Tech Best Practice2

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Best Practice in Nuclear Medicine

Part 2A Technologists Guide

E u r o p e a n A s s o c ia t i on o f N u c le a r M e d i c i n

e

Produced with the kind Support o


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Contributors

Alberto Cuocolo, MD

President o the EANMDepartment o Biomorphological andFunctional SciencesUniversity o Naples Federico IINapoli, Italy

Sylviane PrvotChair o the EANM Technologist CommitteeChie Technologist, Radiation Sa ety O cerService du Pro esseur F. BrunotteCentre Georges-Franois LeclercDijon, France

Ellinor Busemann Sokole, PhD

Member o the EANM Physics CommitteeDept. Nuclear MedicineAcademic Medical CenterUniversity o AmsterdamAmsterdam, The Netherlands

Felicia Zito, PhD

Chie PhysicistDept. o Nuclear MedicineFondazione Ospedale Maggiore Policlinico,Mangiagalli e Regina ElenaMilan, Italy

Cristina Canzi, PhD & Franco Voltini, PhD

PhysicistsDept. o Nuclear MedicineFondazione Ospedale Maggiore Policlinico, Man-giagalli e Regina ElenaMilan, Italy

Eric P. Visser, PhD

PhysicistDept. o Nuclear MedicineRadboud University Medical CentreNijmegen, The Netherlands

Sarah Allen, PhD

Consultant PhysicistDept o Nuclear Medicine,Guys & St Thomas NHS Foundation TrustLondon, United Kingdom

Julie Martin

Director o Nuclear MedicineDept. o Nuclear Medicine,Guys & St Thomas NHS Foundation TrustLondon, United Kingdom

Editor

Sue Huggett

Member o the EANM TC EducationSub-CommitteeRetired Senior University TeacherLondon, United Kingdom

This booklet was produced with the kind support o Bristol-Myers Squibb Medical Imaging. The views expressed arethose o the authors and not necessarily o Bristol-Myers Squibb Medical Imaging.


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ContentsForewordSylviane Prvot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

IntroductionAlberto Cuocolo M. D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Chapter 1 European Regulatory Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.1 Radiation ProtectionSylviane Prvot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.2 What are Quality Assurance and Quality Control and why do we need them?Ellinor Busemann Sokole, PhD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Chapter 2 Best Practice in Radiation Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Felicia Zito, PhD; Cristina Canzi, PhD & Franco Voltini, PhD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Chapter 3 Quality Assurance o Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Eric P. Visser, PhD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30

Chapter 4 Best Practice in Procurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Sarah Allen, PhD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

Conclusion Dealing with Best Practice an Everyday Challenge . . . . . . . . . . . . . . . . . . . . . . . . . . 44Julie Martin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44


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ForewordSylviane Prvot

In the ever-changing eld o Nuclear Medicine,best practice considerations cant simply go un-challenged or months and years ahead. In thisrespect, Nuclear Medicine Technology is no di -erent rom medical practice. Nuclear Medicine

Technologists (NMTs) need constantly to investin additional education to o er best patientcare. While it is recognised that the delivery o education and training varies widely rom oneEuropean country to the other, adherence toEuropean guidelines seems to be the only wayto harmonise practices.

The impact o policy and legislation on best

practice is emphasised in this booklet, theourth in the series Technologists guidethat were produced with the kind support o Bristol-Myers Squibb Medical Imaging (BMS).Many thanks are due to BMS, who have con-tributed enormously to the education o NMTsin Europe or years, as well as to all the con-tributors involved.

Dealing with the complex changes that havebeen driven by European legislation over thelast ten years remains an everyday challenge ina Nuclear Medicine department. Be ore beingextended to the general public and to the pa-

tients, the scope o radiation sa ety was aimedat workers only. A care ul approach xed moreand more restrictive dose constraints andlimits to ensure the sa e practice o NuclearMedicine. Quality control o the per ormanceo imaging equipment and procedures relat-ing to medical exposures are required as parto an e cient and e ective quality assuranceprogramme to ensure patient protection.

Ionising radiation must be treated with carerather than ear.

With this new brochure, the EANM Technolo-gist Committee o ers to the NMT communityone more use ul and comprehensive tool thatmay contribute to the advancement o theirdaily work and, by doing so, to the optimi-sation o national radiation sa ety systemsthroughout Europe.

Sylviane PrvotChair, EANM Technologist Committee

Whatever the value o equipment and methods is, high e ciency fnally depends on the staf in charge o their use Marie Curie


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IntroductionAlberto Cuocolo, MD

Improvements in radionuclide imaging tech-nologies and radionuclide therapy are con-tributing to an increase in the demand or nu-clear medicine services in Europe. This risingdemand has urther rein orced the importantrole o nuclear medicine technologists; andbest-practice guidelines become crucial too er the best service to the public. It is also

important that best-practice guidelines aredeveloped and implemented at the Europeanlevel to harmonise patient care across the Eu-ropean countries.

The Technologist Committee o the EANM hasbeen very active and success ul in promot-ing high standards or the daily work o nu-clear medicine technologists in the di erent

countries o Europe and has assisted in thedevelopment o high-quality national systemso education and training o nuclear medicinetechnologists. The Committee has also con-tributed to several EANM initiatives on educa-tion; and the Education Sub-Committee haspublished a series o Technologists Guides.

The present booklet Best Practice in NuclearMedicine - Part 2 covers important items, suchas European regulatory issues, best practicein radiation protection, quality assurance o equipment and best practice in procure-ment.

This booklet may serve not only as a re erence

or improving the quality o practice but alsoas a resource providing a quick and e cientmethod to nd re erences or additional read-ings.

Alberto Cuocolo, MDPresident, EANM


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Chapter 1 European Regulatory Issues1.1 Radiation ProtectionSylviane Prvot

The potential harm o ionising radiation wasrecognised shortly a ter its rst use or medicalapplications. First recommendations on radia-tion protection date back to the late 1920s.An international radiation protection groupThe International X Ray and Radium Protec-tion Committee was ormed in 1928 duringthe 2 nd International Congress o Radiology

in Stockholm (SE) to respond to the dramaticincrease o leukaemia in radiologists. In 1950,this committee was re-named InternationalCommission on Radiological Protection (ICRP).Other international bodies were establishedlater: United Nations Scienti c Committee onthe E ects o Atomic Radiations (UNSCEAR)(1955), International Agency o Energy Atomic(IAEA) (1956), European Community o Atomic

Energy (ECAE / Euratom) (1957).

Key organisationsUNSCEAR consists o 21 scientists rom di -erent member states. Their role is to assessand report levels and e ects o exposure toionising radiation.

ICRP is an independent registered charityconsisting o international experts whose aimis to provide an appropriate standard o hu-man protection. Recommendations on theprinciples o radiation protection are basedon UNSCEAR scienti c data. Reports address-ing all aspects o protection against ionisingradiation are issued as numbered publications.ICRP 60 (1) published in 1990 orms the basis

o current legislation. A new set o undamen-

tal recommendations taking account o newbiological and physical in ormation and trendsin the setting o radiation standards was ap-proved in Essen (DE) in March 2007. They willreplace ICRP 60.

In the United Nations organisation (UN), theIAEA is an independent inter-governmental,

science and technology based organisa-tion that promotes a high level o sa ety inapplications o nuclear technologies as wellas the protection o human health and theenvironment against ionising radiation. TheIAEA develops basic sa ety standards basedon ICRP publications. Guidelines relating toionising radiation and sa ety o sources intendto harmonise radiation protection standards

at international level.

EURATOM turns ICRP recommendations intoDirectives, aiming at the harmonisation o EUmember states legislation. Contrary to stan-dards issued by other organisations, EuratomDirectives dictate the results to be obtained.Member countries can choose the proceduresand the way they are implemented in order toachieve these results according to their ownnational legislative structure. The objective isto ensure the sa e practice o Nuclear Medi-cine, protecting patients, public and workersagainst the risks o ionising radiation.


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Chapter 1 European Regulatory Issues

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Principles underlying radiationprotection regulationAs any dose is likely to have either determin-istic (with threshold) or stochastic e ects, aradiation protection system must be basedon three principles:

justifcation o a practice: the bene tsmust be believed to be above any healthdetriment it may cause;

optimisation o protection: the bene tsmust be increased and detriments de-creased as ar as possible;

dose limitation: the di erent groups o persons exposed (public, workers, students,apprentices) must be taken into accountin order to ensure the most appropriateprotection avoiding deterministic e ectsand reducing the requency o stochastic

e ects to an acceptable level (Figure 1).


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Three types o exposure can be considered occupational: incurred at work; medical: incurred by individuals as part

o their own medical diagnosis or treat-ment and exposures incurred knowinglyand willingly by individuals helping in thesupport and com ort o patients undergo-

ing diagnosis or treatment;

public: encompassing all exposures to ra-diation except occupational and medicalones.

Since 1980 the ALARA concept the principleo optimisation o radiation protection acro-nym o As Low As Reasonably Achievable -has been part o the European Basic Sa etyStandards. It was progressively introduced intonational regulation. Individual and collectiveexposures must be kept as low as possible un-der the regulation limits. The ALARA principleconcerns workers exposures as well as thoseo members o the public.

The ALARA principle was re-emphasised intwo European Directives both having rootsin ICRP 60 (1):

Euratom Council Directive 96/29 (May 13,1996) (2) laying down basic sa ety stan-dards or the protection o the health o workers and the general public against the

dangers arising rom ionising radiation

Euratom Council Directive 97/43 (June 30,1997) (3) on health protection o individu-als against the dangers o ionising radiationin relation to medical exposure and repeal-ing Euratom Directive 84/466

Euratom Council Directive 96/29

General principles o the radiationprotection o workers and the general publicMany requirements, including prior authorisa-tion or practices involving a risk rom ionisingradiation and those relating to the transport,keeping and disposal o radioactive substanc-es, must be taken into account by memberstates to ensure the best possible protectiono the population. A system o inspection is re-quired to en orce compliance with the law.

In the context o the optimisation o protec-tion in occupational exposure, dose con-straints - restrictions on the prospective dosesto individuals - must be used when designingnew premises. The sources to which they arelinked must be speci ed; and dose limits are

applied as part o the control o practice.

Figure 1 : Principle o limitation o doses


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The e ective dose limits or exposed workers,public and etus are lower than in previouslegislation. The new dose limit or exposure o the public does not include the patients andthe accompanying persons involved with thepatient in their medical exposure (under thecom ort and care exception).

A quali ed expert must be assigned technicalresponsibility or the radiation protection o workers and members o the public.

Limitation o dosesAll exposures must be kept as low as reason-ably achievable and the sum o the dosesrom all relevant practices must not exceedthe doses limits. It is not normally expected

that limits should be reached (Table 1).

LimitsExposed workers

Apprentices & studentsaged 18 years or over

Apprentices & students agedbetween 16 & 18 years

PublicApprentices & students

aged < 16 years

Efective dose100 mSv in 5

consecutive yearsmax 50 mSv in 1 year

6 mSv / year

1 mSv in 1 yearAverage 1 mSv / 5consecutive yearsFoetus 1 mSv over

pregnancy

Equivalent doseLens o eye

SkinHands, Forearms,

Feet, Ankles

150 mSv / year500 mSv / cm 2 / year

500 mSv / year

50 mSv / year150 mSv / cm 2 / year

150 mSv / year

15 mSv in 1 year50 mSv in 1 year / cm 2

-

Table 1: Dose limits

Special protection during pregnancy &breast eedingStudies have shown that the unborn child issensitive to high doses o ionising radiation,more particularly during the rst three monthso gestation (4). Additional controls must beimplemented in order to protect pregnantsta rom the hazards o ionising radiation.

As soon as a pregnant woman in orms heremployers o her condition, the protection tothe child to be born must be comparable withthat provided or members o the public. Theconditions o employment o the pregnantwoman must subsequently be such that theequivalent dose to the unborn child will be aslow as reasonably achievable and that it will be

unlikely that this dose exceeds 1 mSv during atleast the remainder o the pregnancy.


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Policies governing the duties that pregnantsta are allowed to undertake can vary be-tween member countries and sometimes inthe same country rom one Nuclear Medicinedepartment to the other. It is not risky or preg-nant sta to work in Nuclear Medicine provid-ed that practical measures to avoid accidentalhigh dose situations are implemented (4) and

as long as there is reasonable assurance thatthe etal dose is kept below 1 mSv during thepregnancy.

As soon as a breast eeding mother in orms theemployer o her condition, she must not beemployed in work involving a signi cant risk o bodily radioactive contamination.

Operational protection o exposed workers,apprentices and students or practicesMust be based on the ollowing:

Prior evaluation to identi y the nature andmagnitude o radiological risk to exposedworkers & implementation o the optimisa-tion o radiation protection in all workingconditions

Classi cation o workplaces into di erentcategories

Classi cation o workers into two catego-ries

Implementation o control and monitoringmeasures relating to the di erent areas and

working conditions, including individualmonitoring where necessary

Medical surveillance o exposed workers

Delineation o areas and monitoring o workplacesControlled and supervised areas must be des-ignated through a risk assessment o potential

dose received. Signage indicating the type o area, nature o the sources and their inherentrisks is required.

The aim o this classi cation is to ensure thatanyone outside the designated areas doesnot need to be regarded as occupationallyexposed but can be considered as membero the public (Table 2).

Annual limit Public Supervised area Controlled area

Efective dose 1 mSv 6 mSv 20 mSv

Equivalent dose1/10 one o dose limits or

lens o eye, skin or extremities

3/10 one o dose limitsor lens o eye, skin or

extremities

dose limits or lens o eye,skin or extremities

Table 2: Classi cation and delineation o areas


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A controlled area requires the workers to ol-low well-established procedures and practicesspeci cally aimed at controlling radiation ex-posure. Access must be in accordance withwritten procedures and restricted to desig-nated individuals who have received appropri-ate instructions. Wherever there is a signi cantrisk o spread o radioactive contamination,

speci c arrangements must be made includ-ing access and exit o individuals and goods.Radiological surveillance o the working en-vironment must be implemented including,where appropriate, the measurement o exter-nal dose rates, air activity concentration andsur ace density o contaminating radioactivesubstances.

A supervised area is one in which the work-ing conditions are kept under review withoutrequiring special procedures.

Categorisation o exposed workersAccording to the risk, exposed workers mustbe classi ed into two categories:

Category A: exposed workers who are li-able to receive an e ective dose greaterthan 6 mSv / year or an equivalent dose> 3/10 o one o the dose limits or lens o eye, skin or extremities

Category B: exposed workers who are notclassi ed in category A

In ormation and trainingExposed workers, apprentices and studentsmust be in ormed on the health risks involvedin their work. Woman working with ionisingradiation must be in ormed about the needo early declaration o pregnancy and the risk o contaminating the nursing in ant in case o bodily radioactive contamination.

Relevant training in the eld o radiation pro-tection must be implemented or exposedworkers, apprentices and students.

Assessment o exposureRadiological surveillance o the working en-vironment must be organised in controlledareas including measurement o external dose

rates, measurement o air activity concentra-tion and sur ace density o contamination.

Individual monitoring must be systematic orcategory A workers. Monitoring or categoryB workers must be at least su cient to de-monstrate that they are correctly classi ed.Individual monitoring must be recorded oreach exposed category A worker. Recordsmust be retained throughout their workingli e and or not less than 30 years rom thetermination o the work involving radiation.

Medical surveillance The medical surveillance o category A work-ers is the responsibility o approved medicalpractitioners or occupational health services.

A medical examination is required prior to


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Re erences:1. ICRP Publication 60. Vol. 21 n 1-3. Perga-

mon Press

2. Council Directive 96/29 Euratom (OJ nL159, 06/29/96)

3. Council Directive 97/43 Euratom (OJ n

L180, 07/09/97)

4. ICRP Publication 84 Pregnancy and Medi-cal Radiation. Pergamon Press


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subjective visual assessments and decisionsregarding their acceptability. Test methodswere not standardised. In the early 1980s, theequipment organisations NEMA (NationalElectrical Manu acturers Association) and IEC(International Electrical Commission) de neda set o parameters that described the variousaspects o image ormation o the scintillation

camera. They also developed measurementprotocols to quanti y these parameters. Thus,by using these standard measurement proto-cols, each scintillation camera manu acturercould supply a set o speci cations measuredaccording to the same criteria and method. This enabled, or the rst time, a comparisonto be made o the per ormance o camerasrom di erent manu acturers (e.g. parameters

such as the uni ormity, spatial resolution, en-ergy resolution). These protocols have devel-oped over the years and are now available orthe scintillation camera (planar, whole body,SPET), positron emission tomography (PET),and probs. Equipment manu acturers gener-ally apply the NEMA protocols.

It is easy to see that by applying the sameor comparable methods as given by NEMA(or IEC), we can obtain quantitative QC testresults or di erent parameters that can becompared with speci cations. The quanti edQC test results provide objective data, whichcan also be compared with quantitative actionthresholds or the decision making o whetheror not the QC results are acceptable. The QC

tests can then be used or subsequent testing

and, when carried out in a standard way, ormonitoring per ormance over the li etime o the equipment. Thus di erent stages o qualitycontrol testing have developed: acceptancetesting (a ter installation o an instrument), pe-riodic testing (annually or semi-annually, anda ter major maintenance) and routine testing(daily, weekly, or whenever the equipment is

to be used).

For many years, QC testing has been per-ormed at the discretion and responsibilityo the individual nuclear medicine depart-ment. However, the 1997 European CouncilDirective 97/43, which was implemented byeach European country in 2000, speci callystates that or equipment appropriate quality

assurance programmes including quality con-trol measures should be ensured, and that ac-ceptance testing is carried out be ore the rstuse o the equipment or clinical purposes, andtherea ter per ormance testing on a regularbasis and a ter major maintenance procedure.QC is thus no longer a personal responsibilitybut is now a legal requirement.

Acceptance testingWhen we obtain new equipment in the de-partment, we need to learn how the equip-ment works and to test that it per orms cor-rectly be ore it is put into clinical use. Thisrst crucial step in QC is called acceptancetesting. This means con rming not only thatthe equipment per orms according to the

speci cations o the manu acturer, but also


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Chapter 1 What are quality assurance and quality control and why do we need them

that it per orms satis actorily or the intendedclinical applications. This latter condition usu-ally requires extra QC tests, and would includeQC tests or all the radionuclides to be usedwith the equipment.

Our rst encounter with the equipment thathas been purchased and installed is when we

undertake acceptance testing. One can almostsay that this is the start o a relationship withthe equipment, as we shall be working withit or many years. Acceptance testing shouldthere ore be given su cient time and shouldnot be rushed. It is important to understandthe purpose o each test, and how it appliesto the per ormance o the equipment. The ac-ceptance test results orm the baseline re -

erence data or subsequent tests, and mustthere ore be care ully documented and ar-chived. It is a good idea at this time to start arecord (the log book) or each piece o equip-ment, either in written or in digital orm, o anyproblems encountered and their solutions.

Testing requires radioactive sources, phan-toms, standard test protocols and methodsand so tware. Acceptance testing is nevereasy especially when we are con ronted withequipment rom another manu acturer, a newtype o equipment, or a new modality. We re-commend that the technologist works with anexperienced nuclear medicine physicist whoknows and understands the speci c equip-ment type and manu acture, the computer

and the appropriate standard QC test proto-cols. Acceptance testing may be per ormedwith the assistance o an outside agency orthe vendor but an independent evaluationo results must be made. Any dubious QC testresults must be repeated and questioned; andaction has to be taken. Because the equip-ment has a guarantee period, this is the time

to ensure that the components o the equip-ment that have been purchased per ormwithin speci cations and give the best pos-sible quality.

O ten acceptance testing or the sole pur-pose o veri ying equipment speci cations isnot su cient to cover all aspects o per or-mance to be encountered in clinical practice.

As an example, or the scintillation camera,the NEMA NU1 protocols are not su cient tocover all aspects o the camera per ormance.A speci c example is testing the collimator. The collimator is an important mechanicalcomponent in the image ormation. De ectsin the collimator will cause arti acts in clinicalimages. The parallel-hole collimator consistssimply o holes and lead septa that must beexactly aligned perpendicular to the crystalsur ace over the whole sur ace area. This holealignment is susceptible to errors duringmanu acture. Moreover the collimator struc-ture is easily damaged in use. The collimatorthere ore requires care ul extra testing in ad-dition to the methods described by NEMANU1.


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Over the years many documents giving QCprotocols or the di erent equipment o thenuclear medicine department have been pub-lished, and some countries have their own na-tional standard QC protocols. However, theseare usually general protocols. For overall de-partmental quality assurance, speci c standardQC test protocols (giving details o methods,

amounts o radioactivity to be used, analysis,action thresholds, etc.) are required or eachspeci c piece o equipment. In this way thesame methods can be applied within the de-partment; and results can be compared witheach other, regardless o who is per ormingand evaluating the test. This is no di erent rompreparing radiopharmaceuticals or per ormingclinical patient studies. These standard depart-

mental test protocols can be developed anddocumented at acceptance testing.

The International Atomic Energy Agency(IAEA) has produced technical documents orquality control o equipment. These providea good source o detailed re erence materialand include rationale o tests, phantoms to beused, step by step test protocols and evalu-ation criteria. The crucial aspect o decision-making regarding acceptability o test resultsis especially di cult or QC images rom imag-ing equipment. For the scintillation camera,the IAEA Quality Control Atlas or ScintillationCamera Systems can assist with QC test evalu-ation or cameras; and the image examplesgiven in the Atlas provide a comprehensive

overview o types o QC tests to be per-

ormed. These images can be seen in the reedownloadable version o the Atlas at http:// www-pub.iaea.org/MTCD/publications/PDF/ Pub1141_web.pd

Routine testingOnce the equipment has been accepted andis put into routine use, a schedule o routine

testing is required. The priority o routine testsshould have the same status as clinical studies. They must be scheduled, results immediatelyassessed, and action taken i the results are un-acceptable or dubious. The purpose o routinetesting is to assure that the level o quality ismaintained.

Periodic QC testing

Periodic QC tests orm a part o the initial ac-ceptance tests. They are the QC tests to check per ormance parameters that are not routinelyper ormed. They are necessary to con rmsatis actory per ormance o speci c aspectso the equipment whenever a mal unctionis suspected, a ter component replacement,ollowing major equipment maintenance ormodi cation as well as when equipment hasbeen moved to another site. They may also berepeated at annual (or semi-annual) intervalsas a re-acceptance testing procedure.

Quality assurance o clinical studiesUltimately the equipment is used or clinicalstudies. This means using the equipment cor-rectly and taking care to use standard tech-

niques and methods consistently in the clinical


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setting. For imaging, this includes consistentpatient positioning, data acquisition and dataprocessing (e.g. consistency with creating andchecking regions o interest or quanti cation)or each patient study.

ConclusionBy applying QC in order to ensure consis-

tent and optimum equipment per ormanceand by using the equipment in a consistentand optimum way, we have contributed ourpart to overall quality assurance. Each personcontributes to this process. Only with overallquality assurance can the patient eel ree o anxiety knowing that the best care and thebest nuclear medicine procedure or treatmentis available to him or her.

Further reading:Council o the European Union Directive1997/43/EURATOM.

IEC documentswww.iec.ch

IEC/TR 61948 series 1-4:Nuclear medicine instrumentation - Routinetests - Part 1: Radiation counting systems(2001)

Nuclear medicine instrumentation - Routinetests - Part 2: Scintillation cameras and singlephoton emission computed tomography im-aging (2001)

Nuclear medicine instrumentation - Routinetests - Part 3: Positron emission tomographs(2005)

Nuclear medicine instrumentation - Routinetests - Part 4: Radionuclide calibrators (2006)

IEC60789 - Medical electrical equipment -

Characteristics and test conditions o radio-nuclide imaging devices - Anger type gammacameras (2005)

IEC 61675-2 - Radionuclide imaging devices- Characteristics and test conditions - Part2: Single photon emission computed tomo-graphs Consolidated Edition 1.1 (2005)

IEC 61675-3 Radionuclide imaging devices -Characteristics and test conditions - Part 3:Gamma camera based whole body imagingsystems, Ed1 (1998)

NEMA documentshttp://www.nema.org/stds/

NEMA NU1 Per ormance measurement o scintillation cameras (1984, 2001)

NEMA NU2 Per ormance measurement o Positron Emission Tomographs (2001)

NEMA NU3 Per ormance Measurements andQuality Control Guidelines or Non-ImagingIntraoperative Gamma Probes

Chapter 1 What are quality assurance and quality control and why do we need them


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IAEA documentshttp://www-pub.iaea.org/MTCD/ publications/publications.asp

Quality Control Atlas or Scintillation CameraSystems, ISBN 92-0-101303-5, InternationalAtomic Energy Agency, Vienna, 2003. Down-loadable rom

http://www-pub.iaea.org/MTCD/publica-tions/PDF/Pub1141_web.pd

Quality control o nuclear medicine instru-ments. Technical document 602 (TECDOC),Vienna, 1991 (includes probes, and dose cali-brators)http://www-pub.iaea.org/MTCD/publica-tions/tecdocs.asp

IAEA tecdoc 606 (in revision, update to beprinted 2008)

IAEA TECDOC For PET and PET/CT (to beprinted 2007)


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Chapter 2 Best Practice in Radiation ProtectionFelicia Zito, PhD; Cristina Canzi, PhD & Franco Voltini, PhD

The use o unsealed radioactive sourcesimplies a risk to the health o technologistsresulting rom external and internal ionisingradiation exposure. International and nationalcommissions o radiological protection rec-ommend restrictions on individual dose romionising radiation sources, the use o which isheavily regulated by national laws as result o

these recommendations.

The hazards depend on the physical andchemical status o the radionuclides used, andon the type o operation; they are proportionalto the amount o activity manipulated, thetime in contact with it and the time spent inareas where permanent radioactive sourcesare present. When sources are administered

to patients, the hazards depend also on theworkload and the radiopharmaceuticalsbiodistribution and biologic hal -li e in the pa-tients. A good level o sa ety or the workerscan be reached by appropriate planning o the nuclear medicine department dependingupon the hazards. Publication number 57 o the International Commission o RadiologicalProtection (ICRP) gives criteria by which todetermine the category o hazards (Table 1)in order to plan and classi y areas. The criteriaare based on calculations obtained by multi-plying the largest activity that can be presentin any time in the area with weighting actorsaccording to the speci c radionuclide and

operation in which it is used. Once the cat-egory o hazard is established, adequateacilities are required to optimise radiationprotection.

Table 1. Hazard categories

Weighted activity Category

< 50 MBq Low hazard

50 50000 MBq Medium hazard

> 50000 MBq High hazard

External irradiation hazard The situations leading to the highest hazardare:

manipulation o unsealed sources or dose

preparation and administration;

irradiation rom patients rom per ormingthe examination and attending to theirnursing needs.

To quanti y the external irradiation hazard,in the ollowing tables 2-3, typical exposuresare reported, or some unsealed radioactivesources, in contact with syringes and at 1 mrom 10 ml vials and also rom patients orin vitro and in vivo use. Greater hazards re-sult rom manipulation o higher amounts o activity or diagnostic and therapeutic dosesthan in vitro ones.


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Film badge: the lm badge dosimeter is stillthe most widely used personnel dosimeter. The radiation sensitive material is a piece o X-ray lm enveloped in light-tight and resis-tant plastic and contained in a plastic holder,having in ront o the lm a series o radia-tion metal lters. Its advantages are the abil-ity to distinguish between photons and beta

particles, the broad dose range or photonsand beta particles, the capacity to evaluatephotons grossly as high, medium and lowenergy together with the low cost, the smallweight and dimensions. These outweigh itsdisadvantages, which are the environmentale ects (e.g. heat) and the delayed reading.

Thermoluminescent dosimeter (TLD): or

this type o dosimeter, the radiation sensitivematerial is a small piece o inorganic crystalcharacterised by migration o valence-bandelectrons to the higher-energy conductionband when excited by energy absorptionrom ionising radiation. Excited migratingelectrons are trapped in metastable statesleaving vacancies in the conduction band. Themore radiation received by the TLD, the moreelectron traps are generated. TLD reading isnot immediate and requires the crystals tobe heated to 300-400 C to allow metastableelectrons to re-enter the conduction band,lling the holes, with consequent emissiono energy as visible light photons. To collectthese light photons, a photomultiplier tube(PMT) is positioned in the heating chamber;

and the current detected is proportional to

the intensity o the light and hence to the ab-sorbed dose. A ter being heated at a high tem-perature or 24 h, the crystals are reusable. Themost common TLD material is lithium fuoride(LiF): its e ective atomic number is similar tothat o so t tissue and there ore is accurateor absorbed doses over a wide range o X,

radiation energies. The main advantages o

LiF are: the wide range o dose-response (0.1 1000Gy), the tissue equivalent Z, the verysmall dimensions, the light weight and theeasy use. Usually single chips o LiF are usedin nger rings to monitor extremity exposures. The high cost o the reader, the loss o in or-mation a ter reading and the susceptibilityto environmental heat and humidity are itsprincipal disadvantages.

Electronic personnel dosimeters: G-M tubes orsilicon solid-state diodes are used as radiationdetectors. Even i they are larger and heavierthan a lm badge, they have real time displayo dose rate and cumulated absorbed dose asmajor advantages. Models currently availableusing solid-state diodes are quite reliable andsensitive to energies o X/ rays rom 50 keV to 6 MeV, maintaining a good linearity rom10 Sv to 10 Sv. These eatures together withthe possibility o setting visual and acousticalarms at predetermined doses and dose-ratesmake this type o dosimeter particularly suit-able or nuclear medicine workers. The highcost and the impermanent record o the dosemeasurement can be considered as their prin-

cipal disadvantages.


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BioassaysAssays o excreta, usually urine, are per ormedto test or or estimate amounts o radioactivematerial in the bodies o workers. In nuclearmedicine related occupations, workers par-ticularly susceptible to internal contamina-tion, such as technologists manipulating largeamounts o radioactivity, may be checked.

Methods developed to assess e ective doserom the activity measured on a bioassay re-quire the biodistribution and kinetics o therelevant radioactive compounds and theminimum detectable activity to be known ormodelled.

Radiation survey instruments and survey

proceduresRadiation surveys are per ormed to evaluateexternal radiation elds and check contami-nation o acilities and personnel. Surveys as-sist in keeping the level o exposure as low aspossible by showing when corrective actionsneed to be taken to limit exposures. Instru-ments commonly used to detect and mea-sure external radiations are portable ionisationchambers and Geiger-Muller (G-M) monitors.

Portable ionisation chamber (IC): this con-sists o an air- lled chamber containing twoelectrodes, a battery or power supply and asensitive electrometer to measure the currentfowing between the electrodes generatedby ionisation. For X and rays, the higher the

current, the higher the exposure rate. To dis-

tinguish low energy X photons and radia-tion, most ion chambers have plastic/metalcaps that must be placed over the thin en-trance window. Advantages o ion chambersare the wide and accurate range o exposurerate measurements and the ability to corrector environmental actors. Disadvantages areslow response times and low sensitivity.

G-M monitor: this instrument consists o a thin,cylindrical metal shell with a wire mountedat the centre o the cylinder. The detector islled with a noble gas (neon, argon) and asmall amount o halogen such as chlorineor quenching. It works like the IC but with ahigher potential di erence between anode(central wire) and cathode (shell) to supply

su cient kinetic energy to the produced elec-trons so that they cause additional ionisation. This cascade e ect allows a large amount o current to be collected or a single event andthus very high sensitivity albeit with a shortdynamic range. The multiplication e ect has,however, some negative e ects, namely deadtime count loss at high exposure rates andinability to distinguish the type o the inci-dent radiation. To distinguish the and raycomponents, a metal or plastic slide is usu-ally used to cover a portion o the G-M tube.G-M survey meters, calibrated to indicate thedose rate, present a nonlinear response to theenergy o rays; there ore a calibration actordetermined or high energy radiation (600keV) can overestimate low energy photons

in the range 40-100 keV by a actor o ve.

Chapter 2 Best Practice in Radiation Protection


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The ollowing basic rules should be observedwhen working with radioactive substances:

laboratory coats, shoes and protectiveclothing must be worn be ore entering acontrolled area;

body and nger personnel dosimeters

must be worn by workers;

disposable impermeable gloves must beworn and replaced requently during ma-nipulations;

hands should be washed a ter removinggloves;

radioactive sources must be handled indesignated areas, labelled with radioactivewarning signs and enclosed in appropriateshielded boxes;

all preparations o radiopharmaceutical so-lutions should be per ormed in shieldedcells;

no eating, drinking or smoking is allowedin classi ed areas;

pipetting should never be done withmouth;

work areas should be kept as clean as possi-ble, absorbent paper, used to cover benchsur aces, should be changed periodicallyand in cases o contamination;

syringe and vial shields should be alwaysused to trans er radiopharmaceuticals tothe patient administration room;

gaseous radioactive administration shouldbe per ormed in a room with requent airchanges and negative pressure with re-spect to the outside; during gas dispens-ing, the operator should wear a mask toprotect mouth and nose, disposable pro-tective laboratory clothes and gloves;

the recapping o needles should be dis-couraged because o biological and radio-logical risks;

shielded containers, di erentiated or shortand long hal -li e radionuclides, or the dis-posal o solid wastes must be used;

at the end o work, hands, lab-clothes andshoes must be checked or contaminationbe ore leaving the controlled area.

Re erences:1. ICRP Publication 57. Vol. 20 n 3-1989. Radio-logical protection o the worker in medicineand dentistry. Pergamon Press

Chapter 2 Best Practice in Radiation Protection


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Chapter 3 Quality Assurance o EquipmentEric P. Visser, PhD

IntroductionQuality Control (QC) is important to determinethe integrity o nuclear medicine equipmentwhen used in clinical routine or researchstudies. High standards are needed or suchequipment, especially in relation to imagequality, quantitative imaging and size or vol-ume measurements in therapy and dosimetry.

Although nuclear medicine departments mayhave service contracts with their equipmentsuppliers or preventive maintenance and cali-bration, several QC procedures should be car-ried out on a regular basis by the technologistsor physicists working in the department.

Selection o testsNuclear medicine equipment suppliers gener-

ally have many protocols available to assesswhether their equipment meets all its speci-cations. Most o these protocols are complex,time-consuming, and o ten need special testequipment. To guarantee the normal day-to-day unctioning o the equipment, ewer andsimpler tests can be used.

A QC programme can never replace the at-tentiveness o the operator. In normal use,several o the problems with the equipmentthat can occur are immediately obvious. Inthese cases, the investigation can usually berepeated and there is no risk o the patientsdiagnosis being a ected. A QC programme,however, aims at detecting those changesthat happen so slowly that they are normally

not detected in everyday use.

When setting up a QC programme, severalcriteria have to be met.

A QC programme should provide concretetest results. These results should be com-pared with a prede ned value, usually thevalue obtained during equipment accep-tance tests.

An action threshold value should be de-ned, as well as a protocol or the actionsto be taken whenever this threshold is ex-ceeded.

The costs and bene ts o a QC pro-gramme have to be balanced. Examples o costs are the down time o the equipment,

personnel costs, costs o phantoms, radio-active sources and the radiation burden tothe personnel. The level o bene t is relatedto the chance that i any degradation hasactually occurred, it will be detected by thetest and that the consequences o the de-gradation ( or example a aulty diagnosis)can be pre-empted.

Frequency o testsChoosing xed test requencies may eitherresult in too ew tests being per ormed, witha greater chance that the equipment maynot always be at its optimum condition, ortoo many tests being per ormed so that theequipment is not available or patient careor long periods o time. There ore, the test

requencies should be adapted to the reli-


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ability o the equipment and the conditionso use. O course, the cost-bene t aspect o these tests should also be taken into account.However, equipment tests should always beper ormed a ter the rst installation (to obtainre erence values or all test parameters), a terhardware or so tware upgrades, and a ter spe-ci c problems and repair. In other cases, the

tests should be carried out using a requencythat is adapted over time to the reliability o the individual piece o equipment. This willgenerally lead to the optimal test requency.As a rule o thumb, one should start with arelatively high requency, which can be thenhalved i no deviations that exceed the ac-tion threshold occur during our consecutivetests. In case o a sudden, unexpected devia-

tion, the test requency should be increasedagain. However, a certain minimum requencyshould still be used; mostly this coincides withthe requency o (preventative) maintenanceo the equipment.

Action levelsWhereas test procedures and equipmentspeci cations are generally described in a veryexact way (e.g. in NEMA test procedures), thisdoes not hold or action threshold levels. Ingeneral, it is not possible to de ne absolutevalues or action levels rom rst principles.Instead, action levels are determined by ex-perience with the cost-bene t aspect kept inmind. With the proper choice o action levels,degradations should not yet have reached a

stage where they can be detected in clinical

images but on the other hand the equipmentis not put out o use or readjustments, calibra-tions, etc. or too long a time period.

Equipment to be tested The type o equipment present in each nucle-ar medicine department will vary dependingon the local situation. However, in general, the

ollowing equipment will be present in mostdepartments

Gamma cameras PET and / or PET/CT scanners Dose calibrators Flood sources and other sources or calibra-

tion and quality control Probes such as thyroid and surgical

probes Radiation monitors

- Exposure rate meters- Contamination monitors- Personal dose meters

Semiconductor detectors Gamma counters

Gamma camerasA test that should be per ormed with a rela-tively high requency is the intrinsic (withoutcollimator) homogeneity (uni ormity) test.A requency o once a week or ortnight issuitable. The reason is that this test providesa simple and quick indication o the overallper ormance o the gamma camera. Mal unc-tioning o one or more photomultiplier tubes

is immediately seen, and when looking at the


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trend o sequential results, a possible dri trom the optimum value is easily detected.

The intrinsic uni ormity o the detector can bemeasured by using a point source located at along distance rom the detector to provide auni orm fux o parallel gamma photons.

The system (detector with collimator) ho-

mogeneity should be measured on a regularbasis, typically once a month. System uni or-mity images allow checking or any damageto the collimators. Depending on the type o scans per ormed, collimators may have to bechanged requently, thus increasing the risk o mechanical damage to the septa that may beunnoticed rom the outside. The system uni-ormity can be measured by placing a uni orm

food source (e.g. Co-57) onto the collimator.

Other tests should be per ormed using anadaptive requency. The complete list recom-mended is given below. It should be noticedthat some tests partly overlap with others inthe speci c in ormation provided. The usermay there ore decide to skip one or more o these tests.

Zero measurementBy per orming a zero measurement, that is,a measurement with nothing in the eld o view o the detector, one checks or possibleradioactive contamination on the detector orthe patient bed. Since there is always a certainlevel o background radiation, which di ers

rom place to place, it is not possible to give

an absolute value or the acceptable zerolevel measured. However, in order to check or contaminations, one should compare themeasurement results with those o previousmeasurements. I an increase o , say, 20% isrecorded, action should be taken to check orand remove its source.

Shielding The detectors should be shielded at the ront,back and sides in order to minimise back-ground radiation and stray radiation rom oth-er patients or rom parts o the patient outsidethe eld o view. The shielding can be checkedby placing a radioactive source near the detec-tor head and recording the deviation rom thezero measurement. A typical measurement

con guration uses a source strength o 5 MBqat a distance o 50 cm rom the detector. Whenthe measured activity di ers signi cantly romthe zero measurement, the shielding shouldbe checked or damage and or indicationsthat there is a gap between the collimator andthe detector head. This test should be per-ormed during acceptance o the camera andwhen obvious problems are present.

Dead time, count rate per ormanceFor very high activity levels, the gamma cam-era will not register all the counts due to thedead time e ect. According to the NEMAspeci cations, the count rate should be re-corded at which a loss o 20% occurs relativeto the expected rate. This can be done by mea-

suring and plotting the count rate o a strong


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Spatial resolutionSpatial resolution determines the sharpnesso the image. It determines the details thatcan be discerned in an image. A quantitativeexpression is given by the width o the im-age o a line source, expressed as FWHM andFWTM.

Linearity The linearity determines to what extentstraight objects are imaged as straight objects.System spatial resolution and linearity can bemeasured by imaging lines sources e.g. in theorm o a single capillary tube lled with radio-activity. Intrinsic spatial resolution and linearitycan be measured using a lead phantom con-taining several slits (PLES phantom) that areilluminated by a strong point source placedat a large distance rom the slit pattern.

Whole body testsSince the motion o the bed and the trans-

lation o the bed position to the position o

C o u n

t s d e

t e c

t e d

100%

10%

50%

FWTM

FWHM

Distance across camera face

pixels in the whole body image can introduceerrors, several o the above parameters haveto be measured in the whole body mode o operation. Also the proper opening and clos-ing o the electronic window at the start andthe end o a whole body scan, i present, hasto be veri ed. The necessary tests are: wholebody uni ormity, whole body image size or

pixel size, and whole body spatial resolution.

SPECT testsSeveral tests related to SPECT imaging haveto be per ormed. These test are related to thede nition o the centre o rotation and non-circular orbits. In most cases, the equipmentmanu acturer provides so tware protocols andtest phantoms or these tests.

PET and PET/CT scannersSince a PET scanner provides quantitativein ormation about the distribution o radio-pharmaceuticals, that is activity concentra-tions or each organ or other volume o inter-est, attention should be paid to actors thatcould a ect proper quanti cation. On theother hand, since the detectors in a PET scan-ner are xed, several tests related to detectormotion, such as whole body tests or centre o rotation test in SPECT, are not necessary.

Be ore any quality test is per ormed, the PET scanner should be well tuned, which meansthat the ollowing actions should have beenper ormed:


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(NEMA NU 2-2001). Although these para-meters have to be measured during accep-tance or a ter any major hardware or so twareupgrade, they are very stable as long as thedaily QC results do not exceed their thresholdvalues. There ore, routine measurements o these parameters, either with a xed or adap-tive requency, are not necessary.

Dose calibratorsFor nuclear medicine therapy and also ordiagnostics, especially when quantitative re-sults or comparisons with previous scans areimportant, accurate and reproducible dosesare crucial. There ore, strict quality standardsapply to dose calibrators. The parameters o zero reading, stability, accuracy and linearity

should be measured in the QC programme.

For every dose calibrator, the zero read-ing and stability should be checked on aday-to-day basis. These two tests shouldbe per ormed be ore the rst radiophar-maceutical sample is measured. A properzero reading guarantees that there is noradioactive contamination o the dose cali-brator.

The stability measurement can be per-ormed by measuring the same radioactivesource (e.g.Cs-137 which is convenient dueto its long hal li e o 30 y) every day, givinga quick indication o any problem.

Accuracy should be measured as neededby using calibrated sources, pre erably inthe low, medium and high energy ranges(e.g. Co-57 at 122 keV, Ba-133 at 356 keV,and Cs-137 at 662 keV).

Linearity should be measured as neededand should cover the complete range o

activities used, typically rom several GBqor therapeutic doses down to the lowestdiagnostic doses o several tens o MBq. The easiest way to do this is to start witha Tc-99m sample o high activity and tolet it decay over several hal -lives. A typicalexample is Tc-99m with a starting value o 2 GBq, decaying over 5 hal lives (i.e. 30 h)down to 30 MBq. Per orming 3 to 4 mea-

surements each day, over two days, pro-duces the measured decay curve, whichcan be compared with the theoreticaldecay curve.

ProbesNon-imaging detectors such as thyroid probesand surgical probes are also used in nuclearmedicine departments. Although much moreattention is generally given to imaging equip-ment, the less requently used probes shouldbe checked or zero reading, sensitivity, sta-bility, linearity, side shielding, eld o view,and energy resolution. Since these probesare hand held and used at di erent locations,attention has to be given to battery li e, bro-ken cables, damage to the detector head, etc.

When used irregularly, basic quality tests arerecommended be ore each use.


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Radiation monitorsEvery nuclear medicine department needsexposure rate meters (or dose rate meters),contamination monitors and personal dosemeters.

Exposure rate meters have to be checkedtypically once a year. This can most easily

be done using a point source o known ac-tivity (e.g.100 MBq) at a xed distance (e.g.0.5 m). The reading should be comparedwith the calculated exposure rate.

Contamination monitors can be usedor general contamination detection oror quantitative measurements. In therst case, periodic measurements o a

point source at a xed distance can beper ormed. In the second case, a moreelaborate test is necessary to check thatthe maximum allowable contamination(4 Bq/cm2) is being properly detected. The test can be per ormed by uni ormlycontaminating a ltration paper o 10 x 10cm2 using droplets o a Tc-99m solution o known radioactive concentration.

Personal dose meters have to be checkedyearly. This can be done by placing a sourceo known activity (e.g. 500 MBq) at a xeddistance (e.g. 50 cm) and checking thereading against the theoretical value.

Semiconductor detectorsSemiconductor detectors are used to deter-mine the radionuclidic purity o radiophar-maceuticals and calibration sources. They arealso used or quantitative analyses o tracersin di erent kinds o samples (blood, excreta,waste water, etc.) Mostly, the detector utilisesa Ge crystal and is then called a germanium

detector. The important parameters to be test-ed (typically on a yearly basis) are the energycalibration, energy resolution and sensitivity.In the range 50 keV - 2 MeV, the relationshipbetween the energy and the channel numberis linear. There ore, the use o two well-de nedphoto peaks that cover the energy range willsu ce. In the range below 50 keV, the relation-ship is quadratic so that at least three ener-

gies are necessary. One could, or instance,use the X-ray emissions o Cs-137. The energyresolution can be measured by recording theFWHM o the photopeak o several nuclidesin the energy range o the instrument, or in-stance Co-57, Co-60 and Cs-137. Sensitivitycan be measured using a source o knownstrength with photons o di erent energies, e.g.Eu-152. This source should be placed in exactlythe same geometry with the detector as thesamples to be investigated.

Chapter 3 Quality assurance of Equipment


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cial Journal o the European Union (OJS) and published on a website or visibilitythroughout the EU. The website http://ted.publications.eu.int/o cial/ lists the currenttenders, allowing all manu acturers to accessthe in ormation.

The Directive gives options on the Tender

process. You can choose to have an Open orRestricted Tender. The main di erence is thatin a Restricted Tender, you shortlist the suppli-ers be ore issuing the detailed tender docu-ments. In an Open Tender, all expressions o interest are issued with the tender details. Thebest choice in the specialist market o gammacameras is the Restricted Tender option.

You will need to write A Summary o Needor the OJ S: this statement sets out the ba-sic requirements o the purchase and allowscompanies to express their interest. Once theadvert is in place, it makes good sense to meetwith the prospective suppliers. Local require-ments can be discussed ensuring that all par-ties are ully brie ed.

At this pre-tender stage you should begin as-sessing the range o products on the market.Companies display their newest models atcommercial exhibitions during con erences. This is a good starting point when looking intowhat is currently available. Industry represen-tatives are in the best position to organise vis-its to see their products in use in a working

environment. It is advisable to go to depart-

ments that have a similar workload and systemrequirements to your department so that youcan ascertain whether the new equipment willmeet your particular needs. Be ore you go ona visit, make a list o the essential and desir-able eatures. Ask all levels o sta what theirpriorities or system unctionality are. In par-ticular, remember what the camera is being

purchased or. In single camera departments,make sure the camera can do everything youneed. Can it image patients on beds, whatabout children, what about patients whoare claustrophobic, how do you change col-limators, will it t in the available room? Forequipment that comes rom a company withwhich you have not dealt be ore, you will wantto know how reliable the equipment is (usu-

ally quoted as up time or the product) and,when there is a problem, who carries out themaintenance? There ore, allow time duringyour visit to ask all about the practicalities o using the camera and issues concerning reli-ability and service support. Take advantage o their knowledge and experience and ask themwhether you can contact them in the uturewith extra questions; get their email address.All the in ormation will prove to be invaluablewhen it comes to making a decision.

A ter these preliminary discussions and vis-its, the nal tender questionnaire is issued tothe companies. This gives you the opportu-nity to ask numerous questions about manyaspects o the per ormance o the gamma

camera. There are several advantages to us-


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degree and postgraduate levels are just start-ing to incorporate the knowledge required orSPECT-CT but it will take several years be orethese are established. However with care-ul planning and well thought-out trainingprogrammes, hybrid imaging incorporatinghigh-end CT can be established within severalmonths even in departments with no previous

history o imaging at this level.

SummaryEquipment procurement is complicated buti you ollow the process outlined and takeexpert help when needed, you will ensurethat you comply with EU regulations. Con-sider using a standard tender questionnaireto streamline the paperwork and international

standards or acceptance testing. By takingtime to train sta and putting e cient andrelevant protocols in place, you should ndthat the route to nal purchase is not too ardu-ous; and you will emerge with the right equip-ment to meet your speci c needs.

Re erences:http://ted.publications.eu.int/o cial/ http://www.bnms.org.uk

Wells CP, Buxton-Thomas M. Gamma Cam-era Purchasing Nucl Med Commun. 1995, 3,168-185

IAEA Quality Control Atlas or ScintillationCamera Systems. ISBN 92-0-101303-5. Can be

accessed at www.iaea.org

Nuclear Medicine Resources Manual. ISBN920107504-9. Published by IAEA can beaccessed at www.iaea.org .

Chapter 4 Best Practice in Procurement


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Conclusion Dealing with Best Practice an everyday challengeJulie Martin

There is always the eeling that one can domore and that a state o per ection is neverreached. However on reading the contri-butions in this second publication on BestPractice, there is clearly so much expertiseexpressed either in the systems under whicheveryday work is per ormed or by tacit know-ledge, experiences and strategies that are

drawn upon subconsciously to achieve thenal result. We can be justly proud that thereis a determination by pro essionals within thisspeciality to work to a high standard across themany acets o Nuclear Medicine. The know-ledge and skills required are extensive whenlooking at the chapter titles; European regula-tion, quality assurance including theoreticalmodels, scienti c justi cation and practice, ra-

diation protection and its widespread applica-tions and procurement which requires expertknowledge on policy, project management,business planning, legislation and operationalpro ciency to name but a ew.

Despite di erences between European col-leagues (ranging rom cultural actors to vari-ances in the interpretation o the legislation ata national level), we are all aiming to respondto both external and internal requirementswhile at the same time managing our re-sources responsibly. The challenges are many;but by adopting the processes described inthis book, Nuclear Medicine pro essionals candeliver immediate, measurable and sustainedservice improvements and thus ensure not

only a high quality approach to imaging but

also an aspiration to a level o standardisationacross Europe.

In analysing how we can per orm daily at thehighest level, it is important to consider boththe external and internal environment and theactors by which they can prevent or acilitategood practice.

Firstly, analysis o the external environmentcan be undertaken by utilising a model calleda PEST analysis whereby examination o thepolitical, economic, social and technologicalimpacts can help identi y external pressuresthat impact on the capability to maintain anddevelop best practice.

Political mandates and changes in legislationby organisations such as UNSCEAR, ICRP andthe IAEA not only require that we implementchange but o ten require adaptations to prac-tice that a ect already stretched resources. Itis a continuous challenge to meet the everincreasing legislative requirements. NuclearMedicine, however, has always been aboutbalance; and rom the early days o usingqualitative and quantitative judgements todetermine counts versus time, we can usethis balanced proposition to implement bestpractice at a local level.

Technological impacts equally determinechanges in practice. Fi teen years ago whenundertaking SPECT gamma camera quality

control, the trend was to per orm centre o


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achieving the operational and strategic objec-tives o departments.

The nal and the most important challenge(which we meet on a daily basis when endea-vouring to provide best practice) is that o en-suring the training and development o themost important resource within the speciality,

our sta . This is not always highlighted in theguidance; but clearly it is only by developingthe knowledge and skills o Nuclear Medicinepro essionals to per orm the competenciesoutlined that we can ensure best practice. Thisis an ongoing process; and no matter wherewe work, it is the greatest challenge that weace. On reading this and the previous guide(Best Practice in Nuclear Medicine Part 1),

however, it appears that best practice is aliveand well in Europe.

Further reading:Nuclear Medicine Resources Manual 2006,IAEA ISBN 92-0-107504-9

Downloadable romhttp://www-pub.iaea.org/MTCD/publica-tions/PubDetails.asp?pubId=7038


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