Current through Register Vol. 47, No. 6, September 18, 2024
(1)
Definitions. In addition
to the definitions provided in rules
641-38.2 (136C),
641-40.2 (136C), and
641-41.1 (136C), the following
definitions are applicable to this rule.
"Collaborative setting" means a setting in
which a qualified radiologist and surgeon (under 41.7(3)"a" or
41.7(3)"c") are working together in consultation and in
performing stereotactically guided breast biopsies with a common goal of the
patient's benefit.
"Phantom" means an artificial test object used
to simulate radiographic characteristics of compressed breast tissue and
containing components that radiographically model aspects of breast disease and
cancer.
"Procedure" means a stereotactically guided
breast biopsy performed on a patient for diagnostic purposes.
"Qualified training physician" means a
physician who is qualified under 41.7(3) to perform stereotactically guided
breast biopsies and who has performed at least 24 procedures.
"Stereotactic training phantom" means a
training or practice tool or medium used for stereotactically guided breast
biopsy procedures.
"Stereotactically guided breast biopsy" means
a breast biopsy procedure performed with the utilization of a dedicated system
which emits ionizing radiation and is designed specifically for that
procedure.
"Supervising physician" means the physician
designated by the facility/owner to:
1.
Evaluate the equipment, personnel, procedures, and records annually;
and
2. Establish and conduct the
quality assurance program.
(2)
Registration and application
standards and requirements.
a. Each
radiation machine used to perform stereotactically guided breast biopsies shall
be registered according to 641-subrule 39.3(2).
b. Each facility wishing to perform
stereotactically guided breast biopsies shall apply to the agency for
authorization by providing or verifying the following information for each
machine:
(1) The stereotactically guided
breast biopsy equipment and facility meet the general requirements of these
rules for radiation machines.
(2)
The radiation machine is specifically designed to perform stereotactically
guided breast biopsies.
(3) The
radiation machine is used according to these rules on patient radiation
exposure and radiation dose levels.
(4) The radiation machine is operated by
individuals meeting the requirements of this rule.
(5) The entire stereotactically guided breast
biopsy system is evaluated annually by a medical physicist who meets the
requirements of this rule.
(6) The
equipment, personnel, procedures and records are evaluated annually by the
supervising physician.
c. Suspension, revocation, or denial of
authorization.
(1) Authorization may be
suspended or revoked with cause if any machine does not meet one or more of the
standards of these rules.
(2) The
facility shall have an opportunity for a hearing in connection with a denial,
suspension, or revocation of authorization.
(3) An emergency order suspending or revoking
authorization may be issued if the agency finds the radiation machine or
facility violates rules that seriously affect the health, safety and welfare of
the public. An opportunity for hearing shall be held within 20 working days
after the issuance of the order. The order shall be effective during the
proceedings.
(4) If authorization
is revoked, the radiation machine shall not be used until reinstated.
d. Reinstatement of authorization.
(1) An application for reinstatement shall be
submitted and processed the same as an initial application.
(2) The agency shall inspect the radiation
machine within 60 days of the approved reinstatement application. If the
reinstatement is after a revocation, appropriate corrective action shall be
submitted with the application.
(3)
A full reinstatement shall be issued only after the agency has inspected the
radiation machine and facility and determined that they meet the requirements
of these rules.
e.
Inspections. The agency shall conduct an inspection of each radiation machine
no later than 14 months after initial authorization and at least annually
thereafter.
(3)
Physicians. Physicians must be qualified according to the
setting and their role in performing stereotactically guided breast biopsies as
outlined below.
a. Requirements for a
radiologist in a collaborative setting are as follows:
(1) Initial training and qualifications.
1. Must be qualified according to
41.6(3)"a."
2.
Shall have performed at least 12 stereotactically guided breast biopsies prior
to July 1, 1998, or at least 3 hands-on stereotactically guided breast biopsies
under a physician who is qualified under 41.7(3) and has performed at least 24
stereotactically guided breast biopsies.
3. Shall have at least three hours of
Category 1 CME or three hours of training approved by the agency in
stereotactically guided breast biopsy.
4. Shall be responsible for mammographic
interpretation, be experienced as noted in 41.7(3)"a"(1)"2"
above and be experienced in the specific recommendations for each biopsy and
lesion identification at time of each biopsy performed by that physician.
5. Shall be responsible for the
supervision of the radiologic technologist during the procedure.
(2) Maintenance of proficiency and
CME requirements.
1. Following the first
anniversary in which the requirements of this subrule were met, completion of a
total of 12 breast biopsy procedures must be met for each calendar year with at
least 6 being stereotactic breast biopsies. The remaining 6 can be any
combination of the following, and demonstration of the chosen combination needs
to be clearly documented:
* Stereotactic breast biopsy procedures.
* Stereotactic biopsy of a stereotactic training phantom with
documentation of steps taken or a written report.
* Stereotactic breast biopsy case review, which must be
documented to include a review of pre-biopsy mammographic examination, scout
and stereotactic positioning, biopsy needle pre-fire and post-fire positioning
and targeting, specimen radiograph images, post-biopsy images and review of
post-biopsy pathology results.
* Mammographic-guided, stereotactic-guided, or both, wire
localization procedures.
* Ultrasound-guided breast biopsy procedures.
* MRI-guided breast biopsy procedures.
If experience is not maintained, the physician must requalify
by performing three procedures under direct supervision of a qualified training
physician or an agency-approved manufacturer applications specialist before
resuming unsupervised procedures.
2. Following the first anniversary in which
the requirements of this subrule were met, obtain at least three hours of
Category 1 CME or three hours of training approved by the agency in
stereotactic-guided breast biopsy during the 36 months immediately preceding
the date of the facility's annual stereotactic biopsy inspection, or during the
36-month period ending on the last day of the calendar quarter preceding the
inspection. If education is not maintained, the physician must requalify by
obtaining additional CME credits to reach 3 CME credits in the prior 36 months
before resuming unsupervised procedures. These CMEs cannot be obtained by the
performance of supervised procedures.
3. A current state of Iowa medical license
must be in effect whenever procedures are performed independently by the
physician.
b.
Requirements for a physician other than a qualified radiologist in a
collaborative setting are as follows:
(1)
Initial training and qualifications.
1. Must
be licensed to practice medicine in Iowa.
2. Must have at least three hours of Category
1 CME or three hours of training approved by the agency in stereotactically
guided breast biopsy which includes instruction on triangulation for lesion
location.
3. Must have performed at
least 12 stereotactically guided breast biopsies prior to May 9, 2001, or at
least 3 hands-on stereotactically guided breast biopsy procedures under a
physician who is both qualified to perform stereotactic biopsy procedures
according to 41.7(3) and has performed at least 24 stereotactically guided
breast biopsies.
4. Shall be
responsible for post-biopsy management of the patient.
5. Shall be responsible for supervision of
the radiologic technologist during the procedure.
(2) Maintenance of proficiency and CME
requirements.
1. Following the first
anniversary in which the requirements of this subrule were met, completion of a
total of 12 breast biopsy procedures must be met for each calendar year with at
least 6 being stereotactic breast biopsies. The remaining 6 can be any
combination of the following and demonstration of the chosen combination needs
to be clearly documented:
* Stereotactic breast biopsy procedures.
* Stereotactic biopsy of a stereotactic training phantom with
documentation of steps taken or a written report.
* Stereotactic breast biopsy case review, which must be
documented to include a review of pre-biopsy mammographic examination, scout
and stereotactic positioning, biopsy needle pre-fire and post-fire positioning
and targeting, specimen radiograph images, post-biopsy images and review of
post-biopsy pathology results.
* Mammographic-guided, stereotactic-guided, or both, wire
localization procedures.
* Ultrasound-guided breast biopsy procedures.
* MRI-guided breast biopsy procedures.
If experience is not maintained, the physician must requalify
by performing three procedures under direct supervision of a qualified training
physician or an agency-approved manufacturer applications specialist before
resuming unsupervised procedures.
2. Following the first anniversary in which
the requirements of this subrule were met, obtain at least three hours of
Category 1 CME immediately preceding the date of the facility's annual
stereotactic biopsy inspection, or during the 36-month period ending on the
last day of the calendar quarter preceding the inspection. If education is not
maintained, the physician must requalify by obtaining additional CME credits to
reach 3 CME credits in the prior 36 months before resuming unsupervised
procedures. These CMEs cannot be obtained by the performance of supervised
procedures.
3. A current state of
Iowa medical license must be in effect whenever unsupervised procedures are
performed by the physician.
c. Requirements for a radiologist performing
stereotactically guided breast biopsy independently are as follows:
(1) Initial training and requirements.
1. Must be qualified according to
41.6(3)"a."
2.
Initially, must have at least three hours of Category 1 CME or three hours of
training approved by the agency in stereotactically guided breast
biopsy.
3. Initially, must obtain
at least 15 hours of CME in breast imaging including benign and malignant
breast diseases.
4. Must have
performed at least 12 stereotactically guided breast biopsies prior to July 1,
1998, or at least 3 hands-on stereotactically guided breast biopsy procedures
under a physician who is both qualified according to 41.7(3) and has performed
at least 24 stereotactically guided breast biopsies.
5. Must be responsible for mammographic
interpretation.
6. Must be
responsible for patient selection.
7. Must be responsible for the supervision of
the radiologic technologist during the procedure.
8. Must be responsible for post-biopsy
management of the patient which may include referral to a surgeon for a
follow-up on certain lesions.
(2) Maintenance of proficiency and CME
requirements.
1. Following the first
anniversary in which the requirements of this subrule were met, completion of a
total of 12 breast biopsy procedures must be met for each calendar year with at
least 6 being stereotactic breast biopsies. The remaining 6 can be any
combination of the following and demonstration of the chosen combination needs
to be clearly documented:
* Stereotactic breast biopsy procedures.
* Stereotactic biopsy of a stereotactic training phantom with
documentation of steps taken or a written report.
* Stereotactic breast biopsy case review, which must be
documented to include a review of pre-biopsy mammographic examination, scout
and stereotactic positioning, biopsy needle pre-fire and post-fire positioning
and targeting, specimen radiograph images, post-biopsy images and review of
post-biopsy pathology results.
* Mammographic-guided, stereotactic-guided, or both, wire
localization procedures.
* Ultrasound-guided breast biopsy procedures.
* MRI-guided breast biopsy procedures.
If experience is not maintained, the physician must requalify
by performing three procedures under direct supervision of a qualified training
physician or an agency-approved manufacturer applications specialist before
resuming unsupervised procedures.
2. Following the first anniversary in which
the requirements of this subrule were met, obtain at least three hours of
Category 1 CME immediately preceding the date of the facility's annual
stereotactic biopsy inspection, or during the 36-month period ending on the
last day of the calendar quarter preceding the inspection which includes
post-biopsy management of the patient. If education is not maintained, the
physician must requalify by obtaining additional CME credits to reach 3 CME
credits in the prior 36 months before resuming unsupervised procedures. These
CMEs cannot be obtained by the performance of supervised procedures.
3. A current state of Iowa medical license
must be in effect whenever unsupervised procedures are performed by the
physician.
d.
Requirements for a physician other than a qualified radiologist (under
41.7(3)
"c") performing stereotactically guided breast biopsy
independently are as follows:
(1) Initial
training and requirements.
1. Must be licensed
to practice medicine in Iowa.
2.
Must have evaluated at least 480 mammograms in the prior 24 months in
consultation with a physician who is qualified according to
41.6(3)"a."
3.
Initially, must have at least 15 hours of Category 1 CME or 15 hours of
training approved by the agency in stereotactically guided breast imaging and
biopsy or three years' experience having performed at least 36 stereotactically
guided breast biopsies.
4. Must
have four hours of Category 1 CME in medical radiation physics.
5. Must have performed at least 12
stereotactically guided breast biopsies prior to May 9, 2001, or at least 3
hands-on stereotactically guided breast biopsy procedures under a physician who
is both qualified according to 41.7(3) and has performed at least 24
stereotactically guided breast biopsies.
6. Must be responsible for patient
selection.
7. Must be responsible
for the supervision of the radiologic technologist during the
procedure.
8. Must be responsible
for post-biopsy management of the patient.
(2) Maintenance of proficiency and CME
requirements.
1. Continue to evaluate at least
480 mammograms every 24 months in consultation with a physician who is
qualified according to 41.6(3)"a."
2. Following the first anniversary in which
the requirements of this subrule were met, completion of a total of 12 breast
biopsy procedures must be met for each calendar year with at least 6 being
stereotactic breast biopsies. The remaining 6 can be any combination of the
following and demonstration of the chosen combination needs to be clearly
documented:
* Stereotactic breast biopsy procedures.
* Stereotactic biopsy of a stereotactic training phantom with
documentation of steps taken or a written report.
* Stereotactic breast biopsy case review, which must be
documented to include a review of pre-biopsy mammographic examination, scout
and stereotactic positioning, biopsy needle pre-fire and post-fire positioning
and targeting, specimen radiograph images, post-biopsy images and review of
post-biopsy pathology results.
* Mammographic-guided, stereotactic-guided, or both, wire
localization procedures.
* Ultrasound-guided breast biopsy procedures.
* MRI-guided breast biopsy procedures.
If experience is not maintained, the physician must requalify
by performing three procedures under direct supervision of a qualified training
physician or an agency-approved manufacturer applications specialist before
resuming unsupervised procedures.
3. Following the first anniversary in which
the requirements of this subrule were met, obtain at least three hours of
Category 1 CME immediately preceding the date of the facility's annual
stereotactic biopsy inspection, or during the 36-month period ending on the
last day of the calendar quarter preceding the inspection. If education is not
maintained, the physician must requalify by obtaining additional CME credits to
reach 3 CME credits in the prior 36 months before resuming unsupervised
procedures. The CME credits for requalification cannot be obtained by
performing procedures.
4. A current
state of Iowa medical license must be in effect whenever unsupervised
procedures are performed by the physician.
(4)
Medical
physicist.
a. Must be qualified
according to 41.6(3)"c."
b. Must have performed three hands-on
stereotactically guided breast biopsy system physics surveys prior to July 1,
1998; or one hands-on stereotactically guided breast biopsy system physics
survey under the guidance of a medical physicist qualified through
41.7(4)"a" and 41.7(4)"b."
c. Maintenance of proficiency and continuing
education requirements.
(1) Have performed at
least one stereotactically guided breast biopsy system physics survey per year
after the initial qualifications are met or requalify by performing one survey
supervised by a qualified medical physicist; and
(2) Following the third anniversary in which
the requirements of this subrule were met, have obtained at least three hours
of continuing education in stereotactically guided breast biopsy system physics
during the previous 36 months or requalify by obtaining additional CME credits
to reach 3 CME credits in the prior 36 months.
(5)
Radiologic technologist.
a. Must be qualified according to
41.6(3)"b."
b.
Must meet the following initial requirements:
(1) Five hands-on stereotactically guided
breast biopsy procedures on patients under the supervision of a physician or
technologist qualified under rule 641-41.7 (136C).
(2) Three contact hours in stereotactically
guided breast biopsy.
c.
Maintenance of proficiency and continuing education and experience
requirements.
(1) Following the first
anniversary in which the requirements of this subrule were met, completion of a
total of 12 breast biopsy procedures must be met for each calendar year with at
least 6 being stereotactic breast biopsies. The remaining 6 can be any
combination of the following and demonstration of the chosen combination needs
to be clearly documented:
1. Stereotactic
breast biopsy procedures.
2.
Stereotactic biopsy of a stereotactic training phantom with documentation of
steps taken or a written report.
3.
Stereotactic breast biopsy case review, must be documented to include a review
of pre-biopsy mammographic examination, scout and stereotactic images, biopsy
needle pre-fire and post-fire images, specimen radiograph images, post-biopsy
images and review of post-biopsy pathology results.
4. Mammographic-guided, stereotactic-guided,
or both, wire localization procedures.
5. Ultrasound-guided breast biopsy
procedures.
6. MRI-guided breast
biopsy procedures.
If experience is not maintained, the radiologic technologist
must requalify by performing three stereotactically guided breast biopsies
under the supervision of a physician or radiologic technologist qualified under
41.7(3) or 41.7(5).
(2) Following the third anniversary in which
the requirements of this subrule were met, obtain at least three hours of
continuing education in stereotactically guided breast biopsy during the 36
months immediately preceding the date of the facility's annual stereotactic
biopsy inspection, or during the 36-month period ending on the last day of the
calendar quarter preceding the inspection, or requalify by obtaining additional
CME credits to reach 3 CME credits in the prior 36 months. The CMEs cannot be
obtained by the performance of supervised procedures.
(3) If a stereotactic radiologic technologist
performs only stereotactic procedures, the radiologic technologist must perform
at least 100 stereotactic procedures during the prior 24 months immediately
preceding the date of the facility's annual stereotactic biopsy inspection,
during the 24-month period ending on the last day of the previous calendar
quarter, or any 24-month period between the two. In this case, all requirements
for radiologic technologists must be met with the exception of
41.6(3)"b"(4)"1."
(4) Only 50 percent of the total required
stereotactic continuing education hours may be obtained through presenting or
acting as a trainer for a continuing education or training program.
(5) An Iowa permit to practice radiography
must be in effect whenever stereotactic procedures are performed by the
radiologic technologist.
(6)
Obtaining and preserving
records.
a. The facility must make,
for each procedure, a record of the service provided including:
(1) The date of the procedure.
(2) The name of the patient and one
additional patient identifier.
(3)
The name of the radiologic technologists and physicians performing the
procedure.
(4) A description of the
service provided.
(5) The name of
the referring physician, if any.
b. Records retained by the medical facility
must be retained for at least ten years.
(7)
Quality assurance
program.
a. The facility shall have
an equipment quality assurance program specific to stereotactically guided
breast biopsy systems and covering all components of the system to ensure
high-quality images with minimum patient exposure.
b. The facility shall ensure that a general
review of the program is conducted at least annually and have available the
services of a qualified medical physicist who is capable of establishing and
conducting the program.
c. The
facility shall name a supervising stereotactic biopsy physician who shall be
responsible for:
(1) Quality assurance
activities including the medical audit,
(2) Oversight of the quality control program,
and
(3) Supervision of the
radiologic technologist(s) and the medical physicist.
d. Under the direction of the supervising
physician, the medical physicist shall have the responsibility for establishing
and conducting the equipment quality assurance program. The program shall
include:
(1) Conducting equipment performance
monitoring functions, initially and then at least annually, to include:
1. Evaluation of biopsy unit assembly. Any
failed items must be corrected within 30 days of the survey unless the medical
physicist deems that the failure poses a serious injury risk to the patient, at
which time the failure needs to be corrected before further procedures are
performed.
2. Collimation.
* X-ray field must not extend beyond the image receptor by more
than 5 mm on any side.
* Any failures must be corrected within 30 days of the
survey.
3. Evaluation of
focal spot. Focal spot must not degrade from initial measurement. If reduction
in lp/mm is found, focal spot must be corrected within 30 days of
survey.
4. kVp
accuracy/reproducibility. kVp accuracy/reproducibility must be accurate to
within +/- 5% of nominal kVp setting. Failures must be corrected before further
procedures are performed.
5.
Half-value layer measurement. HVL shall be greater than kVp/100 (in units of mm
Al). Failures must be corrected before further procedures are
performed.
6. Exposure
reproducibility. Exposure must be reproducible to within +/- 15% of mean
exposure. Failures must be corrected before further procedures are
performed.
7. Breast entrance
exposure, average glandular dose. Average glandular dose must be less than 300
millirad (3 milliGray) per exposure of a 50 percent glandular/50 percent
adipose 4.2 centimeter breast. Failures must be corrected before further
procedures are performed.
8. Image
quality evaluation.
* Phantom image must meet the criteria of 5 fibers, 4 speck
groups and 3 masses for the ACR accreditation phantom or 3 fibers, 3 speck
groups and 2.5 masses for the mini phantom unless otherwise stated by the
phantom manufacturer.
* Failures must be corrected before further procedures are
performed.
9. Artifact
evaluation. Any significant black or white artifacts seen in the image detector
field must be corrected within 30 days of the survey.
10. Digital field uniformity. For units with
region of interest (ROI) capability, the SNR in each corner must be within +/-
15% of the SNR in the center. Failures must be corrected within 30 days of the
survey.
11. Localization simulation
(gelatin phantom) test. Localization accuracy must be within 1 mm of target,
and the test must include a portion of the test "lesion" in the sample chamber.
Failures must be corrected before further procedures are performed.
(2) Analyzing the monitoring
results to determine if there are any problems requiring correction.
(3) Ensuring that the facility has procedures
in place for carrying out or arranging for the necessary corrective actions as
well as for the calibrations and other preventative maintenance.
e. The supervising physician shall
have the responsibility for establishing and conducting the quality control
program in a facility with a fixed unit. In the case of a mobile stereotactic
unit, the owner or designee shall assume the responsibility for establishing
and conducting the quality assurance program. The program shall include:
(1) Localization accuracy (daily before use
and before using the localization unit after it is adjusted). Each coordinate
must be within manufacturer specifications for the intended target value.
Failures must be corrected before further procedures are performed.
(2) Visual checklist (monthly). Any failed
items must be corrected within 30 days.
(3) Phantom image (weekly). Phantom image
must meet the criteria of 5 fibers, 4 speck groups and 3 masses for the ACR
accreditation phantom or 3 fibers, 3 speck groups and 2.5 masses for the mini
phantom unless otherwise stated by the phantom manufacturer. Failures must be
corrected before further procedures are performed.
(4) Compression (semiannually). The maximum
auto drive compression force shall not exceed 45 pounds. Failures must be
corrected within 30 days.
(5) Any
additional quality control testing indicated by the stereotactic breast biopsy
unit manufacturer must be completed as outlined in the quality control manual
applicable to the unit.
f. Each facility shall establish a medical
audit program to ensure the accuracy and appropriateness of the procedures
performed. This program shall include an imaging-pathology correlation for each
biopsy performed, an ongoing analysis of biopsy results and periodic review of
the utilization of the procedure. The program must include the number of
biopsies performed, the number of cancers found, the number of benign lesions
found, and the number of biopsies repeated.
g. Additional medical physicist evaluations
of stereotactic units shall be conducted whenever a new unit is installed, a
unit is disassembled and reassembled at the same or a new location, or major
components of a stereotactic unit are changed or repaired. These evaluations
shall be used to determine whether the new or changed equipment meets the
requirements of applicable standards in 41.7(7). All problems shall be
corrected before the new or changed equipment is put into service for
examinations.
The stereotactic equipment evaluation shall be performed by a
medical physicist qualified under 41.7(4) or by an individual under the direct
supervision of a medical physicist qualified under 41.7(4).
(8)
Equipment
standards.
a. Be specifically
designed for stereotactically guided breast biopsy.
b. Meet the Food and Drug Administration
(FDA) standards found in 21 CFR.
(9)
Safety standards.
a. Proper safety precautions shall be
maintained and shall include, but not be limited to, adequate shielding for
patients, personnel and facilities. The equipment shall be operated only from a
shielded position.
b. Annual
inspections shall be conducted by an inspector from the agency to ensure
compliance with these rules. Identified hazards shall be promptly
corrected.
c. Equipment shall be
shockproof and grounded to protect against electrical hazards.
d. Records of all inspection reports and
medical physicist surveys shall be maintained for at least seven years.
This rule is intended to implement Iowa Code chapter
136C.
