Standard Operating Procedure- SOP
Name of institution
Results Validation
ID Code:
Ap 11
Topic & Purpose:
Review Period:
Explains how to validate results in the
laboratory
1 year
Location:
Distribution:
Version number:
Annex:
V 1.0
None
Written by:
Name(s), Date(s) and Signature(s) of the Author(s)
Reviewed by:
Name(s), Date(s) and Signature(s)
Authorized by:
Name, Date and Signature
Replaces the version:
Not applicable (1st version)
Changes to the last authorized version:
Not applicable (1st version)
Version: 1.0
Institution:
Date:
ID Code: Ap 11
Number of pages: Name of
3
procedure:
Results Validation QM chapter: 7
Procedure
Results Validation Procedure
Application ....................................................................................................... 2
Objective .......................................................................................................... 2
Definitions ........................................................................................................ 2
References....................................................................................................... 2
Responsibilities ................................................................................................ 2
Operating Mode ............................................................................................... 2
Related documents .......................................................................................... 3
Application
This procedure describes steps to ensure that laboratory results are accurate
and reliable prior to reporting.
Objective
This procedure has been developed to explain how to validate the results of
laboratory tests before sending them to the requestor.
Definitions
Quality control: A set of activities or techniques whose purpose is to ensure
that all quality requirements are being met. Simply put, it is examining
“control” materials of known substances along with patient samples to monitor
the accuracy and precision of the complete examination process.
References
To be filled in if necessary
Responsibilities
The laboratory management or authorized personnel is in charge of the
validation procedures.
Operating Mode
Result validation consists of verifying that the internal quality controls are
acceptable, the quality management system functions correctly, and the
results make sense.
The laboratory management or authorized person will verify that:

The internal quality controls are acceptable. If this is not the case, the
technician will discuss this with the laboratory management and, if
needed, refer to SOP Minor Occurrence. If appropriate, the equipment
will be calibrated, controls run and evaluated, and the test will be
repeated.

Any required calibration of the equipment was done correctly. If this is
not the case, the technician will discuss this with the laboratory
management and, if needed, refer to SOP Minor Occurrence. If
appropriate, the test will be repeated.
2
Version: 1.0
Institution:
Date:
ID Code: Ap 11
Number of pages: Name of
3
procedure:
Results Validation QM chapter: 7
Procedure

There have been no recent reports of a problem in the processing
workflow.

The results are in concordance with the clinical details stated on the
request form.

Critical results are discussed with the technician and these results are
reported as indicated in the SOP Critical Results Reporting.

Abnormal laboratory’s results are verified by repeating the test. The
laboratory management may request (at no cost for the patient) that the
specimen be sent to a reference laboratory for confirmation. In that
case, follow the SOP Sending Samples for External Analysis.

Appropriate commentary accompanies the test result to facilitate the
requestor's comprehension of the result.

When results indicate a complementary test should be performed, it will
be discussed with the requestor according to the SOP Advisory Policy.
If the requestor agrees and if conditions allow, the additional test may
be carried out. The laboratory management will then register the new
test to be performed.

The test reports are printed.

The test report is reviewed and initialed or signed by management. By
this the laboratory management acknowledges review of the report and
accepts responsibility for initiating any necessary follow-up.

The charts and original laboratory’s report are stored in the appropriate
location.
Related documents
SOP Advisory Policy Ref XXX
SOP Critical Results Reporting Ref XXX
SOP Minor Occurrence Ref XXX
SOP Sending Samples for External Analysis Ref XXX
3