Howanitz Peter J, Darcy Theresa P, Meier Frederick A, Bashleben Christine P
From the Department of Pathology, State University of New York, Downstate Medical Center, Brooklyn (Dr Howanitz); the Department of Pathology, University of Wisconsin School of Medicine and Public Health, Madison, (Dr Darcy); the Department of Pathology, Henry Ford Health System, Detroit, Michigan (Dr Meier), and the Surveys Department, College of American Pathologists, Northfield, Illinois (Ms. Bashleben).
Arch Pathol Lab Med. 2015 Sep;139(9):1108-14. doi: 10.5858/arpa.2014-0464-CP.
The anticoagulant warfarin has been identified as the second most frequent drug responsible for serious, disabling, and fatal adverse drug events in the United States, and its effect on blood coagulation is monitored by the laboratory test called international normalized ratio (INR).
To determine the presence of INR policies and procedures, INR practices, and completeness and timeliness of reporting critical INR results in participants' clinical laboratories.
Participants reviewed their INR policies and procedure requirements, identified their practices by using a questionnaire, and studied completeness of documentation and timeliness of reporting critical value INR results for outpatients and emergency department patients.
In 98 participating institutions, the 5 required policies and procedures were in place in 93% to 99% of clinical laboratories. Fifteen options for the allowable variations among duplicate results from different analyzers, 12 different timeliness goals for reporting critical values, and 18 unique critical value limits were used by participants. All required documentation elements were present in 94.8% of 192 reviewed INR validation reports. Critical value INR results were reported within the time frame established by the laboratory for 93.4% of 2604 results, but 1.0% of results were not reported. Although the median laboratories successfully communicated all critical results within their established time frames and had all the required validation elements based in their 2 most recent INR calculations, those participants at the lowest 10th percentile were successful in 80.0% and 85.7% of these requirements, respectively.
Significant opportunities exist for adherence to INR procedural requirements and for practice patterns and timeliness goals for INR critical results' reporting.
抗凝药物华法林已被确定为美国导致严重、致残和致命药物不良事件的第二常见药物，其对血液凝固的影响通过称为国际标准化比值（INR）的实验室检测来监测。
确定参与者临床实验室中INR政策和程序的存在情况、INR实践以及关键INR结果报告的完整性和及时性。
参与者审查了他们的INR政策和程序要求，通过问卷调查确定他们的实践情况，并研究了门诊患者和急诊科患者关键值INR结果的文件记录完整性和报告及时性。
在98个参与机构中，93%至99%的临床实验室制定了5项所需的政策和程序。参与者使用了15种不同分析仪重复结果允许差异的选项、12种不同的关键值报告及时性目标以及18种独特的关键值限制。在192份审查的INR验证报告中，94.8%包含所有必需的文件要素。在2604个结果中，93.4%的关键值INR结果在实验室规定的时间内报告，但有1.0%的结果未报告。尽管中位数实验室在其规定的时间内成功传达了所有关键结果，并且在其最近两次INR计算中具备所有必需的验证要素，但处于第10百分位数最低的参与者分别仅在80.0%和85.7%的此类要求上取得成功。
在遵守INR程序要求以及INR关键结果报告的实践模式和及时性目标方面，存在显著的改进空间。
