NOTES to subsection (a)(1):
Accredited laboratory. A laboratory that is licensed by the CDPH pursuant to Title 17 of the California Code of Regulations (CCR), or which has received a certification of competence based on participation in a quality assurance program administered by a governmental or private organization that tests and certifies laboratories.
Aerosol transmissible disease (ATD) or aerosol transmissible pathogen (ATP). A disease or pathogen for which droplet or airborne precautions are required, as listed in Appendix A.
Aerosol transmissible pathogen -- laboratory (ATP-L). A pathogen that meets one of the following criteria:
Airborne infection isolation (AII). Infection control procedures as described in Guidelines for Preventing the Transmission of Mycobacteriumtuberculosis in Health-Care Settings. These procedures are designed to reduce the risk of transmission of airborne infectious pathogens, and apply to patients known or suspected to be infected with epidemiologically important pathogens that can be transmitted by the airborne route.
Airborne infection isolation room or area (AIIR). A room, area, booth, tent, or other enclosure that is maintained at negative pressure to adjacent areas in order to control the spread of aerosolized M. tuberculosis and other airborne infectious pathogens and that meets the requirements stated in subsection (e)(5)(D) of this standard.
Airborne infectious disease (AirID). Either:
Airborne infectious pathogen (AirIP). Either:
Biological safety officer(s). A person who is qualified by training and/or experience to evaluate hazards associated with laboratory procedures involving ATPs-L, who is knowledgeable about the facility biosafety plan, and who is authorized by the employer to establish and implement effective control measures for laboratory biological hazards.
Biosafety level 3. Compliance with the criteria for laboratory practices, safety equipment, and facility design and construction recommended by the CDC in Biosafety in Microbiological and Biomedical Laboratories for laboratories in which work is done with indigenous or exotic agents with a potential for aerosol transmission and which may cause serious or potentially lethal infection.
Biosafety in Microbiological and Biomedical Laboratories (BMBL). Biosafety in Microbiological and Biomedical Laboratories, Fifth Edition, CDC and National Institutes for Health, 2007, which is hereby incorporated by reference for the purpose of establishing biosafety requirements in laboratories.
CDC. United States Centers for Disease Control and Prevention.
CDPH. California Department of Public Health and its predecessor, the California Department of Health Services (CDHS).
Case. Either of the following:
Chief. The Chief of the Division of Occupational Safety and Health of the Department of Industrial Relations, or his or her designated representative.
CTCA. The California Tuberculosis Controllers Association.
Droplet precautions. Infection control procedures as described in Guideline for Isolation Precautions designed to reduce the risk of transmission of infectious agents through contact of the conjunctivae or the mucous membranes of the nose or mouth of a susceptible person with large-particle droplets (larger than 5 µm in size) containing microorganisms generated from a person who has a clinical disease or who is a carrier of the microorganism.
Drug treatment program. A program that is (A) licensed pursuant to Chapter 7.5 (commencing with Section 11834.01), Part 2, Division 10.5 of the Health and Safety Code; or Chapter 1 (commencing with Section 11876), Part 3, Article 3, Division 10.5 of the Health and Safety Code; or (B) certified as a substance abuse clinic or satellite clinic pursuant to Section 51200, Title 22, CCR, and which has submitted claims for Medi-Cal reimbursement pursuant to Section 51490.1, Title 22, CCR, within the last two calendar years or (C) certified pursuant to Section 11831.5 of the Health and Safety Code.
Emergency medical services. Medical care provided pursuant to Title 22, Division 9, by employees who are certified EMT-1, certified EMT-II, or licensed paramedic personnel to the sick and injured at the scene of an emergency, during transport, or during interfacility transfer.
Epidemiology and Prevention of Vaccine-Preventable Diseases. Epidemiology and Prevention of Vaccine-Preventable Diseases. Centers for Disease Control and Prevention, Atkinson W, Hamborsky J, McIntyre L, Wolfe S, eds. 10th ed. 2nd printing, including chapters from the 9th edition on Anthrax and Smallpox, Washington DC: Public Health Foundation, 2008, which is hereby incorporated by reference.
Exposure incident. An event in which all of the following have occurred:
Exposure incident (laboratory). A significant exposure to an aerosol containing an ATP-L, without the benefit of applicable exposure control measures required by this section.
Field operation. An operation conducted by employees that is outside of the employer's fixed establishment, such as paramedic and emergency medical services or transport, law enforcement, home health care, and public health.
Guideline for Isolation Precautions. The Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, June 2007, CDC, which is hereby incorporated by reference for the sole purpose of establishing requirements for droplet and contact precautions.
Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings. The Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, December 2005, CDC, which is hereby incorporated by reference for the sole purpose of establishing requirements for airborne infection isolation.
Health care provider. A physician and surgeon, a veterinarian, a podiatrist, a nurse practitioner, a physician assistant, a registered nurse, a nurse midwife, a school nurse, an infection control practitioner, a medical examiner, a coroner, or a dentist.
Health care worker. A person who works in a health care facility, service or operation, or who has occupational exposure in a public health service described in subsection (a)(1)(D).
High hazard procedures. Procedures performed on a person who is a case or suspected case of an aerosol transmissible disease or on a specimen suspected of containing an ATP-L, in which the potential for being exposed to aerosol transmissible pathogens is increased due to the reasonably anticipated generation of aerosolized pathogens. Such procedures include, but are not limited to, sputum induction, bronchoscopy, aerosolized administration of pentamidine or other medications, and pulmonary function testing. High Hazard Procedures also include, but are not limited to, autopsy, clinical, surgical and laboratory procedures that may aerosolize pathogens.
Individually identifiable medical information. Medical information that includes or contains any element of personal identifying information sufficient to allow identification of the individual, such as the patient's name, address, electronic mail address, telephone number, or social security number, or other information that, alone or in combination with other publicly available information, reveals the individual's identity.
Infection control PLHCP. A PLHCP who is knowledgeable about infection control practices, including routes of transmission, isolation precautions and the investigation of exposure incidents.
Initial treatment. Treatment provided at the time of the first contact a health care provider has with a person who is potentially an AirID case or suspected case. Initial treatment does not include high hazard procedures.
Laboratory. A facility or operation in a facility where the manipulation of specimens or microorganisms is performed for the purpose of diagnosing disease or identifying disease agents, conducting research or experimentation on microorganisms, replicating microorganisms for distribution or related support activities for these processes.
Latent TB infection (LTBI). Infection with M. tuberculosis in which bacteria are present in the body, but are inactive. Persons who have LTBI but who do not have TB disease are asymptomatic, do not feel sick and cannot spread TB to other persons. They typically react positively to TB tests.
Local health officer. The health officer for the local jurisdiction responsible for receiving and/or sending reports of communicable diseases, as defined in Title 17, CCR.
NOTE: Title 17, Section 2500 requires that reports be made to the local health officer for the jurisdiction where the patient resides.
M. tuberculosis. Mycobacterium tuberculosis complex, which includes M. tuberculosis, M. bovis, M. africanum, and M. microti. M. tuberculosis is the scientific name of the group of bacteria that cause tuberculosis.
Medical specialty practice. A medical practice other than primary care, general practice, or family medicine.
Negative pressure. A relative air pressure difference between two areas. The pressure in a containment room or area that is under negative pressure is lower than adjacent areas, which keeps air from flowing out of the containment facility and into adjacent rooms or areas.
NIOSH. The Director of the National Institute for Occupational Safety and Health, CDC, or his or her designated representative.
Non-medical transport. The transportation by employees other than health care providers or emergency medical personnel during which no medical services are reasonably anticipated to be provided.
Novel or unknown ATP. A pathogen capable of causing serious human disease meeting the following criteria:
NOTE: Variants of the human influenza virus that typically occur from season to season are not considered novel or unknown ATPs if they do not differ significantly in virulence or transmissibility from existing seasonal variants. Pandemic influenza strains that have not been fully characterized are novel pathogens.
Occupational exposure. Exposure from work activity or working conditions that is reasonably anticipated to create an elevated risk of contracting any disease caused by ATPs or ATPs-L if protective measures are not in place. In this context, "elevated" means higher than what is considered ordinary for employees having direct contact with the general public outside of the facilities, service categories and operations listed in subsection (a)(1) of this standard. Occupational exposure is presumed to exist to some extent in each of the facilities, services and operations listed in subsection (a)(1)(A) through (a)(1)(I). Whether a particular employee has occupational exposure depends on the tasks, activities, and environment of the employee, and therefore, some employees of a covered employer may have no occupational exposure. For example, occupational exposure typically does not exist where a hospital employee works only in an office environment separated from patient care facilities, or works only in other areas separate from those where the risk of ATD transmission, whether from patients or contaminated items, would be elevated without protective measures. It is the task of employers covered by this standard to identify those employees who have occupational exposure so that appropriate protective measures can be implemented to protect them as required. Employee activities that involve having contact with, or being within exposure range of cases or suspected cases of ATD, are always considered to cause occupational exposure. Similarly, employee activities that involve contact with, or routinely being within exposure range of, populations served by facilities identified in subsection (a)(1)(E) are considered to cause occupational exposure. Employees working in laboratory areas in which ATPs-L are handled or reasonably anticipated to be present are also considered to have occupational exposure.
Physician or other licensed health care professional (PLHCP) means an individual whose legally permitted scope or practice (i.e., license, registration, or certification) allows him or her to independently provide, or be delegated the responsibility to provide, some or all of the health care services required by this section.
Public health guidelines.
Referral. The directing or transferring of a possible ATD case to another facility, service or operation for the purposes of transport, diagnosis, treatment, isolation, housing or care.
Referring employer. Any employer that operates a facility, service, or operation in which there is occupational exposure and which refers AirID cases and suspected cases to other facilities. Referring facilities, services and operations do not provide diagnosis, treatment, transport, housing, isolation or management to persons requiring AII. General acute care hospitals are not referring employers. Law enforcement, corrections, public health, and other operations that provide only non-medical transport for referred cases are considered referring employers if they do not provide diagnosis, treatment, housing, isolation or management of referred cases.
Reportable aerosol transmissible disease (RATD). A disease or condition which a health care provider is required to report to the local health officer, in accordance with Title 17 CCR, Division 1, Chapter 4, and which meets the definition of an aerosol transmissible disease (ATD).
Respirator. A device which has met the requirements of 42 CFR Part 84, has been designed to protect the wearer from inhalation of harmful atmospheres, and has been approved by NIOSH. for the purpose for which it is used.
Respirator user. An employee who in the scope of their current job may be assigned to tasks which may require the use of a respirator, in accordance with subsection (g).
Respiratory Hygiene/Cough Etiquette in Health Care Settings. Respiratory Hygiene/Cough Etiquette in Health Care Settings, CDC, November 4, 2004, which is hereby incorporated by reference for the sole purpose of establishing requirements for source control procedures.
Screening (health care provider). The initial assessment of persons who are potentially AirID or ATD cases by a health care provider in order to determine whether they need airborne infection isolation or need to be referred for further medical evaluation or treatment to make that determination. Screening does not include high hazard procedures.
Screening (non health care provider). The identification of potential ATD cases through readily observable signs and the self-report of patients or clients. Screening does not include high hazard procedures.
Significant exposure. An exposure to a source of ATPs or ATPs-L in which the circumstances of the exposure make the transmission of a disease sufficiently likely that the employee requires further evaluation by a PLHCP.
Source control measures. The use of procedures, engineering controls, and other devices or materials to minimize the spread of airborne particles and droplets from an individual who has or exhibits signs or symptoms of having an ATD, such as persistent coughing.
Surge. A rapid expansion beyond normal services to meet the increased demand for qualified personnel, medical care, equipment, and public health services in the event of an epidemic, public health emergency, or disaster.
Susceptible person. A person who is at risk of acquiring an infection due to a lack of immunity as determined by a PLHCP in accordance with applicable public health guidelines.
Suspected case. Either of the following:
TB conversion. A change from negative to positive as indicated by TB test results, based upon current CDC or CDPH guidelines for interpretation of the TB test
Test for tuberculosis infection (TB test). Any test, including the tuberculin skin test and blood assays for M. Tuberculosis (BAMT) such as interferon gamma release assays (IGRAs) which:
NOTE: Where surveillance for LTBI is required by Title 22, CCR, the TB test must be approved for this use by the CDPH.
Tuberculosis (TB). A disease caused by M. tuberculosis.
UVGI. Ultraviolet germicidal irradiation.
NOTES to subsection (c)(3):
EXCEPTION to subsection (c)(5)(C): Law enforcement or corrections personnel who transport a person requiring referral in a vehicle need not use respiratory protection if all of the following conditions are met:
EXCEPTION to subsection (c)(6)(D): Seasonal influenza vaccine shall be provided during the period designated by the CDC for administration and need not be provided outside of those periods.
EXCEPTION to subsection (d)(1): Employers with laboratory operations in which employees do not have direct patient contact may establish, implement and maintain an effective, written Biosafety Plan meeting the requirements of subsection (f) in lieu of an Exposure Control Plan for those operations.
NOTE: These work practices may include, but are not limited to; handwashing and gloving procedures; the use of anterooms; and cleaning and disinfecting contaminated surfaces, articles and linens.
EXCEPTIONS to subsection (e)(5)(B):
EXCEPTION to subsection (e)(5)(C): Where no AII room or area is available and the treating physician determines that it would be detrimental to the patient's condition to delay performing the procedure, high hazard procedures may be conducted in other areas. In that case, employees working in the room or area where the procedure is performed shall use respiratory protection, in accordance with subsection (g) and Section 5144, Respiratory Protection of these orders, and shall use all necessary personal protective equipment.
NOTE: Employers with laboratory operations in which employees have direct contact with cases or suspected cases are also required to comply with applicable portions of subsections (d), (e), (g), (h), (i) and (j).
EXCEPTION to subsection (f)(4)(K): Research and production laboratories in which it is not reasonably anticipated that materials containing M. Tuberculosis will be present need not provide surveillance for LTBI.
NOTE to subsection (g)(2): The respiratory protection program may be incorporated into the ATD Exposure Control Plan or the Biosafety Plan.
EXCEPTION 1 to subsection (g)(3)(B): Where a high hazard procedure is performed by placing the patient in a booth, hood or other ventilated enclosure that effectively contains and removes the aerosols resulting from the procedure, and the employee remains outside of the enclosure, the employee may use a respirator meeting the requirements of subsection (g)(3)(A).
EXCEPTION 2 to subsection (g)(3)(B): Paramedics and other emergency medical personnel in field operations may use a P100, R100 or N100 respirator in lieu of a PAPR, providing that the respirator is used in accordance with its NIOSH approval. If an employer selects N100 respirators for use under this subsection, the employer's respiratory protection program and employee training must address how an environment will be assessed for the presence of oil aerosols and how alternate respiratory protection will be made available to employees who must use respirators under conditions for which N materials are not suitable.
EXCEPTIONS to subsection (g)(4)(H):
EXCEPTION to subsection (g)(6)(B)3: Until January 1, 2014, employers may increase the interval for repeat fit testing to no more than two years for employees who do not perform high hazard procedures and are not using respirators for protection against laboratory generated aerosols. Employers shall provide to each employee who is not fit-tested within the previous 12 months a respirator fit-test screening that includes the information in Appendix G, and that obtains a response to the questions included in Appendix G. As of January 1, 2015, an employee who uses a respirator under this section shall have been fit-tested within the previous 12 months.
EXCEPTION to subsection (h)(3): Research and production laboratories in which M. tuberculosis containing materials are not reasonably anticipated to be present, need not provide assessment for LTBI infection.
EXCEPTION to subsection (h)(5): Where the employer cannot implement these procedures because of the lack of availability of vaccine, the employer shall document efforts made to obtain the vaccine in a timely manner and inform employees of the status of the vaccine availability, including when the vaccine is likely to become available. The employer shall check on the availability of the vaccine at least every 60 calendar days and inform employees when the vaccine becomes available.
NOTE 1 to subsection (h)(6)(B): These employees may include, but are not limited to, paramedics, emergency medical technicians, emergency responders, home health care personnel, homeless shelter personnel, personnel at referring health care facilities or agencies, and corrections personnel.
NOTE 2 to subsection (h)(6)(B): Some diseases, such as meningococcal disease, require prompt prophylaxis of exposed individuals to prevent disease. Some diseases, such as varicella, have a limited window in which to administer vaccine to non-immune contacts. Exposure to some diseases may create a need to temporarily remove an employee from certain duties during a potential period of communicability. For other diseases such as tuberculosis there may not be a need for immediate medical intervention, however prompt follow up is important to the success of identifying exposed employees.
EXCEPTION to subsection (h)(8)(B): Precautionary removal provisions do not extend to any period of time during which the employee is unable to work for reasons other than precautionary removal.
EXCEPTION 1 to subsection (h)(10): Seasonal influenza vaccine shall be provided during the period designated by the CDC for administration, and need not be provided outside of those periods.
EXCEPTION 2 to subsection (h)(10): In lieu of the statement in Appendix C2, the employer may utilize an influenza vaccine declination statement acceptable to the CDPH in accordance with Health and Safety Code Section 1288.7.
EXCEPTION: Research and production laboratories do not need to include training on surveillance for LTBI if M. tuberculosis containing materials are not reasonably anticipated to be present in the laboratory.
NOTE to subsection (j)(1)(A): This record may be combined with the medical record required by Section 5193, Bloodborne Pathogens, of these orders, but may not be combined with non-medical personnel records.
EXCEPTION to subsection (j)(1)(B)2.: As to seasonal influenza vaccine, the medical record need only contain a declination form for the most recent seasonal influenza vaccine.
NOTE to subsection (j)(1)(C): These provisions do not apply to records that do not contain individually identifiable medical information, or from which individually identifiable medical information has been removed.
Cal. Code Regs. Tit. 8, § 5199
2. Amendment of subsection (g)(3)(B) -- EXCEPTION 2 filed 8-1-2013; operative 10-1-2013 (Register 2013, No. 31).
Note: Authority cited: Sections 142.3 and 6308, Labor Code. Reference: Sections 142.3 and 6308, Labor Code; and 8 CCR 332.3.
2. Amendment of subsection (g)(3)(B) - EXCEPTION 2 filed 8-1-2013; operative 10-1-2013 (Register 2013, No. 31).