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.
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.
Clinical laboratory total quality management (TQM) systemTapeshwar Yadav
Generally, management can be defined as “an ongoing process that seeks to achieve the objectives of an organization in the most efficient ways possible”.
Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency.
Medical laboratory work is composed of the technical activities that produce laboratory results for patient care and the management activities that support the technical work.
It is the job of the laboratory technical staff to perform pre-analytic activities, analytic activities and post analytic activities that transforms a clinician’s order for a laboratory test.
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.
Clinical laboratory total quality management (TQM) systemTapeshwar Yadav
Generally, management can be defined as “an ongoing process that seeks to achieve the objectives of an organization in the most efficient ways possible”.
Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency.
Medical laboratory work is composed of the technical activities that produce laboratory results for patient care and the management activities that support the technical work.
It is the job of the laboratory technical staff to perform pre-analytic activities, analytic activities and post analytic activities that transforms a clinician’s order for a laboratory test.
Troubleshooting QC Problems: Your QC has failed, what do you do next?Randox
Randox Quality Control's next 'Improving Laboratory Performance Through Quality Control' educational guide has been published with helpful tips that your laboratory can use in order to ensure it has effective troubleshooting procedures in place.
So you ran QC this morning and realised that one of your analytes has been flagged as 'out-of-control', what do you do next? Do you ignore the warning and continue patient testing, repeat the control until it's within range or do you halt patient testing and investigate the source of the error?
When it comes to troubleshooting QC errors, unfortunately there is no easy path to take. However, it's important that you have standard operating procedures in place, outlining what to do in the event of an out-of control error. Errors occur in laboratories all over the world. A lab with effective troubleshooting procedures in place will still have errors but will be able to detect them, quickly reducing their impact and reducing the risk of wasting both time and money.
Laboratory Internal Quality Control presentation master revision, 2014Adel Elazab Elged
Short presentation about using internal quality control material in clinical laboratory to ensure analytical quality laboratory results for the sake of better patient care and minimizing errors in diagnosis, management, and follow up.
Troubleshooting Poor EQA/QC Performance in the Laboratory Randox
Step by step guide for clinical laboratories wishing to troubleshoot poor QC or EQA performance. Tips on how to distinguish between random error and systematic error. Suggested corrective actions are also provided.
Troubleshooting QC Problems: Your QC has failed, what do you do next?Randox
Randox Quality Control's next 'Improving Laboratory Performance Through Quality Control' educational guide has been published with helpful tips that your laboratory can use in order to ensure it has effective troubleshooting procedures in place.
So you ran QC this morning and realised that one of your analytes has been flagged as 'out-of-control', what do you do next? Do you ignore the warning and continue patient testing, repeat the control until it's within range or do you halt patient testing and investigate the source of the error?
When it comes to troubleshooting QC errors, unfortunately there is no easy path to take. However, it's important that you have standard operating procedures in place, outlining what to do in the event of an out-of control error. Errors occur in laboratories all over the world. A lab with effective troubleshooting procedures in place will still have errors but will be able to detect them, quickly reducing their impact and reducing the risk of wasting both time and money.
Laboratory Internal Quality Control presentation master revision, 2014Adel Elazab Elged
Short presentation about using internal quality control material in clinical laboratory to ensure analytical quality laboratory results for the sake of better patient care and minimizing errors in diagnosis, management, and follow up.
Troubleshooting Poor EQA/QC Performance in the Laboratory Randox
Step by step guide for clinical laboratories wishing to troubleshoot poor QC or EQA performance. Tips on how to distinguish between random error and systematic error. Suggested corrective actions are also provided.
Cellular adaptations, injury and death.. Lecture 1Ashish Jawarkar
This is a series of lectures on general pathology useful for undergraduate and postgraduate pathology students. The ppts here have are enriched with explanatory pictures as well as useful video links.. hope you find them useful
Explains what troubleshooting is, what skills are involved, and clears up some common misconceptions. Originally designed with IT Helpdesks in mind, but it could apply to any kind of troubleshooting.
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Wrote this a VERY long time ago! I always meant to revisit/revamp it, but never quite got round to it. But people seem to get value from it, so I'll leave it up :)
Each month, join us as we highlight and discuss hot topics ranging from the future of higher education to wearable technology, best productivity hacks and secrets to hiring top talent. Upload your SlideShares, and share your expertise with the world!
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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 control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer. QC is similar to, but not identical with, quality assurance (QA).
QC IN clinical biochemistry labs and hospitals
This is a powerpoint presentation on the Topic of Diseases of the immune system, part 1 - Chapter 6, based on Robbin's textbook of pathology. Prepared by Dr. Ashish Jawarkar, who is Assistant professor at Parul institute of medical sciences and research, Vadodara. Please subscribe to our youtube channel https://www.youtube.com/channel/UCwjkzK-YnJ-ra4HMOqq3Fkw . Our facebook page: facebook.com/pathologybasics. Instagram handle @pathologybasics
This is a powerpoint presentation on the Topic of Male and female genital tract, based on Robbin's textbook of pathology. Prepared by Dr. Ashish Jawarkar, who is Assistant professor at Parul institute of medical sciences and research, Vadodara. Please subscribe to our youtube channel https://www.youtube.com/channel/UCwjkzK-YnJ-ra4HMOqq3Fkw . Our facebook page: facebook.com/pathologybasics
This is a presentation on the topic of Adaptations, Cell injury and cell death, prepared by Dr Ashish Jawarkar, he is MD in pathology and a teacher at Parul institute of Medical sciences and research Vadodara.
This is a presentation on the topic of hemodynamic disorders, thromboembolic diseases and shock, prepared by Dr Ashish Jawarkar, he is MD in pathology and a teacher at Parul institute of Medical sciences and research Vadodara.
This is a presentation on the topic of Inflammation and repair, prepared by Dr Ashish Jawarkar, he is MD in pathology and a teacher at Parul institute of Medical sciences and research Vadodara.
This is a presentation on the topic of cytology of the breast, prepared by Dr Ashish Jawarkar, he is MD in pathology and a teacher at Parul institute of Medical sciences and research Vadodara.
This is a presentation covering all techniques in histopathology. Comprehensive coverage of all related aspects.. Useful for postgraduate Pathology students and practitioners.
This is a presentation on most common applications of immunohistochemistry in breast lesions. Prepared by Dr Ashish Jawarkar, Assistant professor in pathology, Parul Institute of Medical sciences and research Vadodara
This is a powerpoint presentation of Immunohistochemistry of lesions of prostate. This presentation will be helpful for postgraduate pathology students and practitioners alike. We are also on youtube. Please visit our channel at https://www.youtube.com/channel/UCwjkzK-YnJ-ra4HMOqq3Fkw
Dear all, Pathologybasics is out with a new series of power point presentations on general Pathology.. Following is link presentation on seventh and the most difficult to understand chapter of robbins.. chapter 7,neoplasia. Any suggestions/feedback/constructive criticism are welcome on facebook.com/pathologybasics or pathologybasics@gmail.com
Dear all, Pathologybasics is out with a new series of power point presentations on General Pathology.. Following is link presentation on amyloidosis covered in chapter 6 of Robbins. Remaining topics will be uploaded as a separate presentation soon.
Dear all, Pathologybasics is out with a new series of power point presentations on Systemic Pathology.. Following is link presentation on 12th chapter of robbins - the heart.This presentation includes valvular heart diseases, endocarditis, cardiomyopathies, pericardial diseases and tumors of the heart. Remaining topics will be uploaded as a separate presentation soon.
CSF - Cerebrospinal fluid examination - from tapping to pathological diagnosisAshish Jawarkar
This is a series of notes on clinical pathology, useful for undergraduate and postgraduate students, as well as practising pathologists. Prepared from standard text books with data in tabular and easily readable format
This is a series of lectures on microbiology, useful for both undergraduate and post graduate medical and paramedical students... This lecture covers cholera, typhoid, diarrhoea and dysentry
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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Notes on Quality control in Clinical laboratories.. By Dr. Ashish V. Jawarkar
Contact: pathologybasics@gmail.com... Facebook: www.facebook.com/pathologybasics
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2. 2 of 27
Notes on Quality control in Clinical laboratories.. By Dr. Ashish V. Jawarkar
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OVERVIEW
1. Introduction
2. Terms and Definitions
1. Statistical quality control
2. Errors and mistakes
3. Preanalytic, analytic and post analytic stage
4. Precision and accuracy
5. Types of analytic errors
1.Random error
2.Systematic error
3.Total analytical error
4.Allowable total analytical error
6. Internal and external SQC
7. Control materials
8. Calibrators
3. Internal Quality control
1. Normal distribution
2. Calculation of control limits
3. Levy Jennings chart
4. The Westgard rules
5. The average of Normals method
6. Bull’s algorithm
7. Delta check method
4. External Quality control
1. Basics
2. EQAS charts and statistics
3. Precision index and coefficient of variation ratio
4. EQC normal distribution charts
5. Youden plots
6. Yundt chart
5. Quality specifications
6. Criteria for acceptable performance
7. Appendix
3. 3 of 27
Notes on Quality control in Clinical laboratories.. By Dr. Ashish V. Jawarkar
Contact: pathologybasics@gmail.com... Facebook: www.facebook.com/pathologybasics
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Introduction
1. The purpose of a clinical laboratory is to evaluate the patho-physiologic
condition of an individual patient to assist with the diagnosis and / or to monitor
therapy.
2. To have value for clinical decision making, an individual laboratory test result
must have total error small enough to reflect the biological condition being
evaluated.
3. Moreover nowadays, the overwhelming majority of laboratory results are being
generated by automated analysers.
4. These analysers are developed by integration of technologies; analytical
chemistry, computer science and robotics.
5. This has diminished the routine laboratory work significantly; the role of
technologists and pathologists has been shifted to ensuring that the results that
these machines give are accurate.
6. This is achieved by doing proper maintenance, quality control and calibration and
data management.
4. 4 of 27
Notes on Quality control in Clinical laboratories.. By Dr. Ashish V. Jawarkar
Contact: pathologybasics@gmail.com... Facebook: www.facebook.com/pathologybasics
Web: pathologybasics.wix.com/notes
Terms and definitions
1. Statistical quality control / Statistical process control
1. For centuries, manufacturers have checked the quality of their products to
find out defects. At that time, every product was checked one by one, without
exception.
2. But with large scale production, it became impossible to check each and every
product manufactured.
3. Modern quality control aims to check the quality of a minimum number of
samples from the total production. This procedure is called Statistical quality
control.
4. It would also be wiser to define SQC as the process that focuses on
revealing any deviation from well defined standards.
2. Errors and mistakes
Errors: All “wrong” laboratory measurements due to “non human” actions.
They have a statistical significance.
Mistakes: All “wrong laboratory measurements due to “human” actions.
They have no statistical significance.
3. Pre analytical / analytical and post analytical stage
1. Errors and mistakes can be classified according to the time and stage which
they occur in laboratory practice –
Pre analytical stage – encompasses all procedures that occur before the
analysis of patients samples on automated analyzers (e.g. Blood drawing,
sample transportation, centrifugation, dilution etc.
Analytical stage – Includes analytical methods
5. 5 of 27
Notes on Quality control in Clinical laboratories.. By Dr. Ashish V. Jawarkar
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Post-analytical stage – refers to all procedures after the analysis of
patient’s samples (e.g. Transmission of data from analysers to LIS,
validation of results, printing of results, and communication of results to
clinicians/patients etc.)
MAJORITY OF PRE AND POST ANALYTICAL OUTLIERS ARE
‘MISTAKES’
MAJORITY OF ANALYTICAL STAGE OUTLIERS ARE ‘ERRORS’
2. Most of the laboratory QC processes are directed towards these analytical
stage errors – this is because
a. The analytical errors can be attributed to the laboratory staff
b. These errors can be detected by statistical methods
c. Statistical limits for analytical errors can be established
3. Examples
Preanalytical stage Analytical stage Post analytical stage
1. Inappropriate
specimen (wrong
anticoag, wrong tube,
insufficient specimen)
2. Improper preservation
3. Inappropriate patient
preparation
4. Mistake in patient
identification
1. Expired/denatured
reagents
2. Expired/denatured
control/calibrators
3. Calibration curve
time-out elapsed
4. Failure in sampling
5. Failure in reagent
aspiration
6. Change in analyser
photometric unit/flow cell
7. Analyser failure
1. Wrong matching
between lab result and
patient
2. Wrong copy from
anlyser to laboratory
report
3. Delay in delivering
result to patient/clinician
4. Loss of results
4. Precision and accuracy
1. Precision
1. Precision means repeatability or reproducibility of test results
2. In other words it is the closeness of agreement between repeated
measurements of the same sample (in a very short time, usually on the
same day)
3. PRECISION = xi - x̅
Where xi is a single measurement
x̅ Is average of successive measurements
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2. Accuracy
a. Closeness of agreement between the value obtained by analyser and true
value of the sample
5. Types of analytical errors
1. Random error
a. Result of measurement minus the mean that would result from infinite
measurements of the same sample (see precision – infinite is random
error)
b. RE = xi - x̅ I , where x̅ i is mean of infinite number of measurements
c. Random error affects precision
d. RE is always greater than zero
e. RE can be decreased by increasing the number of measurements
f. It can be attributed to undetermined reasons (inherent error)
2. Systematic error
a. Result of mean that would result from infinite number of
measurements minus the true value of the sample
b. SE = x̅ I - µ , where µ is the true value of the sample
c. Systematic error cannot be decreased by increasing the number of
measurements.
d. It can be attributed to certain reasons and therefore can be eliminated
much easier than random error i.e. it can be zero.
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3. Total analytical error
TE = RE + SE
a. As we have seen from definition of RE, it can never be zero, hence TE can
never be zero.
4. Total allowable analytical error (aTE)
a. Since TE>0 is unavoidable, TE of every single determination must be
lower than a specified limit. This limit is called aTE.
6. Internal and external SQC
a. Random and systematic errors should be detected at an early stage
b. Two statistical methods can help in detection of these errors
1. Internal SQC
a. Performed every day by the laboratory personel with control materials
b. It detects basically the precision
2. External SQC
a. Performed periodically, usually by a third party
b. It checks primarily the accuracy
7. Control materials
a. Control samples are pools of biological fluids
b. They contain analytes which are determined by the laboratory in
concentrations which are close to decision limits where medical action is
required
c. They are usually prepared by the equipment manufacturer / reagent
manufacturers
d. They are available in different levels (concentrations) – these check
performance of laboratory methods over their entire range
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8. Calibrators
1. Calibration is the process of evaluating and adjusting the precision and
accuracy of measurement equipment.
2. For this purpose, reference standards with known values for selected
points covering the range of interest are measured with the instrument in
question. Then a functional relationship is established between the values
of the standards and the corresponding measurements.
3. Enlisting exact steps of calibration is beyond the scope of this document.
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Internal Quality control
1. Normal Distribution
1. Normal or Gaussian distribution (N) is the basis of SQC theory. Distribution chart is a
biaxial diagram (x/y).
2. X-axis represents the values of a variable’s observations and y-axis the frequency of
each value (the number of each value’s appearance).
3. It has a bell-shaped form with its two edges approaching asymptomatically the x-axis.
4. The highest point of normal distribution corresponds to the value with the higher
frequency (mode value). It is always on the top of every
distribution curve.
5. Median value (M) is the value which divides the variable’s observations in two equal
parts. It represents the “center” of the distribution.
6. Mean value or average value (μ or x is equal to the value which all the observations
should have if they were equal. The mean value (µ) or average can be calculated by
the next formula:
Where: xi = Single value, Σxi = Sum of values, N = Total number of values
7. In a normal distribution, mean, median and mode coincide.
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8. Variance – The length of distribution curve defines the variance of the variable. The
most common measure of variance is Standard deviation (SD)(s).
Standard deviation can be calculated by the following formula –
The distance between the upper (UL) and lower limit (LL) of a normal distribution is
six standard deviations (6s). Since mean value is in the center of normal distribution, the
total range of a normal distribution is μ ± 3s (to be more exact, not all, but nearly all
(99.73%) of the values lie within 3 standard deviations (3SD) of the mean).
9. Z Score - Mean and SD allow for calculation of distance of each observation from the
centre (mean). The distance is called the Z score.
It can be calculated by the following formula:
For example we are looking at a distance of value xi = 80 from the mean of the normal
distribution N~(100,5)
Here Z score = 80-100 = -4
5
10. Every normal distribution can defined as N~(μ, s).
For instance N~(76, 2.3) means a normal distribution with mean value = 76 and
standard deviation = 2.3.
11. The distance between upper limit and lower limit of a normal distribution is six
standard deviations (6s). Since mean value is in the center of normal distribution, the total
range of normal distribution is (µ +/- 3s).
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12. The empirical rule of normal distribution
µ+/- s Contains 68.26% of observations
µ+/- 2s Contains 95.46% of observations
µ+/- 3s Contains 99.73% of observations
13. Coefficient of variation (Cv)
Standard deviation depicts variation in the same units as the mean. Hence it
cannot be used to compare distributions with different mean.
In such cases Cv can be used. It is the ratio of standard deviation to mean
expressed as a percentage.
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2. Calculation of normal limits
1. The automated analyzer is calibrated with reference material (calibrator) and
validation of calibration is done with External quality control / Inter Lab
comparison.
2. In internal SQC two or more control level samples are assayed every day at least
once per day before the patient’s samples. Then laboratory checks if all control
values lie within the control limits. If at least one of the two control limits is
outside of one of the two control limits, then further actions may be required until
random or systematic errors are under control.
3. The laboratory staff collects 20-30 successive measurements from any control
level.
4. Standard deviation (s) and mean value (µ) are calculated. Range (µ+/- 3s) is
considered as trial limits (any outlier is rejected).
5. This calculated mean value is then taken as true value of daily controls. Their
standard deviation is the inherent error of the system.
3. Levy Jennings Chart
1. Rotate the normal distribution curve clock wise
2. Draw seven lines from the points µ+ 3s, µ+ 2s, µ+ s, µ, µ - s, µ- 2s, µ- 3s.
3. Values obtained are plotted in the chart date wise.
4. For every different parameter and different level, different LJ chart is plotted.
Random and systematic error in LJ chart
1. If any of the daily control values exceeds 3SD limits, it is a random error.
2. Detection of systematic error is more complicated.
3. In systematic errors two or more successive control values exceed the control limits
which can respectively be 3SD, 2SD or 1SD.
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4. The Westgard Rules
1. Westgard rules are a type of quality criteria used for error detection.
2. They are denoted as AL where A is the number of control values and L is the
control limit.
RULE GRAPH INTERPRETATION
13S One control value lies over
or under 3SD
- Random error
Patient results should be
blocked, and root cause
analysis should be done.
22S Two successive control
values lie between 2SD
and 3SD
- Systematic error
Patient results should be
blocked, and root cause
analysis should be done.
12S One control values lie
between 2SD and 3SD
- Random error
Patient results need not be
blocked, only caution is
warranted.
101S Ten consecutive control
values are on the same side
of the mean
- Systematic error
Patient results should be
blocked, and root cause
analysis should be done.
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5. Average of normals method (AON)
1. LJ chart and Westgard methods are based on analysis of control samples, but
even control samples determination has some disadvantages like –
a. It is costly
b. It is time consuming
2. These disadvantages can be minimized by some other methods – like AON
method.
3. AON method is based on the principle that mean value of all normal results
fluctuate between well defined limits. LJ and Westgard detect random and
systematic errors. AON method detects only systematic error.
4. This method is mostly used for biochemistry analysers.
Method
1. The laboratory collects data for an anaylate from a fixed number of healthy
persons. Its mean value and standard deviation is calculated. This value will be
used as control value.
2. The standard error of these normal samples run daily is calculated with the
following formula.
s = standard deviation, N is number of samples
3. The confidence interval is calculated as follows
4. This confidence interval will be used for definition of control limits of the
method.
5. Every day laboratory calculates the mean value of N normal results, this mean
value is symbolized as AON and is calculated by the following formula –
6. If AON exceeds the control limits, the anaylate’s determination has a systematic
error.
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7. In daily practice AON method has its own control chart which detects only
systematic errors. In AON chart each dot represents a daily mean value of the
same anylate.
6. Bull’s Algorithm
1. The statistical quality control carried out in hematology analyzers has many
important differences from the corresponding techniques in the clinical
chemistry analyzers.
2. These differences are due to reasons such as the high stability of cytometry
technology, the small biological variation of some hematology parameters, the
big reagent vials and the small time lasting of the hematology controls.
3. Because of the above reasons Levey-Jennings charts in hematology analyzers
are different from corresponding charts in clinical chemistry. For instance the
hematology Levey-Jennings charts have only three lines (upper and lower limits
and central line). The reason is that these Levey-Jennings charts are not created
statistically from a normal distribution of former quality control data, which is
not possible because of the very small variation of hematology quality control
values. In hematology analyzers the upper and lower control limits act as the
“specification’s limits” in industry quality control.
4. The small biology variation of many hematology parameters made many
researchers to established quality control methods based only on patients results.
Such suitable parameters are the erythrocyte indexes (MCV, MCHC, MCV)
with the smaller biological variation (due not only to biology but mostly to the
hematology analyzer’s technology).
5. These attributes of them inspired Brian Bull (an American Hematologist) to
establish a new quality control method widely known as “Bull’s algorithm”.
6. Bull’s algorithm (also known as method) detects systematic errors in MCV,
MCHC and MCV and consequently in HgB, Hct and RBC. His method is a kind
of moving average. Its main idea is to estimate the mean value of the last twenty
patients’ values, including in them the mean value of the batch of the previous
twenty values.
7. The algorithm itself is a quite complicated equation which eliminates the outliers
and estimates the moving average of the last twenty values. Bull’s algorithm has
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been proved quite effective in detecting small systematic errors (almost 1%) not
only in erythrocyte indexes but also in almost all the hematology parameters. It
uses all patients’ data without exception. The last fact made Bull’s algorithm the
cheapest quality control method in laboratory medicine.
8. Hematology quality control samples last only 20 – 30 days and are very
expensive, when, on the other hand, whole blood samples are stable in the
refrigerator for 24 hours.
9. These facts led some researchers to find methods which are based on the
repetitive analysis of patient samples. These methods are known as “retained
patient specimens”.
10. In 1988 Cembrowski (Canadian clinical chemist) established the most effective
“retained patient specimens” method. It was based on the repetitive analysis of
the same patient samples between two successive days. His method is known as
“m/nlim”
- “Lim” stands for the quality control limit. It is equal to the double of the
standard deviation of the repetitive analysis (2 x SD).
- “n” stands for the number of patients’ samples which will be analyzed twice.
- “m” stands for the portion of “n” number of samples which is permitted to be
out of limits (“lim”).
Statistical simulations created by Cembrowski proved the effectiveness of his
method. According to him the best combination of “m”, “n” and “lim” is 2, 3, 2 or
2/32s.
Concluding, three different methods are in the disposal of the laboratory in order to
detect the analytical errors in hematology laboratory.
Levey-Jennings detects systematic and random errors. On the contrary, Bull’s
algorithm and “retained patient specimens” detect only systematic errors, but they
have the advantage of the low cost. Laboratory can choose the best combination of
the three
7. Delta check method
1. The AON and Bull’s algorithm detect systematic errors using a group of
patients.
2. Delta check method is used for detecting random errors using previous values of
individual patients.
Delta check = (current value) - ( previous value)
Delta check % = (Current value – Previous value) * 100
Current value
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3. The delta check values should vary between two limits which are called ‘Delta
check limits’. In order to calculate them we must take into consideration the
reasons for delta differences –
a. Intra individual biological variation of the analyate CV1
b. The analytical variation (Smeas) can be easily estimated by the control
values
c. The pre-analytical variation (CVpre-analytical)
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External Quality Control
1. Basics
1. EQC refers to the process of controlling the accuracy of an analytical method
by interlaboratory comparisons.
2. The EQAS co-coordinator prepares a sample pool and sends to the
participants of the scheme one or two samples from the same pool.
3. The samples are assayed by the laboratories using the same equipment and
reagents as they do in routine for patient determinations.
4. The EQAs coordinator gathers all the results and they group them (peer
groupas) according to laboratory analytical methods, analyzers or any other
criteria.
5. Then the coordinator calculates the target value (consensus mean) and its
total variation (standard deviation) of the laboratories results.
6. If any of the laboratories have values outside of the control limits, then this
laboratory is considered ‘out of control’.
7. The out of control laboratories get an indication that there is some problem
with their analysis.
2. Understanding EQAS charts and statistics
a. Standard Deviation Index
1. Standard Deviation Index calculates the distance of laboratory
results from the consensus mean.
2. It quantifies the inaccuracy of the analytical method.
3. It is similar to Z score and calculated by the following formula –
SDI = laboratory result – Mean value of peer group
Standard deviation of peer group
4. The SDI value of each laboratory can be located on proper SDI chart
as follows:
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5. Control limits of SDI are zero+/- 2SDI
6. Four rules are usually employed for SDI evaluation:
a. 2/51SDI – Two from five successive control limits exceed
1SDI, it is a warning rule
b. x̅ 1.5SDI – The mean value of five SDI values exceeds the limits
+/- 1.5SDI. It reveals a lasting systematic error.
c. 13SDI – One value exceeds 3SDI
d. R4SDI – The range between the lower and higher SDI values
exceeds +/- 4SDI
b. Precision index (PI) and coefficient of variation ratio (CVR)
Precision index = Standard deviation of laboratory
Standard deviation of peer group
CVR = CV of laboratory/month
CV of peer group / month
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c. EQC normal distribution charts
1. More often than not, EQAS coordinators represent graphically the
total performance of all the laboratories in a normal distribution
chart.
2. This chart is usually a histogram.
3. The EQAS coordinators usually group the laboratories according to
their analytical methods and their automated analyzer. Histograms
containing two or more peer groups have bars with two or more
different colors respectively.
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d. Youden plot
1. Many EQAS schemes use control samples of different levels in
order to check the performance of the analytical methods.
2. Youden plot is a rectangular chart of which the four angles
correspond to the control limits of the two control levels (-4SD and
+4SD).
3. The acceptable part is the gray zone and the rejected part has
different colors.
4. Each dot represents a different laboratory and therefore Youden plot
describes the whole EQAS scheme.
e. Yundt chart
1. Yundt chart helps to illustrate performance of an analytical method
across all its measuring range.
2. It needs atleast three control levels to be plotted.
3. If the line across the dots of three levels is a straight one, then
laboratory has very good linearity.
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4. If the line across the dots is not straight, the linearity of the method
has several issues.
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Quality Specifications
1. SQCs goal is to detect random and systematic errors or better, to ensure that
total error is lower than total allowable error.
2. aTE depends on certain characteristics of analyate and analytical method like
imprecision, bias, biological variation etc.
3. According to these characteristics some analyates need more or less rigorous
SQC rules than others.
There are two common practices:
United states: depending of analytical performance of the method. This
practice is followed in US. The laboratories follow CLIA regulations.
Europe: aTE depends biological variation of the analyate.
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Criteria for acceptable performance
CV1 - intra individual variation
CV2 – inter individual variation
CVw-day – within day variation
CVb-day – between days variation
CV2
total = CV2
wday + CV2
bday
1st
Criterion of acceptable performance
CVtotal </= 0.5 CV1
2nd
Criteria for acceptable performance
CVwday </= 0.25TE%
3rd
criteria for acceptable performance
CV total </= 0.33 TE%
4th
criteria for acceptable performance
Bias% < 0.25 CV2
1 + CV2
w
5th
criteria for acceptable performance
TE% </= k 0.5 CVw + 0.25 CV2
1 + CV2
w
For k =1.65
TE% </= 1.65 *RE* SE
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APPENDICIES
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