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  • ACOEM Comments on Review of the OSHA Bloodborne Pathogens (BBP) Standard

    August 12, 2010

    OSHA Docket Office
    Docket No. OSHA-2007-0080
    U.S. Department of Labor
    Room N-2625
    200 Constitution Avenue, NW
    Washington, DC 20210

    To Whom It May Concern:

    The American College of Occupational and Environmental Medicine (ACOEM) welcomes the opportunity to respond to the Occupational Safety and Health Administration’s (OSHA) request for comment (RFC) regarding the Regulatory Flexibility Act review of the Bloodborne Pathogens (BBP) Standard. Our comments will be brief as this standard is probably one of the most cogent and successful OSHA regulations seen over the past 40 years. However, as with any document, it deserves to be reviewed and updated if necessary in order to reflect current science, experience, and practical realities.

    The first and most intriguing question posed in the RFC addresses modifications to reduce the burden on small entities while improving worker protection, particularly outside the hospital setting. We suggest that three areas bear investigation – First, in keeping with the CDC guidelines for tuberculosis monitoring in the workplace, OSHA might consider a tiered approach to monitoring of the exposed employee based on the prevalence of disease in the source population, particularly in the case of an unknown source. Such an approach would call for reduced testing in regions/facilities with a low prevalence of disease and perhaps even more stringent post-exposure testing for those with abnormally high prevalence. Second, given the advent of the Health Information Portability and Accountability Act (HIPAA) since the BBP standard became law, we would appreciate clarification of the limits of privacy and confidentiality during an exposure investigation, particularly in the case of a source patient who refuses to be tested or to divulge existing medical information that would be critical to the investigation. Third, the standard could be clarified further regarding a recommended protocol for investigation and follow up of a dual exposure (patient and healthcare worker exchange body fluids, such as with continued surgery after a needlestick.), which is a blend of both worker and patient safety, but which clearly should be addressed in this standard.

    As for recent technological advances in needlestick prevention, needle-less intravenous systems stand out as the most significant of these advances. Telescoping syringe tubes and post-use needle covers have merit but vary considerably in efficacy, depending on manufacturer and design. Most recently, there has been clear evidence that blunt fascia needles can reduce the risk of operator/assistant injury without affecting the procedure itself or outcome of the surgery. Surgeons still need incentives to embrace this technology. We must also emphasize that a large portion of the reported exposures result from splash exposures, particularly to mucus membranes, making proper eye and face shields essential in certain settings.

    Regarding the effectiveness of needlestick prevention programs, education, training, and experience clearly factor into the reduction of the incidence of such injuries. Awareness of the hazards and proper technique should be emphasized as soon as practically possible during training for nurses, doctors, technicians and virtually all healthcare workers. We are particularly concerned about the abnormally high incidence of such injuries in medical and dental students/trainees. Some of our members have reported statistically significant reduction of injuries after identifying work units who demonstrate particularly high risk or actual incidence of needlestick injuries and then developing an intensive training and oversight program, stressing motivation and avoiding punitive measures. One such setting has been in the clinical laboratory, specifically concerning venipuncturists. 

    In the past 20 years, the only bloodborne agent beside HIV and hepatitis B (HBV) to emerge as a principal pathogen is hepatitis C (HCV), which was certainly extant when the BBP standard went into effect and is now the most prevalent pathogen in most patient populations. While there are perhaps dozens of other viruses and bacteria, such as West Nile virus or gonorrhea, that can be transmitted through body fluid exchange, such situations are either rare, fleeting, relatively benign, or self-limited. It bears mentioning that one of our members at the Mayo Clinic in Rochester, MN, reported at our annual meeting in 2009 that, at least in their relatively low-prevalence patient population, concerns about transmission of viral hepatitis during the “window period” between infection and serological conversion were unfounded. They followed employees who were exposed to sources and who were serologically negative, but had elevated liver enzymes in their blood at the time of exposure. Out of more than 9,200 total exposures spanning 15 years, 214 cases met the criteria for the “elevated liver enzyme” protocol. Each exposed employee was followed for 1 year with none demonstrating seroconversion to HBV of HCV. Thus, that protocol has been abandoned. However, as another form of tiered monitoring that was discussed earlier in this letter, such a protocol might be productive in a patient population with a higher prevalence of viral hepatitis.

    As for other experiences with compliance with the BBP standard, one of our members noted that vaccination for HBV has become universal for school entry in the past 20 years, but most children will not have been tested for serological conversion. Thus, the current practice of documenting conversion at time of hire into the healthcare environment if no such documentation exists is likely to falsely identify those vaccinated in childhood as non-immune due to waning antibody levels. We may need to consider alternate approaches to vaccination and documentation of seroconversion as this cohort and subsequent future employees reach the age of majority.  Regarding adult healthcare workers who choose HBV vaccination, novel approaches for stimulating an immune response in so-called non-responders (intradermal injection, higher dose vaccine, combination hepatitis A & B vaccine) have been published and should be considered in an updated standard.

    We hope that these comments will be useful in your investigation. We are particularly sympathetic to the plight of our own colleagues who have had their careers impacted by an inadvertent BBP exposure. We have also been generally pleased with the support this standard has given us in developing BBP exposure programs at our own institutions. Should you wish further clarification of any of these comments, please let us know, and we will forward them to our content experts for a speedy reply.

    ACOEM appreciates the opportunity to provide input.

    Sincerely,
    Hartenbaum 
    Natalie Hartenbaum, MD, MPH, FACOEM
    President
    American College of Occupational and Environmental Medicine