A year ago, laboratory journals, professional meetings and in-house planning were all about the pending deadline for implementation of the new CMS quality control option, the Individualized Quality Control Plan (IQCP), which was replacing the Equivalent Quality Control (EQC) testing already in place. With the January 1 implementation date rapidly approaching, many laboratorians had already begun performing their risk assessments, and making revisions to their existing QC Plans (as needed). Laboratory quality assessment schedules were revised to include QAs for the new IQCPs.
Whether or not IQCP is judged effective at actually improving the quality of the testing performed depends on how well the implementation process is carried out, along with the subsequent quality assessments performed. It is from the quality assessment (QA) findings that judgements are made to determine how effective IQCP is at detecting, controlling or reducing errors in the entire testing process, and if additional steps are needed to ensure quality, such as new training for personnel.
What Do We Know So Far?
Though we are still within the first year of IQCP implementation, recent surveys have begun to provide feedback on the entire IQCP process These studies are providing the first indications as to whether laboratories feel that IQCP is living up to its promise and potential for achieving the highest quality of laboratory work.
One such survey was conducted in July (Westgard S. 2016 IQCP Users Survey (USA). Available at: www.westgard.com/iqcp-user-survey.htm). Dr. James O. Westgard, founder and president of Westgard QC, and Sten Westgard, the organization’s director of client services and technology, published survey results of about 150 laboratories with recently established IQCP programs. These results represent a snapshot of IQCP implementation so far, and include significant indicators regarding resources used to implement the program, how effective these labs judge IQCP vis-a-vis the previously used EQC, and the results of lab inspections conducted that included their IQCP programs. The participating laboratories were all voluntary respondents to a request for feedback by Westgard QC, and the findings are based specifically upon this group. Among the findings:
Who Responded to the Survey?
- Almost 60% of the respondent labs were core or central labs.
- Almost 20% were clinic, outpatient, satellite or point of care labs.
- Only 1.5% were physician office labs.
- The largest number of labs have implemented 1-5 IQCPs; the next largest number of IQCPs implemented is 5-10; smaller numbers of laboratories have implemented as many as 11-20 different IQCPs.
- One third of the laboratories reported using 1-2 staff to complete an IQCP; one quarter of the labs, however, utilized 5 or more staff for this task. As quoted in Westgard QC, “This suggests that some labs may be overburdening their staff, having just one person in some cases, to take on a project that should be collaborative and multidisciplinary.”
- The largest number of labs averaged 15 hours to develop each IQCP; equal numbers reported spending 8-14 hours and 1-4 hours. A small number reported not spending any time, but using IQCPs provided by the manufacturer.
Quality Assessment Results
- The number of potential failures /risks/hazards identified and addressed in the typical IQCP:
- The most common response was 10-20. Dr. Westgard noted that this is approximately the same number of failure modes provided by manufacturers in the IQCP template, adding “but there should probably be more hazards identified in an IQCP. If most labs are just finding around a dozen risks, they may not be adequately assessing their risks or they may be wilfully ignoring them.”
- Did IQCP uncover any risks that were considered unacceptable to the laboratory?
- Slightly less than one third reported that the IQCP process helped them to uncover risks that had previously been unknown or unaddressed.
- More than two thirds of the respondent labs found no new and/or unacceptable risks.
- Did the IQCP results require additional / new control mechanisms to handle the new risks?
- Half the labs said no new risks were found; a third responded that existing control mechanisms were adequate to handle the newly found risks. However, almost one fifth of the labs did add new control mechanisms to manage the newly found risks.
Thus, it should be noted that for the majority of laboratories, based on the quality assessments performed, the IQCP process did not result in any new quality control actions for the labs to take. Essentially, that the quality of work already produced under EQC was affirmed by the IQCP process.
Labs Inspected Since Implementation of IQCP
- One third of the respondent laboratories that have instituted IQCP have been inspected so far.
IQCP Inspection Results
- 5% of the labs: IQCPs were deemed adequate. No new citations.
- 5% of the labs: IQCPs were not evaluated during the inspection of the rest of the lab. This may be due to inspectors not yet adequately trained for IQCP inspections
- 5% of the labs: IQCPs were cited as inadequate. These citations included “need to add components to IQCP” and “not having a count of the actual internal and external QC, and failures documented for a particular time.”
Most of the citations were about format and structure, less about the actual risks identified or addressed. This might be related to the short time IQCPs have been utilized.
The potential of IQCP can only be realized by thoroughly assessing all components of the testing process, through all phases of testing for all potential risks of error within the specific testing environment (lab), and applying this knowledge to control or eliminate these potential errors. This requires the development of a QC plan based on this knowledge, and the implementation of an effective monitoring program through QA.
So far, the results of IQCP implementation are mixed, based on the Westgard QC survey. On one hand, the majority of labs are not reporting that they have uncovered new or previously unknown risks of errors, or the need to change their QC plans. However, almost one fifth of the labs in this survey did uncover previously unknown risks.
Questions remain however, as to how thoroughly laboratories are at performing their risk assessments. A drawback of the IQCP process is that it is labor intensive, averaging as much as 15 hours per IQCP. As a separate IQCP is required for each analyte tested, sufficient staff is a prerequisite for an adequate risk assessment. Almost 20% of the labs responding to this survey utilized only one staff person; and almost 20% used two staff people. Yet, almost 60% of the laboratories in the survey were larger core or central laboratories.
The quality assessments performed must likewise be reviewed for thoroughness. It is only through this monitoring function that the effectiveness of the IQCP can be verified over the long term, regardless of changes within the test systems, personnel or the environment.
At the very least, for many of the laboratories studied, their existing QC programs have been affirmed as adequate to provide the level of quality sought. Further studies will clarify if additional risk assessment strategies are needed to enhance the potential benefits of IQCP.