25 TAC §289.230
The Texas Department of Health (department) adopts an amendment
to §289.230 concerning certification of mammography systems and accreditation
of mammography facilities with changes to the proposed text as published in
the October 5, 2001, issue of the
Texas Register
(26 TexReg 7780), and in a correction of error published in the November
2, 2001, issue of the
Texas Register
(26 TexReg
8888), as a result of comments received during the 30-day comment period.
The revision incorporates equipment standards in the United States Food
and Drug Administration (FDA) rules that implement the Mammography Quality
Standards Act (MQSA) found in Title 21, Code of Federal Regulations (CFR),
Part 900. These become effective October 28, 2002 and include compression
and compression device performance, automatic exposure control, focal spot
condition testing, and radiation output. In addition, the revision contains
new definitions, revises requirements for backup processors, and clarifies
the physicist's requirements for annual surveys on mammography machines and
stereotactic biopsy machines. Qualifications for technologists performing
exams for invasive interventions for localizations or biopsies have been changed,
and requirements for continuing education and experience were added for this
modality. Requirements for suspension of an accreditation were included, and
the requirement to post the address where complaints may be filed was deleted.
The revision also includes increased fees for accreditation as well as new
fees associated with the accreditation process. These fees are the result
of increased costs, including those from the American College of Radiology
for reviewing clinical images. References were updated and minor clarifying
language was added throughout the rule In Figure: 25 TAC §289.230(nn)(3),
the time interval for keeping medical physicist continuing education and experience
documentation in (f)(3)(C) changed from two years to six years; the reference
for FDA variances changed to (g)(14) from (g)(15); and the name of the record
in (s)(7) changed to mammography machines from mammographic machines. Other
minor grammatical changes were made to the section for clarification. This
amendment is part of the department's continuing effort to update, clarify,
and simplify its rules regarding the control of radiation based upon technological
advances, public concerns, legislative directives, or other factors.
Government Code §2001.039 requires that each state agency review and
consider for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). Section 289.230 has been
reviewed and the department has determined that the reasons for adopting the
section continue to exist; however, revisions to the rule are necessary.
The department published a Notice of Intention to Review for §289.230
as required by Government Code §2001.039 in the
Texas Register
(26 TexReg 2201) on March 16, 2001. No comments were
received by the department on this section.
The department is making the following changes due to staff comments to
clarify the intent and improve the accuracy of the section.
Change: Concerning proposed §289.230(c)(33), the department revised
the definition to clarify that the qualifications are established by the accreditation
body and the accreditation body's qualifications are approved by the FDA.
Change is reflected in §289.230(c)(32).
Change: Concerning §289.230(g)(5)(C), the department added the words,
"after the exposure, the target material and/or focal spot actually used during
the exposure" to the end of the subparagraph. The words were inadvertently
removed in the proposed version.
Change: Concerning §289.230(g)(14), the department deleted "(b)" from
the citation, "Title 21, CFR, §900.18(b)" to correct the citation.
The following comments were received concerning the proposed section. Following
each comment is the department's response and any resulting change(s).
Comment: Concerning proposed §289.230(a)(2), a commenter stated that
dropping the words "a license in good standing" at the end of the sentence,
reduces the standards to be met by physicians to a level below that implied
by the definition of physician in §289.231.
Response: A "license in good standing" is a determination that is made
by the licensing board issuing the license, not the department. No change
was made as a result of the comment.
Comment: Concerning proposed §289.230(c)(4), one commenter suggested
the agency remove the range from this definition to allow more flexibility.
Response: The department agrees and deleted the range.
Comment: Concerning proposed §289.230(c)(4), one commenter suggested
the department remove the range in the number of images from this definition
and replace it with the words, "typically will consist of 30 sets of clinical
images," since this is the number suggested by the image reviewers.
Response: The department agrees to delete the range but disagrees with
replacing it with the suggested wording. The department (accreditation body)
makes the determination on the number of images reviewed and not the image
reviewers. No change was made as a result of the comment.
Comment: Concerning proposed §289.230(c)(4)(A), one commenter indicated
that replacing the word "and" with the word "or" would allow the department
to review images and interpretations and in other cases, images only.
Response: The department agrees and made the change.
Comment: Concerning proposed §289.230(c)(9), one commenter stated
that the second sentence goes beyond a definition to establish a standard.
The commenter suggested that this be incorporated into subsection §289.230(l)(1)(B)
of this section. The commenter further indicated that "operating parameters"
is not defined, leaving the term open to interpretation.
Response: The department agrees and deleted the sentence. The department
replaced the words "operating parameters" with "operating levels." Change
is reflected in subsection §289.230(l)(1)(B).
Comment: Concerning proposed §289.230(c)(15), one commenter indicated
that as background for other comments to follow, the Texas Health and Safety
Code referenced in this definition clearly states that to obtain a state certificate,
the facility must meet "at a minimum, the requirements for certification of
the Mammography Quality Standards Act (MQSA) of 1992." The commenter further
stated that the situations noted in comments to follow are less stringent
than the MQSA requirements and therefore not in compliance with Texas's own
law.
Response: The department disagrees and believes that the rules meet the
requirements. No change was made to the definition as a result of the comment.
Comment: Concerning proposed §289.230(c)(19), one commenter suggested
that this definition is redundant as it only provides examples of direct instruction
as defined in proposed §289.230(c)(23).
Response: The department agrees and deleted the definition. Subsequent
definitions were renumbered. Change is reflected in §289.230(c)(19) through
(c)(56).
Comment: Concerning proposed §289.230(c)(20), one commenter suggested
that the department's definition, while used in the same manner as the American
Medical Association (AMA), was defined in 1968 by the United States Department
of Education, then Bureau of Education, as 1/10 of a clock hour. The department
(and AMA) use one clock hour as equal to one continuing education unit (CEU).
The commenter suggests the department change the definition to be consistent
with the U.S. Department of Education's definition.
Response: The department disagrees as the department's definition is consistent
with the MQSA rules. No change was made as a result of the comment.
Comment: Concerning proposed §289.230(c)(20), one commenter indicated
that dropping the word "contact" from this definition of "continuing education
unit" breaks the connection between this term and the terms "contact hour"
and "direct instruction." Without this connection, the Texas regulations would
permit the use of training that is not acceptable under the MQSA regulations
to meet the MQSA personnel standards.
Response: The department agrees and reinserted the word "contact." Change
is reflected in §289.230(c)(19).
Comment: Concerning proposed §289.230(c)(27), one commenter suggested
that this definition be changed to include the American College of Radiology's
language as opposed to the language in the MQSA rules.
Response: The department disagrees as our rules must be consistent with
the MQSA rules. No change was made as a result of the comment.
Comment: Concerning proposed §289.230(c)(29), one commenter questioned
how "direct instruction activities" differ from "direct instruction."
Response: The department agrees and deleted the word "activities" for clarification.
Change is reflected in §289.230(c)(28).
Comment: Concerning proposed §289.230(c)(33), one commenter indicated
that the term "review physician" used in this definition is now a defined
term in the MQSA regulations and should be added to the Texas regulations.
Response: The department agrees and added the definition. Change is reflected
in §289.230(c)(59).
Comment: Concerning proposed §289.230(c)(41), one commenter suggested
adding "full-field digital mammography" as an example in the definition.
Response: The department agrees and added the suggested language and also
deleted "xeromammography," a modality no longer used in the United States.
Change is reflected in §289.230(c)(40).
Comment: Concerning proposed §289.230(c)(44), one commenter indicated
they do not object to changing "unit" to "machine," but stated that this does
not correspond to the terminology in the Health and Safety Code.
Response: The department agrees and added clarifying language to make the
rule consistent with the Radiation Control Act. Change is reflected in §289.230(c)(43)
and §289.230(c)(57).
Comment: Concerning proposed §289.230(c)(58), one commenter questioned
having this definition as it is not used in rule.
Response: The department agrees and deleted the definition and the subsequent
definition is renumbered. Change is reflected in §289.230(c)(58).
Comment: Concerning proposed §289.230(c)(59) and the use of the word
"accreditation," one commenter made reference to the definition in §289.230(c)(1),
and suggests the words "approval of a mammography facility" are used incorrectly.
Response: The department acknowledges the comment, however, §289.230(c)(1)
was not open for comment. The department will consider this comment in future
rulemaking.
Comment: Concerning §289.230(c)(66), one commenter suggested modifying
this definition by revising the second sentence to read: "The review may be
performed due to a serious complaint or a severe item of non-compliance."
Response: The department agrees and added the word "serious" before complaint
and the words " a severe" before "item."
Comment: Concerning proposed §289.230(c)(68), one commenter was concerned
about the words "some or all" in this definition. The commenter indicates
that it appears that this definition is not used in the Texas regulations.
Response: The department agrees and has removed the definition and the
subsequent definition is renumbered. The term was used in a previous version
of §289.230 and inadvertently left in place when the rule was revised.
Change is reflected in §289.230(c)(68).
Comment: Concerning proposed §289.230(d)(3)(A), one commenter was
concerned with the language exempting mammography examinations performed under
the direct supervision of a fully qualified medical radiologic technologist.
Response: The department agrees and has deleted the language.
Comment: Concerning proposed §289.230(f)(1)(D)(i), one commenter stated
that the language "in accordance with subparagraph (C)(i) of this paragraph"
creates an internal conflict within the Texas regulations and will make the
revised regulations significantly less stringent than the MQSA regulations.
Response: The department agrees and has deleted the language.
Comment: Concerning proposed §289.230(f)(1)(D)(ii)(II), one commenter
stated that the language "in accordance with subparagraph (C)(ii) of this
paragraph" creates an internal conflict within the Texas regulations and will
make the revised regulations significantly less stringent than the MQSA regulations.
Response: The department agrees and has deleted the language.
Comment: Concerning proposed §289.230(f)(2)(B), one commenter was
concerned that the "Personnel Checklist" that is used by the State of Texas
Accreditation Body has revealed a deficiency. The commenter suggests that
the rule be revised so that subsequently the "Personnel Checklist" may be
revised.
Response: The department acknowledges the comment; however, §289.230(f)(2)(B)
was not open for comment. The department will consider this comment in future
rulemaking.
Comment: Concerning proposed §289.230(f)(2)(D)(i), one commenter stated
that the language "in accordance with subparagraph (C)(i) of this paragraph"
creates an internal conflict within the Texas regulations and will make the
revised regulations significantly less stringent than the MQSA regulations.
Response: The department agrees and has deleted the language.
Comment: Concerning proposed §289.230(f)(3)(A)(i), one commenter was
pleased that the department revised this clause in a previous draft.
Response: The department acknowledges the comment and made no change to
the rule as a result of the comment.
Comment: Concerning proposed §289.230(f)(3)(D)(i), one commenter stated
that the language "in accordance with subparagraph (C)(i) of this paragraph"
creates an internal conflict within the Texas regulations and will make the
revised regulations significantly less stringent than the MQSA regulations.
Response: The department agrees and has deleted the language.
Comment: Concerning proposed §289.230(f)(3)(D)(ii), one commenter
stated that the language "in accordance with subparagraph (C)(ii) of this
paragraph" creates an internal conflict within the Texas regulations and will
make the revised regulations significantly less stringent than the MQSA regulations.
Response: The department agrees and has deleted the language.
Comment: Concerning proposed §289.230(g)(14), one commenter stated
that the language "meets the requirements for the alternatives to the quality
standards" implies that no action by the FDA is necessary for the alternative
to be in effect. The commenter suggested changing the words after the citation
"1020.31" to "or has had an alternative for a quality standard for equipment
approved by the FDA under the provisions of Title 21, CFR, 900.18(b), shall
maintain copies of those variances or alternative standards."
Response: The department agrees and has added the suggested language.
Comment: Concerning proposed §289.230(l)(1)(B), two commenters had
concerns with the language regarding the backup processor, including certain
testing "before being used initially as a backup processor," and the requirement
to "meet the requirements of subparagraph (A) for a minimum of five days to
establish operating parameters." In addition, one commenter stated that it
is not clear that the processor must meet the requirements for the whole period
and not just the five days.
Response: The department agrees and has added clarifying language
Comment: Concerning proposed §289.230(l)(1)(B), one commenter stated
that this subparagraph does not indicate that the processor "be adjusted and
maintained to meet the technical development specifications for the mammography
film in use."
Response: The department disagrees. The requirement to meet the technical
development specifications for the mammography film in use is delineated in
current §289.230(l)(1)(A). No change was made as a result of the comment.
Comment: Concerning proposed §289.230(l)(2), one commenter questioned
if it was the department's intent that the second added sentence say that
if no mammography is performed within any given seven-day period, this test
does not have to be performed. The commenter further stated that as written,
it does not negate the requirement to perform the test in every seven-day
interval, even if mammography is not performed in that interval. A second
commenter questioned the requirement for performing a phantom test.
Response: The department agrees and has added clarifying language.
Comment: Concerning proposed §289.230(l)(2), one commenter suggested
that a two or three-day time limit beyond the week be allowed for greater
flexibility in performing the test.
Response: The department disagrees with adding a two or three-day time
limit beyond the week. The rule is consistent with the MQSA rule; however,
the department has added clarifying language for better understanding.
Comment: Concerning proposed §289.230(l)(3), one commenter suggested
that a one-week time limit beyond the quarter be allowed for greater flexibility
in performing the tests.
Response: The department acknowledges the comment; however, §289.230(l)(3)
was not open for comment. The department will consider this comment in future
rulemaking.
Comment: Concerning proposed §289.230(l)(4), one commenter suggested
that a one or two-week time limit beyond the six month period be allowed for
greater flexibility in performing the tests.
Response: The department disagrees with adding a one or two-week time limit
beyond the six- month period. The rule is consistent with the MQSA rule; however,
the department has deleted language for clarification.
Comment: Concerning proposed §289.230(l)(5), one commenter suggested
that a two-month time limit beyond the 12 month period be allowed for greater
flexibility in performing the tests.
Response: The department disagrees with adding a two-month time limit beyond
the 12-month period. The rule is consistent with the MQSA rule; however, the
department has deleted language for clarification.
Comment: Concerning proposed §289.230(l)(8), one commenter indicated
that Texas has changed units to machines everywhere in this provision except
in the title.
Response: The department agrees and has changed the title.
Comment: Concerning proposed §289.230(l)(9)(B) and (C), one commenter
suggested that Texas should consider streamlining these provisions.
Response: The department acknowledges the comment, however, the department
believes the proposed language clarified the provisions. No change was made
as a result of the comment.
Comment: Concerning proposed §289.230(l)(10)(C), one commenter suggested
that if Texas streamlines the provisions in §289.230(l)(9)(B) and (C),
then this subparagraph will need to be changed.
Response: The department acknowledges the comment. There were no changes
added to §289.230(l)(9)(B) and (C). No change was made as a result of
the comment.
Comment: Concerning proposed §289.230(q)(5)(A), one commenter stated
that the department offers two pathways for technologists to perform interventional
breast procedures. The commenter suggests that all technologists performing
interventional studies should be qualified mammographers under MQSA and have
initial training and experience in these studies. In addition, the commenter
suggested that current experience in mammography is required to assist in
determining the location of the lesion and whether additional mammographic
views are necessary before the biopsy.
Response: The department disagrees with the comments. The department allows
Texas-certified medical radiologic technologists and Texas-certified mammography
technologists, qualified under MQSA, to perform these procedures under certain
criteria. Technologists working in mammography facilities could meet the requirements
suggested by the commenter; however, those working in surgical centers that
perform only interventional procedures do not have opportunities to perform
routine diagnostic mammography and therefore could not meet the requirements.
In addition, interventional procedures are not used for diagnosis and the
ultimate responsibility of locating the lesion for biopsy is that of the physician.
The department has included criteria to address both situations. The MQSA
rules do not address interventional mammography. No change was made as a result
of the comments.
Comment: Concerning proposed §289.230(q)(6), one commenter suggested
that physicists performing tests on systems used for invasive interventions
should have appropriate initial experience, continuing experience, and continuing
education that is specific to systems used for invasive interventions.
Response: The department disagrees with the comments. Tests performed on
systems used for invasive interventions are similar to those used for diagnostic
mammography systems. In addition, the MQSA rules do not address interventional
mammography procedures or any additional training for physicists for these
procedures. No change was made as a result of the comments.
Comment: Concerning proposed §289.230(t), one commenter suggested
using "Certification of mammography systems (state certification)" to distinguish
between state certification and MQSA certification.
Response: The department agrees and has added the clarifying language.
Comment: Concerning proposed §289.230(w)(4)(D), one commenter stated
that they are assuming that this subparagraph is referring to experimental
machines being used under an Investigational Device Exemption (IDE), and if
this is the case and the facility has a FDA 510K approval, they would not
need an IDE. The commenter further stated that the facility will have little
documentation directly from FDA showing they were part of an approved clinical
trial, but should have documentation from the sponsor of the trial for reference.
Response: The department agrees and has deleted the requirement to submit
a copy of the 510K approval to the agency.
Comment: Concerning proposed §289.230(w)(4)(E), one commenter questioned
whether the "or evaluation periods of 60 days or less" should be "for evaluation
periods of 60 days or less."
Response: The department disagrees as the proposed statement is correct.
No change was made as a result of the comment.
Comment: Concerning proposed §289.230(dd)(1), one commenter stated
that the inclusion of §289.231(d) is inappropriate and would make the
Texas regulations less stringent than the MQSA requirements.
Response: The department agrees and has deleted the requirement.
Comment: Concerning proposed §289.230(dd)(2)(E)(iii), one commenter
stated that a survey involves review of the facility's quality assurance program
and the conduct of testing involved. A mammography equipment evaluation requires
performing only the tests that apply to the machine or processor that is being
installed, reassembled, or having major components changed or repaired and
a review of the quality assurance program is not required. The commenter further
stated that a new facility seeking accreditation cannot perform a survey because
there will be no quality control program results to review. Also, this does
not address a Texas accredited facility wishing to be reaccredited by Texas.
Response: The department agrees and has added "and/or" to the requirement
in this clause. The department has also added a requirement that addresses
a Texas accredited facility wishing to be reaccredited by Texas. Change is
reflected in §289.230(dd)(2)(E)(iii)(III). The department deleted the
"or" at the end of subclause (I) and added an "or" at the end of subclause
(II) for grammatical correctness.
Comment: Concerning proposed §289.230(jj)(1)(A), the commenter indicated
that the subparagraph states that "any application for accreditation may be
denied by the agency when the applicant fails to meet established criteria
for accreditation." The commenter questioned what constitutes "established
criteria" and states that a facility will be accredited if it meets the requirements
of §289.230(dd) and (ee). The commenter further stated that §289.230
(ee) deals with payment of fees and §289.230(dd) requires passing the
image reviews and dose requirements and the department does not address personnel."
Response: The department disagrees with the comment. The criteria is delineated
in §289.230(dd) and includes personnel requirements. The department has
added the words "in accordance with subsection (dd) of this section" for clarification.
Comment: Concerning proposed §289.230(nn)(3), one commenter stated
that the time intervals on some items are excessive and place an unreasonable
and unnecessary burden on a facility. Specific examples are the requirement
to maintain personnel continuing education and experience records for six
years when MQSA inspectors review this material annually. The commenter suggested
that since continuing experience is averaged over two years and continuing
education is averaged over three years, a three-year interval is reasonable
for maintaining the records. The commenter further stated that maintaining
a physicist's report for seven years is likewise excessive. In addition, the
commenter stated that since the "Mammography Equipment Evaluation" was intended
to serve as an "acceptance test" of new equipment, and establishes a baseline
for all of the tests conducted during the annual physicist's annual survey,
that this record be maintained "until termination of certification or replacement
of the unit" instead of two years.
Response: The department disagrees with the comments. Time periods are
reasonable and appropriate based on the experience of inspections and the
movement of personnel between facilities. Time intervals for maintaining physicist
reports are required by state statute. No change was made as a result of the
comments.
Comment: Concerning proposed §289.230(nn)(3), one commenter suggested
clarifying the name of the record referenced in §289.230(cc)(10) to read
"Written procedures for patient notification," instead of "Patient notification."
The commenter further recognized that maintaining copies of all patient lay
letters is an undue burden on facilities and could possibly overtax normal
facility filing resources.
Response: The department disagrees with the comment. The commenter has
misunderstood what this subsection addresses. It does not address patient
lay letters but inspections and patient notification in the event a facility
failed to meet the department's certification standards and continued to perform
mammography. No change was made as a result of the comment.
Commenters included representatives from the American College of Radiology,
the United States Food and Drug Administration, Baylor College of Medicine,
and the Texas Higher Education Coordinating Board. The commenters were neither
for nor against the rule in its entirety; however, they raised questions,
expressed concerns, and offered suggestions for changes to the proposal as
discussed in the summary of the comments.
The amendment is adopted under the Health and Safety Code, Chapter
401.051, which provides the Texas Board of Health (board) with the authority
to adopt rules and guidelines relating to the control of radiation; and §12.001,
which provides the board the authority to adopt rules for its procedures and
for the performance of each duty imposed by law on the board, the department,
or the commissioner of health.
§289.230.Certification of Mammography Systems and Accreditation of Mammography Facilities.
(a)
Purpose.
(1)
This section provides for the certification of mammography
systems and the accreditation of mammography facilities. No person shall use
x-ray producing machines for mammography of humans except as authorized in
a state certification of mammography systems issued by the agency in accordance
with the requirements of this section and in a certificate issued by the United
States Food and Drug Administration (FDA).
(2)
The use of all mammography machines certified in accordance
with this section shall be by or under the supervision of a physician licensed
by the Texas State Board of Medical Examiners.
(b)
Scope. In addition to the requirements of this section,
all registrants are subject to the requirements of §289.203 of this title
(relating to Notices, Instructions, and Reports to Workers; Inspections), §289.204
of this title (relating to Fees for Certificates of Registration, Radioactive
Material Licenses, Emergency Planning and Implementation, and Other Regulatory
Services), §289.205 of this title (relating to Hearing and Enforcement
Procedures), §289.226 of this title (relating to Registration of Radiation
Machine Use and Services), and §289.231 of this title (relating to General
Provisions and Standards for Protection Against Machine-Produced Radiation.
This section does not apply to an entity under the jurisdiction of the federal
government.
(c)
Definitions. The following words and terms, when used in
this section, shall have the following meaning unless the context clearly
indicates otherwise.
(1)
Accreditation--An approval of a mammography facility by
an accreditation body.
(2)
Accreditation body--An entity approved by the FDA under
Title 21, Code of Federal Regulations (CFR), Part 900.3(d) to accredit mammography
facilities.
(3)
Action limit--The minimum or maximum value of a quality
assurance measurement representing acceptable performance. Values less than
the minimum or greater than the maximum action limit indicate that corrective
action must be taken by the facility.
(4)
Additional mammography review--At the request of the FDA
or an accreditation body, a review by the accreditation body of clinical images
and other relevant facility information necessary to assess conformation with
the accreditation standards. The reviews include the following:
(A)
additional mammography review with interpretation; or
(B)
additional mammography review without interpretation.
(5)
Adverse event--An undesirable experience associated with
mammography activities within the scope of this section. Adverse events include
but are not limited to:
(A)
poor image quality;
(B)
failure to send mammography reports within 30 days to the
referring physician or in a timely manner to the self-referred patient; and
(C)
use of personnel who do not meet the applicable requirements
of subsection (f) of this section.
(6)
Air kerma--The kerma in a given mass of air. The unit used
to measure the quantity of air kerma is the Gray (Gy). For x-rays with energies
less than 300 kiloelectronvolts (keV), 1 Gy = 100 rad. In air, 1 Gy of absorbed
dose is delivered by 114 roentgens (R) of exposure.
(7)
Automatic exposure control (AEC)--A device that automatically
controls one or more technique factors in order to obtain at preselected locations
a required quantity of radiation.
(8)
Average glandular dose--The value in millirad (mrad) or
milligray (mGy) for a given breast or phantom thickness that estimates the
average absorbed dose to the glandular tissue extrapolated from free air exposures
and based on fixed filter thickness and target material.
(9)
Backup processor--A processor used to develop mammograms
when the processor commonly in use for mammography is out of service.
(10)
Beam-limiting device--A device that provides a means to
restrict the dimensions of the x-ray field.
(11)
Breast implant--A prosthetic device implanted in the breast.
(12)
Calendar quarter--Any one of the following time periods
during a given year: January 1-March 31, April 1-June 30, July 1-September
30, or October 1-December 31.
(13)
Calibration of instruments--The comparative response or
reading of an instrument relative to a series of known radiation values over
the range of the instrument.
(14)
Category I continuing medical education units (CMEU)--Educational
activities designated as Category I and approved by the Accreditation Council
for Continuing Medical Education, the American Osteopathic Association, a
state medical society, or an equivalent organization.
(15)
Certification of mammography systems (state certification)--A
form of permission given by the agency to an applicant who has met the requirements
for mammography system certification set out in the Texas Radiation Control
Act, Health and Safety Code, Chapter 401 (Act) and this chapter.
(16)
Clinical image--See the definition for mammogram.
(17)
Consumer--An individual who chooses to comment or complain
in reference to a mammography examination. The individual may be the patient
or a representative of the patient, such as a family member or referring physician.
(18)
Contact hour--An hour of training received through direct
instruction.
(19)
Continuing education unit (CEU)--One contact hour of training.
(20)
Control panel--That part of the radiation machine control
upon which are mounted the switches, knobs, push buttons, and other hardware
necessary for manually setting the technique factors.
(21)
Dedicated mammographic equipment--Equipment that has been
specifically designed and manufactured for mammography.
(22)
Direct instruction--Instruction that includes:
(A)
face-to-face interaction between instructor(s) and student(s),
as when the instructor provides a lecture, conducts demonstrations, or reviews
student performance; or
(B)
the administration and correction of student examinations
by an instructor(s) with subsequent feedback to the student(s).
(23)
Direct supervision--Oversight of operations that include
the following.
(A)
During joint interpretation of mammograms, the supervising
interpreting physician reviews, discusses, and confirms the diagnosis of the
physician being supervised and signs the resulting report before it is entered
into the patient's record.
(B)
During performance of a mammography examination, the supervising
medical radiologic technologist is present to observe and correct, as needed,
the individual who is performing the examination.
(C)
During performance of a survey of the registrant's equipment
and quality assurance program, the supervising medical physicist is present
to observe, and correct, as needed, the individual who is conducting the survey.
(24)
Established operating level--The value of a particular
quality assurance parameter that has been established as an acceptable normal
level by the registrant's quality assurance program.
(25)
Facility--A hospital, outpatient department, clinic, radiology
practice, mobile unit, an office of a physician, or other person that conducts
breast cancer screening or diagnosis through mammography activities, including
any or all of the following:
(A)
the operation of equipment to produce a mammogram;
(B)
processing of film;
(C)
initial interpretation of the mammogram; or
(D)
maintaining the viewing conditions for that interpretation.
(26)
Final assessment categories--The overall final assessment
of findings in a report of a mammography examination, classified in one of
the following categories:
(A)
"negative" indicates nothing to comment upon (if the interpreting
physician is aware of clinical findings or symptoms, despite the negative
assessment, these shall be explained);
(B)
"benign" is also a negative assessment;
(C)
"probably benign" indicates a finding(s) that has a high
probability of being benign;
(D)
"suspicious" indicates a finding(s) without all the characteristic
morphology of breast cancer but indicating a definite probability of being
malignant;
(E)
"highly suggestive of malignancy" indicates a finding(s)
that has a high probability of being malignant; or
(F)
"incomplete" indicates there is a need for additional imaging
evaluation. Reasons why no assessment can be made shall be stated by the interpreting
physician.
(27)
First allowable time--The earliest time a resident physician
is eligible to take the diagnostic radiology boards from an FDA-designated
certifying body.
(28)
Formal training--Attendance and participation in direct
instruction . This does not include self-study programs.
(29)
Half-value layer (HVL)--The thickness of a specified material
that attenuates the beam of radiation to an extent such that the exposure
rate is reduced to one-half of its original value. In this definition, the
contribution of all scattered radiation, other than any that might be present
initially in the beam concerned, is deemed to be excluded.
(30)
Healing arts--Any system, treatment, operation, diagnosis,
prescription, or practice for the ascertainment, cure, relief, palliation,
adjustment, or correction of any human disease, ailment, deformity, injury,
or unhealthy or abnormal physical or mental condition.
(31)
Image receptor--Any device, such as a fluorescent screen
or radiographic film, that transforms incident x-ray photons either into a
visible image or into another form that can be made into a visible image by
further transformations.
(32)
Image review board--A group of qualified review physicians
and other individuals who review the clinical and phantom images and whose
qualifications have been established by the accreditation body and the accreditation
body's qualifications have been approved by the FDA.
(33)
Institutional review board (IRB)--Any board, committee,
or other group formally designated by an institution to review, approve the
initiation of, and conduct periodic review of biomedical research involving
human subjects.
(34)
Interpreting physician--A licensed physician who interprets
mammographic images and who meets the requirements of subsection (f)(1) of
this section.
(35)
Kerma--The sum of the initial energies of all the charged
particles liberated by uncharged ionizing particles in a material of given
mass.
(36)
Laterality--The designation of either the right or left
breast.
(37)
Lead interpreting physician--The interpreting physician
assigned the general responsibility for ensuring that a facility's quality
assurance program meets all of the requirements of subsections (k), (l), and
(m) of this section.
(38)
Mammogram--A radiographic image produced through mammography.
(39)
Mammography--The use of x-radiation to produce an image
of the breast that may be used to detect the presence of pathological conditions
of the breast. For the purposes of this section, mammography does not include
radiography of the breast performed as follows:
(A)
during invasive interventions for localization or biopsy
procedures except as specified in subsection (q) of this section; or
(B)
with an investigational mammography device as part of a
scientific study conducted in accordance with FDA's investigational device
exemption regulations.
(40)
Mammographic modality--A technology for radiography of
the breast. Examples are screen-film mammography and full-field digital mammography
.
(41)
Mammography medical outcomes audit--A systematic collection
of mammography results compared with outcomes data.
(42)
Mammography system--A system that includes the following:
(A)
an x-ray machine used as a source of radiation in producing
images of breast tissue;
(B)
an imaging system used for the formation of a latent image
of breast tissue;
(C)
an imaging processing device for changing a latent image
of breast tissue to a visual image that can be used for diagnostic purposes;
(D)
a viewing device used for the visual evaluation of an image
of breast tissue if the image is produced in interpreting visual data captured
on an image receptor;
(E)
a medical radiologic technologist who performs mammography;
and
(F)
a physician who engages in, and who meets the requirements
of this section relating to the reading, evaluation, and interpretation of
mammograms.
(43)
Mammography machine(s)--A unit consisting of components
assembled for the production of x-rays for use during mammography. These include,
at a minimum, the following:
(A)
an x-ray generator;
(B)
an x-ray control;
(C)
a tube housing assembly;
(D)
a beam limiting device; and
(E)
supporting structures.
(44)
Mean optical density--The average of the optical densities
measured using phantom thicknesses of 2, 4, and 6 centimeters (cm) with values
of kilovolt peak (kVp) clinically appropriate for those thicknesses.
(45)
Medical physicist--An individual who performs surveys
and evaluations of mammographic equipment in accordance with this section
and who meets the qualifications in subsection (f)(3) of this section.
(46)
Medical radiologic technologist (operator of equipment)--An
individual specifically trained in the use of radiographic equipment and the
positioning of patients for radiographic examinations, who performs mammography
examinations in accordance with this section and who meets the qualifications
in subsection (f)(2) of this section.
(47)
Mobile services--The use of mammography machines in temporary
locations for limited time periods. The mammography machines may be fixed
inside a mobile van or transported to temporary locations.
(48)
Multi-reading--Two or more physicians interpreting the
same mammogram. At least one physician shall be qualified as an interpreting
physician.
(49)
Optical density (OD)--A measure of the fraction of incident
light transmitted through a developed film and defined by the equation:
Figure: 25 TAC §289.230(c)(49)
(50)
Patient--Any individual who undergoes a mammography examination
in a facility, regardless of whether the person is referred by a physician
or is self-referred.
(51)
Phantom--A test object used to simulate radiographic characteristics
of compressed breast tissue and containing components that radiographically
model aspects of breast disease and cancer. The phantom shall be accepted
by FDA.
(52)
Phantom image--A radiographic image of a phantom.
(53)
Physical science--This includes physics, chemistry, radiation
science (including medical physics and health physics), and engineering.
(54)
Positive mammogram--A mammogram that has an overall assessment
of findings that are either "suspicious" or "highly suggestive of malignancy."
(55)
Qualified instructor--An individual whose training and
experience prepares him or her to carry out specified training assignments.
Interpreting physicians, medical radiologic technologists, or medical physicists
who meet the requirements of subsection (f) of this section would be considered
qualified instructors in their respective areas of mammography. Other examples
of individuals who may be qualified instructors for the purpose of providing
training to meet the requirements of this section include, but are not limited
to, instructors in a post-high school training institution and manufacturer's
representatives.
(56)
Quality control technologist--An individual meeting the
requirements of subsection (f)(2) of this section who is responsible for those
quality assurance responsibilities not assigned to the lead interpreting physician
or to the medical physicist.
(57)
Radiation machine--For the purposes of this part, radiation
machine also means unit.
(58)
Reinstatement fee--The fee charged to reinstate an application
for a mammography machine that has been denied accreditation or whose application
has been abandoned in accordance with subsection (jj) of this section.
(59)
Review physician--An individual who is qualified to review
clinical images on behalf of the accreditation body. To be qualified, this
individual shall comply with the following:
(A)
meet the interpreting physician requirements of subsection
(f)(1) of this section;
(B)
be trained and evaluated in the clinical image review process
for the types of clinical images to be evaluated by a review physician by
the accreditation body before designation as a review physician and periodically
thereafter; and
(C)
clearly document their findings and reasons for assigning
a particular score to any clinical image and provide information to the facility
for use in improving the attributes for which significant deficiencies were
identified.
(60)
Self-referral mammography--The use of x-radiation to test
asymptomatic women for the detection of diseases of the breasts when such
tests are not specifically and individually ordered by a licensed physician.
(61)
Serious adverse event--An adverse event that may significantly
compromise clinical outcomes, or an adverse event for which a facility fails
to take appropriate corrective action in a timely manner.
(62)
Serious complaint--A report of a serious adverse event.
(63)
Source-to-image receptor distance (SID)--The distance
from the source to the center of the input surface of the image receptor.
(64)
Standard breast--A 4.2 cm thick compressed breast consisting
of 50% glandular and 50% adipose tissue.
(65)
Survey--An on-site physics consultation and evaluation
of a facility quality assurance program performed by a medical physicist.
(66)
Targeted clinical image review--A review of two sets of
"negative" clinical images from a specific date at the request of the agency.
The review is performed due to a serious complaint or a severe item of non-compliance.
(67)
Technique chart--A chart that provides all necessary generator
control settings and geometry needed to make clinical radiographs.
(68)
Traceable to a national standard--Calibrated at either
the National Institute of Standards and Technology (NIST) or at a calibration
laboratory that participates in a proficiency program with NIST at least once
every two years. The results of the proficiency test conducted within 24 months
of calibration shall show agreement within plus or minus 3.0% of the national
standard in the mammography energy range.
(d)
Prohibitions.
(1)
Radiographic equipment designed for general purpose or
special nonmammography procedures shall not be used for mammography. This
includes systems that have been modified or equipped with special attachments
for mammography.
(2)
The agency may prohibit use of mammography machines that
pose a significant threat or endanger public health and safety, in accordance
with §289.231 of this title and §289.205 of this title.
(3)
Individuals shall not be exposed to the useful beam except
for healing arts purposes and unless such exposure has been authorized by
a licensed physician. This provision specifically prohibits deliberate exposure
for the following purposes:
(A)
exposure of an individual for training, demonstration,
or other non-healing arts purposes;
(B)
exposure of an individual for the purpose of healing arts
screening (self referral mammography) except as authorized by subsection (h)
of this section; and
(C)
exposure of an individual for the purpose of research except
as authorized by subsection (p) of this section.
(e)
Exemptions.
(1)
Mammography machines or cabinet x-ray machines used exclusively
for examination of breast biopsy specimens are exempt from the requirements
of this section. These machines are required to meet applicable provisions
of §289.226 of this title and §289.227 of this title (relating to
Use of Radiation Machines in the Healing Arts and Veterinary Medicine).
(2)
Xerography systems not used for detection of diseases of
the breast are exempt from the requirements of this section. These machines
are required to meet applicable provisions of §289.226 of this title
and §289.227 of this title.
(3)
Mammography systems used exclusively for invasive interventions
for localization or biopsy procedures are exempt from the requirements of
this section except for those listed in subsection (q) of this section.
(4)
Mammography systems used exclusively for research or investigation
are exempt from the requirements of this section.
(5)
All mammography registrants are exempt from the posting
of radiation area requirements of §289.231(x) of this title provided
that the operator has continuous surveillance and access control of the radiation
area.
(f)
Personnel qualifications. The following requirements apply
to all personnel involved in any aspect of mammography including the production
and interpretation of mammograms.
(1)
Interpreting physician. Each physician interpreting mammograms
shall hold a current Texas license issued by the Texas State Board of Medical
Examiners and meet the following qualifications.
(A)
Initial qualifications. Before interpreting mammograms
independently, the physician shall:
(i)
be certified by the American Board of Radiology, the American
Osteopathic Board of Radiology, or one of the other bodies approved by the
FDA to certify interpreting physicians or have at least three months of documented
formal training in the interpretation of mammograms and in topics related
to mammography in accordance with subsection (nn)(2) of this section;
(ii)
have had 60 hours of documented category I CMEUs in mammography.
At least 15 of the 60 hours shall have been acquired within three years immediately
prior to the date that the physician qualified as an interpreting physician.
Hours spent in residency specifically devoted to mammography will be equivalent
to category I CMEUs and accepted if documented in writing by the appropriate
representative of the training institution. The residency program must be
approved by the Accreditation Council for Graduate Medical Education or the
Council on Postdoctoral Training of the American Osteopathic Association;
and
(iii)
have interpreted or multi-read, under the direct supervision
of an interpreting physician, at least 240 mammographic examinations within
the six month period immediately prior to the date that the physician qualifies
as an interpreting physician.
(B)
Exemptions.
(i)
Physicians who qualified as interpreting physicians in
accordance with the requirements of §289.230 that were in effect prior
to April 28, 1999, or any other equivalent state or federal requirements in
effect prior to April 28, 1999, are considered to have met the initial requirements
of subparagraph (A) of this paragraph.
(ii)
Physicians who have interpreted or multi-read at least
240 mammographic examinations under the direct supervision of an interpreting
physician in any six month period during the last two years of a diagnostic
radiology residency and who became board certified at the first allowable
time, are exempt from subparagraph (A)(iii) of this paragraph.
(C)
Continuing education and experience. The time period for
completing continuing education is a 36-month period and the time period for
completing continuing experience is a 24-month period. These periods begin
when a physician completes the requirements to become an interpreting physician
in subparagraph (A) of this paragraph. The facility shall choose one of the
dates in clause (i) of this subparagraph to determine the 36-month continuing
education period and one of the dates in clause (ii) of this subparagraph
to determine the 24-month continuing experience period. Each interpreting
physician shall maintain qualifications by meeting the following requirements:
(i)
participating in education programs by completing at least
15 category I CMEUs in mammography that shall include at least six CMEUs in
each modality used by the interpreting physician in his/her practice or by
teaching mammography courses. CMEUs earned through teaching a specific course
can be counted only once during the 36-month period. The continuing education
must be completed in the 36 months immediately preceding:
(I)
the date of the registrant's annual inspection;
(II)
the last day of the calendar quarter preceding the inspection;
or
(III)
any date in between the two;
(ii)
interpreting or multi-reading at least 960 mammographic
examinations that must be completed during the 24 months immediately preceding:
(I)
the date of the registrant's annual inspection; or
(II)
the last day of the calendar quarter preceding the inspection;
or
(III)
any date in between the two; and
(iii)
accumulating at least eight hours of CMEUs in any mammography
modality in which the interpreting physician has not been previously trained,
prior to independently using the new modality.
(D)
Re-establishing qualifications. Before resuming independent
interpretation of mammograms, interpreting physicians who fail to maintain
the required continuing education or experience requirements shall re-establish
their qualifications by completing one or both of the following requirements,
as applicable:
(i)
obtain a sufficient number of additional category I CMEUs
to bring their total up to the 15 category I CMEU credits required in the
previous 36 months; and
(ii)
within the six months immediately prior to resuming independent
interpretation and under the direct supervision of an interpreting physician,
interpret or multi-read one of the following, whichever is less:
(I)
at least 240 mammographic examinations; or
(II)
a sufficient number of mammographic examinations to bring
the total up to 960 examinations for the prior 24 months.
(2)
Medical radiologic technologists (operators of equipment).
Each person performing mammographic examinations shall have current certification
as a medical radiologic technologist under the Medical Radiologic Technologist
Certification Act, Texas Occupations Code, Chapter 601 and shall meet the
following qualifications.
(A)
Initial requirements. Before performing mammographic examinations,
the operator of equipment shall have:
(i)
completed a minimum of 40 contact hours of training as
outlined in subsection (nn)(1) of this section by a qualified instructor;
and
(ii)
performed a minimum of 25 mammographic examinations under
the direct supervision of an individual qualified in accordance with the qualifications
of this paragraph. The 25 mammographic examinations may be obtained concurrently
with the 40 contact hours of training specified in clause (i) of this subparagraph
but shall not exceed 16 hours of the 40 contact hours.
(B)
Exemptions. Equipment operators who qualified as medical
radiologic technologists to perform mammography in accordance with the requirements
of §289.230 that were in effect prior to April 28, 1999, or any other
equivalent state or federal requirements in effect prior to April 28, 1999,
are considered to have met the initial requirements of subparagraph (A) of
this paragraph.
(C)
Continuing education and experience. The time period for
completing continuing education is a 36-month period and the time period for
completing continuing experience is a 24-month period. The period for continuing
education begins when a technologist completes the requirements in subparagraph
(A) of this paragraph. The period for continuing experience begins when a
technologist completes the requirements in subparagraph (A) of this paragraph,
or April 28,1999, whichever is later. The facility shall choose one of the
dates in clause (i) of this subparagraph to determine the 36-month continuing
education period and one of the dates in clause (ii) of this subparagraph
to determine the 24-month continuing experience period. Each medical radiologic
technologist shall maintain qualifications by meeting the following requirements:
(i)
participating in education programs by completing at least
15 CEUs in mammography that shall include at least six CEUs in each modality
used by the technologist or by teaching mammography courses. CEUs earned through
teaching a specific course can be counted only once during the 36-month period.
The continuing education must be completed in the 36 months immediately preceding:
(I)
the date of the registrant's annual inspection;
(II)
the last day of the calendar quarter preceding the inspection;
or
(III)
any date in between the two;
(ii)
performing a minimum of 200 mammographic examinations
that must be completed during the 24 months immediately preceding:
(I)
the facility's annual inspection;
(II)
the last day of the calendar quarter preceding the inspection;
or
(III)
any date in between the two; and
(iii)
accumulating at least eight hours of CEUs in any mammography
modality in which the medical radiologic technologist has not been previously
trained, prior to independently using the new modality.
(D)
Requalification. Before resuming independent performance
of mammograms, medical radiologic technologists who fail to maintain the continuing
education or experience requirements shall re-establish their qualifications
by completing one or both of the following requirements, as applicable:
(i)
obtaining a sufficient number of additional CEUs to bring
their total up to the 15 CEU credits required in the previous 36 months; and
(ii)
performing a minimum of 25 mammographic examinations under
the direct supervision of a qualified medical radiologic technologist.
(3)
Medical physicist. Each medical physicist performing mammographic
surveys and evaluating mammographic equipment shall hold a current Texas license
under the Medical Physics Practice Act, Texas Occupations Code, Chapter 602,
in diagnostic radiological physics and be registered with the agency or employed
by a business registered with the agency, in accordance with §289.226(e)
of this title and the Act, unless exempted by §289.226(d)(6) of this
title. Each medical physicist shall meet the following qualifications:
(A)
Initial qualifications. Before performing surveys and evaluating
mammographic equipment independently, the medical physicist shall:
(i)
have a masters degree or higher in a physical science from
an accredited institution, with no less than 20 semester hours or equivalent
(30 quarter hours) of college undergraduate or graduate level physics;
(ii)
have 20 contact hours of documented specialized training
in conducting surveys of mammography facilities; and
(iii)
have experience conducting surveys of at least one mammography
facility and a total of at least ten mammography machines. After April 28,
1999, experience conducting surveys must be acquired under the direct supervision
of a medical physicist who meets the requirements of subparagraphs (A) and
(C) of this paragraph. No more than one survey of a specific machine within
a period of 60 days can be counted towards the total mammography machine survey
requirement; or
(B)
Alternative initial qualifications. Individuals who qualified
as a medical physicist in accordance with the requirements of §289.230
that were in effect prior to April 28, 1999, or any other equivalent state
or federal requirements in effect prior to April 28, 1999, and have met the
following additional qualifications prior to April 28, 1999, are determined
to have met the initial qualifications of subparagraph (A) of this paragraph:
(i)
a bachelor's degree or higher in a physical science from
an accredited institution with no less than ten semester hours or equivalent
of college undergraduate or graduate level physics;
(ii)
40 contact hours of documented specialized training in
conducting surveys of mammography facilities; and
(iii)
experience conducting surveys of at least one mammography
facility and a total of at least 20 mammography machines. No more than one
survey of a specific machine within a period of 60 days can be counted towards
the total mammography machine survey requirement. The training and experience
requirements must be met after fulfilling the degree requirements.
(C)
Continuing education and experience. The time period for
completing continuing education is a 36-month period and the time period for
completing continuing experience is a 24-month period. The period for continuing
education will begin when a physicist completes the requirements in subparagraph
(A) of this paragraph. The time period for continuing experience will begin
when a physicist completes the requirements in subparagraph (A) of this paragraph,
or April 28, 1999, whichever is later. The facility shall choose one of the
dates in clause (i) of this subparagraph to determine the 36-month continuing
education period and one of the dates in clause (ii) of this subparagraph
to determine the 24-month continuing experience period. Each medical physicist
shall maintain their qualifications by meeting the following requirements:
(i)
participating in education programs, either by teaching
or completing at least 15 CEUs in mammography that shall include hours of
training appropriate to each mammographic modality evaluated by the medical
physicist during his or her surveys. CEUs earned through teaching a specific
course can be counted only once during the 36-month period. The continuing
education must be completed in the 36 months immediately preceding:
(I)
the date of the registrant's annual inspection;
(II)
by the last day of the calendar quarter preceding the
inspection; or
(III)
any date in between the two;
(ii)
performing surveys of two mammography facilities and a
total of at least six mammography machines (no more than one survey of a specific
facility within a ten-month period or a specific machine within a period of
60 days can be counted towards the total mammography machine survey requirement).
The continuing experience must be completed during the 24 months immediately
preceding:
(I)
the date of the facility's annual inspection;
(II)
by the last day of the calendar quarter preceding the
inspection; or
(III)
any date in between the two; and
(iii)
accumulating at least eight hours of CEUs in any mammography
modality in which the medical physicist has not been previously trained, prior
to independently using the new modality.
(D)
Re-establishing qualifications. Before resuming independent
performance of surveys and equipment evaluations, medical physicists who fail
to maintain the continuing education or experience requirements shall reestablish
their qualifications by completing one or both of the following requirements,
as applicable:
(i)
obtaining a sufficient number of additional CEUs to bring
their total up to the 15 CEU credits required in the previous 36 months; and
(ii)
performing a sufficient number of surveys, under the direct
supervision of a qualified medical physicist, to bring their total up to two
mammography facilities and a total of at least six mammography units for the
prior 24 months.
(4)
Retention of personnel records. Records documenting the
qualifications, continuing education, and experience of personnel in subsection
(f)(1)-(3) shall be maintained for inspection by the agency in accordance
with subsection (nn)(3) of this section.
(g)
Equipment standards. Only x-ray systems meeting the following
standards shall be used.
(1)
System design. The equipment shall have been specifically
designed and manufactured for mammography and in accordance with Title 21,
CFR, §§ 1010.2, 1020.30, and 1020.31.
(2)
Motion of tube-image receptor assembly. The assembly shall
be capable of being fixed in any position where it is designed to operate.
Once fixed in any such position, it shall not undergo unintended motion. In
the event of power interruption, this mechanism shall not fail.
(3)
Image receptor sizes. Systems using screen-film image receptors
shall, at a minimum, provide for the following:
(A)
operation with image receptors of 18 x 24 cm and 24 x 30
cm;
(B)
operable moving grids matched to all image receptor sizes
provided;
(C)
operation with the grid removed for systems used for magnification
procedures; and
(D)
image receptors to rest, post-loading, 15 minutes between
exposures.
(4)
Magnification. Systems used to perform noninterventional
problem solving procedures shall have radiographic magnification capability
available for use with, at a minimum, at least one magnification value within
the range of 1.4 to 2.0.
(5)
Focal spot and target material selection. Selection of
the focal spot or target material shall be as follows.
(A)
When more than one focal spot is provided, the system shall
indicate, prior to exposure, which focal spot is selected.
(B)
When more than one target material is provided, the system
shall indicate, prior to exposure, the preselected target material.
(C)
When the target material and/or focal spot is selected
by a system algorithm that is based on the exposure or on a test exposure,
the system shall display, after the exposure, the target material and/or focal
spot actually used during the exposure.
(6)
Compression. All mammography systems shall incorporate
a compression device.
(A)
Application of compression. Effective October 28, 2002,
and thereafter, each system shall provide the following features operable
from both sides of the patient:
(i)
an initial power-driven compression activated by hands-free
controls; and
(ii)
fine adjustment compression controls.
(B)
Compression paddle.
(i)
Systems shall be equipped with different sized compression
paddles that match the sizes of all full-field image receptors provided for
the system.
(ii)
Compression paddles for special purposes, including those
smaller than the full size of the image receptor (spot compression) may be
provided. Such paddles are not subject to the requirements of clauses (v)
and (vi) of this subparagraph.
(iii)
Except as provided in clause (iv) of this subparagraph,
the compression paddle shall be flat and parallel to the breast support table
and shall not deflect from parallel by more than 1.0 cm at any point on the
surface of the compression paddle when compression is applied.
(iv)
Equipment intended by the manufacturer's design to not
be flat and parallel to the breast support table during compression shall
meet the manufacturer's design specifications and maintenance requirements.
(v)
The chest wall edge of the compression paddle shall be
straight and parallel to the edge of the image receptor.
(vi)
The chest wall edge may be bent upward to allow for patient
comfort, but shall not appear on the image.
(7)
Technique factor selection and display. Technique factor
selection and display shall be as follows.
(A)
Manual selection of milliampere seconds (mAs) or at least
one of its component parts, milliampere (mA) and/or time, shall be available.
(B)
The technique factors (peak tube potential in kilovolts
(kV) and either tube current in mA and exposure time in seconds or the product
of tube current and exposure time in mAs) to be used during an exposure shall
be indicated before the exposure begins, except when AEC is used, in which
case the technique factors that are set prior to the exposure shall be indicated.
(C)
When the AEC mode is used, the system shall indicate the
actual kVp and mAs used during the exposure. The mAs may be displayed as mA
and time.
(8)
Automatic exposure control. Each screen-film system shall
provide an AEC mode that is operable in all combinations of equipment configuration
provided, for example, grid, nongrid, magnification, non magnification, and
various target filter combinations.
(A)
The positioning or selection of the detector shall permit
flexibility in the placement of the detector under the target tissue.
(i)
The size and available positions of the detector shall
be clearly indicated at the x-ray input surface of the breast compression
paddle.
(ii)
The selected position of the detector shall be clearly
indicated.
(B)
The system shall provide means to vary the selected optical
density from the normal (zero) setting.
(9)
X-ray film. The registrant shall use x-ray film for mammography
that has been designated by the film manufacturer as appropriate for mammography.
(10)
Intensifying screens. The registrant shall use intensifying
screens for mammography that have been designated by the screen manufacturer
as appropriate for mammography and shall use film that is matched to the screen's
spectral output as specified by the manufacturer.
(11)
Film processing solutions. For processing mammography
films, the registrant shall use chemical solutions that are capable of developing
the films used by the facility in a manner equivalent to the minimum requirements
specified by the film manufacturer.
(12)
Lighting. The registrant shall make available special
lights for film illumination (hot lights) capable of producing light levels
greater than that provided by the view box.
(13)
Film masking devices. Registrants shall ensure that film
masking devices that can limit the illuminated area to a region equal to or
smaller than the exposed portion of the film are available to all interpreting
physicians interpreting for the facility.
(14)
Equipment variances. Registrants with mammography equipment
that has been issued variances by FDA to Title 21, CFR, §§1020.2,
1020.30, 1020.31 or has had an alternative for a quality standard for equipment
approved by the FDA under the provisions of Title 21, CFR, §900.18, shall
maintain copies of those variances or alternative standards.
(h)
Self-referral mammography. Any person proposing to conduct
a self-referral mammography program shall not initiate such a program without
prior approval of the agency. When requesting such approval, that person shall
submit the following information:
(1)
the number and type of views (or projections);
(2)
the age of the population to be examined and the frequency
of the exam following established, nationally recognized criteria, such as
those of the American Cancer Society, American College of Radiology (ACR),
or the National Council on Radiation Protection and Measurements;
(3)
written procedures to include methods of:
(A)
advising patients and private physicians of the results
of the mammography examination in accordance with subsection (i)(2) of this
section;
(B)
follow-up with patients and physicians in accordance with
subsection (i)(3) of this section; and
(C)
recommending to patients who do not have a physician means
of selecting a physician;
(4)
methods for educating mammography patients in breast self-examination
techniques and on the necessity for follow-up by a physician.
(i)
Medical records and mammography reports.
(1)
Contents and terminology. Each registrant shall prepare
a written report of the results of each mammography examination that shall
include the following information:
(A)
name of the patient and an additional patient identifier;
(B)
date of the examination;
(C)
name and signature of the interpreting physician who interpreted
the mammogram (electronic signatures are acceptable);
(D)
overall final assessment of findings using the final assessment
categories as defined in subsection (c) of this section; and
(E)
recommendations made to the practitioner about what additional
actions, if any, should be taken. All clinical questions raised by the referring
physician shall be addressed in the report to the extent possible, even if
the assessment is negative or benign.
(2)
Communication of mammography results to the patient and
physicians. Each registrant shall send reports as soon as possible, but no
later than 30 days from the date of the mammography examination to:
(A)
patients advising them of the results of the mammography
examination and any further medical needs indicated. The report shall include
a summary written in language easily understood by a lay person; and
(B)
referring physicians, or in the case of self-referral,
to the physician indicated by the patient, advising them of the results of
the mammography examination, containing the information specified in paragraph
(1) of this subsection, and any further medical needs indicated.
(3)
Follow-up with patients and physicians. Each registrant
shall follow-up to confirm the following:
(A)
that patients with positive findings and patients needing
repeat exams have received proper notification; and
(B)
that physicians have received proper notification of patients
with positive findings needing repeat exams.
(4)
Retention of clinical images. Each registrant that performs
mammograms shall do the following.
(A)
Maintain mammography films and reports in a permanent medical
record for a minimum of five years and if no additional mammograms of the
patient are performed at the facility, they shall be maintained for a minimum
of ten years.
(B)
Upon request or on behalf of the patient, permanently or
temporarily transfer the original mammograms and copies of the patient's reports
to a medical institution, a physician, or to the patient directly.
(C)
If the medical records are permanently forwarded, the receiving
institution or physician shall maintain and become responsible for the original
film until the fifth or tenth anniversary, as specified in subparagraph (A)
of this paragraph unless permanently transferred or forwarded in accordance
with subparagraph (B) of this paragraph.
(5)
Mammographic image identification. Each mammographic image
shall have the following information indicated on it in a permanent, legible
manner and placed so as not to obscure anatomic structures:
(A)
name of patient and an additional patient identifier;
(B)
date of examination;
(C)
view and laterality (this information shall be placed on
the image in a position near the axilla);
(D)
facility name and location (at a minimum the location shall
include city, state, and zip code);
(E)
technologist identification;
(F)
cassette/screen identification; and
(G)
mammography machine identification if there is more than
one machine in the facility.
(6)
Information shall also be maintained for each clinical
image by utilizing a label on each film, recording on the film jacket, or
maintaining a log or other means. The information shall include, but is not
limited to, compressed breast thickness or degree of compression, and kVp.
(j)
Processing of mammographic images. Each registrant shall
utilize the same processor for clinical and phantom images. Clinical images
shall be processed within an interval not to exceed 24 hours from the time
the first clinical image is taken. Facilities utilizing batch processing shall:
(1)
use a container to transport clinical images that will
protect the film from exposure to light and radiation; and
(2)
maintain a log to include each patient name and unique
identification number, date, and time of the first exam of each batch, and
date and time of batch development.
(k)
Quality assurance--general. Each registrant shall establish
and maintain a written quality assurance program to ensure the safety, reliability,
clarity, and accuracy of mammography services performed at the mammography
facility, including corrective actions to be taken if images are of poor quality.
(1)
Responsible individuals. Responsibility for the quality
assurance program and for each of its elements shall be assigned to individuals
who are qualified for their assignments and who shall be allowed adequate
time to perform these duties.
(A)
Lead interpreting physician. The registrant shall identify
a lead interpreting physician who shall have the general responsibility of:
(i)
ensuring that the quality assurance program meets all requirements
of this subsection and subsections (l) and (m) of this section;
(ii)
reviewing and documenting the technologists' quality control
test results at least every three months or more frequently if consistency
has not yet been achieved;
(iii)
reviewing the physicists' results annually or more frequently
when needed; and
(iv)
assigning and determining the individual's qualifications
to perform the quality assurance tasks in subparagraphs (B)-(D) of this paragraph.
(B)
Interpreting physicians. All interpreting physicians interpreting
mammograms for the registrant shall:
(i)
follow the registrant's procedures for corrective action
when the images they are asked to interpret are of poor quality. These procedures
shall be included in the facility's operating and safety procedures; and
(ii)
participate in the medical outcomes audit program.
(C)
Medical physicist. Each registrant shall use the services
of a licensed medical physicist to survey mammography equipment and oversee
the equipment-related quality assurance practices of the facility. At a minimum,
the medical physicist shall be responsible for performing the surveys and
the mammography equipment evaluations and providing the facility with the
reports described in subsection (l)(10) and (11) of this section.
(D)
Quality control technologist. The quality control technologist,
designated by the lead interpreting physician, shall ensure performance of
the items designated in subsection (l)(1)-(4), (7), (9), (12), and (14) of
this section. If other personnel are assigned the quality assurance tasks
in accordance with subparagraph (A)(iv) of this paragraph, the quality assurance
technologist shall insure that the requirements of subsection (l)(1)-(4),
(7), (9), (12), and (14) of this section are met.
(2)
Quality assurance records. The lead interpreting physician,
quality control technologist, and medical physicist shall ensure that records
concerning mammography technique and procedures, quality control (include
monitoring data, corrective actions, and the effectiveness of the corrective
actions), safety, protection, and employee qualifications to meet assigned
quality assurance tasks are properly maintained and updated. These quality
control records shall be kept for each test specified in subsection (l) and
(m) of this section, in accordance with subsection (nn)(3) of this section.
(l)
Quality assurance--equipment. Registrants with screen-film
systems shall perform the following quality control tests at the intervals
specified. In addition to the intervals specified in (l)(4)(B) and (5)(H),
the tests shall be performed prior to initial use.
(1)
Daily quality control tests. Film processors used to develop
mammograms shall be adjusted and maintained to meet the technical development
specifications for the mammography film in use. A processor performance test
shall be completed and the results charted on each day that clinical films
are processed before any clinical films are processed that day.
(A)
Processor performance test. Using mammography film used
clinically at the facility, sensitometer tests shall include assessment of
the following:
(i)
base plus fog density that shall be within plus 0.03 of
the established operating level;
(ii)
mid-density that shall be within plus or minus 0.15 of
the established operating level; and
(iii)
density difference that shall be within plus or minus
0.15 of the established operating level.
(B)
Backup processor. A processor, other than the one commonly
in use for mammography, may be designated as a backup processor that may be
used temporarily. To be designated as a backup processor, the processor shall
be tested and meet the requirements of subparagraph (A) of this paragraph
for a minimum of five days to establish operating levels. The backup processor
shall meet the requirements of subparagraph (A) of this paragraph at all times
during use for developing patient mammograms. Prior to the first patient exposure
of each period of use, a phantom image shall be acquired, developed in the
backup processor, and shall meet the requirements of paragraph (2) of this
section.
(C)
Film processors being used for mammography at multiple
locations, such as a mobile service, shall be subject to the requirements
of this paragraph.
(D)
Film processors utilized for mammography shall be adjusted
to and operated at the specifications recommended by the mammographic film
manufacturer, or at other settings such that the sensitometric performance
is at least equivalent.
(2)
Weekly quality control tests. These tests shall be performed
at an interval no greater than seven days. If mammography is not being performed
on the date the test is due and more than seven days have past since the last
test, the tests shall be performed prior to resuming mammography. An image
quality evaluation test, using an FDA-accepted phantom, shall meet the following
parameters.
(A)
The optical density of the film at the center of an image
of a standard FDA-accepted phantom shall be at least 1.20 when exposed under
a typical clinical condition and shall not change by more than plus or minus
0.20 from the established operating level.
(B)
The density difference between the background of the phantom
and an added test object, used to assess image contrast, shall be measured
and shall not vary by more than plus or minus 0.05 from the established operating
level.
(C)
The phantom image shall be made on the standard mammographic
film in use at the facility with techniques used for clinical images of a
standard breast. The phantom image shall meet the requirements in subparagraphs
(A) and (B) of this paragraph and clause (i) of this subparagraph. No mammograms
shall be taken on patients if any of these minimums are not met.
(i)
The mammographic machine shall be capable of producing
images of the mammographic phantom in accordance with the phantom image scoring
protocol in subsection (nn)(5) of this section.
(ii)
Each phantom image and a record of the evaluation of that
image shall be maintained at the location where the mammography image was
produced or with the radiographic equipment for mobile services.
(3)
Quarterly quality control tests. These tests shall be performed
within the calender quarter at an interval not to exceed 90 days.
(A)
Fixer retention in film. The residual fixer shall be no
more than 5 micrograms per square cm.
(B)
Repeat analysis. A repeat analysis on clinical images repeated
or rejected shall be performed, analyzed, and documented. The total repeat
or reject rate shall not exceed 5.0%. If the total repeat or reject rate changes
from the previously determined rate by more than 2.0% of the total films included
in the analysis, the reason(s) for the change shall be determined. Corrective
action shall be taken and documented if the total repeat or reject rate for
the facility exceeds 5.0% or changes from the previously determined rate by
more than 2.0% of the total films included in the analysis. Test films, cleared
films, or film processed as a result of exposure of a film bin are not to
be included in the count for repeat analysis. Films included in the repeat
analysis are not required to be kept after completion of the analysis.
(4)
Semiannual quality control tests. These tests shall be
performed at an interval not to exceed six months.
(A)
Darkroom fog. The optical density attributable to darkroom
fog shall not exceed 0.05 when a mammography film of the type used in the
facility, which has a mid- density of no less than 1.2 OD, is exposed to typical
darkroom conditions for two minutes while such film is placed on the counter
top, emulsion side up. If the darkroom has a safelight used for mammography
film, it shall be on during this test.
(B)
Screen-film contact. Testing for screen-film contact shall
be conducted using 40 mesh copper screen. The entire area of the cassette
that may be clinically exposed shall be tested. This shall include all cassettes
used for mammography in the facility.
(C)
Compression device performance. The x-ray system shall
be capable of compressing the breast with a force of at least 25 pounds and
shall be capable of maintaining this compression for at least 15 seconds.
Effective October 28, 2002, and thereafter, the maximum compression force
for the initial power drive shall be between 25 pounds and 45 pounds.
(5)
Annual quality control tests. These tests shall be performed
at an interval not to exceed 12 months.
(A)
Automatic exposure control performance. The AEC shall be
as follows.
(i)
The AEC shall be capable of maintaining film optical density
within plus or minus 0.30 of the mean optical density when thickness of a
homogeneous material is varied over a range of 2 to 6 cm and the kVp is varied
appropriately for such thicknesses over the kVp range used clinically in the
facility. If this requirement cannot be met, a technique chart shall be developed
showing appropriate techniques (kVp and density control settings) for different
breast thicknesses and compositions that must be used so that optical densities
within plus or minus 0.30 of the average under phototimed conditions can be
produced.
(ii)
Effective October 28, 2002, and thereafter, the AEC shall
be capable of maintaining film optical density within plus or minus 0.15 of
the mean optical density when thickness of a homogeneous material is varied
over a range of 2 to 6 cm and the kVp is varied appropriately for such thicknesses
over the kVp range used clinically in the facility.
(iii)
The optical density of the film in the center of the
phantom image shall not be less than 1.20.
(B)
Kilovoltage peak accuracy and reproducibility. At the most
commonly used clinical settings of kVp, the coefficient of variation of reproducibility
of the kVp shall be equal to or less than 0.02. The kVp shall be accurate
to within plus or minus 5.0% of the indicated or selected kVp at the following:
(i)
the lowest clinical kVp that can be measured by a kVp test
device;
(ii)
the most commonly used clinical kVp; and
(iii)
the highest available clinical kVp.
(C)
Focal spot condition. Until October 27, 2002, focal spot
condition shall be evaluated either by determining system resolution or by
measuring focal spot dimensions. Effective October 28, 2002, and thereafter,
facilities shall evaluate focal spot condition only by determining the system
resolution.
(i)
System resolution.
(I)
Each x-ray system used for mammography, in combination
with the mammography screen-film combination used in the facility, shall provide
a minimum resolution of 11 cycles/millimeter (mm) (line-pairs/mm) when a high
contrast resolution bar test pattern is oriented with the bars perpendicular
to the anode-cathode axis, and a minimum resolution of 13 line-pairs/mm when
the bars are parallel to that axis.
(II)
The bar pattern shall be placed 4.5 cm above the breast
support surface, centered with respect to the chest wall edge of the image
receptor, and with the edge of the pattern within 1 cm of the chest wall edge
of the image receptor.
(III)
When more than one target material is provided, the measurement
in subclause (I) of this clause shall be made using the appropriate focal
spot for each target material.
(IV)
When more than one SID is provided, the test shall be
performed at the SID most commonly used clinically.
(V)
Test kVp shall be set at the value used clinically by the
facility for a standard breast and shall be performed in the AEC mode, if
available. If necessary, a suitable absorber may be placed in the beam to
increase exposure times. The screen-film cassette combination used by the
facility shall be used to test for this requirement and shall be placed in
the normal location used for clinical procedures.
(ii)
Focal spot dimensions. Measured values of the focal spot
length (dimension parallel to the anode cathode axis) and width (dimension
perpendicular to the anode cathode axis) shall be within the tolerance limits
specified as follows.
Figure: 25 TAC §289.230(l)(5)(C)(ii) (No change.)
(D)
Beam quality and half-value layer (HVL). The HVL shall
meet the specifications of Title 21, CFR, §1020.30(m)(l) for the minimum
HVL. These values, extrapolated to the mammographic range, are shown as follows.
Values not shown in Table II may be determined by linear interpolation or
extrapolation.
Figure: 25 TAC §289.230(l)(5)(D)
(E)
Breast entrance air kerma and AEC reproducibility. The
coefficient of variation for both air kerma and mAs shall not exceed 0.05.
(F)
Dosimetry. The average glandular dose delivered during
a single craniocaudal view of an FDA accepted phantom simulating a standard
breast shall not exceed 3.0 milligray (mGy) (0.3 rad) per exposure.
(G)
X-ray field/light field/image receptor/compression paddle
alignment. All systems shall meet the following:
(i)
All systems shall have beam-limiting devices that allow
the entire chest wall edge of the x-ray field to extend to the chest wall
edge of the image receptor and provide means to assure that the x-ray field
does not extend beyond any edge of the image receptor by more than 2.0% of
the SID.
(ii)
If a light field that passes through the x-ray beam limitation
device is provided, it shall be aligned with the x-ray field so that the total
of any misalignment of the edges of the light field and the x-ray field along
either the length or the width of the visually defined field at the plane
of the breast support surface shall not exceed 2.0% of the SID.
(iii)
The chest wall edge of the compression paddle shall not
extend beyond the chest wall edge of the image receptor by more than 1.0%
of the SID when tested with the compression paddle placed above the breast
support surface at a distance equivalent to standard breast thickness. The
shadow of the vertical edge of the compression paddle shall not be visible
on the image.
(H)
Uniformity of screen speed. Uniformity of screen speed
of all the cassettes in the facility shall be tested and the difference between
the maximum and minimum optical densities shall not exceed 0.30. Screen artifacts
shall also be evaluated during this test.
(I)
System artifacts. System artifacts shall be evaluated with
a high- grade, defect-free sheet of homogeneous material large enough to cover
the mammography cassette and shall be performed for all cassette sizes used
in the facility using a grid appropriate for the cassette size being tested.
System artifacts shall also be evaluated for all available focal spot sizes
and target filter combinations used clinically.
(J)
Radiation output. The system shall be capable of producing
a minimum output of 4.5 mGy air kerma per second (513 milliroentgen (mR) per
second) when operating at 28 kVp in the standard mammography (molybdenum/molybdenum)
mode at any SID where the system is designed to operate and when measured
by a detector with its center located 4.5 cm above the breast support surface
with the compression paddle in place between the source and the detector.
Effective October 28, 2002, and thereafter, the system, under the same measuring
conditions shall be capable of producing a minimum output of 7.0 mGy air kerma
per second (800 milliroentgen (mR) per second). The system shall be capable
of maintaining the required minimum radiation output averaged over a 3.0 second
period.
(K)
Decompression. If the system is equipped with a provision
for automatic decompression after completion of an exposure or interruption
of power to the system, the system shall be tested to confirm that it provides
the following:
(i)
an override capability to allow maintenance of compression;
(ii)
a continuous display of the override status; and
(iii)
a manual emergency compression release that can be activated
in the event of power or automatic release failure.
(L)
The technique settings used for subparagraphs (D) and (F)
of this paragraph and paragraph (2) of this subsection shall be those used
by the facility for its clinical images of a standard breast.
(6)
Densitometer and sensitometer. The calibration of the densitometer
and sensitometer must be in accordance with the manufacturer's specifications.
(7)
Quality control tests--other modalities. For systems with
image receptor modalities other than screen-film, the quality assurance program
shall be substantially the same as the quality assurance program recommended
by the image receptor manufacturer, except that the maximum allowable dose
shall not exceed the maximum allowable dose for screen-film systems in paragraph
(5)(F) of this subsection.
(8)
Mobile mammography machines. The registrant shall verify
that mammography machines used to produce mammograms at more than one location
meet the requirements in paragraphs (1)-(7) of this subsection. In addition,
at each examination location, before any examinations are conducted, the registrant
shall verify satisfactory performance of the mammography machines by using
a test method that establishes the adequacy of the image quality produced
by the machine. Processor performance shall be in accordance with paragraph
(1) of this subsection.
(9)
Use of test results. After completion of the tests specified
in paragraphs (1)-(8) of this subsection, the registrant shall do the following.
(A)
Compare the test results to the corresponding specified
action limits; or, for nonscreen-film modalities, to the manufacturer's recommended
action limits; or for post-move, pre-examination testing of mobile mammography
machines, to the limits established in the test method used by the facility.
(B)
Components of the mammography system that fail any of the
following quality assurance tests shall comply with the actions in subparagraph
(C) of this paragraph:
(i)
paragraph (1) of this subsection describing processor quality
control;
(ii)
paragraph (2) of this subsection describing phantom image
quality;
(iii)
paragraph (4)(A) of this subsection describing darkroom
fog;
(iv)
paragraph (4)(B) of this subsection describing screen-film
contact;
(v)
paragraph (4)(C) of this subsection describing compression
device performance;
(vi)
paragraph (5)(A) of this subsection describing AEC;
(vii)
paragraph (5)(C) of this subsection describing focal
spot condition;
(viii)
paragraph (5)(E) of this subsection describing reproducibility;
(ix)
paragraph (5)(F) of this subsection describing dosimetry;
(x)
paragraph (7) of this subsection describing quality control
tests of other modalities; and
(xi)
paragraph (8) of this subsection describing quality control
tests for mobile mammography machines.
(C)
Test results that are outside of the action limits shall
be corrected as follows.
(i)
In subparagraph (B)(i) or (iii) of this paragraph, corrective
actions shall be taken before any mammography films are processed.
(ii)
In subparagraph (B)(ii) or (iv)-(xi) of this paragraph,
corrective actions shall be taken before any mammography examinations are
performed.
(iii)
In all other tests described in subsection (l) of this
section, corrective actions shall be performed within 30 days of the test
date.
(D)
Documentation of the tests and the corrective actions described
in subparagraphs (A)-(C) of this paragraph shall be maintained in accordance
with subsection (nn)(3) of this section.
(10)
Surveys. At least once a year, each facility shall undergo
a survey by a medical physicist or by an individual under the direct supervision
of a medical physicist.
(A)
At a minimum, this survey shall include the following:
(i)
performance of tests to ensure that the facility meets
the quality assurance requirements of the weekly phantom image quality test
described in paragraph (2) of this subsection, the annual tests described
in paragraph (5) of this subsection, and if applicable, paragraphs (7) and
(8) of this subsection; and
(ii)
evaluation of the adequacy of the results of all tests
conducted by the facility as well as written documentation of any corrective
actions taken and their results in accordance with paragraphs (1)-(4) of this
subsection, and, if applicable, paragraphs (7) and (8) of this subsection.
(B)
The medical physicist shall provide a written survey report
to the facility within 30 days of the date of the survey. The report shall
include a summary of the tests performed by the medical physicist in clause
(i) of this subparagraph and the review of the tests performed by the facility
in clause (ii) of this subparagraph. The report shall also contain recommendations
for any required corrective actions.
(C)
If deficiencies are noted that involve any of the items
listed in paragraph (9)(B)(ii) and (vi)-(ix) of this subsection and, if applicable,
paragraph (9)(x) and (xi) of this subsection, a preliminary oral or written
report of the deficiencies shall be given to the facility within 72 hours
of the survey.
(D)
The survey report shall be dated and signed by the medical
physicist performing or supervising the survey. If the survey was performed
entirely or in part by another individual under the direct supervision of
the medical physicist, that individual and the part of the survey that individual
performed shall also be identified in the survey.
(E)
The survey report shall be maintained by the registrant
in accordance with subsection (nn)(3) of this section.
(11)
Mammography equipment evaluations. Additional evaluations
of mammography machines or image processors shall be conducted whenever a
new mammography machine or processor is installed, a mammography machine or
processor is disassembled and reassembled at the same or a new location, major
components of mammography machine are changed or repaired, or a processor
is repaired. These evaluations shall be used to determine whether the new
or changed equipment meets the requirements of applicable standards in subsections
(g) and (l) of this section.
(A)
All problems shall be corrected before the new or changed
equipment is put into service for examinations or film processing.
(B)
The mammography equipment evaluation and dosimetry shall
be performed by a medical physicist or by an individual under the direct supervision
of a medical physicist.
(12)
Facility cleanliness. The registrant shall establish and
implement adequate protocols for maintaining darkroom, screen, and view box
cleanliness and shall document that all cleaning procedures are performed
at the frequencies specified in the protocols.
(13)
Calibration of air kerma measuring instruments. Instruments
used by medical physicists in their annual survey to measure the air kerma
or air kerma rate from a mammography machine shall be calibrated at least
once every two years and each time the instrument is repaired. The instrument
calibration must be traceable to a national standard and calibrated with an
accuracy of plus or minus 6.0% (95% confidence level) in the mammography energy
range.
(14)
Infection control. Facilities shall establish and comply
with a system specifying procedures to be followed by the facility for cleaning
and disinfecting mammography equipment after contact with blood or other potentially
infectious materials. This system shall specify the methods for documenting
facility compliance with the infection control procedures established and
shall:
(A)
comply with all applicable federal, state, and local regulations
pertaining to infection control; and
(B)
comply with the manufacturer's recommended procedures for
the cleaning and disinfection of the mammography equipment used in the facility;
or
(C)
if adequate manufacturer's recommendations are not available,
comply with generally accepted guidance on infection control, until such recommendations
become available.
(m)
Quality assurance--mammography medical outcomes audit.
Each registrant shall establish and maintain a mammography medical outcomes
audit program to follow-up positive mammographic assessments and to correlate
pathology results with the interpreting physician's findings.
(1)
General requirements. Each registrant shall establish a
system to collect and review outcome data for all mammograms performed, including
follow-up on the disposition of all positive mammograms and correlation of
pathology results with the interpreting physician's mammography report. Analysis
of these outcome data shall be made individually and collectively for all
interpreting physicians at the facility. In addition, any cases of breast
cancer among women imaged at the facility that subsequently become known to
the facility shall prompt the facility to initiate follow-up on surgical and/or
pathology results and review of the mammograms taken prior to the diagnosis
of a malignancy.
(2)
Frequency of audit analysis. The facility's first audit
analysis shall be initiated no later than 12 months after the date the facility
becomes certified or 12 months after April 28, 1999, whichever date is the
latest. This audit analysis shall be complete within an additional 12 months
to permit completion of diagnostic procedures and data collection. Subsequent
audit analyses will be conducted at least once every 12 months. These shall
be maintained in accordance with subsection (nn)(3) of this section.
(3)
Reviewing interpreting physician. Each lead interpreting
physician or an interpreting physician designated by the lead interpreting
physician shall review the medical outcomes audit data at least once every
12 months. This individual shall analyze the results of the audit and shall
be responsible for the following:
(A)
recording the dates of the audit period(s);
(B)
documenting the results;
(C)
notifying other interpreting physicians of their results
and the registrant's aggregate results; and
(D)
documenting any follow up actions and the nature of the
follow up.
(n)
Mammographic procedure and techniques for mammography of
patients with breast implants. Each registrant shall have a procedure to inquire
whether or not the patient has breast implants prior to the mammographic exam.
Except where contraindicated, or unless modified by a physician's directions,
patients with breast implants shall have mammographic views to maximize the
visualization of breast tissue.
(o)
Clinical image quality. Clinical images produced by any
certified facility must continue to comply with the standards for clinical
image quality established by that facility's accreditation body.
(p)
Medical research. Any research using radiation producing
devices on humans must be approved by an IRB as required by Title 45, CFR,
Part 46 and Title 21, CFR, Part 56. The IRB must include at least one licensed
physician to direct any use of radiation in accordance with §289.231(b)
of this title.
(q)
Requirements for mammography systems used exclusively for
invasive interventions for localizations or biopsy procedures. Mammography
systems used exclusively for invasive interventions for localizations or biopsy
procedures, including mobile services, are exempt from this section, except
for the following:
(1)
purpose and scope in accordance with subsections (a) and
(b) of this section;
(2)
the applicable definitions in subsection (c) of this section;
(3)
prohibitions in accordance with subsection (d)(2) and (3)
of this section;
(4)
exemptions in accordance with subsection (e)(5) and (6)
of this section;
(5)
personnel operating equipment used exclusively for invasive
interventions for localizations or biopsy procedures shall have a current
certification as a medical radiologic technologist under the Medical Radiologic
Technologist Certification Act, Texas Occupational Code, Chapter 601.
(A)
Each medical radiologic technologist shall maintain qualifications
by meeting the following requirements:
(i)
participating in education programs by completing at least
6 CEUs on invasive interventions for localizations or biopsy procedures. The
continuing education shall be completed in accordance with subsection (f)(2)(C)(i)
of this section; and
(ii)
performing a minimum of 24 mammographic biopsy examinations
that shall be completed in accordance with subsection (f)(2)(C)(ii) of this
section;
(B)
If the medical radiologic technologist is an individual
who meets the continuing education and experience requirements of subsection
(f)(2) of this section, the accumulated CEUs and experience will satisfy the
requirements of subparagraph (A) of this paragraph;
(6)
medical physicists performing the tests in paragraph (9)
of this subsection shall meet the personnel requirements in subsection (f)(3)
of this section.
(7)
equipment standards in accordance with subsection (g)(6)
and (9) of this section;
(8)
having a written quality assurance program to ensure the
safety, reliability, clarity, and accuracy of mammography services performed
at the facility, including corrective actions to be taken if images are of
poor quality;
(9)
having a medical physicist perform an annual survey of
AEC, kVp, focal spot condition, HVL, and dosimetry tests in accordance with
subsection (l)(5)(A)-(D) and (F) of this section. The medical physicist shall
provide a preliminary oral or written report of deficiencies within 72 hours
of the survey if they involve AEC, focal spot, or dosimetry. The medical physicist
shall prepare a written report for the facility within 30 days of the date
of the survey to include the following:
(A)
a summary of the tests in subsection (l)(5)(A)-(D) and
(F) of this section with recommendations for corrective actions; and
(B)
date and signature of the medical physicist performing
or supervising the survey. If the survey was performed entirely or in part
by another individual under the direct supervision of the medical physicist,
that individual and the part of the survey that individual performed shall
also be identified in the survey.
(10)
correction of the deficiencies indicated in the test results
in accordance with subsection (l)(9)(B)(vi),(vii), and (ix) of this section
before any further examinations are performed;
(11)
maintaining applicable records in subsection (r)(1)-(3);
(12)
operating and safety procedures in accordance with subsection
(s)(1) of this section;
(13)
occupational dose limits in accordance with subsection
(s)(2) of this section;
(14)
technique chart in accordance with subsection (s)(3) of
this section;
(15)
receipt, transfer, disposal, calibration, and maintenance
records in accordance with subsection (s)(4) and (7) of this section;
(16)
viewing system in accordance with subsection (s)(5) of
this section;
(17)
exposure of individuals other than the patient in accordance
with subsection (s)(6) of this section;
(18)
certification requirements, except for FDA accreditation,
in accordance with subsection (t) of this section;
(19)
issuance of certification and specific terms and conditions
of certification in accordance with subsections (u) and (v) of this section;
(20)
responsibilities of a registrant in accordance with the
applicable portions of subsection (w) of this section;
(21)
expiration, termination, renewal, modification, revocation,
and reciprocity of certification in accordance with subsections (x)-(bb) of
this section;
(22)
inspections in accordance with subsection (cc) of this
section, except for subsection (cc)(1) of this section;
(23)
time requirements for record keeping in accordance with
the applicable portions of subsection (nn)(3) of this section; and
(24)
operating and safety procedures in accordance with the
applicable portions of subsection (nn)(4) of this section.
(r)
Record requirements. Records required by this section shall
be maintained for inspection by the agency in accordance with subsection (nn)(3)
of this section. Records may be maintained electronically in accordance with §289.231(ff)(3)
of this title.
(1)
Records for mammography machines authorized for mobile
services.
(A)
Copies of the following shall be kept with mammography
machines authorized for mobile services:
(i)
operating and safety procedures in accordance with subsection
(r)(1) of this section;
(ii)
medical radiologic technologists' credentials;
(iii)
current quality control records for at least the last
90 calendar days for on-board processors in accordance with subsection (l)(1)
of this section;
(iv)
current §289.203 of this title, §289.226 of
this title, §289.230 of this title, and §289.231 of this title;
(v)
copy of certification of mammography system;
(vi)
certification of inspection or notice of failure from
last inspection, if applicable; and
(vii)
copy of mammography facility accreditation.
(B)
Copies of all other records required by this section shall
be maintained at a specified location.
(2)
Records required at authorized use locations. Copies of
the following shall be kept at each authorized use location.
(A)
operating and safety procedures in accordance with subsection
(s)(1) of this section;
(B)
quality assurance program in accordance with subsections
(k), (l), and (m) of this section;
(C)
credentials for interpreting physicians operating at that
location in accordance with subsection (f)(1) of this section;
(D)
credentials for medical radiologic technologists operating
at that location in accordance with subsection (f)(2) of this section;
(E)
credentials for medical physicists operating at that location
in accordance with subsection (f)(3) of this section;
(F)
quality control records in accordance with subsection (k)(2)
of this section;
(G)
continuing education and experience records for interpreting
physicians, medical radiologic technologists, and medical physicists operating
at that location in accordance with subsection (f)(1)(C), (2)(C), and (3)(C)
of this section;
(H)
current physicist annual survey of the mammography system;
(I)
current §§289.203 of this title, 289.204 of this
title, 289.205 of this title, §289.226 of this title, §289.230 of
this title, and §289.231 of this title;
(J)
copy of certification of mammography system;
(K)
certification of inspection or notification of failure,
if applicable;
(L)
records of receipts, transfers, and disposal in accordance
with subsection (s)(4) of this section;
(M)
calibration, maintenance, and modification records in accordance
with subsection (s)(7) of this section; and
(N)
copy of mammography facility accreditation.
(s)
Other operating procedures.
(1)
Operating and safety procedures. Each registrant shall
have and implement written operating and safety procedures that shall be made
available to each individual operating x-ray equipment, including any restrictions
of the operating technique required for the safe operation of the particular
x-ray system. These procedures shall include, but are not limited to, the
items in subsection (nn)(4) of this section.
(2)
Occupational dose limits and personnel monitoring. Except
as otherwise exempted, all individuals who are associated with the operation
of a radiation machine are subject to the occupational dose requirements of §289.231(m)
of this title and the personnel monitoring requirements of §289.231(n)
and (q) of this title.
(3)
Technique Chart. A chart or manual shall be provided or
electronically displayed in the vicinity of the control panel of each machine
that specifies technique factors to be utilized versus patient's anatomical
size. The technique chart shall be used by all operators.
(4)
Receipt, transfer, and disposal of mammography machines.
Each registrant shall maintain records showing the receipt, transfer, and
disposal of mammographic machines. These records shall include the date of
receipt, transfer, or disposal, the name and signature of the individual making
the record, and the manufacturer's model and serial number from the control
panel of the mammographic machine. Records shall be maintained in accordance
with subsection (nn)(3) for inspection by the agency.
(5)
Viewing system. Windows, mirrors, closed circuit television,
or an equivalent system shall be provided to permit the operator to continuously
observe the patient during irradiation. The operator shall be able to maintain
verbal, visual, and aural contact with the patient.
(6)
Exposure of individuals other than the patient. Only the
staff and ancillary personnel required for the medical procedure or training
shall be in the room during the radiation exposure.
(7)
Calibration, maintenance, and modifications. Each registrant
shall maintain records showing calibrations, maintenance, and modifications
performed on each mammographic machine. These records shall include the date
of the calibration, maintenance, or modification performed, the name of the
individual making the record, and the manufacturer's model and serial number
of the control panel of the mammographic machine. These records shall be maintained
in accordance with subsection (nn)(3) of this section.
(t)
Certification requirements (state certification). In addition
to the requirements of §289.226(f) and if applicable, (i) of this title,
each applicant shall comply with the following.
(1)
Each person having a mammographic x-ray machine shall apply
for and receive certification for the mammography system from the agency before
beginning use of the mammographic x-ray machine on humans.
(2)
An application for mammography certification shall be signed
by a licensed physician. The signature of the applicant and the radiation
safety officer (RSO) shall also be required.
(3)
An applicant for certification must obtain a certification
on each mammography system that is used by the applicant or the applicant's
agent (for the purposes of the requirements of this paragraph, the word "used"
refers to the entity other than the technologist that directs the application
of radiation to humans). An application for mammography system certification
may contain information on multiple mammography machines. Each mammography
machine must be identified by referring to the machine's manufacturer, model
number, and serial number of the control panel. The registrant shall maintain
and provide proof of current accreditation and FDA certification status. If
accreditation or FDA certification expires before the expiration of the certification
of mammography systems, the registrant shall submit proof of renewed status
to the agency.
(4)
The applicant shall be qualified by reason of training
and experience to use the mammography machines for the purpose requested in
accordance with this chapter in such a manner as to minimize danger to public
health and safety.
(5)
Each applicant shall submit documentation of the following:
(A)
personnel qualifications, including dates of licensure
or certification, in accordance with subsection (f) of this section;
(B)
manufacturer, model, and serial number of each mammographic
machine control panel;
(C)
evidence of the following by a physicist meeting the requirements
of subsection (f)(3) of this section:
(i)
that each machine meets the equipment standards in subsection
(g) of this section; and
(ii)
the average glandular dose for one craniocaudal-caudal
view for each machine does not exceed the value in subsection (l)(5)(F) of
this section; and
(D)
self-referral program information in accordance with subsection
(h) of this section, if the facility offers self-referral mammography.
(6)
Applications shall be processed in accordance with the
following time periods.
(A)
The first period is the time from receipt of an application
by the Division of Licensing, Registration and Standards to the date of issuance
or denial of the certification or a written notice outlining why the application
is incomplete or unacceptable. This time period is 60 days.
(B)
The second period is the time from receipt of the last
item necessary to complete the application to the date of issuance or denial
of the certification. This time period is 30 days.
(C)
These time periods are exclusive of any time period incident
to hearings and post-hearing activities required by the Government Code, Chapters
2001 and 2002.
(7)
Notwithstanding the provisions of §289.204 of this
title, reimbursement of application fees may be granted in the following manner.
(A)
In the event the application is not processed in the time
periods as stated in paragraph (6) of this subsection, the applicant has the
right to request of the director of the Radiation Control Program full reimbursement
of all application fees paid in that particular application process. If the
director does not agree that the established periods have been violated or
finds that good cause existed for exceeding the established periods, the request
will be denied.
(B)
Good cause for exceeding the period established is considered
to exist if:
(i)
the number of applications for certification to be processed
exceeds by 15% or more the number processed in the same calendar quarter the
preceding year;
(ii)
another public or private entity utilized in the application
process caused the delay; or
(iii)
other conditions existed giving good cause for exceeding
the established periods.
(C)
If the request for full reimbursement authorized by subparagraph
(A) of this paragraph is denied, the applicant may then request a hearing
by appeal to the Commissioner of Health for a resolution of the dispute. The
appeal will be processed in accordance with Formal Hearing Procedures, Chapter
1, §§1.21-1.34 of this title (relating to the Texas Board of Health).
(u)
Issuance of certification of mammography systems. Issuance
of certification of mammography systems shall be in accordance with §289.226(n)
of this title.
(v)
Specific terms and conditions of certification of mammography
systems. Specific terms and conditions of certification of mammography systems
shall be in accordance with §289.226(l) of this title.
(w)
Responsibilities of registrant.
(1)
In addition to the requirements of §289.226(p)(4)-(7)
of this title, a registrant shall notify the agency in writing prior to any
changes that would render the information contained in the application or
the certification of mammography systems inaccurate. These include but are
not limited to the following:
(A)
name and mailing address;
(B)
street address where machine(s) will be used; and
(C)
mammography machines.
(2)
Prior to employing the individuals listed in subparagraphs
(A)-(E) of this paragraph, the registrant is required to verify and maintain
copies of their qualifications. Registrants utilizing relief interpreting
physicians or technologists from a temporary service do not need to notify
the agency unless these personnel will be at the facility for a period exceeding
four weeks. Documentation of qualifications of individuals listed in subparagraphs
(A)-(E) of this paragraph and notification of a change in any of the following
is required within 30 days of such change:
(A)
radiation safety officer;
(B)
lead interpreting physician;
(C)
interpreting physicians;
(D)
operators of equipment; or
(E)
licensed medical physicist.
(3)
Prior to operating mammography equipment at an additional
use location, the registrant shall submit an application to the agency for
approval and receive an amendment to the certification of mammography systems.
(4)
The following criteria applies to new, replacement, or
loaner mammography machines and mammography machines used for clinical trial
evaluations.
(A)
All mammography machines shall have either current accreditation
or have submitted an application to an accreditation body for review. If accreditation
expires, mammograms shall cease to be performed until such time as the accreditation
application is received by the accreditation body and approval is given. Mammography
machines that are loaner machines as described in subparagraph (C) of this
paragraph or machines involved in clinical trial evaluations as described
in subparagraph (D) of this paragraph are exempt from accreditation requirements.
(B)
A facility with an existing certification of mammography
system may begin using a new or replacement machine before receiving an updated
certification if the paperwork regarding the machine has been submitted to
the agency with a licensed medical physicist's report in accordance with subsection
(l)(10) of this section verifying compliance of the new machine with this
section. The physicist's report is required prior to using the machine on
patients.
(C)
Loaner mammography machines may be used on patients for
60 days without adding the mammography machine to the certification. A licensed
medical physicist's report verifying compliance of the loaner mammography
machine with this section shall be completed prior to use on patients. The
results of the survey must be submitted to the agency with a cover letter
indicating period of use. If the use period will exceed 60 days, the facility
shall add the mammography machine to their certification and a fee will be
assessed.
(D)
Mammography machines involved in clinical trial evaluations
may be used on patients for 60 days without adding the mammography machine
to an existing certification. A licensed medical physicist's report verifying
compliance of the unit with the manufacturer's specifications shall be completed
prior to use on patients. If the use period will exceed 60 days, the facility
shall add the machine to their certification and a fee will be assessed.
(E)
No fees will be assessed for loaner mammography machines
or evaluation periods of 60 days or less.
(F)
Loaner mammography machines or mammography machines involved
in clinical trial evaluations are exempt from the inspection requirement in
subsection (cc)(1) of this section.
(5)
Records of training and experience and all other records
required by this section shall be maintained for review in accordance with
subsection (nn)(3) of this section.
(x)
Expiration of certification of mammography systems.
(1)
Except as provided by subsection (z) of this section, each
certification of mammography systems expires at the end of the day in the
month and year stated on the certificate of registration on the expiration
date specified. Expiration of the certification of mammography systems does
not relieve the registrant of the requirements of this chapter.
(2)
If a registrant does not submit an application for renewal
of the certification of mammography systems under subsection (z) of this section,
as applicable, the registrant shall on or before the expiration date specified
in the certification of mammography systems:
(A)
terminate use of all mammography machines;
(B)
submit a record of the disposition of the mammography machines
and film storage location of mammography patient's films; and
(C)
pay any outstanding fees in accordance with §289.204
of this title.
(y)
Termination of certification of mammography systems. When
a registrant decides to terminate all activities involving mammography machines
authorized under the certification of mammography systems, the registrant
shall:
(1)
notify the agency immediately;
(2)
request termination of the certification of mammography
systems in writing;
(3)
submit a record of the disposition of the mammography machines;
(4)
pay any outstanding fees in accordance with §289.204
of this title; and
(5)
notify the agency of the film storage location of mammography
patient's films.
(z)
Renewal of certification of mammography systems.
(1)
Application for renewal of certification shall be filed
in accordance with this subsection and §289.226(e)(1)-(5) of this title.
(2)
If a registrant files an application in proper form at
least 30 days before the existing certification expires, such existing certification
shall not expire until the application status has been determined by the agency.
(3)
A certification for a mammographic system is valid for
three years from the date of issuance unless the certification of the facility
is revoked prior to such deadlines. This is effective for certificates issued
after September 1, 1997.
(A)
If a registrant fails to renew the certification by the
required date, the registrant may renew the certification on payment of the
annual fee and a late fee. If the certification is not renewed before the
181st day after the date on which the certification expired, the registrant
must apply for an original certification under this section.
(B)
A mammography system may not be used after the expiration
date of the certification unless the holder of the expired certification has
made a timely and sufficient application for renewal of the certificate as
provided in this subsection and §289.226(e)(1)-(5) of this title.
(aa)
Modification and revocation of certification of mammography
systems. Modification and revocation of certification of mammography systems
shall be in accordance with §289.226(u) of this title.
(bb)
Reciprocal recognition of out-of-state certificates of
registration. Mammography machines will not be granted reciprocal recognition
and must comply with the requirements of this section.
(cc)
Inspections. In addition to the requirements of §289.231(kk)
of this title, the following applies to inspections of mammography systems.
(1)
The agency shall inspect each mammography system that receives
a certification in accordance with this chapter not later than the 60th day
after the date the certification is issued.
(2)
The agency shall inspect, at least once annually, each
mammography system that receives a certification.
(3)
To protect the public health, the agency may conduct more
frequent inspections than required by this subsection.
(4)
The agency shall make reasonable attempts to coordinate
inspections in this section with other inspections required in accordance
with this chapter for the facility where the mammography system is used.
(5)
After each satisfactory inspection, the agency shall issue
a certificate of inspection for each mammography system inspected. The certificate
of inspection shall be posted at a conspicuous place on or near the place
where the mammography system is used. The certificate of inspection shall
include the following:
(A)
specific identification of the mammography system inspected;
(B)
the name and address of the facility where the mammography
system was used at the time of the inspection; and
(C)
the date of the inspection.
(6)
Any severity level I violation involving a mammography
system, found by the agency, in accordance with §289.205 of this title,
constitutes grounds for posting notice of failure of the mammography system
to satisfy agency requirements.
(A)
Notification of such failure shall be posted:
(i)
on the mammography x-ray machine at a conspicuous place
if the violation is machine-related; or
(ii)
near the place where the mammography system practices
if the violation is personnel-related; and
(iii)
in a sufficient number of places to permit the patient
to observe the notice.
(B)
The notice of failure shall remain posted until the facility
is authorized to remove it by the agency. A facility may post documentation
of corrections of the violations submitted to the agency along with the notice
of failure until approval to remove the notice of failure is received from
the agency.
(7)
The agency shall require registrants who receive a severity
level I violation to notify patients on whom the facility performed a mammogram
during the 30 days preceding the date of the inspection that revealed the
failure. The facility shall:
(A)
inform the patient that the mammography system failed to
satisfy the agency's certification standards;
(B)
recommend that the patient have another mammogram performed
at a facility with a certified mammography system; and
(C)
list the three facilities closest to the original testing
facility that have a certified mammography system.
(8)
In addition to the requirements of paragraph (7) of this
subsection, the agency may require a facility to notify a patient of any other
failure of the facility's mammography system to meet the agency's certification
standards.
(9)
The patient notification shall include the following:
(A)
explanation of the mammography system failure to the patient;
and
(B)
the potential consequences to the mammography patient.
(10)
The registrant shall maintain a record of the mammography
patients notified in accordance with paragraphs (7) and (8) of this subsection
for inspection by the agency. The records shall include the name and address
of each mammography patient notified, date of notification, and a copy of
the text sent to the individual.
(dd)
Accreditation of mammography facilities.
(1)
All mammography facilities shall be accredited by an authorized
FDA accreditation body. All facilities applying for and receiving accreditation
through the agency shall comply with §289.231(f)-(h), (j), (k), and (aa)
of this title, §289.203 of this title, §289.205 of this title, and
subsections (f) and (g), (i)-(o), (s), (w), (cc), (ee), (hh) and (nn)(1)-(4)
of this section.
(2)
In order to be accredited by the agency, the applicant
shall submit an application for accreditation on forms and in accordance with
accompanying instructions prescribed by the agency.
(A)
Each application shall be signed by a licensed physician.
(B)
The agency may at any time after the filing of the original
application, require further statements in order to enable the agency to determine
whether the accreditation document should be issued, denied, modified, or
revoked.
(C)
Applications and documents submitted to the agency may
be made available for public inspection except that the agency may withhold
any document or part thereof from public inspection in accordance with §289.231(aa)
of this title.
(D)
Each application for accreditation shall be accompanied
by the fee prescribed in subsection (ee) of this section.
(E)
Each applicant shall submit documentation of the following:
(i)
personnel qualifications, training, and experience in accordance
with subsection (f) of this section;
(ii)
manufacturer model and serial number of each mammographic
machine control panel; and
(iii)
evidence that a medical physicist performed a survey
and/or a mammography equipment evaluation in accordance with subsection (l)(10)
and (11) of this section within the following time frames:
(I)
no earlier than six months before the date of the accreditation
application for new facilities seeking accreditation;
(II)
no earlier than twelve months before the date of the application
for accreditation for facilities changing accreditation to one issued by this
agency; or
(III)
no earlier than 12 months before the date of the application
for renewal of accreditation for facilities accredited by this agency.
(F)
Upon notification by the agency, each applicant shall directly
submit clinical and phantom images to the image review board in accordance
with their procedures.
(ee)
Fees for accreditation of mammography facilities.
(1)
Each application for accreditation of a mammography facility
shall be accompanied by a nonrefundable fee. No application will be accepted
for filing or processed prior to payment of the full amount specified in paragraph
(3) of this subsection.
(2)
Fee payments shall be in cash or by check or money order
made payable to the Texas Department of Health. The payments may be mailed
or made by personal delivery to the Bureau of Radiation Control, Texas Department
of Health, 1100 West 49th Street, Austin, Texas 78756-3189.
(3)
Fees for accreditation of mammography facilities are as
follows.
(A)
The accreditation fee for the first mammography machine
is $850.
(B)
The accreditation fee for each additional mammography machine
is $460.
(C)
The fee for re-evaluation of clinical images due to failure
during the accreditation process is $250 per mammography machine.
(D)
The fee for re-evaluation of phantom images due to failure
during the accreditation process is $200 per machine.
(E)
The fee for an additional mammography review will be based
on the number of clinical image sets reviewed and the type of review.
(F)
The fee for reinstatement of a mammography machine is $580.
(G)
The fee for replacement of thermoluminescent dosimeters
(TLD) is $70.
(H)
Each facility for which a targeted clinical image review
is required will be charged for actual expenses to the agency arising from
the visit.
(I)
Each facility for which an on-site visit due to three denials
of accreditation is required will be charged for actual expenses to the agency
arising from such visit.
(J)
Payment of the fees in subparagraphs (H) and (I) of this
paragraph shall be made within 60 days following the date of invoice.
(ff)
Issuance of accreditation of a mammography facility. An
accreditation document will be issued when the mammography facility meets
the requirements of subsections (dd) and (ee) of this section and becomes
accredited by the agency. In order for an accreditation to be issued, the
agency must be notified by the image review board that the applicant met the
criteria for clinical images, phantom images, and dose evaluation.
(gg)
Specific terms and conditions of accreditation of mammography
facilities.
(1)
Each accreditation document issued in accordance with this
section shall be subject to the applicable provisions of the Act, now or hereafter
in effect, and to the applicable requirements and orders of the agency.
(2)
No accreditation document issued by the agency under this
section shall be transferred, assigned, or in any manner disposed of, either
voluntarily or involuntarily, to any person.
(hh)
Responsibilities of an accredited facility. A facility
shall notify the agency of any changes that would render the information contained
in the application inaccurate.
(ii)
Expiration and renewal of accreditation of mammography
facilities.
(1)
The accreditation shall expire on the date specified on
the accreditation document.
(2)
Application for renewal of accreditation shall be filed
in accordance with subsections (dd) and (ee) of this section.
(3)
A mammography facility filing an application for renewal
in accordance with (dd) and (ee) at least four months before the existing
accreditation expires may continue to perform mammography until the review
process is complete and the accreditation status has been determined by the
agency.
(4)
A mammography facility filing an application for renewal
in accordance with (dd) and (ee) less than four months before the existing
accreditation expires:
(A)
may continue to perform mammography until the expiration
date of the accreditation; or
(B)
if the facility receives written authorization from the
agency, may continue to perform mammography until the review process is complete
and the accreditation status has been determined by the agency.
(5)
Accreditation for a mammographic facility is valid for
three years from the date of issuance, unless accreditation of the facility
is revoked prior to such deadline.
(6)
Issuance of renewal of accreditation shall be in accordance
with subsection (ff) of this section.
(jj)
Denial or abandonment of an application for accreditation
of mammography facilities.
(1)
Denial of an application.
(A)
Any application for accreditation may be denied by the
agency when the applicant fails to meet established criteria for accreditation
in accordance with subsection (dd) of this section.
(B)
Before the agency denies an application for accreditation,
the agency shall give notice of the intent to deny, and the facts warranting
the denial, and shall afford the applicant an opportunity for a hearing in
accordance with §289.205(h) of this title. If no request for a hearing
is received by the director of the Radiation Control Program within 30 days
of personal service or the date of mailing, the agency may proceed to deny.
The applicant shall have the burden of proof showing cause why the application
should not be denied.
(2)
Abandonment of an application. Agency action on an application
will be abandoned due to lack of response by the applicant to a request for
information by the agency. Abandonment of such actions does not provide an
opportunity for a hearing; however, the applicant retains the right to resubmit
the application and pay a reinstatement fee at any time.
(kk)
Revocation and suspension of accreditation of mammography
facilities.
(1)
Revocation of accreditation of mammography facilities shall
be in accordance with §289.205 of this title.
(2)
Suspension of accreditation of mammography facilities.
(A)
An accreditation of a mammography facility may be suspended
for any of the following reasons:
(i)
any material false statement in the application or any
statement of fact required under provision of the Act;
(ii)
conditions revealed by such application or statement of
fact or any report, record, inspection, or other means that would warrant
the agency to refuse to grant an accreditation of mammography facility on
an original application; or
(iii)
failure to observe any of the terms and conditions of
the Act, this chapter, or order of the agency.
(B)
Before the agency suspends an accreditation of a mammography
facility, the agency shall give notice by personal service or by certified
mail, addressed to the last known address, of the facts or conduct alleged
to warrant the revocation by complaint, and order the accredited mammography
facility to show cause why the mammography facility accreditation should not
be suspended. The accredited mammography facility shall be given an opportunity
to request a hearing on the matter no later than 30 days after receipt of
the notice.
(C)
Any accredited mammography facility against whom the agency
contemplates an action described in subparagraph (A) of this paragraph may
request a hearing by writing the director within 30 days of service or date
of mailing.
(i)
The written request for a hearing must contain the following:
(I)
statement requesting a hearing;
(II)
name, address, and identification number of the accredited
mammography facility against whom the action is being taken.
(ii)
Failure to submit a written request for a hearing within
30 days will render the agency action final.
(D)
If the agency suspends the accreditation of a mammography
facility in accordance with subparagraph (A) of this paragraph, the suspension
shall remain in effect until the agency determines the following:
(i)
that allegations of violations or misconduct were not substantiated;
(ii)
that violations of required standards have been corrected
to the agency's satisfaction; or
(iii)
the facility's accreditation is revoked in accordance
with §289.205 of this title.
(ll)
On-site facility visit, targeted clinical image review,
and random film checks. Each accredited facility shall:
(1)
afford the agency, at all reasonable times, opportunity
to audit the facility where mammography equipment or associated equipment
is used or stored;
(2)
make available to the agency for inspection, upon reasonable
notice, records maintained in accordance with this chapter; or
(3)
upon request by the agency, make clinical images available
to the image review board for a targeted clinical review or random clinical
images review.
(mm)
Complaints. Each facility with accreditation from the
agency shall do the following:
(1)
establish a written procedure for collecting and resolving
consumer complaints;
(2)
maintain a record of each serious complaint received by
the facility in accordance with subsection (nn)(3) of this section; and
(3)
report unresolved serious complaints to the agency within
30 days of receiving the complaint.
(nn)
Appendices.
(1)
Subjects to be included in mammography training for medical
radiologic technologists shall include, but not be limited to, the following:
(A)
anatomy and physiology of the female breast that shall
include:
(i)
mammary glands;
(ii)
external anatomy;
(iii)
retromammary space;
(iv)
central portion;
(v)
Cooper's ligament;
(vi)
vessels, nerves, lymphatics; and
(vii)
breast tissue:
(I)
fibro-glandular;
(II)
fibro-fatty;
(III)
fatty; and
(IV)
lactating;
(B)
mammography positioning that shall include actual positioning
of patients and/or models as follows:
(i)
craniocaudal;
(ii)
mediolateral oblique;
(iii)
supplemental;
(iv)
magnification;
(v)
errors in positioning;
(vi)
postoperative breast and the augmented breast;
(vii)
breast localization and specimen radiography; and
(viii)
use of compression;
(C)
technical factors;
(D)
film evaluation and critique;
(E)
pathology; and
(F)
quality assurance program.
(2)
Subjects to be included in mammography training for interpreting
physicians shall include, but not be limited to, the following:
(A)
radiation physics, including radiation physics specific
to mammography;
(B)
radiation effects;
(C)
radiation protection; and
(D)
interpretation of mammograms. This shall be under the direct
supervision of a physician who meets the requirements of subsection (f)(1)
of this section.
(3)
Time requirements for record keeping. Time requirements
for record keeping shall be in accordance with the following chart.
Figure: 25 TAC §289.230(nn)(3)
(4)
Operating and safety procedures. The registrant's operating
and safety procedures shall include, but are not limited to, the following
procedures as applicable:
(A)
ordering x-ray exams in accordance with §289.231(b)
of this title;
(B)
occupational dose requirements in accordance with §289.231(m)
of this title;
(C)
posting of a radiation area in accordance with §289.231(x)
and (y) of this title;
(D)
personnel monitoring requirements in accordance with §289.231(n)
and (q) of this title;
(E)
posting notices to workers in accordance with §289.203(b)
of this title;
(F)
instructions to workers in accordance with §289.203(c)
of this title;
(G)
notifications and reports to individuals in accordance
with §289.203(d) of this title;
(H)
credentialing requirements for lead interpreting physicians,
interpreting physicians, medical radiologic technologists, and medical physicists
in accordance with subsection (f) of this section;
(I)
self-referral mammography in accordance with subsection
(h) of this section;
(J)
retention of clinical images in accordance with subsection
(i)(4) of this section;
(K)
quality assurance program in accordance with subsections
(k)-(m) of this section;
(L)
image quality and corrective action for images of poor
quality in accordance with subsection (k)(1)(B)(i) of this section;
(M)
repeat analysis in accordance with subsection (l)(3)(B)
of this section;
(N)
procedures and techniques for mammography patients with
breast implants;
(O)
use of a technique chart in accordance with subsection
(s)(3) of this section;
(P)
exposure of individuals other than the patient in accordance
with subsection (s)(6) of this section; and
(Q)
procedure to handle complaints in accordance with subsection
(mm) of this section.
(5)
Phantom image scoring protocol. Each of the following object
groups are to be scored separately. In order to receive a passing score on
the phantom image, all three test object groups must pass. A failure in any
one of the areas results in a phantom failure.
(A)
Fibers. A score of 4.0 for fibers is required to meet the
evaluation criteria. The diameter size of fibers are 1.56 mm, 1.12 mm, 0.89
mm, 0.75 mm, 0.54 mm, and 0.40 mm. Score the fibers as follows.
(i)
Begin with the largest fiber and move down in size, adding
one point for each full fiber until a score of zero or one half is given.
Stop counting at the first point where you lose visibility of objects.
(ii)
If the entire length of the fiber can be seen and its
location and orientation are correct, that fiber receives a score of one.
(iii)
If at least half, but not all, of the fiber can be seen
and its location and orientation are correct, that fiber receives a score
of one half.
(iv)
If less than one half of a fiber can be seen or if the
location or orientation are incorrect, that fiber receives a score of zero.
(v)
After determining the last fiber to be counted, look at
the overall background for artifacts. If there are background objects that
are fiber-like in appearance and are of equal or greater brightness than the
last visible half or full fiber counted, subtract the last half or full fiber
scored.
(B)
Speck groups. A score of 3.0 for speck groups is required
to meet the evaluation criteria. Diameter sizes of speck groups are 0.54 mm,
0.40 mm, 0.32 mm, 0.24 mm, and 0.16 mm. There are six specks per group. Score
the speck groups as follows.
(i)
Begin with the largest speck group and move down in size
adding one point for each full speck group until a score of one half or zero
is given, then stop.
(ii)
If at least four of the specks in any group are visualized,
the speck group is scored as one.
(iii)
If two or three specks in a group are visualized, the
score for the group is one half.
(iv)
If one speck or no specks from a group are visualized,
the score is zero.
(v)
After determining the last speck group to receive a full
or one-half point, look at the overall background for artifacts. If there
are speck-like artifacts within the insert region of the phantom that are
of equal or greater brightness than individual specks counted in the last
visible half or full speck group counted, subtract the artifact speck from
the observed specks, one by one. Repeat the scoring of the last visible speck
group after these deductions.
(C)
Masses. A score of 3.0 is required to meet the evaluation
criteria. Diameter sizes of masses are 2.00 mm, 1.00 mm, 0.75 mm, 0.50 mm,
and 0.25 mm. Score the masses as follows.
(i)
Begin with the largest mass and add one point for each
full mass observed until a score of one half or zero is assigned.
(ii)
Score one for each mass that appears as a minus density
object in the correct location that can be seen clearly enough to observe
round, circumscribed borders.
(iii)
Score one half if the mass is clearly present in the
correct location, but the borders are not visualized as circular.
(iv)
After determining the last full or half mass to be counted,
look at the overall background for artifacts. If there are background objects
that are mass-like in appearance and are of equal or greater visibility than
the last visible mass, subtract the last full or half point assigned from
the original score.
This agency hereby certifies that the adoption
has been reviewed by legal counsel and found to be a valid exercise of the
agency's legal authority.
Filed with the Office of
the Secretary of State on January 18, 2002.
TRD-200200300
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: February 7, 2002
Proposal publication date: October 5, 2001
For further information, please call: (512) 458-7236