| (B) images stored in digital form.
(6) Radiation protocol committee (RPC) for CT systems.
(A) Development of a RPC.
(i) Each registrant utilizing CT systems shall develop
a RPC in accordance with the following:
(I) The registrant may establish a system-wide committee
if the registrant has more than one site.
(II) One or more registrants may form a cooperative
RPC as long as each facility has a representative on the committee.
(III) If the registrant has already established a radiation
safety committee, the requirements of this subsection may be delegated
to that committee if the members meet the requirements of subparagraph
(B) of this paragraph.
(IV) The committee shall meet as often as necessary
to conduct business but no less than once every 14 months.
(V) Interim meetings may be conducted by electronic
means.
(ii) The registrant shall make a record of each RPC
meeting to include the date, names of individuals in attendance, minutes
of the meeting, and any action taken. The registrant shall maintain
the record in accordance with subsection (s)(1) of this section for
inspection by the agency.
(B) Members required for the RPC. Members shall include
but not be limited to the following individuals:
(i) a radiologist or radiation oncologist;
(ii) a licensed medical physicist;
(iii) the RSO; and
(iv) other individuals as deemed necessary by the registrant.
(C) Establish and implement CT system protocols.
(i) The RPC shall establish and implement written protocols,
or protocols documented in an electronic reporting system, that include
but are not limited to the following.
(I) A method to be used to monitor the radiation output.
(II) A recommended reference level for CT procedures
performed.
(III) Actions to be taken for cases when the reference
level was exceeded which may include patient follow-up.
(IV) A review of the established protocols at an interval
not to exceed 14 months.
(ii) The registrant shall make and maintain a record
of each RPC protocol in accordance with subsection (s)(1) of this
section for inspection by the agency. If the RPC revises a protocol,
the registrant shall maintain the previous documentation after the
revision in accordance with subsection (s)(1) of this section for
inspection by the agency.
(D) Procedures for maintaining records.
(i) The registrant shall make and maintain a record
of radiation output information so the radiation dose to the skin
may be estimated in accordance with established protocols. The record
shall include the following:
(I) patient identification;
(II) type and date of examination;
(III) identification of the CT system used; and
(IV) if the CT system is capable of calculating and
displaying these values:
(-a-) CTDI vol ;
(-b-) DLP; or
(-c-) recommendations as identified in "Comprehensive
Methodology for the Evaluation of Radiation Dose in X-ray Computed
Tomography. Report of American Association of Physicists in Medicine,
Task Group 111; The Future of CT Dosimetry, February 2010," may be
used to meet compliance with this subsection.
(ii) The registrant shall maintain records required
by this subparagraph in accordance with record retention policies
of the facility.
(o) Equipment performance evaluation (EPE).
(1) Frequency of EPE. For x-ray, fluoroscopic, and
CT systems, an EPE shall be performed at the frequency listed in the
following table.
Attached Graphic
(2) Performance of EPE. For all x-ray systems an EPE
shall be performed by or under the supervision of a licensed medical
physicist:
(A) within 30 days after initial installation of new
machines;
(B) within 30 days after reinstallation of a machine;
or
(C) within 30 days after repair of a machine component
that would effect the radiation output that includes but is not limited
to the timer, tube, and power supply.
(3) Records of EPE results. Records of the test results
shall include:
(A) measurements and numerical readings;
(B) indicate a pass or fail for each test; and
(C) be reviewed and signed by the licensed medical
physicist.
(4) Correction of EPE results.
(A) Any items not meeting the specifications of the
EPE shall be corrected or repaired. The correction or repair shall
begin within 30 days following the EPE and shall be performed according
to a plan designated by the registrant. Correction or repair shall
be completed no longer than 90 days from discovery unless authorized
by the agency.
(B) The registrant shall make and maintain records
of corrections or repairs in accordance with subsection (s)(1) of
this section for inspection by the agency.
(5) Calibrated dosimetry system. The registrant shall
ensure that measurements of the radiation output of an x-ray system
are performed with a calibrated dosimetry system in accordance with
subsection (i)(14) of this section.
(6) EPE for x-ray systems.
(A) Timer. The accuracy of the timer shall meet the
manufacturer's specifications. If the manufacturer's specifications
are not obtainable, the timer accuracy shall be plus or minus 10%
of the indicated time with testing performed at 0.5 second.
(B) Exposure reproducibility. Exposure reproducibility
shall meet the requirements of subsection (l)(4) of this section.
(C) Linearity. mR/mAs (mGy/mAs) stations shall meet
the requirements of subsection (l)(5) of this section.
(D) kVp. If the registrant possesses documentation
of the appropriate manufacturer's kVp specifications, the radiation
machine shall meet those specifications. If the registrant does not
possess documentation of the appropriate manufacturer's kVp specifications,
the indicated kVp shall be accurate to within plus or minus 10% of
the indicated setting at no less than 3 points over the usual operating
range of the machine.
(E) Tube stability. The x-ray tube shall remain physically
stable during exposures. In cases where tubes are designed to move
during exposure, the registrant shall assure proper and free movement
of the unit.
(F) Collimation. The following items shall meet the
requirements of subsection (l)(1) of this section:
(i) numerical indicators of x-ray field size;
(ii) light field versus x-ray field congruence;
(iii) automatic and semi-automatic collimators unless
disabled; and
(iv) center of x-ray field alignment with center of
image receptor.
(G) Entrance exposure (air kerma) limits. Entrance
exposure (air kerma) limits shall meet the requirements specified
in subsection (j) of this section and shall be determined for all
examinations specified in Table I of subsection (j) of this section,
that are performed by the registrant.
(7) EPE for fluoroscopic systems and spot film devices.
Fluoroscopic systems shall meet the requirements of subsections (i)(14)
and (m)(1)(C) and (3) of this section.
(8) EPE for CT systems. CT systems shall meet the requirements
of subsections (i)(14) and (n)(1)(H) of this section.
(p) Automatic and manual film processing for facilities
and mobile services.
(1) Films shall be developed in accordance with the
time-temperature relationships recommended by the film manufacturer.
The specified developer temperature for automatic processing and the
time-temperature chart for manual processing shall be posted near
the film processing area. If the registrant determines an alternate
time-temperature relationship is more appropriate for a specific facility,
that time-temperature relationship shall be documented and posted.
(2) Chemicals shall be replaced according to the chemical
manufacturer's or supplier's recommendations or at an interval not
to exceed 3 months.
(3) Darkroom light leak tests shall be performed at
intervals not to exceed 6 months.
(4) Lighting in the film processing/loading area shall
be maintained with the filter, bulb wattage, and distances recommended
by the film manufacturer for that film emulsion or with products that
provide an equivalent level of protection against fogging.
Cont'd... |
