> NMS claims CLIA certification. This is the older law where labs self-certify compliance. Congress left CLIA in place alongside FDA IVD regulations to protect small pharmacists, but obviously Quest Diagnostics and LabCorp run fleets through that loophole, and most labwork is CLIA-certified, not FDA-approved.
This is highly misleading. CLIA and the associated federal regulations are the standard to which diagnostic clinical laboratories are held, not an "older" or "loophole" regulation. All laboratories in the US that provide patient results for clinical use are regulated by CLIA. There are FDA-approved test systems and "Lab-developed tests" (LDTs) that are BOTH subject to CLIA obligations, which are unbelievably complex (and in my opinion are a source of regulatory capture in laboratory medicine, but that's not directly relevant). Most high complexity lab tests are LDTs.
FDA-approved tests go through a formal FDA process such that the performing lab only has to "verify" the performance characteristics prior to patient testing. An LDT requires a much more stringent lab-level validation plan prior to patient testing. Both requiring strict ongoing quality control and quality assurance. And while the validation plan for an LDT can be self-designed, there are still strict requirements for what it most contain.
Compliance is NOT "self-certified," instead there are routine, extremely intensive compliance inspections (scheduled and unscheduled), either by a regional CLIA office, or by an organization accredited by CMS to provide such verification of compliance (such as CAP or COLA). These are not cursory inspections but a deep dive into all lab operations and personnel, equipment, maintenance and quality records, and other documentation.
I'm not a huge fan of Quest or Labcorp's presence in the field, and I don't know the specifics of NMS and this PFAS testing (CLIA compliance isn't required for research or non-clinical). If NMS has CLIA certification and they state the methodology and limitations of their LDT it's generally perfectly valid to provide the test, and the burden is generally on the downstream physician or provider to ensure the results are properly interpreted and applied.
This is highly misleading. CLIA and the associated federal regulations are the standard to which diagnostic clinical laboratories are held, not an "older" or "loophole" regulation. All laboratories in the US that provide patient results for clinical use are regulated by CLIA. There are FDA-approved test systems and "Lab-developed tests" (LDTs) that are BOTH subject to CLIA obligations, which are unbelievably complex (and in my opinion are a source of regulatory capture in laboratory medicine, but that's not directly relevant). Most high complexity lab tests are LDTs.
FDA-approved tests go through a formal FDA process such that the performing lab only has to "verify" the performance characteristics prior to patient testing. An LDT requires a much more stringent lab-level validation plan prior to patient testing. Both requiring strict ongoing quality control and quality assurance. And while the validation plan for an LDT can be self-designed, there are still strict requirements for what it most contain.
Compliance is NOT "self-certified," instead there are routine, extremely intensive compliance inspections (scheduled and unscheduled), either by a regional CLIA office, or by an organization accredited by CMS to provide such verification of compliance (such as CAP or COLA). These are not cursory inspections but a deep dive into all lab operations and personnel, equipment, maintenance and quality records, and other documentation.
I'm not a huge fan of Quest or Labcorp's presence in the field, and I don't know the specifics of NMS and this PFAS testing (CLIA compliance isn't required for research or non-clinical). If NMS has CLIA certification and they state the methodology and limitations of their LDT it's generally perfectly valid to provide the test, and the burden is generally on the downstream physician or provider to ensure the results are properly interpreted and applied.