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: 6.0
Authorised by: Rachel Linger
Review date: 04/08/2016
Issue date: 04/08/2015
Uncontrolled if printed
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:
Professor Nazneen Rahman
Consultant Clinical Geneticists:
Dr. Angela George
Clinical and Research Scientists:
Victoria Cloke*
Sheila Seal
Dr. Shazia Mahamdallie
Rachel Linger
Dr. Sandra Hanks
Scientific Officer:
Silvana Powell
Emma Ramsay
Imran Uddin
Harriet Wylie
Database Manager:
Anna Elliott
Statistician / Bioinformaticians:
Dr Elise Ruark
Matthew Clarke
Operational Manager:
Ann Strydom
* Quality Manager
Page 2 of 7
Author: Ann Strydom
Version number: 6.0
Authorised by: Rachel Linger
Review date: 04/08/2016
Issue date: 04/08/2015
Uncontrolled if printed
TGL_Q_21_User_Guide
Contact details:
Laboratory contact: email: tgl@icr.ac.uk
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.
Consent:
Upon receipt of samples, the laboratory assumes that appropriate consent has been
obtained by the referring clinician.
Page 3 of 7
Author: Ann Strydom
Version number: 6.0
Authorised by: Rachel Linger
Review date: 04/08/2016
Issue date: 04/08/2015
Uncontrolled if printed
TGL_Q_21_User_Guide
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)
(N.B. Urgent tests in TGLclinical are defined as testing in individuals affected with cancer, and
non-urgent tests are defined as testing in individuals unaffected with cancer)
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.
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.
Page 4 of 7
Author: Ann Strydom
Version number: 6.0
Authorised by: Rachel Linger
Review date: 04/08/2016
Issue date: 04/08/2015
Uncontrolled if printed
TGL_Q_21_User_Guide
Turnaround time standards
TGLclinical strives to achieve the following standards:
Full Gene Screens
100% within 56 calendar days
(UK National target turnaround time)
95% within 42 calendar days
(TGLclinical target turnaround time)
Specific Mutation Testing
90% urgent tests within 14 calendar days
(UK National target turnaround time)
90% non-urgent tests within 28 calendar
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 information on the number of tests, the test type, the referring
department and/or clinician, and the average turnaround times per test type
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/Broken samples will NOT be accepted. Where possible the
referring clinician will be informed and a new sample requested.
High risk blood samples (HIV, Hep B or C) received by TGLclinical must be indicated as
such both on the blood tubes and the request form. These samples cannot be
extracted by TGLclinical and so will be sent to an external provider for testing. This may
in-turn affect the turnaround time for that specific sample.
Please note that all DNA samples are stored indefinitely unless otherwise requested.
Page 5 of 7
Author: Ann Strydom
Version number: 6.0
Authorised by: Rachel Linger
Review date: 04/08/2016
Issue date: 04/08/2015
Uncontrolled if printed
TGL_Q_21_User_Guide
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 and transported to the lab contained inside an
opaque sample transportation bag. See the HSE guidance on biological agents
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). Failure to abide by these
regulations will result in the rejection of that sample by TGLclinical.
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.
Quality control:
All TGLclinical laboratory examination procedures that generate patient results include
appropriate quality control measures. The results of all quality control samples are evaluated
for every patient sample by an authorised member of staff prior to the release of the
relevant patient results.
If during an individual examination process a quality control result is deemed to have failed
and to invalidate patient results, then these patient results are repeated and are not
released without successful accompanying quality control results.
Page 6 of 7
Author: Ann Strydom
Version number: 6.0
Authorised by: Rachel Linger
Review date: 04/08/2016
Issue date: 04/08/2015
Uncontrolled if printed
TGL_Q_21_User_Guide
Clinical interpretations
TGLclinical examination reports contain a clear explanation of the result and its clinical
implications for the patient and their relatives. To obtain further clinical advice, contact the
lab directly by email to tgl@icr.ac.uk. Please note that TGLclinical does not offer any
interpretation of results obtained from external providers.
Queries and Complaints procedure:
Any questions about test methodology, interpretation of the results or complaints should be
notified by email to tgl@icr.ac.uk, 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: 6.0
Authorised by: Rachel Linger
Review date: 04/08/2016
Issue date: 04/08/2015
Uncontrolled if printed