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Characterization of laboratory practice in CD4+ T-Cell testing laboratories by on-site observation.
Taylor RN; Cross GD; Schalla WO; Siragijsa M; Centers for Disease
November 30, 1996
3rd Conf Retro and Opportun Infect. 1996 Jan 28-Feb 1;:157. Unique

The CDC Model Performance Evaluation Program (MPEP) for CD4+ T-cell testing includes estimates of performance levels derived from voluntary participant laboratory testing of performance evaluation panels and descriptions of laboratories and their procedures based on self-administered survey questionnaries. To estimate the reliability of self-administered survey results and to provide an independent source of information about CD4+ T-cell testing laboratories, the CDC MPEP developed and pilot tested a protocol for the on-site characterization of laboratories by trained observers. The on-site observation process not only permitted validation of data but permitted collection of additional information about the total CD4+ T-cell testing process not usually obtained by other methods. The pilot study included 40 laboratories selected to represent a diversity of laboratory types, specimen testing volumes, external performance evaluation program participation, type of instrumentation, and geographic locations. Seven on-site observers were trained in the administration of the survey instrument to increase the uniformity and interpretation of the questions. The survey included questions related to demographics, personnel training and education, cost and reimbursement, workload, phlebotomy, specimen receipt and accessioning, hematology, safety, sample preparation, reagents, quality control and quality assurance, data acquisition and analysis, reporting, and data storage. The pilot study provided extensive descriptive information about the participating laboratories and a proven survey instrument with recommended guidelines for implementation of a national survey. Since 31 of the laboratories in this study also participated in a recent CD4+ T-cell proficiency testing/accreditation study, the survey data permitted correlation analyses between laboratory practice and performance.

*CD4 Lymphocyte Count Human Quality Control ABSTRACT