16FDA: 2009Symptoms of overdoses of radiation during CT brain perfusion begin to appearOctober 8: FDA Alerts Medical CommunityDecember 7: FDA makes interim recommendations to reviewImaging protocolsCheck radiation levels on scanners displays
17In the news … 3Estimated 3 Million New Cancers From CT: years
24November 8 , 2010FDA sends letter to CT manufacturers recommending HW and SW changes to reduce “the chance of overexposure”
25November 9, 2010FDA Recommends to CT facilities that technologists understand:dosing information on the display screenDose-saving features on the scanner
26November 9 , 2010 FDA Issues Final Report Most over-doses result of user errorManufacturers need to do a better job of training and educating those using CT equipmentCT machines need to have more effective way of warning operators radiation levels are too high
27November 16, 2010Marcie Iseli receives too much radiation during CT scanCabell Huntington Hospital – Huntington , W. VA.
29Marcie Iseli Nerve weakness one side of face, nausea “The only thing I can remember is the weakness, being tired, my hair started coming out in clumps, my head was burning, my face was really hot…”Marcie Iseli
30January 18, 2012Marcie Iseli receives letter from Cabell Huntington Hospital that she received too much radiation during her CT scan
31Timeline: 15 months between event and communication to the patient
32Ms. Iseli’s lawyer“It is unfathomable that Cabell Huntington Hospital could make these mistakes after the entire radiology world and the universe was aware of the problems” Mr. Patterson
33Congress Dr. Rebecca Smith-Bindman, Professor of Radiology Testifies before CongressNeed for more controls over CT scans
37Child Over-radiatedHow will we answerquestions from thisfamily?
38California: CT Technologist How will we answerquestions from thisfamily?The California radiologic technologistaccused of operating the CT scanner thatdelivered a massive radiation overdose toa 23-month-old boy in 2008 testified thatshe only pushed the CT scan button a fewtimes, and she doesn't understand how thetoddler received 151 scans in a singleimaging session…
39West Virginia Hospital Overradiated Brain Scan Patients, Records Show Published: March 5, 2011 A large West Virginia hospital seriously over-radiated patients suspected of having strokes with CT scans for more than a year after similar episodes prompted federal officials to alert nationwide to be especially careful when using those types of scans, interviews and documents show.
40FDA“The events of the past year have certainly raised awareness of the issue.” “…We suspect that overexposures continue to occur and that incidents are underreported.” Karen Riley, Spokewomen FDA
42More comments…… more needs to be done. “An underlying problem here… is that there are almost no federal regulations controlling radiation exposure form medical X-Ray scans, and it seems high time that we consider legislation. Dr. David J. Brenner, Director, Center for Radiological Research, Columbia University Medical Center
43Los Angeles“I cannot believe that this is not occurring in the rest of the country…” “ That’s why we are so keen on the rest of the states to go look at this” Kathleen Kaufman, Head of Radiation Management, Los Angeles Country Dept of Public Health
44MITA: Medical Imaging & Technology Alliance Integration of Appropriateness Criteria into Physician Decision-MakingNational Dose RegistryStorage of Diagnostic Information (Images/Dose) Within the EHREstablish Minimum Standards of Training & EducationDevelopment of Operational Safety ChecklistStandardization of Reporting Medical Errors Associated with Radiation
45MITAALARAImage Gently: Alliance for Radiation Safety in Pediatric Imaging(targeted training in pediatric CT)CT Dose Check Initiative (Dx/RT CT)Reduce cumulative dose (deploying notifications to CT technologist when recommended dose levels will be exceededReduce medical errors (dose alerts/auto shutoff)Consistent documentation of dose information
46Radiation Therapy Readiness Check Initiative AdvaMed (Advanced Medical Technology Association and MITAPatient protection for radiation therapy equipmentTreatment plans delivered as intendedProper patient positioning
47CA Governor Signs Radiation Overdose Bill into Law – October 1, 2010 Gov. Arnold Schwarzenegger1st Law of Its KindEffective July 1, 2012Requires Notification of state Dept Public Health
48The CA Laws RequiresRecord (if possible) the dose of radiation on every CT procedureDose verified annually (unless facility accredited) by a health physicistTechnical factors and dose sent to PACSReporting within 5 days of any eventAdministration of Radiation results in a repeat exam (unless ordered by MD or radiologists)Radiation of a body part other than that intended (if certain dosages are exceeded)
49CA Law: Embryonic/Fetal Exposure >50 mSv (5 rem) dose equivalentResult of radiation to a known pregnant individual unlessDose to embryo or fetus was specifically approved, in advance by a qualified MD
50Collaborations FDA, NEMA, MITA AAPM: Physics Testing Development of safeguards to prevent overexposureDose check notifications/time outs before the delivery of high exposureAccess control standardPrivileges, verification of changes, tracking of modificationsAAPM: Physics TestingIEC: International Electrotechnical Commission
51My personal struggle What is my responsibility? What is my accountability?How do I get others to listen to me? To work with me?
52Where do I start?What is the “real” risk to radiation exposure?
53Answer: it is debatable Physicists argue from both a practical as well as a theoretic perspective.We still use data from Hiroshima (1945) to estimate the effects of radiation exposure on todays populations.
54My answer We must assume there is “risk” in all we do. Large or smallReal or theoreticalAs a “professional” I must work to mitigate that risk where ever it exists.
55Back to CT Create the baseline We collected dose data on every CT Top 5 Adult Procedures by VolumeTop 5 Pediatric Procedures by VolumeReviewed data with health physicist
56Baseline Findings Significant variation in dose: Manufacturer to manufacturerSite to siteProtocol to protocolRadiologists to radiologistTechnologists to technologistsShift to shift
57Other Findings Training Protocols Not all technologists/radiologists participatedNo competency assessmentCheck-offDocumentation lackingProtocolsDocumentationReviewChange Control
58The “Administrative Plan” Assess technologists understanding (aka competency)Equipment safety featuresKnowledge of risk factorsCommunication of risk to:PatientsReferring PhysiciansProtocol selectionReview/reduce variation where possibleExpectation to challenge the status quoEstablish a change control process and communication planInstall dose reducing software (OEM, 3rd Party)Conduct the dose vs. image quality (IQ) debateParticipate in the ACR Dose Index Registry (DIR)Increase associate/physician education
59The “Patient Plan” Documentation Collect data on patient questions Be prepared to answer patient FAQ questionsScript responsesProvide analogies to “risk”Over-exposure communication plan: Patient/ordering physician, other:Who: will communicationWhat: information will you communicateWhere: face-to-face, phone orWhen: how soon after the eventDocumentationCollect data on patient questionsWhat are their concerns/FAQs
60By show of hands… Know the ranges of rad dose for high dose procedures Routine radiation safety educationWho has attended/who has notDocumentationConduct routine/annual protocol reviewHave a change control process to manage their protocols.Have a “rapid” response process in place to manage and communicate an event.24/7Assigned responsibilitiesIdentified communication pathwaysHave a radiation dose management committee in place
61Summary Greater public awareness of radiation dose Greater state and federal regulationImprovements in equipment safeguardsReporting of radiation doses inPACSNational RegistriesDiagnostic ReportsGreater CT Operator Training/CertificationRisk Management
62Ten Years From Now,,, Did you have a CT study in 2014 U Over DosedCall