Is Fluoroscopy Dose Management the Next Big Thing?

1. Is Fluoroscopy Dose Management the Next Big Thing? Vino Durairaj, Ph.D., DABR Senior Medical Physicist West Physics

2. Objective • Biological Effects of Ionizing Radiation • Radiation Dose Management History in CT • Why Fluoroscopy Dose Optimization (FDO) • Need for a Robust Safety Culture • Identifying Targets of Optimization • References

3. Biological Effects of Radiation Due to an alarming increase in patient exposure to medical radiation, Dose management is a Hot Topic

4. Biological Effects of Radiation Nonstochastic Stochastic 2 Gy– Erythema (~ 6 Gy, severe skin reddening) 3 Gy– Hair loss (~ 7 Gy, permanent) 10 Gy– Tissue necrosis

5. Biological Effects of Radiation Nonstochastic Stochastic

6. Biological Effects of Radiation

7. CT Dose Reduction History

8. CT Dose Reduction History 2015 IMV CT report

9. CT Dose Reduction History • 2001 – Publication of CT risks gets lots of media attention • 2004 : 2016 – CT dose issues resurface periodically • 2002 – ACR Introduces CT Accreditation Program (Adult, Pediatric protocols) • 2008 – Image Gently launched (alliance to improve safe and effective imaging care of children) • 2008 – MIPPA approved

10. CT Dose Reduction History • 2009 – Insurance companies start mandating accreditation • 2009 – NCRP report 160 ”Ionizing Radiation Exposure of the Population of the US” • Medical Exposure is one of the largest source of radiation to Americans • CT is the largest source of medical exposure • 2010 – Image Wisely launched • 2012 – CA state law (SB 1237) becomes effective (strict CT dose reporting requirements)

11. CT Dose Reduction History • 2013 – NEMA standard XR-29 developed • 2014 – Congress passes protecting access to Medicare Act (scanners meet XR-29 standards) • 2015 – JC issues diagnostic Imaging requirements for ambulatory care centers • Here we are • Some states requiring stricter dose reporting • Laws affecting reimbursements if CT scanners lack certain features etc.

12. CT Dose Reduction History

13. Why are we here

14. Why Fluoroscopy Dose Optimization (FDO) Fluoroscopy is the source of medical radiation exposure. Third Largest

15. Why Fluoroscopy Dose Optimization (FDO) How is Fluoro dose doing over time?

16. Why Fluoroscopy Dose Optimization (FDO) The use of fluoroscopy has increased tremendously in the last few decades because Fluoroscopy is now routinely used in departments outside Radiology, such as Cardiology, Endoscopy, and Surgery. Philips

17. Why Fluoroscopy Dose Optimization (FDO) • In 2002, approx. 450,000 hospital stays in the US included a PCI procedure. • Cardiac cath lab patient cases have increased at an average rate of 1.7 % per year from 2008 – 2013 (4.06 million patient cases were performed) • Courtesy: IMV.com

18. Why Fluoroscopy Dose Optimization (FDO) • The less invasive interventional fluoroscopy procedures are rapidly replacing the more invasive open surgical procedures in patients for whom it is an option however … • A combination of inadequate training and equipment which can produce high radiation output can cause serious physiological consequences to the patient.

19. FDO – Regulatory Requirements • About 25 states have some form of regulations to monitor/measure dose for Interventional fluoroscopy procedures. • TX: A Radiation Protocol Committee for interventional procedures is required • RPC shall meet every 14 months • Establish written fluoroscopy procedures • Members shall include a licensed physician, physicist

20. FDO – Regulatory Requirements • JC: Considers prolonged fluoroscopy with cumulative dose > 1.5 Gy to a single field, a sentinel event. • FDA: Voluntary reporting if the facility suspects a problem with a fluoroscopic device or any event occurs that suggests a probability that a medical procedure has caused or contributed to death, serious injury or serious illness of patients.

21. FDO – Regulatory Requirements • Colorado: Safe Operation of fluoroscopy equipment for each mode of operation, dose reduction techniques for fluoroscopy. • Veteran’s Administration: Requires reporting on doses > 3 Gy.

22. Dose Reduction Vs. Dose Optimization Optimizing patient dose and minimizing patient dose are not the same!!!

23. Fluoroscopy Dose Optimization (FDO) It is often assumed that the gravity of medical situation merits the radiation exposure. Do you agree?

24. Fluoroscopy Dose Optimization (FDO) • Is Fluoroscopy Dose Management the next big thing?

25. Fluoroscopy Dose Optimization (FDO) What should be done then?

26. Need for a Robust Safety Culture Safety Culture Secretive Blame Reporting Just Weak Robust Robust safety culture forms the core component of optimization!

27. Need for a Robust Safety Culture Before consider changing an organization's culture ...

28. Need for a Robust Safety Culture What is the safety culture at your facility? • Beliefs • Attitudes • Values • Stories and Legends • Safety Equipment • Event Reporting System • Knowledge of Results

29. Need for a Robust Safety Culture Beliefs • Radiation Safety is not our responsibility. It is someone else’s; usually refers to medical physicist, physician, technologist, RSO etc. • Radiation Safety is everyone’s responsibility. OR

30. Need for a Robust Safety Culture Attitudes • Years ago, a committee generated policies and procedures to satisfy the requirements of the JC and other regulations. • The committee continually updates policies and procedures because the culture is to be the best at getting better. OR

31. Need for a Robust Safety Culture Values • Complications are an inevitable consequence of performing fluoroscopic procedures. • It is not ok for me to work in a place where it is considered acceptable for people to get hurt. OR

32. Need for a Robust Safety Culture Stories and Legends • Stories of dramatic rescues without depicting preceding failures. • Legends include near misses such as NASA’s gold plated bolt. OR

33. Need for a Robust Safety Culture Safety Equipment • Used when convenient. • Used reliably. OR

34. Need for a Robust Safety Culture Event Reporting System • Why report events? Such reports just open the door for legal or disciplinary action. • We report events and near misses. We will review them and learn from them. How else can we improve? OR

35. Need for a Robust Safety Culture Knowledge of results • Data on radiation safety metrics is difficult to locate, infrequently updated and rarely discussed in group or hospital wide meetings. • Data on radiation safety is readily available, regularly updated and widely distributed in group and hospital wide meetings. OR

36. Safety Culture Pyramid Behaviors Mindset and Opinions Strategies, Norms, History, Legends and Heroes Basic Values and Beliefs

37. Safety Culture Pyramid Cultural change is evolutionary. It takes sustained, collective efforts over a long period of time to get desirable results.

38. Practical Steps to Transform Safety Culture • Make Safety and continuous improvement, organizational values. • Remove processes, policies that are inconsistent with safety • If necessary, replace them with new processes

39. Practical Steps to Transform Safety Culture • Measure employee attitudes and opinions on an annual basis and compare them with set standards. • Focus on minimizing risky behaviors and on maximizing learning from every procedure regardless of the outcome.

40. Practical Steps to Transform Safety Culture Examine the behaviors: • Practitioners • Other personnel in the system • How people react when there is an error? • Do the consequences of error or magnitude of harm influence the reaction or do they focus on the underlying pattern of behaviors regardless of the consequence?

41. Practical Steps to Transform Safety Culture • Is the organization’s emphasis on the person that committed the error or on the system that enabled the conditions for error, or both? • How does the organization handle disclosure of such errors to the patients and their families?

42. Targets of Optimization

43. Targets of Optimization Four factors contribute to unnecessary radiation exposure: • Improper device use • Lack of access to patient information/history • Lack of consensus regarding risk of radiation exposure and appropriate dose • Lack of awareness of standard protocols and recommendations Lee Ann Jarhousse

44. Targets of Optimization – 1 How comfortable is operator with dose metrics in Fluoroscopy? • Consult with a Qualified Medical Physicist, when needed!

45. Targets of Optimization – 1 & 2 Robust dose optimization training program for fluoroscopic unit operators? • Includes nephrologists, vascular surgeons, urologists, orthopedic surgeons, nurses, technologists etc. • Consult with a Qualified Medical Physicist, when needed!

46. Targets of Optimization – 1 & 3 Is the operator familiar with various operator modes? • Consult with a Qualified Medical Physicist, when needed!

47. Targets of Optimization – 2 Is the patient dose being tracked? • Dose History

48. Targets of Optimization – 2 Are there deficiencies in ordering physician's information technology?

49. Targets of Optimization – 2 & 3 Does facility have appropriate procedure for patient follow up?

50. Targets of Optimization – 3 • Follow up is essential when a a patient has received a radiation dose, where there is a reasonable possibility that skin effects may occur. • Medical professionals need answers to specific questions: • What skin effects can be expected from radiation dose the patient received? • What general advice should be given to the patient? • How should the patient be followed up?