Short presentation about using internal quality control material in clinical laboratory to ensure analytical quality laboratory results for the sake of better patient care and minimizing errors in diagnosis, management, and follow up.
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
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.
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 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
QUALITY
Conformance to the requirements of users or customers satisfaction of their needs and expectations.
Total Quality Management
A management approach that focuses on processes and their improvement.
Quality 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.
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 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
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.
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This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
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The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
3. Internal Quality
Control
Dr. Adel A. Elazab 3
QUALITY ASSURANCE
PROGRAMME
! Internal Quality Control (IQC)
Procedures
! External Quality Assessment
(EQA)
! Quality Management
4. Internal Quality
Control
Dr. Adel A. Elazab 4
Internal Quality Control (IQC)
Procedures
⇒ Done during daily routine work
⇒ Provides an immediate control
⇒ Errors are corrected immediately
⇒ Routinely collect and analyze data from
every test run or procedure
Why do we need Internal Quality Control?
! Ensure that test results are reliable
! Ensure that test results are reproducible
! Control quality of daily routine work
5. Internal Quality
Control
Dr. Adel A. Elazab 5
Internal Quality Control
Monitoring quality of laboratory
testing, accuracy and precision of
laboratory results
8. Internal Quality
Control
Dr. Adel A. Elazab 8
Internal Quality Control
• It ensures continual check that the established
reliability of the laboratory’s work does not
fluctuate and that reports are validated before
they are released.
• It is based on monitoring the procedures which
are actually used for the tests in the laboratory.
It includes:
· Control charts with tests on control materials
· Duplicate tests on all specimens or on a
proportion of the specimens
· Delta check, comparing current test results
with previous results
· Consistency of mean values of patient data
9. Internal Quality
Control
Dr. Adel A. Elazab 9
QC Quantitative Tests
• Use 2-3 levels of controls covering the
medical decision points
• At least 20 control values over a period of
20-30 days for each level of control
• Perform statistical analysis
• Develop Levey-Jenning chart
• Run -regularly- with patient samples
• Monitor control values on chart using
Westgard rules
• Take immediate corrective action, if
needed
• Record actions taken (if any)
10. Internal Quality
Control
Dr. Adel A. Elazab 10
QC Quantitative Tests
• QC material must be available in
large quantities stored in small
aliquots (Ideally should last for at
least 1 year)
• Always consider as Biohazardous
• Requires very accurate
reconstitution if needed
• Always deal with and store as
recommended by manufacturer
11. Internal Quality
Control
Dr. Adel A. Elazab 11
Analysis of Control Materials
• Need data set of at least 20 points
obtained over 20-30 days better by
different operators in different times of day
• Calculate mean, standard deviation,
Coefficient of variation and determine
target ranges
• Develop Levey-Jenning charts
• Plot –on the chart- control values each
run/ day
• Make decisions regarding acceptability of
run using Westgard rules
• Monitor over time and at defined intervals
12. Internal Quality
Control
Dr. Adel A. Elazab 12
1. 192 mg/dL
2. 194 mg/dL
3. 196 mg/dL
4. 196 mg/dL
5. 160 mg/dL
6. 196 mg/dL
7. 200 mg/dL
8. 200 mg/dL
9. 202 mg/dL
10.255 mg/dL
11.204 mg/dL
12.208 mg/dL
13.212 mg/dL
Calculation of the Mean: Outliers
13. Internal Quality
Control
Dr. Adel A. Elazab 13
Levey-Jennings Chart
Calculate the Mean and Standard Deviation;
Record the Mean and +/- 1,2 and 3 SD Control Limits
80
85
90
95
100
105
110
115
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
Mean
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD
14. Internal Quality
Control
Dr. Adel A. Elazab 14
Levey-Jennings Chart -
Record and Evaluate the Control Values
80
85
90
95
100
105
110
115
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
Mean
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD
16. Internal Quality
Control
Dr. Adel A. Elazab 16
Findings Over Time
• Ideally should have control values clustered
around the mean (+/-2 SD) with little variation in
the upward or downward direction
• Imprecision = large amount of scatter around the
mean. Usually caused by errors in technique
• Inaccuracy = may see as a trend or a shift,
usually caused by change in the testing process
• Random error = no pattern. Usually poor
technique, malfunctioning equipment
17. ERRORS
Random Error (RE):
Imprecision
• Causes:
1. Pipetting error
2. Temperature error
3. Mixing defect
4. Machine need
troubleshooting
• Systematic Error
(SE): Inaccuracy
• Causes:
1. Deterioration of
control material
2. Deterioration of
calibrator
3. Deterioration of
reagents
Internal Quality
Control
Dr. Adel A. Elazab 17
18. Internal Quality
Control
Dr. Adel A. Elazab 18
Westgard Rules
• Allows determination of whether an
analytical run s (in control) or (out of
control)
34. Internal Quality
Control
Dr. Adel A. Elazab 34
Westgard Multirules
• When you're running 2 or 4 control
levels, use the rules:
13s/22s/R4s/41s/10x
• When you're running 3 control levels,
use a set that works for multiples of
threes:
13s/2of32s/R4s/ 31s/12x
35. Internal Quality
Control
Dr. Adel A. Elazab 35
When a Rule is Violated
• Warning rule = use other rules to
inspect the control points
• Rejection rule = Out of control=
1. Stop testing
2. Identify and correct problem
3. Repeat testing on pt samples and
control
4. Don’t report pt results until problem is
solved and controls indicate proper
performance
36. Internal Quality
Control
Dr. Adel A. Elazab 36
When a Rule is Violated
• Change one variable at a time to troubleshoot an out of control
(> ±2sd) test.
• The variables are usually common to all instruments or
procedure systems and include the following:
• 1. Try a fresh vial of QC
• 2. Try a new reagent (same lot)
• 3. Try a new consumable (water, part, solution, tubing) if
applicable.
• 4. Try a new reagent (new lot)
• 5. Recalibrate (current calibrator)
• 6. Recalibrate (new lot calibrator)
• If a system cannot be brought into control, notify
senior staff. Do not process patient samples for
the test affected.
37. Internal Quality
Control
Dr. Adel A. Elazab 37
Overlap New Lot of Controls
When changing to a new lot number of control
material, ideally there should be an overlap period
while the new material is being analyzed to
establish the new control limits.
In cases where the overlap period is not sufficient, it
is possible to establish the mean value for the new
control material in a short time, over say a five-day
period, or to start with the manufacturer’s values.
Then apply the previous estimate of SD to establish
the control limits.
These control limits should be temporary, until
sufficient data is collected to provide good
estimates of both the mean and SD of the new
material.
38. Internal Quality
Control
Dr. Adel A. Elazab 38
Establishing the Value of the Mean
for a New Lot of QC Material
• New lots of a quality control material should be
analyzed for each analyte in parallel with the lot of
control material in current use.
• Ideally, a minimum of at least 20 measurements
should be made on separate days when the
measurement system is known to be stable, based
on QC results from existing lots.
• If the desired 20 data points from 20 days are not
available, provisional values may have to be
established from data collected over fewer than 20
days.
• Possible approaches include making no more than
four control measurements per day for five different
days
39. Internal Quality
Control
Dr. Adel A. Elazab 39
QUALITY
“QUALTY IS NEVER AN ACCIDENT;
IT IS ALWAYS THE RESULT OF
HIGH INTETION, SINCERE
EFFORTS BY ALL, INTELLIGENT
AND SKILLFUL DIRECTION AND
EXECUTION, IT REPRESENTS THE
WISE CHOISE OF MANY
ALTERNATIVES”