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 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
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
A routine session on quality assurance practice in a medical laboratory to sensitize and provide basics to those interested in working in a medical testing laboratory.
Quality control, or QC for short, is a process by which entities review the quality of all factors involved in the production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements"
This presentation gives a brief idea of Quality control and how to execute it.
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.
Total Quality Management (TQM) by Dr Anurag YadavDr Anurag Yadav
Laboratory Total Quality Management, Concept of Laboratory errors, the quality control material, quality assurance program, factors affecting the quality of report, Steps in quality management, PDCA cycle, accuracy, precision, EQAS, IQAS, Proficiency testing.
the details are related to medical laboratory and help MBBS, MD, BSc MLT, MSc MLT, etc
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.
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.
A routine session on quality assurance practice in a medical laboratory to sensitize and provide basics to those interested in working in a medical testing laboratory.
Quality control, or QC for short, is a process by which entities review the quality of all factors involved in the production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements"
This presentation gives a brief idea of Quality control and how to execute it.
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.
Total Quality Management (TQM) by Dr Anurag YadavDr Anurag Yadav
Laboratory Total Quality Management, Concept of Laboratory errors, the quality control material, quality assurance program, factors affecting the quality of report, Steps in quality management, PDCA cycle, accuracy, precision, EQAS, IQAS, Proficiency testing.
the details are related to medical laboratory and help MBBS, MD, BSc MLT, MSc MLT, etc
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.
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.
Nursing leadership and management course / Total Quality MnagementMouad Hourani
What is Quality?
Definition of Quality in healthcare?
Quality Evolution .
Quality control.
Quality Assurance.
Total Quality Management.
Old vs. TQM Approach.
The Deming, Juran and Crosby philosophies.
Quality Principles.
Why Quality?
Quality perspectives.
Key Dimensions of Quality.
Good Managers (Leaders)
quality assurance, quality control, total quality management UNIT 1, b pharma 6th sem
Quality management in the drug industry
Why quality is important in pharmaceuticals?
Impacts of ignorance on quality
Quality control
Role of quality control in pharmaceutical industry
Objectives of quality control
Components of quality control
Functions of qc in pharmaceutical industry
Quality assurance
Total quality management
Characteristics of tqm
Benefits of tqm:
Essential Textbook of Biochemistry For Nursing (B.Sc.Nursing & PBN)Tapeshwar Yadav
I have relished teaching Biochemistry during my more than Ten years teaching experience in a medical, dental, nursing and health science colleges. It was because of constant inspiration from my students that I could come up with Essentials Textbook of Biochemistry for Nursing book, which hopefully would meet the inadequacies the students face in other books. In this age when the concepts in this subject are constantly changing, this book attempts to summarise the fundamentals and current state of knowledge in Biochemistry.
Biochemistry has been primarily written for the students of B.Sc. Nursing & Post Basic of Nursing (PBN) in such a way that it will also be suitable for General Medicine, Radiography, Physiotherapy, Ayurveda, Optometry, Dental and Nursing. This book can also be used as Reference for B.Sc. MLT, Bachelor of Pharmacy (B. PHARMA), Bachelor of Public Health (BPH), Bachelor of Physiotherapy (BPT), B. Ophthalmology, Bachelor of Radiography (BRT) and Biomedical Engineering students of Tribhuvan University, Purbanchal University, Kathmandu University and Pokhara University. Similarly, it will be equally useful for all the teachers, academic writers and those who are involved directly or indirectly in teaching and practising Health Sciences.
This is a basic book on Essential Textbook of Biochemistry for Nursing. The book thoroughly discusses some of the major concepts of Biochemistry and provides adequate information to help the students understand its implications in various areas of the subject. Furthermore, the book aims at equipping the students with practical cum theoretical skills. The book covers almost all the topics which have been prescribed in the Syllabus.
This is an introductory course to Biochemistry and is about medical biochemistry including the biochemical processes of - digestion & absorption of foods, metabolism of different kinds of foods & their disturbance effects in our body together with the physiological roles of different kinds of vitamins & enzymes.
The book consists of Theory as well as Practical portion. The author has tried his best to make all the concepts of each unit as lucid and simple as required for the students with supportive examples, samples, diagrams, clinical disorders and practical works. The ultimate purpose of this book is to equip the reader with comprehensive knowledge in Biochemistry with reference to basic as well as clinical aspects.
At last, I have made every effort to make the book error free, I am under no illusion. I expect constructive comments and suggestions from learners and teachers who use this book which will obviously help me in improving the future edition of the book.
Amino acids are a group of organic compounds containing two functional groups amino and carboxyl. The amino group (-NH2) is basic while the carboxyl group (-COOH) is acidic in nature.
The plasma in the liquid medium of blood (55%) in which the cell components namely Erythrocytes, Leucocytes and Platelets are suspended.
If anticoagulated blood is centrifuged, the plasma separates out as a supernatant while the cells remain at the bottom.
Plasma consists of water electrolytes metabolites nutrients proteins and hormones.
Most of the plasma proteins are synthesized in the liver.
Plasma proteins are separated by electrophoresis.
The word protein is derived from the Greek word ‘Proteios’ which means holding the first place. Berzelius (Swedish chemist) suggested the name proteins to the group of organic compounds that are important to life.
Proteins are the most abundant organic molecules of the living system.
They occur in every part of the cell and constitute about 50% of the cellular dry weight.
Proteins form the fundamental basis of structure and function of life.
Out of the total dry body weight, 3/4th are made up of proteins.
Proteins are used for body building; all the major structural and functional aspects of the body are carried out by protein molecules.
Proteins are high molecular weight polypeptides containing α-amino acids joined together by peptide linkage (-CO-NH).
The endocrine system consists of a network of ductless glands that secrete chemicals (called hormones) that affect the function of specific organs within the body, thus regulating many of the intricate functions of the body itself.
These ductless glands secrete their hormones directly into the bloodstream, as opposed to releasing them externally through ducts (as do the sweat glands and the oil glands).
The field of medicine that deals with the study of the endocrine system and the treatment of the diseases and disorders of the endocrine system is known as endocrinology.
The physician who specializes in the medical practice of endocrinology
is known as an endocrinologist.
Carbohydrates are the most abundant organic molecules in nature.
They are commonly known as saccharides or sugars.
They are primarily composed of the elements carbon, hydrogen and oxygen.
The name carbohydrate literally means “hydrates of carbon”.
Carbohydrates are widely distributed in nature in plants and animals.
The most important carbohydrate found in plants is starch.
It occurs abundantly in roots, tubers, vegetables and grains. The carbohydrate found in animals is glycogen.
It is a storage form of carbohydrate present in liver and muscles, which serves as important sources of energy for vital activities.
This field combines biology as well as chemistry to study the chemical structure of a living organism
Biochemistry is a basic science which deals with chemical nature and chemical behaviour of living matter and with the reactions and processes they undergo.
“The branch of science dealing with the study of all the life processes such as control and coordination within a living organism is called Biochemistry”
Medical parasitology : study of parasites that infect human, diseases caused by them, clinical picture, their diagnosis, treatment and prevention as well as controls.
It involves drug development, epidemiological studies and study of zoonoses.
To know various terms related to parasitology.
To know about general parasites and parasitic infections.
To get knowledge about laboratory diagnosis and its importance.
To gain idea about general epidemiological aspects of parasites that affect human.
Apply basic methods of specimen collection , preservation and processing in lab.
To prevent ourselves from these infections and apply control measures.
Microbiology is the study of
living organisms of microscopic
size which includes bacteria ,
Fungi , Algae , Protozoa and Viruses. It is concerned with the forms, structure , reproduction , physiology , metabolism and classification.
Principle Of Microbiology
Medical microbiology deals with the causative agent of the infectious disease of the human , the ways in which they produce disease in the body and essential information for diagnosis and treatment.
Hematology is the branch of medicine, that is concerned with the study of blood, blood forming organs and blood diseases. It includes study of etiology, diagnosis, treatment, prognosis and prevention of blood diseases .
After the completion of this presentation we will know about:
What is hematology and its purpose.
hematology laboratory.
Blood and its compositions and collections
Hematology lab equipment's
Some hematological tests , disease and hazards too.
Biochemistry is the study of the structure and function of biological molecules such as proteins, nucleic acids, carbohydrates and lipids.
Biochemistry is the study of the chemistry of living things. This includes organic molecules and their chemical reactions.
Biochemistry deals with body substance like enzymes, carbohydrates, amino acids, fats, proteins, hormones, DNA, RNA, pigments etc.
The major objective of biochemistry is the complete understanding of all chemical processes associated with living cells at the molecular level. Some of the objectives can be listed as follows:
1. Isolation, structural elucidation and the determination of mode of action of biomolecules.
2. Identification of disease mechanisms.
3. Study of in born errors of metabolism.
4. Study of oncogenes in cancer cells.
5. The relationship of biochemistry with the genetics, physiology, immunology, pharmacology, toxicology etc.
Biochemistry is related to almost all the life sciences and without biochemistry background and knowledge, a through understanding of health and well-being is not possible.
It is a well known fact that metal ions have a profound effect on cellular processes
The importance or the role that ions play in cellular activity can be gauged by the fact that most cells maintain a very critical Na+ & k+ balance between the extracellular and the intracellular spaces.
Any distribution in this critical balance is to the cellular metabolism through a drastic change in the osmotic pressure resulting in cellular swelling.
An ISE operates an exactly the same principles as a PH electrode
In fact, a PH electrode is a type of ion selective electrode sensitive to hydrogen ion.
Just like a PH electrode, the electrode body contains a reference solution and an metal reference electrode
Safety cabinets are intended to protect a laboratory worker from aerosols and airborne particles.
They will not protect the person from spillages and the consequences of mishandling and poor technique.
Aerosol particles of less than 5 µm in diameter and small droplets of 5–100 µm in diameter are not visible to the naked eye.
The laboratory worker is generally not aware that such particles are being generated and may be inhaled or may cross contaminate work surface materials.
BSCs, when properly used, have been shown to be highly effective in reducing laboratory-acquired infections and cross-contaminations of cultures due to aerosol exposures. BSCs also protect the environment.
Most BSCs use high efficiency particulate air (HEPA) filters in the exhaust and supply systems.
The exception is a Class I BSC, which does not have HEPA filtered supply air.
The application of knowledge, techniques and equipment to prevent a personal laboratory and environmental exposure to potentially infectious agents or biohazard is known as biosafety.
Biosafety defines the containment conditions under which infectious agents can be safely manipulated.
The objective of containment is to confine biohazard and to reduce the potential exposure of the laboratory worker, persons outside of the laboratory, and the environment to potentially infectious agents.
A pipette (also called a point or a pipettor) is a laboratory instrument used to transfer a measured volume of liquid.
Pipettes are commonly used in chemistry and molecular biology research as well as clinical biochemistry tests.
Pipettes come in several designs for various purposes with different levels of accuracy and precision, from single piece flexible plastic transfer pipettes to more complex adjustable or electronic pipettes.
A pipette works by creating a vacuum above the liquid-holding chamber and selectively releasing this vacuum to draw and dispense liquid.
Safe Use and Storage of Chemicals and ReagentsTapeshwar Yadav
Even in the smallest laboratory, dangerous chemicals are used directly or incorporated into stains and reagents.
Hence the correct handling and storage of hazardous chemicals is essential to prevent injury and damage.
In addition to this, to reduce accidents caused by chemicals, labeling is very important.
Laboratory Hazards, Accidents and Safety RulesTapeshwar Yadav
Injury, damage and loss by fire can be minimized when laboratory staff:
Understand how fires are caused and spread;
Reduce the risk of fire by following fire safety regulations at all times;
Know what to do if there is a fire in their laboratory;
Know how to use fire fighting equipment;
Know how to apply emergency First Aid, for burns.
Revised Curriculum of Certificate in Medical Laboratory Technology(CMLT) by C...Tapeshwar Yadav
This curriculum of 3 years Certificate in Medical Laboratory Technology is designed to produce middle level skilled laboratory personnel equipped with knowledge, skills and attitudes of medical laboratory with a view to provide diagnostic, curative, preventive and promotive laboratory services to the community. Such technicians collect specimens, process, and perform tests to analyze body fluids, tissue, and other substances. The graduates perform lab procedures and maintain instruments. The graduates are expected to perform tests that help other healthcare professionals such as physicians to detect, diagnose, and treat diseases.
The program extends over three academic years. The first year course focuses on basic science and foundational subjects, the second year course focuses on theory and practical parts of basic medical laboratory subjects. Simultaneously the third year is given to the application of learned skills and knowledge in the comprehensive practical settings, in hospitals and medical laboratory. The graduates will have career opportunities in hospitals, diagnostic laboratories, clinics, industry and physicians' offices, research centers, blood bank, crime investigating laboratories etc. It is based on the code of conduct of Nepal Health professional Council.
Clinical Pathology is the application of laboratory techniques to find out the cause of disease. Clinical pathology laboratory involves all aspect of the medicine ranging from the field of biochemistry, microbiology, Parasitology, haematology, immunology and cytogenetics etc. Clinical pathology laboratory perform qualitative and quantitative analysis of body fluid such as urine, blood, CSF, sputum, other body fluid such as synovial fluid, peritoneal fluid, pericardial fluid and plural fluid. These determinations are useful in diagnosing various clinical conditions such as diabetes mellitus, jaundice, gout, hyperlipidemia, pancreatitis, rickets, etc. The clinical pathological tests are very useful in determining the severity of diseases of many organs such as liver, stomach, heart, kidneys, brain as well as the endocrine disorders and related status of acid-base balance of the body. The clinical pathology tests, in relation to the various clinical conditions can be applicable for:-
1) Reveal the causes of the diseases
2) Screen easy diagnosis
3) Suggest effective treatment
4) Assist in monitoring progress of a pathological condition and
5) Help in assessing response to therapy
Modern medicine says that: Your practice of medicine will be as good as your understanding of pathology.
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Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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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
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.
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.
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.
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
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
2. Introduction:
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.
3. Contd…
Likewise, it is the job of the laboratory supervisory and
managerial staff to design and implement the supportive
infrastructure that is necessary for the technical work to proceed
unimpeded.
An integrated coordinated between technical and managerial
activities are essential for the continuous, unimpeded realization
of high-quality, error-free, efficient, and effective laboratory
operations.
Achieving, maintaining and improving accuracy, timeliness and
reliability are major challenges for health laboratories.
When all of the laboratory procedures and processes are
organized into an understandable and workable structure, the
opportunity to ensure that all are appropriately managed is
increased.
4. Laboratory TQM System
model:
In the total quality management system model, all below 12
quality system essentials must be addressed to ensure accurate,
reliable and timely laboratory results, and to have quality
throughout the laboratory operations.
It is important to note that the 12 quality system essentials may be
implementation will vary with the local situation.
Laboratories not implementing a good quality management
system are guaranteed that there will be many errors and
problems occurring that may go undetected.
Implementing a quality management system may not guarantee an
error -free laboratory, but it does yield a high - quality laboratory
that detects errors and prevents them from recurring.
Approaches to implementation will vary with the local situation.
6. 1. Organization :
Organization is one of the essential elements of the quality system, and is
intimately related to all the other elements in the model.
The term organization in the context of a quality management model is
used to indicate the management and the supporting organizational
structure of the laboratory.
The principal element for a successful quality management system is
managerial commitment. These are:
Management at all levels must fully support and actively participate in
the quality system activities.
Support should be visible to staff so that there is an understanding of the
importance of the effort.
Without the engagement of management, including the decision
-making level of the organization, it will not be possible to put in place
the policies and the resources needed to support and laboratory quality
management system.
8. Contd…
As the laboratory moves from intent to action in the
development of a quality management system, the major
organizational step will be to assign responsibility for
implementation, allocate resources, develop and distribute a
quality manual, being implementation and monitor
compliance with the quality policy and the quality
management system required.
Successful implementation of a quality management system
requires planning management committee, understanding
the benefits, engaging staff at all levels, setting realistic time
frames and looking for ways to continually improve.
9. 2. Personnel:
Personnel are the most important laboratory resource.
Critical to the implementation of the quality management
system are people who possess integrity, recognize the
importance of their work and participate in continuous
improvement.
As a laboratorian it is important to:
Participate in training and continuing education
opportunities.
Request training that may be needed as job responsibility
increases
Maintain records of personal professional development.
10. Contd…
Personal policies:
Ethics
Confidentiality
Employee benefits
Work schedules.
Success or failure depends on the knowledge and skills of the
people in the laboratory, their commitment and motivation to
perform tasks as described in the job description.
Motivated staffs are more likely to be committed to their work.
Management of personnel is critical to the success of a quality
management programme. Several elements are important in this
management process.
11. Contd…
Job description should reflect all skills needed and accurately describe
tasks, roles and authorities.
The competency of personnel will need to be evaluated at the time of
hiring and on a regular, recurring basis.
A very important part of the management process is to seek ways to
attract qualified personnel and to provide motivation and appropriate
benefits and working conditions so as to retain staff.
Personnel are most crucial resources in the laboratory so managers must
create an environment that will fully support all laboratory personnel in
order to maintain a high quality of laboratory performance.
Continuing education is vital to personnel competency, but doesn't need
to be expensive.
New testing methodologies and instruments are constantly introduced
to the marketplace, and employees need to be update their knowledge
and skills.
12. 3. Equipment:
Many kinds of equipment are in used in the laboratory, and
each must be functioning properly.
Proper management of the equipment in the laboratory is
necessary to ensure accurate, reliable and timely testing.
The benefits of a good equipment management programme
are:
Helps to maintain a high level of laboratory performance.
Lengthens instruments life
Increases safety for workers
Produces greater customer satisfaction.
13. Contd…
A great deal of thought and planning should go into
equipment management. These includes:
Selection and purchasing
Installation
Calibration and performance evaluation
Maintenance
Trouble shooting
Service and repair
Retiring and disposing of equipment.
14. Contd…
All laboratories should have a well organised equipment
programme. The programme should address equipment selection,
preventive maintenance and procedures for troubleshooting and
repairs.
A good equipment maintenance programmes results in a high
level of performance and greater confidence in the reliability of
results.
A significant benefit to the laboratory will be fewer interruptions
in test performance, low repair cost and elimination of premature
replacement of equipment.
Day-to-day maintenance should be the responsibility of the
technical operator. Everyone who uses the equipment should be
trained in calibration and daily maintenance.
15. 4.Purchasing and inventory:
Purchasing and inventory management is a critical and essential
component of the quality management system.
Careful management of inventory helps to prevent waste, which
can occur if reagents and supplies are stored improperly or if,
reagents become outdated before they can be used.
Establishing a purchasing and inventory management programme
will ensure that :
Supplies and reagents are always available when needed.
High quality reagents are obtained at an appropriate cost.
It is very important to set expectations and build and maintain
relationships with providers of materials and services.
16. Contd…
Laboratories that purchase directly should look very carefully at
vendors and manufacturer's qualifications, examine such things as
specifications and method of transport.
Successful purchasing and inventory management requires that
policies and procedures be established for maintaining all critical
materials and services.
Properly managed inventory will:
Ensure that patient and clinical needs are met.
Ensure products are available when they are needed.
Increase the efficiency and effectiveness of the laboratory, because
it will provide an uninterrupted flow of needed materials.
17. 5.Process control (quality
control):
Process control is comprised of pre-analytical, analytical and
post analytical factors that are important in ensuring the
quality of the laboratory testing processes.
These factors include quality control for testing, appropriate
management of the sample, including collection and
handling, and method verification and validation.
Laboratory quality can be defined as accuracy, reliability and
timeless of reported test results.
The laboratory must have good samples in order to ensure
accuracy and reliability of testing and confidence in results.
18. Contd…
Quality control is the part of quality management focused on
fulfilling quality requirements.
Simply, it is examining “control” materials of known
substances along with patient's sample to monitor the
accuracy and precision of the complete analytic process.
QC monitors activities related to the examination phase of
testing. The goal of QC is to detect, evaluate, and correct
errors due to test system failure, environmental conditions
or operator performance, before patients results are
reported.
19. Contd…
Sample management
The quality of the work a laboratory produces is only as good
as the quality of the samples it uses for testing.
The laboratory must be proactive in ensuring that the
samples it receives meet all of the requirements for
producing accurate test results.
Written policies for sample management must be established
and reflected in the laboratory handbook. Components to be
addressed include:
Information needed on requisition or forms
20. Contd…
Handling urgent request
Collection, labelling, preservation and transport.
Safety practices
Evaluating, processing and tracking samples.
Storage, retention and disposal.
Collection and preservation:
The collection of appropriate and optimum samples is the
responsibility of the laboratory, even though the actual
collection process is often carried out by persons who are not
part of the laboratory staff.
21. Contd…
Essential information for the test request form
includes:
Patient's identification
Test requested
Time and date of sample collection
Clinical data, when indicated
22. Contd…
Sample processing
Verification of quality:
Once a sample enters the laboratory, there are a number of
steps needed prior to testing.
Verify the sample is properly labelled, adequate in quantity,
in good conditions and appropriate for the test request
Record sample information into a register or log.
Enforce procedures for handling sub optimum samples,
including sample rejection when necessary.
23. Contd…
Rejection of sample: the following sample should be
rejected :
Unlabelled sample
Broken or leak tube or containers
Hemolysed samples
Inadequate volume for quantity of preservative
Insufficient quantity for the test required.
Non-fasting samples, for tests that requires fasting
Sample collected in wrong tube / container
Prolong transport time or other poor handling.
24. Contd…
The register should includes:
Date and time of collection.
Date and time the samples was received in laboratory.
Sample type
Tests to be performed.
Diagnostics test results
Time band date of results reported.
25. Contd…
Elements of a QC programme:
Regardless of the type of examination that is performed, step
for implementing and maintaining a QC programme include:
Establishing written policies and procedures, including
corrective action.
Training all laboratory staff
Ensuring complete documentation.
Reviewing quality control data
Different QC procedures are applied to monitor
quantitative, qualitatively and semi-quantitative tests.
26.
6. Information management:
Information management is a system that incorporates all the
processes needed for effectively managing data - both
incoming and outgoing patient’s information.
The information management system may be entirely paper-
based, computer based, or a combination of both.
Laboratory directors need to ensure that the laboratory has
an effective information management system in place in
order to achieve, confidentiality and privacy of patients
information.
27. Contd…
When planning and developing an information management
system, whether it is manual, paper-based or an electronic
system, there are some important elements to consider :
Unique identifiers for patients and sample.
Standardized test result forms.
Logs and worksheet
Checking processes to assure accuracy of data recording and
transmission
Protection against loss of data
Protection of patient confidentiality and privacy
Effective reporting system
Effective and timely communication
28. Contd…
Common problems
The laboratory should carefully consider potential problem and plan
on how to avoid them. Some of the common problems are:
Incomplete data for test interpretation, or insufficient or illegible
identification
Forms that are inadequately designed to meet laboratory and clients
need
Standardized forms prepared by others that may not be suitable for
all laboratories.
Inability to retrieve data due to poor archiving processes or
insufficient backup of computerized information.
29. Contd…
Poor data organization, which may hinder later data analysis efforts to
meet research or other needs.
Incompatibility between computerized information system and
equipment or other electronic system, resulting in problem with data
transmission.
A good information management system will :
Ensure that all data- the final product of the laboratory is well managed.
Consider all the ways laboratory data will be used when planning a
system.
Ensure the accessibility, accuracy, timeliness and security of data.
Ensure confidentiality and privacy of patient information.
30. 7. Documents and records:
Documents include written policies, processes and procedures and
provide a framework for the quality system. They need to be updated
and maintained.
Records include information captured in the process of performing
and reporting a laboratory test. This information is permanent and
doesn't require updating.
Documents:
Documents include all the written policies, process and procedures of
the laboratory.
In order to develop laboratory document it is important to understand
each of these elements and how they relate to each other.
31. Contd…
Characteristics of documents are that they:
Communicate information to all persons who need it, including
laboratory staff, users and laboratory management personnel.
Need to be updated or maintained.
Must be changed when a policy, process or procedure changes
Establish formats for recording and reporting information by
the use of standardized forms- once the forms are used to
record information, they become records.
Some eg: of document includes a quality manual,
standard operating procedure and job aids.
32. Contd…
Documents are reflection of the laboratory's organization and it's quality
management.
A well - managed laboratory will always have a strong set of documents
to guide its work.
Some of the important documents that every laboratory should have
includes:
Quality manual - this is the overall guiding document for the quality
system and provides the framework for it's design and implementation.
SOPs - contains step-by-step written instructions for each procedures to
perform consistently by everyone in laboratory.
Reference materials - as an ex: photographs and descriptive information
can no very helpful.
33. Contd…
Characteristics of records are:
Need to be easily retrieved or accessed.
Contain information that is permanent and are not revised or
modified and doesn't require updating.
Records are laboratory information, either written by hand or
computer -printed.
They should be complete, legible and carefully maintained, as
they are used for many purposes. Some of them are:
Continuous monitoring
Tracking of samples
Evaluating problems
Management
34. Contd…
Many kinds of records are produced in a laboratory. Some eg
includes:
Sample logbook or register
Laboratory workbooks / worksheet
Quality control data
Instrument printout- maintenance records
Patients test report
Results of internal and external audits.
Continuous improvement projects
User surveys and customers feedback.
35. Contd…
Storing documents and records:
Storage must be given careful consideration, as the main goal of
documentation is finding the information when it is necessary. By using paper
or an electronic system. These include :
Permanence
Accessibility
Security
Traceability
Having a good document control programme ensures that the most current
version of a document is used, and ensures availability and ease of access when
a document is needed.
Records must be meticulously maintained so as to be accurate and accessible.
Note: Documents and records are essential for accuracy, and consistency in the
laboratory.
36. 8. Occurrence management:
An occurrence is an error or an event that should not have
happened. A system is needed to detect these problems or
occurrence to handle them properly, and to learn from
mistakes and take action so that they don't happen again.
An occurrence is any event that has a negative impact on an
organization, including it's personnel, the product of the
organization, equipment or the environment in which it's
operates. All such events must be addressed in an occurrence
management programme.
Occurrence management is a central part of continual
improvement.
37. Contd…
It is the process by which errors or near errors are identified
and handled.
The goal of an occurrence management programme is to
correct the errors in either testing or communication that
results from an event, and to change the process so that the
errors are unlikely to happen again.
There are many other sources of errors, which are frequently
observed. Errors can occur throughout the testing process.
These includes:
Collecting the wrong sample
Mislabeling or failing to label the sample.
38. Contd…
Storing the sample inappropriately, causing sample
deteriorates.
Damaging the reagents or test kits by storing them
improperly.
Transporting the sample under conditions that damages the
sample or endanger the staff and public safety.
Making transcription error when preparing the report.
Sending the report to the wrong location, this often results
in complete loss of the report.
39. Contd…
Consequences of laboratory errors:
Inadequate or inappropriate patients care.
Inappropriate public health actions
Wasting of resources
Undetectable communicable disease outbreaks.
Death of an individual.
40. Contd…
Occurrence management process:
Establish a process to detect all problems, using the tools that
are available.
Keep a log of all problems event that record the error, any
investigation activities and any actions taken.
Investigate the cause of any problem that is detected and
carefully analysed the information that is available.
Take the necessary action, if the problem is detected before
the error actually occurs, take preventive action.
Providing information to all those who need it, and to those
who are affected by the error.
41. Contd…
Responsibilities:
The responsibility for monitoring for occurrence belongs to
everyone in the laboratory.
It is important however, that someone be designated as the
person responsible for marshalling the energies and activities
of all staff into an effective management process.
The laboratory should employ an active process for
occurrence management and take a positive approach.
Make an effort to detect problems as early as possible, and
then take immediate remedial and corrective action.
42. 9. Assessment:
An assessment can be defined as the systematic examination of some
part of the quality management system to demonstrate to all concerned
that the laboratory is meeting regulatory, accreditation and customer
requirements.
The process of assessment is a tool for examining laboratory
performance and comparing it to standards, benchmarks or the
performance of other laboratories.
Assessment may be internal audit (performed within the laboratory
using it's own staff) or it may be external audit (conducted by a group
or agency outside the laboratory ).
Laboratory quality standards are an important part of the assessment
process, serving as benchmarks for the laboratory.
43. Contd…
Central - level laboratories are generally familiar with
assessment processes, as most will have had some kind of
assessment by an external audit.
A laboratory needs this information about it's performance
for:
Planning and implementing the quality system.
Monitoring effectiveness of the quality system
Correcting any deficiencies that are identified
Working towards continuous improvement.
44. Contd…
Assessment is important in monitoring the effectiveness of
the laboratory quality management system.
Both external and internal audits yield useful information.
Audits are used to identify problems in the laboratory, in
order to improve processes and procedures.
An outcome of assessment is finding root cause of problems
and taking corrective actions.
All laboratories should establish an internal audit programme
conducted on a regular basis, it will provide information for
continual improvement.
Problems become opportunities for improvement.
45. 10. Process improvement:
A process is a series or operations contributing to an end.
Process improvement, one of the 12 quality system essential,
establishes a programme for helping to ensure continual
improvement in laboratory quality over time.
The primary goal in a quality management system is
continuous improvement of the laboratory processes and this
must be done in a systematic manner.
Process improvement is a systematic and periodic approach
to improving laboratory quality and the inputs and outputs
that glue these processes together. It is a way of solving
problems.
46. Contd…
A very similar set of activities for achieving continual
improvement in the laboratory are described. These
includes:
Identify potential sources of any system weakness or error.
Develop plans to implement improvement.
Implement the plan.
Review the effectiveness of the action through the process of
focused review and audit.
Adjust the action plan and modify the system in accordance
with the review and audit results.
47. Contd…
The process for continual improvement includes :
Identification of the problem.
Analysis of the data and the processes.
Determination of the root cause of the problem.
Generation of ideas for solution.
Continual improvement is the core of quality management, but
it requires commitment, planning structure, leadership,
participation and engagement.
Quality counts - it is very important goal for any laboratory.
Continual improvement is an outcome of an active laboratory
quality management system.
48. Contd…
Quality indicators are information that is measured. These
indicators:
Give information about the performance of a process.
Determine quality of services.
Highlight potential quality concerns
Identify areas that need further study and investigation.
Track changes over time.
49. 11. Customer service:
Customer satisfaction is a major component of a quality
management system. If The customer is not well served, the
laboratory is not achieving it's primary function.
Good customer service provides:
Valuable information for best patient care.
Valuable information to improve surveillance and other
public health actions.
A professional image for the laboratory.
50. Contd…
The concept of customer service has often been overlooked in
laboratory practices. However, it is important to note that the
laboratory is a service organization; therefore, it is essential that
clients of the laboratory receive what they need.
The laboratory should understand who the customers are, and
should assess their needs and use customer feedback for making
improvement.
Customer service is an integral part of a quality management
system.
When necessary customer satisfaction, whether by survey,
indicators or audits, much will be learned when the method is
successful.
51. Contd…
Seeking customer satisfaction requires commitment from the
laboratory management and staff. It is important to
remember that technical competency is not the only goal for
the laboratory.
A programme for addressing customer satisfaction requires
good planning, the development of appropriate monitoring
tools, and the knowledge to apply the tools to gain useable
information.
Monitoring customer satisfaction requires some resources,
primarily involving staff time. Managers need to ensure that
these resources are available.
52. 12. Facilities and safety:
Laboratory work space and facilities must be such that the
workload can be performed without compromising the
quality of work and the safety of the laboratory staff, other
health care personnel, patients and the community.
A laboratory safety programme is important in order to
protect the lives of employees and patients, to protect
laboratory equipment and to protect the environment and
ultimately to protect the world.
53. Contd…
Many factors must be a part of the quality management of
facilities and safety. These includes:
Service - This is the process of preventing unwanted risks
and hazards from entering the laboratory space.
Containment - which seeks to minimize risks and prevent
hazards from leaving the laboratory space and causing harm to
the community.
Safety - This includes policies and procedures to prevent
harm to workers, visitors and the community.
Ergonomics - This addresses facility and equipment
adaptation to allow safe and healthy working conditions at the
laboratory site.
54. Contd…
As a quality manager, it is necessary to:
Develop a complete and through description of basic safety
rules and organization, and ensure that personnel are trained
in their specific duties when new activities or techniques are
introduced into the laboratory.
Know the basic safety and biosafety management issues when
working with chemicals and pathogens of low level or
moderate risks.
Know how to perform on extensive risks assessment when
developing new activities in the laboratory.
Conduct laboratory safety audits.
55. Contd…
As a laboratorian, it is important to:
Be aware of basic safety rules and processes
Understand the basic safety and biosafety management issues
when working with toxic chemistry, biological samples and
physical hazards and when interacting with patients.
56. Contd…
The safety officer should be assigned responsibility for
ensuring that there is an adequate supply of appropriate
equipment for safety and biosafety, such as:
Fire extinguishers and fire blankets
Appropriate storage and cabinets for flammable and toxic
chemicals
Eyes washers and emergency shower
Waste disposal supplies and equipment.
First aid equipment.
57. Contd…
Personal protective equipment:
Hand protection – gloves
Face protection - goggles, masks
Body protection - apron
If laboratory personnel becomes contaminated with biological
hazards due to splashes or splits, immediate steps to take includes :
Clean exposed skin or body surfaces with soap and water , eyewash (
for eye exposure ) or saline ( for mouth exposure )
Apply first aid and treat as an emergency
Notify supervisors, safety officers, or security desk
Follow appropriate reporting procedures
Report to physician for treatment or counseling.