Results Validationprocedure

Institution:
/ Version: 1.0 / Date: / Number of pages: 3 / Name of procedure:
Results Validation Procedure / ID Code:Ap 11
QM chapter: 7
Results Validation / ID Code:
Ap 11
Topic & Purpose:
Explains how to validate results in the laboratory / Review Period:
1 year
Location: / Distribution:
Version number:
V 1.0 / Annex:
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)

Results ValidationProcedure

Application

Objective

Definitions

References

Responsibilities

Operating Mode

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 managementor authorized personnelis in charge of the validation procedures.

Operating Mode

Result validation consists ofverifying that the internal quality controls are acceptable, the quality management system functions correctly, and the results make sense.

The laboratory management or authorized personwill verify that:

The internal quality controls are acceptable. If this is not the case, the technician will discuss thiswith the laboratory management and, if needed, refer toSOP 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.
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.
Thetest reports are printed.
The test report is reviewed and initialedor 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.