NSW Health Pathology, Department of Clinical Chemistry and Endocrinology, Prince of Wales Hospital, Sydney, NSW 2031, Australia, Phone: +612 93829082, Fax: +612 93829099.
Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, Australia.
Clin Chem Lab Med. 2018 Dec 19;57(1):89-94. doi: 10.1515/cclm-2017-1114.
Individual laboratories are required to compose an alert list for identifying critical and significant risk results. The high-risk result working party of the Royal College of Pathologists of Australasia (RCPA) and the Australasian Association of Clinical Biochemists (AACB) has developed a risk-based approach for a harmonized alert list for laboratories throughout Australia and New Zealand. The six-step process for alert threshold identification and assessment involves reviewing the literature, rating the available evidence, performing a risk analysis, assessing method transferability, considering workload implications and seeking endorsement from stakeholders. To demonstrate this approach, a worked example for deciding the upper alert threshold for potassium is described. The findings of the worked example are for infants aged 0-6 months, a recommended upper potassium alert threshold of >7.0 mmol/L in serum and >6.5 mmol/L in plasma, and for individuals older than 6 months, a threshold of >6.2 mmol/L in both serum and plasma. Limitations in defining alert thresholds include the lack of well-designed studies that measure the relationship between high-risk results and patient outcomes or the benefits of treatment to prevent harm, and the existence of a wide range of clinical practice guidelines with conflicting decision points at which treatment is required. The risk-based approach described presents a transparent, evidence- and consensus-based methodology that can be used by any laboratory when designing an alert list for local use. The RCPA-AACB harmonized alert list serves as a starter set for further local adaptation or adoption after consultation with clinical users.
各实验室均需制定一份用于识别危急值和重要风险结果的警示列表。澳大利亚皇家病理学家学会（RCPA）和澳大利亚临床生物化学家协会（AACB）的高风险结果工作组已制定了一项基于风险的方法，用于为澳大利亚和新西兰的实验室制定统一的警示列表。警示阈值识别和评估的六步流程包括：查阅文献、评估现有证据、进行风险分析、评估方法可转移性、考虑工作量影响以及寻求利益相关者的认可。为了演示这种方法，我们描述了一个用于确定钾的上限警示阈值的实例。该实例的研究结果适用于 0-6 个月龄的婴儿，推荐的血清钾上限警示阈值为>7.0mmol/L，血浆钾上限警示阈值为>6.5mmol/L，对于 6 个月以上的个体，血清和血浆的阈值均为>6.2mmol/L。定义警示阈值的局限性包括缺乏精心设计的研究，这些研究无法衡量高风险结果与患者结局或治疗预防危害的益处之间的关系，以及存在广泛的临床实践指南，这些指南在需要治疗的决策点上存在冲突。所描述的基于风险的方法提供了一种透明、基于证据和共识的方法，任何实验室在为本地使用设计警示列表时均可使用。RCPA-AACB 统一警示列表可作为进一步本地化调整或采用的起点，调整或采用前需与临床用户协商。
