CURRICULUM OUTLINING COMPETENCIES REQUIRED FOR INTERNS TO ATTAIN HPCSA REGISTRATION AS MEDICAL SCIENTISTS CATEGORY

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1 CURRICULUM OUTLINING COMPETENCIES REQUIRED FOR INTERNS TO ATTAIN HPCSA REGISTRATION AS MEDICAL SCIENTISTS CATEGORY Medical Biological Science DISCIPLINE Genetics This document serves to provide a framework describing the competencies an intern medical scientist needs to achieve before making application to the HPCSA to register in the category Independent Practice. Each training facility will have an approved training programme that will detail how these competencies will be achieved over the 24-month intern training period. Each intern will compile a of activities, assessments and competencies attained. The will be submitted to the Committee for Medical Science of the Medical and Dental Board for Board approved assessment. The document is structured into five parts: 1. Generic Elements of Training Programme 2. Discipline Specific Elements of Training Programme 3. Portfolio guidelines 4. Guidelines for a Shortened Internship Following Attainment of an MSc or PhD Degree 5. Guidelines for Migrating into the Discipline from a Related Discipline Page 1 of 16

2 INTRODUCTION In order to register with the Health Professions Council of South Africa (HPCSA) as a Medical Scientist in the category Independent Practice, a two year internship has to be completed in an HPCSA accredited laboratory under the supervision of an appropriate group of medical scientists or specialists who are registered with the HPCSA. Non registered individuals may participate in the training. ENTRY REQUIREMENTS BSc (Honours) or equivalent in an appropriate discipline MSc and PhD degree entrants Appropriate disciplines include: Genetics and Biochemistry (Additional disciplines for eligibility to apply: Microbiology, Zoology, Botany, Physiology, Anatomy, Medical Science). Interns will be subjected to the full training program of the training facility. Applicants with an MSc or PhD degree obtained in a research field relevant to human genetics will be considered for a shortened internship of not less than 6 months. The incumbent of the internship needs to register with the HPCSA as an Intern Medical Biological Scientist (Genetics) within two months of starting the internship. PERIOD OF INTERN TRAINING Full time internship period: 24 months. If the intern fails to attain the necessary knowledge and skill over the 24 month period, the internship period can be extended in consultation with the HPCSA and the training facility (up to an additional 6 months). Page 2 of 16

3 1. GENERIC ELEMENTS OF TRAINING PROGRAMME 1A. Good laboratory practice (GLP) Understand the importance and process of national accreditation Know the requirements or guidelines for GLP (for example SANAS, or other ISO guidelines) Understand the different elements of GLP (audit trail, standard operating procedures, laboratory manual, laboratory handbook) Basic knowledge of health and safety requirements appropriate to the discipline Develop a commitment to lifelong learning through continuing professional development and attend relevant seminars, courses and/or congresses 1B. Quality control/assurance an understanding of the principles of good laboratory practice an understanding of the process involved in accreditation an understanding of health and safety regulations participation in quality audits and compliance with ISO standards partaking and adherence of accepted laboratory practices partaking in the composing and revision of SOPs participation in safety awareness participation in laboratory management meetings Understand basic quality assurance programs, including internal and external proficiency testing and the importance of both Understand the principles of quality control and quality assurance Ability to assess trends and identify the underlying causes of bias and errors Assess the quality of results, outputs and ensuring accuracy by examining measurements of uncertainty and how they influence results Knowledge of the factors affecting final result of test method an understanding of the different elements of a quality program critical thinking to analyse results accurately, perform root-cause analysis, trouble-shooting and determine Page 3 of 16

4 trends an ability to apply quality parameters in reporting/ evaluation of results an ability to perform proficient and accurate testing participating in quality assurance programs partaking in laboratory management meetings participating in a validation study Section 7 - Assessments 1C. Basic research principles Ability to critically appraise literature Ability to define research questions or aims and to develop a research protocol Ability to define the methodology and to execute the experimental work Acquisition of appropriate technical skills to perform experimental work Ability to critically appraise the results in the light of existing knowledge and formulate further research questions Understand the process of obtaining ethics approval and funding for a research project a basic ability to define research topics and selection of the most appropriate research tools a basic ability to perform research acquisition of critical thinking to evaluate outcomes an understanding of statistically significant results participation in research meetings training in the basic principles of research methodology performing a semi-independent research project assessment of oral and written presentation Section 7 - Research experience 1D. Ethics Generic Competencies Understand the ethical principles related to the discipline A thorough understanding of Discipline-Specific Competencies Understand the importance of informed consent and confidentiality Page 4 of 16

5 applying ethics when dealing with patients and clinicians Understand the ethical boundaries in working with human samples and maintaining confidentiality Ability to recognise the limits of personal practice and when to seek advice 1E. Medico/legal knowledge Generic Competencies Broad understanding of the principles of genetic counselling Appreciation of ethical issues relevant to human genetics an understanding of client / patient confidentiality an appreciation of the necessity for ethical behaviour mentoring by an experienced health professional participation in routine diagnostic service compliance with legislation compliance with the HPCSA Code of Ethics Understand the legal boundaries of practice of medical science Understand the legislative framework, including the relevant Acts, regulations and guidelines Discipline-Specific Competencies Understand the legal and ethical boundaries and the practice of how to conduct genetic testing and research in the discipline Understand the relevant Acts (including the Termination of Pregnancy Act, National Health Act and HPCSA Act) Basic knowledge of the application of the guidelines in the Act and the supporting Regulations a working knowledge and understanding of the legal framework for genetic testing and research mentoring by an experienced health professional applying of the regulations of the Acts in diagnostic/clinical and research environment Access to Acts Page 5 of 16

6 1F. Management Generic Competencies Ability to understand laboratory management, including stock management, working within a budget, rotation of staff, competency and training of staff, knowledge of the requirements for GLP and workplace practice Basic knowledge of the structure and organization of the department and relevant financial aspects Understand the principles of appraisal Ability to function as an effective member of a multidisciplinary team Participate in an appropriate CPD scheme (after completion of training) Knowledge about policies, goals and priorities of the healthcare environment Participate in departmental activities related to organizational planning Ability to develop multidisciplinary team working and leadership skills Ability to manage personal workload and prioritize tasks appropriately an understanding of: o Discipline-Specific Competencies An understanding of the interaction between the various sub-disciplines in the modality A working knowledge of validation of methods and calibration of equipment management and leadership in a diagnostic and training environment o financial-based concepts in a routine diagnostic environment o budget management o staff management working practice under mentoring of an experienced health professional involvement in project budgeting Page 6 of 16

7 participation in departmental management meetings 1G. Communication Skills Generic Competencies Ability to assess a situation and act appropriately Ability to respond to enquiries from other health professionals Ability to effectively communicate with members from the public, patients, colleagues and other health care professionals Ability to present relevant information in both a diagnostic setting and research findings to an audience of peers Discipline-Specific Competencies Ability to manage and communicate results within a genetic setting an ability to effectively communicate clearly and with confidence an ability to train and educate others an ability to reply appropriately to clients inquiries direct clinical liaison at meetings and academic discussions an ability to communicate efficiently with clients and staff presentation and/or publication of research/diagnostic outputs participation in local seminars, journal clubs and conferences 1H. Computer literacy Generic Competencies Ability to effectively use modern communication media Ability to use and understand the Discipline-Specific Competencies Understanding and basic use of the appropriate software for DNA sequence analysis and other Page 7 of 16

8 Laboratory Information System for result management 1I. Statistics genetic analyser software Use of information technology including online resources and databases Understand basic bioinformatics, human genome browsers (Ensembl and UCSC), retrieval of sequence data and basic alignments and assessment of genetic variation (SNPs, microsatellites and CNV) a basic knowledge to utilize Windows, internet-based programs, laboratory information systems an understanding on how to compile, retrieve and manage accurate and legible records an understanding and basic knowledge of bioinformatics in a diagnostic setting an understanding of all aspects of information technology pertinent to the provision of laboratorybased genetic services practical application of word processing programs preparing and managing of patients reports on a LIS analysing of results employing basic bioinformatics presentation at journal club and seminars Section 5 Assignments Section 6 - Assessment Understand basic statistics appropriate to the discipline (eg. analysis of research data or output to establish statistical significance) an understanding of the value of biostatistics in research and practice an understanding of statistical sampling participation in a statistical module Section 3 - Acitivities Continual Assessment and Evaluation Page 8 of 16

9 Formal assessments and evaluations should be conducted on a regular basis and will consist of: Direct observation of practice on an ongoing basis Vertical assessment on a regular basis and before deemed competent in a method/technique Formal assessment (at least once every 6 months) Formal report after each rotation round as appropriate Evaluation of or logbook: each intern will be required to keep a detailed record of training activities including seminars, journal clubs, tutorials, lectures attended and clinical/diagnostic competencies attained. 2. DISCIPLINE SPECIFIC ELEMENTS OF TRAINING PROGRAMME The discipline has various sub-disciplines, which include molecular genetics, molecular-cytogenetics (including fluorescent in situ hybridization (FISH)) and cytogenetics. Core knowledge of all fields is required, while competency (technical abilities and skills) has to be obtained in a sub-set of relevant technologies. 2A. Core scientific/medical knowledge Understand the scientific principles of the techniques and methods employed in clinical cytogenetics and molecular genetics Familiarity with sources of the most recent information on genetic disorders, DNA markers, mutations, cytogenetic abnormalities and recurrence risks Familiarity with new trends and developments and to be able to apply them as appropriate Critical appraisal, validation and implementation of new techniques in a diagnostic setting Ability to integrate diagnostic results and relevant information into an interpretation (translational research) Understand the effectiveness, limitations and scope of relevant diagnostic procedures Ability to advise on suitability of samples for genetic testing a sound understanding of the principles of the diagnostic methods employed in clinical cytogenetics and molecular genetics a critical understanding of the integration of genetic results with other relevant diagnostic findings a sound understanding and critical thinking in the application of technology in a clinical diagnosis Page 9 of 16

10 learning and gaining knowledge through appropriate textbooks and journals seminars and structured or semi-structured courses Section 4 - Scientific knowledge 2B. Technical skills Understand the principles, associated-problems, relevancy, limitations and benefits of applicable diagnostic procedures Understand the required standards and guidelines for these procedures Experience of performing and trouble-shooting these techniques Understand the principles of quality control and quality assurance in a diagnostic setting Experience in interpretation and monitoring of quality control and assurance procedures Ability to produce accurate and reproducible results 2C. Interpretive skills an ability to perform commonly used procedures an ability to critically evaluate and review results participation in methods through standard operating procedures supervised practical experience Section 4 - Scientific knowledge Ability to analyse and interpret or translate results to aid a clinical diagnosis Ability to standardise or develop new strategies to fulfil the needs as required in a clinical diagnosis Understand the contribution of genetic results in the clinical management of patients Basic knowledge to communicate results effectively to other health professionals an understanding of the clinical relevance of genetic results in a clinical diagnosis an understanding of pathology of genetic disease the ability to analyse data to write an accurate Page 10 of 16

11 diagnostic report participation in training program participation in case reports and academic meetings participation in compiling patient reports Section 4 - Scientific knowledge 2D. Research project The intern is required to undertake a small research project. This can take the form a semi independent mini-project (R&D related) or in some cases may be the attainment of an additional degree. The intern should acquire training in the preparation of a peer-reviewed project protocol (proposal assessed by a peer not directly involved with the project), the preparation of an application for ethics approval and the submission of a research grant. If this is not appropriate, they should receive exposure to the processes and this should be documented. The intern should understand how to manage a research project and effectively communicate outcomes to colleagues and peers. It is recommended that the intern deliver a seminar on their research project. A higher degree is not required for the successful completion of internship, but may be used towards the research component of the internship. The project should be written up in the style of a short paper and receive formal assessment by an independent assessor. In the case of a higher degree, the intern may submit the protocol and a short report if the degree has not been completed, or proof of attainment of the degree with the title and abstract in the case of a completed degree. Ability to search and critical appraise relevant literature Ability to identify scientific needs or questions, formulate a hypothesis and design appropriate methodology to resolve problems Ability to develop the aims and objectives of research projects Ability to critically appraise the results in the light of existing knowledge Ability to develop or modify techniques or experimental protocols and generate results Knowledge of the requirements for performing a research project an understanding of the current state of research in the specific field (formulate a research question) a basic ability to design, perform and interpret the test method an understanding of the ethical issues surrounding research in a clinical setting application for funding of a project application for ethical approval Page 11 of 16

12 presenting or publication of the outcomes of the projects attendance of relevant training courses (research methodology) peer-reviewed assessment of project Section 6 Assessment by an independent person not directly involved with the research (documented) Section 7 - Research experience 2E. Critical thinking Ability to assess a situation and determine the nature and severity of a problem presented for laboratory testing Experience and knowledge to act accordingly (trouble-shoot) and resolve the issue Ability to seek and establish relationships between independent pieces of information sources and related knowledge Ability to utilize knowledge pertinent to the discipline Knowledge of measures of uncertainty or factors that may influence final results Knowledge of your own limitations and an understanding of when to escalate challenges to more experienced staff an ability to critically appraise clinical information and implement appropriate steps supervised experience of problem solving in the laboratory participation in departmental meetings Section 4 Scientific knowledge Section 5 Assignments 3. PORTFOLIO GUIDELINES The is the product which will demonstrate that the above elements of training have been completed and competence has been achieved. The will be submitted to the HPCSA for Board approved assessment of competence at a national level prior to registration as a medical scientist. Page 12 of 16

13 The will include 8 sections as outlined below. Each must have a table of contents to enable the assessor to easily find relevant information. Section 1: Summary Page Suggested Content (Amend as Appropriate) Activities (Section 3) Scientific knowledge (Section 4) Assignments (Section 5) Assessments (Section 6) Research experience (Section 7) Section 2: Intern Program Summary of activities recorded in logbook (each activity does not have to be submitted, but has to be documented) Journal club Seminars Conferences/workshops attended Patient/case discussions Case studies/scenarios Tests and examinations Presentations Literature reviews/essays Coursework Lectures Trainer assessments Supervisor assessment Performance reports Project proposal or post-graduate protocol Official/applied research methodology courses Approved ethics application (where applicable) Write up or preliminary results and interpretations Examiner s report Publications Presentations at a national or international conference The intern should include a copy of the approved training program. Section 3: Description of Activities (can be listed) Pages The type and number of activities that are needed to efficiently perform the techniques or to attain competency should be determined by the training team at the commencement of training. A list of actions or descriptions of specific activities with reference to standard operative procedures (SOPs) should be part of the. It is not necessary to submit all SOPs, but they should be Page 13 of 16

14 available on request. Every intern should keep a log book of activities (this could be in the form of a laboratory book) including the date when the activity was performed together with a description of the activity and signature/comment by the trainer. The log book does not need to be included with the, but reference to its content should be documented and it should be available on request. The coordinator of the accredited training programme should review the log book with the intern and trainer at regular intervals to discuss difficulties and possible amendments or corrective actions. Section 4: Scientific/medical knowledge Attendance at lectures, seminars, conferences and participation in workshops/ training /methodology courses should be listed. Documented proof of attendance should be retained and be available for review. Section 5: Assignments Subject specific assignments such as case studies, open book and formal tests, presentations, literature reviews, essays and course work should be categorized, marked by the trainer and signed by the supervisor as moderator of the assignments (or an appointed in-house moderator). Section 6: Ongoing Assessments Self-assessments together with the supervisor s appraisals should be performed at specific intervals. Remarks regarding observations, suggestions, amendments, progress according to the time-schedule should form part of the performance report. Section 7: Research experience A peer-reviewed project proposal, i.e. mini-projects and/or formal post-graduate protocol, together with approved ethics (if appropriate) and academic body application for the project, progress or examiners reports could form part of the research. Possible publications (i.e. peer-reviewed article and/or abstract submissions for an oral or poster presentations at national/international conferences), awards obtained for the research, and official/applied research methodology courses completed should be noted. Section 8: Final assessment by training facility including a list of competencies achieved This section will include the final assessment by the training facility and will also summarise the competencies achieved by the intern. The assessment may take the form of an exit interview where the is checked, the intern is asked a number of critical questions to ensure that they are competent in their filed and the process of registration and subsequent CPD compliance are explained to them. The assessment process should include at least one person who has not been directly involved in the training. To align with the dates for the submission of the, the exit assessment may take place up to 6 months prior to Page 14 of 16

15 completion of the internship. Should the process occur prior to completion of the 24 month internship, it should be stated when the completion date is and what will be achieved during the remaining time. The assessment process and conclusions should be summarised in a letter signed by the assessors, dated and included in the. 4. GUIDELINES FOR A SHORTENED INTERNSHIP FOLLOWING ATTAINMENT OF AN MSC OR PHD DEGREE The internship may, at the discretion and recommendation of the Committee, be shortened to a period of not less than 6 months. The purpose is mainly for scientists to enter the field of medical science following the attainment of an MSc or PhD degree and some experience in research in an appropriate discipline. This process can happen at any time of a person s career, but since the individual will be aiming to practice under the scope of medical science, they will require a period of orientation to a clinical environment and the attainment of skills for the discipline in which they plan to register and practice. An abbreviated will be assessed as above. The should include a detailed CV of the applicant and should address how competency has been attained in each of the generic and discipline specific components of competence. These could take the form of brief descriptions and documented evidence of discussions with trainers/supervisors where competence is assessed. The research experience can include the MSc/PhD details (including thesis abstract) and the degree certificate. This would serve as adequate proof of competence in research. A should be submitted to the HPCSA for assessment at the end of the training period. 5. GUIDELINES FOR MIGRATING INTO THE DISCIPLINE FROM A RELATED DISCIPLINE A person is only permitted to register in a maximum of two related disciplines with the HPCSA at any one time. Migration will only be permitted between related disciplines and will need to be justified when application is made. Additional motivation will be required from the prospective employer as to why a specific scientist has the appropriate skills and knowledge to work in the related discipline. Once a person has been registered as a medical scientist in any discipline, generic competence and research competence will have been assessed and only proof of retraining in the discipline specific elements of the Page 15 of 16

16 discipline to which the person is migrating needs to be demonstrated. Written submission should be made to the HPCSA with documented proof of competence in the discipline specific elements of the new discipline, including: core scientific/medical knowledge, technical skills, interpretive skills and critical thinking. Disciplines related to Genetics include: Molecular Biology Haematology Clinical Biochemistry Immunology Microbiology Virology Migration from related disciplines may only take place after peer-review assessment of the. Applicants have to demonstrate applicable scientific knowledge and an understanding of the clinical setting of human genetics as a discipline. Page 16 of 16

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