PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 27. CASE MANAGEMENT FOR CHILDREN AND PREGNANT WOMEN
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes the repeal of §27.1, Purpose and Application; §27.3, Definitions; §27.5, Client Eligibility; §27.7, Client Rights; §27.9, Client Confidentiality; §27.11, Components of Case Management for Children and Pregnant Women Services; §27.13, Prior Authorization; §27.15, Provider Qualifications; §27.17, Provider Approval Process; §27.19, Provider Responsibilities; §27.21, Case Manager Qualifications; §27.23, Case Manager Responsibilities; §27.25, Utilization and Quality Assurance Reviews and Compliance; and §27.27, Termination, Suspension, Probation, and Reprimand of Providers.
BACKGROUND AND PURPOSE
Case Management for Children and Pregnant Women (CPW) services assist eligible Medicaid clients in gaining access to necessary medical, social, educational, and other services related to the client's health conditions and health risks. To be eligible for services, a client must be either a child with a health condition or health risk or a pregnant woman with a high-risk condition. The client must also be Medicaid-eligible in Texas, need case management for CPW services, and choose such services.
HHSC proposes to repeal Chapter 27, Case Management for Children and Pregnant Women, in Title 25, Part 1, Texas Administrative Code (TAC), and proposes a new Chapter 257, Case Management for Children and Pregnant Women, in Title 26, Part 1, TAC. The purpose for moving the CPW chapter from Title 25 to Title 26 is to conform administrative rules to current HHSC practices based on Senate Bill (S.B.) 200, 84th Legislature, Regular Session, 2015. S.B. 200 consolidated functions in the Texas Health and Human Services delivery system and transferred programs, to include CPW, from the Department of State Health Services (DSHS) to HHSC.
The new CPW rules in 26 TAC Chapter 257 are proposed elsewhere in this issue of Texas Register.
SECTION-BY-SECTION SUMMARY
The proposed repeal of §§27.1, 27.3, 27.5, 27.7, 27.9, 27.11, 27.13, 27.15, 27.17; 27.19, 27.21, 27.23, 27.25, and 27.27 in 25 TAC Chapter 27 removes rules that need to be replaced by new rules in Title 26 under HHSC.
FISCAL NOTE
Trey Wood, HHSC Chief Financial Officer, has determined that for each year of the first five years that the repeals will be in effect, enforcing or administering the repeals does not have foreseeable implications relating to costs or revenues of state or local governments.
GOVERNMENT GROWTH IMPACT STATEMENT
HHSC has determined that during the first five years that the repeals will be in effect:
(1) the proposed repeals will not create or eliminate a government program;
(2) implementation of the proposed repeals will not affect the number of HHSC employee positions;
(3) implementation of the proposed repeals will result in no assumed change in future legislative appropriations;
(4) the proposed repeals will not affect fees paid to HHSC;
(5) the proposed repeals will not create a new regulation;
(6) the proposed repeals will repeal existing regulations;
(7) the proposed repeals will not change the number of individuals subject to the repeals; and
(8) the proposed repeals will not affect the state's economy.
SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS
Trey Wood has also determined that there will be no adverse economic effect on small businesses, micro businesses, or rural communities to comply with the proposed repeals because provider and client participation in CPW is optional.
LOCAL EMPLOYMENT IMPACT
The proposed repeals will not affect a local economy.
COSTS TO REGULATED PERSONS
Texas Government Code §2001.0045 does not apply to these repeals because the repeals do not impose a cost on regulated persons and are necessary to implement legislation that does not specifically state that §2001.0045 applies to the repeals.
PUBLIC BENEFIT AND COSTS
Emily Zalkovsky, State Medicaid Director, has determined that for each year of the first five years the repeals are in effect, the public will benefit from having all HHSC rules in the same title of the TAC.
Trey Wood has also determined that for the first five years the repeals are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed repeals because the existing benefits will be reintroduced in the new rules.
TAKINGS IMPACT ASSESSMENT
HHSC has determined that the proposal does not restrict or limit an owner's right to the owner's property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.
PUBLIC COMMENT
Written comments on the proposal may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 4601 West Guadalupe Street, Austin, Texas 78751; or emailed to HHSRulesCoordinationOffice@hhs.texas.gov.
To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If the last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When faxing or emailing comments, please indicate "Comments on Proposed Rule 24R049" in the subject line.
SUBCHAPTER A. GENERAL PROVISIONS
25 TAC §27.1, §27.3
STATUTORY
AUTHORITY
The repeals are authorized by Texas Government Code §531.0055,
which provides that the Executive Commissioner of HHSC shall adopt
rules for the operation and provision of services by the health and
human services agencies, and Texas Government Code §531.033,
which authorizes the Executive Commissioner of HHSC to adopt rules
as necessary to carry out the commission's duties; and Human Resources
Code §32.021 and Texas Government Code §531.021(a), which
authorize HHSC to administer the federal medical assistance (Medicaid)
program.
The repeals affect Texas Government Code §531.651, §531.652, §531.653, §531.654, §531.655,
and
§531.656.
§27.1.Purpose and Application.
§27.3.Definitions.
The agency certifies that legal counsel has
reviewed the proposal and found it to be within the state agency's
legal authority to
adopt.
Filed with the Office
of the Secretary of State on February 5,
2025.
TRD-202500394
Karen
Ray
Chief
Counsel
Department of State Health
Services
Earliest possible date of adoption: March 23,
2025
For further information, please call: (512)
438-2910
25 TAC §§27.5, 27.7, 27.9, 27.11, 27.13
STATUTORY
AUTHORITY
The repeals are authorized by Texas Government Code §531.0055,
which provides that the Executive Commissioner of HHSC shall adopt
rules for the operation and provision of services by the health and
human services agencies, and Texas Government Code §531.033,
which authorizes the Executive Commissioner of HHSC to adopt rules
as necessary to carry out the commission's duties; and Human Resources
Code §32.021 and Texas Government Code §531.021(a), which
authorize HHSC to administer the federal medical assistance (Medicaid)
program.
The repeals affect Texas Government Code §531.651, §531.652, §531.653, §531.654, §531.655,
and
§531.656.
§27.5.Client Eligibility.
§27.7.Client Rights.
§27.9.Client Confidentiality.
§27.11.Components of Case Management for
Children and Pregnant Women Services.
§27.13.Prior Authorization.
The agency certifies that legal counsel has
reviewed the proposal and found it to be within the state agency's
legal authority to
adopt.
Filed with the Office of the Secretary of State on February 5,
2025.
TRD-202500395
Karen
Ray
Chief
Counsel
Department of State Health
Services
Earliest possible date of adoption: March 23,
2025
For further information, please call: (512)
438-2910
25 TAC §§27.15, 27.17, 27.19, 27.21, 27.23, 27.25, 27.27
STATUTORY
AUTHORITY
The repeals are authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and
human services agencies, and Texas Government Code §531.033,
which authorizes the Executive Commissioner of HHSC to adopt rules
as necessary to carry out the commission's duties; and Human Resources
Code §32.021 and Texas Government Code §531.021(a), which
authorize HHSC to administer the federal medical assistance (Medicaid)
program.
The repeals affect Texas Government Code §531.651, §531.652, §531.653, §531.654, §531.655,
and
§531.656.
§27.15.Provider Qualifications.
§27.17.Provider Approval Process.
§27.19.Provider Responsibilities.
§27.21.Case Manager Qualifications.
§27.23.Case Manager Responsibilities.
§27.25.Utilization and Quality Assurance
Reviews and Compliance.
§27.27.Termination, Suspension, Probation,
and Reprimand of Providers.
The agency certifies that legal counsel has
reviewed the proposal and found it to be within the state agency's
legal authority to
adopt.
Filed
with the Office of the Secretary of State on February 5,
2025.
TRD-202500396
Karen
Ray
Chief
Counsel
Department of State Health
Services
Earliest possible date of adoption: March 23,
2025
For further information, please call: (512)
438-2910
SUBCHAPTER E. REGISTRATION REGULATIONS
The Executive Commissioner of the Texas Health and Human Services
Commission (HHSC), on behalf of the Department of State Health Services
(DSHS), proposes an amendment to §289.230, concerning Certification
of Mammography Systems and Mammography Machines Used for Interventional
Breast Radiography, and the repeal of §289.234, concerning Mammography
Accreditation.
BACKGROUND AND
PURPOSE
The purpose of the proposal is to amend §289.230, relating
to requirements for the certification and use of radiation machines
in mammography and interventional breast radiography. The amendment
is necessary to align with the United States Food and Drug Administration
(FDA) Mammography Quality Standards Act (MQSA) under 21 Code of Federal
Regulations (CFR) Part
900.
Additionally, the proposal repeals §289.234, relating to mammography
accreditation, because DSHS no longer accredits mammography facilities
due to an expired contract which ended on August 31, 2024. With the
contract's expiration, this rule is no longer
valid.
SECTION-BY-SECTION
SUMMARY
The proposed amendment to §289.230 updates the requirements
concerning breast tissue density in mammography reports and plain
language notification statements to patients. Three new outcome data
reporting requirements for the interpreting physician and the facility
have been added. The outcome data report must include calculations
for positive predictive value, cancer detection rate, and recall
rate.
Additional changes to §289.230 include reorganizing the rule
to mirror the layout of other sections of this chapter, adding survey
report requirements, and adding and clarifying definitions for various
terms related to mammography machines. The proposal adopts 21 CFR
Part 900 by reference for system design, screen-film, processor performance
testing, equipment variances, and investigational device requirements.
The proposed changes enhance clarity, safety, and regulatory compliance
in the field of mammography. Other edits are made to improve grammar,
formatting, and rule
clarity.
The proposed repeal of §289.234 is necessary to delete an
invalid
rule.
FISCAL
NOTE
Christy Havel Burton, DSHS Chief Financial Officer, has determined
that for each year of the first five years that the rules will be
in effect, enforcing or administering the rules does not have foreseeable
implications relating to costs or revenues of state or local governments.
GOVERNMENT GROWTH IMPACT
STATEMENT
DSHS has determined that during the first five years that the rules
will be in
effect:
(1) the proposed rules will eliminate a government
program;
(2) implementation of the proposed rules will not affect the number
of DSHS employee
positions;
(3) implementation of the proposed rules will result in no assumed
change in future legislative
appropriations;
(4) the proposed rules will not affect fees paid to
DSHS;
(5) the proposed rules will not create a new
regulation;
(6) the proposed rules will expand and repeal existing
regulations;
(7) the proposed rules will decrease the number of individuals
subject to the rules;
and
(8) the proposed rules will not affect the state's
economy.
SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT
ANALYSIS
Christy Havel Burton has also determined that there will be an
adverse economic effect on small businesses or micro-businesses, or
rural communities because there may be a cost to comply with new data
reporting
requirements.
DSHS estimates that the number of mammography facilities subject
to the proposal for §289.230 is 668. The projected economic impact
cannot be determined because the impact is based on the size of the
facility and the age of its current
software.
DSHS determined that alternative methods to achieve the purpose
of the proposed rules for small businesses, micro-businesses, or rural
communities would not be consistent with ensuring the health and safety
of the public, employees, and
patients.
LOCAL EMPLOYMENT
IMPACT
The proposed rules will not affect a local
economy.
COSTS TO REGULATED
PERSONS
Texas Government Code §2001.0045 does not apply to these rules
because the rules are necessary to comply with federal law: 21 CFR
Part 900, and to protect the health, safety, and welfare of the residents
of
Texas.
PUBLIC BENEFIT AND
COSTS
Dr. Timothy Stevenson, Deputy Commissioner, Consumer Protection
Division, has determined that for each year of the first five years
the rules are in effect, the anticipated public benefit will be improved
protection from unnecessary exposure to radiation for the public,
patients, workers, and the
environment.
Christy Havel Burton has also determined that for the first five
years the rules are in effect, persons required to comply with the
proposed rules may incur economic costs because new outcome data reporting
requirements may require additional software or increase staff workload.
The proposed rules do not increase registration fees or increase the
frequency of fee
payment.
TAKINGS IMPACT
ASSESSMENT
DSHS has determined that the proposal does not restrict or limit
an owner's right to the owner's property that would otherwise exist
in the absence of government action and, therefore, does not constitute
a taking under Texas Government Code
§2007.043.
PUBLIC
COMMENT
Written comments on the proposal may be submitted to Rules Coordination
Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247,
or street address 4601 West Guadalupe Street, Austin, Texas 78751;
or emailed to
HHSRulesCoordinationOffice@hhs.texas.gov.
To be considered, comments must be submitted no later than 31 days
after the date of this issue of the Texas
Register. Comments must be (1) postmarked or shipped before
the last day of the comment period; (2) hand-delivered before 5:00
p.m. on the last working day of the comment period; or (3) faxed or
emailed before midnight on the last day of the comment period. If
the last day to submit comments falls on a holiday, comments must
be postmarked, shipped, or emailed before midnight on the following
business day to be accepted. When faxing or emailing comments, please
indicate "Comments on Proposed Rule 24R087" in the subject
line.
STATUTORY
AUTHORITY
The amendment is authorized by Texas Health and Safety Code Chapter
401 (the Texas Radiation Control Act), which provides for DSHS radiation
control rules and regulatory program to be compatible with federal
standards and regulations; §401.051, which provides the required
authority to adopt rules and guidelines relating to the control of
sources of radiation; §401.064, which provides for the authority
to adopt rules relating to inspection of x-ray equipment; Chapter
401, Subchapter J, which authorizes enforcement of the Act; Chapter
401, Subchapter L, which provides for the Certification of Mammography
Systems; and Texas Government Code §531.0055 and Texas Health
and Safety Code §1001.075, which authorize the Executive Commissioner
of HHSC to adopt rules and policies for the operation and provision
of health and human services by DSHS and the administration of Texas
Health and Safety Code Chapter
1001.
§289.230.Certification of Mammography
Systems and X-Ray [
(a) Purpose. This section establishes the requirements
for using mammography systems and x-ray machines for interventional
breast radiography.
(1)
Requirements for the registration
of a person using radiation machines for
mammography.
(A)
A person must not use radiation machines except
as authorized in a certificate of registration issued by the Department
of State Health Services (department) as specified in the requirements
of this
section.
(B)
A person who receives, possesses, uses, owns, or
acquires radiation machines before receiving a certificate of registration
is subject to the requirements of this chapter.
(2) Mammography [
(3) Requirements for specific record
keeping and general provisions for records and
reports.
(b)
Scope.
(1)
This section applies to a person
who receives, possesses, uses, or transfers radiation machines in
mammography facilities. The facility is responsible for the administrative
control and oversight of the mammography systems or x-ray machines
used for interventional breast
radiography.
(2)
[
(A)
§289.203 of this chapter [
(B)
§289.204 of this chapter [
(C)
§289.205 of this chapter [
(D)
§289.226 of this subchapter [
(E)
§289.231 of this subchapter [
(F)
21 Code of Federal Regulations
(CFR) Part 900, except for facilities subject to subsection (w) of
this section. [
(3)
[
(4)
[
(5)
[
(c)
Prohibitions.
(1)
The department prohibits the use of radiographic
equipment designed for general purpose or special non-mammography
procedures for mammographic imaging. This includes systems that have
been modified or equipped with special attachments for
mammography.
(2)
The department prohibits the use of mammography
machines posing a significant threat or danger to occupational and
public health and safety, as specified in §289.205 and §289.231
of this
chapter.
(3)
The department prohibits exposing an individual
to the useful beam, except for healing arts imaging ordered by a practitioner.
This provision specifically prohibits intentional exposure of an individual
for:
(A)
training, demonstration, or other non-healing arts
purposes;
(B)
healing arts screening, or self-referral mammography
except as authorized by subsection (r) of this section;
and
(C)
research, except as authorized by subsection (s)
of this
section.
(4)
The department prohibits remote operation of radiation
machines.
(d)
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 and §289.228 of
this subchapter (relating to Radiation Safety Requirements for Industrial
Radiation
Machines).
(2)
Machines used exclusively for interventional breast
radiography are exempt from the requirements of this section except
for those listed in subsection (w) of this section. These machines
are not required to be accredited by a United States Food and Drug
Administration (FDA)-approved accreditation body
(AB).
(3)
Loaner machines as described in subsection (g)(6)
of this section are exempt from the inspection requirements in subsection
(v)(1) of this section. These machines are not required to be accredited
by an
AB.
(4)
Mammography machines with investigational device
exemptions as described in subsection (s) 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
AB.
(5)
All mammography and interventional breast radiography
facilities are exempt from the posting of radiation area requirements
of §289.231 of this subchapter if the operator has continuous
surveillance and controls access to the radiation
area.
(e)
[
(1)
Accreditation--The approved use of a mammography
machine by an AB [
(2)
Act--Texas Radiation Control Act, Health and Safety
Code[
(3)
Action limit--The minimum or maximum value of a
quality assurance (QA) measurement representing acceptable
performance. Values less than the minimum or greater than the maximum
action limit indicate [
(4)
Additional mammography review (AMR)--A [
[(A)
clinical image review with interpretation;
or]
[(B)
clinical image review without
interpretation.]
(5)
Adverse event--An undesirable experience associated
with mammography activities [
(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 (h) [
(6)
Air kerma--The kinetic energy released in
air by ionizing radiation. Kerma is the quotient of dE by dM, where
dE is the sum of the initial kinetic energies of all the charged ionizing
particles liberated by uncharged ionizing particles in air of mass
dM. The System International (SI) unit of air kerma is joule per kilogram,
and the special name for the unit of kerma is gray (Gy) [
(7)
American Registry of Radiologic Technologists
- Radiography (ARRT(R))--the credential issued by the American Registry
of Radiologic Technologists in radiography [
[(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.]
(8)
[
(9)
[
(10)
[
(11)
[
(12)
[
(13)
[
(14)
[
(15)
[
(16)
[
(17)
[
(18)
[
(19)
[
(20)
[
(A)
interaction between an instructor and student [
(B)
[
(21)
[
(A)
During joint interpretation of mammograms, the
supervising interpreting physician reviews, discusses, and confirms
the interpretation [
(B)
During performance of a mammography examination,
the supervising medical radiologic technologist (MRT) is
present to observe and correct, as needed, the individual [
(C)
During performance of a survey of the facility's [
[(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.]
(22)
[
(A)
operating [
(B)
processing [
(C)
interpreting [
(D)
maintaining the viewing conditions for [
(23)
[
(24)
[
[(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.]
(25) [
(26) [
(27)
[
(28)
[
(29)
Healthcare provider--A doctor
of medicine or osteopathy, podiatrist, dentist, chiropractor, clinical
psychologist, optometrist, physician assistant, or nurse practitioner
authorized to practice by the state of Texas and performing within
the scope of their practice as defined by state
law.
(30)
[
(31)
[
(32)
[
(33)
[
(34)
[
(35)
[
(36)
[
(37)
[
(38)
[
(39)
[
(40)
[
(A)
during invasive interventions for localization
or biopsy procedures, except as specified in subsection (w)
[
(B)
using [
(41)
[
[(A)
an x-ray
generator;]
[(B)
an x-ray
control;]
[(C)
a tube housing
assembly;]
[(D)
a beam limiting device;
and]
(E)
[ supporting
structures.]
(42)
[
(43)
[
(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 [
(E)
an MRT who meets the qualifications specified
in subsection (h)(2) of this section and [
(F)
a physician who interprets [
(44)
[
[(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.]
(45)
[
(46)
[
(47)
[
(48)
[
(49) Operator--An individual who performs
interventional breast mammography examinations.
(50) [
Figure: 25 TAC §289.230(e)(50) (.pdf)
[
(51) [
(52) [
(53) [
(54) [
(55) Physician--An individual licensed
by the Texas Medical Board to practice medicine under Texas Occupations
Code Chapter 155.
(56) Positive mammogram--A mammogram with [
(57) [
(58) [
(59) [
(60) [
(61) [
(62) [
(63) [
(64) [
(65) [
(66) [
(67) [
(68)
[
[(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)
Mammography systems certification.
(1)
[
(A)
[
(B)
[
(C)
[
(i)
LIP;
(ii)
applicant;
and
(iii)
[
(D)
[
(i)
[
(ii)
[
(iii)
[
(I)
[
(II)
[
(III)
[
(iv)
[
(v)
[
(vi)
proof of current
accreditation.
(2)
[
[
(A)
The certification may include [
(i)
[
(ii)
[
(B)
[
(i)
[
(ii)
[
(iii)
[
(C)
[
(3)
[
(A)
To apply for and receive a provisional
certification, a new facility must meet the requirements
of this chapter and submit the necessary information to an AB [
(B)
[
(i)
A provisional certification is [
(ii)
A provisional certification cannot
be renewed, but a facility may apply for a 90-day extension of the
provisional certification.[
(C)
[
(i)
[
(ii)
[
(4)
[
(A)
A previously certified facility that
has allowed its certification to expire, [
(B)
[
(i)
contact an AB [
(ii)
provide documentation of [
(I)
name and address of the facility under which it
was previously provisionally certified or
certified;
(II)
name of previous owner or lessor [
(III)
facility identification number assigned to the
facility under its previous certification by the FDA or the department
[
(IV)
expiration date of the most recent FDA or department
[
(iii)
justify application for reinstatement of accreditation
by submitting to an AB [
(C)
[
(i)
[
(ii)
[
(D)
[
(5)
[
(A)
[
(i)
[
(ii)
[
(iii)
[
(iv)
[
(v)
[
(vi)
[
(B)
[
(i)
[
(ii)
[
(iii)
[
(C)
[
(i)
[
(ii)
[
(I)
[
(II)
[
(III)
[
(D)
[
(i)
[
(ii)
[
(E)
[
(6)
[
(A)
[
(B)
[
(C)
[
(D)
[
(7)
[
(A)
[
(i)
[
(ii)
[
(iii)
[
(iv)
[
(v)
[
(B)
[
(C)
[
(8)
[
(A)
[
(B)
[
(9)
[
(10)
[
(11)
Renewal of
certification.
(A)
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 before such
deadlines.
(B)
A mammography facility filing an application for
renewal of their certification must meet the quality standards in
subsections (h) - (q) of this section and be accredited by an AB.
The renewal must include a list of all IPs, MRTs, and medical physicists
practicing at the facility and must be filed as specified
in:
(i)
§289.226(r) of this subchapter, relating to
renewal of certificates of
registration;
(ii)
§289.204(d) and (g) of this chapter, relating
to payment of
fees;
(iii)
subsection (f)(1)(C) of this section;
and
(iv)
subsection (f)(1)(D)(i) of this
section.
(C)
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
department.
(D)
A facility with mammography machines used for interventional
breast radiography must apply for renewal as specified in subsection
(w)(5) of this section and pay the fee specified in §289.204(d)
of this
chapter.
(12)
Expiration of
certification.
(A)
Each certification expires at the end of the day
on the expiration date listed on the mammography certificate unless
the certificate is suspended or revoked before the expiration date.
Expiration of the certification does not relieve the facility of the
requirements of this
chapter.
(B)
If a facility does not apply for renewal of the
certification as specified in paragraph (11) of this subsection, as
applicable, the facility
must:
(i)
terminate use of all mammography
machines;
(ii)
notify the department in writing of the storage
location of mammography images and address how the requirements of
subsection (j)(7)(E) of this section will be
met;
(iii)
pay any outstanding fees specified in §289.204
of this chapter;
and
(iv)
submit a record of the disposition of the mammography
machine to the
department.
(13)
Termination of certification.
When a facility decides to terminate all activities involving mammography
machines authorized under the certification, the facility
must:
(A)
notify the department and the AB within 30
days;
(B)
request termination of the certification in
writing;
(C)
pay any outstanding fees specified in §289.204
of this
chapter;
(D)
notify the department, in writing, of the storage
location of mammography images and address how the requirements of
subsection (j)(7)(E) of this section will be met;
and
(E)
submit a record of the disposition of the mammography
machine to the
department.
(g)
[
(1)
In addition to the requirements of §289.226(m)(3)
- (7) of this subchapter, relating to responsibilities of the
registrant, the facility must [
(A)
name of the facility;
[
(B)
mailing
address;
(C)
[
[(C)
mammography
machines.]
(D)
addition or removal of any mammography
machine;
or
(E)
name and qualifications of the
RSO or
LIP.
(2)
Before [
(A)
RSO [
(B)
LIP [
(C)
IP [
(D)
MRT [
(E)
medical
physicist.
(3)
A facility [
(4)
For accreditation, a facility adding or replacing
a mammography machine must have a current accreditation or apply to
the AB, unless exempted by subsection (d) of this section [
(5)
For certification, a facility with an existing
certificate may begin using a new or replacement machine before receiving
an updated certificate if the facility submits to the department and
AB an application with a medical physicist report as specified in
subsection (l)(5) and (6) of this section [
(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 must [
(7)
Records of training and experience and all other
records required by this section must [
[(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.]
(h)
[
(1)
Interpreting physician. Each physician interpreting
mammograms must [
(A)
Initial qualifications. Before interpreting mammograms
independently, the physician must
[
(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 IPs [
(ii)
have completed [
(iii)
have interpreted or multi-read, under the direct
supervision of an IP [
(B)
Subjects to be included in mammography
training for interpreting physicians must
include:
(i)
radiation physics, including radiation physics
specific to
mammography;
(ii)
radiation
effects;
(iii)
radiation protection;
and
(iv)
interpretation of mammograms. This must be under
the direct supervision of a physician who meets the requirements of
paragraph (1) of this
subsection.
(C)
[
(i)
A physician [
(ii)
Physicians who have interpreted or multi-read
at least 240 mammographic examinations under the direct supervision
of an IP [
(D)
[
(i)
Each IP must maintain continuing education
by completing at least 15 category I mammography CMEUs, in a rolling
36-month period, by participating in or teaching mammography courses.
CMEUs earned through teaching a specific course can only be counted
once during the 36-month period. [
(I)
The period for the initial continuing education
begins when a physician completes the requirements in subparagraph
(A) of this paragraph. [
(II)
The facility chooses one of the dates in
subclause (III) of this clause to determine the start of the subsequent
36-month continuing education period. [
(III)
Continuing education must be completed in
the 36 months immediately preceding: [
(-a-)
the date of the facility's inspection;
(-b-)
the last day of the calendar
quarter preceding the inspection;
or
(-c-)
any date in between the
two.
(ii)
Each IP must complete at least eight hours
of training in any mammography modality in which the IP has not been
previously trained, before independently using the new modality. [
[(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.
(E)
Continuing
experience.
(i)
Each IP must maintain continuing experience by
interpreting or multi-reading at least 960 mammographic
examinations.
(ii)
The period for the initial continuing experience
begins when a physician completed the requirements in subparagraph
(A) of this
paragraph.
(iii)
The facility chooses one of the dates in clause
(iv) of this subparagraph to determine the start of the subsequent
24-month continuing experience
period.
(iv)
Continuing experience must be completed in the
24 months immediately
preceding:
(I)
the date of the facility's
inspection;
(II)
the last day of the calendar quarter preceding
the inspection;
or
(III)
any date in between the
two.
(F)
[
(i)
obtain [
(ii)
within the six months immediately before [
(I)
at least 240 mammographic examinations;
or
(II)
additional [
(G)
[
(i)
The department [
(ii)
Documentation of the additional mandatory training must [
(iii)
Records of all additional mandatory training must
[
(2)
Medical radiologic technologists (MRTs [
(A)
Initial requirements. Before performing mammographic
examinations, the MRT must [
(i)
complete [
(ii)
perform [
(B)
Subjects to be included in mammography
training for an MRT must include the
following:
(i)
breast anatomy and
physiology;
(ii)
positioning and
compression;
(iii)
QA/QC
techniques;
(iv)
imaging of patients with breast implants;
and
(v)
at least eight hours of training in each mammography
modality to be used by the MRT in performing mammography
examinations.
(C)
[
(D)
[
(i)
Each MRT must maintain continuing education
by completing at least 15 mammography CEUs, in a rolling 36-month
period, by participating in or teaching mammography courses. CEUs
earned through teaching a specific course can only be counted once
during the 36-month period. [
(I)
The period for the initial continuing education
begins when an MRT completes the requirements in subparagraph (A)
of this paragraph, or April 28, 1999, whichever is later. [
(II)
The facility chooses one of the dates in
subclause (III) of this clause to determine the start of the subsequent
36-month continuing education period. [
(III)
Continuing education must be completed in
the 36 months immediately preceding: [
(-a-)
the date of the facility's inspection;
(-b-)
the last day of the calendar
quarter preceding the inspection;
or
(-c-)
any date in between the
two.
(ii)
Each MRT must complete at least eight hours
of CEUs in any mammography modality in which the MRT has not been
previously trained, before independently using the new modality. [
[(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.]
(E)
Continuing
experience.
(i)
Each MRT must maintain continuing experience by completing 200 mammographic
examinations.
(ii)
The period for the initial continuing experience begins when an MRT completes the requirements in subparagraph (A)
of this
paragraph.
(iii)
The facility chooses one of the dates in clause
(iv) of this subparagraph to determine the start of the subsequent
24-month continuing experience
period.
(iv)
Continuing experience must be completed in the
24 months immediately
preceding:
(I)
the date of the facility's
inspection;
(II)
the last day of the calendar quarter preceding
the inspection;
or
(III)
any date in between the
two.
(F)
[
(i)
obtain [
(ii)
perform [
(G)
[
(i)
The department [
(ii)
Documentation of the additional mandatory training must [
(iii)
Records of all additional mandatory training must
[
(3)
Medical physicist. Each medical physicist performing
mammographic surveys, evaluating mammographic equipment, or providing
oversight of the facility QA [
(A)
Initial qualifications. Before performing surveys
and evaluating mammographic equipment independently, the medical physicist must have
[
(i)
[
(ii)
[
(iii)
[
(B)
Alternative initial qualifications. Individuals
who qualified as a medical physicist as specified in [
(i)
a bachelor's degree or higher in a physical science
from an accredited institution with no less than 10 [
(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. [
(i)
Each medical physicist must maintain continuing
education by completing at least 15 mammography CEUs, in a rolling
36-month period, by participating in or teaching mammography courses.
CEUs earned through teaching a specific course can only be counted
once during the 36-month period. [
(I)
The period for the initial continuing education
begins when a medical physicist completes the requirements in subparagraph
(A) of this paragraph, or April 28, 1999, whichever is later. [
(II)
The facility chooses one of the dates in
subclause (III) of this clause to determine the start of the subsequent
36-month continuing education period. [
(III)
Continuing education must be completed in
the 36 months immediately preceding: [
(-a-)
the date of the facility's inspection;
(-b-)
the last day of the calendar
quarter preceding the inspection;
or
(-c-)
any date in between the
two.
(ii)
Each medical physicist must also complete
at least eight hours of training in any mammography modality in which
the medical physicist has not been previously trained, before independently
using the new modality. [
[(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)
Continuing
experience.
(i)
Each medical physicist must perform a survey of
two mammography facilities and at least six mammography machines.
No more than one survey of a specific facility within a 10-month period
or a specific machine within 60 days can be counted toward the total
mammography machine survey
requirement.
(ii)
The period for the initial continuing experience
begins when a medical physicist completes the requirements in subparagraph
(A) of this
paragraph.
(iii)
The facility chooses one of the dates in clause
(iv) of this subparagraph to determine the start of the subsequent
24-month continuing experience
period.
(iv)
Continuing experience must be completed in the
24 months immediately
preceding:
(I)
the date of the facility's
inspection;
(II)
the last day of the calendar quarter preceding
the inspection;
or
(III)
any date in between the
two.
(E)
[
(i)
obtain [
(ii)
perform [
(4)
Retention of personnel records. [
(A)
Facilities must maintain records
of training and experience relevant to their qualifications, as specified
in subsection (h)(1) - (3) of this section, for personnel who work
or have worked at the facility as IPs, MRTs, or medical physicists
for review by the
department.
(B)
Records of personnel no longer
employed by the facility must be maintained for at least 24 months
from the date of the departure of the employee, and these records
must be available for review at the time of an annual inspection occurring
during those 24 months. Personnel records must be maintained by the
facility for inspection by the department as specified in subsection
(x) of this
section.
(i)
The facility must provide copies of these personnel
records to current IPs, MRTs, and medical physicists upon their
request.
(ii)
The facility must provide personnel records to
a former employee if the former employee communicates their request
within 24 months of the date of their
departure.
(I)
If it has been greater than 24 months and the facility
has maintained those records, the facility must provide those records
to former employees upon
request.
(II)
If a facility closes or stops providing mammography
services, it must arrange for current and former personnel to access
their personnel qualification records before closing. Access may be
provided by a permanent transfer of records to the personnel or the
transfer of the records to a facility or other entity that will provide
access to these records for at least 24 months from the date of facility
closure of mammography
services.
(i)
[
(1)
System design. The equipment must be [
(2)
A mammography machine converted
from one mammographic modality to another is considered a new machine
at the facility under this
subsection.
(A)
Before clinical use, the mammography machine must
undergo a mammography equipment evaluation and demonstrate compliance
with applicable
requirements.
(B)
The facility must also follow the accreditation
body's procedures for applying for accreditation of the
unit.
(3)
Screen-film mammography systems
must meet the requirements of 21 CFR Part
900.
(4)
[
[(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.]
(5)
[
(6)
[
(A)
When more than one focal spot is provided, the
system must [
(B)
When more than one target material is provided,
the system must [
(C)
When the target material and [
(7)
[
(A)
Application of compression. Each [
(i)
an initial power-driven compression activated by
hands-free controls;
and
(ii)
fine adjustment compression
controls.
(B)
Compression
paddle.
(i)
Systems must [
(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 must [
(iv)
Equipment intended by the manufacturer's design
to not be flat and parallel to the breast support table during compression must [
(v)
The chest wall edge of the compression paddle must
[
(vi)
The chest wall edge may be bent upward to allow
for patient comfort, but must [
(8)
[
(A)
Manual selection of milliampere seconds (mAs) or
at least one of its component parts, milliampere (mA) or [
(B)
The technique factors (kVp [
(C)
When the AEC mode is used, the system must [
(9)
[
(A)
The positioning or selection of the detector must
[
(i)
The size and available positions of the detector must [
(ii)
The selected position of the detector must [
(B)
The system must [
[(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.]
(10)
[
(11)
Each mammography machine must
meet the following technical
specifications.
(A)
Kilovoltage peak accuracy and reproducibility.
At the most used clinical settings of kVp, the coefficient of variation
of reproducibility of the kVp must be equal to or less than 0.02.
The kVp must be accurate to within plus or minus 5.0 percent 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 used clinical kVp;
and
(iii)
the highest available clinical
kVp.
(B)
Beam quality and half-value layer (HVL). The HVL
must meet the specifications of 21 CFR §1020.30(m)(1) 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.
Figure: 25 TAC §289.230(i)(11)(B) (.pdf)
(C) Breast entrance air kerma and AEC reproducibility.
The coefficient of variation for both air kerma and mAs must not exceed 0.05.
(D) Dosimetry. The average glandular dose delivered
during a single view or DBT exposure of an FDA-accepted phantom simulating
a standard breast must not exceed 3.0 milligray (mGy) (0.3 rad) per exposure.
(E) X-ray field, light field, image receptor, and compression
paddle alignment. All systems must meet the following.
(i) 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 must provide means to ensure the x-ray field does not
extend beyond any edge of the image receptor by more than 2.0 percent
of the SID.
(ii) The light field passing through the x-ray beam
limitation device must be aligned with the x-ray field so the total
of any misalignment of the edges, along the length or the width of
the visually defined field at the plane of the breast support surface,
does not exceed 2.0 percent of the SID.
(iii) When tested with the compression paddle placed
above the breast support surface at a distance equivalent to standard
breast thickness, the chest wall edge of the compression paddle does
not extend beyond the edge of the image receptor by greater than 1.0
percent of the SID. The shadow of the vertical edge of the compression
paddle must not be visible in the image.
(12) [
(j) [
(1) Contents and terminology. Each facility must [
(2)
The mammographic examination presented
for interpretation must be in the original mammographic modality in
which it was performed and must not consist of digital images produced
through copying or digitizing hardcopy original
images.
(3)
The mammography report must include
the:
(A)
patient name [
(B)
[
(C)
facility name and location, including
the city, state, zip code, and telephone number of the
facility;
(D)
[
(E)
[
(i)
"Negative" indicates nothing to
comment upon (if the IP is aware of clinical findings of symptoms,
despite the negative assessment, these must be documented and addressed);
(ii)
"Benign" indicates a normal result,
with benign findings present, but no evidence of malignancy (if the
IP is aware of clinical findings or symptoms, despite the benign assessment,
these must be documented and
addressed);
(iii)
"Probably Benign" indicates
a finding that has a high probability of being
benign;
(iv)
"Suspicious" indicates a finding
without all the characteristic morphology of breast cancer but indicating
a definite probability of being
malignant;
(v)
"Highly suggestive of malignancy"
indicates a finding that has a high probability of being
malignant;
(vi)
"Known biopsy proven malignancy"
is reserved for known malignancies being mammographically evaluated
for definitive therapy;
or
(vii)
"Post procedure mammogram for
marker placement" indicates a mammogram to confirm the deployment
and position of a breast tissue marker;
or
(F)
in cases where the final assessment
category cannot be assigned due to incomplete work-up, the IP must
assign one of the following classification statements and reasons
why the final assessment cannot be
made:
(i)
"Incomplete: Need additional imaging evaluation"
is reserved for examinations where additional imaging needs to be
performed before an assessment category identified in subparagraph
(E)(i) - (vii) of this paragraph can be given;
or
(ii)
"Incomplete: Need prior mammograms for comparison"
is reserved for examinations where comparison with prior mammograms
should be performed before an assessment category identified in subparagraph
(E) of this paragraph can be given; if this assessment category is
used, a follow-up report with an assessment category identified in
subparagraph (E)(i) - (v) of this paragraph must be issued within
30 calendar days of the initial report whether or not comparison views
can be
obtained;
(G)
overall assessment of breast density,
classified in one of the following
categories:
(i)
"The breasts are almost entirely
fatty";
(ii)
"There are scattered areas of fibroglandular density";
(iii)
"The breasts are heterogeneously dense, which
may obscure small masses";
or
(iv)
"The breasts are extremely dense, which lowers
the sensitivity of mammography";
and
(H)
[
(4)
[
(A)
Each facility must send a mammography report
to referring healthcare providers, or patients who do not name a healthcare
provider to receive the mammography report, the report described in
subsection (j)(3) of this section within 30 days of the mammography
examination. If the assessment of the mammography report is "Suspicious"
or "Highly suggestive of malignancy," the facility must send this
report within seven calendar days of the mammography examination. [
(B)
Each facility must send a mammography report
summary, written in plain language, to patients advising them of the
results of the mammography examination and any further medical needs
within 30 days of the mammography examination. If the assessment of
the mammography report is "Suspicious" or "Highly suggestive of malignancy,"
the facility must send this report summary within seven calendar days
of the final interpretation of the mammogram [
(5)
A summary of the report written
in plain language must be provided within 30 days of interpretation
and
include:
(A)
patient
name;
(B)
name, address, and telephone number of the facility
performing the mammographic examination;
and
(C)
assessment of breast density as described in subsection
(j)(3)(G) of this section, as
applicable.
(i)
If the mammography report identifies the patient's
breast density as "The breasts are almost entirely fatty" or "There
are scattered areas of fibroglandular density," the summary must include
the statement, "Breast tissue can be either dense or not dense. Dense
tissue makes it harder to find breast cancer on a mammogram and also
raises the risk of developing breast cancer. Your breast tissue is
not dense. Talk to your healthcare provider about breast density,
risks for breast cancer, and your individual
situation."
(ii)
If the mammography report identifies the breast
density as "The breasts are heterogeneously dense, which may obscure
small masses" or "The breasts are extremely dense, which lowers the
sensitivity of mammography," the summary must include the statement,
"Breast tissue can be either dense or not dense. Dense tissue makes
it harder to find breast cancer on a mammogram and also raises the
risk of developing breast cancer. Your breast tissue is dense. In
some people with dense tissue, other imaging tests in addition to
a mammogram may help find cancers. Talk to your healthcare provider
about breast density, risks for breast cancer, and your individual
situation."
(6)
[
(A)
[
(B)
healthcare providers [
(7)
[
(A)
A facility must implement policies and procedures
to minimize the possibility of loss of these records. The original
mammograms must be retained, in retrievable form in the mammographic
modality in which they were produced, for a minimum of five years.
Original mammograms cannot be produced by copying or digitizing hardcopy
originals [
(B)
Each facility performing [
(i)
Transferred mammograms must be
in the mammographic modality in which they were produced and cannot
be produced by copying or digitizing hardcopy
originals.
(ii)
For digital mammograms or DBT,
if the examination is being transferred for final interpretation purposes,
the facility must be able to provide the recipient with original digital
images
electronically.
(C)
If the medical records are permanently forwarded,
the receiving institution or physician must [
(D)
Any fee charged to a patient for
providing the services in subparagraphs (B) - (C) of this paragraph
must not exceed the documented costs associated with this
service.
(E)
[
(i)
The facility must [
(ii)
[
(I)
Access may be provided by the
permanent transfer of mammographic records to the patient, the patient's
healthcare provider, or a facility or other entity that will provide
access to patients and healthcare providers. Access to the records
must be provided by the facility or other entity for the remainder
of the time periods specified in subparagraph (A) of this
paragraph.
(II)
If a facility ceases to perform
mammography but continues to operate as a medical entity and is able
to satisfy the record keeping requirements of subparagraph (A) of
this paragraph, it may choose to continue to retain the medical records
rather than transfer them to another facility, unless a transfer is
requested by, or on behalf of, the patient. The facility must notify
the AB and department in writing of the arrangements it has made and
must make reasonable efforts to notify all affected
patients.
(iii)
[
(I)
contact information for [
(II)
information that the records will be destroyed
if not retrieved by the patient or the patient's representative within five [
(iv)
[
(8)
[
(A)
patient name [
(B)
date of
examination;
(C)
view and laterality, [
(D)
facility name and location, including [
(E)
MRT [
(F)
cassette [
(G)
mammography machine identification, if
there is more than one machine in the
facility;[
(H)
compressed breast thickness or
degree of compression;
and
(I)
kVp.
[(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.]
(k)
[
(1)
Responsible individuals. Responsibility for the QA
[
(A)
Lead interpreting physician. The facility
must [
(i)
ensuring [
(ii)
reviewing and documenting, with date and
signature, the MRTs' QC [
(iii)
reviewing and documenting, with date and
signature, the physicists' results within 60 days of the receipt
of the results or more frequently when needed;
and
(iv)
assigning the individual and evaluating
their [
(B)
Interpreting physicians. All [
(i)
follow the facility's [
(ii)
participate in the medical outcomes audit
program.
(C)
Medical physicist. Each facility must [
(D)
Quality control technologist. The QC [
(2)
Quality assurance
records.
(A)
The LIP [
(B)
The QC [
(l)
[
(1)
Facilities with screen-film systems must perform
QC tests as specified in 21 CFR Part 900 [
[(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)
Systems with image receptor modalities, other
than screen-film, must follow a QA program that is substantially the
same as the one recommended by the image receptor manufacturer [
[(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.]
[Figure: 25 TAC §289.230(v)(5)(D)]
[(E) Breast entrance air kerma and AEC reproducibility.
The coefficient of variation for both air kerma and mAs shall not
exceed 0.05.]
[(F) Dosimetry. The average glandular dose delivered
during a single craniocaudal view of an FDA accepted phantom simulating
a standard breast shall not exceed 3.0 milligray (mGy) (0.3 rad) per exposure.]
[(G) X-ray field/light field/image receptor/compression
paddle alignment. All systems shall meet the following.]
[(i) All systems shall have beam-limiting devices that
allow the entire chest wall edge of the x-ray field to extend to the
chest wall edge of the image receptor and provide means to assure
that the x-ray field does not extend beyond any edge of the image
receptor by more than 2.0% of the SID.]
[(ii) If a light field that passes through the x-ray
beam limitation device is provided, it shall be aligned with the x-ray
field so that the total of any misalignment of the edges of the light
field and the x-ray field along either the length or the width of
the visually defined field at the plane of the breast support surface
shall not exceed 2.0% of the SID.]
[(iii) The chest wall edge of the compression paddle
shall not extend beyond the chest wall edge of the image receptor
by more than 1.0% of the SID when tested with the compression paddle
placed above the breast support surface at a distance equivalent to
standard breast thickness. The shadow of the vertical edge of the
compression paddle shall not be visible on the image.]
[(H) Uniformity of screen speed. Uniformity of screen
speed of all the cassettes in the facility shall be tested and the
difference between the maximum and minimum optical densities shall
not exceed 0.30. Screen artifacts shall also be evaluated during this test.]
[(I) System artifacts. System artifacts shall be evaluated
with a high-grade, defect-free sheet of homogeneous material large
enough to cover the mammography cassette and shall be performed for
all cassette sizes used in the facility using a grid appropriate for
the cassette size being tested. System artifacts shall also be evaluated
for all available focal spot sizes and target filter combinations
used clinically.]
[(J) Radiation output. The system shall be capable
of producing a minimum output of 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.]
(3)
[
(A)
The mobile facility must [
(B)
At [
(C)
Processor performance testing must be completed
as required by 21 CFR Part 900 [
(4)
[
(A)
The facility must [
(B)
If components [
[(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 must [
(5)
[
[(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.]
(A)
[
(B)
[
[(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.]
(C)
[
(i)
date, name, and signature of the
medical physicist performing or supervising the
survey;
(ii)
name and signature of each individual
under the direct supervision of the medical physicist performing any
part of the survey, as
applicable;
(iii)
name of the
facility;
(iv)
address of
facility;
(v)
registration number of the
facility;
(vi)
make, model, and serial number from the machine control
panel;
(vii)
registration number of the service provider performing the
survey;
(viii)
service provider email
address;
(ix)
business mailing address of the service provider performing the survey;
and
(x)
date of the last calibration of testing
equipment.
(D)
[
(6)
[
[(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.]
(7)
Each diagnostic review workstation (RWS) used to interpret images must follow manufacturer specifications for display conditions and quality control. If the RWS manufacturer does not specify QC procedures, then a QA program that is substantially the same as the QA program recommended by the image receptor manufacturer must be established and
followed.
[(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.]
(8)
[
(9)
[
(A)
comply with all applicable federal, state, and
local regulations pertaining to infection control;
and
(B)
comply with the manufacturer's recommended procedures
for the cleaning and disinfection of the mammography equipment used
in the facility;
or
(C)
if adequate manufacturer's recommendations are
not available, comply with generally accepted guidance on infection
control, until such recommendations become
available.
(m)
[
(1)
General
requirements.
(A)
Each facility must [
(B)
For cases of breast cancer among
patients imaged at the facility that become known to the facility,
the facility must initiate a follow-up on surgical and pathology results
and a review of the mammographic examinations taken before the diagnosis
of a
malignancy.
(C)
The [
(i)
Positive predictive value. The
percent of patients with positive mammograms who are diagnosed with
breast cancer within one year of the date of the mammographic examination.
(ii)
Cancer detection rate. Of the
patients initially examined with screening mammograms who receive
an assessment of "Incomplete: Need additional imaging evaluation,"
"Suspicious," or "Highly Suggestive of Malignancy" on the screening
mammogram or on a subsequent diagnostic mammogram, the number of patients
who are diagnosed with breast cancer within one year of the date of
the initial screening mammogram, expressed as a ratio per 1,000 patients.
(iii)
Recall rate. The percentage
of screening mammograms given an assessment of "Incomplete: Need additional
imaging
evaluation."
(2)
Frequency of audit analysis. The facility's first
audit analysis must begin within [
(A)
Subsequent audit analyses will be conducted at
least once every 12
months.
(B)
The facility must maintain the audit analysis
as specified in [
(3)
Reviewing interpreting physician. Each LIP [
(A)
recording the dates of the audit period
[
(B)
documenting the
results;
(C)
notifying other IPs [
(D)
documenting any follow up actions and the nature
of the follow up;
and[
(E)
recording the audit completion
by providing a signature and date on the
audit.
(n)
[
(o)
[
(1)
establish a written procedure for collecting and
resolving consumer
complaints;
(2)
maintain a record of each serious complaint received
by the facility as specified in [
(3)
provide the consumer with adequate
directions for filing serious complaints with the facility's AB if
the facility is unable to resolve a serious complaint to the consumer's
satisfaction;
and
(4)
[
(p)
[
(q)
[
(1)
If the department [
(A)
the facility's compliance with
this section;
and
(2)
If the department [
(A)
inform the patient the mammography
system failed to satisfy the department and AB's
standards;
(B)
recommend the patient consult
with the patient's healthcare provider regarding the need for another
mammogram;
(C)
list three non-affiliated facilities
closest to the original testing facility that have a certified mammography
system;
and
(D)
include the deficiencies presenting
such risk, the potential consequences to the patient, appropriate
remedial measures, and other relevant information required by the
department.
(3)
If the facility is unable or unwilling
to perform such notification, the department may notify patients and
their referring physicians or other healthcare providers individually
or through the mass
media.
(4)
[
(r)
[
(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 a patient [
(B)
follow-up with patients and healthcare provider
as specified [
(C)
recommending a healthcare provider to
patients who do not have a healthcare provider when clinically
indicated, to include when a patient's mammogram assessment is probably
benign, suspicious, or highly suggestive of malignancy [
(4)
methods for educating mammography patients in breast
self-examination techniques and on the necessity for follow-up by
a
physician.
(s)
[
(1)
Any research using radiation producing devices
on humans must be approved by an IRB as required by [
(2)
Facilities with mammography machines with investigational
device exemptions [
[(A)
21 CFR, Part 812, Investigational
Device
Exemptions;]
(A)
[
(B)
[
(C)
21 CFR Part 56, Institutional
Review
Boards;
(D)
21 CFR Part 812, Investigational Device Exemptions;
and
(E)
21 CFR[
(t)
[
(1)
Each facility must implement and maintain
written OSP [
(2)
The OSP must be available to each
individual operating x-ray equipment, including any restrictions of
the operating technique required for the safe operation of the particular
system.
(3)
The facility's OSP must address
the following requirements, as
applicable:
(A)
§289.203(b) of this chapter, related to posting
notices to
workers;
(B)
§289.203(c) of this chapter, related to instructions
to
workers;
(C)
§289.203(d) of this chapter, related to notifications
and reports to
individuals;
(D)
§289.231(b) of this subchapter, related to
ordering x-ray
examinations;
(E)
§289.231(m) of this subchapter, related to
occupational dose
requirements;
(F)
§289.231(n) and (q) of this subchapter, related
to personnel monitoring
requirements;
(G)
§289.231(x) and (y) of this subchapter, related
to posting of a radiation
area;
(H)
subsection (h) of this section, related to credentialing
requirements for LIPs, IPs, MRTs, and medical
physicists;
(I)
subsection (j)(7) of this section, related to retention
of clinical
images;
(J)
subsections (k) - (m) of this section, related
to quality assurance
program;
(K)
subsection (k)(1)(B)(i) of this section, related
to image quality and corrective action for images of poor
quality;
(L)
subsection (l)(1) - (3) of this section, related
to repeat
analysis;
(M)
subsection (n) of this section, related to procedures
and techniques for mammography patients with breast
implants;
(N)
subsection (o) of this section, related to the
procedure to handle
complaints;
(O)
subsection (r) of this section, related to self-referral
mammography;
(P)
subsection (u)(2) of this section, related to the
use of a technique
chart;
(Q)
subsection (u)(5) of this section, related to exposure
of individuals other than the
patient;
(R)
subsection (u)(6) of this section, related to use
of protective devices;
and
(S)
subsection (u)(7) of this section, related to holding
of patients or image
receptors.
(u)
Other operating procedures.
(1)
Phantom image scoring protocol
must be performed as specified in (l)(1) - (3) of this
section.
(2)
Technique chart. A technique chart or
manual must [
(3)
Receipt, transfer, and disposal of mammography
machines. Each registrant must [
(4)
Viewing system. Windows, mirrors, closed circuit
television, or an equivalent system must [
(5)
Exposure of an individual [
(6)
Protective devices. Protective devices must [
(A)
Protective devices must [
(B)
Protective devices, including aprons, gloves, and
shields must [
(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 must [
(B)
If a patient or image receptor must be held by
an individual during an exposure, the [
(C)
The facility's [
(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 must [
(8)
Calibration, maintenance, and modifications. Each
registrant must [
[(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.]
(v)
[
(1)
The department [
(2)
The department [
(3)
To protect the public health, the department [
(4)
The department [
(5)
After each satisfactory inspection, the department
issues [
(A)
specific identification of the mammography system
inspected;
(B)
[
(C)
[
(6)
Any severity level I violation involving a mammography
system, determined [
(A)
Notification of such failure must [
(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 must [
(7)
Facilities that receive a severity level I violation and are deemed a serious risk to human health must [
[(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 department [
(9)
The patient notification must [
(A)
an explanation of the mammography system failure
to the patient;
and
(B)
the potential consequences to the mammography patient.
(10)
The facility must [
(A)
The record must [
(B)
The record must [
(w)
[
[(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.]
(1)
[
(A)
A person who receives, possesses, uses, owns,
or acquires [
(B)
An application for a COR must [
(i)
a licensed physician, and
(ii)
the RSO [
(C)
An application for a COR [
(D)
Each applicant must [
(2)
[
(A)
[
(B)
Conditions [
(i)
minimize danger to occupational and public health
and
safety;
(ii)
require additional reports and maintain [
(iii)
prevent loss or theft of radiation machines subject
to this
section.
(C)
Additional information. The department [
(3)
[
(4)
[
(5)
Renewal of certification. The
registrant must file an application for renewal of the COR as
follows.
(A)
A person who receives, possesses, uses, owns, or
acquires an interventional breast radiography machine must apply for
renewal as specified in §289.226(e)(1) - (3), (5), and (7) of
this
subchapter.
(B)
An application for renewal must be signed by a
licensed physician and the
RSO.
(C)
An application for renewal must include a medical
physicist's survey as specified in paragraph (11) of this
subsection.
(D)
If a registrant files an application for renewal
in proper form at least 30 days before the existing certification
expires, the existing certification does not expire until the application
status has been determined by the
department.
(6)
Expiration of the certificate
of
registration.
(A)
COR of an interventional breast radiography machine
expires at the end of the day in the month and year stated on the
certificate. Expiration of the COR does not relieve the registrant
of the requirements of this
chapter.
(B)
If a registrant does not apply for renewal of the
certification under paragraph (8) of this subsection, as applicable,
the registrant
must:
(i)
terminate use of all interventional breast radiography
machines;
(ii)
pay any outstanding fees as specified in §289.204
of this chapter;
and
(iii)
submit a record of the disposition of the interventional
breast radiography machine to the department. If the machine was transferred,
include to whom it was
transferred.
(7)
Each diagnostic review workstation
(RWS) used to interpret images must follow manufacturer specifications
for display conditions and quality control. If the RWS manufacturer
does not specify QC procedures, then a QA program that is substantially
the same as the QA program recommended by the image receptor manufacturer
must be established and
followed.
(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).]
(19)
[
(x)
Record requirements. Records specified
in this section must be maintained for inspection by the department
as specified in paragraph (3) of this subsection. Records may be maintained
electronically as specified in §289.231(ff)(3) of this
subchapter.
(1)
Records for mammography machines authorized for
mobile service
operations.
(A)
Copies of the following must be kept with mammography
machines authorized for mobile
services:
(i)
OSP as specified in subsection (t)(1) of this section;
(ii)
operator's
credentials;
(iii)
current quality control records for at least
the last 90 calendar days for on-board processors as specified in
subsection (l)(1) of this
section;
(iv)
current copies of §289.203, §289.226, §289.230,
and §289.231 of this
chapter;
(v)
copy of
certification;
(vi)
certification of inspection as specified in subsection
(v)(5) of this
section;
(vii)
notice of failure from last inspection as specified
in subsection (v)(6) of this section, if applicable;
and
(viii)
copy of mammography
accreditation.
(B)
Copies of all other records specified in this section
must be maintained at a specified
location.
(2)
Records required at separate authorized use locations.
Copies of the following must be kept at each separate authorized use
location:
(A)
credentialing, continuing education, and continuing
experience records for IPs, MRTs, and medical physicists operating
at the location specified in subsection (h) of this
section;
(B)
mandatory training records for IPs and medical
physicists operating at the location specified in subsection (h) of
this section, if
applicable;
(C)
current physicist annual survey of the mammography
system;
(D)
current copies of §289.203, §289.226, §289.230,
and §289.231 of this
chapter;
(E)
copy of
certification;
(F)
QA program as specified in subsections (k), (l),
and (m) of this
section;
(G)
quality control records as specified in subsection
(k)(2) of this
section;
(H)
OSP as specified in subsection (t)(1) of this section;
(I)
records of receipts, transfers, and disposal as
specified in subsection (u)(3) of this
section;
(J)
calibration, maintenance, and modification records
as specified in subsection (t)(8) of this
section;
(K)
certification of inspection as specified in subsection
(v)(5) of this
section;
(L)
notification of failure as specified in subsection
(v)(6), if
applicable;
(M)
records of notification of patients as specified
in subsection (v)(10) this section;
and
(N)
copy of mammography
accreditation.
(3) Retention requirements for record keeping. Time
requirements for record keeping must be according to the following chart.
Figure: 25 TAC §289.230(x)(3) (.pdf)
[(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.]
The agency certifies that legal counsel
has reviewed the proposal and found it to be within the state agency's
legal authority to
adopt.
Filed with the Office of the Secretary of State on February 5, 2025.
TRD-202500401
Cynthia Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: March 23, 2025
For further information, please call: (512) 834-6655
STATUTORY AUTHORITY
The repeal is authorized by Texas Health and Safety Code Chapter
401 (the Texas Radiation Control Act), which provides for DSHS radiation
control rules and regulatory program to be compatible with federal
standards and regulations; §401.051, which provides the required
authority to adopt rules and guidelines relating to the control of
sources of radiation; §401.064, which provides for the authority
to adopt rules relating to inspection of x-ray equipment; Chapter
401, Subchapter J, which authorizes enforcement of the Act; Chapter
401, Subchapter L, which provides for the Certification of Mammography
Systems; and Texas Government Code §531.0055 and Texas Health
and Safety Code §1001.075, which authorize the Executive Commissioner
of HHSC to adopt rules and policies for the operation and provision
of health and human services by DSHS and the administration of Texas
Health and Safety Code Chapter 1001.
§289.234.Mammography Accreditation.
The agency certifies that legal counsel has
reviewed the proposal and found it to be within the state agency's
legal authority to adopt.
Filed with the Office of the Secretary of State on February 5, 2025.
TRD-202500402
Cynthia Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: March 23, 2025
For further information, please call: (512) 834-6655
SUBCHAPTER B. CLIENT SERVICES
SUBCHAPTER C. PROVIDER QUALIFICATIONS AND RESPONSIBILITIES
CHAPTER 289. RADIATION CONTROLMammography] Machines Used
for Interventional Breast Radiography.
[(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.]
The use of all mammography
] machines certified under [in accordance with]
this section must [shall] be used [by or] under the supervision of a physician licensed by the
Texas Medical Board.
(1)] In addition to the
requirements of this section, all facilities [registrants
] are subject to the requirements of:
title] (relating to Notices, Instructions, and Reports to Workers;
Inspections);[,]
title] (relating to Fees for Certificates of Registration, Radioactive
Material Licenses, Emergency Planning and Implementation, and Other
Regulatory
Services);[,]
title] (relating to Hearing and Enforcement
Procedures);[,]
title] (relating to Registration of Radiation Machine Use and
Services);[,
and]
title] (relating to General Provisions and Standards for Protection
Against Machine-Produced Radiation); and
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 as
specified [found] in §289.205 of this chapter
relating to [title for] modifications, suspensions,
revocations, denials, and hearings regarding certificates of registration
are applicable to certifications issued by the department
[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 (HIPAA) as a "covered entity" under[,]
45 [Code of Federal Regulations (]CFR[),] Parts
160 and 164[)], may be subject to privacy standards
governing how information identifying [that identifies]
a patient can be used and disclosed. Failure to follow HIPAA requirements
may result in the department referring [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.
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].
,] Chapter
401.
that] corrective action must be
taken by the
facility.
(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 compliance
[conformation] with [the] accreditation
standards. [The reviews include the
following:]
within the scope of this section].
Adverse events include [but are not limited
to]:
(r)] of this
section.
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].
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].
(9)] Automatic exposure
control (AEC)--A device [that] automatically controlling [controls] one or more technique factors [in order]
to obtain the [at preselected locations a] required
quantity of radiation at preselected
locations.
(10)] Average glandular
dose--The average absorbed dose [accruing] to the glandular
tissue of the
breast.
(11)] Beam-limiting device--A
device providing [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 for mammography or x-ray [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--The [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, including [that
includes]:
face-to-face interaction between instructor(s) and student(s)], such as when the instructor provides a lecture, conducts demonstrations,
or reviews student performance;
or
the] administration and correction
of student examinations by an instructor [instructor(s)]
with subsequent feedback to the student [student(s)].
(22)] Direct supervision--Oversight
of operations, including [that include] the
following.
diagnosis] of the physician
being supervised and signs the [resulting] report before
it is entered into the patient's
record.
who
is] performing the
examination.
registrant's] equipment and QA [quality assurance]
program, the supervising medical physicist is present to observe,
and correct, as needed, the individual [who is] conducting
the
survey.
(24)] Facility--A hospital,
outpatient department, clinic, radiology practice, mobile unit, an
office of a physician, or other person conducting [that
conducts] breast cancer screening or diagnosis through mammography
activities, including [the
following]:
the operation of]
equipment to produce a
mammogram;
of] film or digital
images;
initial interpretation
of] the mammogram;
or
that]
interpretation.
(25)] FDA-approved accreditation
body (AB)--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 (j)(3)(E)
of this section. [one of the following
categories:]
(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 attenuating [that attenuates] the beam of radiation to the [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 created under
45 CFR Part 46 and 21 CFR Part 56, and formally designated by
an institution to review, approve the initiation of, and conduct periodic
review of biomedical research involving human
subjects.
(33)] Interpreting physician (IP)--A licensed physician who interprets mammographic images
and who meets the requirements of subsection (h)(1) [(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 allowing an [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 (LIP)--The interpreting physician assigned the
general responsibility for ensuring [that] a facility's QA
[quality assurance] program meets all [of the]
requirements of subsections (k), (l), and (m) [(u),
(v), and (w)] of this
section.
(39)] Mammogram--A radiographic
image produced through
mammography.
(40)] Mammographic modality--A
technology, within the scope of 42 United States Code (U.S.C.) §263b,
for radiography of the breast. Examples are screen-film mammography, [and] full-field digital mammography, and
digital breast tomosynthesis
(DBT).
(41)] Mammography--The
use of x-rays [x-radiation] to produce an image
of the breast that may be used to detect the presence of pathological
conditions of the breast. Mammography [For the purposes
of this section, mammography] does not include radiography of
the breast performed [as
follows]:
(gg)] of this section;
or
with] an investigational
mammography device as part of a scientific study conducted under
the [in accordance with] FDA's investigational device
exemption
regulations.
(42)] Mammography machine--An
assemblage of components for mammography. This includes an x-ray high-voltage
generator, x-ray control, tube housing assembly, beam-limiting device,
and the necessary supporting structures. Additional components functioning
with the machine are considered integral parts of the system. [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:]
(43)] Mammography medical
outcomes audit--A systematic collection of mammography results and
the comparison of those results [compared] with outcomes
data.
(44)] Mammography system--A
system, including [that includes the
following]:
viewing] device used for viewing
and evaluating [the visual evaluation of] an image
of breast tissue [if the image is produced in interpreting visual
data captured on an image
receptor];
a medical radiologic
technologist who] performs mammography;
and
engages
in] mammography and [who] meets the requirements specified
in subsection (h)(1) of this section [relating to the reading,
evaluation, and interpretation of
mammograms].
(45)] Mandatory training--Additional
training required by the department [agency certifying
body] or AB [FDA-approved accreditation body]
for IPs [interpreting physicians], MRTs [medical radiologic technologists], or medical physicists as
the result of a required corrective
action.
(47)] Medical physicist--An
individual who performs surveys and evaluations of mammographic equipment
and facility QA [quality assurance] programs as
specified in [accordance with] this section and who
meets the qualifications in subsection (h)(3) [(r)(3)]
of this
section.
(48)] Medical radiologic
technologist (MRT [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 as specified in [accordance
with] this section and who meets the qualifications in subsection (h)(2) [(r)(2)] of this
section.
(49)] Mobile service operation--The
provision of mammography machines and personnel at temporary sites to
perform mammography for limited time
periods.
(50)] Multi-reading--Two
or more physicians interpreting the same mammogram. At least one physician must [shall] be qualified as an IP [interpreting physician].
(51)] Optical density (OD)--A
measure of the fraction of incident light transmitted through a developed
film and defined by the equation:
Figure: 25 TAC §289.230(c)(51)]
(52)] Patient--Any individual
who undergoes a mammography examination in a facility, regardless
of whether the individual [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 modeling [that radiographically
model] aspects of breast disease and cancer in a radiograph.
(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.
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 certification category enabling a facility to perform mammography
and obtain the clinical images needed to complete the accreditation
process [provisional authorization described in subsection
(g) of this section].
(59)] Qualified instructor--An
individual whose training and experience prepares the qualified
instructor [him or her] to carry out specified training
assignments. IPs [Interpreting physicians], MRTs
[medical radiologic technologists], or medical physicists
who meet the requirements of subsection (h)[(r)]
of this section are [would be] considered qualified
instructors in their respective areas of mammography. Other examples
of an individual [individuals] who may be a qualified instructor [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 (QC)
technologist--An individual meeting the requirements of subsection (h)(2)[(r)(2)] of this section who is responsible
for those QA [quality assurance] responsibilities
not assigned to the LIP [lead interpreting physician]
or to the medical physicist.
(61)] Radiation machine--see definition for [For the purposes of this part, radiation
machine also means] mammography machine.
(62)] Self-referral mammography--The
use of x-ray [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 percent [%] glandular tissue and 50 percent [%]
adipose tissue.
(67)] Survey--An on-site
physics consultation and evaluation of a facility QA [quality
assurance] program performed as specified in subsection
(l)(5) of this section by a medical physicist meeting the
requirements of subsection (h)(3) of this section.
(68)] Technique chart--A
chart providing [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 participating [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 must [shall]
show agreement within plus or minus 3.0 percent [%]
of the national standard in the mammography energy
range.
(f)] Requirements for [mammography
systems]
certification.
(1)] A facility must [To obtain a certification, facilities shall] meet the quality
standards in subsections (h) - (q) [(r) - (aa)]
of this section and be accredited by an AB. To [FDA-approved
accreditation body. In order to] qualify for certification, a new facility [facilities] must apply to the department [agency certifying body in accordance with the following requirements
and to an FDA-approved accreditation body] and receive acceptance
of an [the] accreditation application by
an AB. [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)] A person who receives,
possesses, uses, owns, or acquires [Each person having]
a mammography machine must apply for certification as specified [shall submit an application] in [accordance with] §289.226(e) of this subchapter, relating to general requirements for application
for registration, [(1) - (3) and (5) - (7) and (f)(4) -
(5) of this title,] and receive certification from the department
[agency certifying body] before using a [beginning use of the] mammography machine on
humans.
(3)] An application for
certification must [shall] be signed by the:
(4)]radiation safety officer (RSO) [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 must [shall] submit documentation of [the
following]:
(A)] personnel qualifications,
including dates of licensure or certification, as specified in
[accordance with] subsection (h)[(r)]
of this
section;
(B)] manufacturer, model
name, and serial number of each mammography machine control
panel;
(C)] evidence that a medical
physicist
has:
(i)] [has] determined
[that] each machine meets the equipment standards in subsection (i)[(s)] of this
section;
(ii)] [has]
performed a survey and a mammography equipment evaluation as
specified in [accordance with] subsection (l)(5)
and (6)[(v)(10) and (11)] of this section;
and
(iii)] [has]
determined [that] the average glandular dose for one craniocaudal
[craniocaudal-caudal] view for each machine is
less than [does not exceed] the value in subsection (i)(11)(D)[(v)(5)(F)] of this
section;
(D)] self-referral program
information as specified in [accordance with]
subsection (r)[(bb)] of this section, if the
facility offers self-referral mammography;[
and]
(E)] items required for
authorization of a mobile service operation as specified in
[accordance with] §289.226(g) of this subchapter,
relating to application for registration of mobile service operations [title], if the facility provides a mobile service;
and[.]
(g)] Issuance of certification
[and provisional
certification].
(1)]
[ Certification.] A certification
will be issued if the department [agency certifying
body] determines the [that an] application
meets the requirements of the Act and [the requirements of]
this chapter. The certification authorizes the proposed operations
and includes [activity in such form and contains such]
conditions and limitations deemed necessary by [as]
the department [agency certifying body deems appropriate
or
necessary].
one
of the
following]:
(A)] mammography systems
and facilities certification, following approval of accreditation
by an AB [FDA-approved accreditation body];
or
(B)] certification of interventional
breast radiography
machines.
(2)] Conditions [Requirements and conditions]. The department [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 reporting
and record keeping [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 department [agency certifying body] may
request[, and the registrant shall provide,] additional
information after the certification has been issued to enable the department
[agency certifying body] to determine whether the
certification should be modified as specified in [accordance
with] §289.226(r) of this subchapter, relating to
renewal of certificates of registration
[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].
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 department's [agency
certifying body's] receipt of the accreditation body's decision
that a facility has submitted the required information, the department
[agency certifying body] may issue a provisional
certification to a facility if [upon determination
that] the facility has satisfied the requirements of the Act
and this
chapter.
shall be] effective for up to six months as noted on the
certificate [from the date of
issuance].
(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 must [shall] submit to the AB [FDA-approved accreditation
body] who issued the original certificate, a statement of actions
taken [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 the [such
] facility did not obtain an
extension.
(B)] The department [agency certifying body] may issue a 90-day extension for a provisional
certification if [upon determination that] the
extension meets the criteria in paragraph (3)[(4)]
of this
subsection.
(C)] Renewal [There can be no renewal] of a provisional certification beyond
the 90-day extension is
prohibited.
(7)] Reinstatement [policy
].
that has] been
refused a renewal of its certification by the department [agency certifying body], or [that has] had its certification
suspended or revoked by the department [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 as specified in [under] subsection (f)(5)[(h)(5)] of this section, a facility applying
for reinstatement must
[shall]:
FDA-approved accreditation
body] for reapplication of [for] accreditation;
fully
document] its history as a previously provisionally certified
or certified mammography facility, and include [including
] the [following
information]:
owner/lessor
];
agency certifying body];
and
agency] provisional certification;
and
FDA-approved accreditation
body] a corrective action plan detailing [that
details] how the facility has corrected deficiencies contributing
[that contributed] to the lapse [of],
denial of renewal, or revocation of its
certification.
(B)] The department [agency certifying body] may issue a provisional certification
to the facility if the department [agency] determines
[that] the facility
has:
has] adequately corrected, or is in
the process of correcting, pertinent deficiencies;
and
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 subparagraph (B) of this paragraph [(2) of this
subsection], the department [agency certifying
body] may suspend or revoke a certification issued by the department
[agency certification body] if it finds, after providing
the owner or [operator of the] facility representative with
notice and an opportunity for a hearing as specified in
[accordance with] §289.205 of this chapter [title], that the owner, facility representative [operator
], or any employee of the facility
has:
(A)] misrepresented
documentation to obtain [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 department [agency
certifying body] or an AB [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 AB [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 department as specified
in [agency certifying body under] §289.205 of
this chapter
[title].
(2)] The department [agency certifying body] may suspend a certification of a facility
before holding a hearing if it makes a finding described in subparagraph
(A) [paragraph (1)] of this paragraph [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 department [agency certifying body] suspends a certification as specified in subparagraph (B) of this [accordance with] paragraph
[(2) of this
subsection]:
(A)] the department
will [agency certifying body shall] provide the facility
with an opportunity to request [for] a hearing as specified in [under] §289.205 of this
chapter [not later than 60 days from the effective date
of this suspension];
and
(B)] the suspension will [shall] remain in effect until it is determined by the department [agency certifying body determines] that
the:
(i)] allegations of violations
or misconduct were not
substantiated;
(ii)] violations of requirements
have been corrected to the department's [agency certifying
body's] satisfaction;
or
(iii)][the]
certification is revoked as specified in subparagraph
(D) [accordance with paragraph (4)] of this paragraph
[section].
(4)] After providing a hearing as specified in §289.205 of this chapter [accordance
with paragraph (3)(A) of this subsection], the department [agency certifying body] may revoke the certification if it
is determined by the department [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 based on [on the basis of] an act
described in §289.205 of this chapter, a [title,
no] person who owned or operated that facility at the time the
act occurred is prohibited from owning [may own or
operate] a mammography facility for [within]
two years following [of] the [date of]
revocation
date.
(i)] Appeal of adverse accreditation
or reaccreditation decisions preventing [that preclude]
certification or
recertification.
(1)] The appeal process
described in this paragraph [subsection] is only
available [only] for adverse accreditation or reaccreditation
decisions preventing [that preclude] certification
by the department. If the department suspends or revokes a certificate
[agency certifying body. Agency certifying body decisions
to suspend or revoke certificates that are] already in effect,
it will be handled as specified in [accordance
with] subsection (f)(5) [(h)] of this
section.
(2)] If [Upon
learning that] a facility has failed to become accredited or
reaccredited, the department [agency certifying body]
will notify the facility that the department [agency
certifying body] is unable to certify the [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 AB's [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 department [agency certifying body] may deny the application if the department
[agency certifying body] has reason to believe
that:
(A)] the facility will not
be operated as specified in [accordance with]
the provisions of subsections (h) - (q)[(r) - (aa)]
of this
section;
(B)] the facility will
not permit inspections or provide access to records or information
[in a] timely
[fashion];
(C)] made a materially [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 department [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 department
[agency].
(2)] Before the department
[agency certification body] denies an application
for certification, the department must [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 chapter [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 department [agency] may proceed to deny. The applicant must bear [shall have] the burden of proof showing
cause why the application should not be
denied.
(3)] If the department [agency certifying body] denies an application for certification from [by] a facility that has received accreditation
from an AB [FDA-approved accreditation body],
the department will [agency certifying body shall]
provide the facility with a written statement of the grounds on which
the denial is
based.
(k)] Appeals of a certification
denial [Appeals of denial of
certification].
(1)] The appeals procedures
described in this paragraph [subsection] are
available only to facilities that are denied certification by the department
[agency certifying body] after they have been accredited
by an AB [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 the
department's [of the agency certifying body's] determination as specified in [accordance with] the applicable
provisions of §289.205(h) of this chapter
[title].
(l)] Modification of certification.
Modification of a certification will follow the requirements
in §289.226(s) of this subchapter, relating to modification,
suspension, and revocation of certificates of registration [shall
be in accordance with §289.226(r) of this
title].
(m)] Specific terms and
conditions of certification. Specific terms and conditions of certification will [shall] be as specified in [accordance
with] §289.226(l) of this subchapter, relating to
terms and conditions of certificates of registration [title].
(n)] Responsibilities of the
facility
[registrant].
title, a registrant shall]
notify the department [agency certifying body]
in writing, within 30 days, of [prior to] any
changes rendering [that would render] the information
contained in the application or the certification inaccurate,
including the[. These include but are not limited to the
following]:
and]
(B)] street address where the machine is [machine(s) will be] used; [and]
Prior to] employing an individual [the individuals] listed in subparagraphs
(A) - (E) of this paragraph, the facility [registrant]
is required to verify and maintain a copy [copies]
of the [their] qualifications of the [. 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]:
radiation safety
officer];
lead interpreting physician];
interpreting
physicians];
medical radiologic technologists];
or
Registrants]
utilizing an IP [interpreting physicians] or MRT
[technologists] from a temporary staffing service must [shall] verify and maintain copies of the qualifications
of these individuals for inspection by the department [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].
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].
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].
shall] be completed before [prior to] use on patients. The results of
the survey must be submitted to the department [agency]
with a cover letter indicating period of use. If the use period will
exceed 60 days, the facility must [shall] add
the mammography machine to its certification and a fee will be
assessed.
shall]
be maintained for review as specified in [accordance
with] subsection (x) [(ee)] of this
section.
(r)] Personnel qualifications.
The following requirements apply to all personnel involved in any
aspect of mammography, including the production and interpretation
of
mammograms.
shall] hold a current Texas
license issued by the Texas Medical Board and meet the following qualifications.
shall]:
interpreting physicians
] or have at least three months of documented formal training
in the interpretation of mammograms and in topics related to mammography as specified in subparagraph (B) of this paragraph [accordance with subsection (hh)(2) of this
section];
had] a minimum
of 60 hours of documented category I CMEUs in mammography and
at [. At] least 15 of the 60 hours must [shall] have been acquired within three years immediately before
[prior to] the date [that] the physician became qualified as an IP (hours [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
interpreting physician],
at least 240 mammographic examinations within the six-month period
immediately before [prior to] the date that
the physician qualifies as an IP. The supervising interpreting
physician's presence is not required when the physician being supervised
makes the initial interpretation. However, the supervising physician
must review and, if necessary, correct the final interpretation before
it is given to the patient [interpreting
physician].
(B)]
Exemptions.
Physicians who]
qualified as an IP as specified [interpreting physicians]
in [accordance with] the requirements of §289.230
that were in effect before [prior to] April
28, 1999, or any other equivalent state or federal requirements in
effect before [prior to] April 28, 1999, is [are] considered to have met the initial requirements of subparagraph
(A) of this
paragraph.
interpreting physician] in any six-month
[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:]
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:]
the date of the registrant's annual
inspection;]
the last day of
the calendar quarter preceding the inspection;
or]
any date in between
the
two;]
interpreting or multi-reading at least 960 mammographic examinations
that must be completed during the 24 months immediately preceding:]
(D)] Re-establishing qualifications.
Before resuming independent interpretation of mammograms, an
IP failing [interpreting physicians who fail] to
maintain the required continuing education or experience must [requirements shall] re-establish their qualifications by completing
one or both of the following requirements, as
applicable:
a sufficient number of] additional
category I CMEUs to bring the [their] total
up to [the] 15 category I CMEU credits required in the
previous 36 months;
[and/or]
prior to] resuming independent interpretation and under the
direct supervision of a physician qualified as an IP [interpreting physician], interpret or multi-read one of the
following, whichever is
less:
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 department
[agency] based on the recommendations of an
AB, the department, [the American College of Radiology]
or the FDA. Training is [Such training will be]
developed on a case-by-case [case by case]
basis.
agency] may
require pre-approval of any additional mandatory
training.
shall] be submitted for review by the date
specified by the department
[agency].
shall] be maintained by the facility [registrant] for inspection by the department as specified [agency] in [accordance with] subsection (x)(3)[(ee)(3)] of this
section.
operators of equipment]). Each individual [person]
performing mammographic examinations must maintain current credentials
as an ARRT(R) and MRT as specified in [shall have current
certification as a medical radiologic technologist under] the
Medical Radiologic Technologist Certification Act, Texas Occupations
Code[,] Chapter 601, and must [shall]
meet the following
qualifications.
operator of equipment
shall
have]:
completed] a minimum
of 40 contact hours of training as specified [outlined]
in subparagraph (B) [subsection (hh)(1)] of
this paragraph [section] by a qualified instructor;
and
performed] a minimum
of 25 mammographic examinations under the direct supervision of an
individual qualified as specified 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 must [shall
] not exceed 16 hours of the 40 contact
hours.
(B)] Exemptions. MRTs [Equipment operators who] qualified [as medical radiologic
technologists] to perform mammography as specified in
[accordance with] the requirements of §289.230 that
were in effect before [prior to] April 28, 1999,
and any other federal requirements in effect before [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:]
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:]
the
date of the registrant's annual
inspection;]
the last day of
the calendar quarter preceding the inspection;
or]
any date in between
the
two;]
performing a minimum of 200 mammographic examinations that must be
completed during the 24 months immediately
preceding:]
(D)] Requalification. Before
resuming independent performance of mammograms, MRTs [medical
radiologic technologists] who fail to maintain the continuing
education or experience requirements must [shall]
re-establish their qualifications by completing one or both of the
following requirements, as
applicable:
obtaining a sufficient
number of] additional CEUs to bring the [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]
performing] a minimum
of 25 mammographic examinations under the direct supervision of a
qualified MRT [medical radiologic
technologist].
(E)] Additional mandatory
training. Additional mandatory training may be required by the department
[agency] based on the recommendations of an
AB, the department, [the American College of Radiology]
or the FDA. Training is [Such training will be]
developed on a case-by-case [case by case]
basis.
agency] may
require pre-approval of any additional mandatory
training.
shall] be submitted for review by the date
specified by the department
[agency].
shall] be maintained by the facility [registrant] for inspection by the department as specified
in [agency in accordance with] subsection (x)(3)[(ee)(3)] of this
section.
quality assurance]
program as specified in [accordance with] subsection (k) [(u)] of this section must [,
shall] hold a current Texas license under the Medical Physics
Practice Act, Texas Occupations Code[,] Chapter 602, in
diagnostic radiological physics. The medical physicist must [and] be registered with the department [agency]
or employed by an entity registered with the department [agency], as specified in [accordance with] §289.226(j)
of this subchapter [title] and the Act, unless
exempted by §289.226(d)(7) [(6)] of this subchapter [title]. Each medical physicist must [shall] meet the following
qualifications.
shall]:
have] a master's [masters]
degree or higher in a physical science from an accredited institution,
with no less than 20 semester hours, 30 quarter hours, or
equivalent [(30 quarter hours)] of college undergraduate
or graduate level
physics;
have] 20 contact hours of documented
specialized training in conducting surveys of mammography facilities;
and
have] experience conducting surveys
of at least one mammography facility and a total of at least 10 [ten] mammography machines. Experience [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),
and (D) 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.
accordance
with] the requirements of this section that were in effect before
[prior to] April 28, 1999, or any other equivalent
state or federal requirements in effect before [prior
to] April 28, 1999, and have met the following additional qualifications before [prior to] April 28, 1999, are determined
to have met the initial qualifications of subparagraph (A) of this
paragraph:
ten]
semester hours or equivalent of college undergraduate or graduate
level
physics;
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:]
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:]
the date of the registrant's annual
inspection;]
by the last day
of the calendar quarter preceding the inspection;
or]
any date in between
the
two;]
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:]
(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 must [shall] reestablish
their qualifications by completing one or both of the following requirements,
as
applicable:
obtaining a sufficient
number of] additional CEUs to bring the [their]
total up to the 15 CEU credits required in the previous 36 months;
[and/or]
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 may [shall] be counted towards the
total mammography machine survey
requirement.
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)] Machine Requirements.
Mammographic machines must meet the following requirements [Equipment
standards. Only systems meeting the following standards shall be used].
shall have been] specifically designed and manufactured for
mammography and as required by [in accordance with
Title] 21[,] CFR[,] §§1010.2,
1020.30, and
1020.31.
(2)] Motion of tube-image
receptor assembly. The x-ray tube must remain physically stable
during exposures. In cases where tubes are designed to move during
exposure, the facility must ensure proper and free movement of the
unit [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 must [shall] not
fail.
(4)] Magnification. Systems
used to perform diagnostic [noninterventional problem
solving] procedures must [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 must
[shall] be as
follows.
shall] indicate, before [prior to] exposure, which focal spot is
selected.
shall] indicate, before [prior to] exposure, the preselected target
material.
and/or]
focal spot are [is] selected by a system algorithm
[that is] based on the exposure [or on a test exposure], after the exposure, the system must [shall]
display[, after the exposure,] the target material and [and/or] focal spot [actually] used during the
exposure.
(6)] Compression. All mammography
systems must [shall] incorporate a compression
device.
Effective
October 28, 2002, and thereafter, each] system must [shall] provide the following features operable from both sides
of the
patient:
shall] be equipped
with different sized compression paddles matching [that
match] the sizes of all full-field image receptors provided
for the
system.
shall] be flat
and parallel to the breast support table and must [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.
shall] meet the manufacturer's design specifications
and maintenance
requirements.
shall] be straight and parallel to the edge of
the image
receptor.
shall] not appear
on the
image.
(7)] Technique factor selection
and display. Technique factor selection and display must [shall] be as
follows.
and/or] time, must [shall] be
available.
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 must
[shall] be indicated before the exposure begins,
except when AEC [automatic exposure control (AEC)]
is used, in which case the technique factors that are set before [prior to] the exposure must [shall] be
indicated.
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 must [shall
] provide an AEC mode [that is] operable in all combinations
of equipment configuration provided, for example, [contact, magnification,
and] various image receptor
sizes.
shall] permit flexibility in the placement of the
detector under the target
tissue.
shall] be clearly indicated at the x-ray input
surface of the breast compression
paddle.
shall] be clearly
indicated.
shall] provide
means to vary the selected optical density from the normal, or
zero, [(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.]
(14)] Equipment variances. Facilities [Registrants] with mammography equipment with [that has been issued] variances issued by the FDA as specified in [to Title] 21[,]
CFR[,] §§1020.2, 1020.30, 1020.31, or have [has had] an alternative to [for] a quality
standard for equipment approved by the FDA as required by [under the provisions of Title] 21[,] CFR[,] §900.18, must [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 must [shall]
provide an average illumination of not less than 160 lux (15 foot
candles) at 100 cm or the maximum SID [source-image
receptor distance (SID)], whichever is less.
(t)] Medical records and
mammography reports.
registrant shall] prepare a written report of the results of
each mammographic examination performed. [mammography
examination that shall include the following
information:]
of the patient]
and an additional patient identifier [date of birth];
date of the] examination
date;
(C)] name and signature
of the IP [interpreting physician] who interpreted
the mammogram (electronic signatures are
acceptable);
(D)] overall final assessment
of findings using the final assessment categories as defined in clauses
(i) - (vii) [subsection (c)] of this subparagraph, [section;] and classified in one of the following categories
with the assessment statement, including only the word or phrase within
the quotation marks:
(E)] recommendations made
to the healthcare provider [physician] about
what additional actions, if any, should be taken. All clinical questions
raised by the referring healthcare provider must [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 healthcare [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:]
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]
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 healthcare provider [physicians]. Each facility
must [registrant shall] follow-up to confirm if [the
following]:
that] patients with positive findings
and patients needing repeat examinations [exams]
have received proper notification;
and
that physicians]
have received proper notification of patients with positive findings
or needing repeat examinations
[exams].
(4)] Retention of clinical
images for a current, closed, or terminated facility
[registrants].
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 not performed at the facility,
the images [films] and reports must [shall] be maintained for a minimum of 10 [ten]
years as specified in subsection (x) of this
section.
registrant
that performs] mammograms must [shall],
within 15 calendar [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.
shall]
maintain and become responsible for the original images [film] until the fifth or tenth anniversary, as specified in
subparagraph (A) of this
paragraph.
(D)] Closure [Upon
closure] or
termination.[,]
the
registrant shall] maintain the mammography images [films] for five [5] years. [If the
facility complies with the
following:]
(i)] Within [within
] 180 days of closing, the facility must [registrant
shall directly] notify each patient or patient's representative
with instructions on how to access [retrieve]
or authorize disposal of the patient's records.[;
and]
(ii)] Within [within] 60 days of closing, the facility must [registrant
shall] publish a notice in at least one newspaper,
or publicly available media, [or more newspapers]
covering the geographical area served by the closing facility. The
notice must [shall]
include:
on]
retrieving patient records;
and
5] years.[;
and]
(iii)] If [if]
records have not been retrieved by the patient or the patient's representative during [following] the five-year [5-year
] period after closing, the registrant may destroy the
records.
(5)] Mammographic image
identification. Each mammographic image must include [shall
have] the following information indicated on it in a permanent,
legible manner and placed so it does [as] not
[to] obscure anatomic
structures:
name of patient]
and date of
birth;
(this information
shall be] placed on the image in a position near the axilla[)];
(at a minimum the location shall include] city, state, and zip
code[)];
technologist] identification;
cassette/screen]
identification, if applicable;
[and]
.]
(u)] Quality assurance -
general. Each facility must [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.
quality assurance] program and [for]
each of its elements must [shall] be assigned
to individuals who are qualified for their assignments and [who
shall be] allowed adequate time to perform these
duties.
registrant shall] identify a LIP [lead interpreting physician] who is responsible for [shall have the general responsibility
of]:
that] the QA [quality
assurance] program meets all requirements of this subsection
and subsections (l) and (m)[(v) and (w)] of
this
section;
technologists' quality
control] test results at least every three months or more frequently
if consistency has not yet been
achieved;
determining the individual's] qualifications
to perform the QA [quality assurance] tasks
in subparagraphs (B) - (D) of this
paragraph.
interpreting]
physicians interpreting mammograms for a facility must [the
registrant
shall]:
registrant's]
procedures for corrective action when the images they are asked to
interpret are of poor quality; these [. These]
procedures must [shall] be included in the facility's
operating and safety procedures (OSP);
and
registrant shall] use the services of a licensed medical physicist
to survey mammography equipment and oversee the equipment-related QA
[quality assurance] practices of the facility. At
a minimum, the medical physicist is [shall be]
responsible for performing the surveys, performing [and
the] mammography equipment evaluations, and providing
the facility with the reports described in subsection (l)(5)
and (6)[(v)(10) and (11)] of this
section.
quality control] technologist, designated by the LIP [lead interpreting physician], must [shall]
ensure performance of the items designated in subsection (l)(1)
- (4), (7), and (9) [(v)(1) - (4), (7) - (9), (12), and
(14)] of this section. If other personnel are assigned the QA [quality assurance] tasks in accordance with subparagraph (A)(iv)
of this paragraph, the QC [quality control]
technologist must ensure [shall insure that]
the requirements of subsection (l)(1) - (4), (7), and (9) [(v)(1) - (4), (7) - (9), (12), and (14)] of this section are
met.
lead interpreting physician], QC [quality control] technologist, and medical physicist must [shall] ensure [that] records concerning
mammography technique and procedures, QC [quality
control] (include monitoring data, corrective actions, and the
effectiveness of the corrective actions), safety, protection, and
employee qualifications related to [meet] assigned QA [quality assurance] tasks are properly maintained
and
updated.
These quality control]
records must [shall] be kept for each test specified
in subsections (l) and (m)[(v) and (w)] of this
section, as specified in [accordance with] subsection (x)[(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.]
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].
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].
(8)] Mobile service
operation.
registrant
shall] verify [that] mammography machines used to
produce mammograms at more than one location meet the requirements
in paragraphs (1) and (2) [(1) - (7)] of this
subsection.
In addition, at] each
examination location, before any examinations are conducted, the facility
must [registrant shall] verify satisfactory performance
of the mammography machines by using a testing [test]
method, as required by the manufacturer, establishing [that
establishes] the adequacy of the image quality produced by the
machine.
shall be in accordance
with paragraph (1) of this
subsection].
(9)] Use of test results.
After completion of the tests specified in paragraphs (1) and
(2) [(1) - (8)] of this subsection, the following must
[shall]
occur.
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].
Components]
of the mammography system [that] fail QA [quality
assurance] tests, the facility must follow [shall
have] corrective actions required by 21 CFR Part 900, or
the QA program recommended by the image receptor manufacturer [as indicated in the
following].
shall
] be maintained as specified in [accordance
with] subsection (x) [(ee)] of this
section.
(10)] Surveys. Annually,
not to exceed 14 months from the date of the previous survey [At least once a year], each mammography system must [facility shall] undergo a survey by a medical physicist, or
[by] an individual under the direct supervision of a medical
physicist, as specified in paragraphs (1) - (3) of this subsection.
(B)] The medical physicist must [shall] provide a written survey report to the
facility within 30 days of the date of the survey. The report must [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 any deficiencies
require immediate corrective action as specified in paragraphs (1)
- (3) of this subsection [the following tests indicate
deficiencies], the physicist must [shall]
give a preliminary [oral or] written report to the facility
within 72 hours of the
survey.[:]
(D)] The survey report must
include the: [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 facility must
maintain the survey report as specified [shall
be maintained by the registrant] in [accordance with]
subsection (x)[(ee)] of this
section.
(11)] Mammography equipment
evaluations. Additional evaluations of mammography machines must
follow manufacturer specifications. Screen-film mammography machines
must follow applicable requirements in 21 CFR Part 900. The mammography
equipment evaluation and dosimetry must be performed by a medical
physicist or an individual under the direct supervision of a medical
physicist [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].
(13)] Calibration of air kerma measuring instruments. Instruments used by medical physicists
in their annual survey and mammography equipment evaluation to
measure the air kerma or air kerma rate from a mammography machine must
[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 six percent, or 95 percent confidence level, [6.0% (95% confidence level)] in the mammography energy
range.
(14)] Infection control.
Facilities must [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 must
[shall] specify the methods for documenting facility
compliance with the infection control procedures established and must
[shall]:
(w)] Quality assurance -
mammography medical outcomes audit. Each registrant must [shall] establish and maintain a mammography medical outcomes
audit program to followup [follow-up] positive
mammographic assessments and to correlate pathology results with the IP's [interpreting physician's] findings. The [This] program must [shall] be designed
to ensure the reliability, clarity, and accuracy of the interpretation
of
mammograms.
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 IP's [interpreting physician's] mammography
report.
Analysis of these] outcome
data must [shall] be made individually and collectively
for all IPs [interpreting physicians] at the
facility and include determinations of the following. [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.]
shall be initiated
no later than] 12 months of the facility becoming certified,
and completed within the following 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.
These shall be maintained in accordance
with] subsection (x)[(ee)] of this
section.
lead interpreting physician] or an interpreting physician designated
by the LIP must [lead interpreting physician shall]
review the medical outcomes audit data at least annually, not
to exceed [once every] 12 months following the
data collection period. This individual must [shall
] analyze the results of the audit and is [shall
be] responsible for the
following:
period(s)];
interpreting
physicians] of their results and the facility's collective [registrant's aggregate] results;
[and]
.]
(x)] Mammographic procedure
and techniques for mammography of patients with breast implants. Each
registrant must [shall] have a procedure to
inquire if [whether or not] the patient has
breast implants before [prior to] the mammographic
exam. Except where contraindicated, or unless modified by a physician's
directions, patients with breast implants must [shall]
have mammographic views to maximize the visualization of breast
tissue.
(y)] Complaints. Each accredited
facility must [shall] do the
following:
accordance with]
subsection (x) [(ee)] of this section; [and]
(3)] report unresolved serious
complaints to the facility's AB [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 the [that] facility's AB [accreditation
body].
(aa)] Additional mammography
review, targeted clinical reviews, and patient
notification.
agency certifying
body] believes the [that] mammography
quality at a facility is [may have been] compromised
and presents a serious risk to human health, the facility must [shall] provide clinical images and other relevant information,
as specified by the department [agency certifying
body], for review by the AB [FDA-approved accreditation
body]. The additional mammography review will assist the
department with determining:
agency certifying
body] determines the [that] mammography
quality at a facility has been compromised and presents a serious
risk to human health, the facility must [shall]
provide clinical images and other relevant information, as specified
by the department [agency certifying body],
for review by the AB [FDA-approved accreditation body].
The department [agency certifying body] may
require such facility to notify patients who received mammograms[,]
and their referring healthcare provider [physicians]. The notification must occur within a time frame and in a manner specified
by the department. The notification must: [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 department,
the AB [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 must [shall] not initiate such a program without
prior approval from [of] the department [agency]. When requesting such approval, the [that]
person must [shall] submit the following information:
patients]
and healthcare provider [private physicians]
of the results of the mammography examination as specified in
[accordance with] subsection (j)(4) [(t)(2)]
of this
section;
physicians] in [accordance with]
subsection (j)(6) [(t)(3)] of this section;
and
physician
means of selecting a physician];
and
(cc)] Medical research and
investigational
devices.
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 as
specified in [accordance with] §289.231(b) of
this subchapter
[title].
that are] involved in clinical studies
must comply with primary regulations governing [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]:
(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;
,] Part 820 [821],
Subpart C, Design Controls [of the Quality System Regulation].
(dd)] Operating and
safety [Other operating] procedures
(OSP).
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].
shall] be provided and followed.
It must be [or electronically] displayed in the vicinity
of the control panel of each machine that specifies technique factors used for a [to be utilized versus] patient's anatomical
size. [The technique chart shall be used by all
operators.]
shall] maintain
records showing the receipt, transfer, and disposal of mammographic
machines. These records must [shall] include
the date of receipt, transfer, and [or] disposal;
the name and signature of the person [individual]
making the record; and the manufacturer's model name and serial number
from the control panel of the mammographic machine. Records must [shall] be maintained as specified in [accordance
with] subsection (x)[(ee)] of this section
for inspection by the department
[agency].
shall]
be provided to permit the operator to continuously observe the patient
during irradiation. The operator must [shall]
be able to maintain verbal, visual, and aural contact with the
patient.
individuals
] other than the patient. Only the staff and ancillary personnel
required for the medical procedure or training may [shall
] be in the room during the radiation exposure unless such individual's
assistance is
required.
shall] be utilized when required, as in paragraph (7) of this
subsection.
shall]
be of no less than 0.25 millimeter (mm) lead
equivalent
material.
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 must [shall]
be replaced or removed from service until repaired. A record of this
test must [shall] be made and maintained by
the registrant as specified in [accordance with]
subsection (x)[(ee)] of this section for inspection
by the department
[agency].
shall] be used when the exam permits.
that]
individual must [shall] be protected with appropriate
shielding devices described in paragraph (6) of this
subsection.
registrant's]
written OSP specified in subsection (t) [operating
and safety procedures required by paragraph (1)] of this section
must [subsection shall] include the
following:
shall]
be protected by not less than 0.25 mm lead equivalent
material.
shall] maintain records showing
calibrations, maintenance, and modifications performed on each mammographic
machine. These records must [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 must [shall] be maintained as specified in [accordance with] subsection (x) [(ee)] of this
section.
(ff)] Inspections. In addition
to the requirements of §289.231(kk) of this subchapter [title], the following applies to inspections of mammography
systems.
agency] may
inspect each mammography system that receives a certification as
specified in [accordance with] this chapter no [not] later than the 60th day after the date the certification
is
issued.
agency] may
inspect, at least once annually, each mammography system that receives
a
certification.
agency] may conduct more frequent inspections than required
by this
subsection.
agency] may
make reasonable attempts to coordinate inspections in this section
with other inspections required as specified in [accordance
with] this chapter for the facility where the mammography system
is
used.
agency shall issue] a certificate of inspection
for each mammography system inspected. The certificate of inspection must [shall] be posted at a conspicuous place on
or near the place where the mammography system is used. The certificate
of inspection includes [may include] the [following
]:
the] name and address of the facility
where the mammography system was used at the time of the inspection;
and
the] date of the
inspection.
found] by the department [agency], as specified in [accordance with] §289.205
of this chapter [title], constitutes grounds
for posting notice of failure of the mammography system to satisfy department
[agency]
requirements.
shall
] be
posted:
shall]
remain posted until the facility is authorized to remove it by the department
[agency]. A facility may post documentation of corrections
of the violations submitted to the department [agency]
along with the notice of failure until approval to remove the notice
of failure is received from the department [agency].
shall]
notify patients as specified in (q)(2) of this section. [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:]
agency]
may require a facility to notify a patient of any other failure of
the facility's mammography system to meet the department's [agency's] certification
standards.
shall]
include the
following:
registrant
shall] make a record of the mammography patients notified as
specified in [accordance with] paragraphs (7) and
(8) of this subsection for inspection by the department
[agency].
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.
records shall]
be maintained as specified in [accordance with]
subsection (x) [(ee)] of this
section.
(gg)] Requirements for interventional
breast radiography
machines.
(3)] Interventional [Requirements for interventional] breast radiography machine certificate
of registration (COR)
[certification].
Each person having] an interventional
breast radiography machine must apply for a certificate of registration
as specified [shall submit an application] in [accordance
with] §289.226(e) [(1) - (3), (5), and (7)]
of this subchapter, relating to general requirements for application
and registration [title], and must [shall
] receive a COR [certification] from the department before using an interventional breast radiography machine
on humans [agency within 30 days of beginning
use].
certification
shall] be signed by:
applicant and the RSO].
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 located on the control
panel.
shall]
submit documentation of [evidence that] a [medical
physicist's] survey [has been] performed by
a medical physicist, as specified in [accordance with]
paragraph (11)[(13)] of this
subsection.
(4)] Issuance of a
certificate of registration
[certification].
Certification.] A COR [certification
] for interventional breast radiography machines will be issued
if the department [agency] determines the [that an] application meets the requirements of the Act and [the
requirements of] this chapter. The COR [certification
] authorizes the proposed operations and includes [activity in such form and contains such] conditions and limitations
[as] the department [agency] deems
[appropriate or]
necessary.
Requirements and conditions
]. The department [agency] may incorporate
in the COR [certification] at the time of issuance,
or [thereafter] by amendment, [such] additional
requirements and conditions for [with respect to]
the facility's [registrant's] possession, use,
and transfer of radiation machines [subject to this chapter as
it deems appropriate or] necessary [in order]
to:
the keeping of] additional records as [may be appropriate
or] necessary;
and
agency] may request[, and the registrant shall provide,]
additional information after the certification has been issued to
enable the department [agency] to determine
whether the certification should be modified as specified in
[accordance with] §289.226(r) of this subchapter
relating to renewal of a certificate of registration [title].
(5)] Modification, suspension,
or revocation of the certificate of registration [certification
]. Modification, suspension, or revocation of the COR must
occur as specified [certification shall be] in [accordance
with] §289.226(s)[(r)] of this subchapter
[title].
(6)] Specific terms and
conditions of the certificate of registration [certification
]. Specific terms and conditions of the COR, as specified [certification shall be] in [accordance with] §289.226
[(l)] of this subchapter, must be followed [title
].
(22)] Technique chart.
A chart or manual must [shall] be provided or
electronically displayed in the vicinity of the control panel of each
interventional breast radiography machine that specifies technique
factors used for a [to be utilized versus] patient's
anatomical size. The technique chart must [shall]
be used by all
operators.
[(hh) Appendices.]
25 TAC §289.234