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State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

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Page 1: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

State of MichiganComputed Tomography Regulations

Don Parry, CHP

Radiation Safety Section

Page 2: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Radiation Safety Section Scope of Authority – Regulates use of

machine produced ionizing radiation. Ionizing Radiation Rules of the State of

Michigan Part 15. Computed Tomography

Installations Effective June 8, 2011

Rules, Guidance Document, and FAQs available at:www.michigan.gov/rss

Page 3: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Why all of the regulatory scrutiny of Computed Tomography?

Two things have contributed to the increased attention to CT.

1. The utilization of computed tomography has increased over the years

II. Publication of Recent CT Medical Events

Page 4: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Patient dose from CT was 3 % of all medical exposure in 1980s

Page 5: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

It increased to 49% in 2006

Page 6: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

CT is 17% of the studies, but contributes to 49% of patient dose

Page 7: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

II. Recent Medical Errors

Page 8: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Topics of the New CT Rules

Medical Physicist RequirementsCT Operator RequirementsConditions of OperationEnclosuresReport and notification of a CT medical events

Quality control program

Page 9: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Rule 705 – CT OperatorsInitial qualifications. Before beginning to perform CT examinations independently, a technologist shall meet both of the following:

Be currently registered by the American registry of radiologic technologists (ARRT) or by the Canadian association of medical radiation technologists (CAMRT). 

Page 10: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Rule 705 – CT Operators

Document at least 20 hours of training and experience in operating CT equipment, radiation physics, and radiation protection or have the advanced certification in computed tomography from the ARRT.

Page 11: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Rule 705 – CT OperatorsContinuing education. A technologist shall be in compliance with the ARRT requirements for continuing education for the imaging modality in which he or she performs services. The continuing education shall include credits pertinent to CT.

Page 12: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Rule 713 – Conditions of Operation (1) Six months after the effective

date of these rules, the CT facility shall establish scanning protocols in consultation with a medical physicist.

Page 13: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Rule 713 – Conditions of Operation (2) The CT operator shall check the display

panel before and after performing each scan to make sure the amount of radiation delivered is appropriate for the technique and individual patient. This may be accomplished by reviewing dose indicator devices if available or dose indices such as the technique factors. Dose indicators or indices outside of expected values shall be documented and reviewed by an interpreting physician or medical physicist.

Page 14: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section
Page 15: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Notification Values

Page 16: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Computed Tomography Dose Index (CTDI)

Page 17: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

CT Dosimetry Phantoms

Page 18: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Dose Indices CTDI100 -CTDI with integration limits of +/- 50

mm CTDI w = (1/3 CTDI100 )center + (2/3

CTDI100 )periphery

CTDI vol = CTDIw / Pitch

Page 19: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Dose Length Product

Page 20: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Dose Length Product

Page 21: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

ACR CTDI Reference Values

CTDIvol is NOT patient dose

CTDIvol is reported in units of mGy for either a 16-cm (for head exams) or 32-cm (for body exams) diameter acrylic phantom

For the same technique settings, the CTDIvol reported for the 16-cm phantom is about twice that of the 32-cm phantom

Page 22: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Rule 713 – Conditions of Operation

(6) Only individuals whose presence is necessary are allowed in a fixed CT scanner room during exposure. Each individual, except the patient, shall be protected by at least a 0.5 millimeter lead equivalent apron or a whole body protective barrier.

Page 23: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Rule 711(4) Enclosures

The control panel for a fixed CT scanner shall be shielded by a protective barrier that cannot be removed from a protective position between the operator and the radiation source during machine operation.

Page 24: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Good example

Page 25: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Bad example

Page 26: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section
Page 27: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Rule 715 Report and notification of a CT medical event Rule 715. (1) A CT facility shall report any CT

medical event.

(c) “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

Page 28: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Alert Values

Alert Threshold - CTDIvol = 1 Gy (half skin injury dose) - FDA suggested

Page 29: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Rule 717 Quality control program

(2) Evaluations and tests shall be performed following written procedures and methods. Corrective action shall be taken and documented according to instructions provided by the medical physicist if the results of an evaluation or test fall outside the control limits.

Page 30: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section
Page 31: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Example of Corrective Action

If either the mean CT number or the noise (standard deviation) is not within the criteria limit for 3 days in a row or 3 times within a 7-day period, corrective action should be taken by reporting the problem to service representatives.

Page 32: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Rule 717 Quality control program

(3)…. An on-site CT radiologic technologist shall be identified to be responsible for the ongoing quality control testing. The tests shall be performed by this technologist or by other personnel qualified by training and experience following written procedures and methods under subrule(2) of this rule.

Page 33: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

FAQsQuestion 8: To become certified with the ARRT in Radiography, the radiography education program I completed included training in radiation physics and radiation protection. Will this training cover the radiation physics and radiation protection portion of the required 20 hours of training?

Page 34: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

FAQs

If you are ARRT registered in Radiography, ARRT(R), and do not have the advanced certificate in CT, we will assume that you have had training in radiation physics and radiation protection but you will still need to document 20 hours of training and experience in operating CT equipment.

Page 35: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

FAQs

Question 9: We use a team of two technologists to perform CT scans. Do both technologists need to be qualified under the CT rules?

Page 36: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

FAQs No. Only one technologist needs to be

qualified. If a team approach is used where only one operator meets the qualifications under the rules, the qualified operator must be in the CT room during the examination. This is to provide reasonable assurance that any mistakes made by any technologist who does not meet the qualification requirements are corrected before patients are irradiated or harm is done to the patient.

Page 37: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Quiz Q1:What percentage of medical

exposures were from computed tomography in 2006?

A: 49% Q2:A patient undergoes a CT scan at a

technique of 120 mAs, pitch of 0.7 and 120 kVp for a scan length of 10 cm and the patient dose is 10 mGy. What is the dose for a 20 cm scan length at the same technique?

A: 10 mGy

Page 38: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

Quiz Q3:The displayed CTDIvol for a pediatric

abdomen was 15 mGy using a pitch of 1.0. What would the CTDIvol be at a pitch of 1.5?

A: 10 mGy The displayed CTDIvol for a pediatric

abdomen was 5 mGy for a 32 cm phantom. Approx. what would it be for the 16 cm phantom used to set reference levels by the ACR?

A: ~10 mGy

Page 39: State of Michigan Computed Tomography Regulations Don Parry, CHP Radiation Safety Section

QUESTIONS? Contact Information

Donald E. Parry, MHP, CHPRegion Physicist-Radiation Safety SectionMIOSHAPhone: 517-636-6797e-mail: [email protected]

[email protected]/rss