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衡量影响:195项检测中实验室误差造成的危害严重程度

Measuring the impact: Severity of harm from laboratory errors in 195 tests.

作者信息

Çubukçu Hikmet Can, Cihan Murat, Alp Hamit Hakan, Bolat Serkan, Zengi Oğuzhan, Uçar Kamil Taha, Topcu Deniz İlhan, Kılınçkaya Muhammed Fevzi, Özdemir Habib, Gülşen Murat, Canbaz Hayri, Yücel Doğan, Serdar Muhittin Abdulkadir

机构信息

Rare Diseases Department, General Directorate of Health Services, Turkish Ministry of Health, Ankara, Turkiye.

Ordu University Education and Research Hospital, Ordu, Turkiye.

出版信息

Am J Clin Pathol. 2025 Mar 8;163(3):453-463. doi: 10.1093/ajcp/aqae144.

DOI:10.1093/ajcp/aqae144
PMID:39436733
Abstract

OBJECTIVES

This study aimed to objectively assess the potential severity of harm associated with erroneous results in 195 laboratory tests by surveying 514 specialist physicians and medical biochemistry experts.

METHODS

The survey obtained participants' (75 medical biochemists, 439 clinicians) opinions on severity of harm for the erroneous results of 195 tests. The comprehensive list of errors and their effects on test results were obtained from the literature, and then matched with severity of harm scores, from 1 (negligible effect) to 5 (life-threatening injury/death), obtained from the survey responses.

RESULTS

Participants perceived tests such as cardiac biomarkers, blood gases, coagulation parameters (activated partial thromboplastin time, prothrombin time, international normalized ratio, and dimerized plasmin fragment D), critical ions (potassium, sodium), toxic trace elements (lead, mercury), and specific serum drug levels (lithium, digoxin) to have a greater potential for patient harm in case of errors. Medical biochemistry specialists assigned higher severity scores to some laboratory tests, including total bilirubin, pseudocholinesterase, platelet indices, and some drug levels (cyclosporine, methotrexate, vancomycin).

CONCLUSIONS

A substantial agreement (91%) was observed between medical biochemists and clinicians in terms of the most frequently chosen severity of harm score. The study provided objective severity scores and identified high-risk tests for targeted quality improvement.

摘要

目的

本研究旨在通过对514名专科医生和医学生物化学专家进行调查,客观评估195项实验室检测中错误结果相关危害的潜在严重程度。

方法

该调查获取了参与者(75名医学生物化学家、439名临床医生)对195项检测错误结果的危害严重程度的意见。从文献中获取错误及其对检测结果影响的综合列表,然后将其与从调查回复中获得的危害严重程度评分(从1分(可忽略不计的影响)到5分(危及生命的伤害/死亡))进行匹配。

结果

参与者认为,心脏生物标志物、血气、凝血参数(活化部分凝血活酶时间、凝血酶原时间、国际标准化比值和二聚体纤溶酶片段D)、关键离子(钾、钠)、有毒微量元素(铅、汞)以及特定血清药物水平(锂、地高辛)等检测项目,若出现错误,对患者造成伤害的可能性更大。医学生物化学专家对一些实验室检测项目给出了更高的严重程度评分,包括总胆红素、假性胆碱酯酶、血小板指标以及一些药物水平(环孢素、甲氨蝶呤、万古霉素)。

结论

医学生物化学家和临床医生在最常选择的危害严重程度评分方面达成了高度一致(91%)。该研究提供了客观的严重程度评分,并确定了针对质量改进的高风险检测项目。

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