Quality in clinical laboratory is a continuous journey of improving processes through team work, innovative solutions, regulatory compliance with final objective to meet the evolving needs of clinicians & patients.
Quality control, quality assurance, and quality assessment are important concepts for ensuring accuracy and reliability in medical laboratory testing. Quality control refers to internal processes like running controls to verify test accuracy during each run. Quality assurance encompasses the overall program to deliver correct results. Quality assessment challenges these programs through external proficiency testing. Proper documentation, trained personnel, validated methods and equipment, and monitoring control rules are key to achieving the goals of quality control, quality assurance and providing quality medical laboratory testing.
This is a series of notes on clinical pathology, useful for postgraduate students and practising pathologists. It covers all internal and external quality control techniques. The topics are presented point wise for easy reproduction.
Harmonization of Laboratory Indicators, 09 03-2017Ola Elgaddar
The document discusses harmonization of quality indicators (QIs) in medical laboratories. It notes that while QIs are important for quality improvement, there is currently no consensus on common QIs or how they should be defined and measured. The Working Group on Laboratory Errors and Patient Safety has developed a Model Quality Indicator (MQI) to address this issue, which defines 53 measurements across 27 QIs. Laboratories can now report results to the MQI website voluntarily. Statistical analysis of early participation in the MQI shows the most widely used QIs relate to pre-analytical errors, analytical test performance, and post-analytical issues. However, broader adoption remains a challenge.
In the continuous quality journey, Controlling laboratory Errors is an integral part & focusing on analytical, post-analytical process is the first step. Developing a reporting culture followed by thorough analysis and implementation of appropriate corrective, preventive actions is required.
Quality control and quality assurance programs are necessary to ensure reliable and accurate laboratory test results. Quality control involves daily monitoring processes like equipment calibration and testing control samples to verify test accuracy and precision. Quality assessment through external proficiency testing further challenges the quality programs. Proper quality control is implemented through all stages of testing - pre-analytical, analytical and post-analytical. Statistical tools like Levey-Jennings charts and Westgard rules are used to monitor quality control data and identify out of control results. The goal is to minimize errors and validate test results for optimal patient care.
Quality in clinical laboratory is a continuous journey of improving processes through team work, innovative solutions, regulatory compliance with final objective to meet the evolving needs of clinicians & patients.
Quality control, quality assurance, and quality assessment are important concepts for ensuring accuracy and reliability in medical laboratory testing. Quality control refers to internal processes like running controls to verify test accuracy during each run. Quality assurance encompasses the overall program to deliver correct results. Quality assessment challenges these programs through external proficiency testing. Proper documentation, trained personnel, validated methods and equipment, and monitoring control rules are key to achieving the goals of quality control, quality assurance and providing quality medical laboratory testing.
This is a series of notes on clinical pathology, useful for postgraduate students and practising pathologists. It covers all internal and external quality control techniques. The topics are presented point wise for easy reproduction.
Harmonization of Laboratory Indicators, 09 03-2017Ola Elgaddar
The document discusses harmonization of quality indicators (QIs) in medical laboratories. It notes that while QIs are important for quality improvement, there is currently no consensus on common QIs or how they should be defined and measured. The Working Group on Laboratory Errors and Patient Safety has developed a Model Quality Indicator (MQI) to address this issue, which defines 53 measurements across 27 QIs. Laboratories can now report results to the MQI website voluntarily. Statistical analysis of early participation in the MQI shows the most widely used QIs relate to pre-analytical errors, analytical test performance, and post-analytical issues. However, broader adoption remains a challenge.
In the continuous quality journey, Controlling laboratory Errors is an integral part & focusing on analytical, post-analytical process is the first step. Developing a reporting culture followed by thorough analysis and implementation of appropriate corrective, preventive actions is required.
Quality control and quality assurance programs are necessary to ensure reliable and accurate laboratory test results. Quality control involves daily monitoring processes like equipment calibration and testing control samples to verify test accuracy and precision. Quality assessment through external proficiency testing further challenges the quality programs. Proper quality control is implemented through all stages of testing - pre-analytical, analytical and post-analytical. Statistical tools like Levey-Jennings charts and Westgard rules are used to monitor quality control data and identify out of control results. The goal is to minimize errors and validate test results for optimal patient care.
This document discusses laboratory errors in medical practice. It notes that 0.1-3% of laboratory tests have errors, with most occurring in the pre-analytic and post-analytic phases rather than the analytic phase. Common pre-analytic errors include inappropriate test requests, order entry mistakes, misidentification of patients, and improper sample collection, transport, or storage. Analytic errors are less than 10% of total errors. The document also provides examples of how biological and behavioral factors can influence test results, and discusses clinical performance characteristics of medical tests.
This document discusses laboratory errors, their causes, types, and impacts. It describes that errors can occur in the pre-analytical, analytical, and post-analytical phases of testing and provide examples of errors in each phase. Errors are categorized as either determinate (systemic) errors, which are reproducible and can be identified and corrected, or indeterminate (random) errors, which are caused by uncontrollable variables and cannot be eliminated. The key goals are improving precision by reducing indeterminate errors and improving accuracy by reducing determinate errors.
The document discusses various pre-analytical and post-analytical errors that can occur in clinical laboratories. It notes that errors commonly occur in specimen receiving, sampling, transport, and results reporting. Some common errors include entering the wrong patient data, incomplete patient information, misidentifying tests, collecting samples from patients with the wrong test orders, and not fulfilling all requested investigations. The document also discusses various biological and environmental factors that can influence laboratory test results, such as patient posture, exercise, underlying medical conditions, drug use, and diet. Proper specimen collection and handling is important to avoid pre-analytical errors.
Quality Assurance of Laboratory Test Results based on ISO/IEC 17025PECB
The document discusses quality assurance of laboratory test results based on ISO/IEC 17025. It discusses the importance of analytical measurement data and ensuring results are accurate and precise. It describes internal quality control procedures like spikes, blanks, and replicates that analysts use to ensure results are correct. It also discusses external quality assurance like participating in inter-laboratory comparisons and proficiency testing schemes. The document emphasizes that laboratories must have quality control procedures to monitor validity of tests and ensure trends in results are detectable.
QUALITY
Conformance to the requirements of users or customers satisfaction of their needs and expectations.
Total Quality Management
A management approach that focuses on processes and their improvement.
Quality assurance in relation to medical laboratory accreditationDr. T.A. Varkey
Dr. TA Varkey PhD, Managing Director, Medilab Speciality Laboratories, Kochi explains the need of Quality Control in Clinical Laboratories and how Quality assurance can be made on various procedures done.
Quality assurance in the department of clinical biochemistryDipesh Tamrakar
This document discusses quality assurance and control in clinical laboratories. It explains that quality control aims to ensure test results are correct by monitoring performance through tools like internal quality control and external quality assessment. The document outlines the pre-analytical, analytical and post-analytical phases of testing and discusses specific quality control procedures used at each stage like storage of controls, monitoring control data, and troubleshooting out of control errors. Westgard rules for determining if quality control is in or out of control are also explained.
ISO 15189 is an international standard that specifies the general requirements for the competence of medical laboratories. It is based on ISO 17025 for testing and calibration laboratories and ISO 9001 for quality management systems. ISO 15189 has both management and technical requirements that medical laboratories must meet in order to be accredited. The standard is designed to ensure that laboratories consistently deliver accurate, reliable and timely medical testing services.
Internal Quality Control Lecture MD General 2014 Course, Clin Path Ain Shams ...Adel Elazab Elged
The document discusses internal quality control in clinical laboratories. It defines key terms like quality control, quality assurance, and quality management. It explains the importance of internal quality control in ensuring accurate and reliable test results. Quality control involves running control samples alongside patient samples and using statistical tools like control charts and Westgard rules to monitor the analytical process and ensure it is in control. Factors that could indicate the process is out of control are also summarized.
This document discusses quality control in laboratories. It defines key terms like quality assurance, quality assessment, total quality management, and continuous quality improvement. It describes factors that can affect quality like pre-analytical, analytical, and post-analytical variables. The importance of standard operating procedures, proficiency testing, and documenting quality control procedures is emphasized. Maintaining accurate and precise results through internal quality control using control charts and Westgard rules is also outlined.
Pre analytic and postanalytic test managementVarsha Shahane
The document discusses principles of pre-analytic, analytic, and post-analytic test management. It covers test selection and evaluation, requisition and test menu formats, and report formatting. The three phases of quality assurance - pre-analytic, analytic, and post-analytic - are described in detail, including factors influencing each phase like specimen handling, equipment calibration, and report review. Quality control procedures are also outlined to ensure test accuracy and reproducibility.
This document discusses laboratory errors and quality control in clinical testing. It describes three types of errors - pre-analytical, analytical, and post-analytical. Pre-analytical errors can occur before the sample reaches the lab due to improper patient preparation, collection, storage, or transport. Analytical errors occur during testing and can be due to issues with samples, equipment, reagents, or operator technique. Post-analytical errors involve improper result reporting. The document emphasizes the importance of quality control, calibration, and statistical analysis to monitor performance and identify errors. Quality control charts can reveal random errors or systematic shifts and trends.
This document discusses external quality assurance (EQA) of serological testing. It outlines key elements of a quality system including documentation, training, assessment, and standards. EQA involves laboratories testing unknown samples provided by an EQA scheme and comparing results to improve accuracy. Participating in EQA allows laboratories to identify any issues, enhance performance, and ensure quality standards are met through objective review of results across laboratories. EQA schemes provide benefits for laboratories and regulatory authorities by establishing networks to improve testing practices and public confidence in testing standards.
Quality control is essential for accurate TTI screening in blood banks. Key elements that must be controlled include the quality of specimens, kits, equipment, standard operating procedures, controls, staff training, validation, record keeping, and result interpretation. Proper labeling and handling of specimens, use of approved kits within expiration dates, calibration of equipment, inclusion of internal and external controls, and validation of results are all important to ensure quality in TTI testing. Control charts can be used to monitor assay performance and identify issues requiring corrective action.
Global Manager Group has prepared presentation to provide information about Medical Laboratory Accreditation Standard - ISO 15189 and about Documentation kit. All the documents like quality manual, procedures, SOPs, audit checklist, etc that required for the ISO 15189 Certification process. are described in details in this presentation.
Understanding statistics in laboratory quality controlRandox
This document discusses laboratory quality control and interpreting quality control results. It outlines a 5 step process: 1) Calculate the mean, 2) Calculate the standard deviation, 3) Establish decision limits, 4) Create a Levey-Jennings chart, and 5) Accept or reject results based on quality control rules. Statistics like the mean, standard deviation, and decision limits are used to monitor the accuracy and precision of analytical testing and ensure reliable patient results. Quality control software can automate the calculation of these statistics and generation of charts to more easily monitor performance.
This document provides an overview of quality control in clinical biochemistry laboratories. It discusses that quality control aims to ensure test results are correct by minimizing errors. Errors can occur in the pre-analytical, analytical, and post-analytical phases. The pre-analytical phase, involving sample collection and handling, accounts for most errors. Laboratories use internal quality control methods like calibration, controls, and Levey-Jennings charts daily, as well as external quality assurance programs, to monitor performance and identify errors. Maintaining quality control is important for generating accurate, reliable test results.
Quality control in a virology laboratory.pdfsamwel18
The document discusses quality control in virology laboratories. It defines quality control as measures taken during each assay to ensure tests are working properly, quality assurance as the overall program ensuring results are correct, and quality assessment as external evaluations of laboratory performance. It emphasizes the importance of quality control, quality assurance, and quality assessment programs in producing accurate and consistent diagnostic test results. Key aspects of these programs discussed include monitoring laboratory staff, equipment, record keeping, transcription accuracy, and following standard operating procedures. Quality control specifically refers to measures taken during each assay like using controls and following test protocols.
This document discusses laboratory errors in medical practice. It notes that 0.1-3% of laboratory tests have errors, with most occurring in the pre-analytic and post-analytic phases rather than the analytic phase. Common pre-analytic errors include inappropriate test requests, order entry mistakes, misidentification of patients, and improper sample collection, transport, or storage. Analytic errors are less than 10% of total errors. The document also provides examples of how biological and behavioral factors can influence test results, and discusses clinical performance characteristics of medical tests.
This document discusses laboratory errors, their causes, types, and impacts. It describes that errors can occur in the pre-analytical, analytical, and post-analytical phases of testing and provide examples of errors in each phase. Errors are categorized as either determinate (systemic) errors, which are reproducible and can be identified and corrected, or indeterminate (random) errors, which are caused by uncontrollable variables and cannot be eliminated. The key goals are improving precision by reducing indeterminate errors and improving accuracy by reducing determinate errors.
The document discusses various pre-analytical and post-analytical errors that can occur in clinical laboratories. It notes that errors commonly occur in specimen receiving, sampling, transport, and results reporting. Some common errors include entering the wrong patient data, incomplete patient information, misidentifying tests, collecting samples from patients with the wrong test orders, and not fulfilling all requested investigations. The document also discusses various biological and environmental factors that can influence laboratory test results, such as patient posture, exercise, underlying medical conditions, drug use, and diet. Proper specimen collection and handling is important to avoid pre-analytical errors.
Quality Assurance of Laboratory Test Results based on ISO/IEC 17025PECB
The document discusses quality assurance of laboratory test results based on ISO/IEC 17025. It discusses the importance of analytical measurement data and ensuring results are accurate and precise. It describes internal quality control procedures like spikes, blanks, and replicates that analysts use to ensure results are correct. It also discusses external quality assurance like participating in inter-laboratory comparisons and proficiency testing schemes. The document emphasizes that laboratories must have quality control procedures to monitor validity of tests and ensure trends in results are detectable.
QUALITY
Conformance to the requirements of users or customers satisfaction of their needs and expectations.
Total Quality Management
A management approach that focuses on processes and their improvement.
Quality assurance in relation to medical laboratory accreditationDr. T.A. Varkey
Dr. TA Varkey PhD, Managing Director, Medilab Speciality Laboratories, Kochi explains the need of Quality Control in Clinical Laboratories and how Quality assurance can be made on various procedures done.
Quality assurance in the department of clinical biochemistryDipesh Tamrakar
This document discusses quality assurance and control in clinical laboratories. It explains that quality control aims to ensure test results are correct by monitoring performance through tools like internal quality control and external quality assessment. The document outlines the pre-analytical, analytical and post-analytical phases of testing and discusses specific quality control procedures used at each stage like storage of controls, monitoring control data, and troubleshooting out of control errors. Westgard rules for determining if quality control is in or out of control are also explained.
ISO 15189 is an international standard that specifies the general requirements for the competence of medical laboratories. It is based on ISO 17025 for testing and calibration laboratories and ISO 9001 for quality management systems. ISO 15189 has both management and technical requirements that medical laboratories must meet in order to be accredited. The standard is designed to ensure that laboratories consistently deliver accurate, reliable and timely medical testing services.
Internal Quality Control Lecture MD General 2014 Course, Clin Path Ain Shams ...Adel Elazab Elged
The document discusses internal quality control in clinical laboratories. It defines key terms like quality control, quality assurance, and quality management. It explains the importance of internal quality control in ensuring accurate and reliable test results. Quality control involves running control samples alongside patient samples and using statistical tools like control charts and Westgard rules to monitor the analytical process and ensure it is in control. Factors that could indicate the process is out of control are also summarized.
This document discusses quality control in laboratories. It defines key terms like quality assurance, quality assessment, total quality management, and continuous quality improvement. It describes factors that can affect quality like pre-analytical, analytical, and post-analytical variables. The importance of standard operating procedures, proficiency testing, and documenting quality control procedures is emphasized. Maintaining accurate and precise results through internal quality control using control charts and Westgard rules is also outlined.
Pre analytic and postanalytic test managementVarsha Shahane
The document discusses principles of pre-analytic, analytic, and post-analytic test management. It covers test selection and evaluation, requisition and test menu formats, and report formatting. The three phases of quality assurance - pre-analytic, analytic, and post-analytic - are described in detail, including factors influencing each phase like specimen handling, equipment calibration, and report review. Quality control procedures are also outlined to ensure test accuracy and reproducibility.
This document discusses laboratory errors and quality control in clinical testing. It describes three types of errors - pre-analytical, analytical, and post-analytical. Pre-analytical errors can occur before the sample reaches the lab due to improper patient preparation, collection, storage, or transport. Analytical errors occur during testing and can be due to issues with samples, equipment, reagents, or operator technique. Post-analytical errors involve improper result reporting. The document emphasizes the importance of quality control, calibration, and statistical analysis to monitor performance and identify errors. Quality control charts can reveal random errors or systematic shifts and trends.
This document discusses external quality assurance (EQA) of serological testing. It outlines key elements of a quality system including documentation, training, assessment, and standards. EQA involves laboratories testing unknown samples provided by an EQA scheme and comparing results to improve accuracy. Participating in EQA allows laboratories to identify any issues, enhance performance, and ensure quality standards are met through objective review of results across laboratories. EQA schemes provide benefits for laboratories and regulatory authorities by establishing networks to improve testing practices and public confidence in testing standards.
Quality control is essential for accurate TTI screening in blood banks. Key elements that must be controlled include the quality of specimens, kits, equipment, standard operating procedures, controls, staff training, validation, record keeping, and result interpretation. Proper labeling and handling of specimens, use of approved kits within expiration dates, calibration of equipment, inclusion of internal and external controls, and validation of results are all important to ensure quality in TTI testing. Control charts can be used to monitor assay performance and identify issues requiring corrective action.
Global Manager Group has prepared presentation to provide information about Medical Laboratory Accreditation Standard - ISO 15189 and about Documentation kit. All the documents like quality manual, procedures, SOPs, audit checklist, etc that required for the ISO 15189 Certification process. are described in details in this presentation.
Understanding statistics in laboratory quality controlRandox
This document discusses laboratory quality control and interpreting quality control results. It outlines a 5 step process: 1) Calculate the mean, 2) Calculate the standard deviation, 3) Establish decision limits, 4) Create a Levey-Jennings chart, and 5) Accept or reject results based on quality control rules. Statistics like the mean, standard deviation, and decision limits are used to monitor the accuracy and precision of analytical testing and ensure reliable patient results. Quality control software can automate the calculation of these statistics and generation of charts to more easily monitor performance.
This document provides an overview of quality control in clinical biochemistry laboratories. It discusses that quality control aims to ensure test results are correct by minimizing errors. Errors can occur in the pre-analytical, analytical, and post-analytical phases. The pre-analytical phase, involving sample collection and handling, accounts for most errors. Laboratories use internal quality control methods like calibration, controls, and Levey-Jennings charts daily, as well as external quality assurance programs, to monitor performance and identify errors. Maintaining quality control is important for generating accurate, reliable test results.
Quality control in a virology laboratory.pdfsamwel18
The document discusses quality control in virology laboratories. It defines quality control as measures taken during each assay to ensure tests are working properly, quality assurance as the overall program ensuring results are correct, and quality assessment as external evaluations of laboratory performance. It emphasizes the importance of quality control, quality assurance, and quality assessment programs in producing accurate and consistent diagnostic test results. Key aspects of these programs discussed include monitoring laboratory staff, equipment, record keeping, transcription accuracy, and following standard operating procedures. Quality control specifically refers to measures taken during each assay like using controls and following test protocols.
Quality Control in Pathological Laboratorysanarehman8159
This document discusses quality control in pathological laboratories. It defines quality as being free from defects and errors. Quality control monitors and evaluates analytical testing processes to ensure reliable patient results. There are two types of quality control: internal quality control performed within the lab, and external quality control performed by an outside agency. Quality assurance involves assessing all aspects of the testing process. Regular quality control using control samples is important to validate test systems and equipment are working properly so patient results can be accurately diagnosed and treated.
Recently ISO 15189:2022 have become available. This would help laboratories set up processes which would yield reproducible results and improve the quality of work.
The document outlines the requirements for medical laboratories to establish and follow quality management standards according to ISO 15189. It describes establishing objectives and policies, managing risks, ensuring adequate resources including personnel, facilities, equipment and processes. Requirements cover pre-examination, examination and post-examination activities including testing, reporting and advisory services. The standard aims to promote quality and competence in medical laboratories to benefit patients.
This document provides a summary of the content areas and competencies tested on the Medical Laboratory Technician (MLT) certification examination. It is organized into six main sections: Blood Bank, Chemistry, Hematology, Microbiology, Urinalysis/Other Body Fluids, and Laboratory Operations. Each section lists the specific topics covered, such as blood typing and crossmatching in Blood Bank or electrolyte and protein testing in Chemistry. Competencies involve technical skills like performing laboratory tests, problem solving abnormal results, verifying quality control, and communicating with clinicians. The examination evaluates knowledge, interpretation, and problem-solving skills through multiple choice questions.
A quality assurance program in a clinical laboratory aims to reduce errors and improve accuracy and precision. It involves preventive activities like staff training, assessment procedures like quality control testing and proficiency testing, and corrective actions. Errors can occur in the pre-analytical, analytical, or post-analytical phases and be either random or systematic. A good quality assurance program detects and addresses errors to deliver reliable results and ensure patient safety.
The document discusses the three phases of TAT (turnaround time) analysis: 1) The pre-analytical phase involves ordering tests, patient preparation, sample collection, processing, and transportation. A large percentage of errors occur during this phase. 2) The analytical phase consists of machine preparation, quality control testing, sample analysis, and result validation. 3) The post-analytical phase covers result evaluation, reporting, communicating critical values, sample storage and disposal, and archiving documents. Together these phases outline the process of testing from start to finish.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, including that GLP was created by the FDA in the 1970s in response to cases of fraudulent laboratory practices. The key objectives of GLP are to ensure study data is accurate, traceable, and promotes international acceptance of tests. GLP establishes requirements for facilities, equipment, personnel, methods, records, and quality assurance programs. Laboratories must adhere to GLP in order to produce reliable results for regulatory submissions.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, explaining that GLP was created by the FDA in the 1970s after investigations found fraudulent activities and poor practices in toxicology labs. The objectives of GLP are to ensure data submitted are an accurate reflection of study results and that data is traceable. GLP provides a framework for planning, conducting, monitoring, recording and reporting laboratory studies while maintaining quality assurance.
The document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of laboratory studies related to health and safety. It provides background on GLP, including that GLP was created by the FDA in the 1970s in response to cases of fraudulent laboratory practices. The key objectives of GLP are to ensure laboratory study data is accurate, traceable, and can be relied upon for regulatory decision making. GLP establishes requirements for facilities, equipment, personnel, methods, records, and management to ensure the integrity of all safety data generated during nonclinical health and environmental safety studies.
White Paper Quality Control for Point of Care TestingRandox
Point of care testing (POCT) refers to testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient.
Quality Control for Point of Care Testing - White PaperRandox
Point of care testing (POCT) refers to testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient. Over the past few years, the popularity and demand of POCT has been growing rapidly. This should come as no surprise as there are many advantages to POCT, for example, the added convenience of being able to obtain a rapid result at the patient’s bedside, thus allowing immediate action, saving time and improving the potential outcome for the patient.
This document summarizes key concepts related to quality systems including change control, out of specifications, and out of trends. It defines change control as a procedure to review, verify, regulate, manage, approve and control changes made to existing systems or processes. It describes the process for managing change control including establishing written procedures and evaluating all changes that could impact quality, safety or efficacy. It also discusses out of specifications results as test results that fall outside established acceptance criteria and the procedures for investigating such results, including retesting and root cause analysis. Finally, it defines out of trend results as those that do not follow the expected trend over time and methods for identifying out of trend results.
This document discusses quality control and quality assurance in microbiological laboratory investigations. It emphasizes the importance of standard operating procedures, internal quality assessment, and external quality assessment. Quality control occurs at multiple stages of analysis, including pre-analytical (specimen collection and transport), analytical (reagents, equipment, procedures), and post-analytical (reporting and interpretation of results). A quality control officer oversees quality control in the department through regular monitoring, assessment, communication, and analysis of quality control data.
This document discusses the importance of validation for point-of-care testing (POCT) devices. It notes that while POCT allows for quick results, the environment is less controlled than a laboratory and results carry a higher risk of inaccuracy. It then outlines several key steps in validating a new POCT device, including establishing clinical need, choosing the correct device, deciding on sample types, parameters to assess like imprecision and accuracy, and who should perform the validation. The document emphasizes that validation in both laboratory and end-user settings is important to ensure a POCT device performs as intended when used outside the lab.
This document discusses the importance of validation for point-of-care testing (POCT) devices. It notes that while POCT allows for quick results, the environment is less controlled than a laboratory and results carry a higher risk of inaccuracy. It then outlines several key steps in validating a new POCT device, including establishing clinical need, choosing the correct device, deciding on sample types, parameters to assess like imprecision and accuracy, and who should perform the validation. The document emphasizes that validation in both laboratory and end-user settings is important to ensure a POCT device performs as intended when used outside the lab.
Quality assurance and quality control procedures are essential for ensuring accurate and reliable laboratory test results. Key aspects of QA/QC include establishing standardized operating procedures, conducting regular quality control tests using standards and controls, participating in proficiency testing, and monitoring all phases of testing from specimen collection through result reporting. Together, an effective QA/QC program helps reduce errors and improve the precision, accuracy, reliability and validity of test results.
This document discusses quality assurance in mycobacteriology laboratories. It describes the three main components of a quality assurance system as quality control, external quality assessment, and quality improvement. Quality control procedures should address pre-analytical, analytical, and post-analytical phases of testing. Monitoring performance indicators such as contamination rates, turnaround times, and proficiency testing scores helps to evaluate laboratory performance and identify areas for improvement.
The medical laboratory workflow can be divided into three main phases: pre-analytical, analytical, and post-analytical. Samples first go through sample collection, transportation, and registration before being prepared for analysis. Quality controls are run regularly to ensure machine accuracy. Samples are then analyzed and results are validated before being reported to clinicians. Proper sample handling and a standardized workflow are important for reducing errors and turnaround time while maintaining quality.
Similar to Post analytical variables dr kamlesh patel (20)
This is simplified lecture, prepared for MBBS students, Nursing students and other medical students also helpful for NEET preparation.
Reference: Essentials of Medical Microbiology by Apurba S Sastry
This document provides an introduction to microbiology and its history. It defines microbiology and medical microbiology, and discusses the classification of microorganisms and the differences between prokaryotes and eukaryotes. Several pioneering scientists in microbiology are described, including their major contributions. Koch's postulates for establishing causation of infectious disease are also summarized. Finally, some Nobel Prize winners in microbiology are listed along with their seminal research.
This document discusses the measles, mumps, and rubella viruses. It provides details on their morphology, genomes, hosts, and pathogenesis. For diagnosis, it recommends microscopy to detect viral antigens, virus isolation in cell culture, and serological tests like ELISA and complement fixation. It describes symptoms and complications for each virus. The mumps virus causes parotid gland inflammation. Measles causes rashes and pneumonia. Rubella can cross the placenta and cause fetal abnormalities. Vaccination with the live attenuated MMR vaccine provides protection.
This document summarizes key information about orthomyxoviruses and influenza viruses. It describes that orthomyxoviruses are enveloped viruses with segmented, single-stranded RNA genomes that cause hemagglutination. Influenza viruses belong to the orthomyxovirus family and have three serotypes: A, B, and C. Influenza A infects both humans and animals and is further classified into subtypes based on two surface proteins, hemagglutinin and neuraminidase. The document outlines the structure, antigens, pathogenesis, diagnosis, epidemiology, and prevention of influenza viruses.
This document provides information on various paramyxoviruses, including parainfluenza virus, mumps virus, measles virus, and respiratory syncytial virus (RSV). It describes their morphology, genome, taxonomy, pathogenesis, transmission, symptoms, complications, diagnosis, and treatment. The paramyxoviruses are enveloped viruses that contain single-stranded, negative-sense RNA genomes. They cause a variety of respiratory illnesses in humans and animals. Laboratory diagnosis involves antigen detection, virus isolation, serology, and molecular techniques like RT-PCR. Vaccines are available to prevent infections from some paramyxoviruses.
Rickettsia are obligate intracellular parasites that can cause several diseases in humans. They are transmitted by arthropod vectors like ticks, fleas and mites. Rickettsia species cause diseases like epidemic typhus, endemic typhus, Rocky Mountain spotted fever and scrub typhus. They multiply within the cells of the host and can cause damage to endothelial cells leading to symptoms such as rashes, fever and organ dysfunction. Diagnosis involves serological tests like the Weil-Felix test or immunofluorescence assays. Treatment is with doxycycline or chloramphenicol.
Stem cell transplantation involves transplanting stem cells from bone marrow, peripheral blood, or umbilical cord blood to treat diseases like cancer or blood disorders. There are two main types - autologous transplants using a patient's own stem cells and allogeneic transplants using donor stem cells. Umbilical cord blood is now commonly used as it contains young stem cells and a better HLA match is tolerated. The transplantation process involves conditioning the patient with chemotherapy or radiation, infusing the stem cells, and managing side effects like graft-versus-host disease and infections during recovery.
The document discusses semen analysis, including:
1. It describes the different fractions that make up semen and their functions, such as nourishing sperm.
2. Semen analysis provides information on sperm production, male duct patency, accessory gland function, and ejaculation. It is used to evaluate male infertility, vasectomy effectiveness, and artificial insemination suitability.
3. Parameters examined in semen analysis include volume, pH, sperm count, motility, morphology, and presence of round cells. Tests are performed within a few hours of collection to assess these parameters.
4. Multiple factors can affect semen analysis results, so repeated testing is often needed for an accurate assessment
Pseudomonas are aerobic, non-spore forming, gram-negative bacilli that can cause opportunistic infections in humans and other hosts. Pseudomonas aeruginosa is a common cause of nosocomial infections and can infect the urinary tract, lungs, blood, and other sites. It is resistant to many antibiotics but can be treated with combinations including gentamicin and carbenicillin. Pseudomonas produces pigments like pyocyanin and pyoverdin and secretes toxins and enzymes that contribute to its virulence and ability to infect compromised hosts like burn patients.
Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...nirahealhty
The South Beach Coffee Java Diet is a variation of the popular South Beach Diet, which was developed by cardiologist Dr. Arthur Agatston. The original South Beach Diet focuses on consuming lean proteins, healthy fats, and low-glycemic index carbohydrates. The South Beach Coffee Java Diet adds the element of coffee, specifically caffeine, to enhance weight loss and improve energy levels.
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Let's Talk About It: Breast Cancer (What is Mindset and Does it Really Matter?)bkling
Your mindset is the way you make sense of the world around you. This lens influences the way you think, the way you feel, and how you might behave in certain situations. Let's talk about mindset myths that can get us into trouble and ways to cultivate a mindset to support your cancer survivorship in authentic ways. Let’s Talk About It!
This particular slides consist of- what is Pneumothorax,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is a summary of Pneumothorax:
Pneumothorax, also known as a collapsed lung, is a condition that occurs when air leaks into the space between the lung and chest wall. This air buildup puts pressure on the lung, preventing it from expanding fully when you breathe. A pneumothorax can cause a complete or partial collapse of the lung.
INFECTION OF THE BRAIN -ENCEPHALITIS ( PPT)blessyjannu21
Neurological system includes brain and spinal cord. It plays an important role in functioning of our body. Encephalitis is the inflammation of the brain. Causes include viral infections, infections from insect bites or an autoimmune reaction that affects the brain. It can be life-threatening or cause long-term complications. Treatment varies, but most people require hospitalization so they can receive intensive treatment, including life support.
Feeding plate for a newborn with Cleft Palate.pptxSatvikaPrasad
A feeding plate is a prosthetic device used for newborns with a cleft palate to assist in feeding and improve nutrition intake. From a prosthodontic perspective, this plate acts as a barrier between the oral and nasal cavities, facilitating effective sucking and swallowing by providing a more normal anatomical structure. It helps to prevent milk from entering the nasal passage, thereby reducing the risk of aspiration and enhancing the infant's ability to feed efficiently. The feeding plate also aids in the development of the oral muscles and can contribute to better growth and weight gain. Its custom fabrication and proper fitting by a prosthodontist are crucial for ensuring comfort and functionality, as well as for minimizing potential complications. Early intervention with a feeding plate can significantly improve the quality of life for both the infant and the parents.
MBC Support Group for Black Women – Insights in Genetic Testing.pdfbkling
Christina Spears, breast cancer genetic counselor at the Ohio State University Comprehensive Cancer Center, joined us for the MBC Support Group for Black Women to discuss the importance of genetic testing in communities of color and answer pressing questions.
About this webinar: This talk will introduce what cancer rehabilitation is, where it fits into the cancer trajectory, and who can benefit from it. In addition, the current landscape of cancer rehabilitation in Canada will be discussed and the need for advocacy to increase access to this essential component of cancer care.
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TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardso...rightmanforbloodline
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
Michigan HealthTech Market Map 2024. Includes 7 categories: Policy Makers, Academic Innovation Centers, Digital Health Providers, Healthcare Providers, Payers / Insurance, Device Companies, Life Science Companies, Innovation Accelerators. Developed by the Michigan-Israel Business Accelerator
This particular slides consist of- what is hypotension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is the summary of hypotension:
Hypotension, or low blood pressure, is when the pressure of blood circulating in the body is lower than normal or expected. It's only a problem if it negatively impacts the body and causes symptoms. Normal blood pressure is usually between 90/60 mmHg and 120/80 mmHg, but pressures below 90/60 are generally considered hypotensive.
2. Preanalytical Phase (40- 60 %)
Analytical Phase (7-15 %)
Post-analytical Phase (18-30 %)
● Postanalytical errors occur with entry, manipulation, and reporting
or releasing report or due to improper TAT.
Laboratory testing cycle: 3 Phases
3. Post analytical phase can be further divided into two phases:
1. Phase inside the laboratory
1. Phase outside the laboratory (post-post-analytical phase):
○ It is not covered in the present recommendations.
○ Refers to procedures in which a physician makes medical
decisions based on laboratory test reports.
Post-analytical can be further divided:
4. 1. Evaluation of test results
2. Decision to release test results
3. Preparation of the laboratory test report
4. Release of the laboratory test report
5. Reporting of test results
6. Sample storage and disposal
7. Archiving of laboratory documentation
8. Post-analytical quality indicators.
Procedures of the post-analytical phase
5. All test results before release must be evaluated through two mutually
independent activities:
A. Review of test results: This includes
1.1. Comparison with reference intervals
1.2. Comparison with previous results
1.3. Additional procedures
B. Confirmation of test results.
PROCEDURE 1: Evaluation of test results
6. 1.1. Comparison with reference intervals:
Reference intervals or relevant limits according to age and gender have to
be present.(Mandatory)
If reference interval can not be defined it has to indicated in the
“Comments” area.
Reference interval is defined as the central 95% interval bounded by the
2.5th and 97.5th percentiles for a reference population.
PROCEDURE 1: Evaluation of test results
7. 1.2. Comparison with previous results
The testing of the difference between two consecutive results (delta
check) (if previous result available)
Difference between successive results may indicate:
a. A significant change in the patient’s clinical condition, or
b. A problem with the sample.
PROCEDURE 1: Evaluation of test results
8. 1.2. Comparison with previous results
1.2.1. Reference change value(RVC %)
It is useful to assess the significant change in serial results from one
individual using the reference change value (RCV).
It can different for every test. Every lab should define reference change
value in %.
1.2.2. Delta check
PROCEDURE 1: Evaluation of test results
9. Methods of performing the delta check:
a. Delta difference: Current value – previous value
b. Delta percent change [(Current value – previous value) / previous
value] x100
Delta check is a post-analytical method, every laboratories should define
methods to perform the delta check as well as actions to be taken when
the delta check exceeds the laboratory-specified limits because it can be
very useful to check overall quality of pre analytical and analytical phase.
PROCEDURE 1: Evaluation of test results
10. Delta check
Recommended actions:
a) Clinical detail: clinical diagnosis, therapeutic interventions, contacting a
physician
b) Retesting the current and previous sample (if available)
c) Checking for the presence of haemolysis, lipemia, icterus, clot
d) Error in tube labelling of the previous and current sample.
PROCEDURE 1: Evaluation of test results
11. 1.3. Additional procedures
1.3.1. Sample dilution
1.3.2. Repeat testing
1.3.3. Communication with a physician/clinical department
1.3.4. Reflex testing: Automated by machine itself as per defined criteria.
1.3.5. Reflective testing: Non-automated procedure in which laboratory
experts add additional tests and/or comments to the original request.
PROCEDURE 1: Evaluation of test results
12. This decision is made based on all factors that may have influenced the
results, including clinical condition and diagnosis, treatment procedures,
as well as pre-analytical and analytical factors.
2.1. Competences of decision-making laboratory personnel
These personnel must hold master’s degrees in medical biochemistry and
laboratory medicine for the authorisation.
PROCEDURE 2: Decision to release test results
13. A laboratory test report has to meet the minimum content
requirements:
3.1. Content and layout of the laboratory test report
● Use of recommended, standardised language.
● Presence of all administrative and patient identification data.
● Measurement results and confirmation data.
● Where appropriate, the report should also include comments
necessary for interpretation.
PROCEDURE 3: Preparation of the lab test report
14. Minimum required content of a laboratory test report
● Administrative data: Detail of the testing laboratory
● Patient identification information* and barcode
● Attributes of measures: Result, reference range, comments,
methods, sample type etc.
● Confirmation of data: Checked by, authorised by etc.
● Comments:
PROCEDURE 3: Preparation of the lab test report
15. ● Electronically or in printed form.
● Electronically released laboratory test reports must be in a “read-only”
format that permits no alterations.
● If releasing laboratory test reports includes sending them
electronically to the patient or the requesting physician via e- mail, the
laboratory must receive signed consent from the patient or physician.
● Results released orally must be documented by the lab.
● The laboratory should record policies and procedures about releasing
reports, including details about who releases reports and to whom.
PROCEDURE 4: Release of the lab test report
16. Each laboratory must define how it reports test results.
● If results are communicated by telephone, the content of the
communication, the authorisation to give and receive the information.
(Policy and documentation must)
5.1. Reporting of critical results:
● The Lab must have critical limits of laboratory test results. (Define
policy and documentation must)
● Reporting critical results to physicians or other authorised medical
personnel.
● Critical results have to be reported within 30 minutes of confirmation.
PROCEDURE 5: Reporting of test results
17. PROCEDURE 6: Sample storage and disposal
● The laboratory must have a documented procedure for storing and
safe disposal of biological samples.
● Primary samples must be stored after analyses to ensure their
availability for re-testing or additional testing.
● The laboratory must define durations of storage for biological
samples.
● Optimal storage conditions and duration depend on the type of
sample, analyte stability and analyte half-life.
18. ● Generally, serum or plasma can be stored for 4 hours at room
temperature in primary uncapped tubes, 48 hours at 4 ºC in primary
capped tubes, and several days to several months at - 20 ºC in
secondary capped tubes.
● When a requesting laboratory sends a sample to a referral laboratory, the
shipment should be documented, and an aliquot of the sample should first be
removed and stored at - 20 ºC.
● Temperature control should be regularly monitored.
● If an institution archives samples for education, research, or other public
health interests, Must define and document)
● Samples must be disposed safely.
PROCEDURE 6: Sample storage and disposal
19.
20. ● Recording and maintenance of medical documentation is a general
(public) duty of health care professionals.
● Archiving of laboratory documentation means storing all important and
meaningful data and notifications in a format that is dated and
certified and can protect the data for a minimum period of time.These
minimum storage periods vary with the type of document.
● the archiving system must protect against documentation loss or
damage.
● If the LIS is linked to the HIS, each employee using the HIS system
should be assigned an account.
PROCEDURE 7: Archiving of lab documentation
21. The importance of personal data (name, address, email address, IP
address and access point (MAC), global positioning system (GPS)
location, telephone number, video recordings of individuals, identification
number, biometric data (genetic data, educational and professional
information, health data, sexual orientation).
PROCEDURE 7: Archiving of lab documentation
22.
23. PROCEDURE 8: Post-analytical quality indicators
Minimum recommended quality indicators for the post-analytical phase
are: turnaround time (TAT), percentage of incorrect laboratory test
reports, and notification of critical results.
8.1. Turnaround time
Turnaround time (TAT) is the time interval from the time when the
laboratory receives the sample until the time the test results for that
sample are validated and released.
Monitoring of turnaround time can be expressed in terms of percentage of
tests not performed within a given time.
24. PROCEDURE 8: Post-analytical quality indicators
8.2. Errors during transcription of results/ incorrect laboratory reports
The percentage all laboratory test reports that are incorrect is another essential
quality indicator in the post-analytical phase
8.3. Notification of critical results
All procedures related to the reporting of critical results have to be recorded and
the data periodically analysed (number or proportion of critical results reported
within a defined period of time).
25.
26. Methods to minimise the post analytical errors
Adherence to the guidelines and proper staff training may reduce the post
analytical errors.
27. Take home message
● Post analytical phase is the reflection of Pre analytical and analytical phase.
● Quality starts from the patient himself, patient has to choose right lab or
service before seeking quality.
I am thankful to
Croatian Chamber of Medical Biochemists (CCMB)