Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 289 - RADIATION CONTROL
Subchapter E - REGISTRATION REGULATIONS
Section 289.234 - Mammography Accreditation
Universal Citation: 25 TX Admin Code ยง 289.234
Current through Reg. 49, No. 38; September 20, 2024
(a) Purpose. This section provides for the accreditation of mammography machines and facilities. The use of all mammography machines accredited in accordance with this section shall be by or under the supervision of a physician licensed by the Texas Medical Board.
(b) Scope. In addition to the requirements of this section, all mammography machines and facilities are subject to the requirements of § 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), § 289.230 of this title (relating to Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography), 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 meanings unless the context clearly indicates otherwise.
(1)
Accreditation--An approval of a mammography machine within a mammography
facility by an accreditation body. A facility may be accredited by the agency
accreditation body or another United States Food and Drug Administration
(FDA)-approved accreditation body.
(2) Act--Texas Radiation Control Act, Health
and Safety Code, Chapter 401.
(3)
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.
(4) 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 §
289.230(r)
of this title.
(5)
Agency accreditation body--For the purpose of this section, the agency as
approved by the FDA under Title 21, Code of Federal Regulations (CFR),
§900.3(d), to accredit mammography facilities in the State of
Texas.
(6) Agency certifying
body--For the purpose of this section, the agency, as approved by FDA, under
Title 21, CFR, §900.21, that certifies facilities within the State of
Texas to perform mammography services.
(7) Certification--An authorization for the
use of a mammography system or the certification of mammography machines used
for interventional breast radiography.
(8) Clinical image--See the definition for
mammogram.
(9) 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.
(10) 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 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.
(11) FDA-approved accreditation body--An
entity approved by the FDA under Title 21, CFR, §900.3(d), to accredit
mammography facilities.
(12)
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.
(13) 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.
(14) Interpreting physician--A
licensed physician who interprets mammographic images and who meets the
requirements of §
289.230(r)(1)
of this title.
(15) Mammogram--A
radiographic image produced through mammography.
(16) 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 §
289.230(z)
of this title; or
(B) with an
investigational mammography device as part of a scientific study conducted in
accordance with FDA's investigational device exemption regulations.
(17) 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.
(18) 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.
(19) Medical physicist--An individual who
performs surveys and evaluations of mammographic equipment and facility quality
assurance programs in accordance with this section and who meets the
qualifications in §
289.230(r)(3)
of this title.
(20) 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 §
289.230(r)(2)
of this title.
(21) 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.
(22) 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.
(23) Phantom image--A
radiographic image of a phantom.
(24) Radiation machine--For the purposes of
this part, radiation machine also means mammography machine.
(25) Reinstatement fee--The fee in accordance
with §
289.204(h)
of this title charged to reinstate an application for a mammography machine
that has been denied accreditation or whose application has been abandoned in
accordance with subsection (h)(3) of this section.
(26) 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 §
289.230(r)(1)
of this title;
(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 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.
(27) 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.
(28) Serious complaint--A
report of a serious adverse event.
(29) Survey--An on-site physics consultation
and evaluation of a facility quality assurance program performed by a medical
physicist.
(30) Targeted clinical
image review--A review of a minimum of two sets of "negative" clinical images
from a specific date, or date range, at the request of the agency.
(d) Accreditation of mammography facilities.
(1) All mammography facilities
shall be accredited by an FDA-approved accreditation body and shall meet the
quality standards in §289.230(r) - (aa) of this title. In order to qualify
for certification in accordance with §
289.230
of this title, new facilities applying to the agency accreditation body shall
receive acceptance of the accreditation application.
(2) The facility shall submit the following
information in addition to the information required in subsection §
289.230(f)
of this title:
(A) an application for
accreditation on forms and in accordance with accompanying instructions
prescribed by the agency accreditation body;
(B) the appropriate accreditation fee
prescribed in §
289.204
of this title; and
(C) evidence
that the medical physicist's survey and mammography equipment evaluation in
accordance with §
289.230(v)(10)
and (11) of this title was performed within
the following time frames:
(i) no more than
six months before the date of the accreditation application for new facilities
seeking accreditation;
(ii) no more
than 14 months before the date of the application for accreditation for
facilities changing accreditation to one issued by the agency accreditation
body; or
(iii) no more than 14
months before the date of the application for renewal of accreditation for
facilities accredited by the agency accreditation body.
(3) Upon notification by the
agency accreditation body, each applicant shall submit clinical and phantom
images directly to the image review board.
(e) Issuance of accreditation of a mammography facility. An accreditation document will be issued when the mammography facility meets the requirements of subsection (d) of this section and § 289.204 of this title and becomes accredited by the agency accreditation body. In order for an accreditation to be issued, the agency accreditation body must receive acceptable dose evaluation information from the dosimetry processor and be notified by the image review board that the applicant met the criteria for clinical images and phantom images, and dose evaluation.
(f) Denial or abandonment of an application for accreditation of mammography facilities.
(1) Any application for accreditation may be
denied by the agency accreditation body when the applicant fails to meet
established criteria for accreditation in accordance with subsection (d) of
this section.
(2) Before the agency
accreditation body denies an application for accreditation, the agency shall
give notice of the denial, 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 date of receipt of the notice, the
agency may proceed to deny. The applicant shall have the burden of proof
showing cause why the application should not be denied.
(3) Action on an accreditation application
will be abandoned due to lack of response by the applicant to a request for
information by the agency accreditation body. 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.
(g) Suspension and revocation of accreditation of mammography facilities.
(1) Suspension of accreditation of
mammography facilities.
(A) An accreditation
of a mammography facility may be suspended or revoked 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 accreditation body 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 accreditation body suspends or revokes an accreditation of a mammography
facility, the agency accreditation body 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 suspension or revocation by complaint, and order
the accredited mammography facility to show cause why the mammography facility
accreditation should not be suspended or revoked. 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 accreditation body contemplates an action described in
subparagraph (A) of this paragraph may request a hearing by writing the
director within 30 days of receipt of the notice.
(i) The written request for a hearing must
contain the following:
(I) a statement
requesting a hearing; and
(II) the
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 accreditation body action
final.
(D) If the agency
accreditation body suspends the accreditation of a mammography facility in
accordance with subparagraph (A) of this paragraph, the suspension shall remain
in effect until the agency accreditation body 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 accreditation body's satisfaction;
or
(iii) the facility's
accreditation is revoked in accordance with §
289.205
of this title.
(2) Revocation of accreditation of
mammography facilities shall be in accordance with §
289.205(g)
of this title.
(h) Appeal of adverse accreditation or reaccreditation decisions that preclude certification or recertification.
(1) The
appeal process described in this subsection is available only for adverse
accreditation or reaccreditation decisions that preclude certification by the
agency certifying body. Agency certifying body decisions to suspend or revoke
certificates that are already in effect will be handled in accordance with
§
289.230(h)
of this title.
(2) A facility that
has been denied accreditation or reaccreditation is entitled to an appeals
process from the agency accreditation body, in accordance with §
289.205
of this title. A facility must avail itself of the accreditation body's appeal
process before requesting reconsideration from the agency certifying
body.
(3) A facility that cannot
achieve satisfactory resolution of an adverse accreditation decision through
the accreditation body's appeal process is entitled to further appeal to the
FDA.
(4) A facility cannot perform
mammography services while an adverse accreditation decision is being
appealed.
(i) 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 accreditation body.
(2) No accreditation document issued by the
agency accreditation body under this section shall be transferred, assigned, or
in any manner disposed of, either voluntarily or involuntarily, to any
person.
(j) Responsibilities of an accredited facility. A facility shall notify the agency accreditation body of any changes that would render the information contained in the application inaccurate.
(k) Expiration and renewal of accreditation of mammography facilities.
(1) The accreditation expires at the end of
the day in the month and year stated on the accreditation document.
(2) An application for renewal of
accreditation with the agency accreditation body shall be filed in accordance
with subsection (d) of this section and with fees in accordance with §
289.204
of this title.
(3) A mammography
facility filing an application for renewal in accordance with subsection (d) of
this section and with fees in accordance with §
289.204
of this title 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 accreditation body.
(4) Accreditation for a mammographic facility
is valid for three years from the date of issuance, unless accreditation of the
facility is suspended or revoked prior to such deadline.
(5) Issuance of renewal of accreditation
shall be in accordance with subsection (e) of this section.
(l) Complaints. Each facility accredited by the agency accreditation body 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 §
289.230(ee)(3)
of this title; and
(3) report
unresolved serious complaints to the accreditation body within 30 days of
receiving the complaint.
(m) 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.
(n) Additional mammography review and patient notification. If the agency certifying body or the agency accreditation body believes that mammography quality at a facility may have been compromised and presents a serious risk to human health, the facility shall provide clinical images and other relevant information, as specified by the agency certifying body or the agency accreditation body for review by the accreditation body.
(o) Record requirements. Records required by this section shall be maintained for inspection by the agency in accordance with § 289.230(ee)(3) of this title. Records may be maintained electronically in accordance with § 289.231(ff)(3) of this title.
(p) On-site facility visit, targeted clinical image review, and random clinical image review.
(1) Each accredited facility shall afford the
agency accreditation body, at all reasonable times, an opportunity to audit the
facility where mammography equipment or associated equipment is used or
stored.
(2) Each accredited
facility shall make available to the agency accreditation body for inspection,
upon reasonable notice, records maintained in accordance with this
chapter.
(3) Each accredited
facility shall, upon request by the agency accreditation body or the agency
certifying body, make clinical images available to the image review board for a
targeted clinical image review or a random clinical image review. The agency
certifying body, the agency accreditation body, another FDA-approved
accreditation body, or the FDA may request a targeted clinical image review due
to, but not limited to, serious complaints or severe items of
non-compliance.
(4) Annually, the
agency accreditation body shall conduct on-site visits and random clinical
image reviews of a sample of facilities to monitor and assess their compliance
with standards established by the accreditation body. Other on-site visits may
be conducted based on problems identified through inspections, serious
complaints received from consumers or others, a previous history of
noncompliance, or any other information in the possession of the accreditation
body, inspectors, or FDA.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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