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.
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. But, 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 QCP. The example in EP23 and those currently being drafted for future education will present some options, but laboratory directors have flexibility in the formatting of their QCPs. 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.
The laboratory director oversight is absolutely acceptable for this type of activity. An independent QA department is not required.
EP23 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 this new way of performing the right QC as this implementation is rolled out by CMS in the interpretive guidelines.
No. The days of doing the requirements listed in the EQC options will eventually be phased out, and replaced by EP23 and performing QC based on risk management.
CMS has not yet fully discussed how it will address CLSI document M22-A3 (Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition) vs EP23. The microbiology staff should continue to follow M22, while staying alert for more information on this topic in the future.
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, while the worksheet is available in electronic format only. Each item is $50 for members or $100 for nonmembers when purchased separately after buying the EP23 document, or the EP23 package.
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 three workshops called “Tools for Tackling EP23: Laboratory Quality Control Based on Risk Management; Approved Guideline.” Learn more/Register now.
There is also an on-demand webinar, as well as other education opportunities that are offered on a continuing basis.
Purchase any CLSI document in the month of October to receive a 30% OFF voucher for a CLSI U webinar!