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.     

External quality assessment with reference to the certification/accreditation of medical laboratories

Since ISO 15189 (Medical Laboratories-Particular requirements for quality and competence) was published in February 2003, interest in the accreditation of medical laboratories has increased in Japan. Under such conditions, the JCCLS (Japanese Committee for Clinical Laboratory Standards) and the JAB (Japan Accreditation Board for Conformity Assessment) are promoting a project on an accreditation program for medical laboratories in Japan. The JAB is planning to start their pilot inspections from October, 2004. In this paper, an external quality assessment scheme in Japan on proficiency testing for the accreditation of clinical laboratories is described.     

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]     

Evaluation of clinical laboratories--assurance of their quality and competence

Since ISO 15189:2003 was published, the accreditation program of clinical laboratories based on ISO 15189 has been introduced in many countries, except for those in USA where all clinical laboratories must be required to follow the federal law, CLIA'88. It will certainly help the accredited clinical laboratories improve their quality and competence. In relation to the activity of JCTLM, reference measurement laboratories will be accredited, based on ISO 15195 which is now under its review and amendment by ISO/TC212/WG2. In Japan, JCCLS (Japanese Committee for Clinical Laboratory Standards) and JAB (Japan Accreditation Board for Conformity Assessment) cojointly started the accreditation program for clinical laboratories, based on ISO 15189:2003, and a total of 15 laboratories including university hospitals, community hospitals and independent clinical laboratories have been accredited up until the end of 2006.     

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.     

Quality control survey implemented by Japan Medical Association and standardization of external quality assessment in Japan]

International Final Draft on quality management of medical laboratory by International Organization for Standardization (ISO) will be published soon. According to this draft, the accreditation of the laboratories should be given by the third party on the basis of objective matter, and the external quality control survey results is thought to be the most important indices for the accreditation. Although variety of external quality control surveys are now implementing in Japan, most of those surveys are done only once a year. Therefore, we could not evaluate the laboratories performance by any of those survey results. If those quality control surveys are done with the standardized system, summative results from different survey could give us fair evaluation on each participating laboratories. Japan Medical Association (JMA) is now making final draft on standardized method for quality assessment system with the consensus between the JMA, Japanese Society of Laboratory Medicine (JSLM, former Japan Society of Clinical Pathology), Japanese Association of Laboratory Medical Technologists (JALMT) and Japan Registered Clinical Laboratories Association (JRCLA). When this quality assessment system actually starts, Japanese people may receive great benefit from the laboratory tests.     

Akkreditierung in der Pathologie

In the last ten years, almost 60 departments of surgical pathology were accredited in Germany according to DIN EN ISO/IEC 17020. Accreditation in pathology was accompanied by the adoption of a highly dynamic process, which requires staff to be more aware of quality and to introduce a quality-oriented system. The accreditation body in turn needed to consider all the duties, responsibilities and processes in surgical pathology and was supported in this regard by the Sector Committee of Pathology and Neuropathology of the DGA German Association for Accreditation. In this review we illustrate the various problems associated with accreditation in surgical pathology by answering eight questions that have arisen over many years of activity. These include the registration and appropriate presentation of the scope of accreditation, the terminology, as well as the extent and depth of documentation. A department of pathology applying for accreditation is required to document the entire step-wise process leading to a surgical pathological diagnosis.     

Ethical problems in utilization of specimens after laboratory examinations for clinical studies

Ethical Committee in Japanese Society of Laboratory Medicine published "Opinions of Japanese Society of Laboratory Medicine about utilization of specimens after laboratory examinations for laboratory work, education and clinical studies" in 2002. Ministry of Health, Labour and Welfare in Japan established "Ethical Guidelines for Clinical Studies" in 2003, and amended the document in 2008. According to the guidelines, Ethical Committee in Japanese Society of Laboratory Medicine revised the "Opinions of Japanese Society of Laboratory Medicine about utilization of specimens after laboratory examinations for laboratory work, education and clinical studies" in 2010. Ethical problems in utilization of specimens after laboratory examinations for clinical studies are discussed.     

Procedure for accurate evaluation of laboratory data and its international trends

From the work at ISO/TC212 (Clinical laboratory testing and in vitro diagnostic test systems), the international standards on medical laboratories--particular requirements for quality and competence and reference materials were issued. The accreditation of clinical laboratory was started using ISO 15189. Furthermore, on setting and usage of reference materials were constituted with compatibility global harmonization by newly organizing JCTLM (Joint Committee on Traceability in Laboratory Medicine). As the results, the work of the standardization based on reliability such as validation of reagent's kits and the measured values and uncertainty evaluation would be internationally advanced.     

What Is a Quality Management System,and Why Should a Microbiologist Adopt One?

The changing landscape of the clinical laboratory is necessitating that the field of clinical microbiology evolve beyond quality control and quality assurance and adopt a quality management system (QMS). QMS standards exceed those required to achieve Clinical Laboratory Improvement Amendments compliance or College of American Pathologists accreditation. Laboratories that adhere to the requirements for a QMS as described by the International Organization of Standards (ISO) ensure that quality is planned, documented, and continually sought. The Clinical and Laboratory Standards Institute (CLSI) has categorized the technical and management ISO standards into 12 quality system essentials that cover the total testing process in the laboratory. The CLSI quality system essentials serve as a checklist when implementing a new test or acquiring new equipment to prevent overlooking a critical step in the process. A laboratory QMS provides the evidence that the laboratory is a valued partner providing a quality outcome for patients and meeting the quality goals and objectives of the organization.     

ISO 15189 accreditation and future perspectives-Chairmen's introductory remarks

Recently, transparency of the organization administration and patient-centered medical care such as patient service and satisfaction have been demanded in the medical field. The role of the clinical laboratory, one of the organizations in the medical field, is to provide quality laboratory data to improve diagnosis and treatment. Other than clinical laboratory facilities, education and the ability of staff to use it, the management of the organization must be appropriate to produce high quality laboratory data. International guidance on how to manage a laboratory is shown in ISO 15189. Clinical laboratories with ISO accreditation in Europe, Australia and Asia are increasing. On the other hand, only 60 institutions (10 national university hospitals, 4 public private university hospitals, 12 private hospitals and 34 referral laboratories) are accredited in Japan. Six speakers spoke at this symposium about the accreditation system of ISO 15189, the experiences of the acquiring institution and the effect of acquisition, as well as the future prospects of ISO 15189. This was a good opportunity to become informed about the current situation of ISO 15189 in Japan and internationally.     

Requirements for accreditation by the College of American Pathologists Laboratory Accreditation Program.

The College of American Pathologists Laboratory Accreditation Program expects a participant laboratory or laboratory section to be able to demonstrate that it is in compliance with the Standards for Laboratory Accreditation. The program expects laboratories to demonstrate that they are continually taking steps to identify and correct deficient areas and improve performance, in compliance with the Clinical Laboratory Improvement Amendments of 1988 regulatory requirements, particularly those pertaining to proficiency testing performance, and participating as inspectors in the accreditation process.     

Laboratory accreditation and proficiency testing

ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.     

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.     

Achieving quality reproducible results and maintaining compliance in molecular diagnostic testing of human papillomavirus

Laboratories contemplating either the addition of new molecular tests or modifying methods approved by the Food and Drug Administration for human papillomavirus testing should be aware of a variety of procedural, performance, and regulatory issues surrounding such activity. Diagnostic medical laboratory testing in the United States is regulated by the Centers for Medicare and Medicaid Services, an agency formerly known as the Health Care Finance Administration. The regulatory vehicle of the Centers for Medicare and Medicaid Services is manifested in the Clinical Laboratory Improvement Amendments (CLIA). The CLIA program has put into place specific regulations for laboratory quality control, which includes specific recommendations for method validation. Regulations that must be followed regarding personnel, quality control, quality assurance, method validation, and proficiency testing depend on the complexity category of the individual test. All molecular diagnostic tests, including those for human papillomavirus, are considered high complexity. The Centers for Medicare and Medicaid Services retains the authority to allow private, national accreditation organizations to "deem" that a laboratory is compliant with CLIA '88 requirements. Accreditation organizations, such as the Joint Commission for Accreditation of Hospitals, the Commission on Office Laboratory Accreditation, and the College of American Pathologists (CAP), as well as several state medical laboratory-accrediting agencies, possess the authority to deem laboratories as "CLIA-approved." The CAP, through its Laboratory Accreditation Program, has promoted standards for laboratory performance and method validation. In general, guidelines set forth in the CAP Laboratory Accreditation Program checklists specify that all clinical laboratory testing must essentially meet those requirements defined for high-complexity testing under CLIA '88, including test validation standards, reportable/reference ranges, performance criteria, and proficiency testing.     

Akkreditierung in der Pathologie

Certification and accreditation describe two different procedures. Certification confirms the conformity of a product, process or service to specified requirements. It does not demonstrate technical or diagnostic competence. Accreditation, on the other hand, is the formal recognition by a third party that a department of anatomical pathology is competent to carry out all the steps involved in tissue processing that lead to the diagnosis formulated by the pathologist. This includes the technical and diagnostic competence to produce valid diagnoses. An accredited department of anatomical pathology does not require any additional certification. In the last few years 55 departments of anatomical pathology were accredited in Germany according to DIN EN ISO/IEC 17020 including private practices, as well as departments of community hospitals and universities. In these cases, more than 150 assessments were carried out. The expertise gained during these assessments is used in the formulation of a guidance document for the interpretation of the DIN EN ISO/IEC 17020 and was written by the Sector Committee of Pathology and Neuropathology of the DAP, which comprises members of the Berufsverband Deutscher Pathologen e. V. and the Deutsche Gesellschaft für Pathologie e. V.. These accreditations have initiated a process of standardization and harmonization in anatomical pathology, which prepares German pathologists for future challenges in patient management and individualized therapy, e.g. providing clinically relevant information through the use of predictive biomarkers.     

The ISO/IEC 11179 norm for metadata registries: Does it cover healthcare standards in empirical research?

In order to support empirical medical research concerning reuse and improvement of the expressiveness of study data and hence promote syntactic as well as semantic interoperability, services are required for the maintenance of data element collections. As part of the project for the implementation of a German metadata repository for empirical research we assessed the ability of ISO/IEC 11179 “Information technology – Metadata registries (MDR)” part 3 edition 3 Final Committee Draft “Registry metamodel and basic attributes” to represent healthcare standards. First step of the evaluation was a reformulation of ISO’s metamodel with the terms and structures of the different healthcare standards. In a second step, we imported instances of the healthcare standards into a prototypical database implementation representing ISO’s metamodel. Whereas the flat structure of disease registries as well as some controlled vocabularies could be easily mapped to the ISO’s metamodel, complex structures as used in reference models of electronic health records or classifications could be not exhaustively represented. A logical reconstruction of an application will be needed in order to represent them adequately. Moreover, the correct linkage between elements from ISO/IEC 11179 edition 3 and concepts of classifications remains unclear. We also observed some restrictions of ISO/IEC 11179 edition 3 concerning the representation of items of the Operational Data Model from the Clinical Data Interchange Standards Consortium, which might be outside the scope of a MDR. Thus, despite the obvious strength of the ISO/IEC 11179 edition 3 for metadata registries, some issues should be considered in its further development.     

CAP quality management system in clinical laboratory and its issue

The CAP (College of American Pathologists) was established in 1962 and, at present, CAP-accredited laboratories include about 6000 institutions all over the world, mainly in the U.S. The essential purpose of CAP accreditation is high quality reservation and improvement of clinical laboratory services for patient care, and is based on seven points, listed below. (1) Establishment of a laboratory management program and laboratory techniques to assure accuracy and improve overall quality of laboratory services. (2) Maintenance and improvement of accuracy objectively by centering on a CAP survey. (3) Thoroughness in safety and health administration. (4) Reservation of the performance of laboratory services by personnel and proficiency management. (5) Provision of appropriate information to physicians, and contribution to improved quality of patient care by close communication with physicians (improvement in patient care). (6) Reduction of running costs and personnel costs based on evidence by employing the above-mentioned criteria. (7) Reduction of laboratory error. In the future, accreditation and/or certification by organizations such as CAP, ISO, etc., may become a requirement for providing any clinical laboratory services in Japan. Taking the essence of the CAP and the characteristics of the new international standard, ISO151589, into consideration, it is important to choose the best suited accreditation and/or certification depending of the purpose of clinical laboratory.     

The clinical pathology for the twenty-first century

At first, the ideal way of the scientific convention should be reexamined. It is approved the future direction which should do the joint with the related societies. It has been decided that it is held at a partly congruence with Japan Society of Clinical Chemistry in the next fiscal year. The Corporation Promotion Committee(chairman of prof. I. Sakurabayashi) negotiates with the Ministry of Education about the incorporation. The Society Improved Committee(chairman of prof. K. Watanabe) is discussing about a retirement system and improved select system of the councilor. And, though the more than 400 persons of clinical laboratory physicians has been registered as a certified clinical laboratory physicians, it copes in the selection committee of each university does not always taking laboratory medical doctor as a professor of the department of clinical laboratory. And, it becomes the name of the Japan Society of Clinical Pathology does not suit at present state. The Appellation Revision Subcommittee(chairman of K. Nakahara) is discussing in the ideal name of the Society. The opinion of the most part of way will concern national medical insurance. The clinical laboratory tests related groups(Japan Society of Clinical Pathology, Japanese Association of Clinical Laboratory Physicians, Japan Society of Medical technologists, Japan Registered Clinical Laboratories Association, Japan Association of Clinical Reagents Industries, Japan Council of Clinical Reagents wholesales) formed the Council on Clinical Laboratory Tests-Related Organization at present, and the demanding paper was submitted to related associations, such as Ministry of Health and Welfare, Japan Medical Association and so on.     

What do the accreditation organizations expect? American Association of Blood Banks.

In 1958, the American Association of Blood Banks introduced the first edition of Standards for Blood Banks and Transfusion Services. That same year, the association implemented the Inspection and Accreditation Program. This program served the association well for 40 years; however, factors such as the application of Current Good Manufacturing Practices by the Food and Drug Administration, the implementation of the Clinical Laboratory Improvement Amendments of 1988 by the Health Care Financing Administration, managed care, competition, and increased cost pressures have changed the way the blood banking community conducts its business. In the early 1990s the board of directors recognized the need to reevaluate the Inspection and Accreditation Program and developed a strategic plan for implementation of a new accreditation program, with an emphasis on prevention rather than detection of errors. The first step in the process was the development of the Accreditation Program Committee. The committee was charged to develop and coordinate a program that would bring the accreditation process in tune with the current climate of blood banking and move it into the 21st century. The board charged the committee with the development of a program that recognizes the differences and similarities within the diverse groups of American Association of Blood Banks institutional members and to take into consideration how they do business and respond to regulations, standards, and other requirements.