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. Administrative Rule Process
Administrative Procedures Act (APA)
State Office of Administrative Rules (SOAHR) CH
Legislative Service Bureau (LSB)
Request for Rulemaking (RFR)
Regulatory Impact Statement (RIS)
Public Hearing
Joint Committee on Administrative Rules (JCAR)
Let me start by providing a little background on how administrative rules are promulgated.
The process is governed by the APA (1999)
SOAHR is the lead agency for ensuring the process outlined in the APA is followed. They also ensure that the agency has the statutory authority needed to promulgate rules.
You can check the status of any administrative rule set at their website.
The CT rules are found under CH.
LSB provides a legal review of the rules and determines if the rules conform to their style guide.
Promulgating administrative rules start with the RFR.
A RFR must be submitted and approved before an agency can formally begin the process of promulgating a rule or rule set.
Rules are then drafted and submitted to SOAHR.
A RIS must be filed. It contains cost estimates that may impact the agency and the regulated community (both organizations and individuals).
Once SOAHR approves the draft rules and RIS a public hearing must be held. Notice of the hearing has to be published in 3 newspapers and the Michigan Register.
After the public hearing the agency drafts a response to any testimony provided, makes any changes to the draft rules, and resubmits the draft to SOAHR.
Substantive changes, typically any change that requires a higher level of regulation, will require another public hearing.
Finally a JCAR report must be prepared when the promulgation process is complete and the rules are to be submitted to the legislature for review. The JCAR report includes a summary of the public hearing testimony, the department’s response to that testimony, and other information demonstrating that the APA was followed.
JCAR has 15 session days to act. 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
There were several factors that prompted the Radiation Safety Section to draft CT rules at this time
Current Ionizing Radiation Rules (1975)
Lack rules specifically regulating CT
High CT workloads
Higher exposure from CT vs conventional imaging
(NCRP Report 160, Ionizing Radiation Exposure of the Population of the United States, 2009 suggests that ~ 24% of our annual exposure is due to CT scans
The various newspaper articles reporting high CT exposures
In early 2009 began to put together an outline of what we would like to include in the rule set. We tried to parallel the ACR CT accreditation program requirements as much as we could. We also tried to create rules that allow registrants and medical physicists sufficient flexibility in order to craft QA programs that are appropriate for the facility and use of their CT scanners.
By early summer we decided to move forward in the process and submitted a RFR to SOAHR that was approved.
Over the next several months we held two meetings with interested stakeholders.
Several drafts were sent out for comment and changes made until we had a draft that we felt was ready for submission.
In late December and early January we submitted the draft rules and the RIS to SOAHR.
SOAHR and LSB requested a few grammatical changes, which were made and approved the rule set and RIS in early February.
A public hearing was scheduled for May 18, 2010.
At the May 18th public hearing six individuals provided verbal testimony and 4 individuals/organizations provided written testimony.
Overall the testimony was supportive of our efforts to draft the CT rules.
However, we received approximately 38 comments and suggestions for change. Many of the comments were similar, addressing the same rule or topic.
After the public hearing we met with several of the individuals who were at the meeting to discuss their testimony.
Based on the comments received the RSS decided to make significant changes and a second draft was prepared.
We then sent the second draft to stakeholders for comment. We received only one suggestion for change.
The second draft was submitted to SOAHR for review. Due to the substantive changes a second public hearing was necessary.
That hearing was held on Monday, November 1, 2010.
Four individuals provided verbal testimony and 2 individuals provided written testimony.
We received approximately 35 comments. Most were similar and involved the same rules and topics.
Based on those comments a third draft has been prepared.
This time we do not feel that the changes we have made are substantive (in SOAHR language – the changes do not require a higher level of regulation) and therefore should not require another public hearing
In late November a the third draft was submitted to SOAHR followed by the JCAR report in early December.
The JCAR report along with the third draft are being reviewed at this time.
FINISH NEXT WEEK TO SEE IF SOAHR AGREES
SOAHR and LSB will need to perform a final review for legal certification.
This may take the rest of December and will probably run into January.
Once the rules are legally certified the JCAR package will be forwarded to the legislature.
As mentioned, JCAR has 15 session days to act.
Since there are no further legislative session days left this year, the rules will go to the next JCAR.
Based on previous legislative calendars it appears that the earliest the rules could take effect is sometime in February. 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
Draft 1 – dated April 12, 2010 was the draft reviewed at the first public hearing.
At the first public hearing many of the comments we received suggested adding rules for physicians who operate CT scanners and for physicians who interpret CT images.
However, the RSS does not have statutory authority to regulate physicians.
Changes made after the first public hearings included:
Changing the effective date of the rules:
Except for rules pertaining to CT operators, review of scanning protocols, and the establishment of quality control programs, the new rule set will take effect upon filing with the Secretary of State. The three exceptions mentioned will take effect six months after the filing.
Beginning six months after filing:
All CT exams will need to be conducted by a licensed physician or by a technologist who holds a current registration by the American Registry of Radiologic Technologists (ARRT) or by the Canadian Association of Medical Radiation Technologists (CAMRT).
All facilities will need to have reviewed their scanning protocols.
All facilities will need to have established a quality control program.
New definitions were added and some were modified.
The radiologic technologist section was updated by:
Changing the name of the rule from “Radiologic technologists” to “CT operators”.
Adding language that allows an individual who holds a current CAMRT registration to operate a CT scanner.
The medical physicist section was updated by:
Adding a definition for “accredited institution”.
Changing the requirements for continuing education.
Rules relating to enclosures and conditions of operation were added in lieu of referencing rules in another part.
A new rule was added that will require facilities to report to the department any CT medical event.
Rules pertaining to quality control functions were grouped together into one rule.
Rules pertaining to records and report retention were also grouped together into one rule.
The language of several of the rules was revised for clarity.
The order of the rules was rearranged to improve the flow.
Rule numbers were updated as a result. 4
December 10, 2010

5. Changes (draft 2 vs draft 3)
R (c) – “CT medical event” definition
R (h) – “SPECT” definition
R (6) – Observation window requirement
R (5) – Notification of a medical event
R (a) – Quality control program
Grammatical changes
December 10, 2010
Draft 2 – dated September 9, 2010 was the draft reviewed at the second public hearing. I believe that is the draft you have had a chance to review.
At the second public hearing several individuals recommended that we require specific training in CT for physicians who operate CT scanners and that we address interpreting physicians in the rules. We checked with our RAO to see if we could add training requirements for physician operators. Once again we were reminded that the RSS does not have statutory authority to do so.
Specific rules that were modified after the second public hearings include:
Definitions:
The definition of a CT medical event was modified to address the concerns of those who provided testimony.
The definition of SPECT was also changed. It is now similar to the definition of PET/CT.
Observation window – Changes in the language of the rule were made for clarity.
Concerns regarding when a patient and a referring physician must be notified about a CT medical event were addressed.
The requirement for checking “Patient image quality” was changed to “Image quality”.
Other grammatical changes were made as necessary. 5

6. Guidance Guidance for facilities Guidance for inspectors
RSS inspections
We are designing a CT guidance document for facilities. We hope that it will help facilities understand and interpret the rules.
We also hope that the guidance document will help facilities understand how inspectors will determine compliance with the rules.
That document is in draft form and currently not ready for facilities.
We also plan to establish an inspection procedure guidance document for our inspectors. Hopefully, this will make inspections more consistent and reduce the time necessary to perform an inspection.
The RSS also plans to inspect each CT facility the first year after the rules become effective. The inspection will be to assist facilities in their understanding of the rules and how to be compliant. Inspection reports will issued outlining what the facility needs to do to become compliant. We do not anticipate citing facilities for items of noncompliance. 6 6
December 10, 2010

7. R  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
December 10, 2010
The purpose and scope of this rule set is to regulate CT scanners used in the healing arts for the intentional exposure of humans for diagnostic imaging.
Part 15 does not cover CT scanners used in veterinary medicine or industry.
Specific exemptions were included for:
CT scanners that operate at 5 kilowatts or less as certified by the manufacturer – this includes most if not all dental CT units and head only CT units.
PET/CT and SPECT systems are exempt if the CT portion is used solely for attenuation corrections and anatomical markers.
CT units used as part of a therapy treatment plan are exempt.
However, if the CT unit in PET, SPECT, or therapy is used for any type of diagnostic imaging, that use would be covered under part 15 (and most likely would require a separate CON).
CT systems used solely for intra-operative guidance are also exempt.
All CT systems are subject to other applicable provisions of the Ionizing Radiation Rules.
We remind you that CT system are still subject to the certificate of need review standards. 7

8. R  Definitions
21 C.F.R , “Computed tomography (CT) equipment” (June 10, 2005)
“Annual” – 12 consecutive months
Several definitions were included to specifically address this rule set.
Some of them that may be of interest include:
The definitions from 21 cfr These definitions were adopted by reference in lieu of adding each one to this rule set.
“Annual” is used in R (1) which requires that a medical physicist complete annual performance evaluations.
“Annual” means a period of 12 consecutive months. Surveys conducted January 1, 2011 would be due by January 31, Surveys conducted January 31, 2011 and February 1, 2012 would not meet the definition of annual. 8
December 10, 2010

9. R  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.
The definition of a CT medical event was changed after the second public hearing.
Two significant changes were made.
The word “Unintended” was added to address concerns regarding the reporting of events that are an expected consequence when the procedure was started, as there might be with an interventional CT procedure.
The phrase ‘either an actual or suspected acute or long term functional damage’ was replaced with the phrase ‘actual damage’. This change should address the concern that there could be issues in determining whether it is truly a CT medical event or is really an interpretive medical event.

10. R  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 
“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 
A medical physicist must meet the requirements of R
They also have to have training in evaluating CT scanners and QC programs.
A radiologic technologist must meet the requirements of R 10
December 10, 2010

11. R  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.
December 10, 2010
“Traceable to a national standard” is used in R (2) which requires the use of a calibrated dosimetry instrument.
The dosimetry instrument must be calibrated at least every 2 years and the calibration must be “traceable to a national standard. 11

12. R 325.5705 CT operators Take effect 6 months Licensed physician OR
Radiologic technologist
ARRT registered
CAMRT registered
AND
Documented 20 hours of training and experience
Have the advanced ARRT CT certification
Continuing education
Compliance with ARRT requirements
Include credits pertinent to CT.
December 10, 2010
This rule defines who may take CT images.
Beginning 6 months after the rules take effect, all CT exams must be performed by
A Licensed physician OR
By a Radiologic technologist who is currently registered with the ARRT or the CAMRT.
The technologist is also required to have 20 hours of documented training in CT.
Although not specified, we hope that at least 10 hours would be from didactic training and that no more than 10 hours would be from on-the-job training.
Technologists who have the advanced ARRT CT certification will not need to provide further evidence of training in CT.
Continuing education
Technologist must remain compliance with ARRT requirements. Therefore, they must have enough continuing education credits (24 every 2 years) to renew his or her ARRT registration.
In addition, they must obtain include more than 1 CT credit as part of the 24. 12

13. R 325.5707 Medical physicist Board certified OR MS or PhD Exemption
ABR
ABMP
CCPM OR
MS or PhD
Accredited institution
Required courses
3 years experience in CT
Exemption
December 10, 2010
Each CT facility will need to employ or contract with a medical physicist to review the quality and safety of the operation of the CT scanner.
Medical physicists must meet one of the following:
Be board certified by an approved board in an appropriate specialty.
The boards and specialties include:
ABR – diagnostic radiological physics or radiological physics
ABMP – diagnostic imaging physics
CCPM – diagnostic radiology physics OR
Have a graduate degree in an approved discipline from an accredited institution. A definition of accredited institution is included in this rule.
Have formal coursework in biology or radiation biology and in anatomy, physiology or other similar topic related to the practice of medical physics.
Have 3 years experience working in a clinical CT environment.
An exemption is provided for physicists that are not board certified or do not have an advanced degree. This exemption was added after the ACR changed the physicists qualifications earlier this year. Our exemption will expire 3 years immediately following the effective date of this part.
An accredited institution is a college or university accredited by a regional accrediting organization that has been recognized either by the U.S. department of education (USDE) or by the council for higher education accreditation (CHEA) or both. Individuals with non-U.S. degrees shall provide documentation that their foreign degrees are equivalent to those granted from an approved institution in the U.S. and that the granting institution is equivalent to a regionally accredited institution in the U.S. 13

14. R 325.5707 Medical physicist Continuing experience
Continuing education
Reestablishing qualifications
December 10, 2010
All medical physicists will need to survey at least 2 CT scanners within a 24 month period to be compliant with the continuing experience requirement.
All medical physicists will need to obtain at least 15 continuing medical education units, at least half need to be category 1, in the prior 36-month period. The continuing education shall include credits pertinent to CT.
Means to reestablishing qualifications were also included. 14

15. R 325.5709 Equipment requirements
21 C.F.R “Computed tomography (CT) equipment” (June 10, 2005)
Maintain compliance with
December 10, 2010
We have adopted most of the equipment requirements from 21 CFR “Computed Tomography”.
Since FDA regulations apply mostly to manufacturers and installers, we added a rule specifying that CT equipment must be maintained in compliance with those regulations. 15

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”
One of the suggestions after the first public hearing was to include in this part all of the rules for enclosures and not to reference rules in another part.
The enclosure requirements are very similar to that required for radiographic equipment in Part 7.
We purposely did not include R (7) which requires the exposure switch to be at arms length from secondary or leakage radiation. We addressed that in the conditions of operation section which I will review with other requirements in that section.
Under R (6), operators must be able to see and communicate with the patient from a shielded position behind the control barrier
If an observation window is provided, it shall have a lead equivalence at least equal to that required of the control barrier in which it is installed.
The highlighted text are changes made between the second and third versions.

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
Many of the conditions of operation come from R of part 7.
Six months after the effective date of these rules, each CT facility shall establish scanning protocols in consultation with the medical physicist. This means that all scanning protocols will need to be reviewed by this time.
(2) Operators will need to 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.
We have not included a definition for doses outside of expected values. We believe that the facility, based on their experience and expertise, will best be able to determine when a dose is unexpectedly high, what type of information should be documented, and at what time the dose should be reviewed
(3) A fixed CT scanner shall be operated from a shielded position behind a protective barrier pursuant to R  (4).
(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 0.5 millimeter lead equivalent aprons or a whole body protective barrier.
(8) Personnel exposure records shall be kept on permanent available file at the facility where the exposure occurs.

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
This rule was added based on concerns expressed during the first public hearing.
The rule will require that all CT facilities report any CT medical event.
Although not specified, all CT facilities should develop procedures for reporting CT medical events.
Much of the reporting criteria listed in the rule is from NRC’s 10 CFR Report and notification of a medical event.
Under this rule facilities will have 15 days to report a CT medical event to the Department.
The specific information that must be reported is outlined in the rule.
Specific information that cannot be included is also outlined in the rule.
Facilities will also need to notify the patient and the referring physician within 1 week of discovery.
After our last public hearing, we changed the patient and referring physician notification time from 24 hours to 1 week. This should allow facilities and medical physicists sufficient time to perform any necessary measurements and calculations.
Complaints that come from a referring physicians.
It will be up to the CT facility to investigate instances where a physician believes that a patient suffered damage to an organ or physiological system that was due to or suspected to be due to exposure to diagnostic radiation from their CT scanner.
If the CT facility determines that the CT scan was the cause or could have been the cause of the damage that needs to be reported.

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
With the assistance of a medical physicist, all CT facilities will need to establish a quality control program within 6 months after the effective date of these rules.
The requirements for a quality control program were written in a manner that provides facilities and medical physicists flexibility to design a program that best suits their needs.
The quality control program must include an evaluation of:
(a) Image quality. This was titled “Patient image quality” in draft 2.
(b) Patient radiation dose
(c) Personnel radiation protection
(d) Compliance with the provisions of this part
(e) Ongoing quality control
Evaluations and tests must be performed following written procedures and methods.
The medical physicist must specify corrective action procedures and facilities must document any action taken for results that fall outside the control limits.
The medical physicist will determine the frequency of each test and who may perform the test.
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.
Tests must be performed following written procedures and methods.
Recommendations for the ongoing QC evaluations come from ACR CT accreditation program.
(4) The ongoing quality control evaluation should include the following:
(a) Image quality, including the following:
(i) High-contrast resolution.
(ii) Low-contrast resolution.
(iii) Image uniformity.
(iv) Noise.
(v) Artifact evaluation.
(b) Alignment light accuracy.
(c) Slice thickness.
(d) CT number accuracy.
(e) Dose display devices.

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
This rule requires that an initial performance evaluation of the CT scanner be completed by a medical physicist before the CT scanner is used on patients
And then on an annual basis thereafter.
A calibrated dosimetry system shall be used to measure the radiation output of a CT scanner.
Dosimetry systems must be calibrated within the preceding 24 months and must be traceable to a national standard as specified in R  (2)(j).
As listed in the rule, recommendations for the performance evaluations are from ACR CT accreditation program.
The medical physicist must prepare a report for the facility that includes all of the following:
(a) A summary of the performance evaluation required under subrule (1) of this rule.
(b) Recommendations for necessary improvements, if any.
(c) Type of dosimetry system used, including the date of the last calibration.
(5) The report required under subrule (4) of this rule shall be provided to the CT facility within 30 days after completion of the evaluation.

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
This rule outlines what records and reports must be kept and for how long.
The rule also specifies that records and reports must be made available for review by the department.
Inspectors will examine the credentials of operators and medical physicists during our surveys.
Records of all current operators and physicists need to be kept current during employment.
Operators or physicists no longer employed, should be kept until the next examination following the employee’s termination has been completed and the department has determined that the facility is in compliance with the CT personnel requirements.
The department may decide to approve CT medical physicist as we do for mammography physicists. The department may also decide to inspect against a facilities procedures to ensure compliance with this rule. Meaning for large facilities with many operators we would ask the facility to explain their institutional requirements for CT operators, how they go about ensuring compliance with those requirements, and if those requirements meet the minimum standards of this rule. We would also review a portion of the credentials.
Reports of CT medical events must be maintained on file for at least 7 years.
Medical physicist survey reports must be maintained on file for at least 5 years.
Records of the results from the ongoing quality control program must be maintained on file for at least 2 years.

22. Summary Descriptive vs prescriptive Final? Stakeholder involvement
Thank you
Questions?
December 10, 2010
The goal of this rule set is to improve the safety and delivery of computed tomography services to the people of this state.
As mentioned we took a descriptive approach vs a prescriptive approach where we could.
This approach should allow facilities some flexibility in determining what approach is best for their facility.
Final?
We appreciate the amount of time stakeholders have put into this rule set and we appreciate the advice we received. Although we did not accept everything, we did address many of the concerns.
Thank you for inviting us to present this rule set.

23. Radiation Safety Section Contacts
Lansing
Phone: (517)
Fax: (517)
Website:
Detroit
Phone: (313)
Fax: (313) 23 23
December 10, 2010