Laboratory Instrument Implementation, Verification, and Maintenance (GP31-P); Protocol for the Evaluation, Validation, and Implementation of Coagulometers (H57-P); Platelet Function Testing by Aggregometry (H58-P)

New CLSI Guideline Provides Protocols for Laboratory Instrument Implementation, Verification, and Maintenance
Wayne, Pennsylvania, USA—July 2007— Today's clinical laboratory is challenged to provide accurate, precise, and high-quality data for patient care at a reasonable cost. Laboratory directors and managers must make appropriate decisions in selection of instrumentation, and once that decision has been made, these persons must, with their chosen instrumentation, adequately and efficiently verify and maintain performance.

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published a new guideline, Laboratory Instrument Implementation, Verification, and Maintenance; Proposed Guideline (GP31-P), which provides a basic understanding of the considerations for the implementation, verification, and maintenance of generic laboratory and pathology equipment in a systematic and easy-to-use format to ensure quality results. William J. Castellani, MD, Penn State Hershey Medical Center, explains, “This guideline provides the laboratory with the information necessary to rigorously approach the installation and maintenance of instrumentation with the goal of consistent, reliable instrument function, leading to decreased downtime, improved quality control and patient results, and ultimately a more efficient laboratory.”
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CLSI Publishes Protocol for the Evaluation, Validation, and Implementation of Coagulometers
Wayne, Pennsylvania, USA—July 2007—Coagulometers are used in clinical laboratories for the common screening tests including prothrombin time, activated partial thromboplastin time, thrombin clotting time, and Clauss fibrinogen assay. In addition, most coagulometers also perform chromogenic and immunoturbidometric assays. Some analyzers may also have the capability to perform chemiluminescent assays. With newer trends in hemostasis testing and tailored reagent/instrument manufacturing, there is a need for a more holistic outlook to instrument evaluation prior to use for patient testing samples.

In response to this need, Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) recently published a new document, Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Proposed Guideline (H57-P), which specifies recommendations on how to plan and execute the selection, evaluation, validation, and implementation of a laboratory coagulometer. It includes assessment of safety, carryover, precision, bias, linearity, and comparability for coagulometers that perform clotting, chromogenic and/or immunoturbidometric and/or chemiluminescent testing. Finally, guidance is given on implementation, including training, education, and interfacing.
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CLSI Publishes Guideline on Platelet Function Testing by Aggregometry
Wayne, Pennsylvania, USA—July 2007—Given the role of platelets in both hemorrhagic and thrombotic conditions and the rising significance of antiplatelet therapy in controlling platelet function across a broad spectrum of vascular disorders, establishing clear standardization to guide uniformity among laboratories performing platelet function testing is critical. Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) recently published a new document, Platelet Function Testing by Aggregometry; Proposed Guideline (H58-P), which provides concrete, standard procedures for using aggregometry to assess platelet function in patient specimens with the intent to achieve greater uniformity of results.
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