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PEPFAR Quality Control and Method Validation Activity 12 Job Aid 1: Comparison of EQA Programs

This PDF contains information needed to complete Activity 12.

Job Aid 1: Comparison of EQA Programs 1214 Effective Date: 12/6/2016 HILS1746 Internal QC - a single laboratory analyzing controls and making immediate internal decisions on the acceptance or rejection of analytical runs. IQC provides a good estimate of the imprecision of the method by reviewing SD and %CV. External QC - a program that involves many laboratories analyzing the same samples (control materials or PT samples). This allows individual laboratories to compare their performance to that of a peer group. EQC is useful for estimating the bias or inaccuracy of a method. Comparison of EQA Programs Proficiency Testing (PT) Inter-laboratory Comparison Description Many laboratories analyzing PT samples from the same pool Many laboratories analyzing the same lot number of control submit their results for each sample to the PT provider material submit monthly summary statistics (Mean, SD, number of control measurements) to a central data base Data Submitted Results obtained from testing provided PT samples. Monthly summary statistics calculated from routine QC testing as Must be analyzed in the same manner as patient testing. per your laboratory's QC protocol schedule . Receive and analyze 1-5 samples per discipline. Samples may require special handling and reconstitution. Frequency 2-4 events a year -refer to PT testing schedule monthly Values of Sample Not known at time of testing Known at time of testing - the new control measurements should show the same distribution as the past control measurements if the system is stable. Provider Accredited PT provider Manufacturers of QC materials Information Captures a snapshot of your test performance for a given Describes your performance relative to your peers. provided by the analyte at a specific point in time Excellent source to determine Target Value for each control service Grades your performance Provides some idea about the amount of bias present in the analytical system. Cost Additional costs to participate in a PT provider's testing scheme Usually no additional cost to participate; service provided with the purchase of QC materials. TAT for Report The time between receipt of PT samples for testing and returned Many manufacturers provide on-line services for up-to-date Receipt report for review may be a few months. information Pitfal If report TAT is extensive it may not allow laboratories to detect Manufacturer of QC materials used for the method does not and correct in a timely manner problems that affect quality provide this service Compliance Required by many regulatory and accrediting bodies Optional, but highly recommended if service is offered Participation may fulfill regulatory and accreditation requirements for the analyte in some countries. 127

  • inter-laboratory comparison
  • mean
  • SD
  • standard deviation
  • peer performance
  • coefficient of variation index
  • CVI
  • SLIPTA
  • SLIPTA checklist
  • proficiency testing
  • PT
  • target
  • true value
  • peer-based metric of imprecision
  • 4 key numbers
  • internal QC
  • external QC
  • EQA programs