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Inside the Lab Regulation and standards, Quality assurance and quality control

Be Ready for IQCP

On the first day of 2016, the US Centers for Medicare and Medicaid Services (CMS) will replace the current Equivalent Quality Control (EQC) QC option for meeting Clinical Laboratory Improvement Amendments (CLIA) standard §493.1256(d) with IQCP (1,2). What this means is that test sites, typically providing point-of-care testing and wanting to implement or continue to use a nonwaived testing device and rely solely on the device’s built-in quality assessments to meet daily QC requirements, will need to develop and follow an IQCP. Nevertheless, note that this is a voluntary option!

Test sites not wanting to develop an IQCP will need to perform external QC for each analyte on patient testing days. While IQCP is a CMS mandate, many tests choose to meet CLIA requirements through professional US accrediting organizations’ (AOs) standards, such as those from the College of American Pathologists (CAP), The Joint Commission (TJC), and Commission on Office Laboratory Accreditation (COLA). These AOs standards now include some form of the CMS IQCP option.

IQCPs and risk management

What’s the difference? IQCP expands the definition of QC to include the assurance of quality in all three phases of the testing process – preanalytical, analytical and post-analytical. For example, a test result will not accurately reflect a patient’s condition when the sample is not drawn or processed correctly.

IQCP is founded on risk management concepts (see “Defining Risk”), which include the systematic application of policies, procedures, and practices to analyze, evaluate, control, and monitor risk (3,4). Test sites continually make decisions based on risk management, although many do not realize this when they develop standard operating procedures (SOPs) for the three phases of the testing process.

Defining Risk

Risk is the chance that an “error” will cause harm or loss to a patient. It is estimated from the probability of error occurrence and the severity of the harm or loss to the patient when the error is present.

The risk assessment process systematically evaluates available information to identify and estimate the significance or acceptability of each potential risk identified.

Risk mitigation is the elimination, reduction, or detection of the significant potential risks identified. Typical practices for mitigation include modifying current quality control and quality assurance practices, developing new practices and/or selecting a different testing device with more mitigation features. The goal is to have mitigation mechanisms in place to eliminate all significant risks.

Developing the IQCP

CMS offers a step-by-step IQCP development guide that details the process (5). According to the guide, all IQCPs must be based on facts – clinical, regulatory, test setting and organizational requirements – while ensuring quality test results. The testing device’s approach to evaluating quality and its error detection and mitigation features are essential to consider when making appropriate decisions in developing the QC plan as part of the whole IQCP.

CMS requires test sites to identify and assess potential errors (risks) that ultimately can influence quality in each phase of the testing process. In its August 2013 memo, CMS provides insight into what should be included in the process (1). The memo mandates that at least five components of testing be included in the risk assessment process: specimen, operator (personnel), testing environment, reagents, and test system. Once the test site identifies the potential errors, it needs to review its current SOPs, practices, and test device’s features to determine whether the identified risks are eliminated and/or detected.

In reality, the risk assessment process is another check on the validity of a test site’s practices. For those potential errors identified but not eliminated by current practices, test sites need to determine whether they are significant (6,7). If they are, the test site needs to modify and/or add additional practices accordingly for quality improvement.

IQCP expands the definition of QC to include the assurance of quality in all three phases of the testing process – preanalytical, analytical and post-analytical.

The quality control plan

While the quality control plan focuses only on the analytical phase and, therefore, analytical quality, CMS assumes that test sites can make more appropriate decisions for what practices are necessary by first ensuring “quality” in the pre- and post-analytical processes.

The quality control plan section of the IQCP must at least include the number, type, and frequency of testing controls; the criteria for acceptable results(s) for each of the QC approaches used; and assurances that the QC performed meets the minimum specified by the manufacturer (1). Test sites need to be explicit on what QC is performed daily, weekly and monthly as well as what response is acceptable for each. CMS requires the laboratory director to take responsibility for the proper development and implementation of the IQCP, which includes the quality control plan. The director can delegate this responsibility in writing, but there must be documented evidence that the director approves.

Quality assessment

Test sites are accustomed to continually evaluate their many activities and make changes when necessary for quality assessment. Specifically, CMS requires a test site to establish a review system for the ongoing monitoring of its quality control plan effectiveness. Most sites use a typical “plan-do-check-act” cycle. With this approach, test sites first develop and then implement the quality control plan. Once the plan is followed (do), it is monitored (check) to verify effectiveness. When problems are identified, the plan should be improved (act), starting the quality assessment cycle again.

Putting the IQCP pieces together

The final step in the development process is the IQCP itself, which summarizes the findings of the development process and demonstrates compliance to CMS mandates. Although site policies, procedures and practices will detail the specific changes resulting from the risk assessment process, a summary of these changes for all three phases of testing together with the location of these details will need including in the IQCP (7). CMS provides no specified or “official” format for the IQCP, so test sites have flexibility in presenting the information. However, CMS inspectors will look for evidence, so test sites will need supporting documentation.

Will you adopt IQCP?

While CMS rationalizes the IQCP option by identifying a series of benefits, each test site needs to decide whether it “fits” its particular testing device and situation (7,8). For me, the primary benefit is the risk assessment because it forces sites to evaluate their current policies, practices, and testing device thoroughly for possible risks and risk mitigation and then to make appropriate decisions for quality improvement based on the information they collect.

Undoubtedly, there will be downsides. IQCPs should, in theory, improve test sites’ testing processes and ensure test result quality. However, when test sites do not properly design a thorough risk assessment to identify problems and make appropriate changes for quality improvement, the “quality” of all testing processes will be in question. The verdict for IQCP effectiveness is still out. Only time will tell what the impact will be.

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  1. US Centers for Medicare & Medicaid Services, “Individualized quality control plan (IQCP): a new quality control (QC) option”, see: Accessed June, 2015.
  2. US Centers for Medicare & Medicaid Services, “Code of Federal Regulations. Part 493 – Laboratory Requirements”. Accessed June, 2015.
  3. Clinical and Laboratory Standards Institute, “CLSI EP23A. Laboratory quality control based on risk management”, Accessed June, 2015.
  4. ISO, “ISO14971:2007. Medical devices – application of risk management to medical devices”, Accessed June, 2015.
  5. US Centers for Medicare & Medicaid Services, “IQCP individualized quality control plan: developing an IQCP a step-by-step guide”, Accessed June, 2015.
  6. JO Westgard, “Six Sigma Risk Analysis”, Westgard QC, Inc., Madison, Wisconsin, USA (2011).
  7. SS Ehrmeyer, “The new poor lab’s guide to the regulations”, Westgard QC, Inc., Madison, Wisconsin, USA (2015).
  8. US Centers for Medicare & Medicaid Services (CMS), “CLIA individualized quality control plan (IQCP) benefits”, Accessed June, 2015.
About the Author
Sharon Ehrmeyer

Sharon Ehrmeyer is professor of pathology and laboratory medicine, School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin, USA.

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