Know where you stand before the survey team arrives — and when a deficiency is cited, turn it into an organized, evidence-based response.
Part of Connexis Laboratory Compliance Consulting, led by Rick Peluso.
Most labs call when a survey is weeks away or a finding has already landed. Support works best across the whole cycle.
Review the areas that apply to your certificate, complexity, test menu, and accreditor — and separate immediate concerns from routine improvements.
Owners, dates, and evidence for each action, plus a follow-up check that the change is actually being used.
Citation review, root-cause support, structured response drafting, and effectiveness checks — with internal closure and agency acceptance tracked separately.
One of the most revealing readiness checks is simple: choose one method and follow it through the lab. What procedure guides the work? Who performs it? Where are the quality records? What happens when a result or required activity falls outside its limits? Then ask someone who doesn’t manage that process to follow the same evidence without a string of verbal explanations.
We pair that kind of practical tracing with a structured review of the areas that apply to your lab, and we write findings people can act on.
An example of a useful observation — specific about what was examined, what remains open, and who resolves it, without assuming missing evidence means no action occurred.
Define the agency, complexity, testing sections, locations, and applicable materials.
Examine selected records, workflows, and practices against an agreed checklist.
Separate immediate concerns from routine improvements, with the rationale behind each.
Recommend actions, owners, timelines, and ways to evaluate effectiveness.
A revised procedure, a training session, or a submitted response shows that an action occurred. It doesn’t show that the underlying issue was addressed — or that the improvement is holding.
We help lab teams move from a cited deficiency or internal finding to a documented path forward: describing the issue precisely, addressing immediate concerns while the investigation continues, correcting the cause, and defining the evidence needed before anything is marked complete.
What was cited, what evidence supports it, and who owns the response?
Why did the issue arise — unclear ownership, an inaccurate procedure, or a technical problem?
What will change, who will do it, and on what timeline?
What later evidence will show the corrected process is actually being used?
Baseline assessments for a new program or operational change, pre-survey mock inspections, and focused follow-ups on areas flagged in an earlier inspection, complaint, or internal finding.
Earlier is better — leave enough lead time to actually correct what is found before the survey window opens.
Yes. The review is scoped to the agency or accreditor that applies to your lab.
Contact us with the type of finding and your deadline so we can discuss scope right away. Please don’t send patient or sensitive data in the initial inquiry.
We draft structured documentation with your team, but the laboratory owns and submits the final response.
Only when the investigation actually supports a training issue and the training addresses it. A training sign-in sheet shows that instruction occurred; a later review of the affected records shows whether the process changed.
That happens more than labs expect — missing technical supervision or competency gaps often trace back to an open seat. Connexis recruiting can help there too.
Keep corrections from drifting with periodic review of QC, PT, competency, and open actions.
Defensible studies and approval packages for new instruments, platforms, and assays.
See the full laboratory compliance practice, led by Rick Peluso.
Tell us your survey timing and the areas where you want a second opinion.
Rick will follow up personally to scope the review.
