136C.15 - RADIATION MACHINES USED FOR MAMMOGRAPHY -- REGISTRATION STANDARDS AND REQUIREMENTS -- APPLICATION FOR AUTHORITY -- INSPECTION.
136C.15 RADIATION MACHINES USED FOR MAMMOGRAPHY --
REGISTRATION STANDARDS AND REQUIREMENTS -- APPLICATION FOR AUTHORITY
-- INSPECTION.
1. A person shall not use a radiation machine to perform
mammography unless the radiation machine is registered with the
department pursuant to the department's rules and is specifically
authorized for use for mammography as provided in this section.
2. The department shall authorize a radiation machine for use for
mammography if the radiation machine meets all of the following:
a. The radiation machine meets the criteria for a mammography
accreditation program approved by the United States food and drug
administration. The department shall make copies of those criteria
available to the public and may by rule adopt modified criteria. The
department may accept an evaluation report issued by such an approved
accreditation program as evidence that a radiation machine meets
those criteria. If at any time the department determines that it
will not accept any evaluation reports issued by such an approved
accreditation program as evidence that a radiation machine meets
those criteria, the department shall promptly notify each person who
has registered a radiation machine under this paragraph.
b. The radiation machine, the film or other image receptor
used in the radiation machine, and the facility where the radiation
machine is used meet the requirements set forth in department rules
for radiation machines.
c. The radiation machine is specifically designed to perform
mammography.
d. The radiation machine is used in a facility that does all
of the following:
(1) At least annually has a qualified radiation physicist provide
on-site consultation to the facility, including, but not limited to,
a complete evaluation of the entire mammography system to ensure
compliance with this section and the rules adopted pursuant to this
section.
(2) Maintains for at least seven years, records of the
consultation required in subparagraph (1) and the findings of the
consultation.
e. The radiation machine is used according to the department
rules on patient radiation exposure and radiation dose levels.
f. The radiation machine is operated only by an individual
who can demonstrate to the department that the individual is
specifically trained in mammography and meets the standards
established in this section, or an individual who is a physician or
an osteopathic physician.
3. The department may issue a nonrenewable temporary
authorization for a radiation machine for use for mammography if
additional time is needed to allow submission of evidence
satisfactory to the department that the radiation machine meets the
standards set forth in subsection 2 for approval for mammography. A
temporary authorization granted under this subsection shall be
effective for no more than twelve months. The department may
withdraw a temporary authorization prior to its expiration if the
radiation machine does not meet one or more of the standards set
forth in subsection 2.
4. To obtain authorization from the department to use a radiation
machine for mammography, the person who owns or leases the radiation
machine or an authorized agent of the person shall apply to the
department for mammography authorization on an application form
provided by the department and shall provide all of the information
required by the department as specified on the application form. A
person who owns or leases more than one radiation machine used for
mammography shall obtain authorization for each radiation machine.
The department shall process and respond to an application within
thirty days after the date of receipt of the application. Upon
determining to grant mammography authorization for a radiation
machine, the department shall issue a certificate of registration
specifying the mammography authorization. A mammography
authorization is effective for three years.
5. The department shall annually inspect each authorized
radiation machine and may inspect the radiation machine more
frequently. The department shall make reasonable efforts to
coordinate the inspections under this section with the department's
other inspections of the facility in which the radiation machine is
located.
6. After each satisfactory inspection by the department, the
department shall issue a written proof of inspection or a similar
document identifying the facility and radiation machine inspected and
providing a record of the date the radiation machine was inspected.
7. The department may withdraw the mammography authorization for
a radiation machine if it does not meet one or more of the standards
set forth in subsection 2.
8. The department shall provide an opportunity for a hearing in
connection with a denial or withdrawal of mammography authorization.
9. Upon a finding that a deficiency in a radiation machine used
for mammography or a violation of this section or the rules adopted
pursuant to this section seriously affects the health, safety, and
welfare of individuals upon whom the radiation machine is used for
mammography, the department may issue an emergency order summarily
withdrawing the mammography authorization of the radiation machine.
The department shall incorporate its findings in the order and shall
provide an opportunity for a hearing within five working days after
issuance of the order. The order shall be effective during the
proceedings.
10. If the department withdraws the mammography authorization of
a radiation machine, the radiation machine shall not be used for
mammography. An application for reinstatement of a mammography
authorization shall be filed and processed in the same manner as an
application for mammography authorization under subsection 4, except
that the department shall not issue a reinstated certificate of
registration specifying the mammography authorization until the
department inspects the radiation machine and determines that it
meets the standards set forth in subsection 2. The department shall
conduct an inspection required under this subsection no later than
sixty days after receiving a proper application for reinstatement of
a mammography authorization.
11. The department shall establish fees pursuant to section
136C.10 for the application for authorization and the inspection
related to a radiation machine used for mammography. Section History: Recent Form
92 Acts, ch 1054, § 2; 93 Acts, ch 139, § 4; 2008 Acts, ch 1058,
§8, 9
Referred to in § 136C.3