(a) Each Covered Operator must provide its Personnel with guidelines for wearing appropriate PPE based on the type of specimen to be collected by Personnel. Covered Operators must provide Personnel with information and training on the proper procedures for putting on and taking off PPE based on the type of specimen collected by the Personnel. Each Covered Operator’s guidelines for wearing appropriate PPE must include the following minimum standards:
(1) If collecting specimens or working within six feet of Examinees, Personnel must wear a Well-Fitted Mask, eye protection, gloves, and a gown.
(2) Personnel who handle specimens, but are not directly involved in collection (e.g., handling self-collected specimens) and not working within six feet of the Examinee, must wear a Well-Fitted Mask and gloves.
(3) Personnel must change gloves after handling a specimen or whenever their gloves become soiled or torn.
(b) Personnel at Specimen Collection Sites must designate a surface area for specimen collection and handling and disinfect that area using a disinfectant product registered with the federal Environmental Protection Agency for use against contagious, infectious, or communicable diseases. Personnel must disinfect the surface areas at the following times: (1) before specimen collection begins each day; (2) after Personnel collect a specimen; (3) when visibly soiled; (4) in the event of a specimen spill; and (5) at the end of every day. Each Covered Operator must at all times during hours of operation make hand sanitizer available for use by Personnel and Examinees.
(c) Each Covered Operator must provide all Examinees a written informed consent form consenting to the collection of the specimen and the testing of that specimen. Before the specimen is collected, the Examinee must sign the informed consent form. Personnel must provide a copy of the signed form, either in hard copy or electronically, to the Examinee.
(d) Each Covered Operator must have written policies covering the following topics:
(1) Specimen collection, storage, and transport, that addresses the specific types of specimens the Specimen Collection Site will collect or are consistent with the test manufacturers’ instructions.
(2) Training of Personnel in PPE requirements; specimen collection, storage, and transport; and protection of personal information of Examinees seeking or considering seeking medical testing at the Specimen Collection Site.
(3) Test Result Notification, including how results are provided to Examinees either by the Covered Operator, its Personnel, or by the CLIA-certified laboratory where the specimens are tested.
(4) A privacy policy regarding Examinees’ medical and health information, biological samples, and test results.
The written policies and procedures specified in subsection (d)(1) through (d)(4) must be provided to: all Personnel; any member of the public, upon request, including, but not limited to, Examinees seeking or considering seeking medical testing at a Specimen Collection Site; City, state, or federal employees conducting inspections or investigations; and any CLIA-certified laboratory where the specimens will be tested to enable the lab to verify the integrity of the specimens being collected.
(e) Covered Operators may use human biological/viral specimens only for (1) clinical testing and (2) laboratory validation and quality control, to the extent such uses are allowed by applicable laws, rules, regulations, and licensure requirements.
(f) Upon request by any member of the public, including, but not limited to, Examinees seeking or considering seeking testing at a Specimen Collection Site, and City, state, or federal employees conducting inspections or investigations, Personnel at Specimen Collection Sites must produce the name of the Specimen Collection Site’s ordering/prescribing provider, where a prescription is required for collection of samples and processing by CDPH-approved laboratories.
(g) Upon request by any member of the public, including, but not limited to, Examinees seeking or considering seeking testing at a Specimen Collection Site, and City, state, or federal employees conducting inspections or investigations, Personnel at Specimen Collection Sites must produce the following documentation from the laboratory that will be processing/performing Tests on the specimens collected at the Specimen Collection Site: (1) a current and valid CLIA license; and (2) a current and valid Clinical and Public Health Laboratory License from CDPH.
(h) A Specimen Collection Site operated by a Covered Operator must comply with all applicable privacy laws, including but not limited to HIPAA. In the event HIPAA does not apply to the Covered Operator, then the Covered Operator must adhere to the same standards as provided by HIPAA to safeguard Examinee confidentiality and medical information.
(i) Each Covered Operator must partner with one of the following entities to perform Tests on behalf of the entity: (a) a governmental entity; (b) a licensed health care provider located in the City; or (c) an educational or academic institution (including but not limited to licensed child care providers, preschools, public and private schools, colleges, universities, and similar institutions of higher learning). Upon request, Personnel at a Specimen Collection Site must demonstrate evidence of the partnership with one of the foregoing entities by producing a written agreement, memorandum, letter, or similar document that shows the entity has requested the Specimen Collection Site perform Tests on behalf of the entity. The ordering prescriber’s standing order, required by subsection (f), shall not constitute sufficient evidence of a partnership.
(j) Covered Operators shall not offer or pay Examinees any remuneration, including anything of value, directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in exchange for, the Examinee using a Test offered by the Covered Operator. The prohibition on remuneration shall not apply to clinical testing performed pursuant to an institutional review board-approved research study or with the approval of the Department.