BHS COVID Testing Playbook:
SARS-CoV-2 Diagnostic Competency-Based Training
Testing plans change often based on availability of test kits and regulations.
After completing the training sections of this document, trainees can take the 3-part online post-test located here. A passing score of 100% is required to complete the training. The tests can be taken as many times as necessary to receive a passing score.
Trainees must also complete an in-person or virtual session with CORRT to be cleared to conduct COVID testing.
OPTIONAL: If you want 1.5 CE credit for this training, then you must complete the pre-test and the course evaluation.
Brief Introduction Video.
If you want a quick answer of WHY you have to complete this training, testing, and check-off,
then watch "Oversight of Point of Care Testing".
Quest Diagnostics - PCR NAAT Test
Use this sample order form when submitting a PCR lab test to Quest Diagnostics.
The client's insurance information must be included, along with all other information.
Failure to provide this information may result in the test being cancelled.
The tube MUST be labeled clearly with the client's full name, date of birth, and collection date.
CDPH COVID Testing Information
Staff who are conducting COVID-19 testing should be familiar information from these links & handouts.
Appendices
Appendix E: Consent Protocol
NOTE: Because SARS-CoV2 is recognized as a communicable disease, which is required to be reported, California state law provides that minors 12 years and older can consent to diagnosis and treatment of COVID-19. Minors ages 12-17 may consent on their own and receive results through their own contact information or through their parent’s contact information. For minors under the age of 12, the parent or legal guardian must provide consent, and use their email/phone to obtain results. Participants must sign consent form (either on printout or electronically through software platform).
Appendix G - Quality Control (QC) Log
A new QC Check must be performed
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements for waived testing state that a testing site must follow the current manufacturer’s instructions provided with the test. This includes instructions for quality control (QC).
QC is designed to detect problems that might arise because of reagent or test kit deterioration, instrument malfunction, improper environmental conditions, or operator error. Performing QC testing procedures provides assurance that the test is performing as expected
and alerts the user when problems occur. QC procedures should describe the type of controls to be used, how to perform QC testing, frequency of QC testing, and actions to be taken when QC results are unacceptable.
QC material should be treated the same as patient samples by being tested in the same way that patient samples would be tested. QC is usually performed with:
● each new operator,
● after an instrument is serviced,
● when reagent lots are changed,
● when test kit temperatures exceed the manufacturer’s limits, ● after calibration, and
● when patient results seem questionable.
Refer to the manufacturer’s instructions for specific QC requirements for each test that your facility performs. Each testing site should determine the appropriate QC frequency for each test system. Keep in mind that the frequency of QC testing cannot be less than what is specified in the manufacturer’s instructions.
Appendix K: Billing for PCR
State Lab (Color): Where the test is covered by the patient’s health coverage (see categories below), the state has contracted with a third-party vendor to submit claims. Therefore, patients will be asked to provide information about their health coverage. Patients without health coverage will be asked to attest that they do not have insurance and provide their State ID or driver’s license number (if applicable).
Note: Patients can take the tests without State IDs, driver’s licenses, or insurance. They can optionally show these items so the State can receive reimbursement from the Federal government.
Appendix L - Site COVID Testing Lead
To Test or Note to Test?
Considerations for Waived Testing, contains tips, reminders, and resources for your testing site.
Statement of Compliance
This playbook was created to meet the following compliance requirements:
The Clinical Laboratory Improvement Amendments of 1988 (CLIA)
Health Resources & Services Administration (HRSA) COVID-19 Testing Supply and N95 Mask Program Conditions of Participation
COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Ace Section 18115 (January 8, 2021)
CDPH AFL 21-25
CA Title 17 CCR section 2500
CA Title 22 CFR sections 70737(a) & 70751