Trends in Radiation Safety and Patient Dose Reductions

1. Trends in Radiation Safety and Patient Dose Reductions Debbie Bray GilleyEnvironmental Manager Florida Bureau of Radiation Control May 4, 2011 ASRT HCIAC Summit

2. Objectives • The attended will be informed about the current national discussion on radiation dose • The attendee will be informed about the current regulatory status of patient dose requirements • The attendee will learn of some of the strategies that may be use to address patient dose

3. Becky Coudert, a 59-year-old teacher, received a CT brain perfusion scan Sept. 8, 2009 atHuntsville Hospital A picture is worth a 1000 words

4. Headlines • California technologist faces testimony in CT overdose case (AuntMinnie.com September 18, 2009) • Hospital error leads to radiation overdoses After Cedars-Sinai reset a CT scan machine in February 2008, more than 200 brain scans on potential stroke patients were performed at eight times the normal dose of radiation, the hospital says. (LATimes 10/13.2009) • Cedars-Sinai finds more patients exposed to excess radiation latime 11/09/2009) • Hospital officials apologize and offer to cover medical care needed because of overdoses.(latime 11/21/2009 • Study: Heart attack patients receive • radiation equivalent of 725 chest X-rays (cnn Health 11/17/2009) • Radiation overdoses found at second hospital (latimes 11/21/2009) • GE sued in Alabama CT excess radiation case (Health Imaging, 12/09/09) • FDA finds new cases of CT radiation overexposure(Aunt Minnie 12/07/2009) • Unindicated CT Series Result in Unnecessary Radiation Exposure for Patients(PRNewswire 11/30/2009) • Two more hospitals report CT scan radiation overdoses (la Times, August 3, 2010)

5. Headlines • General Electric Sued Over Damage From Huntsville Hospital's CAT Scans (January 15, 2010 Videojournalist) • Radiation Offers New Cures, and Ways to Do Harm (NY Times January 24,2010) • THE RADIATION BOOM Case Studies: When Medical Radiation Goes Awry (NY Times 1/27/2010) • As Technology Surges, Radiation Safeguards Lag (NY Times 1/27/2010

6. Headlines • At Hearing on Radiation, Calls for Better Oversight (NY Times 2/27/2010) • Congress surprised at lack of medical radiation oversight (AuntMinnie.com 2/26/2010) • FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging (PRNewswire 2/09/2010) • F.D.A. to Increase Oversight of Medical Radiation (NY Times, 2/10/2010) • Is the Person Exposing You to Radiation Qualified? (PRNewsire 2/26/2010) • FDA aims to rein in radiation based medical scans (Las Vegas Sun 2/15/2010)

7. Is this necessary? Suzanne Sloan also suffered hair loss after receiving a CT perfusion scan at a hospital in Huntsville, Ala. Ms. Sloan, a fifth- grade teacher, began to piece together what had happened to her after seeing a photograph in a newspaper of someone who had experienced the same distinctive hair loss. H. Michael Heuser lost clumps of hair and had other problems after receiving a radiation overdose at Cedars-Sinai Medical Center in Los Angeles. Mr. Heuser, a 52-year-old executive producer of films, received CT perfusion scans after exhibiting stroke symptoms. Hair loss in patients who received radiation overdoses.

8. Environmental • Background (NCRP 160)300 mrem • Cross country USA flight 4 mrem • Annual limit for drinking water 4 mrem • Sleeping next to someone 0.005 mrem • Banana 0.010 mrem • Trip to International Space Lab 10,000 mrem

9. Regulatory Doses Limits (Current) • Emergency Response • Radiation Therapy • Nuclear Medicine • Diagnostic Imaging

10. Emergency Response • US Radiation worker 5 rem/yr • US 15 rem to lens of the eye • US 50 rem to whole body skin or skin to any extremity(NRC CFR part 20) • International radiation worker 2.5 rem/yr (ICRP 103) • Emergency dose limits for property protection 10 rem (lifetime) • Emergency dose limits for lifesavings 25 rem (lifetime) • Urgent rescue operations dose limits 100 rem (lifetime) • US military planned exposure 125 rem (lifetime)

11. Radiation Therapy • Regulations require a patient specific prescription • Must indicate dose or activity to be administered to the patient • Must be site specific (breast, prostate, right lung) • Must be signed by practitioner, authorized user or physician (varies state to state for radiation machines) • Must be confirmed that written directive was followed (f/u CT scan)

12. Radiation Therapy “Written Directive means an authorized user’s written order for the administration of byproduct material or radiation from a byproduct material to a specific patient or human research subject”(10 CFR 35.2)

13. Nuclear Medicine • NRC or agreement state regulated • Must have an order (MD approval for procedure) • Consistent requirements for a written directive or administration following a clinical diagnostic procedure manual (standing orders) • Quality assurance program verifying that radioactive material administered as ordered • No dose limits (Physician/patient driven)

14. Diagnostic Imaging • Prescription requesting the study be performed • Authorized by license practitioner /physician • Dose guidelines for certain procedures (NEXT Study) • Regulations restricting dose for some procedures (CA Law)

15. Diagnostic ImagingEstimated Doses • X-ray arm 0.1 mrem • Dental x-ray 0.5 mrem • Chest x-ray 2 mrem • Mammogram 30 mrem • Barium Enema 298 mrem • Chest CT 580 mrem

16. Issues • When does regulatory requirements dictate medical procedures? • Should there be dose limits for diagnostic studies? • Should physicians and practitioners have radiation safety education? • When does regulations impede the practice of medicine?

17. What’s Happening • State Government • Federal Government • Professional Associations • National Awareness Campaign • International Activities

18. CRCPD (Conference of Radiation Control Program Directors) Is a nonprofit non-governmental professional organization dedicated to radiation protection. Mission is "to promote consistency in addressing and resolving radiation protection issues, to encourage high standards of quality in radiation protection programs, and to provide leadership in radiation safety and education.Goal is to assure that radiation exposure to individuals is kept to the lowest practical level, while not restricting its beneficial uses. Membership is made up of radiation professionals in State and local government that regulate the use of radiation sources.  But anyone with an interest in radiation protection is eligible to join. www.crcpd.org

19. Dose guidelines for certain procedures (NEXT Study) The Nationwide Evaluation of X-ray Trends (NEXT) program is a partnership between the Conference of Radiation Control Program Directors, Inc. (CRCPD) and the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), with financial support from the American College of Radiology (ACR) since 1998, to characterize the radiation doses patients receive during diagnostic x-ray examinations.  http://www.crcpd.org/Pubs/NEXT_Protocols/2008-2009CardiacCath/NEXT2008-2009CardiacCathProtocol.pdf

20. Dose guidelines for certain procedures (NEXT Study) http://www.crcpd.org/Pubs/NEXT_Protocols/2008-2009CardiacCath/NEXT2008-2009CardiacCathProtocol.pdf http://www.crcpd.org/Pubs/NEXT_Protocols/2008-2009CardiacCath/NEXT2008-2009CardiacCathProtocol.pdf

21. CRCPD Proposed Medical Event Registry • Voluntary Reporting • Non Punitive • Anonymous • Reports medical events and near misses • Objective is education and awareness in an attempt to prevent future medical errors • Diagnostic doses that exceed 50 rem to the location of interest

22. State Activities • California Bill Passed 2010 • Texas Regulations in progress • Colorado (CT Quality assurance requirements) • New Jersey (Quality assurance and dose restrictions using NEXT data) • Michigan • New York • Alabama

23. California Law Repeating of a CT examination, unless otherwise ordered by a physician or radiologist, if the following dose values are exceeded:        0.05 Sv (5 rem) effective dose equivalent;        0.5 Sv (50 rem) to an organ or tissue; or        0.5 Sv (50 rem) shallow dose equivalent to the skin. CT X-ray irradiation of a body part other than that intended by the ordering physician or a radiologist if one of the following dose values are exceeded: 0.05 Sv (5 rem) effective dose equivalent; 0.5 Sv (50 rem) to an organ or tissue; or 0.05 Sv (50 rem) shallow dose equivalent to the skin.

24. California Law Law does not require Quality assurance or equipment standards Training and education for operators Qualification and education of Medical Physicists Radiation dose tracked on a per-exam basis Only concerned about individual procedures not lifetime accumulation of radiation

25. Texas Proposed Regulations • Definitions are added for computed tomography dose index (CTDI) and Roentgen • Definition for interventional fluoroscopy is revised • Calibration requirements for dosimetry systems • The term "mobile," as a type of radiation machine, is removed retaining only "portable" • Radiation Protocol Committee requirements for interventional fluoroscopy and computed tomography

26. Texas Proposed Regulations Electronic reporting systems are added as a method to maintain documents Record retention periods are added for interventional fluoroscopy and computed tomography Record retention periods are added for maintenance, and repairs of radiation machines

27. US FDA Public Meeting – Device Improvements to Reduce the Number of Under-Doses, Over-Doses, and Misaligned Exposures From Therapeutic RadiationJune 9-10, 2010 The meeting discussed steps that could be taken by manufacturers of linear accelerators, radiation therapy treatment planning systems, and radiation therapy simulators to reduce misadministration and misaligned exposures.

28. Radiation Medical Imaging Database RoundtableOctober 19, 2010 • Sponsored by the Foundation of the National Institute of Health • Participation by AAMD, AAPM, ACR, ASRT, ASTRO, CDC, CMS, CRCPD and MITA ACR (Development of a CT Dose Index Registry) (how and what) • AAMP/ASTRO subcommittee on event reporting • NRC has event reporting systems

29. Radiation Medical Imaging Database RoundtableOctober 19, 2010 • ACR (Development of a CT Dose Index Registry) (how and what) • MITA Medical Imaging and Technology Alliance (manufacturers) (CT dose check standard) • FDA existing database and review process is limited to older methods (MAUDE) • CRCPD development phase for state participation in a event reporting

30. ASRT CARE Bill Legislation Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy • Reduce health care costs with accurate diagnosis and fewer repeat exams and delays • Maximize patient safety by using certified individuals to perform exams and treatments safely, accurately and effectively while minimizing radiation exposure. • Increase quality by allowing competent, educated and certified technologists and therapists to perform procedures

31. ACR CT Dose Index Registry National Radiology Data Registry (NRDR) A tool for targeting specific areas of improvement An accurate reflection of practice patterns The ability to document the quality of services delivered by your facilities to interested third parties The ability to measure impact of changes in practice The ability to implement a data-driven quality improvement program Dose Index Registry (DIR) DIR will collect and provide feedback on dose estimate information from various modalities. A pilot program focusing on CT that allows participants to compare average CTDIvol and DLP values across facilities is currently in progress.

32. ASTRO Target Safely Plan • Work to create a national database for the reporting of medical errors; • Advocate for new and expanded federal initiatives to help protect patients from radiation errors; support the immediate passage of the Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy ("CARE") Act, which among other things requires national standards for radiation therapy treatment team members; • Work with cancer support organizations to help cancer patients and their families know what to ask their doctors when radiation is a possible treatment option;

33. ASTRO Target Safely Plan • Enhance the radiation oncology practice accreditation program, and develop additional accreditation classes specifically addressing new technologies; • Expand our educational training programs to include an intensive focus on quality assurance and safety; • Accelerate an ongoing effort that seeks to ensure device manufacturers can transfer treatment information from one machine to another seamlessly to reduce the chance of a medical error.

34. AAPM CT Dose Summit: Scan Parameter Optimization • April 29 and 30, 2010 • Sponsored by AAPM Funded by MITA and ACR, endorsed by ABR, CRCPD, HPS, RSNA • This summit demonstrated how scan acquisition and image reconstruction parameters should be selected and managed to improve image quality and reduce radiation dose.  Faculty members explained the essential criteria for specific diagnostic tasks, and participants had the opportunity to practice the selection of optimum scan protocols. The goal of the summit was to provide practical information for users that will help them operate their CT scanners wisely, improving the quality and usefulness of CT images while reducing the radiation dose to patients

35. Safety in Radiation Therapy A Call to ActionJune 25, 2010 • Sponsored by AAPM and ASTRO and endorsed by AAMD, ABR, ACMP, ACR, ACRO,ASRT, CAPCA, CCPM, COM OCPM, CRCPD, The Joint Commission, NPSF, PULSE, SROA • This conference provided the treatment team with the ability to examine their current treatment process to identify and implement safety improvements • This conference examined the treatment delivery systems and identified methods to provide operators with greater knowledge and control over the radiation delivery process at the point of care of patients

36. Safety in Radiation Therapy A Call to Action This conference examined the respective roles of members of the radiation therapy team and determine ways in which they can improve communication and teamwork to ensure safer and more effective treatment of patients  This conference allowed participants to contribute directly to the solutions to improve radiation therapy practice Publication Jan 2011 Medical Physics Journal (Hendee and Herman)

37. IAEASAFRAD (SAFety in RADiogical Procedures) • Radiation induced skin injuries to patients undergoing X ray fluoroscopy procedures to guide interventions in cardiology and radiology have continued to be observed since they were first reported in the early 1990’s • Few injuries are reported to national authorities, and many patients suffer because of lack of proper identification of the cause of injury • This is a voluntary reporting system where information pertaining to patients who are submitted to defined trigger levels will be available by means of an international database • The primary objective of the system is educational in nature. It is believed that going through the process of SAFRAD itself results in safety and quality of service • The ultimate purpose is to avoid injury in the first place through awareness among concerned physicians

38. IAEASAFRON (Safety in Radiation Oncology) Designed to learn from incidents and near misses Dynamic and applicable to a wide range of settings Can respond to new technology and processes Support education and training Easy to share information Integrates retrospective reporting and prospective risk analysis Integrates with existing systems, complementing national systems (NMED and MAUDE)

39. Either we take care of this ourselves or?????

40. CMS Reimbursement • Effective Jan. 1 2012, all providers that bill for MRI, CT, PET and nuclear medicine under part B of the Medicare Physician Fee Schedule must be accredited in order to receive technical component reimbursement from Medicare (MIPPA) • Accrediting agencies are ACR, ICANL, and JC

41. Insurance Companies • Blue Cross/Blue Shield was questioning the approval of a CTA because the patient, a cancer survivor, had 2 CT's per year for ten years. BC/BS had records that the patient had total cumulative dose of 130mSv, and the CTA would unnecessarily add to that. • There are a number of questions that arise: • The cumulative dose seems low to me. Where did this number come from? • Since when has BCBS kept track of such data, and where do they get it? from 10 years ago? • Are other insurers tracking this data, and if so, how?

42. Litigation Jacoby Roth several hours after receiving 151 CT scans in a 68-minute period. Photo courtesy of Roth family attorney Don Stockett.

43. Challenges • Scope diagnostic studies, therapeutic studies • Medical event or potential incident (near misses?) • Actual diagnostic dose or indexed dose (what about image quality) • Terminology • Capturing and reporting information

44. Opportunities • There is a need for consistent regulations for all therapy machines regardless of the origination of the radiation and purpose • There is a need to identify diagnostic dose limits that may cause patient harm • There is a need for an international standard and equivalent definition of medical events, near misses and dose regardless of the purpose • There is a need to share information on radiation dose and events for educational purposes (SAFRAD and SAFRON) • There is a need to have qualified individuals providing radiation medicine • There is a need to work together to continue to save lives using radiation medicine (diagnostic and therapeutic) in the US (internationally)

45. Upcoming Meetings About the Radiation Safety in Radiation Oncology: Issues to Consider in your Practice(ACR, May 14, 2011 Washington, D.C.) CRCPD 43rd National Conference May 15-20, Austin, TX ASRT Educational Conference, June 16th, Albuquerque, NM“Radiation Risk What We Need to Know and What to Tell Our Patients”

46. Contact Information Debbie Bray Gilley Florida Bureau of Radiation Control Training and Quality Assurance Debbie_gilley@doh.state.fl.us 850 245-4266 Join our list server at: http://www.doh.state.fl.us/environment/radiation/Subscribe.htm