6 Colo. Code Regs. § 1007-1-6.5
Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-6.5 - Requirements for use of a fluoroscopy system6.5.1 In addition to the provisions of 6.3 and 6.4, the requirements of 6.5 apply to all fluoroscopic facilities and equipment used for fluoroscopic imaging or for recording images from the fluoroscopic image receptor. 6.5.1.1 Only image-intensified or direct-digital receptor fluoroscopic equipment shall be used for fluoroscopy.6.5.2 Primary Protective Barrier. 6.5.2.1 Limitation of useful beam. (1) The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any SID.(2) The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam.(3) The AKR due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic imaging receptor shall not exceed 3.34x10-3 percent of the entrance AKR, at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor.(4) Radiation therapy simulation systems shall be exempt from 6.5.2.1 provided the systems are intended only for remote control operation.6.5.2.2 Measuring compliance. (1) The AKR shall be measured in accordance with 6.5.5.(2) The AKR due to transmission through the primary barrier combined with radiation from the fluoroscopic image receptor shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm.(3) If the source is below the tabletop, the AKR measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 cm above the tabletop.(4) If the source is above the tabletop and the SID is variable, the AKR measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 cm.(5) Movable grids and compression devices shall be removed from the useful beam during the measurement.(6) For all AKR measurements, the attenuation block shall be positioned in the useful beam 10 cm from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly.6.5.3 Field Limitation. 6.5.3.1 Angulation. (1) For fluoroscopic equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the x-ray beam is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor.(2) Compliance with 6.5.3.5 and 6.5.3.6 shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.6.5.3.2 Further means of limitation. (1) Means shall be provided to permit further limitation of the x-ray field to sizes smaller than the limits of 6.5.3.5 and 6.5.3.6.(2) Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID and/or capability of a visible area of greater than 300 cm2, shall be provided with means for stepless adjustment of the x-ray field.(3) Equipment with a fixed SID and the capability of a visible area of no greater than 300 cm2 shall be provided with either: (a) Stepless adjustment of the x-ray field; or(b) A means to further limit the x-ray field size at the plane of the image receptor to 125 cm2 or less.(4) Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size containable in a square of 5 cm by 5 cm.(5) Compliance with 6.5.3.2 shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.(a) Measurement shall be made in perpendicular directions corresponding to the vertical and horizontal directions on the video monitor image.(b) For collimating systems that are not circular, measurement shall be made along the directions closest to the vertical and horizontal direction on the video monitor image yielding the smallest dimension in each direction.6.5.3.3 Spot-image devices. The following requirements shall apply to spot-image devices, except when the spot-image device is provided for use with a radiation therapy simulation system:
(1) Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the image receptor to the size of that portion of the image receptor which has been selected on the spot-image selector. (a) Such adjustment shall be accomplished automatically when the x-ray field size in the plane of the image receptor is greater than the selected portion of the image receptor.(b) If the x-ray field size is less than the size of the selected portion of the image receptor, the field size shall not open automatically to the size of the selected portion of the image receptor unless the operator has selected that mode of operation.(2) Neither the length nor width of the x-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than 3 percent of the SID when adjusted for full coverage of the selected portion of the image receptor.(a) The sum, without regard to sign, of the length and width differences shall not exceed 4 percent of the SID.(b) On spot-image devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.(3) The center of the x-ray field in the plane of the image receptor shall be aligned with the center of the selected portion of the image receptor to within 2 percent of the SID.(4) Means shall be provided to reduce the x-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor such that: (a) For spot-image devices used on fixed-SID fluoroscopic systems which are not required to, and do not provide stepless adjustment of the x-ray field, the minimum field size, at the greatest SID, does not exceed 125 square cm; or(b) For spot-image devices used on fluoroscopic systems that have a variable SID and/or stepless adjustment of the field size, the minimum field size, at the greatest SID, shall be containable in a square of 5 cm by 5 cm.6.5.3.4 A capability may be provided for overriding the automatic x-ray field size adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic x-ray field size adjustment override is engaged. Each such system failure override switch shall be clearly labeled as follows:
"FOR X-RAY FIELD LIMITATION SYSTEM FAILURE"
6.5.3.5 Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently circular image receptors.(1) For fluoroscopic equipment manufactured before June 10, 2006, other than radiation therapy simulation systems, the following applies:(a) Neither the length nor width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4 percent of the SID.(b) For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.(2) For fluoroscopic equipment manufactured on or after June 10, 2006, other than radiation simulation systems, the maximum area of the x-ray field in the plane of the image receptor shall conform with one of the following requirements:(a) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is less than or equal to 34 cm in any direction, at least 80 percent of the area of the x-ray field overlaps the visible area of the image receptor, or(b) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is greater than 34 cm in any direction, the x-ray field measured along the direction of greatest misalignment with the visible area of the image receptor does not extend beyond the edge of the visible area of the image receptor by more than 2 cm.6.5.3.6 Fluoroscopy and radiography using fluoroscopic imaging assembly with inherently rectangular image receptors. For x-ray systems manufactured on or after June 10, 2006, the following applies:
(1) Neither the length nor width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4 percent of the SID.(2) The error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.6.5.3.7 Override capability. If the fluoroscopic x-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic field adjustment is overridden. Each such system failure override switch shall be clearly labeled as follows:
FOR X-RAY FIELD LIMITATION SYSTEM FAILURE
6.5.4 Activation of Tube.6.5.4.1 X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure.6.5.4.2 When recording serial radiographic images from the fluoroscopic image receptor, the operator shall be able to terminate the x-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process.6.5.5 Air Kerma Rates. 6.5.5.1 Except for fluoroscopic equipment used for radiation therapy simulation purposes, the following requirements apply to fluoroscopic equipment manufactured before May 19, 1995: (1) Equipment provided with automatic exposure rate control (AERC) shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (10 R/min exposure rate) at the measurement point specified in 6.5.5.4, except as specified in 6.5.5.1(5).(2) Equipment provided without AERC shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 44 mGy per minute (5 R/min exposure rate) at the measurement point specified in 6.5.5.4, except as specified in 6.5.5.1(5).(3) Equipment provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (10 R/min exposure rate) in either mode at the measurement point specified in 6.5.5.4, except as specified in 6.5.5.1(5).(4) Equipment may be modified in accordance with this Part to comply with 6.5.5.2. When the equipment is modified, it shall bear a label indicating the date of the modification and the statement: MODIFIED TO COMPLY WITH 21 CFR 1020.32(H)(2)
(5) The AKR requirements of 6.5.5.1(1) through (3) are not applicable during: (a) Recording of (spot) fluoroscopic images; or(b) Operation in high-level control mode(s) as equipped.6.5.5.2 Except for fluoroscopic equipment used for radiation therapy simulation purposes, the following requirements apply to fluoroscopic equipment manufactured on or after May 19, 1995: (1) Shall be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than 44 mGy per minute (5 R/min exposure rate) at the measurement point specified in 6.5.5.4. Provision for manual selection of technique factors may be provided.(2) Shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (10 R/min exposure rate) at the measurement point specified in 6.5.5.4, except as specified in 6.5.5.2.(3).(3) The AKR limits of 6.5.5.2(1) and (2) are not applicable to equipment manufactured prior to June 10, 2006, during the recording of images from a fluoroscopic image receptor using photographic film or a video camera when the x-ray source is operated in a pulsed mode.(4) The AKR limits of 6.5.5.2(1) and (2) are not applicable to: equipment manufactured on or after June 10, 2006:(a) During recording of spot images from the fluoroscopic image receptor;(b) To images resulting from a last-image-hold feature that are not recorded;(c) During operation in high-level control mode(s) as equipped.6.5.5.3 Except for fluoroscopic equipment used for radiation therapy simulation purposes, the following requirements apply to fluoroscopy equipment with optional high-level control (1) When high-level control is selected and the control is activated, in which case the equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 176 mGy per minute (20 R/min exposure rate) at the measurement point specified in 6.5.5.4.(2) Special means of activation of high-level controls shall be required. (a) The high-level control shall be operable only when continuous manual activation is provided by the operator.(b) A continuous signal audible to the fluoroscopist shall indicate that the high-level control is employed.6.5.5.4 Measuring compliance. Except for fluoroscopic equipment used for radiation therapy simulation purposes, the following requirements apply to compliance with 6.5.5.1 through 6.5.5.3 and shall be determined as follows:
(1) If the source is below the x-ray table, the AKR shall be measured at 1 cm above the tabletop or cradle.(2) If the source is above the x-ray table, the AKR shall be measured at 30 cm above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.(3) For a C-arm type of fluoroscope, the AKR shall be measured at 30 cm from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 cm from the input surface of the fluoroscopic imaging assembly.(4) For a C-arm type of fluoroscope having an SID less than 45 cm, the AKR shall be measured at the minimum SSD.(5) For a fixed lateral type of fluoroscope, the air kerma rate shall be measured at a point 15 cm from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.(a) If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 cm to the centerline of the x-ray table.(6) For fluoroscopic systems not specifically addressed in 6.5.5.4(1) through (5) above, the RMP shall determine the measurement point(s) representing the highest expected dose rate and which is based on nationally accepted standards and practices.6.5.6 Indication of potential and current.6.5.6.1 During fluoroscopy and cinefluorography, x-ray tube potential and current shall be continuously indicated.6.5.6.2 Deviation of x-ray tube potential and current from the indicated value shall not exceed the maximum deviation as stated by the manufacturer.6.5.7 Source-skin distance. 6.5.7.1 Means shall be provided: (1) To limit the source-skin distance to not less than 38 cm on stationary fluoroscopes and to not less than 30 cm on mobile and portable fluoroscopes.(2) In addition, for fluoroscopes intended for specific surgical or interventional applications that would be prohibited at the source-skin distances specified in 6.5.7.1(1), provisions may be made for operating at shorter source-skin distances but in no case less than 20 cm, provided a process for such use is justified and documented in the facility procedures and is periodically reviewed by the FGI procedures committee or RMP.6.5.7.2. For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-image receptor distance of less than 45 cm, means shall be provided to limit the source-skin distance to not less than 19 cm. (1) Such systems shall be labeled for extremity use only; and(2) For those systems intended for specific surgical or interventional applications that would be prohibited at the source-skin distance specified in 6.5.7.2, provisions may be made for operation at shorter source-skin distances but in no case less than 10 cm, provided a process for such use is justified and documented in the facility procedures and is periodically reviewed by the FGI procedures committee or RMP.6.5.8 Fluoroscopic irradiation time, display, and signal.6.5.8.1 Fluoroscopic equipment manufactured before June 10, 2006:(1) Shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube.(a) The maximum cumulative time of the timing device shall not exceed 5 minutes without resetting.(b) A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative irradiation time.(c) Such signal shall continue to sound while x-rays are produced until the timing device is reset.(d) Fluoroscopic equipment may be modified in accordance with 21 CFR 1020.30(q) to comply with the requirements of 6.5.8.1.(e) When the equipment is modified, it shall bear a label indicating the statement: MODIFIED TO COMPLY WITH 21 CFR 1020.32(H)(2)
(2) As an alternative to the requirements of 6.5.8.1, radiation therapy simulation systems may be provided with a means to indicate the total cumulative exposure time during which x-rays were produced, and which is capable of being reset between x-ray examinations.6.5.8.2. For x-ray controls manufactured on or after June 10, 2006, there shall be provided for each fluoroscopic tube:(1) A display of the fluoroscopic irradiation time at the fluoroscopist's working position. This display shall function independently of the audible signal described in 6.5.8.2(2). The following requirements apply: (a) When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least once every 6 seconds.(b) The fluoroscopic irradiation time shall also be displayed within 6 seconds of termination of an exposure and remain displayed until reset.(c) Means shall be provided to reset the display to zero prior to the beginning of a new examination or procedure.(2) A signal audible to the fluoroscopist shall sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure.(a) The signal shall sound until manually reset or, if automatically reset, for at least 2 seconds.6.5.9 Display of last-image-hold (LIH). Fluoroscopic equipment manufactured on or after June 10, 2006, shall be equipped with means to display LIH image following termination of the fluoroscopic exposure.
6.5.9.1 For an LIH image obtained by retaining pretermination fluoroscopic images, if the number of images and method of combining a predetermined number of images are selectable by the user, the selection shall be indicated prior to initiation of the fluoroscopic exposure.6.5.9.2 For an LIH image obtained by initiating a separate radiographic-like exposure at the termination of fluoroscopic imaging, the technique factors for the LIH image shall be selectable prior to the fluoroscopic exposure, and the combination selected shall be indicated prior to initiation of the fluoroscopic exposure.6.5.9.3 Means shall be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph shall be replaced by the fluoroscopic image concurrently with re-initiation of fluoroscopic exposure, unless separate displays are provided for the LIH radiograph and fluoroscopic images.6.5.10 Displays of values of AKR and cumulative air kerma. Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist's working position the AKR and cumulative air kerma. The following requirements apply for each x-ray tube used during an examination or procedure:
6.5.10.1 When the x-ray tube is activated and the number of images produced per unit time is greater than six images per second, the AKR in mGy/min shall be continuously displayed and updated at least once every second.6.5.10.2 The cumulative air kerma in units of mGy shall be displayed either within 5 seconds of termination of an exposure or displayed continuously and updated at least once every 5 seconds.6.5.10.3 The display of the AKR shall be clearly distinguishable from the display of the cumulative air kerma.6.5.10.4 The AKR and cumulative air kerma shall represent the value for conditions of free-in- air irradiation at one of the following reference locations specified according to the type of fluoroscope.(1) For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of fixed lateral type, the reference location shall be the respective locations specified in 6.5.5.4(1). 6.5.5.4(2), or 6.5.5.4(5).(2) For C-arm fluoroscopes, the reference location shall be 15 cm from the isocenter toward the x-ray source along the beam axis. Alternatively, the reference location shall be at a point specified by the manufacturer to represent the location of the intersection of the x-ray beam with the patient's skin.6.5.10.5 Means shall be provided to reset to zero the display of cumulative air kerma prior to the commencement of a new examination or procedure.6.5.10.6 The displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ±35 percent over the range of 6 mGy/min and 100 mGy to the maximum indication of AKR and cumulative air kerma, respectively. (1) Compliance shall be determined with an irradiation time greater than 3 seconds.6.5.11 Protection from scatter radiation. 6.5.11.1 For stationary fluoroscopic systems, ancillary shielding, such as drapes, self-supporting curtains, or viewing shields, shall be available and used as supplemental protection for all individuals other than the patient in the room during a fluoroscopy procedure.6.5.11.2 Where sterile fields or special procedures prohibit the use of normal protective barriers or drapes, all of the following conditions shall be met: (1) Shielding required under 6.5.11.1 shall be maintained to the degree possible under clinical conditions;(2) All persons, except the patient, in the room where fluoroscopy is performed shall wear protective apparel (aprons) or shall be positioned behind a stationary or portable shield that provides a lead equivalent shielding of at least 0.25mm;(3) The fluoroscopic field size shall be reduced to the minimum required for the procedure being performed (area of clinical interest); and(4) Operating and safety procedures shall reflect the above conditions, and fluoroscopy personnel shall exhibit awareness of situations requiring the use and/or non-use of the protective drapes.6.5.12 Fluoroscopy specific operator qualifications6.5.12.1 Operation of a fluoroscopic x-ray system shall be performed under direct supervision, except where otherwise specified in these regulations.6.5.12.2 In addition to the applicable sections of these regulations, all persons operating or supervising the operation of a fluoroscopic x-ray system (including for FGI procedures) for clinical purposes on living humans shall be limited to persons meeting the applicable requirements of 6.3.1.6, 6.3.1.9, and Part 2, Section 2.4.5.5, and 2.6.1.5.6.5.13 Equipment operation 6.5.13.1 Overhead fluoroscopy shall not be used as a positioning tool for general purpose radiographic examinations.6.5.13.2 Operators shall be instructed in accordance with Part 2 requirements.6.5.13.3 Procedure planning for fluoroscopic procedures on pregnant patients shall include feasible modifications to minimize the dose to the conceptus.6.5.13.4 Procedure planning for fluoroscopic procedures on pediatric patients shall include feasible modifications to minimize dose.6.5.13.5 The facility shall establish a written policy regarding patient dose management in fluoroscopically guided procedures in conformance with the ACR-AAPM Technical Standard for Management of the Use of Radiation in Fluoroscopic Procedures (ACR Resolution 44-2013), NCRP Report 168, or equivalent. (1) Consistent with facility policy and procedures, the operator shall use methods available on the fluoroscopy system to monitor dose during a fluoroscopic procedure.(2) The written policy shall include a requirement to designate a person in the room to notify the operator that a SRDL or other dose metric value specified in the facility policy is approaching or has been exceeded.6.5.14 Registered Medical Physicist evaluations of fluoroscopic equipment. 6.5.14.1 Fluoroscopic x-ray systems shall have a certification evaluation performed by a RMP under the frequency and conditions specified in Part 2, Section 2.5. At a minimum these evaluations shall include:
(1) A measurement of entrance exposure rates that covers a representative sample of patient thicknesses, including those that are expected to drive the system to maximum output in all modes clinically used, including fluoroscopy, high-level control, and acquisition, when available. These measurements shall:(a) For systems without automatic exposure control, be made utilizing a milliamperage and kVp typical of the clinical use of the fluoroscopic system;(b) For systems with automatic exposure control, be made utilizing sufficient attenuating material in the useful beam to produce a milliamperage and kVp typical of the clinical use of the fluoroscopic system;(2) A measurement and verification of compliance of maximum AKR for fluoroscopy and high-level control, if available. Measurements shall be made in accordance with Section 6.5.5.4.(3) An evaluation of image quality in the modes necessary to achieve the clinical imaging task(s).(4) An evaluation of the operation of the 5-minute timer, warning lights, interlocks, and collision sensors.(5) An evaluation of the beam quality and collimation in the fluoroscopy mode. Additional evaluation may be needed where magnification impacts collimation.(6) An evaluation of the availability and accuracy of technique indicators and integrated radiation dose displays.(7) An evaluation of changes to the fluoroscopy system impacting radiation safety.(8) When operating in the spot image mode, an evaluation of the coefficient of variation of air kerma for both manual and automatic exposure control systems to ensure the value does not exceed 0.05.6.5.14.2 Measurements required in 6.5.14.1 shall be: (1) Performed in accordance with manufacturer recommendations or nationally accepted standards using a calibrated dosimetry system;(2) Dosimetry systems used for measurements shall be calibrated in accordance with manufacturer recommendations or nationally accepted standards not to exceed 2 years.(3) Records indicating the model, serial number and calibration date of equipment used for dosimetry calibrations on FGI systems shall be maintained for 3 years for inspection by the Department.6.5.15 Additional requirements for facilities performing fluoroscopically-guided interventional (FGI) procedures. The requirements of 6.5.15 and other requirements associated with an FGI Procedure Committee in 6.5.15 shall become effective on or after January 1, 2022.
6.5.15.1 A registrant performing FGI procedures shall establish a FGI Procedure Committee in accordance with the following:(1) The registrant may establish a system-wide committee if the registrant has more than one site;(2) Two or more registrants may form a cooperative FGI Procedure Committee as long as each facility has a representative on the committee; and(3) If the registrant has already established a radiation safety committee, the requirements of 6.5.15 may be delegated to that committee if the members meet the requirements of 6.5.15.5.6.5.15.2 At a minimum the FGI Procedure Committee members in 6.5.15.5(1) through (3) shall meet as often as necessary to conduct business, but at intervals not to exceed 12 months.6.5.15.3 A record of each FGI Procedure Committee meeting shall include the date, names of individuals in attendance, minutes of the meeting, and any actions taken. The registrant shall maintain the record for 3 years for inspection by the Department.6.5.15.4 Provide an annual report summarizing the details and activities of the FGI Procedure Committee to the radiation safety committee or radiation safety officer, in the absence of a radiation safety committee.6.5.15.5 FGI Procedure Committee members shall include but not be limited to the following individuals involved in FGI procedures:(1) A supervising physician of the healing arts who meet the requirements in 6.3.1.6(1);(2) A Registered Medical Physicist;(3) A technologist, where applicable(4) A licensed individual who meets the requirements of 6.3.1.6(2), where applicable; and(5) Other individuals as deemed necessary by the registrant.6.5.15.6 Establish and implement FGI procedures(1) The registrant shall establish and implement written procedures, or procedures documented in an electronic recordkeeping system, that include but are not limited to the following: (a) Identification of individuals who are authorized to use fluoroscopic systems for interventional purposes.(b) Methods for patient radiation dose management during FGI procedures.(c) Establishing dose metric notification levels for fluoroscopy procedures at which point the physician, or other authorized operator is notified.(d) SRDL values following nationally recognized standards(e) Actions to be taken for cases when a SRDL is exceeded which may include patient follow-up.(f) A review of the established processes and procedures at an interval not to exceed 12 months.(2) A record of each procedure developed by the registrant shall be maintained for inspection by the Department. If the registrant revises a procedure, documentation shall be maintained that includes the justification for the revision and the previous procedure for inspection by the Department.(3) The FGI Procedure Committee shall review and approve the procedures developed or modified under 6.5.15.6.6.5.16 Procedures for maintaining records for fluoroscopic systems 6.5.16.1 A record of radiation output information shall be maintained in the event a dose reconstruction calculation or estimate is necessary in accordance with established procedures. The record shall include the following:(1) Operator identification;(2) Patient identification;(3) Type and date of examination;(4) Identification of the fluoroscopic system used; and(5) Peak skin dose, cumulative air kerma or dose area product used, beam entry angle(s), and patient position if the information is available on the fluoroscopic system.(6) If the peak skin dose, cumulative air kerma or dose area product are not displayed on the fluoroscopic system, records shall include other available information in the event a dose reconstruction calculation or estimate is necessary in accordance with established procedure or the following as necessary: (a) Fluoroscopic mode, such as, high-level or pulsed mode of operation;(b) Cumulative fluoroscopic exposure time; and(c) Number of films or recorded exposures.(7) The registrant shall maintain records required by 6.5.16.1 for inspection by the Department for 3 years.Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/201438 CR 02, January 25, 2015, effective 2/14/201538 CR 05, March 10, 2015, effective 3/30/201538 CR 12, June 25, 2015, effective 7/15/201538 CR 14, July 25, 2015, effective 8/14/201539 CR 02, January 25, 2016, effective 2/14/201639 CR 16, August 25, 2016, effective 9/14/201639 CR 22, November 25, 2016, effective 12/15/201640 CR 11, June 10, 2017, effective 6/30/201740 CR 20, October 25, 2017, effective 11/14/201742 CR 24, December 25, 2019, effective 1/14/202043 CR 14, July 25, 2020, effective 8/14/202043 CR 18, September 25, 2020, effective 10/15/202044 CR 11, June 10, 2021, effective 7/15/202144 CR 14, July 25, 2021, effective 8/14/202145 CR 22, November 25, 2022, effective 12/15/202247 CR 06, March 25, 2024, effective 4/14/2024