Laboratory Medicine Directorate

Department in Depth

In addition to the main laboratory departments outlined, the Directorate also provides a number of specialised services on a regional and national level.  The specialist pathology services provided at St. James’s are a mixture of national and de facto and designated reference centres and include the following:

Biochemistry:
Translational medical services include comprehensive specialist biochemical and genetic diagnostics for the porphyrias (a group of rare inborn metabolic disorders) and primary dyslipidaemias, including Familial Hypercholesterolaemia, which are directly allied to a clinical metabolic outpatient service provided by the consultant chemical pathologist and also the CVD risk factor Clinic.  In addition, an array of bone markers is provided in support of specialist metabolic bone clinics in St James’s Hospital. Furthermore, bespoke GI diagnostic services are performed including breath tests, faecal elastase and calprotectin.

Cancer Molecular Diagnostics:
Many DNA changes that occur in cancer are well characterised which means that detection of a specific mutation can be used to guide a diagnosis or to indicate treatment. The most well established model for cancer DNA analysis is in the blood cancers where DNA alterations are known to occur in many leukaemias and lymphomas. Blood and bone marrow samples from cancer patients are tested for a range of specific DNA changes as part of a diagnostic workup. The DNA alteration may be specifically linked to one or more therapies, or it may portend a poor prognosis meaning a patient will receive a more aggressive course of treatment which may include a bone marrow transplant. Post-treatment, blood cancers are monitored using molecular methods that count the number of cancer cells in the circulation relative to the number of healthy cells. The performance of a bone marrow transplant is monitored using chimerism analysis where the relative quantity of donor and recipient cells are quantified from the circulating blood cells.
Within the last six years the CMD laboratory has also introduced DNA analysis for solid tumours. The analysis of solid tumours is similar to blood cancers in that the method examines a patient’s tumour to find weaknesses that can be exploited for patient-specific treatment. This information is used to identify and create highly targeted and personalised therapies for patients sparing them unnecessary and unpleasant chemotherapy and allowing them to change therapy within the course of their treatment to optimise their treatment and prolong their health. Since the establishment of the service, analysis of solid tumours has grown to provide broad molecular profiling for a number of cancers, allowing access new and better therapies more quickly. This broad mutation profiling and also allows patients to participate in clinical trials and benefit from the newest drugs available to treat their tumours.

The National Coagulation laboratory (NCL) provides comprehensive, specialist laboratory testing for bleeding and clotting disorders to support clinical care for patients in St James’s Hospital, including those attending the National Coagulation Centre, as well as external hospitals both locally and nationally. Diagnosis of inherited and acquired disorders of haemostasis, including bleeding (as well as platelet disorders) and clotting disorders; monitoring of anticoagulant therapy and monitoring of coagulation factor replacement therapy is carried out in this laboratory. These assays enable the clinical team to optimise prophylaxis regimes and to treat acute and active bleeds in patients with bleeding disorders. The Haemostasis Molecular Diagnostics (HMD) laboratory provides an essential national service for the molecular genetic testing of patients with bleeding disorders including women who are possible carriers of haemophilia. Pre-natal genetic testing is also provided for selected cases with a rapid turnaround time. Reliable and quick access to coagulation factor levels and molecular diagnosis is critical in managing pregnancy in women with a family history of Haemophilia. In addition, better understanding of the molecular genetics in an individual patient when combined with knowledge of factor levels, allows the clinical team to fine-tune the treatment needed for every person with Haemophilia. The NCL also provides specialist testing for patients on anticoagulants. The NCL provides these special tests for patients in St James’s but also for patients in other hospitals, when needed. The research and development program within the laboratory allows the introduction of new laboratory tests to improve the diagnostic profiles for bleeding disorders, platelet disorders and clotting disorders as well as playing an important role in the many clinical trials being conducted by the clinical team.

The Cryobiology laboratory Stem Cell Facility is based in a GMP clean room facility in the National Blood Centre (Irish Blood Transfusion Service) at St James. The Laboratory is involved with the collection, processing and Transplant of haemopoietic stem cells as part National Adult Allogeneic Stem Cell Transplant Programme.  The Cryobiology Laboratory Stem Cell Facility Tissue Establishment (SJH TE) is licensed by The Health Products Regulatory Authority (HPRA) under the EU Tissue Directives 2004/23/EC; 2006/17/EC and 2006/86/EC (SI 598 of 2007, SI 158 of 2006), EU 2015/565 and EU 2015/566. The Laboratory processes mobilised peripheral blood stem cells (PBSC) from patients (Autologous) and from donors (Allogeneic), bone marrow and donor lymphocyte products. Products are issued by the laboratory for immediate Transplant or are cryopreserved and stored in vapour phase liquid nitrogen for later directed use. The Autologous PBSC programme has day case referral from Beaumont (incorporating Drogheda), Mater and Tallaght Hospital and a large national referral facilitated as in-patients in SJH. The Laboratory applies the recommendations outlined by JACIE (Joint Accreditation Committee of ISCT and EBMT) the internationally recognised body for Stem Cell Transplant Accreditation.

Haematology:
The Haemoglobinopathy service provided by Haematology is a de facto national service, serving among many hospitals nationwide and regionally, and all of the Dublin Maternity and Children’s Hospitals (except OLCH, Crumlin) for haemoglobinopathy investigations
The Immunophenotyping service provided by Haematology is a de facto national service.  This service is a vital part of a multi-disciplinary laboratory service for the malignant haematology and bone marrow transplant service based at St James’s Hospital (SJH) and provides comprehensive multi-disciplinary diagnoses in collaboration with the LabMed Cancer Molecular Diagnostics and Histopathology laboratories at SJH, and the National Centre for Medical Genetics based at Our Lady’s Children’s Hospital, Crumlin.

Histopathology:
The Histopathology Department (incorporating Cytopathology) offers subspecialised diagnostic reporting in dermatopathology, gastrointestinal, gynaecological, breast, lung, head and neck, dental, soft tissue, genitourinary and haematolymphoid pathology and cytopathology. The department plays a major role in the extensive multidisciplinary team (MDT) meeting schedule of the hospital as well as having  a large national referral practice.
We work closely with the Cancer Molecular Diagnostics Laboratory in providing diagnostic facilities including automated immunohistochemistry, Flourescent in-situ Hybridisation (FISH), flow cytometry and molecular diagnostics. In addition the department carries out hospital and coroner directed post mortems and provides diagnostic opinion for GPs .

The Immunology Department continues to have a strong tradition of research and development. We have undertaken novel biomarker development projects, for Alzheimer’s disease and autoimmune nephritis. The Alzheimer’s project, undertaken with the MISA, has established us as a centre for referral and was part of an International Standardization Project. We have introduced markers to fully identify white blood cells that are important in immune function. These tests are and invaluable tool in the early diagnosis of inherited immunodeficiencies. Immunology St James has become the de facto national reference centre for the investigation of infants at risk of primary immunodeficiency. The national register of patients with Primary Immune deficiency is maintained by the department and we have established home therapy protocols for these disorders.
New test methods have been introduced for autoimmune encephalitis and neurological disorders associated with some cancers. We have introduced a screening test for latent tuberculosis and extended our test panels for auto-immune conditions affecting the muscles and skin.

The Irish Mycobacteria Reference Laboratory (IMRL) provides a routine and national reference service for diagnosis and treatment of tuberculosis and non-tuberculous mycobacterial disease.  Since its establishment in 2001, the IMRL has supported efforts to provide expertise to laboratories in the diagnosis of M. tuberculosis and other mycobacterial infections; by tracking circulating strains of M. tuberculosis complex as part of continued surveillance, by detecting the emergence of resistance to anti-tuberculous drugs and by participation in research and development initiatives both at a national and international level.  The laboratory plays a key role in multidisciplinary TB case management at SJH. It supports relevant teaching and research and endeavours to keep abreast of the most recent scientific, clinical and epidemiological trends in mycobacterial infections and provide a cost effective and quality assured service.

The Microbiology Laboratory provides a routine diagnostic service to St. James’s Hospital and to General Practitioners in the catchment area, with three main departments: General Bacteriology, Serology and Molecular Microbiology.  The department also provides a reference service as the Gonococcal Reference Laboratory which is available to all hospital microbiology laboratories in Ireland. The Gonococcal Reference Laboratory provides a reference service for the provision of extended antimicrobial susceptibility testing for Neisseria gonorrhoeae (N. gonorrhoeae) to identify and monitor current resistance profiles in Ireland, contributing and participating in gonococcal surveillance including the  European - Gonococcal Antimicrobial Surveillance Programme (Euro-GASP) and also providing both a scientific & clinical advisory service to its users.  The department also provides comprehensive support to the National Bone Marrow Transplant unit, the National tertiary referral centre for Hepatitis B&C, the national centre for Plastics, Burns and Reconstructive surgery; as well as the supra regional services for HIV and Genitourinary medicine.

The National MRSA Reference Laboratory provides a nationwide service for laboratory, clinical and infection control aspects of MRSA.

Accreditation of Laboratories
All laboratory medicine services are accredited, with over 1,000 tests within the scope of accreditation. The laboratory disciplines, outlined below are accredited to the updated international standard ISO 15189:2012 for a five year period (2014-2019). There is an annual surveillance by the Irish National Accreditation Board as part of the accreditation programme and the department has maintained its accreditation every year. The services accredited include:
 
• Biochemistry (including Point of Care Testing-POCT)
• Cancer Molecular Diagnostics
• Haematology (including the National Coagulation Laboratory affiliated to the National Coagulation Centre at St James’s Hospital)
• Histopathology (incorporating Cytopathology)
• Immunology
• The Irish Mycobacteria Reference Laboratory (IMRL)
• Microbiology (including virology)
• The National MRSA Reference Laboratory (NMRSARL)
• Phlebotomy


The Transfusion Medicine Department, incorporating Haemovigilance, is accredited to standards ISO 15189 and AML-BB (SI 360 of 2005) from the Irish National Accreditation Board (INAB)

St. James’s Hospital Tissue Establishment incorporating the Cryobiology Laboratory Stem Cell Facility is licensed to operate as a Tissue Establishment from the Irish Medicine Board (IMB) in accordance with EU Directives 2004/23/EC; 2006/17/EC and 2006/86/EC (SI 598 of 2007 and SI 158 of 2006) and EU 2015/565 and EU 2015/566. It is inspected bi-annually.

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