(a) Since the onset of the COVID-19 emergency, it has become increasingly common for City residents to see organizations and businesses operate clinical testing sites on City sidewalks and in other public locations. Medical testing sites that both collect specimens and then perform clinical tests on those specimens are called “laboratories” or “clinical laboratories,” and are licensed and regulated by federal Centers for Medicare and Medicaid Services and the California Department of Public Health or the applicable state agency for laboratories outside California. By contrast, sites that collect specimens but do not actually perform clinical tests, and merely send the specimens to a laboratory for testing (“Specimen Collection Sites”) are not subject to CMS or CDPH regulation or oversight.
(b) Generally, under the Health Insurance Portability and Accountability Act and its implementing regulations (collectively, “HIPAA”), Specimen Collection Sites that collect specimens on behalf of covered entities, such as clinical laboratories, are business associates of those covered entities as those terms are defined under HIPAA. Business associates are obligated to follow HIPAA’s privacy and safety requirements.
(c) It is critically important that Specimen Collection Sites in San Francisco protect the privacy of individuals’ health information and comply with health and safety protocols for handling and testing infectious disease specimens. Accordingly, the purpose of this Article 49 is to set forth the minimum privacy and health and safety requirements for Specimen Collection Sites to ensure that such sites are operating in a safe and lawful manner.