肿瘤患者血液分析自动审核方案的制定与评价

Establishment and evaluation of an autoverification scheme for hematology analysis in cancer patients

目的根据肿瘤患者群体的血细胞分析的特点和常见问题,制定符合肿瘤患者的血细胞分析自动审核方案,验证评价方案的有效性和审核效率。方法将国际血液学组织提供的“国际41条复检规则”和天津医科大学肿瘤医院自建的复检规则分别与国内多中心自动审核规则进行组合,形成两种自动审核方案。选取天津医科大学肿瘤医院10063份血常规标本(镜检460份)作为自动审核方案建立组,在仪器中间件中进行回顾性判断,比较不同方案的自动审核通过率和自动审核漏检率等各种指标。通过逐一分析漏检标本的数据,结合肿瘤患者诊断治疗特点对自动审核规则进行调整。通过对19300份血常规7日内血小板数量变化进行分析,制定血小板计数的Delta检查规则。将血小板计数Delta检查规则与调整后的审核规则合并形成我院自动审核规则,再结合我院复检规则形成我院的自动审核组合方案,并对自动审核方案建立组和验证组(10876份,其中镜检1740份)标本进行判断。EDTA依赖性假性血小板减少症(EDTA-PTCP)患者标记提示和Delta规则判断功能在LIS中进行,其余规则判断功能均在中间件中执行。经过4个月61602份标本的临床试运行,综合评价自动审核方案的有效性。结果国际41条复检规则、我院复检规则与国内多中心审核规则组合形成的两种组合方案的自动审核通过率分别为46.36%、52.26%和漏检率分别为2.02%、1.06%,我院的自动审核方案在建立组和验证组的自动审核通过率分别为51.19%、52.78%,通过正确率分别为100%和99.95%,漏检率分别为0和0.03%;临床试运行期自动审核通过率为56.06%,通过正确率为100%,无漏检标本,优于目前主流规则组合的自动审核方案。自动审核周转时间(TAT)中位数缩短15 min,P90缩短58 min,明显低于去年同期。“EDTA-PTCP”患者标记功能共识别31例特殊患者,总共进行68次检测,PLT纠正前后差值中位数76.5×10^(9)/L,差异有统计学意义(Z=-7.17,P<0.001)。结论本研究建立了适合肿瘤患者群体的自动审核组合方案,在很低的漏检率的同时具有较高的审核通过率,能保证我院肿瘤患者检验结果的准确,提升工作效能。

Objective According to the characteristics and common problems of hematology analysis in cancer patients,an autoverification scheme for cancer patients was formed,and the effectiveness and efficiency of the autoverification scheme were verified.Methods The hematology review of international consensus and ourselves were respectively combined with Chinese multicenter autoverification rules to form two autoverification schemes.10063 blood samples(460 cases reviewed by microscope)were selected as the establishment group.Retrospective judgment was made in the instrument middleware,and various indexes such as autoverification pass rate and missed detection rate of different schemes were compared.By analyzing the data of missed cases one by one,the autoverification rules are adjusted according to the characteristics of diagnosis and treatment of cancer patients.By analyzing the platelet count variation range within 7 days in 19300 cases,the Delta rules of platelet count were established.The platelet count Delta rules and the adjusted autoverification rules were combined to form the autoverification rules of our hospital and then combined with our hematology review rules to form the autoverification scheme of our hospital.The establishment group and verification group(10876 cases,including 1740 cases of microscopic examination)of the autoverification schemes were judged.The recognition function of Ethylenediaminetetraacetic acid-dependent pseudo thrombocytopenia(EDTA-PTCP)and PLT Delta check were programmed in the laboratory information system(LIS),and other rule judgment functions are performed in middleware.After four months of clinical trial application of 61602 specimens,the effectiveness of our autoverification scheme was comprehensively evaluated.Results The autoverification pass rates of international hematology review rules,our review rules,and Chinese multicenter autoverification rules are 46.36%,52.26%,and the missed detection rates are 2.02%,1.06%,respectively.The autoverification pass rates of our hospital autoverification scheme in the establishment group and the verification group are 51.19%and 52.78%,the missed detection rates are 0%and 0.03%,and the true positive rate are 100%and 99.95%,respectively.56.06%of cases were passed automatically during the clinical trial application,and there were no missing cases,the true positive rate is 100%.The performance of our autoverification scheme is superior to the current autoverification schemes combined with mainstream hematology review rules and autoverification rules.The median time of TAT by autoverification was shortened by 15 minutes,and the 90th percentile time was shortened by 58 minutes,which was significantly lower than that of the same period last year.The marker function of"EDTA-PTCP"identified 31 special patients and 68 samples had been analyzed in total.After correction,the median increase of PLT was 76.5×10^(9)/L(Z=-7.17,P<0.001).Conclusions This study has established an autoverification scheme that combined by rules of hematology review and autoverification rules.It is suitable for cancer patients with high pass rate and very low rate of missed detection.This autoverification scheme can ensure the accuracy of the hematology analysis of cancer patients in our hospital and improve work efficiency.