HHS Offers FAQs on Individualized Quality Control Plan

HHS Offers Summary on Individualized Quality Control Plan (IQCP)

CMS is implementing a new quality control option based on risk management (IQCP). IQCP will provide laboratories with flexibility in customizing quality control (QC) policies and procedures based on the test systems in use and the unique aspects of each laboratory. A transition and education period will begin Jan. 1, 2014 and will conclude Jan. 1, 2016. Following is a list of Frequently Asked Questions provided by HHS.


1. What is IQCP? IQCP stands for Individualized Quality Control Plan, and will be the formal policy name for the alternative CLIA Quality Control (QC) option that will provide for equivalent quality testing for 42 CFR 493.1250 after it is incorporated in Appendix C of the State Operations Manual. Prior to placing IQCP in Appendix C, however, we will allow for an educational period in which the former "Equivalent Quality Control" (EQC) will remain in Appendix C, and IQCP will be available for voluntary use as described in Attachment 1- Individualized Quality Control Plan (IQCP). We will be retiring EQC and adopting IQCP in Appendix C as the official alternative quality control method for CLIA after the IQCP Educational and Transitional period.

2. What are the three parts of an IQCP? What is required in an IQCP? The IQCP consists of three parts: Risk Assessment (RA), Quality Control Plan (QCP), and Quality Assessment (QA), all of which are outlined in the Attachment 1- IQCP.

3. Is IQCP intended to reduce the amount of quality control in laboratories? This new QC protocol will not necessarily reduce QC, but instead, IQCP will permit the laboratory to develop an effective QC protocol that recognizes technology enhancements that are built into test systems and be customizable to reflect the laboratory's own unique environment, patients, testing personnel, test systems, etc.

4. Are CLIA QC regulations changing to accommodate IQCP? What about other CLIA quality system requirements? No, CLIA QC regulations will remain the same as published in 2003. All the preanalytical, analytical and postanalytical systems requirements in the CLIA regulations will remain in effect. We are exercising our enforcement discretion to allow laboratories to use the Attachment 1- IQCP in lieu of certain regulatory requirements in anticipation of placing IQCP in Appendix C of the State Operations Manual as an official "Equivalent Quality Control" method. We note, however, that the regulatory requirements which one would use IQCP in lieu of may present useful concepts to consider when laboratories using IQCP seek to identify where failures in a process may occur and should be considered during the IQCP RA.

5. Will accrediting organizations (AO) and exempt states (ES) be required to accept the use of the IQCP option? It will be optional for AOs and ESs to incorporate IQCP into their standards; however, any standards they use will need to either be a regulatory equivalent to the current CLIA regulations, or an acceptable equivalent to the IQCP option as laid out in Attachment 1- IQCP. Additional guidance on this matter will be forthcoming. In general, accredited laboratories and laboratories in exempt States should follow the current AO/ES QC requirements during the transition period until IQCP is fully effective and then follow the AO/ES QC protocol subsequently approved by CMS.

6. Are all specialties and subspecialties eligible for IQCP? All CLIA specialties, with the exception of pathology, will be eligible for IQCP. Pathology will be reconsidered at a later date. Exception: Under CLIA, certain tests may be assigned to one of several specialties/subspecialties. If the test is eligible for IQCP under one of those potential specialties/subspecialties, then the laboratory may elect to use IQCP for the test regardless of whether it assigned the test a "pathology" specialty/subspecialty in that particular laboratory. For example, a Fluorescence In Situ Hybridization (FISH) test system may be classified as either histopathology or cytogenetics. So, if a laboratory assigns the FISH test to histopathology, it would at first appear to be excluded from IQCP under the pathology exception. However, because the test may also be classified as cytogenetics, this laboratory would be allowed to use IQCP for the test.

7. What is the timeline for Implementing IQCP? A timeline for SA training and IQCP implementation is included in this Survey & Certification (S&C) letter announcing the beginning and end of the Education and Transition period. Also in this S&C letter, we are instructing our survey teams to provide the laboratories with an ample Education and Transition period and have provided resources on the CLIA website, such as documents Attachment 1-IQCP and Attachment 5-FAQs, to learn about, understand, apply and implement IQCP, http://www.cms.gov/Regulations-and- Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html.

8. Will there be an Education and Transition period? Yes, we are providing an Education and Transition period to allow interested laboratories, to learn about and implement IQCP. During this time, survey teams will be instructed to not cite QC deficiencies except in cases of immediate jeopardy, a laboratory has failed to implement any form of QC, or serious quality problems are identified. The laboratories may also continue to use existing EQC policies and procedures in Appendix C of the State Operations Manual (SOM) until the Education and Transition period expires, at which time IQCP will replace the current EQC option.

9. What happens to Equivalent Quality Control (EQC)? And Why? The laboratory may continue to use the EQC policies and procedures in Appendix C of the SOM until that option is replaced with IQCP at the end of the Education and Transition period. To reiterate, IQCP will replace the current EQC when it is formally published in Appendix C of the State Operations Manual which we anticipate doing at the end of the Education and Transition period. IQCP is a total quality assurance process that represents an innovative QC approach, considers the entire testing process, and provides flexibility.

10. Will any test systems currently eligible for EQC be "grandfathered"? We do not anticipate grandfathering test systems under the current EQC policies and procedures. However, historical data accumulated during the EQC evaluation protocol and its ongoing usage could (and likely should) be used in the development of the laboratory's IQCP.

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