Cal. Code Regs. tit. 8, § 5193
(a) Scope and Application. This section applies to all occupational exposure to blood or other potentially infectious materials as defined by subsection (b) of this section.
Exception: This regulation does not apply to the construction industry.
(b) Definitions. For purposes of this section, the following shall apply:
(3) Class III: A total enclosed, ventilated cabinet of gas-tight construction. Operations in the cabinet are conducted through attached protective gloves.
“Blood” means human blood, human blood components, and products made from human blood.
“Bloodborne Pathogens” means pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
“Chief” means the Chief of the Division of Occupational Safety and Health of the California Department of Industrial Relations or designated representative.
“Clinical Laboratory” means a workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials.
“Contaminated” means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on a surface or in or on an item.
“Contaminated Laundry” means laundry which has been soiled with blood or other potentially infectious materials or may contain sharps.
“Decontamination” means the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal. Decontamination includes procedures regulated by Health and Safety Code Section 118275.
“Engineering Controls” means controls (e.g., sharps disposal containers, needlelesss systems and sharps with engineered sharps injury protection) that isolate or remove the bloodborne pathogens hazard from the workplace.
“Engineered Sharps Injury Protection” means either:
(2) A physical attribute built into any other type of needle device, or into a non-needle sharp, which effectively reduces the risk of an exposure incident.
“Exposure Incident” means a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee's duties.
“Handwashing Facilities” means a facility providing an adequate supply of running potable water, soap and single use towels or hot air drying machines.
“HBV” means hepatitis B virus.
“HCV” means hepatitis C virus.
“HIV” means human immunodeficiency virus.
“Licensed Healthcare Professional” is a person whose licensed scope of practice includes an activity which this section requires to be performed by a licensed healthcare professional.
“Needle” or “Needle Device” means a needle of any type, including, but not limited to, solid and hollow-bore needles.
“Needleless System” means a device that does not utilize needles for:
(3) Any other procedure involving the potential for an exposure incident.
“NIOSH” means the Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designated representative.
“Occupational Exposure” means reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties.
“One-Hand Technique” means a procedure wherein the needle of a reusable syringe is capped in a sterile manner during use. The technique employed shall require the use of only the hand holding the syringe so that the free hand is not exposed to the uncapped needle.
“OPIM” means other potentially infectious materials.
“Other Potentially Infectious Materials” means:
(3) Any of the following, if known or reasonably likely to contain or be infected with HIV, HBV, or HCV:
(C) Culture medium or other solutions.
“Parenteral Contact” means piercing mucous membranes or the skin barrier through such events as needlesticks, human bites, cuts, and abrasions.
“Personal Protective Equipment” is specialized clothing or equipment worn or used by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment.
“Production Facility” means a facility engaged in industrial-scale, large-volume or high concentration production of HIV, HBV or HCV.
“Regulated Waste” means waste that is any of the following:
(2) Contaminated items that:
(5) Regulated Waste includes “medical waste” regulated by Health and Safety Code Sections 117600 through 118360.
“Research Laboratory” means a laboratory producing or using research-laboratory-scale amounts of HIV, HBV or HCV. Research laboratories may produce high concentrations of HIV, HBV or HCV but not in the volume found in production facilities.
“Sharp” means any object used or encountered in the industries covered by subsection (a) that can be reasonably anticipated to penetrate the skin or any other part of the body, and to result in an exposure incident, including, but not limited to, needle devices, scalpels, lancets, broken glass, broken capillary tubes, exposed ends of dental wires and dental knives, drills and burs.
“Sharps Injury” means any injury caused by a sharp, including, but not limited to, cuts, abrasions, or needlesticks.
“Sharps Injury Log” means a written or electronic record satisfying the requirements of subsection (c)(2).
“Source Individual” means any individual, living or dead, whose blood or OPIM may be a source of occupational exposure to the employee. Examples include, but are not limited to, hospital and clinical patients; clients in institutions for the developmentally disabled; trauma victims; clients of drug and alcohol treatment facilities; residents of hospices and nursing homes; human remains; and individuals who donate or sell blood or blood components.
“Universal Precautions” is an approach to infection control. According to the concept of Universal Precautions, all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, HCV, and other bloodborne pathogens.
“Work Practice Controls” means controls that reduce the likelihood of exposure by defining the manner in which a task is performed (e.g., prohibiting recapping of needles by a two-handed technique and use of patient-handling techniques).
“Biological Cabinet” means a device enclosed except for necessary exhaust purposes on three sides and top and bottom, designed to draw air inward by means of mechanical ventilation, operated with insertion of only the hands and arms of the user, and in which virulent pathogens are used. Biological cabinets are classified as:
(c) Exposure Response, Prevention and Control.
(1) Exposure Control Plan.
(B) The Exposure Control Plan shall be in writing and shall contain at least the following elements:
5. An effective procedure for 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;
Note: Frequency of use may be approximated by any reasonable and effective method.
(D) The Exposure Control Plan shall be reviewed and updated at least annually and whenever necessary as follows:
1. To reflect new or modified tasks and procedures which affect occupational exposure;
2.a. To reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens; and
(2) Sharps Injury Log.
(C) A description of the exposure incident which shall include:
The employer shall establish and maintain a Sharps Injury Log, which is a record of each exposure incident involving a sharp. The information recorded shall include the following information, if known or reasonably available:
(3) Exposure Determination.
(A) Each employer who has an employee(s) with occupational exposure as defined by subsection (b) of this section shall prepare an exposure determination. This exposure determination shall contain the following:
(d) Methods of Compliance.
(2) Engineering and Work Practice Controls--General Requirements.
(3) Engineering and Work Practice Controls--Specific Requirements.
(A) Needleless Systems, Needle Devices and non-Needle Sharps.
1. Needleless Systems. Needleless systems shall be used for:
2. Needle Devices. If needleless systems are not used, needles with engineered sharps injury protection shall be used for:
4. Exceptions. The following exceptions apply to the engineering controls required by subsections (d)(3)(A)1.-3.:
(B) Prohibited Practices.
2. Contaminated sharps shall not be bent, recapped, or removed from devices.
Exception: Contaminated sharps may be bent, recapped or removed from devices if:
b. The procedure is performed using a mechanical device or a one-handed technique.
(C) Requirements for Handling Contaminated Sharps.
3. At all time during the use of sharps, containers for contaminated sharps shall be:
(D) Sharps Containers for Contaminated Sharps.
1. All sharps containers for contaminated sharps shall be:
(E) Regulated Waste.
1. General.
Handling, storage, treatment and disposal of all regulated waste shall be in accordance with Health and Safety Code Chapter 6.1, Sections 117600 through 118360, and other applicable regulations of the United States, the State, and political subdivisions of the State.
2. Disposal of Sharps Containers.
b. Placed in a secondary container if leakage is possible. The second container shall be:
When any container of contaminated sharps is moved from the area of use for the purpose of disposal, the container shall be:
3. Disposal of Other Regulated Waste. Regulated waste not consisting of sharps shall be disposed of in containers which are:
4. Outside Contamination. If outside contamination of a container of regulated waste occurs, it shall be placed in a second container. The second container shall be:
(F) Handling Specimens of Blood or OPIM.
Specimens of blood or OPIM shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping.
(G) Servicing or Shipping Contaminated Equipment.
Equipment which may become contaminated with blood or OPIM shall be examined prior to servicing or shipping and shall be decontaminated as necessary, unless the employer can demonstrate that decontamination of such equipment or portions of such equipment is not feasible or will interfere with a manufacturer's ability to evaluate failure of the device.
(H) Cleaning and Decontamination of the Worksite.
1. General Requirements.
c. The method of cleaning or decontamination used shall be effective and shall be appropriate for the:
2. Specific Requirements.
a. Contaminated Work Surfaces. Contaminated work surfaces shall be cleaned and decontaminated with an appropriate disinfectant immediately or as soon as feasible when:
(I) Hygiene.
(J) Laundry.
1. Contaminated laundry shall be handled as little as possible with a minimum of agitation.
(4) Personal Protective Equipment.
(A) Provision. Where occupational exposure remains after institution of engineering and work practice controls, the employer shall provide, at no cost to the employee, appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. Personal protective equipment will be considered “appropriate” only if it does not permit blood or OPIM to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used.
Note: For fire fighters, these requirements are in addition to those specified in Sections 3401-3411, and are intended to be consistent with those requirements.
(F) Removal.
(G) Gloves. Gloves shall be worn when it can be reasonably anticipated that the employee may have hand contact with blood, OPIM, mucous membranes, and non-intact skin; when performing vascular access procedures except as specified in subsection (d)(4)(G)4.; and when handling or touching contaminated items or surfaces. These requirements are in addition to the provisions of Section 3384.
4. If an employer in a volunteer blood donation center judges that routine gloving for all phlebotomies is not necessary then the employer shall:
(H) Masks, Eye Protection, Face Shields, and Respirators.
2. Where respiratory protection is used, the provisions of Sections 5144 and 5147 are required as applicable.
Note: Surgical masks are not respirators.
(I) Gowns, Aprons, and Other Protective Body Clothing.
(e) HIV, HBV and HCV Research Laboratories and Production Facilities.
(1) General.
This subsection applies in addition to the other requirements of this section to research laboratories and production facilities engaged in the culture, production, concentration, experimentation, and manipulation of HIV, HBV and HCV.
Exception: This subsection does not apply to clinical or diagnostic laboratories engaged solely in the analysis of blood, tissues, or organs.
(2) Research laboratories and production facilities shall meet the following criteria:
(B) Special Practices.
(C) Containment Equipment.
(3) HIV, HBV and HCV research laboratories shall meet the following criteria:
(B) An autoclave for decontamination of regulated waste shall be available.
Note: Treatment of medical waste should meet the requirements of Health and Safety Code Section 118215.
(4) HIV, HBV and HCV production facilities shall meet the following criteria:
(E) An autoclave for decontamination of regulated waste shall be available within or as near as possible to the work area.
Note: Treatment of medical waste should meet the requirements of Health and Safety Code Section 118215.
(5) Training Requirements.
Training requirements for employees in HIV, HBV and HCV research laboratories and HIV, HBV and HCV production facilities are specified in subsection (g)(2) and they shall receive in addition the following initial training:
(f) Hepatitis B Vaccination and Bloodborne Pathogen Post-exposure Evaluation and Follow-up.
(1) General.
(A) The employer shall make available the hepatitis B vaccine and vaccination series to all employees who have occupational exposure, and post-exposure evaluation and follow-up for bloodborne pathogens exposure to all employees who have had an exposure incident. When an employer is also acting as the evaluating health care professional, the employer shall 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 shall make immediately available to exposed employees a confidential medical evaluation and follow-up from a healthcare professional other than the exposed employee's employer.
Exception: Designated first aid providers who have occupational exposure are not required to be offered pre-exposure hepatitis B vaccine if the following conditions exist:
3. The employer must implement a procedure to ensure that all of the provisions of subsection 2. of this exception are complied with if pre-exposure hepatitis B vaccine is not to be offered to employees meeting the conditions of subsection 1. of this exception.
(B) The employer shall ensure that all medical evaluations and procedures, including the hepatitis B vaccine and vaccination series and post-exposure evaluation and follow-up, including prophylaxis, are:
(2) Hepatitis B Vaccination.
(3) Post-exposure Evaluation and Follow-up. Following a report of an exposure incident, the employer shall make immediately available to the exposed employee a confidential medical evaluation and follow-up, including at least the following elements:
(B) The employer shall identify and document the source individual, unless the employer can establish that identification is infeasible or prohibited by state or local law;
(C) The employer shall provide for collection and testing of the employee's blood for HBV, HCV and HIV serological status;
(4) Information Provided to the Healthcare Professional.
(B) The employer shall ensure that the healthcare professional evaluating an employee after an exposure incident is provided the following information:
(5) Healthcare Professional's Written Opinion.
(B) The healthcare professional's written opinion for post-exposure evaluation and follow-up shall be limited to the following information:
The employer shall obtain and provide the employee with a copy of the evaluating healthcare professional's written opinion within 15 days of the completion of the evaluation.
(6) Medical Recordkeeping.
Medical records required by this standard shall be maintained in accordance with subsection (h)(1) of this section.
(g) Communication of Hazards to Employees.
(1) Labels and Signs.
(A) Labels.
1. Warning labels shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or OPIM; and other containers used to store, transport or ship blood or OPIM, except as provided in subsection (g)(1)(A)5., 6. and 7.
Note: Other labeling provisions, such as Health and Safety Code Sections 118275 through 118320 may be applicable.
2. Labels required by this section shall include either the following legend as required by Section 3341:
)
Or in the case of regulated waste the legend:
BIOHAZARDOUS WASTE or SHARPS WASTE
as described in Health and Safety Code Sections 118275 through 118320.
(B) Signs.
1. The employer shall post signs at the entrance to work areas specified in subsection (e), HIV, HBV and HCV Research Laboratory and Production Facilities, which shall bear the following legend:
)
(Name of the Infectious Agent)
(Special requirements for entering the area)
(Name, telephone number of the laboratory director or other responsible person.)
(2) Information and Training.
(B) Training shall be provided as follows:
(G) The training program shall contain at a minimum the following elements:
14. Interactive Questions and Answers. An opportunity for interactive questions and answers with the person conducting the training session.
Note: Additional training is required for employees of HIV, HBV, and HCV Research Laboratories and Production Facilities, as described in subsection (e)(5).
(h) Recordkeeping.
(1) Medical Records.
(B) This record shall include:
(C) Confidentiality. The employer shall ensure that employee medical records required by subsection (h)(1) are:
(2) Training Records.
(A) Training records shall include the following information:
(3) Sharps Injury Log.
The Sharps Injury Log shall be maintained 5 years from the date the exposure incident occurred.
(4) Availability.
(5) Transfer of Records.
(i) Appendix.
Appendix A to this section is incorporated as a part of this section and the provision is mandatory.
Appendix A. Hepatitis B Vaccine Declination
(MANDATORY)
The employer shall assure that employees who decline to accept hepatitis B vaccination offered by the employer sign the following statement as required by subsection (f)(2)(D):
I understand that due to my occupational exposure to blood or OPIM I may be at risk of acquiring hepatitis B virus (HBV) infection. I have been given the opportunity to be vaccinated with hepatitis B vaccine, at no charge to myself. However, I decline hepatitis B vaccination at this time. I understand that by declining this vaccine, I continue to be at risk of acquiring hepatitis B, a serious disease. If in the future I continue to have occupational exposure to blood or OPIM and I want to be vaccinated with hepatitis B vaccine, I can receive the vaccination series at no charge to me.
Note: Authority cited: Sections 142.3 and 144.7, Labor Code. Reference: Sections 142.3 and 144.7, Labor Code; Sections 117600 through 118360, Health and Safety Code.
1. New section filed 12-9-92; operative 1-11-93 (Register 92, No. 50).
2. Editorial correction of printing errors in subsections (c)(1)(A) and (d)(2)(C) (Register 93, No. 32).
3. Amendment of subsections (g)(1)(A)2. and (g)(1)(B)2. filed 2-5-97; operative 3-7-97 (Register 97, No. 6).
4. Amendment filed 1-22-99 as an emergency; effective 1-22-99 (Register 99, No. 4). The emergency regulation filed 1-22-99 shall remain in effect until the nonemergency regulation becomes operative or until August 1, 1999, whichever first occurs pursuant to Labor Code section 144.7(a).
5. Permanent adoption of 1-22-99 amendments, including further amendments, filed 7-30-99 pursuant to Labor Code section 144.7(a); operative 7-30-99 pursuant to Government Code section 11343.4(d) (Register 99, No. 31).
6. Repealer of subsection (c)(1)(D)2., new subsections (c)(1)(D)2.a.-b. and (c)(1)(E), subsection relettering, amendment of subsection (c)(2), new subsections (c)(2)(D)-(E) and amendment of subsections (d)(3)(B)2.Exception, (d)(3)(E)3.b., (d)(3)(H)1.b. and (d)(3)(H)2.a. filed 8-3-2001; operative 8-3-2001. Submitted to OAL for printing only. Exempt from OAL review pursuant to Labor Code section 142.3 (Register 2001, No. 31).
7. Change without regulatory effect providing more legible illustrations for biohazard symbols filed 3-2-2009 pursuant to section 100, title 1, California Code of Regulations (Register 2009, No. 10).
8. Editorial correction of subsection (g)(2)(E) (Register 2015, No. 37).