Specimen Reception and Rejection Policy.

PATHOLOGY DIRECTORATE
THE ROYAL WOLVERHAMPTON NHS TRUST
SPECIMEN RECEPTION AND REJECTION
POLICY
E5.001P.PAT
Printed copies of this document are for reference purposes only. The electronic copy must
be used as the current version, which is maintained on Q-pulse.
Version
9.0
Date issued
January 2015
Review interval
Biennial
Authorised copy sign
and date
Pathology Directorate Team
Author
Quality Manager, Katy New
Location of printed
copies
Quality Manager Office
Number of pages
including the front page
11
Document number: E5.001P.PAT
Author:
K New
Approved:
Directorate Management Team
Page:
Review Date:
Version:
1 of 11
January 2017
9.0
This is a controlled document; all authorised printed copies must be bound, signed, dated and have footer details printed in red. Any
single sheets printed from this document must be signed by the author or approver and dated. Any copies not meeting these criteria are
not valid and must be discarded.
Contents
Section
1
1.1
1.2
2
2.1
Table 1
2.2
2.3
2.4
3
3.1
3.2
3.3
4
4.1
Table 2
4.2
5
5.1
5.2
Title
Introduction
References and related documents
Responsibilities
Request form
Request information and specimen details required
Acceptance criteria
Urgent requests
Labelling for danger of infection
Labelling for cytotoxic drugs
Reception
Electronic request
Manual request
Urgent request
Rejection of specimens
Reporting a rejected specimen
Summary of ZIP/ ZAP comments
Audit
Non compliant requests in Cellular Pathology
Histopathology
Cytology
Document number: E5.001P.PAT
Author:
K New
Approved:
Directorate Management Team
Page:
Review Date:
Version:
Page No
3
3
3
4
4
5
6
6
6
6
7
7
7
7
8
9
10
10
10
11
2 of 11
January 2017
9.0
This is a controlled document; all authorised printed copies must be bound, signed, dated and have footer details printed in red. Any
single sheets printed from this document must be signed by the author or approver and dated. Any copies not meeting these criteria are
not valid and must be discarded.
1.0
Introduction
The Pathology Directorate frequently receives specimens that are unlabelled, request forms
or specimens with details that are either illegible or with insufficient information to carry out
the investigation, and sometimes specimens with identification details that do not match
those on the request form. Under Clinical Governance the Pathology Directorate has a duty
of care to ensure that the results from specimens processed match the source patient and
that investigations carried out are clinically relevant. Accurate identification of the source
patient from whom the specimen is taken is essential. Therefore, to prevent an adverse
event consequent to the receipt of these requests the following protocol has been adopted
for the acceptance and rejection of pathology requests.
It should be recognised that any specimen is potentially infectious and it is therefore
necessary to ensure that all specimens are safely contained and transported from the
patient to the laboratory [E4.001P.PAT]. If a specimen is known to be high risk then it is
also important to label it in such a way that pathology staff can easily identify it and are
thereby able to take the appropriate precautions.
These guidelines provide an overview of the requirements for reception, labelling and
rejection of specimens and requests and are designed to meet the requirements of ISO
15189: 2012.
1.1
References and related documents
Clinical Pathology Accreditation (UK) Ltd- Standards for the medical laboratory
ISO 15189: 2012 Medical laboratories- Requirements for quality and competence
Institute of Biomedical Sciences- Patient sample and request form identification criteria.
https://www.ibms.org/includes/act_download.php?download=ibms-patient-sample.pdf
Other related documents include [E5.002P.PAT, D2.001P.PAT, E5.076P.CHE,
E3.C021P.CYT and E3.C022P.CYT]
Pathology website http://www.royalwolverhamptonhospitals.nhs.uk/pathology_services/
RWT CP50 Policy for the Management of Risks associated with Clinical Diagnostic tests
and Screening
RWT policy CP08 Cytotoxic drugs
1.2
Responsibility
It is the policy of the Pathology Directorate to ensure that all requests processed comply
with the recommended guidelines on identification and supplementary information [Institute
of Biomedical Sciences- Patient sample and request form identification criteria]. The
Pathology Directorate takes responsibility for all samples received.
The responsibility for requesting a pathology investigation lies with an authorised and
trained practitioner (normally a clinician). It is the responsibility of the requester to ensure
that samples are correctly labelled and request forms are completed to agreed standards.
Up to date information for users in order to facilitate proper use of pathology services is
available on the pathology website (link to Lab Tests online provided). The information
Document number: E5.001P.PAT
Author:
K New
Approved:
Directorate Management Team
Page:
Review Date:
Version:
3 of 11
January 2017
9.0
This is a controlled document; all authorised printed copies must be bound, signed, dated and have footer details printed in red. Any
single sheets printed from this document must be signed by the author or approver and dated. Any copies not meeting these criteria are
not valid and must be discarded.
includes instructions for specimen handling and completion of the request form and
guidance for collecting samples.
If a request fails to meet the essential guidelines on identification then the request may not
be processed.
2.0
Request form
Pathology requests can be made using an electronic requesting system (e-Requesting) via
TDweb or ideagen, which is directly linked to the pathology laboratory computer system (TD
Synergy). Requests can also be made using a paper request form (manual method).
Access to e-Requesting for the purpose of making requests and receiving reports requires
approval of the user and the issuing of a personal login and password. In the case of
electronic requests patient identification details are obtained from the RWT patient
administration system (PAS). e-Requesting should be used as the primary requesting
method, with exception of blood transfusion requests which are made using a transfusion
request form.
The design and development of pathology request forms (paper and electronic versions)
must be controlled through Q-pulse and cannot be released without prior approval.
Amendments are made by the RWT Medical Illustrations department via pathology who
require approval from the Pathology Directorate. The Quality Manager is authorised to
approve request forms on behalf of the directorate.
All requests must be accompanied by a completed request form. Instructions for the
completion of the requests form are contained on the website.
Some specific tests require discussion with the appropriate Pathology Clinician and their
agreement prior to the sample being taken to ensure efficient patient management e.g. TB
spot.
Verbal requests for tests (add-ons) are accepted for samples that have already been
transported or accepted by the laboratory. Verbal requests must only be made be
personnel authorised to request such tests. These requests are only processed if the
sample is still suitable for testing; information regarding the time interval for requesting addons is available on the pathology test database where appropriate. The test requested
verbally must be recorded in TD synergy as an ‘add-on’ test; clearly identifying it as a
verbally requested test.
In the event of electronic requesting being unavailable, the reverse of the carrier form can
be used to manually request pathology investigations.
In the event of a major incident the RWT major incident identification numbering system
must be used in place of the NHS or Hospital number. Further guidance is available in
[F2.001P.PAT].
2.1
Request information and specimen details required
Request and specimen details are categorised into essential and desirable information as
shown in table 1. The NHS number should be used as the primary identifier. Requests that
do not comply with the guidelines for essential information may not be processed, refer to
rejected samples.
Document number: E5.001P.PAT
Author:
K New
Approved:
Directorate Management Team
Page:
Review Date:
Version:
4 of 11
January 2017
9.0
This is a controlled document; all authorised printed copies must be bound, signed, dated and have footer details printed in red. Any
single sheets printed from this document must be signed by the author or approver and dated. Any copies not meeting these criteria are
not valid and must be discarded.
Table 1 Acceptance criteria
Please refer to the following table before filling in a sample request form
Essential
SAMPLE
1 Patient’s Surname*
2 Patient’s forename
3 NHS Number or
4 Hospital number or Date of birth
5 Date and time of collection
6 Nature of sample e.g. left distal etc
6 Phlebotomist’s initials
REQUEST FORM
1 Patient’s Surname*
2 Patient’s forename
3 NHS Number or
Hospital number or Date of birth
4
5
6
7
8
9
10
11
12
13
14
15
16
6
Patient’s address
Destination for report
Patient’s consultant or GP
Clinical information
Date and Time sample collected
Patient’s gender
Signature of requesting clinician
Clinician’s bleep number or contact
number
Signature of person taking the blood
Previous transfusion history
Previous results of group and
antibody screen
Type of sample/ investigation
required
Patients LMP if appropriate
Phlebotomist’s stamp or initials

Desirable **
Blood
transfusion
Mandatory







sometimes
essential dependent
on investigation
required








 sometimes
essential dependent
on investigation
required





both DoB and
Hospital number
essential












Essential
for
cytology


*
**
or proper coded identifier e.g. GUM number
Gynae Cytology require full name, NHS number, date of birth, test date, signature
and PIN of requesting clinician on request form. Request form must be date
stamped upon receipt.
Please ensure that all details are legible and correct before sending the samples to
Pathology.
IMPACT OF NOT COMPLYING: Failure to provide essential / mandatory details will lead to
the request being rejected; this may represent a risk to the patient and may compromise
their safety. Non-repeatable specimens which do not comply with this guidance must be
verified by the requesting practitioner. For urgent samples which do not comply with this
guidance may be analysed at the discretion of the senior BMS or above.
Document number: E5.001P.PAT
Author:
K New
Approved:
Directorate Management Team
Page:
Review Date:
Version:
5 of 11
January 2017
9.0
This is a controlled document; all authorised printed copies must be bound, signed, dated and have footer details printed in red. Any
single sheets printed from this document must be signed by the author or approver and dated. Any copies not meeting these criteria are
not valid and must be discarded.
2.2
Urgent requests
Urgent requests should be sent immediately to the Pathology Centre for analysis. Samples
should be easily identifiable as urgent to enable detection upon receipt by pathology
reception areas. Red specimen bags should be used and the request form should clearly
state which test is required urgently; currently green bags and yellow caps are also used to
indicate urgency, green bags are being phased out. Some investigations required urgently
require notice to be provided prior to the sample being taken or that it has been taken (outof-hours), refer to the pathology website for further details.
2.3
Labelling for danger of infection
It is the responsibility of the person who requests a laboratory test to ensure that both the
form and the container are correctly labelled to indicate danger of infection. Sufficient
clinical detail must be included on the request form to inform laboratory staff upon the
safety precautions they need to take in order to process the specimen without risk of
infection e.g. recent history of relevant foreign travel that may increase the likelihood of
exotic agents being present. Although the warning label must be clearly visible the clinical
information need not be conspicuous to other people.
Labels indicating a danger of infection must be used for specimens that are suspected of
containing a hazard group 3 or 4 pathogen. This includes labelling samples suspected of
HIV, Hepatitis, Mycobacterium species, Salmonella typhi or Neisseria meningitidis risk as
being a danger of infection. For further advice on group 3 or 4 pathogens, contact senior
staff in the Microbiology Department (01902 307999 ext. 8257).
If during patient intervention, further information becomes available that has implications for
the safety of laboratory staff then this must be communicated immediately to the laboratory
so that appropriate steps regarding containment can be taken.
Suitable labels are stocked by Central Stores stationery section; obtainable using the RWT
electronic ordering system (e Series). In keeping with international convention these labels
use black print on a yellow background.
The Pathology Directorate do not provide a diagnostic service for group 4 listed pathogens
or Rabies virus. If infection with a group 4 pathogen or Rabies virus is suspected the
clinician must inform the Duty Consultant/ Clinical Lead of the relevant laboratory before
attempting to take samples for pathology.
2.4
Labelling specimens that contain cytotoxic drugs
Refer to RWT policy CP08.
3.0
Reception
Only trained and competent pathology personnel such as Medical Laboratory Assistants or
Biomedical scientists should receive specimens in accordance with the laboratory’s safety
rules. All specimens labelled ‘High Risk’ or ‘Danger of Infection’ should be processed
according to the laboratory’s safety protocol.
At reception the specimen(s) received must be checked against the associated request
form; cytology samples are delivered to gynae preparation laboratory. For the majority of
Document number: E5.001P.PAT
Author:
K New
Approved:
Directorate Management Team
Page:
Review Date:
Version:
6 of 11
January 2017
9.0
This is a controlled document; all authorised printed copies must be bound, signed, dated and have footer details printed in red. Any
single sheets printed from this document must be signed by the author or approver and dated. Any copies not meeting these criteria are
not valid and must be discarded.
requests a specimen will be identified with both the patient’s full name or coded identifier
(the NHS number is to be used as the primary identifier) and either the hospital number or
date of birth. Greater stringency of identification is required for blood transfusion, refer to
Table 1.
3.1
Electronic request
Once checked, the specimen and the e-Request form must be accepted as received on the
laboratory computer system, TD Synergy. The e Requesting system shall create a unique
accession number that will identify the request and the associated sample(s)
[E5.002P.PAT].
3.2
Manual request
Once checked, paper request forms and associated specimens must be identified by
labelling with an appropriate laboratory barcode number. On data entry the patient’s
demographics and this identifier must be recorded in the laboratory computer system
[E5.002P.PAT]. This will create a unique accession number that will subsequently identify
the request and the associated sample(s).
3.3
Urgent requests
Urgent requests received should be accepted/ entered in TD Synergy and transferred to the
appropriate laboratory immediately for analysis. Due to the volume of work received in
Clinical Chemistry and Haematology a dedicated member of staff is responsible for
ensuring urgent work is prioritised; generally a Band 3 working on the ‘urgent bench’.
Urgent results should be reported as soon as possible and telephoned to the requestor (in
preference) or requesting location, if appropriate.
4.0
Rejection of specimens
Rejection of requests will be made in circumstances where there is a failure to provide
essential / mandatory details and the specimen is repeatable. This may represent a risk to
the patient and may compromise their safety.
Non-repeatable specimens or urgent samples which do not comply with this guidance may
be analysed at the discretion of the senior BMS or above. The report should show a clear
disclaimer detailing the shortcomings of the sample and/or request and alert the requestor
to take responsibility for the results and for any action taken as a result of the report.
It is expected that that there should be at least two identifiers on the specimen container
that match the request form e.g. surname and either the NHS number, hospital number or
date of birth. If there is doubt as to whether a specimen can be discarded advice must be
sought from a senior member of the laboratory staff. In the case of 24 hour urines, faecal
specimens and urine micro albumin these may be accepted with a full name only on the
container provided this matches the accompanying request form.
Specimens that are in a condition too hazardous to process will also be rejected.
Other stringent requirements may pertain to specific tests, such as time from collection to
receipt and specimens may be rejected on this basis, please see the pathology website for
further information.
Document number: E5.001P.PAT
Author:
K New
Approved:
Directorate Management Team
Page:
Review Date:
Version:
7 of 11
January 2017
9.0
This is a controlled document; all authorised printed copies must be bound, signed, dated and have footer details printed in red. Any
single sheets printed from this document must be signed by the author or approver and dated. Any copies not meeting these criteria are
not valid and must be discarded.
Recognised unique identifiers include the GUM, Walsall numbers and Snow Hill. In all these
cases it is the details missing on the request form that are being highlighted; the information
already on TD Synergy need not be considered.
4.1
Reporting a rejected request
When a request is determined to be rejected in accordance with this policy, the receiving
laboratory must issue a report which provides a comment giving the reason(s) why the
request fails to meet the recommended criteria. Standardised comments are to be used as
appropriate, if not applicable the misc. Comment code can be used to enable the entry of a
‘free text’ comment to be recorded. The standardised comments are reported using the
‘ZAP codes’ [E5.002P.PAT]. If the specimen is not examined it will be discarded.
If the request is processed a disclaimer comment will also be issued as part of the report;
these are referred to as ZIP codes [E5.002P.PAT]. Table 2 lists the comment codes used
by the Pathology Directorate. Departments may use additional codes particularly for preexamination comments; refer to departmental reception documents for further information.
Document number: E5.001P.PAT
Author:
K New
Approved:
Directorate Management Team
Page:
Review Date:
Version:
8 of 11
January 2017
9.0
This is a controlled document; all authorised printed copies must be bound, signed, dated and have footer details printed in red. Any
single sheets printed from this document must be signed by the author or approver and dated. Any copies not meeting these criteria are
not valid and must be discarded.
Table 2 Summary of ZIP ZAP comment codes
Processed non
The laboratory can not be held liable for any errors that may
compliant request
occur consequent to the processing of this sample for the
header comment
following reason:
Rejected non
compliant request
header comment
Code
To comply with Clinical Governance and the requirements of
ISO 15189, this request has not been processed for the
following reason:
Comment
.CLOT
Sample clotted - Unsuitable for testing
.HAZ
Hazard! Specimen leaked in transit because sample lid/top inadequately
tightened.
.MAT
Details on sample and request form DO NOT match.
.MISL
There is a problem with a sample accompanying this request because…
.NRQ
No request form received or no tests requested. Please contact the laboratory
within 3 days or you will only receive a U&E on serum tubes and FBC on any
EDTA tubes.
.NOS
No sample received with request form. Please repeat if clinically indicated.
.INAP
Inappropriate sample/ tube received for this test. For correct types please see
pathology test database
.NUM
Illegible or no NHS/Hospital number: Unique Identifier Required
GP requests please provide: NHS number, surname, forename and DoB.
Hospital requests please provide: NHS / Hospital number, surname, forename
and DoB.
Inappropriately identified requests may not be processed.
.INSS
Insufficient sample received to carry out this test. Please repeat if clinically
indicated
.INRQ
Insufficient details on request form. Please check to ensure patient details are correct
and all required tests are requested. Interpret results with caution. Please contact the
laboratory within 3 days if you require further tests
.ILRQ
Illegible details on request form.
.NPDS
No patient’s details on sample(s). Unsafe to process tests.
.ILLS
Illegible and/or information provided on sample container. Clearly provide Full
name, DoB and NHS or Hospital number.
.SDAT
The collection date for the specimen received is outside the acceptable period
for this investigation. Collected:
.DIFP
Details provided DO NOT match existing computer records.
.
Document number: E5.001P.PAT
Author:
K New
Approved:
Directorate Management Team
Page:
Review Date:
Version:
9 of 11
January 2017
9.0
This is a controlled document; all authorised printed copies must be bound, signed, dated and have footer details printed in red. Any
single sheets printed from this document must be signed by the author or approver and dated. Any copies not meeting these criteria are
not valid and must be discarded.
4.2
Audit
The Quality Manager conducts regular audits on compliance with the guidelines described
in Table 2 and the findings from these audits are made available to users. Further details of
rejections by location are provided to users upon request. Rejection rates are discussed at
the Pathology Directorate meeting. Where a particularly poor performer is identified these
should be notified directly.
5.0
Non-compliant requests in Cellular Pathology
5.1
Histology
If the details on the form and specimen do not match, then the specimen cannot be
entered onto TDHC. In the worst case scenario, the incident is error logged and the
specimen and form are returned to the sender with a covering note (if the sender has
come to the laboratory they can be told why the specimen is not being accepted). If
minor discrepancies are apparent then the advice of a BMS2 should be sought.
Generally, the minimum acceptance criteria required on the request form and sample to
enable positive identification is first name or initial, last name, date of birth or NHS
number or hospital number, address and sender.
In all cases there should be a request form for each specimen and all the details from both
should match.
Specimens can arrive in reception via four ways:
1)
2)
3)
4)
Transport
Post
From Theatre by nurse, doctor or porter
Andrology specimens from patients
If problems arise when specimens are brought in by a nurse, porter, patient (semen) or
doctor then the specimen should not be accepted, unless they are able to sanction the
necessary amendments.
In the other instances whereby specimens arrive via transport or post, several problems
can occur:
a)
b)
c)
Specimen or request form missing.
Information missing from form or pot.
Conflicting information between form and pot.
In the first instance contact should be made with the sender to inform them of the problem
and also to inform a BMS2. Sometimes it is necessary for the sender to come to the
laboratory to amend the form or specimen; sometimes as in the case of GP’s, information
can be given over the phone but in all cases, a note should be made on the back of the
request form about the action taken and people spoken to. In the case of a missing form or
pot, then this can be sent to the laboratory as soon as possible, again with a note made
about the action taken.
Advice from the BMS2 should always be sought about which route to follow.
Document number: E5.001P.PAT
Author:
K New
Approved:
Directorate Management Team
Page:
Review Date:
Version:
10 of 11
January 2017
9.0
This is a controlled document; all authorised printed copies must be bound, signed, dated and have footer details printed in red. Any
single sheets printed from this document must be signed by the author or approver and dated. Any copies not meeting these criteria are
not valid and must be discarded.
All serious errors need to be logged on DATIX and minor discrepancies can be entered as
an appropriate ZIP code on Technidata.
5.2
Cytology
All requests for cytology should include adequate patient and sample identity
information as outlined in Table 1. In the event of there being an error associated with a
cytology request, the cytology administrator creates a record of (major) errors in the
Histopathology TDHC LIMS which produces a letter that is forwarded to the relevant
sample taker. The cytology administrator maintains a log of cervical sample errors and
periodically passes this information to the screening lead at the call and recall centre at
the PCT.
5.2.1
Cervical Cytology [E3.C021P.CYT]
IMPORTANT - All cervical cytology samples must be taken by a fully trained and
authorised sample taker who will have been issued a valid smear taker PIN of the format
‘XNNN-AAnn’ where:
 X = Trained smear taker
 N = Numerals relating to practice/location code
 A = letters relating to smear taker identity
 n = numerals relating to smear taker identity
Any request that does not specify sample taker PIN and sample taker signature must be
referred to the cytology administrator who will follow the procedures in [E3.C021P.CYT].
Cytology follow guidance from the NHSCSP and local QARCs regarding specimen
rejection and do not routinely discard samples with discrepancies. Any sample and/or
request form that does not conform to the minimum or desired acceptance criteria listed
in Table 1 or has any other discrepancy should be referred to the cytology administrator
who will follow the procedures in [E3.C021P.CYT] with reference to the error codes in
table 2 above.
5.2.2 Non-cervical Cytology [E3.C022P.CYT]
Sample and request form information must be compatible. The essential information
required is outlined in Table 1 above.
When samples or request forms are received without the minimum essential or desirable
identification criteria stated above, or with any other discrepancy, the sample and
request should be referred to the cytology administrator or cytology BMS who will follow
the procedures in [E3.C022P.CYT] with reference to the error codes in table 2 above.
Document number: E5.001P.PAT
Author:
K New
Approved:
Directorate Management Team
Page:
Review Date:
Version:
11 of 11
January 2017
9.0
This is a controlled document; all authorised printed copies must be bound, signed, dated and have footer details printed in red. Any
single sheets printed from this document must be signed by the author or approver and dated. Any copies not meeting these criteria are
not valid and must be discarded.