the Bill provides the title the "Needlestick Safety and Prevention Act." Section 2 of the bill provides the Congressional findings.
Section 3 of the bill directly modifies the Bloodborne Pathogens Standard, 29 C.F.R. § 1910.1030, one of the health and safety standards promulgated by the Department of Labor's Occupational Safety and Health Administration (OSHA). The legislation builds on the most recent action taken by OSHA related to the Bloodborne Pathogens Standard - the revision in November 1999 to OSHA's Compliance Directive on Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens ("Compliance Directive").
In modifying the Bloodborne Pathogens Standard ("BBP standard") this bill makes narrowly-tailored changes to the BBP standard. It makes clear in the BBP standard the direction already provided by OSHA in its Compliance Directive: namely, that employers who have employees with occupational exposure to bloodborne pathogens must consider and, where appropriate, use effective engineering controls, including safer medical devices, in order to reduce the risk of injury from needlesticks and from other sharp medical instruments ("sharps"). This bill is not intended to change the existing application of OSHA's BBP standard to all employees who are reasonably anticipated to have occupational exposures to blood or other potentially infectious materials, including health care workers, laboratory personnel, housekeepers and waste disposal employees, among others.
The bill accomplishes this in several ways. First, the BBP standard is modified so that the definition of "engineering controls" at 29 C.F.R. § 1910.1030(b) includes as additional examples of such controls, "safer medical devices, such as sharps with engineered sharps injury protections and needleless systems." Following that step, the BBP standard is amended so that both "sharps with engineered sharps injury protections" ("SESIPS") and "needleless systems" are added to the definitions of the standard.
The citing of these examples should not be considered an endorsement or preference of a specific product or assurance of a specific product's effectiveness. Rather, it is the intent of this legislation to reflect innovation and evolving technology in the marketplace, in particular development in safer medical devices such as SESIPS and needleless systems. This legislation anticipates that hospitals and other employers, in crafting their Exposure Control Plans, will adopt procedures and use devices that have been proven to reduce the risk of needlestick injuries. Employers use their Exposure Control Plans to evaluate appropriate practices and devices for reducing occupational exposure. To focus attention on the need for employers to look at changes in technology, this legislation further modifies the BBP standard by adding to the existing requirements concerning Exposure Control Plans at 29 C.F. R. § 1910.1030(c)(1)(iv). Through these modifications, employers will be required to demonstrate in the review and update of their
Exposure Control Plans that their Exposure Control Plans reflect changes in technology and also that they document annually the consideration and implementation of appropriate, commercially available and effective safer medical devices.
It is through an employer's Exposure Control Plan that engineering controls, including safer medical devices, are considered and deployed in the workplace. It is not the intent of this legislation to disturb OSHA's existing determination that to the extent that specific types of devices, such as catheter securement devices or sharps destruction devices can reduce the risk of needlestick injuries, such devices could be appropriate components of an employer's comprehensive exposure control plan. OSHA expressed its understanding of and agreement with this intent in a letter to Senator Jim Bunning, dated October 13, 2000. The letter is submitted as an attachment to this joint statement.
It is also not the intent of this legislation to disturb the underlying flexible, performance-oriented nature of the Bloodborne Pathogens Standard. For example, this legislation's reference to the consideration and implementation of safer medical devices is hinged upon the "appropriateness" and the "commercial availability" of such devices. Finally, while this may be stating the obvious, it is not the intent of this legislation, nor for that matter of the current Bloodborne Pathogens Standard, for employers to implement use of any engineering control, including a safer medical device, in any situation where it may jeopardize a patient's safety, an employee's safety or where it may be medically contraindicated. Moreover, all of the affirmative defenses available to an employer under the current BBP standard remain intact with this legislation. It is not the intent of this legislation to alter OSHA's current enforcement of the BBP standard in these circumstances. Attached to this Joint Statement is a letter from Representatives Ballenger and Owens, the co-sponsors of H.R. 5178, expressing their full support for the views expressed in this statement.
The drafters are aware that some of the newer most effective technologies are more expensive than others and may create higher costs for health care facilities. Because some entities largely dependent on Medicare and/or Medicaid, such as long term care providers, will be required to comply with this legislation, we encourage the Health Care Financing Administration to examine the costs of the new technologies and consider these costs when determining Medicare reimbursement rates. Similarly, we hope that the states will examine these costs and determine whether the costs should be reflected in the Medicaid reimbursement rates.
Section 3 of the bill amends the BBP standard in two additional ways. First, it adds a requirement that in addition to the recordkeeping requirements already found in the BBP standard, employers must record percutaneous injuries from contaminated sharps in a sharps injury log. The legislation sets out the minimum information to be included in such a log, namely the type of device used, an explanation of the incident, and where the injury occurred. Employers are free to include other information should they find it helpful. However, this legislation does require that in recording the information and maintaining the log, the confidentiality of the injured employee is to be protected.
The requirement for a sharps injury log is consistent with current OSHA recordkeeping in two specific ways. First, the sharps injury log requirement does not apply to any employer who is not already required to maintain a log of occupational injuries and illnesses under 29 C.F.R. § 1904. Second, employers are not required to maintain the sharps injury logs for a period of time beyond that currently required for the OSHA 200 logs.
The sharps injury log is to be used as a tool for employers so that they may determine their high risk areas for sharps injuries and use it as a means to evaluate particular devices that may or may not be effective in reducing sharps injuries. At a House Subcommittee on Workforce Protections hearing in June, representatives of the American Hospital Association testified that many health care settings, particularly hospitals, already have in place some type of "surveillance system" for tracking needlestick and other sharps injuries. The AHA witness noted that hospitals have found this to be an effective tool to provide necessary information to help reduce such injuries.
The second way in which Section 3 amends the BBP standard is by specifying that employers must solicit input from non-managerial employees responsible for direct patient care who are potentially exposed to injuries from contaminated sharps in the identification, evaluation and selection of effective engineering and work practice controls. Employers are also to document this in the Exposure Control Plans. The intent of this section is simple - to involve in the selection of engineering controls those workers who are potentially exposed to needlestick injuries.
Section 4 of the legislation explains that the modifications as delineated by Section 3 of the bill can be changed by a future rulemaking by OSHA on the Bloodborne Pathogens Standard.
Finally, Section 5 of the bill directs that the modifications to the BBP standard are to be made without regard to the standard OSHA rulemaking requirements or the requirements of the Administrative Procedures Act. Admittedly, preemption of the OSHA rulemaking procedures is not an action to be undertaken lightly. Indeed, the requirements of this bill are driven by the unique circumstances surrounding this narrow and particular public health issue. Although there is no such thing as binding precedent for Congress, it is not the intent of this legislation, through the process used here, to diminish the carefully constructed requirements and procedures for OSHA rulemaking.
The legislation does prescribe, however, that the changes to the BBP standard are to be made by the Secretary of Labor and published in the Federal Register within six months of enactment and that the changes will take effect 90 days after such publication.
TEXT OF BILL
Needlestick Safety and Prevention Act. (Engrossed in House ) 106th CONGRESS
2d Session
H. R. 5178
AN ACT
To require changes in the bloodborne pathogens standard in effect under the Occupational Safety and Health Act of 1970.
HR 5178 EH
106th CONGRESS
2d Session
H. R. 5178
AN ACT
To require changes in the bloodborne pathogens standard in effect under the Occupational Safety and Health Act of 1970.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the `Needlestick Safety and Prevention Act.'
SEC. 2. FINDINGS.
The Congress finds the following:
(1) Numerous workers who are occupationally exposed to bloodborne pathogens have contracted fatal and other serious viruses and diseases, including the human immunodeficiency virus (HIV), hepatitis B, and hepatitis C from exposure to blood and other potentially infectious materials in their workplace.
(2) In 1991 the Occupational Safety and Health Administration issued a standard regulating occupational exposure to bloodborne pathogens, including the human immunodeficiency virus, (HIV), the hepatitis B virus(HBV), and the hepatitis C virus (HCV).
(3) Compliance with the bloodborne pathogens standard has significantly reduced the risk that workers will contract a bloodborne disease in the course of their work.
(4) Nevertheless, occupational exposure to bloodborne pathogens from accidental sharps injuries in health care settings continues to be a serious problem. In March 2000, the Centers for Disease Control and Prevention estimated that more than 380,000 percutaneous injuries from contaminated sharps occur annually among healthcare workers in United States hospital settings. Estimates for all health care settings are that 600,000 to 800,000 needlestick and other percutaneous injuries occur among health careworkers annually. Such injuries can involve needles or other sharps contaminated with bloodborne pathogens, such as HIV, HBV, or HCV.
(5) Since publication of the bloodborne pathogens standard in 1991 there has been a substantial increase in the number and assortment of effective engineering controls available to employers. There is now a large body of research and data concerning the effectiveness of newer engineering controls, including safer medical devices.
(6) 396 interested parties responded to a Request for Information (in this section referred to as the `RFI')conducted by the Occupational Safety and Health Administration in 1998 on engineering and work practice controls used to eliminate or minimize the risk of occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps. Comments were provided by health care facilities, groups representing healthcare workers, researchers, educational institutions, professional and industry associations, and manufacturers of medical devices.
(7) Numerous studies have demonstrated that the use of safer medical devices, such as needleless systems and sharps with engineered sharps injury protections, when they are part of an overall bloodborne pathogens risk-reduction program, can be extremely effective in reducing accidental sharps injuries.
(8) In March 2000, the Centers for Disease Control and Prevention estimated that, depending on the type of device used and the procedure involved, 62 to 88 percent of sharps injuries can potentially be prevented by the use of safer medical devices.
(9) The OSHA 200 Log, as it is currently maintained, does not sufficiently reflect injuries that may involve exposure to bloodborne pathogens in healthcare facilities. More than 98 percent of healthcare facilities responding to the RFI have adopted surveillance systems in addition to the OSHA200 Log. Information gathered through these surveillance systems is commonly used for hazard identification and evaluation of program and device effectiveness.
(10) Training and education in the use of safer medical devices and safer work practices are significant elements in the prevention of percutaneous exposure incidents. Staff involvement in the device selection and evaluation process is also an important element to achieving a reduction in sharps injuries, particularly as new safer devices are introduced into the work setting.
(11) Modification of the bloodborne pathogens standard is appropriate to set forth in greater detail its requirement that employers identify, evaluate, and make use of effective safer medical devices.
SEC. 3. BLOODBORNE PATHOGENS STANDARD.
The bloodborne pathogens standard published at 29 CAFE 1910.1030 shall be revised as follows:
(1) The definition of `Engineering Controls (at 29 CAFE 1910.1030(b))shall include as additional examples of controls the following: `safer medical devices, such as sharps with engineered sharps injury protections and needleless systems'.
(2) The term `Sharps with Engineered Sharps Injury Protections' shall be added to the definitions (at 29 CFR1910.1030(b)) and defined as `a nonneedle sharp or a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, with a built-in safety feature or mechanismthat effectivelyy reduces the risk of an exposure incident'.
(3) The term `Needleless Systems' shall be added to the definitions(at 29 CFR 1910.1030(b)) and defined asa devicece that does not use needles for (A) the collection of bodily fluids or withdrawal of body fluids after initialvenous or arterial access is established, (B) the administration of medication or fluids, or (C) any otprocedure involvingving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps'.
(4) In addition to the existing requirements concerning exposure control plans (29 CFR 1910.1030(c)(1)(iv)), the review and update of such plans shall be required to also--
(A) `reflect changes in technology that elimireduce exposureexposure to bloodborne pathogens'; and
(B) `document annually consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure'.
(5) The following additional recordkeeping requirement shall be added to the bloodborne pathogens standard at29 CFR 1910.1030(h): `The employer shall establish and maintain a sharps injury log for the recording of percutaneous injuries from contaminated sharps. The information in the sharps injury log shall be recorded and maintained in such manner as to protect the confidentiality of the injured employee. The sharps injury log shall contain, at a minimum--
`(A) the type and brand of device involved in the incident,
`(B) the department or work area where the exposure incident occurred, and
`(C) an explanation of how the incident occurred.'.
The requirement for such sharps injury log shall not apply to any employer who is not required to maintain a log of occupational injuries and illnesses under 29 CFR 1904 and the sharps injury log shall be maintained for the period required by 29 CFR 1904.6.
(6) The following new section shall be added to the bloodborne pathogens standard: `An employer, who is required to establish an Exposure Control Plan shall solicit input from non-managerial employees responsible for direct patient care who are potentially exposed to injuries from contaminated sharps in the identification,e valuation, and selection of effective engineering and work practice controls and shall document the solicitation in the Exposure Control Plan.'.
SEC. 4. EFFECT OF MODIFICATIONS.
The modifications under section 3 shall be in force until superseded in whole or in part by regulations promulgated by the Secretary of Labor under section 6(b) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655(b)) and shall be enforced in the same manner and to the same extent as any rule or regulation promulgated under section 6(b).
SEC. 5. PROCEDURE AND EFFECTIVE DATE.
(a) PROCEDURE- The modifications of the bloodborne pathogens standard prescribed by section 3 shall take effectwithout regard to the procedural requirements applicable to regulations promulgated under section 6(b) of theOccupational Safety and Health Act of 1970 (29 U.S.C. 655(b)) or the procedural requirements of chapter 5 of title 5, United States Code.
(b) EFFECTIVE DATE- The modifications to the bloodborne pathogens standard required by section 3 shall--
(1) within 6 months of the date of the enactment of this Act, be made and published in the Federal Register by the Secretary of Labor acting through the Occupational Safety and Health Administration; and
(2) at the end of 90 days after such publication, take effect.
