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.     

Quality assurance activities of the College of American Pathologists

Since its inception, the College of American Pathologists (CAP) has played a fundamental and pivotal role in the development and execution of quality assurance programs for laboratories. Within the realm of anatomic pathology, operational programs include those in surgical pathology, immunohistochemistry and cytopathology. The emphasis of prior cytopathology programs on cervical cytology has now been expanded to include body fluids and fine needle aspiration material. CAP's role in the expansion of quality assurance programs in cytology may be enhanced in the future by intersociety cooperation with established cytology organizations and will also be influenced by and closely linked to the expansion of its quality assurance programs in surgical pathology. As for the Papanicolaou smear, it can no longer be regarded as the "Cinderella of cytology"; it is in fact the present-day cynosure in the laboratory. In recognition of this, CAP has undertaken efforts to help heighten public awareness about the value of Papanicolaou smear testing and is encouraging women to become more informed about the process involved in the examination of their smears.     

The effect of the health care supply environment on children's nutritional status in rural Nepal

This article examines the effect of access to health infrastructure, personnel and services on children's nutritional status in rural Nepal. Data for the study come from the 1996 Nepal Living Standards Survey, which includes individual- and household-level information on children's nutritional status and its environmental and socioeconomic determinants, and community-level information on the availability of health care infrastructure, personnel and services. The study uses a structural modelling approach to assess the relative contributions of the health care supply environment on children's anthropometric status via the pathway of maternal and child health (MCH) service use. The findings suggest that improvements in the availability of outreach clinics and the structural quality of the closest public facility would be expected to have statistically significant and large effects on the use of MCH services, and that increases in MCH service use would have a statistically significant impact on weight-for-age, but not weight-for-height or height-for-age. The overall impact of the heath care supply environment on nutritional status is assessed through a series of policy simulations.     

The BSCC Code of Practice – exfoliative cytopathology (excluding gynaecological cytopathology)

Exfoliative cytopathology (often referred to as non‐gynaecological cytology) is an important part of the workload of all diagnostic pathology departments. It clearly has a role in the diagnosis of neoplastic disease but its role in establishing non‐neoplastic diagnoses should also be recognised. Ancillary tests may be required to establish a definitive diagnosis. Clinical and scientific teamwork is essential to establish an effective cytology service and staffing levels should be sufficient to support preparation, prescreening, on‐site adequacy assessment and reporting of samples as appropriate. Routine clinical audit and histology/cytology correlation should be in place as quality control of a cytology service. Cytology staff should be involved in multidisciplinary meetings and appropriate professional networks. Laboratories should have an effective quality management system conforming to the requirements of a recognised accreditation scheme such as Clinical Pathology Accreditation (UK) Ltd. Consultant pathologists should sign out the majority of exfoliative cytology cases. Where specimens are reported by experienced biomedical scientists (BMS), referred to as cytotechnologists outside the UK, this must only be when adequate training has been given and be defined in agreed written local protocols. An educational basis for formalising the role of the BMS in exfoliative cytopathology is provided by the Diploma of Expert Practice in Non‐gynaecological Cytology offered by the Institute of Biomedical Science (IBMS). The reliability of cytological diagnoses is dependent on the quality of the specimen provided and the quality of the preparations produced. The laboratory should provide feedback and written guidance on specimen procurement. Specimen processing should be by appropriately trained, competent staff with appropriate quality control. Microscopic examination of preparations by BMS should be encouraged wherever possible. Specific guidance is provided on the clinical role, specimen procurement, preparation and suitable staining techniques for urine, sputum, semen, serous cavity effusion, cerebrospinal fluid, synovial fluid, cyst aspirates, endoscopic specimens, and skin and mucosal scrapes.     

动物实验中的兽医作用

实验动物是现代医学研究中的重要基础和条件,随着我国实验动物科学的迅速发展和实验动物和动物实验质和量的不断提高,对实验动物兽医的需求越来越大,对实验动物兽医的要求和期望也越来越高,本文简要阐述了兽医在动物实验中的作用.文章就实验动物兽医应该具备的资质、实验动物兽医的基本职责以及实验动物健康与兽医管理等方面进行了讨论,明确了实验动物兽医的各项基本职责及任务.兽医在实验动物的管理以及动物实验的过程中有着非常重要的作用,在动物实验中应充分发挥兽医的作用.     

THE ROLE OF GOVERNMENT IN MEDICINE

On the fundamental question of how far a government should be involved in health services, the author believes these things can appropriately be said: The government should continue to assume complete control over public health measures, and public health officials could well be permitted to invade medical services insofar as is necessary to achieve public health ends.To assist in the production of medical personnel, it is also fitting for the government to provide for increased teaching facilities, higher salaries for teachers in the medical field and scholarships for worthy students.In the area of insurance and prepayment plans, a really intelligent supervision of such devices, with the exercise of no more arbitrary governmental power than is now used by the various other regulatory commissions, is a suitable governmental function. The government''s buying policies for its wards, rather than providing direct medical services for them, should be encouraged. This would give the private practice of medicine a boost and would improve the quality of medical care. Government should encourage the regionalization of medical services with as much of the actual controls exercised at the local level as can be achieved. Private means should be utilized for the provision of these services and public means should be used for their payment when this is an obligation of the government.The problem of mass education in health matters should be tackled by government. It would be a fine thing if the medical profession and governmental agencies could agree upon delineation of their respective roles in the health field.Because further experimentation is needed before the ideal solution is found, both government and organized medicine should encourage the exploration of new approaches.     

Barriers in the Delivery of Emergency Obstetric and Neonatal Care in Post-Conflict Africa: Qualitative Case Studies of Burundi and Northern Uganda

Objectives

Maternal and neonatal mortality and morbidity rates are particularly grim in conflict, post-conflict and other crisis settings, a situation partly blamed on non-availability and/or poor quality of emergency obstetric and neonatal care (EmONC) services. The aim of this study was to explore the barriers to effective delivery of EmONC services in post-conflict Burundi and Northern Uganda, in order to provide policy makers and other relevant stakeholders context-relevant data on improving the delivery of these lifesaving services.

Methods

This was a qualitative comparative case study that used 42 face-to-face semi-structured in-depth interviews and 4 focus group discussions for data collection. Participants were 32 local health providers and 37 staff of NGOs working in the area of maternal health. Data was analysed using the framework approach.

Results

The availability, quality and distribution of EmONC services were major challenges across the sites. The barriers in the delivery of quality EmONC services were categorised into two major themes; human resources-related challenges, and systemic and institutional failures. While some of the barriers were similar, others were unique to specific sites. The common barriers included shortage of qualified staff; lack of essential installations, supplies and medications; increasing workload, burn-out and turnover; and poor data collection and monitoring systems. Barriers unique to Northern Uganda were demoralised personnel and lack of recognition; poor referral system; inefficient drug supply system; staff absenteeism in rural areas; and poor coordination among key personnel. In Burundi, weak curriculum; poor harmonisation and coordination of training; and inefficient allocation of resources were the unique challenges. To improve the situation across the sites, efforts are ongoing to improve the training and recruitment of more staff; harmonise and strengthen the curriculum and training; increase the number of EmONC facilities; and improve staff supervision, monitoring and support.

Conclusions

Post-conflict health systems face different challenges in the delivery of EmONC services and as such require context-specific interventions to improve the delivery of these services.     

Telepathology: a tool to aid in diagnosis and quality assurance in cervicovaginal cytology

Telepathology: a tool to aid in diagnosis and quality assurance in cenicovaginal cytology
The purpose of this study is to evaluate the use of a Teletransmission System with regard to quality of diagnosis and screening so as to establish its potential role in gynaecological cytology. Three aspects of its use in cytopathology have been considered: diagnosis, training, and quality control. The circumstances in which the system may be used for diagnosis, together with its advantages and disadvantages, are examined and discussed. In general, the costbenefit in diagnostic use related to the experience of both the expert and the peripheral pathologist. The system may also contribute to training and quality assessment, particularly if combined with other automated services, such as an image data bank.     

Economic evaluation and health care. What does it mean?

Ever since the concept of value for money in health care was introduced into the NHS, economic terms and jargon have become part of our everyday lives--but do we understand what the different types of economic evaluation all mean, particularly those that sound similar to the uninitiated? This article introduces readers to the purpose of economic evaluation, and briefly explains the differences between cost-minimisation analysis (used when the outcomes of the procedures being compared are the same); cost-effectiveness analysis (used when the outcomes may vary, but can be expressed in common natural units, such as mm Hg for treatments of hypertension); cost-utility analysis (used when outcomes do vary--for example, quality of life scales); and cost-benefit analysis (used when a monetary value is being placed on services received). Further articles will deal with each one in more detail.     

Configuring balanced scorecards for measuring health system performance: evidence from 5 years' evaluation in Afghanistan

Background

In 2004, Afghanistan pioneered a balanced scorecard (BSC) performance system to manage the delivery of primary health care services. This study examines the trends of 29 key performance indicators over a 5-year period between 2004 and 2008.

Methods and Findings

Independent evaluations of performance in six domains were conducted annually through 5,500 patient observations and exit interviews and 1,500 provider interviews in >600 facilities selected by stratified random sampling in each province. Generalized estimating equation (GEE) models were used to assess trends in BSC parameters. There was a progressive improvement in the national median scores scaled from 0–100 between 2004 and 2008 in all six domains: patient and community satisfaction of services (65.3–84.5, p<0.0001); provider satisfaction (65.4–79.2, p<0.01); capacity for service provision (47.4–76.4, p<0.0001); quality of services (40.5–67.4, p<0.0001); and overall vision for pro-poor and pro-female health services (52.0–52.6). The financial domain also showed improvement until 2007 (84.4–95.7, p<0.01), after which user fees were eliminated. By 2008, all provinces achieved the upper benchmark of national median set in 2004.

Conclusions

The BSC has been successfully employed to assess and improve health service capacity and service delivery using performance benchmarking during the 5-year period. However, scorecard reconfigurations are needed to integrate effectiveness and efficiency measures and accommodate changes in health systems policy and strategy architecture to ensure its continued relevance and effectiveness as a comprehensive health system performance measure. The process of BSC design and implementation can serve as a valuable prototype for health policy planners managing performance in similar health care contexts. Please see later in the article for the Editors'' Summary     

GLP原则在体外毒理学评价实验室的应用

在动物福利运动的推动下,以减少、优化和替代动物试验为核心内容的体外试验系统已成为安全评价不可或缺的组成部分,在药品、化学品、化妆品毒理学评价中起到重要作用。体外试验系统不同于体内动物实验,体外毒理学实验室GLP原则的建立和运行应充分考虑体外试验系统的特殊性。目前我国专业的体外安全评价实验室的建设刚刚起步,还没有可供借鉴的成熟经验。本文从实验室组织、试验系统维护、人员职责、质量管理和运行几个方面,介绍了GLP原则在化妆品体外毒理学检验和评价实验室的应用。     

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.     

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.     

An approach to the problem of false negatives in gynecologic cytologic screening

A system of quality control for gynecologic cytologic screening designed to minimize the problem of false-negative cytologic reports is proposed. The system involves the harvesting of "quality control" smears, at the time of colposcopic examination, from patients referred to colposcopy because of previous abnormal smears that had been interpreted as representing dysplasia or neoplasia. These quality control smears are then submitted to the cytology laboratory, indistinguishable from bona fide cases, among the routine smears. This appears to be a more effective means of quality control than the current standard system used in the United States, which involves cytology laboratories routinely rescreening 10% of the slides reported out as "negative".     

A comparison of diagnostic techniques for postpartum endometritis in dairy cattle

Holstein cows (n=221) from eight commercial dairy herds were examined for endometritis between 28 and 41 days postpartum using 5 diagnostic techniques: (1) vaginoscopy; (2) ultrasonographic assessment of uterine fluid volume; (3) ultrasonographic assessment of endometrial thickness; (4) endometrial cytology collected by cytobrush; and (5) endometrial cytology collected by uterine lavage. Concordance correlation was used to evaluate the reliability of cytobrush and lavage cytology. Cytobrush cytology was found to have the greatest intraobserver repeatability (cytobrush, rho(c)=0.85 versus lavage, rho(c)=0.76) and was chosen as the reference diagnostic test. Pregnancy data at 150 days postpartum was available for 189 cows. Survival analysis was used to determine the lowest percentage of polymorphonuclear cells associated with time to pregnancy. The sensitivity and specificity of the diagnostic techniques was determined using pregnancy status at 150 days and cytobrush cytology as the diagnostic standards. The risk of non-pregnancy at 150 days was 1.9 times higher in cows with more than 8% PMNs identified using cytobrush cytology than in cows with less than 8% PMNs (P=0.04). Twenty-one cows of 189 cows (11.1%) had >8% PMNs and were considered to be positive for endometritis. Cows with endometritis had a 17.9% lower first service conception rate (P=0.03) and a 24-day increase in median days open (P=0.04). The sensitivities of all five diagnostic tests relative to 150-day pregnancy status ranged from 7.1 to 14.3% and the specificities from 84.0 to 93.3%. Relative to cytobrush cytology, the respective sensitivity and specificity values are as follows: vaginoscopy (53.9%, 95.4%); lavage cytology (92.3%, 93.9%); ultrasonographic assessment of uterine fluid (30.8%, 92.8%); and ultrasonographic assessment of endometrial thickness (3.9%, 89.2%). Endometritis impaired reproductive performance. Cytobrush cytology was the most reliable method of diagnosing endometritis in cattle.     

Cervical cytology quality assurance in Washington State.

The objectives of this study were to establish a profile of cervical cytology laboratories in Washington State, identify quality assurance problems amenable to correction through education or legislation, and describe differences between large and small cytology laboratories. All 43 Washington laboratories that perform cervical cytology were surveyed by mail during 1989. Completed surveys were returned by 37 (86%) of the laboratories. Nearly half (43%) of the respondents reported processing less than 10,000 Papanicolaou smears annually. Only one-third (35%) of the respondents reported participating in relevant proficiency programs. A proportion of smaller cytology laboratories were compensating their cytotechnologists on the basis of the number of slides read and allowing Papanicolaou smears to be read outside the confines of the laboratory. The results of this study suggest that cytotechnologists in some larger Washington laboratories have been exceeding work load limits recommended by professional associations. Recent legislation includes regulations that address cervical cytology quality assurance. However, continued efforts will need to be made to encourage voluntary adoption of quality control measures not addressed by this legislation.     

Molecular genetic testing in the United States: comparison with international practice

OBJECTIVE: To compare data on the practices of molecular genetic testing (MGT) in laboratories in the United States with those in 18 other countries. METHODS: A Web-based survey of MGT laboratory directors (n = 827; response rate 63%) in 18 countries on three continents was carried out, and the response from U.S. laboratories compared to all others. Quality assurance and reporting indices were developed and calculated for each responding laboratory. RESULTS: A comparison of U.S. results with all other countries identified differences in laboratory setting, personnel qualifications, and the specific tests being offered, but similar rates of adherence to MGT quality standards and reporting practices were found. The survey also documented substantial transborder flow of specimens, most commonly due to the lack of availability of the test in the United States or because the test was available only through a research protocol, highlighting the need for common reporting and practice guidelines for the international MGT community. CONCLUSION: The findings presented here provide further support for the need to consider the application of the Organisation for Economic Cooperation and Development (OECD) Guidelines and the establishment of compatible accreditation programs or equivalent mechanisms across national borders to ensure the quality of laboratory services and the clinical usefulness of molecular genetic test reports for referred specimens.     

Health facility characteristics and their relationship to coverage of PMTCT of HIV services across four African countries: the PEARL study

Background

Health facility characteristics associated with effective prevention of mother-to-child transmission of HIV (PMTCT) coverage in sub-Saharan are poorly understood.

Methodology/Principal Findings

We conducted surveys in health facilities with active PMTCT services in Cameroon, Cote d''Ivoire, South Africa, and Zambia. Data was compiled via direct observation and exit interviews. We constructed composite scores to describe provision of PMTCT services across seven topical areas: antenatal quality, PMTCT quality, supplies available, patient satisfaction, patient understanding of medication, and infrastructure quality. Pearson correlations and Generalized Estimating Equations (GEE) to account for clustering of facilities within countries were used to evaluate the relationship between the composite scores, total time of visit and select individual variables with PMTCT coverage among women delivering.Between July 2008 and May 2009, we collected data from 32 facilities; 78% were managed by the government health system. An opt-out approach for HIV testing was used in 100% of facilities in Zambia, 63% in Cameroon, and none in Côte d''Ivoire or South Africa. Using Pearson correlations, PMTCT coverage (median of 55%, (IQR: 33–68) was correlated with PMTCT quality score (rho = 0.51; p = 0.003); infrastructure quality score (rho = 0.43; p = 0.017); time spent at clinic (rho = 0.47; p = 0.013); patient understanding of medications score (rho = 0.51; p = 0.006); and patient satisfaction quality score (rho = 0.38; p = 0.031). PMTCT coverage was marginally correlated with the antenatal quality score (rho = 0.304; p = 0.091). Using GEE adjustment for clustering, the, antenatal quality score became more strongly associated with PMTCT coverage (p<0.001) and the PMTCT quality score and patient understanding of medications remained marginally significant.

Conclusions/Results

We observed a positive relationship between an antenatal quality score and PMTCT coverage but did not identify a consistent set of variables that predicted PMTCT coverage.     

Ensuring quality in cervical screening programmes based on molecular human papillomavirus testing

The increased use of human papillomavirus testing within cervical screening programmes necessarily brings about changes to the laboratory services required to support them. A crucial element of such services is to demonstrate initial and ongoing quality of the test (and associated processes). In this review, we outline some of the quality considerations and challenges with an emphasis on the laboratory including assay and platform validation, internal quality control selection and strengths and weaknesses of external quality assurance schemes. The influence and role of key external entities, including regulatory agencies, guideline groups, programme commissioners and commercial providers, are also discussed.     

Distribution and Availability of Essential Tuberculosis Diagnostic Items in Amhara Region,Ethiopia

Adequate supplies of tuberculosis laboratory reagents and consumables are necessary for tuberculosis diagnosis and monitoring of treatment response. This study assessed the distribution and stock levels of laboratory commodities used in tuberculosis control in health centers of Amhara region, Ethiopia. A cross-sectional study was conducted in 82 health centers, among 801, providing sputum microscopy services. Stock levels were calculated, and distribution of reagents and consumables assessed. Thirty three (40.2%) health centers were under stocked for at least one of the key items for tuberculosis diagnosis at the time of visit. Fifteen (18.3%) health centers had no stocks of at least one of the key items (methylene blue (11%), carbol fuchsin (11%), acid alcohol (8.5%) and sputum cups (3.7%)). Of the 82 health centers, 77 (93.9%) did not fulfill the criteria for effective distribution of tuberculosis laboratory reagents and consumables. There were many health centers that had no or only low stocks of key tuberculosis laboratory reagents and consumables as a result of ineffective distribution system. It is necessary to strengthen supply chain management to ensure uninterrupted TB diagnostic service.