Q&A: How to Plan for IQCP?
Posted by Sten Westgard, MS
As many of you know, EQC is out and IQCP is in. As the expiration date for EQC approaches in 2016, labs need to learn more ab
out Risk QC and IQCPs. CMS has an email address where you can send questions.
We tried out the question and answer line with CMS, see the results after the jump...
-----Question 1. In the August 2013 CMS memo, it was stated that no formal Risk Assessment tools (process maps, assessment matrices, etc.) were required to be part of an IQCP. Does this mean that laboratories can not or should not use the formal risk tools that are often used in risk analysis outside of the laboratory?
CMS Response: The CMS Survey and Cert Letter 13-54- Attachment 1-IQCP document describes the new IQCP procedure and what is required for IQCP in order for a laboratory to be in compliance with CLIA. CLIA does not get prescriptive as to what tools or resources are to be used for a laboratory to meet the regulatory requirements. It is the responsibility of the laboratory director to determine how to meet these requirements, i.e. acceptable tools, resources. The new IQCP option gives laboratories the flexibility to determine the appropriate tool(s) for their test system and environment.
Question 2. Are qualitative judgments on the residual risk (i.e. saying "yes" or "no" without statistics or error/defect rates, etc.) acceptable in an IQCP?
CMS Response: It is the laboratory director’s responsibility to determine how to mitigate the risks identified in the IQCP Risk Assessment. However, the laboratory is required to have in-house data/documented evidence, established by the laboratory in its own environment and by its own personnel, to demonstrate that the stability of the test system supports the number and frequency of the QC documented in the QCP. Data from verification or establishment of performance specifications and historical (existing) QC data can be included. Published data or data from manufacturers (e.g. package inserts) may be taken into consideration, but may not be used as the sole criteria for decision- making.
Question 3. Is it possible to send CMS a template or even a specific IQCP from a laboratory and have that analyzed, reviewed, and/or approved in advance?
CMS Response: CMS is allowing a 2-year Education and Transition Period, from 01/01/2014 to 01/01/2016, for laboratories to familiarize/educate themselves on the new IQCP procedure. CMS will not be reviewing or approving any specific IQCP template/procedure in advance. It will be evaluated as part of the laboratory’s routine survey, using the outcome-oriented survey process.
Question 4. Is it acceptable to use defect rates, statistical QC data, quality indicators of a quantitative nature, as part of an IQCP?
CMS Response: CLIA does not get prescriptive as to what tools or resources are to be used for a laboratory to meet the regulatory requirements. It is the responsibility of the laboratory director to determine how to meet these requirements. The new IQCP option gives laboratories the flexibility to determine the appropriate tool(s) for their test system and environment.
Question 5. I have seen that some organizations and companies are offering pre-built templates for IQCPs (COLA, Carepoint solutions) - I thought that the August 2013 memo said that such templates were not acceptable. If they are acceptable, however, did these organizations submit any of their templates for review? In other words, how can we be sure that any organization is actually providing an appropriate IQCP guide (other than EP23[tm])?
CMS Response: CMS does not prohibit the use of any third-party templates. The laboratory may use any of the available tools/resources. However, pre-built templates may not include all of the requirements of the IQCP procedure nor address the laboratory’s unique/individual environment. CMS will not review third-party templates. Therefore, it is ultimately the laboratory’s responsibility to review these templates and augment them as necessary to ensure that all IQCP requirements are met, including laboratory-specific information.
We thank the CMS for providing these responses.
(Does that clear things up for anyone?)
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