The development of a system for the reporting, classification and grading of quality failures in the clinical biochemistry laboratory

Ann Clin Biochem 2008;45:129-134
© 2008 Association for Clinical Biochemistry


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Original Article

Maurice J O’Kane ,
P L Mark Lynch and
Noel McGowan

Clinical Chemistry Laboratory, Altnagelvin Hospital, Londonderry BT47 6SB, Northern Ireland

Corresponding author: Dr Maurice J O’Kane. Email: Maurice.OKane{at}

Background: There is no agreed system for the reporting, classificationand grading of the severity of quality failures in the clinicalbiochemistry laboratory.

Methods: A ‘Quality Query’ reporting system was set up tolog all quality failures identified by staff and service users.Quality failures were classified into three major groups ofthe preanalytical, analytical and postanalytical phases withappropriate subcategories in each group. The severity of eachquality failure was graded using a five-point scoring systemincorporating both actual (‘A’) and potential (‘P’)score elements. The ‘A’ score measured the actualadverse impact of the quality failure on patient care, whilethe ‘P’ score measured the ‘worst case’potential outcome that might have resulted. The system was assessedover a 19-month period.

Results: Three hundred and ninety-seven Quality Query reports were completed(0.085% of all requests). Breakdown by cause: pre-analyticalphase – 88.9%, analytical phase – 9.6%, post-analyticalphase – 1.5%. The quality failure severity ‘A’scores were skewed towards a low adverse impact on patient care:72.7% allocated an ‘A’ score of 1 (least severegrade). The ‘P’ scores were skewed towards a highpotential impact on patient care: 65.9% allocated a ‘P’score of 5 (most severe grade).

Conclusions: The Quality Query reporting system proved easy to integrateinto routine laboratory practice. Although the great majorityof quality failures had minimal adverse impact on patient care,the potential for adverse outcomes was much higher. This systemgenerates important information on laboratory performance andhelps inform risk management priorities.

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