What did audit achieve? Lessons from preliminary evaluation of a year's medical audit.

OBJECTIVE--To evaluate the experience of a year''s audit of care of medical inpatients. DESIGN--Audit of physicians by monthly review of two randomly selected sets of patients'' notes by 12 reviewers using a detailed questionnaire dedicated to standards of medical records and to clinical management. Data were entered into a database and summary statistics presented quarterly at audit meetings. Assessment by improvement in questionnaire scores and by interviewing physicians. SETTING--1 District general hospital. PARTICIPANTS--About 40 consultant physicians, senior registrars, and junior staff dealing with 140 inpatient records. MAIN OUTCOME MEASURES--Median scores (range 1 to 9) for each item in the questionnaire; two sets of notes were discussed monthly at "general" audit meetings and clinical management of selected common conditions at separate monthly meetings. RESULTS--A significant overall increase in median scores for questions on record keeping occurred after the start of the audit (p less than 0.01), but interobserver variation was high. The parallel audit meetings on clinical management proved to be more successful than the general audits in auditing medical care and were also considered to be more useful by junior staff. CONCLUSIONS AND ACTION--Medical audit apparently resulted in appreciable improvements in aspects of care such as clerking and record keeping. Analysis of the scores of the general audits has led to the introduction of agreed standards that can be objectively measured and are being used in a further audit, and from the results of the audits of clinical management have been developed explicit guidelines, which are being further developed for criterion based audit.     

以内部审核促进医院质量管理持续改进

目的 分析医院质量管理体系运行情况,促进医院质量管理持续改进。方法 通过内部审核,发现不合格项并对其进行统计分析,找出影响医院质量管理的主要问题,采取相应的改进措施。结果 2003—2008年医院共组织内部审核7次,发出不合格项118项,通过采取纠正措施和预防措施,并制定医院质量管理工作重点,不合格项目逐年减少。 结论 医院质量管理体系的运行符合ISO9001标准的要求,是适宜的、有效的。内部审核促进了医院质量管理持续改进。     

Abiotic Resource Depletion Different perceptions of the problem with mineral deposits

Goal, Scope and Background The goal of the present paper is to demonstrate how environmental product declarations (EPDs) are developed based on a set of product category rules (PCRs) in accordance with the requirements in the ISO 14025-standard. This is demonstrated by examples from the furniture industry in Norway, where several case models are evaluated. To ease the capability of developing EPDs in this industry, a database with specific environmental data for materials in furniture is developed. The database is used to produce the LCA for selected furniture models, and further, the database is the backbone of a data-assistance tool used to create the EPDs. Methods The LCA-data are produced based on traditional LCA-methodology. The PCR is based on a stakeholder analysis and the proposed methodology in the ISO 14025-standard. The EPDs developed so far, are results of close collaboration between companies and research centres in the Nordic countries. For the verification of the EPDs, auditing methodologies are used as a part of the audit of the companies' environmental management systems (EMS). Results and Conclusion Based on a hearing of a set of suggested PCRs, a consensus document for seating accommodation is developed. This is further the model for how to develop PCR-documents for all types of furniture, for example sleeping accommodations. Likewise, the database shall contain the most important data for the parts of a furniture model. Within the goal of the project period, EPDs will be developed for 80% of Norwegian furniture. The verification of the EPDs is done as a part of the certification procedures of EMS in accordance with the ISO 14001. Recommendation and Perspective The results presented in the paper are mainly for the pilot models in the project. However, the results will be further tested and the data-tool will be developed as a part of a product design tool where environmental requirements will be combined with quality requirements. The product design tool will be implemented in the furniture industry. Information on how to use EPDs in public purchasing will also be a part of future work.     

Improving Biological Dyes and Stains: Quality Testing Versus Standardization

This paper discusses the impact of both standardization and quality testing of dyes and stains in biology and medicine. After a brief review of why standardized dyes and stains are not presently available commercially, two types of testing and ways of improving dye quality are described. National or international organizations could be established to define standardization of dyes and stains. Standardization would be specifically defined as a list of physico-chemical parameters such as elaborated in this paper. Commercial batches of comparable quality may be labeled by the supplier as “standard dye.” a procedure currently performed by the European Council for Clinical and Laboratory Standardization (ECCLS). Also recommended to improve dye quality is commercial dye testing by independent laboratories with subsequent certification for use. This sort of quality control is currently carried out in the United States by the Biological Stain Commission (BSC). The advantages and disadvantages of both techniques and the use of image analysis for the definition of standards are discussed. A combination of both the BSC testing protocols and the ECCLS standards should be established for extended quality control of biological dyes and stains.     

Using life cycle thinking to analyze environmental labeling: the case of appearance wood products

Purpose

Growing public concern about the current state of our planet led to the creation of numerous regulations, standards, and certifications for the protection of humans and the environment. Ecolabels were defined for products such as cleaning products, paints, and many others. Wood building products are no exception. The objective of this study is to analyze the existing ecolabelling programs for appearance wood products in nonresidential applications and to evaluate them relatively to their effective role in environment protection or reduction of environment footprint.

Methods

The research was conducted on the most common International Organization for Standardization (ISO) type I ecolabels in North America, the European Union, and Japan. Certification schemes applicable to appearance wood products for nonresidential applications were considered. In a life cycle assessment perspective, certification criteria were compared regarding their ability to consider and integrate environment impacts.

Results and discussion

A wide range of ecolabels can apply to appearance wood products, from indoor air quality to wood from sustainable forest management. Moreover, it has been found that among all certification schemes studied, those integrating the whole life cycle were the most relevant.

Conclusions

The remaining limitation of ISO type I ecolabels is the lack of environmental information enabling the differentiation between products bearing the same ecolabel. This can be overcome by ISO type III environmental product declarations. Thus, allowing a better understanding of the implications related with the use of wood products compared to other materials in the nonresidential building sector.     

Evaluating the effectiveness of a process medical audit in a teaching general hospital.

Medical auditing has moved beyond the traditional chart review to the process audit, which identifies deficiencies in care and suggests remedies. In 1981 the audit committee of the Department of Psychiatry at Toronto General Hospital audited the use of hypnotic drugs in the inpatient unit. The audit produced two recommendations: that nursing staff record sleep graphs for inpatients more often, and that an educational program be instituted to change the physicians'' patterns of prescribing hypnotics. In 1983 the audit was repeated to test the effectiveness of the 1981 auditing process. The 1981 recommendation produced the desired improvement in recording of sleep graphs. However, the medical staff failed to change their patterns of prescribing hypnotics: oxazepam remained the preferred hypnotic. For the process audit to be effective in improving patient care those using it must ensure that the methods reflect the nature and structure of the professional group they are trying to influence.     

The role of SSDL in quality assurance in radiotherapy

This paper describes the role of the Polish Secondary Standard Dosimetry Laboratory (SSDL) in quality assurance in radiotherapy by means of providing calibration of ionisation chambers, TLD postal dosimetry audits and end-to-end audits for radiation therapy. A historical review of the methods and results are presented. The influence of the SSDL in Warsaw on radiation protection of patients in Poland is discussed. The International Atomic Energy Agency together with World Health Organisation (IAEA/WHO), through its network of SSDLs around the world, propagates newly developed methods for calibration and auditing. Suitable high quality equipment was provided by the IAEA, as well as special materials and technical support to the SSDL in Warsaw. The activity of the SSDL and the services provided for Polish radiotherapy centres have resulted in a reduction of discrepancies between planned doses and doses delivered to patients. The newly tested IAEA methods of end-to-end on-site dosimetry audits allow for monitoring and improving the quality of IMRT in Poland. The traceability of standards used for the calibration of therapy level dosimeters from Polish radiotherapy centres is assured by the IAEA dosimetry laboratory. The consistency of methods performed in the Polish SSDL with the ISO:17025 norm is supervised by the Polish Centre for Accreditation – a member of International Laboratory Accreditation Cooperation (ILAC), for calibration and testing. Due to the rapid technological development of radiotherapy, special attention has to be paid to newly developed methods for dosimetry auditing and institutions which provide services for assuring radiation safety of patients.     

微生物培养基质量控制技术和标准

微生物培养基的酸碱度、凝胶强度和选择性等直接影响到培养基的质量,在理化试验方法中采用连接可渗透陶器型液体接头的电极和平头电极或者连接微型探头的电极可分别测定液体和固体培养基的pH值,而采用Gelometer和the LFRA Texture Analyser可测定固体培养基的凝胶强度。在微生物学方法中固体培养基采用倾注平板法、涂布法、划线法（半定量法）、改良的Miles-Misra法等测定生长情况,液体培养基采用稀释法测定生长率,用目标菌和杂菌的混合菌株评价选择性增菌培养基的选择性,利用OD值评价液体培养基生长率等。ICFMH（国际食品微生物学和卫生学委员会培养基工作组）、ISO、FDA以及我国卫生部等相继制定了培养基质量控制的标准,但目前还没有一个系统的适合我国国情的培养基质量控制国家标准,以致各相关单位采用的标准不一致,所以制定培养基质量控制国家标准非常关键。     

Audit of 26 years of obstetrics in general practice.

To assess the feasibility and quality of general practitioner obstetrics an audit of 1223 consecutive obstetric deliveries over 26 years was carried out with standard clinical records. The perinatal mortality of 9.0 per 1000 births was significantly better than the national average of about 19.0 per 1000 for the overall period. During the audit home deliveries virtually stopped. The proportion of consultant bookings and deliveries more than doubled because of more stringent booking arrangements despite relocation of the previously isolated general practitioner unit to beneath the consultant unit. Abnormal deliveries also rose significantly. A "steady state" was achieved during the final 11 years in which 73% of women booked to be delivered by their general practitioner, 64% were admitted to the general practitioner unit, and 54% were delivered by their general practitioner. Though this is enough to sustain obstetric experience, the proportion might safely be increased.     

The implementation of tissue banking experiences for setting up a cGMP cell manufacturing facility

Cell manufacturing for clinical applications is a unique form of biologics manufacturing that relies on maintenance of stringent work practices designed to ensure product consistency and prevent contamination by microorganisms or by another patient's cells. More extensive, prolonged laboratory processes involve greater risk of complications and possibly adverse events for the recipient, and so the need for control is correspondingly greater. To minimize the associate risks of cell manufacturing adhering to international quality standards is critical. Current good tissue practice (cGTP) and current good manufacturing practice (cGMP) are examples of general standards that draw a baseline for cell manufacturing facilities. In recent years, stem cell researches have found great public interest in Iran and different cell therapy projects have been started in country. In this review we described the role of our tissue banking experiences in establishing a new cGMP cell manufacturing facility. The authors concluded that, tissue banks and tissue banking experts can broaden their roles from preparing tissue grafts to manufacturing cell and tissue engineered products for translational researches and phase I clinical trials. Also they can collaborate with cell processing laboratories to develop SOPs, implement quality management system, and design cGMP facilities.     

Quality assurance of computer systems what is needed to comply with ISO 9000, GMP,GLP, and GCP?

This paper will interpret the application of the different quality standards like Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and ISO 9000-3 guidelines to computer systems. The ISO 9000-3 contains requirements for developing software, whereas the GxPs have more detailed requirements for use. ISO 9000-3 can be used profitably as a tool for the GxPs. The standards often have vague demands which need to be interpreted. The wordings of the standards are compared to current interpreted requirements. Tables for comparison of the wording of the standards are also included.     

Breaking out of the biomed box: an audit assessment and recommendations for an in-house biomedical engineering program

In order to assess the current performance and to identify future growth opportunities of an in-house biomedical engineering (BME) program, senior management of Lehigh Valley Hospital (Allentown, Penn) engaged (in July 2001) the services of a clinical engineering consultant. Although the current in-house program was both functionally and financially sound, an independent audit had not been performed in over 4 years, and there were growing concerns by the BME staff related to the department's future leadership and long-term support from senior management. After an initial 2-month audit of the existing program, the consultant presented 41 separate recommendations for management's consideration. In order to refine and implement these recommendations, 5 separate committees were established to further evaluate a consolidated version of them, with the consultant acting as the facilitator for each group. Outcomes from each of the committees were used in the development of a formal business plan, which, upon full implementation, would not only strengthen and refine the current in-house service model but could also result in a substantial 3-year cost savings for the organization ($1,100,000 from existing operations, $500,000 in cost avoidance by in-sourcing postwarranty support of future capital equipment acquisitions). Another key outcome of the project was related to the development of a new master policy, titled the "Medical Equipment Management Program," complete with a newly defined state-of-the-art equipment scheduled inspection frequency model.     

食品卫生微生物学检验培养基质量分析

为探讨培养基ISO国际标准对国内培养基质控的等效性,选择国内外4家培养基生产厂家的霉菌培养基、酵母菌培养基和显色培养基,从质控菌株生长率、抑菌效果等方面进行质量分析比对试验.生长率质控标准菌株在各种霉菌培养基、酵母菌培养基上的生长率均值均大于0.5,在显色培养基上的生长率均值均大于0.7,符合ISO国际标准.经统计分析,试验的4家培养基厂家生产的培养基质量水平差异不显著(P＞0.05),这为将新出台的培养基国家标准拟等效采用培养基ISO国际标准提供了基础材料和依据.     

Assessing the impact of errors in sorting and identifying macroinvertebrate samples

This study assesses the impact of errors in sorting and identifying macroinvertebrate samples collected and analysed using different protocols (e.g. STAR-AQEM, RIVPACS). The study is based on the auditing scheme implemented in the EU-funded project STAR and presents the first attempt at analysing the audit data. Data from 10 participating countries are analysed with regard to the impact of sorting and identification errors. These differences are measured in the form of gains and losses at each level of audit for 120 samples. Based on gains and losses to the primary results, qualitative binary taxa lists were deducted for each level of audit for a subset of 72 data sets. Between these taxa lists the taxonomic similarity and the impact of differences on selected metrics common to stream assessment were analysed. The results of our study indicate that in all methods used, a considerable amount of sorting and identification error could be detected. This total impact is reflected in most functional metrics. In some metrics indicative of taxonomic richness, the total impact of differences is not directly reflected in differences in metric scores. The results stress the importance of implementing quality control mechanisms in macroinvertebrate assessment schemes. Peter Haase, Andrea Sundermann: These authors contributed equally to this work.     

The tissue bank at the Instituto Nacional de Investigaciones Nucleares: ISO 9001:2000 certification of its quality management system

Tissue banking is a complex operation concerned with the organisation and coordination of all the steps, that is, from donor selection up to storage and distribution of the final products for therapeutic, diagnostic, instruction and research purposes. An appropriate quality framework should be established in order to cover all the specific methodology as well as the general aspects of quality management, such as research and development, design, instruction and training, specific documentation, traceability, corrective action, client satisfaction, and the like. Such a framework can be obtained by developing a quality management system (QMS) in accordance with a suitable international standard: ISO 9001:2000. This paper presents the implementation process of the tissue bank QMS at the Instituto Nacional de Investigaciones Nucleares in Mexico. Objective: The objective of the paper is to share the experience gained by the tissue bank personnel [radiosterilised tissue bank (BTR)] at the Instituto Nacional de Investigaciones Nucleares (ININ, National Institute of Nuclear Research), during implementation of the ISO 9001:2000 certification process. At present, the quality management system (QMS) of ININ also complies with the Mexican standard NMX-CC-9001:2000. The scope of this QMS is Research, Development and Processing of Biological Tissues Sterilised by Gamma Radiation, among others.     

The New International Standards for Life Cycle Assessment: ISO 14040 and ISO 14044

Background, Aims and Scope The development of the international standards for life cycle assessment (ISO 14040:1997, ISO 14041:1999, ISO 14042:2000, ISO 14043:2000) was an important step to consolidate procedures and methods of LCA. Their contribution to the general acceptance of LCA by all stakeholders and by the international community was crucial. Currently, the process of the revision of this first generation of LCA standards is close to completion. The paper explains the outline as well as formal and technical changes of the coming new international standards of LCA, i.e. the new ISO 14040 and ISO 14044. Methods The paper refers to life cycle assessment based on the international standards for LCA (ISO 14040:1997, ISO 14041:1999, ISO 14042:2000, ISO 14043:2000). The content relates to the Final Draft International Standard (FDIS) versions of the new ISO 14040 and ISO 14044. Results and Discussion With the publication of the two new standards, ISO 14040 and ISO 14044, the existing four standards ISO 14040:1997, ISO 14041:1999, ISO 14042:2000 and ISO 14043:2000 are technically revised, cancelled and replaced. According to the scope of the revision, the core part of the technical contents remains unchanged. Improved readability and the removal of errors and inconsistencies was the focus of the revision. However, despite the fact that the main technical content was confirmed to be still valid, some relevant formal and technical changes were made. On the technical side these include e.g. the addition of principles for LCA, the addition of an annex about applications, the addition of several definitions (e.g. product, process, etc.), clarifications concerning LCA intended to be used in comparative assertions intended to be disclosed to the public, clarifications concerning the critical review panel, clarifications concerning system boundary, etc. On the formal side, changes include the reduced number of standards, a reduced number of annexes, a reduced number of pages that contain requirements, alignment of definitions and clarification of compliance with the standards. Conclusion The two new standards, ISO 14040 and ISO 14044, reconfirm the validity of the main technical content of the previous standards. Errors and inconsistencies were removed and the readability was improved. The added technical content is in line with the previous requirements and serves mainly as a clarification of the technical content. The unanimous vote on the Draft International Standard versions proved that this was achieved on the basis of the broadest possible international consensus. Recommendation and Outlook Currently the national member bodies undertake the final voting on the FDIS-versions of the standards. Based on the voting results at the previous stages of the documents, a positive result is expected. The publication of the new international standards for life cycle assessment (ISO 14040 and ISO 14044) is expected around mid-2006. For the sake of the international and stakeholder acceptance of LCA, it is recommended that the new standards serve as core reference documents for the users and practitioners of LCA.     

Ensuring seed quality in ecological restoration: native seed cleaning and testing

Seeds are a critical and limited resource for restoring biodiversity and ecological function to degraded and fragmented ecosystems. Cleaning and quality testing are two key steps in the native seed supply chain. Optimizing the practices used in these steps can ensure seed quality. Post‐collection handling of seeds can have a profound impact on their viability, longevity in storage, and establishment potential. The first section of this article describes seed cleaning, outlines key considerations, and details traditional and novel approaches. Despite the growth of the native seed industry and the need for seed quality standards, existing equipment and standards largely target agricultural, horticultural, and commercial forestry species. Native plant species typically have complex seed traits, making it difficult to directly transfer existing cleaning and quality standards to these species. Furthermore, in ecological restoration projects, where diversity is valued over uniformity crop standards can be unsuitable. We provide an overview and recommendations for seed quality testing (sampling, purity, viability, germinability, vigor), identity reporting, and seed transfer as well as highlight the need to implement internationally recognized standards for certification for native seeds. Novel and improved cleaning and testing methods are needed for native species from a range of ecosystems to meet the challenges and goals of the United Nations Decade on Ecosystem Restoration. The guidelines outlined in this article along with others in the Special Issue of Restoration Ecology “Standards for Native Seeds in Ecological Restoration” can serve as a foundation for this critical work.     

Démarche d’habilitation au poste de cytologie hématologique selon la norme NF EN ISO 15189

The aim of this work was to construct a capacitation process according to ISO EN NF 15189 standards for an haematological cytology position and to create the associated documents taking into account the evolution of this position with the gathering of the laboratories within the General Hospital of Troyes and the audit of the present practices of abilities evaluations. The method used to achieve this “quality assurance” project is the one of DEMING (Plan, Do, Check, Act). The first part of this work consisted in organizing an internal audit concerning the activities and the practices of training, abilities evaluation and the capacitation for the haematological cytology position. Four elements were enlightened: obsolete position card, lack of internal training plan, evaluation scale not conformed, lack of capacitation process. Among the corrective actions were created in a second time a new position card, a flowchart of the capacitation process and abilities management, an evaluation scale for the haematological cytology position and also a capacitation scale. As the goals of this work were reached, the next step, already in progress, is now to duplicate the process to all the other positions so that the whole abilities and capacitation management will be applied to the whole staff to be evaluated and accredited by the end of 2010.