Although not enforced under the CLIA regulations, it is important that the laboratory be in compliance with the Occupational Safety and Health Administration (OSHA) for bloodborne pathogens. State CLIA inspectors are instructed to contact the appropriate agency to file a complaint should they obtain information regarding potential OSHA violations during the on-site inspection by your local OSHA office.

The goal behind the OSHA bloodborne pathogen standard is to protect health care professionals who have occupational exposure to bloodborne pathogens. There are certain steps you must take to ensure compliance with the standards.

1. Develop and make available to your employees a written exposure control plan (ECP). The ECP, among other things, identifies job classifications, tasks and procedures where a risk of occupational exposure exists.

2. Require your employees to exercise universal precautions. Employers can be fined if they do not require their employees to follow universal precautions when they come into contact with blood and other regulated body fluids. It is imperative that the laboratory director train staff about the importance and necessity of using universal precautions.

3. Offer immunization of laboratory staff against Hepatitis B. Employers are required to provide the vaccine to employees free of charge. Any employee who does not wish to be immunized must sign a statement of declination. Documentation of the vaccination or statement of declination should be retained in personnel files.

4. Institute engineering (e.g., sharps disposal containers) and work practice controls (e.g., prohibiting the recapping of needles by a two-handed technique) to eliminate or minimize employee exposure. Handwashing is imperative before and after drawing blood and before touching one's own eyes and mouth, immediately after contamination from any reagent or specimen. Precautions must be taken to avoid needle sticks (e.g., never remove needles from syringes with hands, never recap needles, never break or bend needles). Laboratory personnel must never pipette with their mouth. Eating, drinking, smoking, and applying cosmetics should be prohibited in any area where biological or chemical hazards are present. Food and drink may not be stored in any area where biological and chemical hazards are stored. Also, the laboratory director should train laboratory staff about the proper use of personal protective equipment including gloves, masks, goggles, face shields, and laboratory coats. Eyewash and fire extinguishers or blankets must be readily available.

5. Conduct post-exposure evaluations and follow-up for all employees who have had an exposure incident.

6. Use appropriate warning labels on containers of regulated waste, refrigerators, freezers, and other containers of blood or other potentially infectious materials. The standard requires that fluorescent orange or orange-red warning labels containing the word BIOHAZARD be used.

7. Train employees with occupational exposure on how to reduce or eliminate exposure to potentially infectious materials.

8. Retain the medical records of each of your employees with occupational exposure.

The Commission on Office Laboratory Accreditation (COLA) has developed a self-assessment checklist to assist you in complying with the federal OSHA bloodborne pathogen standards. Please contact COLA's Customer Service Division at (800) 298-8044 to obtain a copy. Additionally, you should contact your local OSHA office for more information on these standards and to obtain a copy of the standards.

Refer to the keywords "Safety Concerns", and "Precautions, Media", in the Hardy Diagnostics software program HUGO™, for more information regarding safety.