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 was established as testing two levels of external control materials each day of patient testing. However, CLIA Interpretive Guidelines have always 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, the concept of quality control based on Risk Management was developed. CMS named this policy the “Individualized Quality Control Plan” (IQCP).
Presently, we are in the midst of a two year transition period, during which laboratories have the time to study and learn about IQCP; and to decide whether to move forward to develop and implement IQCP. To have an acceptable IQCP in place is not a simple matter, and during this time, laboratories can continue to utilize EQC as their QC option.
However, on January 1, 2016, EQC will no longer be an acceptable option by CMS, and it will either be IQCP or returning to the current CLIA quality control standards. If you wish to move ahead with IQCP, now is the time to master the concepts and applications of IQCP, and begin implementation.
If you are not familiar with the concept of Individualized Quality Control Plans, here are a few key points:
- IQCP is a QC program based on the individual risk factors involved in the performance of each test in your laboratory. IQCP consists of a Risk Assessment, a QC plan; and a Quality Assessment process to monitor the effectiveness of the IQCP.
- IQCP is voluntary; but it can be applied to all non-waived clinical laboratory testing except within the specialties of Pathology including Histopathology; Oral pathology; and Cytology
- You must follow manufacturer’s requirements for QC if they are equal to, or exceed CLIA QC standards. If however, the manufacturer’s QC requirements are less than CLIA QC requirements, you must follow the more stringent CLIA requirements UNLESS you implement IQCP to validate that the risk level is acceptable.
- There is no grandfathering in of test procedures presently using EQC; all IQCP must be newly developed for each test involved.
- The Laboratory Director is responsible for deciding whether the laboratory will utilize IQCP; the development of the IQCPs; and approval of the IQCP before putting it into use.
There are many sources of information available that provide both basic information about IQCP, as well as implementation tools.