Developing Quality Control Plans for Medical Laboratories

Developing quality control plans for medical laboratories

New Quality Control (QC) requirements for medical laboratories take effect in 2016—are you ready for the revised US CLIA regulations? Join us for this four-part eLearning series presented by industry expert Dr. James O Westgard and learn how to develop the best QC Plan for your laboratory.

These webinars were recorded in 2014 on September 17, October 8, November 12 and December 10.

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Overview

This webinar* series is intended to educate healthcare laboratory professionals on the changing Quality Control (QC) requirements that take effect in 2016 and how to develop a QC Plan that’s compliant with the new US CLIA regulations. In these four presentations, Dr. Westgard will discuss:

  • New CLIA options for QC Plan compliance
  • Developing  the right QC Plan for your lab
  • Optimizing QC plans with data-driven Six Sigma techniques
  • Performing Risk Assessment and mitigating risks with an Individualized QC Plan
Co-founder and principal in Westgard

Speaker:    James O Westgard, Ph.D., FACB, Co-founder and principal in Westgard QC, Inc.

Topics covered

Part 1: Developing Quality Control Plans in a Medical Laboratory

Part 2: Right-sizing Statistical QC (SQC) Procedures using Westgard Sigma Rules in a Total QC Plan

Part 3: Performing a Risk Assessment to Identify Hazards and Target Failure Modes

Part 4: Mitigating Risks with an Individualized QC Plan

Key learning objectives

By the end of the webinar series, you will have a clear understanding of the new QC Plan requirements and how to develop a QC Plan using Six Sigma and risk management principles.   

*CE credit not available for this webinar series.

Course details

This webinar series addresses changing QC requirements in the US CLIA regulations.  According to CMS, the current option to use EQC procedures will expire in 2016 and will be replaced by an option called "Individualized QC Plan", or IQCP [1]. An IQCP involves application of risk management principles to identify failure modes, evaluate their risks, and then mitigate those risks by implementing appropriate control mechanisms.  CMS references the CLSI EP23A document [2] for guidance in implementing risk-based QC Plans.  

"QC Plan" is the specific term used by CLSI to assemble control mechanisms and structure their application.  IQCP is the regulatory term [2] for a QC Plan that complies with the CMS’s  requirements to include a (a) risk assessment, (b) QC Plan, and (c) QA Plan on-going monitoring of quality and safety.  In this series, we introduce the term "Total QC Plan" for the general concept of assembling control mechanisms that monitor the "Total Testing Process," which includes pre-analytic, analytic, and post-analytic phases of the process.   For many laboratory applications, a Total QC Plan is a better choice than an Individualized QC Plan.  IQCPs will be needed in applications where Statistical QC is not included as a primary analytic control, such as POC setting that currently utilize EQC.

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  • Review CLIA options for compliance with QC regulations
  • Understand the general concept of a Total QC Plan and the specific requirements for Individualized QC Plan
  • Formulate a general approach for developing QC Plans
  • Assess Sigma quality of a test and test system as a measure of risk
  • Use sigma quality to select the right control rules and right number of control measurements to detect medically important errors
  • Use sigma quality to prioritize other controls for inclusion in a Total QC Plan
  • Review CMS requirements for identifying hazards
  • Compare 2-factor and 3-factor models for estimating risk
  • Rank risk factors for severity, occurrence, and detection on a qualitative scale
  • Prioritize failure modes by calculation of risk
  • Compare approaches for mitigating risk by manufacturers and laboratories
  • Assess important characteristics and capabilities of controls
  • Identify controls that can be implemented in your laboratory
  • Identify controls that can be implemented in POC applications
References
  1. CMS Memo of August 16, 2013: Individualized Quality Control Plan (IQCP): A New Quality Control (QC) Option. www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/IQCPbenefits.pdf
  2. CLSI EP23A.  Laboratory Quality Control Based on Risk Management.  Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne PA, 2011.
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