Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations: Calibration, Calibration Verification and Method Validation

Instructor: Barry Craig
Product ID: 701304
  • Duration: 75 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2013

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Fax: +1-650-362-2367


Read Frequently Asked Questions

The Clinical Laboratory Improvement Amendments (CLIA) training will outline the CLIA standards for frequency, methodology and also give examples of practical application.

Why Should You Attend:

The terms calibration, calibration verification and method validation are sometimes used interchangeably. The reality is that all of these are distinctly different processes and are all required by CLIA as related to medical laboratories. This presentation will explore the definitions, distinctions and rules of all three.

The Clinical Laboratory Improvement Amendments presentation will outline the CLIA standards for frequency, methodology and give examples of practical application. These rules have been in place since 2003 and compliance will be judged on inspections by CLIA, JCAHO, COLA, CAP and AAB. This presentation will give outlines for compliance and address basic formulas used to calculate precision, accuracy etc. We also will discuss the new EP23 regulations and how they affect your lab.

Areas Covered in the Webinar:

  • What do calibration, calibration verification and method validation mean?
  • When each of these processes should take place.
  • What systems are required to use these processes and which ones are not.
  • Requirements for validation of new test systems.
  • Remedial action if these processes are unsuccessful or have unexpected results.
  • Reasoning behind each process and why they are necessary.

Who will Benefit:

This webinar will be valuable to CLIA regulated non-waived laboratories that run automated analyzers or semi-quantitative kit tests. All automated non-waived systems fall under these regulations. Employees who would benefit include:
  • Chemistry and special chemistry supervisors and techs
  • Hematology and coagulation supervisors and techs.
  • Blood bank supervisors and techs.
  • Validation specialists
  • Microbiology (automated) supervisors and techs

Instructor Profile:

Barry Craig, Owner and CEO of Laboratory Consulting, LLC, has over 23 years of experience in laboratory management with a concentration on physician office labs. He was the POL & Clinic Coordinator for a major Birmingham Health System until 01/01/10. He managed 22, COLA accredited POL’s, half waived, half non-waived. He writes the “Ask the Expert” column in Physician Office Resource magazine answering lab related questions monthly. He also has been published in ADVANCE for Administrators of the Laboratory magazine. He is a regular faculty member for the COLA laboratory bi-annual symposiums and a regular speaker on lab related topics nationwide.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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Product Reviews Write review

This was an excellent talk on the basics of calibration and validation. I am in a cinical high complexity lab and would like to hear more on this topic for high complexity testing, especially for non-FDA approved testing.
- Anonymous

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