Accreditation in clinical laboratories

At the beginning of the 21st century there are defined priorities in laboratory medicine such as laboratory automation, laboratory consolidation, molecular diagnostics, and accreditation of laboratories aiming to improve the quality of patient care. Laboratory medicine is backbone in the medical treatment, diagnosis and prevention. Laboratory diagnostics influences 70-80% of hospital health care decisions and costs 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. 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 ISO15189:2007 - 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. There are also different systems in EU countries based on national quality systems which are based on ISO 15189. Accreditation is not about who the best is, but who has a system of standard procedures. Quality system is about people, with people and for people

Accreditation in clinical laboratories

At the beginning of the 21st century there are defined priorities in laboratory medicine such as laboratory automation, laboratory consolidation, molecular diagnostics, and accreditation of laboratories aiming to improve the quality of patient care. Laboratory medicine is backbone in the medical treatment, diagnosis and prevention. Laboratory diagnostics influences 70-80% of hospital health care decisions and costs 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. 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 ISO15189:2007 - 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. There are also different systems in EU countries based on national quality systems which are based on ISO 15189. Accreditation is not about who the best is, but who has a system of standard procedures. Quality system is about people, with people and for people

Documenting metrological traceability as intended by ISO 15189 : 2012: A consensus statement about the practice of the implementation and auditing of this norm element

ISO15189:2012 requires medical laboratories to document metrological traceability of their results. While the ISO17511:2003 standard on metrological traceability in laboratory medicine requires the use of the highest available level in the traceability chain, it recognizes that for many measurands there is no reference above the manufacturer's selected measurement procedure and the manufacturer's working calibrator. Some immunoassays, although they intend to measure the same quantity and may even refer to the same reference material, unfortunately produce different results because of differences in analytical selectivity as manufacturers select different epitopes and antibodies for the same analyte. In other cases, the cause is the use of reference materials, which are not commutable. The uncertainty associated with the result is another important aspect in metrological traceability implementation. As the measurement uncertainty on the clinical samples is influenced by the uncertainty of all steps higher in the traceability chain, laboratories should be provided with adequate and appropriate information on the uncertainty of the value assignment to the commercial calibrators that they use. Although the between-lot variation in value assignment will manifest itself as part of the long-term imprecision as estimated by the end-user, information on worst-case to be expected lot-lot variation has to be communicated to the end-user by the IVD provider. When laboratories use ancillary equipment that potentially could have a critical contribution to the reported results, such equipment needs verification of its proper calibration and criticality to the result uncertainty could be assessed by an approach based on risk analysis, which is a key element of ISO15189:2012 anyway. This paper discusses how the requirement for metrological traceability as stated in ISO15189 should be met by the medical laboratory and how this should be assessed by accreditation bodies.Peer reviewe

Laboratory Capacity Building in Asia for Infectious Disease Research: Experiences from the South East Asia Infectious Disease Clinical Research Network (SEAICRN)

Heiman Wertheim and colleagues discuss a network that aims to improve infectious disease management through integrated, collaborative clinical research in South East Asia

Guidance for laboratories performing molecular pathology for cancer patients

Molecular testing is becoming an important part of the diagnosis of any patient with cancer. The challenge to laboratories is to meet this need, using reliable methods and processes to ensure that patients receive a timely and accurate report on which their treatment will be based. The aim of this paper is to provide minimum requirements for the management of molecular pathology laboratories. This general guidance should be augmented by the specific guidance available for different tumour types and tests. Preanalytical considerations are important, and careful consideration of the way in which specimens are obtained and reach the laboratory is necessary. Sample receipt and handling follow standard operating procedures, but some alterations may be necessary if molecular testing is to be performed, for instance to control tissue fixation. DNA and RNA extraction can be standardised and should be checked for quality and quantity of output on a regular basis. The choice of analytical method(s) depends on clinical requirements, desired turnaround time, and expertise available. Internal quality control, regular internal audit of the whole testing process, laboratory accreditation, and continual participation in external quality assessment schemes are prerequisites for delivery of a reliable service. A molecular pathology report should accurately convey the information the clinician needs to treat the patient with sufficient information to allow for correct interpretation of the result. Molecular pathology is developing rapidly, and further detailed evidence-based recommendations are required for many of the topics covered here

Guideline from Japanese Society of Echocardiography : 2018 focused update incorporated into Guidance for the Management and Maintenance of Echocardiography Equipment

Echocardiography plays a pivotal role as an imaging modality in the modern cardiology practice. Information derived from echocardiography is definitely helpful for a patient care. The Japanese Society of Echocardiography has promoted echocardiography for a routine clinical and research use. One of the missions of the Society is to provide information that is useful for high-quality examinations. To ensure it, we believe equipment in good conditions and a comfortable environment are important for both a patient and an examiner. Thus, the Committee for Guideline Writing, the Japanese Society of Echocardiography published brief guidance for the routine use of echocardiography equipment in 2015. Recently, the importance of international standardization has been emphasized in the medical laboratories. Accordingly, the committee has revised and updated our guidance for the routine use of echocardiography equipment

Retrospective review of internal audit non–conformances at non accredited public health laboratories in Gauteng Province of South Africa

Abstract: Public health medical laboratories are a component of a healthcare sector where clinical pathology tests are performed on clinical samples. The results of these samples aid in the diagnosis, treatment, and monitoring of disease. Laboratory results greatly influence the outcome of patient management. Therefore, it is essential that the laboratories comply with internationally recognized standards to ensure the accuracy and reliability of results. The International standard specifically developed for the medical laboratories is the ISO15189 standard. The laboratories use it to implement and monitor the laboratory quality management system (QMS). Laboratories conduct annual internal audits to verify compliance with the standard. If the laboratory fulfils the requirements of this standard and is assessed by an external body to verify compliance, the laboratory is awarded an accreditation certificate that is recognized internationally. Out of the twenty-four laboratories in Gauteng, eight laboratories were ISO15189 accredited and sixteen laboratories were not accredited in 2018. There has been slow progress in the accreditation of laboratories throughout the years. The study aimed to determine the reasons for non-compliance with the ISO15189:2012 standard that prevented laboratories from being accredited. Internal audit non-conformances in the nonaccredited laboratories in the Gauteng Province of South Africa for the period 2015-2019 were reviewed to investigate the type of non-conformances recorded in these laboratories. The study was conducted in the three disciplines Haematology, Chemical Pathology, and Microbiology. A descriptive non-experimental quantitative research method design was used and a survey and quantitative data were collected. The survey data was collected through an online multiple response survey distributed to internal auditors that conducted audits in Gauteng. The auditors were asked to identify common non-conformances in these nonaccredited laboratories and to share reasons that contributed to the laboratories noncompliance with the ISO15189:2012 standard. They were asked to share recommendations for improvement based on their experience. The quantitative non-conformance data recorded for the period 2015-2019 was collected. Data was analysed using the SPSS program from STATKON. Descriptives were used to analyse data and frequencies and percentages were used to report results. Cross tabulations were done to compare frequencies and percentages observed for management...M.Tech. (Biomedical Technology