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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Webinar | Laboratory Certification and Accreditation: The Joint Commission, COLA Discuss the Most Common Deficiencies and How Labs Should Prepare for Coming Changes


Held Wednesday, April 25, 2018 at 1 PM EDT

Get up-to-date on the latest issues that catch labs off-guard during accreditation assessments and surprise visits by CLIA inspectors!

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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.

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 of this webinar series features accreditation experts from the The Joint Commission and COLA and is entitled “Laboratory Certification and Accreditation: The Joint Commission, COLA Discuss the Most Common Deficiencies and How Labs Should Prepare for Coming Changes,” and took place on Wednesday, April 25, at 1:00 PM EDT.

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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. Many things are changing in the accreditation, certification, and inspection of clinical laboratories in the United States.

Your two expert speakers on this webinar are Heather Hurley of The Joint Commission and Kathy Nucifora from COLA. Chair for the program is Nora Hess from Chi Solutions, an Accumen Company. You’ll get from each of 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.

Order the DVD for part one of this series, featuring representatives from the CAP and A2LA, here

The Top 10 Deficiencies lists you’ll see can alert you to similar issues in your own laboratory, allowing you to address them effectively before your 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. Multiple issues are involved, ranging from the lab’s QA/QC activities to documentation of method validation and verification.

Not surprisingly, high rates of deficiencies identified by the different accrediting organizations include the regular inspection, testing, and maintenance of lab instruments and equipment, as well as the many issues and problems associated with proficiency testing (PT).

Also expect 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. During this webinar, you’ll learn where most labs fail to meet requirements in this important area of compliance.

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Here’s just some of what you’ll learn during this indispensable 90-minute session

  • Hear about the “Top 10 Deficiencies” from the accrediting agencies and identify potential regulatory problems in your lab
  • Learn the top few deficiencies that inspectors look for and how to avoid them
  • Prepare for consistent regulatory readiness through a better understanding of the regulatory process
  • Get 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
  • Learn how laboratory regulatory and accrediting agencies work together to ensure compliance
  • Avoid unwelcome publicity, expensive citations or stiff fines, loss of reimbursement or even certification were lab regulators to find deficiencies
  • Interact directly with accreditation organizations in a non-inspection setting, and much, much more!



DATE:                        Held Wednesday, April 25, 2018

TIME:                         1 PM EDT; 12 Noon CDT; 10 AM PDT

PLACE:                     Your computer and/or speakerphone

COST:                        $195 per site (unlimited attendance per site) through 4/19/18, $245 thereafter

TO ORDER DVD:        Click here or call 512-264-7103

Given the importance of compliance with CLIA requirements and the many changes happening in laboratory regulation, this is a must-attend session for all laboratory managers and medical directors, lab compliance officers and lab QA/QC managers who recognize the potential negative impact to their labs, should deficiencies be spotted in operations or staff practices during a future inspection.

Keep in mind that another unique feature of this webinar is its interactive nature—submit your own specific questions to the experts and ensure that you get the insights you need directly from the organizations who accredit your laboratory to the requirements of CLIA.

The webinar’s cost to ensure your lab’s compliance is far outweighed by the risk of being found deficient—making this information-packed session an incredible value for all laboratories that have a CLIA accreditation.

How to Order DVD:

  1. Online
  2. Call 512-264-7103

Your registration/DVD order includes:

  • A site license to attend the webinar (invite as many people as you can fit around your conference table at no extra charge)
  • A full transcript emailed to you soon after the conference
  • The opportunity to pose specific questions, and connect directly with the speakers during the audience Q&A session

Order DVD Now! Or for more information, call us at 512-264-7103.

Order the March 28 DVD, Part 1 in the series here
Laboratory Certification and Accreditation: CAP & A2LA Discuss
the Most Common Deficiencies and How Labs Should Prepare for Coming Changes”


Heather Hurley, Executive Director, Laboratory Business Development, The Joint Commission, Oakbrook Terrace, IL

In her role at The Joint Commision, Ms. Hurley is responsible for leading business strategies and activities, including the development and implementation of products and services, for The Joint Commission’s Laboratory Accreditation Program which accredits approximately 1,500 U.S. organizations providing clinical and reference laboratory services. Ms. Hurley also leads The Joint Commission’s Laboratory Professional Technical and Advisory Committee (PTAC), Advisory Council and similar groups, and serves as liaison to associations, collaborative partners, and accrediting and regulatory bodies in the laboratory field. In addition, she provides technical oversight and assistance in support of the development of laboratory accreditation manuals, standards, education programs, and other accreditation-related materials.

Kathy Nucifora, Director of Accreditation, COLA, Columbia, MD

Kathy Nucifora has more than 30 years experience in clinical laboratories. She has held positions in both POL and hospital laboratory administration, and also has a wide range of teaching experience in the laboratory field. Ms. Nucifora currently serves on the Editorial Review Board for Lab Tests Online and is a frequent presenter on the topic of IQCP. Ms. Nucifora received a Master of Public Health degree from Wichita State University, a BS in Medical Technology from Ball State University, and is currently the Director of Accreditation at COLA.

Nora L. Hess, MBA, MT(ASCP), PMP — Senior Consultant, Operations Management, Chi Solutions an Accumen Company, San Diego, CA.

Hess has more than 20 years of experience as a health care administrator, with particular expertise in strategic planning, process redesign, compliance, quality management, and cost reduction. Currently, she performs a variety of operational studies for Chi clients, including operations assessments, quality audits, lean design, acquisition due diligence and integration project management, and consolidation assessment and facilitation.