KAKINDO HEALH CENTRE IV LABORATORY

KKHL C4 SE 03 SOP FOR MEASUREMENT OF UNCERTAINITY Vr.3

STANDARD OPERATING PROCEDURE

Title: SOP FOR MEASUREMENT OF UNCERTAINITY

Doc No: KKHL C4 SE 03 Version No. 3.0
Written by: Nambozo Jocelyn Signature and
Date 07.10. 2019
Reviewed by: Mpanga Don Bosco Signature and
Date 15.10.2019
Approved by: Tomusange Joseph Signature and
Date 20.10.2019
Effective Date 17.01. 2020 Obsolete Date
DISTRIBUTION

Location Copy Number Responsible

person
Master file 1 Quality Officer

REVISION DETAILS:

No. Date of Next Date Reviewed Action

Review Reviewed by
1 Jan. 2021

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Approved changes

Change Approved by; Brief description of changes

Mpanga Don Bosco Aligned the SOP to the requirements of the

Quality Officer ISO 15189:2012
15.10.2019
Aligned this sop to sop of sops

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 KAKINDO HEALH CENTRE IV LABORATORY

KKHL C4 SE 03 SOP FOR MEASUREMENT OF UNCERTAINITY Vr.3

1.0 Introduction
Medical laboratories are responsible for ensuring that test results are fit for clinical application by
defining the required analytical performance goals and selecting appropriate measurement
procedures. Measurement uncertainty (MU) provides quantitative estimates of the level of
confidence that a laboratory has in the analytical precision of test results, and is therefore an
essential component of a quality system for medical laboratories.

2.0 Purpose
To determine Measurement Uncertainty for each measurement procedure in the scope of tests.
KKHL estimates measurement of uncertainty because a measurement only gives an approximation
of the true value of the quantity to be measured. KKHL also uses MU to monitor the performance
of the quality management system.

3.0 Scope
The SOP covers the estimation, application and communication of measurement of uncertainty in
KKHL. This SOP applies to all KKHL personnel involved in performing routine procedures in the
laboratory.

4.0 Abbreviations, definitions and terms

4.1 Definitions and terms
Analyte: the substance or constituent of interest that is the subject of measurement. However, a
substance can have a number of properties, some or all of which can be utilized to quantify the
substance in an appropriate measuring system.

Uncertainty: a parameter associated with the result of a measurement that characterizes the
dispersion of the values that could reasonably be attributed to the measurand.

Traceability: Property of the result of a measurement or the value of a standard, whereby it can be
related to stated references, usually national or international standards, through an unbroken chain
of comparisons all having stated uncertainties.

Repeatability: is “a measure of variability derived under specified repeatability conditions”, i.e.

independent test results are obtained with the same method on identical test items in the same
laboratory by the same analyst using the same equipment, batch of culture media and diluents, and
tested within short intervals of time.

Reproducibility: is “a measure of precision derived under reproducibility conditions” i.e. test

results are obtained with the same method on identical test items in different laboratories with

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different operators using different equipment. A valid statement of reproducibility requires
specification of the conditions used.

Measurand:
A measurand is defined as the particular quantity subject to measurement (or the particular
quantifiable property of the analyte used in the measuring system), where the quantity is the
attribute of a substance that can be distinguished and determined quantitatively. It is essential to
define as fully as possible the quantity that is measured (i.e. the measurand) by a given procedure.
There are four aspects of a measurand that should be described (see Table 1):
a) Quantity intended to be measured
b) System
c) Kind-of-quantity and measurement unit
d) Method.

Table 1: Examples of measurand definition

Quantity intended System Kind-of-quantity Measurement Method

to be measured unit
ALT Venous Amount of substance mmol/L Flame photometry
serum concentration

Creatine kinase MB Serum Activity concentration mIU/L at 37ºC Immuno-inhibition

Haemoglobin Venous Mass concentration g/dl Spectrophotometry
whole
blood

4.2 Abbreviations
KKHL : KAKINDO HEALTH CENTRE IV Laboratory
QM : Quality Manual
SOP : Standard Operating Procedure
SO : Safety Officer
QO : Quality Officer
SD : Standard Deviation
CV : Coefficient of Variation
MU : Measurement Uncertainty

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5.0 Tasks, responsibilities

Task Responsible Accountable
Implementation of the QO Lab Manager
procedure
Review of the reports QO Lab Manager/Lab director

Communication of the MU to QO Lab Manager/Lab director

the requestors

6.0 Safety and environment

All samples used during the estimation of measurement uncertainty are regarded as potentially
infectious.

7.0 Procedure
7.1 Determine Measurement of uncertainty on measured quantity values (quantitative
tests);
The uncertainty of measurement is only determined for all quantitative tests within the laboratory
that includes haematology, clinical chemistry and CD4.

7.1.1 Reagents and Materials

Specific method and equipment SOP’s are followed and quality control performed during the
process steps

1) identify the measurand

2) using a minimum of two levels (Low/Normal, Normal/High), Calculate the Uncertainty due to
precision,
i. Use internal quality control data over a period of at least 2 months
ii. Calculate the means, standard deviations and coefficient of variation for the respective
levels;
iii. Calculate the uncertainty due to imprecision using the formula below;

uprec √ (CV H   % ¿¿ 2) X ( N H  −1 )+

(CV N   %¿¿ 2) X ( N N  −1 )
( N H−1 ) + ( NN−1 )
¿¿

3). Calculate uncertainty due to Bias using reference control material

Obtain ucref usually given in the manufacturer’s insert of the control or calibrator
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Convert the expanded uncertainty (ucref) to standard uncertainty using the formula below;

ucref (Standard)= (ucref expanded)

k
Note:
Manufacturers when making control materials, usually make them to cover up to 99.7% of
results (3-SD) thus the k is usually 3.

4). Calculate the uncertainty due to repeatability- perform a minimum of 20 repeated runs of the
reference control material however if resources are limited 10 runs are be performed.

5). Calculate the mean, standard deviation and the standard deviation of the mean (SDM) using the
formula below;

SDM=

Uncertainty due to repeatability (Urepeatability):

CV%= *100

6). Calculate the uncertainty due to bias (ubias) using the formula below;

√( Ustandard  2  +U repeatability  2  )

Ubias
7). Calculate the combined uncertainty using the formula below;

√( U bias2  + U p rec  2  )
Ucombine
8). Calculate the expanded uncertainty using the formula below;
Uexpanded (%) = Ucombined*k

Where K is the coverage factor for a given confidence interval from Normal distribution.

For Measurement uncertainty to cover 68.2% of the served patients (1SD) K=1
For Measurement uncertainty to cover 95.4% of the served patients (2SD) K=2
For Measurement uncertainty to cover 99.7% of the served patients (3SD) K=3

7.2 Acceptance criteria (Performance Requirements for the measurement uncertainty

(e.g Standard Deviation; Clinical decision points)
1) The MU is accepted if it’s less than the total allowable error as per CLIA limits.
2) In case the MU is greater than the total allowable error, verify the steps

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3) If verification confirms that the MU is greater than the total allowable error, perform a root
cause analysis and corrective action (handle as a nonconformity).

7.2.1 Application of MU
Every measurand whose result is generated by the laboratory is compared to the respective
uncertainty within which the true value lies.

7.2.2 Reporting MU
An MU report is written in a format shown in appendix 1 and is made available to the clinicians up
on request.

NOTE:
At KKHL the above factors are minimised by;
 Properly packaging and transporting both patient and EQA/PT test samples as per national
and international guidelines.
 Using Up-to-date reviewed and approved SOPs for each method.
 Routinely monitoring, documenting and reviewing of environmental conditions for all
equipment used.
 Training and competence assessment of all lab personnel involved in each test method
 Using up-to-date Verified and calibrated equipment.

8.0 Related documents and forms

KKHL C4 SE 02 SOP for calibration

KKHL Quality manual

9.0 Attachments

N/A

10.0 Appendices and annexes

Appendix1: Measurement of uncertainty report template

Annex 1: Attestation table

11.0 Reference documents

 ISO 13528:2005(E) Statistical methods for use in proficiency testing by interlaboratory

comparisons

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KKHL C4 SE 03 SOP FOR MEASUREMENT OF UNCERTAINITY Vr.3

 ISO 15189: 2012 Medical laboratories – Particular requirements for Quality and
competence (clause 5.5.1.4)

 EURACHEM/CITAC Guide CH 4, Quantifying Uncertainty in Analytical Measurement, 2nd

Edition, 2000.

 Checklist E-186: “Measurement Uncertainty in Chemical Analysis”.

Order from www.labcompliance.com/solutions/examples

 Monica-Cheesbrough-District-Laboratory-Practice-in-Tropical- Countries-Part-1.

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KKHL C4 SE 03/F01
Appendix 1: Measurement of Uncertainty Report

Equipment/method
Person carrying out MU
Date report XX.MM.YY
Date and initials of the Lab
Manager agreement of carried out
MU

Remarks Satisfactory/Unsatisfactory

Measurand(s)

Units

Test Principle

Reference Ranges

Test Limitations

Clinically significant Interferences

Analytical goal (Westgard

database) (CI%)
Calibrator Traceability Uncertainty

Analytical Bias

Analytical Imprecision
Combined uncertainty

Expanded Uncertainty (U), K=2

UExp=Ucombinedx k
MU Data available for clinicians

Interpretation

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KKHL C4 SE 03 SOP FOR MEASUREMENT OF UNCERTAINITY Vr.3

Annex 1: Attestation Form

Attestation Record (general staff SOP Review-At least annually)
{Please ensure that you have read and understood before signing}
Names Signature/Initials Date

1 Tomusange Joseph

2 Mpanga Don Bosco

3 Gabula Mike

4 Nambozo Jocelyn  

5 Waswa George

6 Ssebugwawo Innocent

7 Nabwami Faustine    

8 Matsiko George

9 Aganyira Mathias  

10 Dr. Byaruhanga Hargreaves

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