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Objectives@#The implementation of Philippine National Standard PNS ISO 15189:2013 to support the medical laboratory to produce competent results is a recognised challenge. It is apparent that the approach of ensuring the equipment availability can be specifically optimised. No known research has focused on exploring on the conduct of conformity evaluation of Afinion 2 Analyzer maintainability for the PNS ISO 15189:2013 accredited medical laboratory. The aim of the current study was to develop a practical tool for the medical laboratory to support the internal audit process by determining the compliance status of Afinion 2 Analyzer maintainability. @*Methods@#The relevant conformance requirements in Clauses 4 (Management requirements) and 5 (Technical requirements) of PNS ISO 15189:2013, manufacturer requirements and specific requirements for accreditation from 70/101 (69%) accreditation bodies in 80/249 (32%) countries were identified as specific audit criteria for Afinion 2 Analyzer conformity evaluation checklists for the maintenance and reference equipment.
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Background:ISO 15189 will equip traineeswith effective auditing techniques and will increase understandingof audit methodologies. Trying to improve the quality of training that will be given underNABL ISO 15189. Material And Methods:The study was done forimproving the training of internal audit. Participants who have already taken training were asked to fill questionnaire in the google form regarding the cost effectiveness, mode of training, material of reference,No. of days of training, frequency at which training should be conducted and mock audit. For each question we had given certain option which will be chosen by earlier participants. For each question % of the answers are calculated individually to analyses whether the training is up to mark or has to be improved.Result:The results obtained are as follow s, for the cost of training to be 58.1% answered it to be five thousand. For the no of days maximum people gave the answer as 3 days. For mode of training results obtained was 80.23% offline.60.46% of trainees wanted weekdays as the days to be included for training session.60.4% of participants wanted power point presentation as the method for training to be conducted. Once in year was selected by 40.6% of trainees for how frequently the training should be conducted. All the participants have answered for the mock audit to be conducted.Conclusion:Most of them seem satisfactory with the training. Many of them suggested we have small break sessions during training. Live training sessions was also suggested as it could be more interactive.
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Since the first edition of ISO15189"Medical laboratories: requirements for quality and competence" was published in 2003, it has been rapidly and widely used in the world under the promotion of the International Laboratory Accreditation Cooperation Organization (ILAC), and has become the basic standard for the quality management, capacity-building and capacity attestation of medical laboratories. The Mutual Recognition Arrangement (MRA) of ILAC for ISO15189 is the most authoritative international permit for examination results, which is accepted by international organizations. Since the establishment of ISO15189 medical laboratory accreditation system in 2004 in China, more than 530 medical laboratories have been accredited, which plays an important role in improving the quality and competence of medical laboratories in China, and improves the influence of Chinese medical laboratories in the world. ISO 15189:2012 is currently being revised by the International Organization for Standardization/Technical Committee on Clinical Laboratory Testing and in vitro diagnostic test systems (ISO/TC212). This revision will bring significant changes and the medical laboratory shall pay attention to these changes. In order to help medical laboratories understand the new ideas in advance, this paper summarizes and analyses the draft of the new international standards, and provides references for users.
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【Objective】 To explore the performance verification of NAT and its procedures for HBV DNA, HCV RNA and HIV RNA-1 using PCR-fluorescence via Cobas s201 automatic NAT system and supporting MPX V2.0 reagents that applied in the laboratories of blood stations, in order to satisfy ISO 15189 accreditation requirements and ensure the accuracy of NAT results. 【Methods】 Samples used in external quality assessment(EQA) of year 2020 were taken to verify the concordance, Performance evaluation panel and sensitivity verification panel of Roche second-generation NAT system were used to verify the sensitivity/ specificity and the lower limit of detection, respectively.And HBV DNA, HCV RNA and HIV RNA-1 quality control products were used to verify the anti-interference ability. 【Results】 The concordance rate of 40 EQA, samples was 100%. The sensitivity and specificity of Cobas s201 automatic NAT system and supporting MPX V2.0 reagents in detecting HBV DNA, HCV RNA and HIV RNA-1 were all 100%. The lower detection limit for HBV DNA, HCV RNA and HIV RNA-1 all met the requirements of reagent instructions. The yielding of HBV DNA, HCV RNA and HIV RNA-1 were affected little with hemolysis at 500 mg/dL but interfered seriously as lipemia reached 3 300 mg/dL. 【Conclusion】 The concordance rate, sensitivity, specificity and lower detection limit of the Cobas s201 fully-automatic NAT system and MPX V2.0 reagents by PCR-fluorescence method all met the requirements of reagent instructions. The verification of anti-interference ability demonstrated the requirements of ISO 15189 and the needs of blood station laboratories could be satisfied, and the detection methods and procedures can ensure the accuracy of NAT results.
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@#International Academy of Pathology, Malaysian Division has initiated and run the external quality assurance program for general diagnostic histopathology since the year 2017. This article introduces the educational philosophy of this external quality assurance program and the technicalities in running such a national program. Challenges in ensuring the successful running of this program to gain wide acceptance by histopathology laboratories in Malaysia as well as experience in overcoming these challenges are detailed. This article charts the future direction of this external quality assurance program.
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To enhance interns' comprehensive ability and qualification in medical laboratory , ISO 15189 quality system that was widely accepted at home and abroad was applied in practice teaching management. First teaching experience was shared with each other, teaching competition was encouraged to improve the qualification of teaching, and then relevant academic conference and the application of scientific or new projects were also advocated to promote the construction of teaching staff. Second, the management system of the intern was improved, the rules of the management of the intern files were optimized, the train-ing and study were regularly organized, the teaching system was perfected, and the practice appraisal was standardized. Practice proved that the graduates had strong ability to work, to master the quality management of ISO 15189 elements and could solve the common problems in clinical work and at the same time they had certain scientific research thinking.
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Objective To develop an efficient and all-round management system of personnel information based on the standards of quality management in clinical laboratory.Methods ASP.NET and database technology were used to construct a web platform and develop the management modules of personnel information.Results The developed system consisted of 4 modules.The module of onestop management for personnel archives was realized,which could be viewed and self-maintained by individuals and auto-retrieved by the system.The module of job post for staff attendance record was realized by continuous,dynamic management and permanent retrievability of registered responsibilities.The module of training and examination could publish the information for staff to complete self-training within deadline and evaluated the training effects and competence by online tests,and granted appropriate authority to staff.The module of performance assessment could evaluate the performances of staff statically and dynamically by using objective indicators and review mechanism.After the application of the system,staff archives were updated in real time instead of once for year.The time for reviewing archives of staff reduced from fifteen minutes to one minute,the error incidents of staff reduced by 20％,workload for staff training and examination reduced by 60％,and the satisfaction degree of customers for staff increased from 93％ to 96.5％.Conclusion The developed management system could realize all-round standard management with high efficiency,so it should be more effective and cost-saving than traditional manners.The staffs would be willing to accept and cooperate with it.
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Objective To design the ISO15189 management information middleware based on laboratory information management system (LIS) and evaluate its application.Methods The ISO15189 management information middleware was designed based on LIS and the middleware technology as underlaying platform,and the multifunction management of LIS was implemented by the data warehouse technology and the data cleaning and extraction technology.Results The designed middleware made LIS implement the functions such as data exchange and transmission,data sharing,and data intelligence processing ISO15189 management information across multiple systems.It constructed a data warehouse by extracting,transforming,and loading useful data from multiple profession systems in laboratories,and flexibly presented data to the users by operating multidimensional data set from various aspects.Conclusion The ISO15189 management information middleware based on LIS has high value in the management of ISO15189 accredit,which may make the management work more standard,efficiency,and intelligence.
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Objective To propose a practice model for implementing procedures employed for the verification of validated ex-amination procedures already used for at least 2 years in their laboratory,in agreement with the ISO 15189 requirement at the Section 5.5.1.2.Methods In order to identify the operative procedure to be used,approved documents were identified, together with the definition of performance characteristics to be evaluated for the different methods;the examination proce-dures used in laboratory were analyzed and checked for performance specifications reported by manufacturers.Then,opera-tive flow charts were identified to compare the laboratory performance characteristics with those declared by manufacturers. Results The choice of performance characteristics for verification was based on approved documents used as guidance,and the specific purpose tests undertaken,a consideration being made of:imprecision and trueness for quantitative methods;diag-nostic accuracy for qualitative methods;imprecision together with diagnostic accuracy for semi-quantitative methods.Conclu-sion The described approach,balancing technological possibilities,risks and costs and assuring the compliance of the funda-mental component of result accuracy,appears promising as an easily applicable and flexible procedure helping laboratories to comply with the ISO 15189 requirements.
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The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189.
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Accreditation , Risk ManagementABSTRACT
Objective To establish a proper internal quality control(QC) system for the automated hematology analyzer accord‐ing to the corresponding stipulation by ISO15189 :2012 .Methods The high ,normal and low levels of controls offered by the instru‐ment were used to detect 22 items in whole blood cells routine analysis ,draw the Levey‐Jennings chart ,analyze and evaluate the quality control data for each month or each batch .Results A proper QC system was established ,including quality goals setting , new QC target value and standard deviation calculating and the QC rules choosing .In setting the target value for new batch of con‐trol ,MCV ,HCT and MCHC should adopt the mean values of at least 20 values ,while other items could adopt the mean values of 10 values ;the difference of CV values for some items existed in different QC levels ,different brands or different instruments in the same brand .Therefore ,the quality goals and standard deviation for new batch should be set according to different levels and differ‐ent instruments .Due to the QC characteristics and existence of QC chart drift phenomenon ,therefore MCV ,HCT and MCHC should adopt the 13 s and 22 s rules .For the other items ,the 13 s ,22 s and 10x rules were adoted .Conclusion Under the corresponding stipulations of ISO15189 and by combining with the laboratory practical situation ,a set of applicable internal quality control system is established .
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External quality assessment (EQA)as an effective tool for quality control can help clinical laboratories to discover quality problems during testing process and prompt clinical laboratories to improve their testing quality.Samples used for traditional EQA frequently have matrix effects which assign the target value by grouping.Ideal samples for EQA are com-mutable which have the same numeric relationship between different measurement procedures as that expected for patients’ samples.And they can assess accuracy against a reference measurement procedure or a designated comparison method.When analyzing,robust statistical method can be used to reflect the variability of testing results between laboratories more truly. And the evaluation standards should be desirable.If unsatisfactory results appear,we should investigate every aspect of tes-ting process,find the root cause,and take corrective action.On condition that no official EQA scheme is launched for some analytes,it is necessary for us to evaluate the performance of analytes by alternative evaluation procedures.
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In-depth application of the combination of theory and practice is one of the keys to improve the clinical undergraduate teaching quality of clinical laboratory diagnosis.Xuanwu Hospital used ISO15189 standards as a guide to make students fully participate in establishing performance verification and recording registration form,partly participate in the gage calibration,external quality assessment and inter-laboratory comparison etc.It also used the combined form of practice with teaching to make students learn the file writing and the equipment calibration.An orderly teaching model composed of knowledge reserve,file learning,calibration and verification was established,which was a closed-loop system that enabled students to become more deeply and extensively involved in the system and more deeply understand the connotation of clinical laboratory quality.
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La calidad hematológica en Venezuela, orientada a garantizar la confiabilidad de los resultados de la hematimetría, ha sido difícil de implementar. Los esfuerzos tanto individuales como institucionales, descritos según nuestras vivencias en el área, confirman la necesidad de continuar trabajando para lograr la acreditación de los laboratorios.
Hematologic quality in Venezuela, intended to ensure the reliability of the CBC results, has been difficult to implement. Both individual and institutional efforts, described according to our experiences in the area, confirm the need to continue the work to achieve laboratories accreditation.
Subject(s)
Schools, Medical , Hematology/education , Hematology/history , Quality Control , Blood Chemical Analysis , Reference StandardsABSTRACT
This review attempts to clarify the concepts of Laboratory Quality Management System (Lab QMS) for a medical testing and diagnostic laboratory in a holistic way and hopes to expand the horizon beyond quality control (QC) and quality assurance. It provides an insight on accreditation bodies and highlights a glimpse of existing laboratory practices but essentially it takes the reader through the journey of accreditation and during the course of reading and understanding this document, prepares the laboratory for the same. Some of the areas which have not been highlighted previously include: requirement for accreditation consultants, laboratory infrastructure and scope, applying for accreditation, document preparation. This section is well supported with practical illustrations and necessary tables and exhaustive details like preparation of a standard operating procedure and a quality manual. Concept of training and privileging of staff has been clarified and a few of the QC exercises have been dealt with in a novel way. Finally, a practical advice for facing an actual third party assessment and caution needed to prevent post-assessment pitfalls has been dealt with.
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Accreditation/methods , Clinical Laboratory Techniques/standards , Humans , Laboratories/standards , Quality Assurance, Health Care/methodsABSTRACT
O Serviço Regional de Referência em Leishmanioses de Pernambuco (Brasil) fornece diagnóstico de complexidade, controle de qualidade para os Laboratórios Centrais (LACENs) do Nordeste e treinamento de Recursos Humanos. Esta prestação de serviço gerou a necessidade de garantia da qualidade dos resultados e da satisfação do cliente, culminando com a busca dos conhecimentos fornecidos pela iso 15189. A interpretação da norma promoveu conhecimentos voltados para o Sistema de Gestão da Qualidade. A redação de documentos (POPs e Manual da Qualidade) envolveu toda a equipe inicialmente voltada apenas para atividades de pesquisa. O apoio institucional foi importante para a superação de pontos de resistência a uma nova realidade. A implementação da Gestão da Qualidade gerou avanços que, a médio e longo prazo, irão reduzir os custos com reposição de equipamentos, perda de reagentes e material biológico. A garantia de um trabalho executado com segurança fornece, além da credibilidade externa, satisfação interna e maior produção científica.
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Total Quality Management , Leishmaniasis , BrazilABSTRACT
As an on-site inspection team leader, I have joined the inspection on the clinical laboratories in six hospitals designed especially 2008 Olympic game organized by China National Laboratory Accreditation Committee (ISO15189 Accreditation). Two years' preparation promotes the standization, skill, management and academic level of these laboratories and boost the development 2-3 years forward. But there still were some deficiencies in the cell morphological examination including: ( 1 ) Low ratio of blood smear check when machine was used for hematological analysis; (2) Lack of criteria for blood smear check ; (3) Low capability of identification of cell; (4) Lack of personnel for microscopic examination. The reasons causing above deficiencies were concluded as follows: (1) The lab director did not pay sufficient attention to the morphological examination;(2)The technicians were unable to perform microscopic examination properly due to the heavy workload and lack of personnel; (3) The technicians were unable to use machine correctly as screening tool. So I put forward some measures for improvement of morphological examination. These measures included: (1) strengthening the propaganda on the importance of morphology examination and training the new stuffs; (2) Renovating the concept and improving the skill of lab technicians.
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Patient,competition and change are characteristics of the modern hospital manage environment,clinical laboratory management must be more scientific and more religious.This article lists the main items of clinical laboratory management using ISO15189,and raised some idea on clinical laboratory management using ISO15189 and points out the difficulties of popularization using ISO15189 in clinical laboratory management.