virology

www.ibms.org

THE INSTITUTE OF BIOMEDICAL SCIENCE

Record of Laboratory Trainingfor the

Specialist Diplomain

Virology

Please address any queries to:

THE INSTITUTE OF BIOMEDICAL SCIENCE12 Coldbath SquareLondon EC1R 5HL

Tel. No. 020 7713 0214; Fax. 020 7837 3286Email: [email protected]

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Personal Record

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:

Secondment Details

Site Dates of Secondment Reasons for Secondment

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Training Review

Reviewed by Date Comments

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CONTENTS

1. Introduction 12

2. Use of Portfolio 18

3. Laboratory Based Training 22

4. Assessment Procedure 26

5. Definitions 32

6. Generic To All Disciplines 34

6.1 Professional Roles and Relationships 35Be able to understand and apply good professional practice inpartnership with other professionals, support staff, patients, andservice users.

6.2 Health and Safety 39Be able to understand and apply health and safety requirements.

6.3 Receipt and Processing of Samples 43Be able to understand and apply the correct procedures for thehandling of specimens before, during and after analysis.

6.4 Laboratory Computer System 49Be able to use the main laboratory computer system in accordancewith service requirements.

6.5 Laboratory Equipment 53Be able to maintain and operate equipment used in the preparationand analysis of samples.

6.6 Quality Assurance 57Be able to understand and apply quality procedures throughout thelaboratory.

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7. Discipline Specific: Virology 62

7.1 Standard Laboratory Procedures 637.1a Immunoassays7.1b Agglutination Assays7.1c Immunofluorescence7.1d Neutralisation Assays7.1e Molecular Techniques7.1f Immunoblot Assays7.1g Electrophoretic and Gel Diffusion7.1i Cell culture techniques7.1j Virus Identification7.1k Complement Fixation Tests7.1l Electron Microscopy7.1m Animal and Egg Culture

7.2 Respiratory Virus Infections 897.2a Diagnostic Algorithm7.2b Immunological Investigations7.2c Detection of Antigen and Replication Virus7.2d Molecular investigations

7.3 Enteric Virus Infections 997.3a Diagnostic algorithm7.3b Immunological Investigations7.3c Electron Microscopy7.3d Molecular investigations

7.4 Sexually Transmitted Diseases 1097.4a Diagnostic algorithm7.4b Immunological Investigations7.4c Electron Microscopy and Cell Culture7.4d Molecular Investigations

7.5 Infections in Pregnancy (Pre- and Post Delivery) 1197.5a Diagnostic Algorithm7.5b Immunological Investigations7.5c Molecular Techniques

7.6 Neurological disease including Prion disease 1277.6a Diagnostic Algorithm7.6b Immunological and Molecular Techniques7.6c Electron Microscopy

7.7 Vesicular and Red Rashes and Systemic infections 1357.7a Diagnostic Algorithm7.7b Immunological Techniques7.7c Electron Microscopy and Cell Culture7.7d Molecular Techniques

7.8 Blood-borne Virus Infections 1457.8a Diagnostic Algorithm7.8b Immunological Techniques

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7.8c Molecular Techniques

7.9 Investigation of Viral Hepatitis 1537.9a Diagnostic Algorithm7.9b Immunological Techniques7.9c Molecular Techniques

7.10 Infections in Neonates and Infants 1617.10a Diagnostic algorithm7.10b Immunological Techniques7.10c Electron Microscopy and Cell Culture7.10d Molecular Techniques

7.11 Immunocompromised Patients 1717.11a Diagnostic algorithm7.11b Immunological investigations7.11c Electron Microscopy and Cell Culture Techniques7.11d Molecular Techniques

7.12 Travel Related and Exotic Infections. 1817.12a Diagnostic Algorithm7.12b Immunological investigations7.12c Electron Microscopy Techniques7.12d Molecular Techniques

7.13 Infection Control 1917.13a Infection Control Procedures

7.14 Application of pre and post exposure prophylaxis andvaccination in virology 195

7.14a Principles of pre and post exposure prophylaxis7.14b Principles of vaccination7.14e Indications for vaccination in the general community

7.15 Application of methods for antiviral treatment andresistance in virology 203

7.15a Principles of anti viral therapy7.15b Principles of viral load monitoring7.15c Principles of anti viral resistance testing

7.16 Application of methods for investigation ofenvironmental samples for virology 211

7.16a River and water samples7.16b Food samples7.16c Air and aerosol sampling7.16d Testing procedures to detect the presence of fomites

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1. Introduction

INSTITUTE OF BIOMEDICAL

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1. INTRODUCTION

To comply with several Department of Health (DH) initiatives, registered practitionersare expected to provide evidence of fitness to practice that can be independentlyassessed. This record of laboratory training (training portfolio) and the supportingevidence of achievement will be used by the Institute of Biomedical Science indetermining eligibility for the award of a specialist diploma; by higher educationinstitutions in assessing work-based learning and accredited prior experientiallearning for postgraduate qualifications; or by employers in determining which of theNational Occupational Standards (NOS) and Agenda for Change criteria have beenachieved when considering promotion.

This portfolio for specialist training will enable a biomedical scientist to build on theirknowledge, skills and competencies at postgraduate level and reflect on, consolidateand develop specialist knowledge and competencies for employment as a specialistpractitioner in biomedical science in the health services of the UK.

In order to be awarded an Institute Specialist Diploma the individual must be acorporate member of the Institute and have completed the Institute’s SpecialistTraining Portfolio in accordance with the Institute’s instruction. The portfolio is notavailable to Affiliate members of the Institute or individuals undertaking pre-registration training.

Individuals awarded the Specialist Diploma will be able, at threshold level, to:

i) Work in accordance with good professional practice in partnership with otherprofessionals, support staff, patients and service users.

ii) Demonstrate an understanding and application of health and safetyrequirements.

iii) Undertake the correct procedures for the handling of specimens, before,during and after analysis.

iv) Use the main laboratory computer system in accordance with servicerequirements.

v) Maintain and operate equipment used in the preparation and analysis ofsamples.

vi) Perform a range of laboratory tests without immediate supervision anddemonstrate an understanding of the scientific basis for tests and the diseaseprocesses under investigation.

vii) Demonstrate awareness of factors affecting sample integrity, risks associatedwith the sample reagents, or method and other tests indicated by the outcomeof the analysis.

viii) Be able to understand and apply principles of quality control and qualityassurance.

The training portfolio for the Institute’s Specialist Diploma is available to corporatemembers of the Institute and is issued on application to the Institute with the requiredpayment, which is inclusive of the end point assessment. Applicants must beworking in an Institute approved training laboratory.

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During completion of the portfolio, biomedical scientists will be gathering evidence ofcontinuing professional development (CPD) and competence to practice. This meetsthe 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

The National Occupational Standards (NOS) for healthcare scientists have beenincorporated into the Institute’s qualification framework for Specialist and HigherSpecialist Diplomas. The standards that are generic to all disciplines are:

A Use of equipmentB Developing protocols, procedures and methodsC Handling of specimensD Interpret results and provide clinical resultsE Maintain a safe and secure working environmentF ManagementG Training and professional developmentH Research and developmentI Patient careJ Advice on healthcare services

Together with discipline-specific NOS standards, these are used as a framework forthe knowledge and competence statements, and for the sectioning of this trainingportfolio:

Section 6 Is generic to all disciplines and defines training leading to competenceat the level of a specialist practitioner in service delivery, health andsafety, management, quality assurance, the use of equipment, andsample preparation, covered in relevant NOS functions of A, B, C, E,F and G.

Section 7 Covers the range of tests appropriate to specific NOS functionsrelated to specialist practice.

The portfolio also maps to the Knowledge and Skills Framework (KSF), which will bean appraisal tool used by employers for identifying education and training needs.

The analyses covered in this training portfolio are those performed by mostlaboratories in the UK but some might not be performed in the candidate’s ownlaboratory. However, knowledge of all the analyses is required, even if practicalcompetence to perform them cannot be demonstrated, as this will express the abilityof the biomedical scientist to operate at the specialist level. There may be other teststhe training laboratory includes in its basic repertoire and therefore requires theindividual to be competent in. These can be recorded in the reflective log at the endof each sub-section.

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Whilst the observation of practical skills and assessment of competence are specificto each of the tests or techniques, essays and case study evidence can be used todemonstrate knowledge and can cover several tests or techniques. The essays,case studies, or other evidence of knowledge may be acquired during formal studyfor a postgraduate award or as part of an internal training regime.

Reference to ‘a range of sample types’ can include blood, serum, plasma, urine,CSF, etc, but also includes demonstration of competence in assessing the suitabilityof the sample under investigation, for example lipaemic, inadequate, haemolysed,inappropriately labelled, transported, or stored samples within a specific sample type.

PLEASE NOTE: Whilst the award of a higher degree is not a prerequisite for theaward of a Specialist Diploma there is the opportunity to integrate the two wherepossible. For example, it is hoped that the in-service training undertaken to completethis portfolio will be recognised by higher education institutions under the category ofwork-based learning and accrue academic credit towards an M level qualification.Equally, the formal education and assessments undertaken as part of a Mastersdegree will provide evidence that can be used in this portfolio.

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2. Use of Portfolio


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2. USE OF PORTFOLIO

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

2.2 The laboratory training officer (or a suitable deputy) and the individualundertaking training must date and sign when the training was completed.

2.3 The portfolio will contain evidence that candidates have applied knowledge,comprehension and analytical skills gained at undergraduate level to the(new) situation in which they work.

2.4 They will demonstrate that they can relate knowledge from several areas,draw conclusions and reflect on their own performance as an independentprofessional learner, thus meeting the requirements for CPD.

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

2.6 Additional evidence of training and internal assessment of competency willsupport the Specialist Portfolio; with appropriate cross-referencing to showwhich aspect of knowledge or skill acquisition is supported. This may include:copies of quality control logs maintenance schedules, audit trail results,essays, notes, case studies, Journal Based Learning (JBL) and PowerPointpresentations.

2.7 A signed statement must be provided by the laboratory manager, whichindicates the laboratory’s repertoire and analyses that a specialist practitionerworking in that laboratory would be expected to perform without supervision.

2.8 The portfolio is the property of the individual and it will form an important partof the registrant’s portfolio of training activity.

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3. Laboratory BasedTraining


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3. LABORATORY BASED TRAINING

3.1 To permit eligibility for the award of a Specialist Diploma, in-service trainingmust demonstrate competence and experience in the stated procedures as‘fitness to practice’ as a specialist in the individual’s chosen discipline.

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

3.3 A training schedule must be prepared and adhered to in accordance with theInstitute’s Standards for Training in the Laboratory and also to meet CPAstandard B9.1.

3.4 The training co-ordinator/officer should ensure that regular reports onprogress from trainers are reviewed at least once a month, discussed with theindividual being trained, and documented. The object of these review pages isto 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 chosendisciplines. Some tests may be considered as ‘core’ and requiredemonstration of practical competence. Other tests may only requiredemonstration of knowledge and understanding that would be applied to thepractical situation, if an investigation were considered to be outside the corerepertoire of a routine laboratory.

3.6 Short periods of secondment to other Institute approved laboratories maysupplement training in order for the individual to gain additional practical skillsand experience.

3.7 Candidates may undertake a selection of the following activities to completethe “Record of Laboratory Training for the Specialist Diploma” and prepare forassessment:

i) Work-based training.

ii) Continuing professional development (CPD).

iii) Journal Based Learning (JBL).

iv) Essays and case studies.

v) Tutorials.

vi) Taught MSc courses at a Higher Educational Institution.

vii) Taught specialist distance-learning courses.

3.8 Evidence of achievement is based on observation and questions set by thetrainer or individual pieces of work related to the knowledge statements ofeach module and based on the examples of evidence listed in Section 5(page 30).

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4. AssessmentProcedure


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4. ASSESSMENT PROCEDURE

4.1 On completion of training in accordance with the requirements of theSpecialist Portfolio, the candidate’s employer (laboratory manager or trainingofficer) should apply to the Institute for the appointment of a visiting externalassessor. The appointed external assessor will be instructed to contact thelaboratory in accordance with the Institute’s assessment procedure.

4.2 The aims of the assessment procedure are to:• Independently verify that competence has been met• 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• Highlight areas of unsatisfactory practice

4.3 There will be a meeting between assessor and candidate during which theassessor establishes confidence in the understanding, ability and practice ofthe candidate. A key component of this will be a twenty-minute presentationduring which the candidate presents a review of their post-registration trainingexperience and current issues important within their discipline.

4.4 The external assessor will establish completion of the portfolio as a record oftraining in the candidate’s ‘home’ discipline. If more specialist areas are notundertaken in the candidates employing laboratory, demonstration ofappropriate knowledge and understanding rather than practical competenceis acceptable.

4.5 The external assessor will review the reflective reports associated with eachmodule and interview the candidate on aspects of their work raised in thecommentary and presentation. The discussion should be supported byexamples contained within an accompanying portfolio of evidence.

4.6 The candidate will conduct the external assessor on a laboratory tour duringwhich further aspects of the candidates training and work are explored.

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5. Definitions


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5. DEFINITIONS

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 of the facts associated with the key task.

UNDERSTAND Thorough comprehension of the principles and concepts of thecontent of the key task.

COMPETENT Has the ability to perform a test or procedure to a set standardon more than one occasion, in a consistent manner and withminimal or no supervision, together with a thoroughcomprehension of the principles and concepts of the content ofthe key task.

EVIDENCE OFACHIEVEMENT

The Institute’s Specialist Diploma will only be awarded if there issupporting evidence that competence has been achieved. Thisevidence will be presented as a portfolio, logically and cross-referenced to the relevant module or sections it supports.

Suggested evidence for inclusion:• Audit trail results• Annotated photomicrographs• Copies of QC logs• Copies of EQA records• Maintenance schedules• Error logs• Essays, (this may include essays submitted at CPD or as

part of academic study)• Quizzes• Notes• PowerPoint presentations• Annotated kit inserts• Annotated journal papers

CoC Health Professions Council Code of Conduct.

CPA Clinical Pathology Accreditation

HPC Health Professions Council

KSF Knowledge and Skills Framework.

NOS National Occupational Standards.

SOP Standard Operating Procedure.

SoP Health Professions Council Standards of Proficiency.

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6. Generic To AllDisciplines

Section 6 is generic to all disciplines and defines training leading to competence atthe level of a specialist practitioner in relation to professional practice, servicedelivery, processing of samples, use of equipment, IT and quality assurance.It reflects the HPC standards of proficiency and can be used as evidence ofcontinuing professional development in a specialist discipline.


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Section 6. GENERIC TO ALL DISCIPLINES

6.1 Professional Roles and Relationships

Be able to understand and apply good professional practice in partnership withother professionals, support staff, patients, and service users.

KNOWLEDGE

• Know limits of own professional practice and referral mechanisms.• Understand the principles of team working, leadership and the significance of

individual contributions in the laboratory team.• Understand the principles of effective communication within the laboratory

and to service users in order to achieve the aims of the service.• Be aware of the roles and relationships of other professional groups in the

clinical setting.• Be aware of the factors influencing the effectiveness of the laboratory service.• Know how and where to access information of relevance to the request for

advice.

COMPETENCEYou must be able to:

a) Clarify your role within the laboratory and expectations of your contribution.

b) Take relevant action to co-ordinate your contribution with the requirements ofothers.

c) Co-operate effectively with service users by providing appropriate advice andassistance.

d) Demonstrate good interpersonal skills and the ability to sustain good workingrelationships within the laboratory team and with service users.

e) Demonstrate good verbal and written communication skills through all stagesof the biomedical process.

f) Ensure that work outside the scope or ability of your practice is passed to theappropriate individual or professional group.

g) Respond to routine requests with accurate and current information.

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EVIDENCE OF ACHIEVEMENT

This section requires the trainer to sign that competence has been successfullyachieved on more than one occasion. Biomedical scientists completing the Institute’sRegistration Portfolio to attain a Certificate of Competence and HPC registration willalready have covered the majority of this section. It is included here to demonstratecontinued competence and continuing professional development (CPD) and tostandardise with the competence requirement for a registered practitioner.

Date of completion:Trainer’s name:Trainer’s signature:

Portfolio and evidence of competence for this standard assessed and passedby:

Assessor’s signature:

Assessor’s name:

Date:

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Reflective Log - Professional Roles and Relationships

1. Profession specific meetings attended.Duration oftrainingFrom

To

2. How have you applied your training to your current role?

3. How will you apply the learning in your future work?

4. Future development possibilities.

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6.2 Health and Safety

Be able to understand and apply health and safety requirements.

KNOWLEDGE

• Be aware of current safety legislation relevant to the laboratory, including theUSDAW “six pack” (that substantiates the Health and Safety at Work Act1974) and other regulations including:o Management of Health and Safety at Work Regulationso Manual Handling Operations Regulationso Display Screen Equipment Regulationso Workplace (Health, Safety and Welfare) Regulationso Provision and Use of Work Equipment Regulationso Personal Protective Equipment Regulationso RIDDORo COSHH

• Understand the responsibilities of the employer and employee defined in theHealth and Safety at Work Act and other appropriate legislation.

• Be aware of the contents of the laboratory safety manual and local safetyprocedures.

• Understand the principles and limitations of hazard analysis, monitoring andmanagement.

• Understand and know appropriate waste routes for various types of wasteand alternatives in different situations.

• Know the types of safety equipment and their proper use.


a) Locate relevant health and safety procedures, guidelines, and documents inthe laboratory.

b) Respond to hazardous situations in an appropriate and safe manner.

c) Perform tasks in accordance with H&S guidelines.

d) Select and use appropriate safety equipment.

e) Perform a risk assessment and a COSHH assessment.

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Supporting evidence should be collected and prepared as indicated below as aportfolio.

i) Answered questions set by the trainer regarding the location and use of thesafety manual and safety equipment in the laboratory.


ii) Provided evidence of attendance at Trust fire safety and manual handlingtraining sessions.


iii) Provided a copy of a risk assessment report and COSHH assessment reportcarried out under the guidance of the safety officer.




Assessor’s name:

Date:

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Reflective Log - Health & Safety

1. Safety lectures/course attended.Duration oftraining.From

To




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6.3 Receipt and Processing of Samples

Be able to understand and apply the correct procedures for the handling ofspecimens before, during and after analysis.

KNOWLEDGE

• Understand the laboratory procedure for test requesting and sample receipt.• Understand the need for patient confidentiality and the implications of the

Data Protection Act.• Be aware of collection techniques appropriate to the sample under

investigation and the sample requirements for particular tests and proceduresto employ when requirements are not met.

• Understand about universal precautions for the handling of all samplesincluding the hazards posed by ‘High Risk’ samples and be aware of theprocedures implemented in their safe handling.

• Understand the laboratory procedures for specimen preparation prior tolaboratory investigation.

• Understand the laboratory procedure for the storage of samples.• Be aware of particular storage requirements for some tests.• Be aware of guidelines for long-term storage of samples for various patient

groups.• Understand the laboratory procedure for the safe disposal of biological

samples.• Be aware of legislation and regulations covering the transport of samples.

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a) Locate information on the sample requirements for a particular test fromLaboratory Handbook and SOPs.

b) Safely receive, handle and move samples according to local procedures.

c) Confirm minimum compliant data set for acceptable patient ID and canconfirm that patient details and test request from request form match those onthe sample.

d) Take appropriate action if the patient details are not completed correctly orare incomplete.

e) Confirm sample type is appropriate to the test being requested, if not, takeappropriate action.

f) Perform sample preparations steps relevant to the investigation.

g) Store samples appropriately and safely in line with long term storageguidelines.

h) Arrange for referral of samples to specialist centre.

i) Dispose of samples appropriately and safely.

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This section requires the trainer to sign that competence has been successfullyachieved on more than one occasion. Biomedical scientists completing the Institute’sRegistration Portfolio to attain a Certificate of Competence and HPC registration willalready have covered the majority of this section. It is included here to demonstratecontinued competence and continuing professional development (CPD) and tostandardise with the competence requirement a registered practitioner.

Supporting evidence should be collected and prepared as a portfolio.

i) Observed by trainer to prepare samples for analysis.


ii) Answered questions set by the trainer on the receipt, preparation, referral (ifappropriate), storage and disposal of samples.


iii) Described the range of techniques used to prepare samples for routineanalysis.




Assessor’s name:

Date:

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Reflective Log - Receipt and Processing of Samples

1. Range of sample types.Duration oftraining.From

To




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6.4 Laboratory Computer System

Be able to use the main laboratory computer system in accordance withservice requirements.

KNOWLEDGE

• Be aware of the basic principles of Information Technology (IT).• Be aware of interfacing with major laboratory equipment, hospital IT and GP

links.• Where applicable, understand the user interface for:

ο booking-in sample requestsο generation of work listsο enquiriesο basic statistics generationο report generation

• Understand the laboratory procedure for test requesting and sample receipt.• Understand the need for patient confidentiality and the implications of the

Data Protection Act.


a) Book-in sample test requests and patient details.

b) Generate work lists (if applicable).

c) Interrogate the laboratory computer system to:

o retrieve specific sample resultso obtain additional information and test results to help in current analysiso retrieve cumulative data on a single patient, groups of patients, or QCo Generate laboratory report.

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This section requires the trainer to sign that competence has been successfullyachieved on more than one occasion. Biomedical scientists completing the Institute’sRegistration Portfolio to attain a Certificate of Competence and HPC registration willalready have covered the majority of this section. It is included here to demonstratecontinued competence and continuing professional development (CPD) and tostandardise with the competence requirement for a registered practitioner.Supporting evidence should be collected and prepared as indicated below as aportfolio.

i) Answered questions set by the trainer on the use of the laboratory computersystem.




Assessor’s name:

Date:

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Reflective Log - Laboratory Computer System

1. Type of laboratory computer system.Duration oftraining.From

To




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6.5 Laboratory Equipment

Be able to maintain and operate equipment used in the preparation andanalysis of samples.

KNOWLEDGE

• Understand the principles and limits of operation of named laboratoryequipment.

• Be aware of the range of application for the main laboratory analysers orequipment used in routine preparation and analysis of samples.

• Understand the use of test profiles and the profiles available.• Know how to use calibration and control materials.• Know the physical, chemical and biological hazards associated with

laboratory equipment.


a) Perform the routine maintenance in accordance with laboratory procedures.

b) Prepare equipment for sample processing or analysis in accordance withlaboratory procedures.

c) Monitor operation of equipment in accordance with laboratory procedures.

d) Complete laboratory records as required.

e) Perform routine decontamination using appropriate procedure.

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This section requires the trainer to sign that competence has been successfullyachieved on more than one occasion. Biomedical scientists completing the Institute’sRegistration Portfolio to attain a Certificate of Competence and HPC registration willalready have covered the majority of this section. It is included here to demonstratecontinued competence and continuing professional development (CPD) and tostandardise with the competence requirement for a registered practitioner.Supporting evidence should be collected and prepared as indicated below as aportfolio.

i) Answered questions set by the trainer on principles of operation and uses ofnamed laboratory equipment, including (where appropriate) routinepreventative maintenance, calibration, and limitations of the equipment.




Assessor’s name:

Date:

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Reflective Log - Laboratory Equipment

1. Main Equipment Used. (eg type of automated analyser, microtome,microscope)

Duration oftraining.From

To




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6.6 Quality Assurance

Be able to understand and apply quality procedures throughout the laboratory.

KNOWLEDGE

• Understand the principles and application of quality control and qualityassurance.

• Understand the difference between vertical and horizontal audit.• Be aware of the use of quality management tools, e.g. Westgard Rules• Understand the purpose of Clinical Pathology Accreditation (UK) Ltd.• Understand the role of the Institute of Biomedical Science and Health

Professions Council relevant to professional standards patient healthcare.• Be aware of the relevant codes of practice, legislation, ethical considerations

and issues of confidentiality applicable to the area of laboratory investigation.


a) Describe the principles and practice of quality control procedures for namedlaboratory investigations.

b) Describe the use of external quality assurance schemes applicable to yourlaboratory.

c) Explain the use of Westgard rules and Levy Jennings plots.

d) Conduct vertical and horizontal audits to check correct application oflaboratory procedures.

e) Demonstrate an understanding of the role and requirements of accreditationby CPA (UK) Ltd through the application of one’s own practice.

f) Describe the different roles of the professional and regulatory organisationsfor biomedical scientists and demonstrate an understanding of the relevanceto professional practice.

g) Show awareness of need to apply relevant legislation relevant to theinvestigation and use of patient samples.

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Supporting evidence should be collected and prepared as indicated below as aportfolio.

i) Answered questions set by the trainer on relevant quality control, qualityassurance and legislative practices.


ii) Presented evidence of a vertical and horizontal audit conducted in theworkplace.




Assessor’s name:

Date:

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Reflective Log - Quality Assurance

1. External Quality Assurance Schemes.Duration oftraining.From

To




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7. Discipline Specific:Virology

This section covers the range of tests appropriate to specific NOS functions relatedto specialist practice in Virology.

The analyses covered are those performed by most laboratories in the UK but somemight not be performed in the candidate’s own laboratory. However, knowledge of allthe analyses is required (or awareness if the test is not performed in the laboratory),as this will express the ability of the biomedical scientist to operate at the specialistlevel. There may be other tests the training laboratory included in its basic repertoireand therefore requires the individual to be competent in. These can be recorded inthe reflective log at the end of each sub-section.

Whilst the observation of practical skills and assessment of competence are specificto each of the test or techniques, supporting evidence in the form of essays and casestudy evidence can be used to demonstrate knowledge and can cover several testsor techniques. The essays, case studies, or other evidence of knowledge may beacquired during formal study for a postgraduate award or as part of an internaltraining regime.


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Section 7. DISCIPLINE SPECIFIC: Virology

7.1 Standard Laboratory Procedures

7.1a ImmunoassaysBe able to perform immunoassay techniques on a range of sample types.

KNOWLEDGE

• Understand the principles and application of immunoassay techniques,including:o direct and indirect immunoassayo competitive immunoassayo capture immunoassayo solid phase and liquid phase immunoassay

• Understand the use and application of detection systems including:o enzymeo enzyme amplificationo immunofluorescenceo chemiluminescenceo radioactive

• Be aware of factors affecting sample integrity and appropriate correctiveaction.

• Be aware of specific risks associated with the reagents or method.• Understand the significance of abnormal results.• Know the relevant internal and external quality procedures.


a) Describe the principles of a variety of immunoassay techniques and thelimitations of each.

b) Perform routine immunoassays in accordance with laboratory procedure.

c) Critically evaluate assay results.

d) Follow-up positive results by confirmation.

e) Complete laboratory records as required.

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This section requires the trainer to sign that the specialist practitioner in training hassuccessfully achieved the level of competence on more than one occasion. Thepractitioner should collect and prepare other supporting evidence as a portfolio.

i) Observed by trainer to perform immunoassay techniques in accordance withstandard procedures.


ii) Answers questions set by trainer on principles and practice of immunoassaytechniques.


iii) Described the advantages and disadvantages of a range of immunoassaytechniques.




Assessor’s name:

Date:

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7.1b Agglutination AssaysBe able to perform agglutination assays on a range of sample types.

KNOWLEDGE

• Understand the principles and application of agglutination assays, including:o haemagglutination (and inhibition)o immune adherence haemagglutinationo particle agglutination




a) Describe the principles of a variety of agglutination and the limitations ofeach.

b) Perform routine agglutination techniques in accordance with laboratoryprocedure.




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i) Observed by trainer to perform agglutination techniques in accordance withlaboratory procedure.


ii) Answers questions set by trainer on the principles and practice ofagglutination techniques.


iii) Described the advantages and disadvantages of different agglutinationtechniques.




Assessor’s name:

Date:

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7.1c ImmunofluorescenceBe able to perform immunofluoresence techniques on a range of sample types.

KNOWLEDGE

• Understand the principles and application of immunofluorescence techniques,including:o direct and indirect immunofluorescenceo antigen detectiono antibody detection




a) Describe the principles of a variety of immunofluorescence techniques andthe limitations of each.

b) Perform routine immunofluorescence techniques in accordance withlaboratory procedure.



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i) Observed by trainer to perform immunofluorescence techniques inaccordance with laboratory procedure.


ii) Answers questions set by trainer on the principles and practice ofimmunofluorescence techniques.


iii) Described the advantages and disadvantages of immunofluorescencetechniques.




Assessor’s name:

Date:

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7.1d Neutralisation AssaysBe able to perform basic neutralisation techniques on a range of sample types.

KNOWLEDGE

• Understand the principles of neutralisation in serology.• Know how to perform serological neutralisation assays in accordance with

laboratory procedure.• Know how to interpret serological neutralisation assay results.• Know the relevant internal and external quality procedures.


a) Describe the principles of neutralisation techniques in serology.

b) Perform routine neutralisation techniques in accordance with laboratoryprocedure.



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i) Observed by trainer to perform neutralisation techniques in accordance withlaboratory procedure.


ii) Answers questions set by trainer on the principles and practice of theneutralisation techniques.




Assessor’s name:

Date:

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7.1e Molecular TechniquesBe able to perform basic molecular techniques on a range of sample types.

KNOWLEDGE

• Understand the use of molecular testing for viral detection, quantitation andgenotypic analysis.

• Understand the use of molecular testing for antiviral resistance determinants.• Understand the use of molecular testing for epidemiological study.• Understand the principles of nucleic acid extraction.• Know the limitations of the extraction method for a range of sample types.• Understand the importance of ultra-centrifugation for concentration of nucleic

acid.• Know the significance of contamination prevention in nucleic acid extraction.• Understand the principles of:

o target amplificationo polymerase chain reaction (PCR), RT-PCR and kinetic PCRo strand displacement assays (SDA)o nucleic acid sequence-based amplification (NASBA)o kinetic PCRo transcription mediated amplification (TMA)o Probe-Primer amplificationo Ligase chain reaction (LCR)o signal amplificationo branched DNA (bDNA)o hybridisation

• Know the principles and practice of molecular techniques for detection of viraldisease.

• Know the relevant internal and external quality procedures.


a) Describe the principles of molecular techniques.

b) Select molecular based assay for diagnosis, monitoring viral load, viralresistance testing and epidemiological surveillance.

c) Perform a selection of routine molecular techniques in accordance withlaboratory procedure.

d) Critically evaluate assay results.


72



i) Observed by trainer to perform a range of molecular techniques inaccordance with laboratory procedure.


ii) Answers questions set by trainer on the principles and practice of moleculartechniques.




Assessor’s name:

Date:

73

7.1f Immunoblot AssaysBe able to perform basic immunoblot techniques on a range of sample types.

KNOWLEDGE

• Understand the principles and limitations of immunoblot techniques, including:o RIBAo LIAo LIPA

• Know how to perform immunoblot assays and interpret results in accordancewith laboratory procedure.



a) Describe the principles of immunoblot techniques.

b) Perform a selection of routine immunoblot techniques in accordance withstandard laboratory procedure.



74



i) Observed by trainer to perform immunoblot techniques in accordance withstandard laboratory procedure.


ii) Answers questions set by trainer on the principles and practice of immunoblottechniques.




Assessor’s name:

Date:

75

7.1g Electrophoretic and Gel DiffusionBe able to perform basic electrophoresis and gel diffusion techniques on arange of sample types.

KNOWLEDGE

• Understand the principles and limitations of electrophoresis and gel diffusionassays.

• Know how to perform electrophoresis and gel diffusion assays.• Know how to interpret electrophoresis and gel diffusion assay results.• Know how to troubleshoot electrophoresis and gel diffusion assays.• Know the relevant internal and external quality procedures.


a) Describe the principles of electrophoretic and gel diffusion assays.

b) Perform a selection of routine assays in accordance with standard laboratoryprocedure.



76



i) Observed by trainer to perform electrophoretic and gel diffusion techniques inaccordance with standard laboratory procedure.


ii) Answers questions set by trainer on the principles and practiceelectrophoretic and gel diffusion techniques.




Assessor’s name:

Date:

77

7.1i Cell culture techniquesBe able to perform basic cell culture techniques.

KNOWLEDGE

• Understand the requirement for good aseptic technique.• Understand the origin and nature of cell line commonly used in virus isolation.• Understand the methods for preserving and recovering cell cultures.• Know how to maintain cell cultures.• Know how to perform good passage.• Know how to interpret cell culture monolayer cytopathic effects.• Understand the requirements for cell culture propagation.• Understand the requirements for incubation at different temperatures.• Know the principles of Mycoplasma detection, control and eradication from

cell lines.• Know how to select different cell lines for various viral cultures.• Know how to prepare samples for inoculation of cell cultures.


a) Perform routine preservation and recovery of cell cultures includingpreparation of cell stocks from tissues.

b) Prepare samples for inoculation of cell cultures.

c) Maintain and propagate cell cultures.

d) Demonstrate good passage technique.

e) Prepare sterile cell culture media and viral transport medium.

f) Perform sterility checks on culture media.

g) Use appropriate cell culture for inoculation of different type of specimens.

h) Interpret monolayer cytopathic effects.

78



i) Observed by trainer to perform basic cell culture techniques in accordancewith standard laboratory procedure.


ii) Answers questions set by trainer on the principles and practice of the cellculture methods.




Assessor’s name:

Date:

79

7.1j Virus IdentificationBe able to perform basic virus identification techniques.

KNOWLEDGE

• Understand the need for regular medium changes of inoculated cells.• Understand the principles of neutralisation in cell culture.• Understand the principles of haemadsorption in cell culture.• Understand the principles of acid tolerance test in cell culture.• Know how to interpret cell culture monolayer cytopathic effects.• Know how to perform virus identification assays and interpret results.


a) Perform various virus identification assays in cell culture in accordance withstandard laboratory procedure.

b) Select required virus identification assays for appropriate disease state.

c) Describe the limitations of each virus identification assay for cell culture.

d) Critically evaluate assay results.

80



i) Observed by trainer to perform virus identification by cell culture techniques inaccordance with standard laboratory procedure.


ii) Answers questions set by trainer on the principles and practice of the virusidentification methods.




Assessor’s name:

Date:

81

7.1k Complement Fixation TestsBe able to perform complement fixation techniques.

KNOWLEDGE

• Understand the principles and limitations of complement fixation tests.• Know how to perform complement fixation tests in accordance with standard

laboratory procedures.• Be aware of the application of functional complement in other techniques,

including SRH.• Know the relevant internal and external quality procedures.


a) Describe the principles and application of complement fixation techniques.

b) Perform complement fixation tests in accordance with standards laboratoryprocedure.


82



i) Observed by trainer to perform complement fixation techniques in accordancewith standard laboratory procedure.


ii) Answers questions set by trainer on the principles and practice of thecomplement fixation methods.




Assessor’s name:

Date:

83

7.1l Electron MicroscopyBe able to describe the use of electron microscopy techniques for theidentification of common viruses.

KNOWLEDGE

• Understand the principles of scanning and transmission electronmicroscopes.

• Understand the safety precautions required when use electron microscopy.• Understand the use of the ultracentrifuge for concentrating virus particles.• Be aware of the techniques used in immuno-electron microscopy.• Be aware of the techniques used to produce ultra-thin sections using the

ultramicrotome.• Know how to process specimens for electron microscopy.• Know how to prepare reagents and stains used in electron microscopy.• Know principles of how to prepare Formavar and carbon coated grids.


a) Describe how to process specimens for electron microscopy.

b) Describe how to prepare reagents and stains used in electron microscopy.

c) Describe how to prepare Formavar and carbon coated grids.

d) Recognise the morphology of the more common viruses.

84



i) Answered questions set by trainer on the principles and practice oftechniques used in the identification of viruses by electron microscopy.




Assessor’s name:

Date:

85

7.1m Animal and Egg CultureBe able to describe the use of animal and egg culture techniques used forvirus isolation.

KNOWLEDGE

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

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


a) Describe the traditional use of egg and animal culture techniques for virusisolation.

b) Describe alternative methods besides the use of eggs and animals for virusisolation and identification.

86



i) Answered questions set by trainer on the principles and practice egg andanimal culture techniques for virus isolation.




Assessor’s name:

Date:

87

Reflective Log – Standard Laboratory Procedures

1. What did you do?Summarise the laboratory techniquesused as standard laboratory procedures. Date(s).

Duration oftraining.

2. What did you learn?

3. How have you applied or will you apply the learning in your future work?

Future development possibilities.

89

7.2 Respiratory Virus Infections

7.2a Diagnostic AlgorithmBe able to describe the viral causes of respiratory infection, diagnosticinvestigations and control of infection.

KNOWLEDGE

• Understand the range of potential respiratory viruses which may infect thehuman respiratory tract e.g. influenza, RSV, etc.

• Know the common causes of respiratory infection and appropriateinvestigations which should be used for diagnosis which range of tests shouldbe used for diagnostic testing.

• Know the less common causes of respiratory infection and when to considerusing appropriate investigations for diagnosis tests which may be used fordiagnostic testing.

• Know the cyclical nature of some respiratory viral pathogens and the alertmechanisms used to establish when they should be investigated for andwhich tests to use.

• Understand other important potential non viral respiratory infections e.g.Mycoplasma pneumoniae.

• Be aware of potential respiratory virus infections that might be circulatingworldwide.

• Understand the requirements for appropriate samples from patients withpotential respiratory virus infections such as naso-pharyngeal aspirate (NPA),brochial-alveolar lavages (BAL), sputum, nasal washings, nose and throatswabs, acute and convalescent serum.

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

• Be aware of potential therapy that may be available for prophylaxis andtreatment of respiratory viral infections, e.g. antivirals, immunoglobulin andvaccines.

• Know which patient groups are at high risk with regard to respiratory virusinfections.

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


a) Describe the causes of respiratory viral infections and relevant investigationsfor diagnosis.

b) Explain factors that should be taken into consideration when selecting aninvestigation.

c) Describe how respiratory viral pathogens are transmitted and how patientswith each of these infections would be managed and treated.

90



i) Answered questions set by trainer on the causes of respiratory viral infectionsand relevant investigations for diagnosis.


ii) Produced a list of factors that should be taken into consideration whenselecting techniques for the investigation of respiratory viral infections.




Assessor’s name:

Date:

91

7.2b Immunological InvestigationsBe able to perform immunological techniques for the investigation ofrespiratory infection.

KNOWLEDGE

• Understand the principles and limitations of techniques available for thedetection of respiratory viruses in samples, including:o rapid test kitso immunofluorescence

• Understand the principles and limitations of techniques available for thedetection of antibodies to respiratory viruses, including:o complement fixation testo enzyme immunoassayo particle agglutination

• Understand the advantages and disadvantages of above methods.• Know the relevant internal and external quality procedures.

COMPETENCEYou must be able:

a) Perform techniques in accordance with standard laboratory procedures.

b) Critically evaluate results and report in accordance with laboratoryprocedures.

92



i) Observed by trainer to perform investigations of respiratory viral infection inaccordance with standard laboratory procedures.


ii) Answered questions set by the trainer on the principles and practice oftechniques available for the investigation of respiratory viral infection.


iii) Produced a list of the advantages and disadvantages of the techniquesavailable for the investigation of respiratory viral infection.




Assessor’s name:

Date:

93

7.2c Detection of Antigen and Replication VirusBe able to perform antigen detection techniques for the investigation ofrespiratory infection.

KNOWLEDGE

• Know the principles and limitations of techniques available for the detection ofrespiratory viruses in a variety of samples, including:o rapid test kitso immunofluorescenceo virus culture including shell vialso immunoassay





94


This section requires the trainer to sign that the trainee has successfully achieved thelevel of competence on more than one occasion. The trainee should collect andprepare other supporting evidence indicated below as a portfolio.

i) Observed by trainer to perform investigations of respiratory virus antigens inaccordance with standard laboratory procedures.


ii) Answered questions set by the trainer on the principles and practice oftechniques available for the investigation of respiratory virus antigens.


iii) Produced a list of the advantages and disadvantages of the techniquesavailable for the investigation of antigens present in respiratory viral infection.




Assessor’s name:

Date:

95

7.2d Molecular investigationsBe able to perform molecular techniques to the investigation of viralrespiratory infection.

KNOWLEDGE

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





96


This section requires the trainer to sign that the trainee has successfully achieved thelevel of competence on more than one occasion. The trainee should collect andprepare other supporting evidence indicated below as a portfolio.

i) Observed by trainer to perform molecular investigations of respiratory virusinfection in accordance with standard laboratory procedures.


ii) Answered questions set by the trainer on the principles and practice ofmolecular techniques available for the investigation of respiratory virusinfection.




Assessor’s name:

Date:

97

Reflective Log – Respiratory Virus Infections

1. What did you do?Summarise the laboratory techniquesused in the investigation of respiratoryvirus infections. Date(s).





99

7.3 Enteric Virus Infections

7.3a Diagnostic algorithmBe able to describe the viral causes of respiratory infection, diagnosticinvestigations and control of infection.

KNOWLEDGE

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

• Be aware of other important non-viral enteric infections e.g. salmonella.• Know the common causes of viral enteric infection and which range of

investigations should be used for diagnostic testing and screening purposes.• Be aware of the less common causes of enteric infection and when to

consider using investigations that may be used for diagnostic purposes e.g.parasitic infections.

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

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

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

• Know which patient groups are at high risk with regard to enteric virusinfections.

• Be aware of infection controls issues and measures which may be taken withregard to enteric virus infections in hospital and within the community.


a) Describe the causes of enteric viral infections and relevant investigations fordiagnosis.


c) Describe how enteric viral pathogens are transmitted and how patients witheach of these infections would be managed and treated.

100



i) Answered questions set by trainer on the causes of enteric viral infectionsand relevant investigations for diagnosis.


ii) Produced a list of factors that should be taken into consideration whenselecting techniques for the investigation of enteric viral infections.




Assessor’s name:

Date:

101

7.3b Immunological InvestigationsBe able to perform immunological techniques to the investigation of entericviral infection.

KNOWLEDGE

• Know the principles and limitations of immunological techniques available forthe detection of enteric viral infections in samples.

• Understand the requirement for confirmatory assays and the role of referencelaboratories.

• Understand the advantages and disadvantages of the methods.• Understand the predictive value of various assays in different population

groups.• Know the relevant internal and external quality procedures.




c) Describe the causes of enteric viral infections and relevant investigations fordiagnosis.

d) Refer specimens to a specialist centre in accordance with laboratoryprocedures.

102



i) Observed by trainer to perform investigations of enteric viral infection inaccordance with standard laboratory procedures.


ii) Answered questions set by the trainer on the principles and practice oftechniques available for the investigation of enteric viral infection.


iii) Produced a list of the advantages and disadvantages of the techniquesavailable for the investigation of enteric viral infection.




Assessor’s name:

Date:

103

7.3c Electron MicroscopyBe able to describe electron microscopy techniques for the investigation ofenteric viral infection.

KNOWLEDGE

• Understand the principles and practice of electron microscopy techniquesavailable for the detection of enteric viral infections in a variety of samples.


• Be aware of internal and external quality procedures.


a) Describe the application of electron microscopy to the investigation of entericviruses.

b) Recognise the morphology of the common enteric viruses.

104



i) Answered questions set by the trainer on the principles and practice ofelectron microscopy for the investigation of enteric viral infection.




Assessor’s name:

Date:

105

7.3d Molecular investigationsBe able to perform molecular techniques to the investigation of enteric viralinfection.

KNOWLEDGE

• Understand the requirements for appropriate samples from patients withsuspected viral enteric infection.

• Understand the principles and limitations of molecular techniques availablefor diagnosis of enteric viral infection.






106



i) Observed by trainer to perform molecular investigations of enteric virusinfection in accordance with standard laboratory procedures.


ii) Answered questions set by the trainer on the principles and practice ofmolecular techniques available for the investigation of enteric virus infection.




Assessor’s name:

Date:

107

Reflective Log – Enteric Virus Infections

1. What did you do?Summarise the laboratory techniquesused in the investigation of enteric virusinfections. Date(s).





109

7.4 Sexually Transmitted Diseases

7.4a Diagnostic algorithmBe able to describe viral and non-viral causes of sexual transmitted diseases,diagnostic investigations and control of infection.

KNOWLEDGE

• Know the range of sexually transmitted viruses which may infect humans,including:o HSVo Molluscum contagiosumo HIV

• Be aware of other important non-viral sexually transmitted infections e.g.syphilis.

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

• Know the less common causes of sexually transmitted infection and when toconsider using investigations that may be used for diagnostic purposes.

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

• Understand the sample collection techniques for the investigation ofChlamydia, vesicular STI’s, HSV or Molluscum contagiosum.

• Understand potential therapy that may be available for prophylaxis andtreatment of sexually transmitted infections, including antivirals,immunoglobulin and vaccines.

• Know which patient groups are at high risk with regard to sexually transmittedinfections.

• Know about infection controls issues and measures which may be taken withregard to sexually transmitted infections.

• Know the potential infection risk to the foetus.• Understand the importance of screening programmes and their role in

prevention of disease.


a) Describe the causes of sexually transmitted infections and investigations fordiagnosis.


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

110



i) Answered questions set by trainer on the causes of sexually transmitteddisease, investigations for diagnosis and treatment of infected patients.


ii) Produced a list of factors that should be taken into consideration whenselecting techniques for the investigation of sexually transmitted diseases.


iii) Described a case study illustrating the pathogenesis and treatment of HIVinfection.




Assessor’s name:

Date:

111

7.4b Immunological InvestigationsBe able to perform serological techniques for the investigation of sexuallytransmitted diseases in a range of samples.

KNOWLEDGE

• Know the principles and limitations of techniques available for the detection ofsexually transmitted infections, including:o rapid test kitso immunofluorescenceo complement fixations testo enzynme immunoassayo particle agglutination





a) Perform a range of immunological investigative techniques in accordance withstandard laboratory procedures.




112



i) Observed by trainer to perform investigations of sexually transmitted infectionin accordance with standard laboratory procedures.


ii) Answered questions set by the trainer on the principles and practice oftechniques available for the investigation of sexually transmitted infection.


iii) Produced a list of the advantages and disadvantages of the techniquesavailable for the investigation of sexually transmitted infection.




Assessor’s name:

Date:

113

7.4c Electron Microscopy and Cell CultureBe able to describe the application of electron microscopy and cell culturetechniques to the investigation of sexually transmitted disease.

KNOWLEDGE

• Understand the principles and practice of electron microscopy and cell culturetechniques available for the detection of sexually transmitted infections insamples.

• Understand the requirement for confirmatory assays and the role of referencelaboratories

• Understand the advantages and disadvantages of the methods.• Be aware of internal and external quality procedures.


a) Describe the application of electron microscopy and cell culture techniques tothe investigation of sexually transmitted infections.

b) Recognise the morphology of the common sexually transmitted viruses.

114



i) Answered questions set by the trainer on the principles and practice ofelectron microscopy and cell culture techniques for the investigation ofsexually transmitted infection.




Assessor’s name:

Date:

115

7.4d Molecular InvestigationsBe able to perform molecular techniques for the investigation of sexuallytransmitted diseases on a variety of patient samples.

KNOWLEDGE

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


• Understand the predictive value of various assays in different populationgroups.





116



i) Observed by trainer to perform molecular investigations of sexuallytransmitted infections in accordance with standard laboratory procedures.


ii) Answered questions set by the trainer on the principles and practice ofmolecular techniques available for the investigation of sexually transmittedinfections.




Assessor’s name:

Date:

117

Reflective Log – Sexually Transmitted Diseases

1. What did you do?Summarise the laboratory techniquesused in the investigation of sexuallytransmitted infections. Date(s).





119

7.5 Infections in Pregnancy (Pre- and Post Delivery)

7.5a Diagnostic AlgorithmBe able to describe the causes of viral infection in pregnancy, diagnosticinvestigations and control of infection.

KNOWLEDGE

• Know the range of viruses which may cause infections in pregnancyincluding: rubella, parvovirus, CMV, VZV

• Understand other important non-viral infections in pregnancy e.g. toxoplasmagondii.

• Know the common causes of viral infections in pregnancy and which range ofinvestigations should be used for diagnostic testing and screening purposes.

• Know the less common causes of viral infections in pregnancy and when toconsider using investigations which may be used for diagnostic purposes.

• Understand the requirements for appropriate samples from patients withpotential virus infections in pregnancy such as urine, swabs, products ofconception, acute and convalescent serum.

• Understand the procedures involved in the collection of the above sampletypes and the optimal time for collection of various samples.

• Understand any potential therapy which may be available for prophylaxis andtreatment. of viral infections in pregnancy e.g. antivirals, immunoglobulin andvaccines.

• Know which trimester patients are at highest risk with regard to specific virusinfections.

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

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


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


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

120



i) Answered questions set by trainer on the causes of viral infection inpregnancy, investigations for diagnosis and treatment of infected patients.


ii) Produced a list of factors that should be taken into consideration whenselecting techniques for the investigation of viral infections in pregnancy.




Assessor’s name:

Date:

121

7.5b Immunological InvestigationsBe able to perform serological techniques for the investigation of viralinfection in pregnancy.

KNOWLEDGE

• Understand techniques available for the detection of viruses, viral antigen andviral antibody in pregnancy, including:o rapid test kitso immunofluorescenceo complement fixation texto enzyme immunoassayo particle agglutination

• Understand the advantages and disadvantages of the methods.• Know the relevant internal and external quality procedures.






122



i) Observed by trainer to perform investigations in accordance with standardlaboratory procedures.


ii) Answered questions set by the trainer on the principles and practice oftechniques available for the investigation of viral infection in pregnancy.


iii) Produced a list of the advantages and disadvantages of the techniquesavailable for the investigation of viral infection in pregnancy.




Assessor’s name:

Date:

123

7.5c Molecular TechniquesBe able to perform molecular techniques to the investigation of viral infectionin pregnancy.

KNOWLEDGE

• Understand the requirements for appropriate samples from patients withsuspected viral infection in pregnancy.

• Understand the principles and limitations of molecular techniques availablefor diagnosis of viral infection in pregnancy.






124



i) Observed by trainer to perform molecular investigations of viral infection inpregnancy in accordance with standard laboratory procedures.


ii) Answered questions set by the trainer on the principles and practice ofmolecular techniques available for the investigation of viral infection inpregnancy.




Assessor’s name:

Date:

125

Reflective Log – Pregnancy (Pre- And Post- Delivery)

1. What did you do?

Date(s).Duration oftraining.




127

7.6 Neurological disease including Prion disease

7.6a Diagnostic AlgorithmUnderstand the viral causes of neurological disease, diagnostic investigationsand control of infection.

KNOWLEDGE

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

• Know the most serious non-viral causes of neurological disease.• Understand the different mechanisms by which viruses affect the central

nervous system (CNS).• Know the difference between encephalitis and meningitis.• Understand the principles for investigating possible viral causes for

encephalitis and meningitis including:o Rabies and Lyssa viruso Herpes Simplex and other herpes viruseso Polioviruso other enteroviruses and mumps.

• Know which laboratory tests to perform to diagnose viral neurologicaldisease.

• Know which tests other pathology departments must perform on a CSF.• Know appropriate management and effective treatment for viral causes of

neurological disease.


a) Describe the causes of viral neurological disease and investigations fordiagnosis.


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

d) Describe which results chemistry tests can provide and their significance to apossible viral diagnosis.

128



i) Answered questions set by trainer on the main viral causes of acutemeningitis, encephalitis and encephalomyelitis and chronic neurologicaldiseases, investigations for diagnosis and treatment of infected patients.


ii) Produced a list the possible viral causes of encephalitis and meningitis andidentify the correct clinical specimens to collect in diagnosis.


iii) Described a case study illustrating the pathogenesis and treatment of aneurological viral infection.




Assessor’s name:

Date:

129

7.6b Immunological and Molecular TechniquesBe able to perform serological and molecular techniques to the investigation ofneurological disease.

KNOWLEDGE

• Know which viral causes of neurological disease can be diagnosedserologically.

• Understand the significance of paired sera in diagnosis of neurologicaldisease.

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

• Know which viral causes of neurological disease can be diagnosed usingmolecular techniques.

• Understand the advantages and disadvantages of serological and molecularmethods.


• Understand the predictive value of various assays in different populationgroups.







130





ii) Answered questions set by the trainer on the principles and practice oftechniques available for the investigation of neurological infection.


iii) Produced a list of the advantages and disadvantages of the techniquesavailable for the investigation of neurological infection.




Assessor’s name:

Date:

131

7.6c Electron MicroscopyBe able to describe electron microscopy techniques for the investigation ofneurological disease.

KNOWLEDGE

• Know which viral causes of neurological disease can be detected by electronmicroscopy and in which samples.

• Know the diagnostic features of possible viral causes of neurological disease• Understand the principles and practice of electron microscopy techniques

available for the detection of neurological viral infections in a variety ofsamples.




a) Describe the application of electron microscopy to the investigation ofneurological infections.

b) Identify viral causes of neurological disease in electron micrographs.

132



i) Answered questions set by the trainer on the principles and practice ofelectron microscopy for the investigation of neurological viral infection.


ii) Listed the viral causes of neurological disease that can be detected byelectron microscopy and in which clinical samples.




Assessor’s name:

Date:

133

Reflective Log – Neurological Infections

1. What did you do?Summarise the laboratory techniquesused in the investigation of neurologicalvirus infections. Date(s).





135

7.7 Vesicular and Red Rashes and Systemic infections

7.7a Diagnostic AlgorithmUnderstand the viral causes of vesicular and red rash and systemic infections,diagnostic investigations and control of infection.

KNOWLEDGE

• Know the common viral causes of vesicular and red rashes (including VZV,rubella, HHV6) and which panels of tests should be used for diagnostictesting.

• Know which of the common viral causes of vesicular and red rashes maycause systemic infections and when additional diagnostic tests should beused.

• Be aware of less common viral causes of vesicular and red rashes and whento consider using tests which may be used for diagnostic testing.

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

• Know the cyclical nature of viral pathogens that elicit vesicular and red rashesand the alert mechanisms used to establish when they should be investigatedfor and which tests to use.

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

• Understand the requirements and procedures involved for collecting samplesfrom patients with potential viral rash and systemic infections such as vesiclefluid, skin scrapings, nose and throat swabs, acute and convalescent serum.

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

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


a) Describe the causes of vesicular, red rash and systemic infections andinvestigations for diagnosis.


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

136



i) Answered questions set by trainer on the causes of vesicular, red rash andsystemic infections, investigations for diagnosis and treatment of infectedpatients.


ii) Produced a list of factors that should be taken into consideration whenselecting techniques for the investigation of vesicular, red rash and systemicinfections.


iii) Described a case study illustrating the pathogenesis and treatment of apatient with a vesicular, red rash or systemic infection.




Assessor’s name:

Date:

137

7.7b Immunological TechniquesBe able to perform serological techniques to the investigation of vesicular andred rashes; and systemic infections.

KNOWLEDGE

• Know the principles and limitations of immunological techniques available forthe detection of viruses and antibodies from patients with rashes or systemicinfections, including:o rapid test kitso immunofluorescenceo complement fixation testo enzyme immyunoassayo particle agglutination



COMPETENCE

You must be able to:





138





ii) Answered questions set by the trainer on the principles and practice oftechniques available for the investigation of infection.


iii) Produced a list of the advantages and disadvantages of the techniquesavailable for the investigation of infection.




Assessor’s name:

Date:

139

7.7c Electron Microscopy and Cell CultureBe able to describe the principles and application of electron microscopy andcell culture techniques to the investigation of vesicular and red rash; andsystemic infections.

KNOWLEDGE

• Understand the available EM and cell culture techniques available for thedetection of viral infections causing rash or systemic infection.





a) Describe the application of electron microscopy to the investigation of viralinfections causing rash or systemic infection.

b) Recognise the morphology of the common viruses causing vesicular and redrash or systemic infection.

140



i) Answered questions set by the trainer on the principles and practice ofelectron microscopy for the investigation of vesicular and red rash or systemicinfection.


ii) Listed the viral causes of causing vesicular and red rash or systemic infectionthat can be detected by electron microscopy and in which clinical samples.




Assessor’s name:

Date:

141

7.7d Molecular TechniquesBe able to perform molecular techniques to the investigation of vesicular andred rash; and systemic infections.

KNOWLEDGE

• Understand the requirements for appropriate samples from patients withvesicular and red rash; and systemic infections.







142



i) Observed by trainer to perform molecular investigations of vesicular and redrash; and systemic infections in accordance with standard laboratoryprocedures.


ii) Answered questions set by the trainer on the principles and practice ofmolecular techniques available for the investigation of vesicular and red rash;and systemic infections.




Assessor’s name:

Date:

143

Reflective Log – Vesicular and Red Rashes; andSystemic Infections

1. What did you do?Summarise the laboratory techniquesused in the investigation of vesicular andred rashes; and systemic infections. Date(s).





145

7.8 Blood-borne Virus Infections

7.8a Diagnostic AlgorithmUnderstand the viral causes of Blood-borne virus infections, diagnosticinvestigations and control of infection.

KNOWLEDGE

• Understand the range of blood-borne viruses which may infect humans e.g.HIV, HTLV etc

• Understand other important non-viral blood-borne infections e.g. malaria• Know the common causes of blood-borne virus infection and which range of

investigations should be used for diagnostic testing and screening purposes.• Know the less common causes of blood-borne virus infection and when to

consider using investigations which may be used for diagnostic purposes.• Understand any potential therapy which may be available for prophylaxis and

treatment of blood-borne viral infections e.g. antivirals, immunoglobulin andvaccines.

• Know which patient groups are at high risk with regard to blood-borne virusinfections

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

• Know the procedures that are put in place to prevent human to humantransmission

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


a) Describe the causes of blood borne virus infections and investigations fordiagnosis.


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

d) Describe the routes of transmission of blood borne viruses that are caused byhuman intervention.

146



i) Answered questions set by trainer on the causes of blood borne viralinfections, investigations for diagnosis and treatment of infected patients.


ii) Produced a list of factors that should be taken into consideration whenselecting techniques for the investigation of blood borne viral infections.


iii) Described a case study illustrating the pathogenesis and treatment of bloodborne viral infections.




Assessor’s name:

Date:

147

7.8b Immunological TechniquesBe able to perform serological techniques to the investigation of blood-bornevirus infections.

KNOWLEDGE

• Understand techniques available for the detection of blood-borne viruses insamples, including:o rapid test kitso immunofluorescenceo complement fixation testo enzyme immyunoassayo particle agglutination

• Understand antigen detection techniques available for diagnosis of possiblecausal agent in samples.









148











Assessor’s name:

Date:

149

7.8c Molecular TechniquesBe able to perform molecular techniques to the investigation of blood borneviruses.

KNOWLEDGE

• Understand the requirements for appropriate samples from patients withsuspected blood-borne viral infections.

• Understand the principles and limitations of molecular techniques availablefor diagnosis of blood-borne viral infections.






150



i) Observed by trainer to perform molecular investigations of blood-borne viralinfections in accordance with standard laboratory procedures.


ii) Answered questions set by the trainer on the principles and practice ofmolecular techniques available for the investigation of blood-borne viralinfections.




Assessor’s name:

Date:

151

Reflective Log – Blood Borne Viral Infections

1. What did you do?Summarise the laboratory techniquesused in the investigation of blood borneviral infections. Date(s).





153

7.9 Investigation of Viral Hepatitis

7.9a Diagnostic AlgorithmBe able to describe the causes of viral hepatitis, diagnostic investigations andcontrol of infection.

KNOWLEDGE

• Understand the range of viruses which may cause liver disease.• Understand other important non-viral infections of the liver.• Know the common causes of viral liver infection and which range of

investigations should be used for diagnostic testing and screening purposes.• Know the less common causes of viral liver infection and when to consider

using investigations which may be used for diagnostic purposes.• Understand any potential therapy which may be available for prophylaxis and

treatment of viral hepatitis e.g. antivirals, immunoglobulin and vaccines.• Know which patient groups are at high risk with regard to viral hepatitis• Know about infection controls issues and measures which may be taken with

regard to viral hepatitis in hospital and within the community.


a) Describe the causes of viral hepatitis and investigations for diagnosis.


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

154



i) Answered questions set by trainer on the causes of viral hepatitis,investigations for diagnosis and treatment of infected patients.


ii) Produced a list of factors that should be taken into consideration whenselecting techniques for the investigation of viral hepatitis.


iii) Described a case study illustrating the pathogenesis and treatment of viralhepatitis.




Assessor’s name:

Date:

155

7.9b Immunological TechniquesBe able to perform serological investigations for viral hepatitis.

KNOWLEDGE

• Understand techniques available for the detection of viruses causing hepatitisin samples, including:o rapid test kitso immunofluorescenceo complement fixation testo enzyme immyunoassayo particle agglutination










156











Assessor’s name:

Date:

157

7.9c Molecular TechniquesBe able to perform molecular techniques to the investigation of viral hepatitisinfections.

KNOWLEDGE

• Understand the requirements for appropriate samples from patients withsuspected viral hepatitis.







158



i) Observed by trainer to perform molecular investigations of viral hepatitis inaccordance with standard laboratory procedures.


ii) Answered questions set by the trainer on the principles and practice ofmolecular techniques available for the investigation of viral hepatitis.




Assessor’s name:

Date:

159

Reflective Log – Viral Hepatitis

1. What did you do?Summarise the laboratory techniquesused in the investigation of viral hepatitis. Date(s).





161

7.10 Infections in Neonates and Infants

7.10a Diagnostic algorithmBe able to describe the viral causes of infections in neonates and infants(including sudden unexpected deaths), diagnostic investigations and control ofinfection.

KNOWLEDGE

• Understand the range of viruses which need to be ruled out in neonates andinfants dying of SUDI e.g. RSV, enteroviruses.

• Understand other important non viral infections which have been linked toneonates and infants as a cause of SUDI.

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

• Know the less common causes of infection in neonates/infants and when toconsider using investigations which may be used for diagnostic purposes.

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

• Understand the requirements for appropriate samples from patients accordingto clinical syndrome.

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

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

• Know about infection controls issues and measures which may be taken withregard to these infections.

• Know the potential infection risk posed to the neonate.


a) Describe the causes of neonatal and paediatric infections and investigationsfor diagnosis.


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

162



i) Answered questions set by trainer on the causes of neonatal and paediatricinfections, investigations for diagnosis and treatment of infected patients.


ii) Produced a list of factors that should be taken into consideration whenselecting techniques for the investigation of neonatal and paediatricinfections.


iii) Described a case study illustrating the pathogenesis and treatment of aneonatal viral infection.




Assessor’s name:

Date:

163

7.10b Immunological TechniquesBe able to perform serological investigations for the diagnosis of viralinfections in neonats and infants.

KNOWLEDGE

• Understand the potential use of stored antenatal samples from mother indiagnostic investigations.

• Understand the requirements for appropriate samples from patients accordingto clinical syndrome.

• Know the principles and limitations of immunological techniques available forthe detection of enteric viral infections in samples, including:o rapid test kitso immunofluorescenceo complement fixation testo enzyme immyunoassayo particle agglutination








c) Refer specimens to a specialist centre in accordance with laboratoryprocedures.

164











Assessor’s name:

Date:

165

7.10c Electron Microscopy and Cell CultureBe able to describe the principles and application of electron microscopy andcell culture techniques to the investigation of infections in neonates andinfants, including sudden unexpected deaths.

KNOWLEDGE

• Understand the principles and practice of electron microscopy techniquesavailable for the investigation of infections in neonates and infants.

• Understand the use of cell culture techniques available for diagnosis ofpossible causal agent in samples.




a) Describe the application of electron microscopy to the investigation ofinfections in neonates and infants.

b) Recognise the morphology of the common viruses causing infection inneonates and infants.

166



i) Answered questions set by the trainer on the principles and practice ofelectron microscopy and cell culture for the investigation of infection onneonates and infants.




Assessor’s name:

Date:

167

7.10d Molecular TechniquesBe able to perform molecular techniques to the investigation of infections inneonates and infants including sudden unexpected deaths.

KNOWLEDGE

• Understand the requirements for appropriate samples from neonates orinfants with suspected viral infection.

• Understand the principles and limitations of molecular techniques availablefor diagnosis of viral infection.






168



i) Observed by trainer to perform molecular investigations of infections inneonates and infants in accordance with standard laboratory procedures.


ii) Answered questions set by the trainer on the principles and practice ofmolecular techniques available for the investigation of infections in neonatesand infants.




Assessor’s name:

Date:

169

Reflective Log – Neonates and Infants

1. What did you do?Summarise the laboratory techniquesused in the investigation of viralinfections in neonates and infants. Date(s).





171

7.11 Immunocompromised Patients

7.11a Diagnostic algorithmUnderstand the viral causes of infections in immunocompromised patients,diagnostic investigations and control of infection.

KNOWLEDGE

• Understand the cause of primary and secondary immunodeficiency, including:o viralo hereditaryo physiological i.e. the 4 hypersensitivity typeso drug induced following medical or surgical treatment

• Understand the range of viruses which may infect immunocompromisedpatients e.g. JC, BK virus.

• Understand other important non-viral infections in immunocompromisedpatients.

• Know the common causes of viral infections in immunocompromised patientsand which range of investigations should be used for diagnostic testing andscreening purposes.

• Know the less common causes of viral infections in immunocompromisedpatients and when to consider using investigations which may be used fordiagnostic purposes.

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

• Know about infection controls issues and measures which may be taken withregard to these infections.

• Know the potential infection risk posed to immunocompromised patients.


a) Describe the causes of viral infections in immunocompromised patients andinvestigations for diagnosis.


c) Describe how immunocompromised patients with infections would bemanaged and treated.

172



i) Answered questions set by trainer on the causes of infection inimmunocompromised patients, investigations for diagnosis and treatment ofinfected patients.


ii) Produced a list of factors which should be taken into consideration whenselecting techniques for the investigation of immunocompromised patients.


iii) Described a case study illustrating an example of viral infection in animmunocmpromised patient.




Assessor’s name:

Date:

173

7.11b Immunological investigationsBe able to perform serological techniques to the investigation of infections inimmunocompromised patients.

KNOWLEDGE

• Know the principles and limitations of immunological techniques available forthe detection of viral infections in immunocompromised patients, including:o rapid test kitso immunofluorescenceo complement fixation testo enzyme immyunoassayo particle agglutination



• Understand the advantages and disadvantages of the methods.• Know the relevant internal and external quality procedures.




c) Refer specimens to a specialist centre in accordance with laboratoryprocedures.

174











Assessor’s name:

Date:

175

7.11c Electron Microscopy and Cell Culture TechniquesBe able to describe electron microscopy and cell culture techniques for theinvestigation of infections in immunocompromised patients.

KNOWLEDGE

• Understand the principles and practice of electron microscopy and cell culturetechniques available for the detection of infections in immunocompromisedpatients.




a) Describe the application of electron microscopy and cell culture to theinvestigation of immunocompromised patients.

b) Recognise the morphology of the common viruses found inimmunocompromised patients.

176



i) Answered questions set by the trainer on the principles and practice ofelectron microscopy for the investigation of immunocompromised patients.




Assessor’s name:

Date:

177

7.11d Molecular TechniquesBe able to perform molecular techniques to the investigation of infections inimmunocompromised patients.

KNOWLEDGE

• Understand the requirements for appropriate samples fromimmunocompromised patients.

• Understand the principles and limitations of molecular techniques availablefor diagnosis of viral infection.






178



i) Observed by trainer to perform molecular investigations ofimmunocompromised patients in accordance with standard laboratoryprocedures.


ii) Answered questions set by the trainer on the principles and practice ofmolecular techniques available for the investigation of immunocompromisedpatients.




Assessor’s name:

Date:

179

Reflective Log – Immunocompromised Patients

1. What did you do?Summarise the laboratory techniquesused in the investigation ofimmunocompromised patients. Date(s).





181

7.12 Travel Related and Exotic Infections.

7.12a Diagnostic AlgorithmBe able to describe the viral causes of travel related and exotic infections,diagnostic investigations and control of infection.

KNOWLEDGE

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

• Know the appropriate laboratory diagnosis for each virus listed.• Know the risk factors, patient history and clinical symptoms which would

indicate a possible travel related or exotic infection.• Know what information can be obtained from examination of bites and

wounds and how that contributes to diagnosis of travel related and exoticinfections.

• Know the groups of virus transmitted via animal bites and insect bites.• Know the important bacterial and parasitic causes of serious illness

associated with travel and exotic infections.• Know the hazards of laboratory acquired infection with such viral, bacterial

and parasitic pathogens.• Know how arboviruses, filoviruses, arenaviruses, hantaviruses, rhabdoviridae,

enteroviruses are transmitted.• Know what control measures are required to prevent or limit the spread of

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

these infections.• Be aware of how a patient suspected of infection with a travel related or

exotic infection would be managed in the UK


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

b) Describe the information that would lead to a suspicion that a patient wasinfected with each of these viruses.

c) Name the important bacteria and parasites that could also be implicated intravel related and exotic infections.

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

e) Describe how the most dangerous travel related and exotic viral infections aretransmitted.

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

182



i) Answered questions set by trainer on the causes of travel related or exoticviral infections, investigations for diagnosis and treatment of infected patients.


ii) Produced a list of factors that should be taken into consideration whenselecting techniques for the investigation of travel related or exotic viralinfections.


iii) Described a case study illustrating the pathogenesis and treatment of anarboviral infection.




Assessor’s name:

Date:

183

7.12b Immunological investigationsBe able describe serological techniques for the investigation of travel relatedand exotic infections.

KNOWLEDGE

• Know the serological tests currently available for arboviruses, filoviruses,arenaviruses, hantaviruses, rhabdoviridae, enteroviruses and which areavailable in a routine diagnostic virology department.

• Know the type of serological test in each case, whether the procedure detectsantigen or antibody and whether paired sera are required.



a) List the serological tests currently available for arboviruses, filoviruses,arenaviruses, hantaviruses, rhabdoviridae, enteroviruses and in each casename the laboratory where they would be carried out.

b) Give details of the quality assurance procedures used in the serological testsdescribed.

184



i) Answered questions set by the trainer on the principles and practice oftechniques available for the investigation of infection.


ii) Produced a list of the advantages and disadvantages of the techniquesavailable for the investigation of infection.




Assessor’s name:

Date:

185

7.12c Electron Microscopy TechniquesBe able to describe electron microscopy techniques to the investigation oftravel related and exotic infections.

KNOWLEDGE

• Know which viruses associated with travel and exotic infections can bedetected by electron microscopy.

• Know at which stage in the infection this is an appropriate diagnostic methodin each case.

• Know in which specimen(s) virus can be detected for each infection.• Know the hazards to laboratory staff of processing specimens from patients

with travel related and exotic infections for electron microscopy.• Know the relevant internal and external quality procedures.


a) List the viruses associated with travel and exotic infections which can bedetected by electron microscopy.

b) Correctly identify the appropriate specimen(s) and at which stage in theinfection they can be collected in each case.

c) Describe the hazards associated with handling specimen specimens frompatients with travel related and exotic infections for electron microscopy andthe precautions required in the laboratory.

d) Give details of the quality assurance procedures used in electron microscopy

186



i) Answered questions set by the trainer on the principles and practice ofelectron microscopy for the investigation of travel and exotic infections.




Assessor’s name:

Date:

187

7.12d Molecular TechniquesBe able to describe molecular techniques to the investigation of travel relatedand exotic infections.

KNOWLEDGE

• Know the molecular techniques currently available for the detection of virusesassociated with travel and exotic infections.

• Know at which stage in the infection this is an appropriate diagnostic methodin each case.

• Know in which specimen(s) viral antigen can be detected by molecularmethods for each infection.

• Know the hazards to laboratory staff of applying molecular techniques tospecimens from patients with travel related and exotic infections.



a) List the viruses associated with travel and exotic infections which cancurrently be detected by molecular techniques.

b) Describe the principles behind each test.

c) Correctly identify the appropriate specimen(s) and at which stage in theinfection they can be collected in each case.

d) Describe the hazards associated with applying molecular methods tospecimens from patients with travel related and exotic infections and theprecautions required in the laboratory.

e) Give details of the quality assurance procedures used in these moleculartechniques.

188



i) Answered questions set by the trainer on the principles and practice ofmolecular techniques available for the investigation of travel and exoticinfections.




Assessor’s name:

Date:

189

Reflective Log – Travel and Exotic Infections

1. What did you do?Summarise the laboratory techniquesused in the investigation of travel andexotic infections. Date(s).





191

7.13 Infection Control

7.13a Infection Control ProceduresBe able to describe the principles and practice of infection control procedures.

KNOWLEDGE

• Understand the principles of control of infection are based on:o removal of sources e.g. decontamination of equipmento blocking of routes of spread e.g. isolation, hand washing etco enhancing resistance of patient e.g. immunisation, prophylaxis

• Know the relevant infection control procedures within the laboratory.• Be aware of the activities of the hospital infection control team (ICT) and

know where to reference their guidelines.• Know the importance of infection control in the hospital setting e.g. RSV or

rotavirus on paediatric wards.• Know the different infection control methods available to prevent transmission

of infection.• Know how to produce and collate virology tests and results in order to help

epidemiological investigations to support infection control in the hospital.• Know the importance of infection control in the community setting.• Be aware of the role of the CCDC (Consultant for Communicable Disease

Control).


a) Describe the principles of infection control.

b) Describe the infection control procedures used in the laboratory, hospital andcommunity.

c) Produce and collate virology tests and results for epidemiologicalinvestigations to support infection control in the hospital.

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

192



i) Answered questions set by the trainer on the principles and practice ofinfection control procedures.


ii) Produced a list of viruses that pose infection control problems in the hospitaland community.


iii) Written a short essay comparing on the role and responsibilities of laboratory,ICT and CCDC.




Assessor’s name:

Date:

193

Reflective Log – Infection Control

1. What did you do?Summarise the role of the laboratory ininfection control. Date(s).





195

7.14 Application of pre and post exposure prophylaxis andvaccination in virology

7.14a Principles of pre and post exposure prophylaxisBe able to describe the principles of pre and post exposure prophylaxis.

KNOWLEDGE

• Understand the principles of and strategies for the use pre-exposureprophylaxis.

• Understand the biological mechanisms of pre-exposure prophylaxis.• Understand the principles of and strategies for the use post-exposure

prophylaxis prophylaxis.• Understand the biological mechanisms of post-exposure prophylaxis.

COMPETENCEYou must be able to: demonstrate KNOWLEDGE of:

a) Can describe the main uses of pre-exposure prophylaxis.

b) Can describe the goals and limitations of pre-exposure prophylaxis.

c) Can describe the main uses of post-exposure prophylaxis.

d) Can describe the goals and limitations of post-exposure prophylaxis

196



i) Answered questions set by the trainer on the principles and practice ofprinciples of and strategies for the use pre-and post exposure prophylaxis.


ii) Written a short essay comparing on use pre-and post exposure prophylaxis.




Assessor’s name:

Date:

197

7.14b Principles of vaccinationUnderstand the principles and application of vaccination.

KNOWLEDGE

• Understand the principles of and strategies for using vaccination.• Understand the biological mechanisms of active immunisation.• Understand the biological mechanisms of passive immunisation.• Understand the need for childhood vaccination.• Understand the principle of the UK Childhood vaccination strategy.• Understand the WHO global immunisation policy.• Understand the principles of herd immunity.• Understand the need for targeted vaccination e.g. HBV in prisons.• Know which vaccinations are available for health care workers and why.• Be aware of the statutory regulations regarding health care workers and

vaccination.

COMPETENCEYou must be able to:Demonstrate KNOWLEDGE of:

a) Can describe how vaccination works.

b) Can describe the goals and limitations of active immunisation.

c) Can describe the goals and limitations of passive immunisation.

d) Describe the legal requirements of HCW vaccinations in accord withEuropean Directive (2000/54/EC); in the UK vaccination is currentlyrecommended.

198



i) Answered questions set by the trainer on the principles and practice ofimmunisation strategies and procedures, including those applicable tohealthcare workers.


ii) Written a short essay comparing goals and limitations of active and passiveimmunisation.




Assessor’s name:

Date:

199

7.14e Indications for vaccination in the general communityUnderstand the indications for vaccination in the general community.

KNOWLEDGE

• Understand the need for childhood vaccination• Understand the principle of the UK Childhood vaccination strategy• Understand the WHO global immunisation policy• Understand the principles of herd immunity• Understand the need for targeted vaccination e.g. HBV in prisons

COMPETENCEYou must be able to demonstrate KNOWLEDGE of:

a) Can describe the goals and limitations of childhood vaccination.

b) Can describe the goals and limitations of WHO global immunisation policy.

c) Can describe the goals and limitations of targeted vaccination schemes.

200




Assessor’s name:

Date:

201

Reflective Log – Pre and Post Exposure Prophylaxisand Vaccination

1. What did you do?Summarise the laboratory role inprophylaxis and vaccination. Date(s).





203

7.15 Application of methods for antiviral treatment andresistance in virology

7.15a Principles of anti viral therapyBe able to describe the principles of anti viral therapy.

KNOWLEDGE

• Understand the strategy for the development of antiviral agents.• Understand the variety of processes by which antiviral agents target the virus.• Know of the clinical application of the most widely used antiviral agents in

areas such as prophylaxis, reactivation, prevention of complications andtreatment of acute disease.

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

COMPETENCEYou must be able to:Demonstrate KNOWLEDGE of:

a) Describe Know what the anti-viral agents are currently available and whattheir mode of action is.

b) Describe when, where and why antiviral agents are used.

204



i) Answered questions set by the trainer on the principles and practice of antiviral therapy.




Assessor’s name:

Date:

205

7.15b Principles of viral load monitoringBe able to describe Understand the principles of viral load monitoring.

KNOWLEDGE

• Understand the importance and relevance of monitoring viral load in someinfections.

• Understand the relevance of emergence of drug resistant mutants in thetreatment of patients on long term therapy.

• Understand the techniques available for measuring viral load such as target.amplification (e.g. PCR, TMA) and signal amplification (e.g. bDNA).



a) Describe the importance of viral load monitoring.

b) Describe when, where and viral load monitoring is used.

c) Confirm sample type is appropriate to the investigation being requested, ifnot, take appropriate action.

d) Perform sample preparations steps relevant to the investigation and followingthe appropriate SOP’S.

e) Demonstrate the ability to carry out the majority of the techniques listed above

f) Demonstrate the ability to consider all relevant factors that should be takeninto account when selecting a test.

g) Demonstrate the ability to interpret results of the tests above with theawareness of the advantages and disadvantages of each method and inconjunction with the internal quality control results.

h) Demonstrate the ability to refer specimens to a specialist centre if required.

206



i) Answered questions set by the trainer on the principles and practice of viralload monitoring.




Assessor’s name:

Date:

207

7.15c Principles of anti viral resistance testingBe able to describe Understand the principles of anti viral resistance testing.

KNOWLEDGE

• Understand the relevance of emergence of drug resistant mutants in thetreatment of patients on long term therapy.

• Understand the techniques available for resistance testing using molecularsequencing including gel and capillary based and cell culture techniques forgenotype and phenotype resistance.



a) Describe the importance of anti viral resistance testing.

b) Describe the techniques principles ands practice of the techniques availablefor resistance testing.

You must be able to demonstrate KNOWLEDGE of:

c) Confirm sample type is appropriate to the investigation being requested, ifnot, take appropriate action.

d) Perform sample preparations steps relevant to the investigation and followingthe appropriate SOP’S.

e) Demonstrate the ability to carry out the majority of the techniques listedabove.

f) Demonstrate the ability to consider all relevant factors which should be takeninto account when selecting a test.

g) Demonstrate the ability to interpret results of the tests above with theawareness of the advantages and disadvantages of each method and inconjunction with the internal quality control results.

h) Demonstrate the ability to refer specimens to a specialist centre if required.

208



i) Answered questions set by the trainer on the principles and practice of viralresistance testing.




Assessor’s name:

Date:

209

Reflective Log – Antiviral Treatment and Resistance

1. What did you do?Summarise the main points of thetechniques used in the laboratory in theperformance of urinary analysis. Date(s).





211

7.16 Application of methods for investigation ofenvironmental samples for virology

7.16a River and water samplesUnderstand the scope of and the methods used for river and water samples.

KNOWLEDGE

• Understand the requirements for appropriate samples from river, sea, lakesand drinking water sources.

• Understand the procedures involved in the collection of the above sampletypes

• Must also have an Understanding of optimal time for collection of varioussamples.

• Know the available methods, both standard and research that can be used toinvestigate water samples for the presence of virus

• Know the analytical limitations of the above• Know the relevant internal and external quality procedures


a) List the viruses associated with river and water samples that can currently bedetected by standard and research techniques.


c) Correctly identify the appropriate sample(s) and when and where they can becollected dependent on the investigation.

d) Describe the hazards associated with applying methods to river and watersamples and the precautions required in the laboratory.

e) Give details of the quality assurance procedures used in these techniques.

212




Assessor’s name:

Date:

213

7.16b Food samplesUnderstand the scope of and the testing methods for food samples.

KNOWLEDGE

• Understand the requirements for appropriate samples from different foodtypes including monitoring and outbreak investigations.



• Know the available methods, both standard and research that can be used toinvestigate food samples for the presence of virus



a) List the viruses associated with food samples that can currently be detectedby standard and research techniques.



d) Describe the hazards associated with applying methods to food samples andthe precautions required in the laboratory.


214




Assessor’s name:

Date:

215

7.16c Air and aerosol samplingUnderstand the scope of and the testing methods for air and aerosol sampling.

KNOWLEDGE

• Understand the requirements for appropriate samples from the air including‘clean air’ and environmental sources and from man made and environmentalaerosol sources.


• Must also have an understanding of optimal time for collection of varioussamples.

• Know the available methods, both standard and research that can be used toinvestigate air and aerosol samples for the presence of virus



a) List the viruses associated with air and aerosol samples that can currently bedetected by standard and research techniques.



d) Describe the hazards associated with applying methods to air and aerosolsamples and the precautions required in the laboratory.


216




Assessor’s name:

Date:

217

7.16d Testing procedures to detect the presence of fomitesUnderstand the scope of and the testing methods for fomites.

KNOWLEDGE

• Understand the requirements for appropriate samples for the detection offomites

• Understand the procedures involved in the collection of the above sampletype


• Know the available methods, both standard and research that can be used toinvestigate inanimate samples for the presence of virus



a) List the viruses associated with inanimate samples that can currently bedetected by standard and research techniques.



d) Describe the hazards associated with applying methods to inanimate samplesand the precautions required in the laboratory.


218




Assessor’s name:

Date:

219

Reflective Log –

1. What did you do?

Date(s).Duration oftraining.




virology

Business

b immunological techniques7

c molecular techniques

d molecular techniques7

diagnostic algorithm7

d molecular investigations

c electron microscopy7

b principles of vaccination

e molecular techniques7