UNASSIGNED:验证新试剂或校准品批次对于保持测试性能的一致性至关重要。医疗保健质量管理研究所(IQMH)进行了实践模式调查和后续案例研究,以收集有关安大略省批次验证实践的信息。
UNASSIGNED:该调查有17个多项选择题,并分发给183个获得许可的实验室。参与者为八类测试系统的批次验证程序提供了有关所用材料和批准/拒绝标准的信息。案例研究提供了一组批次比较数据,并分发给132个实验室。IQMH科学委员会对答复进行了审查。
未经评估:在对试剂批次验证做出回应的175个实验室中,74%的人验证了所有测试,11%的人,15%没有。在对校准器批量验证做出回应的171个实验室中,39%验证了所有校准器,4%的人,57%没有。不进行验证的原因从难以进行平行测试到试剂成本高。对于自动化化学分析和免疫测定,23%的实验室在试剂批次验证中不包括患者来源的材料,42%包括5至6个患者材料;58%的实验室在校准器批次验证中不包括患者来源的材料,23%包括5至6个患者材料。测试特定规则的不同组合用于验收标准。对于一个失败的人来说,98%的实验室将进一步调查并采取纠正措施。在案例研究中,有43%的实验室会接受新的试剂批次。
UNASSIGNED:对调查和案例研究的回应表明,实验室之间的批次验证实践存在差异。
UNASSIGNED: Verifying new reagent or calibrator lots is crucial for maintaining consistent test performance. The Institute for Quality Management in Healthcare (IQMH) conducted a patterns-of-practice survey and follow-up case study to collect information on lot verification practices in Ontario.
UNASSIGNED: The survey had 17 multiple-choice questions and was distributed to 183 licensed laboratories. Participants provided information on materials used and approval/rejection criteria for their lot verification procedures for eight classes of testing systems. The case study provided a set of lot comparison data and was distributed to 132 laboratories. Responses were reviewed by IQMH scientific committees.
UNASSIGNED: Of the 175 laboratories that responded regarding reagent lot verifications, 74% verified all tests, 11% some, and 15% none. Of the 171 laboratories that responded regarding calibrator lot verifications, 39% verified all calibrators, 4% some, and 57% none. Reasons for not performing verifications ranged from difficulty performing parallel testing to high reagent cost. For automated chemistry assays and immunoassays, 23% of laboratories did not include patient-derived materials in reagent lot verifications and 42% included five to six patient materials; 58% of laboratories did not include patient-derived materials in calibrator lot verifications and 23% included five to six patient materials. Different combinations of test-specific rules were used for acceptance criteria. For a failed lot, 98% of laboratories would investigate further and take corrective actions. Forty-three percent of laboratories would accept the new reagent lot in the case study.
UNASSIGNED: Responses to the survey and case study demonstrated variability in lot verification practices among laboratories.