Current through Register Vol. 48, No. 9, September 27, 2024
2.8.1 Any person
who sells, leases, transfers, lends, moves, assembles, or installs x-ray
machines in this state shall notify the Department within thirty (30) calendar
days of:
2.8.1.1 The name and address of
persons who have received these machines;
2.8.1.2 The manufacturer, the control and
tube(s) model number, the control and tube(s) serial number of each radiation
machine transferred; and
2.8.1.3
The date of transfer of each x-ray machine.
2.8.1.4 Notification to the Department shall
be made on forms provided by the Department and shall be submitted to the
Department each month by Class I and Class II-A vendors.
2.8.2 No person shall furnish any x-ray
machine services or make, sell, lease, transfer, lend, maintain, calibrate,
test, repair, assemble, reassemble, reinstall, or install radiation machines or
the supplies used in connection with such machines unless such supplies and
equipment when properly placed in operation and use, meet the requirements of
this regulation. Each vendor shall ensure that the facility it is providing
with services or supplies is registered with the Department prior to providing
services or supplies.
2.8.2.1 Any vendor
acting as a Radiation Safety Officer on behalf of a registered facility shall
be registered as a Class VIII or IX vendor and shall meet all applicable Parts
of this regulation.
2.8.3 Each vendor shall maintain records for
review by the Department. These records shall include, at a minimum:
2.8.3.1 All information required by
RHB 2.7 and 2.8;
2.8.3.2 A copy of any shielding plans and/or
area surveys. Records of shielding plans and area surveys shall include the
date that the service was performed and the legible signature of the person
performing the service;
2.8.3.3
Tests performed at the time of installation to ensure that the equipment
complies with this regulation. A copy of these results shall be provided to the
registrant at the time of installation;
2.8.3.4 Records of any routine maintenance,
repair, alterations, or reassembly of x-ray equipment. Records of maintenance,
repair, alterations, or reassemblies shall include the date that the service
was performed and the legible signature of the person performing the service. A
copy of these records shall be provided to the registrant at the time the
service is provided;
2.8.3.5 Names
of all employees and their dates of employment with the vendor. Records shall
also be maintained of training provided to the employees during their term of
employment; and
2.8.3.6 A copy of
equipment performance tests, including data collected during the testing.
2.8.3.6.1 A copy of the equipment performance
test shall be provided to the facility either at the time of testing or within
thirty (30) calendar days of the testing date.
2.8.3.6.2 The report of equipment performance
testing shall include the testing of all items listed in Part IV, Appendix F,
except as noted in the Appendix.
2.8.3.6.3 The equipment performance test
record provided to the facility must clearly indicate all equipment parameters
tested and each item must include a designation, such as "Pass/Fail" or
"Compliant/Non-compliant," that is easily understandable by the facility. Use
of any designation other than "Pass/Fail" or "Compliant/Non-compliant" shall be
approved by the Department prior to use on equipment performance reports of
testing.
2.8.3.6.4 The equipment
performance test record shall include a summary of findings and recommendations
for necessary improvements and/or corrective actions.
2.8.3.6.5 The record of equipment performance
shall be legible and include the date that the testing was performed; the
facility name, facility location address, and facility registration number
issued by the Department; the legible signature of the person performing the
service; manufacturer, model number, serial number, and the calibration date of
the instrument used to perform the test; and the manufacturer, serial number,
model number, and location of the equipment.
2.8.4 All records required by this Part shall
be maintained by the vendor until their disposal is authorized by the
Department. All records shall be legible, accurate, and factual.
2.8.5 Each vendor shall maintain sufficient
calibrated and operable instruments to perform the testing appropriate to the
class in which the vendor is registered. Instruments shall be calibrated with
sources consistent with the conditions under which they are used. Legible
records shall be maintained of the calibrations performed on instrumentation
used for testing. All provisions of
RHB 1.4.4 apply.
