EXCEPTION: This regulation does not apply to the construction industry.
"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:
"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:
"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:
"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:
"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:
"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).
NOTE: Frequency of use may be approximated by any reasonable and effective method.
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:
EXCEPTION: Contaminated sharps may be bent, recapped or removed from devices if:
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.
When any container of contaminated sharps is moved from the area of use for the purpose of disposal, the container shall be:
Specimens of blood or OPIM shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping.
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.
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.
NOTE: Surgical masks are not respirators.
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.
NOTE: Treatment of medical waste should meet the requirements of Health and Safety Code Section 118215.
NOTE: Treatment of medical waste should meet the requirements of Health and Safety Code Section 118215.
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:
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:
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.
Medical records required by this standard shall be maintained in accordance with subsection (h)(1) of this section.
NOTE: Other labeling provisions, such as Health and Safety Code Sections 118275 through 118320 may be applicable.
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.
(Name of the Infectious Agent)
(Special requirements for entering the area)
(Name, telephone number of the laboratory director or other responsible person.)
NOTE: Additional training is required for employees of HIV, HBV, and HCV Research Laboratories and Production Facilities, as described in subsection (e)(5).
The Sharps Injury Log shall be maintained 5 years from the date the exposure incident occurred.
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.
Cal. Code Regs. Tit. 8, § 5193
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).
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.
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).