Ana Helena Luksic1, Nora Nikolac Gabaj2, Marijana Miler2, Lora Dukic3, Ana Bakliza4, Ana-Maria Simundic3. 1. Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, Vinogradska cesta 29, Zagreb, Croatia, Phone: +385996913474. 2. Department of Clinical Chemistry, Sestre Milosrdnice University Hospital Center, Zagreb, Croatia. 3. Department of Medical Laboratory Diagnostics, University Hospital "Sveti Duh", Zagreb, Croatia. 4. Department of Laboratory Diagnostics, Psychiatric Hospital "Sv. Ivan", Zagreb, Croatia.
Abstract
BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.
Entities:
Keywords:
hemolysis; patient safety; risk assessment; visual assessment of hemolysis
Authors: Belén Larrán; Marta López-Alonso; Marta Miranda; Víctor Pereira; Lucas Rigueira; María Luisa Suárez; Carlos Herrero-Latorre Journal: Sci Rep Date: 2022-08-08 Impact factor: 4.996