QUALITY CONTROL MANAGEMENT

IN LABORATORY SERVICES

 GROUP MEMBERS
 MS.ARSHIA ANJUM
 MS.BAKHTAWAR SIDDIQUE
 MS.LUBNA FATIMA
QUALITY CONTROL MANAGEMENT
IN LABORATORY SERVICES

IFTIKHAR’S MEMORIAL
HOSPITAL
 IFTIKHAR’S MEMORIAL HOSPITAL

SERVICES AVAILABLE 24 HOURS

 Echocardiography
 Color Doppler Ultrasound
 Laboratory
 ICU/CCU
 NICU
 X-RAY
 ECG
 Pharmacy
 Operation Theater
 Physiotherapy
 Private Rooms
QUALITY CONTROL MANAGEMENT
IN LABORTORY SERVICES

 1.QUALITY
 2.CONTROL MATERIAL
 3. STATISTICAL PRESENTATION
 4. PROBLEM SOLVING
QUALITY
DEFINE AS “ To MEET THE DEMAND OF CUSTOMER”
 In a Laboratory services, quality is a cyclic process from
Physician order to physician demands.
 Includes
1.Physician order
2. Phelbotmy
 Sample labelling
 Sample collection (e.g avoid hemolysis,takecare about ca,
mg,hco3)
3. Instrument maintenance , callibration, control.
4. Statistical presentation with the help of Major Central
Tendency & Normal Distribution.
What are Standards

 Substance that has an exact known value and

that, when accurately weighed or measured, can
produce a solution of an exact concentration
 “Reference materials "Not usually used on a
daily basis
 Used to calibrate new instruments, recalibrate
instruments after repair, at manufacturer’s
recommended intervals, or if a method is out of
control
What is Quality Control?
 Quality control is the procedure used to detect
errors that occur due to test system failure,
adverse environmental conditions and variance
in operator performance as well as the
monitoring of the accuracy and precision of the
test performance over time.
Types of Quality Control
Programs
Quality control
Internal QC External QC
program
Blind proficiency
surveys
Control materials
What are Control materials?
• All the materials which can be used for error detection in SQC
methods.
• Control samples are pools of biological fluids (serum, whole
blood, urine or other materials).

What do they contain?

• They contain analytes ideally in concentrations/activities close
to the decision limits where medical action is required.
 Control materials
What are levels of controls and why are they used?
• Control samples with the same analytes but different
concentrations/activities are called “levels”.
• Different levels check the performance of laboratory methods
across all their measuring range.

Who makes control materials?

• In most cases control samples are manufactured by analyzers’
or reagents’ manufacturers.
• Also be made by the laboratory personnel; in house controls
pooling known conc. patients samples.
Control materials

What are type of Control materials?

Commercially prepared controls come in either
frozen, lyophilized or low temperature liquid
forms.
Types of Control materials
Low Temperature
Criteria Frozen Lyophilized
Liquid
Low
Cost Medium; if High Highest
manipulated
Clarity Clear Turbid Clear
Stability 12 months 18-24 months 18-24 months
Regional and
Compared with Regional and
Manufacturer’s peer
accurately measured Manufacturer’s peer
Validation group analysis
materials (NIST and group analysis
available, or by NIST
CAP) available
and CAP
Lyophilize
Absent Present Absent
d Error
Availabilit
Patient samples Commercial Commercial
y
In House Control materials

 Quality control material can also be prepared in the laboratory

from pooled patient samples (serum, plasma, urine and CSF)
 But it can be contaminated with viruses; thus it is essential to
test each specimen or group of specimens and the final pool for
harmful viruses; HIV, Hep-B and C
 Therefore, the following statements apply to all specimen pools
used for quality control. First, all pooled human material
should be monitored for the human immunodeficiency virus
and the hepatitis B virus.
 No pools should be used if there is evidence of either virus.
Second, all control material requires refrigerator or freezer
space for storage of a 1- to 2- year supply
 Types of controls
Commercially prepared controls come in either assayed or
unassayed forms
Assayed controls:
 Assayed controls are tested by multiple methods before sale
 Come with measuring system-specific values that are meant to
be used as target values for the laboratory using the controls
 Are more expensive than unassayed controls
 Are used to evaluate accuracy and precision
 May only be suitable for specific method systems
Unassayed controls:

 Unassayed controls have no assigned analyte

values provided by the manufacturer
 The control values for these materials must be
determined by the individual laboratory
 Are less expensive than assayed controls
 Are used to evaluate accuracy and precision
 Are not linked to specific method systems
Characteristics of good control
1. The composition should be as similar to the patient
sample.
2. The concentration should be stable under storage for
long period of time.
3. Material should be low vial-to- vial variability.
4. After vial has been opened and material prepared, it
should remain stable for the period of use.
5. The material should be reasonably priced (Not
expensive).
6. The material should be available in large quantities.
Which control materials would you
prefer in your lab?
 Commercially prepared
 Assayed with known ranges
 Lyophilized, cost effective & less logistic
issues (transport, storage, preparation)
 Accuracy and Precision
 Accuracy - closeness of a result to the actual
value
 Precision – closeness of values to each other
Accuracy Precision
How well a How well a series
measurement of measurements
agrees with an agree with each
accepted value other
Accuracy and precision
 Types of Errors
1 Random Errors –
 cannot be absolutely identified (Ex. Differences in techniques between
workers, specimen characteristics, etc.)
2 Systematic Errors –
 variation that may make results consistently higher or lower than the mean
value for a control (Ex. Trouble with the instrument, deteriorated reagents,
etc.)
Cause Of Random Error (RE)

May be caused by (for example):

 Variability in volume of sample or reagent delivered
 Change of technologist doing the test
 Low quality glassware being used
 Increase workload
 Faulty thermostat in water bath
 Spectrometer lamp about to fail
Estimated by:
 Standard deviation (SD)
 Coefficient of variation (CV%)
Causes of Systematic Error

 Incorrectly made standards, controls or

reagents
 Instrumentation defects
 Variation in pipettes and volumetric glassware
 Variation in cuvettes
 Variation in temperature
 Variation in time control
 Electronic and optical variation in instruments
 Interpretation of Quality Control

Creating a Levey-Jennings Chart

Interpretation of Quality control :

• Quality control data is most easily visualized using a Levey-
Jennings control chart. The dates of analyses are plotted along
the X-axis and control values are plotted on the Y-axis. The
mean and one, two, and three standard deviation limits are also
marked on the Y-axis. Inspecting the pattern of plotted points
provides a simple way to detect increased random error and
shifts or trends in calibration.
 Using a Levey-Jennings chart
to evaluate Quality
 The laboratory needs to document that quality control
materials and that the quality control results have been
inspected to assure the quality. This documentation is
accomplished by maintaining a QC Log on regular basis. Once
the QC results are entered into the QC log, they should be
plotted on the Levey-Jennings chart. When the results are
plotted, an assessment can be made about the quality of the
run. The technologist performing the test should look for
systematic error and random error.
 Systematic Error : Systematic error is evidenced by a change
in the mean of the control values. The change in the mean may
be gradual and demonstrated as a trend in control values or it
may be abrupt and demonstrated as a shift in control values
Trends & shifts
Trend
 Indicates a gradual loss of reliability in the test system
 Usually subtle
 Causes of trending may include:
 Deterioration of the instrument light source
 Gradual accumulation of debris in sample/reagent tubing
 Gradual accumulation of debris on electrode surfaces
 Aging of reagents
 Gradual deterioration of control materials
 Gradual deterioration of incubation chamber temperature (enzymes only)
 Gradual deterioration of light filter integrity
 Gradual deterioration of calibration
Shifts
 Abrupt changes in the control mean are defined as shifts.
 Shifts in QC data represent a sudden and dramatic positive or negative
change in test system performance
 Shifts may be caused by:
 Sudden failure or change in the light source
 Change in reagent formulation
 Change of reagent lot
 Major instrument maintenance
 Sudden change in incubation temperature (enzymes only)
 Change in room temperature or humidity
 Failure in the sampling system
 Failure in reagent dispense system
 Inaccurate calibration/recalibration
Westgard Multirules
 Developed by Dr. James O. Westgard based on statistical concepts
 Specifies the LJ chart
 Makes use of a series of control rules for interpreting control data
 Has the advantage that false rejection is reduced
 Error detection is improved
 Has lines for control limits at ±1,2,3 SD
 More organized
 Sensitive to errors
Dr. Westgard
 Westgard Multirule System Titles

Used when 2 levels of

 12S rule control material are
 13S rule analyzed per run.
 22S rule
 R4S rule
 41S rule
 10X rule

30
Westgard Rules- 12s
 One control exceeds the mean ±SD ,warning
sign, this rule is used as a warning rule to
trigger careful inspection of the analyte
 WARNING RULE – not cause for rejecting a
run
 One of two control results falls outside ±2SD
 Alerts technologist to possible problems
 Must then evaluate the 13S rule
Westgard – 12S Rule

32
Westgard Rules- 13s
 One control exceeds the mean ±3
SD ,rejection, excessive random error
 A run is rejected when a single control
measurement exceeds the mean plus 3s or the
mean minus 3s control limit.
 Westgard Rules- 13s
100
90
80
Antibody Units

70 +3 sd

60 +2 sd
+1 sd
50 Target value
40 -1 sd

30 -2 sd

20 -3 sd

10
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

Assay Run
Westgard Rules- 22s
 22s - Reject when 2 consecutive control
measurements exceed the same mean plus 2s
or the same mean minus 2s control limit.
 Two consecutive control exceed the same ± SD
limits, rejection, sensitive to random error
 Patient results cannot be reported.
 Requires corrective action
Westgard Rules-R4s
 Reject when 1 control measurement in a group
exceeds the mean plus 2s and another exceeds
the mean minus 2s.
 One control exceeds the mean + 2SD and the
other exceeds the mean -2 SD , rejection ,
random error
Westgard Rules-41s
 Reject when 4 consecutive control
measurements exceed the same mean plus 1s
or the same mean minus 1s control limit.
 Four consecutive observations exceed the
mean + or – 1SD,rejection,systematic error
Westgard Rules-10x
 Reject when 10 consecutive control
measurements fall on one side of the mean.
 Ten consecutive observation fall on one side of
the mean ,rejection, systematic error
 Westgard Rules-10x
100
90
80
Antibody Units

70 +3 sd

60 +2 sd
+1 sd
50 Target value
40 -1 sd

30 -2 sd

20 -3 sd

10
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

Assay Run
VZV IgG ELISA: Target Value = 49 U/ml
Types of error Control rule that’s detects it
Random Error 13s,22S,R4s
Systemic Error 10x,41s,
Detection and Resolution of Quality
Problems
When these problems are identified the following corrective actions
can be taken.
 Check expiration date of the control.
 Check expiration date of the reagent.
 If a new control was used, make sure it was reconstituted
properly.
 Retest the control. If the new value is within acceptable limits,
record both values and proceed with patient testing.
 If the repeat value is still out of range, run a new vial of control. If
the new control value is within acceptable limits, record the
values and proceed with patient testing. The problem with the first
set of controls was probably specimen deterioration.
Detection and Resolution of Quality Problems

 If the new control value is out of control, troubleshoot

the instrument (check sampling, reagent delivery,
mixing, lamp integrity, and reaction temperature).
 Recalibrate the method, run control
 If controls shift after a calibration but in acceptable
range, control shifts are probably acceptable. If they are
poor, reagent may be bad.
 Try a new lot number of reagent. If the problem is
corrected, ask the manufacturer to find out if anyone else
has reported problems regarding reagent lot.
Out of Control System

When analytical problem are found it is best to have a clear plan of action
that is execute sequentially until the problem is resolved, it is necessary to
document the problem, investigation, resolution and any data that indicate
that the problem as actually resolved.
Action taken to bring system back in action (Summery)
 Repeat assay with fresh aliquot.
 Repeat assay with fresh new set of control (old control may be mislabeled,
possible enzyme deterioration, evaporation, precipitation or other error)
 Look for obvious problem such as clot, reagent levels and mechanical
fault.
 Recalibrate the instrument for the out of control analyte then assay
control.
 
Out of Control System

 And if control out after recalibration ,install a new lot number of

the reagent, recalibrate and reassay all the controls.
 Perform periodic maintenance, recalibrate and reassay all of the
control.
 Assay a different control of a similar known concentration to
determine.
 If both controls and additional control show similar shift or trends,
the problem is probably in the instrument or testing system.
 Call the manufacturer to determine the cause of the problem,
follow the manufactures instruction and then reassay all controls.
 Have the instrument serviced by the manufacturer, recalibrate and
reassay all controls if necessary to resolve the problem
Out of Control System

 Every quality control decision should be recorded in a

permanent record , as per CLIA 88 quality control record should
be in acceptable limits and include written documentation of the
action taken in response to out of range value,
include date,
 analyte reagent instrument,
 calibration,

 control,

description of the problem,

 problem resolution and name of the person performing the
test and approving the final action.
 Documentation When system is out of control

 When system is out of control must be communicate all lab person

including director, consultant, lab manager, charge technologist and
immediate supervisor.
 No patient test result is to be released until control is corrected and
the manager approves resumption of the testing.
 Step must be taken to have the test performed by backup system or
use alternate method ,
 The alternative method must be listed in lab manual.
 An out of control condition that cannot be dealt with by the use of
alternative methods or testing system must be communicated within
a reasonable time to the medical staff or any other authorized person.
 
 
 When suspended system back into production
require the following action,

 Recalibration
 Two levels of control run, results within + 2sd.
 The method are use must be informed and authorized
by the supervisor and must entered in to problem log
book and formally sign and dated.
Delta Check

The difference between a patient's present laboratory result and

the previous result which exceeds a predefined limit is referred
to as a delta check. Delta checks are investigated by the lab
internally to rule out:
 mislabeling,
 clerical error
 possible analytical error
 Two main goals
 Identify changes in patient condition or disease state
 Identify sample quality issues or patient misidentification
Why Delta checks

 Reducing manpower.
 Increasing service quality
 Simplifying processes
 Decreasing the report release turnaround time
(TAT).
 In addition to the introduction of automated
equipment and the development of a laboratory
information system (LIS) technology, another
way to raise working efficiency is to build an
auto verification (AV) system
GENERAL CHECKLIST: STARTING THE INVESTIGATION
PRE-ANALYTICAL VARIATION: POST-COLLECTION
Sample transport:
Issues that may affect analyte levels
Timing:
delayed centrifugation, WBC glucose utilization, leakage of RBC contents
Temperature:
Arterial blood gases, cryo globulin, lactic acid, ammonia
Light exposure:
bilirubin, vitamins, Porphyrins
Centrifugation:
Timely separation of serum and cells (within 2 hrs.) Delayed separation affects
glucose, K+, LD, ammonia, phosphate
Short spins: keep cellular components in the serum: K+, enzymes affected
Excessive spins: may cause hemolysis due to RBC membrane damage
Storage :
For frozen sample , avoid excessive freeze-thaw cycles
ANALYTICAL VARIATION

Instrument-specific issues may include:

 Probe or pipette errors
 Variation in reagent volumes, delivery
 Air bubbles
 Calibration
Operator-or method-specific issues may include:
 Dilution errors, improper mixing
 pH, temperature
 Reagent, lot changes
BIOLOGICAL VARIATION:

Main goal of the human body Homeostasis!

The body attempts to keep essential analytes from fluctuating on a
daily basis
Examples of tightly regulated analytes:
Alkaline phosphatase, sodium, calcium, hemoglobin,
Examples of less stringently controlled analytes:
Iron, bicarbonate, lactate, albumin