Monitoring EQA / PT Performance
3 likes2,039 views
The document outlines a procedure for reviewing performance in an external quality assessment (EQA) program, emphasizing the verification of reported results and the registration of instruments and methods. It details steps for investigating poor performance, including reviewing control charts and data trends, while identifying potential errors and their sources. Common errors include clerical, systematic, and random errors, with a flowchart provided to assist in the investigation process.
Monitoring EQA / PT Performance
- 1. NOYES YES Review performance over the cycle Review performance over the cycle Verify that the reported result and units reflect what was obtained. Has a transcription error occurred? Verify that the reported result and units reflect what was obtained. Has a transcription error occurred? Send corrected result to RIQAS along with relevant documentation to support the case. Send corrected result to RIQAS along with relevant documentation to support the case. Verify instrument, method and units are registered correctly for each parameter. Especially important for initial submission and when registration changes have been made. Verify instrument, method and units are registered correctly for each parameter. Especially important for initial submission and when registration changes have been made. Review the summary page. Are the majority of results flagged? Review the summary page. Are the majority of results flagged? Run out of controlRun out of control Look for shifts or trendsLook for shifts or trends Review Levey-Jennings charts. Are any points outside +/- 1SD? Review Levey-Jennings charts. Are any points outside +/- 1SD? There may be a problem specific to that sample • Incorrect sample tested • Reconstitution error • Sample storage There may be a problem specific to that sample • Incorrect sample tested • Reconstitution error • Sample storage Review IQC results from the time the EQA sample was tested. Review IQC results from the time the EQA sample was tested. Review instrument parameters and calibration. Has the reagent batch been changed? Review instrument parameters and calibration. Has the reagent batch been changed? No further actionsNo further actions Investigate and take corrective action Investigate and take corrective action Look for trends within the data • Positive/Negative bias • Poor precision • Changes in performance due to change in reagent, calibrator or standardisation Look for trends within the data • Positive/Negative bias • Poor precision • Changes in performance due to change in reagent, calibrator or standardisation YES YES YES NO NO NO NO Is the parameter result within acceptable limits of performance? • Target Score >50 • SDI <2SDPA • % Deviation < acceptable limits of performance Advise RIQAS of correct details Advise RIQAS of correct details In order to identify the source of the problem it is useful to be aware of the most common causes of poor EQA performance. Errors can occur at any stage of the testing process however EQA is most concerned with detecting analytical errors i.e. errors that occur during the analysis of the sample. Most analytical errors can be easily divided into three main areas; clerical errors, systematic errors and random errors. Systematic errors result in inaccurate results that consistently show a positive or negative bias. Random errors on the other hand affect precision and result in fluctuations in either direction. The flowchart (below) is designed to help you investigate any apparent poor performance. QUALITY CONTROLThe largest global EQA scheme Monitoring EQA Performance : Investigating the source of the problem Randox Laboratories Ltd +44 (0) 28 9442 2413 +44 (0) 28 9445 2912 marketing@randox.com randoxqc.com Information correct at time of print. Randox Laboratories Ltd is a subsidiary of Randox Holdings Limited a company registered within Northern Ireland with company number N.I. 614690. VAT Registered Number: GB 151 6827 08. Product availability may vary from country to country. Please contact your local Randox representative for information. Products may be for Research Use Only and not for use in diagnostic procedures in the USA. LT630APR15