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College of Imaging Administrators 16 Annual Spring Assembly

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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

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