Laboratory audits are stressful, even with the most strenuous preparation. For many people, the worst part of the inspection isn’t the actual inspection. It’s the preparation. Administrators can spend weeks and months working to get themselves ready and even then, still feel a sense of apprehension. Inspections and audits are often viewed as a single […]
At StaffReady, we often write about strategies for addressing coverage with a diminished workforce, and usually the problem is framed as a low pool of staff to schedule from. However, it isn’t always a scarcity of staff, but a scarcity of skills (or skill gaps) that makes constructing schedules and rotations challenging. In today’s piece,
Addressing Skill Gaps in Your Organization Read More »
From 2020 onwards, largely due to Covid-19, we have seen a fundamental shift in strategy in the way we run clinical laboratories and an exponential growth in the use of mobile labs. Already used heavily for public clinics and blood donations, mobile labs have become a crucial part of the medical landscape when it comes
Optimizations on the Road | Making the Most of Your Mobile Lab Operations Read More »
It is no exaggeration to say that clinical laboratories live under constant pressure. Whether it’s the pressure of maintaining compliance, meeting deadlines, or managing staff, there is always a race to meet turnaround times and keep operations moving. Compliance can sometimes feel like a checkbox, or worse, a burden. Regulatory compliance isn’t an annual activity.
Building a Compliance-First Mindset in High-Pressure Lab Environments Read More »
Most labs are vigilant about running daily quality control. But what about the big picture? CLIA requires labs performing non-waived testing to conduct a formal, documented review of QC records at least twice a year. This is not optional and failing to do it is one of the most frequently cited deficiencies during inspections. The
The Twice-Yearly QC Review: The Most Forgotten CLIA Requirement Read More »
Test system failures happen. It’s how your lab responds to them that determines whether you stay compliant or end up with a citation. According to CLIA and CAP, labs must document every test system failure, investigate the root cause, and implement corrective and preventive actions (CAPA). But some labs either fail to document these incidents
The Hidden Deficiency: Undocumented Test System Failures Read More »
At StaffReady, we write about many issues organizations can have during laboratory inspections. Often, the lack of compliance is because of omission: policies or procedures that are not fully documented or are not always followed. However, this isn’t always the most pervasive issue; sometimes organizations face citations because their procedures or policies are not wrong
Version Control Best Practices Read More »
Ancillary services are a crucial part of the medical system, providing additional support for healthcare and laboratory organizations. They are crucial in the medical ecosystem because they provide personal critical care to patients who have undergone or are about to go through treatment. Ancillary services can typically cover a wide range of types, including hospice,
The Keys to Minimizing Cost and Maximizing Value in Ancillary Services Read More »
If it’s not documented, it didn’t happen. That phrase is gospel during a CAP or CLIA inspection and it’s why incomplete or missing test records consistently ranks high in the list of deficiency citations. Inspectors want clear, retrievable, and complete documentation for every test your lab performs. This includes manual logs, instrument outputs, QC records,
Proficiency Testing (PT) is one of the most regulated elements of laboratory compliance, and for good reason: it directly assesses your lab’s ability to produce accurate, reliable results. Unfortunately, labs often file their PT scores and move on without review, reflection, or remediation. CLIA requires that PT results are formally reviewed by the Laboratory Director
Why Proficiency Testing (PT) Results Must Be Reviewed and Acted Upon Read More »
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