Managed Hemostasis ‘Point-Of-Care’ Testing in a Large Hospital: A Three-Year Experience and the Assessment of Clotting Tests

Abstract number: P1564

Paniccia¹ R, Costanzo¹ M, Saracini¹ C, Sestini¹ I, Bandinelli¹ B, Tronchin² M, Messeri² G, Abbate¹ R, Gensini¹ GF, Prisco¹ D

¹¹Department of Medical and Surgical Critical Care, Thrombosis Centre, University of Florence; Azienda Ospedaliero-Universitaria Careggi, Florence, Italy ²²Laboratorio di Analisi Biochimico-Cliniche, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy

Point-of-care (POC) automated systems for coagulation evaluation are key tools in surgical and/or intensive health care units. Activated Clotting Time (ACT) is the most common hemostasis POC test to quickly monitor heparin anticoagulation during cardiopulmonary bypass, interventional cardiology and hemodialysis. Recently, these POC systems have been updated to rapidly perform aPTT and PT on whole blood, to obtain a shortening of time of results. To ensure safe and appropriate patient care, the clinical safety of POC tests in hemostasis is based on achievement of accurate and reliable results. This report was aimed to show the routine quality control (QC) testing and tracking, as a part of a comprehensive quality assurance program, for hemostasis POC devices, performed in Careggi Hospital (Firenze, Italy). Twenty-one Hemochron devices (International Technidyne Corp, USA) were located in 8 buildings. More than 18 500 analysis/year were performed in the different Units. A management staff for hemostasis POC was designed to control the use of these devices. To practice instrument, specific and repeated training courses were held to hospital staff. QCs for each instrument and for each new lot of test cartridges were performed by the POC supervisor. Within-day CVs from normal and abnormal controls were respectively: for ACT < 7% and < 3%; for aPTT < 8% and < 4%; for PT < 10% and < 4%. Day-to-day CVs from normal and abnormal controls were respectively: for ACT < 10% and < 5%; for aPTT < 9% and < 4%; for PT < 11% and < 4%. In vivo duplicate testing values showed significant correlations: for ACT (n= 90) r= 0.99, P < 0.001; for aPTT (n= 45) r= 0.98, P < 0.001; for PT (n= 60) r= 0.94, P < 0.001. Significant relationships were found between values obtained from POC tests and those from centralized laboratory: for aPTT (n= 60) r= 0.98, P < 0.001; for PT (n= 32) r= 0.88, P < 0.001. The sample collections and procedures of POC tests were found properly performed by the staff of each Unit. However, a log-book with registration of results was not set. Although the good performances of these hemostasis POC devices, our data show that the training of local personnel and logistic assistance is absolutely necessary. Supervision of POC systems by laboratory professional is mandatory and a continuous QC evaluation and reporting is only the first step. sults read on-line) will lead to greater improvements of POC tests management.