Most lab leaders don't fall behind on compliance because they don't care. They fall behind because the regulatory work lands on the same few people who already run the bench, the schedule, and the hiring. A memo comes in, someone forwards it to the director, it goes on the next meeting's agenda, and then it waits.
We talk with laboratory directors, managers, and practice administrators every week, mostly about hiring. More and more of those conversations end up on the same subject: "We're not sure our records have caught up." So we've partnered with Creative Concepts Consulting (CCC) to give labs a practical place to start.
It's worth being precise here, because a lot of the outreach labs receive is not.
Already in effect. CMS finalized CLIA updates that took effect in December 2024, with proficiency testing (PT) changes following in January 2025. Those updates touched personnel qualifications, PT requirements, and related documentation. They are not future concerns. They're the rules your lab operates under today.
Proposed, not final. In October 2026, CMS published a proposed rule, CMS-3478-P. It covers topics including virtual access to digital laboratory information, digital images for gynecologic cytology PT, and personnel qualifications. The comment period runs until December 7, 2026.
A proposed rule is a proposal. It is not an enforceable requirement, and it can change substantially before anything is finalized. Labs should keep working under the requirements that apply now while they watch what may come next. The Federal Register notice is the right starting point for what has actually been proposed, and the final text, if one is published, will need a fresh review.
The practical risk isn't that labs ignore the news. It's that nobody owns the follow-through.
In our experience, and in Rick Peluso's at CCC, the trouble rarely sits in the testing itself. It sits in the records around it:
That last one is where hiring and compliance meet, and it's a big reason this partnership made sense to us. Turnover in lab leadership and senior bench roles isn't only a staffing problem. Each departure can also become a documentation problem.
Creative Concepts Consulting, led by Rick Peluso, provides specialist support in laboratory regulatory compliance. Rick works alongside a lab's existing director and staff. He helps them review their processes, organize the evidence behind them, and turn findings into practical next steps.
To be clear about what this is: consulting support helps a lab get organized and ready. It does not guarantee inspection outcomes. It does not replace legal advice or a full audit. And it doesn't appoint anyone to a required CLIA position or shift the laboratory director's responsibilities. The director's decisions stay with the director. The goal is to give that person and their team time back, and a clear picture of what needs attention.
Connexis brings the relationships. We've spent years recruiting for pathology groups, hospital labs, reference labs, and diagnostics companies. CCC brings the regulatory depth. Together we can point labs to help that fits the problem.
Our first step is deliberately small. It's a free, 20-minute call with Rick, built around one question: what is your biggest compliance pain point right now?
On the call, you can expect:
There's no obligation and no sales pitch. If a closer look would help, CCC offers an optional scoped $250 record review. It covers an agreed set of records and ends with written recommendations. Any larger project or ongoing monitoring is proposed separately, so you only buy what you need.
The consult is built for:
If you've already got a full-time quality or compliance team on top of every change, you may not need this. If you read the last regulatory update and thought "we should look at that... eventually," this is the call for you.
Whether or not you book a call, try this. Create a one-page change record for each regulatory update that might affect you. List the source, the publication date, its status (in effect, proposed, or under consideration), the activities it could affect, who is reviewing it, and the next review date.
Sometimes the answer is "no action needed for us," and that's a fine answer. What matters is that a person owns the decision and it's written down.
A condition-level deficiency means a lab is out of compliance with one or more of CLIA's "condition-level" requirements, the broad requirements identified as conditions in 42 CFR Part 493 (see the definitions in 42 CFR 493.2). It is more serious than a standard-level deficiency, which is a failure to meet a specific standard within a condition. Condition-level findings can lead to sanctions under 42 CFR Part 493, Subpart R, ranging from a directed plan of correction or civil money penalties up to limitation, suspension, or revocation of the CLIA certificate.
Under final rule CMS-3326-F, revised personnel qualifications and director responsibilities took effect December 28, 2024. That included continuing-education requirements for director pathways and minimum on-site visits for laboratory directors (42 CFR 493.1405-493.1407 and 493.1443-493.1445). Under final rule CMS-3355-F, updated proficiency testing requirements, including newly regulated analytes and revised acceptance limits, were implemented January 1, 2025. Which changes matter for your lab depends on its certificate type and test menu.
No. CMS-3478-P is a proposed rule published in the Federal Register on October 8, 2026, with comments due December 7, 2026. It would address virtual access, digital images for gynecologic cytology PT, personnel qualifications, and other changes, but none of it is enforceable unless CMS publishes a final rule, which may differ from the proposal. Until then, the current requirements in 42 CFR Part 493 apply.
Routine CLIA surveys generally run on a two-year cycle (accredited labs follow their accreditor's inspection cycle), so readiness works best as an ongoing habit rather than a last-minute push. Start with the records surveyors commonly review: personnel qualifications and competency assessments, PT results and corrective actions, QC and calibration, method verification, and the procedure manual. CMS's interpretive guidelines for surveyors (State Operations Manual, Appendix C) make a useful self-check, and an outside record review or mock inspection can catch gaps before a surveyor does.
Form CMS-2567 is the Statement of Deficiencies and Plan of Correction a lab receives when a survey finds deficiencies. The lab responds with a plan of correction that explains how each deficiency will be fixed, how other affected results or patients will be identified, what will prevent a recurrence, who is responsible, and by when. The response deadline is stated in the cover letter (commonly 10 calendar days from receipt), so start on it as soon as it arrives.
It's a 20-minute call with Rick Peluso of Creative Concepts Consulting, focused on your lab's biggest current compliance concern, whether that's personnel records, PT, QC, verification, or a staffing change. You'll leave with a clearer view of which recent CLIA updates likely apply to you and a few practical next steps. There's no obligation, and the call doesn't guarantee inspection outcomes or replace legal advice or a full audit.
If your records haven't kept pace with the rules, or you're not sure whether they have, a 20-minute conversation is a low-cost way to find out.
Creative Concepts Consulting provides laboratory compliance consulting in collaboration with Connexis Search Group. Consulting supports readiness and does not guarantee inspection outcomes. Information on proposed rules reflects their status as of October 2026. Check the Federal Register for current status.
