Usefulness of EC4 essential criteria for quality systems of medical laboratories as guideline to the ISO 15189 and ISO 17025 documents. European Community Confederation of Clinical Chemistry (EC4) Working Group on Harmonisation of Quality Systems and Accreditation.

Many medical laboratories have made a start with the introduction of quality management systems. However, it is still not clear against which standards such systems should be measured. The existing ISO and CEN standards do not cover essential aspects of medical laboratories. The publication of the EC4 Essential Criteria has stimulated the development of the ISO/Draft International Standard 15189. This standard seems adequate for our type of laboratories. However, it is not easy to read. The EC4 Essential Criteria could well serve as a guide, covering additional aspects, e.g. on total quality management and budget management as required in the EFQM model, that are not (yet) included in the ISO standard. In the present article the EC4 Essential Criteria are cross-referenced with two new international ISO standards, ISO/FDIS 15189 and ISO/FDIS 17025, the latter being the successor of ISO guide 25 and EN 45000. Both new ISO documents are in compliance with the new ISO 9000:2000 standard.     

ISO 9000 quality standards: a model for blood banking?

The recent American Association of Blood Banks publications Quality Program and Quality Systems in the Blood Bank and Laboratory Environment, the FDA's draft guidelines, and recent changes in the GMP regulations all discuss the benefits of implementing quality systems in blood center and/or manufacturing operations. While the medical device GMPs in the United States have been rewritten to accommodate a quality system approach similar to ISO 9000, the Center for Biologics Evaluation and Research of the FDA is also beginning to make moves toward adopting "quality systems audits" as an inspection process rather than using the historical approach of record reviews. The approach is one of prevention of errors rather than detection after the fact (Tourault MA, oral communication, November 1994). The ISO 9000 series of standards is a quality system that has worldwide scope and can be applied in any industry or service. The use of such international standards in blood banking should raise the level of quality within an organization, among organizations on a regional level, within a country, and among nations on a worldwide basis. Whether an organization wishes to become registered to a voluntary standard or not, the use of such standards to become ISO 9000-compliant would be a move in the right direction and would be a positive sign to the regulatory authorities and the public that blood banking is making a visible effort to implement world-class quality systems in its operations. Implementation of quality system standards such as the ISO 9000 series will provide an organized approach for blood banks and blood bank testing operations. With the continued trend toward consolidation and mergers, resulting in larger operational units with more complexity, quality systems will become even more important as the industry moves into the future.(ABSTRACT TRUNCATED AT 250 WORDS)     

医院引用ISO9001:2000质量管理体系时建立护理文件的实践与探讨

目的:探讨医院引用ISO9001:2000质量管理体系时,如何建立护理质量管理文件,以及引用ISO9001:2000质量管理体系对护理质量管理质量的影响。方法:通过学习《ISO 9001:2000质量管理体系要求》,采用过程分析方法,分析护理服务流程,确定和建立护理质量管理文件。结果:通过对护理流程的全面分析,在吸取原来护理质量管理经验的基础上,更加全面、科学地建立了一套操作性、指导性强的护理质量管理文件,并在过程分析中发现和纠正了既往护理质量管理中的薄弱环节。结论:引用《ISO 9001:2000质量管理体系》有助于提高护理服务质量。     

护理质量管理体系问题诊断与改进框架探索

目的 将全面质量管理体系ISO9001标准与医院管理评价标准相结合,探索临床护理质量管理中问题的诊断与改进方法,建立科学、实用、适用于临床护理质量管理体系诊断与改进框架,为护理管理部门做出科学的改进决策提供依据.方法 对ISO9001标准与北京地区医院管理考核评价标准(护理部分)进行比较分析,采用特尔斐法对标准进行筛选和论证,将ISO9001标准和护理考核评价标准集合成框架,应用于临床护理质量管理与改进过程.结果 建立了护理质量管理体系诊断与改进框架,分析、诊断出护理质量管理中存在的主要问题及改进目标.结论 应用护理质量管理体系诊断与改进框架,能够科学判断护理质量管理改进重点,促进护理质量管理与医院管理发展方向保持一致.     

护理质量管理体系问题诊断与改进框架探索

目的 将全面质量管理体系ISO9001标准与医院管理评价标准相结合,探索临床护理质量管理中问题的诊断与改进方法,建立科学、实用、适用于临床护理质量管理体系诊断与改进框架,为护理管理部门做出科学的改进决策提供依据.方法 对ISO9001标准与北京地区医院管理考核评价标准(护理部分)进行比较分析,采用特尔斐法对标准进行筛选和论证,将ISO9001标准和护理考核评价标准集合成框架,应用于临床护理质量管理与改进过程.结果 建立了护理质量管理体系诊断与改进框架,分析、诊断出护理质量管理中存在的主要问题及改进目标.结论 应用护理质量管理体系诊断与改进框架,能够科学判断护理质量管理改进重点,促进护理质量管理与医院管理发展方向保持一致.     

护理质量管理体系问题诊断与改进框架探索

目的将全面质量管理体系ISO9001标准与医院管理评价标准相结合,探索临床护理质量管理中问题的诊断与改进方法,建立科学、实用、适用于临床护理质量管理体系诊断与改进框架,为护理管理部门做出科学的改进决策提供依据。方法对ISO9001标准与北京地区医院管理考核评价标准（护理部分）进行比较分析,采用特尔斐法对标准进行筛选和论证,将ISO9001标准和护理考核评价标准集合成框架,应用于临床护理质量管理与改进过程。结果建立了护理质量管理体系诊断与改进框架,分析、诊断出护理质量管理中存在的主要问题及改进目标。结论应用护理质量管理体系诊断与改进框架,能够科学判断护理质量管理改进重点,促进护理质量管理与医院管理发展方向保持一致。     

应用IS09000族标准进行神经内科护理记录单质量控制的研究

目的 通过应用IS09000族系列标准对神经内科护理记录单进行质量管理.方法 制定标准化神经内科护理记录单小组质量检查标准和护士长审核程序.通过自查、小组检查、护士长终审3个控制点保证书写质量.运用Likert4点评分法,比较管理前后各110份护理记录单.结果 两组有显著差异性(P＜0.01).结论 通过应用IS09000族标准规范了神经内科护理记录单的管理三级管理模式能有效控制质量点,全面提升护理记录质量.     

Certification standards transfer: from committee to laboratory

The ISO 9000 Standards series were developed to provide the international manufacturing industry with a framework to ensure purchased products meet quality criteria. Section 4 of ISO 9001, Quality System Model for Quality Assurance in Design, Development, Production, Installation and Servicing, contains 20 aspects of a quality system that must be addressed by an organization in order to receive ISO 9001 certification. This concept is extended to the clinical laboratory, where a quality system program establishes for the customer (patient/clinician) that the purchased product (requested information on a submitted specimen-test result) meets established quality norms. In order to satisfy the customer, the providing organization must have policies and procedures in place that ensure a quality product, and be certified. To become certified the organization must, through an inspection process, demonstrate to an independent accrediting agency that it meets defined standards. In the United States, the government through the Clinical Laboratory Improvement Amendment (CLIA) 1988 established quality standards for the clinical laboratory. The College of American Pathologists (CAP), through its Laboratory Accreditation Program (LAP), serves as an independent agency that certifies that laboratories meet standards. To demonstrate the applicability of an established clinical laboratory accreditation program to ISO 9001 certification, the standards and checklists of CLIA 1988 and the CAP LAP will be examined to determine their conformance to ISO 9001, Section 4.     

ISO and CEN documents on quality in medical laboratories.

The forthcoming international standard ISO 15189 "Quality management in the medical laboratory" is a document of great importance for the development of quality systems and accreditation for medical/clinical laboratories. For the first time, there will be an internationally recognized standard designed specifically for the accreditation of medical laboratories. The document takes into account the special requirements imposed by the medical environment and by the essential contribution of the medical laboratory service to patient care. It recognizes that medical laboratories must provide not only testing of patient samples, but also advisory, interpretative and educational services. A further document, still in draft form (ISO/DIS 15190), deals with safety management for medical laboratories. ISO 15189 (and probably 15190 also) are expected be adopted by CEN as a European Standard (EN).     

Environmental, health, and safety management systems and auditing programs: part I--The evolution.

Early auditing began as an effort to avoid fines or other action from governmental agencies, without being based on accepted standards. However, for EHS auditing to be accepted as credible in the business world, established standards were necessary. As companies expanded globally, the need for international EHS standards grew, international standards for quality management and environmental program management have now been universally accepted (ISO, 2002). Occupational health nurses increasingly are becoming involved in efforts to help their employers or clients develop management systems to handle EHS issues--whether ISO 9000 (or the automotive equivalent, QS-9000), ISO 14000, or other models are used as the basis for the management system. Many nurses are actively involved in ISO certification efforts. As an extension of those efforts, occupational health nurses are increasingly involved in EHS audits, whether audits are conducted by third parties, by company employees, or as part of a self audit. The next column in this series will focus on strategies to improve the management of occupational health programs so the programs will stand up to rigorous EHS audits.     

ISO 9000 case study: the role of the external consultant

BACKGROUND: Increasingly, blood centers worldwide are turning toward the ISO (International Organization for Standardization) 9000 Quality System Standards to meet regulatory demands of public authorities, competitive demands within their industry, and cost requirements from their customers. CASE REPORT: The South Texas Blood and Tissue Center is the first blood center in North America to achieve registration to the ISO 9002 Quality System Standards. The role of the external consultant in initiating the process and as a facilitator during the implementation process is examined. CONCLUSION: To ensure the long-term success and viability of any quality system, it is necessary for an organization to develop and implement its own program. External consultants can assist in many ways, but it is important that their role be a supporting one rather than one of direct implementation.     

Determination and application of desirable analytical performance goals: the ISO/TC 212 approach

Desirable analytical performance goals are needed to place clinical laboratories' quality management plan on a rational basis. While the most important basis of desirable analytical performance goals is medical needs, a well-established quality management plan must take into account economic and regulatory needs. There are many approaches that have been proposed for determining desirable analytical performance goals. The ISO/TC 212 approach for rationalizing the various approaches for determining desirable analytical performance goals, which is based on the ability to meet medical needs, is presented.     

Determination and application of desirable analytical performance goals: the ISO/TC 212 approach

Desirable analytical performance goals are needed to place clinical laboratories' quality management plan on a rational basis. While the most important basis of desirable analytical performance goals is medical needs, a well-established quality management plan must take into account economic and regulatory needs. There are many approaches that have been proposed for determining desirable analytical performance goals. The ISO/TC 212 approach for rationalizing the various approaches for determining desirable analytical performance goals, which is based on the ability to meet medical needs, is presented.     

Effect of current and forthcoming European legislation and standardization on the setting of quality specifications by laboratories

A network of national and international guidelines and directives developed in the last few decades by various bodies will lead to a new concept of total quality for medical laboratory services comprising legislative regulations on national and international levels, standardizations backed up by legislation and recommendations of professional societies. One example is the IVD Directive of the European Community. It will not only stimulate accreditation in the field of laboratory medicine, but also necessitate numerous standardization activities which are presently co-ordinated by the European Committee for Standardization (CEN). Another standardization example is the development of quality management systems, mainly by ISO. The ISO 9000 series has become the most successful family of standards world-wide. Meanwhile, specific standards for the needs of laboratories (ISO 17025), and in particular of medical laboratories (ISO 15189), are being worked out. A new trend to develop quality management systems towards total quality management systems can be observed including additional aspects such as economic and quality interests of society, customers and owners of laboratories. The goal of all activities is to create a network of confidence which provides some guarantee to the clients, i.e. the physicians and their patients, that they will receive a high-quality medical laboratory service.     

ISO9001《质量管理体系要求》在我院护理质量管理中的应用

目的规范护理单元管理,落实管理制度,提高护理服务质量。方法引入IS09001:2000《质量管理体系要求》,建立标准化、规范化的质量管理体系,采用过程方法、以病人为关注焦点、基于事实的决策方法和坚持持续改进等原则规范护理管理体系,建立质量管理体系文件框架,组织编写《质量手册》、《程序文件》、《作业指导书》,对全院护理人员进行培训,运用IS09001:2000《质量管理体系要求》进行护理质量管理。结果通过应用IS09001:2000护理质量管理体系,使管理目标化、质量考核标准化、质量控制科学化。结论IS09001:2000质量管理体系的建立,满足了老年医院的发展及老年病人的需求。     

体检中心导检人员的管理策略

目的探讨体检中心导检工作的质量管理方法。方法借鉴ISO9001质量管理标准,重新学习,获得职业认同;树立“以人为本,以受检者为中心”的服务理念,规范质量管理体系。结果体检中心的导检管理达到了科学化、规范化,提高了体检中心导检管理水平及工作效率,提高了体检者的满意率。结论建立一套科学的、完整的质量管理体系以适应医学模式转变和社会经济发展的需要,是导检工作的可靠保障。     

Tailor-made quality systems in healthcare

Summary
At present many healthcare organizations are being pressed by national governments or client groups to develop and implement quality systems. Unfortunately, not much is known about the development and implementation of these systems in healthcare organizations. There still are definition questions to be answered and it is not clear in which way a quality system can be outlined and which outline is most effective in a particular situation. In practice, many healthcare organizations adopt ideas from industrial quality management and develop ISO 9000 based quality systems, which are only useful in relatively stable situations. In this paper a typology of healthcare processes is developed on the basis of input and throughput characteristics, following the literature on professional quality systems and service systems. The typology is tested and illustrated by a few case studies. From this typology, on the basis of logic, suggestions have been deduced for tailor-made quality systems in a general hospital setting. The main point of these systems is an examination, treatment and nursing plan with a timescale. Control is executed on the basis of performance indicators for groups of patients.     

ISO 15189:2003--quality management, evaluation and continual improvement.

The requirements of ISO 15189:2003 are discussed in the context of a process- and outcome-based quality management model in which the user's needs are the central focus. The requirements of ISO 15189:2003 are examined in terms of organisation and a quality management system, stressing the importance of evidence, document control, and control of records and clinical material. Examples are provided from the areas of resource management, and pre-examination, examination and post-examination processes. In the final section the importance of evaluation and continual improvement is presented in relation to internal audit and external assessment, non-conformity, corrective and preventative action and management review.     

Factors affecting the turnaround time for manufacturing,testing, and release of cellular therapy products prepared at multiple sites in support of multicenter cardiovascular regenerative medicine protocols: a Cardiovascular Cell Therapy Research Network (CCTRN) study

BACKGROUND: Cellular therapy studies are often conducted at multiple clinical sites to accrue larger patient numbers. In many cases this necessitates use of localized good manufacturing practices facilities to supply the cells. To assure consistent quality, oversight by a quality assurance group is advisable. In this study we report the findings of such a group established as part of the Cardiovascular Cell Therapy Research Network (CCTRN) studies involving use of autologous bone marrow mononuclear cells (ABMMCs) to treat myocardial infarction and heart failure. STUDY DESIGN AND METHODS: Factors affecting cell manufacturing time were studied in 269 patients enrolled on three CCTRN protocols using automated cell processing system (Sepax, Biosafe SA)‐separated ABMMCs. The cells were prepared at five good manufacturing practices cell processing facilities and delivered to local treatment sites or more distant satellite centers. RESULTS: Although the Sepax procedure takes only 90 minutes, the total time for processing was approximately 7 hours. Contributing to this were incoming testing and device preparation, release testing, patient randomization, and product delivery. The mean out‐of‐body time (OBT), which was to be less than 12 hours, averaged 9 hours. A detailed analysis of practices at each center revealed a variety of factors that contributed to this OBT. CONCLUSION: We conclude that rapid cell enrichment procedures may give a false impression of the time actually required to prepare a cellular therapy product for release and administration. Institutional procedures also differ and can contribute to delays; however, in aggregate it is possible to achieve an overall manufacturing and testing time that is similar at multiple facilities.     

Report of a workshop on ensuring sustainable access to safe blood in developing countries: International Blood Safety Forum,March 24, 2017

On March 24, 2017, more than 90 experts in blood safety and international development from blood centers, industry, government, and international and nongovernmental organizations gathered in Arlington, Virginia, for the Third International Blood Safety Forum, cosponsored by America's Blood Centers and Global Healing. This report summarizes presentations and major conclusions. The meeting explored ways to increase access to affordable, safe blood for low‐ and lower‐middle‐income countries (LMICs) in an era when funding from the US President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund has been redirected from preventing the spread of human immunodeficiency virus (HIV) to diagnosing and treating the 25 million‐plus people living with HIV in LMICs. More effective management systems must be developed to improve cost recovery for blood. While blood systems become more sustainable, continued investment is required to keep them operating. The traditional model of large grants from bilateral and multilateral donors will need to be supplemented (or replaced) with public‐private partnerships and nongovernmental investment. A continued emphasis on quality is fundamental. Blood systems must build quality programs, based on accepted standards, including hospitals, clinics, and rural health care providers to ensure proper and safe use of blood. Proposals to resolve health care inequities between LMICs and high‐income countries (HICs) must include helping LMICs to define sustainable national policies and practices for blood availability and utilization to suit local contexts. The blood safety lexicon should be revised to include availability, accessibility, and affordability of safe blood and blood products as the goal of all blood safety initiatives.