Cervical cancer screening from the public health perspective

Many state health departments have a significant role in cervical cancer screening. Given that role, a group of public health personnel from eight southeastern states drafted a set of questions and quality assurance issues to be discussed with a laboratory under consideration as a contract provider of cytology services. The major points of concern included: (1) quality of laboratory services (accreditation, personnel, facilities and operational and quality control procedures); (2) quality of sampling (including techniques used and the training and monitoring of sample takers); (3) terminology for cytology reporting; and (4) protocols used for diagnostic evaluation of abnormal Papanicolaou smears.     

Establishment of laboratory quality control indicators for NAT on blood donors' samples

In order to establish and screen nucleic acid test (NAT) quality control indicators for blood donor samples, C_T value of each test item were detected by NAT, internal and external quality controls, the number of unsuccessful mixed samples, the split positive rate, the rate of detection efficiency, and the equipment failure rate were collected. The "instant method" is used to establish the Levey-Jennings quality control chart, the mixed test positive rate, the rate of unqualified sample. Possion distribution is used to establish the quality control chart, and it is easily to operate and monitor NAT effectively. The results displayed that quality control charts were established, including unqualified sample Possion distribution quality control chart, the rate of equipment failure quality control chart, the failure rate of reagent batch and inefficient quality control chart, test result positive of Possion distribution quality control chart, quality control charts of NAT positive Possion distribution probability, the rate of split positive quality control charts, quality control charts of unsuccessful mixed samples, quality control chart of reagents effective rate, internal quality control chart, correctness, and NAT qualitative quality control chart. The study established quality control indicators throughout the whole NAT process, which were able to effectively improve NAT quality control and the efficacy of laboratory management.     

European guidelines for quality assurance in cervical cancer screening: recommendations for cytology laboratories.

The quality of a cervical cytology laboratory depends on adequate handling and staining of the samples, screening and interpretation of the slides and reporting of the results. These guidelines give an overview of procedures recommended in Europe to manage the balance between best patient care possible, laboratory quality assurance and cost effectiveness and will be published as a chapter 4 in the European Guidelines for Quality Assurance in Cervical Cancer Screening. The laboratory guidelines include protocols for personnel and organisation, material requirements, handling and analysing cervical samples, recording of results, quality management and communication. The section on quality management is comprehensive and includes protocols for all aspects of internal and external quality assurance. The guidelines are extensively referenced and as far as possible the recommendations are evidence-based.     

Requirements for reference (calibration) laboratories in laboratory medicine

In addition to reference measurement procedures and reference materials, reference or calibration laboratories play an integral role in the implementation of measurement traceability in routine laboratories. They provide results of measurements using higher-order methods, e.g. isotope dilution mass spectrometry and may assign values to materials to be used for external quality assessment programs and to secondary reference materials. The requirements for listing of laboratories that provide reference measurement services include a statement of the metrological level or principle of measurement, accreditation as a calibration laboratory according to ISO 15195 and the participation in a proficiency testing system (regular inter-laboratory comparisons) for reference laboratories. Ring trials are currently conducted for thirty well-defined measurands and the results are made available to all laboratories. Through the use of reference laboratory services that are listed by the Joint Committee for Traceability in Laboratory Medicine there is the opportunity to further promote traceability and standardisation of laboratory measurements.     

Within-laboratory and between-laboratory variability in the measurement of anti-müllerian hormone determined within an external quality assurance scheme

Ten laboratories in an external quality assurance scheme used the same assay to measure anti-müllerian hormone concentration (Beckman Coulter Gen II) and received twenty serum samples distributed over a 15 month period. The mean bias for all results was only ?0.089%, but there was large coefficient of repeatability of 38.8% (sample bias ranged from ?37.9% to +54.7%). While each laboratory showed good reproducibility, there was a wide range of average values relative to the consensus value from ?24.0% to +22.7%. This between-laboratory variability suggests clinicians should use the same laboratory to avoid problems with result interpretation.     

基层医院合同制护理人员的聘用与管理

目的：为保证“医院管理年”活动各项工作的深入开展,满足病人对护理服务和护理质量越来越高的要求;保证护理工作的蓖好运行,不断扩大整体护理工作的内涵和外延,提高病人的满意度。方法：5次招聘活动中,护理部通过对外宣传、理论笔试、操作考核、面试考评、综合评分、考察聘用等程序进行招聘活动,并对合同制护理人员进行规范化管理。提高了护理人员的综合素质,提高了护理质量和病人的满意度。体会：护理管理者通过对合同制护理人员的引进和管理,搞活了用人机制,使“优胜劣汰”成为可能,增加了护理人员的危机意识,激发了护理人员的内趋力。     

The Quality of Sputum Smear Microscopy in Public-Private Mix Directly Observed Treatment Laboratories in West Amhara Region,Ethiopia

Ethiopia adopted Public-Private Mix Directly Observed Treatment Short Course Chemotherapy (PPM-DOTS) strategy for tuberculosis (TB) control program. Quality of sputum smear microscopy has paramount importance for tuberculosis control program in resource-poor countries like Ethiopia. A cross-sectional study was conducted to assess the quality of sputum smear microscopy in 37 Public-Private Mix laboratories in West Amhara, Ethiopia. The three external quality assessment methods (onsite evaluation, panel testing and blind rechecking) were employed. Onsite assessment revealed that 67.6% of PPM-DOTS laboratories were below the standard physical space (5 X 6) m². The average monthly workload per laboratory technician was 19.5 (SD±2.9) slides with 12.8% positivity rate. The quality of Acid Fast Bacilli (AFB) staining reagents was sub-standard. The overall agreement for blind rechecking of 1,123 AFB slides was 99.4% (Kappa = 0.97). Reading of 370 AFB panel slides showed 3.5% false reading (Kappa = 0.92). Moreover, the consistency of reading scanty bacilli slides was lower (93%) compared to 1+, 2+ and 3+ bacilli. Based on blind rechecking and panel testing results, PPM-DOTS site laboratories showed good agreement with the reference laboratory. Physical space and qualities of AFB reagents would be areas of intervention to sustain the quality of sputum smear microscopy. Therefore, regular external quality assessment and provision of basic laboratory supplies for TB diagnosis would be the way forward to improve the quality of sputum smear microscopy services in PPM-DOTS laboratories.     

国外诊断相关组付费制度与医疗服务质量关系研究述评

通过理论分析和文献综述,介绍此付费制度与医疗服务质量关系的研究现状,探讨了一些国家通过引入医疗机构提供能力、医疗服务质量评价标准及全面质量管理观念等措施,对制度进行改良的实践效果,对我国医疗付费制度的改革和优化具有重要的启示意义。     

The Yorkshire slide exchange external quality assessment (EQA) scheme

A slide circulation scheme measuring cervical screening performance of individual cytologists in 15 laboratories in Yorkshire Regional Health Authority is described. The advantages and disadvantages are compared with the current National Proficiency Testing (NPT) scheme. The results indicate that a slide circulation scheme can be successfully used in cervical cytology external quality assessment (EQA). Levels of participation are better than those currently achieved by regional variations of the NPT scheme, and the use of laboratory consensus in the selection of scoring slides appears to be no less valid than the use of a pre‐selected slide pool assembled by an expert panel. The volume of data accumulated in one round is considerably greater than that achieved by proficiency testing and the educational value is regarded as high. However, the scheme is very time consuming for participants and consequently expensive for laboratories. The lack of external supervision increases the risk of unfair practices within individual laboratories. Because of these problems, Yorkshire has now switched to an NPT scheme.     

Results of an innovative education, training and quality assurance program for point-of-care HbA1c testing using the Bayer DCA 2000 in Australian Aboriginal Community Controlled Health Services

This study describes the development, implementation and management of a multi-faceted quality assurance program called Quality Assurance for Aboriginal Medical Services (QAAMS) to support point-of-care HbA(1c) testing on the Bayer DCA 2000 in Aboriginal people with diabetes from 45 Australian Aboriginal Community Controlled Health Services.THE QUALITY ASSURANCE PROGRAM COMPRISED FOUR ELEMENTS: production of culturally appropriate education resources, formal training for Aboriginal Health Workers conducting HbA(1c) testing, an external quality assurance program and on-going quality management support services including a help hotline and an annual workshop. Aboriginal Health Workers were required to test two quality assurance (QAAMS) samples in a blind sense every month since July 1999. Samples were linearly related and comprised six paired levels of HbA(1c). The short and long term performance of each service's DCA 2000 was reviewed monthly and at the end of each six month testing cycle.The average participation rate over 7 six-monthly QAAMS testing cycles was 88%. 84% of 3100 quality assurance tests performed were within preset limits of acceptability. The median precision (CV%) for HbA(1c) testing has averaged 3.8% across the past 5 cycles (range 3.4 to 4.0%) and is continuing to improve. The introduction of a medical rebate for HbA(1c) testing has ensured the program's sustainability.Through continuing education and training, Aboriginal Health Workers have achieved consistent analytical performance for HbA(1c) testing on the DCA 2000, equivalent to that of laboratory scientists using the same instrument. This unique quality assurance model can be readily adapted to other Indigenous health settings and other point-of-care tests and instruments.     

Quality assessed nonculture techniques for detection and typing of meningococci

PCR protocols are increasingly used in laboratories worldwide for the diagnosis and confirmation of invasive meningococcal infection. Protocols are now available for the identification of Neisseria meningitidis, for genogrouping, susceptibility to antibiotics and genotyping of the corresponding isolates. The implementation of quality assurance (QA) schemes and standardization of protocols are required. Diagnostic and confirmatory PCRs should perform consistently in clinical and reference microbiology laboratories. General QA schemes address the issues of sample preparation, PCR laboratory environment, equipment and validation of protocols. Moreover, external QA interlaboratory studies are essential. The European Monitoring Group on Meningococci has provided a good forum to conduct such studies through the development and distribution of samples and protocols for nonculture detection and typing of N. meningitidis.     

稀有鮈鲫近交系微卫星多态性分析

利用17对微卫星引物对稀有鮈鲫（Gobiocypris rarus）野生群体和近交系F20和F22进行了遗传分析。结果表明在野生群体中17个微卫星位点均为多态位点,但在F20中仅有6个多态位点,F22中则仅有4个多态位点。在野生群体中共检测到64个等位基因,F20、F22分别为26、21个。近交系的平均基因纯合率均较高,其中F20为86.18%,F22达91.96%,而野生群体平均基因纯合率为46.84%。近交系平均杂合度和平均多态信息含量均较野生群体低。在近交系F20和F22中,群体间遗传相似性指数最大,其遗传距离最小,说明二者之间的亲缘关系最近。HAN系遗传多样性明显降低,已具有较高的遗传纯度。     

Analytical quality--what should we be aiming for?

ISO 15189 5.5.1 "The laboratory shall use examination procedures, ... which meet the needs of the users of laboratory services and are appropriate for the examinations. Requirements for analytical quality include: understanding the analytical goal; seeking an assay that fulfills those goals; establishing your own performance with that assay; setting warning and action limits for your assay; applying quality control tools to every important step.     

中国实验动物产业化发展探讨

实验动物作为生命科学研究的基础和重要支撑条件,其产业化程度已经成为一个国家科学技术发展水平和能力的重要标志,在国民经济中发挥着重要作用.实验动物产业领域主要包括实验动物培育及生产供应、实验动物相关产品研发和生产供应、动物实验技术服务三个方面,其服务于各个科技领域.我国实验动物产业起步较晚.随着我国生命科学研究的发展和综合国力的提升,我国实验动物产业也得到快速发展,实验动物产业化初具规模.但是,我国目前实验动物产业发展还存在一些问题,主要体现在产业规模化不够,缺乏具有一定规模、在国内外占主导地位的企业;产品质量和服务质量有待进一步提高;质量管理和监督体系不健全;人才队伍不足.建议加大政府支持力度,合理布局,培育产业化集团;加强质量管理和监督体系建设,提高产品或服务质量：加强人才队伍建设,提高服务能力.以提升实验动物科学发展水平,推动人类健康事业的发展.     

实验用鱼遗传质量控制及标准化

在遗传学及其他生命科学研究领域, 实验用鱼已成为一类应用越来越广的实验动物, 但是尚缺少标准化的质量控制标准和监管。在我国, 实验动物实行严格的许可证制度和质量监督制度。实验用鱼遗传质量控制标准是实验用鱼质量控制的基础。为了规范实验用鱼的遗传质量, 避免实验用鱼种质退化、遗传漂移, 导致实验结果误差, 开展了本标准的研究。依据《实验动物管理条例》, 参考国内外实验用鱼遗传学相关的研究成果, 结合我国实验用鱼生产和使用的实际情况, 在全面收集、分析实验数据和广泛征询专家意见的基础上, 以实验用斑马鱼和剑尾鱼遗传质量控制为规范对象, 研究制定了实验用鱼遗传质量控制标准, 供科研工作者参考、讨论。本标准对实验用斑马鱼和剑尾鱼的遗传分类及命名原则、实验用鱼的繁殖方法、近交系和封闭群的遗传质量监测进行了规范。新标准将为实验用鱼的使用和管理提供理论支撑。     

Impact of contracted manufacturing organization protocols on operations in an aca demically based Current Good Manufacturing Practice facility

Immunotherapy of cancer and other diseases is often dependent on adoptive transfer to patients of cellular products generated in Current Good Manufacturing Practice (cGMP) facilities. With the availability and approval of various cellular products for therapy, cell production facilities are experiencing unprecedented growth in demand for services. Increasingly, these services involve processing of externally generated cells for transfer to the bedside. The arrival of cells from external manufacturing facilities for processing and eventual infusion of cell therapy products into patients creates a new layer of responsibility and adds to an already demanding list of the existing procedures in academic cGMP facilities. Sponsors introduce their own requirements for the handling of cells that the laboratory must incorporate and follow. The challenges of creating additional access to cleanrooms, writing new standard operating procedures, expanding personnel training, altering pre-existing schedules and incorporating additional monitoring for safety of external products alter the balance of laboratory operations. Adjustments for accommodating externally manufactured products are numerous and varied, as each sponsor has requests that are product-specific. If cells produced by several different external manufacturers are handled by the same facility, the negative impact on the regular activities in this facility may be considerable. Here the authors provide a review of operational challenges that an academic-based laboratory faces and discuss solutions that could ameliorate the difficulties related to an increasing volume of industry-sponsored trials. The solution may be the development under the auspices of the Foundation for Accreditation of Cellular Therapy or the Food and Drug Administration of regulations that will guide the processing of products manufactured by external companies and make these regulations broadly applicable in all cGMP facilities.     

城市生态观测:质量控制对象、体系和规范编制

城市生态系统长期观测是开展城市生态安全评价和制定人居环境健康管理政策的基础。为了确保城市生态观测数据的准确性和科学性,通过辨识城市生态观测质量控制的概念,基于"人机料法环"理论构建了城市生态观测质量控制体系,结合城市生态观测质量控制相关规范的编制与实施现状,探讨了城市生态观测质量控制规范的编制技术。结果表明：（1）城市生态观测质量控制是面向城市生态观测内容（要素、空间格局、功能、服务）,为保证生态观测全过程质量要求、提高生态观测结果的准确性而实施的质量控制活动和措施。（2）城市生态观测质量控制体系可从对象和过程这两个维度进行界定：对象维度方面,包括"人"-人员、"机"-仪器设备、"料"-数据、"法"-文件和"环"-观测过程5个方面;过程维度方面,涵盖城市生态观测全过程,包括城市生态观测前期准备工作、观测过程中以及观测后的数据录入、审核与评价等环节的质量控制措施。（3）我国已发布的生态观测相关技术标准中,发布的时间越晚,质量控制内容越完整,目前生态观测相关标准共102则,仅38则明确提出了质量控制具体要求。（4）《城市生态观测质量控制规范》编制需包含质量体系和质量控制措施两项技术内容,主要包括前引、正文和附录三个章节,对生态观测全过程质量保证和质量控制技术进行规定。     

检验全流程数字化管理及质量控制体系的构建

通过对检验工作各环节流程、质控情况的分析,制定了新的检验业务管理及质量控制流程,并利用数字化技术对流程各环节进行系统实现。检验全流程数字化管理及质量控制体系的构建,有效提高了检验工作的效率与质量安全,进一步促进了医院医疗质量管理水平的提高。     

Fish Communities and Their Associations with Environmental Variables, Lower San Joaquin River Drainage, California

Twenty sites in the lower San Joaquin River drainage, California, were sampled from 1993 to 1995 to characterize fish communities and their associations with measures of water quality and habitat quality. The feasibility of developing an Index of Biotic Integrity was assessed by evaluating four fish community metrics, including percentages of native fish, omnivorous fish, fish intolerant of environmental degradation, and fish with external anomalies. Of the thirty-one taxa of fish captured during the study, only 10 taxa were native to the drainage. Multivariate analyses of percentage data identified four site groups characterized by different groups of species. The distributions of fish species were related to specific conductance, gradient, and mean depth; however, specific conductance acted as a surrogate variable for a large group of correlated variables. Two of the fish community metrics – percentage of introduced fish and percentage of intolerant fish – appeared to be responsive to environmental quality but the responses of the other two metrics – percentage of omnivorous fish and percentage of fish with anomalies – were less direct. The conclusion of the study is that fish communities are responsive to environmental conditions, including conditions associated with human-caused disturbances, particularly agriculture and water development. The results suggest that changes in water management and water quality could result in changes in species distributions. Balancing the costs and benefits of such changes poses a considerable challenge to resource managers.     

实验室质量与实验室条件建设的关系概论

对测量误差的处理、控制和评定方法是决定测量数据质量即实验室质量水平的基础。实验室条件建设是降低和控制测量误差的保障,实验室质量控制的有效手段是建立适合的实验室条件。