AGENDA FOR CHANGE NHS JOB EVALUATION SCHEME JOB DESCRIPTION

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1 AGENDA FOR CHANGE NHS JOB EVALUATION SCHEME JOB DESCRIPTION 1. JOB IDENTIFICATION Job Title: Reports to: Department, Ward or Section: Radiopharmacy Production Manager (Nuclear Medicine) Support Division, Medical Physics and Bio-Engineering Operational Unit/Corporate Department: Inner Moray Firth Operational Unit, Raigmore Job Reference: SSCLSSRAIGPNUC11 No of Job Holders: 1 Date: March JOB PURPOSE To participate in and oversee the day to day operation of the radiopharmacy service. To take responsibility as the named Production Manager for the provision of this service under licence from the Medicines and Healthcare products Regulatory Agency (MHRA), compliant with all applicable regulations. To manage Radiopharmacy staff and resources. To assist in development of the service.

2 3. DIMENSIONS Nuclear Medicine is that specialty concerned with the application of radioactivity in the diagnosis and treatment of disease. The Section is the sole provider of Nuclear Medicine services to a population of approximately 260,000 in the Highland Health Board, Western Isles Health Board and west Grampian Health Board areas. Approximately 2000 patient examinations are performed each year. Major facilities include: o An on-site Radiopharmacy suite with facilities for: aseptic preparation of radiopharmaceuticals for patient injection. radio-labelling of patient blood fractions for subsequent re-injection and imaging. analytical work (e.g. radionuclide purity testing of radiopharmaceuticals prepared in-house). o Two Gamma Cameras for patient imaging, including one SPECT/CT. o Gamma counters for measuring small quantities of radioactivity in patient samples (blood, plasma and urine). o A network of computer workstations for acquisition, processing, analysis and display of diagnostic patient images. o Three Radionuclide Calibrators for radioactivity measurements. 4. ORGANISATIONAL POSITION Organisation Chart attached (see end of file). 5. ROLE OF DEPARTMENT The role of the Department of Medical Physics and Bioengineering is to provide specialist Medical Physics and Bioengineering services to the populations served by NHS Highland, NHS Western Isles, and the west part of NHS Grampian. Services are provided in several diverse fields: Nuclear Medicine, Physiology, Electromedical Equipment Services, Radiation Protection, Radiotherapy Physics, Assistive Technology, Medical Illustration and Engineering. The services provided by these sections are wholly distinct from each other to the extent that staff normally do not have the qualifications and /or experience to move between sections. The Nuclear Medicine Section provides both a diagnostic and therapeutic Nuclear Medicine service. It is a multidisciplinary team consisting of a Medical Consultant in Nuclear Medicine, Scientists, Nuclear Medicine Technologists, Nurses and Admin and Clerical staff. The majority of the work consists of diagnostic imaging of patients using radioactive materials. Specially prepared substances called radiopharmaceuticals are administered to patients, usually by intravenous injection or sometimes by mouth or inhalation, depending on the application. The radiopharmaceuticals are prepared on-site in a purpose-designed Radiopharmacy suite, which has been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA). The purpose of the job described here is to manage and provide this service. Once administered to the patient, the distribution of the radiopharmaceutical in the body is imaged using a gamma camera, so called because it is designed to form an image using gamma radiation rather than light as in a normal camera. Typical examples of

3 diagnostic examinations performed include: Myocardial perfusion imaging to diagnose coronary artery disease and assess prognosis. Bone scanning to assess whether cancer has spread to the skeleton. Cerebral perfusion imaging to investigate patients with Alzheimer s Disease or other forms of dementia. Renal imaging and measurement of the glomerular filtration rate (GFR) for the assessment of kidney function prior to chemotherapy. Another type of renal scan is used to detect kidney scarring after a urinary tract infection, especially in children. Lung imaging to diagnose the presence of potentially fatal blood clots in the lung (pulmonary embolism). Labelled leucocyte imaging, in which the patients own white blood cells are separated and labelled with radioactivity to localise sites of infection and/or inflammation. The other aspect of the Section s work involves radionuclide therapy. Here, larger amounts of longerlived radioactive substances are administered to patients with the aim of curing their disease in some cases or providing a palliative treatment in others. Examples include: Iodine-131 for an overactive thyroid gland or thyroid cancer. Radium-223 to alleviate bone pain in patients whose cancer has spread to the bones. Altogether a total of over 30 different diagnostic and therapeutic procedures are currently offered, with new applications under development. The Section participates in the Scottish Training Scheme for Scientists entering the profession of Medical Physics. Following the completion of a one year Masters degree at the University of Aberdeen, trainees have a placement in the Nuclear Medicine section under the supervision of the, which includes Radiopharmacy. The Department is accredited as an Institute of Physics and Engineering in Medicine (IPEM) approved Training Centre for Nuclear Medicine Technologists. The Section assists with the National Arrangements for Incidents Involving Radioactivity (NAIR) Scheme, an arrangement for obtaining expert advice in the event of any incident involving radiation in the local area. The Section also participates in the local arrangements for handling radiation casualties in the event of an incident at Dounreay or on a nuclear submarine berthed in waters off Highland region.

4 6. MAIN TASKS, DUTIES AND RESPONSIBILITIES Service provision To provide a Radiopharmacy service to Nuclear Medicine to the standards required in terms of licensing by the Medicines and Healthcare products Regulatory Agency and to be the named Production Manager on the licence. To assist in developments of the service in response to : -legislative / regulatory changes -evolving consensus of good practice -the availability of new diagnostic tests and treatments On a daily basis, accountability for: preparation and quality control of sterile radiopharmaceuticals for patient injection preparation and quality control of radiolabelled autologous blood cell fractions for use in imaging or in-vitro tests appropriate remedial action in the case of any QC failure reporting of adverse reactions, unusual bio-distributions or defective products to the appropriate authorities and any follow-up actions required. Responsibility for running the radiopharmacy facility to the standard required to provide the stipulated environment necessary for aseptic preparation of radiopharmaceuticals (Good Manufacturing Practice and associated standards): daily monitoring and recording of environmental parameters (air-flows, air quality, temperature control, room pressures, filter integrity etc) remedial action in response to problems with any of the above. Ensuring that the isolators in the aseptic dispensing suite and blood handling suite are performing to specification: daily and weekly monitoring and recording of equipment function and performance criteria (airflows, depressurisation, alarm function, gauntlet integrity, leak testing) remedial action in response to problems with any of the above. Ensuring that, in conjunction with Pharmacy QA staff, that a programme of quality assurance to nationally agreed standards is fulfilled in respect of the Radiopharmacy facility and the clean room isolators: air sampling particle counting monitoring of air change rates filter testing operator technique testing sterility testing process testing Complying with national recommendations for audit and self-audit of the Radiopharmacy service. Ensuring compliance with relevant parts of radiation legislation: maintenance of records of radiopharmaceuticals administered to patients, radionuclide stock, radionuclides stored for decay and radioactive waste disposal for local and statutory

5 requirements monthly audit of the above liaison with other Nuclear Medicine and Medical Physics staff to perform: daily checks on radionuclide dose calibrators annual QC checks on radionuclide dose calibrators daily checks on contamination monitors Staff Management Fulfilling line management responsibility for the Specialist Technologist (Radiopharmacy), including training and Personal Development Planning and Review. Supervising Radiopharmacy work performed on a rota basis by all relevant Nuclear Medicine staff: - undertaking in-house training and supervision of staff in Radiopharmacy techniques and record-keeping, and ensuring adherence to agreed Radiopharmacy procedures - supervising Radiopharmacy training programmes - organising and implementing a programme of regular assessments of competence of all staff - working in aseptic dispensing in the Radiopharmacy - preparing and keeping up to date written material in Radiopharmacy techniques and protocols for education and training purposes Resource Management Arrangement of cost-effective annual contracts for the supply of pharmaceuticals and radio-isotopes for the Nuclear Medicine service. Assessment of the implications of these contracts for tariffs and financial control. Controlling the stock of radionuclides and associated materials, including purchasing, storage and disposal. To arrange supply of all other materials required for delivery of the Radiopharmacy service. Equipment Management Organising maintenance and repair of all Radiopharmacy plant and equipment (isolators, air-handling unit, compressor, extract system, centrifuge etc). Scheduling the above to avoid adversely affecting the patient diagnostic service. Remedial action in response to problems associated with any of the above. Maintenance of stocks of spare parts and materials. Arranging revalidation of the Radiopharmacy facility. Safety Management To participate in the NHS Highland Safety Management System, with line management responsibility for compliance with all applicable legislation. In particular: to ensure that the hazards associated with handling radioactive materials in the Radiopharmacy are minimized by: staff training

6 regular monitoring of radioactive contamination levels on surfaces hand monitoring of staff. to assess and manage the non-radiation hazards associated with the provision of the Radiopharmacy service: chemical exposures evaluation of materials (COSHH) disposal of toxic waste moving and handling. to work in accordance with relevant safety standards, codes of practice etc and to implement relevant recommendations contained in Hazard Warning Notices, Safety Information Bulletins etc to minimize risks to patients and the organisation, its staff and property. to perform and review risk assessments of all radiopharmacy working arrangements and to prospectively risk assess any proposed changes or new procedures. To undertake any other Health and Safety duties which may be required to comply with the NHS Highland Safety Management System. Research and development To assist the Scientists in developing existing and new techniques for radiopharmaceutical preparation. To assess relevant current technology and its suitability to meet the demands made on the Radiopharmacy service, including review of relevant literature. Professional / Advisory To undertake various advisory roles which arise from time to time both in the hospital and at national level in order to contribute to the continuing and improving standards of service. In particular: to participate in the activities of the UK Radiopharmacy Group. The postholder is likely to be the single most knowledgeable expert in the field of Radiopharmacy within NHS Highland a nd provides detailed advice relating to Radiopharmacy within the organization. Participation in Nuclear Medicine To assist the with the management of resources used by the Section, including Technologist staff and the Radiopharmacy. To assist with patient services of the Section as appropriate. To undertake other appropriate work if requested to do so by the, Consultant in Nuclear Medicine or Head of the Department of Medical Physics and Bio-engineering.

7 7a. EQUIPMENT AND MACHINERY The postholder requires specialist knowledge and experience of the principles of operation of the equipment in the Radiopharmacy. This involves practical use, quality control and first-line diagnosis of faults with the following equipment: 3 radionuclide calibrators, used to measure quantities of radioactivity eg the amount of radioactivity administered to patients. 2 Radiopharmacy isolators, one for aseptic dispensing of radiopharmaceuticals for patient injection and one for radiolabelling autologous blood fractions for re-injection and imaging. Microsoft Windows PC, for general office applications (MS Word, MS Excel, MS Powerpoint), internet/ intranet access, , PECOS e-procurement system and departmental databases. Needles, syringes, tungsten syringe guards and shielded containers for safely handling radioactive materials. Various radioactive sources, for calibration, testing and quality control of equipment. 2 refrigerators, for storage of materials. 2 centrifuges, for processing blood samples. Various radiation monitors, for measurement of radiation doserate and detection of radioactive contamination. General office equipment (photocopier, fax etc). 7b. SYSTEMS The postholder regularly uses a PC for word processing, , internet, e-procurement, access to departmental databases and on-line radiopharmacy networking groups. 8. ASSIGNMENT AND REVIEW OF WORK The post holder is accountable to the (Consultant Scientist) for staff management and technical matters and to the Consultant in Nuclear Medicine for clinical matters. The clinical work of the Section, some of which is highly specialised, is generated by requests for investigations from Consultant and other medical staff. Objectives are agreed and monitored by participation in Personal Development Planning and Review and by informal personal contact with the (Consultant Scientist). Section objectives are discussed, prioritized, assigned and monitored at regular Section meetings (monthly). The (Consultant Scientist) assigns project and development activities, some of which the post-holder may lead. 9. DECISIONS AND JUDGEMENTS The postholder is responsible for the selection and appointment of technical staff within the Radiopharmacy, in consultation with the.

8 The postholder is responsible for authorising expenditure within the Radiopharmacy. 10. MOST CHALLENGING/DIFFICULT PARTS OF THE JOB To provide a reliable, comprehensive and efficient Radiopharmacy service at all times, satisfying the needs of a developing Nuclear Medicine service and at the same time the stringent requirements of licensing from the Medicines and Healthcare products Regulatory Agency (MHRA). To personally have to account to the inspectorate of the MHRA for the running of the Radiopharmacy Service, in the knowledge that they have the power to withdraw licensing, if not satisfied, which would result in the cessation of the entire Nuclear Medicine patient diagnostic service. To achieve the above by means which maintain radiation safety and radiation protection issues as key considerations in all procedures. To maintain the knowledge and skills appropriate to the job in a continuously developing field. 11. COMMUNICATIONS AND RELATIONSHIPS Within Raigmore Hospital, the postholder liaises with: Pharmacy staff regarding aseptic dispensing, quality assurance and quality control Medical staff as required Medical Physics, nursing and other hospital staff as required. Maintenance and Estates staff Finance staff Within the NHS, the postholder liaises with: Radiopharmacy, Pharmacy, Medical Physics and Nuclear Medicine staff in other hospitals Audit personnel External Quality Assurance Services for sterility testing UK Radiopharmacy Group Outwith the NHS, the postholder liaises with: The Medicines and Healthcare products Regulatory Agency, its Inspectorate and its appointed auditors. Equipment manufacturers, suppliers, engineers and service personnel. Suppliers of pharmaceuticals and radioisotopes. Suppliers of clean room clothing and equipment, cleaning materials etc. Clean room laundry service suppliers. Delivery service personnel. 12. PHYSICAL, MENTAL, EMOTIONAL AND ENVIRONMENTAL DEMANDS OF THE JOB Physical Skills Standard keyboard skills. Regular computer use required.

9 A high degree of manual dexterity is required. Frequent manipulation of liquid radioactive materials using needles, syringes and small vials within the confines of a radiopharmaceutical isolator requires great care to avoid radioactive contamination and rapid working to minimise radiation exposure. Physical Effort Long periods standing and working at glove ports of radiopharmaceutical isolators. Occasional heavy lifting (once per week) when moving radionuclide generators, lead shielding, etc. Regular (daily) periods of VDU use. Mental Demands Frequent, prolonged periods of concentration are required when preparing radiopharmaceuticals. Large numbers of patient injections must be prepared before 9am, requiring a 7.30am start. This requires a high degree of teamwork involving: o The ability to work and think with speed and accuracy under pressure. o The ability to perform and double-check many calculations of patient doses in a short period of time. Working to tight deadlines when preparing radiopharmaceuticals for patient injection. Emotional Demands Frequent (daily) indirect exposure to patients with life-threatening or terminal illness. Requirement to interact effectively not only with various staff groupings and patients, but also with suppliers, maintenance engineers etc. Requirement to achieve suitable level of teamwork to provide an effective service. The postholder would be expected to be involved in handling casualties involved in a radiation incident (eg accident at Dounreay). Environmental Conditions Frequent (daily) exposure to alcohol vapour, used for sterilising materials. Frequent exposure to chemicals used in QC and cleaning procedures. Frequent (daily) exposure to ionising radiation and radioactive substances in controlled situations. Occasional (once per year) exposure to ionising radiation and radioactive substances following an accidental spill of radioactivity or during a radiation incident (rare). Frequent (daily) VDU use. Frequent exposure to body fluids (blood).

10 13. KNOWLEDGE, TRAINING AND EXPERIENCE REQUIRED TO DO THE JOB The postholder must have an appropriate degree or equivalent in-depth knowledge and experience in a physical, biological or pharmaceutical science or related subject, or membership of the Register of Technologists. The postholder must have extensive and relevant experience including some or all of the following: supervision of technical staff and management of resources safe handling of radioactive and other hazardous materials aseptic dispensing, preferably in a Radiopharmacy setting principles of Good Manufacturing Practice (GMP) keeping of relevant records to satisfy statutory requirements work in a physical, biological, chemical or pharmaceutical environment. The postholder must be able to demonstrate formal evidence of Continuing Professional Development. The postholder must be able to satisfy the Medicines and Healthcare products Regulatory Agency that they have appropriate knowledge, expertise and managerial skills to fulfil the responsibilities conferred by being named on the MHRA licence. The postholder must have excellent oral and written communication skills. The postholder must have good general computer skills. 14. JOB DESCRIPTION AGREEMENT I agree that the above Job Description is an accurate reflection of my duties and responsibilities at the date of signing. Job Holder s Signature: Manager s Signature: Date: Date:

11 Head of Medical Physics and Bio-engineering Electromedical Equipment Service Radiation Protection Physiology Medical Illustration Assistive Technology Engineering Consultant in Nuclear Medicine Nuclear Medicine Radiopharmacy Production Manager (This Post) Scientist Technical Manager Staff who perform Radiopharmacy duties Specialist Technologist (Radiopharmacy) 0.8 WTE Specialist Technologist Specialist Technologist Specialist Technologist 0.85 WTE Specialist Technologist

JOB DESCRIPTION. Responsible to: Deputy Director of Pharmacy & Aseptics Accountable Pharmacist

JOB DESCRIPTION. Responsible to: Deputy Director of Pharmacy & Aseptics Accountable Pharmacist JOB DESCRIPTION 1. JOB IDENTIFICATION Job Title: Deputy Aseptics Accountable and Clinical Pharmacist B7 (Specialist Clinical Pharmacist B7 ) Responsible to: Deputy Director of Pharmacy & Aseptics Accountable