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Quality Management System (quality + management_system)
Selected AbstractsCPA assessment , the regional assessors' experienceCYTOPATHOLOGY, Issue 2007E. Welsh Many individuals within Laboratory Medicine will be unaware that CPA conducts assessments to two different sets of CPA Standards. There are the Standards for the Medical Laboratory and the Standards for EQA Schemes in Laboratory Medicine. The style and format of both sets of standards is very similar with each being presented in eight sections A , H. The EQA standards are almost identical to the laboratory standards with the exception of the E.F and G standards which are specific to EQA schemes. There are approximately 40 EQA Schemes registered with CPA compared with almost 2 500 laboratories. These EQA schemes vary from very large national/international schemes with numerous analytes to small interpretive schemes run by one individual with a personal interest in that specific subject. The large schemes usually come under the UKNEQAS consortia banner and due to their size and configuration do not present undue problems in the assessment process. Smaller interpretive EQA schemes present a challenge both for the scheme and CPA in gaining accreditation. These schemes are usually within the discipline of Histopathology and are regarded as educational rather than proficiency testing schemes. Very frequently, the scheme is organized by a single individual with a collection of microscope slides, storage facilities for the slides and a computer. This presents the Scheme Organizer with great difficulty in complying with the Quality Management System requirements of the CPA Standards. There are a number of models which can be applied in order to satisfy the requirement of the Quality Management System, but ultimately it must be recognized that in some circumstances it is not possible to accredit these small schemes. The NHSCSP Gynae Cytology EQA Scheme is probably the largest EQA scheme within the UK, in respect of the number of participants and the number of staff supporting the scheme. Scheme Management decided that all nine regions of England would apply for accreditation under one CPA Reference Number. This process meant that the scheme would be assessed as a Managed Pathology Network. This is unique in terms of EQA schemes and presented a number of problems not previously encountered in EQA scheme accreditation. This decision meant that all nine regions must comply with a single Quality Management System and other CPA standards whilst allowing flexibility within the system for each region to facilitate the assessment process specific to their user's requirements. The process worked in a satisfactory manner and the overall outcome was not dissimilar to that of other large EQA schemes. The assessment to the current EQA Standards only commenced in April 2006 whilst the Standards for Medical Laboratories commenced in 2003, and it is perhaps not surprising to find that the principal non-conformities are related to the Quality Management System. This parallels the findings encountered in laboratory accreditation. There is an ongoing educational process for Scheme Management and the Facilitators in each region in how to comply fully with the standards and a commitment to quality improvement which ultimately is beneficial to the participant's of the scheme and to patient safety. [source] CPA assessment , the regional assessors' experienceCYTOPATHOLOGY, Issue 2007G. Guthrie With the introduction in January 2006 of the new posts of Regional Assessors, the process and focus of CPA assessment changed to reflect the inclusion in the current standards of Quality Management systems and processes. Regional Assessors, trained in Quality Management Systems and their assessment against international standards, now form a vital part of the CPA assessment teams, looking specifically at this aspect of laboratory service provision. Their role in the new assessment process will be explained. The presentation will cover differences and similarities in the nature and number of non-compliances experienced since April 2006 when the new format of assessment was introduced. It will also look at a new format of timetable for assessment visits and explain the benefits of good two-way communication between all parties involved in the process - the laboratory, the assessors, particularly the Regional Assessor assigned to that site, and CPA Office staff. Understanding what is required by the standards, particularly in terms of evidential material, their interpretation and their classification of status , Critical, Non-Critical or Observation - is an aspect of assessment which is often not well understood. The presentation will seek to clarify these issues. The successful and timely clearance by laboratories of any non-compliances raised during the visits is vital to the achievement of accredited status and the presentation will give guidance as to how this is best achieved. The current standards, based on the international ISO 15189 standards, are considerably more challenging than the old ones. There is now a significant emphasis on Quality Management and its understanding, ethos and implementation within the laboratory, a key element which underpins all aspects of a laboratory's service. The achievement of accredited status assures our users of,the type of client and patient focused service expected of a modern laboratory. [source] Entities and frequency of neonatal diabetes: data from the diabetes documentation and quality management system (DPV)DIABETIC MEDICINE, Issue 6 2010J. Grulich-Henn Diabet. Med. 27, 709,712 (2010) Abstract Aims, The aim of this study was to elucidate the entities and the frequency of neonatal diabetes mellitus (NDM) in a large representative database for paediatric diabetes patients in Germany and Austria. Methods, Based on the continuous diabetes data acquisition system for prospective surveillance (DPV), which includes 51 587 patients with onset of diabetes before the age of 18 years from 299 centres in Germany and Austria, we searched for patients with onset of diabetes mellitus in the first 6 months of life. Results, Ninety patients were identified, comprising 0.17% of all paediatric cases in the DPV registry. This represented an incidence of approximately one case in 89 000 live births in Germany. A monogenic basis for NDM was established in 30 subjects (seven UPD6, 10 KCNJ11, seven ABCC8, two FOXP3, two PDX1, one INS, one EIF2AK3). Pancreatic hypoplasia or agenesis was reported in 10 patients and seven subjects were classified as having Type 1 diabetes by their centres. Transient neonatal diabetes (TNDM) accounted for approximately 10% of all cases with NDM. No aetiology was defined in 41 subjects, which may reflect incomplete genetic testing or novel genetic aetiologies. Conclusion, Based on a large database, we identified a higher rate of NDM in Germany than has been reported previously. Full molecular genetic testing should be performed in all patients diagnosed before 6 months of age. [source] Food Defense in an Aquaculture SettingJOURNAL OF THE WORLD AQUACULTURE SOCIETY, Issue 2 2010Barbara Rasco Developing an overall food protection program for aquaculture and its related food processing operations includes biosecurity and good aquaculture practices for husbandry operations, and good manufacturing practices, food safety (sanitation standard operating procedures, and hazard analysis critical control point) programs for processing. Because of recent intentional contamination incidents of food and feed, developing and implementing a food defense as part of an overall food safety and quality management system have become more critical. Recent developments in food defense, suitable preventive measures, mitigation strategies, and model implementation plans for an aquaculture operation are presented here. [source] Establishing a standardized quality management system for the European Health Network GA2LEN,ALLERGY, Issue 6 2010L. Heinzerling To cite this article: Heinzerling L, Burbach G, van Cauwenberge P, Papageorgiou P, Carlsen K-H, Lødrup Carlsen KC, Zuberbier T. Establishing a standardized quality management system for the European Health Network GA2LEN. Allergy 2010; 65: 743,752. Abstract Background:, Quality management is increasingly important in clinical practice. The Global Allergy and Asthma European Network (GA2LEN) is a network of clinical and scientific excellence with originally 25 allergy centres in 16 European countries, a scientific society (European Academy of Allergology and Clinical Immunology), and a patient organization (European Federation of Allergy and Airways Diseases Patients' Associations). Although some allergy centres adhere to internal quality criteria, the implementation of a standardized quality management system for allergy centres across Europe was lacking. Objectives:, To implement standardized quality criteria among allergy centres organized within GA2LEN and thus ensure equal standards of diagnosis and care as well as to establish a culture of continuous quality improvement. Methods:, Quality criteria covering, e.g., diagnostic and therapeutic procedures, and emergency preparedness to assure patient safety were developed and agreed upon by all 25 participating centres. To assure implementation of quality criteria, centres were audited to check quality indicators and document deviations. A follow-up survey was used to assess the usefulness of the project. Results:, Deviations were documented mainly in the areas of emergency care/patient safety (27.3% lacked regular emergency training of doctors and nurses; 22.7% inadequate emergency intervention equipment; 22.7% lacked critical incidence reporting/root cause analyses) and handling of extracts/pharmaceuticals (31.8% lacked temperature logs of fridges; 4.5% inadequate check of expiration dates). Quality improvement was initiated as shown by findings of re-audits. Usefulness of the project was rated high. Conclusion:, The establishment of a quality management system with joint standards of care and harmonized procedures can be achieved in an international health network and ensures quality of care. [source] Process improvement evaluation approach using flow diagramsQUALITY ASSURANCE JOURNAL, Issue 3 2006Paul C. Constant Jr. Abstract Maintaining company processes will afford optimum operation and enhance the company's quality management system. A vital part of maintaining processes is their periodic evaluation. An important part of the monitoring and evaluation process is the flow diagram. A detailed flow diagram is an important tool that affords ease in visualizing the total process and is an aid in locating problem areas. The evaluation of a process is broken down into 15 steps. These steps cover gathering pertinent information, such as problem symptoms from knowledgeable sources and carrying these through their route to potential problem areas to the problems, potential causes, and the root cause of the problem. Knowing the problems brings about the need to assess their impact on the process operation as well as what changes to the process are needed and what impact these changes will have on the product , its improved quality and cost , and other vital information, such as, production rate increase, competition status, and company image. With this information, the appropriate changes are made according to a process change action plan. The plan is executed, and the process is continuously monitored according to a monitoring and evaluation plan. The paper ends with conclusions. Copyright © 2006 John Wiley & Sons, Ltd. [source] Practice Characteristics and HMO Enrollee Satisfaction with Specialty Care: An Analysis of Patients with Glaucoma and Diabetic RetinopathyHEALTH SERVICES RESEARCH, Issue 4 2003José J. Escarce Background. The specialist's role in caring for managed care patients is likely to grow. Thus, assessing the correlates of patient satisfaction with specialty care is essential. Objective. To examine the association between characteristics of eye care practices and satisfaction with eye care among working age patients with open-angle glaucoma (OAG) or diabetic retinopathy (DR). Subjects/Study Setting. A total of 913 working age patients with OAG or DR enrolled in six commercial managed care health plans. The patients were treated in 144 different eye care practices. Study Design. We used a patient survey to obtain information on patient characteristics and satisfaction with eye care, measured by scores on satisfaction subscales of the 18-item Patient Satisfaction Questionnaire. We used a survey of eye care practices to obtain information on practice characteristics, including provider specialties, practice organization, financial features, and utilization and quality management systems. We estimated logistic regression models to assess the association of patient and practice characteristics with high levels of patient satisfaction. Principal Findings. Treatment in a practice with a glaucoma specialist (for OAG patients) or a retina specialist (for DR patients) was associated with higher satisfaction, whereas treatment in a practice that obtained a high proportion of its revenues from capitation payments or in a group practice where providers obtained a high proportion of their incomes from bonuses was associated with lower satisfaction. Conclusions. Many eye care patients prefer to be treated by specialists with expertise in their conditions. Financial arrangement features of eye care practices also are associated with patient satisfaction with care. The most likely mechanisms underlying these associations are effects on provider behavior and satisfaction, which in turn influence patient satisfaction. Managed care plans and provider groups should aim to minimize the negative impact of managed care features on patient satisfaction. [source] European best practice in blood transfusion: improvement of quality-related processes in blood establishmentsISBT SCIENCE SERIES: THE INTERNATIONAL JOURNAL OF INTRACELLULAR TRANSPORT, Issue 1 2007Christian Seidl Transfusion medicine is an expanding field comprising the interaction between several medical disciplines. Looking at the ,vein to vein process' covering the donation of blood by the voluntary donor up to the application of blood components to patients, modern blood transfusion services comprise a large variety of sociomedical functions. The production of standard cellular blood components, such as erythrocyte and thrombocyte concentrates, plasmatic blood components as well as special cellular components such as blood stem cells, mesenchymal cells or granulocytes will require an extensive laboratory testing repertoire to monitor product quality and safety. The European blood legislation has defined several key quality elements to achieve good manufacturing practice in the field of blood transfusion. In addition, GMP/GLP and ISO standards are used inter alia by blood establishments. Following the call for proposal in the field of public health by the European Commission, a consortium of blood establishments from 16 European member, acceding and EFTA states has been established in order to survey the individual quality management systems used by the participants and to developed guidelines for quality systems. These guidelines are aimed at assisting blood establishments in preparing for government inspections as required by Directive 2002/98/EC. They could also be used to adapt existing procedures to comply with current EU requirements and/or to prepare for accreditation and certification of these institutions. Major benefits from those quality management systems are (1) the definition of an overall quality policy, (2) improved personnel responsibility, qualification and training, (3) error and risk assessment system, (4) continuous improvement, (5) improved resource management, (6) performance improvement. The definition of cost,benefit relation between certification and accreditation of blood establishments will depend on the individual institution itself and the amount of processes covered. With the release of the new EU Directive 2005/62/EC, there are currently EU requirements available that describe in detail relevant processes to be covered by quality system following good practice used in blood establishments. A future challenge for transfusion medicine would be optimizing the synergetic effects expressed by the EU directive, GMP and ISO standards. [source] Metrological sharp shooting for plasma proteins and peptides: The need for reference materials for accurate measurements in clinical proteomics and in vitro diagnostics to generate reliable resultsPROTEOMICS - CLINICAL APPLICATIONS, Issue 9 2007Frank Vitzthum Dr. Abstract Reliable study results are necessary for the assessment of discoveries, including those from proteomics. Reliable study results are also crucial to increase the likelihood of making a successful choice of biomarker candidates for verification and subsequent validation studies, a current bottleneck for the transition to in vitro diagnostic (IVD). In this respect, a major need for improvement in proteomics appears to be accuracy of measurements, including both trueness and precision of measurement. Standardization and total quality management systems (TQMS) help to provide accurate measurements and reliable results. Reference materials are an essential part of standardization and TQMS in IVD and are crucial to provide metrological correct measurements and for the overall quality assurance process. In this article we give an overview on how reference materials are defined, prepared and what role they play in standardization and TQMS to support the generation of reliable results. We discuss how proteomics can support the establishment of reference materials and biomarker tests for IVD applications, how current reference materials used in IVD may be beneficially applied in proteomics, and we provide considerations on the establishment of reference materials specific for proteomics. For clarity, we solely focus on reference materials related to serum and plasma. [source] | ||||||||||