Stop me if you’ve heard this before. A new instrument has arrived. Staff get trained in it. Testing begins. Results get reported. Everything works. Months later, an inspector asks for competency assessment records for that test system. And the lab discovers that what happened during onboarding was training but not competency assessment. These are two […]
The New Laboratory Test System Nobody Got Formally Assessed On Read More »
CLIA requires that competency assessments for testing personnel include six specific evaluation elements. This is a regulatory requirement that applies to every staff member performing non-waived testing, for every test system they operate on a defined schedule. Most laboratory compliance professionals, managers, and executives are well aware of this. What’s less known and discussed, however,
Closing the Gaps: Are All Six CLIA Elements Truly Covered? Read More »
There is a moment in every document control cycle that gets almost no attention. The SOP has been written, reviewed, and approved. The signatures are in place. The document is technically current. And somewhere between that moment and the moment a staff member opens it to guide their work, something goes wrong. Not catastrophically and
The Gap Between Approval and Implementation Read More »
This one is counterintuitive enough that it’s worth stating plainly before unpacking it: the staff members most likely to create a competency compliance gap in your lab are often not the struggling ones. They’re the experienced, trusted, high-performing staff members who have been doing this work for years, and whose competency everyone already knows is
Your Best Staff Can Be Your Greatest Competency Risk Read More »
Every clinical laboratory generates a significant volume of operational data. Scheduling records that capture who worked when and what coverage decisions were made under pressure. Competency assessment records showing who was assessed, when, and how they performed. Document control logs that track which SOPs were revised, when they were distributed, and who acknowledged them. Most
The Data Your Lab Is Collecting But Not Using Read More »
There is a version of this conversation that happens in almost every clinical lab at some point. Someone proposes investing in better workforce management infrastructure. Someone else points out that the current spreadsheets are working fine. The proposal gets tabled, the spreadsheets stay, and the lab continues managing scheduling, competency, and document control through a
The Spreadsheet That’s Costing You More Than a System Would Read More »
There is a particular kind of preparation that feels productive but accomplishes very little. The mock inspection that surfaces no findings. The internal audit that confirms everything is in order. The walkthrough concluding with quiet satisfaction and no action items. These events are not evidence that your compliance program is strong. They are evidence that
The Case for Failing an Inspection on Purpose Read More »
When a lab manager leaves, the schedule they built goes with them in more ways than one. The actual document incorporating the spreadsheet, the template, and the system stays behind. What leaves is everything that made it work: the informal arrangements negotiated over years, the knowledge of which staff will cover which shifts under which
How to Take Over a Lab Schedule Without Inheriting Someone Else’s Problems Read More »
Taking over as lab manager is rarely a clean handoff. More often it involves walking into a compliance program that was built by someone else, documented to varying degrees, and understood most fully by the person who just left. The institutional knowledge gap is immediate, and the regulatory obligations are not. Whether you’re the new
How to Onboard a New Lab Manager Who’s Inheriting a Compliance Program Read More »
There is a particular kind of professional excellence that makes itself invisible. The kind where the measure of a good day is that nothing happened — no wrong results, no missed findings, no adverse events that trace back to a failure in the lab. Where the quality of the work is most visible not in
The Invisible Workforce: What It Costs to Get It Right Every Time Read More »
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