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

Abstract

Background: There is no agreed system for the reporting, classification and grading of the severity of quality failures in the clinical biochemistry laboratory. Methods: A 'Quality Query' reporting system was set up to log all quality failures identified by staff and service users. Quality failures were classified into three major groups of the preanalytical, analytical and postanalytical phases with appropriate subcategories in each group. The severity of each quality failure was graded using a five-point scoring system incorporating both actual ('A') and potential ('P') score elements. The 'A' score measured the actual adverse impact of the quality failure on patient care, while the 'P' score measured the 'worst case' potential outcome that might have resulted. The system was assessed over a 19-month period. Results: Three hundred and ninety-seven Quality Query reports were completed (0.085% of all requests). Breakdown by cause: pre-analytical phase -88.9%, analytical phase -9.6%, post-analytical phase -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 severe grade). The 'P' scores were skewed towards a high potential impact on patient care: 65.9% allocated a 'P' score of 5 (most severe grade). Conclusions: The Quality Query reporting system proved easy to integrate into routine laboratory practice. Although the great majority of quality failures had minimal adverse impact on patient care, the potential for adverse outcomes was much higher. This system generates important information on laboratory performance and helps inform risk management priorities.

Quality Error Rates in Point-of-Care Testing

“…Whereas a more active and overt approach to identifying errors may well have detected a greater number, it would have had the potential disadvantage of altering the behavior of POCT practitioners (the so-called Hawthorne effect) (11 ) during the observation period and therefore might not have been representative of what happens in standard routine practice. Furthermore, the methodology used here to identify quality errors was identical to that used previously by us to investigate laboratory testing (9,10 ) and involved the same laboratory staff and clinical users. We therefore suggest that the data presented here provide valuable information on the relative quality of performance of POCT compared with laboratory testing.…”

“…This clinical biochemistry laboratory service had in place a Quality Query reporting system for the reporting and logging of defects as described (9,10 ). In brief, all laboratory staff were trained in the reporting of any perceived actual or potential quality lapses anywhere in the pathway from test selection to the timely return of a report to the requesting clinician.…”

Measurement of Errors in Clinical Laboratories

“…The most commonly used taxonomy classifies the failure as per the point in the testing process at which they occur: pre-analytical, analytical or post-analytical phases with further subdivision to indicate the specific step at which the problem occurred [9][10][11][12]. This classification is based on the fact that the pathway from test selection to the retention of an appropriately interpreted report to the requesting clinician is complex, which may be broken down into a sequence of steps.…”

“…The seriousness of each quality failure is described by assigning an Actual (A) score which measures the actual adverse impact on the patient and the Potential (P) score which measures the worst case possible outcome that might have occurred. The A and P score may be quantitated 0-5 point severity scoring system based on the patient outcome (Tables 1, 2) [12].…”

Implantação do modelo lean thinking em saúde: um estudo de caso em serviço de medicina diagnóstica

“…Os materiais coletados (análises clínicas e anatomia patológica) são acondicionados em caixas térmicas conforme a estabilidade de cada material e encaminhado para a distribuição que irá processar a amostra, e posteriormente enviará o material para o setor técnico específico responsável por liberar o resultado, esta fase ocorre em uma área automatizada e muito similar às indústrias. Para os exames de imagem há o envio das fotos para os médicos responsáveis por laudar o resultado, dessa maneira há uma dupla conferência que garante a qualidade e segurança do resultado (O'KANE; LYNCH; MC GOWAN, 2008).…”