m








 
 „
u 







 

  
 

 


 


 
u 
 


 




 
 




 





 
  
m When a laboratory management is committed to meet a
patients need, this is done through an ongoing program
of total quality management program

m Total quality management may be referred to as:

m Total quality control

m Total quality leadership and

m Continuous quality improvement or

m Quality management system

!

 
 

   
m Quality laboratory process (QLPS)

m Quality Assurance (QAS)

m Quality assessment (QC)

m Quality control (QC)

O
 
 
m QLPS includes analytical process as well as general
policies, practices and procedures that define how all
aspects of work get done.
O


m Quality assurance means quality enhancement
m Quality assurance aims at ensuring that the data
provided are reliable and relevant
m Quality assurance involves all measures that can be
taken to improve laboratory efficiency and
effectiveness
m It ensures laboratory performance with minimum
risk for laboratory workers and gives maximum
benefit to the individual and community
O



m Clinical usefulness of selected tests
m Patient preparation
m Sampling
m Specimen handling
m Preservation and storage
m Transport
m Identification and data processing which includes
reporting of results
j 

 




u „edication to quality service must be central

u A true commitment is required by lab directors,
managers and supervisors, if the efforts of the lab
personnel are to be successful
Ú
  



Quality services are developed and maintained on the
basis of the following:
u Adequate space
u Modern materials and equipments
u Adequate stock of requirements and supplies
u Adequate staffing
u Budgetary resources
u Proper supervision
!





m jducational background and experience of personnel

are important
m High quality personnel can render high quality
services.
m In service, training is also needed, which can help
develop and maintain skills
!



 


ood technical procedures are necessary in the

following criteria:

u Preanalytical variables
u Analytical variables
u Post analytical variables
O
 

m Also known as proficiency testing

m Quality Assessment is a means to determine the
quality of the results generated by the laboratory
m Quality Assessment is a challenge to the QA and QC
programs
O


 

m The aim of quality control is to ensure that the

results generated by the test are correct
m QC emphasizes statistical control procedures and
also includes reagent and standard checks, linearity
checks, etc..
m

 



  

m The serum samples are collected

m Pooled serum samples together ( 1-2 litres )

m Screen the serum sample for various infective diseases

m Adjust the PH to 7.5 using concentrated sulphuric acid

m „istribute 10 ml portions of this into several plastic

vials and store in the deep freezer and this is stable for
3 months
m jach day 1 vial is taken and bring it in to room
temperature, once it liquefies analyze the value

m jnter the value on the quality control chart

m If the value on a specific day falls within ± 2 S„ that

indicates all the reagent and standard are good

m In case the value is above or below ± 2 S„ indicates

reagent or standard is deteriorated

m Repeat the assay with fresh reagent and standard

O


 

m À 
 
 

m The internal quality control can be maintained by going

through a complete checklist of items to make sure that
all laboratory systems are being monitored and in
control.

m This checklist includes:

m Maintenance of equipments and glassware.
m Quality control of reagents, standards, control
materials and reference ranges.
m Method selection and evaluation.
„ 




m 3 

m m 
 SD

£ Standard deviation - extent of random

variation
£ SD = Àd2
n-1

d= difference of individual result from mean

n= number of observations
 2

2o-efficient of variation
ÿ relative magnitude of variability while
comparing two procedures

2 % = (SD x 100)/mean
3
3 3D S 
ood Accuracy ood Neither ood
ood Precision Precision precision Nor
Only Accuracy
î
 


 

j




 
m jxternal quality control is a way to compare the
performance of a laboratory with reference to other
laboratories.
m Also known as proficiency surveys.
Such proficiency testing programmes periodically
provide samples of unknown results to participating
laboratories.
£ When a laboratory receives such a sample, it must
analyze and return the results within a specified period
of time for comparison with the results obtained from
other laboratories participating in the proficiency survey.
 ÚÚ
 

O



O
  O


 

O
 O
  
m  m„3
 

m m!  

 


m "m!  

 
 

m 

3
# 
 






 


m À!  






 
 "3$%3
$%


À
m%$
3„

À%
m$

À3"

%%$%

m%
33"
À3"
%%$%

m%$ m$

À3"
%%$%


     

 

 
& 

À„

 




À 



À 

À„
À
 
À 


' 

 (
 

 

À 
  

33"
À3"
%%$%

3 
À 

  

    


)
# 
À 
 


À  

 
À 
 
  


  & 

À„
% 

 
% 
 

 
 
m$

33"
À3"
%%$%


  

À  



*






 
m 


*
3 


  
m 
 

  


 
$&

$
$
%$"


%%$%

m
 
 


% 

 
 


 



 
u m
À



 

  
 





 
 


 







 

 

À„
  
u
  

„ 






 



+
  


% 







 






 

 



 

 


  
u
 
 
3



  
 
)
 


 





 


 

 *





  
 
u m
  
£ "

 



 


£ %



  

 

£ 
£ ) 
£  
£  
£ m 
 

 






 

  

 


 


 
  

 
 



 

 

u 
 

£ m  
 
 


)

 


)

  



 

£  
 
 

 



 






 


£  
 
 
 
£ À 
 

 
  

£



 

  
 
 






 
£




 
 


 




u 
  


 


 
  
 







 
 
 $
%$"
$
33"
À3"
,3%À3"

£ &
 

£   

 
 

£   

  
  




£  

  


£  

  




   
 * 

 


  


 



 

£ m  

£  

£ m  


£ 


£ %


£ m  
£ % 
 
£ 
£ % 

u 

m „efinition:

A value obtained by observation or measurement of

a particular type of quantity on a reference individual
j
 

  

m All groups of reference individuals should be clearly defined

m The patient examined should resemble sufficiently the

reference individuals in all respects other than those under
investigation

m The conditions under which the samples were obtained and

processed for analysis should be known
m All quantities compared should be of the same type

m All laboratory results should be produced with the use of

adequately standardized methods under sufficient analytical
quality control

m The diagnostic sensitivity and specificity, prevalence and

clinical costs of misclassification should be known for all
laboratory tests used
u

 
Reference individual
*
Reference population
*
Reference sample group
*
Reference value
*
Reference distribution
*
reference intervals`
x
 
 

Risk factor :
m Dbesity
m Hypertension
m Risk from occupation of environment
m enetically determined risk
Intake of pharmacologically active agent :
m „rug treatment for disease
m Dral contraceptives
m „rug abuse
m Alcohol
m Tobacco
2



Specific physiological status :

m Pregnancy
m Stress
m jxcessive exercise
m 



 

m Age
m Posture when sampled
m Blood group (ABD)
m Race
m Circadian variation
m Sex
m „iet
m Stage of menstrual cycle
m jthnic background
2



m Stage of pregnancy
m jxercise
m Time of the day when sampled
m Fasting or non fasting
m Use of tobacco
m eographical location
º  

m „iagnosis of disease
m Screening for disease
m „etermination of severity of the disease
m Monitoring progress of disease
m Monitoring response to therapy
m Monitoring drug toxicity
m Predicting response to treatment
m Predicting prognosis
m Reassurance to patients