Three acronyms show up on nearly every laboratory compliance document: CLIA, CAP, and TJC. They are often mentioned in the same breath, which creates a common misunderstanding: that they are competing options, and a lab picks one. They are not competitors, and you do not pick one. CLIA is the law. CAP and TJC are […]
CLIA vs. CAP vs. TJC: Understanding Which Accreditation Standards Apply to Your Lab Read More »
A reference laboratory’s testing menu can span dozens of specialties. Chemistry, hematology, microbiology, molecular diagnostics, toxicology, or immunology often operate simultaneously and across multiple shifts. Each shift is staffed by a rotating pool of testing personnel with varying qualification profiles. The scheduling challenge that creates is fundamentally different from what a hospital lab or single-specialty
Reference Labs: Scheduling Across Specialties Without Creating Qualification Gaps Read More »
Most managers review their schedules regularly. They check coverage gaps, verify that shifts are filled, and confirm that staffing levels meet operational requirements. What’s less common is reviewing those schedules the same way that an inspector would. Those are different reviews which measure different outcomes and the gap between them is where many scheduling-related inspection
How to Review Your Own Schedule the Way an Inspector Would 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 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 »
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 »