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

Hosted by Robert Michel

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

Hosted by Robert Michel
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PRESS RELEASE: Labs get updated on the latest issues catching them off-guard during accreditation assessments and surprise visits from CLIA inspectors, by learning from the top accreditation organizations in a non-inspection setting



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Media Contact: Chris Garcia

AUSTIN, Texas (April 23, 2018)—Compliance with CLIA and other regulations is getting both tougher and more complex. Many labs report that assessments and CLIA inspections of their labs are becoming more rigorous and they’ve found themselves scrambling to respond to the unexpected deficiencies identified during these inspections.

“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,” said Robert L. Michel, Editor-In-Chief of The Dark Report. “These developments make it more important than ever that clinical laboratories work to become ‘inspection ready,’” Michel continued. 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. Many things are changing in the accreditation, certification, and inspection of clinical laboratories in the United States.”

To help all CLIA-certified clinical laboratories stay up-to-date with the latest developments, Dark Daily has arranged two special webinars that will give participants access to representatives from all four primary accrediting bodies with deeming authority from CMS to accredit clinical laboratories to the requirements of CLIA. Part two in the webinar series, entitled “Laboratory Certification and Accreditation: The Joint Commission, COLA Discuss the Most Common Deficiencies and How Labs Should Prepare for Coming Changes,” takes place Wednesday, April 25, 2018 at 1 PM EDT.

On board for this webinar will be Heather Hurley of The Joint Commission and Kathy Nucifora from COLA. Chair for the program is Nora Hess from Chi Solutions, an Accumen Company. Participants will get from these experts their organization’s list of the Top 10 Deficiencies identified during lab assessments over the past year, and learn about the changes in emphasis coming with how each of the organizations assesses laboratories.

The Top 10 Deficiencies lists can alert labs to similar issues in their own laboratory, allowing them to address issues effectively before their next assessment or CLIA inspection. Medical directors of CLIA labs will be particularly interested in the most common deficiencies identified that involve their oversight, review, and involvement.

The webinar will also include plenty of discussion about competency, which has become a hot issue during many lab inspections. It is essential for every laboratory’s compliance that appropriate competency practices be implemented and properly documented. Labs will learn where other labs fail to meet requirements in this important area of compliance.

Here’s just some of what will be covered during this indispensable 90-minute session:

  • The “Top 10 Deficiencies” from the accrediting agencies, enabling labs to identify potential regulatory problems
  • The top few deficiencies that inspectors look for and how to avoid them
  • Preparing for consistent regulatory readiness through a better understanding of the regulatory process
  • Strategies and tips for maintaining regulatory readiness at all times, not just when preparing for an inspection
  • Real-world examples of how and why some labs did poorly during on-site inspections
  • How laboratory regulatory and accrediting agencies work together to ensure compliance
  • Avoiding unwelcome publicity, expensive citations or stiff fines, loss of reimbursement or even certification by proactively addressing deficiencies
  • Ability to interact directly with accreditation organizations in a non-inspection setting, and much more

At the end of the speakers’ presentations there will be a Q&A period, during which labs will be able to submit their own specific questions to experts from the top accreditation organizations in a non-inspection setting—a segment of the webinar that represents particularly high value for labs. For more information about “Laboratory Certification and Accreditation: The Joint Commission, COLA Discuss the Most Common Deficiencies and How Labs Should Prepare for Coming Changes,” and to view additional details about part one of the webinar series, click here. You may also contact Chris Garcia at 512-264-7103.


Established in 1995, THE DARK REPORT is the leading source of exclusive business intelligence for laboratory CEOs, COOs, CFOs, Pathologists and Senior industry executives. It is widely read by leaders in laboratory medicine and diagnostics. The Dark Report produces the famous Executive War College on Laboratory and Pathology Management every spring, which showcases innovations by the nation’s and globe’s leading laboratory organizations. Dark Daily is an Internet-based e-briefing intelligence service, read worldwide by thought leaders in laboratory and pathology management. Other well-known conferences conducted by THE DARK REPORT are Lab Quality Confab (on the use of Lean and Six Sigma methods in labs and hospitals) and Molecular Summit (on the integration of in vivo and in vitro diagnostics). THE DARK REPORT co-produces Frontiers in Laboratory Medicine annually in the United Kingdom; Executive Edge bi-annually in Canada; and The Business of Pathology bi-annually in Australia.