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.

1. QUALITY MANAGEMENT IN
CLINICAL BIOCHEMISTRY
Tapeshwar Yadav
(Lecturer)
BMLT, DNHE,
M.Sc. Medical Biochemistry

2. 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.

3. FIVE ‘Q’ Framework
Quality Planning
Quality Lab Processes
Quality ControlQuality Assessment
Quality Improvement Goals
Objectives
Quality Requirements

4. ‘PDCA’ CYCLE
PLAN
DO
CHECK
ACT
QP - PROVIDES THE PLANNING STEP
QLP - ESTABLISHES STANDARD PROCESS
FOR DOING THINGS
QC AND - PROVIDES MEASURES FOR
QA CHECKING , HOW WELL THINGS
ARE DONE
QI - PROVIDES MECHANISAM FOR ACTING
ON THESE MEASURES

5. QUALITY ASSURANCE
REQUIRES
1. CAUSES OF PROBLEMS BE
IDENTIFIED AND ELIMINATED
2. DETECTION OF THE PROBLEMS
EARLY ENOUGH TO
PREVENT THEIR CONSEQUENCES

6. ELEMENTS OF QUALITY
ASSURANCE
1. COMMITMENT
Dedication to quality service must be
central. A true commitment is
required by Lab Directors,
Managers and Supervisors if the
efforts of the lab personnel are to be
successful.

7. 2.FACILITIES AND RESOURCES
Lab must have the administrative support
necessary to provide the quality of services that is
desired.
This means having ,
adequate space,
equipment,
materials,
supplies,
staffing,
supervision and
budgetary Resources.
These resources provide the basis upon which
quality services can be developed and maintained.

8. 3. TECHNICAL COMPETENCE
High quality personnel are essential for
high quality services. The educational
background and experience are
important. In service training can
develop and maintain skills.

9. 4. TECHNICAL PROCEDURES
Good technical procedures are necessary
Control of preanalytical conditions or variables
such as
Test requests
Patient preparation
Patient identification
Specimen acquisition
Specimen transport
Specimen processing
Specimen distribution
Preparation of work lists and logs
Maintenance of records

10. Control of analytical variables, which includes
Analytical methodology
Standardization and calibration procedures
Documentation of analytical protocols
and procedures
Monitoring of critical equipment and
materials
Monitoring of analytical quantity by the
use of statistical methods and control charts.

11. CONTROL OF PREANALYTICAL VARIABLES
The responsibility for accurate and timely test
reports generally lies with the laboratory but
many problems can arise prior to and after
the analysis of the submitted specimens.
So it is essential to perform a system
analysis of the laboratory and to identify the
type of preanalytical variables.

12. LABORATORY TESTING PROCESSES AND THEIR
POTENTIAL ERRORS
PRE ANALYTICAL ERRORS
PROCESS POTENTIAL ERRORS
Test ordering inappropriate test
Handwriting not legible
Wrong patients ID
Special requirements not specified
Specimen acquisition
Incorrect tube or container
Incorrect patient ID
Inadequate volume
Invalid specimen
(hemolysed or diluted)
Collected at wrong time
Improper transport conditions

13. ANALYTICAL ERRORS
Analytical Instrument not calibrated
Measurement correctly
Specimens mix – up
Incorrect volume of specimen
Interfering substances present
Instrument precision problem
Test reporting Wrong patient ID
Report not legible
Report delayed
Transcription error

14. POST ANALYTICAL ERRORS
Test interpretation Interfering substance not
recognized
Specificity of the test not understood
Precision limitation not recognized
Analytical sensitivity not appropriate
Previous values not available for
comparison

15. HOW TO CONTROL THESE ERRORS?
PRE ANALYTICAL VARIABLES
It is very difficult to establish effective methods for
monitoring and controlling preanalytical variables
because many of the variables are outside the laboratory
areas.
Requires the coordinated effort of many individuals and
hospital departments
Patient Identification
The highest frequency of errors occurs with the use of
handwritten labels and request forms. The use of bar
code technology has significantly reduced ID problems.
Turnaround time
Delayed and lost test requisitions, specimens and
reports can be major problems for labs. Recording of the
actual times of specimen collection, receipt in the lab
and reporting of results with use of computers will solve
these problems.

16. Transcription error
A substantial risk of transcription error exists from
manual entry of data even with the double checking of
results, computerization will reduce this type of
transcription error.
Patient preparation
Lab tests are affected by many factors, such as,
recent intake of food, alcohol, or drugs
smoking
exercise
stress
sleep
posture during specimen collection
The lab must define the instructions and procedures
compliance with these instructions can be monitored
directly efforts should be made to correct non
compliance

17. Specimen Collection
Prolonged tourniquet application causes local anoxia to cells and
excessive venous backpressure, venous stasis and
hemoconcentration.
Blood collection from an arm into which an intravenous infusion is
running can be diluted or contaminated.
Hemolysis during blood collection
Improper containers with incorrect preservatives
To monitor and control these problems, specially trained lab team
assigned to specimen collection
The identification of the person collection a specimen should be
maintained
Clinicians should be encouraged to report clinically inconsistent
results.
Pride of workmanship should be encouraged and quality
performance should be rewarded.
Specimen transport
The stability of specimens during transport from the patient to the
lab is seldom monitored;

18. CONTROL OF ANALYTICAL VARIABLES
There are many analytical variables that
must be carefully controlled –
Water quality
Calibration of analytical balances
Calibration of volumetric glassware
and pipets
Stability of electrical power
Stability of temperature of heating
baths, refrigerators, freezers and
centrifuges

19. The procedure Manual should contain the
following
Procedure name
Clinical significance
Principle of method
Specimen of choice
Reagents and equipments
Procedure
Reference values
Comments
References

20. CONTROL OF THE ANALYTICAL QUALITY
USING STABLE CONTROL MATERIALS
The performance of analytical methods can be
monitored by analyzing specimens whose
concentrations are known and then by
comparing the observed values with known
values.
The known values are usually represented by
an interval of acceptable values, or upper and
lower limits for control (control limits)
When the observed values fall within the
control limits – analysis is working properly
When the observed value fall outside the
control limits the analyst should be alerted to
the possibility of problems in the analysis.

21. GENERAL PRINCIPLES OF CONTROL CHARTS
Control charts are simple graphical displays
in which the observed values are plotted
versus the time when the observations are
made.
The control limits are calculated from the
mean (x) and standard deviations (s)

22. SD
• Standard deviation - extent of random
variation
• SD = εd2
n-1
d= difference of individual result from mean
n= number of observations

23. CV
Co-efficient of variation
relative magnitude of variability while
comparing two procedures
CV % = (SD x 100)/mean

24. Precision:
 Refers to the reproducibility of the result.
 Indicates how close test measurements are to
each other when the same test is run on the
same sample repeatedly.
Accuracy:
 Indicates how close to the true value a
measurement is.
 The closer it is to the actual value the more
accurate.

25. ACCURACY AND PRECISION

26. Good Accuracy
Good
Precision
Good
Precision
Only
Neither Good
precision Nor
Accuracy

27. Levey-Jennings Control Chart

28. External quality assessment :A quality program
in which specimens are submitted to labs for analysis
and the results of an individual lab are compared with
the results for the group of participating labs.
Proficiency Testing:Process whereby simulated
patient specimens made from a common pool are
analyzed by labs the results of this procedure being
evaluated to determine the quality of the lab
performance.