Policy and Procedure: Pathology Specimen Labelling ...

P&P – Pathology Specimen labelling – Acceptance,

Rejection and Cancellation

of 14 Last Updated: 18th June 2014

Policy and Procedure:

Pathology Specimen Labelling – Acceptance, Rejection and Cancellation

1 Document details

Item Details

Section: Pathology Collection Services Manual

Policy number and version: 1.2

Date prepared: 18th

June 2014

Date last updated: 18th

June 2014

Prepared by: Michelle Hecimovic, Pathology Collections Manager, Pathology West

Approved by: Dr Michael Whiley, Locum Network Director, Pathology West

Date: 20th

June 2014

Keywords: Specimen Labelling, Acceptance, Rejection, Cancellation

2 Policy purpose

The purpose is to describe the policies in relation to the correct labelling of pathology specimens with either computer generated labels via Millennium or handwritten information, labelling acceptance and rejection criteria, as well as the notification process when cancelling unacceptable specimens.

3 Policy scope

This policy applies to all Pathology West staff (PW) across the six Local Health Districts (LHD) and all Clinical staff participating in the collection and labelling of Pathology specimens that will be sent / received at any of the Pathology West laboratories.

4 Expected outcomes

The expected outcomes of this policy and procedure are to ensure:

Consistent application of standardised best practice across Pathology West and all Local Health Districts

Compliance with various legal and statutory requirements

Awareness of the legal requirements for labelling Pathology specimens

Awareness of Millennium labels, patient demographics and collection information

Awareness of correct patient identification protocols

Awareness of specimen acceptance criteria

Awareness of specimen rejection criteria

Awareness of cancellation process and notification thereof




5 Roles and responsibilities

1. It is the responsibility of all Pathology West and any Clinical staff performing collection of pathology specimens, to adhere to the policy regarding specimen labelling requirements.

2. It is the responsibility of all staff to ensure correct patient identification is undertaken and that all request forms and specimen containers have sufficient and accurate patient information.

3. It is the responsibility of all Pathology West laboratories to have a standardised approach to the receipt of acceptable and unacceptable samples.

4. It is the responsibility of all Pathology West staff to notify the responsible Collector or Clinical staff in the event that an unacceptable specimen has been received and requires cancellation and recollection.

6 Policy principles

The purpose of this document is to describe the policies in relation to the collection and labelling of pathology specimens. The policy will also define the criteria for acceptance or rejection of all pathology collections.

General principles regarding positive patient identification for pathology collections are:

Acknowledgment that Pathology West is required to meet various legal and statutory regulations and

accreditation requirements in relation to positive patient identification of pathology collections.

The policies are based on:

o International Standard: AS ISO 15189 – Australian Standard Medical laboratories – Particular

requirements for quality and competence

o The Australian & New Zealand Society of Blood Transfusion Ltd. Guidelines for Pre-transfusion

Laboratory Practice (2007)

o NPAAC Requirements for Transfusion Laboratory Practice (Second Edition 2013)

o NPAAC Requirements for Pathology Laboratories (2007)

o NPAAC Guidelines for Approved Pathology Collection Centres (2012)

o NPAAC Requirements for Medical Pathology Services (2013)

o NATA Medical Testing Field Application Document

7 Policy detail

Pathology West and all clinical staff of the LHD’s must abide by policies regarding appropriate patient

identification at the point of collection of pathology specimens.

It is the responsibility of the person collecting the pathology specimen to ensure positive patient identification

prior to the collection.

o Three identifiers must be used on the request form and where practical on the specimen container. The

3 identifiers must be the patient’s full name and date of birth and address or medical record number.

o The patients full name and either date of birth or medical record number must be on the specimen

collection label, as a minimum requirement (with the exception of Blood Bank specimens which require

additional information)

o Where a sample requires de-identification (Examples – patients from Jails, Staff Health) only then the

unique patient identification code given, will be used to replace the patients’ “full name”.




Electronic Ordering will apply to many, but not all pathology tests collected for Inpatients and Emergency

Department Patients using Cerner Millennium.

PathNet Accessions labels will be used as the primary patient identifier on the collection containers where

available (Western Sydney LHD, Nepean Blue Mountains LHD), and where it is deemed appropriate in accordance

with this policy, or else, the specimens should be hand labelled in accordance with this policy (Southern,

Murrumbidgee, Western NSW and Far West LHDs) and submitted with an electronic pathology request form.

If patient demographic labels are used, they must comply with RMPS.

o Where PathNet Accession Labels are used, the PathNet “lead” label must include handwritten

information of the Collector’s Employee’s Number (Millennium Username) and the actual date and time

of collection.

o Where electronic pathology request forms are used, the request form must include handwritten

information of the Collector’s Employee’s Number (Millennium Username) and the actual date and time

of collection.

o Where a Collector does not have a Millennium username or employee number (I.e. agency staff) then

the Collectors full name must be handwritten for identification purposes.

Pathology orders for Blood Bank procedures will be able to be placed electronically, but will always generate a

separate electronic pathology request form, and must be appropriately witnessed. Blood Bank samples should be

handwritten with correct and identical Patient information on both request form and blood tube.

Electronic Ordering will NOT apply to any Anatomical Pathology or Cytology tests requested in Western Sydney

LHD, Nepean Blue Mountains LHD. These will continue to require paper based pathology request forms.

Electronic Ordering is possible for any Anatomical Pathology or Cytology tests requested in Southern,

Murrumbidgee, Western NSW and Far West LHDs

Where Patient identity is in doubt and/or specimens do not comply with mandatory requirements for labelling,

according to the following procedure, these will qualify as rejections and a repeat specimen must be collected

and forwarded to the Pathology if the test is required.

Pathology’s Specimen Reception Management accept that there will be the need to apply some discretion to the

enforcement of the requirement for recollection where Patient Identity is in doubt and/or specimens do not

comply with mandatory requirements for labelling for certain specimen types which are difficult to recollect and

in certain clinical settings e.g. CSFs, tissue and cellular samples

Audits will be conducted in Specimen Reception Management on all rejected samples, together with the reasons

for them, which will monitor the effectiveness of the Acceptance & Rejection policy.

8 Procedures

8.1 - Legal Requirements for Pathology Orders – Electronic and/or Manual Forms

The following standards and statutory requirements apply to the collection and identification of pathology samples. International standard – ISO 15189:2013 requirements for Pathology Requisitions states:

5.4 Pre-examination processes

5.4.3 Request form information The request form or an electronic equivalent shall allow space for the inclusion of, but not be limited to, the following:

a) patient identification, including gender, date of birth, and the location/contact details of the patient and a unique identifier;




b) name or other unique identifier of clinician, health care provider, or other person legally authorised to request examinations or use medical information, together with the destination for the report and contact details;

c) type of primary sample and where relevant, the anatomic site of origin; d) examinations requested; e) clinically relevant information about the patient and the request, for examination

performance and result interpretation purposes; f) date and, where relevant, time of primary sample collection;

5.4.6 Sample reception The laboratory’s procedure for sample reception shall ensure that the following conditions are met.

a) Samples are unequivocally traceable, by request and labelling, to an identified patient or site.

b) Laboratory-developed and documented criteria for acceptance or rejection of samples applied.

NPAAC: Requirements for Pathology laboratories (2007)

5. Collection procedures C5.1 (a) The laboratory must ensure the integrity of the specimen appropriate to the proposed testing. C5.2 Recording of relevant information regarding the specimen is required, for example:

a) Date and time of collection b) Anatomical site of the specimen c) Person performing the collection d) Clinical status

NPAAC Guidelines: for Approved Pathology Collection Centres (2012)

5. – Collection Procedures C5.1 (a) Three identifiers must be used on the request form and where practical on the specimen container. The 3 identifiers must be the patient’s full name and date of birth and address or medical record number.

C5.1 (b) The patient’s full name and either date of birth or medical record number must be on the specimen collection label, as minimum requirements

NPAAC: Requirements for Medical Pathology Services (2013) CA6.2 (i) – Where there are several different identifiers for the one patient (e.g. baby of…, unknown patients, change of maiden to married name, multiple medical record numbers), there must be a policy relating to the merging or linkage of data.

CA6.3 (iii). – When labelling the patient’s Specimen, three identifiers should be used where practical (two must be used if three cannot be accommodated).

CA6.5 – In order to minimise risk to patients, the staff should endeavour to obtain the relevant details during the pre-analytical phase by advising and educating requesting practitioners about the importance of providing necessary information.




8.2 – Placing a Pathology Order Using Electronic Ordering – Acceptance Criteria

8.2.1 Placing a Pathology Order with Pathology Identification Labels (Accession Labels)

This is applicable to electronic orders placed in Western Sydney LHD, and Nepean Blue Mountains LHD.

With the implementation of electronic ordering for most pathology tests, when an order is placed electronically to be collected by clinical staff, a PathNet Millennium Accession (Bar Code) Label will be generated from a printer in the ward vicinity. This label is similar to a patient demographic label, but in addition to patient details, includes information specific to the pathology tests ordered and a bar code with a laboratory identification number, tests ordered and collection container requirements. There will be a “Lead” Label with patient demographic information and the requested date and time of collection, in addition to one label for each container required, which will minimise the problems of both excessive and insufficient collections by staff.

Electronic orders must be placed before collection of any samples, in order that the correct container type and number of tubes are collected. Positive patient identification is the responsibility of the person collecting the samples. In addition to the PathNet Millennium label, the Collector of the sample must handwrite legibly the following information on the lead label:

o Collector Identification – Millennium Username if current or Surname, First Name o Date of collection o Time of collection, using a 24hr clock (e.g. 1700hrs not 5pm)

The additional handwritten information is required for tracking purposes of the specimens and to meet legal requirements.

8.2.1.1 Labelling of Pathology specimens:

Labelling is to be performed after collection of the pathology specimen (not before) at the bedside. Label the specimen tubes by placing the PathNet Millennium label in the correct position on the sample container:

o Place label directly under the cap o Patient name on top o Label must be attached so that the barcode is straight o Leave a visible window to see the blood / sample o Leave some of the tube label available to write on if required

The label on the tube must be positioned correctly to support the instrument reading (on the pathology analysers). This will avoid rework by Pathology or rejection of the specimens. The diagram below provides guidance on appropriate and inappropriate labelling.




8.2.2.1 The diagram below shows - HOW THE LABEL SHOULD BE POSITIONED ON THE TUBE CORRECTLY.




Labelling Blood Culture Bottles:

Labelling is to be performed after collection of the blood specimens. Label the Blood Culture (BC) bottles by placing the PathNet Millennium label in the correct position on the sample container:

o Place label directly over the allocated space provided for labelling o Make certain the labels do NOT obscure the bar code and adjacent sequence

number on the original BC bottle o Label must be attached so that the barcode is straight o Patient demographic labels may be used for the patient instead of handwritten

information. o Leave some of the tube label available to write on if required

The label on the tube must be positioned correctly to support the instrument reading (on the pathology analysers). This will avoid rework by Pathology or rejection of the specimens. The diagram below provides guidance on correct labelling.

8.2.2.1 Labelling paediatric microtainer tubes:

When labelling this tube with a Millennium label, do not discard the backing paper from the label. Peel half of the label from the backing paper and place the paediatric tube in-between the backing paper and the adhesive side of the label. The barcode should be horizontal across the tube. The diagram below shows how the label should be positioned correctly on the paediatric microtainer tubes.




8.2.3.1 Labelling blood gas syringes:

When labelling the syringe with a Millennium label, place the label with the barcode lengthways down the length of the syringe. The diagram below shows how the label should be positioned correctly on the blood gas syringe. In addition to the PathNet Millennium label, the Collector of the sample must handwrite legibly the following information on to the Lead label:

o Collector Identification – Millennium Username if current or name of Collector if Millennium Username not current including Surname, First Name

o Date of collection o Time of collection, using a 24hr clock (e.g. 1700hrs not 5pm)

The additional handwritten information is required for tracking purposes of the specimens and to meet legal requirements.

8.2.4.1 Label reprinting

If you experience problems with the printing of labels contact the Helpdesk on – 1800 285 533 If you require reprinting of labels you must contact the laboratory who will be able to do a label reprint for you.

8.2.2 - Placing a Pathology Order with Electronic Pathology Request Form

This is applicable to electronic orders placed in Southern, Murrumbidgee, Western NSW and Far West LHDs.

When an electronic order is placed, an electronic pathology request form will be generated and labelling of tubes / containers should be handwritten. Refer to Section 8.3.1 – Hand labelling specimens

8.3 - Placing a Pathology Order Using a Paper Request Form – Acceptance Criteria

Handwritten Paper Requests will continue to be required for the following: o Outpatients pathology requests.

o All requests for Anatomical Pathology and Cytology (Western Sydney LHD, and Nepean Blue

Mountains LHD only)

o Downtime

o For any locations not using electronic orders

Three patient identifiers, as a minimum requirement must be placed on the request form, either by sticking a patient’s demographic label or by handwriting the following information on the form –

1. Patient’s full name

2. Patient’s date of birth and

3. Patient’s home address or medical record number.




8.3.1 Hand labelling specimens

Labelling is to be performed after collection of the pathology specimen. Do not pre-label any tubes. Label the blood tubes by writing the following patient information on each tube / container with an indelible marker and print clearly:

o First name o Second name o Date of birth and/or MRN (if applicable)

These are minimum requirements for labelling blood tubes with the exception of Blood Bank samples – Refer to 8.5 – Blood Bank Specimens – Acceptance Criteria Patient demographic labels are accepted on specimen containers, jars and swabs but must include the date and time of collection and the Collectors name / initials.

8.4 - Correct Patient Identification Protocols

IT IS ABSOLUTELY MANDATORY THAT YOU COLLECT THE BLOOD SPECIMEN FROM THE CORRECT PATIENT. Check ward listings for correct room and bed number of the patient, as some patients may be transferred within or out of the ward. Beware of similar / same names. Always ask the patients: “Can you please tell me your full name and date of birth”. Never ask: “Are you Mrs Jones?” Check the details the patient has given you with the patient’s – identification band (inpatients) for full name (first and second), DOB, Medical Record Number (MRN), and then check that they are identical to those appearing on the PathNet Millennium label and / or request form. If an inpatient is not wearing an identification band for a particular reason, then the Collector must check the patient’s full details including the correct MRN with a nurse / staff member to confirm correct patient identification is established. If the patient is unable to identify him or herself with certainty, the patient may be confused, unconscious or not understand the English language, have the nurse/relative positively identify the patient. If any patient details are incorrect they must be corrected with Health Information and Record Service, prior to the collection of any specimens. New labels will need to be generated with the correct details. Discard the incorrect labels, and remember to cancel the tests in Millennium. After the blood collection, show the patient the collected blood tubes that have been labelled in their presence for confirmation of their name and MRN on the labels. If the patient is unable to visualise the specimens, DOUBLE CHECK YOURSELF. IDENTIFICATION IS YOUR RESPONSIBILITY. You, and only you, can make sure the right person’s blood is in the correctly labelled tube(s) that you send to the laboratory. Remember that if using electronic orders, without a paper request form, Pathology have no cross checking mechanism to validate the correct patient collection. Pathology will rely solely on the Collector to positively identify the patient and label the collection tubes appropriately and correctly. If correct patient identification cannot be performed, do NOT proceed with any collection procedures.




8.5 - Blood Bank Specimens – Acceptance Criteria

Blood Bank tests can be ordered electronically and this will generate an electronic pathology request with provision for both the Collector and Witness signatures. The patient must be positively identified.

All relevant patient information should be handwritten on the tube. It is strongly recommended that pre-printed labels are not to be used. The use of printed patient demographic labels placed on the blood tubes should be discouraged, but if used, they need to comply with the inclusion of handwritten labelling detailing the Collector’s name / initial.

Specimen tube labelling requirements are: Patients first and second Name MRN and/or Date of Birth * For Non Hospital / External patients with no MRN – Date of Birth only Time of collection Date of collection Collector must sign or initial all tubes for Blood Banking procedures

Tubes must be labelled after the blood has been collected and in the presence of the patient and witness. Use an indelible marker and print clearly. Do not pre-label tubes, as this may lead to errors in patient identification and is contrary to the above procedure. Blood transfusion request form instructions are to be followed.

Specimens will be rejected, unless clearly identified with the correct patient information. The blood tubes must be clearly labelled and the information on the tubes, the Transfusion request form and the patient’s wristbands must be identical.

The request form must have BOTH the Collectors and Witness signatures on the form. If either of both signatures is absent, the specimen will be rejected and require recollection with a new blood sample and request form.

8.6 - Anatomical Pathology and Cytology Requests – Acceptance Criteria

Anatomical Pathology request includes orders for Surgical Histopathology, Tissue Biopsies and Electron Microscopy. Cytology request includes gynaecological and non- gynaecological procedures. All requests for Anatomical Pathology and Cytology must have as a minimum, the following information:

Patient’s medical record number

Patient’s first and second name

Patient’s date of birth

Patient’s home address

Test requested

Clinical information

Doctors name, signature and contact details and where possible, the Consultant responsible for the patient

Referring hospital / laboratory (where applicable)

Specimen collection date

Specimen collection time

ID of the “Collector”

Nature of sample; e.g. ® frontal skin lesion (histo)

Patient demographic labels may be used for the patient information (as above) instead of handwritten information.




8.7 - Specimen Rejection Criteria

8.7.1 Unlabelled specimens

In the event of an unlabelled specimen being received in the laboratory, the sample will be entered into PathNet Millennium, and then cancelled as “specimen received unlabelled”. This information is used for tracking to indicate that the sample was initially received and also to indicate the reason for sample rejection and legal purposes.

The relevant staff involved in the original request/collection of the specimen will be notified by either the Specimen Reception Management or PW staff. A recollection will be requested. The recollected specimens will be entered in PathNet as a new collection.

There are limited exceptions, for example, tissue and CSF specimens. Unlabelled exception specimens will be entered in PathNet. The Medical Officer or delegate will be notified that he/she needs to attend Laboratory to label the specimens. PW is unable to accept responsibility for the clinical use of results from unlabelled specimens.

8.7.2 Specimen ID Major Mismatch

Whenever the information or identification of specimens and/or request forms does not match, a recollection will be requested. e.g.

Totally incorrect names (James Forman instead of Emily Saunders) Incorrect MRN (0076453 instead of 9886534)

There are limited exceptions, for example, tissue and CSF specimens. Non-matching exception specimens will be entered in PathNet. The Medical Officer or delegate will be notified that he/she needs to attend Laboratory to label / correct the specimen. PW is unable to accept responsibility for the clinical use of results originating from mismatched specimens.

8.7.3 Insufficient specimen identification -

In the event a sample with an accompanying request form is received with a minor discrepancy e.g. Minor spelling error ( Kalie instead of Kaylie, Moffat instead of Moffet) Digit error (0287456 instead of 0287465) Patient alias name used (Maiden name written on form but married name on Medicare card)

There must be a minimum of 2 other patient identifiers that are correct and identical between the patient identifiers on the request form and the labelled specimen. If there are not another 2 patient identifiers present on the sample, accurate identification cannot be performed and therefore the sample should be rejected. There are limited exceptions, for example, tissue and CSF specimens. Non-matching exception specimens will be entered in PathNet. The Medical Officer or delegate will be notified that he/she needs to attend Laboratory to label the specimens.

PW is unable to accept responsibility for the clinical use of results originating from mismatched specimens.




8.7.4 Blood Bank – Unsigned Request Form.

In the event a sample is received with an inadequately signed blood bank request form, the sample will be rejected. Inadequately signed request form includes the omission of:

Collectors’ – signature, printed name, date and time Witness’ – signature, printed name, date and time Both Collector and Witness – signature, printed name, date and time

8.7.5 Blood Bank – Mislabelled specimens / forms.

There is NO acceptance of any mismatches either minor or major. The tube and request form must be identical. A recollection will be requested with a new accompanying request form.

8.7.6 Temporary MRNs and Blood Bank

If a patient presents to the Emergency Department and the iPM is not available (e.g. scheduled outage or access is delayed), a Temporary MRN can be used until the permanent MRN is issued. Temporary MRN’s are not a preferred choice as this MRN cannot merge with the permanent MRN and the Temporary MRN data will not be seen on the patient’s historical file. Cross matched blood can be issued with a Temporary MRN, under these circumstances. This policy only generally applies to hospitals that do not have 24hr availability of iPM and Pathology staff.

8.8 - Using a PathNet Millennium Accession Barcode label.

In the event that a sample is received and labelled with a PathNet Millennium Barcode Label where:

The Collector Identification (Millennium Username if current or Last name, First name) is not included on the lead label

The Actual Time/date of Collection are not included on the lead label

The Barcode Label does not comply with specifications for labelling of specimens Failure to include the Collector’s Millennium Employee ID, failure to include the actual Date/Time of Collection for routine samples types will qualify as rejections. Failure to include this information compromises LHD’s ability to meet mandatory requirements for pathology collections. Reminder - Blood Bank specimens should be handwritten.

8.9 – Cancellations

For any test that requires cancellation, notification by Pathology West staff to a Clinical staff will be given, together with the reason for the cancellation. This information will also be documented as a comment in Millennium.

In the event that a patient’s order is on a Pathology Collectors collection list, but the Dr can’t wait for the round, he/she needs to contact the Pathology Collection staff to notify them that they have collected the bloods themselves. This will eliminate the incidence of unnecessary patient recollections and duplicate processing.

8.10 – Risk Rating

The clinical risk of policy non-compliance is the potential misidentification of patients’ pathology specimens, which may potentially lead to patient clinical mismanagement, mortality or morbidity.




In addition, there will be a loss of ability to undertake full audit tracking of pathology collections in the case of investigation of adverse events related to patient identification. The business risk of policy non-compliance is that Pathology will not meet legal and statutory requirements for accreditation. These risks are considered unacceptable within Pathology West and the Local Health Districts.

8.11 – Educational Notes

It is the responsibility of the person collecting the pathology samples to positively identify the patient at the time of collection and to label the specimens collected appropriately.

9 References and related documents

International Standard: AS ISO 15189 – Australian Standard Medical laboratories – Particular requirements for quality and competence

The Australian and New Zealand Society of Blood Transfusion Ltd. Guidelines for Pre-transfusion Laboratory

Practices (2007) NPAAC Requirements for Transfusion Laboratory Practice (Second Edition 2013)

NPAAC Requirements for Pathology Laboratories (2007)

NPAAC Guidelines for Approved Pathology Collection Centres (2012)

NPAAC Requirements for Medical Pathology Services (2013)

NATA Medical Testing Field Application Document

10 Glossary of terms/abbreviations

The following terms/abbreviations have been used in this policy:

Term/Abbreviation Definition

Cerner Millennium The suite of Clinical Information Applications in which patient information and clinical interactions are recorded, including PathNet (Laboratory Information System) and FirstNet (Emergency Medicine Information System).

Clinical Staff Any Medical or Nursing staff authorised to place pathology orders electronically in the LHD’s.

Electronic Medical Record (EMR)

The electronic repository of patient’s clinical information

LHD Local Health District

LHD Staff For the purpose of this policy LHD Staff refers to any person working in a permanent, temporary, casual, termed appointment or honorary capacity within the various Local Health districts

Medical Record number (MRN)

A unique identifier assigned to each patient within each facility of the LHD’s.

NATA National Association of Testing Authorities, Australia

NPAAC National Pathology Accreditation Advisory Council

PW Pathology West

RMPS Requirements for Medical Pathology Services

SW, GW & GS Sydney West, Greater West & Greater Southern




11 Version history

Date Version Change details Author

23/03/10 2 x original documents –

1) Pathology Specimen labelling, Acceptance , Rejection and Cancellation Policy

2) Pathology Specimen Labelling Procedures

Michelle Hecimovic

22/11/13 1.0 Combination of 2 previous documents

Addition of –

- Policy details for the labelling of “de-identified” patients

- Placing electronic orders in GW & GS

- Labelling Blood culture bottles

- References and related documents

Michelle Hecimovic

21/5/14 1.1 - Reference to acceptance of blood tubes labelled with patient demographic labels with handwritten date/time of collection and Collectors’ name/initials

- Reference to updated NPAAC Requirements for Transfusion Laboratory Practice (2013)

Michelle Hecimovic

18/6/14 1.2 Clarification of minimal labelling requirements 8.3.1 Michelle Hecimovic

Policy and Procedure: Pathology Specimen Labelling ...

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