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.     

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.     

ISO 15189 Accreditation: Requirements for quality and competence of medical laboratories,experience of a laboratory I

AimMedical laboratories are the key partners in patient safety. Laboratory results influence 70% of medical diagnoses. Quality of laboratory service is the major factor which directly affects the quality of health care. The clinical laboratory as a whole has to provide the best patient care promoting excellence.MethodsInternational Standard ISO 15189, based upon ISO 17025 and ISO 9001 standards, provides requirements for competence and quality of medical laboratories. Accredited medical laboratories enhance credibility and competency of their testing services. Our group of laboratories, one of the leading institutions in the area, had previous experience with ISO 9001 and ISO 17025 Accreditation at non-medical sections. We started to prepared for ISO 15189 Accreditation at the beginning of 2006 and were certified in March, 2007. We spent more than a year to prepare for accreditation.ResultsAccreditation scopes of our laboratory were as follows: clinical chemistry, hematology, immunology, allergology, microbiology, parasitology, molecular biology of infection serology and transfusion medicine. The total number of accredited tests is 531. We participate in five different PT programs. Inter Laboratory Comparison (ILC) protocols are performed with reputable laboratories. 82 different PT Program modules, 277 cycles per year for 451 tests and 72 ILC program organizations for remaining tests have been performed. Our laboratory also organizes a PT program for flow cytometry. 22 laboratories participate in this program, 2 cycles per year. Our laboratory has had its own custom made WEB based LIS system since 2001. We serve more than 500 customers on a real time basis. Our quality management system is also documented and processed electronically, Document Management System (DMS), via our intranet.ConclusionPreparatory phase for accreditation, data management, external quality control programs, personnel related issues before, during and after accreditation process are presented. Every laboratory has to concentrate on patient safety issues related to laboratory testing and should perform quality improvement projects.     

Clinical laboratory accreditation in India

Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.     

ISO 15189 accreditation: Requirements for quality and competence of medical laboratories,experience of a laboratory II

ObjectivesOur laboratory was accredited for 531 tests according to ISO 15189 standard (ISO 15189:2003 Medical laboratories - Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories) in 2007. An ambitious and young group of laboratory personnel has spent efforts with commitment and dedication to complete the heavy work of preparation and passed through assessment with success. We herewith share our experience of the accreditation, the stages we have been through; our solutions to obstacles which we came across during the process.Design and methodsOur approaches to topics of environmental conditions, document management system (CentroDMS), use of the laboratory information system (CentroLIS), corrective/preventive actions and measurement uncertainty are summarized in this article.ResultsExperience of our laboratory in different areas of ISO 15189 accreditation is presented in summary.ConclusionAccreditation of medical laboratories increases the quality of the results, motivates the laboratory personnel and is beneficial for all interested bodies. Continous improvement and dedicated people are the key elements for continuation of the quality assurance in an accredited medical laboratory.     

Joint Commission on International Accreditation workshop: Planning,development and provision of laboratory services

Throughout the world, the oversight of health care quality is accomplished through professionally based accrediting bodies and state regulatory agencies. These organizations set standards or define regulations that address important organizational functions. The Joint Commission, a private sector United States-based non-profit organization, is the forerunner and best known among healthcare accreditation groups. One of the functions assessed by the standards of the JCI Clinical Laboratory Accreditation Program is the planning, development and provision of laboratory services. The standards related to this issue adress the necessary processes that should be in place prior to performing patient testing.     

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.     

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.     

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.     

Accreditation of medical laboratories. Some reflections from the Nordic Horizon.

Accreditation has been a successful approach to improved quality management in laboratories and applied to a wide variety of medical laboratories. After the initial enthusiastic phase, in which quality improvement is significant, the endurance is threatened by an increasing bureaucracy of the process. A productive balance between the accreditation bodies and the profession needs to be sought. New standards have been suggested by ISO and the profession needs to take the initiative to assure that a global standard specially adopted to the requirements of medical laboratories becomes recognised and used. The new concept of uncertainty may become an important tool to further improve and describe the performance of laboratories by allowing inclusion of pre- and post-analytical sources of uncertainty as well as bias.     

The laboratory is a key partner in assuring patient safety

Medical errors have a great impact on patient outcomes. They can cause serious injury to patients or even result in their deaths. However, morbidity and mortality can sometimes be prevented by the timely and effective action of health care workers. Several IOM Reports have focused on the problem of errors in the United States health care system and identified gaps that need to be addressed. As part of the overall health care system, clinical laboratories are vulnerable to medical errors. Because of significant efforts on the part of both the laboratories and the manufacturers of laboratory equipment and reagents, the errors in the analytic phase of the total testing process now represent the smallest portion of testing errors. Currently, laboratory testing errors occur most frequently in the preanalytic phase. The primary reason for the high prevalence of preanalytic errors is that, at the present time, it is difficult to monitor all preanalytic variables and to implement necessary improvement processes, particularly when some of the variables (like phlebotomy) are not under the control of the laboratory. Considerable efforts have been made by laboratory professionals and other stakeholders to decrease testing errors. Minimal quality requirements have been set through regulations for both laboratory testing and the manufacture of medical equipment and reagents. At the same time, nonregulatory approaches have greatly affected the quality of laboratory testing. These include laboratory standards, various quality improvement programs, voluntary reporting of adverse events, and, in the near future, the National Report on the Quality of Laboratory Services. The introduction of successful approaches from other industries, such as Six Sigma and Lean, also will help reduce the rate of laboratory errors. The clinical laboratory has done more than most other sectors of health care to decrease the occurrence of medical errors, making it a key partner inpatient safety.     

临床微生物实验室与ISO15189 医学实验室认可标准常见不符合条款分析及持续改进措施

目的　回顾总结临床微生物实验室2011~2019 年在ISO15189 医学实验室认可实施过程中发现的不符合条款, 促进质量体系的持续改进。方法　参照《CNAS-CL02:2012 医学实验室质量和能力认可准则》和《CNAS-CL02-A005 医 学实验室质量和能力认可准则在临床微生物学检验领域的应用说明》,总结微生物实验室近十年发现的不符合条款及 采取的纠正、预防措施。结果　在不符合条款构成比中,第一位是CNAS-CL02:2012 条款5.3 设备、试剂和耗材,占 47.37%;第二位是CNAS-CL02-A005 条款5.6 检验结果质量保证,占15.79%;第三位是CNAS-CL02-A005 条款5.5 检 验过程。结论　不断地总结分析不符合条款,持续改进,有利于提高实验室检验质量,保证ISO15189 质量体系的良好 运转,更好地服务于临床。     

Quality management in the medical laboratory: a comparison of draft standards

Clinical laboratories used to rely almost completely on functional tests to monitor and assess their performance. This is known as internal quality control (IQC). A supporting approach is the interlaboratory comparison. In many countries and other disciplines this is known as proficiency testing, whereas, in Europe, the procedure is better known as external quality assessment taken care of by different schemes (EQAS). Probably all laboratories participate in some kind of EQAS and in some countries it is mandatory. It has gradually become apparent that functional tests are not sufficient to achieve, assure and develop quality in medical laboratories. Therefore other means must be sought. The principles laid down in the ISO 9000 series and the total quality concept has become interesting; in particular, accreditation. Accreditation of laboratories has been available for many years and in fact is routine in some specialities e.g. food, water laboratories and in some countries also for laboratories in the veterinary field. The present paper describes some features of the available and planned ISO standards that deal with accreditation of laboratories and particularly those adopted for the medical laboratories.     

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.     

External Quality Assessment Schemes: need for recognised requirements.

Programs for Accreditation of clinical laboratories consider participation in External Quality Assessment Schemes (EQAS) a key element in the evaluation of testing procedures and improving them. One of the main functions of EQAS is to assess whether laboratories perform tests competently. It is therefore of utmost importance for laboratories to participate in EQAS that are in line with formally recognised requirements. Specific proposals have been made on how to design and execute EQAS by International Working Groups, but there seems to be no consensus on the best strategies to use and quality specifications to set out. The Clinical Pathology Accreditation (CPA) Program for EQA Scheme Accreditation (CPA-EQA) is the only program in Europe to provide a formal recognition of the quality of EQAS activities. The present paper reports on the experience of the Centre of Biomedical Research which is following an accreditation process for their own schemes in line with the CPA-EQA program and a proposal to set requirements that Italian schemes must follow to be recognised as valid and effective.     

Role of a quality management system in improving patient safety — Laboratory aspects

ObjectivesThe aim of this study is to describe how implementation of a quality management system (QMS) based on ISO 15189 enhances patient safety.Design and methodsA literature review showed that several European hospitals implemented a QMS based on ISO 9001 and assessed the impact on patient safety. An Internet search showed that problems affecting patient safety have occurred in a number of laboratories across Canada. The requirements of a QMS based on ISO 15189 are outlined, and the impact of the implementation of each requirement on patient safety is summarized. The Quality Management Program – Laboratory Services in Ontario is briefly described, and the experience of Ontario laboratories with Ontario Laboratory Accreditation, based on ISO 15189, is outlined.ResultsSeveral hospitals that implemented ISO 9001 reported either a positive impact or no impact on patient safety. Patient safety problems in Canadian laboratories are described. Implementation of each requirement of the QMS can be seen to have a positive effect on patient safety. Average laboratory conformance on Ontario Laboratory Accreditation is very high, and laboratories must address and resolve any nonconformities. Other standards, practices, and quality requirements may also contribute to patient safety.ConclusionImplementation of a QMS based on ISO 15189 provides a solid foundation for quality in the laboratory and enhances patient safety. It helps to prevent patient safety issues; when such issues do occur, effective processes are in place for investigation and resolution. Patient safety problems in Canadian laboratories might have been prevented had effective QMSs been in place. Ontario Laboratory Accreditation has had a positive impact on quality in Ontario laboratories.     

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.     

医学实验室认可在临床微生物学检验领域的实践

临床微生物学检验作为医学实验室的认可领域之一,其认可在我国目前主要根据CNAS-CL02：2008《医学实验室质量和能力认可准则》和CNAS-GL23：2008《医学实验室质量和能力认可准则在临床微生物学检验领域的指南》来进行的。本文根据临床微生物检验领域医学实验室认可不同阶段,针对学习认可文件、编写标准化作业指导书、现场评审、分析前质量控制、建立危急结果回报制度、持续改进质量和管理体系以及存在的问题等进行论述与讨论,以促进我国临床微生物检验领域医学实验室认可的发展与进步。     

Contributions of the professional, public, and private sectors in promoting patient safety

Patient safety has become a national priority. This article discusses the contributions of the professional, public, and private sectors regarding patient safety. Definitions and detailed examination of the issues surrounding patient safety are presented. Ideas to create improved systems for the important issue of patient safety are explored. The opportunity for increased interaction among the various groups has great potential. Health care organizations that exemplify best practices in patient safety will be rewarded by the purchasers of health care and by accreditation agencies. The Leapfrog Group and the Joint Commission on Accreditation of Health Care Organizations are leading this effort. Nursing has a major role in leading efforts to find solutions to advance patient safety standards.