Standard Operating Procedure- SOP

Name of institution

Sample Labelling ID Code:

Ap 8

Topic & Purpose: Review Period:

Explains how to label samples arriving in the 1 year
laboratory

Location: Distribution:

Version number: Annex:

V 1.0 1. Test Request Form

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)
Institution: Version: 1.0 Date: Number of pages: Name of ID Code: Ap 8
4 procedure:
Sample Labelling QM chapter: 7
Procedure

Sample Labelling Procedure

Application.......................................................................................................................2
Objective..........................................................................................................................2
Definitions........................................................................................................................2
References......................................................................................................................2
Responsibilities................................................................................................................2
Operating Mode...............................................................................................................2
Methodology................................................................................................................2
Problems and solutions...............................................................................................3
Related documents..........................................................................................................3
Annex 1...........................................................................................................................4

Application
Sampling

Objective
This operating procedure explains how to label a sample correctly before it is sent to
the laboratory for testing.

Definitions
To be filled in if necessary

References
To be filled in if necessary

Responsibilities
To be defined

Operating Mode

Methodology
1. Obtain labelling information and verify this information as correct with the patient
before collecting the patient’s specimen:
 Verify the patient’s identity in a positive manner: this means the collector should
ask the patient for his/her correct name and date of birth, and NOT ask the
patient “Are you Mr. X, born the XX/XX /XX?”
For women, also identify the patient’s maiden name, if applicable.
 Compare the information supplied by the patient with:
o information indicated on the prescription (Test Request Form, Annex 1),

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Institution: Version: 1.0 Date: Number of pages: Name of ID Code: Ap 8
4 procedure:
Sample Labelling QM chapter: 7
Procedure

o hospital records (if the patient is admitted to the hospital) or with the
social security card or other legal identification (if the patient is not
admitted).
 If there is concordance of the patient identifying information, the collector can
proceed to specimen collection.

2. Before starting specimen collection, in the presence of the patient, label all
specimen containers with indelible ink with the following information:
 Patient’s first and last names (including maiden name if applicable);
 Personalized identification number (e.g. social security or hospital accession
number);
 Date of birth;
 Sex;
 Date and hour of specimen collection;
 Type of specimen;
 Specimen collector’s name.

3. The specimens will be accepted if they meet the acceptability criteria established
and detailed in the SOP Sample Rejection or Acceptance.

Problems and solutions

1. If the hospitalized patient has no identity number: ask the patient's nurse or
responsible party to confirm the patient’s identity. Never trust the information found at
the end of the bed. Resolve any discordance before proceeding to specimen
collection.

2. If the patient cannot give his/her name: ask the person accompanying the patient.
Resolve any discordance before proceeding to specimen collection.

3. If the patient’s information does not correspond to information written down on the
Test Request Form: communicate with the person accompanying the patient and
resolve any discordance before proceeding to specimen collection.

Related documents
SOP Sample Rejection or Acceptance Ref XXX, provided in this QM template as Ap 9

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Institution: Version: 1.0 Date: Number of pages: Name of Reference: Ap 8
4 procedure:
Sample Labelling QM Chapter: 7
Procedure

Annex 1
Test Request Form

Patient information
Last name: __________________________ First name: ____________________
(maiden name, if applicable): _______________
Sex (circle one): M F Date of birth: ______________
Identification number: ____________
Address: ______________________ City: ____________________
Zip code: ____________

Collection information
Specimen type: ________________

Date of prescription (request): ____________________

Date of specimen collection: __________________ Hour: ________________
Name of specimen collector: __________________________
Date sample sent to the laboratory: ________________ Hour: ________________

Clinical details: _______________________________________

Tests requested
_______________________________________

Prescriber's name: _______________________________

Address: _______________________________________
Telephone: ________________ Fax: ________________

For the reception of sample at the laboratory

Date sample received at the laboratory: _______________ Hour: ____________
Name of the person receiving the sample: ______________________________

Acceptable sample (circle one): Yes No

An acceptable sample indicates that for the requested tests the following criteria are met:
 specimen was collected by appropriate means in the correct container
 adequate volume
 absence of leaks
 no obvious deterioration
 sample was received by the laboratory:
o within an appropriate time frame after collection
o under appropriate temperature conditions (e.g. on ice).

Comments: __________________________________________________________