Proficiency Testing Survey Exception Report

Survey Event / PT Provider / Date Performed / Date Evaluation Received
2008-B / AAFP / 6/13/2008 / Online 11/4/2008
Failed Analyte/Specimen # / Result Reported / Acceptable Range / Result of retest
HD-6 HCT / 45.6 / 40.0-45.0 / Results obtained too late to retest samples
HD-7 HCT / 28.1 / 29.9-33.7 / Results obtained too late to retest samples
HD-8 HCT / 57.7 / 48.5-54.7 / Results obtained too late to retest samples
HD-10 HCT / 28.4 / 23.8-26.8 / Results obtained too late to retest samples
HD-10 HGB / 9.3 / 8.0-9.2 / Results obtained too late to retest samples
Use the additional page at the end if more space is required.
Investigative Actions
XClerical review
XInstrument function check See comments made for RBC failures
XManufacturer contacted See comments made for RBC failures
Analysis of Unacceptable Results (Explain)
Method problem
XInstrument problem Instrument has been serviced and repaired.
XOther method problem For HGB failure on HD-10, I believe it was a random error. The HGB and
WBC are measured off the same dilution and the WBC was spot on the mean. The range of +7% set by
CLIA is very narrow in light of an SD of 0.64 and a CV of 7.44.
Technical Problem
 Misinterpretation or misidentification
Time delay between reconstitution and analysis
 Run accepted in non-linear range
 Calibration problem
 Run accepted with unacceptable quality control
 Controls in range but demonstrate bias
 Dilution error or incorrect pipetting
 Calculation error
 Specimen mix up
Clerical Errors
 Transcription error
 Failed to submit result
 Incorrect units of measure
 Decimal point error
 Transposition error
 Result submission deadline missed
 Other
Procedural Problems
 Procedure not followed
 Incorrect volume of reagent added
 Incorrect volume of sample added
 Incorrect reagent added
 Most current manufacturer’s guidelines not followed
 Other
Problems with PT Specimens
 Hemolyzed specimen
 Poor growth in culture
 Matrix effect with method
 Late shipment
 Bacterial contamination
 Unstable specimens
 No comparable peer group
No Explanation After Investigation
 Mark this box only when a through investigation has yielded no satisfactory conclusion
Corrective Actions Taken See comments made for RBC failures. No corrective actions taken for
HGB failure on HD-10.
Problem Resolved (Explain) Instrument service and repair has reduced the imprecision; recalibration done after repair. Controls show acceptable performance.
Next Event Results--Not available yet.
Was there any impact on patient results during the time of the unacceptable PT results?Doubtful
Explain: HGB as a group passed—only one sample gave unacceptable results. The range for PT testing is +7% (or about 1SD), which is very narrow. For patient testing we operate within a +2SD range, which would have made this result that failed acceptable. The physicians would go by the HGB result rather than the HCT or RBC result if the results didn’t match for a patient. Staff will be educated to look for incompatible results, but the physicians would catch that and request a retest even if the staff didn’t.
Re-Training of Testing Staff Not possible in this instance since the testing personnel is no longer employed at HDHI.
Testing Staff Review: (See comments for RBC failure review) / Date: 11/4/2008
Technical Consultant Review: / Date: 11/4/2008
Comments: (See comments made throughout this report)
Laboratory Director Review: / Date:
Comments: