Pathology and laboratories directorate the department of laboratory haematology departmental policy code. Many of these procedures are critical to clinical decisions in areas of hematopathology, infectious disease, and transplant medicine. Application of sigma metrics in addition to daily internal quality control can identify analytical deficits and improvement in clinical laboratories. Statistical quality control for quantitative measurement procedures. Statistical quality control is well established as a key assurance technique for medical laboratories. Six sigmafibased quality control diagnostics to table of contents acknowledgements dr. Recommendations for clinical laboratory testing of activated protein c resistance. It applies westgard qc rules to the data to help determine assay and system reliability. Quality control in hematology clinics in laboratory medicine. Seed hematology sysmex educational enhancement and development no 2 2017 why is quality control so important. The quality management qm section of the laboratory general checklist contains requirements for the implementation of the qm program and the monitoring of quality indicators. Internal quality control in hematology lab the purpose of running iqa is to. 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.
When a diagnostic test is performed in the medical laboratory, the outcome of the test is a result. Quality control in the medical laboratory is a statistical process used to monitor and evaluate the analytical process that produces patient results. Approved standardsecond edition provides guidance for the validation, verification, calibration, quality assurance qa, and quality control qc of automated multichannel hematology analyzers. Feb 27, 2012 this module explains and illustrates the basic knowledge required to set up a simple but effective quality control system using statistical process control. The hematology module in the laboratory application automatically receives the results or transmits them manually to the hematology module. The disodium or di or tripotassium salt of edta in a concentration of 1. Clinical chemistry analytes had sigma levels less than 3.
Learn quality control hematology with free interactive flashcards. Laboratory procedure manual centers for disease control and. Combining 45 parameters in total the randox acusera haematology quality control completely covers the commonly tested full blood profile in a single control. Our offerings are designed to enable the clinical laboratory to be more efficient in todays changing healthcare environment.
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. Performing iqc also enables the laboratory to monitor and. Reference health laboratory quality assurance in heamatology. Quality assurance in hematology and hemostasis testing.
Though more sensitive and accurate, there are many variables that can impact flow cytometry results and must be controlled in a comprehensive quality control and quality assurance program. Verification and quality control of routine hematology analyzers article pdf available in international journal of laboratory hematology 38s1 may 2016 with 5,185 reads how we measure reads. Internal quality control practices in coagulation laboratories. Get a printable copy pdf file of the complete article 775k, or click on a page image below to browse page by page.
Quality assurance in hematology laboratory slideshare. This information is intended as general guidance for understanding the concepts involved in selecting, monitoring, and evaluating quality indicators. The laboratory application evaluates the data for completeness and accuracy. Alternate substitutes haematology quality control blood challenges 21. Quality control qc information and troubleshooting guide hematology beckman coulter establishing quality control means and standard deviation for hematology instrument, streck clsi. The various aspects of quality assurance which are. 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. 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. 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. One vital part of quality assurance is the internal quality control iqc, which is used to ensure daytoday consistency of an analytical process, helping to determine whether patient results are reliable enough to be released. Due to this, haematology quality control material is different from freshly collected patient samples. Other critical thinkers and innovators, including arman feigenbaum, kaoru ishikawa, and.
Validation and quality control in clinical flow cytometry. Quality control solution for integrated hematology laboratory network martha davis, annapurna karicherla and patrick oneil beckman coulter, inc. A laboratory guide to clinical hematology open textbook library. Quality assurance in haematology linkedin slideshare. Quality control in haematology sysmex south africa. 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. Quality control methods were not applied in the laboratory until the 1940s. Quality assurance in laboratory haematology proceedings of.
A poor approach can lead to a spectrum of scenarios from validation of incorrect patient results to over investigation of falsely rejected analytical runs. Please place an by each procedure that has been performed satisfactorily under your supervision by this applicant. Quality management quality indicator monitoring guidance. A complete portfolio of hematology solutions including automated analyzers, slidemaker stainers as well as reagents, calibrators and controls for laboratories with diverse testing volumes. Each of these content areas comprise a specific percentage of the overall 100question exam.
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. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. Validation, verification, and quality assurance of automated hematology analyzers. A hematology reference control used in monitoring determinations of blood cell values on sysmex and abbott 3part differential hematology analyzers.
Feb 12, 2017 internal quality control in hematology lab the purpose of running iqa is to. Introduction basic lessons in laboratory quality control. The h and sh exam questions encompass the following content areas within hematology. Cap accreditation checklists, hematology and coagulation, nonwaived tests 81716. This is a controlled document the master copy of this document is held on ipassport. The extent to which a hematology laboratory should be involved depends upon various factors, including availability of facilities, financial resources, range of tests, workload, the number of staff.
This module explains and illustrates the basic knowledge required to set up a simple but effective quality control system using statistical process control. Pdf the authors propose guidelines for the use of retained patient specimens for the quality control of multichannel hematology analyzers. Internal quality control using sysmex analyser specific control bloods external quality assurance schemes xbar m control to automatically monitor performance of instruments using patient samples calibration verification of cbc parameters and sensitivity adjustments using fresh normal human blood samples. A quality control qc protocol for hematology, as for other sections of the laboratory, should encompass both internal and external qc programs. Haematology laboratory handbook churchill hospital. 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. Blood smear, evaluation and differential quality control. Six sigmabased quality control abbott core laboratory. Quality control provides quantitative estimates of analysis and measurement controls that can be used to determine compliance with project objectives. Choose from 500 different sets of quality control hematology flashcards on quizlet. Manufacturing quality control materials for haematology is.
An appropriate quality assurance plan for a hematology laboratory addresses and assures quality at preanalytic, analytic, and postanalytic steps, and its success. Perform quality control procedures using the clia quality control requirements, including daily testing of two levels of external quality control materials, and also follow all specialtysubspecialty requirements in the clia regulations for nonwaived tests or perform an iqcp. Pdf optimized quality control procedure for hematology. The extent to which a hematology laboratory should be involved depends upon various. Internal quality control using sysmex analyser specific control bloods external quality assurance schemes xbar m control to automatically monitor performance of instruments using patient samples calibration verification of cbc parameters and sensitivity. Get a printable copy pdf file of the complete article 775k, or click on a page. Immediate access to quality control data is one key factor within a laboratorys quality control plan.
He is an emeritus professor in the department of pathology and laboratory medicine at the. Quality assurance in hematology laboratory by mohammed abdalla. Example observe the settingsqc range limits established in the laboratory lishis to ensure that the laboratory s stated ranges are accurately reflected ask. A summary of equivalent quality control options is included in this brochure. Example observe the settingsqc range limits established in the laboratory lishis to ensure that the laboratorys stated ranges are. Complete blood count using hmx nhanes 20072008 the coulter hmx hematology analyzer is a quantitative, automated hematology analyzers and leukocyte differential cell counters for in vitro diagnostic use in clinical laboratories. The extent to which a hematology laboratory should be involved depends upon various factors, including availability of facilities, financial resources, range of. 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. Verification and quality control of routine hematology. Of the terms quality control and quality assurance, quality assurance is the broader concept, encompassing. Introduction qa is the sum of all those activities in which the laboratory is engaged to ensure that information generated by laboratory is correct. Providing a true third party solution for sysmex haematology analysers with 5part differential technology an unbiased, independent assessment of analytical performance is guaranteed. The purpose of the hmx hematology analyzer is to separate the normal participant, with all normal.
Validation, verification, and quality assurance of. This means care must be taken to ensure the material has been used correctly when interpreting quality control results. Pdf quality management of hematology tests in blood center. Liquichek sedimentation rate control a bilevel hematology control designed to monitor the precision of both manual and automated methods for measuring erythrocyte sedimentation rates. 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. Reviewed by elizabeth duck, assistant professor in medical laboratory science program, louisiana state university of alexandria on 42020 text appears to be missing a comprehensive introduction to clinical hematology that may be useful for students basics of laboratory safety, quality assessment, specimen collection, and roles. Evaluation of quality control in clinical chemistry and. Clinical and laboratory standards institute document h26a2validation, verification, and quality assurance of automated hematology analyzers. Quality management is not restricted to the development and retention of quality control charts but rather includes all aspects of laboratory. Quality management sum of all those activities in which the laboratory is engaged to ensure that information generated by the laboratory is correct. This chapter addresses the control of the analytical process in the laboratory, as distinct from meeting the typical analytical needs of a specific project. Quality control is a measure of precision, or how well the measurement system reproduces the same. Audit reference test and control section spanish version of preparation of controls for uhcg.
Quality assurance is essential in haematology to ensure that laboratory tests are carried out reliably. A quality control qc protocol for hematology, as for other sections of the. The result may be a patient result or it may be a quality control qc. This handbook is intended to provide a comprehensive reference on laboratory quality management system for all stakeholders in health laboratory processes, from management, to administration, to benchwork laboratorians. Check the accuracy of tests system by comparing the daily run to the assigned mean value. Hematology analyzers, testing equipment and solutions. Laboratory procedure manual centers for disease control. Obviously there are physicians, especially those specializing in hematology, oncology or pathology, but there are many, many others such as physician assistants, nurse clinicians, laboratory specialists, basic research scientists, molecular biologists, epidemiologists, immunologists, statisticians, engineers, research and laboratory technicians. Shewhart developed a method for statistical process control in the 1920s, forming the basis for our quality control procedures in the laboratory. Sysmex control materials include stabilised human red blood cells rbc, white blood cells wbc, and a platelet plt and. This article will provide a practical approach for the routine clinical biochemistry laboratory to introduce an. Hematology physiology, hematology disease states, hematology laboratory testing, hemostasis, and laboratory operations. The system presents quality control qc data in both a summary format and in a chart format. Pdf verification and quality control of routine hematology.