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    Unlabelled and Mislabelled Specimens

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    James Norld
    This document outlines St Vincent's Pathology's labeling requirements for specimens to adhere to regulatory standards that ensure accurate patient identification and testing. Specimens and request forms must include identifying details like patient name, date of birth, and collector information. Blood banking samples have stricter rules and may be rejected if any details are missing or do not match. While mislabeled specimens are usually not processed, exceptions can be made for urgent cases with senior approval, though this does not apply to blood banking.

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    Unlabelled and Mislabelled Specimens

    Uploaded by

    James Norld
    42 views2 pages
    This document outlines St Vincent's Pathology's labeling requirements for specimens to adhere to regulatory standards that ensure accurate patient identification and testing. Specimens and request forms must include identifying details like patient name, date of birth, and collector information. Blood banking samples have stricter rules and may be rejected if any details are missing or do not match. While mislabeled specimens are usually not processed, exceptions can be made for urgent cases with senior approval, though this does not apply to blood banking.

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    This document outlines St Vincent's Pathology's labeling requirements for specimens to adhere to regulatory standards that ensure accurate patient identification and testing. Specimens and request forms must include identifying details like patient name, date of birth, and collector information. Blood banking samples have stricter rules and may be rejected if any details are missing or do not match. While mislabeled specimens are usually not processed, exceptions can be made for urgent cases with senior approval, though this does not apply to blood banking.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    42 views2 pages

    Unlabelled and Mislabelled Specimens

    Uploaded by

    James Norld
    This document outlines St Vincent's Pathology's labeling requirements for specimens to adhere to regulatory standards that ensure accurate patient identification and testing. Specimens and request forms must include identifying details like patient name, date of birth, and collector information. Blood banking samples have stricter rules and may be rejected if any details are missing or do not match. While mislabeled specimens are usually not processed, exceptions can be made for urgent cases with senior approval, though this does not apply to blood banking.

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    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

    _________________________________________________________________________________
    St Vincent’s Pathology, Melbourne. PATH-O-16 v2 1/9/2017 Page 1 of 2
     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.

    _________________________________________________________________________________
    St Vincent’s Pathology, Melbourne. PATH-O-16 v2 1/9/2017 Page 2 of 2

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