국내 임상검사실의 검사전단계 품질관리 현황
Quality Status of the Preanalytical Phase of Clinical Laboratories in Korea
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배경: 진단검사의학에서 검사전단계(preanalytical phase)에서 발생하는 오류는 전체 검사 오류의 반 이상을 차지하나, 국내에서는검사전단계 관련 연구 및 관리가 부족한 상황이다. 저자들은 국내진단검사의학 검사실을 대상으로 검사전단계 관리 현황을 파악하였다. 방법: 병원급 이상 의료기관에 근무하는 진단검사의학과 전문의를 대상으로 2021년 6월 14일부터 8월 16일까지 온라인 설문플랫폼을 이용하여 검사전단계 주요 요소에 대해 관리 현황을 설문조사 하였다. 결과: 채혈 전 환자 확인 시 의식이 없는 환자에서 한 가지 요소만확인하는 기관이 12.5%였다. 대부분의 검사실에서 금식 관련 규정을 가지고 있었으나, 내용에는 차이를 보였다. 검체 라벨은 되도록환자 앞에서 붙이는 것이 원칙이나, 병동 또는 응급실에서는 잘 지켜지지 않았다. 채혈부터 검사실 접수까지 걸리는 시간을 모니터링 하는 기관은 45.7%, 채혈이 규정대로 수행되는지 평가하는 기관은 75.3%에 불과했다. 대부분의 검사실에서 육안확인 방식으로검체 용혈을 확인하였고, 용혈지수를 사용하는 기관은 40% 미만이었다. 용혈지수 보고방식은 다양하였으며, 대부분의 기관에서용혈지수에 대한 내부정도관리를 시행하지 않고 있었다. 결론: 이번 연구를 통해 우리나라 의료기관의 검사전단계 현황을파악하였으며, 금식 규정, 검체 라벨링 및 운반, 채혈 후 접수까지의 소요시간, 검체 내 용혈 등 중요한 요소들이 적절하게 관리되지않음을 확인하였다. 이 연구 결과는 검사전단계 품질향상 활동을위한 중요한 기초 자료로 활용될 수 있을 것이다.
Abstract
Background: In laboratory medicine, preanalytical errors account for more than half of laboratory errors; however, in Korea, research on preanalytical phase management is lacking. This study revealed the status of preanalytical phase management in Korean clinical laboratories. Methods: Clinical pathologists in Korean hospitals, from secondary to tertiary hospital levels, were surveyed on the major preanalytical factors using an online platform from June 14, 2021, to August 16, 2021. Results: For patient identification before blood collection, 12.5% of the laboratories checked only one factor in unconscious patients. Most laboratories had fasting policies; however, the specifics varied. Specimens are supposed to be labeled in front of the patient; however, this was not always followed in the wards or emergency departments. Only 45.7% of the laboratories checked the time from blood collection to laboratory reception. Moreover, only 75.3% of the organizations evaluated whether blood collection was being performed according to protocol. Most laboratories were found to employ visual confirmation to detect in vitro hemolysis, with less than 40% laboratories using the hemolysis index. The reporting of the hemolysis index was inconsistent, as most organizations did not conduct internal quality control for this parameter. Conclusions: The study established the preanalytical phase status in Korean medical institutions and found that crucial factors, such as fasting regulations, specimen labeling and transportation, time from blood collection to reception, and in vitro hemolysis, were not being managed properly. These results can serve as an essential basis for quality improvement activities in the preanalytical phase.
참고문헌 (29)
- Plebani M, "textbook of patient safety and clinical risk management", pp.325~338 (2021), Springer
- Plebani M, "Exploring the iceberg of errors in laboratory medicine", Clin Chim Acta, 404, pp.16~23 (2009)
- Hammerling JA, "A review of medical errors in laboratory diagnostics and where we are today", Laboratory Medicine, 43, pp.41~44 (2012)
- Kim S, "Schemes and performance evaluation criteria of Korean Association of External Quality Assessment(KEQAS)for improving laboratory testing", Ann Lab Med, 41, pp.230~239 (2021)
- Yoon YA, "Standardization status of total cholesterol concentration measurement : analysis of Korean external quality assessment data", Ann Lab Med, 41, pp.366~371 (2021)
- Cornes MP, "The role of european federation of clinical chemistry and laboratory medicine working group for preanalytical phase in standardization and harmonization of the preanalytical phase in Europe", Ann Clin Biochem, 53, pp.539~547 (2016)
- Galloway M, "Benchmarking and the laboratory", J Clin Pathol, 54, pp.590~597 (2001)
- Chang J, "Development and application of computerized risk registry and management tool based on FMEA and FRACAS for total testing process", Medicina(Kaunas), 57, pp.477~ (2021)
- Chang J, "Preanalytical errors in the central laboratory of a university hospital based on the analysis of year-round data", Clin Lab, 66 (2020)
- "WHO guidelines on drawing blood: best practices in phlebotomy" (2010)[URL]
- Clinical Laboratory Standards Institute, "Procedures for the collection of diagnostic blood specimens by venipuncture; Approved standard-" (2007), Clinical and Laboratory Standards Institute
- van Dongen-Lases EC, "Patient identification and tube labelling-a call for harmonisation", Clin Chem Lab Med, 54, pp.1141~1145 (2016)
- Simundic AM, "Compliance of blood sampling procedures with the CLSI H3-A6 guidelines : an observational study by the European federation of clinical chemistry and laboratory medicine(EFLM)working group for the preanalytical phase(WG-PRE)", Clin Chem Lab Med, 53, pp.1321~1331 (2015)
- Wallin O, "Blood sample collection and patient identification demand improvement : a questionnaire study of preanalytical practices in hospital wards and laboratories", Scand J Caring Sci, 24, pp.581~591 (2010)
- Ministry of Health, Welfare, "Ministry of Health and Welfare Notice 2018-795, Patient Safety Standards", ~ (2018)
- Simundic AM, "Standardization of collection requirements for fasting samples : for the working group on preanalytical phase(WG-PA)of the European federation of clinical chemistry and laboratory medicine(EFLM)", Clin Chim Acta, 432, pp.33~37 (2014)
- Stonys R, "Can chewing gum be another source of preanalytical variability in fasting outpatients?", EJIFCC, 31, pp.28~45 (2020)
- Lima-Oliveira G, "Influence of a regular, standardized meal on clinical chemistry analytes", Ann Lab Med, 32, pp.250~256 (2012)
- Andrade NSV, "Instructions on appropriate fasting prior to phlebotomy; effects on patient awareness, preparation, and biochemical parameters", Diagnosis(Berl), 10, pp.175~182 (2023)
- Nordestgaard BG, "Fasting is not routinely required for determination of a lipid profile : clinical and laboratory implications including flagging at desirable concentration cutpoints-a joint consensus statement from the European atherosclerosis society and European federation of clinical chemistry and laboratory medicine", Clin Chem, 62, pp.930~946 (2016)
- "EMR Certification Program 2020 (v1.2)" (2023)[URL]
- Morrison AP, "Reduction in specimen labeling errors after implementation of a positive patient identification system in phlebotomy", Am J Clin Pathol, 133, pp.870~877 (2010)
- Kaufman RM, "Electronic patient identification for sample labeling reduces wrong blood in tube errors", Transfusion, 59, pp.972~980 (2019)
- Wu DW, "How long can we store blood samples : a systematic review and meta-analysis", EBioMedicine, 24, pp.277~285 (2017)
- Laessig RH, "Changes in serum chemical values as a result of prolonged contact with the clot", Am J Clin Pathol, 66, pp.598~604 (1976)
- Sciacovelli L, "Pre-analytical quality indicators in laboratory medicine : performance of laboratories participating in the IFCC working group"Laboratory Errors and Patient Safety"project", Clin Chim Acta, 497, pp.35~40 (2019)
- Plebani M, "The use of extra-analytical phase quality indicators by clinical laboratories : the results of an international survey", Clin Chem Lab Med, 54, pp.e315~e317 (2016)
- Koseoglu M, "Effects of hemolysis interferences on routine biochemistry parameters", Biochem Med(Zagreb), 21, pp.79~85 (2011)
- Hawkins R, "Discrepancy between visual and spectrophotometric assessment of sample haemolysis", Ann Clin Biochem, 39, pp.521~522 (2002)