Decreasing Costs for the Geenius HIV 1/2 Supplemental Assay

Once the area for improvement was selected, the clinical staff team was convened as the QI team. A team lead was selected from the group to manage the project, and the Continuous QI Committee (CQIC) member served as the facilitator for required documentation during the process. In January 2016, CLIA regulations changed to include the option of developing IQCPs for some testing specialty areas to allow laboratories to develop their own quality control (QC) processes based on risk assessment for the method as opposed to defaulting to the CLIA-mandated two levels of daily control performance. The QI team decided to pilot-test the IQCP process with one of their low-demand, high-cost tests with the hope of being able to develop additional IQCPs, and achieve additional cost savings, in the future. All clinical staff participated in a webinar to better understand the IQCP requirements. The team then identified three potential tests where IQCP might be applicable. The Geenius assay was selected because it was the most expensive to run (three controls per run), a rapid turnaround time was critical, and the manufacturer’s support documents for IQCP were readily available. From April to June 2016, preliminary data were collected on the number of the controls and tests performed since implementing the Geenius assay, and a cost per test was calculated. Next, an estimated cost per test was calculated based on the current test volume and monthly controls instead of day-of-use controls. The estimated cost per test was used to develop a specific aim statement of a 30% reduction in cost. Further data on the number of controls performed and monthly test volumes were collected through February 2017 to calculate the actual cost per test over a longer period (thus providing a more accurate estimate than possible with just 3 months of data for a low-volume test). Results of the control tests were also monitored to ensure that the Geenius assay performed as expected during this time frame. Meanwhile, the IQCP activities (identifying risks and risk mitigation) were undertaken to develop and test the alternate monthly control plan. After the laboratory director reviewed the risk assessment, risk mitigation information, and the proposed plan for the IQCP, he approved the new IQCP for implementation.

Cost analysis spreadsheets for the Geenius assay were created. They included control frequency, tech time required, full-time equivalent costs (salary and benefits) required, reagent/supply costs, and indirect costs (division/department overhead). The data collected on test volume and number of controls performed from April 2016 to February 2017 were used to determine the current direct/indirect costs per test at TCPH NTRL. To estimate the direct/indirect costs per test after IQCP implementation, the cost analysis was repeated with the same test volume but with monthly routine QC frequency instead of day-of-use frequency. The desired outcome for this QI project was a cost-per-test reduction for the Geenius assay. The process measures monitored during this project were the number of tests performed (test volume) and the number of control runs required to perform the tests per CLIA regulations (two levels of control each day of use). To implement an IQCP that reduced the frequency of control runs, we had to demonstrate and monitor consistent and acceptable control performance over a significant time frame and with multiple analysts performing the testing.