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College of Imaging Administrators 16 Annual Spring Assembly

Learn about radiation dose management, recent events of over-exposure, and steps for enhancing safety in medical imaging practices. Explore perspectives on safety, regulatory compliance, and patient care.

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College of Imaging Administrators 16 Annual Spring Assembly

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  1. College of Imaging Administrators16 Annual Spring Assembly Sheraton – Lisle Hotel Lisle , Illinois Friday, May 2, 2014 Greg Pilat System Director Radiology Advocate Health Care 630-575-3366 office/voice greg.pilat@advocatehealth.com

  2. Radiation Dose ManagementWhat to do with the Data

  3. Disclosure I have become passionate about safety

  4. Learning Objectives • Review recent events of “over-exposure” • Understand safety from a: • regulatory perspective • patient perspective • facility perspective • CT technologist perspective

  5. How we got here – where we are going…

  6. How we got here – where we are going…

  7. How we got here today…

  8. Hippocratic Oath • “Primum Non Nocere” • First Do No Harm • 4th Century BC • One of the oldest binding documents in history

  9. January 2001

  10. November 2007

  11. November 2007

  12. November 2007

  13. November 2007

  14. November 2007

  15. November 2007

  16. FDA: 2009 • Symptoms of overdoses of radiation during CT brain perfusion begin to appear • October 8: FDA Alerts Medical Community • December 7: FDA makes interim recommendations to review • Imaging protocols • Check radiation levels on scanners displays

  17. In the news … 3 Estimated 3 Million New Cancers From CT: 20-30 years

  18. October 2009

  19. October 2009

  20. October 2009

  21. October 26, 2010 • FDA aware of 385 patients from 6 hospitals exposed to excessive radiation

  22. November 2009

  23. December 2009 Feds Get Involved

  24. November 8 , 2010 • FDA sends letter to CT manufacturers recommending HW and SW changes to reduce “the chance of overexposure”

  25. November 9, 2010 • FDA Recommends to CT facilities that technologists understand: • dosing information on the display screen • Dose-saving features on the scanner

  26. November 9 , 2010 FDA Issues Final Report • Most over-doses result of user error • Manufacturers need to do a better job of training and educating those using CT equipment • CT machines need to have more effective way of warning operators radiation levels are too high

  27. November 16, 2010 • Marcie Iseli receives too much radiation during CT scan • Cabell Huntington Hospital – Huntington , W. VA.

  28. Cabell Huntington Hospital, Huntington, W. VA.

  29. Marcie 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

  30. January 18, 2012 • Marcie Iseli receives letter from Cabell Huntington Hospital that she received too much radiation during her CT scan

  31. Timeline: 15 months between event and communication to the patient

  32. Ms. 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

  33. Congress • Dr. Rebecca Smith-Bindman, Professor of Radiology • Testifies before Congress • Need for more controls over CT scans

  34. June 2011 June 18, 2011

  35. Child Over-radiated How will we answer questions from this family?

  36. California: CT Technologist How will we answer questions from this family? The California radiologic technologist accused of operating the CT scanner that delivered a massive radiation overdose to a 23-month-old boy in 2008 testified that she only pushed the CT scan button a few times, and she doesn't understand how the toddler received 151 scans in a single imaging session…

  37. West Virginia Hospital Overradiated Brain Scan Patients, Records ShowPublished: 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.

  38. FDA “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

  39. Where we’re going

  40. More 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

  41. Los 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

  42. MITA: Medical Imaging & Technology Alliance • Integration of Appropriateness Criteria into Physician Decision-Making • National Dose Registry • Storage of Diagnostic Information (Images/Dose) Within the EHR • Establish Minimum Standards of Training & Education • Development of Operational Safety Checklist • Standardization of Reporting Medical Errors Associated with Radiation

  43. MITA • ALARA • Image 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 exceeded • Reduce medical errors (dose alerts/auto shutoff) • Consistent documentation of dose information

  44. Radiation Therapy Readiness Check Initiative • AdvaMed (Advanced Medical Technology Association and MITA • Patient protection for radiation therapy equipment • Treatment plans delivered as intended • Proper patient positioning

  45. CA Governor Signs Radiation Overdose Bill into Law – October 1, 2010 • Gov. Arnold Schwarzenegger • 1st Law of Its Kind • Effective July 1, 2012 • Requires Notification of state Dept Public Health

  46. The CA Laws Requires • Record (if possible) the dose of radiation on every CT procedure • Dose verified annually (unless facility accredited) by a health physicist • Technical factors and dose sent to PACS • Reporting within 5 days of any event • Administration 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)

  47. CA Law: Embryonic/Fetal Exposure • >50 mSv (5 rem) dose equivalent • Result of radiation to a known pregnant individual unless • Dose to embryo or fetus was specifically approved, in advance by a qualified MD

  48. Collaborations • FDA, NEMA, MITA • Development of safeguards to prevent overexposure • Dose check notifications/time outs before the delivery of high exposure • Access control standard • Privileges, verification of changes, tracking of modifications • AAPM: Physics Testing • IEC: International Electrotechnical Commission

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