On Aug. 16, 2013 CMS published a memorandum describing the interpretive guidelines for IQCP, the new alternative quality control option that will be replacing the Equivalent Quality Control, most commonly known as EQC. The Individualized Quality Control Plan policy outlines how laboratories will have to device a quality control plan based on risk management for each qualifying test. CMS has determined that all non-waived testing in all CLIA specialties and subspecialties, with the exception of pathology, histopathology, oral pathology and cytology are eligible for IQCP.
Laboratories must know that after the educational transition period ends, there will only be two options when it comes to complying with quality control regulations: laboratories must either follow CLIA guidelines as written or implement an IQCP in their laboratories as specified by the interpretive guidelines just released last week.
To recap a previous blog, the goal of IQCP is to minimize the potential for reporting erroneous results and therefore to enhance the quality of patient care. To do this, lab directors and managers must become very familiar with the steps necessary to build an IQCP for a particular test in their laboratories.
CRI, a subsidiary of COLA whose mission is to provide educational and consultative services aimed at improving laboratory medicine and patient care, will soon be publishing an IQCP implementation guide that will explain the steps necessary to implement an IQCP. At a glance, this manual will help readers understand:
- How to identify potential errors in a testing process
- How to conduct a risk assessment
- What steps are necessary to develop an IQCP, etc.
In the next blog, we will cover information regarding identification of potential errors and the tools necessary to conduct a risk assessment. In the meantime, feel free to contact us if you have any questions regarding this new quality control guideline.