stamp for hospital safety
TRANSCRIPT
STAMP for Hospital Safety
STAMPWorkshop2019
LisaSinger,MD,PhDDana-FarberCancerIns@tute
LawrenceWong,SMMIT
Agenda
• Hospitalsafety,radia@ononcology,MRIsimulator• HighlightofSTPAonMRIsimulator• Challengesandsugges@onsforadop@ngSTPAinhealthcare
• Safetymanagementac@vi@eswithSTPAresults
MRI=magne@cresonanceimaging
Hospital Safety
Somepa@entsafetyproblems• errorordelayindiagnosis• adversedrugevents• restraint-relatedinjuriesordeath• infec@ons• burns• mistakeniden@ty
Es@matedasthe3rdleadingcauseofdeathintheUS
IntheUS,~300MRI-relatedadverseeventreportsayear,withthemostcommoneventbeingthermalburns
Overview of Radiation Oncology
Killcancercells
Protons
ElectronsPhotons
Consult
TreatmentPlanning
Treatment
Follow-up
Diagnos@cImaging
CTsimula@onMRsimula@on
LinearacceleratorRemoteaSerloaderMRlinearaccelerator
Diagnos@cimaging
Carestage Deviceused
MRI Simulator • MR-guidedAdvancedProcedureandSimula@onSuite(MAPS)
• Newgenera@onof3TMRIadaptedforRT
• EnablesMR-guidedsimula@on,brachytherapy,treatmentresponseassessment
RT=Radia@ontherapy
Advantage of MRI
Safety Needs for MRI Adoption • Noconsensusguidelinesspecifictoradia%ononcology
• Guidelinesaretakenfromdiagnos@cradiology
• Devicesmorecomplex,withdifferingrisks,thancurrentstandarddevices
OpportunityforaSTAMPProject!
Radia@onOncology
Magne@cResonanceImaging
LossesL1.Thepa%entisinjuredorkilledintheprocessofMRIsimula%on.�L2.Anonpa%entisinjuredorkilledintheprocessofMRIsimula@on.�L3.Thepa@entisinjuredorkilledfromsubsequenttreatmentduetoinaccurateMRIsimula@on.�L4.Damageorlossofequipment.�
STPA for Implementation of MRI Simulator
STPA for Implementation of MRI Simulator HazardsH1.Ferromagne@cobjectexposedtoalargemagne@cfield[L1,L2,L4]
H2.Electronic,electrical,andmechanicaldeviceexposedtolargemagne@corRFfields[L1,L2,L4]
H3.Humanorequipmentexposuretocryogenorquenchgas[L1,L2,L4]
STPA for Implementation of MRI Simulator Hazards(cont.)H4.Humanexposuretoloudnoise[L1,L2]H5.Humanoverexposuretolargemagne@cfieldorRFfield[L1,L2]
STPA for Implementation of MRI Simulator Hazards(cont.)H6.Simula@onacquirediswrongpa@ent,wrongloca@on,wrongiso,orwithpoorimmobiliza@on[L3]
H7.Simula@onacquiredcontainsar@factsorotherwisepoorimagequality,ornottransmidedforRTplanning[L3]…
STPA for Implementation of MRI Simulator
Regulators,accredita@on,professionalgroups
Co-managingins@tu@ons
Radia@ontherapygroup
Pa@ent
Otherproviders
MRImanufacturer
STPA for Implementation of MRI Simulator Oversighten@@es
Radia@ontherapy(RT)group
MRIsimula@on
RTdesign
RTdelivery
Pa@ent
Otherproviders
Therapist
MRIsoSware
QAphysicist
MRImanufacturer
…Changefields
Triggermeasurement…
Performphantomstudy
Registerpt.Startscan
…
STPA for Implementation of MRI Simulator UCA:MRIsoSwarechangefieldsevenwhentrueSAR*limitsareexceeded.[H5]
S1S2
*Specificabsorp@onrate(SAR)[W/kg]astressindicatorofRFenergybeingdepositedtothepa@ent’sbody
STPA for Implementation of MRI Simulator UCA:Using1stlevelcontrolmode*orabovewhenMRsequencecanbeobtainedinnormalmode[H5]
*1stlevelcontrolmode:poten@[email protected]:canbeusedsafelyforallpa@ents
S1
S2
Value of Adopting STPA
• Abilitytoanalyzethesystempriortogolive• Bederresultsthananalysisviaothermeans
• Improvedcomprehensivenessfromexpandedscope• Broadersetoflossscenariosconsidered
• Opportunityforthoroughsystemfamiliariza@on
Abilitytoinformsafetymanagement,especiallysafetypolicymaking
Challenges in Adopting STPA in Health Care
Difficultymappingsystem
Naturalthoughtprocess:workflow
Naturalbiastofocuson
subsystemofinterest
Sugges@ons• Adendaworkshopand/orprac@cumbeforestar@ngtheanalysis• Haveacheatsheet(one-pageSTAMPdefini@onsand@psonsystemmapping)• Includeasystemsengineerontheteam
Challenges in Completing STPA in Health Care Challenge Solu%on
Iden@fyingresourcesforanswerstotechnicalques@onswheninforma@onisproprietary
Focusontechnicalsupportincontrac@ng
InvolvingdomainexpertsnewtoSTPA
Involveexpertsinthebeginningorinquireaboutspecificques@onsoutsideofSTPAworkingmee@ngs
Timerequirement Scheduleregularmee@ngswithfocusedagendas
Veeringofftrack Includein"cheatsheet"ques@onstorefocusdiscussionandpreventearlyworkonscenarios
Trackingchangeswhenmul@pleexpertsinvolved
UsetoolsotherthanExcel
Supporting Safety Management
• Safetymanagementgoesbeyonddefiningfrontlineprocedures
• STPAresultsareusefulforlong-termsafetymanagementac@vi@es
Leadingindicatorsofrisk
Con@nuedSTPAupdates
Organiza@onalsafetylearning
plasormSTPA
Staffingandtraining
Otherac@vi@es
Facilitatestheuseof
Incidentinves@ga@on
(CAST)
Incidentrepor@ng
Common False Sense of Security Substan@alunder-repor@nginhealthcare
Top5barriersforrepor%ngfordoctors
Noincidentfollow-up(57.7%)
Formwastoolong;lackof@me(54.2%)
Incidentseemed“trivial”(51.2%)
Wardwasbusy;forgot(47.3%)
Notsurewhoisresponsibletoreport(37.9%)
%ofstudies
Es@matedunder-repor@ngrates(%)
Safety Monitoring in Health Care Whatmakesametricusefulforsafetymonitoring?• Importanttotheorganiza@on• Representwhattheyintendtomeasure
• Usableforthepeopleexpectedtoemploythedatatoimprovesafety
• Producesimilarresultswhenusedrepeatedly
• Affordabletocollect
Assump%on-basedleadingindicatorofriskDirectlytraceabletohazardsandaccidentsIden@fiesflawsinengineeringprac@cesoropera@onalbehaviorAccompaniedbyhedgingac@onstoprepareforthepossibilitythatanassump@onwillfail
Requiresthoughsulimplementa@on
Leading Indicator of Risk for MRI Simulator Assump4on:• Allpa@entsareregisteredaheadof@mewithno"emergencypa@ents“(UCA46)
Leadingindicator:• Timebetweenpa@entschedulingandtheMRIscanHedgingac4on:• Requirespre-MRIX-rayimagingforrisk-benefitassessment
Priming Incident Reporters
M S S N G
“Whattoreport?”“Thisseemstrivial”
anomaly hazards losses
STPAlossscenarios
Educa@oncanbefurthertailoredforeachrole!Top5barriersforrepor%ngfordoctors
Notsurewhoisresponsibletoreport
Summary
• STPAenhancessafetyandsystemfamiliariza@onforMRIsimulatorimplementa@on
• Solu@onsexisttoovercomechallengesofadop@ngSTPAinhealthcare
• STPAresultscansupportcon@nualsafetymanagement
Acknowledgements
• ElizabethHuynh,PhD,Radia@onOncology,BWH/DFCI• ChristopherWilliams,PhD,Radia@onOncology,BWH/DFCI
• RaymondMak,MD,Radia@onOncology,BWH/DFCI• AlliaKaza,PhD,Radia@onOncology,BWH/DFCI• MRSafetyCommidee,Radia@onOncology,BWH/DFCI• HakimLakhani,Dana-FarberCancerIns@tute• JeffreyDurney,Dana-FarberCancerIns@tute• NancyLeveson,PhD,MIT
