192329934-Internal-Quality-control-in-Clinical-Laboratories-pptx.pdf

12/18/2013
Nazar Ahmed Mohamed Abd-
Alla(Sangoor)
1

Internal Quality control
in Clinical Laboratoreis
12/18/2013
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2
NAZAR AHMED MOHAMED
ABD-ALLA

Topics
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 Quality definition.
 Quality Activity.
 Type of error in clinical laboratory.
 Specimens and Requests .
 Method selection, and Reagents storage
condition .
 Laboratory instruments.
 instruments and equipment calibration.
 SOPs.
 Use of calibrators and control material .

Topics
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 Implementation of quality programs
 Interpretation of internal quality results.
 Corrective action.
 Turn around time.
 Documentation.

Whats Quality
 quality is defined as the totality of features and
characteristics of a product or service that bear on
its ability to satisfy stated or implied needs.
 Medical laboratories must provide a high quality
service by producing accurate, precise, relevant
and comprehensive data that can be applied to the
medical management of patients.
 tests requested must be appropriate to the medical
problem, must be analytically correctly performed
and their results interpreted correctly.
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 Quality assurance: Part of quality management
focused on providing confidence that quality
requirements will be fulfilled . witch contain
many activity.
 Quality control: Part of quality management
focused on fulfilling quality requirements.
 Quality management system: Management
system to direct and control an organization
with regard to quality.
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 Appropriateness of tests can only be obtained by
a dialogue between the clinician and the medical
pathologist.
 Correct analytical results are based on:
 (i) quality management within the laboratory.
 (ii) the quality of industrially prepared reagents
(kits) and instruments .
 (iii) quality management of the pre-analytical
phase outside the laboratory along with analytical
& post-analytical phase.
 A bad system, a wrong sampling or a kit with poor
performance can never produce a reliable result,
even in a laboratory with the best quality
management system. 12/18/2013
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principles aspects of making
reliable analytical measurements:
 1. Analytical measurements should be made to
satisfy an agreed requirement.
 2. Analytical measurements should be made
using methods and equipment that have been
tested to ensure they are fit for purpose.
 3. Staff making analytical measurements should
be both qualified and competent to undertake the
task.
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principles aspects of making
reliable analytical measurements:
 4. There should be a regular independent
assessment of the technical performance of a
laboratory.
 5. Analytical measurements made in one location
should be consistent with those elsewhere.
 6. Organizations making analytical measurements
should have well defined quality control and
quality assurance procedures.
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Quality Assurance
 Quality assurance is a comprehensive and
systematic process that strives to ensure reliable
patient results.
This process includes: every level of laboratory
operation. Phlebotomy services.competency
testing, error analysis, standard protocols, PPE,
quality control, and turnaround time .
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*QA activities encompass all of the non-analytic
activities, those activities that are not part of the
clinical testing process. The laboratory
organizes it activities to provide the best
possible health care to the patient.
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QA activities
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* A. management and monitoring personnel,
B. using quality materials (reagents instruments,
supplies, etc.),
C. using established procedures and established
statistics (a procedure manual),
D. specimen collection, identification, transport,
accession, and handling prior to testing,
E. reporting results,
F. fee charges for tests performed,
G. using corrective actions to obtain desired results,
H. monitoring patient satisfaction.
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Examples of QA Activities
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*The Clinical laboratory is concerned about
quality and accuracy of the tests that are
reported to primary care givers. The
laboratory monitors where these errors can
appear that will affect the accuracy of test
results.
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*These errors can occur prior to the test analysis and if
they manifest, they are called preanalytical errors or
variables.
*If the error occurs during the testing process, then it
become an analytical error.
*If the error appears after the test is performed and
reported, then it is known as a post-analytical error.
*The preanalytical error occurs before the test is
performed. This error source can occur at the
beginning of test ordering and filling out the
requisition.
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Type Of Error
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*type of error
*Pre-Analytical Error:
01- duplicate or missing requisitions
02- tests omitted from the requisition
03- incorrect ordering of tests
04- patient identification error
05- incorrect blood collection
06- specimen transport error
07- specimen handling/processing in the lab
*Analytical errors:
occur during the testing process.
01- deteriorated or wrong reagents
02- any instrument malfunction
03- laboratorial error
04- incorrect recording of test results
15

* Post Analytical Error:
* Examples of these are:
01- failure to notify the physician of critical values:
(Critical values may imply a life-threatening
situation for the patient and are brought to the
immediate attention of the physician and/or the
patient care area responsible for the patient ).
02- failure to report test results in a timely manner.
03- placement of report in the chart of the wrong
patient
04- miscommunications that are detrimental to the
patient regarding the tests performed.
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Specimens and Requests
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1- Request forms.
 Request forms should include:
 Patient details.(age,sex,race,resedance)
 Specimen details .(type,preservatie,time of collection)
 Clinical Remarks .(spleenomegaly,hepatomegly,fever,join pain)
2- Primary sample collection.
• Patient Preparation
• Containers selection
• Blood Collection
• Plasma Preparation
• Specimen storage and Transportation

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3- Samples acceptance criteria.
 Complete request form.
 Patient identification.
 Suitable container selected.
 Sufficient amount of blood collected.
 Sample labeled properly.
 Sample prepared properly.
 Sample separated and store properly.

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4- Samples Rejection Criteria
 Incomplete request form.
 Rung Patient identification.
 Unsuitable container selected.
 Unlabelled or incorrectly labeled sample.
 Haemolysed sample.
 Sample changes due to :
 concentration changes
 compostion changes.
 bacterail changes.
 and enzymatic changes.

METHOD VALIDATION
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 “Method validation” is a term used for the suite of
procedures to which an analytical method is
subjected.
 to provide objective evidence that the method, if used
in the manner specified, will produce results that
conform to the statement of the method validation
parameters.

ISO Definition
 1. The process of establishing the performance
characteristics and limitations of a method and
the identification of the influences which may
change these characteristics and to what extent.
Which analytes can it determine in which matrices
in the presence of which interferences? Within
these conditions what levels of precision and
accuracy can be achieved?
 2. The process of verifying that a method is fit for
purpose, i.e. for use for solving a particular
analytical problem.
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Continue: Method validation
 Method validation involves the evaluation of the
fitness of analytical methods for their purpose.
 The process of proving that an analytical
method is acceptable for its intended purpose.
 the concept of fitness for purpose, a method is
validated for a particular use under particular
circumstances. If those circumstances vary, then
the method would need to be re-validated at
least for the differences.
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METHOD VALIDATION
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 Error assessment is what method validation is
about.
 However, before getting to the assessment of
errors, you have to first select the method to be
validated.
 Method selection is a different process that
needs to be understood in relation to the
validation process that will follow.

Importance of Method Validation Practices
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 Laboratory regulations require that method
performance for any new method be "verified"
prior to reporting patient test results.
 Precision and accuracy are specifically identified,
along with analytical sensitivity, analytical
specificity, reportable range, reference values, and
any other applicable characteristic.

Types of Errors to be assessed by
method validation
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 imprecision or random errors,
 inaccuracy, bias, or systematic errors, which can
be of two types
 constant systematic error or
 proportional systematic error.
 All these errors can be recognized when a group
of measurements are compared to the correct or
true values.

Verification
 Much of the work of method validation is done by
international organizations that publish standard
methods. The reason such methods appear to be
written in a kind of legalese is that there must be
no doubt as to what the method is and how it
should be implemented. When accuracy and
precision data are published from interlaboratory
trials, there is some confidence that the method
has undergone extreme scrutiny and testing.
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Verification
 A laboratory that uses a method for the first time
should spend some time in going through the
analysis with standard materials so that when used
with field samples, the method will yield satisfactory
results.
 This is verification and must be done to an
appropriate level before any method is used. By its
nature, (verification comes under the heading of
Single Laboratory Validation).
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Method performance parameters
assessed in a method validation study
 Identity: Measurement correctly applies to the stated
measurand.
 Selectivity Specificity: Determination of the extent of
the effects of interfering substances and the ability of
the method to measure the measurand; analysis in
different matrices covered by the scope of the
validation.
 Limit of detection: Minimum value of the measurand
at which the presence of the analyte can be
determined with a given probability of a false
negative, and in the absence of the analyte, at a
given probability of a false positive.
 [Limit of determination] Minimum value that can be
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 Calibration [linearity] Model parameters [sensitivity]
:Adequacy of the calibration model; parameters with
uncertainties.
 Calibration range [linear range] Range of values of
the measurand in which the validation holds
 Bias and recovery [accuracy] :Demonstration of the
absence of significant systematic error after
corrections have been made for bias and/or
recovery
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 Robustness or ruggedness: Ability of method to
remain unaffected by small variations in method
parameters (some authors make the distinction
bebetween the property robustness and a
ruggedness test in which deliberate changes are
made in a method to assess the robustness)
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Method Selection
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1. General Characteristics:
Made in ,Expire date, Package Content,
Accessories, Package size ,Stability after open,
and Reagent storage considerations.
2. Application Characteristics:
Specimen type, Sample volume, Turnaround Time,
Stability of reaction product, Cost-per-test, Filter
used, and Safety considerations
3. Methodology Characteristics:
Type of Reaction, Reaction Principle, Measurement
reaction, Temperature, and Time period of
measurement.

Experiments for estimating analytical
errors
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METHOD COMPARISSION FOR HBG
ESTIMATION BETWEEN TOW DIFFERENT
INSTRUMENT
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0
2
4
6
8
10
12
14
16
18
0 2 4 6 8 10 12 14 16 18 20
HBG
HBG

Clinical laboratory instruments
example
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 Spectrophotometers .
 Water bath.
 Vortex.
 Hematology analyzer.
 Microplate reader & washer.
 Centrifuge.
 Flame photometers or ISE.
 Coagulometer.
 Hot air oven.

Maintenance and calibration of
Photometers
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 Includes checking for:
 Wavelength accuracy
 Linearity of instrument
 Stray light
 Base line stability
 Photometric accuracy
 Short circuits
 Check 0% T
 Temperature

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Micropipettes Calibration
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 Gravimetric method (Distilled water weighing
method) (Recommended method)
 Work Requirement:
1. Calibration tools
2. Double distilled water.
3. New compatible tip
4. Analytical electronic balance(3-5 digits)
5. Temperature controlled atmosphere
6. Small plastic beaker.

Checking Micropipettes
Calibration
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 Weighing Should takes place at 20-25ċ constant to ± 0.5ċ.
 Set the desire testing volume of your pipette.
 Carefully fit the tip onto the tip cone.
 Aspirate the distilled water 5 times( Humidity equilibrium
 Carefully aspirate the fluid, keeping the pipette vertical.
 Pipette distilled water into a tred container and read the
weight in mgs.
 Repeat at least five times (ten times )and record each
result in mgs.

Checking Micropipettes
Calibration
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 Convert the recoded weight to volume (V1) either
by divide the weight of the water by its density ( at
20ċ : 0.9982 ) or by multiply the weight by the Z
correction factor (= 1.002899 µl/mg at 20Ċ ).
 Calculate the mean volume (V1)
 Calculate the standard d deviation SD.
 Calculate the Coefficient of Variation.
 Calculate the Inaccuracy and Imprecision .
 Calculate the F max value.

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Systematic Error and Random Error
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 Compare the Systematic Error ( Inaccuracy),
Random Error ( Imprecision ) and F max with
the values in the performance specification .
 If the results fall within the specifications,
the pipette is ready for use .
 Otherwise check both Systematic Error and
Random Error and when necessary
recalibrate the pipette.

Table Shows The Maximum Permitted
Errors( F Max )
Pipettes
Type
Nominal
volume
M.P.E
(F Max )
Nominal
volume
M.P.E
(F Max )
Single
channel
pipettes
5 µl ± 0.3 µl 200 µl ± 2 µl
10 µl ± 0.3 µl 250 µl ± 2.5 µl
20 µl ± 0.4 µl 500 µl ± 5 µl
25 µl ± 0.5 µl 1000 µl ± 10 µl
50 µl ± 0.8 µl 2000 µl ± 20 µl
100 µl ± 1.5 µl 5000 µl ± 50 µl
Multi-
channel
pipettes
10 µl ± 0.6 µl 250 µl ± 5.0 µl
50 µl ± 1.6 µl 300 µl ± 6.0 µl
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Table Shows The Recommended Specification
Nominal
volume
Inaccuracy Imprecision
Nominal
volume
Inaccuracy Imprecision
≤±
%
( A )µl
≤
%
µl
≤±
%
( A )µl
≤
%
µl
5 µl 1.0 O.05 0.8 0.04 200 µl 0.5 1 0.2 0.4
10 µl 1.0 0.1 0.8 0.08 250 µl 0.5 1.25 0.2 0.5
20 µl 0.7 0.14 0.4 0.08 500 µl 0.5 2.5 0.2 1.0
25 µl 0.7 0.175 0.4 0.1 1000 µl 0.5 5 0.2 2.0
50 µl 0.7 0.35 0.4 0.2
10-100
µl 0.5 0.5 0.2 0.2
100 µl 0.5 0.5 0.2 0.2
20-200
µl 0.5 1 0.2 0.4
0.5-10
µl
1.0 0.1 0.8 0.08
25-250
µl 0.5 1.25 0.2 0.5
5-50 µl
0.7 0.35 0.4 0.2
100-
1000 µl 0.5 5 0.2 2.0
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Standard Operating
Procedures
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SOPs are written , up to date instructions and
information which cover in details how to perform
individual tests to insure the correct use ,
availability , reliability , timeliness, and reporting of
blood tests and correct interpretation of the test
result

*Quality control (QC) encompasses quality
assurance as it focuses on analytical activities
that are associated with the testing process. QC
consists of:
A. running control samples with patient samples,
B. using established statistical methods to
determine reliability of test procedures and test
results,
C. monitoring instrument and laboratorial
performance.
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Quality control
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Quantitative QC Materials
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 Calibrator: a solution which has a known
amount of analyte weighed in or has a value
determined by repetitive testing using a
reference or definitive test method
 Control: material or preparation used to monitor
the stability of the test system within
predetermined limits

Sources for Control Materials
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 Commercial product.
 Diagnostic samples (qualitative QC).
 “Homemade” or “In-house”.
 Obtained from:
Another laboratory .
EQA provider.

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Parallel Testing.
-
Validation of new controls
Whenever possible, new lots of control material
must be assayed in parallel alongside the current
in use lot. This is to enable the calculation of
laboratory QC ranges and to demonstrate that the
QC material is performing as expected.

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Controls for Quantitative Assays:
a. In order to validate new controls, the new lot of controls
will be run in parallel with the old lot of controls 2-3 times a
day for 5-10 days, to give a minimum of 20 values to enable
the calculation of laboratory specific QC ranges. The mean
and QC ranges for the new lot of controls will be reviewed
and signed off by the laboratory supervisor or director
before being put into use.

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b. For hematology the new lot of controls should be
run in parallel with the old lot of controls to give a
minimum of 10 values over a period 5 days if possible.
The mean and ranges for the new lot of controls will
be reviewed and signed off by the laboratory
supervisor or director before being put into use.

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Controls for Qualitative Assays:
.
2
Each new lot of QC for qualitative assays must be run
and give an expected response. The lot of controls will
be reviewed and signed off by the laboratory
supervisor or director before being put into use.

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Types of Control Materials
 Assayed
mean calculated by the manufacturer
must verify in the laboratory
 Unassayed
less expensive
must perform data analysis
 “Homemade” or “In-house”
pooled sera collected in the laboratory
characterized
preserved in small quantities for daily use

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Levey-Jennings Chart
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q211q`
o A graphical method for displaying control results
and evaluating whether a procedure is in-control or
out-of-control
o Control values are plotted versus time
o Lines are drawn from point to point to accent any
trends, shifts, or random excursions

Levey-Jennings Chart
 control sample included in each assay run
 data plotted graphically (assay value verses
time
 of day)
 control (or confidence) limits
 mean
 standard deviation (usually + 2 SD)
 if control limits are not met, then no patient
samples run in that batch can be reported.
 if control limits are met, then patient samples
run in that batch can be reported
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QC changes detectable with
Levey-
Jennings plots
 Drift: control value moves progressively in
one direction from the mean for at least 3
days e.g deterioration of reagent or control
 Dispersion :increase in random errors e.g
inconsistency in technique
 Shift: sudden problem develops e.g
instrument malfunction or technique change
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Findings Over Time
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Ideally should have control values clustered
about the mean (+/-2 SD) with little variation in
the upward or downward direction
Imprecision = large amount of scatter about 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

Levey-Jennings Chart -
Record and Evaluate the Control Values
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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
Mean
Day
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD

What are the "Westgard rules”
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They are different combination of rules depending on
the number of control being used, the total allowable
error, and your work environment.
rules That are used as conjunction with each other to
provide a high level of errors detection, while
reducing the incidence of false rejection.

Typical rules combination
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 For control run in multiples of 2 “ typical
chemistry”
 13s / 22s / R4s / 41s / 10 x
 For control run in multiples of 3“ typical
haematology,coagulation, and immunoassays”.
 13s / 2 of 32s / R4s / 31s / 12 x

Westgard Rules
(Generally used where 2 levels of control
material are analyzed per run)
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 12S rule
 13S rule
 22S rule
 R4S rule
 41S rule
 10X rule

Westgard – 12S Rule
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 “warning rule”
One of two control results falls
outside ±2SD
Alerts tech to possible problems
Not cause for rejecting a run
Must then evaluate the 13S rule

12S Rule = A warning to trigger careful inspection of
the control data
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Mean
Day
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD
12S rule
violation

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If either of the two control
results falls outside of ±3SD,
rule is violated
Run must be rejected
If 13S not violated, check 22S

13S Rule = Reject the run when a single control
measurement exceeds the +3SD or -3SD control limit
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Mean
Day
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD
13S rule
violation

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2 consecutive control values for the same level
fall outside of ±2SD in the same direction, or
Both controls in the same run exceed ±2SD
Patient results cannot be reported
Requires corrective action

22S Rule = Reject the run when 2 consecutive control
measurements exceed the same
+2SD or -2SD control limit
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Mean
Day
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD
22S rule
violation

Westgard – R4S Rule
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One control exceeds the mean by –2SD, and the
other control exceeds the mean by +2SD
The range between the two results will therefore
exceed 4 SD
Random error has occurred, test run must be
rejected

R4S Rule = Reject the run when 1 control
measurement exceed the +2SD and the other
exceeds the -2SD control limit
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Mean
Day
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD
R4S rule
violation

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o Requires control data from previous runs
o Four consecutive QC results for one level of
control are outside ±1SD, or
o Both levels of control have consecutive results
that are outside ±1SD

41S - reject when 4 consecutive
control measurements exceed the
same mean ± 1s limit.
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Westgard – 10X Rule
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 Requires control data from previous runs
 Ten consecutive QC results for one level of
control are on one side of the mean, or
 Both levels of control have five consecutive
results that are on the same side of the mean

10x Rule = Reject the run when 10 consecutive control
measurements fall on one side of the mean
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Mean
Day
+1SD
+2SD
+3SD
-1SD
-2SD
-3SD
10x rule
violation

Moving Averages (Bull’s method)
 large laboratories (built into blood analysers)
 assumes the population sampled each day
remains constant
 therefore the calculated indices (MCV, MCH
and MCHC) remain stable
 determine mean indice values for each batch
of 20 patients, plot on control chart
 any change: instrument or technical fault
 as accurate as 4C preparations
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Moving Averages
 MCV = Hct
RCC
 MCH = Hb
RCC
 MCHC = Hb
Hct
 Changes in the
moving
averages graphs
indicate where the
problem might be in
the system. eg. If the
light source for Hb
is becoming weak,
then the calculated
MCH and MCHC
values will fall12/18/2013
Alla(Sangoor)
78

Moving averages
 CAUSE MCV MCH
MCHC
 LowHb no change low low
 High Hb no chang high high
 Low RCC high high no
change
 High RCC low low no
change
 Low Hct low no change high
 High Hct high no change low
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79

Duplicate tests on patient
samples
 tests precision
 will not detect incorrect calibration
(accuracy)
 smaller laboratories
 METHOD
 test 10 samples
 repeat the tests
 calculate the difference between pairs of
results
and derive a standard deviation
 SD should always be < 2SD 12/18/2013
Alla(Sangoor)
80

Check tests on patient samples
 monitors day-to-day precision (small lab)
 detects deterioration within apparatus and
reagents
 METHOD
 » select 3-5 normals in the afternoon, record
and average values (WCC, RCC, Hb). Store at
4oC.
 » re-assay same samples next morning
 » tests should agree within 2SD
 Must ensure there has been no change in
samples
12/18/2013
Alla(Sangoor)
81

Corrective action
12/18/2013
Nazar Ahmed Mohamed
Abd-Alla(Sangoor)
82
 Errors assessment and management:
 Change Old Habits - Recognize Problems.
 Bad habit Repeat the control .
 Inspect the control charts or rules violated to
determine type of error.
 Relate the type of error to potential causes.
 Consider factors in common on multitest systems
 Relate causes to recent changes
 Verify the solution and document the remedy

Turn around Times (TATs)
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83
 Laboratory test turnaround times (TATs) In contrast
to laboratorians, the majority of clinicians defined a
TAT start time as test ordering, and a TAT ending
time as result reporting.
 Timely reporting of patient tests can increase
efficiency of care and improve customer satisfaction.
 In study done 2008 found that postanalytical phase
accounted for 64-88% of total tumround time, the
pre-analytical phase for 7-17%, and the analytical
phase for 2-29%.

12/18/2013
Alla(Sangoor)
84

Definitions
12/18/2013
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86
 Forms: Blank form design to special work to be fill
by data at time of use.
 Records: worksheets, forms, charts, labels,
Used to capture information, activities, or results
when performing a procedure
 Documents: written policies, process
descriptions, procedures, and forms Used to
communicate information
 May be paper or electronic

Hierarchy of Documents
12/18/2013
87
Policies
Processes
Procedures /
Work Instructions
“what to do”
“how it happens”
“how to do it” -
(SOPs)

Document Control
12/18/2013
Alla(Sangoor)
88
Advantages:
Assures that the most current version
is used
Ensures availability when needed
Organizational tool

Summary: Document Preparation
and Control Process
12/18/2013
Alla(Sangoor)
89
Approval
Issue /
Distribution
Review
Revision
Preparation

SUMMARY
12/18/2013
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91
 Pateint preparation, and good specimen
collection, preparation , handling, and storage
of specimen.
 Clinical Laboratory instruments daily, weekly,
and monthly maintenance and calibration done
regular.
 Micropipettes recalibration takes place monthly
.
 Good clinical method selected, and Reagents
storage condition verified by monitoring of
refrigerators temperature.

SUMMARY
12/18/2013
Alla(Sangoor)
92
 SOPs written, approved ,and followed carefully,
then Sops critical point check list used daily.
 MORE than one levels of control sera at least
should used in all batches with patient samples.
 Results of control sera register in quality book
and blotted in levey Jennings chart.
 Westgard rules used as guidance for
acceptability or rejection of patient results
applied.
 Errors assessment and management takes
place, and corrective action documented.
 Turn a round time to all investigation verify
monthly.
 Documentation (to all lab activities)

12/18/2013
Alla(Sangoor)
93

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