임상화학검사 품질관리를 위한 분석수행사양 활용
Application of the Analytical Performance Specification for Quality Management of Clinical Chemistry Tests
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초록
임상 검사실에서 품질관리 시스템의 구현은 환자 진료를 위한 다양한 검사결과의 품질관리에 필수적이다. 분석수행사양(analytical performance specification)은 임상적 요구사항이 충족되었는지를 평가하는 중요한 기준이 되며, 품질관리 결과를 효과적으로 평가하기 위해서 적절한 근거에 기반한 판정기준을 설정하는 것이 중요하다. 본 종설에서는 각 평가 지침에 대한 일련의 판정기준으로 분석수행사양의 목표를 제공하여 검사실에서 이를 보다 쉽게 활용할 수 있도록 하고자 하였다. 이를 위해 정밀도, 직선성 검정, 측정 방법 또는 검체 간의 비교, 시약 로트 간 비교, 변화치검색, 검사방법의 바이어스 평가를 포함하여 임상 검사실의 품질관리에 사용되는 CLSI (임상 및 검사실 표준 연구소) 평가 지침을 조사하였다. ‘대한임상학회 검사표준화및질향상위원회’의 토의를 거쳐 각 지침에서 제시하는 평가기준의 정의와 각 지침과 관련된 비정밀도, 바이어스, 총허용오차 등 분석수행사양의 종류를 제안하였다. 또한, 각 임상화학검사에 대하여 다양한 근거를 기반으로 한 복수의 분석수행사양 목표를 제시함으로써 임상 검사실이 목표로 설정해야 할 검사 성능 수준에 대한 일반적인 범위를 제공하고자 하였다. 본 종설에서 제안된 자료를 통하여 다양한 임상화학검사에 대한 효과적인 품질관리를 촉진하고 각 검사실의 고유한 상황에 맞는 분석수행사양 목표 선택 및 적용 과정을 용이하게 할 것으로 기대된다.
Abstract
In the realm of clinical laboratories, the implementation of a quality management system is vital for the quality management of various test results for patient treatment. Analytical performance specifications (APS) serve as the critical criteria for assessing whether clinical requirements have been fulfilled, and ensuring that these standards are based on appropriate evidence is crucial to effectively estimate the processes and outcomes of the quality management system. Our aim was to define practical APS goals as acceptability criteria for evaluating test quality. This would make it straightforward for laboratories to apply these guidelines. To this end, we examined relevant Clinical and Laboratory Standards Institute guidelines employed in the quality management of clinical laboratories, such as encompassing precision, linearity, comparison between measurement procedures or samples, comparison between reagent lots, delta check of patients’ results, bias evaluation of test methods, among others. Furthermore, after discussion with the Committee on Standardization and Quality Improvement of Korean Society of Clinical Chemistry, we proposed definitions on the evaluation criteria provided in each guideline and the types of APS such as imprecision, bias, and the total allowable error corresponding to them. Setting multiple evidence-based APS goals for each clinical chemistry test would assist in establishing a range of performance levels that clinical laboratories should aim for. We expect the data suggested in this review to facilitate effective quality management for various clinical chemistry tests and simplify the selection and application of APS for the unique circumstances of each laboratory.
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