JOB DESCRIPTION 1. JOB DETAILS Job Title: TCD Islet Cell Laboratory Manager Immediate Senior Officer/Line Manager: Tissues and Cells National Operations Manager Department(s): Tissues and Cells Directorate Division: SNBTS Job Reference: SNBTSS165 2. JOB PURPOSE To manage the Tissue Services Islet Cell Laboratory to allow safe provision of efficacious tissues on a timely basis, meeting all quality and regulatory standards required by SNBTS and its customers and to provide 24 hour cover for the co-ordination of tissue retrieval and issue. To manage the development of the islet laboratory service in line with future clinical needs. 3. DIMENSIONS The SNBTS Tissues and Cells Directorate comprises around 34 tenured staff with a total annual budget of approximately £1.7 million for salaries and £450k for goods and services. This post will have full line management and budget responsibilities for the pancreatic islet cell programme with line management responsibility for 4 scientists. 4. ORGANISATION CHART See attached organisation chart 5. ROLE OF THE DEPARTMENT The core purpose of the Scottish National Blood Transfusion Service is to meet the transfusion needs of patients in Scotland. In support of this, the SNBTS Tissues and Cells Directorate is committed to a programme that will enhance the service provided to NHSScotland in both clinical and operational areas. The Tissues and Cells Directorate is the preferred provider of bone and tissue products to NHSScotland and retrieves tissues from live and cadaveric donors, It also processes haematopoietic cells for Edinburgh patients and is also the provider of pancreatic islet cells to patients in Scotland and the North of England on behalf of NHSScotland. 1 6. KEY RESULT AREAS 1. Responsible for the day to day management of the Tissues and Cells islet cell laboratories to ensure that equipment and facilities are operated according to GMP. 2. Provide safe, efficacious products by procuring and processing donated tissue according to GMP and regulatory standards to meet clinical demands : Specialised procedures include: a) Extraction and isolation of islet cells from pancreata b) heart valve dissection and cryopreservation c) tendon splitting and disinfection d) cryopreservation of ovarian cortical slices 3. Be responsible for the co-ordination of, through communication with source hospitals/testing laboratories, the receipt and processing of samples and documentation from tissue donors to ensure the maintenance of the tissue audit trail. 4. Interpret and evaluate test results and assess tissue quality through the application of professional and clinical knowledge. Apply outcome of this analysis to allow tissue to be cleared for clinical use. 5. Be responsible for the continual review of laboratory procedures, including the maintenance and review of standard operating procedures to incorporate new technology/standards to ensure continued licensing by the Human Tissue Authority (HTA). 6. Manage and conduct the laboratory testing, in line with relevant regulatory standards, of all tissue samples to ensure the sterility of final clinical products. 7. Participate in the on-call rota to take donor referrals, involving analysis of complex medical situations. Provide 24-hour laboratory support for critical equipment and emergency issue of tissue, to provide an outof-hours clinical service. 8. Arranging complex tissue retrieval procedures – co-ordinating laboratory, mortuary, pathology and procurator fiscal staff to allow timely retrieval from donors. 9. Analysis & interpretation of laboratory environmental data to ensure compliance with relevant standards. 10. Be responsible to ensure the confidentiality and security of all data relating to donors and recipients is maintained at all times by Tissues and Cells Staff. 11. To be familiar with the aims, policies and future plans for the Tissues and Cells Directorate. 12. Maintaining an awareness of appropriate scientific literature so that work is carried out according to up-todate knowledge and practice. 13. Manage implementation of TCD policy and suggest changes to working practice as appropriate. 14. Be responsible for the implementation of new service developments. 15. Manage the preparation of formal documentation for new procedures to enable developments to be introduced in a suitably controlled manner. 16. Plan and undertake the development and validation of the new laboratory processing methods and procedures for development purposes and where appropriate, secure funding to allow such work to be performed. 17. High degree of speed & precision is required, as is excellent hand / eye coordination to allow: Manipulation of surgical instruments for dissection of pancreas/heart/ valves/ tendons Draping / suturing of retrieval sites during tissue retrievals 18. Computer knowledge & keyboard skills are necessary to interface with the software controlling the receipt, tracking & issue of donor medical & product data, and ensuring that associated files are kept orderly and up to date. 19. Responsible for managing the Tissues and Cells Islet Laboratory budget. 20. Responsible for sourcing, costing & purchase of physical assets. 21. Authorised signatory for payment of on-call / out of hours claims & expenses 22. Safe use of complex laboratory equipment. 23. Line management responsibility for overall training, organising the work of the laboratory staff so that the work of the Tissue Services Islet Laboratory can be progressed efficiently and effectively. 24. Contribute to the teaching and induction of new National BTS laboratory, nursing and medical staff. 25. Manage the department KSF and PDP programme. 26. Participate in continual personal training and development as a member of a small team in a unique area of health care. 27. Have a working knowledge of UK laws and regulations for organ and tissue donation, and understand the requirements for tissue products and their clinical importance. 28. Be responsible to ensure that the confidentiality and security of all data relating to donors and recipients is maintained at all times by Tissues and Cells Staff. 29. Possess an understanding of the principles of the GMP quality management system. 30. The presentation of data at local, national and international level. 2 31. Inputting donor & laboratory data in both electronic & paper form. 32. Responsible for the compilation of management & activity statistics. 7. ASSIGNMENT AND REVIEW OF WORK and DECISIONS AND JUDGEMENTS Monthly meetings will be held and objectives set in discussion with the Tissues and Cells Operations Manager. The post holder must be able to work independently and unsupervised within current regulatory standards. Assigned work will include planning, undertaking, monitoring, assessing and reporting development progress to the Tissues and Cells team. Review: Success in key result areas will be reviewed by the Tissues and Cells National Operations Manager and Medical Director. 8. COMMUNICATIONS AND RELATIONSHIPS Liaise with SNBTS and other external staff on matters affecting their service arrangements with TCD. Receive complex & sensitive donor information from Transplant Coordinators & medical staff during the referral process. Liaise with nursing, medical and surgical staff to advise end-users on quantity / quality & effective use of tissues and to arrange their timely delivery. Modify laboratory working practice in order to accommodate the fluctuating requirements of clinicians Foster & maintain good working relationships with all staff involved in transplant medicine nationally, from surgeons to laboratory staff. These relationships are vital to achieve lawful tissue retrieval from donors and also to ensure that end-users receive safe and efficacious tissues to meet their demands. Attendance at Tissues and Cells National Operational meetings is required. 9. MOST CHALLENGING PARTS OF THE JOB Although the ultimate objectives of research projects are defined at the start, the steps towards achieving these may not be obvious, even to an individual experienced in the field. This requires an ability to think creatively and develop innovative and possibly unconventional approaches to solving specific problems as well as a degree of self-confidence and effective communication with both peers and managers. Working to tight deadlines and budgets is also an important challenge. Therefore it is important that the individual can work to defined targets. 10. SYSTEMS Experimental data is processed and analysed using statistical packages supplied on the software provided on the PC workstations and on software purchased for specific applications. The post holder will be expected to be proficient in the use of spreadsheets and databases for the storage, manipulation and presentation of experimental data. Includes creation and maintenance of databases containing records of transplants/infusions, stock records of chemicals; records of cells stored in liquid nitrogen. Will be responsible for co-ordinating the receipt, storage and reporting of investigations on samples and products for specialist investigation and analysis, including the appropriate storage and maintenance of records. As a delegated budget holder, will be trained to use the NSS Financial Information System (PECOS) for the requisition and receipt of goods/services. 11. WORKING ENVIRONMENT AND EFFORT 3 Physical Effort There is a frequent requirement to exert moderate physical effort for extended periods e.g. lifting and moving boxes and transport boxes of bone and tissues to and from storage freezers. Working in & maintaining aseptic environment to ensure sterility of final product. Mental Effort Complex dissection of pancreata and heart valves. Collating clinical data to allow clearance of donated tissues for implantation. Preparation of business cases for new projects & development of service. There is a frequent requirement for intense concentration within the work period. There is a need to respond to the unpredictable nature of the work. Adapting to the many changes in working practice in a rapidly developing speciality. Emotional Effort Participate in retrieval of cadaveric tissues in a mortuary environment, assisting & advising pathologist during tissue retrieval. Physically handling cadaveric donors. Assisting Transplant Coordinators to prepare donor for viewing by family after tissue donation. Frequent exposure to distressing or emotional circumstances e.g. receiving information on patient death, attendance at post mortems. 12. ENVIRONMENTAL/WORKING CONDITIONS & MACHINERY AND EQUIPMENT Frequent exposure to hazardous working conditions, including: Working for periods in cold environments –40°C to –80°C. Working with protective gloves handling frozen bone and tissues. Working with dry ice and liquid nitrogen. Working for long periods under class A and B clean room conditions. Exposure to operating theatres and mortuaries during tissue retrieval. Frequent use of VDUs. Direct contact with untested blood samples & tissues. Handling untested and potential/biohazard tissue. Processing & disposal of tissues known to be positive for virology markers or microbiological contaminants. 13. KNOWLEDGE, TRAINING AND EXPERIENCE REQUIRED TO DO THE JOB The post holder must possess an honours degree in a biological sciences subject with a knowledge base and experience gained from post graduate qualification or equivalent in a biomedical area related to Tissue Banking. The individual must be eligible to be registered with the Health Professions Council or Voluntary Registrations Council. After suitable training they must maintain specialist knowledge across a range of work procedures and practices that must be underpinned by theoretical knowledge of relevant practical experience. The ability to manage and motivate the TCD Laboratory Team to work efficiently and effectively to deliver a complex clinical service. 14. JOB DESCRIPTION AGREEMENT A separate job description will need to be signed off by each jobholder to whom the job description applies. Job Holder’s Signature: Date: Head of Department Signature: Date: HR Department will check job description format and content and then send the job 4 description to the AfC Team Date: HR Representative’s Signature: 5 6 TISSUES AND CELLS Associate Director of Manufacturing 13/10/2014 Medical Consultant Head Nurse - Clinical Head of Tissues and Cells Clinical Lead for Tissues and Cells Associate Director of RDI 1xWTE Band 8b PA El ai ne Arthur Nursing Laboratory Quality Manager Lead Nurse 1 x WTE Band 8a 1xWTE Band 8b Dundee Inv erness Tissue & Bone Bank Coord Tissue & Bone Bank Coord 0.5 x WTE Band 7 Cell Therapy 1 x WTE Band 7 Cell Therapy Dev . Manager 1 x WTE Band 8b 0.5 x WTE Band 6 Edinburgh Glasgow Tissue & Bone Bank Coord 0.7 x WTE Band 7 Tissue & Bone Bank Coord 1 x WTE Band 7 0.5 x WTE Band 7 0.75 x WTE Band 6 0.53 x WTE Band 6 0.64 x WTE Band 6 Bone & Tissue Bone and Tissue Lab Manager 1 x WTE Band 8a Aberdeen National Storage Site Manager 1 x WTE Band 7 HPC Islet Cells HPC Lab Manager 1 x WTE Band 8a Islet Cell Lab Manager 1 x WTE Band 8a Tissue Scientist 1 x WTE Band 7 0.64 x WTE Band 6 2 x WTE Band 6 Tissue Scientist 1 x WTE Band 7 MLA 2 x WTE Band 3 Tissue Scientist Tissue Scientist 1 x WTE band 6 2 x WTE Band 6 2 x WTE Band 5 7