Gutiérrez G, Jou J M, Carlos Reverter J, Martínez-Brotons F, Domingo A, Antonio Iriarte J, Remacha A, Rey J, Vives Corrons J L
Hospital Clínic i Provincial (Barcelona).
Sangre (Barc). 1996 Apr;41(2):115-23.
Since 1994, the Standardisation Committee for Haematology publishes yearly the results of its external quality assurance programme (EQAPH), after it has been improved and even integrated in the Health Services of some autonomous communities.
Four hundred and seventy-three laboratories take part in EQAPH. The evaluation of the haematological records is carried out every year from the results of two whole blood samples. Two samples of lyophillised plasma are sent every month to participant laboratories in order to assess prothrombin time (PT), partial thromboplastin time (PTT) and fibrinogen. Samples are sent every three months for antithrombin III (AT-III) determination. According to the types of autoanalysers used, 9 groups have been established: Group I (Technicon H* and H-6000), group II (Technicon H2 and H3), group III (Coulter MaxM, STKS, Cobas Argos and Cell-Dyn 3000/3500), group IV (Coulter STKR), group V (Coulter JS/JT), group VI (Coulter S/T, Cobas Helios/Minos), group VII (Sysmex E/NE), group VIII (Sysmex K-1000), and group IX (other semi-automated counters). Three groups are established for general coagulation tests and two others for AT-III. The value of the mean of all results (consensus mean) and of each particular group (group mean) are used as statistical methods. The results are expressed as: (1) coefficient of variation, % (CV); (2) deviation index (DI); DI values attained with respect to the same group (or method) or all groups (or methods) allowed us to classify the results in four categories: excellent (0 < DI < 0.5), good (0.5 < DI < 1.0), satisfactory (1.0 < DI < 2.0), and out of acceptable limits (ID > 2.0); (3) Youden graphs or graphic representations of DI calculated from the analysis of the control specimens.
Group I yielded lesser values for leucocyte count (0.221) and higher for MCH (0.833). Group II showed high DI values for PCV (0.933) and MCV (1.146). Group III had lower values for red cell count (0.097), haemoglobin concentration (0.133) and MCH (0.91). Group IV showed lower platelet count. Group V had higher haemoglobin concentration values. Group VI yielded higher DI in the platelet count and group VII in the white cell count. Group VII showed the lowest DI for MCV and MHC. Group IX had high values for red cell count and MCH. In the coagulation field, group I had higher values for PT and AT-III. Group II showed higher DI values for PTT and fibrinogen. The highest CV values were seen in groups VIII and IX. The lowest values were present in group II for haemoglobin, IV for MCH, in V for PCV and MCV, in VII for red cell count and MCH, in VII for white cell count and in VII for platelet count. The coagulation tests showed lower CV values than cytometry, the lowest being for PT in group I and PTT and fibrinogenein group II. With regard to the influence of acceptable results on adverse ones within this group, the percentage of laboratories with mean DI over 2 were calculated. Thus, the laboratories achieved 43.5% of values within acceptable limits for platelet count and 56.7% for white cell count. Regarding the PCV, out of 47.9% of the laboratories, only 1.0% showed high deviation of some results. In the coagulation parameters, of the 37.2 in this group for AT-III, 32.4% showed a mean DI over 2.
Participation in External Quality Assurance programmes contributes to the comparability of the results provided by different laboratories, thus increasing their accuracy and improving the quality of patient care.
自1994年以来,血液学标准化委员会在改进其外部质量保证计划(EQAPH)并将其整合到一些自治区的卫生服务中后,每年都会公布该计划的结果。
473个实验室参与了EQAPH。每年根据两份全血样本的结果对血液学记录进行评估。每月向参与实验室发送两份冻干血浆样本,以评估凝血酶原时间(PT)、部分凝血活酶时间(PTT)和纤维蛋白原。每三个月发送样本进行抗凝血酶III(AT-III)测定。根据所使用的自动分析仪类型,分为9组:第一组(Technicon H和H-6000),第二组(Technicon H2和H*3),第三组(库尔特MaxM、STKS、科巴斯阿戈斯和Cell-Dyn 3000/3500),第四组(库尔特STKR),第五组(库尔特JS/JT),第六组(库尔特S/T、科巴斯赫利俄斯/米诺斯),第七组(希森美康E/NE),第八组(希森美康K-1000)和第九组(其他半自动计数器)。一般凝血试验分为三组,AT-III分为另外两组。所有结果的平均值(共识平均值)和每个特定组的平均值(组平均值)用作统计方法。结果表示为:(1)变异系数,%(CV);(2)偏差指数(DI);相对于同一组(或方法)或所有组(或方法)获得的DI值使我们能够将结果分为四类:优秀(0 < DI < 0.5)、良好(0.5 < DI < 1.0)、满意(1.0 < DI < 2.0)和超出可接受范围(ID > 2.0);(3)尤登图或根据对照样本分析计算的DI的图形表示。
第一组白细胞计数的值较低(0.221),平均红细胞血红蛋白含量(MCH)较高(0.833)。第二组红细胞压积(PCV)和平均红细胞体积(MCV)的DI值较高(分别为0.933和1.146)。第三组红细胞计数(0.097)、血红蛋白浓度(0.133)和MCH(0.91)的值较低。第四组血小板计数较低。第五组血红蛋白浓度值较高。第六组血小板计数的DI较高,第七组白细胞计数的DI较高。第七组MCV和平均红细胞血红蛋白浓度(MHC)的DI最低。第九组红细胞计数和MCH的值较高。在凝血领域,第一组PT和AT-III的值较高。第二组PTT和纤维蛋白原的DI值较高。第八组和第九组的CV值最高。血红蛋白方面,第二组的值最低;MCH方面,第四组的值最低;PCV和MCV方面,第五组的值最低;红细胞计数和MCH方面,第七组的值最低;白细胞计数方面,第七组的值最低;血小板计数方面,第七组的值最低。凝血试验的CV值低于血细胞计数,第一组的PT以及第二组的PTT和纤维蛋白原的CV值最低。关于该组内可接受结果对不良结果的影响,计算了平均DI超过2的实验室百分比。因此,实验室血小板计数在可接受范围内的值达到43.5%,白细胞计数达到56.7%。关于PCV,在47.9%的实验室中,只有1.0%的一些结果显示出高偏差。在凝血参数方面,该组中AT-III的37.2个实验室中,32.4%的平均DI超过2。
参与外部质量保证计划有助于不同实验室提供结果的可比性,从而提高其准确性并改善患者护理质量。