Are CLIA Inspections of Clinical Pathology Laboratories Getting Tougher? Why It Pays to Achieve “Inspection Readiness”
Experts say that CLIA inspections are becoming more rigorous, with inspectors taking more interest in how medical labs comply in the areas of personnel, PT, and quality control
Recent reports indicate that regulatory inspections of clinical laboratories are getting tougher. Some pathologists and medical lab managers acknowledge that they’ve had to scramble in response to the unexpected deficiencies identified by Clinical Laboratory Improvement Amendments (CLIA) inspectors following inspections of their labs.
These developments make it more important than ever that clinical laboratories work to become “inspection ready.” At the same time, it is essential that every laboratory compliance officer stay up to date with changes in how CLIA and other regulatory inspections are conducted.
Unwelcome Publicity When Medical Lab Regulators Find Deficiencies
There’s another factor at play in this unfolding story. News headlines immediately follow when federal and state lab regulators discover a problem with a laboratory and the quality of the test results that it is reporting. This raises the stakes for every lab director, because even highly respected medical laboratory organizations can find themselves at the center of unwelcome attention when the public becomes aware of inspection deficiencies. (more…)