Operations Readiness
PGx Laboratory Certification & Compliance Checklist
Everything a direct-to-consumer pharmacogenomic testing operation must have in place — from CLIA certification through genetic consent, physician ordering, and test validation — before accepting its first paying customer. Tap any item to mark it complete.
Clinical Laboratory Improvement Amendments
CMS · CDC
Laboratory Accreditation
College of American Pathologists
Clinical Lab Accreditation
Accreditation Commission
Health Privacy & Security
HHS · OCR
LDT / IVD Oversight
U.S. Food & Drug Administration
NextGen PGx is pursuing the certifications above. These logos identify the regulatory and accreditation bodies whose requirements this checklist tracks — they do not imply current accreditation.
1. CLIA Certification
0 of 5 completeA valid CLIA certificate is legally required before performing and reporting human testing.
2. Accreditation — CAP and/or COLA
0 of 5 completePrivate accreditation provides CMS 'deemed status' and signals quality to partners and payers.
3. State-by-State Laboratory Licensing
0 of 6 completeAll 50 states accept CLIA, but many additionally require their own license — you must hold each state's license before accepting orders from residents there.
4. Laboratory Director Requirements
0 of 5 completeThe director is legally accountable for test performance, validation, and result release.
5. HIPAA Compliance Program
0 of 6 completeAs a laboratory, you are a HIPAA covered entity (or business associate) handling PHI including genetic data.
6. Genetic Consent Requirements
0 of 5 completeGenetic testing requires explicit, informed written consent — with extra protections beyond general medical consent.
7. Physician Ordering Model
0 of 5 completeMost states require a physician order for clinical genetic testing — define the model before selling.
8. FDA / LDT Considerations
0 of 5 completeA lab-developed test (LDT) is not FDA-approved — regulatory posture must be deliberate and claims disciplined.
9. Specimen Collection & Transport
0 of 5 completeThe kit and its journey are part of the regulated testing process.
10. Test Validation
0 of 5 completeNo patient results may be reported before validation is complete and director-approved.
11. Before Accepting Your First Paying Customer
0 of 7 completeThe final launch gate — every item here is a hard prerequisite.
Disclaimer: This checklist is an operational planning tool, not legal advice. Licensing, consent, and direct-access rules vary by state and change frequently — engage qualified healthcare regulatory counsel before launching testing services in any jurisdiction.