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Laboratories that wish to perform HIV testing must receive approval from the Department of Public Health (DPH) prior to beginning testing. The following information must be submitted to DPH for review:
All hospital and clinic laboratories must submit evidence that the HIV testing policies have been approved by an internal review mechanism. This mechanism can be an already established committee at the hospital or clinic, such as the Infectious Disease Committee, or a newly established ad hoc committee. Evidence of review can be satisfied by:
Facilities wishing to perform Waived HIV Testing must be licensed and/or approved by DPH to perform clinical laboratory testing in the sub-specialty area of “Viral/HIV” Serology. The Massachusetts state regulations, 105 CMR 180.000: The Operation, Approval and Licensing of Clinical Laboratories, allow DPH to consider proposals for special projects for the innovative delivery of clinical laboratory services. Under this provision, DPH will consider granting an HIV Special Projects Waiver to facilities that:
Applicants must respond to all questions within this document in order to be considered for approval. The Clinical Laboratory Program works in conjunction with the Bureau of Infectious Disease and Laboratory Sciences, Office of HIV/AIDS to review HIV Special Projects Waiver applications.