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IBMS Professional Qualifications | www.ibms.org/education-development Specialist Diploma Reference Portfolio Institute of Biomedical Science

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Page 1: Specialist Diploma Reference Portfolio · The portfolio enables individuals to provide evidence of training, practical skills, specialist knowledge and competency gained in the two

IBMS Professional Qualifications | www.ibms.org/education-development

Specialist Diploma Reference Portfolio

Institute of Biomedical Science

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3rd Edition (September 2011)

Personal Details

Name:

Degree Qualification(s):

Awarding Institution(s):

Date(s) Obtained:

IBMS Membership Number:

IBMS Membership Grade:

HPC Registration Number:

Date of HPC Registration:

Employment Address:

Telephone Number:

Date Specialist Training Commenced:

Name of Training Officer:

Confirmation of Completed Training

Date Training Completed Training Officer‟s Signature Candidate‟s Signature

Recommendation for Award of Specialist Diploma

Date of External Assessment

External Assessor‟s Signature

External Assessor‟s Name

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Training Review

Reviewed by Date Comments

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CONTENTS

1. INTRODUCTION .......................................................................................................... 7

2. CRITERIA FOR USE OF PORTFOLIO ...................................................................... 13

3. LABORATORY BASED TRAINING ............................................................................ 17

4. EXTERNAL ASSESSMENT PROCEDURE ............................................................... 21

5. FREQUENTLY ASKED QUESTIONS ........................................................................ 27

6. GLOSSARY ................................................................................................................ 33

7. DISCIPLINE SPECIFIC .............................................................................................. 37

7.1 Standard Laboratory Tests .................................................................................. 38

7.1a Immunoassays .............................................................................................. 38

7.1b Agglutination Assays .................................................................................... 40

7.1c Molecular Techniques ................................................................................... 42

7.1d Detection of Viruses (other than by molecular methods) .............................. 46

7.1e Other Serological Assays ............................................................................. 50

7.2 Respiratory Virus Infections ................................................................................. 56

7.2a Diagnostic Algorithm ..................................................................................... 56

7.3 Enteric Virus Infections ........................................................................................ 62

7.3a Diagnostic Algorithm ..................................................................................... 62

7.4 Sexually Transmitted Diseases ............................................................................ 68

7.4a Diagnostic Algorithm ..................................................................................... 68

7.5 Infections in Pregnancy (Pre- and Post- Delivery) ............................................... 74

7.5a Diagnostic Algorithm ..................................................................................... 74

7.6 Neurological Disease including Prion disease ..................................................... 80

7.6a Diagnostic Algorithm Immunoassays ............................................................ 80

7.7 Rashes and Systemic infections including Vesicular and Red Rashes ............... 86

7.7a Diagnostic Algorithm ..................................................................................... 86

7.8 Blood-borne Virus Infections ................................................................................ 92

7.8a Diagnostic Algorithm ..................................................................................... 92

7.9 Investigation of Viral Hepatitis .............................................................................. 98

7.9a Diagnostic Algorithm ..................................................................................... 98

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7.10 Infections in Neonates and Infants ..................................................................... 104

7.10a Diagnostic Algorithm ................................................................................... 104

7.11 Immunocompromised Patients .......................................................................... 110

7.11a Diagnostic Algorithm ................................................................................... 110

7.12 Travel Related and Exotic Infections ................................................................. 116

7.12a Diagnostic Algorithm ................................................................................... 116

7.13 Infection Control ................................................................................................. 122

7.13a Infection Control Procedures ...................................................................... 122

7.14 Pre and Post Exposure Prophylaxis and Vaccination ........................................ 126

7.14a Pre and Post Exposure Prophylaxis ........................................................... 126

7.14b Immunisation .............................................................................................. 128

7.15 Antiviral Treatment and Resistance ................................................................... 132

7.15a AntiViral Therapy ........................................................................................ 132

7.15b Viral Load Monitoring .................................................................................. 134

7.15c Anti Viral Resistance Testing ...................................................................... 136

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1. INTRODUCTION

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1. INTRODUCTION

The IBMS has developed the Specialist Portfolio to enable the recognition of structured, standardised post-registration training and assessment of newly registered biomedical scientists. The portfolio enables individuals to provide evidence of training, practical skills, specialist knowledge and competency gained in the two years after registration into the profession. Newly registered individuals have the opportunity to evidence their development of specialist knowledge and competencies in their chosen field by completion of the Institute‟s Specialist Portfolio. They must, as a minimum requirement, be in the IBMS membership class of Licentiate.

The training portfolio is issued on application to the Institute with the required payment, which is inclusive of the end point assessment. Applicants must be working in a laboratory with Institute post registration training approval. The portfolio is not available to Associate members of the Institute or individuals undertaking pre-registration training.

Completion of the portfolio and successful assessment will lead to the award of a discipline specific Specialist Diploma. The Specialist Diploma confers eligibility to apply to upgrade Institute membership from the class of Licentiate to Member provided the individual has a minimum of 2 years professional experience as a Licentiate member.

In order to be awarded an Institute Specialist Diploma the individual must be a fully paid up corporate member of the Institute for at least one year and have completed the Institute‟s Specialist Training Portfolio in accordance with the Institute‟s instructions.

The portfolio can be used as evidence to help biomedical scientists seeking career advancement, identifying education and training needs if returning to work or working in new disciplines, or by employers when considering eligibility for promotion. The portfolio can also be used by Higher Education Institutions in assessing work-based learning and accredited learning for postgraduate qualifications.

It is recognised that the changes in service delivery and reconfiguration of pathology services is leading to combined disciplines or variations in the scope of practice for individuals within some laboratories. Such is the potential variation that a „one size fits all‟ specialist portfolio in blood sciences is not practical.

A named discipline specific portfolio therefore reflects the range of analyses performed by most routine laboratories in the UK, although some might not be performed in the candidate‟s own laboratory. All sections must be completed in order to express the ability of the biomedical scientist to operate at the specialist level. Where a particular analysis is not performed in the candidate‟s laboratory, knowledge of the principles and practice must still be demonstrated, together with an understanding of the key skills required to perform the test. There may be other tests the training laboratory includes in its basic repertoire and therefore requires the individual to be competent in. These can be assessed and then recorded in the reflective log at the end of each sub-section.

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To support members working in routine service laboratories that reflect a more cross-discipline requirement for specialist practitioners, provision will be made, following purchase of the most appropriate discipline-specific portfolio, for modules to be substituted with one or more modules from specialist portfolios of other disciplines. The Specialist Diploma award transcript will reflect the main discipline plus altered modules. Requests from laboratory managers wishing to use the specialist portfolios to reflect the test repertoire of their laboratory will be considered upon submission of a written proposal of modules (and rationale for the request) to the Institute‟s Education Department, ahead of commencement of training.

Achievement of the required knowledge and competence of the range of analyses expresses the ability of the biomedical scientist to operate at the specialist level as defined in the learning outcomes below:

Learning Outcomes

The learning outcomes of the Specialist Diploma are subdivided into the following three areas which candidates must be able to demonstrate they have met through completion of the portfolio and subsequent assessment procedure.

Knowledge and understanding

a. Demonstrate knowledge of complex scientific and technical aspects of their specialist discipline including: correct procedures for handling specimens before, during and after analysis; maintenance of routine equipment; principles of in-house data management systems and quality control/assurance procedures as evidenced by in-house assessments and laboratory tour.

b. Show an awareness of current issues and developments within healthcare and biomedical science as evidenced by presentation and laboratory tour.

c. Demonstrate knowledge of the scientific basis of the laboratory tests and the disease process under investigation as demonstrated by in house assessments and tour.

Professional skills

a. Perform a range of laboratory tests without immediate supervision Demonstrate self-direction in solving problems and exercising personal autonomy in relation to scope of practice as demonstrated by in-house assessments.

b. Demonstrate a systematic application of professional knowledge and understanding in interpretation of laboratory data to determine action based on best practice as evidenced by in house assessments and portfolio evidence.

Transferable skills

a. Demonstrate communication skills within the healthcare environment and as part of the laboratory team as evidenced by presentation.

b. Demonstrate the ability to critically reflect in order to inform best practice as evidenced by all aspects of the portfolio.

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During completion of the portfolio, biomedical scientists will be gathering evidence of continuing professional development (CPD) and competence to practice. This meets the fundamental requirements of continuing registration with the HPC, i.e. compliance with the following areas:

Professional autonomy and accountability

Professional relationships

Identification and assessment of health and social care needs

Formulation and delivery of plans and strategies for meeting health and social care needs

Critical evaluation of the impact of, or response to, the registrant‟s actions

Knowledge, understanding and skills

Internal Assessments

Each of the standards within the discipline specific section requires the candidate to demonstrate knowledge and competence elements. It is the responsibility of the trainer(s) to ensure that these elements; a) and b) below have been met through internal assessments and filed in a single “specialist” portfolio ready for external assessment.

a. Questions set by trainer

Each standard requires the assessment of competence primarily through the answering of questions set by the trainer on the stated subject areas indicated by the knowledge and competence statements for each module. The portfolio is not prescriptive about the type of assessment which may be done via an oral tutorial, written questions or other suitable task. (Please note: Essays are NOT considered a suitable form of assessment).

b. Other evidence

Although evidence of training and assessment may be generated as part of good laboratory practice only ONE other example of evidence is required for the Evidence of Achievement section. This is chosen by the candidate as an example of evidence that demonstrates their knowledge and competence in performing a particular technique. The choice of evidence is justified in the Reflective log.

Other examples of evidence that may be acquired during the course of training can, if the candidate wishes, be filed for reference purposes in a separate portfolio as additional evidence of competence. THIS IS ENTIRELY OPTIONAL AND IS NOT A MANDATORY PART OF THE EXTERNAL ASSESSMENT PROCESS. This may include the recorded observation of practical skills, case studies or other evidence of knowledge acquired during formal study for a postgraduate award or as part of an internal training regime.

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Reference to „a range of sample types‟ can include blood, serum, plasma, urine, CSF, other fluids and tissues as appropriate to the routine investigation within the discipline, either as a main discipline (e.g. Haematology or Clinical Biochemistry) or a combination of disciplines (e.g. Blood Sciences). It also includes by inference, the knowledge and competence required to assess the suitability of the sample under investigation, for example lipaemic, inadequate, haemolysed, inappropriately labelled, transported, or stored samples within a specific sample type and for analysis using specific equipment.

How to Use This Portfolio

A summary of the criteria for using the Specialist Portfolio is contained in Section 2.

Further information regarding laboratory training is contained in Section 3.

Information about the assessment process is contained in Section 4.

Answers to frequently asked questions can be found in Section 5.

A glossary of commonly used terms is listed in Section 6.

PLEASE NOTE:

Whilst the award of a higher degree is not a prerequisite for the award of a Specialist Diploma there is the opportunity to integrate the two where possible. For example, in-service training undertaken to complete this portfolio could be recognised by higher education institutions under the category of work-based learning and accrue academic credit towards an M level qualification. Equally, the formal education and assessments undertaken as part of an MSc degree may support in-house laboratory training for completion of the portfolio.

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2. CRITERIA FOR USE OF PORTFOLIO

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2. CRITERIA FOR USE OF PORTFOLIO

2.1 Only the Institute‟s Specialist Portfolio can be used for the purpose of recording the training of a biomedical scientist for the Institute‟s award of a Specialist Diploma.

2.2 Specialist portfolio training must take place in a laboratory approved for training by the Institute.

2.3 The Specialist Portfolio will only be issued to a named Institute member upon completion of the application form by the Departmental Training Officer or Manager.

2.4 The portfolio requires specific evidence that indicates that candidates have applied knowledge, comprehension and analytical skills gained at undergraduate level to the (new) situation in which they work as a registered biomedical scientist.

2.5 The portfolio will contain a completed and signed record of laboratory training in the designated speciality, together with a reflective commentary on the learning experience and demonstration of competence.

2.6 Each module contains Knowledge and Competency statements that relate to a laboratory technique or investigative method.

2.7 Requirements for evidence of training and internal assessment of competency are set out in the Evidence of Achievement section of the portfolio.

2.8 The laboratory training officer (or a suitable deputy) and the individual undertaking training must sign and date when the training was completed.

2.9 The candidate must complete the Reflective Log to demonstrate that they can relate knowledge from several areas, draw conclusions and reflect on their own performance as an independent professional learner, thus meeting the requirements for CPD.

2.10 A signed statement must be provided by the laboratory manager, which indicates the laboratory‟s repertoire and analyses that a specialist practitioner working in that laboratory would be expected to perform without supervision.

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3. LABORATORY BASED TRAINING

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3. LABORATORY BASED TRAINING

3.1 To permit eligibility for the award of the Institute‟s Specialist Diploma in a named discipline(s), the in-service training and assessment must demonstrate sufficient good scientific practice, based on the knowledge and competence in the stated procedures, to meet the requirements of the external assessment process.

3.2 Suitable training can be obtained only by working in a laboratory approved by the Institute. Several trainers may be involved and it is essential that all training is co-ordinated and carried out under the control of a designated training co-ordinator or training officer.

3.3 A training programme should be prepared and adhered to in accordance with the Institute‟s Clinical Laboratory Standards for Pre and Post Registration Training of Biomedical Scientists.

3.4 The training co-ordinator/officer should ensure that regular reports on progress from trainers are reviewed at least once a month, discussed with the individual being trained, and documented in the portfolio. The object of these review pages is to ensure that a constructive, detailed, and contemporaneous record is kept, on which future training activities can be based.

3.5 Competence must be achieved by coverage of all modules within the chosen disciplines. Some tests may be considered as „core‟ and require demonstration of practical competence. If an investigation were considered to be outside the core repertoire of a routine laboratory, the tests only requires demonstration of knowledge and understanding that would be applied to the practical situation.

3.6 Short periods of secondment to other Institute approved laboratories may supplement training in order for the individual to gain additional practical skills and experience.

3.7 Candidates and trainers may undertake a selection of the following activities to complete training and assess the application of knowledge and skills, i.e. the assessment of competence.

i) Work-based training with direct observation of practical skills (DOPS);

ii) Case based discussion to demonstrate knowledge of „output‟ of work;

iii) Self-directed reading to broaden knowledge;

iv) Tutorials and scientific discussion to explore extent of knowledge;

v) Reflective practice to self-assess knowledge and skills;

vi) Question and answers sessions with trainer to test knowledge.

3.8 Evidence from all of the examples above is not required. The ONLY evidence required for the external assessment process is based on direct observation of skills and questions set by the trainer to assess working knowledge and the selected piece of work related to the knowledge and competency statements of each module as indicated in the Evidence of Achievement section of the portfolio.

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4. EXTERNAL ASSESSMENT PROCEDURE

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4. EXTERNAL ASSESSMENT PROCEDURE

4.1 On completion of training in accordance with the requirements of the Specialist Portfolio, the candidate‟s employer (laboratory manager or training officer) should apply to the Institute for the appointment of a visiting external assessor. The appointed external assessor will be instructed to contact the laboratory to arrange a mutually acceptable date and time for the assessment visit. Documentation guiding the assessment visit will be sent by the Institute to both the assessor and the training laboratory.

4.2 The aims of the assessment procedure are to:

Independently verify that competence has been met (portfolio) and assess the standard of the candidate for suitability for the award of a Specialist Diploma (presentation and laboratory tour);

Ensure consistency between disciplines and between laboratories;

Check that professional body guidelines and criteria are applied nationally;

Reassure the employer that their training is to the appropriate standard;

Disseminate areas of good practice;

Provide constructive feedback on areas of unsatisfactory practice.

4.3 Role of the External Assessor appointed by the Institute

The external assessor for Specialist Portfolios undertakes the dual role of verifier and assessor/examiner. This individual reviews the portfolio to verify appropriate training has been given and completed, and then assesses the candidate through their oral presentation and during the laboratory tour to determine their suitability for the award of the Specialist Diploma.

It is not the role of the external assessor to assess the competence of the candidate. This is the responsibility of the trainer, the evidence of which is exemplified in the portfolio. The Institute‟s role is to verify this has taken place (by checking the portfolio for evidence of training and assessment of competence) and also assess the ability of the candidate to demonstrate an understanding of the scientific basis for tests, quality control, quality assurance, quality management, health and safety and use of equipment commensurate with the learning outcomes in the portfolio. The Institute‟s representative will also make an assessment on whether or not the laboratory is complying with IBMS standards for approval of the laboratory for training.

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4.4 The following process enables the Institute to award a Specialist Diploma to individuals that meet the criteria and also award a certificate to show “Approved Training Laboratory” status.

Stage 1: Presentation (Indicative time 15-20 mins)

The presentation is to ensure that candidates can demonstrate an understanding of their scope of practice and role in the laboratory. The presentation must be in PowerPoint format. If projection facilities are not available it can be viewed on a computer screen. It is expected that the 15-20 minute presentation will contain the following elements:

An indication of the candidate‟s scope of practice and how it has developed since registration based on the reflective practice elements of the portfolio;

Current developments in the laboratory or recent trends;

Special interests or professional activities of the individual.

Presentations need not be overcomplicated, should be structured to reflect the areas in which experience has been gained and act as a prompt for the dialogue, which supports the work done in the specialist portfolio.

The candidate‟s presentation skills are not being tested so notes are acceptable but not encouraged. They should only be used to support the PowerPoint presentation slides.

The external assessor may wish to ask some questions related to the presentation or seek points of clarification.

Stage 2: Portfolio Assessment (Indicative time 60 mins)

Assessors should aim to review the portfolio in one hour, which is sufficient to look at evidence contained in a single lever arch file. More evidence than this is deemed as excessive although assessors should not use this as a sole reason to fail to the candidate. It is acceptable for the external assessor to check with the laboratory before the visit that evidence is limited to one file, and if not, request that it is.

There should be a signed statement from the laboratory manager testifying to the range of laboratory investigations undertaken by the candidate. (see Section 2: Use of the Portfolio, paragraph 2.5). This can be used by the external assessor to guide the areas for questioning during the laboratory tour. It is acceptable for external assessors to request this prior to the visit when they finalise arrangements with the laboratory.

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Evidence in the portfolio is prescribed in the EVIDENCE OF ACHIEVEMENT section and this is the ONLY evidence that is required. Evidence should be indexed in the same order as the Specialist Portfolio modules. Additional (optional) supporting evidence of training may be provided in a separate portfolio and referred to if required.

The Evidence of Achievement section has three standard requirements:

observed by trainer to carry out a specific function/investigation (signature as evidence);

answered questions set by trainer (single piece of evidence to demonstrate this);

single piece of evidence chosen by candidate (not the trainer) to reflect an aspect of the training.

The signed assessment of practice does not require a separate witness statement (unlike the Registration Portfolio).

“Questions asked by the trainer” are informed by the knowledge component and competence requirements of each module. Evidence should support the fact that candidates understand their role and are competent to perform the work, either through questions they have been asked, set (and marked) questions or notes from tutorials. Evidence must be dated and signed by the candidate/training officer as appropriate.

The third piece of evidence is selected by the candidate and chosen to demonstrate an aspect of the training and competency assessment. This choice is briefly justified in the Reflective Log, (e.g. as my third piece of evidence I chose to annotate a laboratory printout of results from a test I performed because…).

Following the EVIDENCE OF ACHIEVEMENT section the Institute‟s portfolios must be signed by the internal person who has checked that the requirements for evidence for the module have been completed.

The reflective logs are intended to demonstrate that the candidate has developed in the application of their practice and can apply what they have learned in the context of the module. The external assessor will review these reflective reports which should be supported by the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

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Stage 3: Laboratory Tour (Maximum 60 mins)

The tour should not exceed 60 mins which is considered to be sufficient time to examine the candidate‟s knowledge, even in a large department. The candidate should be able to respond to questions asked by the external assessor based on the knowledge components of the portfolio and their scope of practice. The candidate should be able to demonstrate they have knowledge of the underlying principles and practice of laboratory investigations they have performed and the equipment they use. If the candidate is involved in training it is reasonable to expect them to explain how they do this. They should be able to explain NEQAS results, and demonstrate that they know how to apply health and safety. In doing so they demonstrate (in conjunction with their presentation and portfolio of evidence) that they meet the learning outcomes detailed in the introductory section of the portfolio.

Stage 4: Approval of laboratory for Specialist Training

The Institute has published guidance and criteria for approval of laboratories for pre and post registration training. Based on these criteria the laboratory tour also gives the external assessor an opportunity to judge that the laboratory has the appropriate requirements for training against the following checklist. This is provided as separate documentation and is available on the Institute‟s website.

Stage 5: Feedback Comments to Trainer and Candidates.

At the end of the assessment process the external assessor informs the candidate and training officer whether they will be making a recommendation (in their report to the IBMS) that the candidate was successful or unsuccessful, and whether or not a recommendation will be made regarding continued approval of the laboratory for training. This also provides an opportunity to seek further clarification on points of evidence if required.

Feedback should be concise, constructive and based on the Institute‟s guidance for assessors, trainers and candidates in relation to specialist portfolio training and completion. Personal opinions or advice may be offered in the context of examples of good practice, but it should be clear they are NOT a specific requirement of the Institute.

Stage 6: Completion of Reports

Both the external assessor and the laboratory trainer are required to submit reports to the Institute and send a copy to each other. This provides an opportunity to share the feedback, and reflect on this.

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5. FREQUENTLY ASKED QUESTIONS

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5. FREQUENTLY ASKED QUESTIONS

Eligibility

I am not a member of the Institute. Can I complete the specialist portfolio?

No. A candidate must have current corporate membership of the Institute of Biomedical Science. Corporate classes are Licentiate, Member, or Fellow. Associate members are not eligible.

Why do I need to complete the specialist portfolio?

Holding a Specialist Diploma is part of the criteria for upgrading your class of Institute membership from Licentiate to Member. It also demonstrates that you have been assessed against a benchmark standard for a specialist practitioner in your chosen discipline. It is therefore different from the registration portfolio required for HPC registration which is used to evidence that an individual has met a threshold standard of fitness to practise which is profession-specific, rather than based solely on a single discipline.

The charge by the Institute for the specialist portfolio is £125. Who should pay?

This is a local decision. Both the employer and individual benefit from the opportunity provided by the professional body to facilitate, evidence, and formally recognise the acquisition of specialist skills and knowledge. The charge is a nominal one-off amount towards providing this service to Institute members, and will also cover external assessor expenses for the endpoint assessment.

When can my portfolio be assessed?

You are required to be a corporate member of the Institute for a minimum of one year before a specialist portfolio can be externally assessed by the Institute.

How long will it take for a date to be set for my assessment?

This is dependent on the availability of an external assessor. It could be up to two months from receipt of your application form. Please apply well in advance of your preferred date in order for the Institute to organise an external assessor.

Portfolio Organisation and Evidence

When I completed the registration portfolio I was required to have one file of evidence. Must I approach the specialist portfolio in a similar way? Does it involve as much work or do I simply fill in the portfolio?

The principles applied to the registration portfolio also apply to the specialist portfolio. Evidence required for both should not exceed one lever-arch file. Much information has been published in The Biomedical Scientist and in sections of this portfolio.

Can you provide advice on how to present, organise and complete the specialist portfolio?

There should be an index and the evidence should be organised to match the sections of the portfolio.

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What evidence do I need?

The type of evidence is indicated by the Evidence of Achievement section, and this is the ONLY evidence required. It must of course be relevant to the knowledge and competence statements.

In order to sign off some of the sections it says "answered questions set by trainer..." (on a particular subject). Does this mean that there is no point getting other evidence for this, and that the only evidence required are some questions I have answered? Also I have several pieces of evidence for some sections but haven't yet been given any questions to answer from my trainer, so I’m guessing this section cannot be signed off until I’ve done them?

The requirements for the evidence of achievement sections are clearly stated. All of them have "questions set by trainer". It is essential that your trainer conducts an assessment exercise that tests your knowledge as applied to the particular techniques - this is the purpose of the "questions asked by trainer". Once completed and you have evidence of this the trainer can sign off this part of the portfolio.

Can I use evidence from a laboratory I worked in before I started my SP? I used to work in a reference lab and have copies of published papers with my name on which cover techniques in the SP but not done in my current laboratory. Obviously my trainer couldn't sign to say they'd witnessed my practical skills, but would that be ok to cover the principles?

The requirements for the evidence of achievement sections are clearly stated and do not include copies of published papers. (You could put these in your professional portfolio).

Who signs?

The Evidence of Achievement section requires the trainers name and signature, and therefore should be signed by the person who assesses competence at the end of the relevant training. Underneath is an area in which to confirm the section has been completed and the evidence assessed and checked internally (e.g. by the training officer). In some instances this will be the same person.

Is the person who signs the person who actually trained you in that technique, or does it have to be the training officer? Is it okay for a BMS1 to sign (if they did the training) or does it have to be a more senior person? I have a very "reluctant" training officer!

Someone in the laboratory who has assessed your competence should provide the signature for the portfolio. As long as they are competent to train and assess you, the grade of staff should not be an issue. However, the training officer (or someone senior) should take responsibility for assessing the evidence is appropriate for each section and sign the section underneath the Evidence of Achievement section.

You may wish to discuss these points with your trainer and perhaps with them also review the guidance on the IBMS website. It may also be helpful to clarify the role of your training officer with your line manager if they are "reluctant" as this may affect the training status of the laboratory if there is inappropriate support for training.

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How do I complete the Reflective Logs at the end of each section?

The aim of this part of the portfolio is to encourage you to think about your experience and how you can apply your skills in other areas. Try to capture what the laboratory does in relation to the topic, what you have learned, and how you apply this in the context of patient diagnosis. Future learning is identified by how you wish to build on this experience. It is very much an expression of your personal experience.

Training and Standards

I have been working as a trainee biomedical scientist, then as a BMS1 for almost two years in a specialist laboratory (four years in total), but only applied for my specialist diploma book after changing my job and starting an MSc. Should the date of my specialist training be when I became registered with the Health Professions Council (HPC) or when I received my book?

It is normal for a newly registered practitioner to commence a period of specialist training in order to consolidate and extend their skills and knowledge in their specialist discipline. Therefore you may have accumulated evidence suitable for your portfolio in advance of receiving it.

Can I use anything I sent for assessment for my MSc, as I completed this while HPC-registered for the past two years?

It may support you training but evidence should be specific to your training and assessment in the laboratory.

Do I need to complete all sections of the portfolio?

Yes. However, not all sections require evidence of practical competence (it may state „Be able to describe...'). Similarly, some skills may be transferable such that, together with knowledge, competence in some techniques may be considered to be achievable, even if the laboratory does not perform the method routinely.

How long does training take?

Although training can be expected to take up to two years after registration, it may be possible to complete the portfolio in less time if an individual has previous relevant experience to build upon for their specialist training (e.g. experienced gained in a single discipline while on a 12-month university placement).

As a training officer I have just received a specialist portfolio for a member of staff. How best should I proceed?

There can be no substitute for careful reading of the introductory sections of the portfolios, relevant articles in The Biomedical Scientist and the Education and Careers/Specialist Portfolios section of the IBMS website. You may also wish to contact training officers in other departments to share ideas and good practice so that you fully understand what is required. It is important that you develop a training programme. This can be based on the old 'logbook', but should, of course, be geared to the specialist portfolio. The crux of the qualification is the ability of the individual to articulate knowledge relevant to their specialist practice (e.g. training junior staff).

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The portfolio says: "Answered questions set by the trainer". What questions do I set?

Questions must relate to the knowledge and competence sections and are informed by your own professional „working‟ knowledge of the principles and application of the techniques. The level of knowledge should reflect that required of a specialist practitioner (see Learning Outcomes in the introductory section). Questions may be verbal during a tutorial session (if so, keep a record of them), written short questions and answers or multiple-choice exercises. The format is at the discretion of the individual trainer and will depend on local circumstances.

Are there any courses available to support completion of the specialist portfolio?

No specific courses are run by the IBMS, although you may wish to contact your local IBMS branch or university to see if anything is available or can be arranged. Some universities have developed MSc courses with work-based modules linked to the specialist portfolio.

Do I need to complete my training in one laboratory?

No. There is no requirement to complete in one laboratory and in some cases it may be desirable to have a secondment to another laboratory for some modules. However, the laboratory must be approved by the Institute for training.

Specialist Practitioner Status

Do I need the specialist diploma to advance my career?

Although the Institute's qualifications are not mandatory for professional advancement, they do provide a mechanism by which the employer can measure someone's competence to practise at a higher level.

When can I do on-call?

When your employer (and yourself) believes you are competent. Ability to do on-call is defined by the employer and depends on the scope of practice required to perform an out-of-hours laboratory service competently to the required standard. As with the registration portfolio, the specialist diploma in not linked explicitly to on-call (although it might link to certain elements).

I am changing disciplines. Do I need to undertake a second specialist portfolio?

Not necessarily. There is no requirement to complete a second specialist portfolio; however, there is a requirement under HPC regulation to be competent in one‟s scope of practice, and the specialist portfolio is one way you can gain this competence and evidence it. This could also be guided by the requirements of the knowledge and skills framework (KSF).

I work in a Blood Sciences department. Which Specialist Portfolio should I apply for?

Your laboratory manager must apply on your behalf for the most appropriate discipline-specific portfolio that represents the bulk of your scope of practice (i.e. test repertoire). Modules can be substituted with one or more modules from specialist portfolios of other disciplines. The Specialist Diploma award transcript will reflect the main discipline plus altered modules.

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6. GLOSSARY

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6. GLOSSARY

The following terminology is used throughout the portfolio.

BE AWARE OF A general appreciation of the content of the key task.

KNOW A working knowledge (can describe) of the facts associated with the key task.

UNDERSTAND Thorough comprehension (can explain) of the principles and concepts of the content of the key task.

COMPETENT

Has the ability to perform a test, procedure or area of practice to a set standard on more than one occasion, in a consistent manner and with minimal or no supervision, together with a thorough comprehension of the principles and concepts of the content of the key task.

EVIDENCE OF ACHIEVEMENT

The Institute‟s Specialist Diploma will only be awarded if there is supporting evidence (as indicated in the portfolio‟s Evidence of Achievement section) that competence has been achieved. This evidence will be presented as a portfolio, logically and cross-referenced to the relevant module or sections it supports.

Suggested examples of evidence:

Audit trail results

Annotated photomicrographs

Annotated copies of QC/EQA records

Tutorial notes for question and answer sessions

PowerPoint presentations by the candidate

Training records

Witness testimonies

Assessment logs (must clearly indicated level of knowledge and skill achieved)

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CPA Clinical Pathology Accreditation

HPC Health Professions Council

SOP Standard Operating Procedure.

SoP Health Professions Council Standards of Proficiency.

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7. DISCIPLINE SPECIFIC

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7. DISCIPLINE SPECIFIC

This section covers the range of tests appropriate to specialist practice in Virology and therefore reflects the range of analyses performed by most routine laboratories in the UK, although some might not be performed in the candidate‟s own laboratory.

All sections must be completed in order to express the ability of the biomedical scientist to operate at the specialist level. Where a particular analysis is not performed in the candidate‟s laboratory knowledge of the principles and practice must still be demonstrated, together with an understanding of the key skills required to perform the test.

There may be other tests the training laboratory includes in its basic repertoire and therefore requires the individual to be competent in. These can be assessed and then recorded in the reflective log at the end of each sub-section.

To support members working in routine service laboratories that reflect a more cross-discipline requirement for specialist practitioners, provision will be made for modules to be substituted with one or more modules from specialist portfolios of other disciplines, e.g. Medical Microbiology, Clinical Immunology.

The Specialist Diploma award transcript will reflect the main discipline plus altered modules. Requests from laboratory managers wishing to use the specialist portfolios to reflect the test repertoire of their laboratory will be considered upon a written submission of proposed modules (and rationale for the request) to the Institute’s Education Department ahead of commencement of the training.

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7.1 Standard Laboratory Tests

7.1a Immunoassays

Be able to perform immunoassay techniques on a range of sample types.

KNOWLEDGE

Understand the principles and practice of immunoassay techniques, including:

o Direct and indirect immunoassay;

o Competitive immunoassay;

o Capture immunoassay;

o Solid phase and liquid phase immunoassay.

o Immunochromatographic lateral flow (POCT) assay.

Understand the use and application of detection systems including:

o Enzyme;

o Enzyme amplification;

o Immunofluorescence;

o Chemiluminescence;

Be aware of factors affecting sample integrity and appropriate corrective action.

Be aware of specific risks associated with the reagents or method.

Understand the significance of abnormal results.

Know the relevant internal and external quality assurance procedures.

COMPETENCE

You must be able to:

Describe the principles of a variety of immunoassay techniques and the limitations of each.

Perform routine immunoassays in accordance with laboratory procedure.

Critically evaluate assay results.

Follow-up positive results by confirmation.

Complete all relevant documentation in accordance with quality control and audit requirements.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

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7.1b Agglutination Assays

Be able to perform agglutination assays on a range of sample types.

KNOWLEDGE

Understand the principles and practice of agglutination assays, including:

o Haemagglutination (and inhibition);

o Immune adherence haemagglutination;

o Particle agglutination.

Be aware of factors affecting sample integrity and appropriate corrective action.

Be aware of specific risks associated with the reagents or method.

Understand the significance of abnormal results.

Know the relevant internal and external quality assurance procedures.

COMPETENCE

You must be able to:

Describe the principles of a variety of agglutination assays and the limitations of each.

Perform routine agglutination techniques in accordance with laboratory procedure.

Critically evaluate assay results.

Follow-up positive results by confirmation.

Complete all relevant documentation in accordance with quality control and audit requirements.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

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7.1c Molecular Techniques

Be able to perform basic molecular techniques on a range of sample types.

KNOWLEDGE

Understand the principles and practice of molecular techniques for the following:

o Viral detection, quantitation and genotypic analysis;

o Antiviral resistance determinants;

o Epidemiological study.

Understand the principles of nucleic acid extraction.

Know the limitations of the extraction method for a range of sample types.

Understand the importance of ultra-centrifugation for concentration of nucleic acid.

Know the significance of contamination prevention in nucleic acid extraction.

Understand the principles of:

o Target amplification;

o Polymerase chain reaction (PCR), RT-PCR and kinetic PCR;

o Strand displacement assays (SDA);

o Nucleic acid sequence-based amplification (NASBA);

o Kinetic PCR;

o Transcription mediated amplification (TMA);

o Probe-Primer amplification;

o Ligase chain reaction (LCR);

o Signal amplification;

o Branched DNA (bDNA);

o Hybridisation.

Know the principles and practice of molecular techniques for detection of viral disease.

Be aware of recent developments and newly introduced technology being applied to the molecular detection and typing of viruses.

Know the relevant internal and external quality assurance procedures.

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COMPETENCE

You must be able to:

Describe the principles of molecular techniques.

Select molecular based assay for diagnosis, monitoring viral load, viral resistance testing and epidemiological surveillance.

Perform a selection of routine molecular techniques in accordance with laboratory procedure.

Critically evaluate assay results.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

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7.1d Detection of Viruses (other than by molecular methods)

Be able to perform or describe the following techniques which may be used to detect viruses or viral antigens in clinical samples.

KNOWLEDGE

Understand the principles and practice of the following techniques:

o Immunofluorescence;

o Rapid antigen detection;

o Cell culture techniques;

o Virus identification in culture;

o Electron Microscopy;

o Animal and egg culture.

To include:

o Appropriate methods for sample selection and collection;

o Factors affecting sample integrity and appropriate corrective action;

o Advantages, disadvantages and the limitations of each technique;

o Requirements for quality control and audit;

o How to follow-up positive results by confirmation.

Understand the principles and practice of cell culture including commonly used cell lines, maintenance of cell cultures and interpretation of cytopathic effects.

Understand the principles of scanning and transmission electron microscopes and how to process samples for electron microscopy.

Be aware of the limited use of eggs and animals for virus isolation and identification.

Be aware of the importance and use of animals and eggs for the production of vaccine, reagents and research.

Know the principles and limitations of rapid antigen detection techniques available for the detection of viruses in a variety of samples.

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COMPETENCE

You must be able to:

Describe the principles of antigen detection using immunofluorescent techniques.

Discuss the methods used to perform routine cell culture including asceptic technique, selection of cell lines and inoculation of samples.

Discuss interpretation of monolayer cytopathic effects and methods of confirmation of these.

State which viruses can commonly be isolated and in which cell lines.

Describe how to process specimens for electron microscopy.

Recognise the morphology of the more common viruses using the electron microscope.

Describe the traditional use of egg and animal culture techniques for virus isolation.

Perform techniques in accordance with standard laboratory procedures.

Critically evaluate and report results.

Complete all relevant documentation in accordance with quality control and audit requirements.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

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7.1e Other Serological Assays

Be able to perform or describe the following techniques which may be used to detect viral antibodies or antigens in clinical samples.

KNOWLEDGE

Understand the principles and practice of the following techniques:

o Neutralisation assays;

o Immunoblots;

o Electrophoresis and gel diffusion;

o Complement fixation tests.

To include:

o Appropriate sample selection and method of collection;

o Factors affecting sample integrity and appropriate corrective action;

o Advantages, disadvantages and the limitations of each technique;

o Requirements for quality control and audit;

o How to follow-up positive results by confirmation.

Understand the principles and practice of neutralisation assays in serology and how to interpret results.

Understand the principles and limitations of immunoblot techniques, including:

o Recombinant immunoblot assay (RIBA);

o Line immunoassay (LIA);

o Line immunoprobe assay (LIPA).

Understand the principles and practice of electrophoresis and gel diffusion assays.

Understand the principles and limitations of complement fixation tests.

Be aware of the application of functional complement in other techniques, including single radial haemolysis.

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COMPETENCE

You must be able to:

Describe the principles of neutralisation techniques in serology.

Describe the principles of immunoblot techniques.

Describe the principles of electrophoretic and gel diffusion assays.

Describe the principles and application of complement fixation techniques.

Perform a selection of the above techniques in accordance with standard laboratory procedure as appropriate to individual laboratories.

Critically evaluate assay results.

Complete all relevant documentation in accordance with quality control and audit requirements.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

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7.2 Respiratory Virus Infections

7.2a Diagnostic Algorithm

Be able to describe the viral causes of respiratory infection, and the appropriate diagnostic investigations and control of infection issues.

KNOWLEDGE

Understand the range of potential respiratory viruses which may infect the human respiratory tract e.g. influenza, respiratory syncytial virus (RSV).

Know the common causes of respiratory infection and appropriate investigations that should be used for diagnosis.

Understand the principles and limitations of techniques available for the detection of respiratory viruses in samples.

Know the less common causes of respiratory infection and when to consider using appropriate investigations for diagnosis.

Know the cyclical nature of some respiratory viral pathogens and the alert mechanisms used to establish when they should be investigated and which tests to use.

Understand other important potential non-viral respiratory infections, e.g. Mycoplasma pneumoniae, Pneumocystis jiroveci

Be aware of potential respiratory virus infections, which might be circulating worldwide.

Understand the requirements for appropriate samples from patients with potential respiratory virus infections such as naso-pharyngeal aspirate (NPA), broncho-alveolar lavages (BAL), sputum, nasal washings, nose and throat swabs, acute and convalescent serum.

Be aware of the procedures involved in the collection of the above sample types and understand the optimal time for collection of these samples.

Be aware of potential therapy, which may be available for prophylaxis and treatment of respiratory viral infections, e.g. antivirals, immunoglobulin and vaccines.

Know which patient groups are at high risk with regard to respiratory virus infections.

Be aware of infection controls issues and measures which may be taken with regard to respiratory virus infections in hospital and within the community.

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COMPETENCE

You must be able to:

Describe the causes of respiratory viral infections and relevant investigations for diagnosis.

Explain factors, which should be taken into consideration when selecting an investigation.

Describe how respiratory viral pathogens are transmitted and how patients with each of these infections would be managed and treated.

Perform techniques in accordance with standard laboratory procedures.

Critically evaluate and report results.

Complete all relevant documentation in accordance with quality control and audit requirements.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

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7.3 Enteric Virus Infections

7.3a Diagnostic Algorithm

Be able to describe the viral causes of enteric infection, and the appropriate diagnostic investigations and control of infection issues.

KNOWLEDGE

Know the range of enteric viruses which may infect humans, e.g. rotavirus, adenovirus, norovirus.

Be aware of other important non-viral causes of enteric infections.

Know the common causes of viral enteric infection and which range of investigations should be used for diagnostic testing and screening purposes.

Understand the advantages and disadvantages of the methods.

Understand the predictive value of various assays in different population groups.

Know the relevant internal and external quality assurance procedures.

Be aware of the less common causes of enteric infection and when to consider using investigations which may be used for diagnostic purposes, e.g. parasitic infections.

Understand the requirements for appropriate samples from patients with potential enteric virus infections such as faeces, rectal swabs and vomit.

Be aware of the procedures involved in the collection of the above sample types and understand the optimal time for collection of various samples.

Be aware of potential therapy which may be available for prophylaxis and treatment of enteric viral infections and rationale for use, e.g. antivirals, immunoglobulin and vaccines.

Know which patient groups are at high risk with regard to enteric virus infections.

Be aware of infection controls issues and measures which may be taken with regard to enteric virus infections in hospital and within the community. Understand the requirement for confirmatory assays and the role of reference laboratories.

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COMPETENCE

You must be able to:

Describe the causes of enteric viral infections and relevant investigations for diagnosis.

Explain factors, which should be taken into consideration when selecting an investigation.

Describe how enteric viral pathogens are transmitted and how patients with each of these infections would be managed and treated.

Perform techniques in accordance with standard laboratory procedures.

Critically evaluate and report results.

Refer specimens to a specialist centre in accordance with laboratory procedures.

Complete all relevant documentation in accordance with quality control and audit requirements.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

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7.4 Sexually Transmitted Diseases

7.4a Diagnostic Algorithm

Be able to describe viral and non-viral causes of sexually transmitted diseases, and the appropriate diagnostic investigations and control of infection issues.

KNOWLEDGE

Know the range of sexually transmitted viruses which may infect humans, including:

o Herpes simplex virus (HSV);

o Molluscum contagiosum;

o Human immunodeficiency virus (HIV).

Be aware of other important non-viral sexually transmitted infections (STIs) e.g. syphilis, chlamydia.

Know the common causes of sexually transmitted infection and the range of investigations used for diagnostic testing and screening.

Know the less common causes of sexually transmitted infection and when to consider using investigations which may be used for diagnostic purposes.

Understand the requirements for samples from patients with potential sexually transmitted infections such as genital tract and rectal swab, urine, and blood (serum and plasma) and optimal collection time.

Know the principles and limitations of immunological and other techniques available for the detection of sexually transmitted infections.

Understand the principles and limitations of molecular techniques available for diagnosis of sexually transmitted infections in a range of samples.

Understand the advantages and disadvantages of the methods.

Understand the predictive value of various assays in different population groups.

Know the relevant internal and external quality assurance procedures.

Understand the requirement for confirmatory assays and the role of reference laboratories.

Understand the sample collection techniques for the investigation of chlamydia, vesicular STIs, HSV or Molluscum contagiosum.

Understand potential therapy, which may be available for prophylaxis and treatment of sexually transmitted infections, including antivirals, immunoglobulin and vaccines.

Reference Copy

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COMPETENCE

You must be able to:

Describe the causes of sexually transmitted infections and investigations for diagnosis.

Explain factors that should be taken into consideration when selecting an investigation.

Describe how sexually transmitted viral pathogens may infect humans and how patients with these infections would be managed and treated.

Perform a range of immunological investigative techniques in accordance with standard laboratory procedures.

Critically evaluate and report results.

Refer specimens to a specialist centre in accordance with laboratory procedures.

Complete all relevant documentation in accordance with quality control and audit requirements.

KNOWLEDGE (continued)

Know which patient groups are at high risk with regard to sexually transmitted infections.

Know about infection controls issues and measures that may be taken with regard to sexually transmitted infections.

Know the potential infection risk to the foetus.

Understand the importance of screening programmes and their role in prevention of disease. Reference Copy

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

Reference Copy

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Reference Copy

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

Reference Copy

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7.5 Infections in Pregnancy (Pre- and Post- Delivery)

7.5a Diagnostic Algorithm

Be able to describe the causes of viral infection in pregnancy, the appropriate diagnostic investigations and control of infection issues.

KNOWLEDGE

Know the range of viruses that may cause infections in pregnancy, including: rubella, parvovirus, cytomegalovirus (CMV), varicella zoster virus (VZV).

Understand other important non-viral infections in pregnancy, e.g. Toxoplasma gondii.

Know the common causes of viral infections in pregnancy.

Understand techniques available for the detection of viruses, viral antigen and viral antibody in pregnancy.

Understand the advantages and disadvantages of the methods.

Know the relevant internal and external quality assurance procedures.

Know the less common causes of viral infections in pregnancy and when to consider using investigations that may be used for diagnostic purposes.

Understand the requirements for appropriate samples from patients with potential virus infections in pregnancy, such as urine, swabs, products of conception, acute and convalescent serum.

Understand the procedures involved in the collection of the above sample types and the optimal time for collection of various samples.

Understand any potential therapy that may be available for prophylaxis and treatment of viral infections in pregnancy, e.g. antivirals, immunoglobulin and vaccines.

Know which trimester patients are at highest risk with regard to specific virus infections.

Understand the implication of diagnostic test results on the counselling and management of patients from both clinical and patient viewpoints.

Know about infection controls issues and measures which may be taken with regard to virus infections in pregnancy in hospital and within the community.

Reference Copy

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COMPETENCE

You must be able to:

Describe the range of viruses that may cause infection in pregnancy and investigations for diagnosis and screening.

Explain factors that should be taken into consideration when selecting an investigation.

Describe how viral pathogens may cause infection in pregnancy and how patients with these infections would be managed and treated.

Perform techniques in accordance with standard laboratory procedures.

Critically evaluate and report results.

Refer specimens to a specialist centre in accordance with laboratory procedures.

Complete all relevant documentation in accordance with quality control and audit requirements.

Reference Copy

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

Reference Copy

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Reference Copy

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

Reference Copy

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7.6 Neurological Disease including Prion disease

7.6a Diagnostic Algorithm Immunoassays

Be able to describe the viral causes of neurological disease, and the appropriate diagnostic investigations and control of infection issues.

KNOWLEDGE

Know the main viral causes of acute and chronic neurological disease, including meningitis, encephalitis, encephalopathies and dementia and how they are transmitted.

Know the most serious non-viral causes of neurological disease.

Understand the different mechanisms by which viruses affect the central nervous system (CNS).

Know the difference between encephalitis and meningitis.

Understand the principles for investigating possible viral causes for encephalitis and meningitis including:

o Rabies and Lyssavirus;

o Herpes simplex and other herpes viruses;

o Poliovirus;

o Other enteroviruses, mumps and measles.

Know which laboratory tests to perform to diagnose viral neurological disease.

Understand the advantages and disadvantages of serological and molecular methods.

Understand the requirement for confirmatory assays and the role of reference laboratories.

Understand the predictive value of various assays in different population groups.

Know the relevant internal and external quality assurance procedures.

Know which tests other pathology departments must perform on a sample of cerebrospinal fluid.

Know appropriate management and effective treatment for viral causes of neurological disease.

Know which viral causes of neurological disease can be diagnosed serologically.

Understand the significance of paired sera in diagnosis of neurological disease.

Know the principles and limitations of immunological techniques available for the detection of neurological viral infections in samples.

Reference Copy

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COMPETENCE

You must be able to:

Describe the causes of viral neurological disease and investigations for diagnosis.

Explain factors that should be taken into consideration when selecting an investigation.

Describe how neurological disease viral pathogens may infect humans and how patients with these infections would be managed and treated.

Describe which results chemistry tests can provide and their significance to a possible viral diagnosis.

Perform relevant techniques in accordance with standard laboratory procedures.

Critically evaluate and report results.

Refer specimens to a specialist centre in accordance with laboratory procedures.

Complete all relevant documentation in accordance with quality control and audit requirements.

Reference Copy

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82

EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

Reference Copy

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Reference Copy

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

Reference Copy

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7.7 Rashes and Systemic infections including Vesicular and Red Rashes

7.7a Diagnostic Algorithm

Understand the viral causes of vesicular, red rash and systemic infections, and the appropriate diagnostic investigations and control of infection issues.

KNOWLEDGE

Know the common viral causes of vesicular and red rashes (including varicella zoster virus, rubella, human herpes virus 6) and which panels of tests should be used for diagnostic testing.

Know which of the common viral causes of vesicular and red rashes may cause systemic infections and when additional diagnostic tests should be used.

Be aware of less common viral causes of vesicular and red rashes and when to consider using which test.

Be aware of less common viral causes of vesicular and red rashes which may cause systemic infections and when extra diagnostic tests should be used.

Know the cyclical nature of viral pathogens that cause vesicular and red rashes and the alert mechanisms used to establish when they should be investigated for and which tests to use.

Know the common and less common non-viral causes of vesicular and red rashes, and which may cause systemic infections.

Understand the requirements and procedures involved for collecting samples from patients with potential viral rash and systemic infections such as vesicle fluid, skin scrapings, nose and throat swabs, acute and convalescent serum.

Know the control of infection measures required to prevent laboratory, hospital and community-acquired infection from patients with a vesicular or red rash.

Know the first line treatment considerations used for patients with a vesicular or red rash, or patients with a systemic viral infection preceded by a vesicular or red rash.

Know the principles and limitations of diagnostic techniques available for the detection of viruses and antibodies from patients with rashes or systemic infections.

Understand the advantages and disadvantages of the methods.

Understand the predictive value of various assays in different population groups.

Know the relevant internal and external quality assurance procedures.

Understand the requirement for confirmatory assays and the role of reference laboratories.

Reference Copy

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COMPETENCE

You must be able to:

Describe the causes of vesicular, red rash and systemic infections and investigations for diagnosis.

Explain factors that should be taken into consideration when selecting an investigation.

Describe how vesicular, red rash and systemic infections may infect humans and how patients with these infections would be managed and treated.

Perform relevant techniques in accordance with standard laboratory procedures.

Critically evaluate and report results.

Refer specimens to a specialist centre in accordance with laboratory procedures.

Complete all relevant documentation in accordance with quality control and audit requirements.

Reference Copy

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88

EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

Reference Copy

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Reference Copy

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

Reference Copy

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7.8 Blood-borne Virus Infections

7.8a Diagnostic Algorithm

Be able to describe the viral causes of blood-borne virus infections, and the appropriate diagnostic investigations and control of infection issues.

KNOWLEDGE

Understand the range of blood-borne viruses which may infect humans, e.g. human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV).

Understand other important non-viral blood-borne infections, e.g. malaria.

Know the common causes of blood-borne virus infection.

Know which range of investigations should be used for diagnostic testing and screening purposes.

Understand the advantages and disadvantages of the methods.

Understand the requirement for confirmatory assays and the role of reference laboratories.

Understand the predictive value of various assays in different population groups.

Know the relevant internal and external quality assurance procedures.

Know the less common causes of blood-borne virus infection and when to consider using investigations that may be used for diagnostic purposes.

Understand any potential therapy which may be available for prophylaxis and treatment of blood-borne viral infections, e.g. antivirals, immunoglobulin and vaccines.

Know which patient groups are at high risk with regard to blood-borne virus infections.

Know the potential routes of infection by blood-borne viruses that are caused by human intervention.

Know the procedures that are put in place to prevent human to human transmission.

Know about infection controls issues and measures which may be taken with regard to blood-borne virus infections in hospital and within the community.

Reference Copy

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COMPETENCE

You must be able to:

Describe the causes of blood borne virus infections and investigations for diagnosis.

Explain factors that should be taken into consideration when selecting an investigation.

Describe how blood borne viral pathogens may infect humans and how patients with these infections would be managed and treated.

Describe the routes of transmission of blood borne viruses that may be caused by human intervention.

Perform relevant techniques in accordance with standard laboratory procedures.

Critically evaluate and report results.

Refer specimens to a specialist centre in accordance with laboratory procedures.

Complete all relevant documentation in accordance with quality control and audit requirements.

Reference Copy

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94

EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

Reference Copy

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Reference Copy

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

Reference Copy

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98

7.9 Investigation of Viral Hepatitis

7.9a Diagnostic Algorithm

Be able to describe the causes of viral hepatitis, and the appropriate diagnostic investigations and control of infection issues.

KNOWLEDGE

Understand the range of viruses that may cause liver disease.

Understand other important non-viral infections of the liver.

Know the common causes of viral liver infection and which range of investigations should be used for diagnostic testing and screening purposes.

Understand the advantages and disadvantages of the methods.

Understand the predictive value of various assays in different population groups.

Understand the requirement for confirmatory assays and the role of reference laboratories.

Know the relevant internal and external quality assurance procedures.

Know the less common causes of viral liver infection and when to consider using investigations that may be used for diagnostic purposes.

Understand any potential therapy which may be available for prophylaxis and treatment of viral hepatitis, e.g. antivirals, immunoglobulin and vaccines.

Know which patient groups are at high risk with regard to viral hepatitis.

Know about infection controls issues and measures which may be taken with regard to viral hepatitis in hospital and within the community.

Reference Copy

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COMPETENCE

You must be able to:

Describe the causes of viral hepatitis and investigations for diagnosis.

Explain factors that should be taken into consideration when selecting an investigation.

Describe how viral pathogens in hepatitis may infect humans and how patients with these infections would be managed and treated.

Perform relevant techniques in accordance with standard laboratory procedures.

Critically evaluate and report results.

Complete all relevant documentation in accordance with quality control and audit requirements.

Reference Copy

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100

EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

Reference Copy

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Reference Copy

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

Reference Copy

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7.10 Infections in Neonates and Infants

7.10a Diagnostic Algorithm

Be able to describe the viral causes of infections in neonates and infants (including sudden unexpected deaths), and the appropriate diagnostic investigations and control of infection issues.

KNOWLEDGE

Understand the range of viruses that need to be ruled out in cases of sudden unexpected death in neonates and infants, e.g. respiratory syncytial virus (RSV), enteroviruses.

Understand other important non-viral infections that have been linked to neonates and infants as a cause of sudden unexpected death in infants (SUDI).

Know the common causes of infection in neonates/ infants and which range of investigations should be used for diagnostic purposes.

Understand the advantages and disadvantages of the methods.

Understand the predictive value of various assays in different population groups.

Know the relevant internal and external quality assurance procedures.

Understand the requirement for confirmatory assays and the role of reference laboratories.

Know the less common causes of infection in neonates/infants and when to consider using investigations that may be used for diagnostic purposes.

Understand the importance of obtaining a relevant clinical history of the patient and mother if appropriate.

Understand the requirements for appropriate samples from patients according to clinical syndrome.

Understand the requirement to communicate with other pathology disciplines in the case of SUDI to direct appropriate investigation selection.

Understand potential therapy which may be available for prophylaxis and treatment of these infections, e.g. antivirals, immunoglobulin and vaccines.

Know about infection controls issues and measures which may be taken with regard to these infections.

Know the potential infection risk posed to the neonate.

Understand the potential use of stored antenatal samples from mother in diagnostic investigations.

Understand the requirements for appropriate samples from patients according to clinical syndrome.

Reference Copy

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COMPETENCE

You must be able to:

Describe the causes of neonatal and paediatric infections, and investigations for diagnosis.

Explain factors that should be taken into consideration when selecting an investigation.

Describe how neonatal and paediatric viral pathogens may infect humans and how patients with these infections would be managed and treated.

Perform relevant techniques in accordance with standard laboratory procedures.

Critically evaluate and report results.

Refer specimens to a specialist centre in accordance with laboratory procedures.

Complete all relevant documentation in accordance with quality control and audit requirements.

Reference Copy

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106

EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

Reference Copy

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Reference Copy

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

Reference Copy

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7.11 Immunocompromised Patients

7.11a Diagnostic Algorithm

Understand the viral causes of infections in immunocompromised patients, and the appropriate diagnostic investigations and control of infection issues.

KNOWLEDGE

Understand the cause of primary and secondary immunodeficiency, including:

o Viral;

o Hereditary;

o Physiological;

o Drug induced.

Understand the range of viruses which may infect immunocompromised patients, e.g. JC, BK virus, herpes viruses.

Understand other important non-viral infections in immunocompromised patients.

Know the common causes of viral infections in immunocompromised patients and which range of investigations should be used for diagnostic testing and screening purposes.

Understand the advantages and disadvantages of the methods.

Know the relevant internal and external quality assurance procedures.

Understand the requirement for confirmatory assays and the role of reference laboratories.

Know the less common causes of viral infections in immunocompromised patients and when to consider using investigations that may be used for diagnostic purposes.

Understand potential therapy that may be available for prophylaxis and treatment of infections in immunocompromised patients, including antivirals, immunoglobulin and vaccines.

Know about infection controls issues and measures which may be taken with regard to these infections.

Know the potential infection risk posed to immunocompromised patients.

Reference Copy

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COMPETENCE

You must be able to:

Describe the causes of viral infections in immunocompromised patients and relevant investigations for diagnosis.

Explain factors that should be taken into consideration when selecting an investigation.

Describe how immunocompromised patients with infections would be managed and treated.

Perform techniques in accordance with standard laboratory procedures.

Critically evaluate and report results.

Refer specimens to a specialist centre in accordance with laboratory procedures.

Complete all relevant documentation in accordance with quality control and audit requirements.

Reference Copy

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

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7.12 Travel Related and Exotic Infections

7.12a Diagnostic Algorithm

Be able to describe the viral causes of travel related and exotic infections, and the appropriate diagnostic investigations and control of infection issues.

KNOWLEDGE

Know the main causes of viral infections likely to have been acquired in unusual circumstances or outside of the UK, including arboviruses, filoviruses, arenaviruses, hantaviruses, rhabdoviridae, enteroviruses.

Know the appropriate laboratory diagnosis for each virus listed and if these are available in a routine diagnostic virology department.

Demonstrate knowledge of which sample types are appropriate for investigation.

Understand the principles and limitations of the techniques, which immunoglobulin class should be assayed and whether paired sera are required.

Know the relevant internal and external quality assurance procedures.

Know the risk factors, patient history and clinical symptoms that would indicate a possible travel related or exotic infection.

Know what information can be obtained from examination of bites and wounds and how that contributes to diagnosis of travel related and exotic infections.

Know the groups of virus transmitted via animal bites and arthropod bites.

Know the important bacterial and parasitic causes of serious illness associated with travel and exotic infections.

Know the hazards of laboratory acquired infection with such viral, bacterial and parasitic pathogens.

Know how arboviruses, filoviruses, arenaviruses, hantaviruses, rhabdoviridae, enteroviruses are transmitted.

Know what control measures are required to prevent or limit the spread of these viruses.

Be aware of how economic and political factors affect spread and control of these infections.

Be aware of how a patient suspected of infection with a travel related or exotic infection would be managed in the UK, particularly highly infectious viruses such as Lassa virus.

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COMPETENCE

You must be able to:

List the major viral causes of travel related and exotic infections.

Describe the information that would lead to a suspicion that a patient was infected with these viruses.

Name the important bacteria and parasites that could also be implicated in travel related and exotic infections.

Describe the procedure for diagnosing infection with these pathogens, including where specimens should be sent for specialised tests and how specimens would be transported to a reference laboratory.

Describe how the most dangerous travel related and exotic viral infections are transmitted.

Explain how spread of these infections would be controlled or limited.

Give details of the quality assurance procedures which may be used in the serological tests described.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

Reference Copy

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Reference Copy

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

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7.13 Infection Control

7.13a Infection Control Procedures

Be able to describe the principles and practice of infection control procedures.

KNOWLEDGE

Understand the principles that control of infection are based on:

o Removal of sources, e.g. decontamination of equipment;

o Blocking of routes of spread, e.g. isolation, hand washing etc;

o Enhancing resistance of patient, e.g. immunisation, prophylaxis.

Know the relevant infection control procedures within the laboratory.

Be aware of the activities of the hospital infection control team (ICT) and know where to reference their guidelines.

Know the importance of infection control in the hospital setting.

Know the different infection control methods available to prevent transmission of infection.

Know how to produce and collate virology tests and results in order to help epidemiological investigations to support infection control in the hospital.

Know the importance of infection control in the community setting.

Be aware of the role of the Consultant in Communicable Disease Control (CCDC).

COMPETENCE

You must be able to:

Describe the principles of infection control.

Describe the infection control procedures used in the laboratory, hospital and community.

Produce and collate virology tests and results for epidemiological investigations to support infection control in the hospital.

Describe the roles and responsibilities of the laboratory, ICT and CCDC.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

Reference Copy

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

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7.14 Pre and Post Exposure Prophylaxis and Vaccination

7.14a Pre and Post Exposure Prophylaxis

Be able to describe the principles of pre and post exposure prophylaxis.

KNOWLEDGE

Understand the principles of and strategies for the use of pre-exposure prophylaxis.

Understand the biological mechanisms of pre-exposure prophylaxis.

Understand the biological mechanisms of post-exposure prophylaxis.

COMPETENCE

You must be able to:

Describe the main uses of pre-exposure prophylaxis.

Describe the goals and limitations of pre-exposure prophylaxis.

Describe the main uses of post-exposure prophylaxis.

Describe the goals and limitations of post-exposure prophylaxis.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

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7.14b Immunisation

Be able to describe the principles and application of immunisation programmes.

KNOWLEDGE

Understand the principles of and strategies for using active immunisation programmes.

Understand the biological mechanisms of active immunisation.

Understand the biological mechanisms of passive immunisation.

Understand the need for childhood vaccination.

Understand the principle of the UK Childhood vaccination strategy.

Understand the WHO global immunisation policy.

Understand the principles of herd immunity.

Understand the need for targeted vaccination, e.g. Hepatitis B virus in prisons.

Know which vaccinations are available for health care workers and why.

Be aware of the statutory regulations regarding health care workers and vaccination.

COMPETENCE

You must be able to:

Describe how vaccination works.

Describe the goals and limitations of active immunisation.

Describe the goals and limitations of passive immunisation.

Describe the legal requirements of healthcare worker vaccinations.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

Reference Copy

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

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7.15 Antiviral Treatment and Resistance

7.15a AntiViral Therapy

Be able to describe the principles of antiviral therapy.

KNOWLEDGE

Understand the strategy for the development of antiviral agents.

Understand the variety of processes by which antiviral agents target the virus.

Know of the clinical application of the most widely used antiviral agents in areas such as prophylaxis, reactivation, prevention of complications and treatment of acute disease.

Know of the clinical application of antiviral agents in long-term therapy of chronic infections and in immunocompromised patients.

COMPETENCE

You must be able to:

Describe the anti-viral agents that are currently available and their mode of action.

Describe when, where and why antiviral agents are used.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

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7.15b Viral Load Monitoring

Be able to describe the principles of viral load monitoring.

KNOWLEDGE

Understand the importance and relevance of monitoring viral load in some infections.

Understand the relevance of emergence of drug resistant mutants in the treatment of patients on long-term therapy.

Be aware of the principles and practice of techniques available for measuring viral load, including target amplification.

Know the relevant internal and external quality assurance procedures.

COMPETENCE

You must be able to:

Describe the importance of viral load monitoring.

Describe when, where and why viral load monitoring is used.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

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7.15c Anti Viral Resistance Testing

Be able to describe the principles of antiviral resistance testing.

KNOWLEDGE

Understand the relevance of emergence of drug resistant mutants in the treatment of patients on long-term therapy.

Understand the techniques available for resistance testing using molecular sequencing, including gel and capillary based and cell culture techniques for genotype and phenotype resistance.

Know the relevant internal and external quality assurance procedures.

COMPETENCE

You must be able to:

Describe the importance of antiviral resistance testing.

Describe the principles and practice of the techniques available for antiviral resistance testing.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that the specialist trainee has successfully achieved fitness to practice as a biomedical scientist at the specialist level. The specialist trainee is required to present the supporting evidence indicated below as a separate specialist portfolio of evidence.

Assessed by trainer to work in accordance with standard laboratory procedures.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Answered questions set by trainer on the principles and practice of named procedure.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

One other piece of evidence chosen by the candidate as an example of their competence in this area.

Date of completion:

Trainer‟s name:

Trainer‟s signature:

Evidence of competence for this standard has been assessed and passed by the internal person who has checked that the requirements in the Evidence of Achievement section have been met.

Internal Assessor‟s signature:

Internal Assessor‟s name:

Date:

Reference Copy

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Reflective Log

This section is used to demonstrate you can relate knowledge from several areas, draw conclusions and reflect on your own performance as an independent professional learner, thus meeting the requirements for CPD. It is therefore a useful source of information for your CPD profile should you be audited by the HPC. The external assessor will review these reflective reports which should cross reference to the evidence contained in the portfolio. This may lead to further discussion on the laboratory tour.

Period of Training:

Summarise the laboratory role in the previous section(s): Reference Copy

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Personal reflection on training and example of evidence:

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About this document

Document title: Record of Laboratory Training for the Specialist Diploma in Virology

Produced by: Virology Advisory Panel

Contact: Executive Head of Education on [email protected]

Version: Edition 3

Date active: September 2011

Comments:

Copyright and disclaimer

This document and its contents including the IBMS logo are the property and trademarks of the Institute of Biomedical Science. The copyright on this material is owned by the IBMS (unless otherwise explicitly stated). This document or no part of it may be copied, reproduced, republished, downloaded or transmitted in any way, other than for your own personal, non-commercial use. Prior written permission must be obtained from the IBMS for any other use of this material. All rights are reserved.

copyright © Institute of Biomedical Science 2011

About IBMS Publications

The Institute publishes a wide range of professional and scientific publications and guidance. Further information and downloadable publications: www.ibms.org/publications

IBMS vision and purpose.

About biomedical science

Biomedical science is the application of the natural sciences to the study of medicine. Although relating principally to the causes, consequences, diagnosis and treatment of human disease, biomedical science is used in other areas, such as academia, research and veterinary medicine.

It has been estimated that approximately 70% of medical decisions or interventions require the knowledge and expertise of biomedical science. This may range from the results of simple blood tests, the identification of disease causing organisms, the monitoring of chronic conditions (for example diabetes), through to more complex situations such as interpreting and reporting abnormal cervical cytology. Those who practice biomedical science must be competent and professional because lives may depend upon their knowledge and skills.

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IBMS vision

The Institute of Biomedical Science (IBMS) is the professional body for those who work within the field of biomedical science. Its principal aims are to represent its members, set standards of behaviour for its members, enable career development, educate its members, promote biomedical science to the public and award qualifications appropriate to the collective knowledge and skill base of its members.

The Institute was founded in 1912 and represents over 19,000 members employed predominately within the healthcare arena, but also within university and veterinary laboratories, government agencies and other services. Other members also work in related commercial fields and academia. Although most Institute members live and work in the United Kingdom and the Republic of Ireland, many other members are employed throughout the world.

IBMS roles

To aid and support the development of biomedical science, both nationally and internationally.

Develop professional standards to guide those who practice biomedical science and to ensure patient safety.

Assess competence to practise as Health Professions Council (HPC) registered biomedical scientists.

Represent the interests of biomedical science, provide advice and work with UK governments, public & independent healthcare providers, media, universities, industry and commercial sector, professional organisations and all other partners.

Provide professional support and benefits for members.

Develop qualifications, training and diplomas for members to demonstrate levels of expertise and competency along a career pathway.

To enable members to achieve their highest potential via continuing professional development and other professional activities.

Inform and guide biomedical scientists through media, professional and scientific publications, meetings and events.

Promote public awareness of biomedical science.

Award the designation of Chartered Scientist to qualifying members.

Fund research and support charitable causes in biomedical science.

Maintain a historical archive of the Institute and biomedical science profession.

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Contact details

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T: + 44 (0)20 7713 0214

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E: [email protected]

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The Institute of Biomedical Science is a company limited by guarantee registered in England, No 377268, and a registered charity, No 261926 © Institute of Biomedical Science.

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