Selection and implementation for coagulation instruments/reagents in a multiple hospital/clinic network

Abstract

Selection, standardization, and implementation of instrumentation and reagents throughout a health care facility network can often be a difficult process. However, in today's ever-changing health care setting, it is often mandated. The Veteran's Integrated Systems Network 16 (VISN 16) was faced with such a task early in 1999, with the targeted area being its coagulation laboratories. The plan outlined in this paper was drafted to help facilitate the selection, standardization and implementation of coagulation systems for 17 health care facilities that make up the VISN 16 network. The VISN, encompassing 170,000 square miles, has 10 tertiary care hospitals, six of which have close relationships with affiliate universities. There are 299,733 patients enrolled in this health delivery system. The facilities range from large institutions performing both tertiary and outpatient care to small outpatient clinics. Because of the plan's detailed, comprehensive content, which included analyses of a large number of performance parameters as well as cost-efficiency, the selection process was carried out using a checklist that could be helpful to other organizations selecting equipment and reagents for coagulation studies. An implementation process was devised, resulting in coagulation standardization across the Integrated Health Network.

The effect of instrumentation and laboratory site on the accuracy of the APTT‐based heparin therapeutic range

“…In comparison of the same lots, the upper and lower limits varied up to 12 s when determined by different laboratories. This is in contrast to statements presented in other publications that suggest it is acceptable to use the same range across hospitals; however, no data were presented in this article [22]. Based on our data, this is even more true when the instruments are not the same model (but same detection method).…”

“…This method should not be used until the protocol is validated. This is commonly performed but may lead to inappropriate HTR and hence incorrect monitoring of heparin .…”

Evaluation of a commercial set of frozen plasmas for instrument‐to‐instrument comparability

“…Rank correlation coefficients and proportional (slope) and systematic (intercept) difference were evaluated against manufacturer's as well as statistical acceptance criteria. Manufacturer's acceptance criteria were based on existing reproducibility data for the selected systems 5 , as well as data from the package inserts. Results were statistically acceptable if the 95% confidence interval (CI) did not exceed the criterion value.…”