ORDER OF THE MARIN COUNTY PUBLIC HEALTH OFFICER ESTABLISHING SAFETY REQUIREMENTS FOR COLLECTING AND HANDLING CLINICAL SPECIMENS FOR COVID-19 TESTING BY PRIVATE OPERATORS OF SPECIMEN COLLECTION SITES
Date of Order: January 28, 2022
Please read this Order carefully. Violation of or failure to comply with this Order is a misdemeanor punishable by fine, imprisonment, or both. (California Health and Safety Code § 120295, et seq.; Cal. Penal Code §§ 69, 148(a)(1); Marin Municipal Code Chapter 7.99 et seq.)
Summary. Marin County is currently experiencing a surge in new COVID-19 cases and hospitalizations due to the highly contagious Omicron variant, with the increase in hospitalizations mostly among the unvaccinated. Due to the nature of the Omicron variant, people who are fully vaccinated, including people who have received a booster, have been infected mainly with mild disease and are showing symptoms. Very few fully-vaccinated or boosted people have required hospitalization. Timely access to COVID-19 testing is an important way to address the current surge and potential future surges. Individuals who have a COVID-19 symptom or who have been a close contact of someone with COVID-19 should get tested as quickly as possible. As a result, ensuring the integrity of COVID-19 testing operations is of the utmost importance. COVID-19 testing sites sometimes offer on-site testing for serological (antibody) tests or rapid molecular or antigen tests; they sometimes also collect specimens for molecular testing, which are then submitted to an off-site laboratory for clinical testing. Operators of some sites are doing both. Operators of sites that do not actually perform clinical laboratory tests for SARS-CoV-2 on the premises are operating as Specimen Collection Sites (as defined below). It is critically important that collection and testing at Specimen Collection Sites observe best health and safety practices for handling and testing infectious disease specimens. Testing sites that perform clinical laboratory tests on the premises are licensed and regulated by the United States Centers for Medicare & Medicaid Services (CMS) and the California Department of Public Health (CDPH). But sites that operate solely as Specimen Collection Sites are not subject to CMS or CDPH regulation or oversight. Accordingly, this Order sets forth health and safety requirements for private operators acting solely as COVID-19 Specimen Collection Sites to help ensure that such sites are operating in a safe and lawful manner.
UNDER THE AUTHORITY OF CALIFORNIA HEALTH AND SAFETY CODE SECTIONS 101040, 101085, AND 120175, THE HEALTH OFFICER OF THE COUNTY OF MARIN (“HEALTH OFFICER”) ORDERS:
- Definitions. For purposes of this Order, the following initially capitalized terms have the meanings given below:
a. County. The “County” means the County of Marin.
b. Covered Operators. “Covered Operators” has the meaning given in Section 2.
c. COVID-19. “COVID-19” means coronavirus disease 2019, the disease caused by the SARS-CoV-2 virus and that resulted in a global pandemic.
d. CDPH. “CDPH” means the California Department of Public Health.
e. Enforcement Officer. “Enforcement Officer” has the definition provided in Chapter 7.99.02 of the Marin County Municipal Code and includes, but is not limited to, law enforcement officers, code enforcement officers, park rangers, the Health Officer, and other designated individuals.
f. Personnel. “Personnel” means the following people: employees; contractors and sub-contractors (such as those who sell goods or perform services onsite or who deliver goods for the Covered Operator); independent contractors; vendors who are permitted to sell goods onsite; volunteers; and other individuals who regularly provide services onsite.
g. PPE. “PPE” means personal protective equipment, including gowns or other protective clothing, gloves, face shields, goggles, Well-Fitted Masks, and other equipment designed to protect the wearer and those around the wearer from the spread of COVID-19.
h. Specimen Collection Site. “Specimen Collection Site” means sites where specimens for COVID-19 Testing are obtained from a person and then sent to an off-site CLIA certified lab for clinical processing. Specimen Collection Sites do not include sites where clinical laboratory tests are performed on the premises, which are regulated by CDPH and the United States Centers for Medicare & Medicaid Services (CMS).
i. Testing. “Testing” (also being “Tested” or a “Test”) means the use of a diagnostic test to detect SARS-CoV-2 using a test that is approved or has emergency use authorization for diagnosis by the United States Food and Drug Administration, including “molecular” or nucleic acid amplification tests—such as polymerase chain reaction (“PCR”) or loop-mediated amplification (“LAMP”) testing—or antigen tests.
j. Well-Fitted Mask. A “Well-Fitted Mask” means a face covering that is well-fitted to an individual and covers the nose and mouth especially while talking. CDC guidance regarding Well-Fitted Masks may be found at www.cdc.gov/coronavirus/2019-ncov/your-health/effective-masks.html. A well-fitting non-vented N95, KN95, or KF94 respirator is strongly recommended as a Well-Fitted Mask, even if not fit-tested, to provide maximum protection. A well-fitting surgical/procedural mask with a cloth mask worn over it to increase fit is also recommended. Given higher transmissibility of the Omicron variant, cloth masks alone are no longer recommended. 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.
- Application. This Order applies to private for-profit and nonprofit persons, companies, or other organizations in the business of operating one or more Specimen Collection Sites anywhere in the County (“Covered Operators”). It does not apply to government entities or to any facility (such as a general acute care hospital, skilled nursing facility, or ambulatory clinic) that is subject to regulation by CDPH. The business of collecting specimens for COVID-19 Testing includes, without limitation, collecting specimens without charge to the person seeking a COVID-19 test and instead seeking reimbursement or payment from insurance companies or federal, state, or local governmental agencies.
- Requirements for Specimen Collection Sites. Covered Operators of Specimen Collection Sites in the City must comply with all of the following health and safety requirements:
a. Personal Protective Equipment (PPE).
i. If collecting specimens or working within six feet of patients, Personnel must wear a well-fitting N95 (or higher-level) respirator, eye protection, gloves, and a gown.
ii. 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 person providing the specimen, must wear a Well-Fitted Mask and gloves.
iii. Personnel must change gloves after handling a specimen and whenever their gloves become soiled or torn.
iv. Covered Operators must provide Personnel with information and training on the proper procedures for putting on and taking off PPE. Examples include: https://www.cdc.gov/hai/pdfs/ppe/ppe-sequence.pdf.
b. Sanitation and Hygiene.
i. Personnel at Specimen Collection Sites must designate a surface area for specimen collection and handling and disinfect that area—using products on the EPA-approved “N” list, which can be found online here: https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-aga… at these times:
· Before specimen collection begins each day
· At least hourly during the day
· When visibly soiled
· In the event of a specimen spill
· At the end of every day
ii. Specimen Collection Sites must at all times during hours of operation have hand sanitizer available for use by Personnel and people providing specimens for COVID-19 Testing.
c. Informed Consent. Covered Operators must provide all individuals from whom a specimen is collected at the Specimen Collection Site a written informed consent form. The form must be signed by the individual from whom the specimen is collected and a copy of the form must be provided (either in hard copy or electronically) to the individual.
d. Written Policies and Procedures.
i. Covered Operators must have written policies as follows:
(1) Written policies concerning specimen collection, storage and transport that are consistent with the U.S. Centers for Disease Control and Prevention’s “Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing” (available at https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-speci…) or the test manufacturers’ instructions.
(2) Written policies detailing how Personnel are trained in (a) PPE requirements; (b) specimen collection, storage and transport; and (c) protection of personal information of people seeking or considering seeking COVID-19 Testing at the Specimen Collection Site.
(3) Written policies concerning result notification—i.e., how results are provided to people providing specimens, including whether results are provided by the company running the Specimen Collection Site or by the CLIA certified laboratory where the specimens are tested.
ii. The written policies specified above must be provided to:
(1) all Personnel;
(2) any member of the public, upon request—including, but not limited to, people seeking or considering seeking COVID-19 Testing at a Specimen Collection Site operated by the Covered Operator, and County, state, or federal employees conducting inspections or investigations—upon request; and
(3) any CLIA certified laboratory where the specimens will be tested, to enable the lab to verify the integrity of the specimens being collected, as required by CDPH Lab Field Services “Guidance for COVID-19 Collection and Testing Sites” (available at https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/COVID-19Guidance.aspx).
e. Use of Human Biological/Viral Specimens. Covered Operators may use human biological/viral specimens only for (1) COVID-19 clinical testing and (2) COVID-19 laboratory validation and quality control as permitted by applicable laws, rules, regulations, and licensure requirements, and for no other purpose.
f. Documentation of Ordering Prescriber. Upon request by any member of the public—including, but not limited to, people seeking or considering seeking COVID-19 Testing at a Specimen Collection Site operated by the Covered Operator, and County, state, or federal employees conducting inspections or investigations—Personnel at Specimen Collection Sites must be able to produce the name of a valid ordering/prescribing provider, as required for collection of samples and processing by CDPH-approved laboratories.
g. Documentation Regarding Lab for Clinical Processing. Upon request by any member of the public—including, but not limited to, people seeking or considering seeking COVID-19 Testing at a Specimen Collection Site operated by the Covered Operator, and County, state, or federal employees conducting inspections or investigations—Personnel at Specimen Collection Sites must be able to produce the following documentation from the lab 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
- Enforcement. Under Government Code sections 26602 and 41601 and Health and Safety Code section 101029, the Health Officer requests that the Sheriff and the Chiefs of Police in the County ensure compliance with and enforce this Order. The violation of any provision of this Order constitutes an imminent threat and immediate menace to public health, constitutes a public nuisance, and is punishable by fine, imprisonment, or both. The Marin County Department of Public Health is authorized to respond to such public nuisances by issuing Notice(s) of Violation and ordering Specimen Collection Sites closed until the owner or manager submits a written plan to eliminate all violations and finds that plan satisfactory. Such Notice(s) of Violation and orders to vacate and close may be issued based on a written report made by any Enforcement Officer writing the report within the scope of their duty. As a condition of allowing a Specimen Collection Site to reopen, Marin County Public Health may impose additional restrictions and requirements on the site as Marin County Public Health deems appropriate to reduce transmission risks, beyond those required by this Order.
- Effective Date. This Order shall become effective at 12:01am on January 28, 2022. This Order shall continue to be in effect until it is rescinded, superseded, or amended in writing by the Health Officer.
- Copies. Copies of this Order shall promptly be: (1) made available at the Bulletin Board adjacent to the entrance to the Chambers of the Board of Supervisors, Room 330, Administration Building, and in the display case in the center arch of the Hall of Justice, Marin County Civic Center, San Rafael, California; (2) posted on the County of Marin website (www.marincounty.org) as well as the County of Marin Department of Health and Human Services website (www.marinhhs.org); and (3) provided to any member of the public requesting a copy of this Order.
- Severability. If any provision of this Order or its application to any person or circumstance is held to be invalid, the remainder of the Order, including the application of such part or provision to other persons or circumstances, shall not be affected and shall continue in full force and effect. To this end, the provisions of this Order are severable.
IT IS SO ORDERED:
Matt Willis MD, MPH
Health Officer of the County of Marin
Dated: January 27, 2022