CLIA Final Rule

In 2016 we posted a sample IQCP for a POC device. We asked IQCP experts to review and grade this IQCP. Turns out there is a lot of individuality in these IQCPs, and perhaps this variation is significant.

AN IQCP REVIEW

July 2016
Guest Article from CarePoint Solutions

[Editor's note: the IQCP for a POC device was posted on Westgard Web in an earlier issue. We then asked CarePoint Solutions to review this IQCP.]

The team at CarePoint Solutions found the Sample IQCP, which appeared to be based largely on the manufacturer’s guidance documents, was not sufficiently comprehensive. We compared the output of CarePoint Solutions Pro-QCP, a quality management software application, to the Sample IQCP.   Pro-QCP identified 97 likely sources of error for this test system, as compared to the sample IQCP that identified 30. Of course, each IQCP should be custom to the individual test process, and some sources of error may not be present in all situations.

We believe the Sample IQCP does not adequately address sources of error related to the environment or testing personnel, nor does it address verification of performance on multiple identical devices. Also, the Sample IQCP is lacking in historical data relative to the laboratory environment, instrument performance and testing personnel. It was also noted that some of the manufacturer’s minimum requirements (e.g., performing a thermal probe check every 6 months) was missing from the Quality Control Plan (QCP). The Sample IQCP also includes onboard device process controls that eliminate certain risks (e.g., automatic clot detection). In these cases, we believe it is not appropriate to include sources of error in the laboratory’s IQCP that have been effectively eliminated by the device manufacturer.

Comparison Table:

Reference: CAP 2015 All Common Checklist Requirements for IQCP (NEW)

Scoring:

 ★★★    Meets the requirements

 ★★     Partially meets the requirement

 ★      Does not meet the requirement

TBD: To be determined

About the Reviewers

At CarePoint Solutions, we probably view IQCP’s quite differently than most. We view it as a process, not merely a document.

We believe that IQCP’s are the beginning of a transformative wave in healthcare delivery, as we make the transition to quality management systems that will drive improved efficiency, economy, and quality. Just about every other major industry that has adopted these data driven, outcomes oriented processes, has dramatically transformed the quality of their output. Quality feedback loops drive continuous improvement, and these quality management systems foster a culture of quality that includes (and empowers) each participant in the process.

This is really good news, given the recent studies from CDC, the Institute of Medicine, and John Hopkins that implicate preventable medical error as the #3 killer in the US, just behind cancer and heart disease. This translates to about a quarter of a million needless deaths occurring in our hospitals each year. That’s roughly 40 deaths per US hospital, suggesting a systemic problem. And guess what the number one contributor to these errors is? Diagnostic error.

Worse still, these studies conclude that, as the complexity of healthcare delivery increases, the incidence of diagnostic error is increasing as well.

So the CarePoint team is excited to announce the launch of Pro-QCP, a web app that represents a first-of-its-kind quality management system for point of care testing. This is an expanded software app that not only delivers a superior IQCP, but underpins the processes that drive continuous improvement. Incorporating best practices that have been proven in other industries, Pro-QCP has the potential to drive efficiency, significantly lower healthcare costs, and measurably improve patient outcomes.

Pro-QCP takes you step-by-step through a process of identifying sources of error in your test process, collecting your historical data along the way (e.g., the incidence of sample hemolysis or patient misidentification). The software also suggests key performance indicators (KPIs) that will help trend the effectiveness of your quality efforts over time.

CarePoint is already working on the next generation of Pro-QCP that will provide KPI dashboards and real time inter-laboratory comparisons that allow you to compare your error detection, your error mitigation efforts, and your own performance indicators to those of your peers – in real time. In a collaborative way, user data is leveraged to enhance the program content over time. For example, users will be able to compare what process controls are being employed by their peers, and they can see how effective those process controls have been at improving quality. And the value of the data repository increases as the user base grows.

While the incidence of preventable deaths due to diagnostic error is quite concerning, we believe adopting quality management practices is a appropriate response and offers significant promise to improve the outcomes of patients in our care.