This rule provides standards for radiation-generating equipment
used for screening and diagnostic mammography, and mammography equipment used
for invasive localization and stereotactically guided breast biopsy purposes,
except as provided by paragraphs (E) and (F) of this rule. In addition
to Chapters 3701:1-38 and 3701:1-66 of the
Administrative Code, a handler of mammography radiation-generating
equipment that uses either stationary or mobile installations, shall comply
with all applicable standards in 21 C.F.R. part
1020 (as published in the April 1, 2012, Code of
Federal Regulations
effective on the effective
date of this rule) and the
following:
.
(A) In addition to meeting the applicable
equipment standards in rule
3701:1-66-02
of the Administrative Code, a
facility
handler performing screening or diagnostic mammography
shall have a valid certificate issued by the U.S. department of health and
human services, pursuant to the Mammography Quality Standards Reauthorization
Act of 1998,
Public
Law 105-248, and 21 C.F.R. Part
900
(as effective on the effective date of this
rule).
(B) A handler of all
types of mammography radiation-generating equipment shall comply with the
shielding requirements in paragraphs
(I)(2)
(H)(2) to
(I)(4)
(H)(4)
of rule
3701:1-66-02
of the Administrative Code.
(C) In
addition to applicable radiation safety requirements in rules adopted pursuant
to Chapter 3748. of the Revised Code and rule
3701:1-66-02
of the Administrative Code, a handler of all types of screening and diagnostic
mammography radiation-generating equipment shall comply with the following:
(1) When a film/screen mammography system is
used, clinical films shall be processed as soon as possible, but not to exceed
twenty-four hours from the time the first clinical image is taken. Facilities
utilizing batch processing shall:
(a) Use a
container to transport clinical films that will protect the film from exposure
to light, excessive heat and radiation; and
(b) Maintain a log to include date and
identification of each patient, time of first exposure of each batch, and date
and time of each batch processing
.
;
(2)
An individual,
other than a licensed practitioner, operating any type of
Individuals who perform mammography
equipment
procedures on human beings shall
possess
hold
an Ohio radiographer license in accordance with
rules in Chapter 3701-72 of the Administrative Code
and
shall meet at least one of the following
initial qualifications:
(a) Documented evidence of having completed
sixteen hours of structured education in mammography
which was university-awarded or approved by a recognized continuing education
evaluation mechanism as accepted by the "American Registry of Radiologic
Technologists"
the forty contact hours of
training required by
21 C.F.R.
900.12(a)(2)(ii)
;
or
(b)
Proof of
Hold advanced
certification in mammography issued
to the
operator by the "American Registry of Radiologic
Technology
Technologists."
(D) In addition to all applicable quality
assurance requirements in rules
3701:1-66-02
and
3701:1-66-04
of the Administrative Code, the facility shall maintain phantom and quality
control images for three months.
(E) Radiation-generating equipment designed
for mammography
, but used exclusively for
radiography of tissue from a biopsy, shall be exempt from paragraphs (A) to (D)
of this rule, and shall comply with
the requirements
set forth in paragraphs
(A),
(F)
(E),
(H)(1), (I)(2)
(H)(2),
(I)(3)
(H)(3)
and (J) of rule
3701:1-66-02
of the Administrative Code.
(F)
Radiation-generating equipment used for radiography of tissue from a biopsy and
equipped with an x-ray tube enclosure designed to exclude personnel from its
interior during x-ray generation shall be exempt from paragraphs (A) to (E) of
this rule, and shall comply with the requirements set forth in
paragraph (H)(2) of rule
3701:1-68-03
3701:1-68-06 of the Administrative Code.
(G) Quality control testing by a medical
physicist shall be conducted on mammography radiation generating equipment used
for invasive localization or having stereotactically guided breast biopsy
capability. Quality control testing for stereotactically guided breast biopsy
equipment shall follow the "American College of Radiology (ACR) Practice
Guideline
Parameter for the Performance of
Stereotactically Guided
Stereotactic Guided Breast Interventional Procedures"
(as revised in
2009
2016). This document is available from the "American
College of Radiology, 1891 Preston White Drive, Reston, Virginia 20191,
telephone (703) 648-8900."
(1) The medical
physicist shall meet the requirements of the aforementioned ACR guideline; and
(2) The medical physicist shall
document and verify that the facility is taking proper corrective actions when
results of the quality control tests indicate the need.
Notes
Ohio Admin. Code
3701:1-66-08
Effective:
12/20/2019
Five Year Review (FYR) Dates:
9/10/2019 and
05/01/2023
Promulgated
Under: 119.03
Statutory
Authority: ORC 3748.04
Rule
Amplifies: ORC 3748.01,
3748.02,
3748.04,
3748.05,
3748.06,
3748.07,
3748.12,
3748.121,
3748.13,
3748.14,
3748.15,
3748.17,
3748.18,
3748.19,
3748.20,
3748.22,
3748.99
Prior
Effective Dates: 02/15/2001, 02/01/2005, 04/15/2009,
02/01/2014