COMPLIANCE DIRECTIVE FOR
BLOODBORNE PATHOGENS STANDARD UPDATED November 2001

WASHINGTON, D.C. -- The Occupational Safety and Health Administration OSHA issued a new compliance directive for enforcing the bloodborne pathogens standard that became effective on April 18, 2001.

The compliance directive guides OSHA's safety and health inspection officers in enforcing the standard that covers occupational exposure to blood and other potentially infectious materials, and ensures consistent inspection procedures are followed.

The directive implements changes made to the standard that focus on the requirement that employers select safer needle devices as they become available and involve employees in identifying and choosing those devices. The standard now also requires most employers to maintain a log of injuries from contaminated sharps.

The directive highlights the major new requirements of the standard including: (1) evaluation and implementation of safer needle devices as part of the re-evaluation of appropriate engineering controls during an employer's annual exposure control plan; (2) documentation of the involvement of non-managerial, frontline employees in choosing safer devices; and (3) establishment and maintenance of a sharps injury log for recording injuries from contaminated sharps.

Compliance officers are reminded that no one safer medical device is appropriate for all situations; employers must consider and implement devices that are appropriate, commercially available and effective. The directive also includes detailed instructions on inspections of multi-employer worksites, including employment agencies, personnel services, home health services, physicians and health care professionals in independent practices, and independent contractors.

Also included in the directive are engineering control evaluation forms, a web site resource list, a model exposure control plan which incorporates the most current guidelines from the Centers for Disease Control regarding management of occupational exposure to the hepatitis B and C viruses, and the HIV virus.

April 18, 2001 Revision to OSHA's Bloodborne Pathogens Standard
Technical Background and Summary

Background
The Occupational Safety and Health Administration published the Occupational Exposure to Bloodborne Pathogens standard in 1991 because of a significant health risk associated with exposure to viruses and other microorganisms that cause bloodborne diseases. Of primary concern are the human immunodeficiency virus (HIV) and the hepatitis B and hepatitis C viruses.

The standard sets forth requirements for employers with workers exposed to blood or other potentially infectious materials. In order to reduce or eliminate the hazards of occupational exposure, an employer must implement an exposure control plan for the worksite with details on employee protection measures. The plan must also describe how an employer will use a combination of engineering and work practice controls, ensure the use of personal protective clothing and equipment, provide training , medical surveillance, hepatitis B vaccinations, and signs and labels, among other provisions. Engineering controls are the primary means of eliminating or minimizing employee exposure and include the use of safer medical devices, such as needleless devices, shielded needle devices, and plastic capillary tubes.

Nearly 10 years have passed since the bloodborne pathogens standard was published. Since then, many different medical devices have been developed to reduce the risk of Needle Sticks and other sharps injuries. These devices replace sharps with non-needle devices or incorporate safety features designed to reduce injury. Despite these advances in technology, Needle Sticks and other sharps injuries continue to be of concern due to the high frequency of their occurrence and the severity of the health effects.

The Centers for Disease Control and Prevention estimate that healthcare workers sustain nearly 600,000 percutaneous injuries annually involving contaminated sharps. In response to both the continued concern over such exposures and the technological developments which can increase employee protection, Congress passed the Needle Stick Safety and Prevention Act directing OSHA to revise the bloodborne pathogens standard to establish in greater detail requirements that employers identify and make use of effective and safer medical devices. That revision was published on Jan. 18, 2001, and became effective April 18, 2001.

Summary
The revision to OSHA's bloodborne pathogens standard added new requirements for employers, including additions to the exposure control plan and keeping a sharps injury log. It does not impose new requirements for employers to protect workers from sharps injuries; the original standard already required employers to adopt engineering and work practice controls that would eliminate or minimize employee exposure from hazards associated with bloodborne pathogens.

The revision does, however, specify in greater detail the engineering controls, such as safer medical devices, which must be used to reduce or eliminate worker exposure.

Exposure Control Plan
The revision includes new requirements regarding the employer's Exposure Control Plan, including an annual review and update to reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens. The employer must:

take into account innovations in medical procedure and technological developments that reduce the risk of exposure (e.g., newly available medical devices designed to reduce Needle Sticks); and document consideration and use of appropriate, commercially-available, and effective safer devices (e.g., describe the devices identified as candidates for use, the method(s) used to evaluate those devices, and justification for the eventual selection).

No one medical device is considered appropriate or effective for all circumstances. Employers must select devices that, based on reasonable judgment:

Will not jeopardize patient or employee safety or be medically inadvisable; and
Will make an exposure incident involving a contaminated sharp less likely to occur.

Employee Input
Employers must solicit input from non-managerial employees responsible for direct patient care regarding the identification, evaluation, and selection of effective engineering controls, including safer medical devices. Employees selected should represent the range of exposure situations encountered in the workplace, such as those in geriatric, pediatric, or nuclear medicine, and others involved in direct care of patients.

OSHA will check for compliance with this provision during inspections by questioning a representative number of employees to determine if and how their input was requested.

Documentation of employee input
Employers are required to document, in the Exposure Control Plan, how they received input from employees. This obligation can be met by:

Listing the employees involved and describing the process by which input was requested; or
Presenting other documentation, including references to the minutes of meetings, copies of documents used to request employee participation, or records of responses received from employees.

Recordkeeping
Employers who have employees who are occupationally exposed to blood or other potentially infectious materials, and who are required to maintain a log of occupational injuries and illnesses under existing recordkeeping rules, must also maintain a sharps injury log. That log will be maintained in a manner that protects the privacy of employees. At a minimum, the log will contain the following:

the type and brand of device involved in the incident; location of the incident (e.g., department or work area); anddescription of the incident.

The sharps injury log may include additional information as long as an employee's privacy is protected. The format of the log can be determined by the employer.

Modification of Definitions
The revision to the bloodborne pathogens standard includes modification of definitions relating to engineering controls. Two terms have been added to the standard, while the description of an existing term has been amended.
Engineering Controls
Engineering Controls include all control measures that isolate or remove a hazard from the workplace, such as sharps disposal containers and self-sheathing needles. The original bloodborne pathogens standard was not specific regarding the applicability of various engineering controls (other than the above examples) in the healthcare setting. The revision now specifies that "safer medical devices, such as sharps with engineered sharps injury protections and needleless systems" constitute an effective engineering control, and must be used where feasible.

Sharps with Engineered Sharps Injury Protections
This is a new term which includes nonneedle sharps or needle devices containing built-in safety features that are used for collecting fluids or administering medications or other fluids, or other procedures involving the risk of sharps injury. This description covers a broad array of devices, including:

Syringes with a sliding sheath that shields the attached needle after use;
Needles that retract into a syringe after use;
Shielded or retracting catheters
Intravenous medication (IV) delivery systems that use a catheter port with a needle housed in a protective covering.

Needleless Systems
This is a new term defined as devices which provide an alternative to needles for various procedures to reduce the risk of injury involving contaminated sharps. Examples include:

IV medication systems which administer medication or fluids through a catheter port using non-needle connections; and
Jet injection systems which deliver liquid medication beneath the skin or through a muscle.