ISO 15189 medical laboratory accreditation

This International Standard, based upon ISO/IEC 17025 and ISO 9001, provides requirements for competence and quality that are particular to medical laboratories. While this International Standard is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines will also find it useful and appropriate. In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this International Standard as the basis for their activities. The Japan Accreditation Board for Conformity Assessment (AB) and the Japanese Committee for Clinical Laboratory Standards (CCLS) are jointly developing the program of accreditation of medical laboratories. ISO 15189 requirements consist of two parts, one is management requirements and the other is technical requirements. The former includes the requirements of all parts of ISO 9001, moreover it includes the requirement of conformity assessment body, for example, impartiality and independence from any other party. The latter includes the requirements of laboratory competence (e.g. personnel, facility, instrument, and examination methods), moreover it requires that laboratories shall participate proficiency testing(s) and laboratories' examination results shall have traceability of measurements and implement uncertainty of measurement. Implementation of ISO 15189 will result in a significant improvement in medical laboratories management system and their technical competence. The accreditation of medical laboratory will improve medical laboratory service and be useful for patients.     

Current status of ISO 15189 accreditation system

The Japan Accreditation Board (JAB) mainly involves the ISO 15189 accreditation system with support from the Japanese Committee for Clinical Laboratory Standards (JCCLS). The currently available procedure to obtain accreditation is as below. Firstly, it is necessary for applicants to prepare ISO 15189 and related documents in each laboratory. Then a JAB assessor will conduct a preliminary assessment to check if the applicant is ready to be accredited. Subsequently, a team consisting of one to five JAB assessors and/or technical experts will conduct the initial assessment, usually for two days. Finally, the team will make a recommendation to the JAB Accreditation Committee for Medical Laboratory on its evaluation for accreditation. If the Accreditation Committee approves the recommendation of the assessment team, the applicant will be granted accreditation and issued with a certificate of accreditation. According to EU data in February 2011, about 1,300 medical laboratories obtained the ISO 15189 accreditation. The numbers of accredited laboratories are 482 in Germany, 276 in England, 209 in France, 100 in Czechoslovakia etc. Similarly, the data for the Asia-Pacific region in June 2011 showed that the numbers of accredited laboratories are 638 in Australia, 287 in India, 220 in Canada, 160 in Taiwan etc. Although 59 laboratories are accredited in Japan, the ISO 15189 accreditation is not so widespread compared with other countries. It is now expected that the government and/or related bodies will have sufficient understanding of this accreditation system to further its development in Japan. [Rinsho Byori 60: 653-659, 2012]     

Validation of the ISO 15189 trial assessment results of clinical laboratories--effects of accreditation and interpretation of ISO 15189

Japanese Committee for Clinical Laboratory Standards (JCCLS) and the Japan Accreditation Board for Conformity Assessment (JAB) have developed an accreditation program for clinical laboratories using ISO 15189 in Japan. On October 1, 2004, twelve clinical laboratories applied for trial accreditation assessment. Seven laboratories were selected, including a university hospital laboratory, two other hospital-based laboratories, three large private clinical laboratories and an other private clinical laboratory. JAB had given a one week-training course to the candidate technical assessors who were nominated from the Japanese Society of Laboratory Medicine (JSLM) and the Japanese Association of Medical Technologists (JAMT), and candidate system assessors who were nominated from JAB. Thirty-five members had successfully passed the examination. During the period from November 2004 to May 2005, five laboratories were visited for assessment by four to six assessors for two or three days. Final assessment reports were discussed by the program developing committee for the validation of the accreditation program. The conclusions were that the program did not have any critical problems, but the assessment visit would have been more efficient if JAB published an easily understandable guidance document on ISO 15189, and had some training courses for laboratories in Japan in order to understand ISO 15189 more deeply. In addition, JAB should develop a more simplified checklist, mainly describing the important requirements. JAB formally started the clinical laboratory accreditation scheme from August 1, 2005 and five laboratories were accredited by the newly started accreditation committee on August 31, 2005, and four laboratories were additionally accredited on November 28, 2005. The most difficult clauses in ISO 15189:2003 were 5.6.2 and 5.6.3 on uncertainty and traceability, and 5.7.1 on post-examination procedures. Some difficult clauses to understand in the International Standard were discussed.     

Effects of the ISO 15189 accreditation on Nagoya University Hospital

The Department of Clinical Laboratory, Nagoya University Hospital acquired ISO 15189 accreditation in November, 2009. The operation of our Quality Management System (QMS) was first surveyed in October, 2010. In this paper, we reported the activity for the preparation and operation of our QMS and the effects of ISO 15189 accreditation. We investigated the changes in the number and content on nonconformities, incident reports and complaints before and after accreditation as indicators to evaluate the effect of ISO 15189 accreditation. Post accreditation, the number of nonconformities and incident reports decreased, seeming to show an improvement of quality of the laboratory activity; however, the number of complaints increased. We identified the increase of complaints at the phlebotomy station. There had been some problems with blood sampling in the past, but it seemed that staff had a high level of concern regarding these problems at the phlebotomy station and took appropriate measures to resolve the complaints. We confirmed that the ISO 15189 accreditation was instrumental in the improvements of the safety and efficiency on laboratory works. However there was a problem that increase of overtime works to operate the QMS. We deal with development of a laboratory management system using IT recourses to solve the problem.     

Acquisition of accreditation ISO 15189 and view of the future--case of a private college

We received ISO 15189 accreditation (International Organization for Standardization 15189) in 2009. Several effects from the subjective points are shown below, 1. The reliability of the test results has improved. 2. Skill or knowledge level of staff has improved. 3. Internal recognition has improved. 4. Procedures to prevent accidents have been enforced. 5. Management system has improved. 6. Effective management tool for the manager. In addition to high costs for qualification and maintenance, extensive human resources are required to prepare documents. We need to make further efforts to aim at better cost-effectiveness.     

Outline of the revision of ISO 15189 and accreditation of medical laboratory for specified health checkup

GOAL which accredited medical laboratory aims at is to continue "offering useful laboratory's service for patient medicine and treatment or the health of the nation". The medical laboratory, administers a quality management system, is competent technically and offers laboratory's service to satisfy the needs of all patients and clinicians taking responsibility for the medical testing and treatment. International standard ISO 15189 is a tool to embody thought of its basic quality and scientific grounds about the test result, and it was published in 2003. A revision for one part was considered to be it, and it was published afterwards for ISO 15189: 2,007 in this April. On the other hand, Ministry of Health, Labour and Welfare announced that all insurance members from 40 years old to 74 years old must have a checkup by the specified health checkup that paid its attention to visceral fat type obesity from April, 2008. And, in a standard health checkup program, it is shown that it strengthens the quality assurance management of laboratory carrying out medical testing. ISO 15189 which prescribed quality and competence of medical laboratory is an excellent standard, and it is hoped that it can offer high quality medical testing data with using quality management system. Here, I explain both outline of revised ISO 15189 and accreditation of the medical laboratory for specified health checkup using with this standard.     

ISO15189在检验科管理中的应用研究

面对以患者、竞争、变化为特征的现代医院运行环境,对检验科的管理必须更科学、更严谨。本文列出了应用ISO15189对检验科进行管理需要做的主要工作及作者对应用ISO15189进行检验科管理的体会,分析了目前ISO15189应用普及存在的困难。     

Quality management system in the medical laboratory--ISO15189 and laboratory accreditation

Medical laboratory services are essential to patient care and therefore should meet the needs of all patients and clinical personnel responsible for human health care. Recently, ISO15189, the first quality management ISO system for medical laboratories, has attracted the attention of all medical laboratories. ISO 15189:2003, Medical laboratories--Particular requirements for quality and competence, provides a framework for the design and improvement of process-based quality management systems by medical laboratories. It is based on ISO17025:1999, General requirements for the competence of testing and calibration laboratories, but provides specific requirements for implementation in medical laboratories. This will help medical laboratories to comply with regulatory requirements, to meet the expectations of their clients and, most importantly, to improve and maintain their service to patients. ISO15189 will be an important template for assessing and recognizing the competence of medical laboratories in their technical capacity and the effective quality management of a professional service and its staff--with or without the aim of accreditation.     

Development of novel laboratory technology--Chairmen's introductory remarks

The theme of the 58th annual meeting is, "Mission and Challenge of Laboratory Medicine". This symposium is named, "Development of Novel Laboratory Technology" and is held under the joint sponsorship of the Japanese Society of Clinical Chemistry and the Japanese Electrophoresis Society. Both societies have superior skills at developing methodology and technology. The tools used in the lectures are a carbon nanotube sensor, immunochromatography, direct measurement using polyanions and detergents, epigenomic analysis and fluorescent two-dimensional electrophoresis. All of the lectures will be very helpful and interesting.     

ISO15189认可中IQ-200全自动尿液显微镜系统性能验证

目的 对IQ-200全自动尿液显微镜系统进行性能验证和评价.方法 在本院检验科ISO15189实验室认可中对IQ-200全自动尿液显微镜系统的携带污染率、批内精密度、批间精密度、可报告范围、生物参考区间进行验证,并进行仪器间比对.结果 IQ-200全自动尿液显微镜系统的携带污染率、批内精密度、批间精密度、可报告范围均在厂家要求的范围内,生物参考区间验证,仪器间比对结果符合要求.结论 IQ-200全自动尿液显微镜系统各项性能均符合仪器要求范围,可用于临床尿液有形成分的检测.     

Progress in assays for and new developments in autoimmune pathophysioirmen's introductory remarks

We examined the influence of a revision of health insurance in 2004 in Teikyo University Hospital in comparison with 2003. Out to the returns of most hematological tests, especially HbA1c and TK, being included in the treatment charges of outpatients, gross laboratory test sales decreased more than expected. Increased income from judgment charges and management charges could not make up for the deficit in test sales. Therefore, total laboratory test revenues decreased substantially. In 2006, the new revision of health insurance will worsen the revenues further. Hospital laboratory test departments should take appropriate and aggressive management steps in response to these revisions in health insurance.     

雅培CD3700测定白细胞线性范围的验证与ISO15189应用

目的验证雅培CD3700血细胞计数仪测定血液白细胞的线性范围。方法用浓缩白膜层制备高值白细胞标本,以生理盐水稀释成系列浓度标本,每个浓度测定2次,各浓度的测定顺序随机,对数据进行离群值检验、回归分析和随机误差分析。结果测定结果无离群值,经回归检验在(0～219)×109L-1范围内为一条通过0点的直线,直线的随机误差小于1/4CLIA’88允许误差范围(3.75%)。结论CD3700测定血液白细胞的线性范围与该型号仪器出厂标准一致。     

ISO15189认证中Sysmex UF-1000i尿沉渣分析仪的性能验证

目的 按IS015189要求,评价Sysmex UF-1000i尿沉渣分析仪的性能.方法 分别检测UF-1000i尿沉渣分析仪的精密度、准确度、携带污染率、线性范围并对生物参考区间进行验证.结果 UF-1000i的精密度、准确度、携带污染率、可报告范围均在厂家要求的范围内,并且生物参考区间验证结果符合要求.结论 Sysmex UF-1000i尿液沉渣分析仪各项性能均符合仪器要求范围,可用于临床尿液沉渣分析检测.     

Estimation of precision and inaccuracy for serum magnesium determination on the basis of interlaboratory comparison data Accreditation ISO 15189.

Serum Mg is an important biochemical parameter in the context of clinical medicine for monitoring patients and for helping to diagnose some pathologies. The clinical laboratories must offer analytical results of quality in all parameters determined, demonstrating this way the laboratory "skill competence". The aim of this study was to revalidate (ISO 15189 standard) some different colorimetric methods for Mg determination in serum used in clinical and/or biochemical laboratories in four hospitals in Spain, on the basis of results of interlaboratory comparison programmes: Bio-Rad EQAS and external quality control SEQC. Precision and inaccuracy were estimated by analysis of records of an external quality control programme for Mg. The precision and inaccuracy values obtained were both less than 10%, except in one hospital in which the precision was less than 15%. These values of precision and inaccuracy obtained may be considered highly satisfactory taking into account the validation requirement for these ones: less than 10%. These findings demonstrate the effectiveness of the new revalidation methodology for diagnostic methods in medicine, which does not require any disruption of the laboratory's routine activity and which can be used even if the method in question has not been validated previously. It is also suggested that the ideas and requirements of ISO 15189 should be followed by the research laboratories.