台湾临床实验室的质量保证

Hsu W S, Kao J T, Ho S W

School of Medical Technology, College of Medicine, National Taiwan University, Taipei.

J Formos Med Assoc. 2000 Mar;99(3):235-42.

BACKGROUND AND PURPOSE

In 1994, the Taiwan National Health Administration assigned the execution of a quality assurance (QA) survey program to the Association of Laboratory Medicine. The purpose of this program was to investigate the quality of clinical laboratory assessments and to promote QA in the fields of clinical microscopy, hematology, chemistry, microbiology, serology, and blood banking. We report the findings of QA surveys conducted in 1998 and the effect of voluntary training on improvement of clinical laboratory testing.

METHODS

A total of 1,008 clinical laboratories were included in the program in 1998. Proficiency testing (PT) was performed to evaluate various laboratory tests. Continuing education programs were conducted and experts visited laboratories that sought guidance before the PT was conducted. The full mark was set at a score of 100 for each PT scheme. The criterion for acceptability of PT results was set at a score of 80 or more.

RESULTS

The rates of acceptable results were 82.4% (607/736) for hematology, 57.4% (267/465) for blood banking, 69.3% (561/810) for chemistry, and 80.1% (321/401) for microbiology. The rates of acceptable microscopy results were 90.9% (509/560) for urine chemical tests and 84.6% (610/721) for others. The rates of acceptable serology tests were 73.3% (384/524) for hepatitis and 85.6% (441/515) for syphilis. The rates of acceptable performance differed significantly among clinical laboratories with different rankings: clinical laboratories at institutions classified below the level of district hospital showed comparatively poor performance. Laboratories that received guidance showed significant improvement in performance from 1997 to 1998.

CONCLUSIONS

A QA program is urgently needed in Taiwan to improve laboratory performance.

背景与目的

1994年，台湾地区卫生署将质量保证（QA）调查项目的执行工作委托给检验医学协会。该项目的目的是调查临床实验室评估的质量，并促进临床显微镜检查、血液学、化学、微生物学、血清学和血库领域的质量保证。我们报告1998年进行的质量保证调查结果以及自愿培训对改善临床实验室检测的效果。

方法

1998年共有1008家临床实验室纳入该项目。进行能力验证（PT）以评估各种实验室检测。开展继续教育项目，并且在进行PT之前，专家走访寻求指导的实验室。每个PT方案的满分设定为100分。PT结果可接受的标准设定为80分及以上。

结果

血液学可接受结果率为82.4%（607/736），血库为57.4%（267/465），化学为69.3%（561/810），微生物学为80.1%（321/401）。显微镜检查可接受结果率尿液化学检测为90.9%（509/560），其他为84.6%（610/721）。血清学检测可接受率肝炎为73.3%（384/524），梅毒为85.6%（441/515）。不同排名的临床实验室之间可接受表现率存在显著差异：地区医院级别以下机构的临床实验室表现相对较差。接受指导的实验室在1997年至1998年期间表现有显著改善。