News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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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.

This is why every clinical lab and pathology group should strive to achieve the inspection-ready laboratory. Not only is this a cost-effective goal, but it’s also a key attribute of the lab organization that has achieved continuous improvement and is delivering recognized value to its parent hospital, physicians, and patients.

“Those pathologists and lab managers tasked with lab compliance know that it is tough to achieve and sustain a constant inspection-ready atmosphere,” observed Anne Daley, Senior Consultant for Chi Solutions, Inc., a clinical laboratory consulting firm based in Ann Arbor, Michigan. “At the same time, what is more stressful for lab managers than undergoing an inspection during which the CLIA inspectors uncover significant issues?”

The Best and Worst of Medical Laboratory Compliance

Daley has first-hand experience with the best and worst of lab compliance. Who is in a better position to understand the common regulatory mistakes even well-run labs make than someone who has regularly been engaged by hospitals and health systems to come in, assess their lab’s existing state of regulatory compliance, and then play a role in resolving those compliance issues?

Anne Daley, a Senior Consultant with Chi Solutions

One way that clinical laboratories and anatomic pathology groups can prepare for increasingly tougher CLIA inspections and regulatory compliance is to pursue the goal of becoming an inspection-ready lab. That’s the advice of Anne Daley, a Senior Consultant with Chi Solutions. She is pictured here speaking on the subject of inspection readiness at the Lab Quality Confab that took place in New Orleans last fall. (Photo copyright The Dark Report.)

In recent years, like other medical laboratory consultants, Daley and her colleagues have been on the front lines of helping hospital labs at threat of losing their CLIA license. Consultants who work with labs to improve their compliance with federal and state requirements generally agree that things are getting tougher and inspectors are more willing to dig deeper during on-site assessments. As a consequence, CLIA inspectors often find more deficiencies, and some of these are serious deficiencies.

How CLIA Inspectors Are Getting Tougher During Clinical Lab Visits

Experts say that some of the areas of compliance getting heightened attention during CLIA inspections are:

• Having appropriate staff qualifications, particularly for individuals in supervisory positions. Inspectors are getting tougher when checking the CLIA and state regulatory qualifications. One common mistake is to consider that a CLIA-specific CME course to be the same as required laboratory training or experience.

• Inspectors are devoting more attention to how labs comply with the D5413 §493.1252 Standard: test systems, equipment, instruments, reagents, materials, and supplies. In fact, this is almost always on the list of the top ten CLIA deficiencies in most years.

• On the radar screen for most CLIA inspectors at the moment are the required quality control activities of labs. A complicating factor is the timetable laid out by the Centers for Medicare & Medicaid Services (CMS) for labs to comply with requirements that include the option of using an Individualized Quality Control Plan (IQCP).

In a February 2014 blog post for COLA Resources, Inc. (CRI), Nancy Alers MS, MT(ASCP)CM, who is a Quality Assurance Specialist and Data QC Analyst for CHI Health in Baltimore, Maryland, and formerly an employee of CRI, wrote about the “Top 5 Deficiencies for Laboratories and How to Prevent Them.” She grouped the five major deficiencies into the categories of personnel, proficiency testing, and quality control.

Experts in CLIA and medical laboratory compliance agree, “An ounce of prevention is worth a pound of cure.” This is why clinical labs are being urged to make it a goal to become “inspection ready.”

How Clinical Labs and Pathology Labs Can Achieve Inspection Readiness

To help clinical laboratories and anatomic pathology groups understand the steps needed to become an inspection ready lab, The Dark Report is presenting a special 90-minute webinar titled “Achieving the Inspection-Ready Lab.” This session will take place Thursday, April 23, 2015, at 1 PM EDT.

Your presenters will be Anne T. Daley, MS, and Nora L. Hess, MBA, MT(ASCP). Both are Senior Consultant with Chi Solutions and each has years of experience helping clinical laboratories achieve and sustain a state of inspection-readiness.

You’ll hear about the latest developments in CLIA inspections, illustrated with real-world examples of how and why some medical laboratories did poorly during on-site inspections. These case studies will also include information about what makes a lab successful in achieving a state of full inspection-readiness.

For a single tuition, everyone on your lab team can participate. After completion of the webinar, rather than being stressed by laboratory inspections, your team will have gained a greater understanding on how to spot areas for improvement—and how to turn these scenarios into opportunities for achieving the highest laboratory standards and providing a superior level of care for patients. Use this link to register today (or copy and paste this URL in your browser:

Related Information:

Achieving the Inspection-Ready Lab

Top 5 Deficiencies for Laboratories and How to Prevent Them

Top 5 Deficiencies for Laboratories, Part II

Individualized Quality Control Plan (IQCP) by CMS

Clinical Pathology Laboratories Get a New CLIA Accreditation Choice as CMS Grants Deeming Status to A2LA

Clinical Laboratories Face Deadline to Comply with New Standard for Bar Code Labels on Specimens

CLIA Inspections of Clinical Pathology Laboratories Appear to Be Tougher on Loosely-Managed Labs