This document discusses quality control in clinical biochemistry laboratories. It explains that laboratory tests play an important role in clinical diagnosis and treatment decisions. Therefore, test results must be reliable and accurate. Quality control involves measures to ensure test accuracy, including internal quality control procedures done daily in the lab and external quality assessment involving evaluation by an outside agency. Proper quality control is essential to producing test results that healthcare providers can trust in making decisions for patients.
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.
Introduction of Automation of the Analytical Process
Unit Operations
Specimen identification
Specimen preparation
Specimen delivery
Specimen loading and aspiration
Specimen processing
Sample induction and internal transport
Reagent handling and storage
Chemical reaction phase
Measurement approaches
Signal processing, data handling and process control
Applications of automation in clinical lab
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.
Introduction of Automation of the Analytical Process
Unit Operations
Specimen identification
Specimen preparation
Specimen delivery
Specimen loading and aspiration
Specimen processing
Sample induction and internal transport
Reagent handling and storage
Chemical reaction phase
Measurement approaches
Signal processing, data handling and process control
Applications of automation in clinical lab
Use of laboratory instruments and specimen processing equipment to perform clinical laboratory assays with only minimal involvement of technologist .
Automation in clinical laboratory is a process by which analytical instruments perform many tests with the least involvement of an analyst.
The International Union of Pure and Applied Chemistry (IUPAC) define automation as "The replacement of human manipulative effort and facilities in the performance of a given process by mechanical and instrumental devices that are regulated by feedback of information so that an apparatus is self-monitoring or self adjusting”.
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 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
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.
Use of laboratory instruments and specimen processing equipment to perform clinical laboratory assays with only minimal involvement of technologist .
Automation in clinical laboratory is a process by which analytical instruments perform many tests with the least involvement of an analyst.
The International Union of Pure and Applied Chemistry (IUPAC) define automation as "The replacement of human manipulative effort and facilities in the performance of a given process by mechanical and instrumental devices that are regulated by feedback of information so that an apparatus is self-monitoring or self adjusting”.
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 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
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.
How often is Right for Laboratory Quality Control?Randox
Improving Laboratory Performance Through QC - How often is right for QC? Ask the Right Questions to get the Right Answers.
It is widely accepted that laboratories should perform QC at least every day of patient testing. However, is this adequate for every assay and for every laboratory? Is running QC once per day really sufficient? what is the "right" frequency for running QC samples in your laboratory?
Basic QC Statistics - Improving Laboratory Performance Through Quality Contro...Randox
Randox Quality Control's latest educational guide examines Internal Quality Control, External Quality Assessment, Why laboratories should run QC, How often laboratories should run QC, Basic QC statistics and the quality control process.
Using reference materials to meet validation & verification requirements for ...Candy Smellie
Bio-Specimens used in Molecular Diagnostics
Most clinical tissue samples are preserved in FFPE
FFPE samples are now being used for molecular diagnostic testing
FFPE based studies: every specimen is different in terms of % tumor contribution to the specimen and % mutation contribution to the tumor
External Quality Assessment Proficiency Testing Scheme
Therapeutic choices are made based upon these results
False positive and false negative results are detrimental to the patient
Validation occurs across multiple areas of the clinical laboratory. Validation can include equipment, reagents, operators, platforms. Two of the key areas are test and platform validation.
Test development includes:
Establishing protocol
Optimising performance
Determining pooling parameters
Using synthetic variants to compare tools and facilitate optimisation
Test validation includes:
Determine parameters
First tests developed carry highest validation requirements
Changes to tests must follow re-validation required against existing test
Platform validation
Cumulative performance data established
Determine confidence intervals
Track and validate software versions
Changes to platform must follow re-validation required against existing platform
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.
Similar to Quality control in clinical biochemistry (20)
This presentation explains DNA transcription and RNA Processing.
It gives details about prokaryotic DNA transcription and eukaryotic DNA transcription. it also explains post-transcriptional modification both in prokaryotes and eukaryotes.
Biological oxidation (part - III) Oxidative PhosphorylationAshok Katta
Biological oxidation (part - III) Oxidative Phosphorylation
- Mechanism of Oxidative Phosphorylation
-- Chemiosmotic theory
-P:O Ratio
Substrate Level Phosphorylation
Shuttle Systems for Oxidation of Extramitochondrial NADH
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
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.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
- 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 Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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.
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.
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
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.
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
2. 2 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
“Quality is never an accident; it is always the result of
high intention, sincere effort, intelligent direction and
skillful execution; it represents the wise choice of
many alternatives.”
3. 3 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Importance of laboratory test in
clinical medicine
Lab tests constitute only one part of the
diagnostic process in clinical medicine.
In fact, it has been stated that an experienced
physician may arrive at a relatively accurate
diagnosis in ~80% of cases, based solely on a
thorough history and physical examination.
However, there is no doudt that, nowadays,
biochemical and other lab tests are almost always
an important part of the overall diagnostic process.
The use of biochemical investigation and lab tests
is, helping physicians and healthcare workers make
diagnoses and other clinical judgment.
4. 4 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
The results obtained from
laboratory analyses are used
to…
diagnose,
prescribe treatment, and/or
Monitor the health or progress
of the patient.
Since such importance is
placed upon test results, they
must be as reliable and
accurate as possible.
5. 5 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Who determines if a patient gets a statin?
We do !
6. 6 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Who determines if a patient gets a Dx of DM?
We do !
7. 7 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Who determines if a patient gets a prostrate biopsy?
We do !
8. 8 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Who determines if a patient gets dialysis?
We do !
9. 9 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
How do we know we are right?
Do we?We do !
10. 10 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
LAB-1
LAB-2
LAB-3
11. 11 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Fasting Plasma Glucose < 110mg/dl = Non-DM
On two or more occasions can make the diagnosis of Diabetes
Mellitus
Fasting Glucose >110 mg/dl = IFG
Fasting Glucose >126mg/dl = DM
LAB-1
LAB-2
LAB-3
12. 12 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
To know the answer for this
question, first you should
understand
How Clinical Biochemistry
Lab works.
How do we know we are right?
13. 13 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Errors in the
clinical Laboratory
15. 15 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Types of Error
Random error
An error which varies in an
unpredictable manner in…
Magnitude
Sign
Difficult to eliminate but
repetition reduces the influence
of random error
Example – error in pipetting
Can be minimized by training,
supervision and by SOPs
Systematic error
An error which, in the course of a
number of measurements of the same
value of a given quantity remains
constant under same condition.
Systematic errors create a
characteristic bias in the test results
and can be accounted for by applying a
correction.
Example - change in the reagent batch
or modifications in testing method.
16. 16 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Testing Response
Laboratory Workflow
Patient
Pre-analytical Analytical Post-analytical
Test Request
Patient preparation
Sample Collection
Sample Transport
Sample Receipt
Testing Review
Lab Interpretation
Reporting
Record Managment
18. 18 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
3 phases of laboratory testing:
Pre-analytical,
analytical and
post-analytical
Pre-analytical—specimen
collection, transport and processing
Analytical—testing
Post-analytical—testing results
transmission, interpretation, follow-
up, retesting.
19. 19 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Effects of Pre-analytical Variables on the
Quality of Laboratory Testing
What are pre-analytical variables ?
These are variables that can occur from the time when
the test is ordered by the physician until the sample is
ready for analysis.
The pre-analytical stage is the most important.
Pre-analytical variables account for upto 75% of
laboratory errors.
The analytical stage & post analytical stages depend
primarily on the integrity of the specimen submitted to
the laboratory.
Laboratory staff involved in specimen collection have a
direct impact on the outcome of patients lab results.
20. 20 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
The Pre-Analytical process
Identify the patient:
Get A Suitable Sample
Transport to Lab
Receive In Lab:
Prepare For Testing:
21. 21 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Examples of possible preanalytical variables:
Patient Identification:
- It is important to identify a patient accurately so
that blood is collected from the correct person.
- Drawing blood from the wrong person, or labeling
the correct patient’s sample with a different
patient’s label can certainly contribute to
laboratory error. (Mislabeling ???)
22. 22 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Analytical phase
Standardisation
Calibrators
Reagents
Test conditions
Quality Control
External Quality Assurance (EQA)
Internal Quality Control (IQC)
How do we know we are right?
23. 23 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Factors influencing quality:
Post-analytical
• Right recording and reporting
• Right interpretation
– Range of normal values
• Right turnaround time
• Report to right user
24. 24 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Quality control & Quality Assurance
Quality control
Refers to the measures that must be
included during each test run to verify that
the test is working properly
Aim:
• To ensure that the results generated by
the tests are correct
Quality Assurance
Defined as the overall program that
ensures that final results reported by the
laboratory are correct.
Aim:
• Ensure that
Right test is carried out on
Right specimen and
Right result and
Right interpretation is delivered to
Right person at
Right time.
25. 25 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Quality Assurance in Laboratory
Quality assurance in Laboratory involves……
Internal Quality Control (IQC)
External Quality Assurance (EQA)
26. 26 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Internal Quality Control (IQC)
Done daily in the laboratory
Applied to all work processes and to every
test done in the lab.
IQC procedures identify problems
immediately.
27. 27 of 58Quality Control in
Clinical Biochemistry
Ashok Katta
Internal Quality Control (IQC)
Examples
Daily recording of temp in refrigerator / incubator
Repeating tests
Following SOPs
Advantage
Mistakes can be avoided
Quality of test results are raised
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IQC Program
Internal Quality Control program
depends on the use of....
Internal Quality Control (IQC) specimen
Levey Jennings Charts
The use of statistical methods for interpretation.
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What is control?
Material that contains the substance
being analysed
Used to validate reliability of the
test system.
Run after calibrating the instrument
Run periodically during testing
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Steps in Implementing Quality Control
Obtain control material
Run each control daily along
with patient sample. OR
Run each control 20 times over
30 days
Calculate mean and ± 1,2,3 SD
Mean
1SD
1SD
2SD
3SD
2SD
3SD
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Levey- Jennings Chart
Graphically Representing Control Ranges
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80
85
90
95
100
105
110
115
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Mean
Day
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD
Levey-Jennings Chart
Mean = 100
±1SD = 95-105
±2SD = 90-110
±3SD = 85-115
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Levey-Jennings Chart -
Record and Evaluate the Control Values
80
85
90
95
100
105
110
115
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Mean
Day
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD
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Westgard Rules
“Multirule Quality Control”
Uses a combination of decision
criteria or control rules
Allows determination of whether
an analytical run is “in-control” or
“out-of-control”
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Westgard Rules
12S rule
13S rule
22S rule
R4S rule
41S rule
10X rule
(Generally used where 2 levels of control
material are analyzed per run)
38. WARNING RULES -
Warning 12SD : One of two control results falls
outside ±2SD. Alerts tech to possible problems. Not
cause for rejecting a run.
Control Rules – Westguard Multirule Chart
39. WARNING RULES -
Warning 22SD : It detects systematic errors & is violated
when two consecutive IQC values exceed the mean on the
same side of the mean by 2SD.
SENSITIVE TO SYSTEMATIC ERROR
Control Rules – Westguard Multirule Chart
40. WARNING RULES -
Warning 41SD: It is violated if 04 consecutive IQC values
exceed the same limit (mean 1SD) & this may indicate
the need to perform instrument maintenance or reagent.
SENSITIVE TO SYSTEMATIC ERROR
Control Rules – Westguard Multirule Chart
41. MANDATORY RULES -
Mandatory 13SD: It is violated when the IQC value
exceeds the mean by 3SD. The assay run is regarded as
out of control. SENSITIVE TO RANDOM ERROR
Control Rules – Westguard Multirule Chart
42. MANDATORY RULES -
Mandatory R4SD : It is only applied when the IQC is
tested in duplicate. This rule is violated when the
difference in SD between the duplicates exceeds 4SD.
SENSITIVE TO RANDOM ERROR
Control Rules – Westguard Multirule Chart
43. MANDATORY RULES -
Mandatory 10x : Reject the run when 10 consecutive
control measurements fall on one side of the mean.
SENSITIVE TO SYSTEMATIC ERROR
Control Rules – Westguard Multirule Chart
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When a rule is violated
QC Data
12s
13s 22s R4s 41s 10x
Report Results
“Out of control” Take Corrective Action
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If QC is out of control
Stop testing
Identify and correct problem
Repeat testing on patient
samples and controls
Do not report patient results
until problem is solved
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Clinical Biochemistry
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Solving out-of-control problems
Identify problem
Refer to established policies
and procedures for remedial
action.
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Clinical Biochemistry
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Possible Problems
Degradation of reagents or kits
Control material degradation
Calibration error
Operator error
An outdated procedure manual
Equipment failure
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Clinical Biochemistry
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EXTERNAL QUALITY CONTROL /
ASSESSMENT
E Q A S
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External Quality Assessment
A system for objectively checking the
laboratory’s performance using an external
agency or facility.
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EQA
Important for improvement
A measure of laboratory
performance
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EQA process
EQA organization / Provider Laboratory
Corrective Action
EQAS samples
Sent regularly
Analyze
Return results
Evaluation
EQAS performance
report
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Calculation of VIS
Designated Value [DV] = 120 mg %
Participant's result = 95 mg%
% Variation [%V] = Participant's Result – [DV]
---------------------------------- X 100
Designated value
120-95 X 100 = 25 X 100
120 120
= 20.8
Variance
Index = %V X 100 = 20.8 X 100 = 277
CCV 7.5
VIS = 277
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• Check the VIS & OMVIS values for each parameter
every month
• Check if your value is close to DV
• Closer it is lower will be your VIS & better is your lab’s
accuracy
• Remember If your VIS is < 50 it is regarded and given
as zero score
•Even if >400, it is still given as 400 only
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Interpretation of VIS
VIS Performance
<100 Very good
100 -150 good
150 -200 satisfactory room for improvement
> 200 Not acceptable
• If VIS of >200 on two or more occasions for the same
analyte, them check your standardization procedures &
calibration
• Indicates an accuracy problem (systematic error / bias )
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Interpretation of VIS
Check the monthly OMVIS.
OMVIS Performance
< 100 Very good - your result are very close to DV
150-200 Need to take care of those parameters
> 250 You are probably reporting many wrong
results & you should take urgent steps to locate the
problem and correct them
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Performance of our Lab in EQAS
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61. 61 of 58Ashok KattaQuality Control in
Clinical Biochemistry
Key Messages
A QC program allows the laboratory to
differentiate between normal variation and error.
The QC program monitors the accuracy and
precision of laboratory assays.
The results of patient testing should never be
released if the QC results for the test run do not
meet the laboratory target values.
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Contact no. – 07418831766
E mail – ashokkt@gmail.com
For more presentation visit - http://www.slideshare.net/ashokktt
Ashok Katta
Dept. of Biochemistry,
Dhanalakshmi Srinivasan Medical College,
Perambalur