IIDDEENNTTIIFFYY CCLLIINNIICAL REQUIREMENTS · 1. Identify Clinical Requirements 2. Justification...

INTERVENTIONAL EQUIPMENT:CRADLE TO GRAVE

INTERVENTIONAL EQUIPMENT:INTERVENTIONAL EQUIPMENT:CRADLE TO GRAVECRADLE TO GRAVE

Keith J. Strauss, MScDirector, Radiology Physics & Enginee rin g

Child ren’s HospitalHarvard Medical School

Keith J. Strauss,Keith J. Strau ss, MScMScDirect or, Radiology Physics & Engine erin gDirect or, Radiology Physi cs & Engine ering

Chi ldr enChildre n’’s Hospitals HospitalHarvard Medical SchoolHarvar d Medical Scho ol

INTRODUCTIONINTRODUCTION

A. Comprehensi ve Qualit y Impr ovementA. Compreh ensive Quality Improvement1. Meet Clinical Objective s1. Meet Clinical Objectives2. Achieve Good Image Quality2. Achiev e Good Image Quality3. Reduce Radiation Dose to Patients and3. Reduce Radiation Dose to Patients and

PersonnelPersonnel4.4. ManageManage CostsCosts

COMPREHENSIVE QUALITY IMPROVEMENTCOMPREHENSIVE QUALITY IMPROVEMENT

A. Cradle to GraveA. Cradle to Grave1. Identify Clinical Requiremen ts1. Identif y Clinical Requireme nts2. Justification of Project2. Justificati on of Project3. Equipment Acquisition Planning3. Equi pment Acquisition Planning4. Faci lity Planning4. Facility Plann ing5. Acceptance Testing5. Acceptance Testing6. Staff Training6. Staff Training7. Routi ne Testing, Maint enance, and Repair7. Routine Testi ng , Maintenance , and Repair

IDENTIFY CLINICAL REQUIREMENTSIDENTIFY CLINICAL REQUIREMENTS

A. Clinical Stakeholders (end users)A. Clinical Stakeholders (end users)1. Interventi onal ists1. Interve nt ionalis ts2. Technol ogis ts2. Technologi sts3. Nurses3. Nurses4. Anesthesi olog ist s4. Anesthe siologists5. Diagnost ic Imaging Physicis t5. Diagnos tic Imaging Physic ist6. Hospit al Inform ational Services6. Hospital Informational Services7. Radiol ogy Administra tor7. Radiology Administr ator8. (Oncol ogi st, Therap y Physicist,8. (Oncologist, Therapy Physicist,

Radia tion Safety)Radiation Safety)


B. ObstaclesB. Obstacl es1.1. ““ SiloSilo ”” Mentalities: Hospital PoliticsMental ities: Hospital Politics2. Points of Confusion :2. Points of Confus ion:

a.a. End Users:End Users:Imaging EquipmentImaging EquipmentCapabi litiesCapabiliti es

bb.. Vendor sVendors ::Unique ClinicalUnique Clinica lDemandsDemands


C. Clin ical/Tec hni cal Pro ject LeaderC. Clin ical/Techni cal Pro ject Leader1. Develop Global Under1. Develop Global Under--

standing of Proj ectstanding of Projecta. Equipment Specif icati onsa. Equipmen t Specifi cati ons

VendorVendorbb. Clinical Requirements. Clin ical Requirements

Stakehold ersStakeholderscc. Non technical issues. Non technical issues

Administrato rAdministrator


C. Clinical/Technical Project LeaderC. Clinical/T echnical Project Leader2. Serve as Interpret er2. Serve as Interpre ter

a. Clini cal Stakeholdersa. Clini cal Stakeho ldersbb. Vendors. Vendorscc. Administratio n. Administrationdd. Arc hit ects & Construct ion Managers. Archit ects & Constructi on Managers

3. Promote Exchange of Information3. Promote Exchange of Informationa. Ask Question sa. Ask Questio nsbb.. Seek AnswersSeek Answers

4. Make Recommendations4. Make Recommendations


C.C. Serve as InterpreterServe as Interpreter

IDENTIFY CLINICAL OBJECTIVESIDENTIFY CLINICAL OBJECTIVES

D. End Produ ctD. End Product1.1. Project Scope Tailo red to Clinica lPro ject Scope Tailo red to Clinic al

NeedsNeeds2.2. Wishes IgnoredWishes Ignore d

a. Vendora. Vendor ’’ssbb. End User. End User’’ss

3.3. AvoidAvoidA. Unful filled Clinical NeedsA. Unfulfilled Clinical NeedsB. Excessive CostsB. Excessiv e Costs

JUSTIFICATION OF THE PROJECTJUSTIFICATION OF THE PROJECT

A. Comprehensive Busi ness PlanA. Comprehensive Busi ness Plan1. Projecte d Costs1. Projecte d Costs

a. Capit ala. Capit al–– Imaging Equip mentImaging Equipm ent–– Associa ted EquipmentAssoc iated Equipment–– Const ructionConst ruction–– Other Infrastru ctur eOther Infrastructure–– PACS Modification sPACS Modifications–– Equipment for Support SpacesEquipment for Support Spaces–– Test Equipm entTest Equip ment


A. Compreh ensive Business PlanA. Comprehensive Busines s Plan1. Project ed Costs1. Projected Costs

b.b. Operatio nal CostsOperational Costs–– Salarie sSalar ies–– SuppliesSupplie s–– Equipmen t Service CostsEquipment Service Cost s


A. Comprehensive Business PlanA. Comprehensive Business Plan2.2. Projected RevenuesPro jected Revenues

a. New Patien tsa. New Patientsb. Reimbu rsement Poli ciesb. Reimbursem ent Policiesc. Reduced Servi ce Costsc. Reduced Servic e Costs

JUSTIFICATION OF THE PROJECTJUSTIFICATION OF THE PROJECTB.B. ““ Non RevenueNon Revenue ”” Consid erationsConsid erations

1. Mission & Goals1. Mission & Goals2. Retention of Quality Staff2. Retenti on of Quality Staff3.3. Loss/Leade r: PatientLoss/Leader: Patient

Referr al PatternsReferral Patterns4. Communit y Needs4. Community Needs5.5. Lease vs DirectLease vs Direct

PurchasePurchase


C. Benefi ts ofC. Benefits ofJustification StepJustification Step1. Defined Proj ect1. Define d Pro ject

ScopeScope2. Comprehens ive2. Comprehens ive

BudgetBudget3. Pro ject Properly3. Project Proper ly

FundedFunded

EQUIPMENT ACQUSITIONEQUIPMENT ACQUSITION

A. ProcessA. Process1.1. End UserEnd User Writes and Dist ributes aWrit es and Distributes a

Request for Purcha se (RFP)Request for Purchase (RFP) DocumentDocument2. Vendors of fer their2. Vendors offer their ““ bestbest --fitfit ”” productproduct3. Stakeholders3. Stakeholders ObjectivelyObjective ly ChooseChoose ““ bestbest --

fitfit ”” vendorvendor4. Purchas e Order and4. Purcha se Order and Contra ctContract FinalizedFinalized


B. Request for Purc hase (RFP)B. Request for Purchase (RFP)1.1. GenericGener ic Equipment Requireme ntsEquipme nt Requirements

a.a. Customer DefinesCustomer Defin es Scop e of EquipmentScope of Equipmenti. Clinical requ irementsi. Clinical requirement sii. Compo nent pref erencesii. Componen t preferences

b.b. GoalsGoalsi. Commun icate cli nical requiremen tsi. Commu nicate cli nical requireme ntsii. Fost er com peti tiv e biddingii. Foster competit ive biddingiii.iii. Struct uredStruct ured Vendor response allo wsVendor respo nse allows

obje ctive evaluationobjec tive evaluation


A. Request for Purchase (RFP)A. Request for Purc hase (RFP)2.2. Explici t General Purchas e ConditionsExplicit General Purc hase Conditio ns

a.a. Customer DefinesCustomer Defines Contrac tualContractu alResponsibilities ofResponsib ilities ofi. Vendori. Vendorii. Custom erii. Cust omer

b. Major Dispu tes Ident if iedb. Major Disp utes Identi fied EarlyEarly in Evaluationin Evaluationc. Vendorc. Vendor ’’s Purchase Condit ionss Purchase Conditi ons ModifiedModified


A. Request for Purchase (RFP)A. Request for Purch ase (RFP)3.3. Acceptance TestingAcceptanc e Testing

a.a. Customer Defin esCust omer Definesi. Testing Methodsi. Testing Methodsii. Expected Performance Levelsii. Expected Performance Levels

b. Performan ce Levels Achieved Prior tob. Performance Levels Achieved Prio r toFirst Clinical UseFirst Clin ical Use

FACILITY PLANNINGFACILITY PLANNING

A. Pro ject ManagementA. Pro ject Management (Planni ng)(Planni ng)1. Create Cont rolled Environment1. Create Controlled Environme nt2.2. Interpreter:Interpreter: Clinical User, Vendor , and ArchitectClinical User, Vendor, and Arc hitect

a. Clinical Requirementsa. Clinical Requirementsbb. Requirements of Chosen Equipment. Requirements of Chosen Equipmen tcc. Facility & Building Constrai nts. Facili ty & Building Constraint s

3. Construct ion Drawings Becom e3. Construction Drawings Become Contractua lContr actua la.a. Change Order Econom icsChange Order Econ omicsb.b. Get it righ t the first time!Get it right the first time!


Rad/CardiologistRad/Cardiologist

Project ManagersProject ManagersHospit al PlanningHospital PlanningImaging PhysicistImaging Physicist

Anesthesio logistAnesthesiolog ist

Technol ogistTechnol ogist

NurseNurse

Arc hitectsArchitects

EngineersEngineersStructur alStructur alElectricalElectricalHVACHVAC

IS/Communic ationIS/Comm unic ationss

Image Vendo rsImage Vendo rs


B. Site Planning Guide s (Equipment Requirements)B. Site Plannin g Guides (Equipment Requirements)1. Initial1. Initial

a. Generica. Genericb. Useb. Use ““ Worst CaseWorst Case”” VendorVendor

2. Final2. Finala. Architectural Drawi ngs Submitte d to Chosena. Arc hitectural Drawings Submitted to Chos en

VendorVendorb. Vendor Issues Site Speci fic Install atio nb. Vendor Issu es Site Speci fic Insta llation

DrawingsDrawing s


C.C. InterInter departmental Adjacenci esdepar tmen tal Adjacencie s1. Clini cal Requirements1. Clini cal Requirements

a. Other Clinical Servi cesa. Other Clin ical Service sbb. Patient Access. Patient Access

2. Facil ity Cons traints2. Facil ity Const raintsa. Loadi ng Docka. Loadi ng Dockbb. Elevat ors. Elevatorsc.c. Floor/Ceiling DeckFloor /Ceil ing Deck

LoadingLoadingd.d. Floor/Ceiling DeckFloor /Ceil ing Deck

ClearancesClearances

IMAGINGIMAGING

SURGERYSURGERY

ADMITINGADMITINGEMERGENCYEMERGENCY

EELLEEVVAATTOORR


D. Space ProgramD. Space Program1. Listing of Each Room wi th1. Listing of Each Room wi th

Requir ed Square Foota geRequired Square Footage2.2. Determines Total Space AllottedDetermines Total Space Allotted

to Project!to Project!3. Reconci le3. Reconc ile

a. Space Prog ram Needsa. Space Program Needs thatthatb. Exceed Availabl e Spaceb. Exceed Available Space


D. Space Progr amD. Space Program4. Primary Clinical Spaces4. Primary Clinical Spaces

a. Proced ure Roomsa. Procedure Roomsbb. Contr ol Rooms. Control Roomscc. Sedat ion/Recovery Space. Sedation/R ecovery Spacedd. Nurse. Nurse ’’s Stat ions Stationee. Patient Toilets. Patient Toiletsff. Changin g Rooms. Changi ng Rooms


D. Space Prog ramD. Space Program5. Secondary Clinical Spaces5. Secondary Clinical Spaces

a.a. Brachyt herapyBrachyt herapy Radioactive SourcesRadioa ctive Sourcesbb. Locker s. Locke rscc. Wait ing Room. Waiting Roomdd. Reception Desk. Reception Deskee. Patient Exam/Consultat ion Rooms. Patient Exam/Consul tati on Rooms


D.D. Space ProgramSpace Progr am6. Other Work Spaces6. Other Work Spaces

a. Supply Storagea. Supp ly Storagebb. Soiled & Clean Util ity. Soiled & Clean Util ity

StorageStoragecc. Central Computer Room. Central Computer Roomdd. Reading Room. Reading Roomee. Staf f Worksp aces. Staff Workspaces

ii . Offices. Offic esii. Cubiclesii. Cubicles


E. Floor Plans & Other DrawingsE. Floor Plans & Other Drawings1.1. IntraIntra depar tment al Adjac enc iesdepartmental Adja cencies

a. Biggest Blocksa. Biggest BlocksPlaced FirstPlaced First

bb. Gaps Filled with. Gaps Filled withSmall BlocksSmall Blocks

cc. Surr ound. SurroundProcedu re RoomsProcedure RoomsWithWith SoftSoft SpacesSpaces

Three InterventionalThree InterventionalProcedu re &Procedu re &

Control RoomsControl Rooms

Left:Left : Rooms LandRooms LandLockedLocked

ADJACENCIESADJACENCIES

Three InterventionalThree Interventi onalProcedu re &Procedure &Control RoomsControl Rooms

Left :Lef t: Rooms LandRooms LandLockedLocked

Right:Right: Room C canRoom C canGrow in LengthGrow in Lengt h

if Requiredif Required

ADJACENCIESADJACENCIES FACILITY PLANNINGFACILITY PLANNING

E. Floor Plans & Other Drawi ngsE. Floor Plans & Other Drawin gs2.2. AttributesAttributes of Each Roomof Each Room

a. Elect rical Power & Communica tion sa. Electrical Power & Communicatio nsbb. HVAC & Mechanical Issue s. HVAC & Mechanical Issuescc. Lighting. Lig htingdd. Medical Gases & Plumbi ng. Medic al Gases & Plumbingee. Storag e. Storageff. Surface Treatment s & Doors. Surfac e Treatme nts & Doorsgg. Radiati on Shieldi ng. Radia tion Shieldi nghh. Furniture & Auxili ary Equi pment. Furniture & Auxiliary Equipment


E. Floo r Plans & Other DrawingsE. Floo r Plans & Other Drawings3. Floor Plans3. Floor Plans

a.a. ““ BirdBird ’’s eye views eye view ””b. Locates each objectb. Loca tes each object

mounted on flo ormounte d on floori. Tablei. Tableii. Standii. Standiii. Caseworkiii. Casewo rkiv.iv. Scrub SinkScrub Sinkv.v. Equip ClosetEquip Closet

FACILITY PLANNINGFACILITY PLANNINGE. Floor Plans & Other DrawingsE. Floor Plans & Other Drawings

4. Reflecte d Ceiling Plan4. Reflect ed Ceiling Plana. View of Ceilinga. View of Ceilingb. Locates objectsb. Locates object s

Ceiling MountedCeiling Mountedi. Light si. Lightsii. Ventsii. Ventsiii. Sprinkleriii. Sprinkler

HeadsHeadsiv. Unis trutiv. Unistru t


E. Floo r Plans & Other Drawin gsE. Floo r Plans & Other Drawings5. Elevati on Drawing (Wall a)5. Elevation Drawi ng (Wall a)

a. View of Each Wall from Center of Rooma. View of Each Wall from Center of Roomb. Loca tes any Wall Mounted Objec tb. Locates any Wall Mounted Object


E. Floor Plans & Other Drawi ngsE. Floor Plans & Other Drawin gs5. Elevat ion Drawing5. Elevation Drawing

a. View of (Wall c)a. View of (Wall c)


E. Floor Plans & Other DrawingsE. Floor Plans & Other Drawings5. Elevation Drawing5. Elevation Drawing

a. View of Each Wall (Wall b)a. View of Each Wall (Wall b)

FACILITY PLANNINGFACILITY PLANNINGE. Floor Plans & Other DrawingsE. Floor Plans & Other Drawings

6. Electri cal Drawing6. Electrical Drawinga. Floor Plan:a. Floor Plan: ““ BirdBir d’’s Eye Views Eye Viewb. Locatesb. Locates

i. Power Outletsi. Power Outletsii. Light Switchesii. Light Switchesiii. Communicationiii. Commun ication

JacksJacksiv. Call Lightsiv. Call Light sv. Intercomv. Interco m


F. Functional SystemsF. Functional Systems1. Electrical Power1. Electri cal Powe r

a. Dedicateda. Dedicatedb.b. 440440 vsvs 480 Volt Imaging Source480 Volt Imaging Source

of Power?of Power?c.c. UPS?UPS?


F. Functi onal SystemsF. Functional Systems2. Electrical Pathw ays2. Electrical Pathways

a. Avoid Clinical Disrupti on on Other Floorsa. Avoid Clinical Disrupti on on Other Floorsbb. Universal Design. Universal Designcc.. Floor UnitsFloor Units

ii . Sweep Bends. Sweep Bend sii. Extend Inchii. Extend Inch

Above FloorAbove FloorDeckDeck


F. Func tio nal SystemsF. Func tional Systems3. Heating, Ventilation, Air Condition ing3. Heating, Ventilat ion, Air Condition ing

(HVAC) Can be Costly(HVAC) Can be Costlya. Large Heat Gain from Equi pmenta. Large Heat Gain from Equi pmen tbb. Temperature. Temperaturecc. Humidity. Humiditydd. Sterility: High Rate of air Exchange s. Ster ilit y: High Rate of air Exchang ese.e. Source of Chilled WaterSour ce of Chilled Waterf.f. Equipmen t ClosetsEquipment Closets


F. Functional SystemsF. Function al Systems4. Procedure Room Lighting4. Procedure Room Lighting

a. Fluore scen t Lights for Cleaninga. Fluor escent Lights for Cleaningb. Dimmable (on Rheostat), Zonedb. Dimmable (on Rheost at), Zoned

Ceil ing LightsCeiling Ligh tsc. Steerable,c. Steerable, ““ Operating RoomOperating Room ”” LightLightd. Underd. Under --Cabinet Lig htsCabine t Lightse. Light ing Interfaced to Fluoro scop ye. Light ing Interfaced to Fluoros copy

FACILITY PLANNING & CONSTRUCTIONFACILITY PLANNING & CONSTRUCTION

F. Functi onal SystemsF. Functional Systems5. Hallway Light ing5. Hallw ay Lighting

a. Cove Lig hting: Wall Mounteda. Cove Lightin g: Wall Mount edb. Dow n Fluoresc ent Lightsb. Down Fluorescent Light s

i.i. Unacceptab leUnacceptableii. Strobe Effect of Alt ernati ng Inten siti esii. Strobe Effect of Alternati ng Intensitie siii. Rage after Sedat ion or Anesthesi aiii. Rage after Sedat ion or Anes thesia


F. Func tional SystemsF. Func tio nal Systems6. Mechanic al Suppor ts6. Mechanic al Suppor ts

a. Universal Ceiling Schemea. Universal Ceili ng Schemei. Unist ruti. Unistrut (yellow)(yellow )

ii. Perpendicular to Longii. Perpen dicu lar to LongAxis of TableAxis of Table

iii. 4iii. 4’’ 22”” On CenterOn Centeriv. Large Gridiv. Large Grid

FACILITY PLANNING & CONSTRUCTIONFACILITY PLANNING & CONSTRUCTION

F. Func tional SystemsF. Func tio nal Systems6. Mechanical Support s6. Mechanica l Suppor ts

b. Ceiling Supports Heavy Loads on Railsb. Ceiling Supports Heavy Loads on Railsi. Imaging Monitorsi. Imaging Monitor sii. Front al or Lateral Imaging Gantryii. Frontal or Lateral Imagi ng Gantr yiii. Patient Tableiii. Patient Tableiv.iv. Auxili ary Equip mentAuxili ary Equipment

•• Injector HeadsInjector Heads•• Radiat ion ShieldsRadiat ion Shields•• LightsLigh ts•• Monit ors for Physiological DataMonitors for Phys iological Data


F. Func tional SystemsF. Functio nal Systems6. Mechani cal Support s6. Mechanic al Supp orts

c. Safe Attach mentsc. Safe Attachm entsi. Bolt Throughi. Bolt Throug h

aboveabove Prefer redPreferre dii. Anc hor Belowii. Anchor Below

LeftLeft PreferredPreferr ediii.iii. AvoidAvoid AnchorAnchor

Orient ationOrientatio nBelow RightBelow Right

d. Maintenanced. Maintenance


F. Func tional SystemsF. Func tio nal Systems8. Equipme nt Closets8. Equipment Closets

a. Independ ent HVACa. Indepen dent HVACb. Surf ace Mount edb. Surf ace Mounted

Elect rical Pathw aysElect rical Pathwaysc. Lifetime Reducedc. Life time Reduc ed

Installat ion CostInstallat ion Cost

FACILITY CONSTRUCTIONFACILITY CONSTRUCTION

A. Project Managemen tA. Project Management (Cons truction)(Cons truction)1. Monitor Construction Progress1. Monitor Construct ion Progress2. Interpret er:2. Inter preter: Clinical User and Contrac torClinical User and Contra ctor

a. Clinical Requirement sa. Clinical Requirementsb. Requiremen ts of Chosen Equipme ntb. Requirem ents of Chosen Equipm entc. Facility & Buildi ng Constr aintsc. Facility & Building Constrai nts

3. Minimi ze Construction Delays Due to3. Minimi ze Construction Delays Due toChangesChanges

ACCEPTANCE TESTINGACCEPTANCE TESTING

A. Foundation of Equipment Performance TestingA. Foundation of Equipment Performance Testing1. Elimination of1. Elim inat ion of

Install ation ErrorsInstallation Error s2. Elimination of Substa ndard2. Elim inat ion of Subst andar d

ComponentsCompone nts3. Compli ance with Regulatio ns3. Compliance with Regulations

a. Federala. Federalbb StateState

4. Contracted Performance?4. Contracted Performance?5. Baseline Data of Equipment Performance5. Baseline Data of Equipment Perfo rmance


B. Request for Purc hase (RFP)B. Request for Purchase (RFP)1. Customer Proposes1. Customer Propos es

a. Test ing Methodsa. Test ing Methodsb. Expected Perfor manc eb. Expected Perform ance

LevelsLevels

2. Vendor May2. Vendor Maya. Take Exceptiona. Take Exceptionb. Propose Alternat eb. Propose Alternate

3. Compro mise Perfor mance Levels3. Compromise Perfor mance LevelsAchieved Prior to First Clinical UseAchieved Prior to First Clinical Use


C. Test EquipmentC. Test Equip ment1. Limitati ons1. Limitat ions

a. Must be Underst ood by Physicis ta. Must be Understood by Physi cistb. May Affect Measuredb. May Affect Measured

Perfo rmance LevelsPerformance Levels


C. Test EquipmentC. Test Equipment2. Digital Readout Only Non Invasive2. Digital Readout Only Non Invasive

kVp Meter is UnacceptablekVp Meter is Unaccepta ble25 msec Rise Time25 msec Rise Time

ACCEPTANCE TESTINGACCEPTANCE TESTINGD. Why Necessary Today ?D. Why Necessar y Toda y?

19701970

19871987

20002000


D. Why Necessary Today?D. Why Necessary Today?1.1. Hardware fai lures inf requentHardware failures infrequent2.2. Human cal ibrati on errors elim inated byHuman cal ibrati on errors eliminated by

automated algorithmsautomated algorit hms


D.D. Why Necessary Today?Why Necessary Today ?E.E. Exerc ise system with test exposures.Exerc ise system with test exposu res.

a.a. Complete functional test ingComplete fun ctional testi ngb.b. Ident ify software errorsIdent ify software errors

3.3. Check conf iguration of machineCheck configuration of machinea.a. FactoryFactory APR Setting s forAPR Settin gs for AdultsAdultsb.b. DevelopDevelop APR Settings forAPR Settings for ChildrenChildrenc.c. Functional Testing of Image RoutingFunctional Testing of Image Routing

(PACS)(PACS)

TRAINING OF STAFFTRAINING OF STAFF

A. Comprehensive Training FostersA. Comprehen sive Training Fosters1. Full Uti li zation of Equipment Design1. Full Uti li zation of Equipment Design2. Optimum2. Optimum

ImageImageQualityQuality

3. Reduce3. ReduceRadiationRadiationDoseDose


B. Types of TrainingB. Types of Training1.1. Core KnowledgeCore Know ledge Pro vided at Regular InProvi ded at Regular In--

Servi cesServicesa. Basic Imaging Principlesa. Bas ic Imagin g Principlesbb. Quality Control Responsibili ties. Quality Contro l Respon sibili tiescc. Radia tion Protecti on Principl es. Radiat ion Protecti on Princi plesd.d. Equipm ent Care & MaintenanceEquipment Care & Maintenance

2.2. Credentiali ng Progra msCredentia ling Progr ams of Fluoroscopi stsof Fluor oscopi sts


B. Types of TrainingB. Types of Training2.2. ““ ButtonologyButtonology ”” :: Unique Operat ionalUnique Operationa l

FeaturesFeaturesEstablish Lead Operat orsEstablish Lead Operatorsa. Other clinical sit esa. Other clinical sitesb. Vendo rb. Vendor ’’s headquarterss headquartersc. Phantom Imagi ng on Sitec. Phanto m Imagi ng on Sited. First patientsd. First patients

EQUIPMENT MAINTENANCEEQUIPMENT MAINTENANCEAND REPAIRAND REPAIR

A. Equipment is Only as Good as its SupportA. Equipment is Only as Good as its SupportB.B. Planned, Period icPlanned, Periodic Maintenance ProgramMaintenance Program

1. Eliminate proble ms1. Elim inat e problems pr iorprior to clini cal Impactto clinical Impact2.2. Scheduled insta lla tion of Replac ement PartsSchedul ed insta llation of Replacement Parts

C. Prompt Repair of Failed Equipm entC. Prompt Repair of Failed Equipm entD. Include Mechanical and Electri cal SafetyD. Includ e Mechanical and Electr ical Safety

Issue sIssues


E. Type of Coverage Selected Af fectsE. Type of Coverage Selected Affects1. End user control1. End user control2. Degree of Self2. Degree of Self--InsuranceInsurance3. Savings Realized3. Savings Realized


F. Types of Cover ageF. Types of Coverage1. OEM Provided: COST1. OEM Provide d: COST

a. Fix Costs @ 8a. Fix Costs @ 8 -- 10% of Purch ase Price10% of Purchase Priceb. Periodic Maintenanceb. Periodic Maint enance ??c. Best Trained Staffc. Best Train ed Staff


F. Types of CoverageF. Types of Coverage2. Third Party:2. Third Part y: Not Recommen dedNot Recomm ended

a. Savings?a. Savin gs?bb. Periodic Maintenance?. Periodic Maintenance?cc. Training of Staff?. Training of Staff?dd. Ava ilability of Parts?. Availa bility of Parts?


F. Types of CoverageF. Types of Coverage3. Departmental or Institutional Coverag e by3. Departmental or Institutional Coverage by

1 Vendor:1 Vendor: Not RecommendedNot Recommendeda.a. OEM CoverageOEM Coverage onon ownown EquipmentEquipmentb.b. Third Party Cover ageThird Party Coverage on Other Equipmenton Other Equipmentc.c. Cut Throat Pricing:Cut Throat Pricing:

i. Scheduled Maintenance?i. Schedu led Maintenance?ii. Quality of Repai r Parts?ii. Quality of Repai r Parts?

d.d. ““ Conflict of InterestConflic t of Interest ””


F. Types of CoverageF. Types of Coverage4. Thir d Party Insurance Coverage:4. Thir d Party Insura nce Coverage : NotNot

RecommendedRecommendeda. Same Issues as #2 & #3 abovea. Same Issu es as #2 & #3 abovebb. Disputes on Remedial Acti on. Disputes on Remedial Action

ii . OEM. OEM vsvs Third Party PartsThird Party Partsii.ii. ““ Institution alInstit utional ”” LeverageLeverageiii. Must be settled pri or to repairiii. Must be sett led pri or to repai r


F. Types of Cover ageF. Types of Coverage5. In5. In--House Service Organizat ionHouse Service Organization

a.a. Start Up CostsStart Up Costsi. Qual if ied Personneli. Qual if ied Personnel

ii. Ongoing Traini ng of Staffii. Ongoin g Training of Staffiii. Spare Parts Invent ori esiii. Spare Parts Inventorie siv. Tools & Test Equipmentiv. Tools & Test Equipmentv. Spacev. Space

b. Managed as a Businessb. Managed as a Busi nessc. Can Reduce Costs 25c. Can Reduce Costs 25 -- 30%30%

CONCLUSIONSCONCLUSIONS

A.A. Compr ehensive Quality ImprovementCompr ehensive Quality Impro vementRequir es ActiveRequir es Active Equipment ManagementEquipment Managementfrom Concept to Decommission ingfrom Concept to Decommissio ning

1. Acceptance Testing Still Requi red1. Acceptance Testing Still Required


B. Imaging Physici st Must Underst andB. Imaging Physici st Must Unders tand1. Design Limitations of Purchased1. Design Limit atio ns of Purc hased

EquipmentEquipment2. Design Limitations of Test Equ ipment2. Design Limit atio ns of Test Equipment3. Reasonable Performa nce Expectati ons3. Reasonabl e Perfor mance Expectatio ns


B. Pro ject Leader (Imaging Physicist)B. Pro ject Leader (Imaging Physic ist)1. Clinical Needs of End Users1. Clinical Needs of End Users2.2. ““ EnvironmentalEnvironmental ”” Needs of SelectedNeeds of Selected

Equipm entEquip ment3. Building and Construction Lim ita tion s3. Building and Construct ion Limitatio ns4. Consensus Building4. Consensus Building

IIDDEENNTTIIFFYY CCLLIINNIICAL REQUIREMENTS · 1. Identify Clinical Requirements 2. Justification...

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Transcript of IIDDEENNTTIIFFYY CCLLIINNIICAL REQUIREMENTS · 1. Identify Clinical Requirements 2. Justification...