Purpose of QC
The idea behind effective QC is to ensure that reported lab results are accurate and can be trusted for decisions regarding patient care. QC is intended to detect errors due to analyzer problems, environmental conditions, and operator technique, as well as monitoring the performance of the assay itself. Standard CLIA QC requirements for most non-waived analytes call for two levels of QC per day.
In 2004, CLIA introduced an alternative QC program, Equivalent Quality Control (EQC), which was an attempt to simplify QC for lab tests that include internal monitoring systems and are minimally affected by variations in environmental conditions or operator handling. In effect, EQC was put in place to simplify QC for certain POC testing.
CLSI’s EP-23 & IQCP
In 2011, Clinical and Laboratory Standards Institute (CLSI) published their document, EP-23: “Laboratory Quality Control Based on Risk Management.” Since then, CMS has decided to adopt EP-23 key concepts into their new Individualized Quality Control Plan (IQCP). Eventually, IQCP is intended to replace EQC with a better alternative that addresses the risks involved in QC testing; however, this process is intended to phase in over a period of about two years, and even then labs have the option to simply revert back to the minimal CLIA QC requirements.
CMS sees IQCP as “an opportunity to tailor a QC plan that is customized to your unique testing environment.” Currently, from CMS’s perspective, IQCP is voluntary and simply formalizes some actions that the lab already takes. Because of the many laboratory testing advances, the increased number of variables that come into play on any given day, and variations from laboratory to laboratory, the two QC-levels-per-day guideline does not fulfill QC needs in all cases. Variations in different assays, instruments, technologists’ abilities, laboratories, and patient populations all are contributing factors to the performance of a specific analyte. For simple tests, two levels of QC per day is overkill, and for more complex testing, it’s not enough to completely ensure testing accuracy.
Though initially IQCP is intended to replace EQC, CMS recommends IQCP as an alternative approach for all assays because IQCP is more effective QC. It takes into consideration all of the possible sources of error unique to each individual laboratory and is used to develop a customized QC plan that can flex with changing technologies.
Development of IQCP: Not a Simple Task
In order to constructively and thoroughly examine and revamp your entire QC process, knowledge of the analytical and statistical tools available, combined with a team approach, is needed to evaluate all associated risks. QC can then be customized for specific lab and provider needs using the analytical performance of each assay to assess risk and ensure correct test results. Risk-based, customized QC takes into consideration test, method, environment, personnel, and instruments.
On Dr. James Westgard’s website, www.westgard.com, you’ll find an in-depth discussion of the concerns laboratories face as they tackle the implementation of IQCP. He explains, “The difficulties in implementing IQCPs are many, starting with the education and training that is needed to adopt and adapt new concepts and practices, the lack of information from the manufacturer to help laboratories understand critical failure-modes and the detection capabilities built into analyzers, the subjective nature of the risk assessment with its qualitative scales and arbitrary judgments on risk acceptability, the lack of consideration of the detection capabilities of different control mechanisms, and finally the limited ability of accrediting organizations to assess whether laboratory IQCPs really do provide ‘equivalent quality testing.’”
This is part one of a two-part blog post. The next post reviews some successful IQCP implementations and goes into more details of the process.
If you have implemented ICQP and would like to share your experience, we would love to hear it. Orchard is committed to keeping you informed and being a trusted resource that you can turn to for industry-related education. And as always, we welcome your feedback. Feel free to respond to this post by clicking the “Comment” link at the bottom, or by emailing us at firstname.lastname@example.org.
Kim Futrell, MT (ASCP)
Products Marketing Manager
Orchard Software Corporation
Comments (0) Nov 21 2013