Histocompatibility & Immunogenetics Service

Transcription

1 Acute Services Division User Manual Histocompatibility & Immunogenetics Service Histocompatibility and Immunogenetics Laboratory Gartnavel General Hospital, Level 1 Laboratory Medicine Building, 21 Shelley Road, Glasgow, G12 0ZD Telephone:

2 Contents Page No Introduction 3 A) Laboratory Scope and Location 4 B) Aims of the Service 8 C) Contact Details 9 D) Working Hours 10 E) Laboratory Services Repertoire 11 F) Sample Requirements 19 G) Transport of Specimens 22 H) Blood Sample Requirements 24 I) Reporting of results 26 J) Complaints and Continual 28 Quality Improvements Revision 8, Issued December 2012 Page 2 of 30

3 Introduction This user manual is intended as a guide to the service and tests available from the Greater Glasgow and Clyde (NHS GGC), Histocompatibility and Immunogenetics (H&I) Service. It provides details of the test repertoire and the specimen requirements. Revision 8, Issued December 2012 Page 3 of 30

4 A) Laboratory scope and location The field of H&I is a consultant-led specialist discipline represented in the UK by the British Society for Histocompatibility and Immunogenetics (BSHI). The H&I Laboratory (historically referred to as Tissue Typing) is located within Gartnavel General Hospital (GGH) part of NHS GGC. The service was originally located at the Glasgow Royal Infirmary until May 2008 when an organisational move to purpose built laboratories at GGH was undertaken. These laboratories provide state of the art containment rooms to facilitate genetic and cellular testing and analyses. The H&I laboratory is part of the Diagnostic Services division of NHS GGC and provides a comprehensive range of serological, molecular and cellular techniques. These tests aim to identify human leukocyte antigens (HLA) and to detect immunological sensitisation to HLA. Supporting the first renal transplant to be performed at the Glasgow Royal Infirmary in 1968, the laboratory has evolved to support both solid organ and Haematopoetic progenitor cell transplantation (HPC) programs operating locally, nationally and internationally. In addition the laboratory provides HLA testing to aid disease diagnosis and supports pharmacogenetic studies. Laboratory scientists (healthcare scientists) are Health Professions Council (HPC) registered and undertake continuous professional development in order to maintain and develop their specialised technical and scientific skills. The laboratory is accredited by Clinical Pathology Accreditation (CPA) and by the European Federation for Immunogenetics (EFI). Revision 8, Issued December 2012 Page 4 of 30

5 H&I tests are carried out in support of: supra-regional solid organ transplantation, (kidney and heart); haematopoietic progenitor cell transplantation (related and unrelated donor); platelet transfusion (in liason with the local Scottish National Blood Transfusion Service, SNBTS, H&I laboratory); disease diagnosis, (e.g. Narcolepsy; Ankylosing Spondylitis; Coeliac disease; Behçet s disease); pharmacogenetics (abacavir hypersensitivity) Immunogenetic polymorphism analysis is also utilised to aid determination of the immune status in: immunodeficiency disorders, autoimmune disease, vascular disease and transplantation immunology. The majority of test requests are received through secondary and tertiary referrals although direct access from primary care groups also occur. Revision 8, Issued December 2012 Page 5 of 30

6 Location The laboratory is located on Level 1 of the Gartnavel General Hospital, Laboratory Medicine Building. When arriving at no. 21 Shelley Road. Press the buzzer for level 2 and ask for tissue-typing. Once you have gained entry into the building, the laboratory is found on level 1. Postal Address Histocompatibility and Immunogenetics Laboratory, Gartnavel General Hospital Level 1 Laboratory Medicine Building 21 Shelley Road, Glasgow, G12 0ZD Tel: Fax: Revision 8, Issued December 2012 Page 6 of 30

7 Deliveries The building operates a secured entrance that requires an electronic key. Entrance may be obtained by intercom access at the front and rear entrances. Small goods can be delivered via a side entrance using passenger lifts for heavier items. These lifts are security operated and access can only be requested via contact with the laboratory. The majority of samples are delivered to the laboratory via GGH Biochemistry department s collection point Out of hours urgent samples must be delivered to the Porters desk at the main hospital entrance with a follow-up call to the on call tissue-typist at To send samples by taxi or hospital van, check the local transport arrangements operated by your organisation. All samples for crossmatching must be pre-booked with the laboratory and must never be sent on Friday. Parking Parking is accessible in the nearby NHS (maximum 4 hour) car park or adjacent at the Pond Hotel charged parking facility Visitors Company representatives and visitors are seen by appointment only. Revision 8, Issued December 2012 Page 7 of 30

8 B) Aims of the service The H&I Laboratory is committed to providing its users with the highest quality and standard of service within the framework of the NHS Greater Glasgow & Clyde Policies and Codes of Practice. In order to accomplish this, the laboratory: operates a Quality Management System (QMS) that integrates the organisation, policies, procedures, processes and resources in a controlled and fluent manner; upholds professional codes and values with a view to adopt best practice; implements and complies with standards set out by local, national and international regulatory bodies such as Clinical Pathology Accreditation (CPA) (UK) Ltd and the European Federation for Immunogenetics; reports examination results in a manner that is timely, confidential, accurate and clinically useful in the management of patient care; undertakes approved research and development projects in collaboration with other specialities both within NHS GGC and outwith to support development of service; performs duties as would befit a centre of excellence in the specialised field of H&I; ensures that all visitors to the department are treated with respect and due consideration whilst on site; complies with local national and international standards including data protection act Revision 8, Issued December 2012 Page 8 of 30

9 C) Contact details Laboratory Director /Consultant Clinical Scientist Dr Ann-Margaret Little PhD, FRCPath Tel: (GGC 57749) Laboratory Manager Mrs Helen McFarlane Tel: (GGC 57748) Deputy Laboratory Manager / Quality Manager Mr Paul Foley Tel: Paul.Foley@nhs.net Laboratory enquiries/secretary Mrs Suzanne McCunnie Tel: (GGC 57755) Suzanne.McCunnie@ggc.scot.nhs.uk Laboratory Fax No: Fax: (GGC 57761) On call Tissue Typist Contactable via switchboard Tel: and ask for on-call Tissue-Typist Information and availability of documentation such as:- i) Volunteer unrelated donor (VUD) referral forms (VUDRF BMT ), ii) Sample Request forms, iii) Yellow Renal Activation Forms (LFXM 087), iv) External proficiency testing performance can be obtained from the secretary Revision 8, Issued December 2012 Page 9 of 30

10 D) Working hours Normal Working Hours Monday - Friday Weekend and Public Holidays On-call service only - No routine staffing 24 Hour Emergency Transplant On-Call Service An out of hour s service is provided to facilitate solid organ kidney and heart transplants. The Renal and Cardiac transplant units and transplant coordinators are supplied with an on-call rota including contact telephone and page numbers. Contact can also be made via the Gartnavel General Hospital switchboard for the on-call Tissue-Typist: Tel The on-call rota is also available via rotawatch on the staff intranet A one in two on-call Consultant Clinical Scientist rota is shared with the Consultant Clinical Scientist in Edinburgh SNBTS. This information is available via the renal virtual crossmatch list. For other reasons, contact is made via the on-call tissue-typist as above. Revision 8, Issued December 2012 Page 10 of 30

11 E) Laboratory services repertoire E1: H&I Service to support renal transplantation The H&I laboratory supports the renal transplant programme in Glasgow, providing a service to all adults, from the West of Scotland, and all children from Scotland. The laboratory provides the following services: E1.1 Work-up a patient to be registered on the national transplant list operated by the Organ Donation and Transplantation Directorate (ODT) under the auspices of National Health Service Blood and Transplant (NHS BT). a. HLA-A, B, C, (Bw), DRB1,3,4,5, DQB1 type the patient to conform with NHS BT Minimum resolution for reporting donor and recipient HLA types recommendations. HLA typing must be confirmed on two independently drawn blood samples. DPB1 typing performed when required. b. HLA antibody screening (HLA-A, B, C, DR, DQ and DP specificities) on two independently drawn serum samples. c. Collate HLA data, patient data and blood group results and submit data to the national transplant list database i.e. activate patient on the transplant list. E1.2 Provide H&I support for patients registered on the national transplant list according to national standards (British Transplantation Society). a. HLA antibody screening (HLA-A, B, C, DR, DQ and DP specificities) on serum samples taken at 3 monthly intervals (minimum requirement) for all patients awaiting a renal transplant. HLA antibody specificity also determined. b. Maintain (i.e. update, suspend, reactivate) patient details on the ODT transplant list c. Audit all patient details annually Revision 8, Issued December 2012 Page 11 of 30

12 d. Store collected serum samples in frozen state for all patients. E1.3 Perform a crossmatch for recipients receiving a deceased donor kidney transplant. The crossmatch may be prospective or retrospective (following active assessment of histocompatibility virtual crossmatch ) a. Provide a 24 hour 365 days per year service via an on-call rota of scientists and Consultant Clinical Scientist cover. b. HLA-A, B, C, DRB1,3,4,5, DQB1 (DPB1 as required) type the deceased donor in compliance with NHS BT Minimum resolution for reporting donor and recipient HLA types. c. Crossmatch a selection of historic and current sera against donor T and B-cells, using the complement dependent cytotoxic crossmatch method with and without DTT to distinguish IgM antibodies from IgG. d. Report results to transplant surgeon, with Consultant Clinical Scientist advice when required E1.4 Work-up potential live donor for renal transplant. a. Work-up of a potential live donor will not commence until after the recipient has been HLA typed and screened for the presence of HLA alloantibodies on two independent samples. Exceptions to this will only be permitted when geographic restrictions occur. b. HLA-A, B, C, Bw, DRB1,3,4,5, DQB1 typing to conform with NHS BT Minimum resolution for reporting donor and recipient HLA types recommendations. HLA typing must be confirmed on two independently drawn blood samples. HLADPB1 typing may also be performed. At this time an assessment of histocompatibility will be undertaken and reported ( virtual crossmatch ). c. Crossmatches between patient and selected live donor will be performed using a selection of patient sera and donor T and B-cells, by the complement dependent cytotoxic crossmatch method with and without DTT to distinguish IgM antibodies from IgG. For patients with sensitisation to HLA antigens, a flow Revision 8, Issued December 2012 Page 12 of 30

13 cytometry crossmatch may also be performed. The reactivity of separated T and B-cell, from the potential donor, with patient sera (IgG) are analysed. Auto crossmatches are also performed. A minimum of two crossmatches are performed pre-transplant. d. Report results to the live donor transplant coordinator and clinician requesting the tests. E1.5 Monitor transplanted patients for the presence of donor specific (and other) HLA specific antibodies. Currently this service is not funded. Therefore the laboratory will only monitor patients who are referred specifically for this testing due to a change in their clinical status. a. HLA antibody screening (HLA-A, B, C, DR, DQ and DP specificities) and HLA antibody specificity must also be determined b. Report results to Renal Physician E1.6 Monitor potential renal transplant recipients for HLA antibody status whilst undergoing antibody removal therapy (pending funding allocation). a. HLA antibody specificity (HLA-A, B, C, DR, DQ and DP) analysis will be performed on serum samples collected during antibody removal therapy in accordance with the transplant centre s protocol for antibody depletion therapy b. Report results to transplant physician/surgeon E1.7 HLA type local deceased donors a. HLA-A, B, C, DRB1,3,4,5, DQB1 and DPB1 type all locally referred deceased donors in compliance with NHS BT Minimum resolution for reporting donor and recipient HLA types. b. Report HLA types to NHS BT ODT. Revision 8, Issued December 2012 Page 13 of 30

14 E2: H&I service to support Haematopoietic Progenitor Cell Transplantation (HPC) (This may be referred to as Bone Marrow (BM), and haematopoietic stem cell (HSC) transplantation in documents in use in the laboratory). The laboratory provides an H&I service to the HPC transplant units at the Beatson, West of Scotland Cancer Centre and the Royal Hospital for Sick Children, both in Glasgow. The transplant centres perform all unrelated donor allogeneic transplants for children and adults in Scotland, and related allogeneic transplants for all children in Scotland and most adults. E2.1 Work-up a patient for a HPC transplant a. HLA-A, B, C, DRB1,3,4,5, DQB1, DPB1 type to intermediate/high resolution. b. Perform screening for HLA specific alloantibodies if an HLA mismatched donor is selected c. Request and receive CMV testing results d. Perform confirmatory HLA typing on patient. e. If an unrelated donor transplant is planned HLA typing is performed to high resolution. f. Report results to the transplant centre E2.2 Work-up potential related donors a. HLA-A, B, DRB1 type all potential donors. b. Donors to be considered further have complete HLA-A, B, C, DRB1,3,4,5, DQB1 typing performed to intermediate/high resolution. High resolution typing is performed when required to identify haplotypes within a family. HLA-DPB1 typing may be performed. Additional family members are HLA tested when required to resolve haplotypes. c. Request and receive CMV testing results d. Perform confirmatory HLA typing on selected donor e. Results of adult donors are reported to Clinical Apheresis Unit f. Results of non-adult donors are reported to the paediatric transplant unit Revision 8, Issued December 2012 Page 14 of 30

15 E2.3 Undertake a search for an unrelated adult donor a. Initiate a search of the unrelated adult donor registries within the UK upon receipt of a completed VUD form. When appropriate a search of the international registries is also undertaken b. Select and request blood samples from potential unrelated donors c. HLA-A, B, C, DRB1,3,4,5, DQB1 type all potential donors to intermediate/high resolution. DPB1 typing is performed on shortlisted donors. d. Request and receive CMV testing results e. Complete HLA allele typing to high resolution (if not already achieved) for patient and selected unrelated donor to confirm absence of mismatches f. Perform confirmatory HLA-A,B, DRB1 typing on samples received from unrelated donor donation. g. Provide summaries/audits of search process and unrelated donor testing to transplant centre. h. Provide written reports of HLA results and compatibility E2.4 Undertake a search for a cord blood donation a. Initiate a search of the unrelated adult donor registries as described in E2.3 and when appropriate extend the search to cord blood banks b. Prepare a shortlist of ~10 cords according to pre-agreed criteria c. Request unit reports for shortlisted cords d. Request verification HLA typing on cords to be considered for use e. Request DNA sample from selected cord(s) and perform verification typing as described for adult unrelated donors. f. Perform HLA-A, B, DRB1 verification typing on DNA extracted from infused product. g. Provide summaries/audits of cord search process to transplant centre. h. Provide written reports of HLA results and compatibility Revision 8, Issued December 2012 Page 15 of 30

16 E3: H&I support HLA matched platelet transfusion The lab will perform the following, in liaison with the SNBTS H&I lab in Glasgow a. HLA-A, B, C type all patients. b. Report results via SNBTS H&I laboratory E4: H&I support for Cardiac transplantation The laboratory provides support for the cardiac transplantation programme at The Scottish National Advanced Heart Failure Service (Golden Jubilee Hospital, Glasgow) which supports all adult cardiac transplantation for Scotland. E4.1 Work-up a patient for a cardiac transplant. a. HLA-A, B, C, DRB1,3,4,5, DQB1 (and DPB1 when appropriate) typing to conform with NHS BT Minimum resolution for reporting donor and recipient HLA types recommendations. HLA typing must be confirmed on two independently drawn blood samples. b. HLA antibody screening and specificity determination (HLA-A, B, C, DR, DQ and DP) on two independently drawn serum samples. c. Report the results to the cardiac transplant coordinator d. Provide an on-call service for the above for virtual crossmatching and prospective crossmatching. E4.2 Maintaining a patient on the cardiac transplant list a. HLA antibody screening (HLA-A, B, C, DR, DQ and DP specificities) on serum samples taken at 3 monthly intervals for all patients awaiting a cardiac transplant. HLA antibody specificity must also be determined. E4.3 Perform crossmatch for recipients of a cardiac transplant. The crossmatch may be prospective or virtual and retrospective depending on the patient s clinical criteria Revision 8, Issued December 2012 Page 16 of 30

17 a. Provide a 24 hour 365 days per year service via an on-call rota of scientists and consultant cover. b. Crossmatch a selection of sera against donor T and B-cells (and mixed PBLs for prospective crossmatch only), using the complement dependent cytotoxic crossmatch method with and without DTT to distinguish IgM antibodies from IgG. c. HLA-A, B, C, DRB1,3,4,5, DQB1 type the deceased donor in compliance with NHS BT Minimum resolution for reporting donor and recipient HLA types. d. Report results to transplant surgeon, with Consultant Clinical Scientist advice when required E5: H&I service to aid disease diagnosis HLA typing can provide help in the diagnosis of various disorders. These tests may be requested by GPs or hospital physicians. E5.1 HLA-B27 testing to aid diagnosis of ankylosing spondylities and related spondyloarthropathies. The laboratory will test for the presence or absence of HLA-B27 and report results as positive or negative. E5.2 HLA-DQB1*06:02 testing to aid with the diagnosis of narcolepsy. HLA-DQB1 testing is performed and the results reported as positive or negative E5.3 HLA-DQB1*02 (DQ2) and DQB1*03:02 (DQ8) testing to aid diagnosis of Coeliac disease. HLA-DQB1 typing is performed and the results reported as positive or negative. E5.4 HLA-B*57:01 testing is performed to identify individuals who are at risk of hypersensitivity to the anti-hiv drug, abacavir. The laboratory will test for the presence or absence of HLA-B*57:01 and report results as positive or negative. Revision 8, Issued December 2012 Page 17 of 30

18 E5.5 Other HLA typing tests will be undertaken when referred from a recognised authority and where there is clinical evidence to support HLA typing as providing a useful parameter in diagnosis and/or patient treatment E6. Research studies The laboratory will undertake histocompatibility and immunogenetics testing to support appropriately funded and ethically approved research studies. Agreement must be made with the laboratory prior to sending any samples. Revision 8, Issued December 2012 Page 18 of 30

19 F) Sample Requirements Information regarding sample request forms is available from the laboratory. The laboratory operates strict criteria for the acceptance of, and for the processing of patient samples. These criteria are necessary to ensure that the correct results for the correct patient are reported to the appropriate person. It is in the interest of the patient and medical practitioner to get this stage of the process correct as subsequent quality stages are inconsequential should the sample be from the wrong individual. Please note Asterisk * indicates mandatory information the blood sample may not be tested and/or reported if these fields are not completed accurately. Specimen *Name Hospital and ward *CHI number (for samples originating in Scotland) *Date sample taken Request form *Name *Date of Birth *CHI number (for samples originating in Scotland) *Hospital and ward *Consultant/requester to whom the report is to be issued *Date sample taken *Clinical details/ diagnosis Both specimen and request form information MUST agree. If there is a discrepancy this will delay processing and turnaround times Revision 8, Issued December 2012 Page 19 of 30

20 Additional Paperwork that may accompany specific samples 1 Renal patient to be registered on deceased donor transplant list Completed yellow activation form should include details of previous sensitising events i.e. pregnancy and /or transplant and/or transfusion Date commenced dialysis Virology Information (CMV etc) Copy of original blood group reports from testing of two independently drawn blood samples 2 Patient to receive a haematopoietic progenitor cell (HPC) transplant from a volunteer unrelated donor (VUD) Patients for potential HPC transplant must have a VUD referral form submitted (VUDRF BMT ) if a VUD search is to be instigated. CMV status, blood group and patient weight must be included. Please note that as soon as a patient presents with a condition that may at some stage in the future require HPC transplant, then an EDTA sample should be forwarded to the laboratory. This will help prevent unnecessary delay and maximise the efficiency of the registry searches for an unrelated donor when the time arises. 3 Local Deceased donors Copy of blood group report Coordinators details to be given on sample request form Revision 8, Issued December 2012 Page 20 of 30

21 Packaging of diagnostic samples All diagnostic samples must be packaged in containers compliant with UN packaging instruction P650. All packages must be labelled as shown below. Biological Substance Category B Information with regard to high risk specimens (e.g. HIV or Hep B/C status) should be clearly marked on BOTH sample and request form. Labels indicating high risk will suffice. Revision 8, Issued December 2012 Page 21 of 30

22 G) Transport of specimens Specimens should be sent in the sealable bag attached to the yellow H&I (Tissue Typing) request form. Specimens at the GGH site are delivered via local arrangements. All other specimens must be transported by van or taxi or sent by Post (observing postal regulations). Check with your local organisation. Only specimens referred from authorised medical practitioners can be processed. Patients can not self-refer. HLA typing (EDTA) and antibody analysis (clotted) samples EDTA samples and clotted samples are stable at ambient (22 C) temperature for 4 days. Crossmatching Samples - DO NOT REFRIGERATE! Crossmatch Samples (EDTA (20mls) and Clotted (10mls)) should be received within 24 hours of venesection. Please book crossmatch in advance by contacting the laboratory. Urgent deceased donor samples Samples (EDTA peripheral blood, spleen, lymphnode) from deceased donors can be sent directly to the laboratory within working hours (8.00am to 4.30pm). Please notify the laboratory of expected arrival time. Outwith the above hours, deceased donor samples should be forwarded to the porters desk at the main entrance to GGH which is manned 24 hours. Also inform the on-call tissue-typist of their arrival Revision 8, Issued December 2012 Page 22 of 30

23 Urgent antibody screening samples This requires agreement with the laboratory to confirm that the urgent testing can be performed. The samples must be sent by taxi and arrive within the agreed time frame. At present this service is not available out of hours except by arrangement between the requesting consultant and a senior member of the laboratory staff (Laboratory Director, Laboratory Manager or Deputy Manager). Revision 8, Issued December 2012 Page 23 of 30

24 H) Blood sample requirements Patient category/test Disease Association e.g. B27/Coeliac/Narcolepsy/ B*57:01 Sample Type Vol (ml) Contact Lab in advance (Y/N) Target turnaround times (TAT) EDTA 10 No 3 weeks except B*57:01: 1 week EDTA 20 No 2 weeks Renal/Cardiac transplant patient HLA Typing HPC patient HLA typing EDTA 20 No 2 weeks Potential related donor EDTA 20 No 2 weeks for HPC transplant HLA typing Deceased organ donor HLA typing EDTA 50 Yes 4 hours HLA Antibody Screening (Renal /Cardiac /HPC) Crossmatching (CDC XM) First full crossmatch Final crossmatch Flow Cytometry Crossmatch (FCXM) Clotted sample Donor EDTA Recipient EDTA Recipient Clot Recipient EDTA Donor EDTA Recipient Clot 5 Yes, by phone if urgent 20 Yes book date in 20 advance. Deliver 5 <24 hours 2 weeks screen 4 weeks specificity analysis 2 weeks 10 As above 2 weeks Please ensure correct tube/anti-coagulant is selected. EDTA tubes are typically purple top and clotted samples Red or Yellow topped. Different suppliers have different colour codes. Revision 8, Issued December 2012 Page 24 of 30

25 Notes Blood grouping requests should be sent to local or central blood transfusion service. The H&I lab does not test for blood groups Clotted samples from HPC patients are tested for HLA antibody and sent to the virology laboratory for CMV testing Molecular HLA typing involves the extraction of DNA from blood or tissue samples. If the patient has a low WBC count then this information should be conveyed to the laboratory. Non blood samples e.g. amniotic fluid and mouth wash preparations are not routinely processed, therefore prior arrangement with the laboratory is essential. Revision 8, Issued December 2012 Page 25 of 30

26 I) Reporting of results Hard copy reports are computer generated from the controlled laboratory patient management system. A paper copy of each report is printed, signed by designated staff and dispatched by internal hospital mail. Faxed Reports Faxing of reports that include patient name and personal information are covered under data protection act and has been prohibited by The Scottish Government. FAX results will only be permitted between secure fax machines. copy of authorised reports Reports can only be sent between secure addresses e.g. nhs.net to nhs.net and ggc.scot.nhs.uk to ggc.scot.nhs.uk Oral transmission of results In order to prevent sensitive or incorrect information being released to inappropriate persons the oral transmission of results is actively discouraged. Only in an emergency or in the acute setting will an oral authorised report be issued by a senior member of staff to a suitably qualified person. The result will be verbally repeated by the recipient to ensure the accuracy of the communication. A hard copy report will follow ASAP. Revision 8, Issued December 2012 Page 26 of 30

27 Referral of samples for additional testing HPC transplant patient and donor serum samples are referred for CMV testing at: West of Scotland Specialist Virology Centre Gartnavel General Hospital 1053 Great Western Road Glasgow G12 0YN At the time of production of this user guide, the laboratory is CPA accredited (CPA Ref No: 0406) and participates in the national external proficiency testing scheme for CMV testing. Storage of samples Serum samples from solid organ transplant recipients (pre and post transplant) are stored indefinitely. DNA samples from all patients and donors who have undergone HLA typing for are stored for up to five years, except for those patients and donors that have undergone transplantation where DNA is stored indefinitely. Viable lymphocytes are stored from deceased organ donors. Revision 8, Issued December 2012 Page 27 of 30

28 J) Complaints and Continual Quality improvement The laboratory operates a Quality Management System (QMS). The laboratory and its staff endeavour to provide the best service possible to its users. If there has been a shortfall in expectations or an identified problem in the quality or efficacy of service please contact the Quality Manager, Mr Paul Foley, Tel: Formal complaints must be given in writing. All complaints are recorded reviewed and acted upon in a cycle of continual learning via feedback and action to improve the overall service. If you wish to discuss a report or its clinical impact then please consult the Laboratory Director. Revision 8, Issued December 2012 Page 28 of 30

29 Notes Revision 8, Issued December 2012 Page 29 of 30

30 Revision 8, Issued December 2012 Page 30 of 30