O'Kane Maurice J, Lynch P L Mark, McGowan Noel
Clinical Chemistry Laboratory, Altnagelvin Hospital, Londonderry BT47 6SB, Northern Ireland.
Ann Clin Biochem. 2008 Mar;45(Pt 2):129-34. doi: 10.1258/acb.2007.007097.
There is no agreed system for the reporting, classification and grading of the severity of quality failures in the clinical biochemistry laboratory.
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.
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).
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.
临床生物化学实验室中，对于质量故障严重程度的报告、分类和分级尚无统一的系统。
建立了一个“质量问题”报告系统，用于记录工作人员和服务用户发现的所有质量故障。质量故障被分为分析前、分析和分析后三个主要阶段，每个阶段又有相应的子类别。使用包含实际（“A”）和潜在（“P”）评分要素的五点评分系统对每个质量故障的严重程度进行分级。“A”评分衡量质量故障对患者护理的实际不利影响，而“P”评分衡量可能导致的“最坏情况”潜在结果。该系统在19个月的时间内进行了评估。
共完成了397份质量问题报告（占所有请求的0.085%）。按原因分类：分析前阶段——88.9%，分析阶段——9.6%，分析后阶段——1.5%。质量故障严重程度的“A”评分倾向于对患者护理的低不利影响：72.7%的“A”评分为1（最不严重等级）。“P”评分倾向于对患者护理的高潜在影响：65.9%的“P”评分为5（最严重等级）。
质量问题报告系统被证明易于融入实验室日常工作。虽然绝大多数质量故障对患者护理的不利影响最小，但不良后果的可能性要高得多。该系统生成了有关实验室性能的重要信息，并有助于确定风险管理的重点。
