Download BasisandPurposeAttachment2009-00806

STATEMENT OF BASIS AND PURPOSE
AND SPECIFIC STATUTORY AUTHORITY
FOR
AMENDMENTS TO THE COLORADO STATE BOARD OF HEALTH
RULES AND REGULATIONS PERTAINING TO RADIATION CONTROL
6 CCR 1007-1
Part 6, X-ray Imaging in the Healing Arts
Adopted by the State Board of Health on
October 21, 2009
Basis and Purpose
The Colorado Radiation Control Act, Title 25, Article 11, Colorado Revised Statutes (the Act),
requires the State Board of Health to formulate, adopt and promulgate rules and regulations
pertaining to radiation control.
Section 25-11-103 of the Act requires the Colorado Department of Public Health and
Environment (Department) to develop and conduct programs for evaluation and control of
hazards associated with the use of sources of ionizing radiation, including to require registration
of sources of ionizing radiation such as radiation machines and to issue licenses governing the
use of radioactive materials.
Section 25-11-104 of the Act requires Colorado’s radiation regulations to be modeled after the
Suggested State Regulations for Control of Radiation (SSRCR) of the Conference of Radiation
Control Program Directors, Inc., except when the Board of Health concludes, on the basis of
detailed findings, that a substantial deviation from the SSRCR is warranted. The Department’s
regulations, in certain parts, must also be compatible with the regulations adopted by the U.S.
Nuclear Regulatory Commission (NRC). The Act establishes the SSRCR as the model for
Colorado to use in adopting NRC regulatory provisions.
This amendment revises Part 6, X-rays in the Healing Arts. These changes comprise a major
revision of Part 6. Part 6 corresponds to SSRCR Part F, which is being revised in 2009.
These changes also update the rule format to conform to the Colorado Secretary of State
November 7, 2008 Code of Colorado Regulations Rules Styling Manual, version 5.2. The most
recent prior changes to Part 6 were adopted July 21, 1999, and became effective August 30,
1999.
Section 6.3 contains general requirements for use of x-rays in the healing arts, whether the
method used is film/screen (FS), computed radiography (CR), or digital radiography (DR), or a
hybrid technology. New Section 6.3 adds, similar to Section 7.21 for radioactive materials, a
general requirement to act upon, record and report any medical misadministration involving
radiation that is significant from a dose-risk point-of-view.
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This revised Part 6 attempts to bring existing requirements into better alignment with each other
and with radiation protection principles, for example, in the approach to assuring quality.
Avoiding needless repeat x-ray procedures was recognized as a serious radiation protection
matter a century ago. The provisions added to Part 6 are meant as a least common denominator
that is defensible at a minimum while assuring that technological innovation is not constrained.
For example, quality control for monitor images raises complex questions about how best to
avoid repeat exposures due to poor image quality.
Fluoroscopy, especially pediatric fluoroscopy, has emerged as presenting the greatest radiation
dose to the patient and practitioner, followed by some computed tomography methods and then
by other x-ray, dental, and veterinary practices. Report No. 160 of The National Council on
Radiation Protection and Measurements (NCRP) reports that in 2006 Americans were exposed to
more than seven times as much ionizing radiation from medical procedures as was the case in the
early 1980s. In 2006, medical exposure constituted nearly half of the total radiation exposure of
the U.S. population from all sources. According to Dr. Kenneth R. Kase, senior vice president of
NCRP and chairman of the scientific committee that produced Report No. 160, “The increase
was due mostly to the higher utilization of computed tomography (CT) and nuclear medicine.
These two imaging modalities alone contributed 36 percent of the total radiation exposure and 75
percent of the medical radiation exposure of the U.S. population.” The number of CT scans
performed in the U.S. during 2006 was estimated to be 67 million.
This revised Part 6 attempts to add flexibility that will enable Colorado’s qualified experts and
qualified inspectors to effectively and efficiently evaluate the performance and safety of newer
technologies. It has been clear for several years that difficulties have existed under the current
regulations in trying to keep up with the new detection, imaging and computational equipment,
especially in computed and digital radiography.
The requirement that radiation shielding be designed well is clarified. The roles of the facility
radiation safety officer, as required in Part 2 and prescribed Appendix 2A, are made explicit.
The special requirements for each modality are organized more logically into a sequence of five
sections: (1) administrative controls, (2) equipment design, configuration and preparation, (3)
radiation exposure control devices and operation, (4) measurements, maintenance, and records,
and (5) quality assurance program. This five-fold schema is followed in Section 6.3, “General
Requirements”, in Section 6.4, “Requirements for Safe Use of a Diagnostic X-ray Imaging
System of Any Kind”, and in special requirements sections for fluoroscopy (6.5), general purpose
x-ray imaging systems (6.6), dentistry (6.7), veterinary (6.8), computed tomography (6.9) and
mammography (6.10).
Appendix 6A, shielding evaluation information, and Appendix 6B, operator’s booth criteria, are
modified slightly. Appendix 6C, format and content of a shielding design, is added for use by a
qualified expert. Appendix 6D, when a radiation machine is unsafe, was Appendix 2C.
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SSRCR Part F provided new Appendix 6E, human use of portable hand-held x-ray equipment.
Appendix 6F, healings arts screening, is modified from previous Appendix C in Part 6.
The Department has worked closely with stakeholders throughout development of this Part 6.
The first stage was to assemble background information, to interview manufacturer
representatives about new systems and qualified inspectors about known problems with the rule,
then draft a proposed revised Part 6. The second stage was to meet individually and in focused
groups to further redraft Part 6 for presentation to a larger workshop for the whole affected
community. Three rounds of review by the Colorado medical physicist community have yielded
numerous suggestions for improvement. Only after these steps, and further feedback from
attentive publics and interested groups, has the Department brought Part 6 to a third stage of
public involvement, the Board discussion and hearing process.
The Colorado Radiation Advisory Committee approved the modified Part 6 at the June 3, 2009
meeting and approved further modifications at the October 7, 2009 meeting.
Because so many aspects of this Part 6 are being altered, the changes are presented item-by-item
at the end of this Statement of Basis and Purpose.
Specific Statutory Authority
These rules are promulgated pursuant to the provisions of CRS Sections 25-1-108 and
25-1.5-101(1)(l), and 25-11-104.
Major Factual and Policy Issues Encountered
As summarized above, these revisions correct and improve, both in substance and editorially, the
requirements for all registrants who use x-rays in the healing arts.
Alternative Rules Considered and Why Rejected
This revision to Part 6 of Colorado’s radiation regulations uses alternatives drawn from private
practitioners and inspectors, from federal and other state regulatory documents and experts, and
from internal staff logic and accuracy review. This revision is to conform to the Colorado
Secretary of State style manual and to maintain compatibility within the national framework of
FDA, NRC and the Suggested State Regulations for the Control of Radiation.
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The changes to Part 6 are (relatively more substantive items are in bold print):
1. The title of the Part is modified by deleting the word “Diagnostic”. Part 6 contains
provisions that apply broadly across uses of x-rays and imaging in the healing arts.
New equipment has weakened the distinction between diagnostic, therapeutic and
combined human uses of x-rays. Not included from Part F into the title to Part 6 is the
unnecessary word “systems”; x-ray systems are differentiated in the definitions section.
The title thus differs slightly from that the Suggested State Regulations for the Control of
Radiation (SSRCR) Part F, as last revised in 2001, being updated in 2009. Although
explicit inter-comparison with SSRCR Part F is not required by the Colorado
Radiation Control Act, cognate sections are mentioned for information in the items
below. As required by the Act, the reasoning is provided in this Basis and Purpose
document for provisions that deviate from the substance of the model state code.
2. For consistency between parts of the radiation regulations and with the Suggested State
Regulations for the Control of Radiation, the first section, Purpose and Scope, will now
include subsections designated 6.1.1, Authority, 6.1.2, Basis and Purpose, 6.1.3, Scope,
6.1.4, Applicability and 6.1.5, Published Material Incorporated by Reference. The
wording in the Scope and Applicability sections is modified from and not precisely
identical to SSRCR Section F.1. For example, as in the revised title of the part, the
adjective “diagnostic” is deleted before “x-ray equipment” in the Scope section.
In Colorado, healing arts is considered to apply both to humans and other animals,
so the phrase “or veterinary medicine” is deleted in 6.1.3.1. Explicit mention of other
applicable parts of the radiation regulations is added in 6.1.4.1 and 6.1.4.2, analogous to
SSRCR Section F.1.
3. An introductory sentence is added to Section 6.2, Definitions. A number of Colorado
refinements to definitions augment or are improved from and not precisely identical to the
definitions in SSRCR Section F.4.
4. Definitions of “bone densitometry system”, diagnostic imaging system” “HVL”,
“mammography modality”, “PBL”, “PID”, “portable x-ray equipment”, “primary
protective barrier”, “secondary protective barrier”, “secondary x-ray equipment”, “SID”,
“SSD”, “tomosynthesis” and “volumetric dental imaging system” are added. The phrase
“free in air” is added to the definition of “entrance exposure rate” to clarify applicability
to solid-state detectors. The definition of “healing arts screening” is improved.
5. The definition of “diagnostic x-ray imaging system” (now “diagnostic imaging system”)
is deleted because it is in Part 1 by virtue of being used in multiple parts of the Colorado
radiation regulations. The definition of “technique chart” is deleted as outdated and
replaced by usage related to exposure control settings.
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6. Definitions of “CT conditions of operation”, “CT gantry”, “dose profile”, “picture
element”, “reference plane”, “scan”, “tomographic plane”, and “tomographic section” are
moved to Section 6.2 from Section 6.9, Computed Tomography X-ray Systems.
Definitions of “computed tomography dose index”, “contrast scale”, “CTN number”,
“multiple tomogram system”, “nominal tomographic section thickness”, “scan
increment”, “scan sequence”, “scan time”, “single tomogram system” are deleted as no
longer needed.
7. Definitions of “established operating level”, facility”, “laterality”, “mammogram”,
“mammography”, “mammography phantom”, “mammography medical outcomes audit”,
and “standard breast” are moved to Section 6.2 from Section 6.10, Mammography.
Limitations expressed in the federal definition of “mammogram” are included as
regulatory provisions in 6.10.1.1. The slightly different definition of “facility” in Part 6
remains sufficiently compatible with the definition of “facility” in Part 1. The definition
of “mammography” is edited for clarity.
8. The definition of “field emission equipment” is edited slightly. The definition is in Part F
of the SSRCR and is only used in 6.6.3.3. The definition of “technique factor” is also
modified, as suggested by several medical physicists. The definition is only used in
6.6.3.4.
9. The definition of “x-ray equipment” is also modified to clarify that the operative
distinction is between stationary and non-stationary “mobile or portable”
equipment. Mobile x-ray equipment includes equipment designed to be transported from
place to place, including in a vehicle. Portable x-ray equipment includes equipment
designed to be hand-carried and handheld during use.
10. Section 6.3, “General Requirements”, is modified for logic and content. The former
head note, incorporating by reference the federal performance standards for
radiation machines, is moved to subsection 6.3.1.2, after the strong requirement that
each radiation machine be registered in Colorado is placed first in 6.3.1.1. The
wording of subsections 6.3.1.3 through improved and clarified, with some administrative
clauses formerly found elsewhere moved into sequence in 6.3.1. Subsection 6.3.1.5 was
clarified at the suggestion of the Colorado Medical Society in September 2009.
11. Section 6.3.2, “General Specifications for Facility and Equipment Design, Configuration
and Preparation”, strengthens and clarifies the requirements for a shielding design prior to
commencement of operation, or subsequently if warranted, for specified facilities.
Sections 6.3.2.2(1)(e) and also 6.7.3.2(2)(b)(i) are modified at the September 2009
suggestion of the Colorado Dental Association.
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12. Subsection 6.3.2.4 explicitly lists the types of equipment and floor plans that are exempt.
The concept of a “single occupancy room” is eliminated based on recent
improvements in equipment radiation safety. Dental section 6.7.2.2(3) reiterates this,
stating “As provided in 6.3.2.4, neither the shielding design described in 6.3.2 nor the
dimensional drawing, calculation or survey described in 6.3.2.3 are required for a room
using only intraoral or panoramic dental equipment.” Section 6.3.2.4 was further
clarified at the September 2009 suggestion of the Colorado Dental Association to
distinguish the exemption for an enclosed area in (1) from the exemption for an
open area (bay), where separation of another patient or treatment chair and of any
bystander is required.
13. Section 6.3.2.6 requires as-built drawings. An attestation that the shielding design was
followed is required after June 30, 2010, without exception. Based on a September
comment by a qualified inspector, 6.3.2.6 is further modified to be clear that what is
required is a signed statement that “all floor plan and equipment configuration
specifications in any applicable written shielding designs” have been followed. The
wording now tracks precisely with 6.3.2.1(1).
14. Section 6.3.3 iterates customary requirements for “General Radiation Safety and Control
of Radiation Exposure”, including written safety procedures and a protocol for technique
selection for each type of examination. Most of these requirements are carried forward
verbatim from those now in effect, but all are adapted to apply flexibly to the new types
of equipment developed over the past two decades.
15. Section 6.3.3.2 states “To reduce radiation exposure to the minimum that is necessary, the
registrant shall maintain a documented protocol for technique selection for each type of
examination performed by each x-ray imaging system.” As recommended by Colorado
medical physicists, the requirement to have on hand what was formerly called a
“technique chart” is made flexible for computed and digital radiography in
6.3.3.2(3).
16. Section 6.3.3.3 is clarified by using the phrases “human being” and “physician,
chiropractor, dentist or podiatrist who has a current active State of Colorado license”.
17. Sections 6.3.3.3(2) and 6.3.3.3(3) [formerly 6.3.1.1.11] specify requirements
applicable to healing arts screening, as prescribed in new Appendix 6F and 2.4.1.2.
18. Throughout 6.3.3.4 through 6.3.3.10, the wording of existing requirements is modified
and improved for clarity and flexibility with the new imaging modalities. The phrase
“image receptor” is substituted for “film or film-screen combination” to make clear
that computed radiography images and digital radiography images are covered by
these requirement as well as film-screen radiography.
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19. Section 6.3.3.6 requires gonad and thyroid shielding, except for a case in which
shielding would interfere with the diagnostic procedure.
20. A former requirement pertaining to mobile or portable x-ray equipment is removed.
The updated provisions in Part 6, specific to the type of equipment for stationary and nonstationary uses, provide sufficient radiation protection to remove the former stricture that
mobile and portable equipment be used only for examinations “where it is impractical to
transfer the patient(s) to a stationary x-ray installation, or when the mobile or portable
equipment is most suitable for the diagnostic procedure”.
21. Section 6.3.4, similarly to Section 6.3.3, carries forward existing requirements for
monitoring and recordkeeping from those now in effect, but all are adapted to apply
flexibly to both the older and newer types of equipment.
22. Section 6.3.5, general requirements pertaining to the facility quality assurance (QA)
program, is modified extensively. A QA program is to refer to manufacturer
specifications and/or the standards of an appropriate nationally recognized organization,
for example, the American College of Radiology (ACR) or American Association of
Physicists in Medicine (AAPM).
23. Subsection 6.3.5.2 now pertains to a “hard-copy imaging system with transmission
viewing, whether with or without liquid chemistry.” This is newer technology. Section
6.3.5.3 pertains to an automatic film processor. Sections 6.3.5.4 through 6.3.5.6 pertain to
manual film processing, darkroom lighting and film storage.
24. Subsection 6.3.5.7 is new. Based on AAPM Online Report OR-03 (2005), quality
criteria are recommended for monitors used in primary image interpretation.
This assurance of quality is necessary to limit repeated and/or rejected images, which lead
to undue radiation exposure. Section 6.3.5.8 specifies quality assurance for computed
radiography cassettes and cassette readers.
25. Section 6.4, “Requirements for Safe Use of a Diagnostic X-ray Imaging System of Any
Kind,” iterates certain long-standing equipment design, configuration and operating
requirements that apply to any radiation machine. Existing requirements are reworded and
rearranged without much substantive modification.
26. Section 6.5 pertains to fluoroscopy. Section 6.5.1 clarifies who is permitted to
supervise and use a fluoroscopic x-ray system. Subsections 6.5.1.2(1) and 6.5.1.2(3)
are modified to remove the word “dentist” since dentists are subject to self-standing
section 6.7 and do not use fluoroscopic radiation machines.
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27. Section 6.5.2 is strengthened to state in 6.5.2.1 that “only image-intensified or directdigital-receptor fluoroscopic equipment shall be used.” A few very old machines
hardly in use any longer are now precluded from use by this requirement.
Throughout Section 6.5.2, the federal requirements that became effective June 10, 2006
are incorporated, as well as editorial improvements such as changing the word “film” to
the phrase “image receptor”.
28. Section 6.5.3, radiation exposure control devices and operation in fluoroscopy, is edited
throughout, retaining and improving prior provisions and including any new 2006 federal
requirements. Subsections 6.5.3.1(2)(a), 6.5.3.1(3)(a) and 6.5.3.2(3) are also modified
by replacing the generic term “practitioner of the healing arts” by the more explicit
“physician, chiropractor, podiatrist or veterinarian”. Section 6.5.3.4 now contains the
requirements to limit scattered radiation that were previously in the section numbered
6.5.8. Section 6.5.3.5 makes explicit that overhead fluoroscopy shall not be used as a
positioning tool.
29. In Section 6.5.4 under measurement and maintenance requirements, requirements for the
key parameter source-skin distance (SSD) are grouped in 6.5.4.2 by type of equipment.
30. Subsection 6.5.4.4 makes clear that the existing requirement that the type, date and
patient information be kept is particularly important for fluoroscopy procedures.
31. Section 6.5.5 requires written quality assurance procedures and annual evaluation by a
registered medical physicist using the standards of nationally recognized organizations.
32. Section 6.5.6, “Radiation Therapy Simulation Systems”, is brought forward from former
6.5.9 with minor modifications.
33. Section 6.6 contains the special requirements for a general-purpose x-ray imaging system
used for other than fluoroscopy (6.5), dentistry (6.7), veterinary practice (6.8), computed
tomography (6.9) or mammography (6.10). Section 6.6.1.2 cross-references to the
applicable requirements for adequate radiation safety training and experience in 2.6.1.
34. Section 6.6.2 updates configuration requirements for machines with and without positive
beam limitation (PBL). These provisions were formerly Section 6.6.6. These existing and
enhanced requirements are now clarified and combined in a more concise and logical
sequence. The same is true for Section 6.6.3, which is edited and reformatted.
As innovation in radiation machines has occurred, requirements less needed for
radiation protection have been removed or modified and new requirements, for
instance related to digital images, have become necessary to avoid repeated and/or
rejected images, which cause undue exposure.
35. Section 6.6.5 requires a basic quality assurance program to national standards,
including specified routine periodic quality controls and an annual review.
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36. Former Section 6.7 is modified to encompass all dental radiation machines. This will
enable Colorado’s qualified inspectors to find the pertinent special requirements for
dental equipment in one place. A outdated cross-reference is removed from 6.7.1.1.
Protections are retained (see 6.7.2.1 and 6.7.3.1) for cephalometric and volumetric dental
x-ray imaging systems. Based on innovations in equipment radiation safety
performance, the Department has relaxed requirements for intraoral and
panoramic dental x-ray systems (see 6.7.2.2 and 6.7.3.2). The wording in 6.7.2.2(3)
was improved for clarity following the September 2009 public comment period.
37. Subsection 6.7.3.2(2) (b) (iii) provides that portable hand-held dental x-ray
equipment meet Appendix 6E.
38. Subsection 6.7.3.4 makes clear that a thyroid shield is to be used to reduce patient
exposure to scattered radiation, except for a case in which shielding would interfere
with the diagnostic procedure. New subsection 6.7.3.5 is added, moved from a design
requirement in 6.3.2.4 to the section containing operating requirements.
39. Section 6.7.4 simply states that maintenance for each dental x-ray imaging system shall
be to manufacturer specifications.
40. Section 6.7.5 requires a written QA program with annual review.
41. Section 6.8 pertains to veterinary radiation machine use. The section now brings
together for Colorado’s qualified inspectors the pertinent special requirements for
veterinary radiographic equipment in one place. Throughout Section 6.8, the
requirements are analogous to existing past provisions and to the basic radiation safety
requirements of 6.6 and 6.7. The wording 6.8.2.8 is shortened and improved following
the September 2009 public comment period.
42. Section 6.9 pertains to the safe use of a computed tomography system. Section 6.9.1 now
pertains to administrative controls (the definitions formerly in 6.9.1 were moved to 6.2.2).
As in the previous main sections, Section 6.9.2 pertains to equipment design and
configuration (edited slightly), Section 6.9.3 pulls together requirements for operating
procedures and radiation exposure control, including a new 6.9.3.1 for console
performance.
43. Section 6.9.4 pertains to the conduct of surveys, evaluations, calibrations and spot checks
in computed tomography. Subsection 6.8.4.1 was revised in September 2009 at the
request of several medical physicists. A radiation survey is required for any facility
modification and for any portable CT imaging system location. This requirement is in
Part F of the SSRCR and is separate from and in addition to 6.3.2.1(1). Subsection 6.9.4.2
makes explicit that CT dosimetry is to be by a registered medical physicist (RMP).
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44. Section 6.9.5 requires a QA program that follows manufacturer specifications and/or the
recommendations of a national organization or Colorado RMP.
45. Section 6.10 is for safe use of a mammography facility. The regulatory framework for
mammography is the most fully developed nationally of all radiation machine practices.
Since the 1990s Colorado’s requirements have followed closely and explicitly those
promulgated under the Mammography Quality Standards Act (MQSA). Subsection
6.10.1.4 states that any mammographer must meet the qualifications in Appendix 2M,
which exactly match those under MQSA. The modified or new wording in Section 6.10 is
for clarity or to strengthen the applicability of existing requirements to computed or
digital imaging systems used in mammography.
The Radiation Control Program seriously considered the suggestion by local
members of the American Association of Medical Physicists to significantly
streamline Section 6.10 by directly and solely referencing the technical criteria in
21 CFR 900. The Department radiation machine unit staff and Colorado Radiation
Advisory Committee on June 3, 2009, agreed to simply incorporate 21 CFR 900, the
national mammography standards and criteria, directly into Colorado’s radiation
regulations. Although the federal definition of mammography presently excludes
stereotactic biopsy procedures (this is expected to be rectified soon), Colorado will
continue to hold stereotactic biopsy and similar techniques to standards equivalent to
those of MQSA.
46. Appendix 6A regarding information for a shielding evaluation and Appendix 6B for an
operator’s booth are modified slightly from previous appendices.
47. Appendix 6C, standard format and content of a shielding design, is added for use by
a qualified expert.
48. Appendix 6D, criteria for classifying a radiation machine unsafe for routine human use, is
also modified slightly from that previously in effect as Appendix 2C in Part 2.
49. Section 6E.1.2.1 is reworded to make the exemption in 6.3.2.4(3) explicit.
50. SSRCR Part F is the basis for new Appendix 6E, human use of portable hand-held
x-ray equipment. The Colorado Radiation Advisory Committee on June 3, 2009,
recommended that a tripod or stand be required for all uses of hand-held x-ray
devices in Colorado. Subsequent public comment led to a modified and clarified
requirement that applies if a hand-held device cannot be held still by the operator.
51. Appendix 6F pertaining to healings arts screening, is modified from previous
Appendix C in Part 6. The fifteen items of information in the former appendix are
edited and expanded to twenty items. Also, based on September 2009 public comment,
6F.1.12, 6F.1.13 and 6F.1.14 were modified to correspond to 6.3.3.3 more clearly.
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