결핵균 검사의 Quality Assurance
Quality Assurance of Laboratory Tests for Tuberculosis
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임상미생물검사실은 결핵의 진단과 치료에 결정적인 역할을 담당하고 있다. 그러나 검사실의 낮은 검사의 질은 통상적 인 항산균도말검경, 항산균배양 그리고 항결핵제 감수성시험을 통한 결핵진단에 큰 걸림돌이 되고 있다. 도말검경에 대 한 외부정도평가는 quality assurance의 중요한 요소이며 패널검사, 슬라이드 재검경 그리고 검사실 현장방문이 이에 포함 된다. 정기적인 패널검사는 검사실의 숙련도를 평가하는 가장 간단한 방법이다. 슬라이드 재검경은 하부검사실에 대한 평가와 지속적인 동기부여가 가능하므로 권장되는 방법이다. 검사실 현장방문은 실제상황에서 검사자의 수행능력을 평 가할 수 있는 장점이 있다. 항산균 배양은 검사자의 숙련도를 평가하기가 힘든데 기존의 EQA program들은 배양과정을 평가하기에는 충분하지 못하다. 따라서 배양의 정도관리를 위해서는 검사실 규정과 인증심사가 중요하다. 세계보건기구 는 항결핵제 감수성시험을 시행하는 검사실의 수행능력을 향상시키고 기술적으로 지원하기 위해 초국가적 기준검사실 망을 결성하였다. 이에 속하는 초국가적 참고검사실은 매년 숙련도 평가를 위해 30개의 결핵균을 교환하여 결과를 비교 하고 있다. 많은 나라에서 교육과 외부정도평가 프로그램을 통해서 검사의 질을 개선할 수 있음을 보고하였다. 그러나 우리나라의 관련 프로그램은 아직 시작단계이며 일부 검사에만 적용되고 있다. 성공적인 결핵관리를 위해서는 검사실 질관리 프로그램을 확대 강화하는 것이 절실하다.
Abstract
Clinical microbiology laboratories play a critical role in diagnosing tuberculosis (TB) and monitoring its treatment. Poor quality laboratory services remain a major barrier to diagnosis by microscopy and culture, and may complicate the interpretation of drug susceptibility testing (DST) results. External quality assessment (EQA) for microscopy is an important component of quality assurance, and includes panel testing, slide rechecking, and on-site supervision. Periodic panel testing is the simplest way to assess the performance of laboratories. Rechecking of a sample of routine smears by a higher-level laboratory is the method of choice for evaluation and continuous motivation of peripheral laboratories. On-site supervision allows the observation of workers’ performance under actual conditions, including equipment handling, laboratory safety, adequacy of supplies, and the processes used for smearing, staining, reading, recording, and reporting. Culture performance is not easily measured, and existing EQA programs are not sensitive enough to estimate the sensitivity of the process. Therefore, laboratory regulations and accreditation programs are critical to assure the quality of cultures. The Supranational Reference Laboratory Network (SRLN) was organized in 1994 to ensure optimal performance of laboratories conducting DST. A panel of 30 pretested and coded isolates is exchanged annually within the network for proficiency testing. It has been demonstrated that education and an EQA program can improve the proficiency of TB laboratories. However, quality programs in Korea are still weak. Expanded and strengthened laboratory quality improvement systems are necessary to achieve TB control in this country.
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