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 »
Your lab’s procedure manuals are the operational blueprint for every test you perform. And they’re almost always among the first documents a CAP or CLIA inspector will request. Yet “Incomplete or inaccurate procedure manuals” remain a commonly cited deficiency year after year. This post unpacks what inspectors expect from your SOPs, why so many labs
Procedure Manual Problems: What Inspectors Flag First 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 »
With the announcement of new tariffs, there is much concern and uncertainty about what that entails for the medical community. Many raw materials are used to produce medicine and other pharmaceutical compounds, and medical equipment is often imported from overseas. While there is no way to predict the full ramifications completely, it is often best
Maximizing Staff Efficiency During Supply Chain Disruptions Read More »
Long-term care and assisted living facilities face unique challenges regarding workforce management. Ensuring that the right caregivers, nurses, and support staff are always on hand is essential for resident well-being and regulatory compliance. With increasing demands on healthcare workers and evolving staffing regulations, facilities must adopt smarter scheduling solutions to maintain efficiency, improve employee satisfaction,
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 »
In the fast-paced world of healthcare and laboratory operations, the alignment of compliance and workforce scheduling is crucial to ensuring both regulatory adherence and uninterrupted patient care. Compliance demands—from CLIA, CAP, TJC, and other regulatory bodies—dictate competency requirements, staff-to-patient ratios, and licensure verifications, making it essential that scheduling is not just about shift coverage but
The Intersection of Compliance & Scheduling: How to Avoid Coverage Gaps Read More »
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