Specifications include, but are not limited to: 1. Lab must be located in the State of Utah.Description
2. Lab must have a current certificate from Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate or high complexity tests and be in good standing with CLIA.3. Lab must have experience with DNA/RNA extraction processes (manual and automated) as well as previously demonstrated proficiency with PCR.4. Lab must use an FDA approved COVID-19 test(s) and operate within the approved Emergency Use Authorization(s) (EUA(s)) for the test(s) or demonstrate that it has completed any required bridging studies if it is operating outside of an approved EUA.5. Lab must have experience processing over 1,000 COVID-19 diagnostic tests per day or demonstrate similar experience with other diagnostic tests.6. Lab must be able to obtain sufficient supplies and materials to extract samples from over 1,000 COVID-19 collection kits per day and to process the tests.7. Lab must be able to send all test results to the UDOH via HL7 electronic messaging per mandatory reporting rules - U.C.A. § 26-6, R386-702. The electronic messages must contain all required reporting elements and meet required reporting timelines for immediately reportable conditions.1. The following elements from R386-702-7 (1) must be provided at a minimum:1. (a) (i - vi)2. (b) (i - ii) (for the sample collection site)3. (d) (i - vii)2. Laboratory test date must also be provided.8. The vendor must agree to use messaging consistent with what UDOH recommends for reporting test results to individuals.9. Vendor must agree to participate in objective proficiency tests upon request by the Eligible User.