The CLSI guideline EP23-A was created through the consensus from individuals representing the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), industry, and healthcare professions. It enables laboratories to perform “The Right QC” based on risk and guides laboratorians through the process of gathering the right information needed, performing a risk assessment, creating a quality control plan (QCP), and reviewing the plan for effectiveness. Major concepts from the EP23 guideline have been adopted by the CMS CLIA program and placed into a new quality control option based on risk management. This new option, called individualized quality control plan (IQCP), provides the ability to customize QC policies and procedures based on the test system used.
The workbook and worksheet can be purchased online at CLSI Shop. Please note that the workbook and worksheet cannot be purchased separately. They must be purchased with the EP23 document. If you have already purchased the EP23 document, you can obtain these items by contacting the CLSI customer service department. If you purchase the EP23 Online Workshop, they will be included.
Hazard identification and risk assessment will certainly be dependent on both the specific test (and its medical application), as well as the instrument. The decision of how the laboratory performs its risk assessment to develop a quality control plan (QCP) will be up to the laboratory director. Some tests analyzed on the same analyzer may have risks of error so similar that they can be grouped on the same QCP, with only minor additions or deletions for individual tests, while other tests on the same analyzer may have significantly greater, or lesser, risks and need a completely different approach to a QCP. That will be specific to the test, analyzer, or laboratory, and at the laboratory director’s discretion. Ultimately, yes, laboratories can group tests together or treat tests individually as needed, based on their risk assessment and control processes.
There is no specific format that is required for the presentation of a risk assessment or an IQCP. There are sample risk assessment tables in the EP23 document and the EP23 worksheet. There are also sample IQCPs in the worksheet and the workbook. However, laboratory directors have flexibility in the formatting of their own risk assessment and IQCP. There may be some elements, components, or data that the Centers for Medicare & Medicaid Services (CMS) will look for when assessing compliance, but nothing standard.
EP23 and the CMS IQCP guidance does not apply to waived tests, so you can still use the traditional way of performing QC via the manufacturer’s recommendations.
At this point, we are not certain how CAP will embrace this new way of implementing QC. CAP and other accrediting bodies will need to make decisions on how to address performing the right QC as IQCP is rolled out by CMS.
No. The days of doing the requirements listed in the EQC options will be phased out by January 1, 2016, and replaced by IQCP (concepts of EP23), performing QC based on risk management.
CMS will accept CLSI document M22-A3—Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition, CLIA regulations, or IQCP concepts. The microbiology staff can continue to follow M22 if that is what they are using or switch to one of the other two choices.
After purchasing either the EP23 document or the EP23 package (ie, document, workbook, and worksheet), you can purchase as many additional workbooks and worksheets as you need.
The workbook is available in paper format only, unless you purchase the EP23 online workshop. The worksheet is available in electronic format only. Each item is $100 for nonmembers when purchased separately after buying the EP23 document, or the EP23 package. Member discounts apply.
Yes, bulk purchases of six copies or more are available at a discounted rate. Contact CLSI customer service for more information.
Yes, currently we have an online self-paced workshop called EP23 Online Workshop: Risk-Based Tools to Meet IQCP Requirements. Click here to learn more. There is also an on-demand webinar, as well as other education opportunities that are offered on a continuing basis.
Yes, a failure modes and effects analysis table may be used as a checklist or as a tool to help identify potential failures in a testing system. These potential failures are then addressed by an appropriate quality assurance program. Use this template to easily identify these possible failures.
No. You do not have to choose a test to run an IQCP on. If you wish to follow the CLIA QC regulatory requirements as written, then you do not have to implement an IQCP.
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