目的：EZ Rules 3 是一套實用、操作簡易、可自動篩選品管規則、品管次數(N)、及有效呈現錯誤偵測率 (Ped) 與假性排斥率 (Pfr) 的品管軟體。目前國內檢驗室都採用估算的Sigma (σ) 值選擇品管規則，其缺點是無法自動選擇及無法呈現錯誤偵測率與假性排斥率。本研究主要利用 EZ rules 3 評估 CLIA TEa (2019年) 對於血液檢驗內部品管的 σ 值及品管規則與品管次數之評估。

材料與方法：評估110年1月至6月期間，以 Sysmex XN-1000TM Hematology Analyzer (Sysmex Corporation, Japan) 血液分析儀，品管檢體數 (SYSMEX XN-CHECKTM) 共計200次。針對血液常規檢驗品項：WBC、RBC、HCT、HGB、PLT等五項的內部品管結果進行分析與探討。以 EZ Rules 3 評估 CLIA TEa(2003年)與TEa(2019年)，對於血液檢驗內部品管之影響評估，包含各項目的 σ 值、品管規則選擇、品管次數、錯誤偵錯率、及假性排斥率之表現。

結果：TEa(2003年)與TEa(2019年)之評估結果，(1)5項中的WBC、RBC、HGB、HCT縮減 TEa 範圍，TEa(2019年)下降百分比分別為：67%，33%，43%，33%，PLT維持25%。(2) TEa(2019年)下修幅度與 σ 變化幅度成正比。(3) TEa(2019年)的 RBC、HGB、HCT 等3項目的 Ped 與 Pfr 評估，均可維持 Ped > 95 %與 Pfr < 5 %。唯WBC (Level I/II) 與HCT (Level I/II/III) 兩項因 TEa(2019年) 調整後的 σ 值小於6，品管規則改變為 13s/2 of 3 2s/R4s/31s/6x、品管次數(N) 改變為 6，仍無法達到 Ped > 95 % 與 Pfr < 5 %之要求。(4)選擇適當TEa，並評估長期的結果，可達成內部品管的管理目標。

結論：根據 TEa(2019年)，使用 EZ Rules 3，發現 WBC 與 HCT 調整 TEa 後，σ值小於4 ; PLT項目 TEa 維持不變 ; RBC 及 HGB 經調整 TEa 標準後，將過去 σ 值過高的項目有效降低，仍可達到 Ped > 95 % 與 Pfr < 5 %之要求。結果更適合內部品管規則之實際應用，可提昇檢驗品質並達成內部品管的管理目標。

Purpose: EZ Rules 3 is a set of practical, easy-to-operate quality control software that can automatically adapt quality control rules and quality control times (N), and effectively display false detection rate (Ped) and false rejection rate (Pfr). At present, domestic laboratories use estimated Sigma (σ) values to select quality control rules. The disadvantage is that it is not automated and cannot display Ped and Pfr. This study mainly uses EZ rules 3 to evaluate the σ value of CLIA TEa (2019’s) for the internal quality control of blood tests, as well as the quality control rules and times.

Materials and methods: During the period from January to June 2022, the Sysmex XN-1000TM Hematology Analyzer (Sysmex Corporation, Japan) was used to analyze quality control samples from Sysmex (Sysmex XN-CheckTM) for 200 times. The evaluation of internal quality control results was focused on five routine blood test items: WBC, RBC, HCT, HGB, and PLT. EZ Rules 3 was used to evaluate the impact of CLIA TEa (2003’s) and TEa (2019’s) on the internal quality control of blood testing, including the σ value of each item, selection of quality control rules, quality control times, error detection rate, and the performance of pseudo-rejection rate.

Results: The results were shown below. (1) The decline percentage of TEa (2019’s) for WBC, RBC, HGB, and HCT were 67%, 33%, 43% %, and 33% respectively. And the percentage of PLT remained 25%. (2) The degree of declining of TEa (2019’s) is proportional to the change of σ value. (3) The Ped and Pfr in TEa (2019’s) of RBC, HGB, and HCT can be maintained at level of Ped > 95 % and Pfr < 5 %. However, the WBC (Level I/II) and HCT (Level I/II/III) were not met the requirement of Ped > 95% and Pfr < 5% in TEa (2019’s) because an adjusted σ value was still less than 6 due to changing the quality control rules to 13s/2 of 3 2s/R4s/31s/6x, and the number of quality control (N) to 6. (4) Selecting an appropriate TEa and evaluating the long-term result can achieve the goal of the management by internal quality control.

Conclusion: Using EZ Rules 3, it was found that the σ value of WBC and HCT were less than 4 by adjusted TEa(2019’s). And the TEa of PLT remained unchanged. After adjusting the TEa of RBC and HGB, σ values which was higher in the past can be effectively reduced and the requirement of Ped > 95 % and Pfr < 5 % can be met. The result of using EZ Rules 3 disclosed that this software is practical and reliable in application for internal quality control that can improve the quality of inspection and achieve the goal of management by internal quality control.