IQCP, the Individualized Quality Control (QC) Plan, developed as an alternate option to lab based QC. This plan includes all phases of laboratory testing from pre-analytic through postanalytic. At a minimum must include aspects of specimen handling, test system, reagents, environment, personnel, and results. In 2016 we implemented an IQCP for Activated Clotting Time on the Abbott IStat in the OR and Cardiac Cath. This obviated the need for daily QC under both NYS and College of American Pathologists (CAP) guidelines.
Methods: We utilized CLSI Workbook EP23-A as a tool. In order to facilitate the implementation, we purchased online software, CarePoint solutions, tailored for the Abbott IStat. Manual entry of patient results was greatest risk of error.
Results: We created an IQCP Summary Plan. We concluded that we would have to audit our processes on a monthly basis. Prior to risk assessment we thought we could assess every six months. This increase in auditing resulted in unanticipated drain on supervisory personnel. Errors were reported to the onsite managers who were not readily available. We found that the testing personnel in Cardiac Cath were not necessarily those that entered results in the Medical Record .Audit revealed 4 /50 results weren’t entered by testing personnel.
Summary: IQCP can save the cost of daily QC which is expensive in cartridge based testing .Liquid QC wouldnt have captured the workflow error. We propose, interfaces that go from device directly into the patients electronic medical record (EMR) can eliminate this error.