Quality In Medical Laboratories Research Articles

Risk based quality management: the way forward to improve quality in medical laboratories

Risk based quality management: the way forward to improve quality in medical laboratories Risk based quality management is not new. Many different standards including CLSI standard EP23-A, ISO 14971, ISO 31000, and ISO 22367 address risk management in laboratories. Risk and safety are addressed in quality management systems, introduced to provide accreditation and recog-nition of health care institutions. Laboratory quality is different from other quality targets as quality of a test report begins and ends with the same indi-vidual; the patient. Therefore, it is a closed loop having direct repercussions to the patient. In addition, medical laboratories are unique in safety as there are biohazards and chemical hazards. When managing laboratories, we should ensure patient safety as the top priority while ensuring safety of the employees and the environment. The latest version of ISO15189:2022 standard emphasises more on safety and risks. The pro-bability of hazards occurring should be under-stood, and the repercussions of a risk should be given consideration. Combining probability of occurrence and repercussions of risks will enable laboratories to prioritise and plan actions. This

Quality standards and internal quality control practices in medical laboratories: an IFCC global survey of member societies.

The trueness and precision of clinical laboratory results are ensured through total quality management systems (TQM), which primarily include internal quality control (IQC) practices. However, quality practices vary globally. To understand the current global state of IQC practice and IQC management in relation to TQM the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a survey of IFCC member countries on IQC practices and management. The survey included 16 questions regarding IQC and laboratory TQM practices and was distributed to IFCC full and affiliate member countries (n=110). A total of 46 (41.8 %) responses were received from all regions except North America. Of the responding countries, 78.3 % (n=36) had legislative regulations or accreditation requirements governing medical laboratory quality standards. However, implementation was not mandatory in 46.7 % (n=21) of responding countries. IQC practices varied considerably with 57.1 % (n=28) of respondents indicating that they run 2 levels of IQC, 66.7 % (n=24) indicating they run IQC every 24 h and 66.7 % (n=28) using assay manufacturer IQC material sources. Only 29.3 % (n=12) of respondents indicated that every medical laboratory in their country has written IQC policies and procedures. By contrast, 97.6 % (n=40) of responding countries indicated they take corrective action and result remediation in the event of IQC failure. The variability in TQM and IQC practices highlights the need for more formal programs and education to standardize and improve TQM in medical laboratories.

Understanding the key differences between ISO 15189:2022 and ISO 15189:2012 for an improved medical laboratory quality of service

Understanding the key differences between ISO 15189:2022 and ISO 15189:2012 for an improved medical laboratory quality of service

"Six SIGMA" standard kao nivo kvaliteta biohemijskih laboratorija

The principal role of biochemical laboratories is responsibility for reliable, reproducible, accurate, timely, and accurately interpreted analysis results that help in making clinical decisions, while ensuring the desired clinical outcomes. To achieve this goal, the laboratory should introduce and maintain quality control in all phases of work. The importance of applying the Six SIGMA quality model has been analyzed in a large number of scientific studies. The purpose of this review is to highlight the importance of using six SIGMA metrics in biochemical laboratories and the current application of six SIGMA metrics in all laboratory work procedures. It has been shown that the six SIGMA model can be very useful in improving all phases of laboratory work, as well as that a detailed assessment of all procedures of the phases of work and improvement of the laboratory's quality control system is crucial for the laboratory to have the highest level of six SIGMA. Clinical laboratories should use SIGMA metrics to monitor their performance, as it makes it easier to identify gaps in their performance, thereby improving their efficiency and patient safety. Medical laboratory quality managers should provide a systematic methodology for analyzing and correcting quality assurance systems to achieve Six SIGMA quality-level standards.

Problems and Countermeasures in Medical Laboratory Quality Management in Grass-roots Hospitals

Problems and Countermeasures in Medical Laboratory Quality Management in Grass-roots Hospitals

How to meet ISO15189:2012 pre-analytical requirements in clinical laboratories? A consensus document by the EFLM WG-PRE.

The International Organization for Standardization (ISO) 15189:2012 standard aims to improve quality in medical laboratories through standardization of all key elements in the total testing process, including the pre-analytical phase. It is hence essential that accreditation bodies, assessing laboratories against ISO15189:2012, pay sufficient attention to auditing pre-analytical activities. However, there are significant differences in how technicalauditors interpret the pre-analytical requirements described in ISO15189:2012. In this consensus document, the European Federation of Clinical Chemistry and LaboratoryMedicine (EFLM) Working Group for Pre-analytical Phase (WG-PRE) sets out to review pre-analytical requirements contained in ISO15189:2012 and provide guidance for laboratories on how to meet these requirements.The target audience for this consensus document is laboratory professionals who wish to improve the quality of the pre-analytical phase in their laboratory. For each of the ISOrequirements described in ISO15189:2012, members ofEFLM WG-PRE agreed by consensus on minimal recommendationsand best-in-class solutions. The minimal consensus recommendation was defined as the minimal specification which laboratories should implement intheir quality management system to adequately address the pre-analytical requirement described inISO15189:2012. The best-in-class solution describes thecurrent state-of-the-art in fulfilling a particular pre-analyticalrequirement in ISO15189:2012. We fully acknowledge that not every laboratory has the means to implement these best-in-class solutions, but we hope to challenge laboratories in critically evaluating and improving their current procedures by providing this expanded guidance.

Chinese expert consensus on the rapid nucleic acid testing of 2019-nCoV

In order to achieve fast turnaround time, reduce the instruments and workplace requirement, newly developed point-of-care nucleic acid for 2019 novel coronavirus (2019-nCoV) is increasingly used for the purpose of prevention and control of COVID-19. Since the methods used now have not met the requirements for point-of-care (POCT), these methods are temporarily named as nucleic acid testing in this consensus. To standardize the clinical application of rapid nucleic acid of 2019-nCoV, experts from China Association of Medical Equipment of Genetic Testing, China Association of Medical Equipment of Point of Care Testing (POCT), National Clinical Research Center for Clinical Laboratory, Molecular Group of Laboratory Medicine Expert Committee of National Health Commission Capacity Building and Continuing Education Center, Beijing Medical Laboratory Quality Control and Improvement Center jointly developed this expert consensus, which provides the consensus recommendations for nucleic acid testing in clinical laboratories, including general laboratory requirements, specimen collection, transportation and storage, standard operating procedures, verification, internal quality control, external quality assessment, result analysis and reporting, as well as laboratory safety management.

Medical laboratory accreditation in a resource-limited district health centre laboratory, Addis Ababa, Ethiopia.

BackgroundImproving the quality of medical laboratory services is a high priority in many countries. However, quality management systems for laboratories in resource-limited settings are often inadequate.ObjectivesThis article shares the experiences, benefits and challenges of the laboratory journey towards accreditation in a primary healthcare laboratory in Addis Ababa, Ethiopia.MethodsA retrospective review of laboratory records in Addis Ketema Health Center was conducted from 2012 to 2015. The study was supplemented by observations from some of the authors of this article who worked in the laboratory.ResultsThe laboratory journey towards accreditation began with a baseline assessment in 2012 using the World Health Organization African Region Stepwise Laboratory Quality Improvement Process Towards Accreditation; the baseline score was 78 points (0 stars). After mentorship support, the laboratory improved to 198 points (3 stars) in 2013 and 249 points (5 stars) in 2014. The laboratory scaled up to International Organization for Standardization 15189 requirements and received limited-scope accreditation for tuberculosis sputum microscopy and hematology tests in 2015. After adopting and implementing the standards, steady improvement was observed in the reliability of the laboratory services. Lack of resources was the major challenge the laboratory encountered.ConclusionEven though a remarkable quality performance improvement was observed over the entire process, inadequate skilled personnel was the major challenge identified in the road towards accreditation. Therefore, an appropriate, workload-based staffing structure should be developed to improve and sustain medical laboratory quality standards in resource-limited settings.

Plasma creatinine medians from patients partitioned by gender and age used as a tool for assessment of analytical stability at different concentrations

Background Monthly medians of patient results are useful in assessment of analytical quality in medical laboratories. Separate medians by gender makes it possible to generate two independent estimates of contemporaneous errors. However, for plasma creatinine, reference intervals (RIs) are different by gender and also higher over 70 years of age. Methods Daily, weekly and monthly patient medians were calculated from the raw data of plasma creatinine concentrations for males between 18 and 70 years, males >70 years, females between 18 and 70 years and females >70 years. Results The medians of the four groups were all closely associated, with similar patterns. The mean of percentage bias from each group defined the best estimate of bias. The maximum half-range (%) of the bias evaluations provided an estimate of the uncertainty comparable to the analytical performance specifications: thus, bias estimates could be classified as optimum, desirable or minimum quality. Conclusions Medians by gender and age are useful in assessment of analytical stability for plasma creatinine concentration ranging from 60 to 90 μmol/L. The daily medians are valuable in rapid detection of large systematic errors, the weekly medians in detecting minor systematic errors and monthly medians in assessment of long-term analytical stability.

Guidance for quality control practices and precision goals for CBCs based on IQMH patterns-of-practice survey.

Effective medical laboratory quality management systems ensure confidence in analyzing and reporting accurate and reliable patient results. To guarantee quality assurance, each laboratory needs appropriate internal quality control (IQC) procedures to monitor their test systems. The Institute for Quality Management in Healthcare (IQMH) Centre for Proficiency Testing conducted a survey on quality control (QC) practices in routine hematology. An online survey was sent to 184 Ontario laboratories performing complete blood counts (CBC) and leukocyte differentials. All participants used three levels of commercial QC for test system monitoring. Eighty percent of laboratories supplement with in-house patient QC. The frequency of QC analysis was variable based on: Manufacturer recommendations (80%) Parameter stability (25%) Clinical impact of incorrect results (21%) Number of samples potentially requiring retesting if there is a QC failure (11%). All laboratories used established QC rules and limits to monitor results. They utilized various methods in establishing limits including: Standard deviation of QC results (60%) Manufacturer precision goals (55%) Published precision goals (24%) IQMH allowable performance limits (APLs) (37%). Considerable variation in QC practices of Ontario laboratories was identified, and consensus practice recommendations and precision goals were developed to guide and standardize QC practice.

Analytical performance specifications for external quality assessment – definitions and descriptions

External Quality Assurance (EQA) is vital to ensure acceptable analytical quality in medical laboratories. A key component of an EQA scheme is an analytical performance specification (APS) for each measurand that a laboratory can use to assess the extent of deviation of the obtained results from the target value. A consensus conference held in Milan in 2014 has proposed three models to set APS and these can be applied to setting APS for EQA. A goal arising from this conference is the harmonisation of EQA APS between different schemes to deliver consistent quality messages to laboratories irrespective of location and the choice of EQA provider. At this time there are wide differences in the APS used in different EQA schemes for the same measurands. Contributing factors to this variation are that the APS in different schemes are established using different criteria, applied to different types of data (e.g. single data points, multiple data points), used for different goals (e.g. improvement of analytical quality; licensing), and with the aim of eliciting different responses from participants. This paper provides recommendations from the European Federation of Laboratory Medicine (EFLM) Task and Finish Group on Performance Specifications for External Quality Assurance Schemes (TFG-APSEQA) and on clear terminology for EQA APS. The recommended terminology covers six elements required to understand APS: 1) a statement on the EQA material matrix and its commutability; 2) the method used to assign the target value; 3) the data set to which APS are applied; 4) the applicable analytical property being assessed (i.e. total error, bias, imprecision, uncertainty); 5) the rationale for the selection of the APS; and 6) the type of the Milan model(s) used to set the APS. The terminology is required for EQA participants and other interested parties to understand the meaning of meeting or not meeting APS.

Suggestions for analytical performance verification and experimental designs for clinical laboratory tests

The analytical performance verification of clinical laboratory tests plays the key role in the new edition of laboratory quality and Competence Accreditation (ISO15189: 2012). This review, which is based on the new edition of accreditation criteria and Guidance on the Application of Accreditation Criteria for the Medical Laboratory Quality and Competence in the Field of Clinical Chemistry , and with the reference of documents issued from Clinical and Laboratory Standards Institute(CLSI), will give some requirements of analytical performance verification and experimental designs for clinical laboratory tests.(Chin J Lab Med, 2015, 38: 428-430) Key words: Clinical laboratory techniques; Laboratory proficiency testing; Research design

Medical laboratory quality systems - a management review.

The purpose of this paper is to highlight changes in ISO 15189:2012 and ISO 15189:2007 concerning management review requirements and to present a management review checklist, which includes all the revised ISO 15189's requirements. The recent revised and updated ISO 15189:2012 standard recommends a management review using a process approach and includes some additional topics. The management review is a key element in many quality management systems, including medical laboratory management systems in accordance with ISO 15189. The process approach enables laboratory top managers and personnel to achieve all the quality management system's important inputs and outputs. As laboratory staff often encounter difficulties fully exploiting the management review process, this checklist helps laboratory staff carry out an effective management review covering all the quality management system's important aspects.

Quality system for Medical laboratories

According to William Edwards Deming “Good quality does not necessarily mean high quality. Instead it means a predicable degree of uniformity and dependability at low cost with a quality suited to the market.” Whereas according to famous engineer and management consultant Joseph M. Juran quality is “fitness for purpose”. It should meet the customers’ expectations and requirements, should be cost effective.ISO began in 1926 as the International Federation of the National Standardizing Associations (ISA). The name, "ISO" was derived from the Greek word "isos" meaning "equal". (The relation to standards is that if two objects meet the same standard, they should be equal.) This name eliminates any confusion that could result from the translation of "International Organization for Standardization" into different languages which would lead to different acronyms.In health sector, quality plays pivotal role, as it is directly related to patient’s care. Earlier time, health service was simple, quite safe but ineffective. Now health care system is an organizational system with more complex processes to deliver care. Medical laboratory service is an integral part in patient’s management system. So, for everyone involved in the treatment of the patient, the accuracy, reliability and safety of those services must be the primary concerns. Accreditation is a significant enabler of quality, thereby delivering confidence to healthcare providers, clinicians, the medical laboratories and the patients themselves.ISO announced meeting in Philadelphia to form a technical committee to develop a new standard for medical laboratory quality. It took 7 years for the creation of a new Quality standard for medical laboratories. It was named as “ISO 15189” and was first published in 2003. The ISO has released three versions of the standard. The first two were released in 2003 and 2007. In 2012, a revised and updated version of the standard, ISO 15189:2012 (Medical laboratories – Requirements for quality and competence) was released. ISO 15189 is a globally recognized standard that help medical laboratories to develop their quality management systems and assess their competence. The standard is concerned with improving patient safety, risk mitigation and operational efficiency within medical laboratories, where they directly impact upon the continuum of care. To help it achieve this, ISO 15189 specifies quality criteria relating to both technical and managerial competence.Accreditation not only helps patients but also health care organization. It stimulates to seek for continuous improvement and enables the health care organization in demonstrating commitment to quality of care. Furthermore it raises community confidence in the services provided along with international recognition of services. Ultimately it increases revenue of the institution.Accreditation benefits all stake holders, patients/customers are the biggest beneficiary. It results in high quality of care and patients/customer safety as they get services by credentialed staff.Accreditation ensures that rights of patients are respected and protected and their satisfaction is regularly evaluated.Thus, Accreditation can be the single most important approach for improving the quality of health care structures. In an accreditation system, institutional resources, processes and outcome are evaluated continuously to ensure quality of services is maintained and improved on the basis of appropriated standards and regulatory requirements.

Making great strides in medical laboratory quality

No abstract

The challenges of training in medical laboratories in Africa

Sub-Saharan Africa has a considerable deficit in laboratory facilities. For a decade, international and national public and private initiatives have multiplied to expand both the supply and quality of medical laboratories in Africa. By 2020, the World Health Organization, with as its main operator the African Society for Laboratory Medicine, will have provided training for 30,000 laboratory personnel and encouraged 2,500 laboratories to begin the accreditation process. In addition, the World Health Organization recommendations for treatment and care of HIV-infected individuals in resource-limited settings, revised in 2013, emphasize the need for laboratory monitoring to guide antiretroviral therapy. The University Diploma in Biological Retrovirology at the Cheikh Anta Diop University in Dakar, Senegal, offers multidisciplinary training in French at the postgraduate level in the complex and diverse field of biological monitoring of HIV infection in Africa. In nearly 10 years, more than 200 African biologists have been trained.

QCI - Medical laboratory program journey of quality in public medical laboratories": An experience though program evaluation

Objective: Health being a subject of the state and Accreditation of Healthcare Organisations being a voluntary process, the Quality Council of India (QCI) through National Accreditation Board for Hospitals and Healthcare Providers is creating standards and promoting quality in healthcare. The Medical Laboratory Program, which is designed to improve the Quality of Medical Laboratories, is being implemented by both government and private Laboratories to ensure quality of test results. Materials and Methods: A small program Evaluation study was carried out over a period to understand the level of understanding, usefulness and feedback from the participating Laboratories regarding QCI - Essential Standards for Medical Laboratories1 Program. The data was collected and analysed from 55 participating laboratories. Results: The study findings indicated 100% strongly agree that, training programs conducted were really helpful, 98% stated that, this program was instrumental towards Patient Safety and improved the Quality Indicators of laboratory activities. Around 89% of the respondents strongly support the fact that Educational Materials & technical Supports provided by Med-Lab Team were very useful & helpful to implement the standards & this Program has helped to achieve Quality Output with minimal effort & investment. Most of the respondents (4/5 th ) i.e. 80% of the respondents found that implementation of Med-Lab Program was easy & flexible. More than 80% of the respondents have felt either good, very good or excellent on all the parameters that have been spelt out regarding Post-Implementation impact of Med-Lab Program on various quality Indicators. 53 labs (96%) are satisfied with results on post implementation of the Med-Lab Program and agreed to recommend this program to other labs as well. This is the first such study in India. The findings may be an eye opener for the labs and the state governments who haven't yet participated in the Med Lab Program.

Guidelines for quality management of laboratory information systems

After a short presentation of the SFIL, this article presents the working parties initiated by the SFIL. At the end of each of these works were published texts, recommendations and tools for the biologists and vendors, in order that the laboratory information system becomes a component of medical laboratory quality. Recommendations for quality control of information systems, resulting from these documents, are presented.

The current status and future of medical laboratory quality regulation and accreditation in Ghana

High-quality and reliable laboratory services are important components of effective and well-function- ing health systems. Accurate, reliable and timely medical laboratory testing is crucial to patient care and disease surveillance. Unfortunately, in many sub-Saharan African countries, medical laboratory systems are adversely affec- ted by the unavailability of medical laboratories, poor laboratory infrastructure and lack of well-trained personnel (1). Quality in the laboratory is only achieved in a sys- tematic way through the implementation of a quality management system. The results of the study showed that approximately 60 % of the 78 respondents were unaware of the requirements of ISO 15189:2007. A trial of proficiency testing, termed 'blind proficiency testing', was carried out in which 19 laboratories determined the concentrations of urea and cholesterol in a proficiency testing material. Of the 19 laboratories that determined the concentration of urea, 63 % produced satisfactory results with scores between -2 and ?2. Similarly, 63 % of the participating laboratories obtained satisfactory z scores for cholesterol determination. Some of the laboratories that obtained sat- isfactory scores for urea determination had unsatisfactory scores for cholesterol determination and vice versa. It is recommended that the Ghanaian government pass a law and establish a standard to regulate medical laboratories in Ghana in order to improve quality in a significant way.

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

Aim Medical 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. Methods International 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. Results Accreditation 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. Conclusion Preparatory 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.