Are we using the correct quality goals?Ola Elgaddar
Setting quality goals / specifications is a debatable issue since 1999. I am trying here to show the options and the continuos trials from several professional bodies to reach a consensus in this matter.
This was an oral presentation in the first international conference of the Chemical Pathology Department, Medical Research Institute, Alexandria University - February 2016
What do clinicians need to know about lab tests?Ola Elgaddar
A presentation in the Annual meeting of the Egyptian American Scholars (AEAS) in Cairo 2015.
I am trying here to describe, in short, from my point of view as a laboratorian, the points that we need to discuss with clinicians. Both groups should share some terms and definitions and should see things from the same perspective!
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.
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.
Are we using the correct quality goals?Ola Elgaddar
Setting quality goals / specifications is a debatable issue since 1999. I am trying here to show the options and the continuos trials from several professional bodies to reach a consensus in this matter.
This was an oral presentation in the first international conference of the Chemical Pathology Department, Medical Research Institute, Alexandria University - February 2016
What do clinicians need to know about lab tests?Ola Elgaddar
A presentation in the Annual meeting of the Egyptian American Scholars (AEAS) in Cairo 2015.
I am trying here to describe, in short, from my point of view as a laboratorian, the points that we need to discuss with clinicians. Both groups should share some terms and definitions and should see things from the same perspective!
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.
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.
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.
In the continuous quality journey, Controlling laboratory Errors is an integral part & focusing on analytical, post-analytical process is the first step. Developing a reporting culture followed by thorough analysis and implementation of appropriate corrective, preventive actions is required.
This presentation describes the key performance indicators to assess the quality of work in microbiology department. The KPIs in common use are mentioned and other indicators are summarized.
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
Laboratory Management With Constrains Iamm 2010PathKind Labs
Clinical laboratory services are a critical yet much neglected component of health systems in resource poor countries. They are crucial for public health, disease control and surveillance, and guide patient diagnosis and care, but their key role is often not recognized by governments or donors. Laboratory tests should be used to improve the outcome for individual patients or to provide public health information. However, if the quality of laboratory tests is poor, resources will be wasted on repeat tests or inappropriate management and the laboratory service will be inefficient.
The primary goal of Laboratory Medicine is to provide information that is useful to assist medical decision-making, allowing optimal health care. This can only be obtained by generating reliable analytical results on patient samples. Meaningful measurements are indeed essential for the diagnosis, monitoring, treatment, and risk assessment of patients. Inadequate laboratory performance may have extensive consequences for practical medicine, healthcare system, and, in conclusion, for the patient. Poor quality results may actually lead to incorrect interpretation by the clinician, impairing the patient’s
situation.
Accreditation authorities have identified twelve quality system essentials that need to be in place for a laboratory to perform clinical tests adequately and in a quality assured manner. Along with each laboratory performing tests that are in its scope, it is essential that duplication and excess capacity is addressed by forging and operating a network of laboratories leading to consolidation and integration of clinical testing. A network would have collection centers at places convenient to the patients, supported by frequent transfer of samples in appropriate conditions to the laboratory. In the laboratory there is a need for increased automation and relevant training of personnel and the setting up of centralized accessioning, pneumontic chutes for transport of samples to the work bench and for bidirectional interphased equipment to transfer results to desk top of laboratory physicians and after validation of results for the results to be electronically transferred by SMS and/or PDF files via email and/or becoming available online for clients, supplemented by delivery of hard copies of the results.
The challenge in the next decade for laboratory medicine is to accomplish these major changes in organization to meet fiscal restraint and shortage of adequately trained laboratory personnel. Collaborative networks, constructive use of point of care devices, and the development of rapport between laboratories and their clients leading to cost effective utilization of limited resources, are some of the strategies that will maximize patient benefit
Quality Assurance of Laboratory Test Results based on ISO/IEC 17025PECB
The webinar covers:
• Introduction to QA in Laboratories
• Internal Quality Control Techniques
• External Quality Control Techniques
Presenter:
This webinar was presented by Hamidreza Dehnad, PECB Certified Trainer and CEO of Pasargad Quality Pioneers (PQP).
Link of the recorded session published on YouTube: https://youtu.be/IbWcJQDULYA
ELISA is one of the commonly used laboratory techniques. As it is a multi-step manual technique, every step should be carefully monitored. Here is a short presentation on the common things that should be considered when using ELISA.
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.
In the continuous quality journey, Controlling laboratory Errors is an integral part & focusing on analytical, post-analytical process is the first step. Developing a reporting culture followed by thorough analysis and implementation of appropriate corrective, preventive actions is required.
This presentation describes the key performance indicators to assess the quality of work in microbiology department. The KPIs in common use are mentioned and other indicators are summarized.
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
Laboratory Management With Constrains Iamm 2010PathKind Labs
Clinical laboratory services are a critical yet much neglected component of health systems in resource poor countries. They are crucial for public health, disease control and surveillance, and guide patient diagnosis and care, but their key role is often not recognized by governments or donors. Laboratory tests should be used to improve the outcome for individual patients or to provide public health information. However, if the quality of laboratory tests is poor, resources will be wasted on repeat tests or inappropriate management and the laboratory service will be inefficient.
The primary goal of Laboratory Medicine is to provide information that is useful to assist medical decision-making, allowing optimal health care. This can only be obtained by generating reliable analytical results on patient samples. Meaningful measurements are indeed essential for the diagnosis, monitoring, treatment, and risk assessment of patients. Inadequate laboratory performance may have extensive consequences for practical medicine, healthcare system, and, in conclusion, for the patient. Poor quality results may actually lead to incorrect interpretation by the clinician, impairing the patient’s
situation.
Accreditation authorities have identified twelve quality system essentials that need to be in place for a laboratory to perform clinical tests adequately and in a quality assured manner. Along with each laboratory performing tests that are in its scope, it is essential that duplication and excess capacity is addressed by forging and operating a network of laboratories leading to consolidation and integration of clinical testing. A network would have collection centers at places convenient to the patients, supported by frequent transfer of samples in appropriate conditions to the laboratory. In the laboratory there is a need for increased automation and relevant training of personnel and the setting up of centralized accessioning, pneumontic chutes for transport of samples to the work bench and for bidirectional interphased equipment to transfer results to desk top of laboratory physicians and after validation of results for the results to be electronically transferred by SMS and/or PDF files via email and/or becoming available online for clients, supplemented by delivery of hard copies of the results.
The challenge in the next decade for laboratory medicine is to accomplish these major changes in organization to meet fiscal restraint and shortage of adequately trained laboratory personnel. Collaborative networks, constructive use of point of care devices, and the development of rapport between laboratories and their clients leading to cost effective utilization of limited resources, are some of the strategies that will maximize patient benefit
Quality Assurance of Laboratory Test Results based on ISO/IEC 17025PECB
The webinar covers:
• Introduction to QA in Laboratories
• Internal Quality Control Techniques
• External Quality Control Techniques
Presenter:
This webinar was presented by Hamidreza Dehnad, PECB Certified Trainer and CEO of Pasargad Quality Pioneers (PQP).
Link of the recorded session published on YouTube: https://youtu.be/IbWcJQDULYA
ELISA is one of the commonly used laboratory techniques. As it is a multi-step manual technique, every step should be carefully monitored. Here is a short presentation on the common things that should be considered when using ELISA.
Strategic planning, Ola Elgaddar, 12 12-2016Ola Elgaddar
A simple introduction to the basic concepts of strategic planning addressing anyone who works in any organization, aiming at elucidating some vague terms like strategy, environmental scanning, mission, vision,......!!
It is very important to every employee, who is a bit away from decision makers in his organization, to know the basic concepts at least.
The forth lecture about the "Cell".
Here, I am discussing the several signaling pathways.....It is highly dependent on the 3rd lecture; Receptors.
Enjoy :)
Since the beginning of product development, bundle and unbundle products always has been a pretty tricky question to answer. I created this document to put a little of light in that difficult decision when I was product owner of Next Visit, one year ago. I believe that it still being quite valid.
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.
Best Practices of Auditing an Energy Management SystemPECB
Firstly, it will clarify some of the misunderstandings of some of the fundamental audit concepts and principals that are implemented during the audit or planning of the audit program, focusing on audit guidelines, auditor principles, audit process principles and types of audits. Furthermore, it will gain understanding of the management and preparation of an ISO 50001 audit through audit program pillars, good audit practices, prepared work documents and checklists. Outline how to conduct and close an ISO 50001 audit in a professional manner with the precise audit review.
Main points covered:
• Introduction of an EMS in an organization
• Managing an ISO 50001 audit program
• Preparation of an ISO 50001 audit
• Conduct of an ISO 50001 audit & Closing the audit
Presenter:
This webinar was presented by Kefah El-Ghobbas, PECB Certified Trainer and Organizational Development expert and operations manager at TURBO CARBO.
Link of the recorded session published on YouTube: https://youtu.be/7Pq_KGXAns0
Enhancing Laboratory Leadership through Financial Management Skills.pptxOla Elgaddar
In our recent presentation titled 'Strengthening Lab Leadership through Financial Management,' we explored how financial skills can enhance lab management. Attendees discovered practical ways to leverage financial tools for more effective resource allocation and sustainable growth. The session showcased how mastering financial management can streamline lab operations and improve overall leadership performance.
Laboratory diagnosis of H. Pylori infection, Ola ElgaddarOla Elgaddar
A short presentation for the different laboratory techniques used in diagnosing Helicobacter Pylori infection. A special focus is given for the diagnostic performance of every test.
This is the first one of a series of lectures about the "Cell". I am here introducing some basic principles about the cell structure, types, histology and biochemistry
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
2. Improving the Quality and Value
of the Laboratory Self-Inspection
Ola H. Elgaddar
MD, PhD, MBA, CPHQ, LSSGB,
Lecturer of Chemical Pathology
Alexandria University
Ola.elgaddar@alexu.edu.eg
3. Disclosures
In compliance with the accrediting board policies,AACC requires the following disclosure to the
participants:
Grants/Research Support: None
Consultant: None
Other Financial or Material Support: None
Stock/Shareholder: None
Ola H. Elgaddar
4. Learning Objectives
After attending this presentation, you will be able to:
• Understand the Value of self – inspection in CAP
accreditation
• Describe the steps of an effective self - inspection
• Improve the self – inspection practice of your lab using
some simple tools
5. Do you like the term “INSPECTION”
1. YES
2. NO
3. I HAVE NO CHOICE
6.
7. The College of American Pathologists (CAP) has
established and currently directs multiple
accreditation programs. The Laboratory
Accreditation Program (LAP) was established in
1961. In 1995, it received approval as an
accrediting organization under the Clinical
Laboratory Improvement Amendments of 1988
(CLIA) by the Centers for Medicare and Medicaid
Services (CMS)
8. Mission Statement:
“The CAP Accreditation Program improves patient
safety by advancing the quality of pathology and
laboratory services through education and standard
setting, and ensuring laboratories meet or exceed
regulatory requirements.”
9. Inspection:
On-site inspection by an external team and an
interim self-inspection are the cornerstones of the
CAP requirements.
Participating laboratories also provide an
inspection team when requested
10. Detailed list of requirements that the inspector uses to
determine if the laboratory meets the Standards.
Each requirement is uniquely numbered and indicated by
a declarative statement.
Revised periodically
Customized based on the laboratory’s activity menu.
11. Provided to participants upon completion of the initial
application, at accreditation mid-cycle during the self-
inspection year and at the time of each biennial re-
application.
A laboratory will be inspected using the checklist version
sent to it at the time of application/reapplication even
though a new version may have been released, and the
inspection team must utilize the same version that was
sent to the laboratory.
12. Self – inspection ….... Why??
A CAP requirement!!
To overcome human tendency to become
“familiar” with errors or with even error prone
activities.
Identify potential non-compliances and be ready
for the next inspection
Maintain and Improve lab performance and better
patient care
13. Self – inspection ….... What??
At the beginning of the second year of the two-year
accreditation cycle, using the assigned checklists.
Return the self-inspection verification form signed by the
director within 60 calendar days after receiving the self-
inspection materials.
Correct all cited deficiencies and document corrective
actions for review by the next CAP inspection team
14. Failure to perform the self-inspection is a serious
deficiency and may result in an immediate on-site
inspection or denial of accreditation.
15. Which of the following added disciplines, by
a CAP accredited lab, requires a self –
inspection:
1. Anatomic Pathology
2. Histocompatibility
3. Flow cytometry
16. Which of the following added disciplines, by
a CAP accredited lab, requires a self –
inspection:
1. Anatomic Pathology
2. Histocompatibility
3. Flow cytometry
17. The Self-Inspection deficiency corrective
action form should be returned to the CAP
within 60 calendar days:
1. True
2. False
18. The Self-Inspection deficiency corrective
action form should be returned to the CAP
within 60 calendar days:
1. True
2. False
19. How to improve the quality
and value of self – inspection?
Before (Prepare)
During (Conduct)
After (Improve)
21. Mimic the onsite inspection; Treat a self-
inspection like a real event.
CAP inspector and former Continuous Compliance Committee chair Renee R. Ellerbroek”
Formalize it: Policy, fixed time, conducted in one
day,…....
22. In order to formalize the self – inspection,
select a fixed date few months ahead, and
announce it for everyone:
1. Incorrect practice
2. Correct practice
23. In order to formalize the self – inspection,
select a fixed date few months ahead, and
announce it for everyone:
1. Incorrect practice
2. Correct practice
24. View the lab data on e-lab solutions for accuracy
and report any change to the CAP
Diversity of the team:
Involve all staff levels; bench technologists,
supervisors, managers and admins.
• Different perspective
• Confidence
• Sense of ownership
25. Encourage your staff to have the CAP inspector
training courses
Consider using a sister facility or cross-disciplines
for fresh unbiased opinions
27. Start with reviewing the deficiencies cited during
the last inspection and make sure that the
corrective actions reported to CAP are actually
being implemented, otherwise they will come up
in the next inspection.
28. Use the latest CAP checklist; not the last on-site
inspection one and it might not be the next on-site
one as well.
Always check for updates and always follow up
the updates webinars offered by CAP
29. Use the CAP inspector “R.O.A.D”;
Read – Observe – Ask – Discover
Don’t forget the medical director assessment part
and focus only on technical part
Make it a thorough inspection!!
30. Focus review on new tests and methods, low
volume tests, and tests with unacceptable PT
results
Review last inspection recommendations and
decide if they should be implemented or not
32. Culture: Document everything that you find!!
Summation conference attended by all lab staff
from lab director downwards
33. Develop and implement a corrective action plan
for all the deficiencies that you found, follow up
the implementation of this corrective actions.
Give your self enough time before the next
inspection to make sure that corrective actions are
fully implemented and maintained
34. During the self-inspection of Clinical Chemistry, you noted that the
competency assessments of some staff were missing. You were
informed that competency assessments have been completed for
them but the unit manager had the files at home as he was working
on the annual evaluations.
What would you do?
1. Cite a deficiency since the competency assessment documents
are not in the laboratory.
2. Recommend that competency assessment documents should
not leave the laboratory.
3. Move on since the competency assessments have been
completed.
35. During the self-inspection of Clinical Chemistry, you noted that the
competency assessments of some staff were missing. You were
informed that competency assessments have been completed for
them but the unit manager had the files at home as he was working
on the annual evaluations.
What would you do?
1. Cite a deficiency since the competency assessment documents
are not in the laboratory.
2. Recommend that competency assessment documents should
not leave the laboratory.
3. Move on since the competency assessments have been
completed.
36. A final word:
On any day of the year ask yourself:
Are we ready for an unannounced
inspection??
If the answer is no then your self –
inspection is not effective!