S.C. Code Regs. § § 61-64.IV.RHB 4.2

Current through Register Vol. 48, No. 10, October 25, 2024

Section 61-64.IV.RHB 4.2 - General Safety Provisions

4.2.1 An x-ray system which does not meet the provisions of this regulation shall not be operated for diagnostic or therapeutic purposes if so directed by the Department.

4.2.2 The registrant shall assure that all x-ray machines under his or her control are operated only by a radiologic technologist possessing a current, valid certificate from the South Carolina Radiation Quality Standards Association, or a licensed practitioner. For the purpose of this Part, a radiologic technologist is defined as a person who is a limited practice radiographer, radiographer, podiatric limited practice radiographer, or limited chest radiographer certified by the American Registry of Radiologic Technologists, or who is certified by the South Carolina Radiation Quality Standards Association or who has obtained a certificate acceptable to the South Carolina Radiation Quality Standards Association. A person who applies ionizing radiation to humans or performs x-ray exam setups, including, but not limited to, patient positioning and technique selection shall be considered a radiologic technologist.

4.2.2.1 No person other than a licensed practitioner or a radiologic technologist possessing a current, valid certificate from the South Carolina Radiation Quality Standards Association shall use equipment emitting ionizing radiation on humans for diagnostic purposes.

4.2.2.2 No person shall employ or designate as a radiologic technologist a person who does not hold a current, valid certificate issued by the South Carolina Radiation Quality Standards Association.

4.2.2.3 No person holding a certificate issued by the South Carolina Radiation Quality Standards Association shall use equipment emitting ionizing radiation on humans for diagnostic purposes unless under the direction and supervision of a licensed practitioner and unless so directed by prescription of a licensed practitioner.

4.2.2.4 No person who is not certified by the South Carolina Radiation Quality Standards Association shall take, use, or exhibit the title of "limited practice radiographer," "podiatric limited practice radiographer," "limited chest radiographer," or "radiographer" or any other title, sign, display, or declaration that tends to lead the public to believe that the person is authorized to apply ionizing radiation on humans for diagnostic purposes.

4.2.2.5 A student enrolled in and attending a school or college of medicine, osteopathy, chiropractic, podiatry, radiologic technology, or a curriculum approved by the South Carolina Radiation Quality Standards Association, or a resident in an approved graduate education program of medicine, osteopathy, chiropractic, or podiatry may apply ionizing radiation to humans without a certificate from the South Carolina Radiation Quality Standards Association, as long as the student or resident is under the direct supervision of a licensed practitioner or direct supervision of a certified radiologic technologist appropriately trained to supervise the specific procedure.

4.2.2.6 The registrant shall display each operator's current South Carolina Radiation Quality Standards Association certificate or the registrant may post a notice to the public that these certificates are available for review upon request. The certificate or posting shall be displayed in public view, not obstructed by any barrier, equipment, or other object.

4.2.2.7 The registrant shall ensure that each operator has received facility specific training to include the equipment and operating conditions. Documentation of this training for each operator shall be made available for Departmental review.

4.2.2.8 Dentists and their auxiliaries who meet the requirements of the South Carolina Dental Practice Act are exempt from the requirements of RHB 4.2.2.1 through 4.2.2.6.

4.2.3 The operator shall be able to demonstrate familiarity and competence with the facility's operating conditions.

4.2.4 X-ray producing machines and associated equipment shall be maintained in such a condition to ensure that the patient and staff are not exposed to radiation unnecessarily.

4.2.5 If an x-ray system is identified as not being in compliance with the provisions of this regulation and cannot meet the regulation, or if the registrant is unwilling to make corrections, and if that system is accessible for use, it shall be rendered inoperable (i.e., dismantle the x-ray source from the source support assembly) if so ordered by the Department.

4.2.6 For general radiographic systems not equipped with an operational anatomic programming option, techniques shall be documented and readily available to the operator. At a minimum, this shall include:

4.2.6.1 Patient's body part and anatomical size, or body part thickness or age (for pediatrics), versus technique factors to be used;

4.2.6.2 Source to image receptor distance (SID) to be used (except for dental intra-oral radiography);

4.2.6.3 If an automatic exposure control (AEC) system is operated in a manual mode, the technique chart shall specify the requirements of RHB 4.2.6.1 and 4.2.6.2; and

4.2.6.4 The technique chart shall accurately reflect techniques currently in use at the facility.

4.2.7 A sign shall be posted so as to be easily seen by the patient to the effect that if there is a pregnancy or the possibility of a pregnancy, the physician shall be notified.

4.2.8 The effectiveness of protective equipment and apparel shall not be impaired. Protective aprons and gloves shall be checked at least annually for cracks and holes that could compromise the radiation protection it provides. These checks shall be documented and records shall be kept for two (2) years, or until the next Department inspection, whichever is later.

4.2.9 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.

4.2.9.1 All individuals shall be positioned such that no part of the body will be struck by the useful beam, unless protected by not less than 0.5 mm lead equivalent material.

4.2.9.2 The x-ray operator, other staff, and ancillary persons shall be protected from the direct scattered radiation by protective aprons or whole body protective barriers of not less than 0.25 mm lead equivalent material. Temporary placement of the physician's and/or assistant's hands in the primary beam during procedures that require sterility and increased dexterity are exempt from RHB 4.2.9.2.

4.2.9.3 Persons who cannot be removed from the room shall be protected from the direct scattered radiation by whole body protective barriers of 0.25 mm lead equivalent and when feasible shall be so positioned that the nearest portion of the body is at least two meters (2 m) from both the tube head and the nearest edge of the image receptor.

4.2.9.4 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 quarter of the maximum permissible dose as defined in RHB 3.4 of this regulation, additional protective devices may be required by the Department.

4.2.10 The useful x-ray beam shall be limited to the area of clinical interest.

4.2.11 Individuals shall not be exposed to the useful beam of electronically produced ionizing radiation except for healing arts purposes, and unless such exposure has been authorized by a licensed practitioner. This provision specifically prohibits deliberate exposure for the following purposes:

4.2.11.1 Exposure of an individual for training, demonstration or other purposes unless there are also healing arts requirements and proper prescription has been provided. Demonstrations or training on new x-ray equipment must be performed with proper protection of the observers and operator(s). Phantoms, not humans, must be used for demonstrations and training.

4.2.11.2 Healing arts screening. Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the Department. When requesting such approval, that person shall submit the information outlined in Appendix A of this Part. If any information submitted to the Department becomes invalid or outdated, the Department shall be notified within fifteen (15) calendar days. Approval to conduct a healing arts screening program shall be renewed on an annual basis if deemed necessary by the Department.

4.2.12 When a patient or film must be provided with auxiliary support during a radiation exposure:

4.2.12.1 Mechanical holding devices shall be used when the technique permits.

4.2.12.2 The facility shall indicate the requirements for selecting a holder, and the procedure the holder shall follow.

4.2.12.3 The human holder shall be instructed in personal radiation safety and shall be protected as required by 4.2.9.

4.2.12.4 No person shall be used routinely to hold patients or film.

4.2.12.5 In those cases where the patient must hold the film, except during intraoral examinations, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 mm lead equivalent material.

4.2.12.6 When practical, a pregnant female shall not be used to hold film or patients.

4.2.12.7 Each facility shall have leaded aprons and gloves available in sufficient numbers to provide protection to all personnel who are involved in x-ray operations who are not otherwise shielded.

4.2.13 Procedures and auxiliary equipment designed to minimize patient and personnel exposure shall be used.

4.2.13.1 The speed of the screen and film combinations used shall be the fastest speed consistent with the diagnostic objective of the examinations. Film cassettes without intensifying screens shall not be used for any routine diagnostic radiological imaging. The film cassettes shall provide good contact between the intensifying screens and the film.

4.2.13.2 The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality. Exposures shall not exceed limits for the specified anatomical thicknesses listed in Appendix D.

4.2.13.3 Portable or mobile x-ray equipment shall be used only for examinations where it is impractical to transfer the patient(s) to a stationary x-ray installation. Portable or mobile dental equipment shall be exempt from this regulation.

4.2.13.4 Radiologic technologists performing fluoroscopy as a localizing procedure shall be monitored by the supervising radiologist who is personally and immediately available.

4.2.14 Personnel Monitoring.

4.2.14.1 All persons 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 which are stated in RHB 3.4. In addition, the following requirements are made:

4.2.14.1.1 When protective clothing or devices are worn on portions of the body and a personnel monitoring device(s) is required, at least one (1) such device shall be utilized as follows:

4.2.14.1.2 When an apron is worn, and one (1) monitoring device is worn, the monitoring device shall be worn at the collar outside of the apron. If more than one (1) monitoring device is worn, the devices shall be worn in accordance with RHB 3.12.5.

4.2.14.1.3 The dose to the whole body based on the maximum dose attributed to any one (1) critical organ shall be recorded in the reports required by RHB 3.22. If more than one (1) 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.

4.2.14.2 Exposure of a personnel monitoring device to falsely indicate a dose delivered to an individual is prohibited.

4.2.14.3 When an individual who has been given responsibility that involves occupational exposure to x-rays declares that she is pregnant, the employer must, at her request, provide her with an additional personnel monitoring device to be worn on the trunk underneath the leaded apron, when such apron is worn.

4.2.15 X-ray Log.

4.2.15.1 Each facility (excluding dental and veterinary facilities) shall keep an x-ray log containing the patient's name; the type of examination, given by title as denoted on the technique chart; identification of the operator performing the examination; and the dates the examinations were performed.

4.2.15.2 When the examination is performed using any type of fluoroscopy, the log shall include a record of the amount of time that fluoroscopy was performed or the number of times that the cumulative timer was reset. The fluoroscopy time is not required to be recorded for radiation therapy simulation units or instrument guided radiation therapy units.

4.2.15.3 X-ray log records shall be maintained for two (2) years or until the next Department inspection, whichever is later.

4.2.16 Quality Assurance.

4.2.16.1 Each registrant covered under RHB 4.5 through 4.12 must have "Equipment Performance Tests" performed on each x-ray unit. The registrant is required to meet the minimum performance criteria and test frequency. Facilities utilizing x-ray equipment for teaching or demonstration purposes only are exempt from this Part. Appendix F provides the required minimum performance criteria that must be tested. Equipment performance tests results must include numerical data. Items found to be non-compliant during such testing shall be corrected within sixty (60) calendar days of receipt of the report. Records showing the test results and the correction of any non-compliant items found must be retained for five (5) years or until the next Department inspection, whichever is later. Equipment performance tests are to be performed:

4.2.16.1.1 At the time installation at all facilities, including veterinary facilities; or

4.2.16.1.2 Within thirty (30) calendar days of installation, provided that the manufacturer's specified testing is performed at the time of installation and before patient use; and

4.2.16.1.3 At the following specified intervals thereafter:

4.2.16.1.3.1 Dental intraoral and dental extraoral units shall be tested every two (2) years. Dental computed tomography and dental handheld units shall be tested annually.

4.2.16.1.3.2 All medical x-ray equipment, including fluoroscopic, computed tomography, and radiation therapy simulators, shall be tested annually. Self-calibrating bone densitometry systems are exempt from this requirement. Mammography units shall meet the requirements of Part V.

4.2.16.1.3.3 Veterinary facilities are required to have equipment performance tests performed at the time of installation, every five (5) years, and at any time the Department deems necessary.

4.2.16.1.4 On any unit expected to remain at a facility for more than thirty (30) calendar days. If a unit is expected to remain at a facility for less than thirty (30) calendar days, the manufacturer's specified testing must be performed, at a minimum, prior to patient use. Mammography units shall meet the requirements of Part V.

4.2.16.2 The darkroom shall be light tight to the dark-adapted eye and use proper safelighting such that a film exposed to x-radiation sufficient to produce an optical density from 1 to 2 when processed shall not suffer an increase in density greater than 0.1 when exposed in the darkroom for two (2) minutes with all safelights on. If used, daylight film handling boxes shall preclude fogging of the film.

4.2.16.3 If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast the grid shall:

4.2.16.3.1 Be positioned properly (i.e., tube side facing the right direction, and grid centered to the central ray).

4.2.16.3.2 If of the focused type, be of the proper focal distance for the source-to-image receptor distance (SIDs) being used.

4.2.16.4 Repeat Analysis.

4.2.16.4.1 Each registrant shall establish a repeat analysis program. An analysis of repeats shall include, at a minimum, the overall repeat rate and the causes for the repeats.

4.2.16.4.2 The repeat analysis shall be done at least quarterly. Records shall be maintained for two (2) years or until the next Department inspection, whichever is later.

4.2.16.4.3 Facilities with a single operator may document reasons for repeats on the patient log in lieu of a repeat analysis rate.

4.2.16.4.4 Registrants possessing dental or veterinary x-ray equipment are exempt from this requirement.

4.2.17 X-ray Film Processing. Each installation using a radiographic x-ray system and using analog imaging systems (radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions:

4.2.17.1 Manual Film Processing Systems.

4.2.17.1.1 Processing tanks shall be constructed of mechanically rigid, corrosion resistant material.

4.2.17.1.2 A dedicated darkroom thermometer shall be used. The thermometer shall be used to adjust the film processing time according to solution temperature.

4.2.17.1.3 A dedicated darkroom timer with an adjustable preset function shall be used. The timer shall be used to adjust film processing time according to solution temperature.

4.2.17.1.4 Documentation shall be kept of the frequency at which film processing chemicals are changed. At a minimum, the interval as recommended by the chemical manufacturer shall be used.

4.2.17.1.5 Safelight. If a safelight is used, it shall be adequate for the film speed(s) used to prevent fogging of unprocessed film.

4.2.17.1.6 The temperature of solutions in the tanks 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 recommended by the film manufacturer, or, in the absence of such recommendations, with the following time-temperature chart:

TIME TEMPERATURE CHART

Thermometer Reading (Degrees)	Minimum Developing Time (Minutes)
°C	oF
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
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

4.2.17.1.7 Radiographs shall not be "sight developed." 4.2.17.2 Automated Processors and Other Closed Processing Systems.

4.2.17.2.1 The temperature of film processing chemicals shall be appropriate for the type of film(s) being processed at the film transport speed selected.

4.2.17.2.2 The film processing chemicals used and their replenishing rate (if applicable) shall be appropriate for the film transport speed selected.

4.2.17.2.3 Documentation shall be kept of the frequency at which film processing chemicals are changed. At a minimum, the interval recommended by the chemical manufacturer shall be used.

4.2.17.2.4 Safelight. If a safelight is used, it shall be adequate for the film speed(s) used to prevent fogging of unprocessed film.

4.2.17.2.5 Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer, or, in the absence of such recommendations, the film shall be developed using the following chart:

Developer Temperature	Minimum Immersion Time *
°C	°F	Seconds
35	95	20
34	94	21
34	93	22
33	92	23
33	91	24
32	90	25

*Immersion time only, no crossover time included.

4.2.17.2.6 The specified developer temperature shall be available.

4.2.17.2.7 The sensitometric performance of an automatic processor shall be equivalent to other operating processor models set up to meet the above developer temperature and immersion time specifications. This is determined by processing identically exposed film through each model and comparing the results.

4.2.17.2.8 Densitometric and sensitometric performance testing.

4.2.17.2.8.1 Densitometric and sensitometric performance testing of the processor is required of facilities that process more than two hundred fifty (250) films per week.

4.2.17.2.8.2 Control limits shall be established for each parameter monitored. Provisions for correctable action shall be undertaken whenever the pre-established control limits are exceeded.

4.2.17.2.8.3 Documentation of testing must be maintained for at least two (2) years or until the next Department inspection, whichever is later.

4.2.17.2.8.4 Facilities processing more than two hundred fifty (250) films per day are required to perform this testing on each day that examinations are performed before any clinical films are processed that day.

4.2.17.2.8.5 Facilities that operate twenty-four (24) hours per day must perform the required testing once each day.

4.2.17.2.8.6 Registrants possessing dental or veterinary x-ray equipment are exempt from this requirement.

4.2.17.2.9 Records of processor maintenance shall be kept for at least two (2) years or until the next Department inspection, whichever is later.

4.2.17.3 Other Requirements.

4.2.17.3.1 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.

4.2.17.3.2 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.

4.2.17.3.3 Film cassettes and intensifying screens shall be cleaned and replaced as necessary to best assure radiographs of good diagnostic quality. Documentation of this periodic inspection and cleaning must be maintained for at least two (2) years or until the next Department inspection, whichever is later.

4.2.17.4 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.

4.2.17.5 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.

S.C. Code Regs. § 61-64.IV.RHB 4.2

Replaced and amended by State Register Volume 40, Issue No. 06, eff. 6/24/2016; State Register Volume 47, Issue No. 05, eff. 5/26/2023.