SF’s Health Officer issued a new Health Order requiring privately run COVID-19 testing sites that collect specimens and send off-site for processing to follow new health and safety requirements in the collection of specimens. While sites that perform clinical laboratory tests are already required to be licensed and follow proper protocols, there has been a gap in health and safety regulation of sites that only perform the specimen collection portion of COVID-19 testing.
The new health and safety requirements include personal protective equipment (PPE) for staff, use of proper sanitation measures, and a requirement to have written policies on specimen collection, storage, and transport consistent with the U.S. Centers for Disease Control and Prevention (CDC) or the manufacturer's instructions that are available to anyone upon request.
COVID-19 testing sites sometimes offer on-site testing for rapid molecular or antigen tests. Sometimes they 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.”
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.
The Order, which became operational on January 25 and remains in effect until rescinded or modified, is filling in a gap in state and local regulation of private operators by requiring health and safety protocols for those sites that collect specimens and send to an off-site lab.
The requirements that the covered operations must comply with, include:
- Personal protective equipment (PPE) for staff
- Disinfecting of surfaces used for specimen handling and collection at regular intervals
- Making hand sanitizer available for use
- Written informed consent
- Written policies governing
- Specimen collection, storage, and transport (that are consistent with the CDC’s Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing” or the test manufacturers’ instructions)
- Personnel training
- Result notification
- Provide written policies to all Personnel, the CLIA lab where swabs are sent, and anyone else upon request (including people interested in tests and city investigators)
- Use biological 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
- Provide, upon request, information about the ordering provider
- Provide, upon request, CLIA and CDPH license of the lab where swabs will be processed
A copy of the full Health Order can be found at the following link: https://www.sfdph.org/dph/alerts/coronavirus-healthorders.asp