Is a physician order needed for a COVID-19 test?
A health care practitioner order is required. California Business and Professions Code Section 1288 states, “Any person conducting or operating a clinical laboratory may accept assignments for tests only from and make reports only to persons licensed under the provisions of law relating to the healing arts or their representatives….” In addition to physicians, the U.S. Department of Health and Human Services has issued guidance authorizing pharmacists to order (and administer) COVID-19 tests, including serology tests. This authorization preempts state licensing laws and qualifies pharmacists for immunity from any related claims under the Public Readiness and Emergency Preparedness Act. The California Board of Pharmacy allows pharmacists to order COVID tests also; see Order Waiving Restrictions on Pharmacies, Pharmacists and Pharmacy Technicians Relating to Ordering, Collecting Specimens for, and Performing COVID-19 Tests.
Note also that nurse practitioners and physician assistants are authorized to order COVID-19 tests.
For employee COVID-19 testing, many hospitals have the medical director of the hospital’s employee health department order the tests. (12/14)
What are the hospital lab requirements to perform COVID-19 testing?
Four criteria are used to screen labs for readiness to receive COVID-19 testing:
- Lab has obtained a California clinical laboratory license and Clinical Laboratory Improvement Amendments (CLIA) certificate for high or moderate complexity testing (depending on test categorization)
- Lab is running FDA EUA RT-PCR molecular or antigen-based tests approved for clinical diagnostic use
- Lab is registered with Laboratory Field Services for COVID-19 testing
- Lab is submitting data to the California Reportable Disease Information Exchange (CalREDIE)
What type of COVID-19 tests are available?
There are two different types of tests: diagnostic tests and antibody tests. Diagnostic tests are classified as either a molecular test or an antigen test. The molecular (RT-PCR) test detects the virus’ genetic material, and the antigen test detects specific proteins on the surface of the virus.
Antibody tests detect antibodies that are made by the immune system in response to a threat, such as a specific virus. Antibody tests are called serology tests and should not be used to diagnose an active coronavirus infection. For more information, visit www.fda.gov/consumers/consumer-updates/coronavirus-testing-basics. (6/8)
What types of molecular test kits are available, and what are their specifications for turn-around time, sensitivity, sample method, etc.?
The California COVID-19 Testing Task Force has developed a PCR Test Analysis spreadsheet explaining the individual tests.
There are two things to consider: (1) some molecular assays recently approved are missing, and (2) a number of previously approved assays are on the list but have recently been granted modifications to their protocol. Unfortunately, The Food and Drug Administration no longer provides a summary of changes made, and it removed the initial emergency use authorization (EUA) summary, so there is no easy way to identify the specific changes made without doing a thorough re-review of the EUA and comparing to data collected in this spreadsheet. Anyone interested in a particular assay should look up the details of their protocol at the FDA website.(9/28)
How are testing needs being addressed across the state?
The state has been rapidly increasing its testing capacity through the work of the COVID-19 Testing Task Force. Information on all aspects of testing is available here. (9/28)
The July 14 CDPH testing guidance has been updated as of September 22. Each hospital’s respective city or county may also have specific testing guidance orders or ordinances. (9/28)
How are testing sites determined?
See the “finding a test site” section on testing task force website to locate testing sites in your area. Hospitals that need additional resources should continue to work with their local health officer and send their concerns to the testing task force at [email protected]. (6/4)
How do testing supplies get distributed when the task force identifies them?
The testing task force assesses the field and uses collected data to understand testing capacity and supply issues, and then determines, through the Governor’s Office of Emergency Services’ system, what the Medical Health Operational Area Coordinator (MHOAC) and state and national supplies are, and where the distribution will occur. Decisions by the task force are always made by state officials. Individuals from the private sector are providing important support and do not make decisions. Hospitals can request testing supplies through their MHOAC. (6/5)
Do our labs need to report testing information and, if so, where?
Yes, labs need to report information to the state testing task force, California Reportable Disease Information Exchange (CalREDIE), and to the U.S. Department of Health and Human Services. The state has developed a testing app to replace the manual data entry. (6/5)
We need to test many more people — how can we best direct people to get the coronavirus tests?
If a test comes back positive, what should our immediate next steps be?
The CDPH has allowed that hospitals that complete the CHA COVID-19 tracking tool on a daily basis do not need to report COVID-19 positive and suspected patients to CDPH, but they should continue to report them to the local public health officer. Instructions for the tool are available here. (4/12)
I see that the CDPH suspended a lot of Health and Safety Code laws. Do we still need to report positive COVID-19 test results to the local public health officer?
Yes. Positive COVID-19 test results must be reported to the local public health officer. In addition, your hospital reports the number of COVID-19-positive patients to CDPH daily using the CHA COVID-19 Tracking Tool. (7/20)
When will more testing become available, and how can we access them?
Testing capacity continues to be challenging, with periodic supply shortages (reagents and cassettes). The state is unable to increase hospital supplies that come from your lab platform manufacturer. The federal government has been contracting with many of the lab manufacturers to redistribute supplies to high-priority states, and the manufacturers are unable to keep up with demand. Continue to report your needs to your Medical Health Operational Area Coordinator. Also, consult the COVID -19 Testing Task Force site for labs with additional capacity.
The state has entered into an agreement with Perkin Elmer to set up a “super lab” in Valencia, CA that will be available to anyone and add testing capacity of up to 150,000 tests/day. (9/28)
Are hospitals required to provide testing to skilled-nursing facilities (SNFs), which must implement comprehensive testing programs, including baseline testing of all their residents and staff and residents by the end of June, as well as ongoing surveillance and other training?
No, hospitals are not required to do so. However, many SNFs and local health departments are asking hospitals to assist by providing testing for SNFs in their regions. While some hospitals are able to provide testing support, others are declining, based on limited resources and/or concerns they will not be able to disengage in the future. (6/8)