Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, Vinogradska cesta 29, Zagreb, Croatia, Phone: +385996913474.
Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, Zagreb, Croatia.
Clin Chem Lab Med. 2018 Mar 28;56(4):574-581. doi: 10.1515/cclm-2017-0532.
Manual handling of hemolyzed samples is not standardized and is vulnerable to errors. This study aimed to evaluate laboratory errors due to manual handling of hemolyzed samples and to assess the risk they might have for patient safety.
Data were retrospectively obtained from a laboratory information system for 25 emergency tests from hemolyzed samples. Hemolysis (concentration of free hemoglobin >0.5 g/L) was visually assessed by comparison with a color chart. The reference person reestimated the routinely assessed degree of hemolysis to all samples (n=3185) received in the laboratory in a 1-week period. For each test, the correct and incorrect way of handling results was determined. Risk assessment was performed according to ISO 14971 standard with five categories of risk (S1-S5) and error occurrence (O1-O5).
In the studied period, the emergency laboratory received 495 hemolyzed samples (15.5%) with a total of 2518 laboratory test requests (15.5%): 102 (20.6%) of the reports from hemolyzed samples had a comment on hemolysis; 31% of the test results were handled incorrectly (20.7% due to the incorrect release of the test result despite hemolysis interference and 10.3% due to unnecessary suppression), accounting for 4.8% of the total test volume. Tests with the highest combination of risk and occurrence rate were troponin T, potassium and total bilirubin.
Manual handling of hemolyzed samples may lead to risk of errors in reporting results for troponin T, potassium and total bilirubin, which may have an effect on clinical decision. In addition, unnecessary suppression of the sample results unaffected by hemolysis could affect patient outcome.
手动处理溶血样本未标准化，容易出现错误。本研究旨在评估因手动处理溶血样本而导致的实验室误差，并评估其对患者安全的潜在风险。
从实验室信息系统中回顾性获取 25 例溶血样本的急诊检验数据。通过与色标比较，肉眼评估溶血（游离血红蛋白浓度>0.5 g/L）。参考人员重新评估了实验室在一周内收到的所有样本（n=3185）的常规评估溶血程度。对于每个测试，确定处理结果的正确和错误方式。根据 ISO 14971 标准进行风险评估，风险等级分为五类（S1-S5）和错误发生等级（O1-O5）。
在研究期间，急诊实验室共接收 495 例溶血样本（15.5%），总共有 2518 项实验室检测请求（15.5%）：102 份（20.6%）来自溶血样本的报告有溶血注释；31%的检测结果处理不当（20.7%是由于尽管存在溶血干扰仍错误释放检测结果，10.3%是由于不必要的抑制），占总检测量的 4.8%。风险和发生率最高的组合测试是肌钙蛋白 T、钾和总胆红素。
手动处理溶血样本可能会导致报告肌钙蛋白 T、钾和总胆红素结果出现错误风险，这可能会对临床决策产生影响。此外，对不受溶血影响的样本结果进行不必要的抑制可能会影响患者的结果。
