Performing Quality Control (QC) gives healthcare professionals confidence that test results obtained on patient specimens are accurate and reliable.  It is designed to detect, reduce, and correct deficiencies in a laboratory’s internal analytical process prior to the release of patient results.

Concepts of what makes for effective quality control have continued to evolve since the original requirements were defined by the Clinical Laboratory Improvement Act of 1988, and became effective in 1992.   At that time the minimum requirement for most tests was established as two levels of external control materials each day of patient testing (due to specialty specific requirements, exceptions are made for  Coagulation,  Arterial Blood Gas studies, and Microbiology).   CLIA Interpretive Guidelines subsequently allowed for an alternative to daily external Quality Control requirements as long as “equivalent quality testing” is assured.  Since 2004, this alternative has been Equivalent Quality Control (EQC).    Even though many laboratories implemented EQC without difficulty, there were a number of potential errors that could lead to inaccurate results that were not detected by the test system’s internal controls or by the EQC qualifying studies.

Out of these concerns, and after a summit conference attended by accrediting organizations, industry representatives, professional organizations and the government, the concept of quality control based on Risk Management was developed.  CMS named this new equivalent quality option “Individualized Quality Control Plan” (IQCP).

COLA, leading laboratory accreditor, has officially adopted IQCP as the acceptable QC option to CLIA mandated standards.

The  present transition period  from using EQC to using IQCP as an acceptable QC option ends on January 1, 2016.  After that date, EQC will no longer be the acceptable QC alternative for many laboratories.  During this transition period,  laboratories using EQC will need to transition away from the EQC protocol and either implement the regulatory QC requirements (typically twoEQC levels of external QC each day of patient testing for most tests) OR implement IQCP.

How is IQCP an improvement over traditional QC as an internal monitor for laboratory quality?

IQCP is effective QC:  Quality Control is most effective when it takes into consideration all of the circumstances that are unique to each laboratory. That is exactly what IQCP does, allowing the laboratory to develop a QC plan that is customized for how the test is performed on site while maintaining compliance with the applicable regulations.

An Individualized Quality Control Plan for a specific test system consists of three components:

  • The Risk Assessment
  • The Quality Control Plan (QC Plan)
  • The Quality Assessment Review – as a component of your (QA) Plan

The Risk Assessment:

This is the means of identifying and evaluating the risk of potential problems or errors that may occur in your testing process.  The testing process encompasses all phases of testing beginning with the specimen collection (pre analytic) and continues through the analysis of the specimen (analytic) until the final test result is reported (post analytic).[i]

These risk assessments must include, at a minimum, an evaluation of the following five components of the testing process:

  • Specimens
  • Environment
  • Reagents
  • Test System
  • Personnel

Identifying, evaluating, and controlling potential errors that are relevant to each laboratory by implementing targeted Quality Control measures is the cornerstone of IQCP.

What you learn from your Risk Assessment will be used to develop your Individualized Quality Control Plans.

The Quality Control Plan

A strong, well-documented individualized QC Plan will establish control procedures that reduce the likelihood of providing an inaccurate patient test result in your laboratory. Your QC Plan must at least include the number, type and frequency of testing, and criteria for acceptable result(s) of the quality control(s). Your lab’s own data must support the rationale for the number, type and frequency of testing. It’s possible that you may find your customized QC Plan will be less than the CLIA control requirements. However, at a minimum, your QC Plan must not be less stringent than the manufacturer’s instructions for testing QC. The QC Plan may also describe the use of electronic controls, procedural controls, training and competency assessment and all other QC activities.[ii]

The QC Plan will also include any additional practices adopted by your lab to reduce the incidence of errors throughout all phases of testing.

As with traditional QC plans, your QC Plan must:

  • Detect immediate errors that occur due to test system failure, adverse environment conditions, and operator performance.
  • Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance.
  • Meet all applicable regulatory requirements. In addition to the federal CLIA regulations, your laboratory may be subject to more stringent requirements such as state laws,  Accrediting  Organization criteria, or facility/organization Quality Control protocols that must be followed[iii].

IQCP Evaluation and Monitoring (Quality Assessment)

Ensuring effective quality control requires ongoing monitoring, corrective actions when needed, and follow up to ensure that quality is maintained.  A review should be conducted any time a problem is discovered, or a failure occurs, but annual reviews  must be conducted specifically to evaluate  each of your IQCPs.

To accomplish this, add regular, documented reviews of each of your IQCPs to your existing Quality Assessment Plan. The monitoring must include, but is not limited to, each required component of IQCP (testing personnel, environment, specimens, reagents, test system, post-analytic (Result Interpretation and Reporting).   At regular intervals review each of the elements that your plan incorporates to prevent errors and ensure accurate results, including reviews of  QC results and graphs, other quality measures implemented, proficiency testing results, incidence of specimen rejection, concerns or complaints from providers; and any incidents related to this test.

The introduction and utilization of IQCP affects your laboratory in many ways, from improving the effectiveness of your quality control through risk identification,  evaluation and mitigation, to  greater involvement by your testing staff in the evaluation of the testing process,  the  decisions made as to the level of QC performed,  and accreditation requirements and standards.

To learn more about implementing an IQCP in your own laboratory, join COLA Resources Inc (CRI®) and Advance for Administrators of the Laboratory for the free webinar “Understanding What IQCP Means for Your Laboratory” on Thursday, August 27th at 1:00 pm EST.

 

[i] IQCP Brochure 13, What is an IQCP?  November 2014. What is Risk Assessment?   IQCP@cms.hhs.gov.

[ii] IQCP Brochure 13, What is an IQCP?  November 2014. IQCP QC Plan.   IQCP@cms.hhs.gov.

[iii] Individualized Quality Control Plan (IQCP)  Implementation Guide.  Developing a Plan to Minimize Risk.  P 44. COLA  Resources, Inc. 2013.