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.
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