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    Best Practice in Nuclear Medicine

    Part 1A Technologists Guide

    European Association of Nuclear Medici

    ne

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    ContributorsIgnasi Carri M.D.

    President o the EANM

    Proessor o Nuclear Medicine

    Autonomous University o Barcelona

    Director, Nuclear Medicine Department

    Hospital Sant Pau

    Barcelona, Spain

    Suzanne Dennan (*)

    Deputy Radiographic Services Manager,

    Dept. o Diagnostic Imaging

    St. Jamess Hospital

    Dublin, Ireland

    Wendy Gibbs

    Delivery Manager

    Dept. o Nuclear Medicine

    Guys and St. Thomas Hospitals

    London, United Kingdom

    Julie Martin

    Director o Nuclear Medicine Service

    Dept. o Nuclear Medicine

    Guys and St. Thomas Hospitals

    London, United Kingdom

    Brendan McCoubrey

    Radiation Saety OcerDept. o Diagnostic Imaging

    St. Jamess Hospital

    Dublin, Ireland

    Sylviane Prvot

    Chair, EANM Technologist Committee

    Chie Technologist, Radiation Saety Ocer

    Service de Mdecine Nuclaire

    Centre Georges-Franois Leclerc

    Dijon, France

    Helen Ryder

    Clinical Specialist Radiographer

    Dept. o Diagnostic Imaging

    St. Jamess Hospital

    Dublin, Ireland

    Linda Tutty

    Senior Radiographer

    Dept. o Diagnostic Imaging

    St. Jamess Hospital

    Dublin, Ireland

    Anil Vara

    Clinical Modality Manager Nuclear Medicine

    Dept. o Nuclear Medicine

    Royal Sussex County Hospital

    Brighton, United Kingdom

    Editors

    Suzanne Dennan (*)

    Sue HuggettSenior University Teacher

    Dept. o Radiography

    City University, London, United Kingdom

    This booklet was sponsored by an educational grant from Bristol-Myers Squibb Medical Imaging . The views expressed

    are those of the authors and not necessarily of Bristol-Myers Squibb Medical Imaging.

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    EA

    NM

    ForewordSylviane Prvot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

    IntroductionIgnasi Carri M.D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

    Section 1 Managing a Nuclear Medicine Service 7

    Anil Vara . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

    1.1. Patient Workow and Ecient Scheduling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

    1.2. Stock Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

    1.3. Cost Implications Budgeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

    1.4. Risk Assessments and Incident Training/Practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

    1.5. Business and Strategic Planning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

    1.6. Audit/Clinical Governance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

    1.7. Accreditation Quality Awards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

    Section Guidelines / Policies / Protocols 19

    2.1. Available Guidelines

    Brendan McCoubrey. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .192.2. Protocols and Policies in Nuclear Medicine DepartmentsHelen Ryder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

    2.3. Clinical Research PoliciesLinda Tutty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

    Section Staf Aspects o Best Practice

    3.1. Best Practice or Recruitment and SelectionWendy Gibbs and Julie Martin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32

    3.2. Best Practice or Induction

    Wendy Gibbs and Julie Martin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .383.3. Best Practice or AppraisalWendy Gibbs and Julie Martin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46

    3.4. Education and TrainingSuzanne Dennan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48

    3.5. Lielong Learning and CPDSuzanne Dennan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51

    3.6. Multidisciplinary Team WorkingLinda Tutty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54

    Reerences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56

    Contents

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    ForewordSylviane Prvot

    One o the major achievements o the EANM

    Technologist Committee in the past 2 years

    has been the publication o a series o bro-

    chures Technologists guides that was ini-

    tially planned with two main goals: to en-

    courage Nuclear Medicine Technologists

    (NMTs) reection on the quality o their daily

    practice and to advance it i necessary.

    The aim o this third volume is to provide

    an introduction to best practice in Nuclear

    Medicine considering three main items : man-

    agement o a modern day Nuclear Medicine

    service, clinical guidelines & protocols, man-

    agement o human resources. The impact o

    policy and legislation on best practice will be

    the purpose o a second part to be published

    at the EANM Congress 2007 in Copenhagen.

    I am grateul or the eorts and hard work o

    all the contributors, who are the key to the

    content and educational value o this book-

    let. The most essential and relevant aspects

    o best practice are emphasized here. Many

    thanks to Suzanne Dennan or her dedication

    to the success o this guide. This publication

    wouldnt have been possible without Bristol-

    Myers Squibb Medical Imaging support. Their

    collaboration and generous sponsorship was

    greatly appreciated.

    Quality is not just a nice concept : quality is a

    state o mind. I hope this brochure will meet

    the expectations. Contributing to the qual-

    ity assurance o Nuclear Medicine practice it

    may also become a useul tool or motivated

    technologists in the optimization o the overall

    quality o healthcare in Europe.

    Sylviane PrvotChair, EANM Technologist Committee

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    IntroductionIgnasi Carri M.D.

    Nuclear Medicine departments oer a large

    diversity o diagnostic and therapeutic pro-

    cedures, which oten play a central role in pa-

    tient management. At the same time, the feld

    is constantly evolving with new procedures

    being continuously introduced. In such a rich

    and developing scenario, adherence to best-

    practice guidelines becomes crucial to oer

    best patient care.

    Nuclear Medicine technology is a demanding

    and sophisticated proession. The continuous

    developments in technology, radiopharmaceu-

    ticals, procedures and patient care make it one

    o the most rapidly evolving health care proes-

    sions. For example, novel targets or imaging

    have emerged, such as labelled glucose or the

    imaging o cancer, labelled somatostatin tracersor the imaging o neuroendocrine disease, beta

    CIT homing onto the dopamine transporter or

    the investigation o patients with movement dis-

    orders. Progress is coming in the imaging o the

    Alzheimers disease, the imaging o atheroscle-

    rotic plaque and the imaging o angiogenesis

    and hypoxia. Sentinel lymph node detection has

    changed the surgical management o patients

    presenting with early breast cancer. At the same

    time, all diagnostic procedures have benefted

    rom major progress in instrumentation; and in

    the last 5 years, the emergence o multimodal-

    ity imaging has become routine. Conventional

    gamma cameras have been linked to advanced

    CT scanners (SPECT/CT) and modern PET scan-

    ners have been linked to multi-slice CT devices

    (PET/CT).

    Nuclear Medicine therapy has also been grow-

    ing ar beyond the established treatment o

    benign and malignant disease o the thyroid. I-

    131 when linked to metaiodobenzylguanidine

    is used in the treatment o neuroendocrine

    malignancies, such as pheochromocytomas

    and neuroblastomas. Newer ligands target-

    ing the SS2 receptor subtypes are emerging,

    labelled with Yttrium 90, Lutetium 177 andother radionuclides. Pain palliation in ad-

    vanced metastatic and skeletal prostate and

    breast disease has become available, with one

    third o patients showing excellent response

    to a variety o radionuclides, including stron-

    tium 89-chloride, rhenium-186 as etidronate,

    samarium-153 as ethylene-diaminetetrameth-

    ylene phosphonate. Several labelled antibod-

    ies have been entered in clinical trials andsome have now been approved as specifc

    treatment options, such as Zevalin or Yttrium-

    90 labelled ibritumomab tiuxetan and Bexxar

    I-131 labelled tositumomab.

    With such continuing developments and in-

    novation, best-practice may become a mov-

    ing target. Clearly, best-practice guidelines

    must be developed and implemented at the

    European level that help Nuclear Medicine

    departments to provide best patient care. Up-

    dated procedural and clinical guidelines are

    available rom the EANM website or many o

    the well established diagnostic and therapeu-

    tic procedures. Adherence to such guidelines

    is highly desirable to harmonize patient care

    across the diversity o European countries. Eu-

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    ropean Nuclear Medicine technologists prac-

    tice Nuclear Medicine in departments where

    most o these procedures are perormed in a

    patients diagnosis or ollow-up. As members

    o their institutional health care team, they

    also unction as patient advocates, educators,

    health care researchers, technical and therapy

    specialists, and interdisciplinary consultants

    and play a key role to oer best clinical prac-tice. Nuclear Medicine must embrace the prin-

    ciples o best-practice as the basis or clinical

    judgement, within the context o working as

    part o a multi-disciplinary team in medical

    diagnosis and therapy. Within such multi-disci-

    plinary teams, Nuclear Medicine technologists

    must play a leading role in establishing clinical

    standards and clinical protocols.

    In order to oer best practice, continuing edu-

    cation is essential. The education process in

    Nuclear Medicine includes graduating rom

    an accredited programme, completing a

    summary o clinical competence and com-

    pleting a proessional certifcation examina-

    tion when available. The education process

    assures that Nuclear Medicine technologists

    have the knowledge, skills and judgement to

    be competent health care providers in their

    highly specialized discipline. In addition, lie-

    long learning is a core value or all health care

    proessions. Thereore, entry-level education in

    Nuclear Medicine must be supported by both

    ormal and sel-directed proessional devel-

    opment programmes. All these programmes,

    including cognitive, aective and clinical com-

    petence, must be part o best-practice codes

    in any Nuclear Medicine department.

    Like all healthcare proessions, Nuclear Medi-

    cine must move with the times, changing and

    adapting its principles and relationships, ac-

    knowledging the expectations o patients and

    the developing practice o other healthcare

    disciplines. Like all healthcare proessions, onlyby understanding, accepting and adapting

    to these changes can Nuclear Medicine oer

    best-practice and retain its relevance within

    medicine and society.

    Ignasi Carri, M.D.

    President, EANM

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    Section 1 Managing a Nuclear Medicine Service1.1. Patient Workow and Ecient Scheduling

    Anil Vara

    Introduction

    An ecient Nuclear Medicine department

    relies mainly on good scheduling o patients

    or an ecient workow. Nuclear Medicine

    has various types o examinations, each with

    its own time scale, preparation, and various

    complications. Diagnostic imaging is the most

    common type o examination most centres

    schedule routinely.

    TIME STUDY PATIENTS NAME COMMENTS

    09:00 URGENT BONE

    09:15/09:30 RBC/MECKELS/MAG3

    09:45

    10:00 BONE/DMSA INJ 110:15

    10:30 LUNG PERFUSION

    10:45 BONE/DMSA INJ 2

    11:00 BONE/DMSA INJ 3

    11:15 BONE/DMSA INJ.4

    11:30 3 PHASE BONE 5

    12:00 3 PHASE BONE 6

    12:15 URGENT BONE SCAN

    13:00 BONE/DMSA SCAN 1

    13:45 BONE/DMSA SCAN 2

    13:45

    14:00 BONE/DMSA SCAN 3

    14:15

    14:30 BONE SCAN 4

    14:45

    15:00 BONE SCAN 5

    16:30 BONE SCAN 6

    Diagnostic Imaging

    Diagnostic imaging makes up the bulk o

    examinations in Nuclear Medicine. Ecient

    scheduling or this is mainly dependent on

    sta availability, gamma camera numbers,

    and gamma camera types. Some centres may

    operate with a single gamma camera, whilst

    some departments may have multiple gamma

    cameras at their disposal.

    7

    Table 1: Example outline o a day list illustrating exibility in Nuclear Medicine exam type.Courtesy o Kingston NHS Hospital, Surrey; Vara 2001

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    One Gamma Camera Department

    Centres that have only one gamma camera

    are most likely to schedule various types o

    examinations during a working day. Careul

    planning and organisation is critical to achieve

    this, in light o the complexity involved in vari-

    ous Nuclear Medicine exams. Block booking

    particular exams could be dicult to achieve,

    whilst having the exibility or all types o ex-ams over a working day would be more e-

    cient. Table 1 illustrates an example o a typical

    days workow on a single gamma camera.

    The outline o the example takes account o

    the various camera times required or each

    exam, whilst ully utilising all the capacity

    available to schedule the various exams. This

    type o day diary can be easily set up or singlecamera departments, but care must be given

    on examinations that are higher in demand.

    Systematic review o all workows should take

    place regularly, especially ollowing a protocol

    review.

    Multiple Gamma camera departments

    Scheduling on multiple gamma cameras can

    be exible, but the main advantage is that

    block booking o particular exams can be

    achieved more eciently than in single cam-

    era departments. The option o block booking

    or higher demand studies, or example Myo-

    cardial Perusion studies such as Octreotides

    or MIBG can be better streamlined, not hin-

    dering common types o work such as Bone

    scanning etc.

    Other types o examinations

    Scheduling non-imaging examinations

    alongside diagnostic imaging is needed in

    most Nuclear Medicine departments. These

    could be exams such as GFR, red cell mass

    or therapeutic administrations. In-vitro based

    exams are mainly perormed by trained sta

    that are commonly multi-tasking and involved

    in other areas. Rotating sta through all areasmaximises expertise and is best or exibility

    in scheduling non-imaging work alongside

    diagnostic imaging. Scheduling in-vitro work

    has to be carried out with care to ensure ad-

    equate capacity is maintained at all times in

    all areas o the department.

    Therapy is very dependent on key proes-

    sionals such as consultants and/or medicalphysicists. Usually in this case, scheduling o

    these patients is independent o other Nucle-

    ar Medicine work, but attention is needed i

    technological sta have delegated responsi-

    bility in Therapy.

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    Section 1 Managing a Nuclear Medicine Service1.2. Stock Control

    Anil Vara

    Introduction

    Stock control in Nuclear Medicine is an es-

    sential task or the ecient operation o the

    Nuclear Medicine department.

    The types o stocks routinely handled are:

    1. Radiopharmacy consumables

    2. Clinical consumables3. Pharmacy consumables

    4. Administrative consumables

    1. Radiopharmacy Consumables

    Radiopharmacy consumables include cold

    kits, nuclides and items used or radiopharma-

    cy production. Cold kits have to be careully

    managed, as their requirement is very much

    dependent on the particular demands orcertain types o examinations, which can vary

    over quite short periods o time. Most centres

    have purpose built databases or spreadsheets

    or managing these stocks. These are usually

    or the purpose o recording incoming stock

    and auditing the level o use based on the

    service need. Such databases allow a concise

    record allowing all aspects o stock control to

    be monitored but there is still an element o

    good communication needed between the

    production service and the diagnostic service

    to reduce the occurrence o overstocking and

    to accommodate any service changes. When

    ordering cold kits and 99m Tc generators, this is

    best accomplished by a standing order with the

    supplier, but a regular stock take every month

    is essential in conjunction with this, in order to

    minimise costs and waste. Commercial com-

    panies are now oering sotware packages to

    carry out the overall management o radiophar-

    macy stock, with options built in to warn o low

    stock levels and automatic updating.

    Ordering long-lived radiopharmaceuticals such

    as 111In Octreotide, I131MIBG etc. is usually carried

    out on a per usage basis.

    2. Clinical Consumables

    Clinical consumables range rom requently

    consumed items such as syringes, needles,

    gloves, sharps bins etc to items that are used

    less requently such as, ventilation kits or aero-

    sols, specialised nursing aids etc.

    The golden rule is not to overstock on theseitems, which is a common practice in some

    Nuclear Medicine departments. This can lead

    to excess requirement or storage space, the

    risk o items expiring and o accumulating

    unused items which would incur costs. Com-

    monly, these types o stocks are controlled and

    ordered as a common pool with other modali-

    ties such as Radiology and CT. By averaging out

    consumption, this does achieve an adequate

    stock o clinical consumables which can be

    reviewed weekly or every ortnight. Most hos-

    pitals operate an online ordering system, direct

    to their stores and even set up standing orders.

    Standing orders would be practical or consum-

    ables that have average usage (per week or

    example) and the average usage is sustained.

    9

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    10

    3. Pharmacy Consumables

    Nuclear Medicine routinely has to stock both

    drugs that are commonly used as part o

    the examinations and essential drugs which

    are used or intervention when aced with

    emergencies. Usually a standing order with

    the pharmacy department would be best to

    manage the incoming stock o drugs with

    the advantage o cross charging made easierto budget or every month. Additional drugs

    can be requested when stock is low. The most

    crucial element is that pharmacy drugs are all

    checked or expiry regularly and that drugs

    used should be replaced as soon as possible.

    In these cases, it is oten useul to stock take

    once or twice a week so the drugs cabinet

    is not in surplus and that all essential drugs

    are in stock.

    4. Administrative Consumables

    These consumables are essential or the e-

    fcient clerical operation o Nuclear Medicine.

    Again overstocking could result in unneces-

    sary costs to the department. The common

    practice or most institutes is that administra-

    tion consumables are managed by a central

    department, which is usually also covering

    many modalities other than Nuclear Medicine.

    Increasing turnover in this way, it can be en-

    sured that stock is well controlled and that

    surpluses do not occur.

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    11

    Financial pressure is always a concern or an e-

    fcient operation o a Nuclear Medicine service,

    usually associated with overall Health/Trust

    service pressures. It is important to manage

    the departmental budget properly in order

    to have eciency and exibility.

    In the UK, departments that are in the NHS

    are paid by the activity completed. This iscalled Payment by Results, and requires good

    data keeping and strict audit on all activity

    within the department, so that all income is

    accounted or.

    Departmental budgets are usually broken

    down into the ollowing components:

    1. Pay Sta costs2. Non-Pay All other costs

    3. Income Pay that is received by the

    department

    In the UK it is common practice to cross charge

    or internal (within the hospital) and external

    (other hospital) work. This would account to

    the income the department will receive. Set-

    ting up local trading accounts can achieve

    this best.

    1. Pay

    The pay budget is allocated or sta. Once

    sta and their unding have been agreed, the

    institute accountant will assign an annual bud-

    get against each one. Pay budgets should be

    reviewed regularly especially when a vacancy

    occurs. This would allow a review o the ser-

    vice needs at the current time and provide

    an opportunity to prove the need or addi-

    tional posts and/or restructure sta gradings

    to maximise numbers. Reviews o this kind are

    essential, as service needs do change and oc-

    casionally higher demand areas can be unded

    within the existing budget.

    2. Non-pay

    This budget represents all costs involved in

    running the Nuclear Medicine service. These

    are usually broken down into individual ac-

    counts such as equipment, radiopharmacy,

    maintenance, provisions etc. Again, the insti-

    tute accountant will place a budget limit to

    each account based on an estimate o the true

    costs rom previous years. Good managemento this budget is required to prevent over-

    spending. Items should be charged to the

    correct account so that a review at the end

    o the year shows a true reection o where

    adjustments need to be made or the ollow-

    ing year. Regular (monthly) review o each

    account is important, as during the fnancial

    year it may be ound that certain accounts are

    not being used whilst others are at risk o be-

    ing overspent. By making slight adjustments

    across accounts, it is possible to balance each

    account properly, making the end o year re-

    view easier. Occasionally, however, it may be

    ound that a budget set against an account

    is not used at all until a particular month. An

    example o this would be a contract o some

    kind, or which a bulk payment is taken in one

    Section 1 Managing a Nuclear Medicine Service1.3. Cost Implications Budgeting

    Anil Vara

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    1

    month only. In these cases, accounting meth-

    ods can adjust or this so as not to give a alse

    impression o the account.

    3. Income

    Most departments will receive income, mainly

    or services to outside institutes usually via

    service level contracts or monthly activity re-

    charges. These budgets are reviewed at theend o every fnancial year. Managing income

    is very important. All activity must be logged

    and cross-charged so that regular income

    payments are made. Late payments need to

    be borne in mind at monthly reviews. I ex-

    cess income is obtained, this can be used or

    o-setting any other budgets such as pay or

    non-pay, but this is rare once annual budgets

    are set.

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    EA

    NM

    1

    Risk assessments

    Risk assessments should be carried out be-

    ore any new work within Nuclear Medicine

    commences. The most common types o risk

    assessments are based on radiation risks and

    health and saety issues.

    These assessments are drated, usually based

    on advice orm the RPA (Radiation ProtectionAdvisor), so relevant sta are aware o risks in

    each area o the department. They should be

    read by all personnel who would be working

    in the assessed areas. The assessments or as-

    sociated radiation risk should be drated or

    each area o Nuclear Medicine and regularly

    reviewed, preerably once a year or i an in-

    cident or near miss has taken place. During

    the review process, control measures must

    be updated to minimise the risk as much as

    possible.

    The 5 steps to a risk assessment are as ollows:

    1. Identiying the hazard

    2. Control measures in place

    3. Evaluating the risks4. Action plan/records

    5. Review

    Risk assessments should be kept as simple

    as possible and be concise. It is usually best

    to produce a series o assessments based on

    each room within Nuclear Medicine. An ex-

    ample is shown in Table 1:

    In the UK, all risk assessments must conorm to

    IRR99 regulations (Ionising Radiation regula-

    tions 1999). Areas in Nuclear Medicine desig-

    nated as controlled or supervised should be

    defned within the risk assessment.

    Incident training

    Unortunately incidents do happen in Nuclear

    Medicine, even when assessments are made.

    When an incident does occur, it must always

    Area Types o risks associated

    Gamma Camera roomUnsealed sources, patient contaminants, sealed sources, doses to sta rom

    patients

    Injection room Dose rates to authorised sta, sealed and unsealed sources,

    Waiting area Dose rates rom radioactive patients, patient contaminants

    be documented, with records fled. A review

    must take place ollowing the incident, so the

    risks associated can be minimised urther, i

    possible.

    The radiation protection supervisor should

    have a training programme, which all sta

    working in relevant areas o Nuclear Medicine

    should undergo, beore commencing work.

    The training should consist o the ollowing:

    Table 1: Risk assessments

    Section 1 Managing a Nuclear Medicine Service1.4. Risk Assessments and Incident Training/Practice

    Anil Vara

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    1. To read and ollow the local rules or the

    department

    2. To be amiliar with the procedures when a

    radiation incident occurs

    3. To be aware o the documents that need

    to be completed when a incident occurs

    4. To be cognisant o the sta that have to be

    notifed.

    The local rules should be concise and as short

    as possible. They should contain key inorma-

    tion such as contact details, types o sources

    within the department, decontamination

    procedures, and systems o work, operational

    procedures and contingency plans.

    Generic hospital incident logbooks can be

    used or logging incidents. Although a pur-pose made record is just as good. Following

    an incident, a record should be drated as soon

    as possible. Depending on the severity o the

    risk, incidents should be ollowed up quickly,

    reviewing systems o work to minimise the

    risk. All incidents should be discussed at the

    next radiation saety committee, where urther

    support can be acquired, i needed.

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    Business planning in Nuclear Medicine is

    very important, especially when immediate

    or uture changes need to be made. Nuclear

    Medicine is a growing area in medicine, and

    services have to be adapted in order to meet

    the rapid changes that will occur.

    Initial planning

    When an idea needs to be taken orward, suchas new equipment, sta or even a new tech-

    nique, it is important that all the evidence is

    available to take the plan orward and make

    its possible implementation as smooth as pos-

    sible. The types o evidence that should be

    considered are:

    1. Financial unding and support

    2. Any income revenue or other benefts tothe trust/organisation

    3. Capacity and demand data or the Nuclear

    Medicine department

    4. Recommendations and audits rom recog-

    nised proessional groups e.g. NICE

    (National Institute o Clinical Excellence,

    UK) EANM

    5. Impact on the service i the plan is

    declined

    Business case

    The business case is the essential docu-

    ment, which will allow all the evidence to

    be placed together and illustrate options to

    be considered or the business proposal. The

    business case should be drated accurately

    and in conjunction with the trust accountant.

    Section 1 Managing a Nuclear Medicine Service1.5. Business and Strategic Planning

    Anil Vara

    Once a business case is prepared, it is usually

    submitted to the trust board or approval and

    implementation.

    Essentials o the business case

    When drating a business case, the ollowing

    essential sections should be included:

    1. Executive summaryThis section should begin with an introduc-

    tion and purpose o the case. Good evidence

    such as rom regulatory bodies, government,

    commissioning bodies etc is well suited here.

    Following this, a section on demand and ca-

    pacity o the current service should be includ-

    ed. This will be based on graphical representa-

    tion o the demand (amount o work entering

    the service) and capacity (current sta andequipment) available and any changes pro-

    posed that may aect this. Finally, at the end

    o this section, a list o options should be listed.

    This is called an options appraisal. Although,

    you will have evidence to support the new

    case, all options should still be considered in

    any business case. This should always include

    a Do Nothing option, so the business case

    reects all possibilities, including the impact

    on the service i the trust board rejected the

    business case.

    2. Economic case

    This section should be used or detailing and

    arguing the fnance proposed or the case. It

    should begin by listing the fnance require-

    ments behind each o the above listed op-

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    tions. This is called an economic appraisal.

    All fnance initiatives, including negative im-

    pacts, should be included under each option.

    Following this, an assessment o the risks and

    benefts o this case should be made. This is

    very similar to a risk assessment in Nuclear

    Medicine, where a scoring method can be

    derived and used to measure the positive andnegative aspects o each option. All associ-

    ated risks and benefts should be included to

    make the case look strong. The outcomes o

    the scoring can be presented in a results sec-

    tion, ollowed by a simple conclusion.

    3. Finance and recommendations

    This last section should indicate the amount,

    source and pressures o the fnancial supportneeded to justiy the best option. Usually at

    this point, prior agreement o the source o

    unding will have been obtained and this will

    need to be documented here.

    The fnal recommendation should highlight

    the best option to proceed with. The data

    provided in the relevant section should agree

    with the departments recommendations, and

    i the evidence is clear, usually the business

    case is accepted. Occasionally, one or more

    options may be suitable; and in these types

    o situations it is very dicult to agree on the

    case. But, when possible, i there is just one

    easible option in the recommendations, it

    works to the departments advantage.

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    Audits (examinations o records to check their

    accuracy) and clinical governance (the system

    through which organisations are accountable

    or continuously improving the quality o their

    services and saeguarding high standards o

    care, by creating an environment in which

    clinical excellence will ourish) are essential

    in Nuclear Medicine as with any other part

    o medicine. Clinical governance teams (orequivalent) should be set up to perorm this.

    The audit group should comprise o essential

    sta rom each clinical area. A person specif-

    cally employed within speciality areas, such

    as Radiology and Nuclear Medicine, would

    normally lead on this.

    When audit projects are set up, they should

    begin with a defnite aim and methodology.Audits within the service should cover the ol-

    lowing areas:

    1. Change or implementation o clinical

    practice

    2. Changes in service provisions with best

    patient care practice

    3. Evidence towards a new business case

    The aim o the sub specialty group is to ensure

    that best practice is always implemented and

    any new evidence that arises can be discussed

    or easibility to improve patient management.

    Generally once the group agrees to the results,

    these are used to implement any changes and

    support any urther case. Discussions and

    ideas rom these meetings should be taken

    Section 1 Managing a Nuclear Medicine Service1.6. Audit/Clinical Governance

    Anil Vara

    orward to management meetings where fnal

    decisions are made. All audits should be well

    documented, even published, and available

    to any external auditors.

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    Section 1 Managing a Nuclear Medicine Service1.7. Accreditation Quality Awards

    Anil Vara

    Accreditation towards a good Nuclear Medi-

    cine service is always an indicator o high

    achievement and movement in the right di-

    rection. Essentials o a good quality service

    should include

    1. Good written policies and procedures or

    the department

    2. Practice that complies well with the localregulations

    3. A review structure that covers all aspects

    o Nuclear Medicine

    4. A department that liaises with other insti-

    tutes within a local area and gets involved

    with local activities to help maintain a good

    level o service.

    Well written policies and procedures are es-sential. They help maintain proessional and

    sae practice in Nuclear Medicine as well as

    help develop the service through audits and

    reviews.

    Practice in conjunction with regulatory bod-

    ies is very important. For example, in the UK,

    the Department o Health has written various

    documents that require compliance. Although

    the practice associated with implementing

    these documents will vary rom department to

    department, the principles remain the same.

    Good communication with other institutes

    will help achieve this as well as regular inspec-

    tions by the governing bodies to highlight

    areas o poor quality. Proessional institutes

    such as National and European Nuclear Medi-

    cine societies will drat polices and procedures

    which should be ollowed.

    Reviewing current practice should give an

    opportunity to enhance the service or deal

    with a concerning situation. Reviews should

    be made in line with local or national audit

    programmes/data and should be included

    across the whole unction o the departmentincluding sta competencies.

    Taking the departments work orward to Na-

    tional or European meetings is an essential

    practice to demonstrate to other institutes

    how the department is progressing and to

    share new initiatives. Usually single or joint

    departmental ventures are undertaken. Most

    departments do fnd it dicult to take thisorward, due to service and sta pressures, but

    this should be encouraged as ar as possible.

    This is why joint ventures can make it easier.

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    In preparing a document on best practice

    in Nuclear Medicine, it is important to draw

    on the existing research, which has been

    conducted by the various relevant authori-

    ties concerned with the provision o a Ra-

    dionuclide Imaging service throughout the

    world. In particular it is necessary to ocus on

    the guidelines which have been ormulated

    in the context o evolving European legisla-tion and practice. National interpretation o

    European Regulations on the administration

    o radioactive substances and dierences in

    clinical practice and service delivery mean

    that guidelines do not readily apply across

    regional and national boundaries. The Euro-

    pean Association o Nuclear Medicine (EANM)

    http://www.eanm.org recognises the need or

    the development o clinical guidelines at aninstitutional level to incorporate those aspects

    o the available guidelines that impact on the

    tailored service provided by the institution.

    O greater relevance than detailed guidelines

    covering perormance aspects o individual

    diagnostic and therapeutic procedures are

    Generic Quality Guidelines, which outline the

    perormance characteristics aecting overall

    quality. From these Generic Quality Guidelines,

    individual institutions should derive specifc

    local guidelines covering those practices rel-

    evant to their service requirements.

    By ollowing the links given, a cross section

    o the existing guidelines provided by rel-

    evant authorities at both European level and

    Section 2 Guidelines / Policies / Protocols2.1. Available Guidelines

    Brendan McCoubrey

    worldwide can be ound. These guidelines are

    resultant rom the research assimilated by the

    national and international institutions. A brie

    introduction is given concerning the history

    o the particular association.

    Guidelines are available or download on the

    EANM website at the ollowing address :

    http://www.eanm.org/scientifc_ino/guidelines/guidelines_intro.php?navId=54

    International Links

    Further links to the International Associations

    and Societies may be ound at the ollowing

    address:

    http://www.eanm.org/pat_ino/links.

    php?navId=57

    Nationally produced guidelines can be ound

    on each societys website.

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    Section 2 Guidelines / Policies / Protocols2.2. Protocols and Policies in Nuclear Medicine Departments

    Helen Ryder

    A cornerstone o good practice in a Nuclear

    Medicine department is the development

    and usage o protocols and policies or that

    particular unit. O diering origins, protocols

    tend to be an amalgam o standard scanning

    techniques with local radiological preerences

    whereas policies are normally devolved rom

    legislation regarding the use o diagnostic

    radiation or the health and welare o thepatient.

    So who uses these protocols?

    The development o protocols is intended to

    standardize technical actors, timing o imag-

    ing and the views obtained during imaging

    to provide the best inormation rom which

    the scan may be reported. By making these

    protocols available within the department,either electronically or on paper, new or ro-

    tating sta/personnel may be kept up to date

    on latest changes in techniques. It also acts

    as a reerence or examinations that are not

    regularly perormed by the department.

    Reerence to written protocols can also alert

    sta members to the individual needs o the

    reporting clinician. Most departments have

    more than one member o the medical sta

    who undertake and oversee scanning ses-

    sions, and adaptations by scanning sta to

    their preerred techniques are o vital impor-

    tance.

    Developing protocols

    A starting point in preparing an examination

    protocol is to list the technical actors required

    to complete the scan. These actors can in-

    clude:

    Equipment used in a multi-camera de-

    partment some equipment may be more

    suitable than others. Myocardial peru-

    sion imaging generally requires the use o

    a multi-tangential dual-headed gammacamera; brain imaging may best be acili-

    tated by utilising a dedicated triple-headed

    system.

    Quality Assurance and pre-set Gamma

    Maps when using rotating cameras, or

    diering or multiple isotopes, preliminary

    QA and gamma maps may need to be per-

    ormed or defned.

    Radioisotope isotope channel, peak and

    acceptance window to be used.

    Acquisition Parameters :

    Matrix size can vary either or type o acquisi-

    tion required (dynamic; planar; tomographic)

    or within a specifc acquisition (e.g. The vas-

    cular/dynamic and blood pool/static planar

    phases o bone imaging). These are usually set

    within the acquisition protocol logged onto

    the scanning computer.

    Type of acquisition e.g. dynamic, static, whole-

    body, SPECT, gated.

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    Time of acquisition/count statistics some im-

    ages may be ended by reaching either a time

    or count limit, or in terms o gated studies by

    the number o cycles completed.

    Indications/Contraindications in some cases

    the scan requested may not be the most ap-

    propriate examination. The Royal College o

    Radiologists (UK) in London has produced abooklet which oers guidance in these cases

    or a wide range o diagnostic imaging proce-

    dures. The booklet is called Making the best use

    o a Department o Clinical Radiology and is

    available through their website at http://www.

    rcr.ac.uk/index.asp. The European Commission

    has adapted the RCR reerral guidelines or use

    in their guidance document Radiation Protec-

    tion 118 Reerral guidelines or imaging, whichis available at the ollowing web address:

    http://ec.europa.eu/energy/nuclear/radiopro-

    tection/publication/doc/118_en.pd.

    Contraindications can apply both or choice o

    examinations or, more relevant in departmen-

    tal protocols, or medical and physical reasons.

    For example when choosing a pharmaceuti-

    cal or myocardial stress procedures, it should

    be noted that asthmatic patients should not

    be given either adenosine or dipyridamole.

    Physical limitations may also defne which ex-

    amination may be appropriate e.g. diculty in

    perorming physical exercise.

    Patient Preparation o vital importance in

    the production o diagnostic scan results,

    Section 2 Guidelines / Policies / Protocols

    these should be defned or all examina-

    tions perormed in the department. Prepa-

    rations should include the need or asting;

    hydration requirements; medications to be

    halted prior to examination; medication

    to be taken pre- and/or post examination.

    The timings o such preparations as well as

    medication lists etc should be logged both

    in the protocols and any inormation sheetssent out to the patient when the appoint-

    ment is scheduled.

    Scan time delays some examinations re-

    quire that scans be perormed at certain

    time intervals, be they minutes, hours or

    days. These timings should be included in

    the protocol listings.

    Images/views taken whilst many examina-

    tions can be perormed as pre-programmed

    imaging e.g. wholebody procedures, others

    require a series o static planar images to

    be taken to demonstrate the physiology

    required. This includes, or instance, the

    multi-planar imaging o lung perusion us-

    ing Tc99m-MAA. A typical series o the lungs

    may include: Anterior; Posterior; Let Ante-

    rior Oblique; Right Anterior Oblique; Right

    Lateral; Let Lateral. Positional angulations

    should be recorded or successul compara-

    tive imagery.

    Adaptation o protocols although the

    ramework o a successul scan is laid down

    in the protocol list as above, it should be

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    noted that this protocol can be adapted

    or the medical condition o the individual

    patient or or the requirement o a partic-

    ular requesting physician. An example o

    this adaptation could be the basic Isotope

    Bone Scan. Dierent patient history could

    inuence the views taken during the ex-

    amination in the ollowing ways:

    - metastatic disease --- wholebody scan

    plus detailed static planar imaging o

    areas o interest.

    - osteo- or rheumatoid arthritis --- whole-

    body scan plus static planar imaging o

    hands and eet

    - inection/racture e.g. diabetic oot --- dynamic imaging o area o interest

    with three-hour delayed static planar

    imaging o relevant areas

    - mandibular asymmetry --- static planar

    imaging o head plus SPECT imaging o

    mandible.

    Analysis protocols many nuclear medi-

    cine examinations require that data be

    analyzed and presented in certain or-

    mats, especially where fnal fgures are

    produced e.g. ejection raction as a result o

    gated cardiac wall motion studies (MUGA

    scans). In most cases the analysis is objec-

    tive, utilizing preset analysis programmes,

    but some variations can be introduced in

    their usage with reerence to positioning

    o regions o interest. To minimize the sub-

    jective eects o individual on the various

    programs, protocols should be included

    to give step-by-step guidance in their ac-

    curate application.

    Relevant papers copies o relevant arti-

    cles, papers, monographs and manuactur-ers details are oten useul to include within

    a protocol fle, or additional reerence and

    constant updating o good practice.

    A sample protocol is shown in Appendix 1.

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    Gallium67 Whole Body Scans

    Radiopharmaceutical: 110MBq Gallium-67 Citrate (one patient dose).

    Radiologist should give injection.

    Patient Preparation: Day 1 Ga67 injection given no scans.

    Day 2 no scans. Patient should ast rom midnight, be givenbowel preparation or next day.

    Day 3 (48 hours) Scan, patient to ast and be given urther

    bowel prep

    Day 4 (72 hours) Scan

    Scan Delay: Scan on Day 3 (48 hours) and Day 4 (72 hours)

    Scan Name: Ga67 wholebody scan (48hrs), Ga67 wholebody

    scan (72 hrs), Ga67 planars (under Other on protocols list)

    Scan Parameters:

    Camera: Axis Dual-head

    Isotope channel: Ga67 , 184, 296, and 388 keV, 10- 20% window widths

    Collimators: MEGAP

    Routine Views: Wholebody scan (anterior and posterior) + planars o areas o

    interest i necessary at 48 Hours and 72 hours post-injection.

    Due to low injected and retained activity, tomography is not

    routine.Indications or Scanning: Non-specifc inection, inammation, PUO; tumors;

    sarcoidosis

    Display: As wholebody display, attach relevant static images. Label with

    scan type and time (post injection) or each day.

    Section 2 Guidelines / Policies / Protocols

    Appendix 1: Sample protocol (Courtesy o St. Jamess Hospital, Dublin)

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    Application o Departmental Policies

    Policies are designed to be applied within

    the Nuclear Medicine department as a whole,

    rather than on an individual scan basis. The

    policies generally are developed rom the

    point o view o good practice, including

    radiation protection, health and saety, and

    inection control. All policies should be ap-

    plied with the ull knowledge and co-opera-tion o all branches o personnel within the

    department (nuclear medicine physician/ra-

    diologist, physicists and radiographers/tech-

    nologists) and should be made known to all

    clinicians and departments making use o

    the range o services oered by the Nuclear

    Medicine department.

    Radiation Protection Radiation dose to the patients as most

    nuclear medicine procedures require an

    injection o radioactive material attached

    to a tracer, utmost care must be taken to

    ensure that the correct procedure has

    been selected to maximize diagnostic

    suitability; that the radioactivity o the

    injected dose ollows the principles o

    ALARA (as low as reasonably achievable)

    or ALARP (as low as reasonably practi-

    cable); that the patient has been given

    adequate inormation prior to the pro-

    cedure and such atercare details as are

    appropriate.

    Protection with regard to a possible preg-

    nancy the prime responsibility or iden-

    tiying such patients lies with the reerring

    clinician, but all personnel involved are

    expected to actively ensure that radiation

    is not used inappropriately with regard to

    possible oetal irradiation.

    All nuclear medicine procedures require

    that precautions be taken when admin-

    istering radioactive materials to emaleso child-bearing age. Details can be set

    locally but with regard to nuclear medi-

    cine procedures the 10-day Rule is most

    oten applied. This requires that all ex-

    aminations that include exposure o the

    pelvic regions be deerred until the emale

    is within the frst 10 days o the menstrual

    cycle. Generally the only nuclear medicine

    procedure that can be carried out duringpregnancy is an isotope lung perusion

    study, and in many cases CT Pulmonary

    Angiograms are perormed instead. The

    European Commission provides practical

    advice on the protection o pregnant pa-

    tients and breasteeding mothers in the

    guidance document Radiation Protection

    100 Guidance or the protection o un-

    born children and inants irradiated due

    parental medical exposures, which avail-

    able at the ollowing web address:

    http://ec.europa.eu/energy/nuclear/

    radioprotection/publication/doc/100_

    en.pd

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    Radiation protection o sta where a

    patient is due to undergo a series o ex-

    aminations on the same day, either in the

    x-ray department or in other diagnostic

    procedural units, these examinations

    should preerably be perormed prior

    to the nuclear medicine examination.

    Where this is not possible e.g. during

    breast surgery ollowing sentinel nodeimaging, protocols or such procedures

    should have been confrmed in advance

    and put in operation with the theater and

    pathology sta concerned.

    For inpatients undergoing a nuclear medi-

    cine examination ollowing the injection

    o radioactive material or when a nuclear

    medicine procedure has been completed,an advice sheet is sent with the patient to

    the ward regarding the type o procedure

    undertaken, the radiopharmaceutical and

    dose administered and the time or which

    any restrictions apply.

    Sample advice sheets are shown in

    Appendix 2.

    Section 2 Guidelines / Policies / Protocols

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    DEPARTMENT OF NUCLEAR MEDICINE

    ST.JAMESS HOSPITAL

    Name o Patient: _______________________________________________________________

    Consultant: ________________________ Ward: ______________________________________

    Date: _____________________________ Time: ______________________________________

    The above named patient has attended the Nuclear Medicine Department or the ollowing:

    Scan Type: _________________________ Isotope: ____________________________________

    Activity: ______________________________________________________________________

    The ollowing precautions should be ollowed or a period o 24/48/72 hours (delete as necessary).

    1. In general, try to avoid unnecessary close contact (less than 0.5m) with the patient.

    2. Examination gloves and plastic aprons should be worn when handling urine bags, bottles, bedpans

    and dirty linen. Any spillages should be cleaned up quickly and careully.

    3. Soiled linen should be bagged and then stored or 24 hours beore being sent to the laundry.

    4. Pregnant sta should minimise the time spent close to the patient and avoid close contact where

    possible.

    5. Pregnant visitors or small children should not be allowed to visit the patient or the period o theserestrictions.

    6. Consider postponement o non-urgent investigations and treatments requiring sta working in

    direct contact with the patient or more than 5 minutes.

    7. Patient should drink plenty o uids and empty bladder requently.

    SPECIAL PRECAUTIONS:

    For urther inormation, please contact the Nuclear Medicine Department.

    Appendix 2: Sample advice sheets (Courtesy o St. Jamess Hospital, Dublin)

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    Section 2 Guidelines / Policies / Protocols

    Guidance Notes or Nursing Sta Caring

    or Nuclear Medicine Patients

    Background

    Patients attending or nuclear medicine scans

    receive a pharmaceutical (usually although not

    always by injection) that has been labelled with

    a radioactive material. The pharmaceutical is

    selected so that it is processed or metabolised

    in the organ o the patients body that the clini-

    cian wishes to assess. Ater the patient has been

    injected he/she is eectively radioactive and

    can act as a source o exposure to those with

    whom they come into contact. Although this

    exposure will be relatively low, in order to mi-

    nimise sta exposure, some simple precautions

    are advised and these are outlined below.

    The isotope that is used most requently is

    Technetium-99m (Tc-99m). This is a relatively

    short-lived isotope with a hal-lie o approx.

    6 hours. In eect, this means that precautions

    generally only have to be ollowed or a period

    o 24 hours ater the isotope scan. Occasion-

    ally, other isotopes (e.g. Indium-111, Gallium-67,

    Thalium-201, Iodine-123, Iodine-131) are used.Because some o these isotopes have longer

    hal-lives than Tc-99m, precautions have to

    be ollowed or a longer period. The time or

    which precautions should be ollowed will be

    indicated on the inormation sheet that is sent

    back with the patient rom the Nuclear Medi-

    cine Department

    Guidance

    The ollowing guidelines should be ollowed

    or the period indicated on the instruction

    sheet accompanying the patient back rom

    the Nuclear Medicine Department:

    1. In general, try to avoid unnecessary close

    contact (less than 0.5m) with the patient.

    2. Examination gloves and plastic aprons should

    be worn when handling urine bags, bottles,

    bedpans and dirty linen. Any spillages should

    be cleaned up quickly and careully.

    3. Soiled linen should be bagged and then

    stored or 24 hours beore being sent to

    the laundry.

    4. Pregnant sta should minimise the time

    spent close to the patient and avoid close

    contact where possible.

    5. Pregnant visitors or small children should

    not be allowed to visit the patient or the

    period o these restrictions.

    6. Consider postponement o non-urgent in-

    vestigations and treatments requiring sta

    working in direct contact with the patient

    or more than 5 minutes.

    7. Patient should drink plenty o uids and

    empty bladder requently.

    For urther advice or inormation, please con-

    tact the Nuclear Medicine Department.

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    Health and Saety -

    The health and saety o both sta and pa-

    tients must always be placed frst in any con-

    sideration o policies. Regrettably incidents

    can occur within a department ranging rom

    a change or deterioration o the patients

    condition that requires advisement o nurs-

    ing or medial support to accidental injury to

    reactions to injected radiopharmaceuticals.Although the latter are relatively rare, they

    are not unknown, and a policy and protocol

    should be in place to ensure a record is made

    o such incidents, and to register them with

    the appropriate departments within the hos-

    pital or with manuacturers. Most hospitals

    have Risk Assessment teams that will log all in-

    cidences and place them on permanent fle.

    Inection Control -

    Protocols regarding the operation o inec-

    tion control procedures should be included

    in departmental protocols. With the rise o

    hospital-based inections such as MRSA and

    C.Di., there is an increased need to be vigilant

    in the prevention o cross-inection. Rigorous

    cleansing regimes should be enorced when

    known carriers o inections are scanned in the

    Nuclear Medicine department, and protec-

    tive clothing and equipment utilized. Similarly,

    other pro-active steps e.g. usage o plastic pro-

    tective sheeting on gamma cameras and scan-

    ning tables should be used when an inectious

    state cannot be ruled out.

    The Nuclear Medicine department is also an

    area o high risk when it comes to blood-borne

    viruses, most especially HIV, because o blood-

    labelling techniques utilized or certain exami-

    nations. Sadly, instances where HIV inected

    blood products were inadvertently injected

    into the wrong patient have been recorded,

    resulting in inection o the previously-HIV

    negative patient. A report can ound at:http://www.cdc.gov/mmwr/preview/

    mmwrhtml/00017383.htm

    A proactive policy regarding the sae labelling

    and introduction o labelled blood products

    should be at the oreront o departmental

    inection control procedures.

    Similarly, a policy and protocol should be inplace to assist and record incidents involving

    contamination o sta through needlestick

    injuries. This should be co-ordinated with the

    hospitals Occupational Health Department.

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    Knowledge and compliance with the Good

    Clinical Practice (GCP) is essential or ev-

    eryone involved in clinical research trials.

    Clinical trials should be carried out within

    the ramework o a good clinical practice

    environment in accordance with interna-

    tional guidelines and regulations as detailed

    in the Declaration o Helsinki. Research trials

    involving ionising radiation require adher-ence to the ALARA (as low as reasonably

    achievable) principle. The International

    Commission o Radiological Protection

    and the World Health Organisation (WHO)

    have publications that deal with this issue in

    clinical research. From the legislation point

    o view, the 97/43/EURATOM Directive rep-

    resents the most comprehensive reerence

    to clinical research using ionising radiation.While GCP should orm the backbone to

    successul nuclear medicine clinical stud-

    ies, radiopharmaceuticals used in these trials

    need to be produced according to the Good

    Manuacturing Practice (GMP). Compliance

    and understanding o the GCP is essential to

    everyone involved in clinical research.

    In an eort to overcome international GCP

    inconsistencies throughout countries, the

    International Conerence on Harmonisation

    (ICH) published the ICH Guidelines: A num-

    ber o components have been included to

    ensure the protection o trial subjects and

    the quality/integrity o data obtained rom

    clinical testing.

    Section 2 Guidelines / Policies / Protocols2.3. Clinical Research Policies

    Linda Tutty

    These are:

    Institution review board (IRB)/indepen-

    dent ethics committee (IEC) review and

    approve;

    The trial protocol;

    Freely obtained inormed consent romeach subject;

    Saety monitoring requirements;

    Data handling and archiving require-

    ments;

    Clinical trial responsibilities o the IRB/IEC,

    investigator and sponsor.

    The IRB/IEC protects the rights, saety and well-

    being o all trial subjects. The IRB/IEC should

    examine the qualifcations o the investigator

    or the proposed trial. It should carry out re-

    views o each ongoing trial at intervals appro-

    priate to the degree o risk to human subjects.

    The IRB/IEC may request or additional inor-

    mation be given to the subjects where that

    inormation would add to the rights, saety

    and/or well-being o the subjects. The IRB/IEC

    should establish that the proposed protocol

    and other documentation adequately address

    relevant ethical concerns and meet applicable

    regulatory requirements or trials.

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    Accurate dosimetry

    Clinical trials involving the use o ionising ra-

    diation, as in the case o nuclear medicine,

    require special consideration with regard to

    the GCP. In addition to direct detrimental e-

    ects, protection o humans against ionising

    radiation requires consideration o the prob-

    ability o induction o stochastic eects, such

    as cancer and induction o leukaemia, even atlow doses. The beneft to society, by increase

    in knowledge, must outweigh the potential

    harm to the exposed individual. Such research

    trials should only be perormed on a voluntary

    basis as set out in the Declaration o Helsinki.

    Dierent organisations have published speci-

    ic recommendations with respect to research

    using ionising radiation in medicine. The WHOpublished a report in 1977 concerning the

    use o ionising radiation and radionuclides

    on human subjects or areas including medi-

    cal research. More recently the International

    Commission on Radiological Protection (ICRP)

    published a number o documents on the pro-

    tection o patients with recommendations in

    nuclear medicine, including exposure in bio-

    medical research (Bacher & Thierens, 2005).

    From the legislation perspective, in the EU,

    the 97/43/EURATOM Directive represents the

    reerence to clinical research using ionising

    radiation (Bourguignon MH, 2000). In this

    document the justifcation and optimisation

    o exposure ollowing the ALARA principle

    is crucial. With respect to optimisation, it is

    important or accurate calculation o patient

    radiation doses, and in the case o diagnostic

    cases, to ensure that the radiation dose is as

    low as possible. For therapeutic purposes, such

    as radionuclide therapy, there is a requirement

    or individual treatment planning by monitor-

    ing the absorbed dose o the target volume

    and by considering possible detriment o non-

    target tissues. The eective dose may be usedas an overall indicator o the risk on late sto-

    chastic eects to an average individual. Mean

    organ doses and eective doses are typically

    derived based on the data available in ICRP

    publications 53, 62 and 80. I no established

    biokinetic models exist or the applied radio-

    labelled tracer, dosimetry may be based on

    animal experiments which should be then

    tested in pilot research on human subjectsbeore any extensive research is planned. For

    radionuclide therapy investigations, where de-

    terministic eects may occur, doses to critical

    organs outside the target volume should be

    examined accurately and individually or each

    patient.

    Good Manuacturing Guidelines

    With the introduction o the European Direc-

    tive, all pharmaceuticals used in clinical studies

    must be prepared under good manuacturing

    practice (GMP) conditions (De Vos et al, 2005).

    Radiopharmaceuticals or clinical research pur-

    poses must be manuactured in accordance

    with the basic principles o GMP. Due to their

    short hal-lives, many radiopharmaceuticals

    are administered to patients shortly ater their

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    production, so some elements o the quality

    control may be retrospective. Thereore strict

    adherence to GMP is essential. Special atten-

    tion should be given to the production area

    environment and personnel, the two basic

    requirements o GMP production.

    Radiopharmaceuticals are nearly always used

    beore all quality control testing has beencompleted. Thereore the compliance with

    the quality assurance programme is crucial.

    Quality assurance should incorporate the

    monitoring and validation o the production

    process.

    When conducting research trials in nuclear

    medicine, special attention should be given

    to the guidelines and legislation surround-ing GCP, radiation dosimetry and GMP. GCP

    and the policies linked to it should be well

    understood beore contemplating any clinical

    research study in nuclear medicine.

    Section 2 Guidelines / Policies / Protocols

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    This Recruitment Chapter has been designed

    to enable you to help carry out the recruit-

    ment and selection process eectively.

    The ollowing objectives should be achieved:

    The right candidate should be recruited,

    ensuring equality o opportunity or all

    candidates and that there is the right can-didate or the right job in the right place.

    The recruitment process should take place

    in a timely and cost eective way.

    Relevant legislation should be taken into

    consideration.

    The three stages in the recruitment processare:

    Defning Requirements

    Attracting Candidates

    Selecting Candidates

    Defning the requirements when the vacancy

    occurs, the frst questions to ask will be:

    Is there a vacancy?

    I there is, who do we need to fll the post?

    Sometimes it may be a case o reorganising

    the work or using agency sta or making the

    Section 3 Sta Aspects o Best Practice3.1. Best Practice or Recruitment and Selection

    Wendy Gibbs and Julie Martin

    job part-time or a job-share. We should al-

    ways analyse the requirements at that mo-

    ment in time as well as consider uture plans

    and requirements.

    In order to defne the requirements the ol-

    lowing steps must be undertaken:

    Job Analysis

    Job Description

    Personal Specifcation

    Job Analysis

    It is necessary to ask what the job consists

    o and whether it is likely to be any dierent

    than that o the previous postholder. NuclearMedicine covers many areas and the skills

    required o a Nuclear Medicine Technologist

    post will vary. It may be that a specialist such

    as a Nuclear Cardiology Technologist is essen-

    tial or a technologist who is newly qualifed,

    to ensure that the right mix o sta is there

    supporting the clinical work and providing

    career progression.

    Job Description (See Appendix 1)

    The ollowing should be included:

    The context o the post including respon-

    sibilities and accountabilities

    A small paragraph on the job summary

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    The job content will include the main

    duties and responsibilities to encompass

    managerial, clinical, proessional & teach-

    ing responsibilities and research & devel-

    opment duties i appropriate

    Personal Specifcation (See Appendix 2)

    The personal specifcation should provide the

    ollowing inormation:

    Essential and desirable qualifcations

    Knowledge and experience required to

    undertake the job

    Other inormation may be provided at this

    point, such as working conditions, potential

    career progression and in some cases peror-mance standards.

    Advertising

    The most cost eective and appropriate method

    o recruitment should be selected. It is essential

    the advertisement is placed where candidates

    who are qualifed to take on the role are most

    likely to look. In some cases this may mean adver-

    tising internally only or internally and externally

    simultaneously. This will depend on the market

    orces and candidates available locally.

    The ollowing is a checklist o items which

    should be included in the advert:

    Name & Brie details o employing organi-

    zation

    Job role and duties

    Training to be provided

    Key points o the personal specifcation

    Salary

    Instructions on how to apply

    At this point the interview date may be set.

    Shortlisting

    Using the essential criteria in the personal

    speciication, panel members individually

    produce a list o applicants that meet the

    criteria. They will be scored according to

    criteria provided. The panel will then revealtheir lists and ind a consensus. Successul

    candidates will then be invited or inter-

    view.

    Interviews or Nuclear Medicine Technolo-

    gists will not generally involve a test, how-

    ever it is suggested that in a senior role, a

    presentation may be appropriate. Some or-

    ganizations may use psychometric testing

    as a matter o course.

    Interviews: Points to remember

    Legible notes to be written by each panel

    member during the interview.

    The same questions should be asked

    apart rom speciics related to the CV and

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    particular issues that may arise out o the

    application orm and/or the interview.

    Attention to any legislation such as the

    (UK) Disability Discrimination Act should

    be practiced.

    Preparation is essential both by individu-

    als and the panel. It is necessary to decidewho is chairing the interviews. In most

    cases this will be the most senior per-

    son. For a Technologists post it would be

    appropriate to have the Senior or Chie

    Technologist, Physicist or Radiopharma-

    cist and/or a Medical Physician depending

    on the seniority o the post.

    The interview should start with introduc-tions and outline the interview process.

    General biographical inormation would

    be examined frst ollowed by examina-

    tion o the application orm and compe-

    tencies identifed or the job. The panel

    will be listening and answering questions

    and the chairperson closes the interview

    by summarising and confrming uture

    actions. He/she may be responsible or

    checking qualifcations and details related

    to occupational health and accommoda-

    tion.

    All panel members should be given a

    copy o the interview plan beore the in-

    terview.

    Attention should be paid to the environ-

    ment e.g. mobile phones switched o.

    Ensure preparation is timely.

    Dont leave candidate waiting and explain

    any unoreseen delays.

    Ensure proessional conduct at timesthroughout the process.

    Upon completion o the interview, individual

    members o the panel give their eedback

    and agree on the appointment (or not) by

    consensus.

    Subject to the organisations policy, oers may

    be made subject to; reerences, occupationalhealth clearance and/or Criminal Record

    check.

    A job oer will be sent out ormally and com-

    mencement procedure and start date dis-

    cussed.

    APPENDIX 1

    Sample Job Description

    Post Title:Senior Nuclear Medicine

    Technologist

    Service: Nuclear Medicine

    Hours o Work 37.5 hours

    Reports to: Chie Technologist

    Hospital / Organization Inormation

    (small paragraph: 2-3 lines)

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    Section 3 Staf Aspects o Best Practice

    Nuclear Medicine Services

    (small description 3-4 lines)

    The Nuclear Medicine Department employs

    sta and has an annual budget o . The

    department undertakes general nuclear medi-

    cine and osteoporosis screening. The depart-

    ment has its own radiopharmacy and works

    within the radiology unit.

    Job summary

    To provide high quality diagnostic images across

    the range o all Nuclear Medicine investigations.

    An understanding o the departmental protocols

    is essential. Encouraging the highest proessional

    and technical standards in all sta by personal

    example and constructive supervision.

    Main duties / key responsibilities1. Perorm all clinical nuclear medicine pro-

    cedures using specialized equipment, in a

    timely and accurate manner.

    2. Perorm all diagnostic & therapeutic proce-

    dures with due regard or Health & Saety

    o sel, patients and sta.

    3. Undertake administration o all diagnostic

    radiopharmaceuticals and drugs used in

    the practice o nuclear medicine.

    4. Assist in cardiac exercise and pharmaco-

    logical stress testing.

    5. Schedule all nuclear medicine studies in

    accordance with departmental protocol.

    6. Take responsibility or patient consent,

    identifcation and relevant clinical de-

    tails.

    7. Provide clinical inormation to the pa-

    tient whilst interpreting, negotiating and

    adapting the procedure as applicable to

    that patient.

    8. During exposure to sealed and unsealed

    radioactive material, blood samples and

    other hazardous waste, ensure working

    practice is in accordance with govern-

    ment legislation and departmental poli-

    cies.

    9. Understand and apply all relevant legisla-

    tion when perorming all nuclear medi-cine investigations.

    10. Undertake quality assurance o all rel-

    evant equipment and take responsibility

    or reporting discrepancies to appropriate

    personnel.

    11. Participate in research and development

    studies being carried out in the depart-

    ment.

    12. Take responsibility or continuing proes-

    sional development while liaising with

    the line manager or advice, guidance

    and allocation o appropriate resources

    or training and development.

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    Standard Requirements

    The post holder may be required to carry out

    other duties in line with the grading o the

    post.The job description may be subject to

    change and i so this will take place in con-

    sultation with the post holder.

    The ollowing policies should be adhered to

    at all times as per induction: Confdentiality,Code o Conduct, Equal Opportunities, Health

    and Saety, Smoking Policy, Data Protection

    Act, Terms and Conditions o Employment.

    APPENDIX 2

    Sample Person Specifcation

    Person Specifcation

    Senior Nuclear Medicine Technologist

    Qualifcations

    Essential: BSC Radiography or other relevant

    science degree with a post gradu-

    ate qualifcation in nuclear medi-

    cine or Nuclear Medicine Degree

    (BSc Applied Science in Nuclear

    Medicine Imaging)

    Desirable: Paediatric IV cannulation course

    ILS or ALS certifcate

    Basic and advanced ECG inter-

    pretation

    EANM PET course or equivalent

    CT accreditation

    Knowledge & Experience

    Scientifc, Technical & Clinical

    Minimum 5 year ull-time experience post

    qualifcation.

    Competent in all nuclear medicine proce-

    dures.

    Demonstrate an ability to work within amulti-disciplinary team.

    Competent in all data acquisition and

    analysis or nuclear medicine procedures.

    Able to recognise normal and abnormal

    bio distribution o radiopharmaceuticals.

    Provide a high quality proessional stan-dard o care to both patients and sta.

    Legislation: Understand and comply with

    relevant legislation, national standards, and

    proessional guidelines.

    Skills:

    IT: Proven IT skills to intermediate level on MS

    Oce & Outlook.

    Communication: Developed skills required

    to work with patients and

    sta rom diverse back-

    grounds. Capable o ex-

    tracting/imparting sensi-

    tive inormation.

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    Section 3 Sta Aspects o Best Practice3.2. Best Practice or Induction

    Wendy Gibbs and Julie Martin

    Providing an eective and thorough induction

    ensures new starters are settled quickly into

    their new working environment. It is about

    presenting the basics that experienced em-

    ployees take or granted.

    A good integration into the working environ-

    ment must include the ollowing elements:

    General training relating to the organiza-

    tion, including values and philosophy as

    well as structure and history, organizational

    charts etc. (see appendix 1)

    Mandatory training relating to health and

    saety and other essential or legal areas.

    Job training relating to the role the newstarter will be perorming.

    Training evaluation, entailing confrma-

    tion o understanding, and eedback about

    the quality o and response to the training.

    It is the responsibility o a new employees

    manager to ensure that induction training is

    properly planned. An induction plan should

    be issued to the new employee on their frst

    working day i not beore and sent to all sta

    involved with the training. Although an induc-

    tion period should be specifed, there is no

    right induction time or new employees. In

    some instances an induction can span over a

    ew months. In these cases it is important or

    the new employee that the induction does

    not lose momentum and that s/he has pro-

    tected time to undertake and complete the

    induction period.

    Induction is a two-way process. The manager

    is responsible or ensuring:

    That the inormation, explanation, guid-

    ance and direction needed is providedwithin the induction plan.

    That mandatory training required has been

    booked e.g. Basic lie support, fre training

    etc.

    That the new employee has the opportu-

    nity to ask questions and seek guidance.

    That the new employee is eectively in-

    ducted into their job and competent to

    undertake the necessary tasks saely.

    That a checklist or induction is provided

    to ensure all areas are completed (see ap-

    pendix 2) and sign o as completed (see

    appendix 3).

    The new recruit is responsible or:

    Reading and absorbing all inormation pro-

    vided throughout the induction period.

    Attending any training provided and re-

    quired as part o the job.

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    Section 3 Staf Aspects o Best Practice

    Asking questions and seeking guidance

    where help or clarity is needed.

    Completing and making the most out o

    the planned induction.

    APPENDIX 1

    Organisational Chart

    The ollowing checklists have been provided as

    a guide (and are by no means all encompass-

    ing) to help acilitate the induction process.

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    APPENDIX 2

    Induction Checklist

    Employee Name: ____________________________________________________________

    To be achieved within the frst week o startingTick as appropriate

    Done N/A

    I have been introduced to my Personnel Team

    I have signed my joining papers (or payroll)

    I have been given the opportunity to have an induction buddy

    I have discussed the job description and person specifcation and

    understand the purpose o my job

    I have been ormally introduced to:

    Other members o my team/dept

    Head o Nuclear Medicine Service Manager

    Lead Clinician or Nuclear Medicine

    Other Consultant Colleagues within dept

    Key Clinical Sta (list sta)

    Key Consultant Colleagues outside o dept

    Key Management Sta (list sta)

    Divisional Management Team

    I have been shown:

    The layout o the department

    Any areas I will be working in outside my department/ward

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    Fire escapes, the location o fre alarm points and the fre assembly

    point

    Toilets/cloakroom/rest room acilities

    Area to store and make rereshments

    Sta dining acilities

    Telephone acilities

    Bleep system

    The location o the frst aid box

    The location o the resuscitation equipment

    The photocopying acilities

    The location o linen room

    The equipment I will be using - computer, medical equipment etc.

    The location o the post room

    The location o the security oce

    I have been advised o:

    The cardiac arrest number

    The fre & emergency security number

    I have been provided with:

    Uniorms

    Facilities to lock away my personal belongings

    A current copy o the organisations Newsletter/Team Briefng

    Reports

    A copy o the Sta Handbook and sta policies summary

    Section 3 Staf Aspects o Best Practice

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    A copy o the Organisations Code o Conduct

    An ID Security Badge/Access Swipe Card

    Training: I have been given a date to attend:

    Fire training

    Training in basic lie support resuscitation

    Training in paediatric lie support resuscitation

    Manual handling training

    The corporate induction programme

    Child protection training

    Training to receive organisations IT system/s

    Proession-specifc induction (i provided)

    Local induction programme (i provided)

    I have been made aware o the ollowing policies/procedures:

    Hours o work, rotas, breaks

    Salary payment procedures

    Sickness reporting procedures, sick pay entitlement and medical

    certifcate requirements

    Annual leave entitlement and booking procedure

    Policies and procedures manuals

    Fire alarm and fre drill procedure

    Data Protection Act and the importance o data quality

    Resuscitation guidelines

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    Risk management guidelines

    Health risks and saety procedures including protective clothing

    Personal/patient security

    Medicines policy

    New patient records policy

    Raising a matter o concern policy

    Adverse incident reporting

    Compliments & complaints policy

    Waste disposal procedure/policy including types o bags

    Patient care philosophy

    Inection control & hand washing

    Standard Operating Procedures/ Service Level Agreements (SOPs/

    SLAs as required)

    Confdentiality

    Regulatory policies aecting working area

    Any other procedures relevant to the area o work (please list):

    To be achieved within two weeks o startingI have been made aware o the ollowing policies/procedures/

    protocols:

    Access to medical records

    Equal opportunities policy

    Waste disposal policy

    Trust email and internet policy

    Section 3 Staf Aspects o Best Practice

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    Sta benefts/acilities e.g. crche, sta clubs, ftness centres

    Media policy

    Learning & development ramework

    Major incident plan

    To be achieved within frst month o starting

    I have been made aware o the ollowing:

    My organizations & team objectives

    The Trusts Perormance Management Process

    To be achieved within 3 months o starting

    I have a date when I will meet with my line manager to plan my

    perormance and development objectives

    I have received a contract o employment

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    APPENDIX 3

    Sign o sheet

    INDUCTION REVIEW FORM

    Evidence o Induction Process

    Name: __________________________ Post: _____________________________________

    Start Date: _______________________ Department: ______________________________

    Induction completed: _______________________________________________________

    Employees comments:

    _________________________________________________________________________

    _________________________________________________________________________

    _________________________________________________________________________

    Managers comments:

    _________________________________________________________________________

    _________________________________________________________________________

    _________________