Implementation and evaluation of a national external quality control program for cervical cytology in Mexico

OBJECTIVE: To evaluate cytology laboratories and the performance of cytotechnologists for establishing efficient external quality control for Mexico's National Program for the Prevention and Control of Cervical Cancer. MATERIAL AND METHODS: During January and February 1998, an onsite evaluation of all cytology laboratories of the Ministry of Health found that only 70% of the microscopes were in adequate working conditions, reagents were out of date, and working conditions were sub-optimal. A program for external quality control based on proficiency testing was established for cytotechnologists. Fifty slide sets with 20 Papanicolaou slides and 10 photographic slides were prepared. The sets were given to the cytotechnologists for evaluation and again one year later by courier. RESULTS: Twenty-one percent of microscopes were repaired and 9% replaced; reagents were distributed and laboratory facilities improved. Only 16% of cytotechnologists passed the initial proficiency test. Cytotechnologists received a refresher training course: one year later 67% of them passed the proficiency test. To ascertain that each slide was correctly diagnosed, 41 sets were rescreened by expert cytopathologists or cytologists and their diagnoses compared to the original ones. Thirty-seven sets had 86% to 96% concordance. CONCLUSIONS: This new system for external quality control of cervical cytology allowed the opportune and reliable evaluation of the performance of cytotechnologists.     

Proposed evaluation of laboratory performance in an external hematology quality control scheme

The commercial control material for hematology Cell Dyn 16 Tri Level gave a good precision an accuracy using the four blood cell counters currently mostly used in Indonesia, the Coulter, Sysmex, Serono and Cell Dyn. It could be used as one of the hematology control material in an external quality control scheme. Result of the CV from participating laboratories are higher compared to this trial are caused by different level of laboratory technical ability although the geographical area and climate may also play a role. The new scoring calculation to evaluate the participant's performance gave a more wider range of DI scores, to give better insight to the performance of each laboratory.     

Performance of semiquantitative and quantitative D-dimer assays in the ECAT external quality assessment program

D-dimer levels are used in clinical practice as markers for the presence or exclusion of venous thrombosis. Therefore, it is important that the performance of the D-dimer tests is well controlled. One of the components of a laboratory quality program is external quality assessment (EQA). The main aim of EQA is to identify the degree of agreement among laboratories. In addition to identifying the individual laboratory performance, it also identifies the characteristics of the different reagents and methods that are used in different laboratories. Recently, the D-dimer test was included in the ECAT External Quality Assessment program. Eighty-one laboratories in four rounds applied semiquantitative and quantitative D-dimer assays to three samples (concentrations normal, slightly elevated, and elevated). Although the reported values varied widely, the classification of the samples was mostly correct for the normal and the elevated samples. The slightly elevated sample was classified as normal by all laboratories using semiquantitative methods and by 60% of the laboratories using quantitative methods, and this varied between 45% and 86% for the different methods. In conclusion, D-dimer methods show a large variation, and the quality of the D-dimer assessment could be improved by standardization and by using cut-off ranges.     

Protocol-based follow-up program for heart failure patients: Impact on prognosis and quality of life

IntroductionHeart failure is associated with high rates of readmission and mortality, and there is a need for measures to improve outcomes. This study aims to assess the impact of the implementation of a protocol-based follow-up program for heart failure patients on readmission and mortality rates and quality of life.MethodsA quasi-experimental study was performed, with a prospective registry of 50 consecutive patients discharged after hospitalization for acute heart failure. The study group was followed by a cardiologist at days 7-10 and the first, third, sixth and 12th month after discharge, with predefined procedures. The control group consisted of patients hospitalized for heart failure prior to implementation of the program and followed on a routine basis.ResultsNo significant differences were observed between the two groups regarding mean age (67.1±11.2 vs. 65.8±13.4 years, p=0.5), NYHA functional class (p=0.37), or median left ventricular ejection fraction (27% [19.8-35.3] vs. 29% [23.5-40]; p=0.23) at discharge. Mean follow-up after discharge was similar (11±5.3 vs. 10.9±5.5 months, p=0.81).The protocol-based follow-up program was associated with a significant reduction in all-cause readmission (26% vs. 60%, p=0.003), heart failure readmission (16% vs. 36%, p=0.032), and mortality (4% vs. 20%, p=0.044). In the study group there was a significant improvement in all quality of life measures (p<0.001).ConclusionA protocol-based follow-up program for patients with heart failure led to a significant reduction in readmission and mortality rates, and was associated with better quality of life.     

湖北省凝血试验室间质量评价和质量控制现状分析

目的：对湖北省二级以上医疗机构临床实验室实施凝血试验室间质量评价活动,了解全省凝血试验项目,包括凝血酶原时间（PT）、国际正常化比值（INR）、活化部分凝血活酶时间（APTT）、纤维蛋白原（FIB）检测的现状,提出改进的措施,促进检测质量,以期更好地为临床服务。方法：对全省近190个临床实验室1年2次发放室间质量评价质评物（包括正常、中度异常和高度异常3种水平）,收集各检测数据,对参加实验室按使用仪器、试剂情况进行分组,采用美国PT评分方法进行统计评价。结果：全省各参控实验室合格率2005年为41%,2006年为55%,2007年为67%,2008年为79.2%,逐年上升。分析各项目各组变异系数（CV%）,发现质评物异常程度越高,检测结果的变异系数CV值越大,及格率越低。使用与仪器配试剂的检测系统变异系数比非配套检测系统小,及格率高。结论：实验室通过参加室间质评活动及开展室内质量控制,及时发现、分析实验中存在的问题,采取相应的措施,提高检测质量。     

Effects of increasing age onto procedural parameters in pacemaker implantation: results of an obligatory external quality control program

Aims: The aim of the study was to evaluate the effects of increasingpatients' age onto procedural parameters, especially complications,during primary pacemaker implantation, evaluating the databaseof the Institute of Quality Assurance Hessen in the federalstate of Hessen, Germany. Methods and results: The database of the obligatory external quality control programwas evaluated retrospectively for the years 2003–2006.A total of 17 826 patients undergoing stationary primary pacemakerimplantation have been registered in 72 centres. In single-chamberimplants, the implant duration is shortest in non-agenarians.For dual-chamber implants, the implant duration shortens withincreasing age. Thus, as well as fluoroscopy time is significantlyshorter in the oldest patients. Atrial and ventricular pacingthresholds as well as R-wave amplitudes do not change with age.P-wave amplitudes showed a small but steady decline with increasingages. Complications do not increase with advanced age. Conclusion: In this large-scale real-life patient cohort of primary stationarypacemaker implantation, increasing age resulted only in reducedP-wave amplitudes. Higher age was not associated with an increasedrisk of complications. Thus, pacemaker implantations in theelderly can be performed with the same reliability as in youngerpatients.     

Internal quality control and external quality assurance in testing for antiphospholipid antibodies: Part II--Lupus anticoagulant

In addition to the presence of appropriate clinical features, the diagnosis of the antiphospholipid antibody syndrome (APS) fundamentally requires the finding of positive antiphospholipid antibody (aPL) test result(s), with these comprising clot-based assays for the identification of lupus anticoagulant (LA) and immunologic ("solid-phase") assays such as anticardiolipin antibodies (aCL) and anti-β2-glycoprotein I antibodies (aβ2GPI). This article is the second of two that review the process for, and provide recommendations to improve, internal quality control (IQC) and external quality assurance (EQA; or proficiency testing) for aPL assays. These processes are critical for ensuring the quality of laboratory test results, and thence the appropriate clinical diagnosis and management of APS. This article covers LA testing. We provide some updated findings from the Royal College of Pathologists of Australasia Haematology Quality Assurance Program, and cover testing results for the past 3 years (2009 to 2011 inclusive). In brief: (1) essentially all laboratories currently perform LA testing using activated partial thromboplastin time (APTT) and dilute Russell viper venom time (dRVVT) methods, and about one-third also employ the kaolin clotting time (KCT); (2) KCT usage has dropped slightly, from around 50% of laboratories in 2009, to around 35% in 2011, presumably reflecting take up of the latest consensus recommendations; (3) other methodologies such as silica clotting time (SCT) and the platelet neutralization procedure (PNP) are only used by <5% of laboratories; (4) interlaboratory coefficients of variation (CVs) are in general moderate, and substantially better than those reported for solid-phase assays such as aCL and aβ2GPI, with median (range) values being 11.6% (9.2 to 25.5%) for APTT ratios, 16.7% (10.1 to 19.2%) for KCT ratios, and 11.7% (5.7 to 17.4%) for dRVVT ratios; (5) CVs increase slightly with increasing LA positivity; (6) most laboratories correctly interpreted test findings for LA, reporting normal samples as normal, and LA-positive samples as positive (albeit with varying gradings of positivity); and (7) however, some laboratories found interpretation to be challenging for some samples, namely a weak LA sample (which was reported as normal by around 50% of laboratories) and a very strong LA sample (which was reported as normal by around 10% of laboratories, primarily those that did not perform mixing studies).     

SIHONSCORE: a scoring system for external quality control of leukaemia/lymphoma immunophenotyping measuring all analytical phases of laboratory performance

For the diagnosis of leukaemia and leukaemic lymphoma, clinicians frequently have to rely on the results of immunophenotyping. To improve the quality of these results, the Dutch Foundation for Immunophenotyping of Haematological Malignancies (SIHON) initiated external quality rounds in 1986. Over a period of more than 10 years, this has led to improvements in the interpretation of immunophenotyping results. However, the evaluation of results focused mainly on the correctness of the interpretation of the immunophenotypical data, leaving the preceding analytical phases unevaluated. Therefore, in 1996 SIHON developed a more comprehensive scoring system, called SIHONSCORE, covering all three phases of immunophenotyping, namely the pre-analytical (i.e. choice of the staining panels), analytical (i.e. the technical part consisting of sample preparation, data acquisition and analysis) and the post-analytical phase (i.e. the interpretation) of the laboratory process. Here, we report how SIHONSCORE was successfully applied to three consecutive external quality rounds consisting of a total of nine different cases tested. For laboratory certification, participation in external quality control programmes is required. Evidently, criteria are needed to define the minimum acceptable performance of a certified laboratory. With SIHONSCORE, a useful instrument is obtained evaluating all phases of the performance of laboratories in leukaemia and lymphoma immunophenotyping.     

Impact of external quality assessment on antinuclear antibody detection performance

Our objective was to evaluate performance of the clinical laboratories for the detection of antinuclear antibodies (ANA) by using indirect immunofluorescence method (IIF), in France. A national external quality assessment (EQA) on ANA detection was organized by the French health products safety agency once a year since 1998. Between 606 to 687 laboratories together with six university reference laboratories experienced in performing tests in autoimmunity participated in the six-year consecutive survey. Each laboratory had to answer to methodological procedures and give coded responses. Variability in IIF methodological procedure was observed. Use of inappropriate microscope magnifications for reading slides or nonconventional cutoff dilution of serum were pointed out to concerned laboratories. Concerning ANA measurement, the rate of good responses ranged from 92.7% to 99.5% of the laboratories when the samples contained ANA. A wide dispersion of ANA titers obtained on a same sample was repeatly observed every year. Misinterpretation of particular fluorescence pattern was noticed. On ANA negative sample, the rate of good responses was 94.3%. In conclusion, ANA detection in routine practice is far from being standardized. However, EQA may have an impact on ANA detection performance when it is conducted on several consecutive year surveys, by providing advice for participating laboratories to limit inter laboratory variations related to methodological procedures.     

全国2011年碘缺乏病实验室盐碘检测能力评价

目的评价参加全国碘缺乏病实验室外质控网络运行实验室的盐碘检测能力。方法用参考值±不确定度的方法对检测结果进行评价。结果参加考核的省级实验室全部合格;地市级实验室反馈率98．9％,合格率97．7％;县级实验室反馈率100％,合格率98．8％。结论本次质控发现,全国只有2．3％的地市实验室和1．2％的县级实验窄不合格。通过几年全国实验室网络的运行和持续的技术培训,各级实验室的检测能力有了明显的提高。     

2008年全国碘缺乏病实验室盐碘检测能力评价

目的评价参加全国碘缺乏病实验室外质控网络运行实验室的盐碘检测能力。方法用参考值±不确定度的方法对检测结果进行评价。结果参加考核的省级实验室全部合格; 地市级实验室反馈率是99.4%,合格率是96.7%; 县级实验室反馈率是100%,合格率是88.8%。结论全国3.3%的地市级实验室和11.2%的县级实验室不合格; 通过几年来全国实验室网络的运行和持续的技术培训,各级实验室的检测能力有了明显的提高。     

2009年全国碘缺乏病实验室盐碘检测能力状况及分析

目的评价全国碘缺乏病实验室外质控网络运行实验室的盐碘检测能力及状况。方法用参考值±不确定度的方法对检测结果进行评价。结果参加考核的省级实验室全部合格;地市级实验室反馈率是98.5%,合格率是97.9%;县级实验室反馈率是100%,合格率是98.1%。结论通过几年全国实验室网络的运行和持续的技术培训,各级实验室的检测能力有了明显的提高。     

2004年全国盐碘外质控结果

目的　评价全国参加盐碘实验室外质控网络实验室的检测能力。方法　采用参考值±不确定度的方法对检测结果进行评价。结果　参加考核3 1个省级盐碘实验室全部反馈了质控结果并全部合格,地市级盐碘实验室反馈率为96.4% ,合格率为90 .9% ,县级盐碘实验室反馈率为97.8% ,合格率为88.8%。结论　通过几年全国实验室网络的运行和持续的技术培训,各级实验室的检测能力有了明显的提高。     

2010年全国碘缺乏病实验室盐碘检测能力评价

目的评价参加全国碘缺乏病实验室外质控网络运行实验室的盐碘检测能力。方法用参考值±不确定度的方法对检测结果进行评价。结果参加考核的省级实验室全部合格;地市级实验室反馈率是99.1%,合格率是98.3%;县级实验室反馈率是99.9%,合格率是98.4%。结论本次质控发现,全国只有1.7%的地市实验室和1.6%的县级实验室不合格。通过几年全国实验室网络的运行和持续的技术培训,各级实验室的检测能力有了明显的提高。     

Interdisciplinary strategies for arrhythmia program development: measuring quality,performance, and outcomes

Evidence-based medicine has provided the foundation for refinement of the guideline development process and the emergence of the disciplines of measuring quality, performance, and outcomes. With implementation of electronic medical records as part of healthcare reform, multiple aspects of these disciplines will be incorporated into clinical cardiac electrophysiology. Performance measures and quality metrics will assume an influential role in the management of patients with heart rhythm disturbances in the near future.     

标准化结直肠肿瘤生物样本库的建立、管理及质量控制的经验探讨

目的依托哈尔滨医科大学大肠癌研究所,在东北地区建立一个规范化、标准化的结直肠肿瘤生物样本库。探究结直肠肿瘤组织样本的采集、保存,样本库构建方法,样本数据管理以及对所存储样本的质量控制技术,为结直肠肿瘤的发生、发展、转移、生物标志物的研究及转化医学和个体化治疗提供高质量的样本资源。 方法收集自2013年于哈尔滨医科大学结直肠肿瘤外科诊断并行手术切除的结直肠肿瘤组织、癌旁组织、远端正常组织,将样本置于-80 ℃低温冰箱冷冻保存;同时定期对所取样本进行随机的DNA、RNA质量检测。 结果截止2017年10月,本生物样本库共收集了440例患者的肿瘤、癌旁、正常组织及少量的血液样本共1 828份。且随机抽取样本的DNA、RNA质量检测结果均符合标本质量标准,能够满足科学实验需求。 结论初步建立了一定规模标准化、规范化的结直肠肿瘤样本库,制定了标准化的样本库运行和管理规程,提高了生物样本利用的效率,为结直肠肿瘤基础和临床研究提供了宝贵的生物样本资源。     

Effects of body weight control on changes in blood pressure: three-year follow-up study in young Japanese individuals.

Numerous epidemiological studies have shown a close relationship between obesity and hypertension. However, there have been few reports on the relationship between changes in the body weight and blood pressure of lean to normal-weight young subjects. The purpose of this study was to investigate the effects of body weight control on blood pressure in lean to obese young Japanese individuals in a 3-year follow-up study. University students (3,558 males and 1,418 females, aged 18.6+/-0.8 in 1994) were classified into 4 groups according to the baseline body mass index (BMI), and were followed up for 3 years. Among male students, changes in body weight were significantly correlated with changes in blood pressure during the 3 years in all 4 BMI groups, and the correlation coefficient was larger in the group with higher baseline BMI. Positive correlations between changes in body weight and changes in heart rate were noted only in the obese and mildly-obese groups. Also in female students, positive correlations were observed between changes in body weight and changes in blood pressure in lean to obese groups. However, no correlations between changes in body weight and changes in heart rate were noted in any of the female groups. To summarize, close correlations were observed between changes in body weight and those in blood pressure during the 3 years in both male and female university students. These findings suggest the importance of body weight control not only in obese but also in normal to mildly-obese young subjects in reducing or preventing an increase in blood pressure. There could be, however, a gender difference in the effects of body weight change on heart rate.