Florida Regulations 64E-5.502: General Requirements
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(1) Administrative Controls.
(a) Registrant. The registrant shall be responsible for directing the operation of the x-ray systems which are subject to registration as described in Fl. Admin. Code R. 64E-5.511 The registrant or the registrant’s agent shall assure that the following requirements are met in the operation of the x-ray system.
1. Any x-ray system which does not meet the provisions of these regulations shall not be operated for diagnostic or therapeutic purposes unless the Department determines that such operation will not endanger the public health, safety and welfare.
2. An x-ray system operator shall receive instruction on and be competent in the safe use of the x-ray system. A medical x-ray system operator shall also be certified or authorized in accordance with Florida Statutes Chapter 468, Part IV
3. A chart shall be provided in the vicinity of the diagnostic x-ray system’s control panel, which specifies techniques and procedures to be used for all examinations which are performed by that system.
4. Except for patients who cannot be moved out of the room, only the staff and ancillary personnel required for the medical procedure or training shall be in the room during the radiographic exposure. Other than the patient being examined:
a. All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by 0.5 millimeter lead equivalent.
b. Staff and ancillary personnel shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 millimeter lead equivalent.
c. Other patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of 0.25 millimeter lead equivalent or shall be so positioned that the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the useful beam.
d. When a portion of the body of any staff or ancillary personnel is potentially subjected to stray radiation which could result in that individual receiving one-fourth of the maximum permissible dose as defined in Part III, additional protective devices may be required by the Department.
5. Gonad shields of not less than 0.25 millimeter lead equivalent shall be used for patients who have not passed the reproductive age, during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.
6. Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits the following:
a. Exposure of an individual for training, demonstration or other purposes unless there are also healing arts requirements and a proper prescription has been provided.
b. Exposure of an individual for the purpose of a healing arts self-referral program except when authorized by subFl. Admin. Code R. 64E-5.502(1)(a)11.
c. Advertisement of free x-ray examinations unless the advertisement states that a determination of need will be made prior to the x-ray examination.
7. An x-ray system is exempt from the requirements of subFl. Admin. Code R. 64E-5.502(1)(a)6., only if:
a. The system is a stationary, non-mobile system installed and used only in a jail or penal institution,
b. The system is used only on legal detainees in a jail or penal institution, and never on detainees’ family members, children, institution employees, contractors, visitors, the public, or any other persons,
c. The system is manufactured, maintained, and operated solely for security screening purposes in strict compliance with, and fully according to, the most restrictive standards found in ANSI/HPS N43.17-2009, “”Radiation Safety for Personnel Security Screening Systems Using X-Ray or Gamma Radiation,”” which is herein incorporated by reference. This ANSI publication may be examined and inspected at the Florida Department of Health, Bureau of Radiation Control at Building 4042 Bald Cypress Way, Suite 210, Tallahassee, Florida 32399-1741, and at the Florida Department of State, Room 701, The Capitol, Tallahassee, Florida 32399-0250, and is available from the American National Standards Institute, Inc., at http://www.ansi.org. The agency has determined that posting the publication on the internet for purposes of public inspection and examination would constitute a violation of federal copyright law; and,
d. The institution tracks radiation dose for each detainee, as specified by ANSI/HPS N43.17-2009, “”Radiation Safety for Personnel Security Screening Systems Using X-Ray or Gamma Radiation,”” to ensure the detainee does not exceed the recommended dose limit.
8. When a patient or film must be provided with auxiliary support during a radiation exposure:
a. Mechanical holding devices shall be used when the technique permits,
b. Written safety procedures shall be available to indicate the requirements for selecting a holder, list the individual projections where holding devices cannot be used and describe the procedure the holder shall follow,
c. The human holder shall be protected as required by subparagraph (1)(a)4., above; and,
d. No individual shall be used routinely to hold film or patients.
9. Exposure Procedures Designed to Minimize Patient and Personal Exposure.
a. The speed of film or screen and film combinations shall be the fastest speed consistent with the diagnostic objectives of the examination.
b. The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality.
c. Portable or mobile equipment shall be used only for examinations where it is impractical to transfer the patient to a stationary radiographic installation.
d. X-ray systems subject to Fl. Admin. Code R. 64E-5.505, shall not be utilized in procedures where the source to patient distance is less than 30 centimeters.
e. A person shall not perform fluoroscopic imaging or otherwise expose a human to x-rays from a fluoroscopic system unless the person is a:
(I) Licensed practitioner as that term is defined in Florida Statutes § 468.301, or
(II) Certified radiologist assistant practicing in accordance with the requirements of Florida Statutes Chapter 468, Part IV, or
(III) Certified general radiographer practicing in accordance with the requirements of Florida Statutes Chapter 468, Part IV; and,
(A) The general radiographer has been trained and authorized in writing by the licensed practitioner in charge to perform the specified imaging; and,
(B) The specified imaging does not rely upon the general radiographer to provide any diagnostic interpretation, or to determine suspicious areas for additional imaging, or to otherwise modify the scope of authorization for the imaging; and,
(C) The specified imaging is designed to prevent or reduce exposure to patients by facilitating proper location and positioning for the authorized radiographic imaging.
10. Personnel Monitoring. All individuals who are associated with the operation of an x-ray system are subject to the occupational exposure limits and the requirements for the determination of the doses stated in Rules 64E-5.304 and 64E-5.308, F.A.C. In addition, when protective clothing or devices are worn on portions of the body and a personnel monitoring device is required, at least one such device shall be utilized as follows:
a. When a protective apron is worn, the monitoring device shall be worn at the collar outside of the apron.
b. The dose to the whole body shall be recorded in the records required by Fl. Admin. Code R. 64E-5.339 If more than one device is used and a record is made of the data, each dose shall be identified with the area where the device was worn on the body.
11. Healing arts self-referral. Only healing arts self-referral programs for mammography screening will be authorized by the Department.
(b) Information and Maintenance Records and Associated Information. The registrant shall maintain at least the following information for each x-ray system:
1. Tube rating charts and cooling curves.
2. Record of surveys, calibrations, maintenance, modifications from the original schematics and drawings performed on the x-ray machine along with the names of persons who performed the service.
3. A copy of all correspondence with the Department regarding each x-ray system.
4. An x-ray log containing the patient’s name, the type of examination and the dates the examinations were performed. When the patient or film must be provided with human auxiliary support, the name of the human holder shall be recorded.
(c) Maintenance of X-ray Equipment. X-ray systems and accessory devices shall be maintained in good working condition, both mechanically and electrically, so that the clinical objectives may be fulfilled without risk of unproductive exposure due to equipment failure or malfunction.
(2) Shielding.
(a) Each x-ray facility shall have primary and secondary protective barriers as needed to assure that an individual will not receive a radiation dose in excess of the limits specified in Part III of these regulations.
(b) Structural shielding in walls and other vertical barriers required for personnel protection shall extend without breach from the floor to a height of at least 7 feet (2.1 m).
(c) Doors, door frames, windows and window frames shall have the same lead equivalent shielding as that required in the wall or other barrier in which they are installed.
(d) In computation of protective barrier requirements, the maximum anticipated workload, use factors, occupancy factors and the potential for radiation exposure from other sources shall be taken into consideration.
(e) Prior to construction, the floor plans and equipment arrangement of all new installations, or modifications of existing installations, utilizing x-ray energies of 200 keV and above for diagnostic or therapeutic purposes shall be submitted to the Department for review and approval.
1. The plans shall show, as a minimum, the following:
a. The normal location of the x-ray system’s radiation port; the port’s travel and traverse limits; general direction of the useful beam; locations of any windows and doors; the location of the operator’s booth; and the location of the x-ray control panel.
b. The structural composition and thickness or lead equivalent of all walls, doors, partitions, floor and ceiling of the room concerned.
c. The dimensions of the room concerned.
d. The type of occupancy of all adjacent areas inclusive of space above and below the room concerned. If there is an exterior wall, the distance to the closest area where it is likely that individuals may be present.
e. The make and model of the x-ray equipment and the maximum technique factors.
f. The type of examinations or treatments which will be performed with the equipment.
2. Information on the anticipated maximum workload of the x-ray system.
3. If the services of a qualified person have been utilized to determine the shielding requirements, a copy of the report, including all basic assumptions used, shall be submitted with the plans.
(3) X-ray Film Processing Facilities and Practices.
(a) Processing Facilities. Each installation using a radiographic x-ray system shall provide suitable equipment for handling and processing radiographic film in accordance with the following provisions:
1. The area in which undeveloped films are handled for processing shall be devoid of light with the exception of light in the wave lengths having no significant effect on the radiographic film.
2. Film pass boxes, if provided, shall be so constructed as to exclude light when film is placed in or removed from the boxes, and shall incorporate adequate shielding to prevent exposure of undeveloped film to stray radiation.
3. Darkrooms used by more than one individual shall be provided a positive method to prevent accidental entry while undeveloped films are being handled or processed.
4. Where film is developed manually,
a. At least one tri-sectional tank made of mechanically rigid, corrosion resistant material shall be utilized; and,
b. The temperature of each solution shall be maintained within the range of 60° F to 80° F (16° C to 27° C). Film shall be developed in accordance with the time-temperature relationships specified by the film manufacturer, or, in the absence of such recommendations by the film manufacturer, with the following time-temperature chart:
Time-Temperature Chart
Thermometer Reading
Minimum Developing
(Degrees)
Time (Minutes)
C
F
26.7
80
2
26.1
79
2
25.6
78
2 1/2
25.0
77
2 1/2
24.4
76
3
23.9
75
3
23.3
74
3 1/2
22.8
73
3 1/2
22.2
72
4
21.7
71
4
21.1
70
4 1/2
20.6
69
4 1/2
20.0
68
5
19.4
67
5 1/2
18.9
66
5 1/2
18.3
65
6
17.8
64
6 1/2
17.2
63
7
16.7
62
8
16.1
61
8 1/2
15.6
60
9 1/2
c. Devices shall be utilized which will:
(I) Indicate the actual temperature of the developer; and,
(II) Signal the passage of a preset time as short as 2 minutes.
(b) Precautionary Practices.
1. Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light tight container.
2. Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary to best assure radiographs of good diagnostic quality.
3. Outdated x-ray film shall not be used for human diagnostic radiographs, unless the film has been stored in accordance with the manufacturer’s recommendations and a sample of the film passes a sensitometric test for normal ranges of base fog and speed.
4. Film developing solutions shall be prepared in accordance with the directions given by the manufacturer, and shall be maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer.
5. Safe light and darkroom fog shall be such that, when a radiographic film is exposed to radiation to achieve a density of 1.0 and is exposed for 1 minute on any darkroom working surface, the film shall not have a density change greater than 0.1.
(c) Automatic Processors and Other Closed Processing Systems. Preventive maintenance shall be performed on the unit, except for extended periods of nonuse, on a frequency basis which is not less than that schedule recommended by the manufacturer. In the event that no schedule is available from the manufacturer, a maintenance schedule shall be established which will preserve good diagnostic film quality.
(d) Radiographic Film Quality.
1. Developed radiographs of patients or phantoms shall have an optical density of 0.5 to 2.0 in the area of clinical interest to allow for diagnostic interpretation of the image, unless justified due to special circumstances. Radiographs which provide the necessary diagnostic information shall not be repeated for the sole purpose of meeting the stated density range.
2. Radiographic film used for diagnostic purposes shall be free from light fog and artifacts.
Rulemaking Authority 404.051, 404.081, 404.141, 404.22 FS. Law Implemented 404.051, 404.081, 404.141, 404.22, 468.302 FS. History-New 7-17-85, Amended 4-4-89, 1-1-94, 11-20-94, 1-5-95, Formerly 10D-91.603, Amended 5-18-98, 8-16-07, 3-21-16.
1. Any x-ray system which does not meet the provisions of these regulations shall not be operated for diagnostic or therapeutic purposes unless the Department determines that such operation will not endanger the public health, safety and welfare.
2. An x-ray system operator shall receive instruction on and be competent in the safe use of the x-ray system. A medical x-ray system operator shall also be certified or authorized in accordance with Florida Statutes Chapter 468, Part IV
3. A chart shall be provided in the vicinity of the diagnostic x-ray system’s control panel, which specifies techniques and procedures to be used for all examinations which are performed by that system.
4. Except for patients who cannot be moved out of the room, only the staff and ancillary personnel required for the medical procedure or training shall be in the room during the radiographic exposure. Other than the patient being examined:
a. All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by 0.5 millimeter lead equivalent.
b. Staff and ancillary personnel shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 millimeter lead equivalent.
c. Other patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of 0.25 millimeter lead equivalent or shall be so positioned that the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the useful beam.
d. When a portion of the body of any staff or ancillary personnel is potentially subjected to stray radiation which could result in that individual receiving one-fourth of the maximum permissible dose as defined in Part III, additional protective devices may be required by the Department.
5. Gonad shields of not less than 0.25 millimeter lead equivalent shall be used for patients who have not passed the reproductive age, during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.
6. Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits the following:
a. Exposure of an individual for training, demonstration or other purposes unless there are also healing arts requirements and a proper prescription has been provided.
b. Exposure of an individual for the purpose of a healing arts self-referral program except when authorized by subFl. Admin. Code R. 64E-5.502(1)(a)11.
c. Advertisement of free x-ray examinations unless the advertisement states that a determination of need will be made prior to the x-ray examination.
7. An x-ray system is exempt from the requirements of subFl. Admin. Code R. 64E-5.502(1)(a)6., only if:
a. The system is a stationary, non-mobile system installed and used only in a jail or penal institution,
b. The system is used only on legal detainees in a jail or penal institution, and never on detainees’ family members, children, institution employees, contractors, visitors, the public, or any other persons,
c. The system is manufactured, maintained, and operated solely for security screening purposes in strict compliance with, and fully according to, the most restrictive standards found in ANSI/HPS N43.17-2009, “”Radiation Safety for Personnel Security Screening Systems Using X-Ray or Gamma Radiation,”” which is herein incorporated by reference. This ANSI publication may be examined and inspected at the Florida Department of Health, Bureau of Radiation Control at Building 4042 Bald Cypress Way, Suite 210, Tallahassee, Florida 32399-1741, and at the Florida Department of State, Room 701, The Capitol, Tallahassee, Florida 32399-0250, and is available from the American National Standards Institute, Inc., at http://www.ansi.org. The agency has determined that posting the publication on the internet for purposes of public inspection and examination would constitute a violation of federal copyright law; and,
d. The institution tracks radiation dose for each detainee, as specified by ANSI/HPS N43.17-2009, “”Radiation Safety for Personnel Security Screening Systems Using X-Ray or Gamma Radiation,”” to ensure the detainee does not exceed the recommended dose limit.
8. When a patient or film must be provided with auxiliary support during a radiation exposure:
a. Mechanical holding devices shall be used when the technique permits,
b. Written safety procedures shall be available to indicate the requirements for selecting a holder, list the individual projections where holding devices cannot be used and describe the procedure the holder shall follow,
c. The human holder shall be protected as required by subparagraph (1)(a)4., above; and,
d. No individual shall be used routinely to hold film or patients.
9. Exposure Procedures Designed to Minimize Patient and Personal Exposure.
a. The speed of film or screen and film combinations shall be the fastest speed consistent with the diagnostic objectives of the examination.
b. The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality.
c. Portable or mobile equipment shall be used only for examinations where it is impractical to transfer the patient to a stationary radiographic installation.
d. X-ray systems subject to Fl. Admin. Code R. 64E-5.505, shall not be utilized in procedures where the source to patient distance is less than 30 centimeters.
e. A person shall not perform fluoroscopic imaging or otherwise expose a human to x-rays from a fluoroscopic system unless the person is a:
(I) Licensed practitioner as that term is defined in Florida Statutes § 468.301, or
(II) Certified radiologist assistant practicing in accordance with the requirements of Florida Statutes Chapter 468, Part IV, or
(III) Certified general radiographer practicing in accordance with the requirements of Florida Statutes Chapter 468, Part IV; and,
(A) The general radiographer has been trained and authorized in writing by the licensed practitioner in charge to perform the specified imaging; and,
(B) The specified imaging does not rely upon the general radiographer to provide any diagnostic interpretation, or to determine suspicious areas for additional imaging, or to otherwise modify the scope of authorization for the imaging; and,
(C) The specified imaging is designed to prevent or reduce exposure to patients by facilitating proper location and positioning for the authorized radiographic imaging.
10. Personnel Monitoring. All individuals who are associated with the operation of an x-ray system are subject to the occupational exposure limits and the requirements for the determination of the doses stated in Rules 64E-5.304 and 64E-5.308, F.A.C. In addition, when protective clothing or devices are worn on portions of the body and a personnel monitoring device is required, at least one such device shall be utilized as follows:
a. When a protective apron is worn, the monitoring device shall be worn at the collar outside of the apron.
b. The dose to the whole body shall be recorded in the records required by Fl. Admin. Code R. 64E-5.339 If more than one device is used and a record is made of the data, each dose shall be identified with the area where the device was worn on the body.
11. Healing arts self-referral. Only healing arts self-referral programs for mammography screening will be authorized by the Department.
(b) Information and Maintenance Records and Associated Information. The registrant shall maintain at least the following information for each x-ray system:
1. Tube rating charts and cooling curves.
2. Record of surveys, calibrations, maintenance, modifications from the original schematics and drawings performed on the x-ray machine along with the names of persons who performed the service.
3. A copy of all correspondence with the Department regarding each x-ray system.
4. An x-ray log containing the patient’s name, the type of examination and the dates the examinations were performed. When the patient or film must be provided with human auxiliary support, the name of the human holder shall be recorded.
(c) Maintenance of X-ray Equipment. X-ray systems and accessory devices shall be maintained in good working condition, both mechanically and electrically, so that the clinical objectives may be fulfilled without risk of unproductive exposure due to equipment failure or malfunction.
(2) Shielding.
(a) Each x-ray facility shall have primary and secondary protective barriers as needed to assure that an individual will not receive a radiation dose in excess of the limits specified in Part III of these regulations.
(b) Structural shielding in walls and other vertical barriers required for personnel protection shall extend without breach from the floor to a height of at least 7 feet (2.1 m).
(c) Doors, door frames, windows and window frames shall have the same lead equivalent shielding as that required in the wall or other barrier in which they are installed.
(d) In computation of protective barrier requirements, the maximum anticipated workload, use factors, occupancy factors and the potential for radiation exposure from other sources shall be taken into consideration.
(e) Prior to construction, the floor plans and equipment arrangement of all new installations, or modifications of existing installations, utilizing x-ray energies of 200 keV and above for diagnostic or therapeutic purposes shall be submitted to the Department for review and approval.
1. The plans shall show, as a minimum, the following:
a. The normal location of the x-ray system’s radiation port; the port’s travel and traverse limits; general direction of the useful beam; locations of any windows and doors; the location of the operator’s booth; and the location of the x-ray control panel.
b. The structural composition and thickness or lead equivalent of all walls, doors, partitions, floor and ceiling of the room concerned.
c. The dimensions of the room concerned.
d. The type of occupancy of all adjacent areas inclusive of space above and below the room concerned. If there is an exterior wall, the distance to the closest area where it is likely that individuals may be present.
e. The make and model of the x-ray equipment and the maximum technique factors.
f. The type of examinations or treatments which will be performed with the equipment.
2. Information on the anticipated maximum workload of the x-ray system.
3. If the services of a qualified person have been utilized to determine the shielding requirements, a copy of the report, including all basic assumptions used, shall be submitted with the plans.
(3) X-ray Film Processing Facilities and Practices.
(a) Processing Facilities. Each installation using a radiographic x-ray system shall provide suitable equipment for handling and processing radiographic film in accordance with the following provisions:
1. The area in which undeveloped films are handled for processing shall be devoid of light with the exception of light in the wave lengths having no significant effect on the radiographic film.
2. Film pass boxes, if provided, shall be so constructed as to exclude light when film is placed in or removed from the boxes, and shall incorporate adequate shielding to prevent exposure of undeveloped film to stray radiation.
3. Darkrooms used by more than one individual shall be provided a positive method to prevent accidental entry while undeveloped films are being handled or processed.
4. Where film is developed manually,
a. At least one tri-sectional tank made of mechanically rigid, corrosion resistant material shall be utilized; and,
b. The temperature of each solution shall be maintained within the range of 60° F to 80° F (16° C to 27° C). Film shall be developed in accordance with the time-temperature relationships specified by the film manufacturer, or, in the absence of such recommendations by the film manufacturer, with the following time-temperature chart:
Time-Temperature Chart
Thermometer Reading
Minimum Developing
(Degrees)
Time (Minutes)
C
F
26.7
80
2
26.1
79
2
25.6
78
2 1/2
25.0
77
2 1/2
24.4
76
3
23.9
75
3
23.3
74
3 1/2
22.8
73
3 1/2
22.2
72
4
21.7
71
4
21.1
70
4 1/2
20.6
69
4 1/2
20.0
68
5
19.4
67
5 1/2
18.9
66
5 1/2
18.3
65
6
17.8
64
6 1/2
17.2
63
7
16.7
62
8
16.1
61
8 1/2
15.6
60
9 1/2
c. Devices shall be utilized which will:
(I) Indicate the actual temperature of the developer; and,
(II) Signal the passage of a preset time as short as 2 minutes.
(b) Precautionary Practices.
1. Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light tight container.
2. Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary to best assure radiographs of good diagnostic quality.
3. Outdated x-ray film shall not be used for human diagnostic radiographs, unless the film has been stored in accordance with the manufacturer’s recommendations and a sample of the film passes a sensitometric test for normal ranges of base fog and speed.
4. Film developing solutions shall be prepared in accordance with the directions given by the manufacturer, and shall be maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer.
5. Safe light and darkroom fog shall be such that, when a radiographic film is exposed to radiation to achieve a density of 1.0 and is exposed for 1 minute on any darkroom working surface, the film shall not have a density change greater than 0.1.
(c) Automatic Processors and Other Closed Processing Systems. Preventive maintenance shall be performed on the unit, except for extended periods of nonuse, on a frequency basis which is not less than that schedule recommended by the manufacturer. In the event that no schedule is available from the manufacturer, a maintenance schedule shall be established which will preserve good diagnostic film quality.
(d) Radiographic Film Quality.
1. Developed radiographs of patients or phantoms shall have an optical density of 0.5 to 2.0 in the area of clinical interest to allow for diagnostic interpretation of the image, unless justified due to special circumstances. Radiographs which provide the necessary diagnostic information shall not be repeated for the sole purpose of meeting the stated density range.
2. Radiographic film used for diagnostic purposes shall be free from light fog and artifacts.
Rulemaking Authority 404.051, 404.081, 404.141, 404.22 FS. Law Implemented 404.051, 404.081, 404.141, 404.22, 468.302 FS. History-New 7-17-85, Amended 4-4-89, 1-1-94, 11-20-94, 1-5-95, Formerly 10D-91.603, Amended 5-18-98, 8-16-07, 3-21-16.