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Highlights from OSHA's 1999 Bloodborne Pathogen Compliance Directive

Exposure Control Plan

  • OSHA inspectors will not only review your OSHA exposure control plan for completeness, but will conduct employee interviews to assess their understanding of your plan.
  • Each year, exposure control plans must be updated and this activity must be documented.
  • An exposure control plan may be maintained on a computer, but a hard copy must be made available within 5 working days to employees who request it.

Hepatitis B Vaccine

  • Employers may permit employees to use their health care insurance to pay for the hepatitis B vaccine or post exposure follow-up only if employers cover the cost of insurance plus any co-pays or deductibles. Employees may not incur out-of-pocket expenses.
  • Employees obtained temporarily from a personnel service must be offered the hepatitis B vaccine and post exposure evaluation, but not necessarily at the laboratory's expense. While your lab exercises day-to-day supervision over personnel service workers, they are the employees of both the lab and the personnel service, and thus the lab must comply with all of the provisions of the bloodborne pathogens standard with respect to these workers. With respect to hepatitis B vaccination and post exposure evaluation and follow-up, your lab should take reasonable measures to ensure that the personnel service firm has complied with these provisions.

Post Exposure Follow-up

  • An "injury" for bloodborne pathogens standard purposes includes needlesticks, splashes, and lacerations (including a hangnail or acne).
  • According to the Centers for Disease Control and Prevention (CDC), hepatitis C virus (HCV) is the most common chronic bloodborne infection in the US.
  • Employers must test employees for Ab to HBsAg within one to two months after the completion of the 3-dose vaccination series. The hepatitis B vaccination must be given in the standard dose and through the standard route of administration as recommended by the United States Public Health Services and CDC guidelines. The most current CDC recommendation advises that employees receive post-vaccination testing for hepatitis B surface antigen and re-vaccinating non-responders with a second 3-dose vaccine series followed again by post-vaccine testing for HBsAg.
  • After receiving the hepatitis B vaccine series, employees are considered "responders" if they achieve anti-HBs >= 10 mIU/mL; inadequate response to vaccination is serum anti-HBs <10 mIU/mL.
  • Pre-vaccination screening for antibody status can be made available to employees at no charge. Employees may decline this screening, and employers must still make the hepatitis B vaccination available to them at no charge.
  • The requirement to provide boosters for hepatitis B vaccination is currently under assessment by the United States Public Health Service, but at this time is not recommended.
  • You may test post exposure employee blood samples in your laboratory, as long as the requirements for consent and confidentiality have been followed.
  • No treatment for hepatitis B is indicated for an exposed employee who was previously vaccinated against hepatitis B and is a known "responder."
  • The hepatitis B vaccine series is the preferred treatment for an unvaccinated employee who is exposed to a source patient whose hepatitis B status is unknown.

Engineering Controls: Safety Devices

  • OSHA does not approve, endorse, register or certify particular brands or types of safety devices for use in medical facilities.
  • Laboratories that use glass capillary tubes could be cited under the bloodborne pathogens standard. An effective engineering control isolates or removes the bloodborne pathogens hazard from the workplace. An example is plastic capillary tubes.
  • Regularly scheduled inspections of engineering controls are required to confirm that engineering controls function as expected, i.e., that safety devices continue to function effectively; that protective shields have not been removed or broken; and that physical, mechanical or replacement-dependent controls are functioning as needed.
  • fsdfSafety devices such as syringes, scalpels, and phlebotomy equipment must be evaluated as they become commercially available. Maintain written evaluations in your Exposure Control Plan. OSHA does not mandate that a facility must switch to a safer device, per se, but if safety devices are not in use, the OSHA compliance officer will ask to see written documentation proving that the device failed the evaluation and that your facility has in use the most effective engineering control possible.

Personal Protective Clothing and Equipment

  • Gloves are usually not necessary when administering intramuscular or subcutaneous injections as long as bleeding that could result in hand contact with blood is not anticipated.
  • Employers may be cited if employees are not wearing the correct protective clothing (e.g., lab coat instead of a rubber apron) or if protective clothing does not fit correctly (e.g., loose-fitting gloves).
  • If an employee is allergic to a particular brand of glove, the employer must provide, at no expense to the employee, an alternative. Plastic film (food-handling or cafeteria-style) gloves are not considered appropriate for bloodborne exposure-related tasks.

Employee Training

  • Employee training records must include the training date, program content, trainer's name and qualifications, and names and job titles of all persons trained.
  • During annual OSHA training sessions, employees must have access to a qualified individual to answer their questions, either directly or through a telephone hotline.

Medical Records

  • You do not need to retain the medical records of an employee who remained in your employ less than one year if you turn them over to the worker at departure time.
  • Employees must have access to their own medical records and may give written permission for others to see them. A copy must be made available within 15 working days of the employee's request.
  • OSHA inspectors may review employee medical records on site. If requested, this review may occur under the observation of the medical record holder (or other employer-designated health care professional). The OSHA inspector may not record or take off site any information from the medical record other than documentation of the fact of compliance or noncompliance.

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