Bloodborne pathogens — California

Scope

It is up to every employer to ensure that employees who can reasonably be anticipated to come into contact with blood or other potentially infectious materials (OPIM) as a result of doing their job duties are protected. If you have at least one employee with one or more tasks or procedures that result in exposure, Cal/OSHA requires your company to develop a bloodborne pathogens exposure control program. You should be aware that some facilities and operations are considered by Cal/OSHA to involve “occupational exposure,” because the intrinsic nature of the facility or operation is such that contact with blood or OPIM is reasonably anticipated for at least some of the employees involved with the facility or operation.

Regulatory citations

• 8 CCR 5193 — Bloodborne pathogens

Key definitions

• Blood: Human blood, human blood components, and products made from human blood. The term includes plasma, platelets, and serosanguineous fluids (e.g., exudates from wounds). Also included are medications derived from blood, such as immune globulins, albumin, and factors 8 and 9.
• Bloodborne pathogens: Pathogenic microorganisms that are present in human blood and can cause disease in humans. While HBV and HIV are specifically identified in the standard, the term includes any pathogenic microorganism that is present in human blood or OPIM and can infect and cause disease in persons who are exposed to blood containing the pathogen. Pathogenic microorganisms can also cause diseases such as hepatitis C, malaria, syphilis, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, Creutzfeldt-Jakob disease, adult T-cell leukemia/lymphoma (caused by HTLV-I), HTLV-I associated myelopathy, diseases associated with HTLV-II, and viral hemorrhagic fever.
• Engineering controls: Controls (e.g., sharps disposal containers, self-sheathing needles, and safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace.
• Exposure incident: A specific eye, mouth, other mucous membrane, non-intact skin (which includes skin with dermatitis, hangnails, cuts, abrasions, chafing, acne, etc.), or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee’s duties.
• Occupational exposure: Reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or OPIM that may result from the performance of an employee’s duties. Note: This term does not include Good Samaritan acts.
• Other Potentially Infectious Materials (OPIM): (1) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids; (2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and (3) HIV-containing cell

Summary of requirements

California’s state requirements regarding bloodborne pathogens include some regulatory information beyond the federal requirements. A summary of the additional requirements includes the following:

• California refers also to Hepatitis C (HCV) in their regulation.
• California includes definitions for “Biological Cabinet,” “Engineered Sharps Injury Protection,” “HCV,” “One-Hand Technique,” “Sharps Injury Log,” and “Sharps.”
• The Exposure Control Plan must be consistent with the IIPP (§3203) and contain (in addition to the federal requirements) effective procedures for:
  • Gathering the information required by the Sharps Injury Log;
  • Periodic determination of the frequency of use of the types and brands of sharps involved in the exposure incidents documented on the Sharps Injury Log;
  • Identifying currently available engineering controls, and selecting such controls, where appropriate, for the procedures performed by employees in their respective work areas or departments;
  • Documenting patient safety determinations made by licensed healthcare professionals (when they determine that engineering controls are not required for a patient); and
  • Obtaining the active involvement of employees in reviewing and updating the exposure control plan with respect to the procedures performed by employees in their respective work areas or departments.
• The Exposure Control Plan must be reviewed and updated:
  • To review and evaluate the exposure incidents which occurred since the previous update; and
  • To review and respond to information indicating that the Exposure Control Plan is deficient in any area.
• Exposure incidents must be recorded on the sharps injury log within 14 working days of the date the incident is reported to the employer. The information recorded must include the date and time of the exposure incident, and a description of the exposure incident, which must include:
  • Job classification of the exposed employee;
  • The procedure the employee was performing at the time of the incident;
  • The body part involved;
  • If the sharp had engineered sharps injury protection, whether the protective mechanism was activated, and whether the injury occurred before the protective mechanism was activated, during activation of the mechanism, or after activation of the mechanism, if applicable;
  • If the sharp had no engineered sharps injury protection, the injured employee's opinion as to whether and how such a mechanism could have prevented the injury; and
  • The employee's opinion about whether any other engineering, administrative, or work practice control could have prevented the injury.
• Employee training must include the procedure for recording exposure incidents on the Sharps Injury Log.
• The Sharps Injury Log must be provided upon request for examination and copying to employees, employee representatives, the Chief of the Division of Occupational Safety and Health of the California Department of Industrial Relations, the Department of Health Services, and the National Institute for Occupational Safety and Health.
• Work practice controls must be evaluated and updated on a regular schedule to ensure their effectiveness.
• Needleless systems must be used for the withdrawal of body fluids (after initial venous or arterial access is established), administration of medications or fluids, and any other procedure involving the potential for an exposure incident for which a needleless system is available as an alternative to the use of needle devices.
• If needleless systems are not used, needles with engineered sharps injury protection must be used for withdrawal of body fluids, accessing a vein or artery, administration of medications or fluids, and any other procedure involving the potential for an exposure incident for which a needle device with engineered sharps injury protection is available.
• If sharps other than needle devices are used, these items must include engineered sharps injury protection.
• The engineering controls required for sharps are not required if:
  • They are not available in the marketplace;
  • A licensed healthcare professional directly involved in a patient's care determines that use of the engineering control will jeopardize the patient's safety or the success of a medical, dental or nursing procedure involving the patient;
  • The employer can demonstrate by means of objective product evaluation criteria that the engineering controls are not more effective in preventing exposure incidents than the alternatives used by the employer; or
  • The employer can demonstrate that reasonably specific and reliable information is not available on the safety performance of the engineering controls for the employer's procedures, and that the employer is actively determining by means of objective product evaluation criteria whether use of the engineering controls will reduce the risk of exposure incidents occurring in the employer's workplace.
• Containers for contaminated sharps must be replaced as necessary to avoid overfilling.
• Sharps containers for contaminated sharps must be rigid and portable (if necessary). If discarded sharps are not to be reused, the sharps container must also be closeable and sealable so that when sealed, the container is leak resistant and incapable of being reopened without great difficulty.
• In HIV, HBV, and HCV research laboratories, written biosafety procedures must be prepared and adopted into the Exposure Control Plan.
• Biological safety cabinets must be certified by the employer that they meet manufacturers' specifications when installed, whenever they are moved, and at least annually.
• When an employer is also acting as the evaluating health care professional, the employer must advise an employee following an exposure incident that the employee may refuse to consent to post-exposure evaluation and follow-up from the employer-healthcare professional. When consent is refused, the employer must make immediately available to exposed employees a confidential medical evaluation and follow-up from a healthcare professional other than the exposed employee's employer. Designated first aid providers who have occupational exposure, however, are not required to be offered pre-exposure hepatitis B vaccine under certain conditions.
• During post-exposure evaluation and follow-up, additional collection and testing must be made available as recommended by the U.S. Public Health Service.
• The biohazard label, when required, may be attached to the regulated container or may be an integral part of the container.
• Bags used to contain regulated waste must be color-coded red and must have the biohazard label. Labels on red bags or red containers do not need to be color-coded.
• Biohazard signs must meet the requirements of 8 CCR 3340, Accident Prevention Signs.
• Additional training must be provided when new engineering, administrative, or work practice controls are introduced.