Gamma testing experience with the ACL TOP hemostasis testing system.

As a gamma testing site or a limited early release site for the ACL TOP, St. Michael's Hematology Laboratory evaluated the ACL TOP for its ability to fit into a laboratory whose workflow includes large volumes of routine and specialty hemostasis assays. This evaluation included the determination of the ACL TOP's precision, normal ranges, and reagent sensitivities. Analytical correlation studies for the ACL TOP were performed in comparison to the ACL ADVANCE. The ACL TOP was also tested for its ability to handle large volumes of not only routine assays but also more specialized coagulation assays. Instrument precision, normal reference range assignment, and factor sensitivities met the requirements of this laboratory. The ACL TOP correlated favorably to the ACL ADVANCE, and in a workup for thrombophilia its throughput was twice what was seen with the ACL ADVANCE. The speed of the ACL TOP was impressive, generating results at a rate of almost 5 results/min. In this gamma testing study, the ACL TOP has demonstrated suitability as a precise coagulation analyzer for use in the settings of a high-volume, fast-paced, specialized coagulation laboratory faced with demanding turnaround times.

Experience of implementing a quality management system in an Ontario hospital laboratory.

This article describes the process of building and implementing a quality management system in the Department of Laboratory Medicine at St. Michael's Hospital in Toronto. This was done in part to fulfill the requirements of the Ontario Laboratory Accreditation program. During the process, we revised and created new procedure manuals and documents through the use of focus groups and inter-departmental committees. The entire project took approximately two-and-a-half years to complete and required teamwork, personal commitment, and professional sacrifices by key personnel.