Tools, Technologies and Training for Healthcare Laboratories

CLIA Final Rule

Example IQCP for POC chemistry system

It's time for another IQCP example. So what can you make with 1 spreadsheet, 7 worksheets, 60 rows, 13 columns, and 304 completed cells? An IQCP built for a Point-of-Care chemistry system.

An Example IQCP for a Point-of-Care Chemistry device

Sten Westgard, MS
May 2016

The IQCP regulations have kicked in, and it's time to start sharing practices and templates with each other. We're lucky enough to have one of the Westgard website members willing to share their IQCPs with us. These IQCPs were developed with the help of the CLSI's EP23[trademarked], CMS directions, webinars and information from different vendors and publications. The CMS spreadsheet for IQCP was the source for the worksheets displayed below.

Remember, every IQCP must be individualized by every laboratory. You cannot simply cut and paste the examples below here into your own IQCP, but you can use the same topics, risks, failure modes, etc., and then evaluate them to the particular context of your laboratory.


POC chemistry IQCP Specimen

Test System

POC IQCP TestSystem


POC IQCP Reagent


POC IQCP Environment

 Testing Personnel


Quality Control Plan


Quality Assessment


While we here at Westgard QC may disagree with the implementation of IQCP in laboratories and some of the conclusions that labs reach, there are still benefits from sharing the experiences of other laboratories who must implement these regulations.

The full PDF of this Excel spreadsheet is available in our download section.  You need to login as a member before you access this part of the website.

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