SlideShare a Scribd company logo
QUALITY CONTROL IN
LABORATORY
WHAT IS QC ?
• QC is a technique that is used to detect &
correct errors before they result in a defective
product or service.
• It refers to the measures that must be
included during each assay run to verify that
the test is working properly.
• QC must be practical, achievable & affordable.
TERMINOLOGY
• PRECISION: This indicates how close test
measurements to each other when the same
test is run on the same sample repeatedly.
• Precision does not imply accuracy.
• Precision does not imply accuracy.
• ACCURACY: How close to the true value a
measurement is.
• The closer to the actual value, the more
accurate.
• STANDARD: This is a substance of constant
composition of sufficient purity to be used for
comparison purpose.
• CONTROL: This is a sample i.e. chemically &
physically similar to the unknown specimen.
physically similar to the unknown specimen.
• STANDARD DEVIATION: This is a statistical
expression of scatter or dispersion of values
around a central average value.
Calculation of Standard Deviation
Calculation of Standard Deviation
Coefficient of Variation
Coefficient of Variation
• The Coefficient of Variation (CV) is the
standard Deviation (SD) expressed as a
percentage of the mean
-Also known as Relative Standard
deviation (RSD)
• CV % = SD x 100
Mean
CALCULATION OF MEAN
Data set
(30.0, 32.0, 31.5, 33.5, 32.0, 33.0, 29.0,29.5, 31.0,
32.5, 34.5, 33.5, 31.5, 30.5, 30.0, 34.0,32.0, 32.0,
32.5, 34.5, 33.5, 31.5, 30.5, 30.0, 34.0,32.0, 32.0,
35.0, 32.5.) mg/dL
The sum of the values (X1 + X2 + X3 … X20)
divided by the number (n) of observations
The mean of these 20 observations is (639.5 ÷ 20)
= 32.0 mg/dL
P
PRECISE & INACCURATE
RECISE & INACCURATE
IMPRECISE & INACCURATE
IMPRECISE & INACCURATE
PRECISE & ACCURATE
PRECISE & ACCURATE
L. J. CHART
• L-J chart is a graph that quality control data is
plotted on to give a visual indication whether
a laboratory test is working well.
• It is named after S.LEVEY & E.R.JENNINGS in
1950.
lj with Manufacturer & Lab Calculated Mean & SD
213
234
255
276
297
318
339
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Glucose (Jan 2011) with Manufacturer Mean & Ranges (SD – 21 ; CV- 7.6%)
Level 3
266.58
269.31
272.04
274.77
277.5
280.23
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Glucose (Jan 2011) with Lab defined Mean & Ranges(SD – 2.73; CV- 0.99%)
Level 3
Normal Distribution
Normal Distribution
• All values are symmetrically distributed around the mean
• Characteristic “bell-shaped” curve
• Assumed for all quality control statistics
INTERNAL QUALITY CONTROL
• Use of standard glassware , reagent
, equipment
• Well trained staff
• Selection of accurate & precise
method.
• At least one primary std. is included
with each batch of unknown specimen
analysis.
• Occasionally a different primary std . of
higher concentration is included to
check the reliability of routine primary
higher concentration is included to
check the reliability of routine primary
std.
• The batch result are accepted if the
values of control sera are within first SD.
Types of Errors
• Intrinsic : due to an imprecise &
inaccurate method.
• Systemic : all high values , all low
values.
• Random : technical errors.
• Intrinsic errors can be eliminated by
A) selecting precise & accurate method.
B) by using fresh batches of reagents.
• systemic errors can be eliminated by using diff.
concentration of primary std. & analyzing
concentration of primary std. & analyzing
control serum.
• Technical with a proper analytical application
can be correct random errors.
Systematic vs. Random Errors
Systematic vs. Random Errors
Systematic Error
Avoidable error due to
controllable variables in a
measurement.
Random Errors
Unavoidable errors that
are always present in any
measurement. Impossible
measurement. measurement. Impossible
to eliminate
PREVENTIVE PHASE
• Collection of specimen
• Separation of serum
• Specimen analysis
• Calculation of test values etc..
RETROSPECTIVE PHASE
• Optimum condition variance
• Routine condition variance
OPTIMUM CONDITION VARIANCE
• Refers to the results obtained under
optimum conditions i.e. by using
i)freshly prepared reagents
ii)by using standardized glassware
ROUTINE CONDITIONS VARIANCE
• Refers to the results obtained by using routine
requirements i.e. by using routinely stored
reagents and glassware in regular use.
WESTGARD RULES
• 1-2S
• 1-3S
• 2-2S
• 2-2S
• R-4S
• 4-1S
• 10X
• Multi control QC rules (WESTGARD RULES)
given by Dr. James Westgard of the University of
Wisconsin in an article in 1981 on laboratory
quality control that set the basis for evaluating
analytical run quality for medical laboratories.
• The Westgard system -based on the principles of
statistical process control used in manufacturing
statistical process control used in manufacturing
nationwide since the 1950s
• Six basic rules in the Westgard scheme: 1-3s, 2-
2s, R-4s, 1-2s, 4-1s, and 10x. These rules are used
individually or in combination (multi-rule) to
evaluate the quality of analytical runs.
• Detect random or systematic errors
• Warning 12SD or 1-2s:
It is violated if the single IQC
value exceeds the mean by ± 2SD.
• Rejection 22SD or 2-2s:
• This rule detects systematic error and is applied within and across
runs.
• It is violated within the run when two consecutive control values
exceed the "same" (mean + 2s or mean - 2s) limit.
• The rule is violated across runs when the previous value for a
particular control level exceeds the "same"
(mean + 2s or mean - 2s) limit.
(mean + 2s or mean - 2s) limit.
Within run violation Across run violation
• Rejection 13SD or 1-3s:
• It is violated when the single IQC
value exceeds the mean by ±3SD.
• This rule is applied within control
material only.
• The 1-3s rule identifies unacceptable
random error or possibly the
beginning of a large systematic error.
• Rejection 41SD or 4-1s:
It is violated if four consecutive IQC
values exceed the same mean plus 1s
or the same mean minus 1s control limit.
• Rejection 10x:
• This rule detects systematic bias and is applied both within and
across control materials.
• It is violated across control materials if the last 10 consecutive
values, regardless of control level, are on the same side of the
mean.
• The rule is violated within the control materials if the last 10
values for the same control level are on the same side of the
mean.
Westgard Procedure Flowchart
Westgard Procedure Flowchart
EXTERNAL QUALITY CONTROL
• All the participating laboratories daily
analyze the same lot of control material.
• The results are tabulated monthly & sent
the sponsoring groups for the data
the sponsoring groups for the data
analysis.
• Summary reports are prepared by the
program sponsor & are distributed to all
participating laboratories .
• The mean of values of all reference
laboratories is taken as the “ true “ or
correct value & is used for comparison
with the individual laboratory reported
values.
values.
• If the difference between the reported
value & the true value is statistically
significant then the reporting lab is
alerted.
THANK YOU

More Related Content

Similar to safety_in_laboratory.pdf

Quality Control in a Medical Testing Laboratory
Quality Control in a Medical Testing LaboratoryQuality Control in a Medical Testing Laboratory
Quality Control in a Medical Testing Laboratory
Dr. Bikash Kumar Chaudhury
 
Quality assurance
Quality assuranceQuality assurance
Quality assurance
Dr Nidhi Rai Gupta
 
Quality control
Quality controlQuality control
Quality control
SKYFALL
 
Clinical lab qc sethu
Clinical lab qc sethuClinical lab qc sethu
Clinical lab qc sethu
subramaniam sethupathy
 
(IQC) - Internal Quality Control.pptx
(IQC) - Internal Quality Control.pptx(IQC) - Internal Quality Control.pptx
(IQC) - Internal Quality Control.pptx
Dr.Rajeev Ranjan
 
medical -laboratory- quality- control --
medical -laboratory- quality- control --medical -laboratory- quality- control --
medical -laboratory- quality- control --
zahraaali64
 
ANALYTICAL VARIABLES IN QUALITY CONTROL.pptx
ANALYTICAL VARIABLES IN QUALITY CONTROL.pptxANALYTICAL VARIABLES IN QUALITY CONTROL.pptx
ANALYTICAL VARIABLES IN QUALITY CONTROL.pptx
Dr. Jagroop Singh
 
Quality assurance in the department of clinical biochemistry
Quality assurance in the department of clinical biochemistryQuality assurance in the department of clinical biochemistry
Quality assurance in the department of clinical biochemistry
Dipesh Tamrakar
 
Quality control chemical
Quality control chemicalQuality control chemical
Quality control chemical
Appy Akshay Agarwal
 
Quality control.pptx
Quality control.pptxQuality control.pptx
Quality control.pptx
aditisikarwar2
 
Laboratory Internal Quality Control presentation master revision, 2014
Laboratory Internal Quality Control presentation master revision, 2014Laboratory Internal Quality Control presentation master revision, 2014
Laboratory Internal Quality Control presentation master revision, 2014
Adel Elazab Elged
 
2. Quality Control Notes
2. Quality Control Notes2. Quality Control Notes
2. Quality Control Notes
Leah Molai
 
Quality management system BY M .REJA
Quality management system BY M .REJAQuality management system BY M .REJA
Quality management system BY M .REJA
MamunReja1
 
Basics of laboratory internal quality control, Ola Elgaddar, 2012
Basics of laboratory internal quality control, Ola Elgaddar, 2012Basics of laboratory internal quality control, Ola Elgaddar, 2012
Basics of laboratory internal quality control, Ola Elgaddar, 2012
Ola Elgaddar
 
Method validation terms quality control and assurance
Method validation terms quality control and assurance Method validation terms quality control and assurance
Method validation terms quality control and assurance
MuhammadImranMirza2
 
Laboratory Quality Control .ppt
Laboratory Quality Control .pptLaboratory Quality Control .ppt
Laboratory Quality Control .ppt
ABRARAHMED767665
 
Basic QC Statistics - Improving Laboratory Performance Through Quality Contro...
Basic QC Statistics - Improving Laboratory Performance Through Quality Contro...Basic QC Statistics - Improving Laboratory Performance Through Quality Contro...
Basic QC Statistics - Improving Laboratory Performance Through Quality Contro...
Randox
 
ICP QC protocol
ICP  QC  protocolICP  QC  protocol
ICP QC protocol
Gamal Abdel Hamid
 
Quality Control in Laboratory
Quality Control in LaboratoryQuality Control in Laboratory
Quality Control in Laboratory
Manal Elsayed CPPS, CPHQ, CLSSBB, FISQua, DTQM
 
QA-QC-PSK.pdf
QA-QC-PSK.pdfQA-QC-PSK.pdf
QA-QC-PSK.pdf
JacknJill2
 

Similar to safety_in_laboratory.pdf (20)

Quality Control in a Medical Testing Laboratory
Quality Control in a Medical Testing LaboratoryQuality Control in a Medical Testing Laboratory
Quality Control in a Medical Testing Laboratory
 
Quality assurance
Quality assuranceQuality assurance
Quality assurance
 
Quality control
Quality controlQuality control
Quality control
 
Clinical lab qc sethu
Clinical lab qc sethuClinical lab qc sethu
Clinical lab qc sethu
 
(IQC) - Internal Quality Control.pptx
(IQC) - Internal Quality Control.pptx(IQC) - Internal Quality Control.pptx
(IQC) - Internal Quality Control.pptx
 
medical -laboratory- quality- control --
medical -laboratory- quality- control --medical -laboratory- quality- control --
medical -laboratory- quality- control --
 
ANALYTICAL VARIABLES IN QUALITY CONTROL.pptx
ANALYTICAL VARIABLES IN QUALITY CONTROL.pptxANALYTICAL VARIABLES IN QUALITY CONTROL.pptx
ANALYTICAL VARIABLES IN QUALITY CONTROL.pptx
 
Quality assurance in the department of clinical biochemistry
Quality assurance in the department of clinical biochemistryQuality assurance in the department of clinical biochemistry
Quality assurance in the department of clinical biochemistry
 
Quality control chemical
Quality control chemicalQuality control chemical
Quality control chemical
 
Quality control.pptx
Quality control.pptxQuality control.pptx
Quality control.pptx
 
Laboratory Internal Quality Control presentation master revision, 2014
Laboratory Internal Quality Control presentation master revision, 2014Laboratory Internal Quality Control presentation master revision, 2014
Laboratory Internal Quality Control presentation master revision, 2014
 
2. Quality Control Notes
2. Quality Control Notes2. Quality Control Notes
2. Quality Control Notes
 
Quality management system BY M .REJA
Quality management system BY M .REJAQuality management system BY M .REJA
Quality management system BY M .REJA
 
Basics of laboratory internal quality control, Ola Elgaddar, 2012
Basics of laboratory internal quality control, Ola Elgaddar, 2012Basics of laboratory internal quality control, Ola Elgaddar, 2012
Basics of laboratory internal quality control, Ola Elgaddar, 2012
 
Method validation terms quality control and assurance
Method validation terms quality control and assurance Method validation terms quality control and assurance
Method validation terms quality control and assurance
 
Laboratory Quality Control .ppt
Laboratory Quality Control .pptLaboratory Quality Control .ppt
Laboratory Quality Control .ppt
 
Basic QC Statistics - Improving Laboratory Performance Through Quality Contro...
Basic QC Statistics - Improving Laboratory Performance Through Quality Contro...Basic QC Statistics - Improving Laboratory Performance Through Quality Contro...
Basic QC Statistics - Improving Laboratory Performance Through Quality Contro...
 
ICP QC protocol
ICP  QC  protocolICP  QC  protocol
ICP QC protocol
 
Quality Control in Laboratory
Quality Control in LaboratoryQuality Control in Laboratory
Quality Control in Laboratory
 
QA-QC-PSK.pdf
QA-QC-PSK.pdfQA-QC-PSK.pdf
QA-QC-PSK.pdf
 

Recently uploaded

Charaka Samhita Sutra sthana Chapter 15 Upakalpaniyaadhyaya
Charaka Samhita Sutra sthana Chapter 15 UpakalpaniyaadhyayaCharaka Samhita Sutra sthana Chapter 15 Upakalpaniyaadhyaya
Charaka Samhita Sutra sthana Chapter 15 Upakalpaniyaadhyaya
Dr KHALID B.M
 
Cervical & Brachial Plexus By Dr. RIG.pptx
Cervical & Brachial Plexus By Dr. RIG.pptxCervical & Brachial Plexus By Dr. RIG.pptx
Cervical & Brachial Plexus By Dr. RIG.pptx
Dr. Rabia Inam Gandapore
 
Evaluation of antidepressant activity of clitoris ternatea in animals
Evaluation of antidepressant activity of clitoris ternatea in animalsEvaluation of antidepressant activity of clitoris ternatea in animals
Evaluation of antidepressant activity of clitoris ternatea in animals
Shweta
 
Hemodialysis: Chapter 3, Dialysis Water Unit - Dr.Gawad
Hemodialysis: Chapter 3, Dialysis Water Unit - Dr.GawadHemodialysis: Chapter 3, Dialysis Water Unit - Dr.Gawad
Hemodialysis: Chapter 3, Dialysis Water Unit - Dr.Gawad
NephroTube - Dr.Gawad
 
Couples presenting to the infertility clinic- Do they really have infertility...
Couples presenting to the infertility clinic- Do they really have infertility...Couples presenting to the infertility clinic- Do they really have infertility...
Couples presenting to the infertility clinic- Do they really have infertility...
Sujoy Dasgupta
 
The hemodynamic and autonomic determinants of elevated blood pressure in obes...
The hemodynamic and autonomic determinants of elevated blood pressure in obes...The hemodynamic and autonomic determinants of elevated blood pressure in obes...
The hemodynamic and autonomic determinants of elevated blood pressure in obes...
Catherine Liao
 
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?Report Back from SGO 2024: What’s the Latest in Cervical Cancer?
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?
bkling
 
POST OPERATIVE OLIGURIA and its management
POST OPERATIVE OLIGURIA and its managementPOST OPERATIVE OLIGURIA and its management
POST OPERATIVE OLIGURIA and its management
touseefaziz1
 
KDIGO 2024 guidelines for diabetologists
KDIGO 2024 guidelines for diabetologistsKDIGO 2024 guidelines for diabetologists
KDIGO 2024 guidelines for diabetologists
د.محمود نجيب
 
Antiulcer drugs Advance Pharmacology .pptx
Antiulcer drugs Advance Pharmacology .pptxAntiulcer drugs Advance Pharmacology .pptx
Antiulcer drugs Advance Pharmacology .pptx
Rohit chaurpagar
 
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...
i3 Health
 
Are There Any Natural Remedies To Treat Syphilis.pdf
Are There Any Natural Remedies To Treat Syphilis.pdfAre There Any Natural Remedies To Treat Syphilis.pdf
Are There Any Natural Remedies To Treat Syphilis.pdf
Little Cross Family Clinic
 
Physiology of Chemical Sensation of smell.pdf
Physiology of Chemical Sensation of smell.pdfPhysiology of Chemical Sensation of smell.pdf
Physiology of Chemical Sensation of smell.pdf
MedicoseAcademics
 
For Better Surat #ℂall #Girl Service ❤85270-49040❤ Surat #ℂall #Girls
For Better Surat #ℂall #Girl Service ❤85270-49040❤ Surat #ℂall #GirlsFor Better Surat #ℂall #Girl Service ❤85270-49040❤ Surat #ℂall #Girls
For Better Surat #ℂall #Girl Service ❤85270-49040❤ Surat #ℂall #Girls
Savita Shen $i11
 
ANATOMY AND PHYSIOLOGY OF URINARY SYSTEM.pptx
ANATOMY AND PHYSIOLOGY OF URINARY SYSTEM.pptxANATOMY AND PHYSIOLOGY OF URINARY SYSTEM.pptx
ANATOMY AND PHYSIOLOGY OF URINARY SYSTEM.pptx
Swetaba Besh
 
BRACHYTHERAPY OVERVIEW AND APPLICATORS
BRACHYTHERAPY OVERVIEW  AND  APPLICATORSBRACHYTHERAPY OVERVIEW  AND  APPLICATORS
BRACHYTHERAPY OVERVIEW AND APPLICATORS
Krishan Murari
 
The Normal Electrocardiogram - Part I of II
The Normal Electrocardiogram - Part I of IIThe Normal Electrocardiogram - Part I of II
The Normal Electrocardiogram - Part I of II
MedicoseAcademics
 
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in StockFactory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
rebeccabio
 
Ocular injury ppt Upendra pal optometrist upums saifai etawah
Ocular injury  ppt  Upendra pal  optometrist upums saifai etawahOcular injury  ppt  Upendra pal  optometrist upums saifai etawah
Ocular injury ppt Upendra pal optometrist upums saifai etawah
pal078100
 
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...
VarunMahajani
 

Recently uploaded (20)

Charaka Samhita Sutra sthana Chapter 15 Upakalpaniyaadhyaya
Charaka Samhita Sutra sthana Chapter 15 UpakalpaniyaadhyayaCharaka Samhita Sutra sthana Chapter 15 Upakalpaniyaadhyaya
Charaka Samhita Sutra sthana Chapter 15 Upakalpaniyaadhyaya
 
Cervical & Brachial Plexus By Dr. RIG.pptx
Cervical & Brachial Plexus By Dr. RIG.pptxCervical & Brachial Plexus By Dr. RIG.pptx
Cervical & Brachial Plexus By Dr. RIG.pptx
 
Evaluation of antidepressant activity of clitoris ternatea in animals
Evaluation of antidepressant activity of clitoris ternatea in animalsEvaluation of antidepressant activity of clitoris ternatea in animals
Evaluation of antidepressant activity of clitoris ternatea in animals
 
Hemodialysis: Chapter 3, Dialysis Water Unit - Dr.Gawad
Hemodialysis: Chapter 3, Dialysis Water Unit - Dr.GawadHemodialysis: Chapter 3, Dialysis Water Unit - Dr.Gawad
Hemodialysis: Chapter 3, Dialysis Water Unit - Dr.Gawad
 
Couples presenting to the infertility clinic- Do they really have infertility...
Couples presenting to the infertility clinic- Do they really have infertility...Couples presenting to the infertility clinic- Do they really have infertility...
Couples presenting to the infertility clinic- Do they really have infertility...
 
The hemodynamic and autonomic determinants of elevated blood pressure in obes...
The hemodynamic and autonomic determinants of elevated blood pressure in obes...The hemodynamic and autonomic determinants of elevated blood pressure in obes...
The hemodynamic and autonomic determinants of elevated blood pressure in obes...
 
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?Report Back from SGO 2024: What’s the Latest in Cervical Cancer?
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?
 
POST OPERATIVE OLIGURIA and its management
POST OPERATIVE OLIGURIA and its managementPOST OPERATIVE OLIGURIA and its management
POST OPERATIVE OLIGURIA and its management
 
KDIGO 2024 guidelines for diabetologists
KDIGO 2024 guidelines for diabetologistsKDIGO 2024 guidelines for diabetologists
KDIGO 2024 guidelines for diabetologists
 
Antiulcer drugs Advance Pharmacology .pptx
Antiulcer drugs Advance Pharmacology .pptxAntiulcer drugs Advance Pharmacology .pptx
Antiulcer drugs Advance Pharmacology .pptx
 
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...
 
Are There Any Natural Remedies To Treat Syphilis.pdf
Are There Any Natural Remedies To Treat Syphilis.pdfAre There Any Natural Remedies To Treat Syphilis.pdf
Are There Any Natural Remedies To Treat Syphilis.pdf
 
Physiology of Chemical Sensation of smell.pdf
Physiology of Chemical Sensation of smell.pdfPhysiology of Chemical Sensation of smell.pdf
Physiology of Chemical Sensation of smell.pdf
 
For Better Surat #ℂall #Girl Service ❤85270-49040❤ Surat #ℂall #Girls
For Better Surat #ℂall #Girl Service ❤85270-49040❤ Surat #ℂall #GirlsFor Better Surat #ℂall #Girl Service ❤85270-49040❤ Surat #ℂall #Girls
For Better Surat #ℂall #Girl Service ❤85270-49040❤ Surat #ℂall #Girls
 
ANATOMY AND PHYSIOLOGY OF URINARY SYSTEM.pptx
ANATOMY AND PHYSIOLOGY OF URINARY SYSTEM.pptxANATOMY AND PHYSIOLOGY OF URINARY SYSTEM.pptx
ANATOMY AND PHYSIOLOGY OF URINARY SYSTEM.pptx
 
BRACHYTHERAPY OVERVIEW AND APPLICATORS
BRACHYTHERAPY OVERVIEW  AND  APPLICATORSBRACHYTHERAPY OVERVIEW  AND  APPLICATORS
BRACHYTHERAPY OVERVIEW AND APPLICATORS
 
The Normal Electrocardiogram - Part I of II
The Normal Electrocardiogram - Part I of IIThe Normal Electrocardiogram - Part I of II
The Normal Electrocardiogram - Part I of II
 
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in StockFactory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
 
Ocular injury ppt Upendra pal optometrist upums saifai etawah
Ocular injury  ppt  Upendra pal  optometrist upums saifai etawahOcular injury  ppt  Upendra pal  optometrist upums saifai etawah
Ocular injury ppt Upendra pal optometrist upums saifai etawah
 
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...
 

safety_in_laboratory.pdf

  • 2. WHAT IS QC ? • QC is a technique that is used to detect & correct errors before they result in a defective product or service. • It refers to the measures that must be included during each assay run to verify that the test is working properly. • QC must be practical, achievable & affordable.
  • 3. TERMINOLOGY • PRECISION: This indicates how close test measurements to each other when the same test is run on the same sample repeatedly. • Precision does not imply accuracy. • Precision does not imply accuracy. • ACCURACY: How close to the true value a measurement is. • The closer to the actual value, the more accurate.
  • 4. • STANDARD: This is a substance of constant composition of sufficient purity to be used for comparison purpose. • CONTROL: This is a sample i.e. chemically & physically similar to the unknown specimen. physically similar to the unknown specimen. • STANDARD DEVIATION: This is a statistical expression of scatter or dispersion of values around a central average value.
  • 5. Calculation of Standard Deviation Calculation of Standard Deviation
  • 6. Coefficient of Variation Coefficient of Variation • The Coefficient of Variation (CV) is the standard Deviation (SD) expressed as a percentage of the mean -Also known as Relative Standard deviation (RSD) • CV % = SD x 100 Mean
  • 7. CALCULATION OF MEAN Data set (30.0, 32.0, 31.5, 33.5, 32.0, 33.0, 29.0,29.5, 31.0, 32.5, 34.5, 33.5, 31.5, 30.5, 30.0, 34.0,32.0, 32.0, 32.5, 34.5, 33.5, 31.5, 30.5, 30.0, 34.0,32.0, 32.0, 35.0, 32.5.) mg/dL The sum of the values (X1 + X2 + X3 … X20) divided by the number (n) of observations The mean of these 20 observations is (639.5 ÷ 20) = 32.0 mg/dL
  • 11. L. J. CHART • L-J chart is a graph that quality control data is plotted on to give a visual indication whether a laboratory test is working well. • It is named after S.LEVEY & E.R.JENNINGS in 1950.
  • 12.
  • 13.
  • 14. lj with Manufacturer & Lab Calculated Mean & SD 213 234 255 276 297 318 339 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Glucose (Jan 2011) with Manufacturer Mean & Ranges (SD – 21 ; CV- 7.6%) Level 3 266.58 269.31 272.04 274.77 277.5 280.23 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Glucose (Jan 2011) with Lab defined Mean & Ranges(SD – 2.73; CV- 0.99%) Level 3
  • 15. Normal Distribution Normal Distribution • All values are symmetrically distributed around the mean • Characteristic “bell-shaped” curve • Assumed for all quality control statistics
  • 16.
  • 17. INTERNAL QUALITY CONTROL • Use of standard glassware , reagent , equipment • Well trained staff • Selection of accurate & precise method.
  • 18. • At least one primary std. is included with each batch of unknown specimen analysis. • Occasionally a different primary std . of higher concentration is included to check the reliability of routine primary higher concentration is included to check the reliability of routine primary std. • The batch result are accepted if the values of control sera are within first SD.
  • 19. Types of Errors • Intrinsic : due to an imprecise & inaccurate method. • Systemic : all high values , all low values. • Random : technical errors.
  • 20. • Intrinsic errors can be eliminated by A) selecting precise & accurate method. B) by using fresh batches of reagents. • systemic errors can be eliminated by using diff. concentration of primary std. & analyzing concentration of primary std. & analyzing control serum. • Technical with a proper analytical application can be correct random errors.
  • 21. Systematic vs. Random Errors Systematic vs. Random Errors Systematic Error Avoidable error due to controllable variables in a measurement. Random Errors Unavoidable errors that are always present in any measurement. Impossible measurement. measurement. Impossible to eliminate
  • 22. PREVENTIVE PHASE • Collection of specimen • Separation of serum • Specimen analysis • Calculation of test values etc..
  • 23. RETROSPECTIVE PHASE • Optimum condition variance • Routine condition variance
  • 24. OPTIMUM CONDITION VARIANCE • Refers to the results obtained under optimum conditions i.e. by using i)freshly prepared reagents ii)by using standardized glassware
  • 25. ROUTINE CONDITIONS VARIANCE • Refers to the results obtained by using routine requirements i.e. by using routinely stored reagents and glassware in regular use.
  • 26. WESTGARD RULES • 1-2S • 1-3S • 2-2S • 2-2S • R-4S • 4-1S • 10X
  • 27. • Multi control QC rules (WESTGARD RULES) given by Dr. James Westgard of the University of Wisconsin in an article in 1981 on laboratory quality control that set the basis for evaluating analytical run quality for medical laboratories. • The Westgard system -based on the principles of statistical process control used in manufacturing statistical process control used in manufacturing nationwide since the 1950s • Six basic rules in the Westgard scheme: 1-3s, 2- 2s, R-4s, 1-2s, 4-1s, and 10x. These rules are used individually or in combination (multi-rule) to evaluate the quality of analytical runs. • Detect random or systematic errors
  • 28. • Warning 12SD or 1-2s: It is violated if the single IQC value exceeds the mean by ± 2SD.
  • 29. • Rejection 22SD or 2-2s: • This rule detects systematic error and is applied within and across runs. • It is violated within the run when two consecutive control values exceed the "same" (mean + 2s or mean - 2s) limit. • The rule is violated across runs when the previous value for a particular control level exceeds the "same" (mean + 2s or mean - 2s) limit. (mean + 2s or mean - 2s) limit. Within run violation Across run violation
  • 30. • Rejection 13SD or 1-3s: • It is violated when the single IQC value exceeds the mean by ±3SD. • This rule is applied within control material only. • The 1-3s rule identifies unacceptable random error or possibly the beginning of a large systematic error. • Rejection 41SD or 4-1s: It is violated if four consecutive IQC values exceed the same mean plus 1s or the same mean minus 1s control limit.
  • 31. • Rejection 10x: • This rule detects systematic bias and is applied both within and across control materials. • It is violated across control materials if the last 10 consecutive values, regardless of control level, are on the same side of the mean. • The rule is violated within the control materials if the last 10 values for the same control level are on the same side of the mean.
  • 33. EXTERNAL QUALITY CONTROL • All the participating laboratories daily analyze the same lot of control material. • The results are tabulated monthly & sent the sponsoring groups for the data the sponsoring groups for the data analysis. • Summary reports are prepared by the program sponsor & are distributed to all participating laboratories .
  • 34. • The mean of values of all reference laboratories is taken as the “ true “ or correct value & is used for comparison with the individual laboratory reported values. values. • If the difference between the reported value & the true value is statistically significant then the reporting lab is alerted.