Internal Quality Control in Clinical Laboratories

1
Nazar Ahmed Mohamed AbdAlla(Sangoor)
12/18/2013
Internal Quality control in Clinical Laboratoreis

NAZAR AHMED MOHAMED ABD-ALLA
2 Nazar Ahmed Mohamed AbdAlla(Sangoor) 12/18/2013
Topics
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 . Nazar Ahmed Mohamed AbdAlla(Sangoor)
12/18/2013
Topics
Implementation of quality programs
Interpretation of internal quality results. Corrective action.
Turn around time.

Documentation.
12/18/2013
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.
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.
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 Nazar Ahmed Mohamed Abd12/18/2013 management system. Alla(Sangoor)
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.
12/18/2013
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.
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 .
10
12/18/2013
QA activities
*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.
11
12/18/2013
Examples of QA Activities
* 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.
*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.
13
12/18/2013
Type Of Error
*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.
*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
* 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.
Specimens and Requests

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
17
12/18/2013
Specimens and Requests

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.
Nazar Ahmed Mohamed AbdAlla(Sangoor) 12/18/2013
18
Specimens and Requests 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.
19
12/18/2013
METHOD VALIDATION
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.
20
Nazar Ahmed Mohamed Abd-Alla(Sangoor)
12/18/2013
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.
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.
METHOD VALIDATION
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.
23
12/18/2013
Importance of Method Validation Practices
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.
24
12/18/2013
Types of Errors to be assessed by method validation

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.
25
12/18/2013
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.
26
12/18/2013
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).
Method performance parameters assessed in a method validation study

Identity: Measurement correctly applies to the stated
28
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 Nazar false positive. Ahmed Mohamed Abd12/18/2013 Alla(Sangoor) [Limit of determination] Minimum value that can be

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
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)
30
12/18/2013
Method Selection
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.
1.
31
12/18/2013
Experiments for estimating analytical errors
32
12/18/2013
HBG
18 16 14 12 10 HBG 8 6 4 2 0 0 2 4 6 8 10 12 14 16 18 20
METHOD COMPARISSION FOR HBG ESTIMATION BETWEEN TOW DIFFERENT INSTRUMENT

Clinical laboratory instruments example

Spectrophotometers .
Water bath.
Vortex. Hematology analyzer. Microplate reader & washer. Centrifuge. Flame photometers or ISE. Coagulometer. Hot air oven.
Maintenance and calibration of Photometers

Includes checking for: Wavelength accuracy Linearity of instrument Stray light
Base line stability

Photometric accuracy Short circuits Check 0% T Temperature
35
12/18/2013
36
12/18/2013
37
12/18/2013
38
12/18/2013
Micropipettes Calibration
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.

39
12/18/2013
Checking Micropipettes Calibration

Weighing Should takes place at 20-25 constant to 0.5.
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.
40
12/18/2013
Checking Micropipettes Calibration

Convert the recoded weight to volume (V1) either
by divide the weight of the water by its density ( at 20 : 0.9982 ) or by multiply the weight by the Z correction factor (= 1.002899 l/mg at 20 ). 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.
42
12/18/2013
Systematic Error and Random Error

Compare the Systematic Error ( Inaccuracy),
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.
Random Error (
43
12/18/2013
Table Shows The Maximum Permitted Errors( F Max )

Pipettes Nominal Type volume
5 l 10 l
M.P.E (F Max )
0.3 l 0.3 l
0.4 l 0.5 l 0.8 l 1.5 l 0.6 l l
Nominal volume
200 l 250 l
500 l 1000 l 2000 l 5000 l 250 l 300 l
M.P.E (F Max )
2 l 2.5 l
5 l 10 l 20 l 50 l 5.0 l 6.0 l 12/18/2013
Single channel pipettes
20 l 25 l 50 l 100 l
44
Multichannel pipettes
10 l
Nazar Ahmed Mohamed Abd50 l Alla(Sangoor) 1.6
Table Shows The Recommended Specification

Inaccuracy
Nominal volume
Imprecision
Inaccuracy Nominal volume
Imprecision
%
1.0
( A )l
%
0.8
5 l
O.05
0.04
200 l
% 0.5
( A )l
% 0.2
0.4
10 l
20 l 25 l 50 l 100 l 0.5-10 l 5-50 l
45
1.0
0.7 0.7 0.7
0.1
0.14 0.175 0.35
0.8
0.4 0.4 0.4
0.08
0.08 0.1 0.2
250 l
500 l 1000 l 10-100 l
0.5
0.5 0.5 0.5
1.25
2.5 5 0.5
0.2
0.2 0.2 0.2
0.5
1.0 2.0 0.2
0.5
1.0
0.5
0.1
0.2
0.8
0.2
0.08
20-200 l
25-250 l
0.5
0.5
1
1.25
0.2
0.2
0.4
0.5
0.7
Nazar Ahmed 0.35 0.4 Mohamed 0.2 Abd-
1001000 l Alla(Sangoor)
0.5
0.2 2.0 12/18/2013
Standard Operating Procedures

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
46
12/18/2013
Quality control
*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.
Quantitative QC Materials
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
48
12/18/2013
Sources for Control Materials

Commercial product.
Diagnostic samples (qualitative QC). Homemade or In-house. Obtained from: Another laboratory . EQA provider.
49
12/18/2013
Validation of new controls -Parallel Testing. 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.
50
12/18/2013
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.
51
12/18/2013
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.
52
12/18/2013
2. Controls for Qualitative Assays: 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.
53
12/18/2013
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
54
12/18/2013
55
12/18/2013
Levey-Jennings Chart
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
12/18/2013 q211q` 57
Levey-Jennings Chart
control sample included in each assay run
data plotted graphically (assay value verses

58
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 inNazar that batch can be reported Ahmed Mohamed AbdAlla(Sangoor)
12/18/2013
QC changes detectable with LeveyJennings 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
59
12/18/2013
Findings Over Time

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
60
12/18/2013
Levey-Jennings Chart Record and Evaluate the Control Values

+3SD +2SD +1SD
115 110 105
Mean 100 -1SD -2SD -3SD
95 90 85 80 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
What are the "Westgard rules

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.
62
12/18/2013
Typical rules combination

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
63
12/18/2013
Westgard Rules
(Generally used where 2 levels of control
material are analyzed per run)
12S rule 13S rule 22S rule
R4S rule
41S rule 10X rule
64
12/18/2013
Westgard 12S Rule 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
+3SD +2SD +1SD Mean -1SD -2SD -3SD
12S rule violation
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
Westgard 13S Rule

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
13S rule violation
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
Westgard 22S Rule

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
69
12/18/2013
22S Rule = Reject the run when 2 consecutive control

measurements exceed the same +2SD or -2SD control limit
22S rule violation
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
Westgard R4S Rule

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
71
12/18/2013
R4S Rule = Reject the run when 1 control

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

24
-2SD -3SD
Day
Westgard 41S Rule

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
73
12/18/2013
41S - reject when 4 consecutive control measurements exceed the same mean 1s limit.
74
12/18/2013
Westgard 10X Rule

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
75
12/18/2013
10x Rule = Reject the run when 10 consecutive control

measurements fall on one side of the mean
10x rule violation

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Day
Moving Averages (Bulls 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
77
12/18/2013
Moving Averages
MCV = Hct Changes in the
RCC
MCH = Hb
RCC MCHC = Hb Hct
78
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 12/18/2013 values will fall
Moving averages
CAUSE
MCV no change no chang high low
MCH low high high low low high no no
79
MCHC LowHb High Hb Low RCC change High RCC change Low Hct High Hct
low high
no change no change low
high
12/18/2013
Duplicate tests on patient samples

tests precision
will not detect incorrect calibration

80
(accuracy) smaller laboratories METHOD test 10 samples repeat the tests calculate the difference between pairs of results and derive a standard deviation Nazar Ahmed Mohamed AbdSD should always be < 2SD 12/18/2013 Alla(Sangoor)
Check tests on patient samples

monitors day-to-day precision (small lab)
detects deterioration within apparatus and

81
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 Nazar Ahmed Mohamed AbdAlla(Sangoor)
12/18/2013
Corrective action
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

82
12/18/2013
Turn around Times (TATs)

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%.
84
12/18/2013
Documentations
Definitions
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
86
12/18/2013
Hierarchy of Documents
what to do
Policies
how it happens
Processes
how to do it (SOPs)
Procedures / Work Instructions

87 Nazar Ahmed Mohamed Abd-Alla(Sangoor)
12/18/2013
Document Control
Advantages: Assures that the most current version is used Ensures availability when needed Organizational tool
88
12/18/2013
Summary: Document Preparation and Control Process

Preparation Approval Revision
Issue / Distribution
89 Nazar Ahmed Mohamed AbdAlla(Sangoor)
Review
12/18/2013
ANY QUESTION?
SUMMARY
Pateint preparation, and good specimen
91
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. Nazar Ahmed Mohamed Abd12/18/2013
Alla(Sangoor)
SUMMARY
SOPs written, approved ,and followed carefully,
92
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) Nazar Ahmed Mohamed AbdAlla(Sangoor)
12/18/2013
93
12/18/2013

Internal Quality Control in Clinical Laboratories

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Internal Quality Control in Clinical Laboratories

Uploaded by

Copyright:

Available Formats

1

Nazar Ahmed Mohamed AbdAlla(Sangoor)

Internal Quality control in Clinical Laboratoreis

Type of error in clinical laboratory.

Turn around time.

Nazar Ahmed Mohamed AbdAlla(Sangoor)

Quality assurance: Part of quality management

Appropriateness of tests can only be obtained by

principles aspects of making reliable analytical measurements:

Nazar Ahmed Mohamed AbdAlla(Sangoor)

principles aspects of making reliable analytical measurements:

Nazar Ahmed Mohamed AbdAlla(Sangoor)

Nazar Ahmed Mohamed AbdAlla(Sangoor)

Nazar Ahmed Mohamed AbdAlla(Sangoor)

Specimens and Requests

2- Primary sample collection.

Nazar Ahmed Mohamed AbdAlla(Sangoor)

Specimens and Requests

Specimens and Requests 4- Samples Rejection Criteria

Method validation is a term used for the suite of

Nazar Ahmed Mohamed Abd-Alla(Sangoor)

Continue: Method validation

Nazar Ahmed Mohamed Abd-Alla(Sangoor)

Importance of Method Validation Practices

Laboratory regulations require that method

Nazar Ahmed Mohamed Abd-Alla(Sangoor)

Types of Errors to be assessed by method validation

proportional systematic error.

All these errors can be recognized when a group

of measurements are compared to the correct or true values.

Nazar Ahmed Mohamed Abd-Alla(Sangoor)

Method performance parameters assessed in a method validation study

Method performance parameters assessed in a method validation study

Method performance parameters assessed in a method validation study

Robustness or ruggedness: Ability of method to

Nazar Ahmed Mohamed AbdAlla(Sangoor)

Nazar Ahmed Mohamed AbdAlla(Sangoor)

Experiments for estimating analytical errors

Nazar Ahmed Mohamed Abd-Alla(Sangoor)

METHOD COMPARISSION FOR HBG ESTIMATION BETWEEN TOW DIFFERENT INSTRUMENT

Clinical laboratory instruments example

Maintenance and calibration of Photometers

Base line stability

Nazar Ahmed Mohamed AbdAlla(Sangoor)

Nazar Ahmed Mohamed AbdAlla(Sangoor)

Nazar Ahmed Mohamed AbdAlla(Sangoor)

method) (Recommended method)

6. Small plastic beaker.

Checking Micropipettes Calibration

Set the desire testing volume of your pipette.

Nazar Ahmed Mohamed AbdAlla(Sangoor)

Checking Micropipettes Calibration

Nazar Ahmed Mohamed AbdAlla(Sangoor)

Systematic Error and Random Error

Nazar Ahmed Mohamed AbdAlla(Sangoor)

Table Shows The Maximum Permitted Errors( F Max )

Single channel pipettes

Nazar Ahmed Mohamed Abd50 l Alla(Sangoor) 1.6

Table Shows The Recommended Specification

Inaccuracy Nominal volume

Nazar Ahmed 0.35 0.4 Mohamed 0.2 Abd-

0.2 2.0 12/18/2013