INADEQUATELY LABELLED SPECIMENS AT ST VINCENT’S

PATHOLOGY
REGULATORY REQUIRMENTS REGARDING LABELLING

In keeping with international and national regulatory requirements as well as good clinical
practice that govern all pathology services, St Vincent’s Pathology adheres to strict
specimen and request form acceptance rules. This includes mislabelled, unlabelled and
inadequately labelled specimens and requests.

It is acknowledged that unsuitable specimens, especially those related to labelling

issues, are a great risk to all concerned, including the: referring doctor, patient, collector
and the pathology service. Consequently, specimens and request forms should have as
much detail as possible to allow the accurate identification and testing of samples.

General Pathology Samples

At the very least, general request forms must have three major patient identifiers.
Tubes and specimen containers ideally have three identifiers but must have at least two
full identifiers.

Patient identifiers in order of priority:-

 Surname and full given name(s) (1 identifier only)
 Date of birth
 Unit record number (if applicable)
 Medicare number
 Address
 Gender
 Phone number
Request forms and specimens must match. They should have date and time of
collection and have a collector identification or signature.

Blood Banking Samples

Requests and specimens related to blood banking have even more stringent
requirements. There are specialised request forms for blood bank related testing that are
to be fully completed.

As well as above, specimens must have:-

 Hand written Surname and full given name(s)

 Date of birth
 Unit record number (if applicable)
 Gender
 Date and time of collection
 A collector signature on the specimen
Request forms must have
 A completed collection declaration

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  Request and specimen must match all details exactly

Request and specimen must match all details exactly

For both general requests, and for blood banking requests, episodes that do not conform
to minimum criteria are dealt with as unsuitable specimens.

UNSUITABLE SPECIMENS

Group 1

For urine, faeces and Blood (other than Blood Bank specimens or blood cultures).These
are rejected and a new specimen is sought. If at all possible, the doctor or collector is
contacted and notified.

Group 2

Special requirements may exist for handling and processing of certain types of
unsuitable specimens and requests within each Pathology discipline. These are referred
to and handled by senior staff in the relevant discipline.

PROCESSING EXCEPTIONS AND UNSUITABLE SPECIMENS

There are a minority of instances where by negotiation; mislabelled, inadequately

labelled or unlabelled specimens may be processed and reported. These are almost
invariably from group 2. Negotiation will involve the requesting doctor whenever possible
and a senior Pathology staff member, usually the pathologist. Consideration is given to
the risks, urgency, inconvenience and clinical implications.

Note that there are no such exceptions for blood banking requests.

If processing proceeds, the test report will have a comment added. For example:-

WARNING: Unlabeled specimen. The laboratory cannot take

responsibility for patient/specimen identification. Specimen
processed at the request of Dr. ……………...

REFERENCED REGULATORY STANDARDS

 Requirements for Medical Pathology Services. National Pathology Accreditation Advisory Council (NPAAC) –
sixth Ed 2013
 Australian Standard: Medical Laboratories Requirements for quality and competence AS ISO 15189-2013
 NATA Interpretation of NPAAC Requirements and ISO 15189. Medical Testing Field Application Document.
Requirements for accreditation. November 2013
 NSQHS Standards – National Safety and Quality Health Service Standards, Standard 5: Patient Identification
and procedure matching. Australian Commission on Safety and Quality in HealthCare. September 2012

This information brochure has been drafted using the above standards and St Vincent’s
policies. We thank you for your assistance in appreciation of this difficult and critically
important aspect of the service. These rules are in place to protect all concerned.

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