Chapter 27 : Selection and Implementation of New Equipment and Procedures

Abstract:

This chapter establishes the requirements that mandate acquisition and implementation of new equipment or procedures. Prior to the acquisition or implementation of any new diagnostic equipment or assay it is critical that the laboratory define exactly what is driving the potential process change. Once the decision has been made as to what the laboratory needs and wants from a given assay or platform, and the data regarding the subjective and objective specifications of available platforms or assays have been collected, the list of possible choices will be narrowed due to elimination of those products that do not meet the minimal criteria. The chapter lists the practical considerations involved in the selection and implementation of new equipment or procedure(s). It describes the preevaluation and information gathering stages of planning, selection, and decision making. On acquisition of equipment and/or implementation of new procedures, laboratories are required to establish policies and procedures to maintain or improve the reliability, efficiency, and clinical utility of the testing systems. Two critical analyses performed in the laboratory are method verification and validation. These processes provide critical objective evidence that the chosen system is fit for purpose, meaning that the particular requirements for a specific intended use are fulfilled. Monitoring and disseminating information about trends in proficiency testing (PT) performance during the ongoing implementation of the CLIA regulations can assist individual laboratories in assessing their performance relative to other laboratories.