OSHA - Compliance with the bloodborne pathogens standard
- OSHA regulatory requirements
- OSHA Implementation Strategies
The Occupational Safety and Health Administration (OSHA) is the primary regulatory agency with authority over needlestick prevention. This website provides basic program information needed for compliance with OSHA's bloodborne pathogen standard as well as implementation strategies.
OSHA's primary website on bloodborne pathogens and needlestick prevention provides a full array of resources to assist in complying with these federal standards, including descriptions of the requirements of the standard in simple language. Additional resources and guidance documents can be found in our section on resources and tools.
The Occupational Safety and Health Administration (OSHA) published the original Bloodborne Pathogens Standard (BBP) in 1991. This standard requires employers to take action to reduce employees' risk of exposure to bloodborne pathogens. The standard includes a description of who is covered by the standard, definition of terms used in the document and sections to describe the requirements for employers. The standard requires employers to do the following:
- Establish a written "Exposure Control Plan" that is updated annually.
- Implement the use of universal (standard) precautions
- Ensure the use of engineering controls, including the use of commercially-available effective safer medical devices; for example, sharps disposal containers, self-sheathing needles, and needleless systems.
- Ensure the use of work practices to reduce exposure, such as appropriate practices for handling and disposing of laundry and cleaning contaminated surfaces.
- Provide personal protective equipment, such as gloves, gowns, eye protection and masks.
- Provide hepatitis B vaccination at no cost to employees within 10 days of assignment.
- Provide post-exposure evaluation according to CDC guidelines following any occupational exposure incident (such as a needlestick) at no cost to employees.
- Communicate information about bloodborne hazards to employees through training, signage and labels.
- Record injuries, including maintenance of medical records for injured workers.
At the time of this initial standard in 1991, there were few safer devices on the market to prevent needlesticks and other percutaneous injuries. So, the "engineering controls" mentioned in the original standard focused primarily on sharps disposal containers, self-sheathing needles and work practices controls, such as prohibiting needle clipping or recapping. Following publication of the standard, users stepped up the demand for more options for safer engineered medical devices and manufacturers responded with a flood of newly designed devices in wider ranges of sizes for more diverse applications.
Despite additional options becoming available for safer needlestick prevention devices, it was recognized that these devices were underutilized and there was a need to update OSHA's BBP standard. In response, on November 6, 2000 President Clinton signed into law the Needlestick Safety and Prevention Act, which directed OSHA to revise the BBP standard. One of the main revisions was to include a new emphasis on the requirement to use safety-engineered needlestick prevention devices to reflect the current market availability and feasibility of their use.
Premier supported the passage of this law, provided information so Congressional committees members could gain a better understanding of the issues involved, and was present at the signing of the bill.
OSHA issues a revised bloodborne pathogen standard
On January 18, 2001, OSHA published a revised bloodborne pathogen standard to reflect the changes Congress specified in the Needlestick Safety and Prevention Act. In addition to the original BBP standard, the revised standard requires employers to:
- Use an expanded definition of engineering controls to include devices with engineered sharps injury protection and needleless systems.
- Ensure that exposure control plans reflect changes in technology which reduce exposure to bloodborne pathogens and annually document the consideration of devices to minimize occupational exposure.
- Document input from non-managerial (i.e. frontline) workers for identification, evaluation, and selection of devices and other engineering controls; and
- Maintain a Sharps Injury Log of percutaneous injuries with information on the type and brand of device involved, the department where the incident occurred, and an explanation of how the injury occurred. (See section below on record keeping).
OSHA requires employers with more than 10 employees to maintain Occupational Injury and Illness Recording and Reporting forms. Additionally, employers must keep certain records for employees exposed to bloodborne pathogens, including specific medical records, injury and illness records and a sharps injury log.
[Note: Some employers, such as small medical or dental practices, are exempt from OSHA recordkeeping requirements. Check with the local OSHA office or call OSHA at 1-800-321-OSHA to determine eligibility for this exemption.]
- Medical records
Confidential employee medical records for workers with exposure to bloodborne pathogens must be maintained for the duration of employment plus 30 years. For more details, see OSHA's BBP standard , particularly paragraph 1910.1030(f) "Hepatitis B Vaccination and Post-exposure Evaluation and Follow-up" and paragraph 1910.1030(h) "Recordkeeping".
- Injury and illness records
If work-related needlestick injuries and cuts from sharp objects that are contaminated with another person's blood or other potentially infectious material occur, employers must record these events. Specific instructions are available on the OSHA website on recordkeeping. Forms for this recording are available from your local OSHA office (1-800-321-OSHA) or online .
Sharps injury log
The sharps injury log records all needlestick injuries. OSHA intends the sharps injury log to be used as a tool for identifying high-risk areas and providing information that may be helpful in evaluating safer devices. It should be reviewed regularly during the review and update of the Exposure Control Plan. For details about the sharps injury log, see the OSHA BBP standard.
The confidential sharps injury log must include, at a minimum, the following information:
- Type and brand of the device causing the injury (if known)
- Department or work areas where incident occurred
- Description of the events surrounding the injury -, for example:
- Procedure being performed
- Body part affected
- Objects or substances involved in exposure
The sharps injury log may be kept in any format, such as electronic or paper. Employers may also use existing mechanisms for data collection, such as incident reports or the OSHA forms 300, 300A, 301 to meet the requirements of the sharps injury log. If these alternative systems are used, they must provide the necessary information , and be maintained in a way that segregates sharps injuries from other types of work-related injuries and illnesses, or otherwise allows sharps injuries to be easily separated.
Some states have additional requirements above and beyond the federal law, such as requiring healthcare facilities to report needlestick injury data to a state agency. States laws with stricter requirements apply over the federal requirements.
On the other hand, if a state needle safety law is less stringent than the federal law, the federal law's requirements take precedent and must be followed. "State Plan" states with their own OSHA plans should also be consulted for additional requirements for OSHA Bloodborne Pathogen Requirements. Locate your local OSHA office on the OSHA website.
On November 27, 2001, OSHA revised its Enforcement Procedures for Occupational Exposure to Bloodborne Pathogens and incorporated the new sharps injury prevention requirements. This document provides uniform procedures for enforcement of the standard.
In summary, all employers are required to provide sharps injury prevention devices and OSHA has been enforcing this requirement since November 1999.
The BBP standard, issued in 1991 and updated in 2001 with an increased emphasis on the use of sharps safety devices, changed the way healthcare workers and their employers viewed needlestick injuries. Manufacturers responded with additional new devices to address the clinical needs of users. Subsequent revisions to the standard brought even greater changes on needlestick injury rates. According to research data from the University of Virginia Healthcare Worker Safety Center, needlestick injuries in the hospitals studied dropped 38 percent between 2001 and 2005.
In another long-term study published by the Massachusetts Department of Public Health, the annual sharps injury rate in acute care hospitals decreased by 22 percent between 2002-2007.
The OSHA requirement for Hepatitis B virus (HBV) vaccination of workers with potential exposure to blood also had dramatic effects on the incidence of HBV. A CDC study reported that from 1983 to 1995 there was a dramatic (95 percent) decline in the incidence of observed HBV among healthcare workers, a 1.5 fold greater reduction than among the general population. Although needlestick injuries continue to be a risk in healthcare, it is clear from these and other studies that well-crafted legislation bolstered by effective enforcement can result in a safer work environment and a protected workforce.Back to top
Healthcare facilities of all types as discussed are required to use sharps safety devices. Hospitals and other care delivery sites are currently being cited for lack of safety devices. Frontline workers need to be involved in the evaluation and selection process, and a detailed sharps injury log must be maintained. OSHA may be flexible in issuing citations if there is evidence of safety devices already being used in some clinical applications, and a written plan with a realistic timeline that outlines the process for completion of the selection, evaluation and adoption of safety devices in all areas where sharps are used. The bloodborne exposure control plan should be revised to reflect the process that will be used to accomplish this. Basic and supplemental materials to revise or your current program may be found at key agencies and resources and tools for guidance.
OSHA wants to ensure that management does not select devices without input from non-managerial workers -- those responsible for direct patient care or potentially exposed to injuries from contaminated sharps. Input may be obtained from these frontline workers in any manner appropriate to the circumstances of the workplace. This input will be needed for identifying devices to consider, performing some type of assessment or evaluation of the devices, and selecting devices for implementation. Such input may be formal or informal; OSHA has explained that it does not prescribe any specific procedures for obtaining worker input. Frontline worker involvement in the evaluation and selection of safety devices can help promote acceptance of these devices when they are implemented. Although it may not be feasible to involve every worker who will use a device in the selection and evaluation of every device, a representative sample of workers should always be included. See resources and tools for suggested tools.
Device selection can be challenging but the device evaluation process can be formal or informal. A formal evaluation might include a pilot study on a particular unit, with written evaluation forms completed by each worker. An informal evaluation might include bringing sample devices to the department or setting for a representative sample of frontline workers to evaluate them and provide informal feedback.
Nor are there exact formulas for the number of workers needed to evaluate a device, the number of devices to be evaluated, or the length of time an evaluation should be conducted. What is important: having a mechanism in place to solicit input from workers on an ongoing basis regarding their needs and preferences for safety devices. This input will be combined with data from exposure incidents and the sharps injury log and employee feedback, and will guide future decisions on selection and implementation of safety devices. In some cases, it may be necessary to replace the device that was originally selected with a more suitable device. This determination can only be made by the individual facility or work site based on its own data and experiences.
The final selection will be based on the preferences of the workers as they perform their duties and procedures using the safety devices. Preferences may vary for a single device, depending on the department and workers evaluating the device. The preferences are influenced by a number of factors -- for example, prior experience with safety devices, type of clinical procedures being performed, noise or lighting in the clinical setting, or even the size of the workers' hands.
Other factors that might be considered in the final selection include:
- Functional reliability of safety feature
- Suitability for a range of uses across patient populations and procedures
- Intuitiveness/ease of use
- Active versus passive
- Single- or two-handed use
- Positioning of hands behind sharp
- Extent of change in technique required
- Indication of activation
- Undefeatable safety feature
- Permanent coverage of the sharp
- Lack of interference with procedure
- Patient safety
- Right- or left-handed use
- Breadth of product line
- Studies in the literature on efficacy
The information from the sharps injury log can be used to guide the selection and evaluation of safety devices. The data from the sharps log is only one source of information for assessing the effectiveness of engineering controls. Employee interviews and informal feedback are other examples of input that should be considered. Trends in the data may be helpful in making a general assessment of the effectiveness of the sharps injury prevention program. However, calculation of rates of injury by device or brand is often inaccurate and misleading for a number of reasons: 1) Injuries are significantly underreported (up to 70 percent in some studies); and 2) Individual facilities usually do not have enough data to calculate rates that are statistically significant.
A series of forms and tools from various resources are available to assist in assessing current bloodborne pathogen programs, selecting and/or evaluating safer sharps devices and evaluating safe work practices.
- OSHA bloodborne pathogen program assessment tool
A comprehensive checklist for assessing compliance with OSHA's bloodborne pathogen rule, including considerations for a complete sharps injury prevention program.
- Evaluation form for phlebotomy safety devices (Updated August 2011)
Sample evaluation tool to assist facilities doing product evaluations.
- Evaluation form for
safety needle/syringe device (Updated August 2011)
Sample evaluation tool to assist facilities doing product evaluations.
- Exposure control plan update checklist
Short checklist focusing on the most recent requirements for safer sharps devices.
- Sharps safety device evaluation & selection checklist
Short checklist summarizing steps in the revised rule for Identification, Evaluation and Selection of sharps injury prevention devices.
- Sample occupational sharps injury log addendum
Sample alternative form that may be used for recording device-related injuries as required.
- Checklist for exposure prevention Selection from Advances in Exposure Prevention.
- Premier sharps injury prevention devices. This list is continuously updated and remains current.
- Premier's educational brochure on needlestick prevention in all healthcare settings
- Zip file of all documents
OSHA forms for recording needlestick injuries can be downloaded as noted earlier. Additional examples of exposure/injury data collection forms that capture the information OSHA requires in the sharps injury prevention log are found below:
- Epinet sharp object injuries and blood and body fluid exposure form (Microsoft Word file). This form can also be downloaded from the University of Virginia International Healthcare Worker Safety Center under resources: http://www.med.virginia.edu/epinet
- Massachusetts Department of Public Health bloodborne pathogen exposure incident recording form This form includes all elements required for collection of sharps data in Massachusetts, as well as for OSHA. More information from MDPH: http://www.state.ma.us./dph/bhsre/ohsp/ohsp.htm.
- NHSN CDC's National Healthcare Safety Network collects data on a variety of occupational risks to healthcare workers. This program was formerly known as the National Surveillance System for Hospital Healthcare Workers (NaSH).
Quick Takes is a free electronic bi-monthly newsletter produced by OSHA to inform the public about recent OSHA activities. To subscribe go to the OSHA Home Page or go to: http://www.osha.gov/as/opa/quicktakes/index.html
OSHA contact - OSHA can also be reached through their "hot line" at 1-800-321-OSHA (6742) or by email See: http://www.osha.gov/ecor_form.html
OSHA Training tools
Training materials to give you a "Quick Start" on OSHA general compliance in healthcare settings.
- OSHA's "Hospital e-tool" is a web-based training tool for safety and health hazard assessments in hospitals. For a virtual hospital using graphics and other visual assists for learning go to: http://www.osha.gov/SLTC/etools/hospital/index.html
- Other training and education resources including formal courses as well as self-training on multiple topics using slide presentations. For training courses go to: http://www.osha.gov/dte/index.html