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