OSHA safety and health administration program
OSHA Regulatory Requirements
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 as well as implementation strategies.
OSHA’s primary website provides a full array of resources to assist in complying with these federal standards: Bloodborne Pathogens and Needlestick Prevention Additional resources and guidance documents can be found on Resources and tools.
Bloodborne pathogens standard
On November 6, 2000 President Clinton signed into law the
bloodborne pathogens standard (BBP). This Federal law requires the use of universal precautions to any setting where occupational exposure to blood or other potentially infectious materials occurs.
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.
Premier receives letter of thanks & appreciation for its help and support to enact the "Needlestick Safety and Prevention Act" from the Chairman of the Subcommittee on Workforce Protections, Committee of Education and the Workforce, U.S. House of Representatives.
In addition to a description of the scope of the standard and basic definition of terms, the standard includes sections that describe the requirements for employers to:
- Establish a written "Exposure Control Plan"
- Implement methods of compliance to reduced risk, including requirements for handwashing, use of personal protective equipment, housekeeping procedures, and management of regulated waste and laundry;
- Provide hepatitis B vaccination;;
- Provide post-exposure evaluation according to CDC Guidelines at no cost to employees;
- Communicate information about bloodborne hazards to employees through training and signage; and
- Record injuries, including maintenance of medical records for injured workers..
On January 18, 2001, OSHA published a bloodborne pathogen standard revision that clarified the definitions for safety devices and added a requirement for the Sharps Injury Log and for front-line worker input in device selections.
The revised BBP standard includes:
- An expanded definition of engineering control to include devices with engineered sharps injury protection and needleless systems;
- Exposure control plans that reflect changes in technology which reduce exposure to bloodborne pathogens and that document the consideration, at least annually, of devices to minimize occupational exposure;
- Documentation at least annual input from non-managerial (i.e. frontline) workers for identification, evaluation, and selection of devices and other controls; and
- 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.
OSHA recordkeeping
OSHA requires employers to record and maintain certain records related to bloodborne pathogens’ exposures. Note: Some employers are partially exempt from OSHA recordkeeping requirements and may also be exempt from the requirement of maintaining a sharps injury log, but are encouraged to do so. Check with the local OSHA office or call OSHA at 1-800-321-OSHA to determine eligibility for this exemption.
Injury and illness records
Employers must record all work-related needlestick injuries and cuts from sharp objects that are contaminated with another person's blood or other potentially infectious material. OSHA Recording and Reporting requirements for needlesticks are available on the OSHA website.
A small number of healthcare facilities may be exempt from OSHA recordkeeping, such as medical or dental offices. Check the OSHA website for applicability.
Sharps injury log and forms
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 devices. Thus, it should be reviewed regularly and during the review and update of the Exposure Control Plan.
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 -- including, 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. For further information, link to OSHA Recording Criteria for Needlestick and Sharps Injuries Section 1904.8
State laws
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.
Enforcement
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.
OSHA Implementation Strategies
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.
Involvement of frontline workers
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 evaluation
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
- Packaging
- 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
Selecting devices
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.
OSHA compliance tools
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
Additional device evaluation tools can be downloaded from the "Training for Development of Innovative Control Technology (TDICT)" project at http://www.tdict.org. See Resources and tools.
Sharps injury data collection - additional tools
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).
Communicating with OSHA
OSHA Updates
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