MODERNISING SCIENTIFIC CAREERS Scientist Training Programme Work Based Training Learning Guide CELLULAR SCIENCES 2012/13 Page | 1 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) STP WORK BASED PROGRAMME IN CELLULAR SCIENCES Contents SECTION 1: GENERAL INTRODUCTION ................................................................. 4 READERSHIP ..................................................................................................................... 5 1.1 Scientist Training Programme (STP) Overview ......................................................... 6 1.2 Outcomes of the work based STP .............................................................................. 9 1.3 Key Components of Work Based Training in STP................................................... 11 1.4 Host Training Departments ........................................................................................ 12 1.5 National School of Healthcare Science (NSHCS) and the STP ............................. 16 1.6 The Structure of the Learning Frameworks .............................................................. 17 1.7 Assessment during Work Based Training ................................................................ 18 1.8 Quality Assurance and Quality Management ........................................................... 21 SECTION 2: PROGRAMME OVERVIEW ................................................................ 23 SECTION 3: ROTATIONAL LEARNING FRAMEWORKS ...................................... 30 Principles and Practice of Cervical Cytology and Diagnostic Cytopathology (CP-1) . 32 Introduction to Principles and Practice of Histopathology (HP-1)................................. 38 Principles and Practice of Reproductive Science and Diagnostic Semen Analysis (RS-1) ... 45 Genetics and Molecular Science (CG-1) ........................................................................ 51 SECTION 4: PROFESSIONAL PRACTICE LEARNING FRAMEWORK................. 57 Professional Practice (PP1) ............................................................................................. 60 SECTION 5: ELECTIVE LEARNING FRAMEWORK............................................... 71 Elective (EL)....................................................................................................................... 73 SECTION 6: SPECIALIST LEARNING FRAMEWORK CYTOPATHOLOGY ......... 75 Pathological Basis of Disease (CP-2) ............................................................................. 78 Systematic Investigation of Pathological Specimens (CP-3) ........................................ 83 Major Organ Histopathology including Cancer (CP-4) .................................................. 87 Gynaecological Cytopathology (CP-5) ............................................................................ 93 Non-Gynaecological Cytopathology (CP-6) .................................................................... 98 SECTION 7: SPECIALIST LEARNING FRAMEWORK HISTOPATHOLOGY ...... 103 Pathological Basis of Disease (HP-2) ........................................................................... 106 Systematic Investigation of Pathological Specimens (HP-3) ...................................... 111 Major Organ Histopathology excluding Cancer (HP-4) ............................................... 115 Cancer (HP-5).................................................................................................................. 121 Specialised Histopathology (HP-6) ................................................................................ 127 SECTION 8: SPECIALIST LEARNING FRAMEWORK REPRODUCTIVE SCIENCE . 132 Infertility, Treatment and Role of Regulation (RS-2) .................................................... 135 Gametes and Fertilisation (RS-3) .................................................................................. 139 Culture of Gametes and Embryos (RS-4) ..................................................................... 144 Micromanipulation and Cryopreservation (RS-5) ......................................................... 148 Embryology (RS-6) .......................................................................................................... 152 Page | 2 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) SECTION 9: CONTRIBUTORS .............................................................................. 155 SECTION 10: APPENDICES ................................................................................. 157 APPENDIX 1: GLOSSARY ............................................................................................ 158 APPENDIX 2: GOOD SCIENTIFIC PRACTICE ........................................................... 160 APPENDIX 3: FURTHER INFORMATION ................................................................... 167 Page | 3 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) SECTION 1: GENERAL INTRODUCTION Page | 4 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) READERSHIP This Scientist Training Programme (STP) Learning Guide describes the STP work based training programmes in the UK: • • • • • Trainees, host departments and managers of services that employ healthcare science staff; Work based trainers, which includes all those involved in supervising, coordinating, assessing and delivering education and training; Academic and administrative staff within Higher Education Institutions (HEIs); Strategic Health Authorities (SHAs), and their successor health and education commissioning bodies; Those involved in Modernising Scientific Careers (MSC) accreditation events and reviews. A glossary of terms used is provided in Appendix 1. Page | 5 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 work based 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 www.networks.nhs.uk/nhs-networks/msc-framework-curricula. Further details of the Page | 6 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 work-based 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 2012. 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 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 | 7 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Modernising Scientific Careers: Scientist Training Programme (STP): Diagrammatic representation of employment-based, pre-registration 3 year NHS commissioned education and training programme Page | 8 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 methodologies and develop critiques of them and, where appropriate, propose new research questions and hypotheses; Page | 9 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 | 10 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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-today 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 officer1 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 self-evaluation and action planning. 1 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 | 11 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 work based 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:www.nshcs.org.uk. Page | 12 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 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. Page | 13 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 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. Page | 14 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 | 15 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 work based 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 email [email protected] and at www.nshcs.org.uk . Page | 16 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 | 17 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 | 18 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Table 1 Summary of the STP Work Based Assessment Tools Assessment Tool Direct observation of practical skills (DOPS) 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. 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. Method Observed clinical event (OCE) Case based discussion (CbD) Multi source feedback (MSF) To assess the trainee’s 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. 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. ability to apply their knowledge and understanding of an aspect of an activity for example the underpinning science, aspects of professional practice . 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. Page | 19 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 | 20 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 work based 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; Page | 21 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) • • 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; 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 work based 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 | 22 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) SECTION 2: PROGRAMME OVERVIEW CELLULAR SCIENCES Page | 23 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) STP WORK BASED TRAINING PROGRAMME IN CYTOPATHOLOGY The diagram below provides an overview of the programme each trainee in Cytopathology 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 | 24 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) ROTATIONAL COMPONENT Trainees must then successfully complete the Cytopathology rotation followed by the other THREE rotations listed below: Rotation 1 (CP-1) Rotation 2 (HP-1) Rotation 3 (RS-1) Rotation 4 (CG-1) Principles and Practice of Cervical Cytology and Diagnostic Cytopathology Introduction to Principles and Practice of Histopathology Principles and Practice of Reproductive Science and Diagnostic Semen Analysis Genetics and Molecular Science Duration: Each rotation should be of approximately 12 weeks duration. Order: It is expected that the first rotation completed will be Cytopathology. 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 (CP-2) Pathological Basis of Disease Module 2 (CP-3) Systematic Investigation of Pathological Specimens Module 3 (CP-4) Major Organ Histopathology including Cancer Module 4 (CP-5) Gynaecological Cytopathology Module 5 (CP-6) Non-Gynaecological Cytopathology The following sections of the learning guide contain the learning frameworks for the rotational, elective, specialist and professional practice modules. Page | 25 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) STP WORK BASED TRAINING PROGRAMME IN HISTOPATHOLOGY The diagram below provides an overview of the programme each trainee in Histopathology 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 | 26 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) ROTATIONAL COMPONENT Trainees must then successfully complete the Histopathology rotation followed by the other THREE rotations listed below: Rotation 1 (HP-1) Introduction to Principles and Practice of Histopathology Rotation 2 (CP-1) Principles and Practice of Cervical Cytology and Diagnostic Cytopathology Principles and Practice of Reproductive Science and Diagnostic Semen Analysis Genetics and Molecular Science Rotation 3 (RS-1) Rotation 4 (CG-1) Duration: Each rotation should be of approximately 12 weeks duration. Order: It is expected that the first rotation completed will be Histopathology. 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 (HP-2) Pathological Basis of Disease Module 2 (HP-3) Systematic Investigation of Pathological Specimens Module 3 (HP-4) Major Organ Histopathology excluding Cancer Module 4 (HP-5) Cancer Module 5 (HP-6) Specialised Histopathology 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 | 27 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) STP WORK BASED TRAINING PROGRAMME IN REPRODUCTIVE SCIENCE The diagram below provides an overview of the programme each trainee in Reproductive 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 | 28 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) ROTATIONAL COMPONENT Trainees must then successfully complete the Reproductive Science rotation followed by the other THREE rotations listed below: Rotation 1 (RS-1) Rotation 2 (HP-1) Rotation 3 (CP-1) Rotation 4 (CG-1) Principles and Practice of Reproductive Science and Diagnostic Semen Analysis Introduction to Principles and Practice of Histopathology Principles and Practice of Cervical Cytology and Diagnostic Cytopathology Genetics and Molecular Science Duration: Each rotation should be of approximately 12 weeks duration. Order: It is expected that the first rotation completed will be Reproductive 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 (RS-2) Infertility, Treatment and Role of Regulation Module 2 (RS-3) Gametes and Fertilisation Module 3 (RS-4) Culture of Gametes and Embryos Module 4 (RS-5) Micromanipulation and Cryopreservation Module 5 (RS-6) Embryology 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 | 29 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Cellular Sciences SECTION 3: ROTATIONAL LEARNING FRAMEWORKS Page | 30 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) STP Learning Framework 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 Modules DIVISION Life Sciences THEME Cellular Sciences SPECIALISM Cytopathology Page | 31 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE TITLE AIM SCOPE Principles and Practice of Cervical Cytology and Diagnostic Cytopathology (CP-1) COMPONENT Rotation This module will provide trainees with the knowledge and understanding of Cervical Cytology and an overview of the role and limitations of Diagnostic Cytopathology. Trainees will be able to recognise normal cells in cervical cytology preparations. They will gain knowledge of the cervical screening programme, the role of fine needle aspiration cytology and non-gynaecological cytology preparation techniques. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. 2. 3. 4. Receive, prepare and process specimens for cytopathological investigation. Select appropriate methods for preparation, fixation and staining Use microscopic examination techniques on a selection of cytopathology samples. Recognise the appearance of normal and abnormal cellular patterns in Cervical Cytology. Page | 32 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: • • • • • • Participate in multidisciplinary review meetings at which cytopathology results are presented as part of the clinical record. Reflect and discuss in terms of the benefits of a multidisciplinary approach to patient care and the importance for the patient pathway. Review and discuss the application of the range of cytochemical, immunocytochemical and molecular techniques available in the training department, including application to non-gynaecological specimens. Review, reflect on and discuss the operation of current cervical screening programmes, with particular reference to their importance to patient groups, to identification and prevention of disease and to the patient pathway. Review and discuss the application and interpretation of quality assurance methodologies in Cytopathology. Discuss with practitioners the preparation and interpretation of cytopathological reports. Reflect and report on the importance and implications of effective reporting. Undertake a range of work activities that involve working in partnership between the cytopathology laboratory and other clinical specialisms in the investigation of disease. Reflect and report on the importance of this partnership approach to the patient experience of investigation, treatment and management. 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. 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. Page | 33 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1 COMPETENCES Receive, label and store a wide range of cytopathology specimens. KNOWLEDGE AND UNDERSTANDING • • • • • • • • 2 Prepare, select and use appropriate fixative and staining solutions to a variety of tissue samples, to include: • Papanicolaou and MayGrünwald-Giemsa staining technique. • • • • • • 3 Set up and use light microscopy at various magnifications levels to • 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. Relevant records, their importance and how to complete these correctly. Types and implications of hazards and risks associated with handling of cytopathology specimens and relevant control measures. Correct location and storage of documentation and specimens at each stage of processing. 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. Types, purposes and use of fixatives, preservatives, stains and equipment associated with specimen preparation and processing. Potential hazards and risks associated with specimen preparation and associated control measures. Principles of liquid-based cytology and imaging technologies. Principles of non-gynaecological cytology preparation techniques. Special stains used to aid diagnosis relevant to cytology, including Grocott and Ziehl–Neelsen (ZN). Relevant statutory, regulatory and legislative requirements and guidance associated with processing of specimens. The function of microscopic components and how to set up a microscope for investigation of cytopathology specimens. Page | 34 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 2 COMPETENCES investigate a range of cytopathology specimens. Select the appropriate enzyme cytochemical techniques required to demonstrate a specific disease process using appropriate control material. KNOWLEDGE AND UNDERSTANDING • • • • 2 4 4 Select the appropriate immunocytochemical techniques and antibodies to demonstrate a specific disease process using appropriate control material • • • • Based on representative cervical cytology specimens, identify normal cellular appearance under the microscope and be able to recognise commonly occurring pathological features. • • Produce a basic interpretative report on cytopathology investigations. • • • • • Relevance and importance of specificity, sensitivity, accuracy and precision in the evaluation of analytical methods. Capabilities and limitations of methods, techniques and equipment. Safe laboratory practices, including principles of sterilisation and decontamination. Principles and applications of techniques using different instrumentation. Use and application of reagents for analysis. Significance of standard operating procedures (SOPs), internal quality control (IQC) and external quality assessment (EQA). Factors that influence the quality and integrity of prepared specimens. The range of further investigations that may be required, their purpose, capabilities and limitations. Factors that influence the quality and integrity of prepared specimens. The range of further investigations that may be required, their purpose, capabilities and limitations. How to recognise common pathological features of dyskaryosis, cervical glandular intraepithelial neoplasia and common infections seen in cervical samples. 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 Page | 35 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING • 1,2,3 Control infection risks in accordance with departmental protocols. • • 1,2,3 Minimise risks and hazards in compliance with health and safety policies. • • • • 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 | 36 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) STP Learning Framework 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 Modules DIVISION Life Sciences THEME Cellular Sciences SPECIALISM Histopathology Page | 37 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE TITLE AIM SCOPE Introduction to Principles and Practice of Histopathology (HP-1) COMPONENT Rotation This module will provide trainees with the knowledge and understanding of the principles and practice of Histopathology as applied to clinical medicine. Trainees will use a range of histological techniques and gain experience of interpreting results from patient investigations. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Receive, prepare and process specimens for histopathological investigation. To include dissection, tissue selection cutting, fixation and staining as appropriate. 2. Select the appropriate demonstration technique in the investigation of representative histopathology specimens. 3. Use microscopic examination techniques to investigate histopathological specimens. 4. Recognise normal cellular morphology of representative tissues and organs and common pathobiological processes associated with them. 5. Comply with quality assurance processes associated with histopathological investigations. Page | 38 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: • Participate in multidisciplinary review meetings at which histopathology results are presented as part of the clinical record. Reflect and report on the importance of a multidisciplinary approach to patient investigation, treatment and management. • Review, discuss and report on the application of the range of histochemical, immunocytochemical and molecular techniques available in the training department. • Observe, review and discuss the application and interpretation of quality assurance methodologies in Histopathology. • Discuss, with practitioners, the preparation and reporting of FRCPath category A, B and C specimens. • Undertake activities that demonstrate the partnership between the histopathology laboratory and other clinical specialisms in the investigation of disease. Reflect on your experiences and the implications for patient investigation, treatment and care 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. 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. Page | 39 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1,5 COMPETENCES Receive, label and store of a wide range of histopathology specimens. 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. Legal and ethical considerations and requirements in respect of examination of tissue, selection of control material and disposal of specimens. Infection risk from blood samples and how to deal with fresh tissue samples. Safe laboratory practices, including principles of decontamination of equipment and work areas. Specimen acquisition, viability, collection and delivery, including renal biopsies and bullous skin diseases. Quality assurance procedures and their application. Local and national health and safety policies and procedures and their application. The range of imaging procedures available and their use, including storage of images. Correct and safe use of imaging equipment and processing of Xrays or photographic films if required. The dissection of FRCPath category A, B and C specimens. Page | 40 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1 COMPETENCES Prepare and use a microtome on a range of tissue samples within different embedding materials. KNOWLEDGE AND UNDERSTANDING • • • • • • • • • • • 2 2 2 Apply the haematoxylin and eosin staining technique to a variety of tissue samples. Select the appropriate tinctorial and/or histochemical staining techniques required to demonstrate a specific disease process using appropriate control material. Select the appropriate impregnation techniques required to demonstrate a specific disease process using • • • • • • Principles and practice of fixation. Principles of specimen dissection and block selection. Tissue processing and embedding techniques. Decalcification. Microtomy, cryotomy. Macrophotography. Normal cellular morphology and ultrastructure of specified tissues and organ systems, including skin, building on basic anatomy and physiology. Basic principles of tissue preparation techniques, including factors affecting selection and their application. Factors that influence the quality and integrity of prepared specimens. The principles of specimen dissection and manipulation to expose features of interest. Basic principles of demonstration techniques and their rationale and hazards. Haematoxylin and eosin staining techniques and their application. Special stains to identify individual tissue/cellular components, e.g. connective tissues, nucleic acids, mucins, lipids, pigments. Histochemical techniques and their application. Potential artefacts, their identification and importance. The range of tinctorial and histochemical staining techniques, their selection and application to disease processes. The range of control materials and their appropriate use. Page | 41 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES appropriate control material. KNOWLEDGE AND UNDERSTANDING • • • 3 4 4 4 1,2,3,4 Set up and use light microscopy at various magnifications in the investigation of a range of tissue specimens. Select the appropriate enzyme histochemical techniques required to demonstrate a specific disease process using appropriate control material. Select the appropriate immunohistochemical and/or immunofluorescence techniques and antibodies to demonstrate a specific disease process using appropriate control material. Select the appropriate molecular techniques, markers and reagents required to demonstrate a specific disease process using appropriate control material. Produce a basic interpretative report on histopathology investigations. Capabilities and limitations of methods, techniques and equipment. Principles and applications of techniques using different instrumentation. Correct use and application of reagents for analysis. • The function of microscopic components and how to set up a microscope for investigation of histopathology specimens. • Histochemical techniques and their application. • The principles and common application of immunohistochemistry and immunofluorescence. • The principles and common application of molecular techniques in Histopathology. • The components required for a histopathology report and their relevance to patient care. The information to be included in an interpretative report. How to construct an interpretative report and the format required for • • Page | 42 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING • • • • • 1,2,5 Control infection risks in accordance with departmental protocols. • • 1,2,5 Minimise risks and hazards in compliance with health and safety policies. • • • • 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. Relevance and importance of specificity, sensitivity, accuracy, precision and linearity in the evaluation of analytical methods. The range of further investigations that may be required, their purpose, capabilities and limitations. 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 | 43 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) STP Learning Framework 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 Life Sciences THEME Cellular Sciences SPECIALISM Reproductive Science Page | 44 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE TITLE AIM SCOPE Principles and Practice of Reproductive Science and Diagnostic Semen Analysis (RS-1) COMPONENT Rotation This module will provide trainees with the knowledge and understanding of the normal physiology of the male and female reproductive tracts. The trainees will gain an insight into the in vitro fertilisation patient pathway. Trainees will be able to perform diagnostic semen analysis and recognise how the differing semen parameters relate to clinical treatment. They will gain knowledge of current legislation and regulations and will be able to apply appropriate standards of health and safety and perform to expected standards. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. 2. 3. 4. 5. Apply and interpret quality assurance methodologies in reproductive science. Apply health and safety methodologies and practices appropriate to the reproductive science laboratory. Perform to accepted standard relevant techniques for semen analysis and preparation. Prepare, interpret and report on diagnostic semen analysis (under supervision). Work in partnership with the reproductive science laboratory and other clinical specialisms in the investigation of infertility. Page | 45 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: • • • • • • • Participate in multidisciplinary team meetings at which a range of relevant clinical cases and/or procedures are discussed. Review and discuss the patient pathway through the treatment process and the benefits of a multidisciplinary approach. Visit a clinical biochemistry laboratory. Review and discuss the methods used for the measurement and reporting of reproductive hormones. Attend infertility clinics and assisted conception units. Review and report on their role and importance in the patient pathway. Observe work activities with specific reference to embryology procedures from egg collection to embryo transfer (including in vitro fertilisation [IVF], intracytoplasmic sperm injection [ICSI], embryo culture, embryo freezing and thawing) and theatre procedures (including egg collection and embryo transfer), and review these procedures in relation to the patient journey through investigation and treatment. Observe follicular and clinical pregnancy scanning to follow the patient pathway and understand how monitoring is carried out in a controlled ovarian stimulation regimen. Observe, participate and review the application and interpretation of quality assurance methodologies in Reproductive Science. Review and discuss the preparation, interpretation and reporting of diagnostic semen analysis. 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. 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. Page | 46 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1,2,5 COMPETENCES Receive, process and store samples for analysis. KNOWLEDGE AND UNDERSTANDING • • • • • • • • • • • • 3 1,2,3 Set up and use relevant microscopes. To include optical principles, maintenance and clinical applications. Measure semen volume, extent of liquefaction and appearance. • • • Minimum data set required for identification of samples and the importance of ensuring that this is complete and correct. The importance of patient confidentiality and how this is maintained. Factors affecting sample integrity and appropriate corrective action. Instructions that need to be provided to patients pre sample. 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. Legal and ethical considerations and requirements in respect of handling and processing samples in Reproductive Science. Infection risk from samples and how to deal with fresh tissue 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. The function of microscopic components and how to set up a microscope for investigation of reproductive specimens. Normal male and female reproductive anatomy and physiology. Current legislation and regulation as it applies to Reproductive Science. Page | 47 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1,2,3 1,2,3 3,4 3,4 4 COMPETENCES Perform repeated sperm counts for concentration and motility using the same semen sample and be able to explain the variation observed. Perform diagnostic sperm counts for concentration and motility on different patients and be able to prepare reports for discussion with your supervisor. Identify normal and abnormal semen samples. To include sperm concentration, motility assessment, morphology, anti-sperm antibody testing, sperm viability testing. Perform gradient and swim-up techniques for the preparation of semen samples for treatment. Produce a record of reports seen and discussed with your supervisor. KNOWLEDGE AND UNDERSTANDING • • • Principles of and standards for diagnostic semen analysis. Characteristics of normal and abnormal semen samples. Semen preparation, including different methodologies, diagnostic tests and functional tests. • • • • • • • Characteristics of normal and abnormal semen samples. Hormonal control of male reproduction. Reasons for referral. Causes of and treatments for infertility. The anatomy and physiology of the male reproductive tract. SSR (surgical sperm retrieval). The advantages and disadvantages of different methodologies used for the preparation of sperm. • Requirements for records and reports of investigations in Reproductive Science. 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. • • • • Page | 48 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 2,3 COMPETENCES Control infection risks in accordance with departmental protocols. KNOWLEDGE AND UNDERSTANDING • • 2,3 Minimise risks and hazards in compliance with health and safety policies. • • • • • • 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. Use and maintenance of centrifuges. Responsibilities and scope of practice of laboratory personnel involved in performing investigations and reporting those investigations to users. The patient pathway through a treatment cycle. Page | 49 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) STP Learning Framework 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 Life Sciences THEMES Blood and Cellular Sciences SPECIALISM Genetics and Molecular Science Page | 50 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE TITLE AIM SCOPE Genetics and Molecular Science (CG-1) COMPONENT Rotation This module will provide the trainee with an introduction to human Genetics 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 gain an understanding of the interpretation of patient results in a variety of clinical settings. The investigation, interpretation and reporting of chromosomal abnormality and molecular disease, using the correct sampling and laboratory techniques, and 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. Assist with the investigation of chromosomal abnormality, the correct sampling technique and the use of the International System for Chromosome Nomenclature (ISCN). 2. Play a supporting role in cell culture, slide making and G-band staining techniques used in the investigation of chromosome anomalies. 3. Assist with the investigation of the molecular basis of disease, the correct sampling technique and relevant quality parameters. 4. Perform DNA extraction technique, polymerase chain reactions (PCRs) and observe sequencing reactions used in the investigation of the molecular basis of disease. 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 genetic disorders. Page | 51 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: • • • • Attend multidisciplinary team meetings at which the results of genetic investigations are discussed, and reflect on discussions and the impact of multidisciplinary working on patient treatment and management. Attend specialist genetics clinics and review/report on the process, patient engagement and experience in connection with the work of these clinics. 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: • investigation of chromosomal abnormality, the correct sampling technique and the use of ISCN • investigation of the molecular basis of disease, the correct sampling technique and relevant quality parameters • interpretation and reporting of laboratory results in the context of named genetic disorders • the partnership between Genetics and other clinical specialisms in the investigation of genetic disorders. 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. 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. Page | 52 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY COMPETENCES LEARNING OUTCOMES 1,3,5 Receive, label and store specimens for chromosome investigation and understand referral patterns. KNOWLEDGE AND UNDERSTANDING • • • • • • • • • • 1 Perform a basic chromosome analysis on a minimum of five cases that demonstrate different chromosomal syndromes or anomalies. • • • • 2 Perform a basic chromosome analysis using microscopy and digital imaging. • 3 Receive, label and store specimens • • 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. Use of laboratory and hospital information systems to identify and record patient demographics, clinical details and relevant laboratory results. How to generate a unique sample identifier. 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 storage of diagnostic materials. An understanding of the common reasons for referral for chromosome investigations. Basic chromosome identification. Karyotype construction. Numerical and structural anomalies and normal variation. Relationship of basic chromosomal anomalies to clinical features in patients. Procedures for manual, digital and photographic storage and retrieval of data from chromosome investigations. The reasons for referral for molecular diagnostic testing. Minimum data set required for identification of samples and the Page | 53 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING for molecular diagnostic testing. • • • • • 1,2,3,4 Perform both manual and/or automated DNA extraction techniques (to be performed after observation). • • • • • • • • • 3 Observe and perform PCRs and observe a basic sequencing reaction and fragment analysis. • • • • • 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. Use of laboratory and hospital information systems to identify and record patient demographics, clinical details and relevant laboratory results. How to generate a unique sample identifier. The importance of maintaining correct and unique labelling, including transfer of labels throughout the preparation process. Documentation relevant to sample preparation and its importance. The common reasons for referral for molecular testing. Policy for authorisation and disclosure of results. The purpose, process, capabilities and limitations of extraction procedures and associated equipment. Relevant protocols and their application, including health and safety considerations. Requirements for containment levels. 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. Correct mutation nomenclature. Principles and applications of relevant methods and techniques. The principles of PCR. The significance of contamination and sensitivity of PCR. Hazards and risks associated with PCR. Page | 54 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING • • • • 4 Perform a basic molecular analysis on five cases demonstrating common molecular genetics syndromes. • • • • • • • • • • • • • • 5 Apply internal quality control (IQC) and external quality assessment (EQA) methods used in cytogenetics and molecular genetics. 6 Apply microcomputer software for • tasks related to Genetics. To include Relevant current quality control procedures. Characteristics of substandard reactions. Factors affecting the integrity of samples and reagents, including liability and contamination. Factors affecting integrity of reagents used in the tests conducted 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 artefact. Analysis of results using standard laboratory processes. Ethical guidelines for testing. The clinical background and molecular pathology of the disorder being investigated. The range of tests available for the individual or the family. Professional and local guidelines for tests appropriate to each disorder. Significance of previous results in relation to the current sample. Relevant professional guidelines and correct interpretation. The importance of IQC during the testing process. Importance of EQA. Access, use and limitations of Online Mendelian Inheritance in Man (OMIM), genome and mutation databases. Page | 55 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES an introduction to bioinformatics. KNOWLEDGE AND UNDERSTANDING • • 7 Support the preparation of reports and the reporting process for patients being investigated for named genetic disorders. • • • • • • 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. • • • • Importance of maintaining long-term records because of implications for heritable genetic disorders to 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. 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. Requirements for disclosure and confidentiality. 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 | 56 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Cellular Sciences SECTION 4: PROFESSIONAL PRACTICE LEARNING FRAMEWORK Page | 57 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) STP Learning Framework This section describes the Learning Framework for the Professional Practice Component of 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 PROFESSIONAL PRACTICE DIVISION Life Sciences, Physiological Sciences, Physical Sciences and Biomedical Engineering THEME ALL SPECIALISM ALL Page | 58 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 | 59 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) COMPONENT GENERIC MODULE Professional Practice (PP1) TITLE Professional Practice is part of the generic curriculum (applicable to all trainees) on the Scientist Training AIM SCOPE 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. Page | 60 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 7. Promote the importance of patient safety and general health, safety and security in the workplace, including infection control and information governance. 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 | 61 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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. 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 | 62 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING Professional Practice 1 1 2 Treat each patient as an individual, respecting their dignity and confidentiality and upholding the rights, values and autonomy of every service user. 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. Communicate effectively with the public, services users and other healthcare • 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, Page | 63 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES professionals, adapting 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. Present complex ideas in understandable terms in both oral and written formats. 2 KNOWLEDGE AND UNDERSTANDING increase patient satisfaction, enhance treatment adherence, and reduce patient 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. 2 2 3 Use effective negotiation skills, including influencing colleagues. Work constructively and effectively as a member of a multidisciplinary team. Comply with relevant guidance and laws, to include those relating to: • 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 Page | 64 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES • • • • • • • 4 4 4 4 4 your scope of practice research ethics and governance patient confidentiality data protection equality and diversity use of chaperones informed consent. Contribute to the education and training of colleagues. Take responsibility for your learning and demonstrate a commitment to continuing professional development. Meet commitments and goals in your professional practice, using a range of organisational and planning tools. 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. Take responsibility for KNOWLEDGE AND UNDERSTANDING information governance • informed consent • 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 Page | 65 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 4 COMPETENCES keeping your professional and scientific knowledge and skills up to date. Develop an action plan based on your experiential learning and reflection on completion of the Scientist Training Programme. KNOWLEDGE AND UNDERSTANDING innovative technologies and scientific advances. • Action planning. • Models and frameworks for critical reflection. Clinical Practice 5 6 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 • email. Under supervision, demonstrate that you can obtain and present a patient history from a normal volunteer or • 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. Page | 66 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 7 7 COMPETENCES consenting patient in order to better understand the clinical decision-making process in your clinical practice. 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. Use clinical coding and medical terminology in accordance with stated guidance, as appropriate to KNOWLEDGE AND UNDERSTANDING • Process of patient-centred interviewing and the features of a good consultation, • • • • • • • • including Initiating the session, gathering information, building the relationship, 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. Page | 67 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 7 7 7 COMPETENCES scope of practice. Keep accurate records in accordance with current guidelines and the legal framework for data security. Use, in your practice: • standard operating procedures • protocols • clinical guidelines. Continuously improve your practice through good practice in: • identifying common sources of error • identification of risk • reporting critical incidents. KNOWLEDGE AND UNDERSTANDING • Best practice recommendations for record keeping and data security. • 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 8,9 Participate in innovation, research, service development and audit activities complying with compliance with guidance and laws relating to research ethics. • • • • • • • 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 Page | 68 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING • 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. 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. • • • • 8,9 Contribute to service and quality improvement and productivity in the work base and embed evidence-based developments within routine practice. • • • • • 8,9 8,9 Undertake a literature review and prepare and present to peers a critical analysis of a publication from the scientific literature. Prepare and deliver an oral scientific communication to peers at a local, national or Page | 69 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING international meeting. Clinical Leadership 10 10 Lead in your clinical role through appropriate application of; • self-management • self-development • integrity • self-direction • problem solving • dealing with complex issues • making sound judgements in the absence of complete data. Identify potential areas for change and accept change identified by others, working across different provider landscapes as required. • 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 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 | 70 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Cellular Sciences SECTION 5: ELECTIVE LEARNING FRAMEWORK Page | 71 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 Life Sciences, Physiological Sciences, Physical Sciences and Biomedical Engineering THEME ALL SPECIALISM 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 | 72 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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. 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 | 73 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1 2 3 COMPETENCES Produce learning outcomes for the elective training period and link these to Good Scientific Practice. 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. 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 | 74 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Cellular Sciences SECTION 6: SPECIALIST LEARNING FRAMEWORK CYTOPATHOLOGY Page | 75 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) STP Learning Framework 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 Life Sciences THEME Cellular Sciences SPECIALISM Cytopathology Page | 76 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CYTOPATHOLOGY – SPECIALIST MODULES Module 1 (CP-2) Pathological Basis of Disease Module 2 (CP-3) Systematic Investigation of Pathological Specimens Module 3 (CP-4) Major Organ Histopathology including Cancer Module 4 (CP-5) Gynaecological Cytopathology Module 5 (CP-6) Non-Gynaecological Cytopathology Page | 77 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE 1 AIM SCOPE Pathological Basis of Disease (CP-2) COMPONENT Specialist This module will provide trainees with the overall knowledge and understanding of the pathological basis of disease and the principles and practice of histopathology as applied to clinical medicine. The trainee will use a range of histological techniques and learn to recognise different types of pathology under the microscope in order to gain experience of interpreting results from patient investigations. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. 2. 3. 4. 5. 6. 7. Recognise and interpret the microscopical appearance of the tissue or cell and relate to the pathobiological process. Determine adequacy of samples taken by clinicians. Determine adequacy of margins of exision or clearance where applicable. Advise on or request appropriate additional tests to aid in the diagnosis of disease. Recognise carcinoma and local and metastatic tumour spread in microscopic specimens. Under supervision, prepare preliminary reports based on using interpretive and diagnostic skills. Work in partnership with other clinical specialisms as part of the diagnosis and review of individual cases. Page | 78 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: • • • • Review prepared microscope slides with your supervisor and draft a diagnosis, taking into account all relevant clinical details, and the macroscopical and microscopical appearances of the tissues. Double-headed microscopical slide review – working directly with a pathologist perform light microscopy studies on specimens from a range of clinical referrals. In each case identify key histological or cytological features and agree how these may be incorporated into a report prepared in the correct clinical context Attend multidisciplinary team meetings – participate in multidisciplinary review meetings at which histopathology results are presented as part of the clinical record. Prepare a portfolio of cases to illustrate how key histological and cytological findings influenced diagnosis and patient management Prepare a portfolio of cases from named clinical conditions where you have played a significant role in the systematic investigation 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). 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. 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. Page | 79 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1,4 1,4 1,4 COMPETENCES KNOWLEDGE AND UNDERSTANDING Using representative specimens from a range of tissues, identify the different types of inflammatory disease: • acute inflammation • chronic inflammation • granulomatous inflammation. • • • Using representative specimens from a range of tissues, identify cell proliferation, growth and death: • hypoplasia • hyperplasia • metaplasia • benign neoplasia • premalignancy • neoplastic proliferation • cell injury and adaptation • apoptosis • necrosis • degenerative disease. Identify the mechanisms of transmission and clinical manifestations of both acute and chronic infections in tissue sections: • bacteria • viruses • • • • • • • • • • • Normal morphology of tissues and organs. Epidemiology of common pathologies. The mechanisms involved in the inflammatory process, including the cell types involved and the cascade of inflammatory response. The differences between all three types of inflammation and their role in disease, repair and healing. Rationale of the histological techniques required to demonstrate the different cell types involved in a tissue section. Normal morphology of tissues and organs. Epidemiology of common pathologies. The microscopical differences between normal tissue morphology and proliferative tissue morphology. The microscopical differences between normal tissue morphology and tissue undergoing necrosis. Principles of good fixation and paraffin processing. Rationale of the different histological techniques required to demonstrate the different cell types involved in a tissue section. Principles of infectious diseases and the immune response to infection. General principles of infection control in the management of the patient. Rationale of the histological techniques required to demonstrate a wide range of infectious agents in a tissue section. Page | 80 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1,4 1,4 2,3,5 COMPETENCES • fungi • parasites. Using representative specimens from a range of tissues, identify the immune response and immunological disease in: • normal immune system • primary and secondary immunodeficiency • autoimmune disease • transplant rejection. Using representative specimens from a range of tissues, identify cell injury, wound healing and repair in: • tissue and cell injury • hypertrophy • thrombosis • atherosclerosis • embolism • oedema. Using representative specimens from a range of tissues, identify carcinoma and local and metastatic tumour spread, including: • premalignancy change • benign neoplastic change • malignant neoplastic change • angiogenesis KNOWLEDGE AND UNDERSTANDING • • • • • • • • • • The normal immune response mechanism and how this can be triggered following organ transplantation. The use of immunological techniques, and how the immune response and immunological disease may be identified in microscopic specimens. Normal morphology of tissues and organs. The identification of a range of cell injuries, wound healing and tissue repair in microscopic specimens. Rationale of the histological techniques required to demonstrate the different cell types involved in a tissue section. Normal morphology of tissues and organs. The identification of carcinoma and local and metastatic tumour spread, at a macroscopic, microscopic and molecular level. Rationale of the histological techniques required to demonstrate the different cell types involved in a tissue section. Methods for marking excision margins. Methods for measuring distance of tumour spread from margins of excision. Page | 81 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 6,7 COMPETENCES • metastasis. Interpret the histological or cytological findings in the correct clinical context and discuss in detail with a senior colleague. KNOWLEDGE AND UNDERSTANDING • • • The use of the light microscope. The relationship between clinical presentation and the diagnosis. The relative merits of cytology, histology and pathology results when making an informed and accurate diagnosis. Page | 82 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE 2 AIM SCOPE Systematic Investigation of Pathological Specimens (CP-3) COMPONENT Specialist This module will provide trainees with the knowledge and understanding of the pathological basis of disease and the use of histopathology to detect and diagnose disease. The trainees will become competent in the application of a range of techniques to case studies in clinical practice and gain experience of interpreting results from patient investigations. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. 2. 3. 4. 5. Participate in the collection of a range of histopathology and cytopathology clinical specimens. Perform investigations for the diagnosis, treatment and monitoring of named clinical conditions. Evaluate and communicate the limitations of a range of investigative techniques in named clinical conditions. Determine and give clinical advice on the sensitivity and specificity of investigative techniques in named clinical conditions. Under supervision, prepare and interpret reports that involve a range of histological and cytological techniques as part of the systematic investigation of named clinical conditions. 6. Work in partnership with other clinical specialisms as part of the diagnosis and review of individual cases. Page | 83 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: • Prepare an evidence-based report listing the strengths and limitations of a range of investigative techniques used in named • • • • • clinical conditions. Describe and apply evidence-based data on the sensitivity of investigative techniques in named clinical conditions. To include suggesting clinical advice in specific clinical cases. Working directly with a pathologist, discuss the systematic investigation that you have performed in named clinical conditions on specimens from a range of clinical referrals. In each case, agree how these may be incorporated into a report prepared in the correct clinical context. Participate in multidisciplinary review meetings at which histopathology results are presented as part of the clinical record. Prepare a portfolio of cases to illustrate how key histological and cytological findings may be integrated with imaging and other diagnostic findings to facilitate diagnosis and patient management in named clinical conditions. Attend clinics and ward rounds where patients with named clinical conditions are investigated. Gain understanding of the importance of pathology to the patient journey and write a reflective account of what you have learned. Prepare a portfolio of cases from named clinical conditions where you have played a significant role in the systematic investigation and include the use and interpretation of sensitivity and specificity data. 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. 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. Page | 84 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1 2 4 3 COMPETENCES Use a range of methods for the identification and collection of tissue and cellular preparations for the microscopic investigation of named common conditions, to include: • needle biopsy • surgical biopsy. Interpret clinical requests and associated specimens to prioritise investigations, including the identification of urgent cases. Interpret clinical requests and associated specimens from named clinical conditions and plan the investigations to be performed in line with agreed protocol. Prepare and perform macroscopic examination and dissection of specimens as part of systematic investigation of named clinical conditions, to include: • macroscopic examination of organs and tissues • orientation and marking • dissection and sampling of Category A to C specimens according to local protocol • macrophotography during KNOWLEDGE AND UNDERSTANDING • • • • • • • • • • Dissection and sample preparation protocols for a wide range of invasive and non-invasive sample types and identification of the factors that influence the choice of invasive or non-invasive technique, e.g. smears, aspirates, biopsies, excisions, resections. Use of ultrasound to accurately identify biopsy site. Clinical terminology for a variety of clinical conditions. The relative seriousness of different clinical conditions and the need for rapid results, e.g. cancer pathway, frozen sections while the patient is in theatre, etc. RCPath minimum data sets. Awareness of the relationship between imaging and the histological and cytological sample, e.g. ultrasound to identify the specific sample site, and appreciate possible pitfalls. Anatomy and physiology of normal tissues and organs. Use of an example systemic pathway, e.g. urology, and follow agreed protocols for dissection and sample preparation to obtain the best result for the patient. Limits of own practice and when to seek clinical advice. RCPath minimum data sets. Page | 85 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 6 5,6 COMPETENCES dissection • note taking during dissection • specialised containment to prevent sample loss or crosscontamination • containment of high-risk samples • recognition of own limits of practice. Prepare and section tissue blocks and perform routine and specialised procedures in line with systematic investigation of named clinical conditions, to include: • routine and special stains • decalcification of tissues • immunocytochemistry • in situ hybridisation • molecular pathology. Interpret routine and specialised investigations performed and recommend appropriate action, to include: • identification microscopically of normal and abnormal tissue • request specialised demonstration techniques • reporting. KNOWLEDGE AND UNDERSTANDING • • • • • • • • • Rationale and protocols for a range of histological techniques. Application of a range of sampling and staining techniques and using them in a systematic way, relating them to the clinical presentation and following agreed protocols, to ensure quality control is maintained. Quality assurance relating to techniques used. Imaging techniques applied to tissue sections. Microscopic appearance of normal and abnormal cells. Appreciation of the importance of a timely and accurate histopathology and cytopathology diagnosis in the clinical management of the patient. Appreciation of how the formatting of a report assists the clinician in understanding the findings. Appreciation of the contribution of the results of other clinical investigations and other pathology results. Current legislation relating to the retention of cells, tissues and organs. Page | 86 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE 3 AIM SCOPE Major Organ Histopathology including Cancer (CP-4) COMPONENT Specialist This module will provide trainees with the knowledge and understanding of the cellular structure and function of the major organs, and the cellular pathological findings in a range of clinical disorders, including commonly occurring forms of cancer. The trainee will become competent in the application of a range of techniques to these clinical disorders and gain experience of interpreting results from patient investigations. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Identify and confirm the clinical presentation of a range of major organ diseases and commonly occurring forms of cancer. 2. Perform to quality standards a range of established cellular pathology techniques to named disorders of the major organs and commonly occurring forms of cancer. 3. Identify and evaluate new equipment, methods or procedures to enhance the contribution of the cellular pathology laboratory to the diagnosis and management of major organ disease and commonly occurring forms of cancer. 4. Under supervision, prepare and interpret reports that involve cellular pathology findings as part of the investigation of major organ disease. 5. Work in partnership with other clinical specialisms as part of the diagnosis and review of named clinical diseases of major organs and commonly occurring forms of cancer. Page | 87 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: • Prepare an example cellular pathology report for a resection specimen and demonstrate the ability to discuss the essential elements included. • Produce a portfolio demonstrating knowledge and understanding of dissection practice and how it relates to the diagnostic • • • • process and subsequent patient care. Include details of investigations undertaken, with explanations, in the portfolio of cases prepared for learning outcome 1. Attend wards and clinics at which patients with named major organ diseases and commonly occurring cancers are being investigated and write a reflective account of what you have learned. Attend multidisciplinary meetings where patients with a major organ system disorder and a commonly occurring cancer are being discussed and write a reflective account of the experience. Visit a laboratory involved in supporting organ transplantation and describe the interaction with the clinical transplant team. Write a reflective account of your visit. Prepare a portfolio of illustrative cases with a minimum of three from the listed major organ pathologies and three from the listed commonly occurring cancers. Include the plan of laboratory investigation. To be developed further in learning outcomes 2 and 5. 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. 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. Page | 88 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1 2 COMPETENCES From routine requests, identify the cellular pathology specimens required to confirm a diagnosis in each of the following major organ systems and perform the relevant techniques to process the sample: • dermatopathology • breast pathology • hepatobiliary pathology • gastrointestinal pathology • genitourinary pathology • respiratory pathology • gynaecological pathology • male reproductive pathology • endocrine pathology • ear, nose and throat pathology • osteoarticular pathology. Perform and record details of macroscopic examination of tissue received from named major organ disease and commonly occurring cancers, to include: • dermatopathology • breast pathology • hepatobiliary pathology • gastrointestinal pathology • genitourinary pathology • respiratory pathology KNOWLEDGE AND UNDERSTANDING • • • • • • • The aetiology and clinical presentation of a selection of common tissue samples in named major organ disease (excluding cancer). Impact on the patient pathway of the accuracy and timeliness of the histological diagnostic process. Anatomy and physiology of normal tissues and organs. Appropriate methods of sample preparation and processing protocols. Impact on the patient pathway of the accuracy of the description of samples and its importance in the timeliness of the histological diagnostic process. Macroscopic appearance of a range of cellular pathology specimens relating to common diseases, including cancer, in different organ systems (non-cancer). Specific dissection criteria applicable to specific disease conditions. Page | 89 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 2 3 1,2,3 COMPETENCES • gynaecological pathology • male reproductive pathology • endocrine pathology • ear, nose and throat pathology • osteoarticular pathology. Perform to quality standards, basic and appropriate specialised cellular pathology techniques as part of the systematic investigation of tissue received from named major organ diseases and commonly occurring cancers, to include: • dermatopathology • breast pathology • hepatobiliary pathology • gastrointestinal pathology • genitourinary pathology • respiratory pathology • gynaecological pathology • male reproductive pathology • endocrine pathology • ear, nose and throat pathology • osteoarticular pathology. Perform a detailed evaluation of one new piece of equipment, method or procedure. Perform to quality standards, cellular pathology tests of rejection KNOWLEDGE AND UNDERSTANDING • The requirements of quality-based diagnostic procedures in ensuring safe and effective care of the patient. Rationale of the cellular pathology techniques required to demonstrate the different cell types involved in tissue sections from major organs and from commonly occurring cancers. • • • • The impact of effective methodological assessment. Use of controls. Report writing. Ethical and legal issues around transplantation and the role of immunosuppression. • Page | 90 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES from tissue grafts and/or organ transplantation. KNOWLEDGE AND UNDERSTANDING • • 4 In discussion with a pathologist, interpret in the correct clinical context the results of: • macroscopic examination • basic microscopic examination • appropriate specialised techniques • diagnostic algorithms from specimens received from a range of named major organ diseases and commonly occurring cancers, to include: • dermatopathology • breast pathology • hepatobiliary pathology • gastrointestinal pathology • genitourinary pathology • cardiac and vascular pathology • respiratory pathology • gynaecological pathology • male reproductive pathology • endocrine pathology • • • • • The role of the clinical laboratory in major organ transplantation, including ethical and legal issues and the role of immunosuppression. Multi-organ transplantation and the microscopic appearance of rejection. Morphological presentation of a range of major organ systems. Microscopic appearance of normal and abnormal cells. Application of a wide range of cellular pathology techniques. The importance of a timely and accurate histopathology and cytopathology diagnosis in the clinical management of the patient. How the formatting of a report assists the clinician in understanding the findings. Page | 91 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 4,5 COMPETENCES • ear, nose and throat pathology • osteoarticular pathology. In discussion with a pathologist, prepare and issue reports from the selected cases of named major organ disease and commonly occurring cancer in the context of other clinical information. KNOWLEDGE AND UNDERSTANDING • • • Impact on the patient pathway of the detail and accuracy of the description within the diagnosis, and its importance in the timeliness of the treatment and management pathway of the patient. How the formatting of a report assists the clinician in understanding the findings. The contribution of the results of other clinical investigations and other pathology results. Page | 92 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE 4 AIM SCOPE Gynaecological Cytopathology (CP-5) COMPONENT Specialist This module will provide the trainee with the knowledge and understanding of the aetiology, pathogenesis and main clinical and morphological features of cervical and other gynaecological cancers. They will understand and gain experience of the role of the cytology laboratory in the diagnosis of cervical pre-cancer and gynaecological malignancy. The trainee will become skilled in the use of the microscope in the initial diagnosis of a range of gynaecological disorders. They will gain experience of interpreting results from patient investigations. The trainee will be able to describe national and international screening programmes and achievements in the prevention, diagnosis and management of cervical cancer. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. 2. 3. 4. 5. Recognise and interpret the microscopical appearance of cells and relate to the pathobiological process. Recognise the clinical presentation of a range of gynaecological malignancies. Screen and interpret cervical cytology samples to quality standards. Advise on or request appropriate additional tests to aid in the diagnosis of disease. Identify and evaluate new equipment, methods or procedures to enhance the contribution of the cytopathology laboratory to the prevention, diagnosis and management of gynaecological malignancies. 6. Analyse national and international data on the incidence, screening, diagnosis, management and survival of gynaecological malignancies. 7. Draft interpretative reports that involve cytopathological findings as part of the investigation of gynaecological malignancies. 8. Work in partnership with other clinical specialisms as part of the diagnosis and review of gynaecological malignancies. Page | 93 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: • Attend and participate in multidisciplinary review meetings at which cytopathology results from cases of gynaecological cancer • • • • • • • • are presented as part of the clinical record. Wherever possible include those cases in your portfolio of named cancers. Record the outcomes of the multidisciplinary review meetings. Include details of investigations undertaken, including molecular techniques, with explanations, in the portfolio of cases prepared for learning outcome 2. Review prepared microscope slides on a double-headed microscope with a supervisor and draft a diagnosis taking into account all relevant clinical details. Perform an audit on a specific topic analysing the morphological findings and clinical outcomes. Perform a detailed evaluation of one new piece of equipment, method or procedure. Critically appraise the results of the evaluation and produce a report with recommendations. Describe the operation of the NHS Cervical Screening Programme and indicate your role in the programme. Write a cytopathology report on a range of gynaecological cancers, appreciating the partnership between the cytopathology laboratory and other clinical specialisms. Suggest ways in which improved diagnostics could lead to better clinical outcomes in gynaecological malignancy. Prepare a portfolio of a minimum of 10 illustrative cases of gynaecological malignancies where you have played a significant role in the investigation. Include the plan of laboratory investigation. 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. 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. Page | 94 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1 1,2,4 2 COMPETENCES Analyse cervical samples to identify normal morphology, inflammation and dyskaryosis. Prepare a diagnostic pathway, from diagnosis to treatment for gynaecological cancers, to include: • cervical pathology • cervical intraepithelial neoplasia (CIN) • cervical glandular intraepithelial neoplasia (CGIN) • cervical cancer • ovarian cancer • endometrial cancer • extrauterine malignancies. Perform the reception and preparation cytopathological specimens for the investigation of cervical pre-cancer. KNOWLEDGE AND UNDERSTANDING • • • • Normal morphology. Inflammatory changes in epithelial cells. Inflammatory agents. Low-grade dyskaryosis. High-grade dyskaryosis in squamous and endocervical cells. Invasive squamous cell carcinoma. Endocervical adenocarcinoma. Malignancy from non-cervical origin. Pitfalls in diagnosis. External quality assessment in cervical cytology. Aetiology. Screening history. Clinical symptoms. Cytomorphology. Molecular and ancillary tests (including human papilloma virus [HPV] primary screening). Histopathology. Role of the multidisciplinary team. Treatment. Prognosis. • • • • • Technologies used to prepare cervical cytology samples. The limitations of liquid-based cytology (LBC) technologies. Troubleshooting of instrument failure. Novel approaches to LBC preparation. Routine staining methods. • • • • • • • • • • • • • • • Page | 95 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES 3,4 Perform to quality standards, basic and appropriate specialised cytopathological techniques as part of the systematic investigation of gynaecological malignancy. 5 Use and evaluate new equipment relevant to the cytological investigation of gynaecological cancer. Present the evidence base for the effectiveness and limitations of the NHS Cervical Screening Programme. 6 7 KNOWLEDGE AND UNDERSTANDING • • • • • • • • • • • • • • • • • • • • In discussion with a histopathologist, • interpret in the correct clinical • context the histopathology of: • • cervical intraepithelial neoplasia • (CIN) • HPV test of cure and triage. Cytocentrifugation. Cell blocks. Impact of preparation techniques on subsequent ancillary testing. Molecular techniques, including quality control. Imaging-assisted screening. Internal quality control methods in cervical cytology. Methodology for assessing new pieces of equipment and introducing new techniques in comparison with existing methodologies. ABC3 standards. NHS Cervical Screening Programme publications. Cancer registry. Management of the screening programme. Call recall. Invasive audit. HPV vaccination. Role of colposcopy. HPV testing. Screening intervals. Age range for screening. HPV primary screening pathways in other countries. Recognition of normal pathology. Identification of benign processes. Recognition of CIN and CGIN. Identification of malignancy. Rationale of additional histological techniques. Page | 96 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING cervical glandular intraepithelial • neoplasia (CGIN) • cervical cancer • ovarian cancer • endometrial cancer • extrauterine malignancies. In discussion with a histopathologist, • prepare and issue reports from the selected cases of gynaecological malignancy. • • 7,8 • Treatment of CIN, CGIN and cervical cancer. Impact on the patient pathway of the detail and accuracy of the description within the diagnosis, and its importance in the timeliness of the treatment and management pathway of the patient. How the formatting of a report assists the clinician in understanding the findings. The contribution of the results of other clinical investigations and other pathology results. Page | 97 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE 5 Non-Gynaecological Cytopathology (CP- COMPONENT Specialist 6) AIM This module will provide the trainee with the knowledge and understanding of the aetiology, pathogenesis and main clinical features of cancers and benign conditions detected by nongynaecological cytopathology. They will understand and gain experience of the role of the cytology laboratory in the diagnosis of selected cancers detected by non-gynaecological cytopathology. The trainee will become skilled in the use of cellular pathology techniques in the initial diagnosis and follow-up of a range of cancers and benign conditions. They will gain experience of interpreting results from patient investigations. SCOPE LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Recognise and interpret the microscopical appearance of cells and relate to the pathobiological process. 2. Recognise the clinical presentation of cancers detected by non-gynaecological cytopathology. 3. Perform to internal quality standards a range of established cytopathological techniques used in non-gynaecological cytopathology. Advise on or request appropriate additional tests to aid in the diagnosis of disease. 4. Identify and evaluate new equipment, methods or procedures to enhance the contribution of the cytopathology laboratory to the diagnosis and management of non-gynaecological malignancies. 5. Draft interpretative reports that involve cytopathological findings as part of the investigation of non-gynaecological malignancies. 6. Work in partnership with other clinical specialisms as part of the diagnosis and review of non-gynaecological malignancies. 7. Analyse national and international data on the incidence, diagnosis, management and survival of malignancies detected by nongynaecological cytopathology. Page | 98 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: • • • • • • • • • Attend, and where appropriate assist in, the collection of specimens for cytopathological investigation. To include: • exfoliative techniques • brush techniques • aspiration techniques. Attend and participate in multidisciplinary review meetings at which cytopathology results are presented as part of the clinical record. Wherever possible include those cases included in your portfolio of named cancers. Record the outcomes of the multidisciplinary review meetings. Include details of investigations undertaken, including histochemical and molecular techniques, with explanations, in the portfolio of cases prepared for learning outcome 1. Perform a detailed evaluation of one new piece of equipment, method or procedure. Critically appraise the results of the evaluation and produce a report with recommendations. Write a cytopathology report of a range of non-gynaecological cancers, appreciating the partnership between the cytopathology laboratory and other clinical specialisms. Suggest ways in which improved diagnostics could lead to better clinical outcomes in non-gynaecological malignancy. Prepare a portfolio of a minimum of 10 illustrative cases of non-gynaecological malignancies. Include the plan of laboratory investigation. Review prepared microscope slides on a double-headed microscope with a supervisor and draft a diagnosis taking into account all relevant clinical details. Perform an audit on a specific topic analysing the morphological findings and clinical outcomes. 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. 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. Page | 99 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1 1 2 COMPETENCES KNOWLEDGE AND UNDERSTANDING Analyse non-gynaecological samples to identify normal morphology, inflammation, benign neoplasia and malignancy. • Interpret adequacy of samples at on-site clinical procedures, including: • endobronchial ultrasound (EBUS) • endoscopic ultrasound (EUS) • bronchoscopy • endoscopic retrograde cholangio-pancreatography (ERCP) • fine-needle aspiration (FNA) of palpable and non-palpable lesions. Prepare a diagnostic pathway, from diagnosis to treatment for nongynaecological cancers, to include: • respiratory tract • urinary tract • • The cytological features of malignancies and benign conditions commonly identified by non-gynaecological samples in the following organ systems: • respiratory tract • urinary tract • gastrointestinal tract • serous cavities • thyroid gland • salivary glands • lymph nodes. Assessment criteria for sample adequacy using the light microscope. Communication of findings with clinical staff. • • • • • Aetiology. Clinical symptoms. Diagnostic modalities. Cytomorphology. Molecular and ancillary tests. Page | 100 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 2 3 3 COMPETENCES • gastrointestinal tract • serous cavities • thyroid gland • salivary glands • lymph nodes. Perform the reception and basic preparation of specimens for the investigation of non- gynaecological cancer. Perform to quality standards appropriate specialised cytopathological techniques as part of the systematic investigation of non-gynaecological cancer. Perform to quality standards at least three of the following specialised techniques, including: • immunocytochemistry • immunofluorescence • fluorescence in-situ hybridisation • molecular techniques • interrogation of molecular KNOWLEDGE AND UNDERSTANDING • • • • Histopathology. Role of multidisciplinary team. Treatment. Prognosis. • • • • • • • • • • • Technologies used to prepare non-gynaecological cytology samples. The limitations of preparation techniques. Novel approaches to non-gynaecology specimen preparation. Impact of preparation techniques on subsequent ancillary testing. Direct wet-fixed and air-dried preparations. Wet preparation techniques. Routine Papanicolaou and Romanowsky stains. Cytocentrifugation. Cell blocks. Internal quality control in preparation of non-gynaecology specimens. Histochemical and molecular techniques. • • Theoretical knowledge of principles of specialised techniques. Appropriate application of these techniques to the condition under investigation. Page | 101 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 4 5 5,6,7 COMPETENCES databases • electron microscopy • flow cytometry • image analysis. Use and evaluate new equipment relevant to the cytological investigation of non-gynaecological cancer. In discussion with a supervisor, interpret in the correct clinical context the results of cytological investigations in non-gynaecological cancer, to include: • respiratory tract • urinary tract • gastrointestinal tract • serous cavities • thyroid gland • salivary glands • lymph nodes. In discussion with a pathologist, prepare and issue reports from the selected cases of nongynaecological cancer. KNOWLEDGE AND UNDERSTANDING • Methodology for assessing new pieces of equipment and introducing new techniques in comparison with existing methodologies. • • • Features of normal, benign and malignant pitfalls in diagnosis. Knowledge of available ancillary tests and their appropriate use. Significance of clinical histories. • Impact on the patient pathway of the detail and accuracy of the description within the diagnosis, and its importance in the timeliness of the treatment and management pathway of the patient. How the formatting of a report assists the clinician in understanding the findings. The contribution of the results of other clinical investigations and other pathology results. • • Page | 102 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Cellular Sciences SECTION 7: SPECIALIST LEARNING FRAMEWORK HISTOPATHOLOGY Page | 103 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) STP Learning Framework 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 Life Sciences THEME Cellular Sciences SPECIALISM Histopathology Page | 104 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) HISTOPATHOLOGY – SPECIALIST MODULES Module 1 (HP-2) Pathological Basis of Disease Module 2 (HP-3) Systematic Investigation of Pathological Specimens Module 3 (HP-4) Major Organ Histopathology excluding Cancer Module 4 (HP-5) Cancer Module 5 (HP-6) Specialised Histopathology Page | 105 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE 1 AIM SCOPE Pathological Basis of Disease (HP-2) COMPONENT Specialist This module will provide trainees with the overall knowledge and understanding of the pathological basis of disease and the principles and practice of Histopathology as applied to clinical medicine. The trainee will use a range of histological techniques and learn to recognise different types of pathology under the microscope in order to gain experience of interpreting results from patient investigations. LEARNING OUTCOMES On successful completion of this module the trainee will: 8. Recognise and interpret the microscopical appearance of the tissue or cell and relate to the pathobiological process. 9. Determine adequacy of samples taken by clinicians. 10. Determine adequacy of margins of excision or clearance, where applicable. 11. Advise on or request appropriate additional tests to aid in the diagnosis of disease. 12. Recognise carcinoma and local and metastatic tumour spread in microscopic specimens. 13. Under supervision, prepare preliminary reports based on using interpretive and diagnostic skills. 14. Work in partnership with other clinical specialisms as part of the diagnosis and review of individual cases. Page | 106 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: • Review prepared microscope slides with your supervisor and draft a diagnosis taking into account all relevant clinical details, the macroscopical and microscopical appearances of the tissues. • Double-headed microscopical slide review. Working directly with a pathologist, perform light microscopy studies on specimens from a range of clinical referrals. In each case identify key histological or cytological features and agree how these may be incorporated into a report prepared in the correct clinical context. • Attend multidisciplinary team meetings. Participate in multidisciplinary review meetings at which histopathology results are presented as part of the clinical record. Prepare a portfolio of cases to illustrate how key histological and cytological findings influenced diagnosis and patient management. • Prepare a portfolio of cases from named clinical conditions where you have played a significant role in the systematic investigation. 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). 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. 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. Page | 107 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1, 4 1, 4 1,4 COMPETENCES KNOWLEDGE AND UNDERSTANDING Using representative specimens from a range of tissues, identify the different types of inflammatory disease: • acute inflammation • chronic inflammation • granulomatous inflammation. • • • Using representative specimens from a range of tissues, identify cell proliferation, growth and death: • hypoplasia • hyperplasia • metaplasia • benign neoplasia • premalignancy • neoplastic proliferation • cell injury and adaptation • apoptosis • necrosis • degenerative disease. Identify the mechanisms of transmission and clinical manifestations of both acute and chronic infections in tissue sections: • bacteria • viruses • fungi • • • • • • • • • • • Normal morphology of tissues and organs. Epidemiology of common pathologies. The mechanisms involved in the inflammatory process, including the cell types involved and the cascade of inflammatory response. The differences between all three types of inflammation and their role in disease, repair and healing. Rationale of the histological techniques required to demonstrate the different cell types involved in a tissue section. Normal morphology of tissues and organs. Epidemiology of common pathologies. The microscopical differences between normal tissue morphology and proliferative tissue morphology. The microscopical differences between normal tissue morphology and tissue undergoing necrosis. Principles of good fixation and paraffin processing. Rationale of the different histological techniques required to demonstrate the different cell types involved in a tissue section. Principles of infectious diseases and the immune response to infection. General principles of infection control in the management of the patient. Rationale of the histological techniques required to demonstrate a wide range of infectious agents in a tissue section. Page | 108 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1,4 1,4 2,3,5 COMPETENCES • parasites. Using representative specimens from a range of tissues to identify the immune response and immunological disease in: • normal immune system • primary and secondary immunodeficiency • autoimmune disease • transplant rejection. Using representative specimens from a range of tissues identify cell injury, wound healing and repair in: • tissue and cell injury • hypertrophy • thrombosis • atherosclerosis • embolism • oedema. Using representative specimens from a range of tissues identify carcinoma and local and metastatic tumour spread including: • premalignancy change • benign neoplastic change • malignant neoplastic change • angiogenesis • metastasis. KNOWLEDGE AND UNDERSTANDING • • • • • • • • • • The normal immune response mechanism and how this can be triggered following organ transplantation. The use of immunological techniques, and how the immune response and immunological disease may be identified in microscopic specimens. Normal morphology of tissues and organs. The identification of a range of cell injuries, wound healing and tissue repair in microscopic specimens. Rationale of the histological techniques required to demonstrate the different cell types involved in a tissue section. Normal morphology of tissues and organs. The identification of carcinoma and local and metastatic tumour spread, at a macroscopic, microscopic and molecular level. Rationale of the histological techniques required to demonstrate the different cell types involved in a tissue section. Methods for marking excision margins. Methods for measuring distance of tumour spread from margins of excision. Page | 109 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 6,7 COMPETENCES Interpret the histological or cytological findings in the correct clinical context and discuss in detail with a senior colleague. KNOWLEDGE AND UNDERSTANDING • • • The use of the light microscope. The relationship between clinical presentation and the diagnosis. The relative merits of cytology, histology and pathology results when making an informed and accurate diagnosis. Page | 110 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE 2 AIM SCOPE Systematic Investigation of Pathological Specimens (HP-3) COMPONENT Specialist This module will provide trainees with the knowledge and understanding of the pathological basis of disease and the use of Histopathology to detect and diagnose disease. The trainees will become competent in the application of a range of techniques to case studies in clinical practice and gain experience of interpreting results from patient investigations. LEARNING OUTCOMES On successful completion of this module the trainee will: 7. Participate in the collection of a range of histopathology and cytopathology clinical specimens. 8. Perform investigations for the diagnosis, treatment and monitoring of named clinical conditions. 9. Evaluate and communicate the limitations of a range of investigative techniques in named clinical conditions. 10. Determine and give clinical advice on the sensitivity and specificity of investigative techniques in named clinical conditions. 11. Under supervision prepare and interpret reports that involve a range of histological and cytological techniques as part of the systematic investigation of named clinical conditions. 12. Work in partnership with other clinical specialisms as part of the diagnosis and review of individual cases. Page | 111 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: • • • • • • Prepare an evidence-based report listing the strengths and limitations of a range of investigative techniques used in named clinical conditions. Describe and apply evidence-based data on the sensitivity of investigative techniques in named clinical conditions. To include suggesting clinical advice in specific clinical cases. Working directly with a pathologist, discuss the systematic investigation that you have performed in named clinical conditions on specimens from a range of clinical referrals. In each case agree how these may be incorporated into a report prepared in the correct clinical context. Participate in multidisciplinary review meetings at which histopathology results are presented as part of the clinical record. Prepare a portfolio of cases to illustrate how key histological and cytological findings may be integrated with imaging and other diagnostic findings to facilitate diagnosis and patient management in named clinical conditions. Attend clinics and ward rounds where patients with named clinical conditions are investigated. Gain understanding of the importance of Histopathology to the patient journey and write a reflective account of what you have learned. Prepare a portfolio of cases from named clinical conditions where you have played a significant role in the systematic investigation and include the use and interpretation of sensitivity and specificity data. 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. 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. Page | 112 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1 2 4 3 COMPETENCES Use a range of methods for the identification and collection of tissue and cellular preparations for the microscopic investigation of named common conditions, to include: • needle biopsy • surgical biopsy. Interpret clinical requests and associated specimens to prioritise investigations, including the identification of urgent cases. Interpret clinical requests and associated specimens from named clinical conditions and plan the investigations to be performed in line with agreed protocol. Prepare and perform macroscopic examination and dissection of specimens as part of systematic investigation of named clinical conditions, to include: • macroscopic examination of organs and tissues • orientation and marking • dissection and sampling of category A to C specimens according to local protocol • macrophotography during dissection KNOWLEDGE AND UNDERSTANDING • • • • • • • • • • Dissection and sample preparation protocols for a wide range of invasive and non-invasive sample types and identification of the factors that influence the choice of invasive or non-invasive technique, e.g. smears, aspirates, biopsies, excisions, resections. Use of ultrasound to accurately identify biopsy site. Clinical terminology for a variety of clinical conditions. The relative seriousness of different clinical conditions and the need for rapid results, e.g. cancer pathway, frozen sections while the patient is in theatre, etc. RCPath minimum data sets. Awareness of the relationship between imaging and the histological and cytological sample, e.g. ultrasound to identify the specific sample site, and appreciate possible pitfalls. Anatomy and physiology of normal tissues and organs. Use of an example systemic pathway, e.g. urology, and follow agreed protocols for dissection and sample preparation to obtain the best result for the patient. Limits of own practice and when to seek clinical advice. RCPath minimum data sets. Page | 113 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES note taking during dissection specialised containment to prevent sample loss or crosscontamination • containment of high-risk samples • recognition of own limits of practice. Prepare and section tissue blocks and perform routine and specialised procedures in line with systematic investigation of named clinical conditions, to include: • routine and special stains • decalcification of tissues • immunocytochemistry • in situ hybridisation • molecular pathology. Interpret routine and specialised investigations performed and recommend appropriate action, to include: • identification microscopically of normal and abnormal tissue • request specialised demonstration techniques • reporting. KNOWLEDGE AND UNDERSTANDING • • 6 5,6 • • • • • • • • • Rationale and protocols for a range of histological techniques. Application of a range of sampling and staining techniques and using them in a systematic way, relating them to the clinical presentation and following agreed protocols, to ensure quality control is maintained. Quality assurance relating to techniques used. Imaging techniques applied to tissue sections. Microscopic appearance of normal and abnormal cells. Appreciation of the importance of a timely and accurate histopathology and cytopathology diagnosis in the clinical management of the patient. Appreciation of how the formatting of a report assists in the clinician in understanding the findings. Appreciation of the contribution of the results of other clinical investigations and other pathology results. Current legislation relating to the retention of cells, tissues and organs. Page | 114 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE 3 AIM SCOPE Major Organ Histopathology excluding Cancer (HP-4) COMPONENT Specialist This module will provide trainees with the knowledge and understanding of the cellular structure and function of the major organs and the cellular pathological findings in a range of clinical disorders other than cancer. The trainee will become competent in the application of range of techniques to these clinical disorders and gain experience in interpreting results from patient investigations. The trainee will be able to describe the role of the clinical laboratory in major organ transplantation, including ethical and legal issues and the role of immunosuppression. LEARNING OUTCOMES On successful completion of this module the trainee will: 6. Identify and confirm clinical presentation of a range of major organ diseases. 7. Perform to quality standards a range of established histopathological techniques to named disorders of the major organs. 8. Identify and evaluate new equipment, methods or procedures to enhance the contribution of the histopathology laboratory to the diagnosis and management of major organ disease. 9. Under supervision, prepare and interpret reports that involve histopathological findings as part of the investigation of major organ disease. 10. Work in partnership with other clinical specialisms as part of the diagnosis and review of named clinical diseases of major organs. Page | 115 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: • Prepare an example histopathological report for a resection specimen and demonstrate the ability to discuss the essential • • • • • elements included. Produce a portfolio demonstrating knowledge and understanding of dissection practice and how it relates to the diagnostic process and subsequent patient care. Include details of investigations undertaken, with explanations, in the portfolio of cases prepared for learning outcome 1. Attend wards and clinics at which patients with named major organ disease are being investigated, and write a reflective account of what you have learned. Attend a multidisciplinary team meeting where patients with a major organ system disorder are being discussed and write a reflective account of the experience. Visit a laboratory involved in supporting organ transplantation and describe the interaction with the clinical transplant team. Write a reflective account of your visit. Prepare a portfolio of illustrative cases with a minimum of one from each listed major organ pathology. Include the plan of laboratory investigation. To be developed further in learning outcomes 2 and 5. 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. 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. Page | 116 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1 COMPETENCES From routine requests, identify the histopathological specimens required to confirm a diagnosis in each major organ system and perform the relevant techniques to process the sample. Essential • Dermatopathology • Breast pathology • Hepatobiliary pathology • Gastrointestinal pathology • Genitourinary pathology • Respiratory pathology • Gynaecological pathology • Male reproductive pathology • Endocrine pathology 2 Desirable • Ear, nose and throat pathology • Osteoarticular pathology • Cardiac and vascular pathology • Neuropathology. Perform and record details of macroscopic examination of tissue received from named major organ disease. To include: Essential KNOWLEDGE AND UNDERSTANDING • • • • • • The aetiology of and clinical presentation of a selection of common tissue samples in named major organ disease (excluding cancer). Impact on the patient pathway of the accuracy and timeliness of the histological diagnostic process. Anatomy and physiology of normal tissues and organs. Appropriate methods of sample preparation and processing protocols. Impact upon the patient pathway of the accuracy of the description of samples and its importance in the timeliness of the histological diagnostic process. Macroscopic appearance of a range of histological specimens relating to common diseases in different organ systems (non- Page | 117 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES • • • • • • • • • 2 Dermatopathology Breast pathology Hepatobiliary pathology Gastrointestinal pathology Genitourinary pathology Respiratory pathology Gynaecological pathology Male reproductive pathology Endocrine pathology. Desirable • Ear, nose and throat pathology • Osteoarticular pathology • Cardiac and vascular pathology • Neuropathology. Perform to quality standards, basic and appropriate specialised histopathological techniques as part of the systematic investigation of tissue received from named major organ disease. To include: KNOWLEDGE AND UNDERSTANDING • • • cancer). Specific dissection criteria applicable to specific disease conditions. The requirements of quality-based diagnostic procedures in ensuring safe and effective care of the patient. Rationale of the histological techniques required to demonstrate the different cell types involved in tissue sections from major organs. Essential • Dermatopathology • Breast pathology • Hepatobiliary pathology • Gastrointestinal pathology • Genitourinary pathology Page | 118 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES • • • • 3 1,2,3 KNOWLEDGE AND UNDERSTANDING Respiratory pathology Gynaecological pathology Male reproductive pathology Endocrine pathology Desirable • Ear, nose and throat pathology • Osteoarticular pathology • Cardiac and vascular pathology • Neuropathology. Perform a detailed evaluation of one new piece of equipment, method or procedure. Perform to quality standards histopathological tests of rejection from tissue grafts and/or organ transplantation. • • • The impact of effective methodological assessment. Use of controls. Report writing. • Ethical and legal issues around transplantation and the role of immunosuppression. The role of the clinical laboratory in major organ transplantation, including ethical and legal issues and the role of immunosuppression. Multi-organ transplantation and the microscopic appearance of rejection. Morphological presentation of a range of major organ systems. Microscopic appearance of normal and abnormal cells. Application of a wide range of histological techniques. The importance of a timely and accurate histopathology and cytopathology diagnosis in the clinical management of the patient. How the formatting of a report assists in the clinician in understanding the findings. • • 4 In discussion with a pathologist interpret in the correct clinical context the results of: • macroscopic examination • basic microscopic examination • appropriate specialised techniques • • • • • Page | 119 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES • 4 KNOWLEDGE AND UNDERSTANDING diagnostic algorithms. from specimens received from a range of named major organ diseases, to include: • dermatopathology • breast pathology • hepatobiliary pathology • gastrointestinal pathology • genitourinary pathology • cardiac and vascular pathology • respiratory pathology • gynaecological pathology • male reproductive pathology • endocrine pathology • ear, nose and throat pathology • osteoarticular pathology. In discussion with a pathologist, • prepare and issue reports from the selected cases of named major organ disease in the context of other • clinical information. • Impact on the patient pathway of the detail and accuracy of the description within the diagnosis and its importance in the timeliness of the treatment and management pathway of the patient. How the formatting of a report assists in the clinician in understanding the findings. The contribution of the results of other clinical investigations and other pathology results. Page | 120 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE 4 AIM SCOPE Cancer (HP-5) COMPONENT Specialist This module will provide trainees with the knowledge and understanding of the principles of carcinogenesis, malignancy and metastasis. They will understand how to apply cellular pathology to the diagnosis and management of a range of common cancers. The trainee will become competent in the use of cellular pathology techniques in the initial diagnosis of cancer and monitoring subsequent spread and will gain experience of interpreting results from patient investigations. The trainee will be able to describe national and international targets and achievements in the diagnosis, management and survival of cancer patients. LEARNING OUTCOMES On successful completion of this module the trainee will: 9. Identify and confirm the clinical presentation of a range of common cancers. 10. Perform to quality standards a range of established histopathological techniques to named cancers. 11. Identify and evaluate new equipment, methods or procedures to enhance the contribution of the histopathology laboratory to the diagnosis and management of cancer. 12. Apply diagnostic algorithms and prognostic indicators to the investigation and management of cancer patients. 13. Draft preparation and interpretation of reports that involve histopathological findings as part of the investigation of cancer. 14. Work in partnership with other clinical specialisms as part of the diagnosis and review of a range of common cancers. Page | 121 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: • Participate in multidisciplinary review meetings at which histopathology results from cases of cancer are presented as part of the • • • • • • clinical record. Wherever possible include those cases in your portfolio of named cancers. Record the outcomes of the multidisciplinary review meetings. Include details of investigations undertaken, with explanations, in the portfolio of cases prepared for learning outcome 1. Perform a detailed evaluation of one new piece of equipment, method or procedure. Critically appraise the results of the evaluation and produce a report with recommendations. Participate in the application of the three different diagnostic algorithms and/or prognostic indicators to your portfolio of cases in named cancers. Write a histopathology report of a range of common cancers appreciating the partnership between the histopathology laboratory and other clinical specialisms. Suggest ways in which improved diagnostics could lead to better clinical outcomes in your three selected common cancers. Prepare a portfolio of a minimum of 10 illustrative cases from different common malignancies. Include the plan of laboratory investigation. To be developed further in learning outcomes 2 and 6. 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. 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. Page | 122 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1 COMPETENCES Plan and implement, using aetiology and clinical presentation information, a diagnostic process to identify common cancers and their prognosis. Essential • Skin malignancy • Breast malignancy • Hepatobilary malignancy • Gastrointestinal malignancy • Genitourinary malignancy • Respiratory malignancy • Gynaecological malignancy • Male reproductive malignancy • Endocrine malignancy. 2 Desirable • Haemopoietic malignancy • Neuromuscular malignancy • Ear, nose and throat malignancy • Osteoarticular malignancy • Vascular malignancy • Neurological malignancy. Perform the examination of and record details of the macroscopic examination of tissue received from KNOWLEDGE AND UNDERSTANDING • • • • • • • The whole patient pathway and appreciation of the role Histopathology plays in improving outcomes for patients and the importance of providing an early and accurate diagnosis to enable treatment/resection decisions to be made. Biology of normal and abnormal cell growth. Homeostasis tumour growth, angiogenesis, apotosis and metastasis. Role of oncogenes in cancer development and molecular basis of oncogenesis. Mechanisms of clinical and surgical treatments for cancer. Dissection protocols, anatomy and physiology. Normal and abnormal macroscopic appearance of a range of tissue types. Page | 123 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING named cancers. Essential • Skin malignancy • Breast malignancy • Hepatobilary malignancy • Gastrointestinal malignancy • Genitourinary malignancy • Respiratory malignancy • Gynaecological malignancy • Male reproductive malignancy • Endocrine malignancy. 1 2 Desirable • Haemopoietic malignancy • Neuromuscular malignancy • Ear, nose and throat malignancy • Osteoarticular malignancy • Vascular malignancy • Neurological malignancy. Perform dissection and sample cancer resection specimens received in accordance with local protocols. Perform to quality standards basic and appropriate specialised histopathological techniques as part of the systematic investigation of • • Anatomy and physiology of normal tissues and organs. The macroscopic appearance of cancer in a selection of different tissues. • • Rationale and protocols for histological techniques. Quality control/external quality assurance. Page | 124 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING tissue received from a minimum of 10 different named cancers. 3 Use and evaluate new equipment relevant to the histological investigation of cancer. • Methodology for assessing new pieces of equipment and introducing new techniques in comparison to existing methodologies. 4 Present orally the evidence base for three different diagnostic algorithms and/or prognostic indicators used by your unit in the investigation and management of cancer patients. • Application of diagnostic algorithms and prognostic and predictive indicators to the investigation and management of cancer patients. 5. Identify and interpret national and international cancer targets and survival statistics for at least three common cancers. • Application of national and international targets and achievements in the diagnosis, management and survival of cancer patients. Genetic aspects of predisposition to cancer. In discussion with a pathologist interpret in the correct clinical context the results of: • 4,5 macroscopic examination basic microscopic examination appropriate specialised techniques • diagnostic algorithms. from specimens received from a range of named cancers. • • • • • • • • • • • Identification of normal and abnormal cells and tissue structures using light microscopy. The formulation of a histopathology report to include all of the different elements required by minimum cancer data sets. RCPath guidelines. The role of multidisciplinary team meetings. The principles of radioactive and chemical carcinogenesis. The role of radiotherapy and chemotherapy in the treatment of cancer. The importance of monitoring some cancers with biochemical and haematological markers. The clinical care involved with looking after patients with cancer. Page | 125 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING To include: Essential • Skin malignancy • Breast malignancy • Hepatobilary malignancy • Gastrointestinal malignancy • Genitourinary malignancy • Respiratory malignancy • Gynaecological malignancy • Male reproductive malignancy • Endocrine malignancy. Desirable • Haemopoietic malignancy • Neuromuscular malignancy • Ear, nose and throat malignancy • Osteoarticular malignancy • Vascular malignancy • Neurological malignancy. Page | 126 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE 5 AIM SCOPE Specialised Histopathology (HP-6) COMPONENT Specialist This module will provide trainees with the knowledge and understanding of the application of specialised histopathology techniques to subspecialised specimens in clinical situations, including electron microscopy and autopsy. The trainee will become competent in the use of specialised cellular pathology techniques in clinical situations and gain experience of interpreting results from patient investigations. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Identify the clinical presentation of a range of relevant disorders of specialised organ groups and clinical subspecialist areas. 2. Perform to quality standards a range of specialised histopathology techniques. 3. Identify and evaluate new equipment, methods or procedures to enhance the contribution of the histopathology laboratory to the diagnosis and management of specialised organ groups and clinical subspecialist areas. 4. Support the organisation and use of specialised histopathology laboratory services in the UK. 5. Under supervision, prepare and interpret histopathology reports that involve specialised organ groups and clinical subspecialist areas. 6. Support mortuary operation, the autopsy process and the associated regulatory framework. Where appropriate, observe autopsy in action. 7. Work in partnership with other clinical specialisms as part of the diagnosis and review of patients with disorders of specialised organ groups and from clinical subspecialist areas. Page | 127 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical experiential learning for this module is: • Participate in multidisciplinary review meetings at which histopathology results from relevant specialised areas of medicine are • • • • • presented as part of the clinical record. Wherever possible include those cases in your portfolio. Record the outcomes of the multidisciplinary review meetings. Perform a detailed evaluation of one new piece of equipment, method or procedure. Critically appraise the results of the evaluation and produce a report with recommendations. Participate in the referral of five specimens for different specialised histopathology investigations and gain an understanding of the importance of the report returned in the context of patient diagnosis and/or management. Visit and be able to describe the role and operation of an NHS mortuary. If possible attend an autopsy examination and gain an understanding of the roles undertaken by the pathologist and by the anatomical pathology technologist. Attend wards and clinics at which patients from relevant specialised areas of medicine are being investigated and write a reflective report. Prepare a portfolio of illustrative cases with a minimum of one from each listed specialised area of pathology. Include the plan of laboratory investigation. Include details of investigations undertaken, with explanations, and details of results, interpretation and reports with explanations, in the portfolio of cases prepared for learning outcome 1 and 5. 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. 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. Page | 128 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1 2 2 2 COMPETENCES KNOWLEDGE AND UNDERSTANDING From routine requests, identify the histopathological specimens required to confirm a diagnosis for: • ophthalmic pathology • neuromuscular pathology • central nervous system pathology • haemopoietic pathology. Perform and record details of macroscopic examination of tissue received from named diseases of: • ophthalmic pathology • neuromuscular pathology • central nervous system pathology • haemopoietic pathology. Dissect and sample specimens received in accordance with local protocols. • Perform to quality standards basic and appropriate specialised histopathological techniques as part of the systematic investigation of tissue received from named diseases of: • ophthalmic pathology • neuromuscular pathology • The particular difficulties relating to the handling of these specialist specimens and the main diagnostic reasons for the clinical investigations. The aetiology of and clinical presentation in named diseases. • • Specific dissection criteria applicable to specific disease conditions. Different tissue processing regimens. • Dissection protocols and standard operating procedures. • • Rationale and protocols for relevant specialised techniques. Quality control/external quality assurance. Page | 129 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES central nervous system pathology • haemopoietic pathology. Identify and describe relevant new equipment, methods or procedures that may be able to enhance the contribution of the histopathology laboratory specialised areas of medicine. KNOWLEDGE AND UNDERSTANDING • 3 • • Methodology for assessing new pieces of equipment and introducing new techniques in comparison to existing methodologies. The operating protocols for an electron microscope. 4 Report on the UK centres undertaking specialised histopathology investigations, giving examples from your own experience of the specialised tests provided in named disorders. • List of specialised diagnostic services provided locally, regionally, supra-regionally and nationally. 5,7 In discussion with a pathologist interpret in the correct clinical context the results of: • macroscopic examination • basic microscopic examination • appropriate specialised techniques • diagnostic algorithms from specimens received from a range of named specialist systems, to include: • ophthalmic pathology • • • RCPath guidelines. The role of multidisciplinary team meetings. The importance of monitoring some cancers with biochemical and haematological markers. The clinical care involved with looking after patients with specialised conditions. Appreciation of how the formatting of a report assists the clinician in understanding the findings. Appreciation of the contribution of the results of other clinical investigations and other pathology results. • • • Page | 130 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES • • • 6 KNOWLEDGE AND UNDERSTANDING neuromuscular pathology central nervous system pathology haemopoietic pathology. Identify and apply the relevant legislation and guidance that applies to the autopsy and the retrieval of tissue. • • • The requirements of the Human Tissue Act (2004) and the Codes of Practice of the Human Tissue Authority. Clinical Pathology Accreditation (UK) Ltd standards. MHRA guidelines. Page | 131 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Cellular Sciences SECTION 8: SPECIALIST LEARNING FRAMEWORK REPRODUCTIVE SCIENCE Page | 132 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) STP Learning Framework 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 Life Sciences THEME Cellular Sciences SPECIALISM Reproductive Science Page | 133 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) REPRODUCTIVE SCIENCE – SPECIALIST MODULES Module 1 (RS-2) Infertility, Treatment and Role of Regulation Module 2 (RS-3) Gametes and Fertilisation Module 3 (RS-4) Culture of Gametes and Embryos Module 4 (RS-5) Micromanipulation and Cryopreservation Module 5 (RS-6) Embryology Page | 134 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE 1 Infertility, Treatment and Role of Regulation COMPONENT Specialist (RS-2) This module will provide the trainee with the knowledge and understanding of the causes and treatment AIM SCOPE options for male and female infertility and the approach to managing the infertile couple. They will understand the role of regulation in treating infertility and become familiar with legislatory and quality management aspects of licensed treatments. On completion of this module the trainee will have gained further experience of involvement in clinical appointments and multidisciplinary team meetings to improve their understanding and skills in the investigation and treatment of infertility. They will be able to perform a range of procedures and quality assurance tasks associated with working within the infertility clinical laboratory. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Suggest a patient’s pathway, including treatment options and stimulation regimens based on clinical presentation. 2. Perform procedures within the statutory and regulatory framework. 3. Perform quality management tasks. Page | 135 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical learning experience for this module is: • Attend clinical appointments to gain experience of the clinical presentation of male and female infertility (with the permission of • • • • • patients). Evaluate your experience in terms of both the clinical presentation and patient experience/needs and discuss with your supervisor. Attend clinical appointments to gain experience and review the range of treatment options for the infertile couple (with the permission of the patient). This may include attendance at initial medical consultation, nurse consultation or follow-up consultation within the clinical setting of the assisted conception unit. Shadow at least one patient pathway to gain experience of the endocrine and physiological responses to different ovarian stimulation regimens and discuss the clinical situations in which each would be used, the monitoring undertaken and patient safety considerations. Attend multidisciplinary team meetings to participate in case discussion to review a wide range of clinical cases. Select one case discussion and review in more detail, following patient progress and actual/potential outcomes, to include the clinical presentation, options considered, treatment provided and patient engagement and experience in the process. Attend multidisciplinary team meetings to gain experience and describe the partnership between the reproductive science laboratory and other clinical specialisms in the investigation of infertility, for example Clinical Genetics. 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 as appropriate to all specialist modules). 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. 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. Page | 136 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1 COMPETENCES Review case notes to link the cause of infertility with the suggested treatment plan and produce an interpretive report of the investigations. KNOWLEDGE AND UNDERSTANDING • • • 1 2 2 3 3 2,3 Plan and optimally time a thaw/warming cycle within a natural or hormone replacement therapy (HRT) cycle. Perform witness checks during a procedure to meet Human Fertilisation and Embryology Authority (HFEA) requirements. Review the required consents appropriate for a variety of treatment cycles, including those involving donated gametes. Perform quality assurance and quality control tasks within the laboratory. Perform and report a risk assessment for one procedure performed in your laboratory. Follow the appropriate guidelines for incident reporting within the centre. • • • • Basic knowledge of the cause and diagnosis of male and female infertility. Awareness of the different stimulation regimens with respect to their mode of action and the reasons why they are used in different clinical situations. Awareness of the key factors in the case history that may influence the choice of treatment options. Requirements for interpretive reporting. Awareness of when natural and HRT cycles are used for thaw/rewarming cycles. Working knowledge of the menstrual cycle/endocrinology in order to time when embryos are replaced in frozen/thawed cycles. In-depth knowledge of the HFEA Code of Practice with respect to witnessing requirements and the implications of incorrect witnessing procedures. • In-depth knowledge of which consents are applicable to treatment options for local and HFEA Code of Practice requirements. The importance of accurately completing and checking consent forms. • Working knowledge of the principles of quality management, validation and quality control and assurance, and the benefits of both external and internal quality assurance. The importance of performing risk assessment and the implications of non-compliance with requirements. • • A comprehensive knowledge of local clinical governance procedures as well as HFEA requirements. Page | 137 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING • 2 Minimise risks and hazards in compliance with health and safety policies. • The type and range of potential incidents, their causes and control measures. The relevant health and safety regulations and the potential hazards and risks and the actions taken to minimise these. Page | 138 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) MODULE 2 AIM SCOPE Gametes and Fertilisation (RS-3) COMPONENT Specialist This module will provide the trainee with the knowledge and understanding of the development of male and female gametes and the process of fertilisation. They will understand and gain experience in egg collection, sperm preparation and insemination methodologies, and identify normally and abnormally fertilised oocytes. The trainee will also learn how to report results from insemination/fertilisation. On completion of this module the trainee will have gained experience in a range of procedures, including sperm assessment and preparation, egg collection, in vitro fertilisation insemination and identifying oocytes for normal and abnormal fertilisation. They will be able to communicate results with the multidisciplinary team and patients. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. 2. 3. 4. Handle gametes correctly to maintain viability. Undertake an egg recovery procedure and identify oocytes. Perform the different methods of sperm preparation techniques. Identify patients who, based on clinical parameters, require either in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). 5. Advise patients on their treatment pathway through discussion of the different insemination methods. Perform the different methods of routine (not ICSI) insemination. 6. Identify stages of oocyte maturity and normally and abnormally fertilised oocytes. 7. Record and report accurately patients’ fertilisation results. Page | 139 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical learning experience for this module is: • • • • • Review patient notes where the course of treatment has been changed with regard to method of insemination. Reflect on the reasons for change and the intended/actual improvements in treatment outcomes for the patient. Discuss with your supervisor. Attend multidisciplinary team meetings to review and discuss cases of failed fertilisation to recommend further treatment options. Reflect on the reasons for failure, the recommendations and potential outcomes, and the impact of failure on the patient experience. Discuss with your supervisor. Review presenting cases and prepare to discuss with clinical colleagues the presenting infertility causes that would indicate the methods of insemination. Prepare your own recommendations, with rationale for discussion, and reflect on the outcomes of review with colleagues. Review cases where insemination has not taken place post egg recovery and discuss the reasons for this with your colleagues and supervisor. Reflect and review the discussion and implications for your own future practice. Review patients’ notes where donated gametes have been used. Review and discuss the patient pathway, including why donor gametes were required, the counselling and consent process. Consider from both the specialist and patient perspectives. 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. 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. Page | 140 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 5 COMPETENCES Discuss insemination methods used in treatment based on semen quality with patients. KNOWLEDGE AND UNDERSTANDING • • • • • • 1,4 Make a clinical decision regarding the method of insemination with respect to semen quality. • • • 6 Label and witness samples used for insemination. • 3 Prepare epididymal and testicular samples for use with ICSI. Perform and interpret swim-up techniques and density gradient • 1,3,4 • Information needs of a patient and the implications of consent. The importance of preparing for discussion with patients, including review of specific case histories. In-depth knowledge of the clinical reasons when ICSI is used with regard to semen quality and previous treatment outcomes. Comprehensive knowledge of the methods involved in IVF and ICSI and the advantages, disadvantages and risks of each method and the implications of failed fertilisation. Basic knowledge of when it is necessary to consider the use of donor sperm and the regulatory requirements associated with donor gamete use. Common questions and concerns of the patient about procedures. In-depth knowledge of the reasons why ICSI may be recommended as a treatment option and the resulting effects on the patient treatment pathway. In-depth knowledge of the risks and the importance of the regulations associated with ICSI. Factors influencing a clinical decision and the required decisionmaking process. A comprehensive knowledge of the Human Fertilisation and Embryology Authority (HFEA) Code of Practice with respect to witnessing requirements and the implications of incorrect witnessing procedures. Basic knowledge of male anatomy and the physiology of mature sperm, and implications of using immature sperm for ICSI. In-depth knowledge of the World Health Organization (WHO) criteria for normal and abnormal semen parameters. Page | 141 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 2 COMPETENCES separation of sperm samples of different quality, including: • antisperm antibody-positive samples • retrograde samples • severe oligoasthenozoospermic samples • frozen samples, including donor samples. Identify granulosa cells, cumulus cells and oocytes during egg collection. KNOWLEDGE AND UNDERSTANDING • • • • • • • 2 1 Identify cysts during an oocyte collection. Handle and manipulate oocytes to maintain viability. • • • • • 6 Perform the identification and witnessing checks carried out at the time of insemination for IVF and ICSI. • 6 Perform insemination for IVF. • In-depth knowledge of the importance of how suboptimal samples may affect fertilisation rates. Basic knowledge of the aetiology of male factor infertility. Comprehensive knowledge of the different methods that can be applied to prepare semen samples of differing qualities. Working knowledge of how cryoprotectants may affect the quality of sperm and how osmotic shock may occur during the process. Implications of incorrect use of cryoprotectants on sample quality and outcomes. Basic knowledge of follicular physiology and oocyte maturation in vivo. Awareness of the egg retrieval procedure and factors that could impair oocyte quality during the procedure. Awareness of the correct timing and administration of chorionic gonadotrophin to complete oocyte maturation and the implications for treatment. Awareness of the different types of cysts and why they may arise. Recognition of type and implications for further processing/treatment. The importance of aseptic techniques and maintaining sterility. Implications of incorrect application of aseptic technique and the potential risks. Working knowledge of the environmental variables such as temperature and CO2 and their impact on sample viability. A comprehensive knowledge of the HFEA Code of Practice with respect to witnessing requirements and the implications of incorrect witnessing procedures. An in-depth knowledge of methods of insemination and implications for the fertilisation rate and treatment outcome if the wrong method Page | 142 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1,7 1,7 COMPETENCES KNOWLEDGE AND UNDERSTANDING Perform cumulus removal before ICSI and categorise the state of maturity of denuded oocytes. • Perform fertilisation checks. • • • 8 8 7 Communicate bad news to patients in the event of low or failed fertilisation. • Discuss fertilisation results with patients and the multidisciplinary team. Correctly identify and record normal and abnormally fertilised oocytes. • • • • or concentration of sperm is used. In-depth knowledge of the different stages of oocyte maturation and the implications of immature oocytes for ICSI procedure. Working knowledge of the enzymatic process involved in the process of cumulus removal. In-depth knowledge of normal and abnormal fertilisation, including failed fertilisation of the oocyte. Comprehensive knowledge of pronuclear formation and the completion of the second meiotic division. A working knowledge of the reasons why fertilisation may not occur and how to deliver bad news to patients. Awareness of when it is necessary to consider the use of donor sperm/oocytes and the regulatory requirements associated with donor gamete use. The importance of communicating scientific information in an understandable manner to patients and colleagues. The importance of accurately identifying and recording normal and abnormally fertilised oocytes. Implications of replacing an abnormally fertilised embryo back in a patient and the implications for treatment outcome. Page | 143 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Module 3 AIM SCOPE Culture of Gametes and Embryos (RS-4) COMPONENT Specialist This module will provide the trainee with the knowledge and understanding of the principles and practice of culture systems used in an in vitro fertilisation laboratory. They will gain experience of the culture of gametes and embryos in a clinical setting. They will gain understanding on how quality management integrates with the laboratory processes, and how to identify, troubleshoot and correct problems. On completion of this module the trainee will have gained experience in a variety of culture systems by preparing the dishes and tubes used to culture gametes and embryos within the laboratory and by visiting other centres that use different systems. They will have taken part in a range of quality management tasks to perform system evaluations. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. 2. 3. 4. 5. Use sterile technique to prepare culture dishes appropriate for gametes and embryos. Culture embryos to maintain viability. Perform quality control checks within the laboratory. Analyse key performance indicators with respect to defined outcomes. Identify, troubleshoot and solve problems. Page | 144 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical learning experience for this module is: • • • Visit at least two reproductive science laboratories other than your own to review the different clinical settings and culture systems used to support embryo development. Reflect on your experience in terms of the differentiation between them and consider how this influences your future practice. Evaluate and discuss the different types of culture systems used, including the implications for selection, processing and outcome. Evaluate the impact on your future practice, Participate in multidisciplinary team meetings to present and review key performance indicators. Identify at least one potential problem and how to troubleshoot with clinical colleagues. Discuss at a multidisciplinary team meeting, review your experience and the impact on both the patient experience, and your own future practice. 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. 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. Page | 145 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1,2 2 1 COMPETENCES Assess air quality in the laboratory. Correctly use incubators, heated stages and tube warmers to maintain temperature conditions. Use workstations/safety cabinets correctly to maintain sterility of samples. KNOWLEDGE AND UNDERSTANDING • • • • • • • • 1 1,2 3,4,5 Perform sterilisation and decontamination techniques for equipment and facilities used in tissue culture. Prepare consumables and media for oocyte collection; fertilisation checks; embryo culture; embryo transfer; embryo cryopreservation and thawing/warming. Analyse data required for specific • • • • • • • The importance of air quality and the implications for maintaining sterility. An awareness of methodology to assess air quality such as particulate counts, microbiological testing and volatile organic compound (VOC) measurements. A working knowledge of regulatory requirements. The importance of controlling the culture environment and the implications for embryo viability if suboptimal conditions are used. Working knowledge of the measurements that can be taken to assess parameters directly affecting embryo quality and the implications of exceeding tolerance limits. Identification of common faults and remedial action. The importance of aseptic techniques and maintaining sterility. Implications of incorrect application of aseptic technique and the potential risks. Working knowledge of the environmental variables, such as temperature and CO2, and their impact on sample viability. Identification of common faults and remedial action. The importance of aseptic techniques and maintaining sterility. Implications of incorrect application of aseptic technique and the potential risks. Protocols and requirements for hygiene and infection control. An in-depth knowledge of water purity, osmolality, pH, temperature, protein supplements, antibiotics and microbiological contamination and their effects on oocyte and embryo viability in culture. A comprehensive knowledge of the physiological requirements of an embryo at the different stages of development in culture. In-depth knowledge of data analysis for KPIs and defining tolerance Page | 146 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING key performance indicators (KPIs) • 3 Perform inward receipt of consumables to carry out the necessary quality control checks and traceability requirements. • limits. The importance of recognising non-compliances and the implications for the system. A working knowledge of the regulatory requirements and quality issues relating to consumables used in the laboratory. Page | 147 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Module 4 AIM SCOPE Micromanipulation and Cryopreservation (RS-5) COMPONENT Specialist This module will provide the trainee with the knowledge and understanding of the principles and practice of micromanipulation and cryopreservation and associated regulatory requirements. They will gain experience of the micromanipulation and cryopreservation of gametes and embryos in a clinical setting. On completion of this module the trainee will have gained experience of performing intracytoplasmic sperm injection (ICSI) and be able to make a clinical decision as to when a patient requires ICSI. They will be able to cryopreserve gametes and embryos and thaw/rewarm samples for use in treatment cycles. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Perform micromanipulation techniques. 2. Perform cryopreservation and thawing/warming of gametes and embryos. Page | 148 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical learning experience for this module is: • • Participate in multidisciplinary team meetings and discuss when intracytoplasmic sperm injection (ICSI) should be used in treatment. Identify one case study relating to this decision-making process, prepare and discuss with the multidisciplinary team. Reflect on the discussion and outcomes and the impact for your future practice. Participate in audits to gain experience of the statutory and regulatory requirements of cryopreservation, including the review of patients with stored material, consent checking and billing process. Reflect on the importance of audits to comply with regulation and to inform patients of their choices with respect to continued storage. The quality of the process and the importance/options/action. 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. 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. Page | 149 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1 COMPETENCES KNOWLEDGE AND UNDERSTANDING Label and perform witnessing prior to micromanipulation of oocytes. • 1 Use correctly the micromanipulation equipment. • 1 Perform ICSI. • 2 Label and perform witnessing prior to cryopreservation and following thawing/warming of semen, oocytes and embryos. Perform sperm cryopreservation. • 2 • • • • 2 Thaw semen samples and compare pre-freeze and post-thaw parameters. • • A comprehensive knowledge the Human Fertilisation and Embryology Authority (HFEA) Code of Practice with respect to witnessing requirements and the implications of incorrect witnessing procedures. The importance of correctly setting up and using ICSI equipment and the implications for oocyte viability of setting up incorrectly. Working knowledge of the equipment used for ICSI and troubleshooting techniques. Comprehensive knowledge of the methodology of the process, including sperm selection and immobilisation, positioning of the polar body and the injection process. A comprehensive knowledge the HFEA Code of Practice with respect to witnessing requirements and the implications of incorrect witnessing procedures. In-depth knowledge of the required consents that need to be completed before any samples can be stored and the implications for the centre if consents are not completed. In-depth knowledge of the principles of cryobiology, including the physical and chemical processes occurring during cryopreservation and thawing, and the use and properties of cryoprotectants. Working knowledge of the health and safety regulations to be applied when handling liquid nitrogen. Comprehensive knowledge of the regulatory requirements with regard to screening and storage limits. Working knowledge of how cryoprotectants may affect the quality of sperm and how osmotic shock may occur during the process. Implications of incorrect use of cryoprotectants on sample quality and Page | 150 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES COMPETENCES KNOWLEDGE AND UNDERSTANDING • 2 Perform embryo freezing and embryo vitrification. • • • 2 2 2 Thaw cryopreserved samples and warm vitrified samples. Release and receive cryopreserved gametes and embryos to other centres. • Discuss embryo development with patients and the multidisciplinary team with specific reference to the suitability for cryopreservation and the survival. • • • outcomes. In-depth knowledge of the physiological changes that occur in gametes during cryopreservation. In-depth knowledge of principles of cryobiology, including the physical and chemical processes occurring during slow rate freezing and vitrification, and the use and properties of cryoprotectants. The methods used and the consumables that are available for different methods. In-depth knowledge of the regulatory requirements with regard to screening, storage limits and consent. In-depth knowledge of the physiological changes that occur in gametes and embryos during thawing/rewarming. In-depth knowledge of the regulatory requirements with regard to moving samples between centres. Importance of maintaining appropriate conditions during transport to ensure viability is not compromised. In-depth knowledge of the effect of cryopreservation on embryo quality and the implications of quality in relation to treatment outcome. Page | 151 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Module 5 AIM SCOPE Embryology (RS-6) COMPONENT Specialist This module will provide the trainee with the knowledge and understanding of the development of preimplantation embryos. They will gain experience of the morphological assessment of embryos and the assessments used to identify embryos for transfer or cryopreservation. On completion of this module the trainee will have gained experience in the methods used to assess embryos and be able to select embryos for transfer and cryopreservation. They will be able to discuss embryo quality with colleagues and patients and be able to apply the multiple births minimisation strategy. LEARNING OUTCOMES On successful completion of this module the trainee will: 1. Perform oocyte and embryo morphology assessments. 2. Perform embryo transfer. 3. Assess, interpret and report embryology results. Page | 152 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) CLINICAL EXPERIENTIAL LEARNING The clinical learning experience for this module is: • Identify a case involving a difficult embryo transfer, consider the options available and review and discuss with your supervisor. Consider the implications for the patient and how the results of your discussion will inform your future practice. • Attend a medical follow-up consultation to gain experience of cycle analysis, consider possible options and discuss future decisions for patient treatment. Reflect on the implications for patient experience/outcome and the impact on your own future practice. • Review the embryology detail of at least one patient treatment, evaluate the cycle and prepare a report that could be entered into a patient’s clinical notes. Review and discuss with your supervisor. • Prepare a portfolio of significant clinical cases where you have been involved in performing laboratory investigations and/or reporting. Discuss and review the clinical outcome and main learning points for each case. 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. 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. Page | 153 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) KEY LEARNING OUTCOMES 1 1,3 COMPETENCES KNOWLEDGE AND UNDERSTANDING Grade embryos both at the cleavage • stage and the blastocyst stage. Accurately record embryo grading • and outcome. • 1,2,3 Label, identify and witness embryos for use in embryo transfer. • 2 Use procedures and workstations to maintain embryo viability during embryo transfer. • • • 1,3 Dispose of unused embryos. 1,3 Make clinical decisions regarding • the number of embryos to be transferred. Communicate number of embryos to • be transferred to patients. • 1,3 • In-depth knowledge of human embryonic development and differentiation at all stages of the pre-implantation embryo. The importance of participating in internal and external quality assurance. The importance of the assessment of embryos intended for treatment and the effect embryo quality has on cycle outcome. A comprehensive knowledge the Human Fertilisation and Embrology Authority (HFEA) Code of Practice with respect to witnessing requirements and the implications of incorrect witnessing procedures. The importance of aseptic techniques and maintaining sterility. Implications of incorrect application of aseptic technique and the potential risks. Working knowledge of the environmental variables, such as temperature and CO2, and their impact on sample viability. The importance of documentation and informing patients of fate of individual embryos. In-depth knowledge of the HFEA regulations with regard to multiple births. In depth knowledge of the HFEA regulations with regard to multiple births Awareness of the multiple births minimisation strategy and the risks associated with multiple births. Page | 154 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Cellular Sciences SECTION 9: CONTRIBUTORS Page | 155 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Contributor List Members of the STP Work Based Learning Guide Development Group for Life Sciences: Cellular Sciences Production of the STP work based learning guides for Cellular Sciences has been coordinated by the Modernising Scientific Careers team and the National School of Healthcare Science working with NHS colleagues. The professionals who have contributed to the development of this Learning Guide include: Jane Rachel Anne Nick Barbara Julia Behdad Ian Allan Blower Cutting Goodall Kirk Lloyd Sarson Shambayati Sturdgess Wilson University Hospitals of Leicester NHS Trust Sheffield Teaching Hospitals Oxford Radcliffe NHS Hospitals Trust Papworth Hospital, Cambridge Addenbrooke's Hospital, Cambridge Oxford Radcliffe NHS Hospitals Trust Ashford Hospital. Kent Addenbrooke's Hospital, Cambridge Monklands Hospital, Airdrie Professional bodies and societies were invited to review the Learning Guides for Cellular Sciences and their feedback has shaped the final publication: Association of Cytopathology Institute of Biomedical Science Association of Clinical Biochemists: Clinical Microbiology Section Modernising Scientific Careers Professional Advisor Dr Graham Beastall Ms Nicky Fleming National School of Healthcare Science Professional Lead Dr Barbara Lloyd September 2012 Page | 156 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Cellular Sciences SECTION 10: APPENDICES Page | 157 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) APPENDIX 1: 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: 189–19)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, specialist, Page | 158 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Learning Outcome Mentoring Module Aim Module Scope National Occupational Standards Practical Skill Programme Provider Role Specialism Trainer Theme Work based learning Work Performance Work place 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). 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 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 | 159 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) APPENDIX 2: 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. Page | 160 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 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 be interpreted appropriately for the context of the specific role. There will, however, always be a requirement for an individual to work within the limits of their scope of practice and competence. Students and trainees will be expected to be working towards meeting the expectations set out in this document. However, if an individual is undertaking further training and development following qualification from a professional training programme, he or she will be expected to be able to meet the standards in this document within their scope of practice. The standards have been used to support curriculum development and will be used to underpin the process of judging individual equivalence, particularly for emerging specialisms. The standards have been divided into five domains. The domains of Good Scientific Practice detailed in section 2 are: 1. 2. 3. 4. 5. Professional Practice Scientific Practice Clinical Practice Research and development Clinical Leadership Section 2: The domains of Good Scientific Practice Domain 1: Professional Practice All patients and service users are entitled to good standards of professional practice and probity from the Healthcare Science workforce including the observance of professional codes of conduct and ethics. In maintaining your fitness to practice as a part of the Healthcare Science workforce, you must: 1.1 Professional Practice 1.1.1 Make the patient your first concern 1.1.2 Exercise your professional duty of care 1.1.3 Work within the agreed scope of practice for lawful, safe and effective healthcare science 1.1.4 Keep your professional, scientific, technical knowledge and skills up to date 1.1.5 Engage fully in evidence based practice 1.1.6 Draw on appropriate skills and knowledge in order to make professional judgements 1.1.7 Work within the limits of your personal competence Page | 161 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 1.1.8 Act without delay on concerns raised by patients or carers or if you have good reason to believe that you or a colleague may be putting people at risk 1.1.9 Never discriminate unfairly against patients, carers or colleagues 1.1.10 Treat each patient as an individual, respect their dignity and confidentiality and uphold the rights, values and autonomy of every service user, including their role in the diagnostic and therapeutic process and in maintaining health and well-being. 1.1.11 Respond constructively to the outcome of audit, appraisals and performance reviews, undertaking further training where necessary 1.2 Probity 1.2.1 Make sure that your conduct at all times justifies the trust of patients, carers and colleagues and maintains the public’s trust in the scientific profession 1.2.2 Inform the appropriate regulatory body without delay if, at any time, you have accepted a caution, been charged with or found guilty of a criminal offence, or if any finding has been made against you as a result of fitness to practice procedures, or if you are suspended from a scientific post, or if you have any restrictions placed on your scientific, clinical or technical practice 1.2.3 Be open, honest and act with integrity at all times, including but not limited to: writing reports, signing documents, providing information about your qualifications, experience, and position in the scientific community, and providing written and verbal information to any formal enquiry or litigation, including that relating to the limits of your scientific knowledge and experience 1.2.4 Take all reasonable steps to verify information in reports and documents, including research 1.2.5 Work within the Standards of Conduct, Performance and Ethics set by your profession 1.3 Working with colleagues 1.3.1 Work with other professionals, support staff, service users, carers and relatives in the ways that best serve patients’ interests 1.3.2 Work effectively as a member of a multi-disciplinary team 1.3.3 Consult and take advice from colleagues where appropriate 1.3.4 Be readily accessible when you are on duty 1.3.5 Respect the skills and contributions of your colleagues 1.3.6 Participate in regular reviews of team performance. 1.4 Training and developing others 1.4.1 Contribute to the education and training of colleagues 1.4.2 If you have responsibilities for teaching, develop the skills, attitudes and practices of a competent teacher 1.4.3 Ensure that junior colleagues and students are properly supervised 1.4.4 Support colleagues who have difficulties with performance, conduct or health Page | 162 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 1.4.5 Share information with colleagues to protect patient safety 1.4.6 Provide work-based development for colleagues to enhance/improve skills and knowledge Domain 2: Scientific Practice As a part of the Healthcare Science workforce, you will keep your scientific and technical knowledge and skills up to date to effectively: 2.1 Scientific Practice 2.1.1 Develop investigative strategies/procedures/processes that take account of relevant clinical and other sources of information 2.1.2 Provide scientific advice to ensure the safe and effective delivery of services 2.1.3 Undertake scientific investigations using qualitative and quantitative methods to aid the screening, diagnosis, prognosis, monitoring and/or treatment of health and disorders appropriate to the discipline 2.1.4 Investigate and monitor disease processes and normal states 2.1.5 Provide clear reports using appropriate methods of analysing, summarising and displaying information 2.1.6 Critically evaluate data, draw conclusions from it , formulate actions and recommend further investigations where appropriate 2.2 Technical Practice 2.2.1 Provide technical advice to ensure the safe and effective delivery of services 2.2.2 Plan, take part in and act on the outcome of regular and systematic audit 2.2.3 Work within the principles and practice of instruments, equipment and methodology used in the relevant scope of practice 2.2.4 Demonstrate practical skills in the essentials of measurement, data generation and analysis 2.2.5 Assess and evaluate new technologies prior to their routine use 2.2.6 Identify and manage sources of risk in the workplace, including specimens, raw materials, clinical and special waste, equipment, radiation and electricity. 2.2.7 Apply principles of good practice in health and safety to all aspects of the workplace 2.2.8 Apply correct methods of disinfection, sterilisation and decontamination and deal with waste and spillages correctly. 2.2.9 Demonstrate appropriate level of skill in the use of information and communications technology 2.3 Quality 2.3.1 Set, maintain and apply quality standards, control and assurance techniques for interventions across all clinical, scientific and technological activities Page | 163 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 2.3.2 Make judgements on the effectiveness of processes and procedures 2.3.3 Participate in quality assurance programmes 2.3.4 Maintain an effective audit trail and work towards continuous improvement Domain 3: Clinical Practice As a part of the Healthcare Science workforce, you will keep your clinical skills up to date and undertake the clinical duties appropriate to your role in order to effectively: 3.1 Clinical Practice 3.1.1 Ensure that you and the staff you supervise understand the need for and obtain relevant consent before undertaking any investigation, examination, provision of treatment, or involvement of patients and carers in teaching or research 3.1.2 Ensure that you and the staff you supervise maintain confidentiality of patient information and records in line with published guidance 3.1.3 Ensure that you and your staff understand the wider clinical consequences of decisions made on your actions or advice 3.1.4 Demonstrate expertise in the wider clinical situation that applies to patients who present in your discipline 3.1.5 Maintain up to date knowledge of the clinical evidence base that underpins the services that you provide and/or supervise and ensure that these services are in line with the best clinical evidence 3.1.6 Plan and determine the range of clinical/scientific investigations or products required to meet diagnostic, therapeutic, rehabilitative or treatment needs of patients, taking account of the complete clinical picture 3.1.7 Plan and agree investigative strategies and clinical protocols for the optimal diagnosis, monitoring and therapy of patients with a range of disorders 3.1.8 Ensure that detailed clinical assessments are undertaken and recorded using appropriate techniques and equipment and that the outcomes of these investigations are reviewed regularly with users of the service 3.1.9 Ensure the provision of expert interpretation of complex and or specialist data across your discipline in the context of clinical questions posed 3.1.10 Undertake and record a detailed clinical assessment using appropriate techniques and equipment 3.1.11 Provide specialised clinical investigation and/or analysis appropriate to your discipline 3.1.12 Provide interpretation of complex and/or specialist data in the context of the clinical question posed 3.1.13 Provide clinical advice based on results obtained, including a diagnostic or therapeutic opinion for further action to be taken by the individual directly responsible for the care of the patient 3.1.14 Provide expert clinical advice to stakeholders in order to optimise the efficiency and effectiveness of clinical investigation of individuals and groups of patients 3.1.15 Prioritise the delivery of investigations, services or treatment based on clinical need of patients Page | 164 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) 3.1.16 Represent your discipline in multidisciplinary clinical meetings to discuss patient outcomes and the appropriateness of services provided 3.1.17 Ensure that regular and systematic clinical audit is undertaken and be responsible for modifying services based on audit findings. 3.2 Investigation and reporting 3.2.1 Plan and conduct scientific, technical, diagnostic, monitoring, treatment and therapeutic procedures with professional skill and ensuring the safety of patients, the public and staff 3.2.2 Perform investigations and procedures/design products to assist with the management, diagnosis, treatment, rehabilitation or planning in relation to the range of patient conditions/equipment within a specialist scope of practice 3.2.3 Monitor and report on progress of patient conditions/use of technology and the need for further interventions. 3.2.4 Interpret and report on a range of investigations or procedures associated with the management of patient conditions/equipment Domain 4: Research, Development and Innovation As part of the Healthcare Science workforce, research, development and innovation are key to your role. It is essential in helping the NHS address the challenges of the ageing population, chronic disease, health inequalities and rising public expectations of the NHS. In your role, you will undertake the research, development and innovation appropriate to your role in order to effectively: 4.1 Research, Development and Innovation 4.1.1 Search and critically appraise scientific literature and other sources of information 4.1.2 Engage in evidence-based practice, participate in audit procedures and critically search for, appraise and identify innovative approaches to practice and delivery of healthcare 4.1.3 Apply a range of research methodologies and initiate and participate in collaborative research 4.1.4 Manage research and development within a governance framework 4.1.5 Develop, evaluate, validate and verify new scientific, technical, diagnostic, monitoring, treatment and therapeutic procedures and, where indicated by the evidence, adapt and embed them in routine practice 4.1.6 Evaluate research and other available evidence to inform own practice in order to ensure that it remains at the leading edge of innovation. 4.1.7 Interpret data in the prevailing clinical context 4.1.8 Perform experimental work, produce and present results 4.1.9 Present data, research findings and innovative approaches to practice to peers in appropriate forms 4.1.10 Support the wider healthcare team in the spread and adoption of innovative technologies and practice Page | 165 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) Domain 5: Clinical Leadership All patients and service users have a right to expect that Healthcare Science services efficiently and effectively managed to meet service needs. As a leader in Healthcare Science, you will seek to effectively: 5.1 Leadership 5.1.1 Maintain responsibility when delegating healthcare activities and provide support as needed 5.1.2 Respect the skills and contributions of your colleagues 5.1.3 Protect patients from risk or harm presented by another person’s conduct, performance or health 5.1.4 Treat your colleagues fairly and with respect 5.1.5 Make suitable arrangements to ensure that roles and responsibilities are covered when you are absent, including handover at sufficient level of detail to competent colleagues 5.1.6 Ensure that patients, carers and colleagues understand the role and responsibilities of each member of the team 5.1.7 Ensure that systems are in place through which colleagues can raise concerns and take steps to act on those concerns if justified 5.1.8 Ensure regular reviews of team performance and take steps to develop and strengthen the team 5.1.9 Take steps to remedy any deficiencies in team performance 5.1.10 Refer patients to appropriate health professionals 5.1.11 Identify and take appropriate action to meet the development needs of those for whom you have management, supervision or training responsibilities 5.1.12 Act as an ambassador for the Healthcare Science community Good Scientific Practice AHCS V.2 Final Page | 166 STP_LG Cellular Sciences 2012-2013 Final Version (4.0) APPENDIX 3: FURTHER INFORMATION NHS Networks An open network to share curricula produced for the Modernising Scientific Careers programme. Join this network to get updates whenever there is new content. http://www.networks.nhs.uk/nhs-networks/msc-framework-curricula/ Details of the Scientist Training Programme including MSc Clinical Science Curricula, Work Based Learning Guides. http://www.networks.nhs.uk/nhs-networks/msc-framework-curricula/stp Chief Scientific Officer (CSO), Department of Health Source of information and news including the CSO Bulletin, latest press releases, publications and consultations. http://www.dh.gov.uk/health/category/chief-scientific-officer/ National School of Healthcare Science (NSHCS) The National School of Healthcare Science is an important part of the new system for healthcare science training established through Modernising Scientific Careers. This new system was set up to ensure that patients benefit from the scientific and technical advances by ensuring that healthcare science staff have the knowledge and skills to put these advances into practice. www.nshcs.org.uk Academy for Healthcare Science (AHCS) The Academy for Healthcare Science (AHCS) is a UK wide organisation bringing together a diverse and specialised scientific community working within the National Health Service (NHS) and other associated organisations (e.g. the Health Protection Agency, NHS Blood and Transplant), Health and Social Care Northern Ireland (HSCNI) and the academic and independent healthcare sector. http://www.academyforhealthcarescience.co.uk/ Health and Care Professions Council (HCPC) The HPC are a regulator set up to protect the public. They keep a register of health professionals who meet the HPC standards for their training, professional skills, behaviour and health. http://www.hpc-uk.org/ Last Accessed 29th September 2012 Page | 167 STP_LG Cellular Sciences 2012-2013 Final Version (4.0)
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