1. Ionizing Radiation Rules Part 15 Computed Tomography Installations John Ferris, Health Physicist Manager, Region II Michigan Department of Community Health Radiation Safety Section December 10, 2010

2. 2 Administrative Rule Process Administrative Procedures Act (APA) State Office of Administrative Rules (SOAHR) www.michigan.gov/dleg 2009-040-CH Legislative Service Bureau (LSB) Request for Rulemaking (RFR) Regulatory Impact Statement (RIS) Public Hearing Joint Committee on Administrative Rules (JCAR) 2 December 10, 2010

3. 3 Timeline July 20, 2009 – SOAHR approves RFR Late summer 2009 – met with stakeholders February 2010 – SOAHR approved first draft February 2010 – SOAHR approved RIS May 18, 2010 – first public hearing November 1, 2010 – second public hearing November 2010 – final(?) draft submitted December 2010 – JCAR report submitted SOAHR/LSB/JCAR 3 December 10, 2010

4. 4 Changes (draft 1 vs draft 2) Effective date of the rules Definitions CT Operators Medical physicist Enclosures & Conditions of operation Reporting CT medical events QC rules grouped together Record/report retention rules grouped together Changes were made for clarity, flow Rule numbers were updated 4 December 10, 2010

5. 5 Changes (draft 2 vs draft 3) R 325.5703(c) – “CT medical event” definition R 325.5703(h) – “SPECT” definition R 325.5711(6) – Observation window requirement R 325.5715(5) – Notification of a medical event R 325.5717(a) – Quality control program Grammatical changes 5 December 10, 2010

6. 66 Guidance Guidance for facilities Guidance for inspectors RSS inspections December 10, 2010 6

7. 7 R 325.5701 Purpose and scope Part 15 - CT used for diagnostic imaging in the healing arts Exemptions Low powered CT units < 5 kilowatts PET/CT and SPECT Therapy simulation Intra-operative guidance tomography Other applicable IRR CON CT review standards 7 December 10, 2010

8. 8 R 325.5703 Definitions 21 C.F.R. 1020.33, “Computed tomography (CT) equipment” (June 10, 2005) “Annual” – 12 consecutive months 8 December 10, 2010

9. 9 R 325.5703 Definitions “CT medical event” means an unintended event where a physician determines that actual damage has occurred to an organ or a physiological system of an individual due to or suspected to be due to exposure to diagnostic radiation from a CT scanner.

10. 10 R 325.5703 Definitions “Medical physicist” means a person trained in evaluating the performance of CT scanners, related equipment, and facility quality assurance programs and who meets the requirements in R 325.5707. “Radiologic technologist” means an individual specifically trained in the use of radiographic equipment and the positioning of patients for radiographic examinations and who meets the requirements in R 325.5705. 10 December 10, 2010

11. 11 R 325.5703 Definitions “Traceable to a national standard” means an instrument is calibrated at either the national institute of standards and technology (NIST) or at a calibration laboratory that participates in a proficiency program with the NIST at least once every 2 years and the results of the proficiency test conducted within 24 months of calibration show agreement within ± 3% of the national standard in the appropriate energy range. 11 December 10, 2010

12. 12 R 325.5705 CT operators Take effect 6 months Licensed physician OR Radiologic technologist ARRT registered OR CAMRT registered AND Documented 20 hours of training and experience OR Have the advanced ARRT CT certification Continuing education Compliance with ARRT requirements Include credits pertinent to CT. 12 December 10, 2010

13. 13 R 325.5707 Medical physicist Board certified ABR ABMP CCPM OR MS or PhD Accredited institution Required courses 3 years experience in CT OR Exemption 13 December 10, 2010

14. 14 R 325.5707 Medical physicist Continuing experience Continuing education Reestablishing qualifications 14 December 10, 2010

15. 15 R 325.5709 Equipment requirements 21 C.F.R. 1020.33 “Computed tomography (CT) equipment” (June 10, 2005) Maintain compliance with 1020.33 15 December 10, 2010

16. 16 R 325.5711 Enclosures Similar to Part 7 No “40” inch exposure switch rule Observation window “shall have a lead equivalence at least equal to that required of the control barrier”

17. 17 R 325.5713 Conditions of operation Scanning protocols Checking techniques or doses Document/investigate high doses Operated from a shielded position Pb aprons or whole body barrier Exposure records on file

18. 18 R 325.5715 Report and notification of a CT medical event Reporting requirements similar to NRC Department notified within 15 days Patient/referring physician notified within 1 wk Investigations

19. 19 R 325.5717 Quality control program Effective 6 months Medical physicist supervision Quality control program Image quality Patient radiation dose Personnel radiation protection Compliance with this part Ongoing quality control Written procedures Corrective action Frequency Assigned to a technologist or qualified individual

20. 20 R 325.5719 Initial and annual medical physicist performance evaluations Initial evaluation – before use on patients Annual evaluation Calibrated dosimetry system Recommended tests/evaluations Reports Summary of performance evaluation Recommendations for improvement Dosimetry system and calibration date Provided in 30 days

21. 21 R 325.5721 Records and report retention Operators and medical physicists Kept current during employment Until the next inspection for former employees CT medical events – 7 years Survey reports – 5 years Ongoing quality control – 2 years

22. S UMMARY Descriptive vs prescriptive Final? Stakeholder involvement Thank you Questions? 22 December 10, 2010

23. 23 R ADIATION S AFETY S ECTION C ONTACTS Lansing Phone: (517) 241-1989 Fax: (517) 241-1981 Website: www.michigan.gov/rss Email: rssinfo@michigan.gov Detroit Phone: (313) 456-4660 Fax: (313) 456-4676 Email: jeferri@michigan.gov December 10, 2010 23