Part 2: Regulatory compliance

Agencies should ensure and document that their activities are in compliance with all applicable federal, state, and local laws and regulations. For example, if you are planning to use rapid HIV testing, then you should 1) obtain a Certificate of Waiver under the Clinical Laboratory Improvement Amendment (CLIA), or 2) establish a relationship with a laboratory to operate under the laboratory’s CLIA certificate. Also necessary is evidence of compliance with CLIA requirements and relevant state and local regulations applicable to waived HIV testing in the settings proposed for the program.

Agencies should ensure that all staff are appropriately credentialed for the functions they will be performing (e.g., state credentialing for HIV CTR, if required). Protocols should describe how agencies will ensure and document that their activities are in compliance with applicable laws and regulations and that all staff are appropriately credentialed.

Agencies should be aware of, and comply with, any state or local requirements related to the Health Information Portability Privacy Act. Protocols should clearly describe such requirements and how they will be addressed.

Go to Section 3 part 3