Daria Pašalić
Department of Medical Chemistry, Biochemistry and Clinical Chemistry
Zagreb University School of Medicine
Šalata ul 2.
10 000 Zagreb, Croatia
Phone +385 (1) 4590 205; +385 (1) 4566 940
E-mail: dariapasalic [at] gmail [dot] com

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Galjanić S1, Franić Z2.S03-1: Laboratory accreditation process and role of the lead assessor. Biochemia Medica 2009;19(Suppl 1):S32.
1Croatian Accreditation Agency, Zagreb, Croatia
2Institute for medical research and occupational health, Zagreb, Croatia
Corresponding author: slobodan [dot] galjanic [at] akreditacija [dot] hr
The short description of the Croatian accreditation system is presented, as well as the organization of Croatian Accreditation Agency (HAA) and its role as the part of the national quality infrastructure, which besides HAA, consists of the Croatian Standards Institute (HZN) and the State Office for Metrology (DZM).
The results of HAA activities are presented.
The process of accreditation according to the requirements of HRN EN ISO 15189 is described in details.
The main groups of activities within the accreditation process are identified and discussed (application, selection and appointment of assessors, assessment, decision on accreditation, surveillance).
The role of the lead assessor, her/his duties and responsibilities during the assessment procedure were described (document review, preparation for assessment, organization and coordination of on-site assessment, formulation of nonconformities, preparation of final report, proposal for the scope of accreditation, check of corrective actions performed, etc.).
Zima T. S03-2: Quality management system and accreditation – goals, indicators and improvements. Biochemia Medica 2009;19(Suppl 1):S32-S34.
Institute Clinical Biochemistry and Laboratory Diagnostics, First Faculty of Medicine, Charles University, Prague, Czech Republic
Corresponding author: zimatom [at] cesnet [dot] cz
At the beginning of the 21st century there are defined priorities in laboratory medicine such as laboratory automation, robotics, informatics, laboratory consolidation, molecular diagnostics, imaging analysis, POCT, and accreditation of laboratories aiming to improve the quality of patient care. Quality in the health care is the level of excelence of the health care provided in relation to the current level of knowledge and technical development.
The main indicators of health care quality are the health of the population, equal opportunities in access to health care, effective provision of services, the efficiency and accessibility of the system and also the results of the health care provided. Lifestyle, genetic and environmental factors have a much higher influence on the health of the population than health care itself.
Laboratory medicine is backbone in the medical treatment, diagnostics or prevention. Laboratory diagnostics has influence on 70-80% of hospital health care decisions and cost between 3-5% of total health care costs.
Laboratory attempts to improve quality aim to reduce diagnostic errors and decrease turn around time with traceability of all laboratory procedures and to assure the safety of patients and staff alike; they concentrate on “tailor-made” or personalised medicine, striving for the highest possible quality service. Basic requirements and criteria for laboratories from client’s perspective are availability, comprehensiveness, fast response, reliability and accuracy, information and consultation and analysis of complaints and claims.
First systems or level of QMS in labs are internal and external quality control and educational activities.
Concerning quality, the strategic plans of IFCC and EFCC include focusing of accreditation of labs based on ISO standards and cooperation with European Accreditation and national accreditation bodies. IFCC recognises that ISO 15189:2007 - Medical laboratories – Particular requirements for quality and competence, encompasses all the assessment criteria specified in the policy statement and as such should form the basis for the accreditation of laboratories. Accreditation is done in several countries by independent National Accreditation Bodies. For each medical field, mentioned in the scope, it is expected that the laboratory provides a full service, which includes all pre-examination, examination and post-examination aspects that are essential to provide an effective and efficient laboratory service to the patients. Within this, it is expected that a medical laboratory is able to demonstrate its competence in interpreting the results of the examinations performed.
There are also different systems in EU countries based on national quality systems which have the basement in ISO 15189.
The negations of accreditation are investments to equipment, facilities, expences with accreditation, time consuming process. The benefits are standardization of all processes, responsibility of each member of team, personal policy, demostrability of results, systematic evaluation of suppliers, better communication with partners.
Laboratory services will be the centre of attention regarding quality due to their wide ranging impact on the care for patients. Accreditation is not about who is the best, but who have system of standard procedures. Quality system is about people, with people and for people.
Maglić L.S03-3: Internal audit. Biochemia Medica 2009;19(Suppl 1):S34-S35.
Mechanical engineering faculty, Slavonski Brod, Croatia
Corresponding author: lmaglic [at] brod [dot] sfsb [dot] hr
Quality is very important factor in life of many people in industrial societies. To ensure product of quality or service, organization apply quality management systems. In order to simplify implementing of quality management systems, standards have been introduced to describe requirements of quality management systems. Audits are used to check level of fulfilment of requirements which are described by relevant standard.
Generally, audit is systematic, independent and documented process by which level of fulfilment of defined requirements is evaluated. Requirements are defined by audit criteria. Audit criteria is group of regulations, procedures and requirements used as reference. Most often case is performing audit related to requirements of standard ISO 9001, but audits are performed for other standards and regulations such as ISO 14001, ISO 22000, HACCP. Organization and performing of audit process is mostly the same, non-related to standard against which audit is performed, but there are some differences related to requirements of relevant standard and regulation. This paper deals with performing of internal audits, particularly related to requirements of standard ISO 15189.
Croatian standard HRN EN ISO 15189, medical laboratories - requirements for quality and competence, is based on standards HRN EN ISO/IEC 17025 and HRN EN ISO 9001. Accreditation of medical laboratories is performed related to requirements of HRN EN ISO 15189. During implementation of HRN EN ISO 15189 some difficulties were noticed at process of internal audit.
Internal audit is audit performed by organization on their management system. Standard HRN EN ISO 15189 define internal audit as requirement 4.14 Internal independent assessment. In this paper phases of internal audit, audit techniques, requirements for internal auditors and documentation used during internal audit process, are described. Process of creating high level and low level check lists is described. Non-conformities noticed at internal audit are explained. At practical examples, documenting and monitoring of corrective actions process is explained. Internal audit report for laboratory management is described, too.
Internal audit is one of the most important requirements of any management system. Objective of this work is to achieve easier performing of internal audits in organizations that implement requirements of standard HRN EN ISO 15189.
Flegar-Meštrić Z1, Juretić D2.S03-4:Assuring quality of examination procedures – interlaboratory comparisons. Biochemia Medica 2009;19(Suppl 1):S35-S36.
1Institute of Clinical Chemistry, Merkur University Hospital, Zagreb, Croatia
2Croatian Society of Medical Biochemists, Zagreb, Croatia
Corresponding author: zlata [dot] mestric [at] zg [dot] t-com [dot] hr
According to requests of standard HRN EN ISO 15189:2006 Medical laboratory - Special requests for quality and qualification, a laboratory must have procedures for monitoring quality of results and examinations, what can be accomplished by participating in quality examination schemes (proficiency testing, PT; external quality assurance, EQA), interlaboratory comparisons (ILC) or in some other way (reference materials usage, repeating examination by the same or some other method).
The role of PT/EQA/ILC schemes in quality improvement of medical laboratories is important because the result analysis of participating laboratories assures an independent and objective evaluation for an individual laboratory, evaluation of reproducibility of applied analytical methods on a large number of participating laboratories, comparison of different analytical methods through certain period of time and on different geographical areas and continuous surveillance of current state on the field of laboratory equipment, applied technology and recommended analytical methods.
Each laboratory should choose a PT/EQA/ILC scheme to take part in. It can be defined by the law or dependent on expert recommendations. It is important to define criteria for choosing a PT/EQA/ILC scheme and those must include data about control material traceability, control samples must be as similar as possible to patients’ samples, number of participating laboratories, number of surveys, review of obtained results, educational value and availability.
Laboratories must monitor PT/EQA/ILC scheme results and analyze whether there is trend of changes that warns about possible imprecision or bias increase attributive to some concentration levels. This way, possible trends of changes can be revealed what is impossible to see from individual results. Therefore, evaluation of PT/EQA/ILC scheme results is considered a continuous mechanism of quality improvement which should eliminate that potential nonconformities have negative impact on patient’s results.
Every laboratory will occasionally obtain unacceptable PT/EQA/ILC results. They can arise from inadequate sample handling or analytical mistakes. Laboratory must have s written sequence of activities which must be performed and which must include analysis of potential impact on patient’s results, thorough analysis of occurred nonconformity, initiating a corrective action, surveillance implementation to evaluate this corrective action. According to published literature there are about 19-24% of unacceptable results where detailed examinations could not explain what exactly brought to that unacceptable result within a PT/EQA/ILC scheme.
Laboratory is responsible for the PT/EQA/ILC scheme choice, handling with PT/EQA/ILC samples in the same way as with patient’s samples and analysis of unacceptable results which includes: examination of possible impact on patient’s results, initiating of corrective actions, PT/EQA/ILC results monitoring in order to determine trends of change or bias, storing documentation about schemes and all examinations for unacceptable results.
According to the guidelines of Croatian Accreditation Agency (HAA) for interlaboratory examination implementation and other laboratory comparisons the recommended minimum period for participation of accredited laboratories in concordance with EA and ILAC documentation is once for each individual discipline included in accreditation area, within the validity period of the Accreditation certificate (5 years). Laboratory must have documented procedures for result analysis between laboratory programs and for implementation of adequate corrective and/or preventive actions. It is laboratory’s duty to inform the HAA in written on participation in PT/EQA/ILC schemes and achieved results.
Participation in PT/EQA/ILC schemes contributes to continuous quality improvement of laboratories because through monitoring of the current state of the profession new standards are recommended, their implementation is monitored, making of new guidelines is encouraged and constant education of laboratory staff is implemented.
Vukasović I.S03-5: Technical assessors and experts. Biochemia Medica 2009;19(Suppl 1):S37-S38.
University Department of Chemistry, Sestre Milosrdnice University Hospital, Zagreb, Croatia
Corresponding author: ines [dot] vukasovic [at] gmail [dot] com
On-site assessment is the one of the activities to verify compliance with all requirements during the accreditation procedure. It is implemented by impartial and independent assessors in applicant laboratory. The assessors are appointed by the accreditation agency based on pre-defined criteria, such as full awareness of the accreditation process, its objectives and the on-site assessment procedure. Regarding their technical knowledge and experience, the assessors are divided into categories as follows: 1) lead assessor; 2) technical assessor; 3) technical expert; 4) potential assessor (observer).
A lead assessor has overall responsibility for the established activities. Before starting the assessment the lead assessor should prepare an assessment schedule to include sections/areas/activities to be assessed and assignment to various assessors based on their expertise. The potential assessor (observer) should also be guided about the conduct of assessment. The lead assessor is required to monitor the performance of technical assessor(s) and the observer. He shall recommend whether the observer is capable to perform the role of a technical assessor in his next visit. The lead assessor must review the document laboratory’s quality system to verify compliance with the standard requirements (HRN EN ISO 15189). He should assess implementation and effectiveness of the quality system, and record observations in the appropriate form. He has to collect reports and documents from all technical assessors including his own report and compile it. A consolidated statement of nonconformities raised during the assessment shall be listed.
The technical assessor should clearly understand the areas/activities to be assessed. He must review the laboratory’s documented system to verify compliance with the standard requirements and related accreditation agency criteria. He should verify that the documented procedures, work instructions, test methods, records are indeed implemented and effective, as described and record observations in appropriate form. All nonconformities must be identified and reported.
The technical expert must be experienced in specific laboratory fields such as laboratory immunology, molecular diagnostics and toxicology. He should not necessarily know the standard although very often the expert is the technical assessor, too.
The potential assessor (observer) will be assigned to accompany a lead assessor and technical assessor(s) as per the provided schedule. He shall be guided by the lead assessor and the technical assessor(s). He is not required to submit any report; however, his form may be submitted to the lead assessor.
Besides professional knowledge the assessor should possess specific skills: communication, realistic situation assessment, the proper use of available time, facts-based making conclusions, overcoming possible interference with the responses. It has been expected from the assessor to overcome possible interference with giving answers and presentation of documents he didnt request, and to react appropriately in case of conflicts and reconciling possible indistinctness. The assessor must raise clear and unambiguous questions, such as: how, where, who, show. The Scope of Accreditation to be granted to the Laboratory must be checked thoroughly with necessary recommendations. Any deletions or alterations in the scope must be clearly brought out and signed by both the laboratory representative and the assessor.