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Division of Laboratory Sciences |
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National Center for Environmental Health |
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DLS Brochure |
STANDARDIZATION PROCESS
Section Navigation
Testing Protocol
Participating laboratories that comply with the LSP protocol and successfully meet performance criteria are ensured high-quality performance during the course of each study. Each laboratory performs quarterly evaluations (monitoring surveys) throughout a 12-week period. Participating laboratories must carefully follow specific instructions provided for analyzing samples and reporting data. The analytical workload consists of single measurements of each analyte from 72 sample vials; each sample is analyzed in 12 separate weekly runs (i.e., 6 vials per run). The LSP testing samples must be included in routine analytical runs along with clinical samples and appropriate levels of bench QC materials. After each survey period, CDC provides a statistical report that evaluates accuracy and precision. CDC can provide technical assistance to resolve any problems in meeting the performance standards, thus ensuring the participant's long-term success in maintaining standardized lipid measurements.
Laboratories newly enrolled in the LSP must first meet accuracy and precision criteria through a qualifying survey. Once performance criteria are fully met, CDC will notify the participant and arrange shipment of quarterly monitoring surveys. If these criteria are not met, the participant must take appropriate corrective actions before proceeding with another qualifying survey. CDC can provide technical assistance to ensure the participant's success in this phase of the program.
Data Reporting and Evaluation
Participants must report data for each quarterly survey to CDC using the LSP Laboratory Data Collection System (LDCS). This system is located on a secure Web site.
CDC provides log-in information to participants enrolled in the program. A user manual with detailed instructions also is provided on the LDCS Web site. Each participant can access only their own laboratory's profile, quarterly data, and statistical reports.
Participating laboratories can access their final quarterly reports after all laboratories' analytical data have been processed and reviewed by CDC. Each report includes a precision evaluation chart providing a visual representation of the components of the overall analytical precision, as well as how bias varies across runs and pools. CDC also provides a sample report explaining the evaluation process for accuracy and precision; the sample report is accessible on the LDCS.
CDC issues annual certificates to all laboratories participating in the monitoring phase of the program that documents enrollment and performance in the LSP. Standardization seals, which can be affixed to the certificate, are provided quarterly to all laboratories that successfully meet the accuracy and precision performance criteria established by the National Cholesterol Education Program (NCEP) (1, 2, 3, 4).
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