1. College of Imaging Administrators 16 Annual Spring Assembly
Sheraton – Lisle Hotel Lisle , Illinois Friday, May 2, 2014 Greg Pilat System Director Radiology Advocate Health Care office/voice

2. Radiation Dose Management What 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: 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

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

38. 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…

39. West 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.

40. 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

41. Where we’re going

42. 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

43. 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

44. 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

45. 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

46. 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

47. 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

48. 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)

49. 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

50. Collaborations FDA, NEMA, MITA AAPM: Physics Testing
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

51. My personal struggle What is my responsibility?
What is my accountability?
How do I get others to listen to me? To work with me?

52. Where do I start?
What is the “real” risk to radiation exposure?

53. Answer: 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.

54. My answer We must assume there is “risk” in all we do.
Large or small
Real or theoretical
As a “professional” I must work to mitigate that risk where ever it exists.

55. Back to CT Create the baseline We collected dose data on every CT
Top 5 Adult Procedures by Volume
Top 5 Pediatric Procedures by Volume
Reviewed data with health physicist

56. Baseline Findings Significant variation in dose:
Manufacturer to manufacturer
Site to site
Protocol to protocol
Radiologists to radiologist
Technologists to technologists
Shift to shift

57. Other Findings Training Protocols
Not all technologists/radiologists participated
No competency assessment
Check-off
Documentation lacking
Protocols
Documentation
Review
Change Control

58. The “Administrative Plan”
Assess technologists understanding (aka competency)
Equipment safety features
Knowledge of risk factors
Communication of risk to:
Patients
Referring Physicians
Protocol selection
Review/reduce variation where possible
Expectation to challenge the status quo
Establish a change control process and communication plan
Install dose reducing software (OEM, 3rd Party)
Conduct the dose vs. image quality (IQ) debate
Participate in the ACR Dose Index Registry (DIR)
Increase associate/physician education

59. The “Patient Plan” Documentation Collect data on patient questions
Be prepared to answer patient FAQ questions
Script responses
Provide analogies to “risk”
Over-exposure communication plan: Patient/ordering physician, other:
Who: will communication
What: information will you communicate
Where: face-to-face, phone or
When: how soon after the event
Documentation
Collect data on patient questions
What are their concerns/FAQs

60. By show of hands… Know the ranges of rad dose for high dose procedures
Routine radiation safety education
Who has attended/who has not
Documentation
Conduct routine/annual protocol review
Have a change control process to manage their protocols.
Have a “rapid” response process in place to manage and communicate an event.
24/7
Assigned responsibilities
Identified communication pathways
Have a radiation dose management committee in place

61. Summary Greater public awareness of radiation dose
Greater state and federal regulation
Improvements in equipment safeguards
Reporting of radiation doses in
PACS
National Registries
Diagnostic Reports
Greater CT Operator Training/Certification
Risk Management

62. Ten Years From Now,,, Did you have a CT study in 2014
U Over Dosed
Call

63. Thank you
Questions