Specialist Diploma Reference Portfolio · development of specialist knowledge and competencies in their chosen field ... be filed for reference purposes in a separate portfolio

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Specialist Diploma Reference Portfolio

Institute of Biomedical Science

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 Laboratory Automation ......................................................................................... 38

7.1a Laboratory Automation ................................................................................. 38

7.2 Fluid and Electrolyte Disorders ............................................................................ 44

7.2a Fluid and Electrolyte Disorders ..................................................................... 44

7.3 Acid-Base Disorders ............................................................................................ 48

7.3a Acid-Base Disorders ..................................................................................... 48

7.4 Kidney Disease .................................................................................................... 54

7.4a Kidney Disease ............................................................................................. 54

7.5 Liver Function and Associated Disease States .................................................... 60

7.5a Liver Function and Associated Disease States ............................................ 60

7.6 Biochemical Investigation of Diabetes Mellitus and Hypoglycaemia ................... 66

7.6a Biochemical Investigation of Diabetes Mellitus and Hypoglycaemia ............ 66

7.7 Lipids, Lipoproteins and Cardiovascular disease ................................................. 72

7.7a Major Lipids in Atherosclerosis and Cardiovascular Disease ....................... 72

7.7b Diagnosis of Cardiovascular Disease ........................................................... 74

7.7c Diagnosis of Cardiovascular Disease ........................................................... 76

7.7d Diagnosis of Cardiovascular Disease ........................................................... 80

7.8 Investigations for Disorders of Calcium, Phosphate and Magnesium Homeostasis ..................................................................................... 84

7.8a Investigations for Disorders of Calcium, Phosphate and Magnesium Homeostasis ............................................................................. 84

7.9 Cancer Biochemistry and Tumour Markers ......................................................... 90

7.9a Cancer Biochemistry and Tumour Markers .................................................. 90

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7.10 Specific Protein Markers ...................................................................................... 94

7.10a Specific Protein Markers ............................................................................... 94

7.11 Hyperuricaemia and Gout .................................................................................. 100

7.11a Hyperuricaemia and Gout ........................................................................... 100

7.12 Investigation of Micronutrients ........................................................................... 104

7.12a Vitamins ...................................................................................................... 104

7.12b Trace Elements ........................................................................................... 106

7.13 Gastrointestinal Disorders and Maladsorption ................................................... 112

7.13a Gastrointestinal Disorders and Maladsorption ............................................ 112

7.14 Therapeutic Drug Monitoring ............................................................................. 118

7.14a Essential requirements of Therapeutic Drug Monitoring (TDM) ................. 118

7.14b Core Drugs ................................................................................................. 122

7.14c Drug Monitoring Investigations ................................................................... 124

7.15 Chemical Toxicology .......................................................................................... 128

7.15a General Toxicology ..................................................................................... 128

7.15b Drugs of Abuse ........................................................................................... 132

7.16 Gastrointestinal Inherited Metabolic Disorders and Newborn Screening: Prenatal Screening for Predicting Down‟s Syndrome ........................................ 138

7.17 Investigation of Thyroid Disease ........................................................................ 146

7.17a Investigation of Thyroid Disease ................................................................. 146

7.18 Abnormal Pituitary Function ............................................................................... 152

7.18a Abnormal Pituitary Function ........................................................................ 152

7.19 Reproductive Endocrinology .............................................................................. 156

7.19a Reproductive Endocrinology ....................................................................... 156

7.20 Investigation of Adrenal Disease ....................................................................... 160

7.20a Investigation of Adrenal Disease ................................................................ 160

7.21 Point of Care Testing (POCT) ............................................................................ 166

7.21a Point of Care Testing (POCT) ..................................................................... 166

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1. INTRODUCTION Reference Copy

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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 Clinical Biochemistry 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. Haematology and Hospital Transfusion, 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 Laboratory Automation

7.1a Laboratory Automation

Be able to perform a standard range of analyses on automated analysers commonly found in clinical chemistry laboratories.

KNOWLEDGE

Know which tests can be analysed on the automated analysers utilised in clinical chemistry laboratories both broadly in terms of applied technique and specifically in the employing laboratory.

Know the key automated steps within the analyser.

Know the name, location and function of the key mechanical components of automated analysers and how they contribute to the analytical process.

Know the pre and post analytical laboratory processes that can be automated either as stand-alone automation or integrated with the analysers, for example with tracking systems.

Understand the scientific principles and application of the analytical techniques employed on the automated instrumentation:

o Spectrophotometry;

o Immunoassay;

o Electrochemistry.

Know the range of samples that may be analysed on general chemistry and immunoassay analysers.

Know the structure of the instrument software/ user interface.

Know the function and design of the basic instrument and chemistry parameters.

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

Know specific health and safety risks associated with the analyser‟s general and specific reagents.

Know the procedures associated with running internal quality control and the interpretation of the QC data.

Know which maintenance procedures are undertaken on a daily, weekly, fortnightly or less frequent interval on general chemistry and immunoassay analysers.

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COMPETENCE

You must be able to:

Undertake standard maintenance of automated analysers.

Calibrate and quality control a standard repertoire of tests on automated instruments, including the interpretation of calibration and quality control data

Assess the suitability of clinical samples for analysis on the appropriate laboratory analyser and take appropriate action if not.

Perform named test in accordance with standard laboratory procedure.

Monitor results, consider possible interference, and take appropriate action.

Identify abnormal results and likely significance to clinical detail.

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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:


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

Date of completion:

Trainer‟s name:


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:

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7.2 Fluid and Electrolyte Disorders

7.2a Fluid and Electrolyte Disorders

Be able to perform a range of investigations to assess fluid and electrolyte balance.

KNOWLEDGE

Know the basic physiology of water and electrolyte control with specific reference to:

o Role of anti-diuretic hormone;

o The renin-angiotensin-aldosterone system;

o Associated regulatory mechanisms.

Know the range of analytical parameters undertaken in the assessment of water and electrolyte metabolism, including sodium and potassium in plasma/serum and urine.

Know the principles and practice of methods commonly utilised for analysis of sodium and potassium in biological fluids, including the difference between direct and indirect ion selective electrodes and their application with a range of devices (i.e. POCT systems and larger laboratory based systems).

Know the relationship between osmolality, osmolarity and plasma constituents and how to calculate a plasma osmolarity.

Know the principles and practice of the methods available to measure osmolality.

Understand the significance of the water deprivation test.

Know the common causes of electrolyte disturbances and how persistent abnormalities may be investigated further with additional biochemical testing.

Know that electrolyte analysis may be subject to artefactual effects, particularly sample collection.

COMPETENCE


Assess the suitability of clinical samples for analysis of electrolytes including appropriate selection of tests and analysers and take appropriate action if not.

Analyse sodium and potassium with both POCT and automated methods.

Perform analysis of samples in accordance with standard laboratory procedure.



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

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7.3 Acid-Base Disorders

7.3a Acid-Base Disorders

Be able to perform a range of investigations to assess blood gases. (Core analytes: hydrogen ion (pH), bicarbonate, pO2, pCO2, lactate).

KNOWLEDGE

Understand the homeostasis and physiological significance of buffer systems.

Understand normal acid-base balance including bicarbonate readsorption and hydrogen ion excretion, including the transport of carbon dioxide and oxygen.

Understand the link between disturbances of hydrogen ion homeostasis and other disease states.

Be aware of acid-base disturbances (including anion gap). To include examples of:

o Non respiratory (metabolic) acidosis;

o Respiratory acidosis;

o Respiratory alkalosis.

Understand the principles and limitations of pH, pO2, pCO2 and lactate electrodes.

Understand the principles and limitations of the analytical methods employed for bicarbonate.

Be aware of sample requirements for blood gas analysis.

Be aware of secondary functions of the blood gas analyser (e.g. Hb, measurement of Hb derivatives, other ISE electrodes).


Know the relevant internal and external quality assurance procedures.

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COMPETENCE


Assess suitability of sample for analysis and take appropriate action if not.

Perform or observe the analysis and validation of blood gases (including pH, pO2 and pCO2) in accordance with standard laboratory procedure.

Perform or observe the preparation of equipment for the analysis of blood gas samples.




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7.4 Kidney Disease

7.4a Kidney Disease

Be able to perform a range of investigations to assess kidney function.

KNOWLEDGE

Know the basic anatomy and physiology of normal kidney function and common pathologies that may arise including the differences between acute and chronic kidney disease.

Know which investigations can provide indicators of glomerular filtration rate (GFR), specifically plasma or serum creatinine, urea and cystatin C, and their analytical and clinical limitations.

Be aware of how to derive a calculated/estimated GFR, including creatinine clearance, the MDRD equation and other equations that may be applied locally, including those appropriate to children.

Be aware of the additional analyses, measures and variables that are required in the calculation of GFR, for example urine creatinine, timed urine volume, subject age, gender, ethnicity, height and weight depending on the GFR calculation applied.

Be aware of reference GFR procedures that use exogenous markers, e.g. Chromium EDTA or iohexol clearance.

Know which methods are available to measure urinary protein (including urine test strip methods) and their relative merits.

Understand how urinary albumin can be used in monitoring kidney disease and its specific application for the assessment of diabetic nephropathy.

Be aware of analyses in urine that may be used to assess renal tubular function including urine phosphate, glucose, pH and specific proteins.

Understand the effects of renal disease on a range of biochemical analyses other than those specifically listed above, for example plasma potassium, PTH, vitamin D and haematinic investigations.

Understand the categorisation of chronic kidney disease stages based on clinical findings and GFR values.

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COMPETENCE


Assess the suitability of clinical samples for analysis of markers of renal disease including appropriate selection of tests and analysers and take appropriate action if not.

Analyse urea and creatinine in plasma/serum and urine with standard automated methods.

Accurately calculate eGFR using a formula based method such as MDRD.

Perform analysis of samples in accordance with standard laboratory procedure.




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7.5 Liver Function and Associated Disease States

7.5a Liver Function and Associated Disease States

Be able to perform a range of investigations to assess liver function and associated diseases.

KNOWLEDGE

Know the role of the liver in: carbohydrate, fat, protein and hormone metabolism; storage; the metabolism and excretion of bilirubin; and detoxification of drugs and foreign compounds.

Be aware of the most common disease processes affecting the liver and their management including: cholestasis; hepatitis; cirrhosis; malignancy.

Be aware of the causes of pancreatitis, and the importance of the laboratory in providing differential diagnosis and ongoing support for the patient.

Be aware of the epidemiology of liver disease according to race, age and sex and the role of liver disease in pregnancy

Know the metabolism and breakdown of haemoglobin; the excretion and physiological importance of total and direct bilirubin.

Know the major causes of jaundice, including pre-hepatic, post hepatic and hepatic.

Know the inherited abnormalities of bilirubin metabolism, including Gilbert‟s syndrome.

Know the significance of abnormal bilirubin in plasma/serum/urine.

Know the synthesis of albumin in the liver and its use to indicate functional capacity of the organ.

Know the link between measurement of total protein, albumin and secondary globulin estimation.

Know the link between bile acid measurement and cholestasis in pregnancy.

Know the metabolic function of the enzymes listed and understand the principles and limitations of diagnostic enzymology.

Know of the role and significance of alkaline phosphatase isoenzymes.

Know how to perform investigations to measure the following core analytes:

o Total bilirubin;

o Conjugated (Direct) bilirubin;

o Total Protein and albumin;

o Bile Acids;

o AST, ALT, GGT, ALP, amylase;

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KNOWLEDGE (continued)

Know how to perform investigation to measure the following associated analytes:

o Autoantibodies;

o ALP Isoenzymes;

o Urine bilirubin and urine urobilinogen;

o - globulins;

o -fetoprotein;

o 1-antitrypsin;

o Copper and ceruloplasmin.

Understand the principles and limitations of the analytical methods employed and sample requirements.

Be aware of factors affecting sample integrity and specific risks associated with the reagents or method of investigation.

Know the reference ranges for stated analytes and understand the significance of abnormal results individually and as part of a multi analyte profile.


COMPETENCE


Assess suitability of sample for analysis on the appropriate laboratory analyser and take action if not.

Perform and validate the following in accordance with standard laboratory procedure:

o Total bilirubin in serum/plasma/urine;

o Conjugated (direct);

o Urine urobilinogen;

o Albumin, total protein and bile acids;

o Stated enzymes in serum/plasma;

o Alkaline phosphatase isoenzymes.




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7.6 Biochemical Investigation of Diabetes Mellitus and Hypoglycaemia

7.6a Biochemical Investigation of Diabetes Mellitus and Hypoglycaemia

Be able to explain the laboratory diagnosis of diabetes and associated disturbances of glucose metabolism.

KNOWLEDGE

Know the aetiology and pathophysiology of diabetes and know the difference between Type 1, Type 2 and secondary diabetes.

Know the pathways of gluconeogenesis, glycogen synthesis and glycogen breakdown.

Be aware of the metabolic effects of insulin.

Be aware of the WHO diagnostic criteria for diabetes and Impaired Glucose Regulation as endorsed by Diabetes UK.

Know the local policy on the investigation of individuals with suspected diabetes and the sample requirements for glucose, HbA1c, insulin, C-Peptide and lipid analyses.

Know the difference between diabetes, impaired fasting glucose and impaired glucose tolerance.

Be aware of self-induced/deliberately induced hypoglycaemia and its investigation.

Know the local procedure for performing an oral glucose tolerance test and interpretation with respect to the WHO criteria.

Be aware of the methodologies available for the estimation of glucose and the limitations of using glucose levels in the monitoring of diabetes.

Understand the differences found by using different sample types (whole blood, plasma/serum, capillary).

Be aware of the implications of the NICE guidelines (Clinical Guidance 66, May 2008) on the monitoring of diabetes and the need for monitoring lipids in diabetes.

Be aware of the different methodologies for measuring glycated haemoglobin (HbA1c) and the effect of Hb variants on these assays.

Be aware of the role of measuring glycated protein (fructosamine).

Understand the role of urinary microalbumin and methods available for measurement.

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Be aware of the following mechanisms for monitoring and management glucose levels:

o Diet;

o Different classes of drugs;

o Self-monitoring of blood glucose;

o The effect of slow release drug preparations and fast/slow acting insulin.

Be aware of situations that will require closer monitoring than is usual, for example pregnancy.

Know the common causes of and be able to discuss the investigation of fasting hypoglycaemia and reactive hypoglycaemia.

Understand the role of insulin and C-Peptide assays in the investigation of hypoglycaemia.

Be aware of the metabolic deficiencies that cause hypoglycaemia in neonates/infants and the laboratory investigations used to identify them.

Be aware of the methods available for urinary sugar analysis and the role of urinary sugar chromatography in neonates.

Be aware of the reference ranges for all parameters measured by your laboratory when investigating diabetes mellitus and hypoglycaemia and what levels are designated as good control, adequate control and poor control.

Know the role of the laboratory in the selection, user training and performance monitoring of POCT glucometers within their Trust.

Know the local protocol for the communication of abnormal glucose results to wards & GPs.

Be aware of the role of other healthcare services in the management of diabetes (e.g. podiatry, retinal screening, dieticians).

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COMPETENCE


Demonstrate a clear understanding of the local guidelines and sample requirements for the investigation of suspected cases of diabetes and subsequent control.

Explain the role of the laboratory in the diagnosis, treatment and monitoring of diabetes mellitus and hypoglycaemia in adults and neonates.

Be able to measure glucose, HbA1c, lipids and other analytes used by your laboratory to investigate diabetes mellitus and hypoglycaemia e.g. insulin, C-Peptide and describe the methodological techniques used.

Be able to use POCT devices to investigate diabetes mellitus and hypoglycaemia in your laboratory and describe the methodological techniques used.

Describe methodological techniques used to measure sugars in urine and fructosamine.

Explain why different values are obtained for glucose using different sample types.

Describe the effect of Hb variants on the laboratory HbA1c assay.

Describe the local protocol for the investigation of a neonate that “fails to thrive”

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7.7 Lipids, Lipoproteins and Cardiovascular disease

Core Analytes: Cholesterol, Triglyceride, HDL-Cholesterol, Creatine Kinase, Troponin, BNP or NTproBNP Associated analytes: CK-MB, Myoglobin, hs-CRP

7.7a Major Lipids in Atherosclerosis and Cardiovascular Disease

Be able to describe the relationship of major blood lipids to atherosclerosis and cardiovascular disease and associated investigations.

KNOWLEDGE

Understand the role and transport of the major lipids in the blood to include: fatty acids; triglycerides; cholesterol; and phospholipids.

Understand the classification of lipoproteins, their composition, metabolism and principle function.

Demonstrate an understanding of hypercholesterolemia (when due to LDL) as an important risk factor in Coronary Heart Disease.

Understand the rationale of treatment of hyperlipidaemia in relationship to cardiovascular disease with reference to the relevant NICE guidelines.

Understand the definition, diagnosis and treatment of patients presenting with Acute Coronary Syndrome (ACS).

Understand the definition, diagnosis, treatment and prognosis of patients presenting with Chronic Heart Failure (CHF).

COMPETENCE


Demonstrate an understanding of the implication of treating cardiovascular disease has on the NHS and the overall economic effect.

Show an awareness of the epidemiology of cardiovascular disease according to all associated risk factors.

Demonstrate an understanding of the implication of treating Chronic Heart Failure for the NHS with reference to the NICE guidelines

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7.7b Diagnosis of Cardiovascular Disease

Be able to perform investigations to assist in the diagnosis of cardiovascular risk factors.

KNOWLEDGE

Understand of the use of national or international guidelines in determining risk in association with reference intervals.

Understand the use of triglyceride measurements in Chronic Heart Disease (CHD) and its association with other disease states particularly pancreatitis.

Understand the influence of sex, age, exercise, obesity, alcohol and extraneous oestrogens on lipoproteins.

Understand the causes of secondary hyperlipidaemia.

Know the causes of primary hyperlipidaemia and treatment (NICE guidelines)

Understand the principles and limitations of the analytical methods employed and sample requirements for:

o Cholesterol;

o Triglyceride;

o HDL-cholesterol.


Know how to calculate LDL-cholesterol and understand its limitations.

Be aware of other proposed markers of CHD.

COMPETENCE


Assess suitability of sample for analysis on the appropriate laboratory analyser and take appropriate action if not.

Perform the timely analysis and validation of lipids in serum/plasma.

Validate the results.


Report results appropriate to the significance of the result.


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7.7c Diagnosis of Cardiovascular Disease

Be able to perform investigations to assist in the diagnosis of acute coronary syndrome.

KNOWLEDGE

Understand the rationale of using multiple analytes in the diagnosis of Acute Coronary Syndrome (ACS) and factors that influence this, including serial measurements if applicable.

Understand the impact the laboratory result may have on treatment of patients presenting with ACS.

Understand the metabolic role of creatine kinase (CK).

Understand the principles and limitations of diagnostic enzymology.

Understand what an isoenzyme is; the types and sources of CK isoenzymes.

Be aware of the normal reference ranges for CK and if measured CK-MB.

Be aware of the structural and physiological role of the troponins.

Be aware of algorithm for diagnostic use and interpretation of:

o CK-MB;

o Troponins.

Understand the principles and limitations of the analytical methods employed for:

o CK-MB (activity and mass assays);

o Troponins.

Understand the meaning of clinical sensitivity and specificity.

Be aware of knowledge of other markers of ACS and use of POCT.

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COMPETENCE


Explain the laboratory role in the diagnosis, treatment and prognosis of a patient presenting with chest pain, against current national guidelines.


Perform the timely analysis and validation of:

o CK (and CK-MB if measured);

o Troponin.




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7.7d Diagnosis of Cardiovascular Disease

Be able to perform investigations to assist in the diagnosis of Chronic Heart Failure (CHF).

KNOWLEDGE

Understand the variety of causes which may result in heart failure as a medical emergency or asymptomatic presentation.

Know the impact the laboratory result may have on patients presenting with heart failure.

Be aware of the structural and physiological role of BNP or NTproBNP.

Be aware of the normal reference ranges for BNP or NTproBNP.

Be aware of algorithm for interpretation of BNP or NTproBNP.

Be aware of the clinical use of cut-off values for BNP or NTproBNP.

Understand the meaning of clinical sensitivity and specificity.

Understand the role that POCT may play in diagnosis of CHF

Understand the principles and limitations of the analytical methods employed and sample requirements.


COMPETENCE



Perform the timely analysis and validation of BNP:




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7.8 Investigations for Disorders of Calcium, Phosphate and Magnesium Homeostasis

7.8a Investigations for Disorders of Calcium, Phosphate and Magnesium Homeostasis

Be able to process samples for investigations for disorders of calcium, phosphate and magnesium.

KNOWLEDGE

Understand the relationship between calcium, phosphate and magnesium and their hormonal control.

Be aware of the role of these minerals in bone formation and resorption in bone disorders and the consequences of treatment.

Understand the role of calcium, phosphate and magnesium in various disease states.

Know the principles and practice of techniques for the measurement of calcium, phosphate and magnesium.

Understand the relationships and roles of PTH, PTHrp, Vitamin D and calcitonin in calcium regulation, and when and how these hormones may be measured.

Understand the mechanisms involved in calcium and magnesium homeostasis.

Understand the principles and limitations of methods used to measure calcium, magnesium and phosphate.

Understand the relationship and physiological significance of ionised and total calcium and the calculations used to correct calcium results.

Understand the role of PTH, vitamin D in regulating levels of calcium in the body.

Be aware of the principles and techniques used for the measurement of PTH and the limitations of the assays.

Be aware of the principles and techniques used in measurement of vitamin D.

Understand the implications and causes of Hypercalcaemia and Hypocalcaemia.

Understand the implications and causes of Hypermagnesaemia and Hypomagnesaemia.

Understand the implications and causes of Hypophosphataemia and Hyperphosphataemia.

Understand the role of the kidneys in regulation of calcium levels in blood.

Be aware of the biochemical testing for and implications of bone disease, including markers of bone turnover.

Understand the principles and practice of techniques used to measure calcium, phosphate and magnesium.

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COMPETENCE


Explain the physiological significance of calcium, phosphate and magnesium.

Give examples of calcium and magnesium disorders and the consequences for biochemical test results.

Locate information for sample requirements for PTH, vitamin D, calcitonin and markers of bone turnover.

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7.9 Cancer Biochemistry and Tumour Markers

7.9a Cancer Biochemistry and Tumour Markers

Be able to describe the biochemical investigations which are undertaken by your laboratory in the diagnosis, treatment and monitoring of cancer. Estimations should include PSA, AFP, CEA, HCG, FOB and HIAA.

KNOWLEDGE

Understand the different types of tumour and the disorders in biochemistry they can cause.

Understand the staging of tumour growth and the implications for the patient biochemically.

Understand the appropriate use of tumour markers in screening, diagnosis and monitoring malignant disease.

Be aware of the criteria for the ideal tumour marker.

Be aware of clinical sensitivity and specificity of methods, problems with cross reactivity and prozone effects.

Understand the possible biochemical consequences of tumour growth such as ectopic hormone production.

Be aware of the roles of faecal occult blood, PSA, CEA, CA125, CA153, CA19-9, AFP, HCG, HIAA, catecholamines and metadrenalines and how these assays may be performed.

Understand the sample requirements for tumour marker measurement and possible interferences or cross reactions.

COMPETENCE


Explain the physiological significance of tumour marker measurements.

Give examples of routinely used tumour markers and how they are used appropriately.

Locate information for sample requirements for tumour marker tests and be able to give advice to clinicians regarding sample types

Explain the methodological techniques used to measure tumour markers and how different methods and standards used may alter results obtained.

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7.10 Specific Protein Markers

7.10a Specific Protein Markers

Be able to perform quantitative and qualitative analysis of specific proteins on a range of sample types.

KNOWLEDGE

Know the basic chemical and physical properties of protein molecules.

Understand the relationship between serum, plasma, urine, CSF and other fluid type proteins.

Understand the principles, limitations and roles of the following techniques:-

o Gel Electrophoresis;

o Capillary Electrophoresis;

o Immunofixation;

o Turbidimetry;

o Nephelometry;

o Immunoassay.

Be aware of abnormalities on serum protein electrophoresis and be able to identify the 6 major groupings seen.

Be able to describe the patterns most likely to be seen in the following conditions:

o Acute phase reaction;

o Chronic Infection;

o Myeloma / MGUS.

Be aware of how immunoglobulins are synthesised in the body and the roles of the five classes of Immunoglobulin (IgG, IgA, IgM, IgD, IgE) and the difference between “heavy” and “light” chains.

Understand the importance of identification of and monitoring of monoclonal bands.

Understand the laboratory protocol for the investigation of suspected myeloma.

Know the laboratory protocol and diagnostic criteria for myeloma.

Be aware of the prognostic factors for myeloma.

Know the relevance of Hyperviscosity Syndrome.

Know the difference between myeloma and MGUS.

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Be aware of specific proteins that are commonly measured and their roles.

o Beta2 microglobulin;

o CRP;

o Alpha-1-Antitrypsin;

o Ceruloplasmin;

o IgE;

o Complement;

o Cryoglobulins.

Understand the value of measuring urinary total protein and carrying out urinary protein electrophoresis in relation to:

o Local methodology and alternative methods;

o Identification of the major components seen on urinary protein electrophoresis;

o Significance of the presence of free light chains in the urine;

o The role of urinary protein measurement in the diagnosis and monitoring of renal disease (protein/creatinine ratio);

o Identification and typing a monoclonal component seen in urine;

o The relationship between serum and urine protein.

Be aware of investigations carried out on CSF and other bodily fluids in relation to:

o Origins of and the role of immunoglobulins in CSF;

o Methods used to measure CSF Total Protein and CSF Immunoglobulins;

o Causes of increase CSF Total Protein concentration;

o Role of CSF electrophoresis in the diagnosis of conditions such as Multiple Sclerosis;

o The difference between a fluid that is a Transudate as opposed to an Exudate.

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COMPETENCE


Assess suitability of sample for analysis.

Select the appropriate method for the specific protein under investigation and perform analysis and measurement of proteins.

Identify specific proteins and validate results.

Consider possible interference, and take appropriate action.



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7.11 Hyperuricaemia and Gout

7.11a Hyperuricaemia and Gout

Be able to perform a range of investigations to assess hyperuricaemia and gout.

KNOWLEDGE

Know the basic biochemistry of purine synthesis and degradation.

Know the common methods available for the analysis of uric acid.

Be aware of the clinical conditions in which uric acid analyses may be of value including: gout, renal disease, pregnancy and malignancy.

Understand the relationship between uric acid and other purines in the context of inborn errors of metabolism, for example xanthinuria.

COMPETENCE


Assess the suitability of clinical samples for analysis of uric acid and take appropriate action if not.

Analyse uric acid with a standard automated method.

Validate the results taking note of analytical and clinical error messages.



Complete laboratory records as required.

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7.12 Investigation of Micronutrients

7.12a Vitamins

Be able to perform or describe investigations for the diagnosis and monitoring of vitamins.

KNOWLEDGE

Know the biological requirement for the different vitamins and vitamers in the human body.

Be aware of the recommended daily amounts for vitamins.

Know the clinical effect of deficiency or excess of the different vitamins.

Understand the biological requirement for B12 and folate in the human body and the effect of deficiency.

Be aware of the effects of B12 and folate on haematological parameters.

Understand the principles, techniques and limitations used in the measurement of vitamins including:


o Flame photometry (atomic emission spectrometry);

o Atomic absorption spectrophotometry;

o Mass spectrometry (inductively coupled plasma);

o Immunoassay;

o High performance liquid chromatography;

o Gas chromatography.

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


COMPETENCE


Locate information for sample requirements for vitamins not performed in your department.

Provide advice on sample requirements and collection for vitamin and haematinics estimation.

Analyse or process sample for transport to referral laboratory.

Correctly enter results and any comment to laboratory computer system.

Validate and report results appropriately to the significance of the result.


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7.12b Trace Elements

Be able to perform or describe investigations for the diagnosis and monitoring of trace elements.

KNOWLEDGE

Know the biological requirement for the different trace elements in the human body.

Understand the clinical and biochemical features of lead poisoning.

Understand the biological requirement for copper, magnesium and zinc in the human body and the effect of deficiency and excess.

Be aware of national guidelines for the monitoring of aluminium in patients on renal dialysis.

Be aware of the requirements for the monitoring of industrial workers using lead and other heavy metals.

Be aware of relationship between magnesium and calcium homeostasis.

Be aware of inherited defects affecting the transport and metabolism of copper.

Be aware of ceruloplasmin estimation.

Be aware of the importance of iron measurements and the treatment techniques for patients admitted with an iron overdose.

Understand the principles, techniques and limitations used in the measurement of trace elements including:



o Atomic absorption spectrophotometry;

o Mass spectrometry (inductively coupled plasma);

o Immunoassay;


o Gas chromatography.

Understand the comparative benefits of using ICP-MS and atomic absorption spectrophotometry for the estimation of trace metals.

Understand the difference between flame photometry and atomic absorption spectrophotometry, and the use of a furnace for estimation of heavy metals.



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COMPETENCE


Explain the different sample types and specimen collection bottles required for trace element analysis and any special precautions when undertaking the assays.

Locate information for sample requirements for trace elements not performed in your department.

Provide advice on the correct procedure for sample collection.

Analyse or process sample for transport to referral laboratory.

Correctly enter results and any comment into laboratory computer system.

Validate and report results appropriately to the significance of the result.


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7.13 Gastrointestinal Disorders and Maladsorption

7.13a Gastrointestinal Disorders and Maladsorption

Be able to explain the role of the laboratory in diagnosing malabsortion and monitoring nutritional status.

KNOWLEDGE

Understand the functions of the major regions of the gastrointestinal tract and associated organs, the principal digestive secretions and their role in respect to nutritional status:

o Oral Cavity;

o Oesophagus;

o Stomach;

o Duodenum, proximal jejunum;

o Liver & biliary system;

o Exocrine pancreas;

o Distal small intestine;

o Large Intestine;

o Rectum.

Be aware of the processes involved in the digestion and absorption of the following nutrient classes:

o Proteins;

o Carbohydrates;

o Fats;

o Nucleic acids;

o Water and minerals;

o Trace elements;

o Vitamins.

Be aware of the main causes of malabsorption including:

o Gastric surgery with bypass or gastric banding;

o Thyrotoxicosis;

o Pancreatic insufficiency;

o Bile salt insufficiency;

o Mucosal disorders.

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Be aware of the clinical features associated with malabsorption and possible causes.

o Diarrhoea, steatorrhoea, borborygmi;

o Weight loss & growth failure;

o Abdominal distension;

o Anaemia;

o Metabolic bone disease;

o Easy bruising.

Be aware of the physical investigations used to assess nutrition status including Body Mass Index (BMI), skinfold thickness and MUST (Malnutrition Universal Screening Tool).

Know the principles and practice of the analytical investigations used in your laboratory to assess and monitor nutritional status. These should include:

o Urea, Albumin Calcium, Phosphate, Alkaline phosphatase, Magnesium, C-reactive protein;

o Thyroid function tests, Copper, Zinc, Selenium, Iron & Ferritin, Glucose, VitD, Folate;

o Vit B12.

o Faecal Elastase

o Faecal Calprotectin

COMPETENCE


Explain the functions of the major regions of the GIT and associated organs.

Give examples of tests routinely used in your laboratory to assess GI disorders and malabsorption.

Locate information for sample requirements for tests and be able to give advice to clinicians regarding sample types.

Explain the methodological techniques used to measure the assays listed in the „Knowledge‟ section and how different methods and standards used may alter results obtained.

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7.14 Therapeutic Drug Monitoring

7.14a Essential requirements of Therapeutic Drug Monitoring (TDM)

KNOWLEDGE

There are a large number of drugs which require therapeutic monitoring but many of these are only measured in specialised services attached to specific clinical units. Therefore, it is expected that the specialist trainee will have a thorough theoretical grounding in the contents of section (7.14a), exposure to the measurement of the drugs in section (7.14b); and be aware of the need for monitoring of the drugs in section 7.14c

Understand the purpose of therapeutic drug monitoring (TDM).

Understand the principles and limitations of pharmacokinetics.

Understand the importance of sampling time.

Be aware of the growing field of pharmacogenomics.

Know the definitions of half-life, dosing interval, trough level, minimum effective dose, maximum therapeutic dose.

Be aware of the principles and techniques used in measurement of drugs, including:

o Colourimetry;


o Immunoassay;


o Gas chromatography;

o Mass spectrometry.

Understand the principles and limitations of the analytical method employed and sample requirements.

Understand the significance of results outside the therapeutic range.




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COMPETENCE


Explain the need for sample and last dose time to a variety of professional groups (phlebotomist, nursing staff [including community based staff], hospital clinicians and general practitioners).

Explain the reasons for the difference in measured concentration using different assay technologies.

Locate information for sample requirements for TDM not performed in your department.

Explain the methodological techniques used in TDM.

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7.14b Core Drugs

Be able to describe how to perform estimation of levels of the following drugs on a range of sample types.

KNOWLEDGE

Understand the purpose of therapeutic drug monitoring for each agent.

Understand the principles and limitations of drug assays to measure:

o Lithium, digoxin, phenytoin, carbamazepine (CBZ) and valproate;

o Gentamicin (or other aminoglycoside antibiotic);

o Caffeine / Theophylline;


o Immunoassay;


o Ion selective electrodes.





COMPETENCE


Confirm that the sample was collected at the optimum time since last dose.

Perform the timely analysis of antimicrobial drug in plasma/serum.



Report results appropriately to the significance of the result.


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7.14c Drug Monitoring Investigations

Be able to perform investigations for drug monitoring or process samples for referral.

KNOWLEDGE

Know how to monitor the following classes of drugs and the reasons for this. (The drug names are given as examples only and not exhaustive as there are clearly other members of each class of drug). Knowledge of all the drug assays either referred from or analysed in their laboratory is expected.

o Anti-epileptics – lamotrigine;

o Anti-psychotics – clozapine;

o Anti-tumour – methotrexate;

o Cardiac drugs – amiodarone;

o Anti-retroviral drugs – constituents of HAART;

o Immunosuppressives – ciclosporin, azathioprine (TMPT phenotyping or genotyping).

Know how to access information to advise clinicians on sample requirements for all these classes of drugs



o Colorimtery;

o Immunoassay;


o Mass spectrometry.

Understand the general principles and limitations of the analytical method employed and sample requirements.



COMPETENCE


Provide advice on the correct procedure for sample collection.

Either analyse or process sample for transport to referral laboratory.

Correctly enter results and any comment to laboratory computer system.



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7.15 Chemical Toxicology

7.15a General Toxicology

Be able to describe the role of the laboratory in the diagnosis, treatment and support of the poisoned patient.

KNOWLEDGE

Know the role of the laboratory in the diagnosis, treatment and support of the poisoned patient, including the estimation of paracetamol, salicylate, ethanol, ethylene glycol and carbon monoxide in a range of sample types

Be aware of the role played by your laboratory in the diagnosis, treatment and support of patients poisoned by heavy metals.

Understand the diagnosis of the poisoned patient.

Be aware of routine toxicology analysis available in most laboratories and those only available in specialist centres.

Be aware of the principles of treatment of poisoning.

Understand the metabolism of toxic substances at therapeutic and overdose levels e.g. salicylate and paracetamol.

Be aware of other laboratory investigations used to support the poisoned patient.

Understand the principles and limitations of the analytical method employed and sample requirements, e.g. spectrometry, chromatography (gas, liquid, thin layer), including: factors affecting sample integrity appropriate corrective action and the risks associated with the reagents or method.

Understand the metabolism of ethanol.

Be aware of acute and chronic abuse of ethanol and other alcohols including methanol and ethylene glycol.

Understand the significance of ethanol, methanol and ethylene glycol. levels in acute poisoning, chronic alcohol abuse and legal/forensic cases.

Be aware of other analyses which may be measured to reflect alcohol use over differing time periods and how to interpret the results.

Understand the toxic effect posed by carbon monoxide.

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KNOWLEDGE

Be aware of the use of hyperbaric treatment and the availability of such treatment.

Be aware of Point of Care Testing (POCT) as well as laboratory testing.

Be aware of national and international guidelines on the timing of collection, type of sample and timing of analysis for use in investigation of the poisoned patient.

Be aware of analyses used to monitor chronic substance abuse.

Be aware of Occupational and Environmental toxicology.

Be aware of the Poisons Advisory Service and TOXBASE.


Know the difference between qualitative and quantitative analysis.

COMPETENCE


Confirm the presence of paracetamol, salicylate, iron, ethanol, ethylene glycol and carbon monoxide in a range of sample types.

Deal with requests for heavy metals according to local procedures.

Confirm the time from exposure to sample collection and analysis.

Perform the timely analysis of plasma/serum and other body fluids.





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7.15b Drugs of Abuse

Be able to describe how to confirm the presence of drugs of abuse and perform estimation of specific drugs present on a range of sample types.

KNOWLEDGE

Know the role of your laboratory in support of the poisoned patient including the estimation and confirmation of the presence of common drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and metabolites, LSD and opiates) and those used in the treatment of chronic abusers including: Buprenorphine and metabolites; Methadone and metabolites.

Be aware of legislation relating to the use and abuse of drugs.

Be aware of regulations relating to the storage and security of drugs.

Be aware of the principles and limitations of screening and confirmation analysis for tests associated with drugs of abuse in your own laboratory.

Understand the need to use different analytical principles for screening and confirmation testing.

Be aware of sample types used in the detection and estimation of abused drugs, including:

o Urine;

o Blood/serum/plasma;

o Hair;

o Gastric contents;

o Saliva;

o Tissue samples.

Know the local rules for „Chain of custody‟ sample handling and reporting of results.

Know the difference between qualitative and quantitative analysis.

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Be aware of the principles, techniques and sample requirements used in the measurement of drugs, including:


o Immunoassay;



o Mass spectrometry;

o Ion-specific electrodes;

o Flame emission spectrophotometry.

Be aware of the principles and limitations of pharmacokinetics.


Be aware of the problems associated with post mortem samples and drug redistribution.


Be aware of the Poisons Advisory Service and TOXBASE.


COMPETENCE


Maintain „Chain of Custody‟ handling and completion of documentation according to standard operating procedure.

Describe the principles and practice of screening procedures and confirmation of positive screening results (and quantitative analysis, if appropriate).

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7.16 Gastrointestinal Inherited Metabolic Disorders and Newborn Screening: Prenatal Screening for Predicting Down’s Syndrome

KNOWLEDGE

There are a large number of disorders that can be investigated. Many are only measured in specialised Laboratories others as services attached to specific clinical units. Therefore it is expected that the trainee will not necessarily have much exposure to all of the analytical processes described but they should be exposed to the „first line‟ testing such as detection of reducing substances in urine.

a) The major categories of inherited metabolic diseases : A working knowledge of the overall scope and prevalence of diseases within the populations that are served will be expected and the tests offered within and outwith the candidate‟s own laboratory. The disorders that may warrant consideration will include the following types with examples given in brackets:

carbohydrate metabolism (glycogen storage disease);

amino acid metabolism (phenylketonuria, maple syrup urine disease, glutaric acidemia type 1);

organic acid metabolism (organic acidurias - alcaptonuria);

fatty acid oxidation and mitochondrial metabolism (medium chain acyl dehydrogenase deficiency, glutaric acidemia type 2);

porphyrin metabolism (acute intermittent porphyria);

purine or pyrimidine metabolism (Lesch-Nyhan syndrome);

steroid metabolism (congenital adrenal hyperplasia);

mitochondrial function (Kearns-Sayre syndrome );

peroxisomal function (Zellweger syndrome);

lysosomal storage disorders (Gaucher's disease).

Understand in the principles of metabolic disorders and screening programmes.

Know the procedures used to screen within their own laboratory.

Be aware of the tests used within specialized centres.

Be aware of the need for ongoing monitoring in certain conditions.

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http://wapedia.mobi/en/Organic_aciduria

http://wapedia.mobi/en/Alcaptonuria

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http://wapedia.mobi/en/Lesch-Nyhan_syndrome

http://wapedia.mobi/en/Mitochondrial

http://wapedia.mobi/en/Kearns-Sayre_syndrome

http://wapedia.mobi/en/Peroxisomal

http://wapedia.mobi/en/Gaucher%27s_disease

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b) The case to screen for disease

Understand the genetic basis of inherited disease.

Understand the metabolic significance and classification of:

o organic acids;

o carbohydrate intolerance.

Be aware of inborn errors of metabolism presenting with organic aciduria.

Understand the principles and limitations of screening tests for organic acidurias and carbohydrates.

Be aware of inborn errors of amino acid metabolism.

Be aware of the underlying metabolic disorder causing cystic fibrosis.

Understand the porphyrin biosynthetic pathway and classification of the porphyrias.

Be aware of the screening programmes for inherited and congenital disorders.

Understand the purpose, principles and limitations of screening.

Understand the importance of sampling time in terms of integrity of sample and in terms of timely therapy

Understand the following terms in the context of screening for differences: Predictive Value, Sensitivity, Specificity, Selectivity, Prevalence, False Negative, False Positive

Be aware of the specimen needs, tests offered and limitations of the Newborn Screening Services including:

o UK Newborn Screening Programme Centre and Blood Spot Forms;

o Tests offered;

o Factors that may affect suitability of samples including Blood Transfusion and Prematurity;

o Patients‟ rights and ethical issues.

Understand the genetic basis of Down‟s syndrome.

Be aware of the screening programmes for inherited and congenital disorders.

Be aware of non-laboratory techniques used in the pre-natal screening for Down‟s syndrome.

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.KNOWLEDGE (continued)

c) Analytical Techniques

Understand the purpose of common analyses and the principles and limitations of the analytical method employed and sample requirements.


Be aware of the principles and techniques used in measurement, including:

o Colorimetry;

o Immunoassay;



o Mass spectrometry;

o Thin layer Chromatography.

Know where molecular genetics and other analyses should be used.

Understand the principles and limitations of sweat collection methods.

Understand the principles and limitations of methods for the estimation of sodium chloride, osmolality, and electrical conductivity of sweat samples.

Understand the principles and limitations of the AFP, HCG, inhibin A and Oestriol methods used in the prenatal screening for neural tube defects and Down‟s syndrome.

Understand the principle behind the calculation of Down‟s syndrome risk using the Triple/Quadruple test.

Be aware of further investigations by specialist units (including IRT and molecular techniques).

Understand the principles of Prenatal Diagnosis including Chorionic Villus Sampling and ethical and medical risks associated


Be aware of other tests initiated as a result of detecting abnormal amino acid patterns.


Understand the significance of results outside the reference range.

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COMPETENCE


Explain the clinical manifestation of at least one inherited metabolic disease resulting from:

o Decreased synthesis of a normal metabolite;

o Increased synthesis of a normal metabolite;

o Compromised trans-membrane transport;

o Decreased receptor synthesis;

o Altered binding of a coenzyme to an enzyme.

Confirm times when the samples should be collected.

Explain the methods available and the associated advantages and disadvantages for markers of the most common inborn metabolic disorders.

Analyse results, consider possible interference, and take appropriate action.

Report results appropriately to the significance of the test.


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7.17 Investigation of Thyroid Disease

7.17a Investigation of Thyroid Disease

Be able to perform the estimations on a range of sample types.

KNOWLEDGE

Estimations should include Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Free T4 (fT4), Tri-iodothyronine (T3) and/or Free T3 (fT3) and anti-Thyroid peroxidase antibodies (TPO).

Be aware of the mechanism of hormone control and action on target organ.

Understand the synthesis, control and function of hormones in the hypothalamic pituitary-thyroid axis.

Understand the biochemistry and physiology of the thyroid gland.

Know how to perform the measurement of T3, T4 and thyroid stimulating hormone (TSH).

Understand the clinical significance of free hormones compared to total hormone levels.

Be aware of dynamic function tests requiring estimation of thyroid hormones.

Understand the principles and limitations of total and free hormone assays in general.


Understand the significance of abnormal results.




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COMPETENCE



Perform the timely analysis of plasma/serum: T4 total or free, T3 total or free (depending on local repertoire), TSH and be aware of the methods available for TPO analysis.








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7.18 Abnormal Pituitary Function

7.18a Abnormal Pituitary Function


KNOWLEDGE

Estimations should include Growth Hormone, Prolactin, Adrencorticotrophic Hormone (ACTH), TSH, LH and FSH.


Understand the synthesis, control and function of Growth Hormone, Prolactin, ACTH, TSH, LH and FSH in health and disease.

Understand the biochemistry and physiology of the hypothalamic pituitary axis.

Understand the principles and limitations of peptide hormone assays in general.


Be aware of dynamic function tests requiring estimation of pituitary hormones.





COMPETENCE


Assess suitability of sample for analysis (use of preservatives, storage conditions, timing) taking appropriate action if not.

Select the appropriate method of analysis which may or may not be available in your local laboratory.

Prepare equipment for analysis.

Perform in a timely manner, the investigations undertaken by your laboratory where adrenal disease is suspected, e.g. growth hormone, prolactin, TSH, LH and FSH in serum, ACTH in plasma.



Report results appropriate to the significance.


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7.19 Reproductive Endocrinology

7.19a Reproductive Endocrinology


KNOWLEDGE

Estimations should include follicle stimulating hormone (FSH), leutinising hormone (LH), prolactin (PRL), oestradiol (E2), progesterone (PRG), testosterone (TES) and sex hormone binding globulin (SHBG).


Understand the synthesis, control and function of hypothalamic/pituitary hormones.

Understand the biochemistry and physiology of the female menstrual cycle.

Be aware of the role of dynamic function testing and the assays involved.

Understand the principles and limitations of hormone assays in general.






COMPETENCE


Determine the day of the menstrual cycle (for females) from the information given on the request form.


Perform the timely analysis of sex hormones in serum, plasma or urine.


Monitor results, consider possible interference, and take appropriate action



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7.20 Investigation of Adrenal Disease

7.20a Investigation of Adrenal Disease

Be able to describe the biochemical investigations which are undertaken by your laboratory when adrenal disease is suspected and be competent to perform the estimations on a range of sample types.

KNOWLEDGE

Estimations should include cortisol, adrencorticotrophic hormone (ACTH) and catecholamines.


Understand the synthesis, control and function of cortisol, ACTH and catecholamines in health and disease.

Understand the biochemistry and physiology of the adrenal cortex and medulla.

Understand the role of neurotransmitters in the autonomic nervous system and causes of abnormal secretion.

Understand the principles and limitations of peptide and steroid hormone assays in general.


Be aware of dynamic function tests requiring estimation of adrenal hormones.





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COMPETENCE


Assess suitability of sample for analysis (use of preservatives, storage conditions, timing) taking appropriate action if not.

Select the appropriate method of analysis which may or may not be available in your local laboratory.

Prepare equipment for analysis.

Perform in a timely manner, the investigations undertaken by your laboratory where adrenal disease is suspected, e.g. cortisol in serum and urine, ACTH in plasma, catecholamines in plasma and urine.





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7.21 Point of Care Testing (POCT)

7.21a Point of Care Testing (POCT)

Be able to describe common POCT systems used in your hospital and the role of the laboratory in providing support for them which may include blood gases and electrolytes, glucose, pregnancy testing, lactic acid, drugs of abuse screening, urine screening, HbA1c, cardiac markers.

KNOWLEDGE

Understand what is meant by point of care testing. Consider definitions by the IBMS and the ISO standard.

Understand the advantages and disadvantages of point of care.

Know the various areas or settings point of care testing is carried out.

Be aware of the growing field of point of care testing.

Understand the importance of correct sample collection and analysis.

Be aware of the factors affecting sample integrity and the implications of producing incorrect results.

Understand the principles and limitations of the analytical methods utilized in point of care testing equipment including:

o Amperometry;

o Absorbance;

o Spectroscopic analysis;

o Reflectance;

o Fluorescence;

o Conductimetry;

o Potentiometry;

o Multi-wave spectroscopy;

o Dry-reagent biosensors;

o Microchip technology;

o Immunoassay;

o Non-invasive assays.

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Understand the importance of regular training of clinical staff and competency testing.

Be aware of the principles and techniques used in modern point of care equipment.

Understand the importance of correct data handling and storage.

Be aware of the guidelines and policies associated with point of care testing, including CPA/ RCPath.

Understand the importance of staff using individual passwords.


Importance of pre and post analytical-patient preparation, sample collection and analysis.

COMPETENCE


Define what is meant by point of care testing.

List the advantages and disadvantages of POCT?

Define where point of care testing is used in your own laboratory environment.

Describe the role of your laboratory in supporting POCT.

Provide advice on the correct sample type and/or collection device for sample collection.

Perform in a timely manner, analyses as required.

Validate results.




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About this document

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

Produced by: Clinical Chemistry Advisory Panel

Contact: Executive Head of Education

Version: Edition 3

Date active: September 2011

Comments:

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