For purposes of this Article 49, the following terms have the following meanings:
“CDC” means the federal Centers for Disease Control and Prevention.
“CDPH” means the California Department of Public Health.
“City” means the City and County of San Francisco.
“CLIA” means the Clinical Laboratory Improvement Amendments, codified at 42 U.S.C. § 263a, as it may be amended from time to time, and including any implementing regulations or guidance promulgated by CMS, the CDC, or the federal Food and Drug Administration.
“CMS” means the federal Centers for Medicare and Medicaid Services.
“Covered Operator” means a private, for-profit or non-profit person, company, or other organization operating one or more Specimen Collection Sites anywhere in the City. Covered Operator includes a person, company, or organization that collects specimens without charge to the Examinee, regardless of whether reimbursement or payment is sought from insurance companies or federal, state, or local governmental agencies. Covered Operator does not include government entities or any facility (such as a general acute care hospital, skilled nursing facility, or ambulatory clinic) that directly collects specimens and is subject to regulation by CDPH.
“Department” means the San Francisco Department of Public Health.
“Director” means the Director of Health, or the Director’s designee.
“Examinee” means an individual providing a specimen to the Specimen Collection Site.
“Personnel” means employees, contractors and sub-contractors, including but not limited to those who sell goods or perform services onsite or who deliver goods for the Covered Operator, vendors who are permitted to sell goods onsite, volunteers, and other individuals who regularly provide services to a Covered Operator.
“PPE” means Personal Protective Equipment.
“Specimen Collection Site” means a site where a Covered Operator or its Personnel obtain specimens for testing for medical or health conditions, including by way of example but not limitation, COVID-19 and flu, from an Examinee and for delivery to an off-site CLIA-certified laboratory for clinical processing. Specimen Collection Sites do not include sites regulated by CMS or CDPH where clinical laboratory tests are performed on the premises.
“Test” means the diagnostic test used to detect any infectious, contagious, or communicable disease and that the Covered Operator sends to a CLIA-certified laboratory for clinical processing.
“Well-Fitted Mask” means a face covering that is well-fitted to an individual and covers the nose and mouth while talking. A Well-Fitted Mask does not include a scarf, ski mask, balaclava, bandana, turtleneck, collar, or single layer of fabric, or any mask that has an unfiltered one-way exhaust valve.