16 Del. Admin. Code § 4465-F-3.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4465-F-3.0 - General and Administrative Requirements

3.1 Radiation Safety Requirements. The registrant shall be responsible for directing the operation of the x-ray system(s) under his or her administrative control and shall assure that the requirements of these regulations are met in the operation of the x-ray system(s).

3.1.1 The registrant shall have a radiation safety program. The radiation safety program shall include but not be limited to the following:

3.1.1.1 The use of ionizing radiation within its purview is performed in accordance with existing laws and regulations.

3.1.1.2 All persons are protected as required by Regulation 4465, Part D, Standards for Protection Against Radiation, of these regulations.

3.1.1.3 Upon discovery of a medical event, the registrant shall:

3.1.1.3.1 Contact the Agency regarding the medical event within one business day;

3.1.1.3.2 Provide a written report, including the analysis of the medical event, by a QMP (QE) to the Agency within 15 business days;

3.1.1.3.3 Provide a clinical summary to the prescribing physician and patient within 15 business days; and

3.1.1.4 Maintain record of the medical event as part of the patient's permanent medical record, and

3.1.1.5 Maintain record of the medical event as reported to Radiation Protocol or Safety Committee for at least three years, available for inspection.

3.1.2 An x-ray system which does not meet the provisions of these regulations shall not be operated for diagnostic or interventional purposes unless the Agency or a QMP (QE) determines that the non-compliance shall not pose a significant radiation risk or significantly affect image quality, and arrangements have been made to correct the non-compliance within 30 days.

3.1.3 The QMP (QE), if required in this Part, shall complete initial and routine compliance evaluations following nationally recognized procedures. These evaluations shall include a review of the required QC tests.

3.1.4 All x-ray equipment shall be installed, maintained, and used in accordance with the equipment manufacturer's specifications.

3.1.5 Individuals operating the x-ray systems shall meet the qualifications required by the Agency.

3.1.6 A sufficient number of protective apparel (e.g., aprons, gloves, collars) and shields shall be available to provide the necessary radiation protection for all patients and personnel who are involved with x-ray operations.

3.1.7 All protective apparel and auxiliary shields shall be evaluated annually for integrity and clearly labeled with their lead equivalence.

3.1.8 Each registrant should have a mechanism in place for the referring licensed practitioner to access information on selecting the most appropriate diagnostic procedure to answer the clinical question.

3.1.9 Nationally recognized diagnostic reference levels (DRLs) should be utilized when applicable.

3.1.10 The registrant shall use dose reduction strategies designed to minimize patient and personnel exposure commensurate with the needed diagnostic information.

3.1.11 Portable or mobile x-ray equipment shall be used only for examinations where it is impractical to transfer the patient to a stationary x-ray installation.

3.1.12 Neither the x-ray tube housing nor the collimating device shall be held during an exposure. An exemption or variance is required for devices specifically designed to be hand-held, except for devices in non-human use, such as veterinary medicine or forensics.

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

3.1.14 Consideration shall be given to selecting the appropriate technique and employing available dose reduction methods and technologies across all patient sizes and clinical indications.

3.1.15 A facility shall have a documented procedure in place for verification of patient identity and exam to be performed, including identification of the appropriate body part.

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

3.1.16.1 Patient's (adult and pediatric, if appropriate) body part and anatomical size

3.1.16.2 Technique factors

3.1.16.3 Type of image receptor used

3.1.16.4 Source to image receptor distance used (except for dental intraoral radiography)

3.1.16.5 Type of grid, if any.

3.1.17 The registrant shall create and make available to x-ray operators written safety procedures, including instructions for patient holding and any restrictions of the operating technique required for the safe operation of the particular x-ray system. The operator shall be able to demonstrate familiarity with these procedures.

3.1.18 The registrant shall restrict the presence of individuals in the immediate area of the patient being examined to those required or in training for the medical procedure, or the parent or guardian of a patient while the x-ray tube is energized. The following applies to all individuals, other than the patient being examined:

3.1.18.1 All persons 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 millimeter lead equivalent material;

3.1.18.2 All persons shall be protected from the secondary radiation by protective garments or whole body protective barriers of not less than 0.25 millimeter lead equivalent material;

3.1.18.3 Instances may warrant having human patients other than the one being examined in the room during the exam. If the procedure results in scatter radiation in excess of 0.02 mSv (2 mR) in any one hour at the position of these patients, they shall be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 millimeter lead equivalent material or shall be positioned so that the 0.02 mSv (2 mR) in any one hour limit is met.

3.1.19 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. This provision specifically prohibits deliberate exposure for the following purposes:

3.1.19.1 Exposure of an individual for training, demonstration, or other non-healing arts purposes; and

3.1.19.2 Exposure of an individual for the purpose of healing arts screening except as authorized by the Agency, or under the following circumstances: Exposure of an individual to the useful beam when conducting research approved by an Institutional Review Board (IRB) as allowed by Title 45, Code of Federal Regulations (CFR), Part 46 and Title 21,CFR, Part 56.

3.1.20 In cases where a patient or image receptor must be provided with auxiliary support, mechanical support devices shall be used whenever possible. If a patient or image receptor must be provided with auxiliary support during a radiation exposure:

3.1.20.1 Written safety procedures, as required by Part F, subsection 3.1.15, shall indicate the requirements for selecting a holder and the procedure the holder shall follow;

3.1.20.2 The human holder shall be instructed in personal radiation safety and protected as required by Part F, subsection 3.1.16;

3.1.20.3 No individual shall be used routinely to hold the image receptor or patient during a radiation exposure;

3.1.20.4 In those cases where the patient must hold the image receptor, 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 millimeter lead equivalent material.

3.1.21 All individuals who are associated with the operation of an x-ray system are subject to the requirements of Part D of these regulations.

3.1.22 Healing Arts Screening. Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the Agency. When requesting such approval, that person shall submit the information outlined in Appendix A of Part F of these regulations. If any information submitted to the Agency becomes invalid or outdated, the Agency shall be immediately notified. FDA/MQSA-certified facilities are registered with the Agency for the use of dedicated mammographic equipment to conduct mammography screening.

3.1.23 Maintenance of Records. The registrant shall maintain the following information on each x-ray system for inspection by the Agency for a minimum of 5 years or as noted below:

3.1.23.1 Model and serial numbers of all major components, and user's manuals for those components, including software, shall be maintained for the life of the system.

3.1.23.2 Records of surveys, calibrations, maintenance, and modifications (e.g., major software and hardware upgrades) performed on the x-ray system(s); and

3.1.23.3 A copy of all correspondence with the Agency regarding the x-ray system.

3.1.24 X-Ray Utilization Record. Each facility shall maintain a record containing the patient's name, the type of examinations, and the dates the examinations were performed.

3.2 Quality Assurance.

3.2.1 The registrant shall establish and maintain a quality assurance (QA) program. In addition to the standards in the modality specific sections, the registrant shall:

3.2.1.1 Maintain documentation of minimum qualifications for licensed practitioners, medical physicists, and x-ray equipment operators.

3.2.1.2 Designate an appropriately trained individual to manage the QA program.

3.2.1.3 Establish and maintain written QA and quality control (QC) procedures, including evaluation frequencies and tolerances.

3.2.1.4 Check each study for artifacts. If an artifact is present, the source shall be identified and appropriate action taken.

3.2.1.5 Perform repeat / reject analysis of radiographic images at least quarterly following specifications of a nationally recognized organization.

3.2.1.6 Complete preventative maintenance on each x-ray system in accordance with manufacturer specifications at intervals, not to exceed 24 months.

3.2.1.7 Maintain documentation showing the testing instruments used in determining compliance with the provisions of this section are properly calibrated and maintained in accordance with accepted professional standards.

3.2.1.8 Complete and document an annual review of the QA program.

3.2.1.9 Retain QA/QC records of evaluations and reviews in accordance with state statutes, regulations, but in no case less than three years.

3.2.2 X-Ray Film Processing Facilities. A registrant using analog image receptors (e.g. radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions:

3.2.2.1 Manually developed film:

3.2.2.1.1 Processing tanks shall be constructed of mechanically rigid, corrosion resistant material; and

3.2.2.1.2 Developing solutions shall be prepared, replenished, and replaced following manufacturer recommendations.

3.2.2.1.3 The temperature of solutions in the tanks shall be maintained within the range of 60^o F to 80^oF (16^o C to 27^o 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:

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3.2.2.1.4 Devices shall be utilized which will indicate the actual temperature of the developer solution and signal the passage of a preset time.

3.2.3 Automatic processors and other closed processing systems:

3.2.3.1 Automatic processors shall be operated and maintained following manufacturer specifications.

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

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3.2.3.3 Processing deviations from the requirements of Part F, subsection 3.2.2 shall be documented by the registrant in such manner that the requirements are shown to be met or exceeded (e.g., extended processing, and special rapid chemistry).

3.2.4 Additional Requirements for Facilities using X-ray Film.

3.2.4.1 Pass boxes, if provided, shall be so constructed as to exclude light from the darkroom when cassettes are placed in or removed from the boxes, and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.

3.2.4.2 Darkrooms typically used by more than one individual shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed.

3.2.4.3 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.

3.2.4.4 Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary.

3.2.4.5 Outdated x-ray film shall not be used for diagnostic radiographs.

3.2.4.6 The film and intensifying screen shall be spectrally compatible.

3.2.4.7 Facilities shall maintain a light-tight darkroom, use proper safelighting and safeguards, and evaluate darkroom integrity and daylight loading systems for film fog every six months and after a change that may impact film fog.

3.2.4.8 Facilities other than dental, podiatry, and veterinary shall:

3.2.4.8.1 Have a continuous and documented sensitometric quality control program, including quality control tests for speed, contrast and fog, These tests shall be performed according to specifications of the manufacturer, a QMP (QE), or a nationally recognized organization.

3.2.4.8.2 Maintain a light-tight darkroom and use proper safelighting and safeguards such that any film type in use exposed in a cassette to x-radiation sufficient to produce an optical density from 1 to 2 when processed shall not suffer an increase in optical density greater than 0.1 when exposed in the darkroom for 2 minutes with all safelights on. If used, daylight film handling boxes shall preclude fogging of the film.

3.2.4.8.3 Limit the base plus fog of unexposed film to an optical density less than 0.25 when developed by the routine procedure used by the facility.

3.2.5 Facilities Using Computed Radiography (CR) or Direct Digital Radiography (DDR).

3.2.5.1 When exposure indicators are available, the facility shall establish and document an acceptable range for the exposure values for examinations routinely performed at the facility. The indicated exposure values for each image shall be compared to the established range. Consistent deviations from established ranges shall be investigated, corrective actions taken as necessary, and results documented.

3.2.5.2 Facilities shall establish and follow an image quality control program in accord with the recommendations of a QMP (QE), the system manufacturer, or a nationally recognized organization.

3.2.5.3 Facilities other than dental, podiatric and veterinary, shall complete phantom image evaluation using a phantom approved by a QMP (QE), or the system manufacturer. The analysis at a minimum shall include: artifacts, spatial resolution, contrast/noise, workstation monitors, and exposure indicator constancy.

3.2.5.4 In addition to Part F, subsections 3.2.4.1 through 3.2.4.3, CR facilities shall perform erasure of all CR cassettes, at least on a weekly basis.

3.3 Exemptions.

3.3.1 Dental facilities. Dental facilities performing only intra-oral, panoramic, cephalometric or volumetric dental imaging are exempt from the following provisions of this Section: Part F, subsection 3.1.8 (information available to referring physician) and Part F, subsection 3.2.1.5 (repeat analysis).

3.3.2 Podiatry facilities. Podiatry facilities are exempt from the following provisions of this Section: Part F, subsection 3.1.8 (information available to referring physician) and Part F, subsection 3.2.1.5 (repeat analysis).

3.3.3 Veterinary facilities. Veterinary facilities are exempt from the following provisions of this Section: Part F, subsection 3.1.8 (information available to referring physician), Part F, subsection 3.1.9 (use of reference levels), Part F, subsection 3.1.14 (use of dose reduction techniques), Part F, subsection 3.1.15 (patient identification), Part F, subsection 3.1.14 (protocol control), Part F, 3.1.18.3 (routine holding of patient), Part F, subsection 3.1.22 (healing arts screening), Part F, subsection 3.2.1.5 (repeat analysis), and Part F, subsection 3.2.4.8.1 (use of sensitometric equipment).

16 Del. Admin. Code § 4465-F-3.0

16 DE Reg. 1274(6/1/2013)
22 DE Reg. 401( 11/1/2018) (Final)