Many independent pharmacies have stepped up to provide testing for COVID-19, offering a valuable, potentially life-saving service to their communities and creating an opportunity to boost revenues during a time of great economic uncertainty. 

The path to testing requires focus and constant attention to changing federal requirements and state regulations, however. 

Pharmacies need to receive a Clinical Laboratory Improvements Amendments (CLIA) Certificate of Waiver to conduct testing and must enroll as Independent Clinical Diagnostic Laboratories to bill Medicare. They can administer only those tests that have emergency-use authorization for COVID-19 and are approved for use in a pharmacy setting.

On June 4, the U.S. Department of Health and Human Services (HHS) issued new guidelines for pharmacies that are conducting COVID-19 testing. The guidelines outline reporting requirements that will help state and federal agencies track cases and trends and correctly attribute the number of tests performed by pharmacies.

HHS said that pharmacists should “make every reasonable effort to collect complete demographic information and should include such data when ordering a laboratory test to enable the entities performing the test to report these data to state and local public health departments.”

Pharmacists should report the data on a daily basis to HHS through existing public-health reporting systems. The following information should be provided within 24 hours of obtaining test results:

1. Test ordered (using Logical Observation Identifier Names and Codes provided by CDC)
2. Device identifier
3. Test result
4. Test result date
5. Accession number/specimen ID
6. Patient age
7. Patient race
8. Patient ethnicity
9. Patient sex
10. Patient residence ZIP code
11. Patient residence county
12. Ordering provider name and National Provider Identifier (NPI, as applicable)
13. Ordering provider ZIP code
14. Performing facility name and/or CLIA number, if known
15. Performing facility ZIP code
16. Specimen source
17. Date test ordered (date format)
18. Date specimen collected (date format)
19. Is the patient pregnant?
20. Is this a first test for the patient?
21. Is the patient employed in healthcare?
22. Is the patient symptomatic? If so, date of onset?
23. Is the patient hospitalized or a resident of a congregate care facility?

In addition, the American Pharmacy Association said that pharmacists should also report patients’ full name (first, middle initial, last), street address, phone number, and date of birth, and address and phone number for the ordering provider (if any) to state and local public-health agencies. 

Testing data may be submitted through centralized public-health platforms, via messages that adhere to Health Level 7 standards or the CDC-provided CSV format, or through a state or regional Health Information Exchange.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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