LabOratory: The New Individualized Quality Control Plan (IQCP) Interpretive Guidelines: What Do They Mean For Waived, Moderate And High Complexity Laboratories?

When CLIA ’88 became effective in 1992, the minimum requirement for quality control (QC) was established as testing two levels of control materials each day of patient testing.  Since then, evolving technologies for laboratory instrumentation and test methodologies have required reconsideration of how QC is carried out.   Fortunately, the CLIA Interpretive Guidelines allows an alternative to daily external QC as long as “equivalent quality testing” is assured.  Since 2004, this alternative has been Equivalent Quality Control (EQC).


Even though many labs implemented EQC without difficulty, it was observed that 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.  Consequently, in 2005, CMS encouraged the Clinical Laboratory and Standards Institute to develop a new QC guideline.  The resulting guideline, EP-23 Laboratory Quality Control Based on Risk Management, was published in October 2011.[i]

The CLIA Interpretive Guidelines incorporated key concepts from EP-23 to develop a new alternative QC policy named “Individualized Quality Control Plan” (IQCP). This replaces EQC after January 1, 2016.  

What is IQCP, and what does it mean for you?

This stands for Individualized Quality Control Plan. The key word here is Individualized. It is the new  equivalent quality control option for non-waived testing that allows your laboratory to create a quality control plan customized to its specific environment. Quality control is most effective when it takes into consideration all of the circumstances that are unique to the laboratory.

By properly implementing IQCP, potential sources of error in the pre-analytic, analytic and post-analytic phases of testing will be examined, and the appropriate QC and quality practices established. After completing this process, you will have created and documented a comprehensive QC program, which reflects your laboratory’s unique operation.[ii]

Components of IQCP

  1. Risk Assessment  (RA):

Risk Assessment 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).[iii]  The first step in developing your IQCP for a test is to gather as much information as possible.  This information will be used to identify and evaluate potential risks (i.e., errors with the potential to cause harm).

These risk assessments must include an evaluation of the following five components:

  • Specimens
  • Testing Personnel
  • Reagents
  • Laboratory Environment
  • Test System

Review your specimen collection, handling and storage procedures and the specific specimen requirements for the test. Review instructions provided to patients for specimens that they collect themselves..

You need to know information about the personnel performing the test. Review training and competency assessment records. Have they been adequately trained? Has their competency been assessed and confirmed?

Reagents are considered as part of the testing process.  Errors that can compromise reagents can occur during shipment, handling and storage and processing.  Gather package inserts and storage records to assess these potential risks.

Check the environment where the test system is used.  Where is the testing  performed and what other activities occur nearby?   Review the stability of the temperature and humidity;   consider lighting, electric, water quality and other utilities.

Examine the test system.  Much of this information is supplied by the manufacturer in the package insert and/or operator’s manual. You also have your own historical data to consider, for example:   maintenance logs, QA and QC records, verification of performance specifications, and calibration and calibration verification records. [iv]  

During this process ask yourself these questions:

  • What is the likelihood (frequency) of this error happening? If this error occurs, what is the potential severity of harm to patients?
  • How do I minimize or reduce the likelihood that this error could occur anywhere in the testing process?

What you learn from your risk assessment will be used to develop your individualized quality control plans[v].

  1. Quality Control Plan (QC Plan)

A strong, well-documented QC Plan will establish control procedures that reduce the likelihood of providing an inaccurate patient test result. 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).  The QC Plan may also describe the use of electronic controls, procedural controls, training and competency assessment and all other QC activities.[vi]

As with traditional QC plans, your QC Plan must:

  • Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance.
  • Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance, environmental conditions, and variance in operator performance.
  • Meet all regulatory requirements. This includes the Federal CLIA regulations, as well as applicable state laws, accrediting organization criteria, or facility/organization QC protocols[vii].

3     Quality Assessment  (QA)

Monitoring your IQCPs must be part of your laboratory’s overall Quality Assessment Plan.  The concept is the same as the quality assessment reviews that you perform for other elements in your laboratory’s operations.  Conduct a review anytime you discover a problem, but also conduct periodic reviews specifically to evaluate the effectiveness of each of your IQCPs. The monitoring must include, but is not limited to, each required component of IQCP (testing personnel, environment, specimens, reagents, and test system).  

When the laboratory discovers a testing process failure, the laboratory must conduct an investigation to identify the cause of the failure, its impact on patient care, and make appropriate modifications to their QC Plan, as applicable. If necessary, the laboratory must update the risk assessment with the new information and modify the QC Plan, as needed.[viii]

Considering IQCP ?   Please remember…..

  1. This is a voluntary equivalent quality control option.  You can always continue to follow CLIA guidelines for quality control.
  2. IQCP replaces EQC on January 1, 2016.  If you are presently performing EQC, you may continue to do so, until that date.
  3. You must follow manufacturer’s requirements for quality control if they are equal to, or exceed CLIA QC requirements.  If, however, manufacturer’s QC requirements are less than CLIA requirements, you must follow the more stringent CLIA requirements unless you implement IQCP to validate the risk level involved as acceptable.
  4. All CLIA specialties are eligible for IQCP except for: Pathology; Histopathology; Oral Pathology; and Cytology.[ix]
  5. The laboratory director is responsible for deciding whether the laboratory will utilize IQCP for some or all of its tests and for ensuring that the quality control plan (QCP) developed effectively meets the IQCP requirements. The laboratory director may assign, in writing, specific duties for the IQCP to qualified laboratory personnel but is still responsible overall for the entire testing process.  The Laboratory Director must review and approve the IQCP before it is put into use.
  6. Additional information on the CLIA Interpretive Guidelines is available at:  IQCP@cms.hhs.gov.

 

[i] Individualized Quality Control Plan (IQCP) Implementation Guide. Evolution of Quality Control              Pp 7-8.  COLA

Resources, Inc. 2013.

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

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

[iv] Individualized Quality Control Plan (IQCP) Implementation Guide. Introduction To Risk Management Pp 19-20.

 COLA  Resources, Inc. 2013.

[v] Individualized Quality Control Plan (IQCP)  Implementation Guide. What Is IQCP? Pp 11.  COLA

  Resources, Inc. 2013.

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

[vii] Individualized Quality Control Plan (IQCP)  Implementation Guide.  Developing a Plan to Minimize Risk.  P 44.

  COLA  Resources, Inc. 2013.

[viii] IQCP  Interpretive Guidelines Memorandum Aug. 6, 2013.  Attachment #1: Individualized Quality Control Plan:  Quality  Assessment.   IQCP@cms.hhs.gov.

[ix] IQCP  Interpretive Guidelines Memorandum Aug. 6, 2013.  Attachment #1: Individualized Quality Control Plan: Regulatory Considerations.  IQCP@cms.hhs.gov.

 

Irwin Z. Rothenbergis a Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel, and allied health professionals.  CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at www.criedu.org or call 1-800-981-9883.


Irwin Z. Rothenberg, MBA, MS, M.T. (ASCP)

Technical Writer/ Quality Advisor, COLA Resources, Inc.