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NOTE: HHS has published their implementation guidance table:

Revision Log:

9/9/2022: Updated the OTC reporting guidance document so that the "Performing Organization Address (OBX-24)" does NOT use any state (OBX-24.4) or zip code (OBX-24-5)

3/8/2022: Updated with link to reporting guidance changes on CDC webpage effective 4/4/2022: and added a link to FAQs around OTC reporting


Added this link 3/8/2022:  Over-The-Counter (OTC) Home Testing and CLIA Applicability Frequently Asked Questions - Updated March 4, 2022

Updated 9/9/2022: Update the "Performing Organization Address (OBX-24)" to NOT use any state (OBX-24.4) or zip code (OBX-24-5) - see updated guidance document: 

View file
nameOTC Guidance updated 8-22-22.docx

Flat File

ONLY if no HL7 v2.x support then use flat file to HL7 converter excel file - first box on this page:  But if you have a HL7 v2 feed continue to use and upgrade as quickly as possible.