What is quality?
Importance of a quality management system in the laboratory
Quality system essential elements
The history of development of quality principles
Discuss relationship of this quality model to ISO and CLSI standards
Quality control lecture CPath master 2014 Ain ShamsAdel Elazab Elged
Basics of quality management or assurance program detailing values of internal quality control material analysis and interpretation and external quality control or proficiency testing programs in medical laboratories
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.
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.
What is quality?
Importance of a quality management system in the laboratory
Quality system essential elements
The history of development of quality principles
Discuss relationship of this quality model to ISO and CLSI standards
Quality control lecture CPath master 2014 Ain ShamsAdel Elazab Elged
Basics of quality management or assurance program detailing values of internal quality control material analysis and interpretation and external quality control or proficiency testing programs in medical laboratories
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.
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.
How to write Standard Operating Procedures (SOPs) for clinical laboratories -...Tamer Soliman
How to write Standard Operating Procedures (SOPs) for Clinical Laboratories
Based on WHO Laboratory Quality Stepwise Implementation Tool
By Dr. Tamer Soliman
1. SOPs Introduction
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
Quality in clinical laboratory is a continuous journey of improving processes through team work, innovative solutions, regulatory compliance with final objective to meet the evolving needs of clinicians & patients.
Quality control (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
Harmonization of Laboratory Indicators, 09 03-2017Ola Elgaddar
Most of Medical labs are having KPIs to monitor their performance and enhance process improvement. This presentation discusses in short the IFCC attempts to reach a consensus and harmonize medical labs quality indicators.
How to write Standard Operating Procedures (SOPs) for clinical laboratories -...Tamer Soliman
How to write Standard Operating Procedures (SOPs) for Clinical Laboratories
Based on WHO Laboratory Quality Stepwise Implementation Tool
By Dr. Tamer Soliman
1. SOPs Introduction
1.1 Overview
1.2 Purpose
1.3 Benefits
1.4 Writing Styles
Quality in clinical laboratory is a continuous journey of improving processes through team work, innovative solutions, regulatory compliance with final objective to meet the evolving needs of clinicians & patients.
Quality control (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
Harmonization of Laboratory Indicators, 09 03-2017Ola Elgaddar
Most of Medical labs are having KPIs to monitor their performance and enhance process improvement. This presentation discusses in short the IFCC attempts to reach a consensus and harmonize medical labs quality indicators.
The National accreditation Board for Testing and Calibration laboratories (NABL) is an independent organization operating under the supervision of the Department of Science and Technology, Government of India. Its primary objective is to provide certification to clinical labs in India for their testing and calibration activities.
Internal Audit Training.
Training Objectives.
What is an audit?
How to prepare for and plan an audit?
How to conduct an audit?
How to report on an audit?
What is audit follow-ups?
Contact:
nomanaleemft@gmail.com
00923084089243
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
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
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.
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
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
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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
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.
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
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
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
- 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
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
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.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?
Laboratory audit ls
1. DR LUKMAN SHITTU
DEPT OF CHEMICAL
PATHOLOGY
DR LUKMAN SHITTU
DEPT OF CHEMICAL PATHOLOGY
LABORATORY AUDIT
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LABORATORY AUDIT BY DR LUKMAN
SHITTU.... 1
2. OUTLINE
INTRODUCTION
TYPES OF AUDIT
INTERNAL AUDIT
EXTERNAL AUDIT
SUDDEN
ESSENTIAL RE
RESPONSIBILITY
WITNESSING
ISO REQUIRED
INTERNAL AUDIT
OBJECTIVES
AUDIT PROCESS
EXTERNAL AUDIT SUMMARY REFERENCES
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3. INTRODUCTION….
Assessment can be defined as the systematic examination of some part
(or sometimes all) of the quality management system to demonstrate to all
concerned that the laboratory is meeting regulatory, accreditation and
customer requirements.
• Assessment is an important element of the 12 quality system essentials
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5. INTRODUCTION……
• Assessment can be achieved by;
• Laboratory accreditation.
• External quality assessment or proficiency testing.
• Laboratory audit.
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6. INTRODUCTION…
• LABORATORY AUDIT is defined as a planned and
documented activity performed in accordance with written
procedures and check-lists to verify by investigation, and
the examination and evaluation of objective evidence, that
applicable elements of a quality assurance programme
have been developed, documented and implemented.
•
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7. INTRODUCTION….
• Audit is an essential part of the quality assurance program
of a laboratory.
• A quality assurance program covers all aspects of the
service provided.
• Audit is a means of assessing whether one is achieving
one's stated objectives.
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8. INTRODUCTION….
• Total Quality Management involves comprehensive quality
assurance programme which must include The Quality System
Essentials, with the development, documentation and
implementation of General Guidelines and Standards Operating
Procedures (SOP) .
• Internal Audit is a component of TQM and involves the process of
Monitoring and Evaluation of the implementation of developed
guideline and SOP.
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9. TYPES OF AUDIT…
• INTERNAL AUDIT
HORIZONTAL AUDIT
VERTICAL AUDIT
• EXTERNAL AUDIT
• SUDDEN AUDIT
• WITNESSING/EXAMINATION AUDIT
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10. TYPES OF AUDIT…
EXTERNAL AUDIT:
• Assessments conducted by groups or agencies from outside
the laboratories are called external audits.
• They can include assessments for the purpose of
accreditation, certification or licensure
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11. INTERNAL AUDIT
• A type of assessment of a laboratory where staff working in one area of the
laboratory conduct assessments on another area of the same laboratory.
• This provides information quickly and easily on how the laboratory is
performing and whether it is in compliance with policy requirements.
• Both horizontal and vertical audits should be carried out.
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12. HORIZONTAL AUDITS:
• Checking one aspect of the Quality System (for example,
equipment), for all the associated requirements.
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13. QualitySystem
Essential
HORIZONTAL AUDIT
1
Documents &
Records
2.
Management
Reviews
3
Organization
& Personnel
1.Is there an
approved
organogram
2.Are there
appropriate
personnel
3.Are there
personnel
files
4.Do
personnel
files contain
CVs
5.Do
personnel
files contain
other
records
6
4
Client
Management
& Customer
Service
5
Equipment
1.What
equipment are
available
2. the
equipment
functioning
3.Are they
regularly
maintained
4.When is
the next
Expected
date of
routine
maintenance
5.Is there a
maintenance
contract
6 Internal Audit
7 Purchasing &
Inventory
8 Process
Control and
Internal &
External
Quality
Assessment
9 Information
Management
1
0
Corrective
Action
1
1
Occurrence/Inci
dent
Management &
Process
improvement
1
2
Facilities and
Safety
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14. TYPES OF AUDIT….
VERTICAL AUDITS:
• Test samples are selected at random from work that has recently passed through
the laboratory and each operation associated with those samples is checked.
• The route of entry into the audit system when performing vertical audits can be
varied, for example, by selecting different items (test reports, worksheets or
retained samples) on different occasions
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15. VERTICAL ASSESSMENT: The Assessment or Audit of a particular patient request:
From sample collection to result release,using all or most of the quality system essentials
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16. TYPES OF AUDIT…
UNSCHEDULED AUDITS
• In addition to the planned programme, it may be necessary to carry
out unscheduled audits whenever there is reason to doubt the
effectiveness of the Quality System.
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17. TYPES OF AUDIT…
WITNESSING/ EXAMINATION AUDIT
• An examination (test) procedure, currently being carried out in the laboratory
and randomly selected is witnessed as it is performed.
• To ensure that what is being done reflects what is described in the procedure,
• And that the person carrying out the examination has a good understanding of
all aspects of the procedure.
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18. INTERNAL AUDIT…
• ISO REQUIREMENT:
• ISO standards put much emphasis on internal audits, and for those seeking
accreditation under ISO, internal audits are required. ISO requirements state
that:
• the laboratory must have an audit programme;
• the auditors should be independent of the activity;
• audits must be documented and reports retained;
• results must be reported to management for review;
• problems identified in the audits must be promptly addressed and appropriate
actions taken
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19. INTERNAL AUDIT…
OBJECTIVES OF AUDIT
• Audits are planned to establish that:
• management objectives are met in full.
• all staff are carrying out their assigned duties and responsibilities satisfactorily.
• procedures detailed in the Quality System manual are being followed
• Audits are designed to reveal the extent to which the laboratory complies with
requirements in all the aspects examined.
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20. INTERNAL AUDIT
• ESSENTIAL REQUIREMENTS OF AUDITS
• Audits should be carried out according to a pre-planned programme devised
by the Quality control committee headed by the laboratory director.
• Auditors should be nominated by the Quality control committee as the persons
responsible for carrying out audits.
• Audit procedures should be documented and all results recorded.
• Corrective action should be initiated to resolve all non-compliances identified
within an agreed timescale.
• Such corrective action should be effective and completed promptly.
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21. INTERNAL AUDIT…
• AUDITOR:
• is a technically qualified individual who evaluates the activity being audited.
• Any knowledgeable person in the laboratory can perform internal audits, not
just the manager or supervisor. E.g. HODs, Pathologist & their designated reps
like the CMLS e.t.c.
• It is very important, and required by ISO standards, that the auditors are
independent of the area audited.
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22. INTERNAL AUDIT..
• Criteria for Selection of Auditors
• Must have technical skills in the area being audited.
• Must understand the laboratory’s QMS
• Must be able to pay attention to detail
• Must be able to communicate effectively and diplomatically
• Must be trained – in-house/ external
• Poor auditors = Poor audit
• The laboratory may hire a consultant for internal audit process
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23. INERNAL AUDIT..
• VALUES OF INTERNAL AUDIT:
• The internal audit is a valuable tool in a quality management system. An internal
audit can help the laboratory to:
• prepare for an external audit;
• increase staff awareness of quality system requirements;
• identify the gaps or nonconformities that need to be corrected—the
• opportunities for improvement;
• understand where preventive or corrective action is needed;
• identify areas where education or training needs to occur;
• determine if the laboratory is meeting its own quality standards
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SHITTU.... 23
24. INTERNAL AUDIT…
• AUDIT PROCESS:
• There are five key questions in the audit process:
• what should we do?
• what do we do?
• Are we doing what we should be doing?
• Can we improve what we do?
• Have we improved?
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25. INTERNAL AUDIT..
• THE QUALITY MANAGER or other designated qualified personnel should organize the
internal audit following these steps:
• develop a formal plan
• prepare a checklist based on selected guidelines or standards
• meet with all staff and explain the audit process
• select staff to serve as auditors
• collect and analyze information
• share results with staff
• prepare a report
• present the report to management
• retain the report as a permanent laboratory record
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26. INTERNAL AUDIT
• During audits, information is gathered about:
• processes and operating procedures
• staff competence and training
• equipment
• environment
• handling of samples
• quality control and verification of results
• recording and reporting practices.
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27. INTERNAL AUDIT
• Audits should include the evaluation of steps in the whole laboratory path of
workflow.
• They should be able to detect problems throughout the entire process.
• The findings are compared with the laboratory’s internal policies and to a
standard or external benchmark. Any breakdown in the system or departure
from procedures will be identified.
• The advantages of internal audits are that laboratories can perform them as
frequently as needed, and at very little or no cost.
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29. INTERNAL AUDIT..
• SELECT AREA FOR AUDIT.
• Focus on defined areas of the laboratory activities, identified by issues such as customer
complaints or quality control problems.
• horizontal or vertical.
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30. INTERNAL AUDIT…
ESTABLISH A SCHEDULE.
• ISO 15189:2007 [4.14.2] states:
The main elements of the quality management system should normally be subject to internal audit
once every twelve months
• In general, audit regularly
• consider three to six-month intervals between audits.
• If audits reveal specific problems, it may be necessary to include more frequent audits.
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31. INTERNAL AUDIT..
CHECKLISTS AND FORMS USED
When developing checklists for internal audits:
• Take into account any established national policies and standards.
• Ensure checklists are easy to use and include areas for recording information.
• Forms will be needed for recording corrective actions and for making reports.
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32. A SAMPLE CHECKLIST FOR AUDIT
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34. INTERNAL AUDIT…...
RECORDS OF AUDIT:
• The laboratory should maintain detailed documentary records of all audits to
provide management with a continuous history of performance and a means of
identifying particular areas of weakness.
• Records should be kept by the Quality Manager and they may be checked
during inspections by accreditation bodies.
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35. INTERNAL AUDIT….
CONTINUOUS MONITORING
• Continuous monitoring is the key element to success in the quality system.
• It is through this process that we are able to achieve the continual improvement that is our
overall goal.
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36. EXTERNAL AUDIT
Assessments conducted by groups or agencies from outside the laboratory are called external audits.
• EXTERNAL AUDITORS:
• Health authorities;
• Accreditation bodies are organizations that provide accreditation or certification.
• Public health programmes, or by agencies that provide funding for programmes. (WHO) Polio
Initiative regularly assess disease-specific laboratories according to their own standards with
their own checklists.
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37. EXERNAL AUDIT
• THE STANDARDS
• In conducting external audits, the assessors will verify that laboratory policies, processes and
procedures are documented and comply with designated standards.
• Different standards can be used for the assessment processes, ranging from international
standards to a locally developed checklist.
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38. EXTERNAL AUDIT…
• PREPARATION
To be ready for the external audit, it is necessary to:
• plan thoroughly and carefully;
• organize everything ahead of time, including documents and records, to save valuable time
during the audit;
• make all staff aware of the audit, and arrange schedules so that all staff needed for the audit will
be available.
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39. EXTERNAL AUDIT..
AUDIT REPORT AND PLAN OF ACTION.
• After the audit, the recommendations of the assessors are often presented as a verbal summary to the
laboratory management and staff, which are then followed by a thorough written report.
After the external audit has been completed the laboratory should:
• review the recommendations of the assessors;
• identify gaps or nonconformities, learning where benchmarks or standards were not fully met;
• plan to correct the nonconformities
• record all results and actions taken
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40. EXTERNAL AUDIT….
• ACTIONS AS A RESULT OF AUDIT:
• Audits should lead to actions—this is why laboratories conduct them, to further the process of
continual improvement in the laboratory.
• Audits identify opportunities for improvement (OFIs).
• Both preventive and corrective actions are steps taken to improve a process or to correct a
problem.
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41. SUMMARY
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 causes of problems and taking corrective actions.
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