Quality control (QC) is an essential component of laboratory medicine. Designed to detect, reduce, and correct deficiencies in a laboratory’s analytical testing, effective QC reassures health-care providers that test results obtained on patient specimens are accurate. QC also establishes more cost-effective medical care through improved efficiency and reduced medical diagnostic errors.
Yet, despite its importance, laboratory procedures for QC have long been debated. Questions have arisen: How do you define QC? Are there defined guidelines outlining when and how QC should be performed? Can QC be “one size fits all,” or do the physician’s office laboratory and hospital laboratory have different QC requirements?
Despite these ongoing controversies, a comprehensive approach to QC, which complies with regulations while meeting the needs of the majority of the laboratory community, is now emerging in the form of the Individualized Quality Control Plan (IQCP), recently announced by the Centers for Medicare and Medicaid Services (CMS).
Beginning this month, CLIA (Clinical Laboratory Improvement Amendments) laboratories are able to start transitioning away from Equivalent Quality Control (EQC) and use either the default CLIA recognized manufacturer’s QC requirement or IQCP. An IQCP plan is not necessary if the manufacturer’s stated number, type, and frequency of control procedures meet or exceed the CLIA requirement of two levels of external controls each day.
The goal of the new voluntary program is to allow healthcare professionals at all levels of patient care the ability to identify, assess, and mitigate all potential errors in their laboratories, throughout all phases of specimen testing. Using the concept of risk management, IQCP allows laboratorians to consider all possible sources of errors unique to their individual laboratory and to develop a QC plan that is customized for their testing workflow process, while maintaining compliance with applicable regulations. IQCP is also adaptable, permitting physician office laboratories and clinical laboratories to customize and align their QC procedures with changing technology.
The IQCP Education and Transition Period began on January 1, 2014, and will conclude on January 1, 2016. During this period, labs will have three acceptable QC options:
- Follow the CLIA QC regulatory requirements as written.
- Continue to follow the Equivalent Quality Control (EQC) procedures as described in the current Interpretive Guidelines.
- Implement IQCP.
At the end of the transition, EQC will no longer be an acceptable option to meet CLIA QC requirements, and will be removed from the regulatory guidelines. Labs will choose either to follow the CLIA QC regulatory requirements as written (two levels of QC for each day of testing), or implement IQCP, as applicable.
It is also important for labs to keep these key points in mind:
- IQCP includes, for each test, a risk assessment performed within a laboratory based on its unique circumstances.
- IQCP recognizes that all phases of testing impact quality; therefore, the scope of risk assessments must encompass the entire testing process: pre-analytic, analytic, and post-analytic phases.
- IQCP focuses on the “right” QC for each test, which is not necessarily less frequent QC.
- IQCP is formalized as a documented Quality Control Plan. It may be electronic or hard copy, and it may be documented as part of the testing procedure or as a separate manual.
Surveys during the transition
CMS surveys will continue in their educational mode throughout the two-year transition period, and will only cite deficiencies in those situations where serious testing problems result from deficient QC practices, where no QC is performed at all, or where immediate jeopardy is found. Meanwhile, private, CMS-approved Accrediting Organizations, such as COLA, can choose whether or not to incorporate IQCP guidelines into their accreditation processes. However, any standards they use will need to be either a regulatory equivalent to the current CLIA regulations or an acceptable equivalent to the IQCP option.
COLA Resources, Inc., (CRI) has created a comprehensive program to address the critical changes in laboratory QC. The CRI IQCP Program is designed to assist labs in developing and implementing IQCP, customized to the diversity and unique testing conditions in their laboratory.
Although the debate surrounding QC may continue, healthcare providers at all levels of patient care (physicians, nurses, laboratory personnel, etc.) will agree that the objective is to enable laboratories to meet their unique quality control requirements while achieving regulatory compliance, thus paving the way to continuous quality patient care. IQCP is an important step forward toward realizing this goal.
- Interpretive Guidelines for Laboratories – Appendix C. Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services. www.cms.gov/Regulations-and-guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html. Accessed November 29, 2013.