Abstract
Purpose: The Levey-Jennings chart controlled measurement values that deviated from the tolerance value (mean ${\pm}2SD$ or ${\pm}3SD$). On the other hand, the upgraded Westgard Multi-Rules are actively recommended as a more efficient, specialized form of hospital certification in relation to Internal Quality Control. To apply Westgard Multi-Rules in quality control, credible quality control substance and target value are required. However, as physical examinations commonly use quality control substances provided within the test kit, there are many difficulties presented in the calculation of target value in relation to frequent changes in concentration value and insufficient credibility of quality control substance. This study attempts to improve the professionalism and credibility of quality control by applying Westgard Multi-Rules and calculating credible target value by using a commercialized quality control substance. Materials and Methods : This study used Immunoassay Plus Control Level 1, 2, 3 of Company B as the quality control substance of Total T3, which is the thyroid test implemented at the relevant hospital. Target value was established as the mean value of 295 cases collected for 1 month, excluding values that deviated from ${\pm}2SD$. The hospital quality control calculation program was used to enter target value. 12s, 22s, 13s, 2 of 32s, R4s, 41s, $10\bar{x}$, 7T of Westgard Multi-Rules were applied in the Total T3 experiment, which was conducted 194 times for 20 days in August. Based on the applied rules, this study classified data into random error and systemic error for analysis. Results: Quality control substances 1, 2, and 3 were each established as 84.2 ng/$dl$, 156.7 ng/$dl$, 242.4 ng/$dl$ for target values of Total T3, with the standard deviation established as 11.22 ng/$dl$, 14.52 ng/$dl$, 14.52 ng/$dl$ respectively. According to error type analysis achieved after applying Westgard Multi-Rules based on established target values, the following results were obtained for Random error, 12s was analyzed 48 times, 13s was analyzed 13 times, R4s was analyzed 6 times, for Systemic error, 22s was analyzed 10 times, 41s was analyzed 11 times, 2 of 32s was analyzed 17 times, $10\bar{x}$ was analyzed 10 times, and 7T was not applied. For uncontrollable Random error types, the entire experimental process was rechecked and greater emphasis was placed on re-testing. For controllable Systemic error types, this study searched the cause of error, recorded the relevant cause in the action form and reported the information to the Internal Quality Control committee if necessary. Conclusions : This study applied Westgard Multi-Rules by using commercialized substance as quality control substance and establishing target values. In result, precise analysis of Random error and Systemic error was achieved through the analysis of 12s, 22s, 13s, 2 of 32s, R4s, 41s, $10\bar{x}$, 7T rules. Furthermore, ideal quality control was achieved through analysis conducted on all data presented within the range of ${\pm}3SD$. In this regard, it can be said that the quality control method formed based on the systematic application of Westgard Multi-Rules is more effective than the Levey-Jennings chart and can maximize error detection.
Levey-Jennings 정도관리는 측정치가 관리 허용치(평균 ${\pm}2SD$ 또는 ${\pm}3SD$)를 벗어나는 우연오차만 관리를 했었다면, Westgard Multi-Rules 정도관리는 우연오차와 계통오차의 분리분석을 할 수 있고 복합적용이 가능해 병원 인증 내부정도관리에서도 적극 권장하고 있다. 하지만 검체검사 정도관리에서는 kit 내 같은 기질의 정도관리 물질을 사용해 계통오차의 인지가 쉽지 않고 잦은 농도 변경으로 목표치 설정이 어려워 Westgard Multi-Rules의 적용이 힘들었다. 따라서 본 연구는 정도관리 물질을 상용화된 제 3의 물질을 사용해 신뢰성 있는 목표치를 산출하고 Westgard Multi-Rules을 적용함으로써 정도관리를 개선하고자 한다. 갑상선 검사인 Total T3를 대상으로 정도관리 물질을 B사의 Immunoassay Plus Control Level 1, 2, 3를 사용하여 ${\pm}2SD$를 벗어난 값을 제외한 1개월 동안 295회 데이터의 평균값으로 목표치를 설정하였다. 그리고 20일간 총 194회 실험의 정도관리 물질 측정치를 표준편차 지수를 이용하여 하나의 관리도상에 놓고 Westgard Multi-Rules 중 12s, 22s, 13s, 2 of 32s, R4s, 41s, $10\bar{x}$, 7T의 규칙들을 적용하여 우연오차와 계통오차를 분리하여 분석하였다. Total T3의 목표치는 정도관리 물질 1, 2, 3번이 각각 84.2 ng/dl, 156.7 ng/dl, 242.4 ng/dl로 설정되었고 표준편차는 각각 11.22 ng/dl, 14.52 ng/dl, 14.52 ng/dl로 설정되었다. 설정된 목표치를 기준으로 Westgard Multi-Rules을 적용한 뒤 유형을 분석한 결과 우연오차인 12s가 48회, 13s가 13회, R4s가 6회로 분석되었고 계통오차인 22s는 10회, 41s가 11회, 2 of 32s가 17회, $10\bar{x}$가 10회로 분석되었으며 7T는 적용되어지지 않았다. 통제 불가능한 우연오차의 유형들은 전체실험과정을 재확인하고 재검사 비중을 높이는 등의 조치를 취하였으며 통제 가능한 계통오차의 유형들은 원인을 찾아 조치사항 양식에 기록하고 필요 시 내부정도관리 위원회에 보고하였다. 상용화된 제 3의 물질을 정도관리 물질로 사용하고 목표치를 설정함에 따라 하나의 관리도 상에서 3가지 정도관리 물질에 대한 Westgard Multi-Rules의 적용이 가능하게 되었고, 그 결과 12s, 22s, 13s, 2 of 32s, R4s, 41s, $10\bar{x}$, 7T 규칙들의 분석으로 우연오차와 계통오차의 정밀분석이 가능해 졌다. 또한 ${\pm}3SD$ 내의 모든 데이터를 분석 할 수 있어 Error 검출을 최대화 할 수 있게 되었다. 이와 같이 체계적으로 Westgard Multi-Rules을 적용한 정도관리는 검체검사의 정도관리에 질적 향상을 가져다 줄 것이다.
(Department of Nuclear Medicine, Samsung Medical Center)
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