Tell us what is consuming your time or keeping you up at night. We will help identify your most pressing issue, discuss practical corrective steps, and explore ways to stay ahead of future problems.
We will use these answers to prepare a focused discussion. Please do not include patient names, results, or other protected health information.
Questions? Rick Peluso, (704) 941-5913 · rickpeluso2025@gmail.com
What is included: A complimentary introductory conversation and concise recommendations for one primary challenge. Document review, formal validation, written plans of correction, and continuing consulting are separate services, quoted if needed.
Want to prepare? Have your certificate type, accreditor, upcoming deadlines, and a non-confidential description of the issue handy. Never upload patient records through this page.
Pre-consultation questions: What happens if the issue is not resolved? What has already been tried? Who owns it? When is the next inspection or submission? Which monthly checks currently catch problems early? What would a successful next 30 days look like?
Generally yes, when it tests human specimens for health assessment or diagnosis, even if it only runs waived tests. Check the specific testing and site arrangement before applying.
No. CLIA sets the federal requirements. Approved accreditation organizations such as CAP and COLA inspect against their own standards, which meet the applicable federal conditions. Accreditation can support a CLIA certificate of accreditation.
Updated CLIA proficiency-testing requirements began applying on January 1, 2025. Review the revised list of regulated analytes and the performance criteria for your testing menu.
No. CMS and CDC published it as a proposed rule in the Federal Register on October 8, 2026. It is not a final requirement and may change before any final rule.
December 7, 2026, according to the published notice. Comments go to docket CMS-3478-P. Watch for later developments.
Usually not. Assess the potential impact and draft contingency plans, but don't replace compliant current procedures based only on proposed wording.
These answers are educational starting points, not substitutes for the applicable regulation, approved accreditor checklist, manufacturer instructions, jurisdiction-specific law or a laboratory director's judgment. Requirements vary by test category, accreditation, state and specialty. The October 8, 2026 CLIA proposal is proposed, not effective. This is not legal advice and does not guarantee inspection outcomes. Sources: CMS CLIA, 42 CFR Part 493, 91 FR 64480. Last reviewed October 26, 2026.
