Chemical Toxicity Public Health Laboratories Exceptions

6012 - Chemical Toxicity Public Health Laboratories Exceptions (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) The Centers for Disease Control and Prevention (CDC) worked with the Association of Public Health Laboratories (APHL) to establish and prepare the national Laboratory Response Network (LRN) to ensure that there are robust, adequate laboratory testing services available in the event of a chemical terrorism attack. A Chemical Toxicity Public Health Laboratories (CT PHL) will be issued an effective CLIA certificate at their highest level of testing, regardless of whether they are testing human samples or not. This policy applies to only the laboratories designated by APHL. This allows the laboratory to operate within the scope of CLIA, ensure quality patient testing and avoid delays should an untoward event occurs. These laboratories may hold either a certificate of compliance or certificate of accreditation depending upon whom they select as their survey agency, as do all enrolling laboratories. A new CT PHL is surveyed immediately and within the surveyor’s availability using the CLIA Outcome-Oriented Survey Process (OOSP). Subsequent surveys should be performed following the survey agencies’ routine biennial schedule. If a CT PHL already has a CLIA certificate, but has added chemical toxicity testing to its test menu since its last survey, the surveyors should visit and review only this testing in the interim until the next biennial survey. All CT PHL surveys will be entered into the CLIA database by CMS. Survey findings are entered in to the “Notes” portion to identify these laboratories in the system, but do not identify them in any fields that could be observed externally.