NHS NATIONAL SERVICES SCOTLAND JOB DESCRIPTION 1. JOB DETAILS Job Holder Job Title Tissues and Cells Scientist, band 7 Immediate Senior Officer Tissues and Cells Laboratory Manager Division BTC Location Tissues and Cells Services (TCS), EGR, Edinburgh Job Reference SNBTSS269 2. JOB PURPOSE To provide safe, 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. Assist in developing the service in anticipation of future clinical needs. 3. DIMENSIONS Postholder has budget responsibility for £5K of the laboratory budget and specific responsibility for bacteriological issues within the TCS team. Responsible for sourcing, costing & purchase of physical assets. Authorised signatory for payment of on-call / out of hours claims & expenses. Responsible for safe use of highly complex laboratory equipment. Manages research grant for payment of staff and purchase of necessary equipment. 4. ORGANISATION CHART See attached sheet 5. ROLE OF THE DEPARTMENT The Tissues and Cells Services department of SNBTS is the preferred provider of bone and tissue products to NHS Scotland. These are collected from live and cadaveric volunteer donors throughout Scotland and processed to provide a range of products for clinical use. Peripheral blood stem cells and bone marrow are collected and processed on behalf of NHS Lothian from patients at the Western General Hospital and Royal Infirmary in Edinburgh. National pancreatic islet cell isolation and processing facility has been established in collaboration with NSD and the Edinburgh organ transplant team. TCS is expanding its tissue repertoire and is positioned to further develop its expertise in Good Manufacturing Page 1 of 5 Practice in partnership with clinical and University colleagues in the extraction, processing and manipulation of stem cells. 6. KEY RESULT AREAS Provide safe, efficacious products by procuring and processing donated tissue according to GMP and regulatory standards to meet the clinical demands of surgeons: Specialised procedures include: 1. heart valve dissection and cryopreservation 2. tendon splitting and disinfection 3. cryopreservation of ovarian cortical slices 4. quarantine, clearance and issue of bone 5. processing, storage and distribution of clinical stem cells 6. processing, storage and transplant of pancreatic islet cells Co-ordinate, 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. 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. Apply microbiological knowledge to advise Tissues and Cells Head on suitability of tissue for transplant. Participate in the continual review of laboratory procedures, including the maintenance and review of standard operating procedures to incorporate new technology/standards to ensure continued accreditation by the Medicines and Healthcare Products Regulatory Agency (MHRA). Conduct laboratory testing, in line with relevant regulatory standards, of all tissue samples to ensure the sterility of final clinical products. Participate in the on-call rota to take donor referrals. This involves analysis of complex medical situations. Provide 24 hour laboratory support for critical equipment and emergency issue of tissue, to provide an out-of-hours clinical service. Arranging complex tissue retrieval procedures – co-ordinating laboratory, mortuary, pathology and procurator fiscal staff to allow timely retrieval from donors. Analysis & interpretation of laboratory environmental data to ensure compliance with relevant standards. Establish and maintain a centralised bacteriology testing service to ensure national bone donations are screened by a standard, consistent protocol. Monitor and review this protocol to reflect current regulatory standards and best practice. Implement new policies, which change current sampling regime of donated bone. Represent TCS at the on-site health and safety committee and report all relevant issues to TCS staff. Compose risk and COSHH assessments for all laboratory tasks. As a member of the National Bacteriology Working Group in collaboration with National Institute for Biological Safety and Control, contribute to national research programmes to improve the safety and quality of banked tissue. The group comprises consultant microbiologists, surgeons and tissue bankers. Present results from this research at appropriate national (U.K.) meetings and conferences. Incorporate results from this research into current laboratory practice. Implementation of new service developments, including changes to departmental policies & working practice. Lead or participate in planned or ad hoc research projects into improving the microbiological safety of tissue procurement and processing. Source and secure funding for research and implement programme. Prepare formal documentation for new procedures to enable developments to be introduced in a suitably controlled manner. 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. Daily supervision of research assistant. High degree of speed & precision is required, as is excellent hand / eye coordination to allow: Manipulation of surgical instruments for dissection of heart valves / tendons Draping / suturing of retrieval sites during tissue retrievals Computer knowledge and keyboard skills are necessary to interface with the software controlling the receipt, tracking and issue of donor medical and product data and ensuring that associated files are kept orderly and up to date. Participate in continual personal training and development as a member of a small team in a unique area of health care. Training and daily supervision of medical laboratory assistant. Train bone bank nurses and laboratory staff in changes to current practice to ensure consistent sampling of bone across Scotland. Inputting donor & laboratory data in both electronic & paper form, ensuring accurate record keeping. Ensure the confidentiality and security of all data relating to donors and recipients is maintained at all times. Page 2 of 5 7. ASSIGNMENT AND REVIEW OF WORK Detailed work planning is self generated and requires considerable judgement and flexibility in responding to unpredictable and competing demands that have major significance for the service and its customers. (Tissue retrievals must take place within a short time frame following death, so there is a frequent requirement to change work plans at very short notice. This is particularly relevant when several procedures may be running concurrently and staff numbers are limited, meaning that the post-holder must be flexible in their work practices and also be able to exercise good judgement & time management when there may be competing demands on their time). Coordinates the activities of Transplant Coordinators /pathologists / surgeons / consultants / nursing staff (tissue retrievals / ovary harvests / stem cell collection & reinfusions). Weekly meetings will be held with the Tissues and Cells Laboratory Manager to discuss any on-going issues. Monthly lab meetings will be held with laboratory staff and TCS Operations Manager to discuss ongoing workload and any new projects. Following appropriate training, the post holder must be able to work independently and under own initiative guided by SOPs and good practice. Assigned work will include undertaking, monitoring and reporting of tissue processing to the Tissues and Cells Team. Regular progress meetings with TCS Head to discuss research project. Review: TCS Laboratory Manager and Operations Manager will review success in key result areas. Formal assessment of performance will be done during an annual review. 8. 9. 10. COMMUNICATIONS AND WORKING RELATIONSHIPS Liaise with SNBTS and other external staff on matters affecting their service arrangements with TCS. Liaise with bone bank nurses throughout Scotland regarding the retrieval, storage and bacteriological testing of tissue. Liaise with nursing, medical and surgical staff to advise end-users on quantity/quality of tissues and to arrange their timely delivery. Modify laboratory working practice in order to accommodate the fluctuating requirements of cardiac and orthopaedic surgeons. Maintain good working relationships with all staff involved in transplant medicine, from surgeons to laboratory staff. These relationships are vital to achieve lawful retrieval of tissue from donors across Scotland and also to ensure that end-users receive safe and efficacious tissues to meet their demands. Liaise with Consultant Microbiologist and medical microbiology staff regarding bacteriological testing of tissue. Establish links with microbiologists involved in Tissue Banking world-wide to keep up-to-date with current practice. MOST CHALLENGING PART OF THE JOB Dealing with the changing demands of a clinical support service coupled with the needs of expanding development activities. SYSTEMS Microsoft Office is used as a key software tool and the postholder will be expected to be use this in the day to day function of the post, entering and manipulating information and data and generating reports. Tissue Trace is a proprietary database system for tracking and controlling tissue products and is essential for the data handling of these. The postholder will, after training, be expected to interface and use the system as required, entering data and issuing product etc. Familiarity with E-mail systems is necessary for routine communication with colleagues. Page 3 of 5 11. WORKING ENVIRONMENT AND EFFORT Physical Effort Highly developed physical skills to allow manipulation of surgical instruments during heart dissections to yield aortic and pulmonary heart valves suitable for surgical implantation. Particularly high skill levels when carrying out paediatric heart dissection with fine surgical instruments. 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 Frequent required for prolonged concentration during heart dissection and clinical evaluation of the valves (up to 3 hours per procedure sitting at Microbiological Safety Cabinets with restricted movement). Frequent requirement for intense concentration during stem cell procedures to ensure cells are processed safely and the correct cells go back to the correct patient (up to 2 cryopreservation procedures/week @ up to 2 hours, up to 1 reinfusion/week @ up to 2 hours). Collating clinical data to allow clearance of donated tissues. Preparation of business cases for new projects & development of service. There is a frequent requirement for prolonged concentration during retrievals (when acting as TCS sterile operator or TCS assistant, up to 2 times/week for periods of up to 3 hours). 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 12. 13. 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. Regular exposure to distressing or emotional circumstances e.g. receiving information on patient death, attendance at post mortems. 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. Frequent on-call & out of hours work. QUALIFICATIONS AND/OR EXPERIENCE SPECIFIED FOR THE POST The postholder must possess a degree in Biomedical Science, preferably microbiology, and have related demonstrable experience from working in a GMP environment, preferably within the disciplines of Tissue Banking, Page 4 of 5 Haematology, Blood Transfusion or Cell Biology. The postholder must possess a knowledge of Tissues and Cells procedures acquired through ongoing specialist training and experience to masters level or equivalent. 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. Appropriate training will be given in all aspects of the Service's tissue banking activities. 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 Title HR Department will check job description format and content and then send the job description to the AfC Team HR Representative’s Signature Date Job Description Agreed: Page 5 of 5
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