Recent activities of EC4 in the harmonization of clinical chemistry in the European Union.

This article describes the recent activities of the European Communities Confederation of Clinical Chemistry (EC4). Main goal of EC4 is harmonization of clinical chemistry in the European Union and Europe. EC4's actions connected to that are training and registration of professionals, and accreditation of laboratories. The 35000 professionals practising clinical chemistry in the EU have different backgrounds (medical, pharmaceutical, science-oriented, veterinary, or microbiological). Thus, for the harmonization of training of clinical chemists, EC4 has published a European Syllabus for Postgraduate Training, and instituted a European Union Register for Clinical Chemists. The Syllabus is an indication of the level of requirements in postgraduate training. The EC4 initiative to implement the European Register for Clinical Chemists is based on the 8 years vocational training necessary to obtain sufficient knowledge in clinical chemistry according to the European Syllabus. A guide to the EC4 Register has been published; registration leads to the title European Clinical Chemist (EurClinChem). The accreditation of laboratories must be based on a total quality management system. EC4 has described guidelines (essential criteria) which it judges appropriate for establishing the quality of medical laboratory service; it does not wish to fulfil the role of an accrediting body. Moreover, a working group has been set up to seek to harmonize the work of national accrediting bodies. Therefore, it is logical that EC4 monitors the activities of the different standardizing bodies that might influence the practice of clinical chemistry in the EU. Finally, some aspects concerning the future strategy of EC4 are brought forward.     

IVD industry role for quality and accreditation in medical laboratories.

Manufacturers of in vitro diagnostic (IVD) medical devices and laboratory management have become integral partners in building and improving the quality of laboratory services. There is an increasing awareness that quality is inherent in the design of any reagent or analytical system. In vitro diagnostic medical devices should provide patients, users and third parties with a high level of health protection. Therefore, both manufacturers and users must work in partnership for continual improvement. For manufacturers, standards such as ISO 9000 already exist to guide applications of quality practices. In the field of laboratory medicine, the availability of a specific, universal standard (ISO/DIS 15189) for quality management in medical laboratories will represent a great opportunity for harmonising medical laboratories at an international level. In addition, accreditation of medical laboratories according to the proposed ISO 15189 standard can help develop the relationships between laboratories, and the biological follow-up of travelling patients. Manufacturers are able to help laboratory management to reach a high level of quality, not only by providing high value products, but also on the basis of their own experience of ISO 9000 certification.     

Accreditation of medical laboratories in The Netherlands.

Among the medical laboratory professionals, a growing interest exists in the systematic application of quality assurance to their own practice, and consequently in The Netherlands, there is an increasing request for an official accreditation of the quality management system and the competence of the professionals through Coordinatie Commissie voor Kwaliteitsbewaking in Laboratoria in de gezondheidszorg (CCKLtest), the Dutch Accreditation Board for Medical Laboratories.This article gives an overview of the current situation in The Netherlands; regarding the standards, the rules for accreditation, the training and selection assessors and what meanwhile is achieved.Since 1994, 60 clinical laboratories have been recognized by CCKLtest and another 40 laboratories have requested accreditation and are waiting for the inspection in 2001. Thus, 25% of all clinical laboratories in The Netherlands will be inspected within the current year.     

Joint commission accreditation and quality measures in U.S. nursing homes

This study examines the association between accreditation and select measures of quality in U.S. nursing homes, both cross-sectionally and over time. Data analyzed in this research originated from a web-based search of The Joint Commission (TJC) accredited facilities and the Nursing Home Compare set of Quality Measures relating to physical restraint use, pain management, urinary catheter use, and pressure sores. Five-Star Nursing Home Quality Rating System information was also used to calculate overall quality measure and health inspection scores. Data were analyzed using negative binomial regression. Comparing quality in the year before accreditation with the 1st year after accreditation, all five Quality Measures and both Five-Star categories demonstrated improvement. In comparing quality after 8 years of accreditation, three of the Quality Measures examined continued to improve. There were no cases where accreditation was associated with decreased quality. These results indicate that TJC accredited nursing homes improve their quality immediately after accreditation but do not continue to improve in all areas over time.     

FESCC survey on accreditation and post-graduate training in clinical chemistry in European countries. Federation of European Societies of Clinical Chemistry.

Promotion of the professional growth and development of specialists in the field of clinical chemistry in European countries, and harmonisation of quality assessment and accreditation procedures are listed among the main goals and activities of Federation of European Societies of Clinical Chemistry (FESCC), according to its 1999-2000 strategic plan. The European countries that are members of the European Union are in the process of establishing the "European Register for Clinical Chemists", based on minimum standards of education, training and experience as defined by the European Communities Confederation of Clinical Chemists (EC4). Many other European countries would like to adapt their system of professional education to this model. Data on post-graduate training in EC4 FESCC members have already been gathered in 1998. However, at the present time, there is no detailed knowledge of pre- and post-graduate professional education of specialists in clinical chemistry in the non-EC4 European countries. FESCC launched a survey in July 1998 in order to gather this information with the hope to start a database about existing systems. All FESCC members received the same questionnaire on accreditation (seven questions) and non-EC4 FESCC members received an additional questionnaire with 11 questions related to post-graduate training in clinical chemistry. The response rate of the 35 FESCC member countries was 93% from the 15 EC4 members (14 responses/15 countries) and 80% from the 20-non-EC4 (16 responses/20 countries). The heterogeneity of the data on post-graduate training in clinical chemistry indicates that a great effort will be needed before harmonisation is reached. These results, however, will provide an interesting basis for further discussion and promotion of post-graduate training in clinical chemistry. The data provided on accreditation show that the total number of accredited laboratories was relatively low in EC4 countries and even lower in non-EC4 members. It was not surprising to see that the number of accredited laboratories was the highest in the two countries which started accreditation the earliest (i.e. Sweden and UK, 1992). This situation, however, is changing at a fast rate in most countries and the number of the accredited sites is expected to increase rapidly in the next few years.     

Standards for the medical laboratory--harmonization and subsidiarity.

An International Standard, ISO 15189, specifically for 'Quality management in the medical laboratory' for use by accrediting 'bodies that recognize the competence of medical laboratories,' is expected to be published shortly. The origins, content and limitations of the new standard are discussed and the diversity of current arrangements for accreditation is reviewed. A new International Standard is an important step towards harmonization of laboratory practice but an accreditation system is more than its standards and a harmonized approach to the treatment of noncompliances found at inspection is important. Experience gained in writing national standards can improve the approach to the drafting and improvement of International Standards. Recognition of the principle of subsidiarity aids rather than hinders progress to harmonization and empowers the 'fourth element' (the laboratories to be accredited) to be a part of the accreditation process.     

Laboratory quality regulations and accreditation standards in Canada

ObjectivesTo review the current status of laboratory quality regulations and accreditation standards in Canada.Design and methodsThe review is written based on information collected by survey questionnaires, a comprehensive review of available websites, and personal communications.ResultsAccreditation of medical laboratories in Canada is regulated by provincial health authorities. Out of the ten provinces of Canada, five have provincial accreditation bodies, while in the other five provinces, medical laboratories are accredited by Canadian Counsel on Health Service Accreditation (CCHSA). Each of these accreditation bodies has developed their own standards, implementing the International Organization for Standardization (ISO) documents to variable extent. Canadian Coalition for Quality in Laboratory Medicine (CCQLM) has recently been incorporated to provide a national structure for harmonizing quality management in medical laboratories across Canada.ConclusionsAlthough provincially regulated, implementation of ISO in accreditation standards and coalition of accreditation bodies have been promoting the harmonization of quality regulations in Canada.     

Accreditation of medical laboratories in the European Union.

BACKGROUND: Using a questionnaire, the EC4 (European Communities Confederation of Clinical Chemistry and Laboratory Medicine) has collated an inventory of the accreditation procedures for medical laboratories in the EU. RESULTS AND DISCUSSION: Accreditation of medical laboratories in the countries of the EU is mostly carried out in cooperation with national accreditation bodies. These national accreditation bodies work together in a regional cooperation, the European Cooperation for Accreditation (EA). Professionals are trained to become assessors and play a prominent role in the accreditation process. The extent of the training is diverse, but assessors are kept informed and up-to-date by annual meetings. The frequency of assessments and surveillance visits differs from country to country and ranges from 1 to 4 years. More harmonisation is needed in this respect, based on a frequency that can be pragmatically handled by laboratory professionals. In the majority of EA bodies, accreditation is carried out on a test-by-test basis. Many professionals would prefer accreditation of the entire service provided within the actual field of testing (i.e., haematology, immunology, etc.), with accreditation granted if the majority of tests offered within a service field fulfil the requirements of the ISO 15189 standard. The scope of accreditation is a major point of discussions between the EC4 Working Group on Accreditation and representatives of accreditation bodies in the EA Medical Laboratory Committee.     

Laboratory accreditation and inspection

Clinical laboratories perform diagnostic testing in a highly regulated environment in which federal, state, and private accreditation agencies monitor the quality of testing processes. These agencies vary in the focus and stringency of their requirements, and differences exist among states. Continued accreditation requires regular inspection to assure quality of test results for physicians, insurers, and, ultimately, the patients being tested. Preparation for inspection requires understanding of the unique accreditation requirements for each institution, establishment of quality assurance and quality improvement oversight, and communication of each staff member's role in delivering quality test results for patient care.     

The development of national guidelines for pain control: synopsis and commentary

This synopsis outlines factors that prompted development of national clinical practice guidelines for the management of pain and presents the essential content of major pain control guidelines. Also described is the concurrent growth of the evidence-based pain management movement worldwide in the decade since initial US federal guidelines on acute and cancer pain were developed, and products of this global movement. The latter include systematic reviews and meta-analyses about treatments for pain, their assemblage in resources such as the Cochrane Collaboration, and (in the US) the embedding of pain assessment and management within quality assurance requirements for hospital accreditation. This survey will highlight recent research that evidence-based guidelines alone are insufficient to overcome established attitudes, practices and myths that hinder pain assessment and management. Hypotheses for the inadequacy of scientific evidence per se to overcome clinicians' attitudes and practices will be advanced, along with suggestions as to how those in the ‘pain treatment community’ may help to tip the balance.     

The regulation of medical laboratories in Australia

Australia has had a system of compulsory accreditation and inspection of medical laboratories since 1986. This article details the regulations that have evolved over the years and the specific requirements of this system. The importance of separation of powers of various authorities, including standards, accreditation, payment, inspection, quality assurance, and education, is emphasized.     

Best practice using Excellence in Practice Accreditation Scheme

This article describes how the University of Teesside School of Health and Social Care practice development team, in partnership with local professional colleagues and organizations, have addressed the issue of providing continuous quality evidence-based practice within the context of clinical governance. The newly devised Excellence in Practice Accreditation Scheme (EPAS) measures the standard of practice for a given health and social care setting by providing objective data indicating the level of clinical excellence obtained for the team or organization. The EPAS differs from other organizational accreditation schemes by facilitating excellence based upon a comprehensive set of measurable core standards: working in organizations, collaborative working, user-focused care, continuous quality improvements, performance management, and measuring efficiency and effectiveness. The standards are derived from a professional peer review of best practices. The uniqueness of EPAS is in consolidating the various organizational standards to elicit the core themes related to best practice where individuals, teams and organizations can be benchmarked and accredited for a level of excellence.     

Measuring against clinical standards

Systematic improvement of health services requires the objective measurement of people, practices and organisations against valid and explicit standards in order to identify and implement appropriate change. Effective quality systems must embrace a wide range of definitions of quality, and a similar variety of approaches to defining, measuring and improving. Clinical performance may be examined from three professional viewpoints--clinical competence: assessment of individual practitioners against explicit criteria to recognise achievement and to promote continuing development. Traditional mechanisms of training, registration and accreditation enable clinicians to reach career grades but responsibility for subsequent support is often unclear between employers, professions and registering bodies. Clinical practice: assessment of actual clinical process and outcomes against research-based "best practice" to identify and reduce variation. Peer review, clinical audit and confidential enquiries are examples of this approach, which may involve single or multiple professional groups and their interface with management. Service accreditation: systems to assess health care organisations against published standards in order to encourage best management practice. These are usually run on a regional or national basis and, though sensitive to expectations of patients, managers, clinicians, paying agencies and government, they are usually managed by an impartial but authoritative organisation.     

European Communities Confederation of Clinical Chemistry Working Group on Accreditation: past, present and future.

During the past 10 years, many activities have taken place in the field of quality systems and accreditation in medical laboratories.Each country in Europe has a slightly different approach. The Working Group on Accreditation of the European Communities Confederation of Clinical Chemistry (EC4) tries to support harmonisation of these efforts. For this purpose, they edited the Essential Criteria for quality systems of medical laboratories and supported the forthcoming International ISO standard "Quality management for the medical laboratory". At this moment, a Model Quality Manual is nearly ready for publication. The next items are setting up criteria for auditing the quality system and criteria for the accreditation process.     

Quality regulations and accreditation standards for clinical chemistry in Turkey

ObjectiveThe purpose of this paper is to review the current status of laboratory quality regulations and accreditation standards in Turkey.Design and methodThis paper is written based on the current regulations, information collected by available websites and congress proceedings, and personal communications.ResultsA total of 14 private and one public laboratory have been accredited according to ISO 15189 voluntarily. The total number of the JCI accredited hospitals is 24. One hospital has been accredited by HQS. A few medical laboratories have been accredited according to ISO 17025, whereas a lot of them have ISO 9001 certification from Turkish Accreditation Agency, TURKAK. There are no comprehensive laboratory standards and/or regulations to maintain a mandatory minimum quality of laboratories. External QC is not mandatory and there is no national proficiency testing program. It is a requirement to get a license to open a laboratory. There are residency programs for clinical chemistry and clinical microbiology. The Association of Clinical Biochemists, KBUD, is the youngest society in the field of clinical chemistry and is a leader in quality and accreditation activities. KBUDEK is an external QC program of KBUD. KBUD has organized four national and an international symposiums on quality and accreditation in addition to annual congresses and courses.ConclusionThe new standard and regulation should be designed and applied to all laboratories to increase the quality of laboratory service in Turkey. It will be useful if the ISO 15189 standard can be incorporated into the national standards and regulations.     

问卷调查和6西格玛质量管理方法在血常规检验质量改进中的应用

目的通过问卷调查和6西格玛(σ)质量管理方法进行血常规检验质量的持续改进,切实提高单位实验室检验水平,确保检验质量。方法采用问卷调查的方法,对参与项目研究的11家单位进行体系文件化、质量指标等实验室质量管理现状调查。针对第1次调查中存在的问题进行针对性的培训、并及时对整改效果进行验证。时隔2年再次对上述单位进行问卷调查,并对2次问卷的结果进行比较分析,包括允许总误差、变异系数(CV)、偏差(Bias)、σ、质量目标指数(QGI)。结果通过该项目的推进使参与单位逐步完善了质量体系文件;规范了参与单位的血常规性能验证;使用3个浓度质量控制品的实验室由2016年的54.55%(6/11),上升至2018年的100.00%(11/11);11家医院分析性能的σ值优秀率(σ≥4)由2016年的77.04%,上升至2018年的88.00%,增长率为14.23%;参加国家卫生健康委临床检验中心质评比例由2016年的90.90%上升至2018年的100.00%;参加本省(市)临床检验中心质评由2016年的81.82%上升至2018年的90.91%;相关院内质量培训次数由2016的162次增加到2018年的322次,增长了98.77%。结论通过问卷调查结合σ质量管理方法开展血常规检验质量改进活动,可提高参与单位实验室检测水平,使血常规质量指标满足临床需求。     

追踪方法学在迎接等级医院评审模拟自查中的应用与体会

在迎接等级医院评审中,进行了自评自查、督查整改、模拟评审等准备工作。成立了护理检查组,检查组人员首先接受了追踪方法学的理论和实践培训,然后根据卫生部评审标准制订了护理评审内容及评审方法,利用现场查看、人员访谈、患者追踪、系统追踪等进行了模拟评审,取得了满意效果。     

护理部在巩固等级医院评审成果中的做法与体会

目的巩固等级医院评审成果,促进护理质量持续改进。方法护理部依据评审新标准完善了护理管理体系,建立常态化长效运行机制,运用追踪法、PDCA循环体系等新理念、新方法,实施科学的护理质量管理。结果护理质量和患者满意度提高(P<0.01);护理不良事件发生率降低(P<0.01)。结论巩固等级医院评审成果是促进护理工作全面建设和科学发展的重要举措。     

National Committee on Quality Assurance health-plan accreditation: predictors,correlates of performance,and market impact

CONTEXT: Accreditation of health care organizations has traditionally been considered a building block of quality assurance. However, the differences between accredited and nonaccredited health plans and the impact of accreditation on plan enrollment are not well understood. OBJECTIVES: To determine the characteristics of plans that have submitted to accreditation review, the performance of accredited plans on quality indicators and the impact of accreditation on enrollment. DESIGN: The databases containing 1996 data on health plans' National Committee on Quality Assurance (NCQA) accreditation status, organizational characteristics, Health Plan Employer Data and Information Set (HEDIS) scores, and patient-reported quality and satisfaction scores were linked to compare accredited health plans to nonaccredited plans. We also combined longitudinal data sets (1993-1998) on accreditation and health plan enrollment. MAIN OUTCOME MEASURES: Mean performance of accredited and nonaccredited plans on HEDIS measures and patient-reported measures of quality; health plan enrollment changes. RESULTS: Accredited plans have higher HEDIS scores but similar or lower performance on patient-reported measures of health plan quality and satisfaction. Furthermore, a substantial number of the plans in the bottom decile of quality performance were accredited suggesting that accreditation does not ensure high quality care. Receipt of accreditation has been associated with increased enrollment in the early years of the accreditation program; however, plans denied NCQA accreditation do not appear to suffer enrollment losses. CONCLUSION: NCQA accreditation is positively associated with some measures of quality but does not assure a minimal level of performance. Efforts now underway to incorporate plan performance on HEDIS into criteria for accreditation seem warranted.     

医院评审评价提升护理科学化管理故能的实践

以评审评价的理念转变工作模式,提高临床护理科学化管理效能。借助全院支持系统统筹规范临床工作,利用信息技术支持护理决策,运用管理工具改善管理方法,采取多部门联动解决实际难题。科学化管理促进了护理管理水平及护理质量的提升,形成了常态化管理机制。医院评审评价使护理管理更加规范化,促进了护理质量持续改进,体现了团队协作精神。