The CLIA Individualized Quality Control Plan (IQCP) is a recently developed, risk-based, objective approach to performing quality control testing. The IQCP is based on assessment of the unique laboratory testing in use, patient populations, and other aspects (for example, internal quality checks built into new instruments). The use of IQCPs will be implemented under the CMS regulation 42 CFR 493.1256 Standard: Control Procedures, and applies to most CMS-certified current and new non-waived tests. It does not apply to waived tests.
While IQCP is voluntary, it will replace the current Equivalent Quality Control (EQC) procedure, which was designed as a standardized approach and intended to minimize the amount of external QC required and laboratory costs. One may think of IQCP as a laboratory-specific tailored plan (“the right QC”) as opposed to a general standardized plan (“one size fits all”). Regulatory/accreditation requirements, manufacturer/product information, and the individual facility setting will all have an effect on the development of an IQCP. However, CLIA concepts and regulations will not change, and laboratories may elect to follow current CLIA QC regulations directly in order to demonstrate compliance. Pathology, histopathology, oral pathology, and cytology tests (and a few others) are not eligible for use of IQCP.
The IQCP incorporates key concepts from the Clinical and Laboratory Standards Institute document CLSI EP23: Laboratory Quality Control Based on Risk Management; Approved Guideline. The concepts include (1) Risk Assessment, (2) the Quality Control Plan, and (3) Quality Assessments (surveillance). While providing a scientific basis for QC strategies, EP23 is not prescriptive. It describes risk assessment elements; quality system essentials; quality control tools, strengths and weaknesses; information to be gathered; and surveillance and follow-up guidelines. Laboratories will need to assess their current quality practices as they apply to test systems, clinical use of technologies, patient populations, etc.
Because it is risk-based, an IQCP may result in quality control that is less stringent than the CLIA QC requirements. However, if a manufacturer’s instructions are less rigorous than the CLIA QC requirements, the requirements or an IQCP must be followed.
A Risk Assessment (RA) is a comprehensive process that identifies potential failures/sources of error (risks), evaluates the risks, ranks the risks by severity and likelihood of harm, describes risk prevention/control measures (mitigations), and determines residual risk and its acceptability. For IQCP this must include risks associated with the specimen, environment, reagent, test system, and testing personnel covering the preanalytic, analytic, and postanalytic phases. The process requires information gathering that includes regulatory/accreditation requirements, measuring system information (i.e., manufacturer’s information), factors impacting the methodology, and patient care factors (i.e., effect on results). Testing load, frequency of testing, and complexity of testing methodologies are also considerations. The RA should be primarily assessed using in-house obtained data (verification, validation data; QC data), although other relevant data may be considered (published data or manufacturer’s data).
Process mapping is a useful tool for risk identification. Once risks are identified, a risk ranking (or estimation) is calculated (likelihood of harm times the severity of harm). For laboratories, the likelihood of harm may be more appropriately based on number of patient tests or defect rates, rather than time. These data can be incorporated into a risk acceptability matrix, categorizing acceptable/unacceptable risks. If the risk of harm is not acceptable, risk control measures are identified and implemented, with the intent of limiting the residual risk to being clinically acceptable. After implementation of mitigations, the risk ranking is recalculated and the evaluation repeated.
A useful tool for documenting the elements of the risk analysis is the Failure Modes and Effects Analysis (FMEA) table. For this purpose, a FMEA might include the risk, risk cause, harm, risk ranking, and controls (mitigations). There are many risk analysis references and tools available on the web.
The outcome of the Risk Assessment is the development of a Quality Control Plan.
Quality Control Plan
The Quality Control Plan (QCP), based on the identified risk(s), is a comprehensive strategy that includes all control procedures to reduce residual risk and methods to immediately detect errors, using both prevention and monitoring strategies. The QCP is intended to proactively address potential risks before they occur and result in failures, compared to the practice of addressing failures after they occur.
The QCP describes practices, resources, and procedures necessary to control the quality of a given test process. Using risk profiles, laboratories may determine that an individual test requires an individual QCP, or that tests with similar risk profiles may be grouped together in a single QCP. The QCP will also describe how to monitor performance through the use of quality assessment after implementation and over time.
Quality Assessment (QA) is a method of surveying QCP effectiveness/performance through ongoing laboratory monitoring and review of documentation generated as part of the QCP. Monitoring is not limited to one-time data review, but includes trending over time. Documentation examples include quality control review, results of proficiency testing and competency assessments, patient test result review, specimen rejection rates, test turnaround times, and corrective/preventive action and follow-up records. The assessment may identify a lack of effectiveness, unanticipated failures, or underestimated risks requiring identification of root cause, corrective action and preventive action, and follow-up. Conversely, it may identify reliable performance that qualifies for less stringent quality control. Either finding may result in modification of the QCP, making it a “living” document.
CMS is providing training, information and guidance prior to the January 1, 2016, IQCP implementation date. The IQCP Education and Transition period began on January 1, 2014, and will conclude on January 1, 2016. As of the implementation date, the IQCP will be written into the CLIA Interpretive Guidelines for Laboratories to replace equivalent quality control procedures currently described. Between now and the implementation date, laboratories may: 1) follow CLIA QA requirements as written; 2) continue to use EQC; or 3) implement IQCP. After implementation, the second option will no longer be acceptable, and if it is still in use, it will result in a citation for noncompliance.
Laboratories may perform quality control per other CLSI standards, and should check with CMS regarding acceptance in lieu of an IQCP. (For example, CLSI M22-A3: Quality Control for Commercially Prepared Microbiological Culture Media will be accepted by CMS.) It is currently unknown if, or how, accrediting organizations (for example, CAP) or states that have additional requirements will accept IQCP. Laboratories should continue to meet their accrediting organization’s or state QC standards until they receive notice to do otherwise, or should check with them prior to implementing IQCP.
Sharyn Orton, MT(ASCP), SBB, MPSH, PhD, is Senior Consultant for Massachusetts-based MEDIcept, Inc.
- CMS IQCP information:
- Self-paced Online Workshop: Risk-Based Tools to Meet IQCP Requirements: http://www.clsi.org/edu/workshops
- CLSI EP23 Laboratory Quality Control Based on Risk Management; Approved Guideline and other information: http://www.clsi.org/edu/workshops/ep23-qa/
- CLSI EP-18A2 Risk Management Techniques to Identify and Control Laboratory Error Sources: Approved Guideline: http://shopping.netsuite.com/s.nl/c.1253739/it.A/id.280/.f
- Six Sigma Risk Analysis: Designing analytical QC Plans for the medical Laboratory, First Edition, 2011, James Westgard, PhD:http://www.westgard.com/books-and-reference-manuals/six-sigma-risk-analysis.htm