Korean Journal of Clinical Laboratory Science (대한임상검사과학회지)

Korean Society for Clinical Laboratory Science (대한임상검사과학회)
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Application of Patient-based Real-time Quality Control

환자 기반 실시간 정도관리의 적용

  • Seung Mo LEE (Department of Laboratory Medicine, Samsung Medical Center) ;
  • Kyung-A SHIN (Department of Clinical Laboratory Science, Shinsung University)
  • 이승모 (삼성서울병원 진단검사의학과) ;
  • 신경아 (신성대학교 임상병리과)
  • Received : 2024.03.26
  • Accepted : 2024.05.07
  • Published : 2024.06.30
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Abstract

Clinical laboratories endeavor to secure quality by establishing effective quality management systems. However, laboratory environments are complex, and single quality control procedures may inadequately detect many errors. Patient-based real-time quality control (PBRTQC) is a laboratory tool that monitors the testing process using algorithms such as Bull's algorithm and several variables, such as average of normal, moving median, moving average, and exponentially weighted moving average. PBRTQC has many advantages over conventional quality control, including low cost, commutability, continuous real-time performance monitoring, and sensitivity to pre-analytical errors. However, PBRTQC is not easily implemented as it requires statistical algorithm selection, the design of appropriate rules and protocols, and performance verification. This review describes the basic concepts, methods, and procedures of PBRTQC and presents guidelines for implementing a patient-based quality management system. Furthermore, we propose the combined use of PBRTQC when the performance of internal quality control is limited. However, clinical evaluations were not conducted during this review, and thus, future evaluation is required.

임상검사실은 질관리 시스템(quality management system)을 구축하여 일정 수준 이상의 질 확보를 위해 노력하여야 한다. 그러나 검사실 환경은 매우 복잡하여 단일 정도관리 절차로는 다양한 유형의 오류를 감지하는데 충분하지 않을 수 있다. 환자 기반 실시간 정도관리(patient-based real-time quality control, PBRTQC)는 테스트 과정을 모니터링하기 위한 검사실 도구로써 Bull's 알고리즘, 정상치 평균, 이동 중앙값, 이동평균, 지수가중이동평균과 같은 알고리즘이 활용되고 있다. PBRTQC는 저렴한 비용, 교환 가능성, 지속적인 실시간 성능 모니터링, 분석 전 오류에 대한 민감도 등 기존 정도관리에 비해 많은 이점이 있다. 그러나 PBRTQC는 통계 알고리즘의 선택, 적절한 규칙과 프로토콜의 설계, 성능검증 등을 고려해야하므로 구현하기가 쉽지만은 않다. 본 리뷰에서는 PBRTQC의 기본 개념과 방법 및 절차에 대해 설명하였으며, 이를 통해 환자 기반 정도관리 시스템 구현을 위한 지침을 제시하고자 하였다. 이에 기존의 내부정도관리의 성능이 제한적일 경우 PBRTQC 절차를 병용하는 것을 제안하고자 한다. 본 리뷰에서는 임상적 평가는 배제되었으며, 향후 이에 대한 평가가 요구된다.

Keywords

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