Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download TGLclinical User Guide
Document related concepts
no text concepts found
Transcript
TGL_Q_21_User_Guide TGLclinical User Guide The Institute of Cancer Research Brookes Lawley Building 15 Cotswold Road Sutton, Surrey SM2 5NG Page 1 of 7 Author: Ann Strydom Version number: 4.0 Authorised by: Rachel Linger Review date: 08/12/2015 Issue date: 08/12/2014 TGL_Q_21_User_Guide TGLclinical This document describes the services provided by TGLclinical to internal and external users. The laboratory is situated in the Brookes Lawley Building, on the Sutton campus of the Institute of Cancer Research (ICR). TGLclinical provide a molecular diagnostic service for germline mutation analysis of genes that confer a predisposition to cancer. Uniquely TGLclinical provides an integrated laboratory and clinical interpretation service utilising expertise based at ICR and RMH to test for and interpret germline variation in cancer predisposition genes to aid and inform clinical management decisions. Staff list: Laboratory Director: Consultant Clinical Geneticists: Professor Nazneen Rahman Dr. Clare Turnbull Dr. Helen Hanson Dr. Angela George Clinical and Research Scientists: Victoria Cloke* Sheila Seal Dr. Shazia Mahamdallie Rachel Linger Dr. Sandra Hanks Scientific Officers: Ben Coupland Silvana Powell Emma Ramsay Imran Uddin Harriet Wylie Database Manager: Anna Elliott Statistician / Bioinformaticians: Elise Ruark Matthew Clarke Operational Manager: Ann Strydom * Quality Manager Page 2 of 7 Author: Ann Strydom Version number: 4.0 Authorised by: Rachel Linger Review date: 08/12/2015 Issue date: 08/12/2014 TGL_Q_21_User_Guide Contact details: Laboratory contact: email: [email protected] or or rmh‐[email protected] Phone: 02087224122 Postal address: TGLclinical laboratory Brookes Lawley Building The Institute of Cancer Research 15 Cotswold Road Sutton, Surrey SM2 5NG Website www.tglclinical.com Hours of service: 9.00am to 5.00pm, Monday to Friday (excluding bank holidays). Out of hours service: No out of hours service is provided. Samples received after 5.00pm will be processed the following working day. Instructions for completion of the request form: Please fill ALL the fields provided with the relevant demographic/clinical information. For patient details, stickers with the patient’s information can be used. Similarly, stickers can be used for the Consultant and referring hospital information. If some information is unknown or not applicable please fill the field in with “UNKNOWN” and “N/A”, respectively, rather that leaving it blank. Samples with attached request forms that do not contain all the relevant information can be rejected by the lab or put “on hold” until a new and completely filled request form has been received. Clinical details, required investigations and family history should be filled in where possible. If in doubt please contact us on the laboratory email or numbers given above. Page 3 of 7 Author: Ann Strydom Version number: 4.0 Authorised by: Rachel Linger Review date: 08/12/2015 Issue date: 08/12/2014 TGL_Q_21_User_Guide Consent: Upon receipt of samples, the laboratory assumes that appropriate consent has been obtained by the referring clinician. Laboratory repertoire Hereditary breast and ovarian cancer: BRCA1 and BRCA2 full gene test Target Turnaround times: 42 calendar days. (UK National target: 56 calendar days) BRCA1 and BRCA2 Ashkenazi founder mutation test BRCA1 specific mutation test BRCA2 specific mutation test Target Turnaround times: 14 calendar days for urgent tests. (UK national target: 14 calendar days) 28 calendar days for non‐urgent tests (UK national target: 28 calendar days) Specific mutation testing for other cancer predisposition genes (i.e. of a known mutation that has been identified in a relative or a research study): Target Turnaround times: 14 calendar days for urgent tests. (UK national target: 14 calendar days) 28 calendar days for non‐urgent tests (UK national target: 28 calendar days) Cancer predisposition gene tests not performed by TGLclinical: When requests are received for cancer predisposition gene tests not offered by TGLclinical we will arrange testing by external providers. These providers will have Clinical Pathology Accreditation (CPA), and may also have accreditation to the internationally recognised standard ISO15189:2012. When the results are received by TGLclinical, they are forwarded to the referring clinician with a clear indication as to the accreditation status of the external laboratory. Reporting times and accreditation status of the external labs are monitored by TGLclinical. Page 4 of 7 Author: Ann Strydom Version number: 4.0 Authorised by: Rachel Linger Review date: 08/12/2015 Issue date: 08/12/2014 TGL_Q_21_User_Guide DNA storage: We can store DNA from individuals for which no test is currently indicated, but for which it is considered possible that testing may be appropriate in the future. We do not store blood samples and thus if blood samples are received for storage the DNA is extracted and stored. Turnaround time standards TGLclinical strives to achieve the following standards: Full Gene Screens Specific Mutation Testing 100% within 56 calendar days 90% urgent tests within 14 calendar days (UK National target turnaround time) (UK National target turnaround time) 95% within 42 calendar days 90% non‐urgent tests within 28 calendar (TGLclinical target turnaround time) days (UK National target turnaround time) Reporting of service and standards Where TGLclinical undertakes more than 10 tests per month for any individual institution a monthly report will be provided within the first seven working days of the following month, which will include the following information: Number of tests Test type Referring department and/or clinician Average turnaround times per test type Page 5 of 7 Author: Ann Strydom Version number: 4.0 Authorised by: Rachel Linger Review date: 08/12/2015 Issue date: 08/12/2014 TGL_Q_21_User_Guide Specimens required: Please send 2 x 9mls of blood in PLASTIC EDTA tubes. Smaller volumes, for example from children, can be extracted if necessary, but we require a minimum of 2mls. Samples should be sent on the day of collection and at ambient temperature. DNA samples can also be received. We strongly prefer to receive blood samples but if this is not possible, please contact the lab to discuss sending a saliva sample. Unsuitable samples: Clotted samples are occasionally unsuitable for molecular analysis, where possible the referring clinician will be informed and a new sample requested. Samples should be labelled with the patient first name and surname, D.O.B., hospital number and the date and time the sample was taken. The details on the sample tube must correspond to those on the request form. At least two unique identifiers are required. Unidentifiable/Unlabelled samples will NOT be accepted. Where possible the referring clinician will be informed and a new sample requested. Please note that all DNA samples are stored indefinitely unless otherwise requested. Transportation of samples: Internal samples will be sent together with the request form from the phlebotomy unit to the Royal Marsden Hospital Central Pathology Department at the Sutton site, or can be delivered to TGLclinical pigeon hole at BLB reception. Samples should be dispatched as soon as possible after taking the sample. In the case of samples sent from the Chelsea site, they will be transported in the pathology containers on the RMH inter‐site coach, to be delivered to the RMH Central Pathology. Samples will be then collected from the RMH Central Pathology and the BLB pigeon hole by laboratory staff. See HSE guidance on http://www.hse.gov.uk/biosafety/biologagents.pdf Blood and DNA samples from external users should be sent by first class mail, please address specimens to the TGLclinical postal address given above. Any diagnostic sample sent to the laboratory should be sent in accordance with the UN3373 regulations and the P650 Packaging instruction (http://www.un3373.com/info/regulations). Page 6 of 7 Author: Ann Strydom Version number: 4.0 Authorised by: Rachel Linger Review date: 08/12/2015 Issue date: 08/12/2014 TGL_Q_21_User_Guide Data protection: TGLclinical ensures secure and safeguarded storage of patient information and compliance with the Data Protection Act. Charges for tests: TGLclinical will provide notice of any charge in advance of any service being undertaken. Receipt of a test request by TGLclinical will be considered an agreement of that charge. Any changes in charges will be notified 3 months in advance of the change being effected. Queries and Complaints procedure: Any questions about test methodology, interpretation of the results or complaints should be notified by email [email protected], phone 02087224122 or by post to: TGLclinical laboratory Brookes Lawley Building The Institute of Cancer Research 15 Cotswold Road Sutton, Surrey SM2 5NG Queries will be responded to as soon as possible. Complaints will be acknowledged as being received within two working days. Feedback will be provided within seven working days and will include a timeline and process for more detailed consideration of the complaint if necessary. Page 7 of 7 Author: Ann Strydom Version number: 4.0 Authorised by: Rachel Linger Review date: 08/12/2015 Issue date: 08/12/2014
