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College of Imaging Administrators 16 Annual Spring Assembly Sheraton – Lisle Hotel Lisle, Illinois Friday, May 2, 2014 Greg Pilat System Director Radiology.

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Presentation on theme: "College of Imaging Administrators 16 Annual Spring Assembly Sheraton – Lisle Hotel Lisle, Illinois Friday, May 2, 2014 Greg Pilat System Director Radiology."— Presentation transcript:

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 1

2 Radiation Dose Management What to do with the Data 2

3 Disclosure I have become passionate about safety 3

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

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

6 6

7 How we got here today… 7

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

9 January

10 November

11 November

12 November

13 November

14 November

15 November

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 16

17 In the news … 3 Estimated 3 Million New Cancers From CT: years 17

18 October

19 October

20 October

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

22 November

23 December 2009 Feds Get Involved 23

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

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

26 November 9, 2010 FDA Issues Final Report 1.Most over-doses result of user error 2.Manufacturers need to do a better job of training and educating those using CT equipment 3.CT machines need to have more effective way of warning operators radiation levels are too high 26

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

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

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 29

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

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

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 32

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

34 June 2011 June 18,

35 35

36 36

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

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… 38

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. 39

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 40

41 Where we’re going 41

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 42

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 43

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 44

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 45

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 46

47 CA Governor Signs Radiation Overdose Bill into Law – October 1, 2010  Gov. Arnold Schwarzenegger  1 st Law of Its Kind  Effective July 1, 2012  Requires Notification of state Dept Public Health 47

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) 48

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 49

50 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 50

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? 51

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

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. 53

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. 54

55 Back to CT 1.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 55

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 56

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

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, 3 rd Party) –Conduct the dose vs. image quality (IQ) debate  Participate in the ACR Dose Index Registry (DIR)  Increase associate/physician education 58

59 The “Patient Plan”  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 59

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

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 61

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

63 Thank you Questions 63


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