Pdf preanalytical errors in hematology laboratory an. In chemistry and other disciplines, the use of statistical quality control and westgard rules is common, but the implementation of these techniques is less well understood in hematology. An equivalent procedure, which may be carried out by a laboratory computer, gives automated online quality control ofthe coulter s blood counter. Quality control refers to the process of detecting analytical errors within the lab to ensure both the reliability and accuracy of test results in order to provide the best possible patient care. Alternate substitutes haematology quality control blood challenges 21. Sysmex haematology control materials are to be stored with a closed cap at 2 8c. Performing iqc also enables the laboratory to monitor and document the quality of its work. Rather, it includes preexamination, examination, and postexamination activities. Prevention and control of laboratory accidents and. The ideal quality control system minimizes the risk of reporting erroneous test results while streamlining operations and increasing productivity. Quality assurance manual clinical laboratory of san. This chapter addresses the control of the analytical process in the laboratory, as distinct from meeting the typical analytical needs of a specific project. The laboratory application evaluates the data for completeness and accuracy.
Automated quality control for the haematology laboratory. Two simple methods of using sophisticated statistical techniques to analyse intralaboratory quality control data are described. Learn quality control hematology with free interactive flashcards. Qa in haematology laboratory qa in haematology lab is intended to ensure the reliability of the lab tests. Laboratory quality control is designed to detect, reduce, and correct deficiencies in a laboratorys internal analytical process prior to the release of patient results, in order to improve the quality of the results reported by the laboratory. Laboratory procedure manual centers for disease control.
Health laboratory technology and blood safety unit. Quality assurance in laboratory haematology includes a constant checking of test reliability by internal quality control, b external quality assessment by an independent agency to check performance of a number of laboratories at intervals in order to obtain a retrospective indication of their ability and c proficiency control by supervision of the pretest and posttest phases of. Providing a true third party solution for sysmex haematology analysers with 5part differential technology an unbiased, independent assessment of analytical performance is guaranteed. Analytical phase in hematology lab composed of internal quality control external quality assessment or proficiency testing. Check the accuracy of tests system by comparing the daily run.
Qa includes all aspects of laboratory activities that affects the results produced, from the choice of methods, to the education of personnel, to the handling of specimens and reporting results. Feb 12, 2017 internal quality control in hematology lab the purpose of running iqa is to. Sncs the quality control solution for the haematology laboratory the purpose of this newsletter is to provide an overview of the concept and functionality of the sysmex network communication system sncs illustrating its value to the haematology laboratory as an integral component of the quality management system. With the current focus on consumerism, a recognized challenge to medicine is the quality assurance in health care provided to the public. The importance of the quality control of laboratory. The importance of quality control in laboratory testing. Quality management and accreditation in laboratory hematology. Internal quality control in hematology lab the purpose of running iqa is to. Quality assurance is essential in haematology to ensure that laboratory tests are.
That book introduced industrial principles of total quality management tqm and demonstrated their application. Choose from 500 different sets of quality control hematology flashcards on quizlet. The objective is to achieve precision and accuracy 4 components of qa programme. When internal quality control is insufficient or inefficient. It is apparent that a wellmanaged health laboratory with an appropriate quality assurance program has a major role in enhancing the standard of health service delivery to the community. A shortterm increase in temperature, which may occur during transportation, does not affect the quality of the product. Six sigmabased quality control abbott core laboratory. Elements such as controls, job management, defined and well managed processes. Many physicians do not realize that a test can be precise repetitively getting the same number without being accurate correct in relation to an accepted standard. Pdf laboratory quality control in clinical laboratory. Overview of quality control for qualitative and semiquantitative procedures role in quality management system quality control qc is a component of process control, and is a major element of the quality management system.
An appropriate quality assurance plan for a hematology laboratory addresses and assures quality at preanalytic, analytic, and postanalytic steps, and its success. Quality control provides quantitative estimates of analysis and measurement controls that can be used to determine compliance with project objectives. Laboratory quality standards and their implementation ix scope and objectives the objective of this document on laboratory quality standards is for it to be used as a guideline for evaluation, development and implementation of quality systems and standards for health laboratory services. Basic quality management systems essentials for quality management in the medical laboratory. Moreover, this course is extremely important for the student as it paves the ways to easily understand various professional courses such as hematology, bacteriology, urinalysis. Textbooks on laboratory management and quality control for students of medical laboratory technology are rare in most teaching institutions of the country. Routine quality control qc and maintenance of laboratory automation plays an important part in the upkeep and performance of instruments. Laboratory procedure manual centers for disease control and. Hughes chairman, haematology qap committee, royal introduction the haematology laboratory encompasses a mix of activity not usually found in other disciplines of pathology.
The extent to which a hematology laboratory should be involved depends upon various factors, including availability of facilities, financial resources, range of. Quality assurance in hematology laboratory by mohammed abdalla elhassan, m. That book introduced industrial principles of total. A new method of laboratory quality control is described in this paper which is simple, sensitive, and requires only a little clerical work for its use. Clinical and laboratory standards institute document h26a2validation, verification, and quality assurance of automated hematology analyzers. Daids guidelines for good clinical laboratory practice.
The essentials of correct quality control in laboratory hematology disciplines are presented concisely in these 17. Guidelines on standard operating procedures for microbiologyguidelines on standard operating procedures for microbiology page viipage vii pagpapaggee general laboratory directions for safety 58 99 quality assurancequality assurancequality assurance 59. This task is difficult enough when all agree on how to do the test and what reagents should be used. Statistical quality control is well established as a key assurance technique for medical laboratories. Quality control in haematology sysmex south africa. Hematology standard 2 hm s2 for manual cellular hematology procedures, one level of quality control material shall be run during each eight hours of operation. Quality control samples external quality assessment schemes eqas aims to analyse the accuracy of the entire testing process from receipt of sample and testing of sample to reporting of results also known as proficiency testing who manual for organizing a national external quality assessment programme for health laboratories and other.
One method uses a plastic grid to assess the cumulative sum cusum graph. Verification and quality control of routine hematology analyzers article pdf available in international journal of laboratory hematology 38s1 may 2016 with 4,690 reads how we measure reads. An interlaboratory quality control scheme has been established in britain by the british committee for standards in haematology. Intralaboratory control internal can check on the reproducibility but not guarantee accuracy. Haematology laboratory handbook churchill hospital. In the first instance this has been confined to haemoglobin, red blood cell count, and packed cell volume. Assess the precision of test system through cumulative run comparison cv% predict and or to detect the potential errors and fluctuations in test system before it could affect. Quality management quality indicator monitoring guidance. If a laboratorys primary cellular hematology procedures are manual methods, a minimum of two levels of quality control material are required during each eight hours of operation. Qc is important to check the accuracy and reproducibility of liquid handling, and indicates any deterioration in performance, ensuring the equipment is performing to expectations. The idea of quality management in the medical laboratory has. Managing the quality and productivity of analytical processes 1.
When handled in this manner, the products are guaranteed stable. These include procedure manuals, maintenance schedules, calibrations, a quality assurance program, training and quality control. Automated quality control the haematology laboratory. A complete portfolio of hematology testing equipment and solutions including automated analyzers, slidemaker stainers as well as reagents, calibrators and controls for clinical laboratories. Today laboratory personnel s duties have been shifted from manual work to the maintenance of the equipment, internal and external quality control, instrument calibration and data management of the generated results. Managing the quality of laboratory testing processes in 1986, patricia barry and i authored a book titled costeffective quality control. The haematologist must be responsible for laboratory performance. External quality control allows a laboratory to compare its precision and. Verification and quality control of routine hematology. Thepossible development ofsimple apparatus to carry outthe samefunction is discussed. Quality assurance in laboratory haematology proceedings of. This information is intended as general guidance for understanding the concepts involved in selecting, monitoring, and evaluating quality indicators. Quality control is a measure of precision, or how well the measurement system reproduces the same. The laboratory director communicates with the qaqc manager to ensure that the clsb quality assurance manual and sops are followed as written.
Six sigmafibased quality control diagnostics to table of contents acknowledgements dr. Quality control quality control is defined as the operational techniques and activities that are used to fulfill the requirements of quality iso. Manufacturing quality control materials for haematology is a challenge compared with controls for. Approved standardsecond edition provides guidance for the validation, verification, calibration, quality assurance qa, and quality control qc of automated multichannel hematology analyzers. Pdf verification and quality control of routine hematology.
Iso 9000 defines quality control as a part of quality management focused on fulfilling quality requirements this approach places emphasis on three aspects enshrined in standards such as iso 9001. Although quality control is a familiar concept in manufacturing, it is not a uniform practice in all medical laboratories. Download the pdf to view the article, as well as its associated figures and tables. Pathology and laboratories directorate the department of laboratory haematology departmental policy code. A quality control qc protocol for hematology, as for other sections of the laboratory, should encompass both internal and external qc programs. To support the many laboratories that conduct quality laboratory testing for clinical trials around the world, daids has developed, in collaboration with ppd, the attached daids guidelines for good clinical. Introduction there is no doubt that some form of quality control is essential in the clinical laboratory in order to ensure reliability of results of tests, with acceptable levels of accuracy and precision. It monitors the processes related to the examination phase of testing and allows for detecting errors. Division of laboratories, norwalk hospital norwalk, conn. Laboratory quality control is our passion and with more than 30 years experience developing laboratory quality control for the in vitro diagnostics market we believe in producing high quality material designed to streamline procedures, whilst reducing costs in laboratories of all sizes and budgets. An appropriate quality assurance plan for a hematology laboratory addresses and assures quality at preanalytic, analytic, and postanalytic steps, and its success depends upon the cooperative efforts of all those involved in patient care. Usually, these quality control samples are obtained from the manufacturer and they consist of two or.
Combining 45 parameters in total the randox acusera haematology quality control completely covers the commonly tested full blood profile in a single control. The final decision to accept or reject a result is the responsibility of the medical technologist. An equivalent procedure, which may be carried out by a laboratory computer, gives automated online quality control of the coulter s blood counter. Flow diagram of quality management in the laboratory. Laboratory quality control the importance of quality control in laboratory testing on january 26, 2011 at 15. Other quality control procedures may be useful in monitoring.
Check the accuracy of tests system by comparing the daily run to the assigned mean value. Verification and quality control of routine hematology analyzers. Of the terms quality control and quality assurance, quality assurance is the broader concept, encompassing. Quality assurance in hematology laboratory slideshare. Pdf quality management of hematology tests in blood center. The ultimate responsibility for laboratory operations and quality assurance is that of the laboratory director. Quality assurance in laboratory haematology proceedings. Quality control isproduct oriented and is used to verify that a product test result in the case of the clinical laboratory is of acceptable quality. Quality control is a measure of precision, or how well the measurement system reproduces the same result over time and under varying operating conditions. The laboratory director works with each department supervisor to implement the qaqc. If project requirements are more stringent than typical laboratory qc criteria, the project manager and the laboratory should. Full text full text is available as a scanned copy of the original print version. Preanalytical errors in hematology laboratory an avoidable incompetence article pdf available in iranian journal of pathology 112. A study of various estimators for the derivation of quality.
The essentials of correct quality control in laboratory hematology disciplines are presented concisely in these 17 chapters from a symposium of international origin. This is a controlled document the master copy of this document is held on ipassport. Acusera laboratory quality control randox quality control. Successful implementation of an appropriate quality assurance plan is essential to quality patient care. Introduction qa is the sum of all those activities in which the laboratory is engaged to ensure that information generated by laboratory is correct. Get a printable copy pdf file of the complete article 775k, or click on a page. Periodic interlaboratory trials, at a national level, in conjunction with regular individual intra laboratory quality control procedures, are. Reliability requires vigilance and effort on the part of all laboratory staff members, and this effort is often directed by an experienced medical laboratory scientist who is a quality assurance and quality control specialist. Purpose of quality control qa of clinical laboratory examination numeric results is not simply the processing of liquid commercial controls, generation of leveyjennings control charts, and multirule analysis. Although quality control is a familiar concept in manufacturing, it is not a uniform. Usually, these quality control samples are obtained from the manufacturer and they consist of two or three levels low, medium, high.
He is an emeritus professor in the department of pathology and laboratory medicine at the. Quality assurance in hematology and hemostasis testing. Helping you build a more complete quality control system at biorad, we understand that you need a robust quality plan designed to meet your specific quality control goals and objectives. All haematology control materials must be protected from freezing. View the article pdf and any associated supplements and figures for a period of 48 hours. Scope this manual describes the test procedures that are currently in use in the material laboratory of the construction section. Quality control blood must provide stable results for all measured parameters over prolonged period of time blood cells need to be stabilised to prevent disintegration with time but not all cells can be stabilised without unacceptable loss of function.