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Standardization Process

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 throughout a 12-week period. Participating laboratories must carefully follow specific instructions provided for analyzing samples and reporting data. The analytical workload consists of duplicate measurements of each analyte from 12 sample vials; one sample is analyzed in 12 separate weekly runs (i.e., 1 vial 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.

If performance criteria are not met, the participant must take appropriate corrective actions before proceeding with subsequent surveys. CDC can provide technical assistance to ensure the participant's success in the program.

Data Reporting and Evaluation

Participants must report data for each quarterly survey to CDC. Guidelines and instructions are provided to all participants. Reports are accessed 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 program that documents enrollment and performance in the LSP.


 
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