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OSHA’s new bloodborne pathogen regs

By Andrew J. Kennedy, Esq

Last year saw some major changes in government regulation of occupational safety that significantly affect those in the health care industry, particularly physicians in private practice. The Occupational Safety and Health Administration has been busy issuing regulations, compliance directives and guidance over the last year, some of which have been contradictory, and much of which is certain to cause confusion. Given the flurry of activity, now is a good time for employers to ensure that they are in compliance.

OSHA’s activity has surrounded two separate issues: new requirements aimed at preventing needlestick injuries and revised regulations dealing with recordkeeping of workplace injuries and illnesses. The new needlestick regulations stem from the Needlestick Safety and Prevention Act, which Congress passed in 2000. The new recordkeeping requirements are the result of a long-standing revision of OSHA’s 30-year-old rules. What has not been clear until recently is how these separate initiatives will interact. OSHA’s latest compliance directive clarifies this, and some industries, including physicians in private practice, will be substantially affected.

New Bloodborne Pathogen Standard

The new Bloodborne Pathogen Standard applies to all employers who have employees with reasonably anticipated occupational exposure to blood or other potentially infectious materials. Thus, it will apply to many health care providers. The revised regulations came into effect in April of last year but it was not until November that OSHA issued a new compliance directive, CPL 2-2.69, to assist employers in complying with the new rules. With the issuance of the compliance directive last year, it appears that OSHA will be focusing on enforcement this year. Therefore, those employers who have not made policy or practice changes to ensure compliance should do so.

The new standard focuses on the requirement that employers select safer needle devices, as they become available. The new requirements include: (1) annual evaluation and implementation of safer needle devices as part of the re-evaluation of appropriate engineering controls for the employer’s Exposure Control Plan; (2) documentation of the involvement of non-managerial employees in choosing safer devices; and (3) establishment and maintenance of a sharps injury log for recording injuries from contaminated sharps. The new directive also gives a list of web sites giving information that will assist employers in evaluating effective engineering controls.

One of the more challenging issues regarding compliance is in the evaluation of safer medical devices. The new directive indicates that no one safer medical device is appropriate for every situation. Instead of requiring a particular medical device, employers should consider and implement devices that are appropriate, commercially available and effective. While that standard appears flexible, it is clear OSHA presumes that the safest device possible should be utilized.

OSHA’s position is that the most important factors in choosing a safer medical device are its appropriateness to the procedure, its effectiveness, and its availability on the market. OSHA makes clear that, during the employer’s annual review of devices, the employer must inquire about new or prospective safer options and document this fact in the written Exposure Control Plan. Moreover, if a safer device is available, but is on back order, the Exposure Control Plan must document as much, and the safer device must be used when it becomes available. The plan must then be revised once this occurs. In the meantime, if there are no engineering controls available, work practice controls and personal protective equipment must be used.

It is not entirely clear whether cost can be a significant factor in choosing safer medical devices. The regulations clearly focus on safety as the determinative factor. But OSHA also issued evaluation forms as guidelines that expressly rely on cost as a valid consideration. That leaves open the question of how much a factor cost can be in evaluation of safer medical devices.

The New Recordkeeping Requirements

In addition, OSHA also issued sweeping changes to the general recordkeeping requirements that became effective January 1, 2002. Compliance Directive CPL 2-0.131 modifies OSHA’s very detailed requirements regarding keeping records of injuries and illnesses in the workplace. The most prominent change for employers is that in place of the two forms previously used, OSHA now requires employers to use three new forms. This is in addition to new recordkeeping requirements for needlestick and sharps injuries, as well as new rules for recording injuries and illnesses.

To add to the confusion regarding these rules, OSHA turned in an about face in October, issuing a statement that it will delay implementation of the portion of the new recordkeeping rules. Those rules deal with cases involving occupational hearing loss and cases involving work-related musculoskeletal disorders until January 2003. Until then, there are provisional recordability requirements for such cases.

More importantly, a part of those changes included reclassifying many employers. Some employers who previously were partially exempt from these requirements now must adhere to them. Some employers who previously were required to keep such records are no longer required to do so. Among the latter are offices of medical doctors, dentists and other health practitioners. The sharps injury log is required only for those industries that are required to keep such records under 29 C.F.R. ß1904 et seq. Therefore, offices of medical doctors, which were required to begin keeping the log in April of 2001, will no longer be required to keep such logs after January 1, 2002.

Ensuring Compliance

What OSHA gave with one hand, it took away with the other. While the new compliance directive makes clear that the sharps injury logs are not required for partially exempt industries, other documentation has increased. Therefore, even those employers who are exempt from documentation of the new OSHA forms are still required to document post-exposure procedures as well as to document the required annual review.

What is the bottom line to ensure compliance for physician’s offices? First, the employer’s bloodborne pathogen policy and procedure should be reviewed for compliance with the new standard. The key changes require:

• Evaluation and implementation of safer needle devices as a part of the re-evaluation process of the employer’s annual exposure control plan.

• Documentation of the involvement of the non-managerial employees in choosing safer devices.

• Maintenance of a sharps injury log (a must for employers who are required to comply with OSHA’s general recordkeeping requirements).

Second, employers should ensure that they have proper documentation for post-exposure procedures. Generally, that includes documentation of the route(s) of exposure, source individual, testing of that individual’s blood where permitted by law, results of that testing made to the exposed employee (along with a review of the laws regarding disclosure of that information), collection and testing of the employee’s blood, counseling and evaluation. While this should already be a part of the exposure control plan, employers should ensure that the plan provides for the proper documentation.

This documentation is far more detailed than the requirements for the sharps injury log, which physicians offices (as a newly partially exempt industry) will no longer be required to keep. But keeping the injury log will be of great assistance as a part of the annual review process because it gives a brief, bird’s-eye view of exposure in the workplace. So while OSHA’s newest directive makes clear that the new requirement for a sharps injury log is not required by law for exempt industries, practically speaking, many employers will continue to keep it.

Third, employers should review OSHA’s guidance for compliance. The new compliance directive has attached some helpful forms and checklists. They include suggested reviews by various committees, evaluations of engineering controls, reviewing disposal container performance, evaluating needlestick prevention devices, a model exposure control plan, and a sharps injury log. These are available on OHSA’s website at These changes may be incorporated into the employer’s OSHA compliance plan or the employee handbook, depending on how the employer ensures compliance with the bloodborne pathogen standard.

Andrew J. Kennedy, Esq., is an attorney in the Labor and Employment practice group of Houston Harbaugh.

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