Ionizing Radiation Rules Part 15 Computed Tomography Installations
23
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
-
Upload
cally-ramirez -
Category
Documents
-
view
36 -
download
0
description
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. Administrative Rule Process. Administrative Procedures Act (APA) - PowerPoint PPT Presentation
Transcript of Ionizing Radiation Rules Part 15 Computed Tomography Installations
Ionizing Radiation Rules
Part 15Computed Tomography
Installations
John Ferris, Health Physicist
Manager, Region II
Michigan Department of Community Health Radiation Safety Section
December 10, 2010
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
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
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
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
De
cem
be
r 10
, 20
10
66
Guidance
Guidance for facilities
Guidance for inspectors
RSS inspections
December 10, 2010
6
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
De
cem
be
r 10
, 20
10
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
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
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
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
De
cem
be
r 10
, 20
10
12
R 325.5705 CT operators Take effect 6 months Licensed physician
OR Radiologic technologist
ARRT registered OR
CAMRT registeredAND
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
De
cem
be
r 10
, 20
10
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
De
cem
be
r 10
, 20
10
14
R 325.5707 Medical physicist
Continuing experience
Continuing education
Reestablishing qualifications
14
De
cem
be
r 10
, 20
10
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
De
cem
be
r 10
, 20
10
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
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
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
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
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
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
SUMMARY
Descriptive vs prescriptive Final? Stakeholder involvement Thank you Questions?
22
De
cem
be
r 10
, 20
10
2323
RADIATION SAFETY SECTION CONTACTS
Lansing Phone: (517) 241-1989 Fax: (517) 241-1981 Website: www.michigan.gov/rss Email: [email protected]
Detroit Phone: (313) 456-4660 Fax: (313) 456-4676 Email: [email protected]
December 10, 2010
23
