Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 289 - RADIATION CONTROL
Subchapter E - REGISTRATION REGULATIONS
Section 289.230 - Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography
Universal Citation: 25 TX Admin Code ยง 289.230
Current through Reg. 49, No. 38; September 20, 2024
(a) Purpose.
(1) This section provides for the
certification of mammography systems and mammography machines used for
interventional breast radiography. No person shall use radiation machines for
mammography of humans or for interventional breast radiography except as
authorized in a certification issued by the agency in accordance with the
requirements of this section. Certification by this agency includes
certification of mammography systems and facilities that have received
accreditation by the agency accreditation body or by another United States Food
and Drug Administration (FDA)-approved accreditation body and certification of
mammography machines used for interventional breast radiography.
(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 Medical Board.
(b) Scope.
(1) 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). Mammography facilities choosing to be
accredited by the agency accreditation body will be subject to §
289.234
of this title (relating to Mammography Accreditation).
(2) The procedures found in §
289.205
of this title for modifications, suspensions, revocations, denials, and
hearings regarding certificates of registration are applicable to
certifications issued by the agency.
(3) This section does not apply to an entity
under the jurisdiction of the federal government.
(4) An entity that is a "covered entity" as
that term is defined in HIPAA (the Health Insurance Portability and
Accountability Act of 1996, 45 Code of Federal Regulations (CFR), Parts 160 and
164) may be subject to privacy standards governing how information that
identifies a patient can be used and disclosed. Failure to follow HIPAA
requirements may result in the department making a referral of a potential
violation to the United States Department of Health and Human
Services.
(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
FDA-approved accreditation body.
(2) Act--Texas Radiation Control Act, Health
and Safety Code, Chapter 401.
(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 (includes targeted clinical image reviews)--At the request
of the agency certification body or an FDA-approved accreditation body, a
review by the FDA-approved accreditation body of clinical images and other
relevant facility information necessary to assess conformation with the
accreditation standards. The reviews include the following:
(A) clinical image review with
interpretation; or
(B) clinical
image 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 (r) of
this section.
(6) Agency
accreditation body--For the purpose of this section, the agency as approved by
the FDA under Title 21, CFR, §900.3(d) to accredit mammography facilities
in the State of Texas.
(7) Agency
certifying body--For the purpose of this section, the agency, as approved by
FDA, under Title 21, CFR, §900.21, to certify facilities within the State
of Texas to perform mammography services.
(8) 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.
(9) 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.
(10) Average glandular
dose--The average absorbed dose accruing to the glandular tissue of the
breast.
(11) Beam-limiting
device--A device that provides a means to restrict the dimensions of the x-ray
field.
(12) Breast implant--A
prosthetic device implanted in the breast.
(13) 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.
(14) 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.
(15) 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.
(16)
Certification--An authorization for the use of a mammography system or
mammography machines used for interventional breast radiography.
(17) Clinical image--See the definition for
mammogram.
(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
setting the technique factors.
(21)
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).
(22) 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.
(23) 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.
(24) 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.
(25) FDA-approved accreditation body--An
entity approved by the FDA under Title 21, CFR, §900.3(d), to accredit
mammography facilities.
(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 abnormality" 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;
(F) "known biopsy proven
malignancy" indicates appropriate action should be taken;
(G) "post procedure mammogram" indicates a
mammogram to confirm the deployment and position of a breast tissue marker;
or
(H) "incomplete" indicates there
is a need for additional imaging evaluation and/or prior mammograms for
comparison. 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 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) 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.
(33) Interpreting physician--A licensed
physician who interprets mammographic images and who meets the requirements of
subsection (r)(1) of this section.
(34) Interventional breast
radiography--Imaging of a breast during invasive interventions for localization
or biopsy procedures.
(35)
Investigational device exemption--An exemption that allows the investigational
device to be used in a clinical study in order to collect safety and
effectiveness data required to support a Premarket Approval application or a
510(k) Premarket Notification submission to FDA.
(36) Kerma--The sum of the initial energies
of all the charged particles liberated by uncharged ionizing particles in a
material of given mass.
(37)
Laterality--The designation of either the right or left breast.
(38) 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 (u), (v), and (w) of this section.
(39) Mammogram--A radiographic image produced
through mammography.
(40)
Mammographic modality--A technology for radiography of the breast. Examples are
screen-film mammography and full-field digital mammography.
(41) 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 (gg) 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.
(42) 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.
(43) Mammography medical outcomes
audit--A systematic collection of mammography results compared with outcomes
data.
(44) 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 mammography
and who meets the requirements of this section relating to the reading,
evaluation, and interpretation of mammograms.
(45) Mandatory training--Additional training
required by the agency certifying body or FDA-approved accreditation body for
interpreting physicians, medical radiologic technologists, or medical
physicists as the result of a required corrective action.
(46) Mean optical density--The average of the
optical densities measured using uniform, defect-free absorber thicknesses of
2, 4, and 6 centimeters (cm) with values of kilovolt peak (kVp) clinically
appropriate for those thicknesses.
(47) 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 subsection (r)(3) of this section.
(48) 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 (r)(2) of this
section.
(49) Mobile service
operation--The provision of mammography machines and personnel at temporary
sites for limited time periods.
(50) Multi-reading--Two or more physicians
interpreting the same mammogram. At least one physician shall be qualified as
an interpreting physician.
(51)
Optical density (OD)--A measure of the fraction of incident light transmitted
through a developed film and defined by the equation:
(52)
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.
(53) 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.
(54) Phantom
image--A radiographic image of a phantom.
(55) Physical science--This includes physics,
chemistry, radiation science (including medical physics and health physics),
and engineering.
(56) Positive
mammogram--A mammogram that has an overall assessment of findings that are
either "suspicious" or "highly suggestive of malignancy."
(57) Practitioner of the healing arts
(practitioner)--For the purposes of this section, a person licensed to practice
healing arts by the Texas Medical Board as a physician.
(58) Provisional certification--A provisional
authorization described in subsection (g) of this section.
(59) 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
(r) 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 manufacturers'
representatives.
(60) Quality
control technologist--An individual meeting the requirements of subsection
(r)(2) of this section who is responsible for those quality assurance
responsibilities not assigned to the lead interpreting physician or to the
medical physicist.
(61) Radiation
machine--For the purposes of this part, radiation machine also means
mammography machine.
(62)
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.
(63) 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.
(64) Serious complaint--A
report of a serious adverse event.
(65) Source-to-image receptor distance
(SID)--The distance from the source to the center of the input surface of the
image receptor.
(66) Standard
breast--A 4.2 cm thick compressed breast consisting of 50% glandular and 50%
adipose tissue.
(67) Survey--An
on-site physics consultation and evaluation of a facility quality assurance
program performed by a medical physicist.
(68) Technique chart--A chart that provides
all necessary generator control settings and geometry needed to make clinical
radiographs.
(69) 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 intentional 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 (bb) of this section; and
(C) exposure of an individual for the purpose
of research except as authorized by subsection (cc) 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 §
289.228
of this title (relating to Radiation Safety Requirements for Analytical and
Other Industrial Radiation Machines).
(2) Mammography machines used exclusively for
interventional breast radiography are exempt from the requirements of this
section except for those listed in subsection (gg) of this section. These
machines are not required to be accredited by an FDA-approved accreditation
body.
(3) Loaner machines as
described in subsection (n)(5) of this section are exempt from the inspection
requirements in subsection (ff) of this section. These machines are not
required to be accredited by an FDA-approved accreditation body.
(4) Mammography machines with investigational
device exemptions as described in subsection (cc) of this section and used in
clinical studies are exempt from the requirements of this chapter. These
machines are not required to be accredited by an FDA-approved accreditation
body.
(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) Requirements for mammography systems certification.
(1) To obtain a certification,
facilities shall meet the quality standards in subsections (r) - (aa) of this
section and be accredited by an FDA-approved accreditation body. In order to
qualify for certification, new facilities must apply to the agency certifying
body in accordance with the following requirements and to an FDA-approved
accreditation body and receive acceptance of the accreditation application. If
the facility chooses to be accredited by the agency accreditation body, the
facility shall submit the information required in this subsection and §
289.234(d)
of this title.
(2) Each person
having a mammography machine shall submit an application in accordance with
§289.226(e)(1) - (3) and (5) - (7) and (f)(4) - (5) of this title, and
receive certification from the agency certifying body before beginning use of
the mammography machine on humans.
(3) An application for certification shall be
signed by the lead interpreting physician. The signature of the applicant and
the radiation safety officer (RSO) shall also be required.
(4) An application for certification may
contain information on multiple mammography machines. Each mammography machine
must be identified by referring to the machine's manufacturer, model name, and
serial number on the control panel. If this is not a new certification, the
registrant shall maintain and provide proof of current accreditation. If
accreditation expires before the expiration of the certification, the
registrant shall submit proof of renewed status to the agency.
(5) Each applicant shall submit documentation
of the following:
(A) personnel
qualifications, including dates of licensure or certification, in accordance
with subsection (r) of this section;
(B) manufacturer, model name, and serial
number of each mammography machine control panel;
(C) evidence that a medical physicist:
(i) has determined that each machine meets
the equipment standards in subsection (s) of this section;
(ii) has performed a survey and a mammography
equipment evaluation in accordance with subsection (v)(10) and (11) of this
section; and
(iii) has determined
that the average glandular dose for one craniocaudal-caudal view for each
machine does not exceed the value in subsection (v)(5)(F) of this
section;
(D)
self-referral program information in accordance with subsection (bb) of this
section, if the facility offers self-referral mammography; and
(E) items required for authorization of a
mobile service operation in accordance with §
289.226(g)
of this title, if the facility provides a mobile service.
(g) Issuance of certification and provisional certification.
(1) Certification.
A certification will be issued if the agency certifying body determines that an
application meets the requirements of the Act and the requirements of this
chapter. The certification authorizes the proposed activity in such form and
contains such conditions and limitations as the agency certifying body deems
appropriate or necessary. The certification may include one of the following:
(A) mammography systems and facilities
certification, following approval of accreditation by an FDA-approved
accreditation body; or
(B)
certification of interventional breast radiography machines.
(2) Requirements and conditions.
The agency certifying body may incorporate in the certification at the time of
issuance, or thereafter by amendment, such additional requirements and
conditions with respect to the registrant's possession, use, and transfer of
radiation machines subject to this chapter as it deems appropriate or necessary
in order to:
(A) minimize danger to
occupational and public health and safety;
(B) require additional reports and the
keeping of additional records as may be appropriate or necessary; and
(C) prevent loss or theft of radiation
machines subject to this section.
(3) Additional information. The agency
certifying body may request, and the registrant shall provide, additional
information after the certification has been issued to enable the agency
certifying body to determine whether the certification should be modified in
accordance with §
289.226(r)
of this title.
(4) Provisional
certification application. A new facility is eligible to apply for a
provisional certification. The provisional certification will enable the
facility to perform mammography and to obtain the clinical images needed to
complete the accreditation process. To apply for and receive a provisional
certification, a facility must meet the requirements of this chapter and submit
the necessary information to an FDA-approved accreditation body. If the
facility chooses to be accredited by the agency accreditation body, the
facility shall submit the information required in subsection (f) of this
section and §
289.234(d)
of this title to the agency accreditation body.
(5) Issuing provisional certifications.
Following the agency certifying body's receipt of the accreditation body's
decision that a facility has submitted the required information, the agency
certifying body may issue a provisional certification to a facility upon
determination that the facility has satisfied the requirements of the Act and
this chapter. A provisional certification shall be effective for up to six
months from the date of issuance. A provisional certification cannot be
renewed, but a facility may apply for a 90-day extension of the provisional
certification.
(6) Extension of
provisional certification. Extension of provisional certifications shall be in
accordance with the following.
(A) To apply
for a 90-day extension to a provisional certification, a facility shall submit
to the FDA-approved accreditation body who issued the original certificate, a
statement of what the facility is doing to obtain certification and evidence
that there would be a significant adverse impact on access to mammography in
the geographic area served if such facility did not obtain an
extension.
(B) The agency
certifying body may issue a 90-day extension for a provisional certification
upon determination that the extension meets the criteria in paragraph (4) of
this subsection.
(C) There can be
no renewal of a provisional certification beyond the 90-day
extension.
(7)
Reinstatement policy. A previously certified facility that has allowed its
certification to expire, that has been refused a renewal of its certification
by the agency certifying body, or that has had its certification suspended or
revoked by the agency certifying body, may reapply to have the certification
reinstated so that the facility may be considered to be a new facility and
thereby be eligible for a provisional certification.
(A) Unless prohibited from reinstatement
under subsection (h)(5) of this section, a facility applying for reinstatement
shall:
(i) contact an FDA-approved
accreditation body for reapplication for accreditation;
(ii) fully document its history as a
previously provisionally certified or certified mammography facility, including
the following information:
(I) name and
address of the facility under which it was previously provisionally certified
or certified;
(II) name of previous
owner/lessor;
(III) facility
identification number assigned to the facility under its previous certification
by the FDA or the agency certifying body; and
(IV) expiration date of the most recent FDA
or agency provisional certification; and
(iii) justify application for reinstatement
of accreditation by submitting to an FDA-approved accreditation body a
corrective action plan that details how the facility has corrected deficiencies
that contributed to the lapse of, denial of renewal, or revocation of its
certification.
(B) The
agency certifying body may issue a provisional certification to the facility if
the agency determines that the facility:
(i)
has adequately corrected, or is in the process of correcting, pertinent
deficiencies; and
(ii) has taken
sufficient corrective action since the lapse of, denial of renewal, or
revocation of its previous certification.
(C) After receiving the provisional
certification, the facility may lawfully perform mammography while completing
the requirements for accreditation and certification.
(h) Suspension or revocation of certification.
(1) Except as provided in
paragraph (2) of this subsection, the agency certifying body may suspend or
revoke a certification issued by the agency certification body if it finds,
after providing the owner or operator of the facility with notice and
opportunity for a hearing in accordance with §
289.205
of this title, that the owner, operator, or any employee of the facility:
(A) has been guilty of misrepresentation in
obtaining the certification;
(B)
has failed to comply with the requirements of this chapter;
(C) has failed to comply with requests of the
agency certifying body or an FDA-approved accreditation body for records,
information, reports, or materials that are necessary to determine the
continued eligibility of the facility for a certification or continued
compliance with the requirements of this chapter;
(D) has refused a request of a duly
designated FDA inspector, state inspector, or an FDA-approved accreditation
body representative for permission to inspect the facility or the operations
and pertinent records of the facility;
(E) has violated or aided and abetted in the
violation of any provision of or regulation promulgated pursuant to the
requirements of the Act and the requirements of this chapter; or
(F) has failed to comply with prior sanctions
imposed by the agency certifying body under §
289.205
of this title.
(2) The
agency certifying body may suspend a certification of a facility before holding
a hearing if it makes a finding described in paragraph (1) of this subsection
and also determines that:
(A) the failure to
comply with requirements presents a serious risk to human health;
(B) the refusal to permit inspection makes
immediate suspension necessary; or
(C) there is reason to believe that the
violation or aiding and abetting of the violation was intentional or associated
with fraud.
(3) If the
agency certifying body suspends a certification in accordance with paragraph
(2) of this subsection:
(A) the agency
certifying body shall provide the facility with an opportunity for a hearing
under §289.205 not later than 60 days from the effective date of this
suspension; and
(B) the suspension
shall remain in effect until the agency certifying body determines that:
(i) allegations of violations or misconduct
were not substantiated;
(ii)
violations of requirements have been corrected to the agency certifying body's
satisfaction; or
(iii) the
certification is revoked in accordance with paragraph (4) of this
section.
(4)
After providing a hearing in accordance with paragraph (3)(A) of this
subsection, the agency certifying body may revoke the certification if the
agency determines that the facility:
(A) is
unwilling or unable to correct violations that were the basis for suspension;
or
(B) has engaged in fraudulent
activity to obtain or continue certification.
(5) If a facility's certification was revoked
on the basis of an act described in §
289.205
of this title, no person who owned or operated that facility at the time the
act occurred may own or operate a mammography facility within two years of the
date of revocation.
(i) 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
subsection (h) of this section.
(2)
Upon learning that a facility has failed to become accredited or reaccredited,
the agency certifying body will notify the facility that the agency certifying
body is unable to certify that facility without proof of
accreditation.
(3) A facility that
has been denied accreditation or reaccreditation and cannot achieve
satisfactory resolution of an adverse accreditation decision through the
FDA-approved 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.
(j) Denial of certification.
(1) The agency certifying body
may deny the application if the agency certifying body has reason to believe
that:
(A) the facility will not be operated
in accordance with the provisions of subsections (r) - (aa) of this
section;
(B) the facility will not
permit inspections or provide access to records or information in a timely
fashion;
(C) any material false
statement in the application or any statement of fact required under provision
of the Act was made;
(D) conditions
revealed by such application or statement of fact or any report, record,
inspection, or other means that would warrant the agency certification body to
refuse to grant a certification of mammography facility on an original
application; or
(E) the facility
failed to observe any of the terms and conditions of the Act, this chapter, or
order of the agency.
(2)
Before the agency certification body denies an application for certification,
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) If the agency certifying body denies an
application for certification by a facility that has received accreditation
from an FDA-approved accreditation body, the agency certifying body shall
provide the facility with a written statement of the grounds on which the
denial is based.
(k) Appeals of denial of certification.
(1) The
appeals procedures described in this subsection are available only to
facilities that are denied certification by the agency certifying body after
they have been accredited by an FDA-approved accreditation body. Appeals for
facilities that have failed to become accredited with the agency accreditation
body shall be in accordance with §
289.234(h)
of this title.
(2) A facility that
has been denied certification may request reconsideration and appeal of the
agency certifying body's determination in accordance with the applicable
provisions of §
289.205
of this title.
(l) Modification of certification. Modification of certification shall be in accordance with § 289.226(r) of this title.
(m) Specific terms and conditions of certification. Specific terms and conditions of certification shall be in accordance with § 289.226(l) of this title.
(n) Responsibilities of registrant.
(1) In addition to the
requirements of §289.226(m)(3) - (7) of this title, a registrant shall
notify the agency certifying body in writing prior to any changes that would
render the information contained in the application or the certification
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. If a facility makes a change in the RSO, the qualifications of
the RSO shall be submitted to the agency within 30 days of such change. Written
notification of a change in any of the following in subparagraphs (B) - (E) of
this paragraph is required within 30 days of such change:
(A) radiation safety officer;
(B) lead interpreting physician;
(C) interpreting physicians;
(D) medical radiologic technologists;
or
(E) medical physicist.
(3) Registrants utilizing
interpreting physicians or technologists from a temporary service shall verify
and maintain copies of the qualifications of these individuals for inspection
by the agency. The registrant does not need to notify the agency certifying
body unless these personnel will be at the facility for a period exceeding four
weeks.
(4) All mammography
facilities installing new or replacement mammography machines shall have either
current accreditation or have submitted an application to an FDA-approved
accreditation body for review unless exempted by subsection (e)(1) - (3) of
this section. A mammography machine shall not be used to perform mammograms if
an application for accreditation for that machine has been denied, or if the
accreditation has been suspended or expired.
(5) A facility with an existing certification
may begin using a new or replacement machine before receiving an updated
certification if the registrant submits to the agency certifying body and to
the FDA-approved accreditation body, documentation with a medical physicist's
report in accordance with subsection (v)(10) and (11) of this section,
verifying compliance of the new machine with this section. The medical
physicist's report is required prior to using the machine on
patients.
(6) Loaner mammography
machines may be used on patients for 60 days without adding the mammography
machine to the certification. A 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 its certification and a fee
will be assessed.
(7) Records of
training and experience and all other records required by this section shall be
maintained for review in accordance with subsection (ee) of this
section.
(o) Renewal of certification.
(1) A certification for a
mammography system is valid for three years from the date of issuance unless
the certification of the facility is suspended or revoked prior to such
deadlines.
(2) A mammography
facility filing an application for renewal of their certification shall meet
the quality standards in subsections (r) - (aa) of this section and be
accredited by an FDA-approved accreditation body. The renewal shall be filed in
accordance with the following:
(A)
§289.226(e)(1) - (3), (5) and (7) of this title and §
289.226(f)(4)
and (5) of this title;
(B) signatures of appropriate personnel in
accordance with subsection (f)(3) of this section;
(C) machine information and medical
physicist's survey in accordance with subsection (f)(5)(B) and (C) of this
section;
(D) fees in accordance
with §
289.204
of this title; and
(E) a list of
all interpreting physicians, medical radiologic technologists and medical
physicists practicing at the facility.
(3) A mammography facility filing an
application for renewal before the existing certification expires may continue
to perform mammography until the application status has been determined by the
agency.
(4) A facility with
mammography machines used for interventional breast radiography shall file an
application for renewal in accordance with subsection (gg)(8) of this section
and pay the fee required by §
289.204
of this title.
(p) Expiration of certification.
(1) Except as
provided by subsection (o) of this section, each certification expires at the
end of the day in the month and year stated on the mammography certificate.
Expiration of the certification 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
under subsection (o) of this section, as applicable, the registrant shall on or
before the expiration date specified in the certification:
(A) terminate use of all mammography
machines;
(B) notify the agency
certifying body in writing of the film storage location of mammography
patients' films and address how the requirements of subsection (t)(4)(D) of
this section will be met;
(C) pay
any outstanding fees in accordance with §
289.204
of this title; and
(D) submit a
record of the disposition of the mammography machine(s) to the agency
certifying body. If the machine(s) was transferred, include to whom it was
transferred.
(q) Termination of certification. When a registrant decides to terminate all activities involving mammography machines authorized under the certification, the registrant shall:
(1) notify the agency certifying body and the
FDA-approved accreditation body immediately;
(2) request termination of the certification
in writing;
(3) pay any outstanding
fees in accordance with §
289.204
of this title;
(4) notify the
agency certifying body, in writing, of the film storage location of mammography
patients' films and address how the requirements of subsection (t)(4)(D) of
this section will be met; and
(5)
submit a record of the disposition of the mammography machine(s) to the agency
certifying body. If the machine(s) was transferred, include to whom it was
transferred.
(r) 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 Medical Board 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 (hh)(2) of
this section;
(ii) have had a
minimum of 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; 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 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;
(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/or
(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.
(E) Additional mandatory training. Additional
mandatory training may be required by the agency based on the recommendations
of the American College of Radiology or the FDA. Such training will be
developed on a case by case basis.
(i) The
agency may require pre-approval of any additional mandatory training.
(ii) Documentation of the additional
mandatory training shall be submitted for review by the date specified by the
agency.
(iii) Records of all
additional mandatory training shall be maintained by the registrant for
inspection by the agency in accordance with subsection (ee)(3) of this
section.
(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 (hh)(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 requirements 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, and any other 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 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, at least six of which shall be
related to each modality used by the technologist in mammography;
and/or
(ii) performing a minimum of
25 mammographic examinations under the direct supervision of a qualified
medical radiologic technologist.
(E) Additional mandatory training. Additional
mandatory training may be required by the agency based on the recommendations
of the American College of Radiology or the FDA. Such training will be
developed on a case by case basis.
(i) The
agency may require pre-approval of any additional mandatory training.
(ii) Documentation of the additional
mandatory training shall be submitted for review by the date specified by the
agency.
(iii) Records of all
additional mandatory training shall be maintained by the registrant for
inspection by the agency in accordance with subsection (ee)(3) of this
section.
(3)
Medical physicist. Each medical physicist performing mammographic surveys,
evaluating mammographic equipment, or providing oversight of the facility
quality assurance program in accordance with subsection (u) of this section,
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 an entity registered with the agency,
in accordance with §
289.226(j)
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.
(B)
Alternative initial qualifications. Individuals who qualified as a medical
physicist in accordance with the requirements of this section 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 his/her 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/or
(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 machines for the prior 24
months. No more than one survey of a specific machine within a period of 60
days shall be counted towards the total mammography machine survey
requirement.
(4) Retention of personnel records. Records
documenting the qualifications, continuing education, and experience of
personnel in subsection (r)(1) - (3) shall be maintained for inspection by the
agency in accordance with subsection (ee) of this section.
(s) Equipment standards. Only 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 receptors. 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 from
between the source and image receptor 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 (for
example, 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 automatic exposure control (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, contact,
magnification, and various image receptor sizes.
(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.
(15) Light
fields. For any mammography system with a light beam that passes through the
x-ray beam-limiting device, the light shall provide an average illumination of
not less than 160 lux (15 foot candles) at 100 cm or the maximum source-image
receptor distance (SID), whichever is less.
(t) 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 date of
birth;
(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 physician
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 health care providers or physicians, as applicable.
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 or needing
repeat exams.
(4)
Retention of clinical images for current, closed or terminated registrants.
(A) Each registrant that performs mammograms
shall maintain mammography films and reports in a permanent medical record for
a minimum of five years. If no additional mammograms of the patient are
performed at the facility, the films and reports shall be maintained for a
minimum of ten years.
(B) Each
registrant that performs mammograms shall, within 30 days of request by 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.
(D) Upon closure or termination, the
registrant shall maintain the mammography films for 5 years. If the facility
complies with the following:
(i) within 180
days of closing, the registrant shall directly notify each patient or patient's
representative with instructions on how to retrieve or authorize disposal of
the patient's records; and
(ii)
within 60 days of closing, the registrant shall publish a notice in one or more
newspapers covering the geographical area served by the closing facility. The
notice shall include:
(I) contact information
on retrieving patient records; and
(II) information that the records will be
destroyed if not retrieved by the patient or the patient's representative
within 5 years; and
(iii) if records have not been retrieved by
the patient or the patient's representative following the 5-year period after
closing, the registrant may destroy the records.
(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
date of birth;
(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.
(u) 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 (v) and (w) 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
within 60 days of the receipt of the results 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 (v)(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 (v)(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 control technologist shall
insure that the requirements of subsection (v)(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 subsections (v) and (w) of this section, in accordance with
subsection (ee) of this section.
(v) 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 paragraphs (4)(B) and (5)(H) of this subsection, 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) Film processors being used for
mammography at multiple locations, such as a mobile service operation, shall be
subject to the requirements of this paragraph.
(C) 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.
(D) Each registrant shall utilize the same
film 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 do the
following:
(i) use a container to transport
clinical images that will protect the film from exposure to light and
radiation; and
(ii) 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.
(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 (hh)(4) of
this section or paragraph (7) of this subsection.
(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
service operations.
(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 maximum compression force for the initial power drive shall be
between 25 pounds and 45 pounds. The 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.
(5) Annual quality control tests. These tests
shall be performed at an interval not to exceed (14) months.
(A) Automatic exposure control performance.
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 and in the AEC mode used clinically in the
facility.
(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. Facilities shall evaluate focal spot condition by determining the
system resolution as follows.
(i) Each 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 clause (i) of this subparagraph 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.
(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. This test is performed using the clinical kVp on the standard
breast. Values not shown in Table I may be determined by linear interpolation
or extrapolation.
(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 7.0 mGy air kerma per second (800
milliroentgen (mR) per second) when operating at 28 kVp in the standard
mammography mode at any SID where the system is designed to operate. 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 subparagraph (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
service operation. 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 following shall occur.
(A) The registrant shall 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 quality assurance tests shall have corrective actions as indicated in the
following.
(i) If components in subclause (I)
and (II) of this clause fail, corrective action shall be taken before any
mammography films are processed:
(I)
paragraph (1) of this subsection describing processor quality control;
and
(II) paragraph (4)(A) of this
subsection describing darkroom fog;
(ii) If components in subclause (I) - (VI) of
this clause fail, corrective action shall be taken before any mammography
examinations are performed:
(I) paragraph (2)
of this subsection describing phantom image quality;
(II) paragraph (4)(B) of this subsection
describing screen-film contact;
(III) paragraph (4)(C) of this subsection
describing compression device performance;
(IV) paragraph (5)(F) of this subsection
describing dosimetry;
(V) paragraph
(7) of this subsection describing quality control tests of other modalities;
and
(VI) paragraph (8) of this
subsection describing quality control tests for mobile mammography
machines.
(iii) If
components in the remaining quality assurance tests in subsection (v) of this
section fail, corrective action shall be taken within 30 days of the test
date.
(C) Documentation
of the tests and the corrective actions described in subparagraph (B) of this
paragraph shall be maintained in accordance with subsection (ee) 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, quality control tests as described for other modalities in
paragraph (7) and for mobile service operations as described in paragraph (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 test performed, all test conditions,
specifications, results and recommendations for corrective actions, in
accordance with subparagraph (A)(i) and (ii) of this paragraph.
(C) If the following tests indicate
deficiencies, the physicist shall give a preliminary oral or written report to
the facility within 72 hours of the survey:
(i) processor quality control in accordance
with paragraph (9)(B)(i)(I) of this subsection;
(ii) phantom images, screen-film contact,
compression device performance, or dosimetry in accordance with paragraph
(9)(B)(ii)(I) - (IV) of this subsection;
(iii) quality control tests for other
modalities, if applicable, in accordance with paragraph (9)(B)(ii)(V) of this
subsection; or
(iv) quality control
tests for mobile mammography machines, if applicable, in accordance with
paragraph (9)(B)(ii)(VI) of this subsection.
(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 (ee) 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 overhauled or
reconditioned. These evaluations shall be used to determine whether the new or
changed equipment meets the requirements of applicable standards in this
subsection and subsection (s) 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.
(w) 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. This program shall be designed to ensure the reliability, clarity, and accuracy of the interpretation of mammograms.
(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 (ee) 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.
(x) 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.
(y) Complaints. Each accredited facility 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 (ee) of this
section; and
(3) report unresolved
serious complaints to the facility's FDA-approved accreditation body within 30
days of receiving the complaint.
(z) 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.
(aa) Additional mammography review, targeted clinical reviews, and patient notification.
(1) If the agency certifying 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, for
review by the FDA-approved accreditation body.
(2) If the agency certifying body determines
that mammography quality at a facility has 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, for
review by the FDA-approved accreditation body. The agency certifying body may
require such facility to notify patients who received mammograms, and their
referring physicians. The notification shall include the deficiencies
presenting such risk, the potential consequences to the patient, appropriate
remedial measures, and such other relevant information as the agency certifying
body may require. Such notification shall occur within a time frame and in a
manner specified by the agency.
(3)
The agency certifying body, the agency accreditation body or 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.
(bb) 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
(t)(2) of this section;
(B)
follow-up with patients and physicians in accordance with subsection (t)(3) of
this section; and
(C) recommending
to patients who do not have a physician means of selecting a physician;
and
(4) methods for
educating mammography patients in breast self-examination techniques and on the
necessity for follow-up by a physician.
(cc) Medical research and investigational devices.
(1) 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.
(2) Facilities with
mammography machines with investigational device exemptions that are involved
in clinical studies must comply with primary regulations that govern the
conduct of clinical studies and that apply to the manufacturers, sponsors,
clinical investigators, institutional review boards, and the medical device.
These regulations include the following:
(A)
21 CFR, Part 812, Investigational Device Exemptions;
(B) 21 CFR, Part 50, Protection of Human
Subjects;
(C) 21 CFR, Part 56,
Institutional Review Boards;
(D) 21
CFR, Part 54, Financial Disclosure by Clinical Investigators; and
(E) 21 CFR, Part 821, Subpart C, Design
Controls of the Quality System Regulation.
(dd) 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 system. These procedures shall include, but are not
limited to, the items in subsection (hh)(3) of this section.
(2) 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.
(3) 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 name and serial
number from the control panel of the mammographic machine. Records shall be
maintained in accordance with subsection (ee) of this section for inspection by
the agency.
(4) 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.
(5)
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 unless such individual's assistance is
required.
(6) Protective devices.
Protective devices shall be utilized when required, as in paragraph (7) of this
subsection.
(A) Protective devices shall be
of no less than 0.25 mm lead equivalent material.
(B) Protective devices, including aprons,
gloves, and shields shall be checked annually for defects such as holes,
cracks, and tears. These checks may be performed by the registrant by visual or
tactile means, or x-ray imaging. If a defect is found, protective devices shall
be replaced or removed from service until repaired. A record of this test shall
be made and maintained by the registrant in accordance with subsection (ee) of
this section for inspection by the agency.
(7) Holding of patient or image receptor.
(A) When a patient or image receptor must be
held in position during radiography, mechanical supporting or restraining
devices shall be used when the exam permits.
(B) If a patient or image receptor must be
held by an individual during an exposure, that individual shall be protected
with appropriate shielding devices described in paragraph (6) of this
subsection.
(C) The registrant's
written operating and safety procedures required by paragraph (1) of this
subsection shall include the following:
(i) a
list of circumstances in which mechanical holding devices cannot be routinely
utilized; and
(ii) a procedure used
for selecting an individual to hold or support the patient or image
receptor.
(D) In those
cases where the patient must hold the image receptor, any portion of the body
other than the area of clinical interest struck by the useful beam shall be
protected by not less than 0.25 mm lead equivalent material.
(8) 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 manufacture's
model name and serial number of the control panel of the mammographic machine.
These records shall be maintained in accordance with subsection (ee) of this
section.
(ee) Record requirements. Records required by this section shall be maintained for inspection by the agency in accordance with paragraph (3) of this subsection. Records may be maintained electronically in accordance with § 289.231(ff)(3) of this title.
(1) Records for mammography
machines authorized for mobile service operations.
(A) Copies of the following shall be kept
with mammography machines authorized for mobile services:
(i) operating and safety procedures in
accordance with subsection (dd)(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 (v)(1) of this section;
(iv) current §
289.203
of this title, §
289.226
of this title, § 289.230 of this title, §
289.231
of this title, and §
289.234
of this title if accredited by the agency accreditation body;
(v) copy of certification;
(vi) certification of inspection in
accordance with subsection (ff)(5) of this section;
(vii) notice of failure from last inspection
in accordance with subsection (ff)(6) of this section, if applicable;
and
(viii) copy of mammography
accreditation.
(B)
Copies of all other records required by this section shall be maintained at a
specified location.
(2)
Records required at separate authorized use locations. Copies of the following
shall be kept at each separate authorized use location:
(A) credentials for interpreting physicians
operating at that location in accordance with subsection (r)(1) of this
section;
(B) credentials for
medical radiologic technologists operating at that location in accordance with
subsection (r)(2) of this section;
(C) credentials for medical physicists
operating at that location in accordance with subsection (r)(3) of this
section;
(D) continuing education
and experience records for interpreting physicians, medical radiologic
technologists, and medical physicists operating at that location in accordance
with subsection (r)(1)(C), (2)(C), and (3)(C) of this section;
(E) mandatory training records for
interpreting physicians and medical physicists operating at that location in
accordance with subsection (r)(1)(E) and (2)(E) of this section, if
applicable;
(F) current physicist
annual survey of the mammography system;
(G) current §
289.203
of this title, §
289.226
of this title, § 289.230 of this title, §
289.231
of this title, and §
289.234
of this title if accredited by the agency accreditation body;
(H) copy of certification;
(I) quality assurance program in accordance
with subsections (u), (v), and (w) of this section;
(J) quality control records in accordance
with subsection (u)(2) of this section;
(K) operating and safety procedures in
accordance with subsection (dd)(1) of this section;
(L) records of receipts, transfers, and
disposal in accordance with subsection (dd)(3) of this section;
(M) calibration, maintenance, and
modification records in accordance with subsection (dd)(8) of this
section;
(N) certification of
inspection in accordance with subsection (ff)(5) of this section;
(O) notification of failure in accordance
with subsection (ff)(6), if applicable;
(P) records of notification of patients in
accordance with subsection (ff)(10) this section; and
(Q) copy of mammography
accreditation.
(3) Time
requirements for record keeping. Time requirements for record keeping shall be
according to the following chart.
(ff) Inspections. In addition to the requirements of § 289.231(kk) of this title, the following applies to inspections of mammography systems.
(1) The agency may 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 may 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 may 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 may 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 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) Facilities that receive a severity level
I violation shall notify patients on whom the facility performed a mammogram
during the period in which the system failed to meet the agency's certification
standards. The facility shall:
(A) inform the
patient that the mammography system failed to satisfy the agency certifying
body's standards;
(B) recommend
that the patient consult with the patient's physician regarding the need for
another mammogram; 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)
an explanation of the mammography system failure to the patient; and
(B) the potential consequences to the
mammography patient.
(10) The registrant shall make 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. The records shall be maintained
in accordance with subsection (ee) of this section.
(gg) Requirements for interventional breast radiography machines.
(1) Prohibitions.
(A) The agency may prohibit use of
interventional breast radiography machines that pose a significant threat or
endanger public health and safety, in accordance with §
289.231
and §
289.205
of this title.
(B) 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. The provision
specifically prohibits intentional exposure of an individual for training,
demonstration, or other non-healing arts purposes.
(2) Exemptions.
(A) Machines used exclusively for
interventional breast radiography are not required to be accredited by an
FDA-approved accreditation body.
(B) Loaner machines as described in
subsection (n)(6) of this section are exempt for the inspection requirements in
subsection (ff) of this section.
(C) All interventional breast radiography
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.
(3) Requirements for interventional breast
radiography machine certification.
(A) Each
person having an interventional breast radiography machine shall submit an
application in accordance with §289.226(e)(1) - (3), (5), and (7) of this
title, and shall receive certification from the agency within 30 days of
beginning use.
(B) An application
for certification shall be signed by a licensed physician, the applicant and
the RSO.
(C) An application for
certification may contain information on multiple interventional breast
radiography machines. Each machine must be identified by referring to the
machine's manufacturer, model name and serial number on the control
panel.
(D) Each applicant shall
submit documentation of evidence that a medical physicist's survey has been
performed in accordance with paragraph (13) of this subsection.
(4) Issuance of certification.
(A) Certification. A certification for
interventional breast radiography machines will be issued if the agency
determines that an application meets the requirements of the Act and the
requirements of this chapter. The certification authorizes the proposed
activity in such form and contains such conditions and limitations as the
agency deems appropriate or necessary.
(B) Requirements and conditions. The agency
may incorporate in the certification at the time of issuance, or thereafter by
amendment, such additional requirements and conditions with respect to the
registrant's possession, use, and transfer of radiation machines subject to
this chapter as it deems appropriate or necessary in order to:
(i) minimize danger to occupational and
public health and safety;
(ii)
require additional reports and the keeping of additional records as may be
appropriate or necessary; and
(iii)
prevent loss or theft of radiation machines subject to this section.
(C) Additional information. The
agency may request, and the registrant shall provide, additional information
after the certification has been issued to enable the agency to determine
whether the certification should be modified in accordance with §
289.226(r)
of this title.
(5)
Modification, suspension, or revocation of certification. Modification,
suspension, or revocation of certification shall be in accordance with §
289.226(r)
of this title.
(6) Specific terms
and conditions of certification. Specific terms and conditions of certification
shall be in accordance with §
289.226(l)
of this title.
(7) Responsibilities
of registrant.
(A) The registrant shall
comply with the following:
(i) purpose and
scope in accordance with subsections (a) and (b) of this section; and
(ii) applicable definitions in subsection (c)
of this section.
(B) In
addition to the requirements of §289.226(m)(3) - (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
inaccurate. These include but are not limited to the following:
(i) name and mailing address;
(ii) street address where interventional
breast radiography machine(s) will be used; and
(iii) interventional breast radiography
machine(s).
(C) If a
facility makes a change in the RSO, the qualifications of the RSO shall be
submitted to the agency within 30 days of such change.
(D) A facility with an existing certification
may begin using a new or replacement interventional breast radiography machine
before receiving an updated certification if the registrant submits to the
agency (required/prescribed) documentation with a medical physicist's report in
accordance with paragraph (13) of this subsection, verifying compliance of the
new interventional breast radiography machine with this section. The medical
physicist's report is required prior to using the interventional breast
radiography machine on patients.
(E) Loaner interventional breast radiography
machines may be used on patients for 60 days without adding the interventional
breast radiography machine to the certification. A medical physicist's report
verifying compliance of the loaner interventional breast radiography machine
with this section shall be completed prior to use on patients. If the use
period will exceed 60 days, the facility shall add the interventional breast
radiography machine to its certification and a fee will be assessed.
(8) Renewal of certification. The
registrant shall file an application for renewal of certification as follows.
(A) Each person having an interventional
breast radiography machine shall submit an application for renewal in
accordance with §289.226(e)(1) - (3), (5), and (7) of this
title.
(B) An application for
renewal shall be signed by the RSO, licensed physician, and the
applicant.
(C) An applicant for
renewal shall submit a medical physicist's survey in accordance with paragraph
(13) of this subsection.
(D) If a
registrant files an application for renewal 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.
(9) Expiration
of certification.
(A) Each certification of
interventional breast radiography machine expires at the end of the day in the
month and year stated on the certificate. Expiration of the certification does
not relieve the registrant of the requirements of this chapter.
(B) If a registrant does not submit an
application for renewal of the certification under paragraph (8) of this
subsection, as applicable, the registrant shall on or before the expiration
date specified in the certification:
(i)
terminate use of all interventional breast radiography machines;
(ii) pay any outstanding fees in accordance
with §
289.204
of this title; and
(iii) submit a
record of the disposition of the interventional breast radiography machine(s)
to the agency. If the machine(s) was transferred, include to whom it was
transferred.
(10) Termination of certification. When a
registrant decides to terminate all activities involving interventional breast
radiography machine(s) authorized under the certification, the registrant shall
notify the agency immediately and do the following:
(A) request termination of the certification
in writing signed by the RSO, owner, or an individual authorized to act on
behalf of the registrant;
(B) pay
any outstanding fees in accordance with §
289.204
of this title; and
(C) submit a
record of the disposition of the interventional breast radiography machine(s)
to the agency certifying body. If the machine(s) was transferred, include to
whom it was transferred.
(11) Personnel requirements.
(A) A medical radiologic technologist
(operators of equipment) shall hold a current general certificate in accordance
with the Medical Radiologic Technologist Certification Act, Texas Occupations
Code, Chapter 601.
(B) A medical
physicist 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 an entity registered with the
agency, in accordance with §
289.226(j)
of this title and the Act, unless exempted by §
289.226(d)(6)
of this title.
(12)
Requirements to have a written quality assurance program. Requirements to have
a written quality assurance program as described by the manufacturer and/or the
medical physicist to ensure the safety, reliability, clarity, and accuracy of
services performed at the facility shall comply with the following.
(A) If any failures are noted, corrective
actions shall be taken within the time frame indicated/established by the
manufacturer or medical physicist. In the event, that no time frames are
indicated, corrective action shall be completed within 30 days of the
failure.
(B) If any component
tested fails the dosimetry test, the corrective action will be taken before any
further interventional breast radiography examinations are performed.
(13) Interventional breast
radiography machine evaluations and annual survey.
(A) Interventional breast radiography
machines are required to have a medical physicist perform a survey:
(i) whenever a new interventional breast
radiography machine is installed, disassembled, and reassembled at the same or
a new location;
(ii) whenever major
components of an interventional breast radiography machine are changed or
repaired; and
(iii) on an annual
basis.
(B) The following
quality assurance tests shall be performed: AEC, kVp, focal spot condition,
HVL, collimation, alignments, and dosimetry tests in accordance with subsection
(v)(5)(A) - (G) of this section.
(C) The medical physicist shall provide the
facility with a preliminary oral or written report of deficiencies within 72
hours of the survey if it involves dosimetry.
(D) The medical physicist shall prepare a
written report for the facility within 30 days of the date of the survey to
include the following:
(i) a written survey
report that includes a summary of the tests performed, all test conditions,
specifications, results, and recommendations for corrective actions;
and
(ii) 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.
(14)
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 system.
These procedures shall include, but are not limited to:
(A) posting notices to workers in accordance
with §
289.203(b)
of this title;
(B) instructions to
workers in accordance with §
289.203(c)
of this title;
(C) notifications
and reports to individuals in accordance with §
289.203(d)
of this title;
(D) ordering x-ray
exams in accordance with §
289.231(b)
of this title;
(E) occupational
dose requirements in accordance with §
289.231(m)
of this title;
(F) personnel
monitoring requirements in accordance with §
289.231(n)
and (q) of this title;
(G) credentialing requirements for medical
radiologic technologists, and medical physicists in accordance with paragraph
(11) of this subsection;
(H) use of
a technique chart in accordance with paragraph (22) of this
subsection;
(I) exposure of
individuals other than the patient in accordance with paragraph (18) of this
subsection; and
(J) holding of
patients or image receptors in accordance with subsection (dd)(7) of this
section.
(15) Receipt,
transfer, and disposal of interventional breast radiography machines. Each
registrant shall maintain records showing the receipt, transfer, and disposal
of interventional breast radiography 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 name and serial
number on the control panel. These records shall be maintained in accordance
with subsection (ee) of this section for inspection by the agency.
(16) Calibration, maintenance, and
modifications. Each registrant shall maintain records showing calibrations,
maintenance, and modifications performed on each interventional breast
radiography 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 name and serial number on the control
panel. These records shall be maintained in accordance with subsection (ee) of
this section for inspection by the agency.
(17) 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.
(18) 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 unless such individual's assistance is required.
(19) Maintenance of records. Maintenance of
applicable records in subsection (ee) of this section.
(20) Inspection requirements. Inspection
requirements in accordance with subsection (ff)(2) - (4) of this
section.
(21) Equipment
requirements. Equipment requirements in accordance with §
289.227(h)
of this title (relating to Use of Radiation Machines in the Healing
Arts).
(22) Technique chart. A
chart or manual shall be provided or electronically displayed in the vicinity
of the control panel of each interventional breast radiography machine that
specifies technique factors to be utilized versus patient's anatomical size.
The technique chart shall be used by all operators.
(hh) Appendices.
(1) Subjects to be included in mammography
training for medical radiologic technologists shall include, but not be limited
to, the following:
(A) breast anatomy and
physiology;
(B) positioning and
compression;
(C) quality
assurance/quality control techniques;
(D) imaging of patients with breast implants;
and
(E) at least eight hours of
training in each mammography modality to be used by the technologist in
performing mammography exams.
(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 (r)(1) of this section.
(3) Operating and safety procedures. The
registrant's operating and safety procedures shall include, but are not limited
to, the following procedures as applicable:
(A) posting notices to workers in accordance
with §
289.203(b)
of this title;
(B) instructions to
workers in accordance with §
289.203(c)
of this title;
(C) notifications
and reports to individuals in accordance with §
289.203(d)
of this title;
(D) ordering x-ray
exams in accordance with §
289.231(b)
of this title;
(E) occupational
dose requirements in accordance with §
289.231(m)
of this title;
(F) personnel
monitoring requirements in accordance with §
289.231(n)
and (q) of this title;
(G) posting of a radiation area in accordance
with §
289.231(x)
and (y) of this title;
(H) credentialing requirements for lead
interpreting physicians, interpreting physicians, medical radiologic
technologists, and medical physicists in accordance with subsection (r) of this
section;
(I) retention of clinical
images in accordance with subsection (t)(4) of this section;
(J) quality assurance program in accordance
with subsections (u) - (w) of this section;
(K) image quality and corrective action for
images of poor quality in accordance with subsection (u)(1)(B)(i) of this
section;
(L) repeat analysis in
accordance with subsection (v)(3)(B) of this section;
(M) procedures and techniques for mammography
patients with breast implants in accordance with subsection (x) of this
section;
(N) procedure to handle
complaints in accordance with subsection (y) of this section;
(O) self-referral mammography in accordance
with subsection (bb) of this section;
(P) use of a technique chart in accordance
with subsection (dd)(2) of this section;
(Q) exposure of individuals other than the
patient in accordance with subsection (dd)(5) of this section;
(R) use of protective devices in accordance
with subsection (dd)(6) of this section; and
(S) holding of patients or image receptors in
accordance with subsection (dd)(7) of this section.
(4) Phantom image scoring protocol for
film-screen modality. 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 in the last group scored, one by one. Note that the highest
number of speck-like artifacts that can potentially be subtracted is the number
of visible specks that were scored in the last group. 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.
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