Modernising Scientific Careers Scientist Training Programme Work-based training. Learning Guide Blood Sciences 2017/18

Transcription

1 Modernising Scientific Careers Scientist Training Programme Work-based training Learning Guide Blood Sciences 2017/18

2 Contents SECTION 1: GENERAL INTRODUCTION... 4 READERSHIP Scientist Training Programme (STP) Overview Outcomes of the work-based STP Key Components of Work-based Training in STP Host Training Departments National School of Healthcare Science (NSHCS) and the STP The Structure of the Learning Frameworks Assessment during Work-based Training Quality Assurance and Quality Management SECTION 2: PROGRAMME OVERVIEW SECTION 3: ROTATIONAL WORK-BASED LEARNING FRAMEWORKS Clinical Biochemistry Investigation of Major Organ Function (CB-1) Immunity and the Principles and Practice of Clinical Immunology (CI-1) Haematology and Transfusion Science (HT-1) Immunity and the Principles and Practice of Histocompatibility and Immunogenetics (H&I-7) LEARNING OUTCOMES Genetics, Genomics and Molecular Science (CG-1) SECTION 4: PROFESSIONAL PRACTICE LEARNING FRAMEWORK Professional Practice (PP1) SECTION 5: ELECTIVE LEARNING FRAMEWORK Elective (EL) SECTION 6: SPECIALIST WORK-BASED LEARNING FRAMEWORK: CLINICAL BIOCHEMISTRY Clinical Disorders of the Major Organs and Cancer (CB-2) Endocrinology and Diabetes (CB-3) Nutrition (CB-4) Drug Investigation (CB-5) Pregnancy, Neonatology and Paediatric Clinical Biochemistry (CB-6) SECTION 7: SPECIALIST WORK-BASED LEARNING FRAMEWORK CLINICAL IMMUNOLOGY Immunology and Infection (CI-2) Immunodeficiency and Immunotherapy (CI-3) Hypersensitivity and Allergy (CI-4) Haematological Malignancies and Transplantation (CI-5) Autoimmunity (CI-6) SECTION 8: SPECIALIST WORK-BASED LEARNING FRAMEWORK HAEMATOLOGY AND TRANSFUSION SCIENCE Disorders of Red and White Blood Cells (HT-2) Core Transfusion (HT-3) Haemostasis (HT-4) Haematological Malignancy (HT-5) Specialised Transfusion (HT-6) SECTION 9: SPECIALIST WORK-BASED LEARNING FRAMEWORK HISTOCOMPATIBILITY AND IMMUNOGENETICS Clinical Immunology in Histocompatibility and Immunogenetics (H&I-8) Page 2

3 Histocompatibility (H&I-9) Solid organ transplantation (H&I-10) Immunogenetics (H&I-11) Haematopoietic Stem Cell Transplantation (HSCT) (H&I-12) SECTION 10: APPENDICES APPENDIX 1: Contributor List APPENDIX 2: Programme Amendments Amendments February Amendments November Amendments March Amendments March APPENDIX 3: Glossary APPENDIX 4: Good Scientific Practice APPENDIX 5: Further Information Page 3

4 SECTION 1: GENERAL INTRODUCTION Page 4

5 READERSHIP This Scientist Training Programme (STP) Learning Guide describes the STP workbased training programmes in the UK: academic and administrative staff, including external examiners within Higher Education Institutions (HEIs); employers; learners, host departments and managers of services that employ healthcare science (HCS) staff; work-based trainers, including all those involved in supervising, mentoring, coordinating, assessing and delivering STP education and training; Health Education England (HEE) Local Education and Training Boards (LETBs) and all HCS education and training commissioning organisations in the UK; National School of Healthcare Science (NSHCS); Academy for Healthcare Science (AHCS); patients and the public. A glossary of terms used is provided in Appendix 1. Page 5

6 Introduction 1.1 Scientist Training Programme (STP) Overview 1. Healthcare science (HCS) involves the application of science, technology, engineering and mathematics to health. Good Scientific Practice (GSP) [Appendix 2] sets out the principles and values on which education and training for healthcare science are founded. It makes explicit the professional standards of behaviour and practice that must be achieved and maintained in the delivery of work activities and clinical care for all those who work in healthcare science, the public and healthcare providers. 2. GSP and the Education and Training Standards of the Health and Care Professions Council (HCPC) are the basis for all MSC training curricula which contextualise the Standards of Proficiency set down by the HCPC in a way that is accessible to the profession and the public. 3. The healthcare science workforce and services have traditionally been grouped into three broad areas called Divisions, namely: Life Sciences/Clinical Laboratory Sciences, Physical Sciences/Medical Physics and Biomedical Engineering and Physiological Sciences/Clinical Physiology Sciences. Within each Division there are a number of healthcare science specialisms. With advances in scientific technology, changes to the delivery of healthcare scientific services and the development of MSC, the boundaries between these Divisions have been shifting. MSC recognises this important change and to date has identified nine themes within healthcare science for the STP, which enables training across a total of 24 healthcare science specialisms, with curricula for additional specialisms still under development. 4. The STP is designed to provide healthcare scientist trainees with strong sciencebased, patient-centred clinical training in a specialist area of healthcare science. Initial rotational training provides a broad base of knowledge, skills and experience across a group of related cognate specialisms reflective of the evolving clinical and scientific changes and requirements followed by specialisation in a single HCS specialism. 5. During the STP programme the scientist trainee is supernumerary but may contribute to the clinical work of the department in which they are training to gain the required clinical experience and competence. 6. The STP is an integrated training programme combining academic study leading to the award of a specifically commissioned MSc in Clinical Science and a workbased training programme. Completion of both will lead to the award of a Certificate of Completion of the Scientist Training Programme (CCSTP) by the National School of Healthcare Science (NSHCS). Graduates are then eligible to apply to the Academy for Healthcare Science for a Certificate of Attainment and will then be eligible to apply to HCPC for registration as a Clinical Scientist. 7. The MSc Clinical Science Learning Outcomes and Indicative Content, and the associated work-based learning outcomes, can be found by following the link Page 6

7 1 Further details of the MSc in Clinical Science can be found in the student handbook from the university with which each trainee is registered. 8. This Introduction to Work-based Learning provides an overview of the workbased training programme and the guidance provided by the NSHCS for users of the Online Assessment Tool (OLAT) and e-learning Portfolio. All trainees and trainers will have access to the OLAT throughout their training. In addition, The Reference Guide for Healthcare Science Training and Education in England will be published in autumn This will contextualise the STP within the wider MSC programme. 9. All STP trainees will be registered with the NSHCS for the duration of their training and will be allocated a National Science Training Number (NSTN). The NSHCS working through its Themed Boards provides oversight and coordination of the STP, communicates with trainees and trainers with respect to national policy and events, liaises with the work-based trainers, host employers and the academic providers, reviews progress on assessments and trainee performance including OLAT/ Structured Final Assessment (SFA) and quality assurance of the work place training environment. The School overall has a responsibility to provide confidential reports in accordance with agreed governance and oversight arrangements. 10. The work-based training programme has four components each underpinned by the professional practice curriculum: Induction; Rotational Training; Elective Training; Specialist Training. 11. It is anticipated that trainees will have a brief induction period in their host employing organisation prior to commencing the introduction to their MSc in Clinical Science. As the induction period may be up to 6 weeks in some departments the time should be used to begin rotational training as well as the induction period. The subsequent initial academic period is specifically designed to give an overview of the basic science and an introduction to aspects of professional practice relevant to HCS and the STP rotational training. The duration of this first university session will vary, depending on the MSc degree which is undertaken. 12. Details of the work-based assessment programme can be found in Section III of this guide and also by logging onto the online assessment tool. Details of the 1 This section will be updated in the planned STP curricula review. The NSHCS assumed responsibility for curricula development and maintenance from From 2016 all new curricula or updated versions are available on the NSHCS website Page 7

8 assessment programme for the MSc in Clinical Science will usually be published in the student handbook provided by each university. A broad overview of the STP is shown in the diagram overleaf: Page 8

9 Modernising Scientific Careers: Scientist Training Programme (STP): Diagrammatic representation of employment-based, pre-registration 3 year NHS commissioned education and training programme Page 9

10 1.2 Outcomes of the work-based STP 13. On successful completion of the work-based STP trainees will have clinical and specialist expertise in a specific healthcare science specialism, underpinned by broader knowledge and experience within a healthcare science division or theme. They will undertake complex scientific and clinical roles, defining and choosing investigative and clinical options, and making key judgements about complex facts and clinical situations. Many will work directly with patients and all will have an impact on patient care and outcomes. They will be involved, often in lead roles, in innovation and improvement, research and development and education and training. Some will pursue explicit academic career pathways, which combine clinical practice and academic activity in research, innovation and education. On successful completion of the work-based training programme which forms part of the MSC STP, trainees will possess the essential knowledge, skills, experience and attributes required for their role and should demonstrate: A systematic understanding of clinical and scientific knowledge, and a critical awareness of current problems, future developments, research and innovation in health and healthcare science practice, much of which is at, or informed by, the forefront of their professional practice in a healthcare environment; Clinical and scientific practice that applies knowledge, skills and experience in a healthcare setting, places the patient and the public at the centre of care prioritising patient safety and dignity and reflecting NHS/health service values and the NHS Constitution; Clinical, scientific and professional practice that meets the professional standards defined by GSP and the regulator (HCPC); Personal qualities that encompass self-management, self-awareness, acting with integrity and the ability to take responsibility for self-directed learning, reflection and action planning; The ability to analyse and solve problems, define and choose investigative and scientific and/or clinical options, and make key judgements about complex facts in a range of situations; The ability to deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and to communicate their conclusions clearly to specialist and non-specialist audiences including patients and the public; The ability to be independent self-directed learners demonstrating originality in tackling and solving problems and acting autonomously in planning and implementing tasks at a professional level; A comprehensive understanding of the strengths, weaknesses and opportunities for further development of healthcare and healthcare science as applicable to their own clinical practice, research, innovation and service development which either directly or indirectly leads to improvements in clinical outcomes and scientific practice; alternative; Conceptual understanding and advanced scholarship in their specialism that enables the graduate to critically evaluate current research and innovation Page 10

11 methodologies and develop critiques of them and, where appropriate, propose new research questions and hypotheses; Scientific and clinical leadership based on the continual advancement of their knowledge, skills and understanding through the independent learning required for continuing professional development. 14. Once registered as a Clinical Scientist, a range of career development options will be available including competitive entry into Higher Specialist Scientist Training (HSST). Alternatively, others may choose to undertake further career development in post through a structured programme of Continuing Professional Development (CPD), provided by Accredited Expert Scientific Practice or pursue a clinical academic career. Clinical Scientists who successfully complete HSST, or who can demonstrate equivalence to its outcomes, will be eligible to compete for available Consultant Clinical Scientist posts. Page 11

12 1.3 Key Components of Work-based Training in STP The Trainee 15. The trainee is at the centre of the STP, supported on the one hand by the national oversight role taken by the NSHCS, working closely with local quality monitoring and performance processes currently undertaken by SHAs and on the other by the day-to-day delivery of training in the workplace, facilitated by the underpinning and integrated MSC in Clinical Science programme. This Guide contains important information which will help the trainee understand how the work-based programme operates and its key elements. 16. At the core of successful work-based training is appropriate educational supervision, facilitation and feedback. Each trainee will be allocated to a clinical training supervisor or training officer 2 from within the employing host department. Trainees should ensure that a planned schedule of meetings with their training officer is agreed early in training, commencing with a meeting during the first week. Conversations between trainees and trainers are confidential, unless patient safety is at risk. When the trainee is following a rotational module a trainer from the host department will act as their main contact whilst they are away from their host department. 17. The local training departments, supported by the NSHCS working with others, are responsible for ensuring that trainees have access to training opportunities to enable the achievement of the learning outcomes of the STP. In return trainees are expected to take responsibility for: ensuring that they fulfill their obligations to their employer and to patients (especially with regard to patient safety and confidentiality) as healthcare professionals; engaging as active adult learners by initiating work-based assessments; contributing to learning activities; taking into account feedback received from their trainers and assessors and; giving considered and constructive feedback on their experience of their training; meeting the requirements of the academic MSc Clinical Science programme. 18. Critical reflection on progress and performance is an integral part of both the STP and of being a professional. Trainees should therefore regularly critically reflect on their progress and performance, enabling them to develop skills in selfevaluation and action planning. 2 For the purposes of this document Training Officer has be used however the title may vary between departments and may be subject to a title change in England as part of developments for the whole of the professional healthcare workforce. In essence this is the person in the host department who is responsible for the training of each trainee for the duration of the 3 years. Page 12

13 1.4 Host Training Departments 19. The third key component for successful training in the STP is the employing host department and other service units facilitating work-based training. The success of the training and the trainee experience requires the commitment and enthusiasm of those in the work base who provide the training. 20. Host departments should therefore ensure that they are fully familiar with the four components of the work-based training programme, namely: induction, rotational, elective and specialist; the underpinning professional practice curriculum and be aware of how the academic MSc in Clinical Science degree integrates with workbased training. 21. All trainees must have a designated training officer who will have responsibility for: provision of support, guidance and mentoring for the duration of the programme, in the host department and related training environments; provision of a timetable which enables an appropriate balance of work and learning for the trainee; ensuring adequate support during periods of training outside the host department; ensuring that the programme of work-based assessment is understood and that its outcomes for individual trainees is documented through the use of OLAT; ensuring that the e-learning Portfolio is discussed with the trainee and that there is clarity and agreement about its use; ensuring that clinical practice is well supervised for the safety of patients and the trainee, so that the acquisition of clinical competence is facilitated; ensuring that other contributors to the assessment process are fully aware of the requirements and the use of the OLAT. Organisation of the Training Programme 22. The host department is responsible for organising the training programme for each of its trainees. This may involve liaising with other departments to facilitate necessary work-based learning and other contributors to the associated assessment requirements. Whilst the NSHCS will provide support, host departments need to be satisfied that they are providing a training environment of appropriate quality including appropriately trained staff and facilities. Furthermore, host departments are required to engage in the quality assessment management process established by the NSHCS and provide information as necessary to enable the NSHCS to fulfil this critical function. Details of the NSHCS quality assessment management policy for work-based training provider departments can be found at: Page 13

14 23. Induction At the start of the STP training programme and of each new placement, trainees should be provided with an induction programme explaining trust and departmental arrangements. Initial work-based induction in the host department should include an overview of the: hospital/healthcare setting and local policies including health and safety, confidentiality, data protection etc relevant to the placement; range of services provided by the department; range of people who use the services provided by the department; function, operation and routine and corrective maintenance requirements of equipment appropriate to the section(s) of the department in which the trainee will be working. Moreover, the host department should ensure that the trainee has access to: Host Trust IT systems including the library and knowledge service as necessary; On-line Assessment and Personal Management System. Induction should include an early discussion (within the first week) between the trainee and his/her training officer so that the curriculum, assessment and placement arrangements can be discussed. In addition, trainers should provide trainees with copies of: Good Scientific Practice; The STP work-based Learning Guide; The OLAT learning guide; Links to the NSHCS (see section III for details of the role of the NSHCS in relation to STP training). 24. Rotational Training During rotational training each trainee will undertake four rotations which will include a rotation in the area in which they will subsequently specialise. Trainees must successfully achieve all of the learning outcomes. Each rotational placement should be of approximately 12 weeks duration. It is the responsibility of the host department to organise this rotational programme and to liaise with the trainers in the rotational placement departments on the requirements of work-based training and supervision and the use of the online assessment tool. The NSHCS and the SHA MSC leads (and successors) will help to facilitate rotational placements for small specialisms or where there are local issues in respect of access to particular training elements. The host department is responsible for setting the timetable for each of the 4 rotations, which will depend on local availability and may require some time to be spent out with your locality to ensure that the learning outcomes in totality can be achieved. In agreeing the rotational training the host department will Page 14

15 need to consider the periods of time the trainee will be required to attend the University or undertake academic activities for the MSc within the work place. The host department must be familiar with the content, delivery and assessment programme of the MSc in Clinical Science which the trainee is undertaking at university and ensure that the departments where the trainee is placed for rotational placements are also familiar with the expected outcomes of each period of training and are trained in the assessment methods. The training officer in the host department should maintain contact with the trainee and should liaise with the person taking overall responsibility for the trainee whilst they are undertaking the rotation. Supervision meetings between the training officer and the trainee should continue whilst they are on their rotational placements. 25. Elective Training Each trainee must undertake elective training and successfully achieve all of the learning outcomes. The host department should agree the timing and content of the elective training period with the trainee and should then inform the NSHCS of the plans for the elective by completing the appropriate form and submitting it to the School. The aim of the elective is to facilitate a wider experience of health care and/or the practice of healthcare science in a cultural and/or clinical setting that is different from the usual training environment. This may involve health care or healthcare science in a different area of the health service and may involve study abroad or pursuit of a particular clinical or research interest. The elective period can be taken any time during the specialist training, and may comprise a single period of 4 6 weeks or a series of shorter periods of elective training. It is important that the trainee is able to express their preferences for the elective period which is designed to provide a broader experience and for these to be fully taken into consideration. 26. Specialist Training The host department will plan the timetable for specialist training. This will usually be in a single health care science specialism (except for Gastrointestinal Physiological and Urodynamic Science who share modules in the specialist training period, and Immunogenetics and Histocompatibility who share some specialist modules with Clinical Immunology). Each trainee must successfully achieve all of the learning outcomes in the specialist training modules including, by the end of the training programme, all of the professional practice learning outcomes. If the host department itself is unable to provide the necessary work-based training to enable the trainee to complete all of the required learning outcomes, it will need to arrange training in other training departments and environments. 27. Supervision STP clinical and educational supervision should promote learning, reflective practice and support the trainee to produce action plans to address identified learning needs. It will need to ensure that the trainee learns specific skills and Page 15

16 competencies, helping them to develop self-sufficiency and self-awareness in the ongoing acquisition of skills and knowledge. At every stage, patient safety must be paramount. Supervision will require the provision of pastoral care for some trainees. Supervision may, at times during the programme, be provided by other healthcare professionals outside of healthcare science who will be appropriately trained e.g. medical colleagues. The first supervision meeting should be set up during the first week of the training programme. At this meeting the training officer should ensure that the trainee is undertaking an induction programme that includes the hospital and department. It is recommended that following areas should be explored and agreement reached at the first meeting with respect to the: expectations of the training officer and trainee; responsibilities of the training officer and trainee; boundaries between the training officer and trainee; confidentiality; frequency and duration of planned supervision meetings; methods of communication and responsibility for arranging meetings; level of support and arrangements for communications between meetings; models of reflection and action planning; record keeping; content of the work-based training programme; the approach to assessment and the use of the assessment tools and the online system; sources of help and support. Page 16

17 1.5 National School of Healthcare Science (NSHCS) and the STP 28. The NSHCS provides a national coordinating and oversight function to support trainees and host departments in the delivery of training. It is responsible for: national recruitment into STP, enabling a transparent and robust selection of the very best science graduates; providing national oversight of STP trainees throughout their training by managing and monitoring their progress through the OLAT, supporting trainees in difficulty as well as co-ordinating national structured assessments both during and at the end of STP training; evaluation of ongoing work-based assessment outcomes through the OLAT, enabling the School to benchmark training programme delivery for early identification of programme issues which may need to be addressed and resolved and reporting these as part of agreed MSC governance arrangements; liaising with each HEI s MSc Clinical Science programme director to ensure the integration and coordination needed to deliver the academic and workbased programmes that form the STP;liaising with MSC SHA leads (and education and quality leads in the future arrangements) on local issues and problems and their resolution; working closely with work place training departments and providing support as appropriate; organising national Train the Trainer programmes to ensure common standards of delivery and content and recommending on-going training activities to support the continuing professional development of work-based trainers. Professional Leads in each of the scientific divisions within the NSHCS will provide help and support with respect to organising rotations and/or specialist training that might require national coordination. In order to optimise the educational benefit and value of OLAT and the e-learning Portfolio, Professional Leads will also work with and support training departments in its use. The School can be contacted on the following nshcs@wm.hee.nhs.uk Page 17

18 1.6 The Structure of the Learning Frameworks 29. The work-based programme is divided into modules, with each module following a standard format. The aim and scope of the module are described followed by: Learning outcomes high level descriptors of required achievements for module; Clinical Experiential Learning the learning activities that will facilitate learning and achievement of stated outcomes; Competences further, outcome based statements for each Learning Outcome; Knowledge and Understanding as APPLIED to appropriate competences. All of the above are focused on service need, patient care/pathway and continuous service improvement Page 18

19 1.7 Assessment during Work-based Training Trainee Assessment 30. The work-based assessment is designed to promote learning, skill development and competence within the specialist healthcare context. Trainees will be able to identify areas for development and improvement. The assessment programme is designed to enable both trainee and trainer to obtain regular feedback on progress and achievement. It aims to nurture the trainee by providing professional educational support and encouraging critical reflection and generating regular feedback about progression. The programme embeds assessment tools to enable trainees to learn and develop but also to generate evidence so that judgments about progression can be made and areas identified for trainee improvement based on supportable evidence. The work-based education and training programme should offer a constructive environment where a trainee understands that he/she is still developing and the assessment tools are intended for use in this context. As part of each assessment, the work-base assessor will facilitate a discussion in which the trainee is encouraged to reflect on his/her performance and identify his/her strengths and areas that could be improved, setting an action plan to achieve that improvement. 31. The structure of the work-based assessment programme. There are distinct elements of the work-based assessment programme for all trainees: Assessment Tools, see Table 1 overleaf; Competency Log; Online Assessment and Personal Learning Management System (OLAT); Exit assessment Objective Structured Final Assessment (OSFA). Assessment Tools 32. The assessment programme utilises a range of work-based assessment tools, designed to promote continuous assessment and generate feedback throughout training. The assessment promotes student centred feedback to enable the trainee to gain skills in self-assessment. There is a requirement for each trainee to engage with the assessment process and to complete a defined number and range of assessments to successfully complete each module. These are set out in OLAT. Page 19

20 Table 1 Summary of the STP Work-based Assessment Tools Assessment Tool Direct observation of practical skills (DOPS) Observed clinical event (OCE) Case based discussion (CbD) Multi source feedback (MSF) Purpose To assess a practical skill or procedure which may include interaction with a patient. Feedback is generated, learning needs identified and an action plan generated. To assess a clinical encounter. To assess the trainee s ability to apply their knowledge and understanding of an aspect of an activity for example the underpinning science, aspects of professional practice. To provide a sample of attitudes and opinions of colleagues on the performance and professional behaviour of the trainee. It helps to provide data for reflection on performance and gives useful feedback for selfevaluation. Method The assessor observes a practical activity and facilitates student centred feedback either during or immediately following the observation. The trainee then generates an action plan. The assessor observes a clinical activity and facilitates student centred feedback either during or immediately following the observation. The trainee then generates an action plan. The assessor facilitates a discussion with the trainee about a clinical case with which the trainee has been involved. This may include a report, record, result or an aspect of professional practice arising from the case. Following the discussion the trainee generates an action plan. Using an on-line system the trainee gains feedback from a range of people (8 10) who work with them and the trainee also rates themselves. On completion the report generated is reviewed in a discussion between the trainee and trainer and using critical reflection an action plan generated by the trainee. Page 20

21 33. Competences All trainees are required to provide evidence to demonstrate that they have completed each competence which should then, at the request of the trainee, be signed off by a trainer. Trainees will gain competence at their own pace, but in line with the overall delivery of the relevant modules. Each competence may link directly to a specific learning outcome and some competences may be linked to more than one learning outcome, therefore successful completion cannot be achieved until demonstrated for all learning outcomes. All of the competences are contained within a competency log within the OLAT. Completion of the competency log is essential for progression within the programme and in order to exit from the programme. The expectation is that as the trainee progresses the competency log will demonstrate an evidence base of achievement. 34. Online Assessment and Personal Management Tool (OLAT) The achievement of competences and all work-based assessments are recorded on OLAT. OLAT is customised for each specialism and contains all the above assessment tools as well as the full list of competences for each programme and a reflective log. NSHCS will provide trainees with the information to allow them to register on OLAT at the start of their programme. As part of their registration they must nominate their training officer, even though others may contribute during the total period of work base training to the assessment process. Short film clips which explain the principles of the assessment process and how to use each of the assessment tools are available on OLAT. 35. Objective Structured Final Assessment At the end of training trainees will be assessed using an Objective Structured Final Assessment (OSFAs). This is a performance based assessment used to measure trainees across a number of different stations encompassing scientific, clinical and professional practice. The NSHCS, in partnership with the professional bodies and supported by the NSHCS Themed Boards, will design and deliver the OSFA and the Academy for Healthcare Science will provide external Quality Assurance All trainees will have the opportunity to undertake an OSFA mid-programme to provide formative experience of this assessment. Page 21

22 1.8 Quality Assurance and Quality Management Quality Assurance of work-based training 36. All host and training departments are responsible for the delivery of the workbased training quality standards detailed in the Learning and Development Agreement (LDA) agreed with and issued by with the local Strategic Health Authority (SHA) and their successor bodies. All host and training departments providing training for trainees on the STP must also be MSC approved and accredited. 37. MSC work-based accreditation is carried out by the NSHCS on behalf of MSC. 38. The NSHCS provides oversight of the quality management and quality control of the STP work-based training environments as agreed by the appropriate MSC governance arrangements and to be maintained into the future. 39. The NSHCS works in partnership with the professional bodies through its Themed Boards and the SHAs/LETBs to deliver a robust Quality Assessment Management (QAM) programme for the work-based education and training programme. This QAM programme is UK wide and independent from the direct delivery of education and training. The purposes of the QAM programme are to: all STP training environments are accredited to deliver work-based training; ensure that all training settings are working to the agreed standards; create an open and transparent culture where issues and concerns can be raised, investigated and resolved; ensure that trainees receive a high quality educational experience wherever their training takes place; Identify and share examples of good practice; provide evidence of the quality of work-based education and training environments to those who regulate and register the profession; provide evidence of the high standard of work-based education and training and assurance that these standards are robustly managed. 40. Details of the quality management approach is available from the NSHCS (Ref NSHCS Policy 03), in summary, the quality framework includes: Receipt, analysis, review and response with respect to: o annual self assessment progress reports from each work base; o trainee feedback questionnaires; o assessment progress reports; o ad hoc reporting of exceptions or changes to programmes; o individual work-based education and training timetables for each trainee; A mechanism for receiving and reviewing reports with respect to the STP programme from trainees, trainers, patients or other stakeholders; Visit Programme including: o a five year rolling visit programme to each work base; Page 22

23 o adhoc visits to departments as required. 41. The NSHCS monitors the progress of each trainee and provides support for trainees in difficulty (Trainees in Difficulty Ref NSHCS Policy 04). Staff in the NSHCS also regularly review the STP programmes using information from the OLAT and other sources through the Themed Boards (See NSHCS Policy 01) 42. The QAM processes, established jointly by the MSC governance arrangements involving all current SHAs and the NSHCS, do not absolve the training provider from responsibility for continuously managing and maintaining the quality of its own provision. Local training departments are responsible for ongoing quality control and local education providers should therefore ensure that a high quality education and training environment is maintained. The following sections of this Learning Guide include an overview of the STP workbased programme for the specialisms within this theme. This is followed by the Learning Frameworks for the Rotational, Elective, Specialist and Professional Practice components of the programme. Further information can be found in Appendix 3. Page 23

24 SECTION 2: PROGRAMME OVERVIEW BLOOD SCIENCES Page 24

25 STP WORK-BASED TRAINING PROGRAMME IN CLINICAL BIOCHEMISTRY The diagram below provides an overview of the programme each trainee in Clinical Biochemistry will follow: Modernising Scientific Careers: Scientist Training Programme (STP): Diagrammatic representation of employment based, 3-year NHS commissioned, pre-registration Education and Training programme PROFESSIONAL PRACTICE This module spans the whole of the 3-year training programme, underpinning both work-based training and the MSc in Clinical Science. INDUCTION COMPONENT At the start of the training programme and of each new placement all trainees will complete an induction programme. Page 25

26 ROTATIONAL COMPONENT Trainees must then successfully complete the Clinical Biochemistry rotation followed by the other THREE rotations listed below: Rotation 1 (CB-1) Rotation 2 (CI-1) Rotation 3 (HT-1) Rotation 4 (CG-1) Clinical Biochemistry Investigation of Major Organ Function Immunity and the Principles and Practice of Clinical Immunology Haematology and Transfusion Science Genetics, Genomics and Molecular Science Duration: Each rotation should be of approximately 12 weeks duration. Order: It is expected that the first rotation completed will be Clinical Biochemistry. ELECTIVE COMPONENT The elective period can be taken any time during the specialist training. It may comprise a single 4- to 6-week elective or a series of shorter periods of elective training. SPECIALIST COMPONENT Module 1 (CB-2) Module 2 (CB-3) Module 3 (CB-4) Module 4 (CB-5) Module 5 (CB-6) Clinical Disorders of the Major Organs and Cancer Endocrinology and Diabetes Nutrition Drug Investigation Pregnancy, Neonatology and Paediatric Clinical Biochemistry Duration: The work-based component of the five specialist modules should be completed during the specialist training period. The work-based component of the modules can run in parallel in order to use the time and clinical contacts to best advantage. The following sections of the learning guide contain the learning frameworks for the rotational, elective, specialist and professional practice modules. Page 26

27 STP WORK-BASED TRAINING IN CLINICAL IMMUNOLOGY The diagram below provides an overview of the programme each trainee in Clinical Immunology will follow: Modernising Scientific Careers: Scientist Training Programme (STP): Diagrammatic representation of employment based, 3-year NHS commissioned, pre-registration Education and Training programme PROFESSIONAL PRACTICE This module spans the whole of the 3-year training programme, underpinning both work-based training and the MSc in Clinical Science. INDUCTION COMPONENT At the start of the training programme and of each new placement all trainees will complete an induction programme. Page 27

28 ROTATIONAL COMPONENT Trainees must then successfully complete the Clinical Immunology rotation followed by the other THREE rotations listed below: Rotation 1 (CI-1) Rotation 2 (CB-1) Rotation 3 (HT-1) Rotation 4 (CG-1) Immunity and the Principles and Practice of Clinical Immunology Clinical Biochemistry Investigation of Major Organ Function Haematology and Transfusion Science Genetics, Genomics and Molecular Science Duration: Each rotation should be of approximately 12 weeks duration. Order: It is expected that the first rotation completed will be Clinical Immunology. ELECTIVE COMPONENT The elective period can be taken any time during the specialist training. It may comprise a single 4- to 6-week elective or a series of shorter periods of elective training. SPECIALIST COMPONENT Module 1 (CI-2) Module 2 (CI-3) Module 3 (CI-4) Module 4 (CI-5) Module 5 (CI-6) Immunology and Infection Immunodeficiency and Immunotherapy Hypersensitivity and Allergy Haematological Malignancies and Transplantation Autoimmunity Duration: The work-based component of the five specialist modules should be completed during the specialist training period. The work-based component of the modules can run in parallel in order to use the time and clinical contacts to best advantage. The following sections of the learning guide contain the learning frameworks for the rotational, elective, specialist and professional practice modules. Page 28

29 STP WORK-BASED TRAINING IN HAEMATOLOGY AND TRANSFUSION SCIENCE The diagram below provides an overview of the programme each trainee in Haematology and Transfusion Science will follow: Modernising Scientific Careers: Scientist Training Programme (STP): Diagrammatic representation of employment based, 3-year NHS commissioned, pre-registration Education and Training programme PROFESSIONAL PRACTICE This module spans the whole of the 3-year training programme, underpinning both work-based training and the MSc in Clinical Science. INDUCTION COMPONENT At the start of the training programme and of each new placement all trainees will complete an induction programme. Page 29

30 ROTATIONAL COMPONENT Trainees must then successfully complete the Haematology and Transfusion Science rotation followed by the other THREE rotations listed below: Rotation 1 (HT-1) Rotation 2 (CI-1) Rotation 3 (CB-1) Rotation 4 (CG-1) Haematology and Transfusion Science Immunity and the Principles and Practice of Clinical Immunology Clinical Biochemistry Investigation of Major Organ Function Genetics, Genomics and Molecular Science Duration: Each rotation should be of approximately 12 weeks duration. Order: It is expected that the first rotation completed will be Haematology and Transfusion Science. ELECTIVE COMPONENT The elective period can be taken any time during the specialist training. It may comprise a single 4- to 6-week elective or a series of shorter periods of elective training. SPECIALIST COMPONENT Module 1 (HT-2) Module 2 (HT-3) Module 3 (HT-4) Module 4 (HT-5) Module 5 (HT-6) Disorders of Red and White Blood Cells Core Transfusion Haemostasis Haematological Malignancy Specialised Transfusion Duration: The work-based component of the five specialist modules should be completed during the specialist training period. The work-based component of the modules can run in parallel in order to use the time and clinical contacts to best advantage. The following sections of the learning guide contain the learning frameworks for the rotational, elective, specialist and professional practice modules. Page 30

31 STP WORK-BASED TRAINING IN HISTOCOMPATIBILITY AND IMMUNOGENETICS The diagram below provides an overview of the programme each trainee in Histocompatibility and Immunogenetics will follow: Modernising Scientific Careers: Scientist Training Programme (STP): Diagrammatic representation of employment based, 3-year NHS commissioned, pre-registration Education and Training programme PROFESSIONAL PRACTICE This module spans the whole of the 3-year training programme, underpinning both work-based training and the MSc in Clinical Science. INDUCTION COMPONENT At the start of the training programme and of each new placement all trainees will complete an induction programme. Page 31

32 ROTATIONAL COMPONENT Trainees must then successfully complete the Histocompatibility and Immunogenetics rotation followed by the other THREE rotations listed below: Rotation 1 (H&I-7) Immunity and the Principles and Practice of Histocompatibility and Immunogenetics Rotation 2 (HT-1) Haematology and Transfusion Science Rotation 3 (CB-1) Rotation 4 (CG-1) Clinical Biochemistry Investigation of Major Organ Function Genetics, Genomics and Molecular Science Duration: Each rotation should be of approximately 12 weeks duration. Order: It is expected that the first rotation completed will be Histocompatibility and Immunogenetics. ELECTIVE COMPONENT The elective period can be taken any time during the specialist training. It may comprise a single 4- to 6-week elective or a series of shorter periods of elective training. SPECIALIST COMPONENT Module 1 (H&I-8) Module 2 (H&I-9) Module 3 (H&I-10) Module 4 (H&I-11) Module 5 (H&I-12) Clinical Immunology in Histocompatibility and Immunogenetics Histocompatibility Solid organ transplantation Immunogenetics Haematopoietic Stem Cell Transplantation Duration: The work-based component of the five specialist modules should be completed during the specialist training period. The work-based component of the modules can run in parallel in order to use the time and clinical contacts to best advantage. The following sections of the learning guide contain the learning frameworks for the rotational, elective, specialist and professional practice modules. Page 32

33 Blood Sciences SECTION 3: ROTATIONAL WORK-BASED LEARNING FRAMEWORKS Page 33

34 This section describes the Learning Framework for the Rotational Component of work-based training covering the Learning Outcomes, Clinical Experiential Learning, Competence and applied Knowledge and Understanding. Each trainee is also expected to build on and apply the knowledge, skills and experience gained from the MSc in Clinical Science. Rotational Module DIVISION THEME SPECIALISM Life Sciences Blood Sciences Clinical Biochemistry Page 34

35 MODULE TITLE AIM SCOPE Clinical Biochemistry Investigation of Major Organ Function (CB-1) COMPONENT Rotation This module will provide trainees with the knowledge and understanding of the normal physiology of the major organs and the biochemical parameters in common use for the investigation and management of major organ dysfunction. They will perform a selection of common methods used in the investigation of major organ function and gain experience of the interpretation of patient results in a variety of clinical settings. Biochemical investigation, interpretation and reporting of major organ disease in the patient pathway, using a range of laboratory and point-of-care techniques and including application of quality control principles and use of relevant IT systems. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Interpret routine requests for clinical biochemistry investigations of major organ function in the correct clinical context and process the specimens that accompany those requests. 2. Perform a range of laboratory and point-of-care techniques (POCTs) used in the workplace to investigate major organ function. 3. Apply the principles of internal quality control and external quality assessment and draw conclusions about assay performance. 4. Report the results of commonly performed clinical biochemistry investigations of major organ function. 5. Use laboratory IT systems for handling, processing and storage of patient data. Page 35

36 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this rotation is: Attend multidisciplinary review meetings at which biochemical results of major organ function are presented as part of the clinical record. Reflect on these discussions and the impact for patient care and management. Reflect on the partnership between clinical biochemistry and other clinical specialisms in the investigation of disorders of major organs. Review at least one biochemical investigation of major organ disease in the patient pathway, including the correct sampling technique and the use and validity of reference range. Review and discuss at least two examples of the interpretation and reporting of laboratory results in the context of common clinical disorders. Attend a clinical unit where POCT for major organ function is performed. Discuss the method(s) with trained users. Demonstrate an understanding of the preparation of reports and the reporting process for patients being investigated for major organ function by observing technical and clinical validation. Record case overviews observed and identify key factors that will influence your own future practice. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome.. Page 36

37 KEY COMPETENCES LEARNING OUTCOMES 1 Identify the most appropriate test for at least two example clinical presentations, e.g. diabetes, acute coronary syndrome, acute kidney injury etc. 1,5 Use computer software associated with the LIMS and laboratory equipment. 1,5 Receive, label and store routine clinical biochemistry samples. 2,3 Use automated instrumentation (modular systems, elementary robotics and automated immunoassay analysers) in your training laboratory, which incorporates the following techniques: KNOWLEDGE AND UNDERSTANDING The application of common biochemical markers of major organ function to a range of frequently encountered clinical disorders. The repertoire, specimen requirements, storage, ordering, reference ranges and turnaround times of the methods used to investigate major organ function. Request entry, result enquiry, result validation, rules base and reporting procedures. Minimum data set required for identification of samples and the importance of ensuring that this is complete and correct. Factors affecting sample integrity and appropriate corrective action. Types and implications of hazards and risks associated with handling specimens and relevant control measures. Procedures for handling samples which may contain category 2,3 and 4 pathogens. Safe laboratory practices, including principles of decontamination of equipment and work areas. Local and national health and safety policies and procedures and their application. Legal and ethical considerations and requirements in respect of examination, selection of control material and disposal of specimens. Relevant records, their importance and how to complete these correctly. Scientific basis of the following techniques: spectrophotometry, osmometry, ion selective electrodes, enzymology, immunochemical techniques, electrophoresis, chromatography and solid phase chemistry. The biological and statistical basis of biological variation, reference Page 37

38 KEY LEARNING OUTCOMES COMPETENCES ion selective electrodes spectrophotometry immunoassay enzymology plus one other from: fluorimetry nephelometry/turbidimetry. Use manual and semi-automated techniques to specified standard operating procedures, to include: spectrophotometry osmometers urine analysis (e.g. dipsticks or pregnancy tests) HbA1c analysis. 2,3 Use one of the following POCT methods/devices to specified quality standards: blood gas analysers co-oximetry blood glucose meters. 2,3 Perform analysis of the following analytes: albumin creatinine calcium bilirubin transaminases KNOWLEDGE AND UNDERSTANDING values and action limits. Use of calibration and control materials. The quality management process that ensures the correct location and storage of documentation and specimens at each stage of the process. The design, operation and performance of automated analytical platforms, including random access, modular, robotics, etc. Principles and practice of internal quality control and external quality assessment. Common analytical interferences caused by contamination, interferences, age of sample, etc. Performance of analyses in accordance with appropriate standard operating procedure. Page 38

39 KEY COMPETENCES LEARNING OUTCOMES troponin glucose sodium and potassium. 4,5 Produce reports using validated results on common clinical biochemistry investigations. 2,3 Control infection risks in accordance with departmental protocols. 2,3 Minimise risks and hazards in compliance with health and safety policies. KNOWLEDGE AND UNDERSTANDING The preparation of reports and the reporting process for patients being investigated for major organ function. Essential information to be included in a report (CPA report, standard). The appropriate use of interpretive comments and limits of responsibility in the authorisation and issue of reports. Critical action limits that may require urgent action and how to instigate such action. Limits of responsibility in the authorisation and issue of interpretative reports. Clinical conditions that may require urgent action and how to instigate such action. Normal and abnormal results and their significance to clinical question or condition. Protocols and requirements for hygiene and infection control related to the relevant range of investigations, including preparation, conduct and completion of investigation. Protocol for hand washing and how effective hand washing contributes to control of infection. The relevant health and safety regulations for laboratory and clinical investigations. The specific health and safety regulations for the specialism, type of specimen/sample and investigation. The potential hazards and risks and the actions to be taken to minimise these. Page 39

40 KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING Responsibilities and scope of practice of laboratory personnel involved in performing investigations and reporting those investigations to users. Page 40

41 This section describes the Learning Framework for the Rotational Component of work-based learning covering the Learning Outcomes, Clinical Experiential Learning, Competence and Applied Knowledge and Understanding. Each trainee is also expected to build on and apply the knowledge, skills and experience gained from the MSc in Clinical Science Rotational Module DIVISION THEME SPECIALISM Life Sciences Blood Sciences Clinical Immunology Page 41

42 MODULE TITLE AIM SCOPE Immunity and the Principles and Practice of Clinical Immunology (CI-1) COMPONENT Rotation This module will provide trainees with an introduction to the immune system and immune responses. Trainees will understand the organisation and delivery of a clinical immunology laboratory service. They will perform some common methods used in Clinical Immunology and gain an understanding of the interpretation of patient results in a variety of clinical settings. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Interpret routine requests for common clinical immunology investigations in the correct clinical context and process the specimens that accompany those requests. 2. Use laboratory IT systems for handling, processing and storage of patient data. 3. Perform a range of laboratory techniques used in the workplace in clinical immunology. 4. Report the results of commonly performed clinical immunology investigations of major organ function. 5. Apply the principles of internal quality control and external quality assessment and draw conclusions about assay performance. Page 42

43 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Participate in review meetings at which results from patients with at least two of the following are reviewed. Discuss the review process and outcomes in terms of the benefits of review for patient investigation and management. Protein disorders Autoimmune disease Immunodeficiency Allergy Observe and discuss with your trainer the investigation of the immune response, correct sampling technique and the use and validity of reference ranges. Review and report on the role of the immune response in common clinical disorders where the immune system is dysfunctional. Support the interpretation and reporting of laboratory results in the context of common clinical disorders where the immune system is dysfunctional. Present a report on the partnership between Clinical Immunology and other clinical specialisms in the investigation and management of disorders of the immune system. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 43

44 KEY COMPETENCES LEARNING OUTCOMES 1,2 Identify the most appropriate test for at least two example clinical presentations. 1,2 Receive, label and store of a wide range of immunological specimens. 3,5 Select and apply appropriate control materials. KNOWLEDGE AND UNDERSTANDING The repertoire, specimen requirements, referral pattern and storage, ordering, reference ranges and turnaround times of the methods used in Clinical Immunology. The major clinical users of the immunology service for protein tests, autoantibody tests and allergy tests. The range of investigative techniques used in Clinical Immunology and their application. Minimum data set required for identification of samples and the importance of ensuring that this is complete and correct. Factors affecting sample integrity and appropriate corrective action. Procedures for handling samples which may contain category 2,3 and 4 pathogens. Types and implications of hazards and risks associated with handling of specimens and relevant control measures. The quality management process that ensures the correct location and storage of documentation and specimens at each stage of process. Safe laboratory practices, including principles of decontamination of equipment and work areas. Local and national health and safety policies and procedures and their application. Relevant records, their importance and how to complete these correctly. Correct use of manual and computerised systems for generating labels for the products and components. Specimen preservation, distribution, separation, storage and disposal procedures. Selection and use of suitable and appropriate control materials. Use and application of reagents for analysis. Page 44

45 KEY LEARNING OUTCOMES COMPETENCES 3,5 Use automated methods, techniques and instrumentation to include at least four of the following: protein analysis immunoassay nephelometry/turbidimetry electrophoresis immunofixation iso-electric focusing densitometry immunoblotting immunodiffusion immunofluorescence microscopy agglutination assays flow cytometry allergy testing. 1,4,5 Interpret laboratory data in light of clinical details on patients with common disorders where the immune system is dysfunctional, including at least two of the following: protein disorders autoimmune disorders immunodeficiency disorders basic allergy testing. Page 45 KNOWLEDGE AND UNDERSTANDING Correct conditions and locations for storage of test reagents. Capabilities and limitations of methods, techniques and equipment. Use, care, monitoring, calibration and routine maintenance of clinical immunology laboratory equipment to include (relevant to automated methods available) from the following list: pipettes balances centrifuges refrigerators water baths incubators ph meters freezers radioactive counters, sample preparation units automated analysers. Organisation and components of the immune system. Immunoglobulins, complement and opsonins. Inflammatory markers. Ranges and values needed for interpretation of results. Cellular components (lymphocytes; granulocytes; monocytes/macrophages). Humoral components (autoantibodies: the range of autoantibodies and the role they play in autoimmune disease; immunoglobulins: importance of their levels and their absence; complement: importance of their levels and their absence).

46 KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING Central molecules of the immune system (major histocompatibility molecules class I & II; CD molecules/cell surface markers; receptor molecules; recognition molecules; adhesion molecules; effector molecules). Majority are used in conjunction with flow cytometry. It will be important to have a basic knowledge of their use in a clinical immunology laboratory and in which diseases their levels and absence is crucial. Antigen presentation. Innate immune response (endothelial cells; neutrophils; macrophages; natural killer cells; complement). Have a basic working knowledge of which of the components of the innate immune system routine assays can be usefully examined in a clinical immunology laboratory and in which suspected key diseases such assays are performed. Adaptive immune response (antigen processing; dendritic cells; T cell responses; B cell responses; primary and secondary responses; vaccination/immunisation). Have a basic working knowledge of which of the components of the adaptive immune system routine assays can be usefully examined in a clinical immunology laboratory and in which suspected key diseases such assays are performed. Outcome of immune responses (immunity/immunological memory; direct and indirect functions of antibodies; incidental tissue damage; hypersensitivity and allergy). Causes and physiological basis of allergy caused by IgE involvement. Have a good basic working knowledge of the major assay performed in clinical immunology laboratories that aid the diagnosis of suspected allergic reactions. Hypersensitivity causes and physiological factors. Have a good basic working knowledge of the major assays performed in a clinical immunology laboratory that will aid in the diagnosis of severe Page 46

47 KEY LEARNING OUTCOMES COMPETENCES 1,2,4 Produce basic interpretative reports on immunological investigations. 1,3 Control infection risks in accordance with departmental protocols. 1,3 Minimise risks and hazards in compliance with health and safety policies. KNOWLEDGE AND UNDERSTANDING hypersensitivity reactions. The information to be included in an interpretative report. How to construct an interpretative report and the format required for presentation. Limits of responsibility in the authorisation and issue of interpretative reports. Clinical conditions that may require urgent action and how to instigate such action. Normal and abnormal results and their significance to the clinical question or condition. Protocols and requirements for hygiene and infection control related to the relevant range of investigations, including preparation, conduct and completion of investigation. Protocol for hand washing and how effective hand washing contributes to control of infection. The relevant health and safety regulations for laboratory and clinical investigations. The specific health and safety regulations for the specialism, type of specimen/sample and investigation. The potential hazards and risks and the actions to be taken to minimise these. Responsibilities and scope of practice of laboratory personnel involved in performing investigations and reporting those investigations to users. Page 47

48 This section describes the Learning Framework for the Rotational Component of work-based learning covering the Learning Outcomes, Clinical Experiential Learning, Competence and Applied Knowledge and Understanding. Each trainee is also expected to build on and apply the knowledge, skills and experience gained from the MSc in Clinical Science Rotational Module DIVISION THEME SPECIALISM Life Sciences Blood Sciences Haematology and Transfusion Science Page 48

49 MODULE TITLE AIM SCOPE Haematology and Transfusion Science (HT-1) COMPONENT Rotation This module will provide trainees with the knowledge and understanding of the formation of red blood cells, the mechanism of haemostasis and the relevance of blood group antigens and antibodies. On completion of this module the trainee will understand the formation of red blood cells, the mechanism of haemostasis and the relevance of blood group antigens and antibodies. They will be able to apply the principles and practices of common methods used in haematology, haemostasis and blood transfusion, and perform a specified range of investigations in the laboratory. They will have gained an understanding of common clinical disorders associated with abnormal haematology and haemostasis and have some experience of the interpretation of patient results in a variety of clinical settings. They will have attached a basic knowledge of blood transfusion in a variety of settings, and an understanding of how to provide patients with safe and effective transfusion support. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Perform a range of laboratory techniques used in screening and investigating haematological disorders. 2. Perform the range of laboratory and point-of-care techniques (POCTs) used in the investigation of disorders of haemostasis. 3. Perform blood group serology in the context of pre-transfusion testing. 4. Select safe and appropriate blood and blood components for patients with a range of clinical conditions. 5. Apply the principles of internal quality control and external quality assessment and draw conclusions about assay performance. 6. Use laboratory IT systems for handling, processing and storage of patient data. Page 49

50 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Participate in the local programme for monitoring anticoagulation therapy. Reflect on its importance to the service, to the patient and the benefits for patient management. Under supervision, prepare a report for patients being investigated for one of the following: basic haematological disorders haemostasis blood transfusion. Attend multidisciplinary team meeting, including the identification of at least one clinical case and review/report on the benefits of a multidisciplinary approach to patient investigation and management. Review and discuss the scope of the hospital haematology laboratory in the investigation of basic haematological disorders, haemostasis and blood transfusion. Report and discuss with your trainer the range of blood components and products in common use and their correct storage. Provide support in the investigation of basic haematological disorders, and discuss with your trainer the correct sampling technique and the use and validity of reference ranges. Review and discuss the interpretation and reporting of laboratory results in the context of common clinical disorders. Reflect on and present a report regarding the partnership between Haematology and Transfusion Science and other clinical specialisms in the investigation and management of common disorders. Observe, support and reflect on blood film preparation, staining and interpretation in normal and pathological conditions, including parasites. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. Page 50

51 The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 51

52 KEY COMPETENCES LEARNING OUTCOMES 1,2,5,6 Receive, process and store common haematology specimens. 1,2,3,5,6 Interpret request forms and recommend the most appropriate investigation strategy to investigate: basic haematological disorders haemostasis patients for blood transfusion. KNOWLEDGE AND UNDERSTANDING Minimum data set required for identification of samples and the importance of ensuring that this is complete and correct. Factors affecting sample integrity and appropriate corrective action. Procedures for handling samples which may contain category 2, 3 and 4 pathogens. Types and implications of hazards and risks associated with handling of specimens and relevant control measures. The quality management process that ensures the correct location and storage of documentation and specimens at each stage of the process. Infection risk from blood samples. Safe laboratory practices, including principles of decontamination of equipment and work areas. Quality assurance procedures and their application. Local and national health and safety policies and procedures and their application. Relevant records, their importance and how to complete these correctly. The repertoire, specimen requirements, referral patterns and storage, ordering, reference ranges and turnaround times of the methods used to investigate the specified range of disorders and requests listed. Principles, scientific basis and clinical application of commonly performed analytical procedures in haematology. Significance and importance of bottle and anticoagulant types. The major clinical users of the haematology and transfusion service for the following core investigations: Page 52

53 KEY LEARNING OUTCOMES COMPETENCES 1,2,3 Interpret laboratory data in light of clinical details and prepare basic interpretive written reports on patients with at least two of the following: iron deficiency anaemia and iron overload haemolytic anaemia megaloblastic anaemia/folate deficiency polycythaemia abnormal haemoglobin and thalassaemia (initial tests) haematological malignancy (blood cell abnormalities). 1 Identify one case requiring urgent intervention and describe relevant clinical advice on follow-up and/or further management. Page 53 KNOWLEDGE AND UNDERSTANDING full blood counts coagulation testing pre-transfusion testing and requests for blood components. The clinical features and haematological characteristics of: iron deficiency and iron overload the anaemia of chronic disease abnormal haemoglobin and thalassaemia haematological malignancy. Relevant specific national/international guidelines. The information to be included in an interpretative report. How to construct an interpretative report and the format required for presentation. The lines of communication and responsibility for reporting reactions or complications both in the clinical management of the reaction and the documentation and reporting of the incident. Limits of responsibility in the authorisation and issue of interpretative reports. Normal and abnormal results and their significance to the clinical question or condition. Importance of pre-analytical variables. Reference values and the significance of abnormal results. Limitations of interpretation and reporting. How to deal with out-of-range quality control values. Clinical conditions that may require urgent action and how to instigate such action. Critical values in haematology. 1,2,5 Perform at least three of the Principles and scientific basis of automated analysers.

54 KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING following methods to specified quality Point-of-care testing in haematology. standards: Principles and methods of laboratory investigations and clinical automated analysers to quantify findings in testing of suspected inherited platelet disorders. erythrocytes, leucocytes, platelets, The effect of medication on results of testing. reticulocytes and white cell Bone marrow aspiration, trephine biopsy, preparation and staining differentiation techniques for the morphological identification of cells in bone erythrocyte sedimentation rate marrow in normal and pathological conditions. prepare blood and bone marrow aspirate films Collection of trephine and bone marrow aspirates and their correct application. peripheral blood cell microscopy Methods and techniques for preparation of bone marrow cells for recognition of malarial parasites. microscopy. Principles of microscopy. The principles of staining and the application of staining techniques. The pre-analytical variables that will affect the appearance of cells. 1,5,6 Interpret laboratory data in light of clinical details and prepare written Principles and correct use of the instrumentation, reagents and methodology to assess a specific coagulation factor deficiency. reports on patients with one of the Reference values and the significance of abnormal results. following: Interpretation of lupus results and the importance of confirmation common bleeding disorders test. common thrombotic disorders Relevance and significance of linearity and parallelism. lupus anticoagulation. Common clinical findings and laboratory investigation of suspected haemophilia A, B and von Willebrand disease. Laboratory findings in acquired coagulation disorders. Laboratory investigations of suspected factor inhibitors. Principles of replacement therapy. Effects of liver disease and vitamin K deficiency on coagulation factors. 1,2,5,6 Perform the following range of Appropriate time to investigate following a thrombotic event. Page 54

55 KEY LEARNING OUTCOMES COMPETENCES investigations: prothrombin time (PT) activated partial thromboplastin time (APTT) anticoagulation therapy monitoring (INR) POCT for INR d-dimer 3,5,6 Apply sample acceptance criteria for samples for pre-transfusion testing. Perform routine transfusion tests, including: indirect antiglobulin test (IAT) and immediate spin cross-match ABO and RhD typing antibody screening simple antibody identification by IAT and enzyme (single specificity) Rh and K red cell phenotyping. 3,5,6 Issue appropriate blood components for patients with a range of clinical conditions. Store blood components used locally in correct conditions. KNOWLEDGE AND UNDERSTANDING Laboratory investigations of venous thromboembolism (VTE) and arterial thrombosis. The effect of medication on results of testing. The principles of anticoagulant therapy, therapeutic ranges and laboratory monitoring of warfarin, unfractionated heparin and low molecular weight heparin. The use of d-dimer for the investigation of a suspected VTE. The relationship between abnormal anticoagulation screening and other laboratory tests such as full blood count and liver function tests. Basics of blood group systems genes, antigens and antibodies. The range of manual and automated routine serological tests, their underlying principles and appropriate use in pre-transfusion testing. Clinical significance of red cell antibodies. Antibody-mediated intra- and extravascular red cell destruction and the role of complement. Selection of controls for serological testing, recognising control failures and further actions required. The limitations of the testing repertoire available in-house and options for referral. Principles of, and current guidelines relating to, pre-transfusion testing. Use of IT systems to issue blood components, and the need for security/traceability. Awareness of the range of blood components / products available, their correct storage conditions and clinical use. Awareness that there are categories of patients requiring components with additional specifications, e.g. neonates, patients Page 55

56 KEY LEARNING OUTCOMES COMPETENCES 1,2,3,5 Produce a basic interpretative report on haematological investigations. 1,2,3,4 Control infection risks in accordance with departmental protocols. 1,2,3,4 Minimise risks and hazards in compliance with health and safety policies. KNOWLEDGE AND UNDERSTANDING with sickle cell disease (SCD). Awareness that some patients are not suitable for electronic issue (EI). Aetiology, pathophysiology and clinical features of conditions requiring transfusion support. Overview of legislation/guidelines relevant to blood transfusion practice. The information to be included in an interpretative report. How to construct an interpretative report and the format required for presentation. Limits of responsibility in the authorisation and issue of interpretative reports. Clinical conditions that may require urgent action and how to instigate such action. Normal and abnormal results and their significance to the clinical question or condition. Protocols and requirements for hygiene and infection control related to the relevant range of investigations, including preparation, conduct and completion of investigation. Protocol for hand washing and how effective hand washing contributes to control of infection. The relevant health and safety regulations for laboratory and clinical investigations. The specific health and safety regulations for the specialism, type of specimen/sample and investigation. The potential hazards and risks and the actions to be taken to minimise these. Responsibilities and scope of practice of laboratory personnel Page 56

57 KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING involved in performing investigations and reporting those investigations to users. Page 57

58 This section describes the Learning Framework for the Rotational Component of work based training covering the Learning Outcomes, Clinical Experiential Learning, Competence and applied Knowledge and Understanding. Each trainee is also expected to build on and apply the knowledge, skills and experience gained from the MSc in Clinical Science. Rotational Module THEME SPECIALISM ROTATION Life Sciences Blood Sciences Histocompatibility and Immunogenetics Page 58

59 MODULE TITLE AIM SCOPE Immunity and the Principles and Practice of Histocompatibility and Immunogenetics (H&I-7) COMPONENT Rotation This module will enable trainees to apply their knowledge and understanding of the immune system and immune responses to (i) the services provided by Histocompatibility and Immunogenetics (H&I) laboratory services and (ii) the organisation and delivery of these services. On completion of this module the trainees will apply their knowledge and understanding as they perform a range of laboratory techniques undertaken as part of the provision of H&I laboratory services. They will be able to interpret routine requests and test results in the correct clinical context across a range of clinical settings. They will also be able to use laboratory information technology systems, adhering to quality assurance and information governance processes. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Interpret routine requests for common H&I investigations in the correct clinical context and process the specimens that accompany those requests. 2. Use laboratory IT systems for handling, processing, storing and retrieving patient data. 3. Perform a range of laboratory techniques used in the workplace in H&I. 4. Report the results of commonly performed H&I investigations. 5. Apply the principles of internal quality control and external quality assessment and draw appropriate conclusions about assay performance. Page 59

60 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this rotation is: Participate in multi-disciplinary meetings at which results from patients are reviewed; discuss the review process and outcomes with your training supervisor in order to understand the benefits of the clinical review process for patient investigation and management. Observe and discuss with your training supervisor the investigation of the patient HLA profile, correct sampling technique and the use and validity of reference ranges. Review the role of the immune response in common clinical disorders where transplantation is the therapy of choice and present your review to your colleagues at a departmental meeting. Regularly participate in discussions on the interpretation and reporting of laboratory results in the context of common clinical disorders where transplantation is the therapy of choice; critically reflect on your learning and set out your development actions in a plan as part of your continuing professional development plan. Use your experience to critically reflect on the partnership of H&I to other clinical specialisms in the investigation and management of patients requiring transplantation, identifying areas of good practice and areas where changes may result in stronger partnerships. Document how this learning will impact on your future role as a clinical scientist. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 60

61 KEY COMPETENCES LEARNING OUTCOMES 1,2 Identify the appropriate tests for at least two H&I clinical presentations. 1,2 Receive, label and store a range of immunological specimens Serum specimens DNA specimens Lymphocyte specimens 3,5 Select and apply appropriate control materials. 3,5 Use automated methods, techniques and instrumentation to include at least Page 61 KNOWLEDGE AND UNDERSTANDING The repertoire, specimen requirements, referral pattern and storage, ordering, reference ranges and turnaround times of the methods used in H&I. The major clinical users of the H&I service. The range of investigative techniques used in H&I and their application. Minimum data set required for identification of samples and the importance of ensuring that this is complete and correct. Factors affecting sample integrity and appropriate corrective action. Procedures for handling samples which may contain category 2,3, and 4 pathogens. Types and implications of hazards and risks associated with handling of specimens and relevant control measures. The quality management process that ensures the correct location and storage of documentation and specimens at each stage of process. Safe laboratory practices including principles of decontamination of equipment and work areas. Local and national Health and Safety policies and procedures and their application. Relevant records, their importance and how to complete these correctly. Correct use of manual and computerised systems for generating labels for the products and component. Specimen preservation, distribution, separation, storage and disposal procedures. Selection and use of suitable and appropriate controls. Use and application of reagents for analysis. Correct conditions and locations for storage of test reagents. Capabilities and limitations of methods, techniques and equipment. Use, care, monitoring, calibration and routine maintenance of clinical

62 KEY LEARNING OUTCOMES COMPETENCES four of the following: Immunoassay Electrophoresis Immunoflourescence Microscopy Flow cytometry X map technology Complement dependent cytotoxicity PCR 1,4,5 Interpret laboratory data in the light of clinical details on patients with common disorders where transplantation is the therapy of choice, including at least 2 of the following; Autoimmune disorders Immunodeficiency disorders Renal disorders Other solid organ disorders Haematological malignancies Disease associations Drug hypersensitivity KNOWLEDGE AND UNDERSTANDING immunology laboratory equipment to include (relevant to automated methods available) from the following list: Pipettes Balances Centrifuges Refrigerators Water baths Incubators ph meters freezers automated analysers flow cytometer thermal cycler Organisation and components of the immune system. Ranges and values needed for interpretation of results. Cellular components (lymphocytes; granulocytes; monocytes/macrophages). Humoral components (autoantibodies, the range of autoantibodies and the role they play in autoimmune disease; immunoglobulins and the importance of their levels and their absence; complement and the importance of their levels and their absence). Central molecules of the immune system (major histocompatibility molecules, classes I ⅈ Cluster of Differentiation (CD) molecules/cell surface markers; receptor molecules; recognition molecules; adhesion molecules; effector molecules). Antigen presentation. Innate immune response (endothelial cells; neutrophils; macrophages; natural killer cells; complement). Page 62

63 KEY LEARNING OUTCOMES COMPETENCES 1,2,4 Produce interpretative reports on laboratory investigations. 1,3 Control infection risks in accordance with departmental protocols. 1,3 Minimise risks and hazards in compliance with Health and Safety policies. KNOWLEDGE AND UNDERSTANDING Adaptive immune response (antigen processing; dendritic cells; T cell responses; B cell responses; primary and secondary responses; vaccination/immunisation). The adaptive immune system routine assays which can be usefully examined in an H&I laboratory. Outcome of immune responses (immunity/immunological memory; direct and indirect functions of antibodies). Major assays performed in an H&I laboratory. The information to be included in an interpretative report. How to construct an interpretative report and the format required for presentation. Limits of responsibility in the authorisation and issue of interpretative reports. Clinical conditions which may require urgent action and how to instigate such action. Normal and abnormal results and their significance to clinical question or condition. Protocol for hand washing and awareness of how effective hand washing contributes to control of infection. Protocols and requirements for hygiene and infection control related to the relevant range of investigations, including preparation, conduct and completion of investigation. The relevant health and safety regulations for laboratory and clinical investigations. Any specific health and safety regulations required in H and I, taking into account the sample and the investigation. The potential hazards and risks and the actions to be taken to minimise these. Page 63

64 KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING Responsibilities and scope of practice of laboratory personnel involved in performing investigations and reporting those investigations to users. Page 64

65 This section describes the Learning Framework for the Rotational Component of work-based learning covering the Learning Outcomes, Clinical Experiential Learning, Competence and Applied Knowledge and Understanding. Each trainee is also expected to build on and apply the knowledge, skills and experience gained from the MSc in Clinical Science. Rotational Module DIVISION THEMES SPECIALISM Life Sciences Blood, Cellular and Genomic Sciences Genetics, Genomics and Molecular Science Page 65

66 MODULE TITLE AIM SCOPE Genetics, Genomics and Molecular Science (CG-1) COMPONENT Rotation This module will provide the trainee with an introduction to human genetics, genomics and molecular science. They will understand the organisation and delivery of a genetics laboratory service. They will perform some common methods used in genetics and genomics and gain an understanding of the interpretation of patient results in a variety of clinical settings. The investigation, interpretation and reporting of chromosomal abnormalities and molecular disease, using the correct sampling and laboratory techniques, including the application of principles of quality control and the use of IT systems. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Observe and reflect on the patient pathway from sample receipt to issuing of the clinical reports for a range of genetic referrals. 2. Observe and reflect on preparation of samples for genetic analysis in current use. 3. Apply the correct genetic nomenclature to genetic alteration, including International System for Chromosome Nomenclature (ISCN) and Human Genome Variation Society (HGVS) nomenclature. 4. Identify the appropriate testing strategy for a range of referral reasons. 5. Apply the principles of internal quality control and external quality assessment and draw conclusions about assay performance. 6. Assist with the interpretation and reporting of laboratory results in the context of named genetic disorders. 7. Participate in activities that involve working in partnership with other clinical specialisms in the investigation of patients referred for genetic disorders. Page 66

67 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Attend multidisciplinary team meetings at which the results of genetic and genomic investigations are discussed and reflect on discussions and the impact of multidisciplinary working on patient treatment and management, in addition to the partnership between Genetics and other clinical specialisms in the investigation of genetic and genomic disorders functions in the patient pathway. Attend specialist genetics clinics and review/report on the process, patient engagement and experience in connection with the work of these clinics. LABORATORY EXPERIENTIAL LEARNING Observe cell culture and chromosome preparation techniques and reflect on their importance in the investigation process Gain experience of each of the following and personally reflect on the importance, application and effect on patient management: o Investigation of chromosomal abnormality, the correct sampling technique, relevant quality parameters and the correct use of nomenclature o Investigation of the molecular basis of disease, the correct sampling technique, relevant quality parameters and the correct use of nomenclature o Interpretation and reporting of laboratory results in the context of named genetic disorders Page 67

68 KEY COMPETENCES LEARNING OUTCOMES 1,2,3,4 Apply infection control risks in accordance with departmental protocols. 1,2,3,4 Minimise risks and hazards in compliance with health and safety policies. 1,3,5,7 Critically reflect on referral patterns for genetic investigation following standard laboratory practices including sample receipt. KNOWLEDGE AND UNDERSTANDING Protocols and requirements for hygiene and infection control related to the relevant range of investigations, including preparation, conduct and completion of investigation. Protocol for hand washing and how effective hand washing contributes to control of infection. The relevant health and safety regulations for laboratory and clinical investigations. The specific health and safety regulations for the specialism, type of specimen/sample and investigation. The potential hazards and risks and the actions to be taken to minimise these. Responsibilities and scope of practice for laboratory personnel involved in performing investigations and reporting those investigations to users. Minimum data set required for identification of samples and the importance of ensuring that this is complete, correct and appropriate. Factors affecting sample integrity and appropriate corrective action. Procedures for handling samples which may contain category 2, 3, and 4 pathogens. Use of laboratory and hospital information systems to identify and record patient demographics, clinical details and relevant laboratory results. The importance of maintaining correct and unique labelling, including transfer of labels throughout the preparation. Process documentation relevant to sample preparation and its importance. Retention policy for diagnostic materials and records of analysis. Ethical guidelines for testing and storage of diagnostic materials. Common reasons for referral of genetic investigations. Page 68

69 KEY LEARNING OUTCOMES COMPETENCES 1,2,3,4 Observe and assist with the preparation of samples for genetic testing. 1 Perform a basic chromosome analysis on a minimum of three cases that demonstrate different chromosomal syndromes or anomalies. 2 Perform a basic dosage analysis using chromosomal microarray. KNOWLEDGE AND UNDERSTANDING Factors to be considered to determine which processing pipeline is the most appropriate in order to generate a robust result for the patients. The purpose, process, capabilities and limitations of cell culture procedures and associated equipment. Cell culture, slide making and chromosome preparation techniques (Gbanding) and their importance in the investigation process. The purpose, process, capabilities and limitations of nucleic acid extraction procedures and associated equipment. Relevant protocols and their application, including health and safety considerations. Requirements for containment levels to maintain the integrity of the sample and to protect the member of staff. The quality and quantity of DNA/RNA required for each test to be performed. Factors affecting the quality of extractions. The range and requirements for records and documentation associated with extractions. Basic chromosome identification. Karyotype construction. G-banding. Numerical and structural anomalies and normal variation. Relationship of basic chromosomal anomalies to clinical features in patients. Correct ISCN nomenclature. Correct nomenclature for description of any copy number changes. Principles and applications of relevant methods and techniques. The principles of chromosomal microarray. The significance of sensitivity and limitations of technique. Page 69

70 KEY LEARNING OUTCOMES COMPETENCES 3 Observe and assist with the range of laboratory methods and their application to generate genetic test results for patients. 4 Perform a basic molecular analysis on three cases demonstrating common genetic condition. KNOWLEDGE AND UNDERSTANDING Relevant current quality control procedures and characteristics of substandard results. Factors affecting the integrity of samples and reagents, and contamination. The nature and effect of possible artefact. Use of appropriate analytical software and clinically interpret findings. Principles and applications of relevant methods and techniques. The principles of PCR and sequence methods, including the significance of contamination, sensitivity and associated hazards and risks. The principles of chromosomal microarray and other dosage techniques, including the significance of contamination, sensitivity and associated hazards and risks. Relevant internal quality control procedures and characteristics of substandard reactions. Factors affecting the integrity of samples and reagents and relevant sensitivities to conditions of cold, heat and light. Principles of electrophoresis of nucleic acids. Principles of radioactive and fluorescent image detection. Principles of mutation detection and DNA sequencing. Limitations and sensitivity of each test method. The nature and effect of possible artefacts. Analysis of results following standard laboratory procedures. The clinical background and molecular pathology of the disorder being investigated. The range of tests available for the individual or the family. Significance of previous results in relation to the current sample. Relevant professional guidelines and correct interpretation. Page 70

71 KEY COMPETENCES LEARNING OUTCOMES 5 Apply internal quality control (IQC) and external quality assessment (EQA) methods used in genetics. 6 Use software for tasks related to genetic analysis. To include a general introduction to bioinformatics. 6,7 Support the preparation of reports and the reporting process for patients being investigated for genetic disorders. KNOWLEDGE AND UNDERSTANDING The importance of IQC during the entire testing process. Importance of participating in EQA. The development and application of national guidance. Validation and verification of analytical processes and procedures. Requirements for UKAS accreditation and ISO Access, use and limitations of genome and mutation databases. Importance of maintaining long-term records to inform management of heritable genetic disorders in future generations and genomic changes within an individual associated with a clinical disorder. Limits and performance characteristics of each test, including instrumentation and software packages for data analysis. Range of reporting formats and options. Relevant professional guidelines for reporting. Policy for authorisation and disclosure of results and the need for confidentiality and information governance. Factors involved in evaluation of clinical risk to the patient and their family. Procedures for issuing written results, verbal results or for faxing. Patterns of inheritance (Mendelian and non-mendelian), including imprinting. Page 71

72 Blood Sciences SECTION 4: PROFESSIONAL PRACTICE LEARNING FRAMEWORK Page 72

73 This section describes the Learning Framework for the Professional Practice Component of workbased learning covering the Learning Outcomes, Clinical Experiential Learning, Competence, and Applied Knowledge and Understanding. This module spans the Rotational and Specialist period of training. Each trainee is also expected to build on and apply the knowledge, skills and experience gained from the MSc in Clinical Science DIVISION THEME SPECIALISM PROFESSIONAL PRACTICE Life Sciences, Physiological Sciences, Physical Sciences ALL ALL Page 73

74 Introduction Good Scientific Practice (GSP) sets out the principles and values on which good practice undertaken by the Healthcare Science workforce is founded. GSP sets out for the profession and the public the standards of behaviour and practice that must be achieved and maintained in the delivery of work activities and the provision of care. GSP uses as a benchmark the Health Professions Council (HPC) Standards of Proficiency and Standards of Conduct, Performance and Ethics, but expresses these in the context of the modalities within Healthcare Science. Good Scientific Practice represents standards and values that apply throughout an individual s career in Healthcare Science at any level of practice. Therefore the standards have been contextualised for the role of healthcare scientist. There will, however, always be a requirement for an individual to work within the limits of their scope of practice and competence. Professional Practice in the STP Training Programme This generic professional practice module, which all STP trainees have to complete, defines the knowledge, skills and experience that each trainee is expected to gain and apply during the STP programme and develop in subsequent employment. The degree to which each specialism applies the knowledge, skills and experience will vary, but this module sets the baseline for all trainees. Each rotational and specialist learning framework then develops areas as appropriate, for example clinical history taking in patientfacing specialisms. While it is expected that trainees will be able to achieve the majority of the learning outcomes and competences within their specialism, some specialisms may have to make special arrangements to ensure all trainees achieve the learning outcomes and competences defined in this learning framework. For example, to work with a local clinical skills laboratory to help trainees develop basic skills in history taking. The Learning Framework that defines the learning outcomes, clinical experiential learning, competences, and knowledge and understanding are contained on the following pages. Page 74

75 MODULE TITLE AIM SCOPE Professional Practice (PP1) COMPONENT GENERIC Professional Practice is part of the generic curriculum (applicable to all trainees) on the Scientist Training Programme. The overall aim of the module is to ensure that each trainee has the underpinning knowledge and applies this and the accompanying skills and attitudes to work as a healthcare scientist in accordance with Good Scientific Practice (GSP). GSP sets out the principles and values on which the practice of Healthcare Science is undertaken. It sets out for the profession and the public the standards of behaviour and practice that must be achieved and maintained in the delivery of work activities and the provision of care. This module encompasses the knowledge, skills, experience and attitudes across four of the five domains of Good Scientific Practice, namely Professional Practice, Scientific Practice, Clinical Practice, Research and Development, and Clinical Leadership, but all other modules within this programme will contribute to embedding professional practice at the centre of the work of each trainee. LEARNING OUTCOMES On successful completion of this module the trainee will: Professional Practice 1. Place the patient at the centre of care in daily practice, ensuring the needs of patients are respected. 2. Communicate with patients, relatives, service users, other healthcare professionals, colleagues and the public with respect, empathy and sensitivity, including listening, speaking, giving and receiving information, giving and receiving feedback. 3. Respond to the ethical and legal issues and challenges arising from the practice of Healthcare Science. 4. Demonstrate a commitment to the continuing professional development of themselves and others, and attend professional meetings. Clinical Practice 5. Make appropriate and effective use of information and communication technology. 6. Under supervision, obtain a patient history from a normal volunteer or typical patient referred to your service and present the findings to a colleague or peer in order to understand the clinical decision-making process in clinical practice. 7. Promote the importance of patient safety and general health, safety and security in the workplace, including infection control and information governance. Page 75

76 Research, Development and Innovation 8. Apply knowledge, skills and experience of research, development and innovation appropriate to the role in order to identify effectively actions that will improve service provision. 9. Engage in evidence-based practice, participate in audit procedures and critically search for, appraise and identify innovative approaches to practice and delivery. Clinical Leadership 10. Demonstrate a range of leaderships skills required of an emerging leader within Healthcare Science. Page 76

77 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Attend clinics, ward rounds, treatment and/or rehabilitation sessions, etc., in primary or secondary care, or in the charity or voluntary sector where patients attend, and observe how patient professional relationships are developed and maintained, and reflect on how the following impact on the patient professional relationship: response to illness patient and carer perspective health belief models diversity of the patient experience disability, including learning disabilities potential health inequalities self-care impact of life-threatening and critical conditions patient involvement in decisions regarding their healthcare. Observe a current screening programme in the workplace and discuss the principles and practice of screening programmes in healthcare as a means of reducing disease burden with your training officer. Observe and participate in internally and externally accredited quality management systems and critically appraise both in your area of practice. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 77

78 KEY LEARNING OUTCOMES COMPETENCES 1 Treat each patient as an individual, respecting their dignity and confidentiality and upholding the rights, values and autonomy of every service user. 1 Discuss personal values, principles and assumptions, emotions and prejudices, and how these may influence personal judgement and behaviour, and identify how you will practise in accordance with Good Scientific Practice. 2 Communicate effectively with the public, services users and other healthcare professionals, adapting Professional Practice KNOWLEDGE AND UNDERSTANDING NHS Constitution. Patient-centred care and the patient carer perspective with respect to: response to illness patient and carer perspective health belief models diversity of the patient experience disability, including learning disabilities potential health inequalities self-care impact of life-threatening and critical conditions patient involvement in decisions regarding their healthcare. Local guidelines for responding to unacceptable behaviour by patients, carers, relatives, peers and colleagues, including harassment, bullying and violent behaviour. Good Scientific Practice. The importance of maintaining own health. The principles of effective communication including: written and electronic, verbal and non-verbal and feedback the way effective communication can assist in identifying problems accurately, increase patient satisfaction, enhance treatment adherence, and reduce patient Page 78

79 KEY LEARNING OUTCOMES COMPETENCES communication style and language to meet the needs of listeners. 2 Give and receive feedback sensitively to or from a peer or colleague. 2 Obtain, analyse and act on feedback from a variety of sources and use it to consider personal impact and change behaviour. 2 Present complex ideas in understandable terms in both oral and written formats. 2 Use effective negotiation skills, including influencing colleagues. 2 Work constructively and effectively as a member of a multidisciplinary team. 3 Comply with relevant guidance and laws, to include those relating to: your scope of practice research ethics and KNOWLEDGE AND UNDERSTANDING distress and anxiety the importance of some key ideas, for example signposting, listening, language, non-verbal behaviour, ideas, beliefs, concerns, expectations and summarising in communication the range of question types that can be used in a communication. The range of feedback models for giving and receiving feedback. The evidence base underpinning the importance of effective feedback/feedback models. How to analyse feedback and frameworks for action planning. Behavioural change models. The importance of public engagement in science and its role in health and society. The factors that enable scientists to communicate to specialist and non-specialist audiences. Barriers to effective communication. Communication channels with/in your host department; patients and the public; your employing institution; your profession and professional body; the wider Healthcare Science community. The underpinning principles of effective teamwork and working within and across professional boundaries. Principles, guidance and law with respect to: medical ethics confidentiality information governance informed consent Page 79

80 KEY LEARNING OUTCOMES COMPETENCES governance patient confidentiality data protection equality and diversity use of chaperones informed consent. 4 Contribute to the education and training of colleagues. 4 Take responsibility for your learning and demonstrate a commitment to continuing professional development. 4 Meet commitments and goals in your professional practice, using a range of organisational and planning tools. 4 Reflect on your practice and generate a reflective diary that demonstrates how you utilise the skills required of an independent learner and your commitment to your continuing professional development. 4 Take responsibility for keeping your professional and scientific knowledge KNOWLEDGE AND UNDERSTANDING equality and diversity child protection elder abuse use of chaperones probity fitness to practise. The importance of maintaining your own health. The key principles and evidence base underpinning clinical education, encompassing curriculum design, planning, delivery and assessment. How continuous personal development can improve personal performance. Different methods of planning, prioritising and organising, and how they can enhance personal effectiveness. Core theories of learning, particularly adult learning and reflective practice, and demonstrate how these are relevant to your practice as a healthcare scientist. Personal values, principles and assumptions, emotions and prejudices, understanding how these may influence personal judgement and behaviour. The role of critical reflection and reflective practice and the methods of reflection that can be used to maintain or improve knowledge, skills and attitudes. How to horizon scan, identify and evaluate the potential role for new and innovative technologies and scientific advances. Page 80

81 KEY COMPETENCES LEARNING OUTCOMES and skills up to date. 4 Develop an action plan based on your experiential learning and reflection on completion of the Scientist Training Programme. 5 Use a range of information and communication technologies within the workplace for service delivery, research, audit and innovation, including data filing and archiving: word processing databases statistics packages PowerPoint internet . 6 Under supervision, demonstrate that you can obtain and present a patient history from a normal volunteer or consenting patient in order to better understand the KNOWLEDGE AND UNDERSTANDING Action planning. Models and frameworks for critical reflection. Clinical Practice The range and application of clinical information systems used in the work base. The systems in use in the work base to file and archive information and the processes for retrieval. The principles underpinning identification, storage and retrieval of scientific literature for example end note/end note web. The purpose of a range of NHS information systems, including the regulations in place to ensure data security and confidentiality. This may include hospital information system, linked information systems (e.g. laboratory information management system) and middleware linking equipment to information systems. The importance of patient-centred care and how it ensures that the wishes, beliefs, concerns, expectations and needs of patients are respected. Patient and carer perspective with respect to illness, disability, health inequalities and diversity of the patient experience. Structured models for presenting a patient history. Process of patient-centred interviewing and the features of a good consultation, including Initiating the session, gathering information, building the relationship, Page 81

82 KEY LEARNING OUTCOMES COMPETENCES clinical decision-making process in your clinical practice. 7 Apply current regulations with respect to patient safety and safe systems within the workplace. To include, as appropriate to scope of practice: risk management biological specimen handling COSHH RIDDOR radioactivity fire safety electrical safety moving and handling display screen equipment incident reporting infection control. 7 Use clinical coding and medical terminology in accordance with stated guidance, as appropriate to scope of practice. KNOWLEDGE AND UNDERSTANDING explaining and planning, and closing the session. Link between the patient history and examination and development of clinical investigation and management plans. The importance of health and safety within the workplace, wider healthcare environment and NHS. Principles, process and governance of risk management. Factors influencing health, safety and security. Current legislation, codes of practice, guidance notes and related documents. Principles and practice of health and safety in the workplace. The requirements of relevant local health and safety guidelines, manuals and other documents, including the underpinning legislation. The cause of errors related to patient safety, including patient and/or sample identification. The importance of the correct use of clinical coding and medical terminology in contributing to good healthcare science practice. Information governance principles and process. 7 Keep accurate records in Best practice recommendations for record keeping and data security. Page 82

83 KEY LEARNING OUTCOMES COMPETENCES accordance with current guidelines and the legal framework for data security. 7 Use, in your practice: standard operating procedures protocols clinical guidelines. 7 Continuously improve your practice through good practice in: identifying common sources of error identification of risk reporting critical incidents. 8,9 Participate in innovation, research, service development and audit activities complying with compliance with guidance and laws relating to research ethics. KNOWLEDGE AND UNDERSTANDING The Data Protection Act and current key guidelines, and the legal framework for data security. Standard operating procedure, protocol and guideline, and understand the purpose of and difference between each document. Evidence base that underpins the use of procedures employed by the service. The desirability of monitoring performance, internal and external quality control, learning from mistakes and adopting a no-blame culture in order to ensure high standards of care and optimise patient safety. The importance of honesty and effective apology in responding to errors of practice. The principles and practice of risk management and the effective investigation of incidents, resulting in the identification of root causes. Research and Innovation The importance of innovation across healthcare science. The role of innovation in improving quality and patient care. Processes to disseminate innovation, research and audit findings. The role of the healthcare scientist and the potential impact of scientific research in your area of practice. The role of the healthcare scientist in service developments in your area of practice. Current and developing clinical practice. The effectiveness of investigations, therapies, interventions and treatments and the mechanisms by which they contribute to patient care. How to horizon scan, identify and evaluate the potential role for new and innovative technologies and scientific advances. Page 83

84 KEY LEARNING OUTCOMES COMPETENCES 8,9 Contribute to service and quality improvement and productivity in the work base and embed evidence-based developments within routine practice. 8,9 Undertake a literature review and prepare and present to peers a critical analysis of a publication from the scientific literature. 8,9 Prepare and deliver an oral scientific communication to peers at a local, national or international meeting. 10 Lead in your clinical role through appropriate application of; KNOWLEDGE AND UNDERSTANDING The role of the healthcare scientist and the potential impact of scientific developments, for example health prevention, genomic medicine, diagnostics and rehabilitation. The importance of public engagement in science and its role in health and society. The legal framework relevant to informed consent and the application to clinical care, research, audit and teaching. How planning can actively contribute to the achievement of service goals. How to measure and monitor performance against agreed targets. The current structure, management, legal framework and quality improvement structures and processes within the NHS. The current quality improvement structures and processes within the NHS and give examples of the implications for Healthcare Science. Importance of self-care and shared care as part of NHS function and the impact of life-threatening and critical conditions. Principles and application of evidence-based practice. How to critically analyse scientific literature. How to structure and present a critical analysis. Systems of referencing. Reference manager software. How to prepare an oral scientific communication. How to give an effective and timely oral presentation. How to respond to questioning. Clinical Leadership How self-awareness, self-management and self-development and acting with integrity at all times contribute to leadership. The use of evidence, both positive and negative to identify options in addressing Page 84

85 KEY COMPETENCES LEARNING OUTCOMES self-management self-development integrity self-direction problem solving dealing with complex issues making sound judgements in the absence of complete data. 10 Identify potential areas for change and accept change identified by others, working across different provider landscapes as required. KNOWLEDGE AND UNDERSTANDING challenges. Methods of prioritising and organising academic and work-based tasks to optimise own performance. Structure of the NHS. The need for change, working across different provider landscapes as required. Change management methodologies. Page 85

86 Blood Sciences SECTION 5: ELECTIVE LEARNING FRAMEWORK Page 86

87 STP Learning Framework This section describes the Learning Framework for the Elective component of Specialist work-based learning, covering the Learning Outcomes, Clinical Experiential Learning, Competence, and Applied Knowledge and Understanding. This module spans the Rotational and Specialist period of training. Each trainee is also expected to build on and apply the knowledge, skills and experience gained from the MSc in Clinical Science ELECTIVE DIVISION THEME SPECIALISM Life Sciences, Physiological Sciences, Physical Sciences and Biomedical Engineering ALL ALL The elective period can be taken any time during the specialist training. It may comprise a single 4- to 6-week elective or a series of shorter periods of elective training. Page 87

88 MODULE TITLE AIM SCOPE Elective (EL) COMPONENT Specialist The aim of the elective period is to facilitate wider experience of healthcare and/or the practice of Healthcare Science in a cultural and/or clinical setting that is different from the usual training environment. This may involve healthcare or Healthcare Science in a different area of the health service, or in pursuit of a particular clinical or research interest. The elective provides opportunities for you to: explore in depth areas of particular interest beyond the scope of the scientist training programme increase awareness of important health issues and develop an understanding of the effect of disease on communities and individuals in different cultural contexts explore unfamiliar scientific, social, economic or cultural areas become more proficient at communication with individuals from different social, cultural and ethnic backgrounds gain hands-on experience that might not otherwise be possible in a scientist training programme design and undertake a significant assignment with appropriate guidance and supervision, thereby developing personal and organisational skills undertake a small audit or research project in a different clinical setting relate your experiences to your own area of practice. LEARNING OUTCOMES Learning outcomes are specific to each student: with guidance, you are expected to identify your own educational objectives and organise an elective to achieve them. On successful completion of this module the trainee will: 1. Agree, organise and complete a period of education and training that provides a wider experience of healthcare and/or the practice of healthcare science, and aligns with Good Scientific Practice. 2. Critically reflect on your experience in your elective and develop an action plan as part of your continuing personal and professional development. 3. Prepare a presentation and present your elective experiences to colleagues, including trainee healthcare scientists. Page 88

89 KEY COMPETENCES LEARNING OUTCOMES 1 Produce learning outcomes for the elective training period and link these to Good Scientific Practice. 2 Write a report of your elective training that includes your learning outcomes (mapped to Good Scientific Practice), a critical reflection on your experience and an action plan. 3 Plan, prepare and deliver an oral presentation that describes and reflects on the learning from your elective and shows how your experience will shape your future practice. KNOWLEDGE AND UNDERSTANDING Good Scientific Practice. Report writing. Critical reflection. Action planning. How to prepare an oral communication. How to give an effective and timely oral presentation. Use of visual aids. How to respond to questioning. Page 89

90 Blood Sciences SECTION 6: SPECIALIST WORK-BASED LEARNING FRAMEWORK: CLINICAL BIOCHEMISTRY Page 90

91 This section describes the Learning Framework for the Specialist Component of work-based learning covering the Learning Outcomes, Clinical Experiential Learning, Competence and Applied Knowledge and Understanding. Each trainee is also expected to build on and apply the knowledge, skills and experience gained from the MSc in Clinical Science Specialist Modules DIVISION THEME SPECIALISM Life Sciences Blood Sciences Clinical Biochemistry Page 91

92 CLINICAL BIOCHEMISTRY:SPECIALIST MODULES Module 1 (CB-2) Module 2 (CB-3) Module 3 (CB-4) Module 4 (CB-5) Module 5 (CB-6) Clinical Disorders of the Major Organs and Cancer Endocrinology and Diabetes Nutrition Drug Investigation Pregnancy, Neonatology and Paediatric Clinical Biochemistry Page 92

93 MODULE 1 AIM SCOPE Clinical Disorders of the Major Organs and Cancer (CB-2) COMPONENT Specialist Provide detailed knowledge and understanding of the normal physiology of the major organs and the biochemical analyses used for the investigation of major organ dysfunction and malignancies. Perform the analyses used in the investigation of major organ function and gain experience in result interpretation. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Perform the range of laboratory and point-of-care testing techniques used in the work-base to investigate major organ function. 2. Perform clinical and laboratory investigation of homeostatic mechanisms. 3. Perform clinical and laboratory investigation of kidney function and renal replacement therapy. 4. Perform clinical and laboratory investigation of liver function. 5. Perform clinical and laboratory investigation of cardiac function in acute and chronic conditions. 6. Perform clinical and laboratory investigation of bone metabolism. 7. Apply Clinical Biochemistry to the screening, diagnosis and treatment of common cancers. 8. Perform clinical and laboratory investigation of disorders associated with specific protein abnormalities. 9. Interpret and report clinical and laboratory investigation and analysis in the correct clinical context. Page 93

94 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Participate in multidisciplinary review meetings at which biochemical results of major organ function and malignancies are presented as part of the clinical record and prepare reports. Reflect on your experience in terms of the role of multidisciplinary working and its benefits for patients. Attend ward rounds and clinics at which patients are being investigated for disorders of major organ function and malignancies and prepare reports. Select, with permission, one patient and follow their investigative and diagnostic experience. Reflect and report on the results with regard to service delivery and patient care. Visit a GP centre and review/reflect on its use of the clinical biochemistry service and the role of GPs, nurses and other staff in the patient pathway. Suggest possible improvements to this service. Attend a phlebotomy clinic to observe patients undergoing venepuncture. LABORATORY EXPERIENTIAL LEARNING Become familiar with the laboratory quality management system and perform examination and other audits as part of the laboratory accreditation process (applies to all specialist modules). PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 94

95 KEY LEARNING OUTCOMES COMPETENCES 1,2 Perform the analyses to laboratory standard operating procedures on patients with: fluid balance disorders acid base disorders fluid replacement therapy. 1,3 Perform the analyses to laboratory standard operating procedures on patients with disorders of: renal pathophysiology. 1,4 Perform the analyses to laboratory standard operating procedures on specimens for: liver function tests INR (international normalised ratio) tumour markers ferritin and iron saturation copper and caeruloplasmin. 1,5 Perform the analyses to laboratory standard operating procedures specimens for: cardiac biomarkers Page 95 KNOWLEDGE AND UNDERSTANDING The common causes of fluid balance disorders. Acid base disorders. Differential diagnosis and further investigation of the following conditions: hypo- and hyperkalaemia hypo- and hypernatraemia. The causes of acute kidney injury. The causes and stages of chronic renal failure. How the following conditions are monitored: renal replacement therapy renal transplantation. Differential diagnosis and further investigation of the following conditions: renal tubular acidosis renal calculi. The causes of jaundice, acute and chronic hepatitis, cirrhosis, alcohol/drug hepatotoxicity, cholestatic liver disease, fatty liver disease. The inherited causes of liver disease (e.g. haemochromotosis, alpha-1 antitrypsin deficiency, Wilson s disease). Identification of liver malignancies and monitoring of treatment. Cardiovascular risk stratification. The causes of primary and secondary cardiovascular disease and treatment strategies. Acute coronary syndromes and chronic heart failure and the efficacy

96 KEY LEARNING OUTCOMES COMPETENCES lipids metadrenalines renin and aldosterone. 1,6 Perform the analyses to laboratory standard operating procedures on: bone metabolism (calcium, phosphate, magnesium and alkaline phosphatase) vitamin D and its metabolites parathyroid hormone (PTH) markers of bone turnover. 1,7 Perform the analyses to laboratory standard operating procedures on: tumour markers. 1,8 Perform the analyses to laboratory standard operating procedures on: markers of inflammation immunoglobulins and paraproteins Page 96 KNOWLEDGE AND UNDERSTANDING of treatment options. Suitable investigations for hypertension. The abnormalities of bone metabolism. The causes of hypo- and hypercalcaemia. Hypo- and hypermagnesaemia. Hypo- and hyperphosphataemia. The suitability of tumour markers for screening, diagnosis, prognosis and monitoring treatment of the following malignancies: prostate cancer Gastrointestinal (GI) tract cancers pancreatic cancer bladder cancer lung cancer liver cancer ovarian cancer breast cancer choriocarcinoma testicular cancer. The abnormalities of protein metabolism and appropriate investigation of the following conditions: hypo- and hyperalbuminaemia inflammatory disease

97 KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING cryoglobulins alpha-1 antitrypsin deficiency. raised immunoglobulins paraproteinaemia cryoglobulinaemia alpha-1 antitrypsin deficiency. 2,3,4,5,6,7,8 Identify cases that require urgent intervention and offer clinical advice on the follow-up and/or further management of the patient. 9 Interpret biochemical data in light of the clinical details. 9 Draft written reports on results of investigations. Time-critical and grossly abnormal results requiring urgent clinical interventions for the disorders in this module. Correct use and interpretation of data in relation to the full range of investigations specified within this module. Report requirements and their importance. Sources of information, including appropriate use of patient records, reference materials and current national/international guidelines. Page 97

98 MODULE 2 Endocrinology and Diabetes (CB-3) COMPONENT Specialist AIM SCOPE Provide detailed knowledge and understanding of the normal physiology of the endocrine glands and the biochemical analyses used for the investigation of endocrine disorders. Perform the common analyses used in the investigation and management of endocrine disorders and gain experience in result interpretation. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Perform the range of laboratory techniques used in the work-base to investigate endocrine disorders and diabetes. 2. Undertake clinical and laboratory investigation and management of the following endocrine pathologies: pituitary, thyroid, gonadal and adrenal disorders; endocrine disorders of calcium metabolism, the gastrointestinal tract; and endocrine causes of obesity. 3. Perform clinical and laboratory investigation and analysis and management of diabetes mellitus. 4. Work in partnership with other clinical specialisms in the investigation of endocrine disorders and diabetes. 5. Interpret and report on clinical and laboratory investigations for endocrinology and diabetes in the correct clinical context. Page 98

99 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this rotation is: Participate in multidisciplinary/clinical review meetings at which biochemical results of endocrine disorders are presented as part of the clinical record. Reflect on the case of one patient and follow through their investigation and treatment plan. Discuss your learning in terms of service delivery and benefits/outcomes for the patient. Attend ward rounds and clinics at which patients are being investigated for endocrine disease. Reflect on the process of investigation, the patient experience and the role of ward rounds and clinics in providing patient care. Identify key learning points for your future practice. Visit a GP centre/outreach clinic to reflect on its use of the biochemical service and the role of GPs, nurses and other staff in the diabetic patient pathway. Discuss and review possible improvements. Attend an Endocrine Investigation Unit to observe patients undergoing dynamic function tests. Review and discuss in terms of the procedure, the patient experience and care and your own future learning points. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 99

100 KEY COMPETENCES LEARNING OUTCOMES 1,2,3 Perform the analyses to laboratory standard operating procedures on patients with: pituitary tumours hypopituitarism growth hormone deficiency multiple endocrine neoplasia diabetes insipidus. 1,2 Perform the analyses to laboratory standard operating procedures on patients with: thyroid diseases thyroid cancers. 1,2 Perform the analyses to laboratory standard operating on patients with: male hypo- and hypergonadism female hypo- and hypergonadism infertility and/or patients undergoing fertility treatment pubertal disorders Page 100 KNOWLEDGE AND UNDERSTANDING The clinical symptoms, biochemistry and diagnosis of common pituitary disorders, including: hyperprolactinaemia acromegaly Cushing s disease. The differential diagnosis of common pituitary endocrine disorders using dynamic function tests, including: oral glucose tolerance tests insulin/glucagon tolerance test water deprivation test. The role of imaging in the differential diagnosis of pituitary disorders. The clinical symptoms and biochemistry of common thyroid disorders, including: hypo- and hyperthyroidism subclinical thyroid disease thyroid carcinoma medullary thyroid carcinoma. The effect of the following clinical scenarios on the interpretation of thyroid function tests: neonates, pregnancy, non-thyroidal illness and thyroid hormone replacement monitoring. The clinical symptoms, biochemistry and diagnosis of common gonadal pathophysiologies, including: erectile dysfunction male subfertility mnovulation/amenorrhoea polycystic ovary syndrome (PCOS) and hirsutism the menopause gonadal hormone-secreting tumours

101 KEY LEARNING OUTCOMES COMPETENCES intersex disorders gonadal malignancies. 1,2 Perform the analyses to laboratory standard operating procedures on patients with: primary hypo- and hypercortisolism secondary hypo- and hypercortisolism hyperaldosteronism disorders of adrenal steroidogenesis adrenal androgen excess disorders of the adrenal medulla. 1,2 Perform the analyses to laboratory standard operating procedures on patients with: hypo- and hyperparathyroidism hypo- and hypervitaminosis D. Page 101 KNOWLEDGE AND UNDERSTANDING delayed and precocious puberty. Differential diagnosis of common gonadal endocrine disorders using dynamic function tests, including: gonadotrophin-releasing hormone (GnRH) test human chorionic gonadotrophin (HCG) stimulation test. The role of imaging in the differential diagnosis of gonadal disorders. The clinical symptoms, biochemistry, diagnosis and monitoring of replacement therapy in common adrenal disorders, including: Cushing s syndrome Conn s syndrome Addison s disease congenital adrenal hyperplasia adrenal androgen-secreting tumour phaeochromocytoma and paraganglioma. Differential diagnosis of common adrenal endocrine disorders using dynamic function tests, including: short synacthen test depot synacthen test dexamethasone suppression test corticotrophin-releasing hormone (CRH) test adrenal vein sampling. The role of imaging in the diagnosis of adrenal disorders. The clinical symptoms, biochemistry and diagnosis of common endocrine disorders of calcium metabolism, including: primary, secondary and tertiary parathyroid disease vitamin D deficiency chronic renal impairment sarcoidosis.

102 KEY LEARNING OUTCOMES COMPETENCES 2 Perform the analyses to laboratory standard operating procedures on patients with: hyperinsulinaemia GI hormone-secreting tumours. 2 Perform the analyses to laboratory standard operating procedures on patients with endocrine causes of obesity. 1,4 Perform the analyses to laboratory standard operating procedures on patients with: newly diagnosed type 1 and type 2 diabetes stable diabetes on treatment acute diabetic complications chronic diabetic complications. Page 102 KNOWLEDGE AND UNDERSTANDING The role of imaging in the diagnosis of parathyroid disorders. The clinical symptoms, biochemistry and diagnosis of: insulinoma Zollinger Ellinson syndrome rare GI tract tumours carcinoid tumours. The diagnosis of endocrine disorders of the GI tract using: prolonged fast markers of neuroendocrine tumours (e.g. chromogranins). The following causes of endocrine obesity, including how to exclude: hypothyroidism type 2 diabetes Cushing s syndrome growth hormone deficiency. The clinical symptoms, biochemistry and diagnosis of diabetes mellitus: primary and secondary diabetes diabetic ketoacidosis gestational diabetes. Differential diagnosis and monitoring of diabetes using the following test(s): fasting glucose test oral glucose tolerance test insulin and C-peptide HbA1c urinary albumin. The role of point-of-care (POC) glucose in the management of diabetes.

103 KEY LEARNING OUTCOMES COMPETENCES 1,2,3,4 Identify cases that require urgent intervention and offer clinical advice on the follow-up and/or further management of the patient. 5 Interpret biochemical data in light of the clinical details. 5 Draft written reports on the results of investigations. KNOWLEDGE AND UNDERSTANDING The governance issues of POCT testing for HbA1c and glucose. Time-critical and grossly abnormal results requiring urgent clinical interventions for the disorders in this module. The options for clinical interventions and their selection. Responsibility for patient follow-up and further management. Correct use of data in relation to the full range of investigations specified within this module. Requirements of reports, including sources of information, appropriate use of patient records, reference materials and current national/international guidelines. Page 103

104 MODULE 3 Nutrition (CB-4) COMPONENT Specialist AIM SCOPE Provide detailed knowledge of normal nutrition and clinical disorders associated with malnutrition, malabsorption and obesity. Provide knowledge biochemistry of haematinics and the investigation of anaemia. Provide detailed knowledge of the disorders of haem synthesis. Perform analyses used in the assessment of nutritional status and gain experience in clinical and laboratory investigation, including result interpretation and reporting in the correct clinical context. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Perform the range of laboratory and point-of-care techniques used in the work-base to investigate nutritional disorders. 2. Perform the clinical and laboratory investigation and analysis and management of nutritional status. 3. Perform the clinical and laboratory investigation and analysis and management of digestion, absorption and pancreatic function. 4. Perform the clinical and laboratory investigation and analysis and management of disorders of iron metabolism and haem synthesis. 5. Perform laboratory techniques used in the work-base to investigate trace element and vitamin status. 6. Work in partnership with other clinical specialisms in the investigation and analysis of nutritional disorders. 7. Interpret and report on the results of clinical and laboratory investigation of nutrition in the correct clinical context. Page 104

105 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Participate in nutrition team ward rounds and appreciate the multidisciplinary approach to investigation and management of disorders of nutrition in terms of both the patient experience and service delivery. Attend outpatient clinics that have a formal dietetic input (e.g. obesity, diabetic, anaemia) to appreciate the nutritional investigation and management of these patients. Discuss and review your experiences of at least two patients. Attend a clinic that manages porphyria patients. Reflect and report on the role of such specialist clinics in the diagnosis, treatment and management of patients. Observe a urea breath test reflect and discuss on the use, effectiveness and potential outcomes of this test and other tests that may be appropriate depending on results. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 105

106 KEY COMPETENCES LEARNING OUTCOMES 1,2,3,4,6 Perform the analyses to laboratory standard operating procedures: tests of malabsorption exocrine pancreatic function tests amylase/lipase. 1,4 Perform the analyses to laboratory standard operating procedures: haematinics (B12, folate) iron ferritin transferrin saturation (ironbinding capacity). 1,4 Perform the analyses to laboratory standard operating procedures: Page 106 KNOWLEDGE AND UNDERSTANDING The investigation of: malabsorption inflammatory bowel disease exocrine pancreatic function acute pancreatitis chronic pancreatitis. The assessment and management of patients undergoing: protein energy balance assessment receiving enteral nutrition receiving parenteral nutrition GI obstruction peptic ulceration coeliac disease pernicious anaemia GI bleeding. The specialist biochemical tests (e.g. calprotectin, faecal elastase) and other diagnostic modalities used in the investigation of the above disorders. The investigation and management of patients with: anaemia (including pernicious anaemia) haemochromatosis. The other diagnostic modalities used in the investigation of the above disorders: haemochromatosis genetics haematological investigations cellular pathology investigations (liver biopsy analysis). The investigation and management of patients with:

107 KEY LEARNING OUTCOMES COMPETENCES porphobilinogen (PBG) porphyrin screen (qualitative) porphyrins (quantitative). 1,5 Perform at least three of the following analyses (following observation of analysis performed by practitioner): caeruloplasmin copper zinc manganese selenium lead aluminium mercury. 1,5 Perform at least two of the following analyses (following observation of analysis performed by practitioner): vitamin A vitamin E vitamin B1 vitamin B2 vitamin B6. Page 107 KNOWLEDGE AND UNDERSTANDING porphyria. Other diagnostic modalities used in the investigation and confirmation of the diagnosis of porphyria: molecular testing quantitative analysis and identification of porphyrin and porphyrin precursors. The analytical techniques, their applications and limitations: immunoturbidmetric methods for protein analysis inductively coupled plasma mass spectrometry atomic absorption trace metal deficiencies trace metal toxicities. Vitamin deficiency. Vitamin toxicity. Analytical techniques used to measure vitamins, their applications and limitations. 1,2,3,4,5 Identify cases that require urgent Time-critical and grossly abnormal results requiring urgent clinical

108 KEY LEARNING OUTCOMES COMPETENCES intervention and offer clinical advice on the follow-up and/or further management of the patient. KNOWLEDGE AND UNDERSTANDING interventions for the disorders in this module. 7 Interpret biochemical data in light of the clinical details. Correct use of data in relation to the full range of investigations specified in this module. 7 Draft written reports on patients. Requirement for reports, including sources of information, appropriate use of patient records, reference materials and current national/international guidelines. Page 108

109 MODULE 4 Drug Investigation (CB-5) COMPONENT Specialist AIM SCOPE This module will provide trainees with the knowledge and understanding of basic pharmacology and the clinical use of certain drugs. They will have an understanding of pharmacokinetics, pharmacogenomics and the criteria for valid therapeutic drug monitoring (TDM). They will be able to help investigate the poisoned patient, screen for and confirm the presence of drugs of abuse. They will perform a selection of methods used in drug analysis and gain experience of the interpretation of patient results in a variety of clinical settings. Biochemical and toxicological investigation, interpretation and reporting of drug analysis for the purpose of effective patient management, using a range of laboratory and point-of-care techniques. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Perform a range of laboratory techniques used in the workplace to monitor therapeutic drug concentrations. 2. Interpret the results of commonly used therapeutic drug monitoring (TDM) assays in the correct clinical context. 3. Perform a range of laboratory and point-of-care techniques to investigate drugs of abuse and other toxic substances in cases of acute poisoning and understand the clinical context in which such techniques can be useful. 4. Decide the testing strategy for the investigation of patients taking drugs of abuse in the correct clinical and legal context. 5. Decide the testing strategy for the investigation of the poisoned patient in the correct clinical and forensic context. 6. Perform a range of pharmacogenetic tests. 7. Interpret and report the results of analyses of drug abuse, poisons and pharmacogenetic tests in the correct clinical or forensic context. Page 109

110 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Investigate the role of drug testing in a variety of clinical situations, the importance of correct sampling and the use and validity of target ranges. Report on your review and discuss the benefits and implications in terms of service delivery and patient care. Review and report on the importance of medico-legal considerations in the field of drug testing. Observe and discuss the preparation of reports, the reporting process for patients undertaking a variety of drug analyses and record case overviews observed. Discuss with your trainer/supervisor and identify the key learning points for your future practice. Undertake activities that involve the partnership of Clinical Biochemistry with other clinical specialisms in drug investigation. Review and report on the range of multidisciplinary working required to address issues of drug/poison investigations. Visit clinics and other health units at which patients receiving therapeutic drugs and patients abusing drugs are monitored. Report on your visits in terms of both service delivery and patient experience. Examples could include the following: transplantation team pharmacy accident & emergency local community drugs of abuse clinic psychiatry. Attend a clinical unit where POCT for drug analysis is performed. Discuss the method(s) with trained users. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 110

111 KEY COMPETENCES LEARNING OUTCOMES 1,2 Perform the analyses to laboratory standard operating procedures for the following drugs: digoxin and other cardioactive drugs lithium anticonvulsants theophylline ciclosporin and other immunosuppressive drugs. 1,3,4 Perform the analyses to laboratory standard operating procedures for drugs of abuse testing, including: screening protocols confirmation tests. Page 111 KNOWLEDGE AND UNDERSTANDING The range of methods available for the individual drug analyses and the advantages/disadvantages of each method. The principles of therapeutic drug monitoring (TDM); the criteria for valid TDM and the essentials of a TDM service. For each drug selected: its clinical use pharmacokinetics including common drug interactions toxicity monitoring therapy including target ranges, recommended sampling times and sample types. Mode of analysis (including advantages and disadvantages of the different methods in use). A selection of methods available for drugs of abuse analysis in both screening and confirmation testing and the advantages/disadvantages of each method. Use of the following techniques: immunoassay POCT thin layer chromatography gas chromatography high performance liquid chromatography mass spectrometry. Medico-legal considerations. Specimen collection according to chain of custody requirements. Methods used to establish sample integrity and adulteration. Screening and confirmation protocols, including qualitative, semiquantitative and quantitative analysis. Range of drugs commonly abused.

112 KEY LEARNING OUTCOMES COMPETENCES 1,3,5 Perform the analyses to laboratory standard operating procedures for drugs/toxins commonly found in overdose: salicylates paracetamol ethanol carbon monoxide. 1,3,5 Assist with two of the following analyses (following observation of a practitioner performing the relevant analysis): toxic metals (Al, Fe, Hg, Pb) ethanol ethylene glycol, methanol and related alcohols paraquat organophosphorus insecticides KNOWLEDGE AND UNDERSTANDING Metabolism of drugs commonly abused (including opiates and amphetamines). Testing of patients on opiate maintenance or withdrawal therapy (methadone, buprenorphine). Signs and symptoms of acute toxicity with identification of cases requiring urgent intervention and offer clinical advice on follow-up and/or further management. The methods used for salicylate and paracetamol analysis in the base laboratory. The methods used for ethanol and carbon monoxide, including laboratory and POCT techniques. Specialist toxicological investigations and understand the protocol for the referral of samples to external laboratories. The clinical signs and symptoms of individual drug toxicity and the expected pattern of laboratory results seen in cases of toxicity. In-depth knowledge of sampling time requirements. The identification of cases requiring urgent intervention, including knowledge of specific treatment protocols for paracetamol overdose. The methods used for metal analysis (AAS, ICPMS, colorimetric). Toxicological investigations and understand the protocol for the referral of samples to external laboratories. The clinical signs and symptoms of individual poison toxicity and the expected pattern of laboratory results seen in cases of toxicity. Sampling time requirements. The identification of cases requiring urgent intervention, including specific treatment protocols and antidotes where available. Page 112

113 KEY COMPETENCES LEARNING OUTCOMES or nerve agents. 6 Assist with at least one of the following pharmacogenetic assays (following observation of performance by practitioner): cholinesterase variants TPMT CYP variability in drug metabolism Acetylation. 1 Perform review of internal quality control (IQC) and external quality assessment (EQA) performance of a range of TDM and other drug assays. 2,3,4,5,6 Identify cases that require urgent intervention and offer clinical advice on the follow-up and/or further management of the patient. 2,3,4,5,6 Interpret biochemical and toxicological data in light of the clinical details. 2,3,4,5,6 Draft written reports on investigations. KNOWLEDGE AND UNDERSTANDING The methods used and their application. The software packages to enable the use of pharmacokinetics. The different EQA schemes and the scoring used in drug analysis, The different cut-off levels used to assess drugs of abuse analysis (clinical versus workplace testing). Time-critical and grossly abnormal results requiring urgent clinical interventions for the full range of investigations in this module. Types and options for intervention, follow-up and clinical management and factors affecting their selection. Responsibilities for follow-up, further management and interventions. Correct use of data in relation to the full range of investigations specified within this module. Requirements of report, including sources of information, appropriate use of patient records, reference materials and current national/international guidelines. Page 113

114 MODULE 5 AIM SCOPE Pregnancy, Neonatology and Paediatric Clinical Biochemistry (CB-6) COMPONENT Specialist Provide detailed knowledge and understanding of the normal physiology and biochemistry of pregnant women, neonates and infants. Perform the analyses used in the investigation of the pathophysiology of pregnancy, neonatal and paediatricrelated conditions and gain experience in result interpretation. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Perform the range of biochemical, point-of-care and molecular techniques used in the work-base to investigate pregnant women, neonates and infants. 2. Use reference ranges for the interpretation and reporting of results from pregnant women, neonates and infants. 3. Understand the UK antenatal and newborn screening programmes and the methodologies. 4. The clinical and laboratory investigation and management of neonates and infants with failure to thrive, hypoglycaemia, jaundice, and hyperammonaemia. 5. The clinical and laboratory investigation and management of neonates and infants suspected of having an inborn error of metabolism. 6. Work in partnership with other clinical specialisms in the investigation of neonates and infants. 7. Interpret and report results of clinical and laboratory investigations relating to pregnancy, neonatology and paediatric clinical biochemistry in the correct clinical context. Page 114

115 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Attend/visit antenatal screening centres to reflect on the use of antenatal screening service and the role of GPs, nurses and other healthcare professionals in the maternal pathway. Attend/visit newborn screening laboratory and report on your experience in terms of its importance for patient care and the process of screening. Attend ward rounds and clinics to gain an appreciation of the range of pregnancy-associated clinical conditions. Reflect and report on your experience, including key learning points for your future practice. With appropriate permission, attend ward rounds and clinics at which patients are being investigated for inherited metabolic disease (IMD). Using case history data prepare a portfolio of cases to illustrate the role of the clinical biochemistry laboratory in the diagnosis, follow-up and monitoring of treatment of at least five different inborn errors of metabolism Participate in multidisciplinary team review meetings at which biochemical results of investigation of IMD are presented as part of the clinical record. Prepare a portfolio of relevant cases, including learning points and clinical outcome. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 115

116 KEY COMPETENCES LEARNING OUTCOMES 1,2 Perform the analyses to laboratory standard operating procedures on patients with pregnancy associated disorders: HCG progesterone liver function tests. 1,2,3 Perform the analyses to laboratory standard operating procedures on common biochemical disorders associated with pregnancy: oral glucose tolerance test HbA1c/fructosamine thyroid function tests liver function tests uric acid bile acids. 2 Produce a draft report and interpret biochemical data using appropriate reference ranges in: pregnancy neonates and infants. 1,4,5,6 Perform the analyses to laboratory standard operating procedures, or follow the local protocol for the investigation of an acutely sick Page 116 KNOWLEDGE AND UNDERSTANDING The clinical signs and symptoms, biochemistry and diagnosis of pregnancy-associated disorders, including the need for surveillance with molar pregnancies: ectopic pregnancy hydatidiform mole choriocarcinoma HELLP syndrome miscarriage. Role of imaging in the diagnosis of the complications of pregnancy. The clinical signs and symptoms, biochemistry and diagnosis of common disorders of pregnancy: diabetes (screening and monitoring) thyroid disease liver disease (bile acids). Why reference ranges differ in: pregnancy neonates and infants The complexity and compromise involved in deriving reference values for neonates and infants. The clinical signs and symptoms, biochemistry and differential diagnosis and investigation of the following conditions: hyperammonaemia hypoglycaemia

117 KEY LEARNING OUTCOMES COMPETENCES neonate: ammonia glucose bilirubin (total and conjugated). 1,5 Perform the analyses to laboratory standard operating procedures, or following the local protocol in the investigation of a patient with suspected inborn error of metabolism. 1,3,6 Assist with the laboratory standard operating procedures for the screening pathways (following observation of procedure by practitioner): Page 117 KNOWLEDGE AND UNDERSTANDING prolonged jaundice in a neonate hypo- and hypercalcaemia hypo- and hypermagnesaemia CAH and salt wasting ambiguous genitalia. The clinical features and the clinical and laboratory investigation of neonates and infants suspected as having an inborn error of metabolism: amino acid disorders organic acid disorders urea cycle disorders fatty acid oxidation defects carbohydrate disorders lysosomal storage disorders respiratory chain disorders peroxisomal disorders purine and pyrimidine disorders. The laboratory techniques involved in the investigation of an inborn error of metabolism: gas chromatography liquid chromatography tandem mass spectrometry molecular diagnostics. The clinical signs and symptoms, biochemistry for the diagnosis of: Down syndrome neural tube defects other fetal malformations haemoglobinopathy.

118 KEY LEARNING OUTCOMES COMPETENCES antenatal screening newborn screening. 4,5,6,7 Assist with at least two of the analyses performed for the investigation of: inherited metabolic disease (IMD) sudden unexpected death in infancy (SUDI). KNOWLEDGE AND UNDERSTANDING The clinical signs and symptoms, biochemistry for the diagnosis of: phenylketonuria hypothyroidism cystic fibrosis medium chain acyl CoA dehydrogenase and other inborn errors of metabolism sickle cell disease. The role of internal quality control (IQC) and external quality assessment (EQA) of a screening method. The clinical signs and symptoms, biochemistry and diagnosis of inborn errors of metabolism, for example: orntihine transcarbamylase deficiency maple syrup urine disease methylmalonic acidaemia. The standardised protocol for collection and storage of appropriate samples in the (expected) event of SUDI. 3,4,5,6,7 Identify cases that require urgent intervention and offer clinical advice on the follow-up and/or further management of the patient. Page 118 Time-critical and grossly abnormal results requiring urgent clinical interventions for the disorders in this module. The type and range of interventions available for follow-up/further management of pregnancy, neonate and paediatric disorders and disease. Responsibilities for follow-up, management and intervention. Correct use of data in relation to the full range of investigations specified within this module. 7 Interpret biochemical data in light of the clinical details. 7 Draft written reports on patients. Requirements for reports, including sources of information, appropriate use of patient records, reference materials and current national/international guidelines.

119 Blood Sciences SECTION 7: SPECIALIST WORK-BASED LEARNING FRAMEWORK CLINICAL IMMUNOLOGY Page 119

120 This section describes the Learning Framework for the Specialist Component of work-based learning covering the Learning Outcomes, Clinical Experiential Learning, Competence and Applied Knowledge and Understanding. Each trainee is also expected to build on and apply the knowledge, skills and experience gained from the MSc in Clinical Science. DIVISION THEME SPECIALISM Specialist Modules Life Sciences Blood Sciences Clinical Immunology Page 120

121 CLINICAL IMMUNOLOGY: SPECIALIST MODULES Module 1 (CI-2) Module 2 (CI-3) Module 3 (CI-4) Module 4 (CI-5) Module 5 (CI-6) Immunology and Infection Immunodeficiency and Immunotherapy Hypersensitivity and Allergy Haematological Malignancies and Transplantation Autoimmunity Page 121

122 MODULE 1 Immunology and Infection (CI-2) COMPONENT Specialist AIM SCOPE This module will provide the trainee with knowledge and understanding of the investigation and clinical significance of immunity as applied to infection. They will become familiar with methods and strategies to investigate immunity and gain experience of the interpretation of patient results in a variety of clinical settings. This module focuses on the range of assays and investigations relating to viral, bacterial and fungal infections. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Select immunology tests to investigate the role of the immunity system against infection. 2. Undertake clinical and laboratory investigation of the immune system relating to defence against infection. 3. Select and perform immunology tests to investigate the role of the immune system against infection. 4. Interpret and report clinical immunological tests in the correct clinical context. 5. Work in partnership with other clinical specialisms to investigate the immune system in infection. Page 122

123 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Observe a range of platforms used in Clinical Immunology to assess the integrity of the immune system in infection and discuss the strengths and weaknesses of each platform with your training supervisor. Attend multidisciplinary review meetings where the results from patients with disorders of the immune system are discussed, and prepare a portfolio of relevant cases, reflecting on the contribution immunology investigations make to the clinical outcome for each patient. Critically appraise the internal quality control and external quality assessment performance of three different markers of immune function. Visit a microbiology laboratory and discuss the sources of requests and the methods used to investigate common infections with your training supervisor. Describe the partnership between Clinical Immunology and other clinical specialism in the investigation of the immune system in infection and the effect of multidisciplinary working on the patient s management. LABORATORY EXPERIENTIAL LEARNING Become familiar with the laboratory quality management system and perform examination and other audits as part of the laboratory accreditation process (applies to all specialist modules). PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 123

124 KEY COMPETENCES LEARNING OUTCOMES 1 Select the appropriate immunological assay to investigate the status of the immune system in protecting the patient against a range of bacteria, viruses and fungi. 1,2,3 Apply methods to specified quality standards for all the following investigations: acute phase reactants complement measurement of immunoglobulins functional assays to detect humoral immune responses to pathogens nephelometry ELISA/ImmunoCAP Luminex (if available) flow cytometry (if available). 4 Interpret immunological data in light of clinical details and be aware of the process of authorising written reports on patients with a variety of common infections, prior to and during therapy, including all of the following: viral infections bacterial infections Page 124 KNOWLEDGE AND UNDERSTANDING The range and application of assay techniques for investigation of immune system status. Factors affecting the selection of appropriate immunological assay. The range, use and application of specified quality standards for each investigation. Relevant quality standards associated with the range of investigations. Current protocols and authority for variance from accepted protocol. Factors influencing the choice of method used for different investigations e.g. reflex testing, or understanding the evidence base for use of different methods. Factors influencing the selection and use of investigative methods. The identification and differentiation of markers of immune function. Internal and external quality control and assessment requirements and their significance. The type of blood samples required. Correct timing of patient samples prior to and during investigation (i.e. when infection will affect the normal levels of immunoglobulins/lymphocytes/complement, etc.). Which component of the immune system should be measured and understand the usefulness of the results obtained. Correct interpretation of immunological data. Requirements of interpretive reports.

125 KEY COMPETENCES LEARNING OUTCOMES fungal infections infection after secondary immunodeficiency. 4 Identify cases requiring urgent intervention and be able to suggest what clinical advice on follow-up and/or further management could be offered. 5 Identify relevant clinical investigations from other disciplines that will impact on the interpretation of the immunological investigation. KNOWLEDGE AND UNDERSTANDING Responsibility and level of authority for production and authorisation of reports. The identification of factors that require concerns to be raised. When abnormal results should be urgently discussed and brought to the attention of senior staff. The options for follow-up and/or further management and their appropriateness to findings. Appropriate assays from biochemistry, microbiology and haematology that will impact on interpreting the immunology results. Page 125

126 MODULE 2 AIM SCOPE Immunodeficiency and Immunotherapy (CI-3) COMPONENT Specialist This module will provide the trainee with an understanding of the causes of immunodeficiency. The trainee will understand the clinical presentation and investigation of a range of immunodeficient conditions and the principles and practice of immunotherapy. The trainee will become familiar with methods and strategies to investigate immunodeficiency and gain experience of the interpretation of patient results in a variety of clinical settings. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Select immunology tests for the diagnosis and management of immunodeficiency and monitoring of immunotherapy. 2. Perform clinical and laboratory investigation of immunodeficiency. 3. Interpret and report results of investigation of immunodeficiency in the correct clinical context. 4. Apply immunotherapeutic strategies for inpatients with a range of primary and secondary immunodeficiences. 5. Work in partnership with other clinical specialisms in the investigation of immunodeficiency and immunotherapy. Page 126

127 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Attend outpatient clinics where patients with a range of primary and secondary immunodeficiencies are treated and reflect on the efficacy of each treatment strategy, the side effects and effect on quality of life, and prepare some case reviews to describe your learning. Participate in multidisciplinary review meetings where immunology results are presented as part of the clinical care of patients who have an immunodeficiency and/or are undergoing immunotherapy and critically evaluate how a partnership approach between Clinical Immunology and other clinical specialisms benefits patients who are undergoing investigations of the immune system. Attend clinics where patients are referred for the investigation of immunodeficiency and/or are undergoing immunotherapy and review and generate your own report from the immunological investigations undertaken. Critically appraise the internal quality control and external quality assessment performance of three different methods used in the investigation of immunodeficiency. Contribute to Immunology teaching programme. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 127

128 KEY COMPETENCES LEARNING OUTCOMES 1 Select the appropriate immunological assay to investigate whether the immune system of the patient is immunocompetent or immunodeficient. To include all of the following: immunoglobulins and subclasses neutrophil function tests lymphocyte function tests specific antibody responses to vaccine antigens complement activity cytokine production molecular assays to define immunodeficiencies. 2 Perform the appropriate investigation of immunodeficiency to include all specified above. 3 Interpret immunological data in the light of clinical details on patients with primary immunodeficiency, including: deficiencies of innate immunity B lymphocyte deficiencies T lymphocyte deficiencies combined T and B cell defects. 3 Interpret immunological data in light of clinical details on patients with KNOWLEDGE AND UNDERSTANDING The range of immunological assays used to investigate the specified range and their selection. Factors influencing the selection of assays. The requirements of both internal and external quality control and assessment for immunodeficiency disease in an immunology laboratory. Relevant protocols and procedures and their application. Factors influencing the possible outcomes of investigation and relevant control measures. The correct interpretation of each assay and the importance/implications of incorrect interpretation. The correct interpretation of each assay and the importance/implications of incorrect interpretation. Page 128

129 KEY COMPETENCES LEARNING OUTCOMES secondary immunodeficiency, including all of the following: iatrogenic neoplasia infection. 3 Interpret immunological data in light of clinical details. 4, Apply the appropriate immunotherapeutic strategies/treatment regimens for patients with a range of primary and secondary immunodeficiencies. 3,4 Interpret, assess the effectiveness of and report results from patients receiving a range of immunotherapies, including at least three of the following: antibodies as immunosuppressive agents immunosuppressive drugs physical methods of immunosuppression cytokines and anti-cytokines KNOWLEDGE AND UNDERSTANDING The process of authorising written reports on patients with a variety of immunodeficient conditions. Correct interpretation of immunological data relating to immunodeficient disorders. The requirements of interpretive reports. The responsibility and level of authority for production and authorisation of reports. Options for clinical management of a range of immunodeficiencies and their application to the identified immunodeficiency. Factors influencing the selection of immunotherapeutic strategies/regimens for both primary and secondary immunodeficiences. The full range of immunotherapies available to patients who are immunodeficient, either primary or secondary immunodeficient. Current methods for assessing the effectiveness of immunotherapies. Factors that may influence the effectiveness of immunotherapies. Page 129

130 KEY LEARNING OUTCOMES COMPETENCES intravenous immunoglobulins immunisation against infection novel approaches to autoimmunity, i.e. infliximab and rituximab stem cell therapies, specifically for immunodeficiencies. 5 Identify relevant clinical investigations from other disciplines that will impact on the interpretation of the immunological investigation. KNOWLEDGE AND UNDERSTANDING Appropriate assays from biochemistry, microbiology and haematology that will impact on interpreting the immunology results. Page 130

131 MODULE 3 Hypersensitivity and Allergy (CI-4) COMPONENT Specialist AIM SCOPE SHARED This module will provide the trainee with knowledge and understanding of the mechanism of hypersensitivity and allergy. The trainee will understand the clinical presentation and investigation of a range of conditions associated with hypersensitivity and will become familiar with methods and strategies to investigate hypersensitivity and allergy. The trainee will gain experience of the interpretation of patient results in a variety of clinical settings. This module is shared by trainees in Histocompatibility and Immunogenetics, where it is coded H&I-4. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Select appropriate methods to investigate hypersensitivity and immunology laboratory tests for specific IgE. 2. Perform clinical and laboratory investigation of hypersensitivity and allergy. 3. Interpret and report results of investigations of hypersensitivity and allergy in the correct clinical context. 4. Work in partnership with other clinical specialisms in the investigation of hypersensitivity and allergy. Page 131

132 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Identify a patient with mild, moderate or severe allergy, understand the care pathway of the patient from the initial consultation, investigations, follow-up appointment and treatment, and understand the role of Clinical Immunology in the care pathway. Observe history taking in patients with a range of conditions associated with hypersensitivity and use the information to suggest appropriate investigation strategies based on this information. Attend clinics and multidisciplinary team meetings at which patients are being investigated for hypersensitivity and allergy, and discuss the allergic mechanisms and potential treatments for each patient with your training supervisor. Critically appraise the internal quality control and external quality assessment performance of methods used in allergy testing. Observe the treatment of adults and children with allergy and discuss the effect of a chronic disease on quality of life. Observe the treatment of adults with eczema and the non-pharmacological and pharmacological treatment regimens that are available and discuss the impact of eczema on quality of life with your training supervisor. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 132

133 KEY COMPETENCES LEARNING OUTCOMES 1 Select the appropriate immunological assay to investigate whether the immune system of the patient is producing an allergic response. 1,2 Perform immunological testing of allergic response using the appropriate assay. 2 Perform allergy testing including all of the following (to be performed after observation of the procedure): skin prick test patch test oral challenge mast cell tryptase and histamine release assays ELISA/ImmunoCAP component-resolved diagnostics. 3 Interpret allergy test data in light of clinical details and on patients with a range of common allergies including food allergy KNOWLEDGE AND UNDERSTANDING The range of immunological assays available for investigation of hypersensitivity and allergic response. The selection and application of immunological assays in the investigation of hypersensitivity and allergic response. The laboratory protocols and procedures for the performance of immunological assays to investigate hypersensitivity and allergic response. The recognition of factors that may affect the outcome of investigations and control measures. The requirements of both internal and external quality control and assessment for allergy in an immunology laboratory. The pitfalls of the first three largely clinical assays currently performed by nurses/medics and how they relate to the laboratory assays used to investigate allergy. Contraindications to performance of clinical allergy testing. The laboratory protocols and procedures for the performance of allergy testing across the full range specified. Requirements for interpreting and reporting results with regard to correct timing of patient samples prior to and during investigation, i.e. pre- and post-therapy/clinical management. Page 133

134 KEY COMPETENCES LEARNING OUTCOMES inhalant allergy drug allergy. 3 Interpret immunological data in light of clinical details. 3,4 Identify cases requiring urgent intervention (e.g. anaphylaxis) and be able to offer clinical advice on follow-up and/or further management. KNOWLEDGE AND UNDERSTANDING The process of authorising written reports on patients with hypersensitivity and allergy. Correct Interpretation of immunological data relating to allergy. The requirements of interpretive reports. The responsibility and level of authority for production and authorisation of reports. For anaphylaxis, the importance of when to measure mast cell tryptase levels and the implications of failure to do so. The guidelines of the timing of these blood samples. Factors that indicate when to raise concerns. When abnormal results should be urgently discussed and brought to the attention of senior staff. The range of options available for the follow-up and further management of hypersensitivity and allergy. Page 134

135 MODULE 4 AIM SCOPE Haematological Malignancies and Transplantation (CI-5) COMPONENT Specialist This module will provide the trainee with knowledge and understanding of the scientific basis of diagnosis of haematological malignancies, transplantation and appropriate investigations. The trainee will understand the clinical presentation and investigation of a range of haematological malignancies, transplantation and the principles of appropriate therapy. The trainee will become familiar with methods and strategies to investigate haematological malignancies and gain experience of the interpretation of patient results in a variety of clinical settings. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Select and perform laboratory tests for haematological malignancies and data analysis. 2. Undertake the clinical laboratory work-up of patients awaiting haemopoetic stem cell transplantation. 3. Interpret results of investigations for haematological malignancies and transplantation in the correct clinical context. 4. Work in partnership with other clinical specialisms in the investigation of haematological malignancies and transplantation. Page 135

136 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Prepare case reports on newly diagnosed patients and follow-up patients in a haematological malignancy outpatient clinic and critically appraise the process of diagnosis, treatment and management. Prepare for and contribute to multidisciplinary review meetings where immunology results are presented as part of the clinical record in patients with haematological malignancies, and reflect on your contribution, identifying areas that went well and those that could be improved for future meetings. Attend clinics at which patients are being investigated for haematological malignancies. Critically appraise the internal quality control and external quality assessment performance of the different methods used in the diagnosis of haematological malignancies. Contribute to multidisciplinary team meetings for haematological malignancies. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 136

137 KEY COMPETENCES LEARNING OUTCOMES 1 Select the appropriate immunological assay to investigate the immune system of a patient with a haematological malignancy for all of the following: chronic lymphocytic leukaemia acute leukaemia lymphomas multiple myeloma Waldenström s macroglobulinaemia post-bone marrow transplantation lymphocyte levels (immune reconstitution). 1,2 Perform the appropriate immunological investigations, to include the following: flow cytometry morphological assays relevant molecular techniques electrophoresis free light chains immunoglobulin measurement. 3 Interpret data from all the above immunological investigations. 3,4 Interpret immunological data in light of clinical details and be KNOWLEDGE AND UNDERSTANDING The importance of immunological data in light of clinical details in patients with haematological malignancies prior to and during therapy. The range of appropriate assays for the investigation of haematological malignancy. The factors affecting the selection of appropriate immunological assay for investigation of haematological malignancies. Relevant protocols and procedures and their application. Factors influencing the possible outcomes of investigation and relevant control measures. Specific quality issues associated with immune assays used in haematological malignancies. The importance of correctly interpreting the data from these assays. Correct interpretation of data from immunological investigations of haematological malignancy and its importance. Appropriate reports for immunological investigations in haematological malignancies and transplantation. Page 137

138 KEY LEARNING OUTCOMES COMPETENCES aware of the process of authorising written reports of patients with a variety of haematological malignancies. 3,4 Assist with the clinical laboratory work-up of patients awaiting haemopoietic stem cell transplantation. KNOWLEDGE AND UNDERSTANDING Correct interpretation of immunological data relating to immunodeficient disorders. The requirements of interpretive reports. The responsibility and level of authority for production and authorisation of reports. The importance of correctly interpreting the data from these assays. The prognostic indicators for patients that may result in a haemopoietic stem cell transplantation. Current diagnostic guidelines for haematological malignancies. Current national and international guidelines relating to haematological malignancies and donor registries. The clinical indications for haemopoietic stem cell transplantation. Appropriate assays from biochemistry, microbiology, virology, radiology and haematology for the work-up of patients awaiting haemopoietic stem cell transplantation. Page 138

139 MODULE 5 Autoimmunity (CI-6) COMPONENT Specialist AIM SCOPE This module will provide the trainee with knowledge and understanding of the mechanism of autoimmunity. The trainee will understand the clinical presentation and investigation of a range of autoimmune diseases. They will become familiar with methods and strategies to investigate autoimmunity and gain experience of the interpretation of patient results in a variety of clinical settings. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Select immunology tests for the diagnosis and management of a range of autoimmune diseases. 2. Perform clinical and laboratory investigation of a range of autoimmune diseases. 3. Interpret and report results of investigation of autoimmune disease in the correct clinical context. 4. Work in partnership with other clinical specialisms in the investigation of autoimmune disease. Page 139

140 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Attend a rheumatology clinic to understand the effect of an autoimmune disease on the quality of life of the patient. Reflect on your discussion and identify key learning points that will influence your future practice. Attend a range of outpatient clinics that patients with autoimmune diseases may attend and discuss the role and impact of the multi-professional team in the care of such patients. This may include outpatients and primary care chronic disease management clinics. Prepare two to three autoimmune patient cases where the results from immunology investigations have altered in response to treatment or where results of immunology investigations influence diagnosis or management. Critically appraise the internal quality control and external quality assessment performance of three different methods used in the investigation of autoimmune disorders. Contribute to appropriate immunology teaching programmes. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 140

141 KEY COMPETENCES LEARNING OUTCOMES 1 Select appropriate methods for investigation of autoimmune disorders. 1,2 Perform appropriate methods for the investigation of autoimmune disorders, including all of the following: autoimmune serology immunofluorescence Western blotting nephelometry iso-electric focusing agglutination assays Luminex, where available. 3,4 Interpret immunological data in light of clinical details on patients with autoimmune disorders, including at least five of the following: adrenal ANA ANCA-P AND C Crithidia endomysial GBM GPC HEp 2 patterns, including centromere ICA KNOWLEDGE AND UNDERSTANDING The range and application of assay techniques for investigation of autoimmune disorders. Factors affecting the selection of appropriate immunological assay. The appropriate immunological assay to investigate whether the patient s immune system is producing an autoimmune response. The range of available methods, their use and application. The application of appropriate methods for the investigation of each autoimmune disorder. The requirements of both internal and external quality control and assessment for autoimmune disease in an immunology laboratory. The interpretation and reporting of results correctly with regard to correct timing of patient samples prior to and during investigation, i.e pre and post therapy/clinical management. Page 141

142 KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING Hu and Yo LKM LM mitochondria ovary pemphigoid pemphigus rheumatoid factor smooth muscle skeletal skin salivary thyroid others. 3 Interpret immunological data in light of clinical details. The process of authorising written reports on patients with a variety of autoimmune diseases. Correct interpretation of immunological data relating to autoimmune disorders. The requirements of interpretive reports. The responsibility and level of authority for production and authorisation of reports. 3,4 Identify cases requiring urgent intervention and be able to suggest When autoimmune disease will affect the normal ranges/levels of immunoglobulins/lymphocytes/complement components. what clinical advice on follow-up Factors that influence the need to raise concerns. and/or further management could be When abnormal results should be urgently discussed and brought to offered. the attention of senior staff in suspected or known autoimmune disease. 4 Identify relevant clinical Appropriate assays from biochemistry, microbiology and Page 142

143 KEY LEARNING OUTCOMES COMPETENCES investigations from other disciplines that will impact on the interpretation of the immunological investigation. KNOWLEDGE AND UNDERSTANDING haematology that will impact on interpreting the immunology results. Page 143

144 Blood Sciences SECTION 8: SPECIALIST WORK-BASED LEARNING FRAMEWORK HAEMATOLOGY AND TRANSFUSION SCIENCE Page 144

145 This section describes the Learning Framework for the Specialist Component of work-based learning covering the Learning Outcomes, Clinical Experiential Learning, Competence and Applied Knowledge and Understanding. Each trainee is also expected to build on and apply the knowledge, skills and experience gained from the MSc in Clinical Science. Specialist Modules DIVISION THEME SPECIALISM Life Sciences Blood Sciences Haematology and Transfusion Science Page 145

146 HAEMATOLOGY AND BLOOD TRANSFUSION SCIENCE: SPECIALIST MODULES Module 1 (HT-2) Module 2 (HT-3) Module 3 (HT-4) Module 4 (HT-5) Module 5 (HT-6) Disorders of Red and White Blood Cells Core Transfusion Haemostasis Haematological Malignancy Specialised Transfusion Page 146

147 MODULE 1 AIM SCOPE Disorders of Red and White Blood Cells (HT-2) COMPONENT Specialist This module will provide understanding and experience of the investigation of disorders of red and white blood cells. This module will provide the trainee with the knowledge and understanding of the pathophysiology and clinical presentation of a range of disorders associated with abnormalities of red and white blood cell function. They will perform methods related to red cell and white cell number and function, and gain experience of the interpretation of patient results in a variety of clinical settings. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Perform a range of laboratory and molecular techniques used in the work-base to investigate anaemia, red cell disorders. 2. Perform a range of laboratory and molecular techniques used in the work-base to investigate white cell disorders. 3. Identify appropriate clinical and laboratory investigations and outline the management of acquired and hereditary red cell disorders. 4. Identify appropriate clinical and laboratory investigations and outline the management of non-malignant white cell disorders. 5. Perform quality assurance and control tasks across the range of investigations associated with the investigation of red and white blood cell disorders. Page 147

148 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Attend a haematology outpatients clinic to gain experience of the patient consultant interaction and write a reflective report to include key points concerning the patient experience and service delivery. Attend ward rounds and/or clinics at which patients are being investigated and treated for haematological disorders. Follow the investigation and diagnosis of at least one patient and discuss the process, outcomes and role of laboratory investigations in the diagnosis, treatment and management of patients. Participate in multidisciplinary review meetings at which haematology results are presented as part of the clinical record in patients with haematological disorders. Reflect and report on the importance of a multidisciplinary approach to the diagnosis, treatment and management of patients. Prepare a portfolio of relevant cases, including learning points and clinical outcomes including key learning points for your own future practice. Observe family counselling and report on your experience, including perceptions of the importance of this approach, the effectiveness of the process and the potential outcomes for the patient and their family. Critically appraise the findings of a review of the internal quality control and external quality assessment of three methods in haematology. Identify key learning points for your future practice. LABORATORY EXPERIENTIAL LEARNING Become familiar with the laboratory quality management system and perform examination and other audits as part of the laboratory accreditation process (applies to all specialist modules). PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. Page 148

149 The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 149

150 KEY LEARNING OUTCOMES COMPETENCES 1,5 Perform methods for the investigation of anaemia including the following: iron deficiency anaemia anaemia of inflammation megaloblastic anaemia hereditary haemolytic anaemias acquired haemolytic anaemias. 1,5 Perform methods for the investigation of a range of hereditary red cell disorders, including the following: sickle cell disease (SCD) thalassaemias other haemoglobin variants red cell enzymopathies red cell membrane defects. 2,5 Perform methods for the investigation of non-malignant white cell disorders including: automated quantitation of white cells, including white cell differential Page 150 KNOWLEDGE AND UNDERSTANDING The initial, routine screening tests for anaemia, including FBC, reticulocyte count and blood film morphology. How to asses haematinics using representative assays for the investigation of iron, B12 and folate status. The common screening tests for hereditary and acquired red cell disorders, including enzymopathies and red cell membrane defects, haemoglobinopathies and haemoglobin variants. Performance characteristics of methods, internal quality control (IQC) and external quality assurance (EQA). Methods used in the investigation of haemoglobin variants, including: electrophoresis HPLC DNA-based methods mass spectrometry. The operation of the national screening programme for SCD and thalassaemia. Methods for the investigation of red cell enzymopathies and membrane defects including: cell morphology enzymic methods molecular methods. Performance characteristics of methods, IQC and EQA. Principles of automated white cell counting. Normal and abnormal white cell morphology and blood film examination. Morphological features associated with viral illnesses and further testing for infectious mononucleosis.

151 KEY LEARNING OUTCOMES COMPETENCES Page 151 KNOWLEDGE AND UNDERSTANDING blood film morphology Performance characteristics of methods, IQC and EQA. infectious mononucleosis screen. The clinical significance and the laboratory presentation in relation to the disorder chosen. 3 Interpret haematology data in light of clinical details and authorise The clinical significance and the laboratory presentation, in relation to the disorder chosen. reports under supervision of patients with anaemia, including: BCSH, NICE and other clinical practice guidelines for the investigation of anaemia. iron deficiency anaemia Correct timing of patient samples prior to and during investigation. anaemia of inflammation Correct interpretation of haematological results relative to reference megaloblastic anaemia data. hereditary haemolytic anaemias Requirements of interpretive reports. acquired haemolytic anaemias. Responsibility and level of authority for production and authorisation of reports. 3 Interpret haematology data in light of clinical details and authorise The clinical significance and the laboratory presentation, in relation to the disorder chosen. reports under supervision of patients with a range of hereditary red cell BCSH, NICE and other clinical practice guidelines for the investigation of red cell disorders. disorders, including the following: Correct timing of patient samples prior to and during investigation. SCD Correct interpretation of haematological results relative to reference thalassaemias data. other haemoglobin variants, Requirements of interpretive reports. red cell enzymopathies Responsibility and level of authority for production and authorisation red cell membrane defects. of reports. 3 Interpret laboratory data and reports from the national screening The incidence of SCD and thalassaemia as revealed by the national screening programme for SCD and thalassaemia. programme for SCD and thalassaemia. Reporting methodology for the national screening programme and responsibilities at local level for communication and follow-up. 4 Interpret haematology data in light The clinical significance and the laboratory presentation, in relation to

152 KEY LEARNING OUTCOMES COMPETENCES of clinical details and authorise reports under supervision on patients with at least one of the following of white cell disorders: lymphopenia neutropenia leucocytosis. 3,4 Identify cases requiring urgent intervention and be able to offer suggest clinical advice on follow-up and/or further management. KNOWLEDGE AND UNDERSTANDING the disorder chosen. BCSH, NICE and other clinical practice guidelines for the investigation of white cell disorders. Correct timing of patient samples prior to and during investigation. Correct interpretation of haematological results relative to reference data. Requirements of interpretive reports. Responsibility and level of authority for production and authorisation of reports. Red cell and white cell abnormalities that require urgent intervention, management and further investigation. The need for urgent intervention (e.g. high WBC) and the range of further follow-up tests. Page 152

153 MODULE 2 Core Transfusion (HT-3) COMPONENT Specialist AIM SCOPE This module provides the trainee with laboratory and clinical experience in the selection, performance and interpretation of core transfusion services. This module will provide the trainee with an in-depth knowledge of blood groups and their clinical significance in transfusion medicine. It will also provide the knowledge and skills required to work at a basic level within the transfusion hospital laboratory, operating within regulatory requirements and providing safe and compatible blood and components for patients. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Perform routine pre-transfusion procedures and serological tests, correctly interpret results and investigate anomalies to ensure provision of compatible blood for patients. 2. Select and issue appropriate blood, components and products for patients with a wide range of clinical conditions, in routine and emergency settings. 3. Investigate suspected adverse reactions and events according to clinical presentation. 4. Manage blood stocks, including full traceability and maintenance of the cold chain. 5. Interpret and comply with national guidelines for transfusion, applicable regulatory requirements (e.g. Blood Safety and Quality Regulations) and quality management systems in the hospital transfusion laboratory. Page 153

154 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Attend a multidisciplinary review meeting at which specific cases involving blood transfusion are reviewed. Attend a hospital transfusion committee meeting. Reflect and report on your experience, including the importance of these meetings and their impact on the patient and service delivery. Attend a unit where blood is collected from donors. Reflect on and discuss the engagement and experience of donors and the role and responsibilities of staff within this unit. Review and discuss the role and responsibilities of staff in this unit and the interaction of this unit with other laboratory and patient services. Attend a ward round and/or clinic at which patients are being monitored following receipt of blood or blood components. Follow the progress of one patient and reflect and discuss the patient pathway and the impact of laboratory services. Participate in reporting and investigation of adverse reactions to transfusion. Discuss the possible reactions, outcomes and implications for patient care and management. Shadow other staff involved throughout the whole transfusion pathway. Report and discuss the roles, responsibilities and impact on both service delivery and patient care throughout the pathway. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 154

155 KEY COMPETENCES LEARNING OUTCOMES 1 Apply sample acceptance criteria for samples for pre-transfusion testing. 1 Perform manual and automated serological tests, with appropriate controls, and recognise discrepant results in: ABO/D typing antibody screening antibody identification serological cross-matching red cell phenotyping. 1 Select further tests to investigate ABO/D typing anomalies, and to recognise situations where conclusive results cannot be obtained in-house and referral for further testing is required. 1 Interpret the results of simple antibody identification investigations (i.e. single antibody or two antibodies reacting distinctly by different techniques) and recognise cases requiring additional tests or clinical advice. KNOWLEDGE AND UNDERSTANDING Sample acceptance criteria for transfusion and risks associated with mislabelled samples and incomplete paperwork. Value of linking to historical records. Security afforded by automation and IT, and risks of manual testing and transcription steps in pre-transfusion testing. Specifications, performance characteristics and limitations of reagents used for patient blood grouping, and specific reagent controls required. Principles of routine, manual and automated tests for grouping and antibody screening, and controls required. Principles behind different indirect antiglobulin test (IAT) technologies (e.g. column agglutination, tube, solid phase) and potential sources of error in each. BCSH guidelines for compatibility testing or national equivalent. ABO subgroups (A 2, A x, etc.). Partial D and weak D (especially D VI ). Selection of reagents and techniques to investigate ABO/D grouping anomalies. Recognition of mixed field reactions and of the clinical significance of multiple populations of cells. Process for systematic exclusion of clinically significant red cell antibodies, and positive identification of antibodies present. Patient/request criteria for electronic issue. Page 155

156 KEY COMPETENCES LEARNING OUTCOMES 1 Perform routine pre-transfusion compatibility testing by serological cross-matching, and apply criteria for use of electronic issue (if used). Interpret results and identify cases requiring additional tests or clinical advice. Complete relevant documentation on paper and using IT systems as appropriate. 2 Provide safe blood components for patients (if clinically necessary) before a confirmed ABO/D result can be established. 2 Interpret requests for blood, components and products to determine what tests are required before issue. 2 Select, handle and issue blood components with additional specifications including: irradiated HbS negative phenotyped red cells washed components. 2 Select appropriate blood components or product in accordance with patient special requirements, including for the KNOWLEDGE AND UNDERSTANDING System criteria for electronic issue. Principles of expected values for haematology and tests used to determine the need for blood components. Appropriate use of blood and transfusion triggers. Use of maximum blood ordering schedules. Use of IT to record and check for patient special requirements. Clinical risks where special requirements are not met and value of clinical/transfusion history. Minimum requirements for pre-transfusion testing in emergency situations. Appropriate use and risks associated with flying squad group O RhD negative units. Testing and labelling criteria to be met before issuing group-specific blood in an emergency. Value of trauma packs and rationale behind ratios of red cells: fresh frozen plasma (FFP): platelets used in major haemorrhage. Thawing of frozen components such as FFP and cryoprecipitate for issue, and understanding of changed storage conditions/expiry once thawed. Page 156

157 KEY COMPETENCES LEARNING OUTCOMES following: Intrauterine transfusion neonates post stem cell transplant (SCT)/ bone marrow transplant (BMT) autoimmune haemolytic anaemia (AIHA) post solid organ transplant sickle cell disease red cell antibodies. 2 Provide safe and effective blood and components for emergency use, and provide transfusion support in cases of major haemorrhage, demonstrating the ability to communicate effectively with all parties involved. 2 Evaluate the requirement for routine blood components, e.g. platelets, FFP, and prepare FFP for issue. 2 Recognise the potential need for specialist components, e.g. cryopecipitate. 2 Visually inspect blood, component or product to ensure it is fit for use. Label and issue via local computer system to ensure full traceability. 3 Respond to the report of a suspected transfusion-related Page 157 KNOWLEDGE AND UNDERSTANDING Reasons why blood components may be visually not fit for use, e.g. haemolysed, lipaemic or bacterially contaminated units. Appropriate actions if a component is rejected for issue. Process for systematic investigation of a suspected adverse

158 KEY LEARNING OUTCOMES COMPETENCES adverse reaction or event according to local protocol. Identify the probable type of reaction and refer or perform the appropriate investigations. 3 Perform repeat serological testing on pre- and post-transfusion samples in cases of suspected haemolytic reactions. Interpret results in clinical context and report to clinical and transfusion specialist staff. 3 Assist in completion of relevant internal documentation relating to adverse reactions/events and external incident reporting, including: serious adverse blood reactions and events (SABRE) serious hazards of transfusion (SHOT). 4 Demonstrate compliance with regulations and guidance for the labelling, storage and transport of blood. 4 Be able to advise non-laboratory staff on safe collection, transport and administration of blood. 4 Participate in ordering of blood and Page 158 KNOWLEDGE AND UNDERSTANDING transfusion reaction. Reporting for SHOT and SABRE how and what to report to each, and in which category. Safe storage and transport conditions for blood and components. Rules for packaging of blood samples and blood components when being moved within the hospital and between sites. Application of methods for monitoring temperature storage and documenting evidence of continuity of the cold chain. Availability of blood with special requirements and notice required when ordering.

159 KEY LEARNING OUTCOMES COMPETENCES components in routine and urgent situations and for patient with special requirements. 4 Manage blood stocks in order to ensure the most efficient use within a hospital setting. 4 Assist in collection, analysis and audit of data relating to the use of blood components. 5 Apply national guidelines for transfusion practice (e.g. BCSH) relevant to own scope of practice. 5 Demonstrate compliance with applicable regulatory requirements for transfusion services (e.g. BSQR and successor regulations). 5 Participate in audit of the departmental quality management system for transfusion services. 5 Perform and interpret results of internal quality control and external KNOWLEDGE AND UNDERSTANDING Use of online blood ordering systems. Safe transfer of information on blood components to the IT system and use of Electronic Data Interchange (EDI). ISBT 128 coding, or equivalent labelling systems. Local procedures to minimise blood wastage, e.g. first in, first out stock control. Practical application of BCSH guidelines, including those for: compatibility procedures in blood transfusion laboratories administration of blood components use of irradiated blood components use of fresh frozen plasma, cryoprecipitate and cryosupernatant neonates and older children use of platelet transfusions clinical use of red cell transfusion management of massive blood loss specification and use of information technology (IT) systems in blood transfusion practice validation and qualification, including change control, for hospital transfusion laboratories. Local compliance with BSQR and MHRA standards. Local application of GMP and GLP or equivalent. Participation in the audit cycle and the value of audit in clinical and laboratory settings. Application of IQC and EQA in the laboratory environment. Relevance of EQA reports. Page 159

160 KEY LEARNING OUTCOMES COMPETENCES quality assessment relating to patient pre-transfusion testing. KNOWLEDGE AND UNDERSTANDING Corrective and preventive action required where results of IQC or EQA are not as expected. Page 160

161 MODULE 3 Haemostasis (HT-4) COMPONENT Specialist AIM SCOPE The trainee will gain experience of the clinical and laboratory investigation and management of congenital and acquired bleeding disorders and management of thrombophilia. This module will provide the trainee with the detailed knowledge and understanding of platelet function and the pathophysiology and clinical presentation of a range of acquired and genetic bleeding disorders and thrombotic disorders. They will perform relevant laboratory methods and gain experience of the interpretation of patient results in a variety of clinical settings. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Identify appropriate clinical and laboratory investigations for the investigation of haemostasis. 2. Perform the range of laboratory, molecular and point-of-care testing (POCT) techniques used in the work-base to diagnose and monitor treatment of bleeding disorders and thrombophilia. 3. Interpret and report results of investigations of haemostasis in the correct clinical context. Page 161

162 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Attend a haematology outpatients clinic (including anticoagulation clinics) and observe near patient testing and monitoring. Reflect on and review your experience, and discuss the patient experience, the key factors reflecting the importance of such clinics for patient management and key learning points for your future practice. Observe family counselling and report on your experience, including the role of this service and its integration with laboratory investigation of haemostasis. Critically appraise the internal quality control and external quality assessment of three methods used to investigate haemostasis and two methods used to investigate thrombosis. Report and discuss your findings, including key learning points for your future practice. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 162

163 KEY COMPETENCES LEARNING OUTCOMES 1 Identify suitable methods for the investigation of disorders of haemostasis and thrombosis including: platelet number, morphology and aggregation coagulation factor activity assays (FVIII, IX) prothrombin time activated partial thromboplastin time thrombin time fibrinogen d-dimer inhibitor screen anticoagulation therapy monitoring: warfarin, heparin. 2 Select and perform to specified quality standards methods for investigating and managing thrombosis, including: d-dimer molecular markers of thrombotic risk anticoagulation therapy monitoring International normalised ratio (INR) KNOWLEDGE AND UNDERSTANDING The clinical significance and the laboratory presentation in relation to the disorder chosen. The methods used to investigate disorders of haemostasis. The use of methods in the monitoring of anticoagulant therapy in both primary care (POCT) and secondary care settings. The need for internal and external quality assessment and how to remedy poor performance. The methods used to investigate thrombotic disorders, and factors affecting their selection. Anticoagulation therapy, including both conventional anticoagulants and the new oral anticogulants. The need for internal and external quality assessment and how to remedy poor performance. Page 163

164 KEY COMPETENCES LEARNING OUTCOMES laboratory methods POCT. 3 Interpret haematology data in light of clinical details and authorise reports under supervision on patients with thrombophilia. This should include one congenital example and one acquired example: congenital, e.g. factor V Leiden prothrombin mutation, and MTHFR mutation acquired, e.g anti-cardiolipin antibodies lupus anticoagulants heparin-induced thrombocytopenia antithrombin, protein C and protein S. 3 Interpret haematology data in light of clinical details and authorise reports under supervision on patients disorders of the coagulation system including: haemophilia A, B von Willebrand disease disseminated intravascular coagulation (DIC). KNOWLEDGE AND UNDERSTANDING The aetiology and clinical presentation of thrombophilia disorders. The clinical significance and the laboratory presentation in relation to the disorder chosen. Factors affecting results, e.g. oral contraceptive pill, pregnancy, liver disease. The aetiology and clinical presentation of coagulation disorders. The clinical significance and the laboratory presentation in relation to the disorder chosen. 3 Identify cases requiring urgent Coagulation abnormalities that require urgent intervention, Page 164

165 KEY LEARNING OUTCOMES COMPETENCES intervention and be able to offer clinical advice on follow-up and/or further management. KNOWLEDGE AND UNDERSTANDING management and further investigations. The need for urgent intervention in certain cases and range of followup testing. Page 165

166 MODULE 4 Haematological Malignancy (HT-5) COMPONENT Specialist AIM SCOPE The trainee will gain experience of the clinical and laboratory investigation and management of haematological malignancy. This module will provide the trainee with knowledge and understanding of the pathophysiology, clinical presentation and management of patients with haematological malignancy. They will perform relevant laboratory methods and gain experience of the interpretation of patient results in a variety of clinical settings. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Perform a range of laboratory and molecular testing techniques used in the work-base to diagnose and monitor treatment of haematological malignancy. 2. Perform laboratory investigations and outline the management of haematological malignancy in the correct clinical context, including the interpretation and reporting of results. 3. Interpret and comply with national and international guidance (e.g. NICE, WHO, BCSH) on the diagnosis and management of haematological cancer. Page 166

167 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is Observe a bone marrow aspiration and trephine to experience the importance to the patient of appropriate sample processing. Reflect on and discuss your experience in terms of patient care pathway. Observe peripheral blood collection in the outpatients clinic setting to gain knowledge of and report on patient experience. Prepare case study reports to illustrate how laboratory results link to clinical outcomes. Participate in multidisciplinary review meetings at which laboratory results are presented as part of the clinical record in patients with haematological malignancy. Prepare a portfolio of relevant cases, including learning points and clinical outcomes. Visit a histopathology and/or specialist laboratory and gain experience of the investigation and reporting of haematological malignancies. Reflect and report on the partnership between different laboratories and their impact on the quality of patient care. Attend ward rounds and/or clinics at which patients with haematological malignancy are being investigated and treated. Discuss and report on the process with regard to the role of ward rounds/clinics and their integration with laboratory investigation for patient care. Attend a centre where stem cells are processed and stored, and reflect on the procedures and storage conditions used and their importance in maintaining the quality of the cells PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 167

168 KEY COMPETENCES LEARNING OUTCOMES 1 Perform a range of methods for diagnosing and monitoring treatment of haematological malignancy, including: morphology screening immunophenotyping by flow cytometry karyotyping fluorescence in-situ hybridisation panels molecular diagnostics, including: IgH gene rearrangement TCR gene rearrangement BCRABL JAK2 FLT3/NPMI minimal residual disease monitoring post-transplant chimera monitoring. 2 Interpret haematology data in order to aid the classification of haematological malignancies. 2 Interpret laboratory data in light of clinical details and authorise written reports under supervision on patients with lymphoid cell disorders, including: KNOWLEDGE AND UNDERSTANDING The principles underlying the methods listed. Understanding of BCSH guidelines for selection of appropriate tests. Relevant white cell morphology (bone marrow and peripheral blood). Immunophenotyping. Cytogenetic abnormalities commonly associated with haematological disease. A minimum of two molecular tests from the following list: IgH gene rearrangement TCR gene rearrangement BCRABL JAK2 FLT3/NPMI minimal residual disease monitoring post-transplant chimera monitoring. The need for internal and external quality assessment and how to remedy poor performance. WHO classification system and other relevant systems/guidelines. The different types of leukaemia. Understanding of the role of immunophenotyping in the diagnosis and prognosis of leukaemias and lymphomas. BCSH, NICE and other clinical practice guidelines for the investigation and management of haematological malignancy. Page 168

169 KEY COMPETENCES LEARNING OUTCOMES acute lymphoblastic leukaemia chronic lymphocytic leukaemia Hodgkin s lymphomas non-hodgkin s lymphomas acute myeloid leukaemia chronic myeloid leukaemia myelomas. 3 Interpret laboratory data in patients for whom haemopoietic stem cell transplantation is the appropriate treatment. 3 Interpret and comply with appropriate national and international guidelines for the diagnosis and management of haematological malignancies. KNOWLEDGE AND UNDERSTANDING Correct timing of patient samples prior to and during investigation. Correct interpretation of haematological results relative to reference data. Requirements of interpretive reports. Responsibility and level of authority for production and authorisation of reports. Knowledge of the clinical indications appropriate for stem cell transplantation. Types of donor and donor registry. Appropriate national and international guidelines (e.g. NICE) for the diagnosis and management of haematological malignancies. Page 169

170 MODULE 5 Specialised Transfusion (HT-6) COMPONENT Specialist AIM SCOPE This module provides the trainee with clinical experience and development in the selection, performance and interpretation of serological tests in the transfusion setting. On completion of this module the trainee will be able to undertake serological testing, including troubleshooting. They will be able to test for differential diagnosis and for donor suitability, and use correct algorithms for both routine and non-routine antenatal testing. They will be proficient in selection and performance of tests across a range of predictive and monitoring requirements and will have a greater understanding of the role and interaction of specialist blood transfusion services within the patient care pathway. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Troubleshoot serological tests, investigate patient and donor blood grouping anomalies, and make interpretations in clinical context. 2. Select, perform and interpret the results of non-routine additional tests to elucidate alloantibodies in complex cases (mixtures, high frequency, etc.), and liaising with clinicians and blood services regarding transfusion support. 3. Select and perform serological tests for differential diagnosis of autoimmune haemolytic anaemia (AIHA) and for provision of suitable blood for transfusion. 4. Use algorithms for routine and non-routine antenatal testing and the use of anti-d prophylaxis and feto-maternal haemorrhage (FMH) testing. 5. Select and perform tests to predict and monitor haemolytic disease of the fetus and newborn (HDFN), and provide appropriate transfusion therapy for the fetus and neonate. 6. Work with specialist blood transfusion services to provide safe transfusion support for patients and be able to inform clinicians on blood safety issues. Page 170

171 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Attend antenatal clinics and observe the collection of specimens for routine antenatal testing and assess the potential for problems with sample identity. Observe routine antenatal anti-d prophylaxis and report on the logistics and documentation of anti-d prophylaxis. Participate in multidisciplinary review meetings at which clinical cases involving complex transfusion related issues are presented. Prepare a portfolio of relevant cases, including learning points and clinical outcomes. Attend a unit where blood is collected from donors. Reflect and discuss on the engagement and experience of donors and the role and responsibilities of staff within this unit. Attend a unit where blood is collected from donors, and report on how compliance with procedures ensures safety of the donor and the product. Attend an establishment where blood is tested and processed prior to transport and storage. Shadow other staff involved throughout the whole transfusion pathway and report on how they all contribute. Present a case study/audit report/training session to an invited audience (>10 people). PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 171

172 KEY COMPETENCES LEARNING OUTCOMES 1 Recognise, investigate and resolve patient blood grouping anomalies, selecting appropriate reagents/techniques and making interpretations in clinical context, including: post haematopoietic stem cell transplant (HSCT) immunocompromised patients AIHA. 1 Recognise cases where referral for further investigation is required before a blood group can be assigned. 1 Identify the group/phenotype of red cells required for safe transfusion where blood grouping is not straightforward. 1 Identify and investigate. Interpret anomalous donor ABO/D typing results and assign appropriate groups, or quarantine donations following further investigation. 2 Select, perform and interpret specific antibody tests in non-routine or complex cases with red cell alloantibodies. Report results in the correct clinical context, including the implications for transfusion. KNOWLEDGE AND UNDERSTANDING Correct selection of red cell and plasma-rich blood components throughout the chimerism of a HSCT: major mismatch minor mismatch bi-directional mismatch. Risks of abbreviated testing for ABO. Additional requirements for blood components for immunocompromised patients. Rare blood group problems, including Bombay phenotype. Dealing with patients with multiple populations of cells recently transfused patients, post HSCT. Unexpected results in reverse grouping : presence of atypical red cell antibodies AIHAs neonates immunosuppressed patients large volume transfusion hyper- /hypo-gammaglobulinaemias. Reasons for weak antigen expression in patients. Unexpected reactions in forward grouping, e.g. acquired B. Principles, limitations and applications of the following serological tests: IAT strictly at 37ºC two-stage enzyme direct agglutination Page 172

173 KEY COMPETENCES LEARNING OUTCOMES 2 Select and perform non-routine serological tests to investigate cases with red cell antibodies: IAT strictly at 37ºC two-stage enzyme direct agglutination enzyme IAT. 2 Perform more complex antibody identification, selecting techniques and additional panel cells required to elucidate antibodies present and exclude all other antibodies of clinical significance, recognising situations where specialist referral is required. 2 Perform red cell phenotyping, interpret results in the context of antibody identification and prediction of HDFN, and recognise situations where serological testing is not appropriate and molecular genotyping is required. 3 Select and perform tests for the differential diagnosis of AIHA including: monospecific direct antiglobulin test (DAT) specific antibody identification KNOWLEDGE AND UNDERSTANDING enzyme IAT. Serological characteristics of red cell alloantibody specificities, including thermal range and expected reactions with enzyme-treated cells. Correlation between serological reactivity and potential clinical significance of red cell alloantibodies. Strategies to identify antibodies in complex mixtures of specificities. High frequency antigens, strategies for identification of corresponding antibodies and populations where antigen negative individuals are most likely to be found. Identifying and reporting antibodies of low clinical significance, including those with no apparent specificity. Clinical significance of detecting underlying red cell alloantibodies in patients with autoantibodies. Types of haemolytic anaemias and their management. Non-serological: hereditary mechanical anaemias microangiopathy Page 173

174 KEY LEARNING OUTCOMES COMPETENCES Page 174 KNOWLEDGE AND UNDERSTANDING adsorption elution. infectious agents. Serological: WAIHA cold primary CHAD, CHAD secondary to HBV PCH PNH drug-induced combined warm-cold. Monospecific DAT, its uses and the limitations: harmless DAT positives in donors and patients reasons for a positive DAT other than AIHA AIHAs with negative DATs problems with phenotyping DAT-positive patients and application of genotyping in this situation. Autoantibody specificities and their effect on transfusion. Practical considerations of selecting and cross-matching blood for patients with autoantibodies. 3 Interpret and report results in the correct clinical context. 3 Select and provide safe blood for transfusion for patients with AIHA. 4 Perform routine antenatal testing on pregnant women including: ABO and RhD type red cell antibody screen. The methods used to detect and identify red cell alloantibodies in patients with warm and cold reacting autoantibodies, and the frequency of testing required where these patients are transfusion dependent. Principles of adsorption elution techniques including: situations where autoadsoption is not appropriate selection of cells for alloadsoption. Practical application of national guidelines for antenatal testing and anti-d prophylaxis (e.g. BCSH, NICE). The management of potentially sensitising events during pregnancy.

175 KEY COMPETENCES LEARNING OUTCOMES 4 Interpret and report results in the correct clinical context. 4 Select and issue appropriate doses of prophylactic anti-d immunoglobulin; for antenatal cases following potentially sensitising events, as RAADP, and as a postnatal standard dose. 4 Perform FMH tests by acid elution, evaluate the need for referral for confirmation by flow cytometry, request follow-up samples and communicate with midwives/clinicians on the need for additional doses of anti-d. 4 Perform FMH testing by flow cytometry, interpret results, and determine follow-up actions and additional anti-d prophylaxis required. Page 175 KNOWLEDGE AND UNDERSTANDING Factors affecting the severity of HDFN: stage when antibody first detected previous history of HDFN antibody specificity antibody class and subclass antibody concentration. Mode of action in causing HDFN and antenatal testing requirements if detected in a maternal sample: anti-d anti-c anti-k ABO antibodies other clinically significant red cell antibodies. Role of anti-d in perinatal mortality and morbidity and the risk of anti- D sensitisation. Anti-D immunoglobulin: how it works dosage timing of administration for RAADP, in response to a potentially sensitising event (PSE) and post delivery. Role of feto-maternal haemorrhage in sensitisation of the mother and how to measure and manage sensitising events. What to do if anti-d prophylaxis is missed. Advice given to women whose pregnancies are at risk from anti-d. Reasons for estimating the size of FMHs. Use and limitations of the acid-elution technique to determine FMHs. Flow cytometry technique to determine FMHs and its limitations. Prophylactic anti-d estimation of dose.

176 KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING Problems encountered by the inability to distinguish between immune and prophylactic anti-d. Identification of what constitutes a PSE in the first, second and third trimesters of pregnancy. Consideration of different RAADP programmes one-dose vs twodose. 5 Perform tests on cord and maternal blood to predict, diagnose and monitor potential HDFN including: direct antiglobulin test elution of red cell antibodies titration of ABO and IgG antibodies red cell alloantibody identification. 5 Undertake follow-up in antenatal cases with red cell antibodies, including additional serological testing, referral to specialist units, paternal typing (and fetal genotyping where appropriate). Report results in clinical context, recognising the need for referral, and communicating with clinicians and midwives. 5 Provide transfusion support for Aetiology, and clinical presentation of HDFN, and the specificities of red cell antibodies implicated. The antenatal testing requirements of those antibodies known to cause HDFN: anti-d anti-c Kell-related antibodies. Prediction of risk/severity of HDFN from laboratory testing during pregnancy: titration of antibodies and the selection of cells and reagents to perform the titration quantification of antibodies significant levels for anti-d, anti-c, anti-k and other potentially clinically significant red cell antibodies which specificities do not cause HDFN and why role of immunoglobulin class and subclasses in the severity of HDFN phenotyping of the father to predict the phenotype of the fetus and likelihood of HDFN Page 176

177 KEY COMPETENCES LEARNING OUTCOMES pregnant women with red cell antibodies. 5 Provide transfusion support for the fetus and neonate, undertaking appropriate compatibility testing and selecting blood components with the correct specifications for IUT, neonatal top-up and exchange transfusion. 6 Inform clinicians (and patients where applicable) on the specifications of components, blood safety, risk benefit of transfusion and blood supply issues. 6 Co-operate with blood services to co-ordinate testing and provision of blood components for patients with special requirements. KNOWLEDGE AND UNDERSTANDING the criteria and limitations when free fetal DNA testing for the fetal genotype can be employed non-serological monitoring of the fetus throughout pregnancy, e.g. middle cerebral artery Doppler and ultrasound. The significance of a positive DAT in a neonatal sample. Strategies for the reduction of impact on the fetus of HDN: IUT premature delivery exchange transfusion, top-up transfusions and phototherapy new and emerging strategies. Logistics of ongoing support throughout pregnancy and delivery for women requiring rare blood and liaison with reference services. Additional specifications of units suitable for IUT, neonatal top-up and neonatal exchange. Cross-matching considerations for neonates. Methods used to prepare blood components and products within a defined quality and legislative framework, including preparation, validation, labelling, shelf life quality monitoring and storage of: red cells platelets fresh frozen plasma cryoprecipitate washed cells irradiated blood components. Emerging technologies in blood component preparation and therapy such as pathogen inactivation. Donor selection and the measures taken by the blood service to prevent transfusion transmitted infections (TTIs) and the methods Page 177

178 KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING used to test for: HIV HBV HCV syphilis HTLV I/II other infective agents emerging pathogens. Algorithms to assess the acceptability of donated blood and donor suitability based on screening and follow-up tests for transfusiontransmissible infections. The time frame in which blood components with special requirements can reasonably be expected to be available. Page 178

179 Blood Sciences SECTION 9: SPECIALIST WORK-BASED LEARNING FRAMEWORK HISTOCOMPATIBILITY AND IMMUNOGENETICS Page 179

180 This section describes the Learning Framework for the Specialist Component of work based learning, covering the Learning Outcomes, Clinical Experiential Learning, Competence and Applied Knowledge and Understanding. Each trainee is also expected to build on and apply the knowledge, skills and experience gained from the MSc in Clinical Science. Specialist Modules DIVISION THEME SPECIALISM Life Sciences Blood Sciences Histocompatibility and Immunogenetics Page 180

181 HISTOCOMPATIBILITY AND IMMUNOGENETICS: SPECIALIST MODULES Module 1 (H&I-8) Module 2 (H&I-9) Module 3 (H&I-10) Module 4 (H&I-11) Module 5 (H&I-12) Clinical Immunology in Histocompatibility and Immunogenetics Histocompatibility Solid organ transplantation Immunogenetics Haematopoietic Stem Cell Transplantation Page 181

182 MODULE 1 AIM SCOPE Clinical Immunology in Histocompatibility and Immunogenetics (H&I-8) COMPONENT Specialist This module will provide the trainee with the practical application of knowledge and skills relating to a range of immunological conditions, including immunodeficiencies, hypersensitivities and allergies and haematological malignancies. The trainee will understand the clinical presentation and investigation of immunological conditions including immunodeficiencies, hypersensitivities and allergies and haematological malignancies and the principles and practice of immunotherapy. The trainee will become familiar with methods and strategies to investigate clinical immunology and gain experience of the interpretation of patient results in a variety of clinical settings. The trainee will also be expected to consistently demonstrate professional practice that meets the standards of Good Scientific Practice, including the limitations of consent and the impact of culture, equality and diversity on practice. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Select appropriate methods for the diagnosis and management of a range of immunological conditions. 2. Interpret and report results of clinical investigations undertaken in patients with: immunodeficiency hypersensitivity and allergy haematological malignancies a transplantation procedure 3. Work in partnership with other clinical specialisms in the investigation and therapy for a range of immunological conditions and, where appropriate, with service users and support staff. Page 182

183 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Actively participate in out-patient clinics involving patients with a range of immunodeficiency conditions. Critically reflect on the efficacy of each treatment strategy, the side effects and effect of quality of life and prepare a series of case reviews to describe your learning and how this will impact on your future practice. Identify patients with immunodeficiency, hypersensitivities and allergies and/or haematological malignancy in order to gain an understanding of the care pathway of the patient from the initial consultation, investigations, follow-up appointment and treatment. Where possible, undertake discussions with patients to gain a better understanding of the contribution of clinical immunology in care pathways. Actively participate in a range of clinics and multi-disciplinary team meetings (MDTs) where patients are being investigated for immunodeficiency, hypersensitivity and allergy and/or haematological malignancy and discuss the mechanisms and potential treatments/outcomes for each patient with your training supervisor. Critically reflect on your own experience of supervision and mentoring and identify how you will use these in your learning training, supervising and mentoring of others. Prepare a series of case reports on newly diagnosed patients and follow-up patients in an immunodeficiency, hypersensitivity and allergy and/or haematological malignancy outpatient clinic and critically appraise the process of diagnosis, treatment and management. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 183

184 KEY COMPETENCES LEARNING OUTCOMES 1 Select the appropriate immunological assay to investigate whether the immune system of the patient is immunocompetent or immunodeficient and have the laboratory skills to undertake at least two of the following laboratory analyses: assay of immunoglobulins and subclasses neutrophil function tests lymphocyte function tests specific antibody responses to vaccine antigens complement activity cytokine production molecular assays to define immunodeficiencies. 2 Interpret immunological data in the light of clinical details on patients with primary immunodeficiency including: deficiencies of innate immunity B Lymphocyte deficiencies T Lymphocyte deficiencies combined T and B cell defects. 1 Select the appropriate immunological assay to investigate whether the immune system of the patient is producing an allergic response. 2 Interpret allergy test data in the light of clinical details and on patients with a range of common KNOWLEDGE AND UNDERSTANDING The range and appropriate selection of immunological assays used to investigate specific immunological conditions and the normal range for these. Factors influencing the selection of assays. The requirements of both internal and external quality control and assessment for immunodeficiency disease in an immunology laboratory. How to assure the quality of personal practice. The correct clinical interpretation of each assay and the impact/implications of incorrect interpretation. How to assure the quality of personal practice. The range of immunological assays available for investigation of hypersensitivity and allergic response. The selection and application of immunological assays in the investigation of hypersensitivity and allergic response. How to assure the quality of personal practice. Requirements for interpreting and reporting results with regard to correct timing of patient samples prior to and Page 184

185 KEY COMPETENCES KNOWLEDGE AND UNDERSTANDING LEARNING OUTCOMES allergies including: during investigation, i.e. pre and post therapy/clinical food allergy management. inhalant allergy The need to manage records and all other information in drug allergy. accordance with applicable legislation, protocols and guidelines. How to assure the quality of personal practice. 1 Select the appropriate immunological assay to investigate the immune system of patients with haematological malignancies such as: The importance of immunological data in the light of clinical details in patients with haematological malignancies prior to and during therapy. Chronic lymphocytic leukaemia The range of appropriate assays for the investigation of Acute leukaemia haematological malignancy. Lymphomas The factors affecting the selection of appropriate Multiple myeloma immunological assay for investigation of haematological Waldenstrom s macroglobulinaemia malignancies. Post BMT lymphocyte levels (immune reconstitution). The need to manage records and all other information in accordance with applicable legislation, protocols and guidelines. How to assure the quality of personal practice. 2 Interpret data from immunological investigations, such as: The importance of correctly interpreting the data from these assays. Flow cytometry Correct interpretation of data from immunological Morphological assays investigations of haematological malignancy and its Relevant molecular techniques importance. Electrophoresis The need to manage records and all other information in Free light chains accordance with applicable legislation, protocols and Immunoglobulin measurement. guidelines. How to assure the quality of personal practice. 3 Work in partnership with other clinical specialisms The need to build and sustain professional relationships Page 185

186 KEY LEARNING OUTCOMES COMPETENCES in the investigation of a range of immunological conditions and, where appropriate, with service users and support staff. 3 Communicate effectively with the healthcare team recognising and responding appropriately to situations where it is necessary to share information to safeguard service users or the wider public. KNOWLEDGE AND UNDERSTANDING both as an independent practitioner and collaboratively as a member of a team. Methods of effective communication. How communication skills affect assessment of, and engagement with, service users and how the means of communication should be modified to address and take account of factors such as age, capacity, learning ability and physical ability. Situations where it is necessary to share information to safeguard service users or the wider public. The limits of the concept of confidentiality. Page 186

187 MODULE 2 Histocompatibility (H&I-9) COMPONENT Specialist AIM SCOPE This module will provide the trainee with the practical application of knowledge and skills relating to the scientific and practical basis of Histocompatibility. The trainee will understand the principles and practice of Histocompatibility and become competent with the methods used in support of transplantation and blood transfusion. The trainee will also be expected to consistently demonstrate professional practice that meets the standards of Good Scientific Practice, including the limitations of consent and the impact of culture, equality and diversity on practice. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Select and perform laboratory tests for Human Leukocyte Antigen (HLA) antibody identification, definition and data analysis. 2. Select and perform laboratory tests required for the clinical work up of patients awaiting solid organ transplantation, including cross matching for solid organ transplantation. 3. Perform the clinical and laboratory work up of patients referred for investigation of platelet refractoriness. 4. Work in partnership with other clinical specialisms in the investigation of patients referred for transplantation, platelet transfusion, and where appropriate, with other service users and support staff. 5. Apply specific accreditation standards governing the use of serological practices. Page 187

188 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Actively participate in ward rounds and/or clinics at which patients are being worked up for transplantation. Discuss and critically reflect on your experiences and the involvement of the services provided by the laboratory in the management of patients. Attend multidisciplinary review meetings at which laboratory results are presented as part of the clinical record in patients awaiting or being monitored following solid organ transplantation. Critically reflect on your learning from this activity and set out a personal development action plan and provide evidence of completing each action. Critically reflect on your own experience of supervision and mentoring and identify how you will use this in your learning training, supervising and mentoring of others. Review the case notes of a patient requiring transfusion of Human Leucocyte Antigen (HLA) matched platelets and discuss the indications, contraindications, potential side effects and the transfusion support the patient may need with the clinical team. Critically reflect on your learning and how it will affect your future practice PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Review the case notes of a patient requiring transfusion of Human Leucocyte Antigen (HLA) matched platelets and discuss the indications, contraindications, potential side effects and the transfusion support the patient may need with the clinical team. Critically reflect on your learning and how it will affect your future practice Page 188

189 KEY COMPETENCES LEARNING OUTCOMES 1, 2, 3 Receive samples for patients undergoing transplant workup or investigation of platelet refractoriness and enter onto laboratory Information Management System (IMS). 1,2,3 Isolate serum/plasma from blood samples according to local protocol. 2 Isolate and quantify lymphocytes from anticoagulated blood according to local protocol. 2, Isolate and quantify lymphocytes from deceased potential donor spleen and lymph node according to local protocol. 2 Perform the cryopreservation of lymphocytes from different sources 1, 2,3,5 Perform laboratory methods for HLA antibody detection for example: Complement dependent cytotoxicity ELISA Flow cytometry X-MAP Technologies(Luminex) KNOWLEDGE AND UNDERSTANDING The local repertoire, source of requests and turnaround times for investigations performed by the training H&I laboratory. Clinical indications for solid organ and haemopoietic stem cell transplantation and blood transfusion. Minimum data set required for identification of laboratory samples. Factors affecting sample integrity and appropriate corrective action. Correct use of manual and computerised systems for entering laboratory samples. How to assure the quality of personal practice. Safe handling of biological materials. Principles involved in lymphocyte isolation methods. Procedures available for T and B cell isolation. Lymphocyte identification by microscopy. Principles involved in lymphocyte isolation methods. Lymphocyte identification by microscopy. Principles involved in lymphocyte cryopreservation. Principles of HLA antibody production. Sources of HLA sensitisation. Selection and principles of laboratory methods for HLA antibody detection and definition. Internal quality controls and external quality assessment measures appropriate to the methods used. Correct and safe use of equipment used. Page 189

190 KEY LEARNING OUTCOMES COMPETENCES 1, 2, 3, 5 Perform laboratory methods for HLA antibody definition, including: Complement dependent cytotoxicity ELISA Flow cytometry xmap Technologies(Luminex) 2, 5 Select appropriate sera for the crossmatching of donor and recipients in accordance with local and national guidelines. 2,, 5 Perform according to local protocol, laboratory methods for crossmatching donors and recipients for solid organ transplantation by the following methods as appropriate Complement dependent cytotoxicity Flow cytometry 3,5 Perform laboratory testing for a patient referred for investigation of platelet refractoriness, including: HLA typing Page 190 KNOWLEDGE AND UNDERSTANDING How to assure the quality of personal practice. Operational and performance characteristics of each assay technique. Strengths and weaknesses of each assay technique. Clinical significance of HLA and non- HLA antibodies in transplantation: Class I and Class II IgM allo/autoantibodies red cell antibodies endothelial cell antibodies How to assure the quality of personal practice. How to assure the quality of personal practice. Principles of laboratory methods for crossmatching donors and recipients for solid organ transplantation o Complement dependent cytotoxicity o Flow cytometry Internal quality controls and external quality assessment measures appropriate to the methods used. Problems likely to be encountered in these assays, including cellular/microbiological contamination false negative and positive reactions low/high cell yield poor viability of cells drug interactions How to assure the quality of personal practice. The clinical significance of HLA and non-hla antibodies in blood transfusion: HLA antibodies

191 KEY LEARNING OUTCOMES COMPETENCES Antibody testing HPA antibodies 4 Work in partnership with other clinical specialisms in the investigation of patients referred for transplantation, platelet transfusion and where appropriate, with service users and support staff. 4 Communicate effectively with the healthcare team, recognising and responding appropriately to situations where it is necessary to share information to safeguard service users or the wider public. KNOWLEDGE AND UNDERSTANDING The need to build and sustain professional relationships as both an independent practitioner and collaboratively as a member of a team. Methods of effective communication. How communication skills affect assessment of, and engagement with, service users and how the means of communication should be modified to address and take account of factors such as age, capacity, learning ability and physical ability. Situations where it is necessary to share information to safeguard service users or the wider public. The limits of the concept of confidentiality. Page 191

192 MODULE 3 AIM SCOPE Solid organ transplantation (H&I-10) COMPONENT Specialist This module will provide the trainee with the practical application of knowledge and skills relating to Histocompatibility and Immunogenetics techniques applicable to solid organ transplantation and blood transfusion. The trainee will understand the clinical significance of Histocompatibility and Immunogenetics within the context of solid organ transplantation and blood transfusion. They will become familiar with the interpretation and reporting of patient and donor results and their application to a variety of clinical settings. The trainee will also be expected to consistently demonstrate professional practice that meets the standards of Good Scientific Practice, including the limitations of consent and the impact of culture, equality and diversity on practice. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Perform the clinical and laboratory work up of patients awaiting solid organ transplantation, including the interpretation and reporting of results in the correct clinical context. 2. Assess the suitability of patients for crossmatch and transplantation within the national deceased donor organ allocation scheme. 3. Analyse and report laboratory tests for donor and recipient compatibility to facilitate transplantation within the national deceased donor organ allocation scheme. 4. Assess the suitability of patients for crossmatch and transplantation for living donation. 5. Perform clinical and laboratory monitoring of patients who have received a solid organ transplant. 6. Work in partnership with other clinical specialisms in the investigation of solid organ transplantation and platelet transfusion and, where appropriate with service users and support staff. 7. Assess the suitability of patients for HLA/HPA selected platelets and identify compatible platelet units. Page 192

193 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Actively participate in ward rounds and/or clinics at which patients are being worked up for or monitored following solid organ transplantation. Discussion and critical reflection of your experiences and the involvement of the laboratory in the management of patients. Actively participate in multidisciplinary review meetings at which laboratory results are presented as part of the clinical record in patients being worked up for living donor transplantation. Actively participate in multidisciplinary review meetings at which laboratory results are presented as part of the clinical record in patients being monitored following solid organ transplantation. Shadow clinical scientists performing on call laboratory and clinical assessments of potential recipients and donors for transplantation in the acute situation and discuss their experience of on-call. With permission 3 talk to a patient and family and explore their experience of transplantation and critically reflect on your learning and how it will affect your future practice. Observation of a living donor transplant procedure, including critical reflection on your experience and the impact it may have on your future role as a clinical scientist. Critically reflect on your own experience of supervision and mentoring and identify how you will use these in your learning training, supervising and mentoring of others. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. 3 Whilst it is recognised that this experience may be difficult to arrange it is recommended that as far as possible, all trainees are given this opportunity to meet with a patient and their family Page 193

194 The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 194

195 KEY COMPETENCES LEARNING OUTCOMES 1 Assess patients for registration onto the national transplant list and perform the tests necessary to achieve this including: HLA typing HLA antibody detection/definition 1,2, 4, 5 Interpret data from HLA antibody identification tests and prepare clinically meaningful reports on patients awaiting solid organ transplantation. 1, 2,3, 4, 7 Interpret crossmatch data and produce a crossmatch report for clinical colleagues according to local protocol. Page 195 KNOWLEDGE AND UNDERSTANDING How to assure the quality of personal practice. Local protocols for the clinical and laboratory work up of patients awaiting solid organ transplantation including: o kidney transplantation o other organs as appropriate to the laboratory. National requirements for transplant patient registration HLA type HLA antibody profile ABO blood group Sensitisation history Policy for registration of unacceptable antigens. How to assure the quality of personal practice. Current molecular HLA nomenclature. HLA antibody specificity nomenclature. Correct use of manual and computerised systems for interpreting and entering laboratory results. The need to manage records and all other information in accordance with applicable legislation, protocols and guidelines. How to assure the quality of personal practice. Correct use of data in relation to the full range of investigations specified within this module. Requirements of reports including sources of information, appropriate use of patient records, reference materials and current National/International Guidelines. The need to manage records and all other information in accordance with applicable legislation, protocols and guidelines.

196 KEY COMPETENCES LEARNING OUTCOMES 2,3 HLA type a deceased potential donor according to local protocols and complete a donor HLA report form for submission to NHSBT-ODT. 2,3 Assess the suitability of potential kidney/pancreas recipients for a deceased donor organ. 2,3 Assess the suitability of potential cardio thoracic or other solid organ (liver, islets, bowel) recipients for a deceased donor. 2,3,4,7 Analyse crossmatch data for a potential transplant recipient according to local policy and prepare a crossmatch report for clinical colleagues. 2,3,4,7 Perform a virtual crossmatch assessment for a potential transplant recipient according to local policy and prepare a cross-match report for clinical colleagues. 2,3,4,7 Assess the suitability of potential kidney donor/recipients for a living donor transplant and produce an interpretive report for clinical colleagues. KNOWLEDGE AND UNDERSTANDING How to assure the quality of personal practice. Interpretation of HLA typing data. Current HLA nomenclature. Requirements for ODT reporting of HLA typing results. Current National and International guidelines for solid organ allocation and transplantation. The need to manage records and all other information in accordance with applicable legislation, protocols and guidelines. NHSBT-ODT algorithm for deceased donor organ allocation. HLA match o ABO blood group compatibility o HLA antibody compatibility o Other criteria affecting allocation National guidelines for risk assessment of cardiothoracic and other organ recipients. Local criteria for cross-match suitability. Local policy for virtual cross-match suitability. Clinical interpretation of cross-match results, in relation to HLA antibody testing. Current legislation for living donor transplantation Human Tissue Act Directed and non-directed donation NLDKSS Strategies to improve access to transplantation for sensitised patients, including Antibody removal ABOi and HLA antibody incompatible (HLAi) Page 196

197 KEY LEARNING OUTCOMES COMPETENCES 5 Perform tests to detect or monitor donor specific antibodies for post transplant patients. 6 Work in partnership with other clinical specialisms in the investigation of solid organ transplantation and platelet transfusion and, where appropriate with service users and support staff. 6 Communicate effectively with the healthcare team recognising and responding appropriately to situations where it is necessary to share information to safeguard service users or the wider public. 7 Analyse antibody data for a patient referred for platelet refractoriness and produce an interpretive report for clinical colleagues 7 Select appropriate platelet units for patients requiring HLA/Human Platelet Antigen (HPA) selected platelets KNOWLEDGE AND UNDERSTANDING transplantation Epitope matching How to assure the quality of personal practice. Local protocols for the clinical and laboratory monitoring of patients who have received solid organ transplantation ABOi/HLAi transplants Donor Specific Antibody (DSA) monitoring Post transplant complications including: o Graft rejection (hyperacute, accelerated, acute, chronic) o Immunosuppression (IS) regimens. The need to build and sustain professional relationships as both an independent practitioner and collaboratively as a member of a team. Methods of effective communication. How communication skills affect assessment of, and engagement with, service users and how the means of communication should be modified to address and take account of factors such as age, capacity, learning ability and physical ability. Situations where it is necessary to share information to safeguard service users or the wider public. How to assure the quality of personal practice. Local protocols for the selection of HLA and / or Human Platelet Antigen (HPA) compatible platelets. Indications for platelet transfusion, e.g. Immune and non-immune causes of platelet refractoriness Matching algorithms Page 197

198 KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING Pre and post transfusion monitoring Page 198

199 MODULE 4 AIM SCOPE Immunogenetics (H&I-11) COMPONENT Specialist This module will provide the trainee with the practical application of knowledge and skills relating to the scientific principles of molecular techniques available for HLA typing and their applications for different clinical conditions. The trainee will select and perform a range of current methods used within an immunogenetics service and report the results of tests used to support transplantation, disease association and pharmacogenetics. The trainee will also be expected to consistently demonstrate professional practice that meets the standards of Good Scientific Practice, including the limitations of consent and the impact of culture, equality and diversity on practice. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Select and perform HLA typing methods and HLA loci to be tested for solid organ and haematopoietic stem cell transplantation, associated diseases and pharmacogenetic reactions according to current practice. 2. Prepare good quality DNA template for HLA typing techniques. 3. Identify the correct specimen tubes for HLA typing and be able to troubleshoot issues around DNA extraction. 4. Perform all aspects of the current range of molecular techniques available for immunogenetic testing. 5. Report on the results from a range of current techniques available for immunogenetic testing. 6. Apply the specific accreditation standards governing the use of molecular techniques. 7. Select and perform the appropriate HLA typing resolution in accordance with relevant standards required for different clinical applications. Work in partnership with other clinical specialisms in the investigation disease association and pharmacogenetics and patients referred for transplantation and, where appropriate with service users and support staff. Page 199

200 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Actively participate in multidisciplinary review meetings at which laboratory results are presented as part of the clinical record in patients awaiting or being monitored following haematopoietic stem cell transplantation. Identify how your experience will impact on your future practice as a clinical scientist. Review the case notes of a patient referred for disease association to gain an understanding of the care pathway of the patient from the initial consultation, investigations, follow-up appointment and treatment the patient may need, with the clinical team. Critically reflect on your learning and how it will affect your future practice Critically reflect on your own experience of supervision and mentoring and identify how you will use these in your learning training, supervising and mentoring of others. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. Page 200

201 KEY COMPETENCES KNOWLEDGE AND UNDERSTANDING LEARNING OUTCOMES 1,3 Receive samples for HLA typing and enter onto laboratory IMS. Minimum data set required for identification of laboratory samples. Factors affecting sample integrity and appropriate corrective action. Correct use of manual and computerised systems for entering laboratory samples. 1,2,3 Extract and quantify DNA from Local protocols. samples according to local protocol. Principles of DNA extraction, quantification and purity assessment. Impact of sample source. Safe handling of biological materials. 1 2,3,4 Use local molecular based How to assure the quality of personal practice. techniques in accordance with Clinical indications for which HLA typing is required. quality standards for intermediate The local repertoire, source of requests and resolution HLA typing. turnaround times for investigations performed by the training H&I laboratory. 1,2,3,4,6,7 Use local molecular based Internal quality controls and external quality techniques in accordance with assessment measures appropriate to the methods quality standards for High used. resolution typing. Correct and safe use of equipment used. Principles of PCR. Principles of HLA typing assays, for example: Sequence specific primers (SSP) DNA probe based hybridisation Real time PCR Sequence based typing (SBT) Next generation sequencing 1 2,5,6,7 Interpret data from HLA typing How to assure the quality of personal practice. Page 201

202 KEY LEARNING OUTCOMES COMPETENCES tests using current nomenclature and produce an HLA typing report for clinical colleagues. 1,5,6,7 Produce an interpretive genotyping report for a patient referred for disease association and pharmacogenetic reactions. 8 Work in partnership with other clinical specialisms in the investigation of disease association and pharmacogenetics and patients referred for transplantation and, where appropriate with service users and support staff. KNOWLEDGE AND UNDERSTANDING Current HLA nomenclature. Use of National and International standards for reporting of HLA types. Correct use of interpretation software. Correct use of manual and computerised systems for recording test results. Correct use of manual and computerised systems for generating laboratory reports. Factors influencing interpretation of HLA typing data. The need to manage records and all other information in accordance with applicable legislation, protocols and guidelines. How to assure the quality of personal practice. The proposed mechanisms for disease association and pharmacogenetic reactions. The clinical impact of positive/negative or presence/ absence of the associated HLA for the patient. The need to manage records and all other information in accordance with applicable legislation, protocols and guidelines. The need to build and sustain professional relationships as both an independent practitioner and collaboratively as a member of a team. Methods of effective communication Page 202

203 KEY COMPETENCES LEARNING OUTCOMES 8 Communicate effectively with the healthcare team recognising and responding appropriately to situations where it is necessary to share information to safeguard service users or the wider public. KNOWLEDGE AND UNDERSTANDING How communication skills affect assessment of, and engagement with, service users and how the means of communication should be modified to address and take account of factors such as age, capacity, learning ability and physical ability. Situations where it is necessary to share information to safeguard service users or the wider public. Page 203

204 MODULE 5 AIM SCOPE Haematopoietic Stem Cell Transplantation (HSCT) (H&I-12) COMPONENT Specialist This module will provide the trainee with the practical application of knowledge and skills relating to Histocompatibility and Immunogenetics techniques applicable to haematopoietic stem cell transplantation. The trainee will understand a range of clinical conditions associated with stem cell transplantation requirements. They will gain experience of HLA typing in the matching of donors and suitable recipients. They will perform relevant laboratory methods and gain experience of the interpretation and reporting of patient and donor results in a variety of clinical settings. The trainee will also be expected to consistently demonstrate professional practice that meets the standards of Good Scientific Practice, including the limitations of consent and the impact of culture, equality and diversity on practice. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Perform the clinical and laboratory investigation of patients being considered for HSCT including the interpretation and reporting of results in the correct clinical context. 2. Select suitable donors for HSCT under supervision. 3. Assess the suitability of potential related and unrelated (adult and cord blood) donors for HSCT. 4. Perform clinical and laboratory monitoring of patients who have received haematopoietic stem cell transplantation. 5. Work in partnership with other clinical specialisms in the investigation of haematopoietic stem cell transplantation and, where appropriate, with service users and support staff. Page 204

205 CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: Actively participate in ward rounds and clinics at which patients are being worked up for or monitored following haematopoietic stem cell transplantation. Discussion and critical reflection of your experiences, including ethical issues, and the involvement of the laboratory in the management of patients. Actively participate in multidisciplinary review meetings at which laboratory results are presented as part of the clinical record in patients awaiting or being monitored following haematopoietic stem cell transplantation. Identify how your experience will impact on your future practice as a clinical scientist. With permission 4 talk to a patient and family and explore their experience of transplantation and critically reflect on your learning and how it will affect your future practice Critically reflect on your own experience of supervision and mentoring and identify how you will use these in your learning training, supervising and mentoring of others. PROFESSIONAL PRACTICE Trainees should ensure they refer to the professional practice learning framework and continue to achieve the professional practice competences alongside the competences defined in this module. All of these experiences should be recorded in your e-portfolio. The following section details the competence and knowledge and understanding each trainee must gain. Each competence is linked to the relevant learning outcomes and trainees must demonstrate achievement of each competence for each linked learning outcome. 4 Whilst it is recognised that this experience may be difficult to arrange it is recommended that where possible all trainees are given the opportunity to meet with a patient and their family Page 205

206 KEY COMPETENCES KNOWLEDGE AND UNDERSTANDING LEARNING OUTCOMES 1 Analyse family HLA results to produce How to assure the quality of personal practice. pedigree data. HLA haplotypes and inheritance. Selection of extended family members for HLA typing. Recombination events. 1,2 Review and select potential related donors How to assure the quality of personal practice. for HSCT, using local and national Local and national protocols. protocols. Types of HSCT donor including: 1,2 Review and select potential unrelated adult o HLA matched related donors for HSCT, using local and national o Haplo-identical protocols. o Related/unrelated cord 1,2 Review and select potential cord donors for o Unrelated adult HSCT, using local and national protocols. Factors affecting HSCT donor selection. 1,2,3,5 Assess the suitability of potential related and National and international standards and legislation unrelated (adult and cord blood) donors for relating to haematopoietic stem cell transplantation. HSCT, using local and national protocols Relevant advisory groups for donor selection. 1,2,3,5 Produce an interpretive report of the Sources of stem cells and donor registries applicable suitability of potential related and unrelated to haematopoietic stem cell transplantation. (adult and cord blood) donors for HSCT for Local protocols for the clinical and laboratory work up clinical colleagues. of patients awaiting haematopoietic stem cell transplantation. Impact of HLA antibodies in HSCT and donor selection. Non-HLA factors relevant to donor selection. The need to manage records and all other information in accordance with applicable legislation, protocols and guidelines. 1,4 Perform chimerism analysis to assess and How to assure the quality of personal practice. Page 206

207 KEY LEARNING OUTCOMES COMPETENCES Page 207 KNOWLEDGE AND UNDERSTANDING monitor patients post HSCT. HSC transplant complications including: Acute graft versus host disease (GVHD) Chronic GVHD Graft failure, non-engraftment and delayed engraftment Infection Relapse in leukaemia, infertility, secondary malignancies Local immunosuppression regimes and assessment as to whether immunosuppression is adequate Local protocols for the clinical and laboratory monitoring of patients who have received haematopoietic stem cell transplantation. 1,4,5 Produce an interpretive chimerism report for clinical colleagues, using local and national protocols. 5 Work in partnership with other clinical specialisms in the investigation of Conditioning regimens and applicability of chimaerism analysis. Principles of methods employed for post transplant monitoring including: Fluorescence in-situ hybridisation (FISH) Minimal Residual Disease Monitoring STR/microsatellite analysis Real-time PCR Relevance of Cell Lineage Analysis. National guidelines for chimerism analysis. The need to manage records and all other information in accordance with applicable legislation, protocols and guidelines. The need to build and sustain professional relationships as both an independent practitioner and

208 KEY LEARNING OUTCOMES COMPETENCES haematopoietic stem cell transplantation and, where appropriate with service users and support staff. 5 Communicate effectively with the healthcare team recognising and responding appropriately to situations where it is necessary to share information to safeguard service users or the wider public. KNOWLEDGE AND UNDERSTANDING collaboratively as a member of a team. Methods of effective communication How communication skills affect assessment of, and engagement with, service users and how the means of communication should be modified to address and take account of factors such as age, capacity, learning ability and physical ability. Situations where it is necessary to share information to safeguard service users or the wider public. Page 208

209 Blood Sciences SECTION 10: APPENDICES Page 209

210 APPENDIX 1: Contributor List Members of the STP Blood Sciences curriculum (MSc and Work-based Learning Guide) from 2009 Production of this STP been coordinated by the Modernising Scientific Careers team and the National School of Healthcare Science working with NHS and Higher Education colleagues and patients including: Annie Armston Southampton University Hospital Trust David Baty Ninewells Hospital, Dundee Jennie Bell Birmingham Women s Hospital Michelle Bishop HEE Genomics Education Programme Frances Boa St George s Healthcare NHS Trust, London Geoff Bosson University of Northumbria, Newcastle upon Tyne Laura Boyes Birmingham Women s NHS Foundation Trust Anne Brookes National Blood Service (Retired) Kathryn Brownbill Royal Blackburn Hospital George Burghel Central Manchester University Hospitals NHS Foundation Trust David Cameron NHS Greater Glasgow & Clyde Rachel Carling St Thomas Hospital, London Peter Charles Imperial College Healthcare NHS Trust, London Sean Conlon Belfast Health and Social Care Trust Alistair Crockard Belfast Health and Social Care Trust Gareth Cross Nottingham City Hospital Anne Dalton Sheffield Children s NHS Foundation Trust Sue Davey NHS Blood and Transplant Val Davison National School of Healthcare Science and Birmingham Women s Hospital Tricia Dening-Kendall Southmead Hospital, Bristol Mandy Donaldson Imperial College Healthcare NHS Trust, London Ruth Evans NHS Blood and Transplant Berne Ferry The Churchill Hospital, Oxford Bob Flanagan King s College Hospital, London Danielle Freedman Luton & Dunstable NHS Trust Lorraine Gaunt St Mary s Hospital, Manchester Georgina Hall Manchester Centre for Genomic Medicine Stephen Halloran Royal Surrey County Hospital, Guildford Don Henderson Imperial College Healthcare NHS Trust, London Elizabeth Hodges Southampton University Hospitals NHS Trust Lowri Hughes Birmingham Women s NHS Foundation Trust Tim James John Radcliffe Hospital, Oxford Ian Jennings UK NEQAS, Sheffield Helen Jolley Manchester Centre for Genomic Medicine Betty Kyle NHS Lanarkshire Abirami Koneswaran St George s Healthcare NHS Trust, London John Lord Royal Blackburn Hospital Gordon Lowther Southern General Hospital, Glasgow Marion McAllister Cardiff University Page 210

211 Marion Macey Barts and the London NHS Trust Rhona MacLeod Manchester Centre for Genomic Medicine Gwyn McCreanor Kettering General Hospital Anna Middleton Wellcome Trust Sanger Institute, Cambridge Andy Miller NHS London Bridget Montague Leeds Teaching Hospitals NHS Trust Jane Needham Basingstoke and Hampshire Foundation Trust Sheila O Connor Leeds Teaching Hospitals NHS Trust Michael Palmer Kings Mill Hospital, Mansfield Christine Patch Guy s and St Thomas NHS Foundation Trust Hospital Joan Peel Midlands and East Strategic Health Authority Dan Pelling Imperial College Healthcare NHS Trust, London Les Perry Barts and The London NHS Trust Neil Porter Yorkshire and Humber SHA Kay Poulton Central Manchester Foundation Trust Tracey Rees Welsh Blood Service David Ricketts North Middlesex Hospitals NHS Trust Eileen Roberts Southmead Hospital, Bristol Amanda Robson Manchester Royal Infirmary Gill Rumsby University College Hospital London Deborah Sage NHS Blood and Transplant, Tooting Centre, London Marion Scott Southmead Hospital, Bristol Anneke Seller Churchill Hospital, Oxford Ruhena Sergeant Imperial College Healthcare NHS Trust Jo Sheldon St George s Healthcare NHS Trust, London Robert Simpson Queen Alexandra Hospital, Portsmouth Heather Skirton Plymouth University Paul Sinnott Barts and The London NHS Trust John Stevens Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Dan Smith John Radcliffe Hospital, Oxford Dave Stockwell Morriston Hospital, Swansea Alison Taylor-Beading Great Ormond Street NHS Foundation Trust Julian Waldron University Hospitals North Staffordshire Anthony Warrens Imperial College Healthcare NHS Trust, London Jonathan Waters Great Ormond Street Hospital for Children, London Melanie Watson Bristol Royal Infirmary Ian Watson Aintree Hospitals, Liverpool Stephen Whiting Royal Free Hospital, London Jenny White West Hertfordshire Hospitals NHS Trust David Wilson Raigmore Hospital, Inverness Eileen Williams Southmead Hospital, Bristol Professional bodies and societies were invited to review this Learning Guide and their feedback has shaped the final publication: Institute of Biomedical Science Association of Clinical Biochemists Page 211

212 Modernising Scientific Careers Professional Advisor Dr Graham Beastall Ms Nicky Fleming National School of Healthcare Science Professional Lead Dr Barbara Lloyd September 2012 February 2017 Page 212

213 APPENDIX 2: Programme Amendments This section lists the programme amendments following first publication. Amendments February 2012 The Association for Clinical Biochemistry (Clinical Immunology) requested that the following changes were made to the 2010/11 edition of the Clinical Immunology Year 2 specialism sections of the MSc Clinical Sciences (Blood Sciences). The MSC team have made the changes requested by the professional body, detailed below and reissued as MSc Clinical Sciences (Blood Sciences) v2 (see footer). Page 56 section 6.1 Year 2 Specialist Practice for Clinical Immunology Year 2: C1-2: Immunity: Implications for Infection, for Cancer and for Pregnancy Clinical Immunology does not deal specifically with pregnancy and therefore: The learning outcomes in the Knowledge and Understanding and Associated work-based curriculum have been revised. All learning outcomes associated with pregnancy have been removed. The title of the Module has been updated and is now Year 2: C1-2: Immunity: Implications for Infection and for Cancer Page 59 section 6.1 Year 2 Specialist Practice for Clinical Immunology Year 2: C1-3: Autoimmunity Clinical Immunology does not deal specifically with pregnancy and therefore: The learning outcomes in the Knowledge and Understanding and Associated work-based curriculum have been revised. All learning outcomes associated with pregnancy have been removed. All other content in this curriculum remains unchanged. The amended version is titled MSc Blood Sciences v2 (see footer). For any queries regarding this change please nshcs@wm.hee.nhs.uk Page 213

214 Amendments November 2012 The Association for Clinical Biochemistry (Clinical Immunology) and the British Society for Histocompatibility and Immunogenetics jointly requested that the following changes were made to the 2010/11 edition of the Clinical Immunology and the Histocompatibility and Immunogenetics Years 2 and 3 specialism sections of the MSc Clinical Sciences (Blood Sciences). The MSC team have made the changes requested by the professional bodies, detailed below in this updated version of the MSc Clinical Sciences (Blood Sciences) version 3 (see footer). The changes result from experience of using the MSc. It was agreed by both professional bodies that the original content of the syllabus did not adequately reflect the latest learning in transplantation that is required by trainees in this in Clinical Immunology and Histocompatibility and Immunogenetics. In outline the changes comprise: 1. The preparation of a new module that is common to both curricula and which replaces two different modules (one from each curriculum). 2. The change of title for one module in the Histocompatibility and Immunogenetics curriculum. 3. A change of order of the modules to ensure that the three common modules are at the same stage in each of the two curricula. The detailed changes are given below. The changes to the Clinical Immunology syllabus carry into the Histocompatibility and Immunogenetics syllabus except where indicated. For clarity all Clinical Immunology modules have been coded CI and all Histocompatibility and Immunogenetics modules have been coded HI. Commonality between the two syllabi is maintained with modules CI-3/HI-3; CI-4/HI-4; and CI-5/HI- 5 being identical. Clinical Immunology Curriculum Page 58 section 6.1 Year 2 Specialist Practice for Clinical Immunology The module entitled Immunodeficiency and Immunotherapy has been renumbered as CI-3 (previously CI-5). The earlier introduction of this module into the syllabus is seen as a sensible move. Page 66 section 6.3 Year 3 Specialist Practice for Clinical Immunology The new module CI-5 entitled Haematological Malignancy and Transplantation has been introduced as a replacement for the previous module CI-6 entitled Transplantation. This better reflects the work of trainees in supporting the investigation and treatment of haematological malignancy. Page 68 section 6.3 Year 3 Specialist Practice for Clinical Immunology The module entitled Autoimmunity has been renumbered as CI-6 (previously CI-3). This is a standalone module and there is no difficulty in repositioning it as the final specialist module for Clinical Immunology. Histocompatibility and Immunogenetics Curriculum Page 214

215 Page 71 section 6.5 Year 2 Specialist Practice for Histocompatibility and Immunogenetics Module HI-2 has been renamed Histocompatibility and given a new number. This module was previously CI-6 and entitled Transplantation. The module has been removed from the Clinical Immunology syllabus (see above). The module focuses on histocompatibility and so it is appropriate to be the first specialist module in the Histocompatibility and Immunogenetics variation to the Clinical Immunology curriculum. Page 73 section 6.6 Year 3 Specialist Practice for Histocompatibility and Immunogenetics The new module HI-5 entitled Haematological Malignancy and Transplantation has been introduced as a replacement for the previous module HT-2 entitled Clinical Haematology (shared with the Haematology and Transfusion syllabus). This better reflects the work of trainees in supporting the investigation and treatment of haematological malignancy. Page 75 section 6.6 Year 3 Specialist Practice for Histocompatibility and Immunogenetics The module entitled Haemopoetic Stem Cell Transplantation has been renumbered HI-6 (previously CI-3B). Repositioning this specialist module after the common module CI-5/HI-5 is appropriate. The table below gives a summary of the revised modules. Revised Modules for Clinical Immunology and Histocompatibility & Immunogenetics Module CI-1 CI-2 Clinical Immunology Module Title Immunity and the Principles and Practice of Clinical Immunology Immunity: Implications for Infection and Cancer Immunodeficiency and Immunotherapy Module Histocompatibility and Immunogenetics Module Title HI-1 Immunity and the Principles and Practice of Clinical Immunology HI-2 Histocompatibility CI-3 HI-3 Immunodeficiency and Immunotherapy CI-4 Hypersensitivity and Allergy HI-4 Hypersensitivity and Allergy CI-5 Haematological Malignancy and Transplantation HI-5 Haematological Malignancy and Transplantation CI-6 Autoimmunity HI-6 Haemopoetic Stem Cell Transplantation For any queries regarding this change please nshcs@wm.hee.nhs.uk Page 215

216 Amendments March 2013 These amendments apply to trainees commencing STP in the academic year 2013/ A generic introduction to all STP MSc Clinical Science programmes has been added. 2. In order to improve the alignment to QAA level 7 the word understand has been replaced with an appropriate verb from Bloom s Taxonomy for the Knowledge domain. 3. The generic module Healthcare Science has been renamed Introduction to Healthcare Science, Professional Practice and Clinical Leadership. 4. The generic modules Healthcare Science (which incorporates Professional Practice) and Research Methods have been revised and updated. 5. The Research Project has been revised and all students are expected to complete a single 60-credit research project spanning Years 2 and 3, see relevant section. 6. Good Scientific Practice (GSP) sets out for the healthcare science profession and the public the standards of behaviour and practice that must be achieved and maintained in the delivery of work activities, the provision of care and personal conduct. GSP has been added in the Appendices of each curricula and aspects of professionalism strengthened to reflect areas such as the need to ensure the shared nature of clinical decision making. 7. The learning outcomes related to Personal Attitudes and Behaviours now appear in the Professional Practice section of this document but apply to all modules. The new version is called STP MSc Blood Sciences Version 4.0 for For any queries regarding this change please nshcs@wm.hee.nhs.uk Amendments March 2017 Revised Genetic Sciences Rotational Module In 2016 the original STP in Genetic Sciences was reviewed, updated and extended to become the STP in Genomic Sciences. This programme includes 3 specialist outcomes in Genomics, Genomic Counselling and (for 2018) Molecular Pathology). As part of this process the rotational module Genetics and Molecular Science (shared by Genetic Sciences, Blood Sciences and Cellular Sciences) was revised and is now called " Genomic Sciences: Genetics, Genomics and Molecular Science. The revised module is now included within the STP in Blood Sciences. This amendment applies to trainees commencing STP in the academic year 2017/18. Revised Histocompatibility and Immunogenetics work-based learning programme Page 216

217 In 2016 the British Society of Histocompatibility and Immunogenetics (BSHI) identified an urgent need to develop STP Histocompatibility and Immunogenetics (H&I) training to secure an adequate clinical scientific workforce in this area in order to meet the predicted growth in organ transplantation. The National School of Healthcare Science has worked with the BSHI to revise the work-based education and training of trainees in H & I within the STP in Blood Sciences. The MSc syllabus is unchanged. Changes to the work-based syllabus for H&I are summarised below. Rotational Training The rotational programme for trainees in H&I will now comprise: Rotation 1(H&I-7) Immunity and the Principles and Practice of Histocompatibility and Immunogenetics New module replacing Immunity and the Principles and Practice of Clinical Immunology Rotation 2 (HT-1) Haematology and Transfusion Science Rotation 3 (CB-1) Rotation 4 (CG-1) Clinical Biochemistry Investigation of Major Organ Function Genetics, Genomics and Molecular Science New module replacing Genetics and Molecular Science The new version is: STP Blood Sciences v 1.0 for Page 217

218 Specialist Training (work-based learning guide) In specialist training the work-based syllabus has been modified to give more focus to the practical application of the knowledge and skills required by Clinical Scientists in Histocompatibility and Immunogenetics. Three Clinical Immunology plus two H&I modules have been replaced with one Clinical Immunology and 4 H&I modules. The modules complement each other in the following way: The first module, Clinical Immunology in Histocompatibility and Immunogenetics, addresses the Clinical Immunology knowledge and skills relevant for H&I Clinical Scientists. The trainee will become familiar with methods and strategies to investigate clinical immunology and gain experience of the interpretation of patient results in a variety of clinical settings The second module, Histocompatibility, focuses on the understanding of the principles and practice of Histocompatibility leading to competence with the methods used in support of transplantation and blood transfusion. In the third module, Solid Organ Transplantation, the focus is on the understanding of the clinical significance of Histocompatibility and Immunogenetics within the context of solid organ transplantation and blood transfusion and the trainee will become familiar with the interpretation and reporting of patient and donor results. The fourth module, Immunogenetics focuses on the scientific principles of molecular techniques available for HLA typing and their applications for different clinical conditions. During the final module, Haematopoietic Stem Cell Transplantation (HSCT) the trainee will gain experience of HLA typing in the matching of donors and suitable recipients in HSCT. They will perform relevant laboratory methods and gain experience of the interpretation and reporting of patient and donor results in a variety of clinical settings. Module 1 (H&I-2) Module 2 (H&I-3) Module 3 (H&I-4) Version 2012/13 to 2016/17 Histocompatibility Module 1 (H&I-8) Immunodeficiency and Immunotherapy Module 2 (H&I-9) Hypersensitivity and Allergy Module 3 (H&I-10) Version 2017/18 Clinical Immunology in Histocompatibility and Immunogenetics Histocompatibility Solid organ transplantation Module 4 (H&I-5) Haematological Malignancies and Transplantation Module 4 (H&I-11) Immunogenetics Module 5 Haemopoietic Stem Cell Module 5 Haematopoietic Stem Cell Page 218

219 (H&I-6) Transplantation (H&I-12) Transplantation The new STP Blood Sciences version is called: STP MSc Blood Sciences version 1.0 for 2017 For any queries regarding these changes please Page 219

220 APPENDIX 3: Glossary Term Clinical Experiential Learning Clinical Experiential Learning Outcomes Competence Competence statements Component Curricula Division Domains of Learning Feedback Good Scientific Practice Host Department Job Key Learning Outcome Knowledge and Understanding Learning Framework Learning Module Definition The cyclical process linking concrete experience with abstract conceptualisation through reflection and planning. The activities that the trainee will undertake to enable and facilitate their learning in the workplace. The ability of an individual to perform a role consistently to required standards combining knowledge, understanding, skills and behaviour. Active and outcome-based statements that provide a further breakdown of the Learning Outcomes reflecting what the trainee will be able to do in the workplace at the end of the programme. Each competence should linked back to the numbered Learning Outcomes. An indication of the type of module within a learning guide ie; rotational, specialist or elective An outline of the expected educational outcomes across a subject area The learning that is expected to take place during the Scientist Training Programme described in terms of knowledge, skills and attitudes, A high level description of an area of practice within healthcare science. There are three divisions: Life Sciences, Physical Sciences and Biomedical Engineering and Physiological Sciences. Cognitive (knowledge and intellectual skills), affective (feelings and attitudes), interpersonal (behaviour and relationships with others) and psychomotor (physical skills) Specific information about the comparison between a trainee s observed performance and a standard, given with the intent to improve the trainee s performance (van de Ridder JMM, Stokking KM, McGaghie WCand ten Cate OT. What is feedback in clinical education? Medical Education 2008: 42: )7 Non-statutory guidance on the minimum requirements for good practice for the healthcare science workforce. The department which is responsible for the 3-year training programme and which the training officer is based. A specific definition of the work activities, requirements, skills required to undertake work activities within a local context. This differs from a role see below. A defined learning outcome linked to relevant competence(s) within the workplace Learning Guide The knowledge and understanding that must be applied in the work place to achieve the stated competence. The specification for work-based learning contained within the Learning Guide A distinct set of learning outcomes and competences that form part of a programme. Modules may be rotational, Page 220

221 Term Learning Outcome Mentoring Definition specialist, elective or professional practice and can be combined to meet the needs of specific programmes A high level, outcome based statement that describes what a trainee will be able to do at the end of the module Mentoring is a process in which a trainer (mentor) is responsible for overseeing the career and development of the trainee. The emphasis is therefore on the relationship (rather than the activity). Module Aim The overall objective of a work-based learning module defining the intended learning achievements of the trainee. The Aim works together with the Scope statement to define the overall objectives and scope of the module Module Scope National Occupational Standards Practical Skill Programme Provider Role Specialism Trainer Theme Work-based learning Work Performance Work place A statement within work-based learning modules that defines the range/limits/ of the learning undertaken by the trainee in a module patients/investigations/equipment/modalities etc) Nationally recognised standards of expected workplace performance and level of competence for a role. The standards are outcome-based, defining what the role holder should to be able to do, as well as what they must know and understand to demonstrate competent work performance. National Occupational Standards are supported by nationally agreed frameworks of expected attitudes, behaviour and skills. A cognitive, psychomotor, physical or communicative ability that supports performance of required role. The package of learning, teaching assessment and quality assurance leading to an award. An organisation that delivers required training and learning activities, to specified quality assurance requirements A collection of functions undertaken in the workplace that represent the main broad areas of work for all similar workers at national level. A role differs from a job, the latter being defined specifically for a local context. A focused area of practice within a theme of healthcare science. A qualified individual who provides learning and development support for trainees A cluster of related specialisms within a division of healthcare science. Learning that takes place in a real work setting and involves the application of academic learning to real work activities The requirements of satisfactory and consistent demonstration of competence in specified functions for a work role. A real work setting in which the trainee can apply learning. Page 221

222 APPENDIX 4: Good Scientific Practice Good Scientific Practice Section 1: The purpose of this document There are three key components to the Healthcare Science workforce in the UK: 1. Healthcare Science Associates and Assistants who perform a diverse range of task based roles with appropriate levels of supervision. 2. Healthcare Science Practitioners have a defined role in delivering and reporting quality assured investigations and interventions for patients, on samples or on equipment in a healthcare science specialty, for example Cardiac Physiology, Blood Sciences or Nuclear Medicine. They also provide direct patient care and more senior Healthcare Science Practitioners develop roles in specialist practice and management. 3. Healthcare Scientists are staff that have clinical and specialist expertise in a specific clinical discipline, underpinned by broader knowledge and experience within a healthcare science theme. Healthcare scientists undertake complex scientific and clinical roles, defining and choosing investigative and clinical options, and making key judgements about complex facts and clinical situations. Many work directly with patients. They are involved, often in lead roles, in innovation and improvement, research and development and education and training. Some pursue explicit joint academic career pathways, which combined clinical practice and academic activity in research, innovation and education. This document sets out the principles and values on which good practice undertaken by the Healthcare Science workforce is founded. Good Scientific Practice sets out for the profession and the public the standards of behaviour and practice that must be achieved and maintained in the delivery of work activities, the provision of care and personal conduct. Good Scientific Practice uses as a benchmark the Health Professions Council (HPC) Standards of Proficiency and Standards of Conduct, Performance and Ethics, but expresses these within the context of the specialities within Healthcare Science, recognising that three groups of the workforce, Biomedical Scientists, Clinical Scientists and Hearing Aid Dispensers are regulated by the HPC. The aim is that the standards are accessible to the profession and understandable by the public. Good Scientific Practice represents standards and values that apply throughout an individual s career in healthcare science at any level of practice. The standards will be contextualised by the role within Healthcare Science that an individual undertakes. This means that the standards must be interpreted based on the role that an individual performs. For example, in supervised roles where individuals work within defined procedures, rather than autonomously, some standards will need to Page 222