What Is an HHS-Certified Instrumented Initial Test Facility (IITF)?

An instrumented initial test facility (IITF) is a permanent location where, for urine, initial testing, reporting of results and recordkeeping are performed under the supervision of a responsible technician, as defined in Section 1.5 of the HHS Mandatory Guidelines for urine. An IITF performs initial tests only. It does not perform the confirmatory drug tests that an HHS-certified laboratory performs.

How an IITF differs from a laboratory. Under the same guidelines, a laboratory is a permanent location where initial and confirmatory drug testing, reporting of results and recordkeeping are performed under the supervision of a responsible person. Both may report certain results. For example, Section 3.8 of the urine guidelines allows an HHS-certified laboratory or an HHS-certified IITF to report a specimen as dilute based on creatinine and specific gravity results on a single aliquot.

Urine only. HHS does not allow IITFs to conduct oral fluid testing. Section 12.1 of the HHS oral fluid guidelines states that only HHS-certified laboratories are authorized to test oral fluid specimens for federal agency workplace drug testing programs.

Certification. To become certified, an applicant laboratory or IITF must undergo three rounds of performance testing plus an on-site inspection. To keep certification, it must take part in quarterly performance testing and undergo periodic on-site inspections. HHS publishes the list of certified laboratories and IITFs in the Federal Register monthly, and SAMHSA posts the current list online.

Not for DOT specimens. The HHS list notes that the U.S. Department of Transportation (DOT) does not allow IITFs to test DOT-regulated specimens. Part 40 defines a laboratory as one certified by HHS under the National Laboratory Certification Program, or an approved foreign laboratory (49 CFR 40.3). IITFs are relevant to federal agency programs under the HHS guidelines.

The FAQ on finding HHS-certified laboratories explains how to locate the current list.