216 R.I. Code R. 216-RICR-40-20-4.3

Current through October 15, 2024

Section 216-RICR-40-20-4.3 - General and Administrative Requirements

4.3.1Administrative Controls

A. The registrant shall be responsible for directing the operation of the X-ray system(s) under their administrative control. The registrant or the registrant's agent shall assure that the requirements of this Subchapter are met in the operation of the X-ray system(s).

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

1. The use of ionizing radiation within its purview is performed in accordance with the Act and Agency Regulations.

2. All persons are protected as required by Part 1 of this Subchapter.

C. The registrant shall have a mechanism in place for the referring physician to access information on selecting the most appropriate diagnostic procedure to answer the clinical question.

D. The registrant shall utilize nationally recognized diagnostic reference levels (DRLs) when applicable.

E. The registrant shall select the appropriate technique and employ available dose reduction methods and technologies across all patient sizes and clinical indications.

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

G. All X-ray equipment shall be installed and used in accordance with the equipment manufacturer's specifications.

4.3.2Operation Prohibited

An X-ray system which does not meet the provisions of this Part shall not be operated for diagnostic purposes unless the Agency or a Qualified Medical Physicist determines that the non-compliance will not pose a significant radiation risk or significantly affect image quality, and arrangements have been made to correct the non-compliance within thirty (30) days.

4.3.3Individuals Operating X-ray Systems for Healing Arts Use

A. Individuals who will be operating the X-ray systems for healing arts use shall possess a current license in accordance with Subchapter 05 Part 34 of this Chapter, Licensure of Radiographers, Nuclear Medicine Technologists, and Radiation Therapists, unless the individual is specifically exempted from licensure by said Regulations. Individuals who will be operating the X-ray systems and who are not subject to licensure under Subchapter 05 Part 34 of this Chapter shall be adequately instructed in the safe operating procedures and be competent in the safe use of the equipment. As a minimum, such instruction shall consist of subjects outlined in § 4.12 of this Part.

B. The names and qualifications of all personnel operating X-ray equipment for healing arts use must be kept on file for Agency inspection at each facility location.

C. All individuals operating, or supervising the operation of, fluoroscopic X-ray systems shall have completed a minimum of four (4) hours training, prior to performing fluoroscopy procedures that includes but is not limited to the following:

1. Biological effects of X-ray;

2. Radiation protection methods for patients and staff;

3. Factors affecting fluoroscopic outputs;

4. Dose management including dose reduction techniques, monitoring, and recording;

5. Principles and operation of the specific fluoroscopic X-ray system(s) to be used;

6. Fluoroscopic and fluorographic outputs of each mode of operation on the system(s) to be used clinically;

7. Basic properties of radiation;

8. Units of measurement and dose, including DAP (dose-area product) values and air kerma;

9. High level control options; and

10. Applicable requirements of this Subchapter.

D. All persons operating, or supervising the operation of, fluoroscopy systems during fluoroscopically-guided interventional (FGI) procedures shall have completed a minimum of eight (8) hours of training approved by the Agency. The training shall include, but not be limited to:

1. The topics provided in §4.3.3(C) of this Part;

2. Methods to reduce patient dose using advanced imaging and recording features;

3. Procedures for recording pertinent data specified in §4.5.13 of this Part; and

4. A minimum of one (1) hour of hands-on fluoroscopic machine training demonstrating application of topics required in §4.3.3(D) of this Part.

E. The training required §§4.3.3(C) and (D) of this Part shall be provided by a Qualified Medical Physicist or another individual approved by the Agency.

F. The registrant shall either provide a minimum of two (2) hours in-service training for all individuals operating or supervising the operation of fluoroscopy systems used, at intervals not to exceed twenty-four (24) months or require evidence of continuing medical education, in fluoroscopic radiation safety and patient dose management at intervals not to exceed twenty-four (24) months.

G. Documentation pertaining to the requirements of §§4.3.3(B), (C) and (D) of this Part shall be maintained for review for three (3) years.

H. A dental facility registrant shall provide initial training and shall ensure that X-ray operators have completed a course in dental radiography offered by an educational institution with a program accredited by the commission on dental accreditation (§05-2.10.3(A)(11) of this Chapter). Annual evaluations of X-ray operators to include but not limited to: positioning of the X-ray tube, image processing, operator location during X-ray exposure, source to skin distance, radiation protection, appropriate radiographic protocol, and applicable regulatory requirements. Records of training and annual evaluations shall be maintained for inspection by the Agency for three (3) years.

4.3.4Technique Protocols

A. 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 the following information:

1. Patient's (adult or pediatric, as applicable) body part and anatomical size;

2. Technique factors;

3. Type of the image receptor to be used;

4. Source to image receptor distance to be used (except for dental intraoral radiography, which shall list cone length to be used); and

5. Type of grid, if any.

4.3.5Written Safety Procedures

The registrant of a facility shall create and make available to X-ray operators written safety procedures, including 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.

4.3.6Room Occupancy During Radiographic Exposure

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

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 one half millimeter (0.5 mm) lead equivalent material.

2. All individuals shall be protected from the secondary radiation by protective garments or whole-body protective barriers of not less than twenty-five one hundredths of one quarter millimeter (0.25 mm) lead equivalent material.

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 two one hundredths (0.02) mSv (2 mR) in any one (1) hour at the position of these patients, such patients shall be protected from the direct scatter radiation by whole body protective barriers of not less than twenty-five one hundredths of one quarter millimeter (0.25 mm) lead equivalent material or shall be positioned so that the two one hundredths (0.02) mSv (2 mR) in any one (1) hour limit is met.

4. Written safety procedures, as required by §4.3.5 of this Part, shall describe how the requirements of this section will be met when using mobile or portable X-ray systems.

4.3.7[Reserved]

4.3.8Non-Healing Arts Exposure Prohibited

Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been ordered in writing by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing-arts purposes, and exposure of an individual for the purpose of healing arts screening except as authorized by §4.3.12 of this Part.

4.3.9When a Patient or Image Receptor Must be Provided with Auxiliary Support During a Radiation Exposure

A. In cases where a patient or image receptor must be provided with auxiliary support, mechanical support devices shall be used whenever possible. The written safety procedures, required by §4.3.5 of this Part, shall list individual projections where holding devices cannot be utilized;

B. Written safety procedures, as required by §4.3.5 of this Part, shall indicate the requirements for selecting a holder and the procedure the holder shall follow;

C. The human holder shall be instructed in personal radiation safety and protected as required by §4.3.6 of this Part;

D. No individual shall be used routinely to hold image receptor or patients during a radiation exposure; and E. Each facility shall have protective garments (e.g., aprons, gloves, collars) and shields available in sufficient numbers to provide protection for all personnel who are involved with X-ray operations and who are otherwise not shielded.

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

F. A record shall be made of the examination and shall include the name of the human holder, date of the examination, number of exposures and technique factors utilized for the exposure(s).

4.3.10Procedures and Auxiliary Equipment Designed to Minimize Patient and Personnel Exposure Commensurate with The Needed Diagnostic Information Shall Be Utilized

A. The fastest imaging system consistent with the diagnostic objective of the examinations shall be used. Film cassettes without intensifying screens shall not be used for any diagnostic radiological imaging, with the exception of veterinary radiography and standard film packets for intraoral use in dental radiography.

B. The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality. The registrant shall use auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information.

C. 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.

D. 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.

1. Manually Developed Film

a. The temperature of solutions in the tanks shall be maintained within the range of sixty degrees Fahrenheit (60º F) to eighty degrees Fahrenheit (80º F) (sixteen degrees Celsius (16º C) to twentyseven degrees Celsius (27º 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:

Manual Film Developing Technique Chart
Developer Temperature °C/°F	Developing Time (Minutes)	Developer Temperature °C/°F	Developing Time (Minutes)
26.7/80	2.0	20.6/69	4.5
26.1/79	2.0	20.0/68	5.0
25.6/78	2.5	19.4/67	5.5
25.0/77	2.5	18.9/66	5.5
24.4/76	3.0	18.3/65	6.0
23.9/75	3.0	17.8/64	6.5
23.3/74	3.5	17.2/63	7.0
22.8/73	3.5	16.7/62	8.0
22.2/72	4.0	16.1/61	8.5
21.7/71	4.0	15.6/60	9.5
21.1/70	4.5

b. Devices shall be utilized which will:

(1) Indicate the actual temperature of the developer; and

(2) Give an audible or visible signal indicating the termination of a preset time.

c. Developing tanks shall be constructed of mechanically rigid, corrosion resistant material.

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

2. Automatic Developers and Other Closed Developing Systems

a. Films 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 timetemperature chart; and

Developer Temperature		Minimum Immersion Timea/
°C	°F	Seconds
35.5	96	19
35	95	20
34.5	94	21
34	93	22
33.5	92	23
33	91	24
32	90	25
31.5	89	26
31	88	27
30.5	87	28
30	86	29
29.5	85	30
a/ Immersion time only, no crossover time included.

b. Developing deviations from the requirements of §4.3.10(D)(2)(a) of this Part 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).

c. Automatic developers shall be operated and maintained following manufacturer specifications.

E. Additional Requirements for Facilities Using Analog Image Receptors

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.

2. 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 (6) months and after any change that may impact film fog.

3. Darkrooms typically used by more than one (1) individual shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed.

4. 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.

5. Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary to assure radiographs of good diagnostic quality.

6. Outdated X-ray film shall not be used for diagnostic radiographs.

7. The film and intensifying screen shall be spectrally compatible.

8. Facilities other than dental, podiatry, and veterinary facilities shall:

a. 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 Qualified Medical Physicist, or a nationally recognized organization.

b. Maintain a light-tight darkroom and use proper safelighting such that any film type in use exposed in a cassette to X-ray radiation sufficient to produce an optical density from one (1) to two (2) when developed shall not suffer an increase in density greater than one tenth (0.1) when exposed in the darkroom for two (2) minutes with all safelights on. If used, daylight film handling systems shall preclude fogging of the film.

c. Limit the base plus fog of unexposed film to an optical density less than twenty-five one hundredths (0.25) when developed by the routine procedure used by the facility.

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

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.

2. CR facilities shall perform at least weekly erasure of all CR cassettes.

G. Dental Facilities

1. If using film, the facility shall maintain a light-tight darkroom, use proper safelighting and safeguards, and evaluate darkroom integrity and daylight loading systems for film fog every six (6) months and after any change that may impact film fog.

2. If using a filmless system, the facility shall maintain and operate photostimulable storage phosphor (PSP) and DDR systems according to manufacturer specifications.

4.3.11Additional Compliance Required

All individuals who are associated with the operation of an X-ray system are subject to the applicable requirements of Parts 1 and 2 of this Subchapter.

4.3.12Healing 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 § 4.11 of this Part. If any information submitted to the Agency becomes invalid or outdated, the Agency shall be immediately notified.

4.3.13Information and Maintenance Record and Associated Information

A. The registrant shall maintain the following information. The information shall be maintained in a separate file or package in chronological order for each X-ray system, for a minimum of five (5) years or as noted below:

1. Maximum rating of technique factors;

2. 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. Aluminum equivalent filtration in the useful beam, including any routine variation;

4. Tube rating charts and cooling curves;

5. Records of surveys, calibrations, maintenance, and modifications (e.g., major software and hardware upgrades) performed on the X-ray system(s), with the names of the persons who performed such services;

6. A scale drawing of the room in which a stationary X-ray system is located with such drawing indicating the current use of areas adjacent to the room and an estimate of the extent of occupancy by an individual in such areas. In addition, the drawing shall include the results of a survey for radiation levels present at the operator's position, and at pertinent points outside the room at specified test conditions; or the type and thickness of materials, or lead equivalency, of each protective barrier.

7. A copy of all correspondence with this Agency regarding that X-ray system.

4.3.14X-ray Utilization Log

A. Except for veterinary facilities, each facility shall maintain a record containing the patient's name, the type of examinations, and the dates the examinations were performed. The record shall also include the following information:

1. Name of the licensed practitioner of the healing arts ordering the examination.

2. Name(s) of individuals who performed the examination.

3. Any deviation from the standard procedure as specified on the technique chart, including all repeat exposures.

4. When applicable, the X-ray system used.

5. When the patient or image receptor must be provided with human auxiliary support, the name of the human holder.

B. X-ray utilization logs shall be maintained for a minimum of five (5) years following the examination or treatment of adult patients. Records of examination or treatment of minors shall be maintained for a minimum of five (5) years beyond the age of majority.

C. If X-ray utilization logs are stored electronically, records shall be maintained in a manner that will allow retrieval of records for any specified time period.

D. Each veterinary facility shall maintain a record containing the type of examinations and the dates the examinations were performed. The record shall also include the following information:

1. Name(s) of individuals who performed the examination;

2. Any deviation from the standard procedure as specified on the technique chart, including all repeat exposures;

3. When applicable, the X-ray system used; and

4. When the patient or image receptor must be provided with human auxiliary support, the name of the human holder.

4.3.15Report and Notification of a Dose to an Embryo/Fetus

A. A registrant shall report any dose to an embryo/fetus that is greater than fifty (50) mSv (five (5) rem) dose equivalent that is a result of an administration of radiation to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the prescribing physician.

B. The registrant shall notify the Agency by telephone no later than the next business day after discovery of a dose to the embryo/fetus that requires a report in §4.3.15(A) of this Part.

C. The registrant shall submit a written report, prepared by a Qualified Medical Physicist, to the Agency within fifteen (15) business days after discovery of a dose to the embryo/fetus that requires a report in §4.3.15(A) of this Part.

1. The written report must include:

a. The registrant's name and registration number;

b. The name of the prescribing physician;

c. A brief description of the event;

d. Why the event occurred;

e. The effect, if any, on the embryo/fetus;

f. What actions, if any, have been taken or are planned to prevent recurrence; and

g. Certification that the registrant notified the mother (or the mother's or child's responsible relative or guardian), and if not, why not.

2. The report must not contain the individual's or child's name or any other information that could lead to identification of the individual or child.

D. The registrant shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than twenty-four (24) hours after discovery of an event that would require reporting under §4.3.15(A) of this Part, unless the referring physician personally informs the registrant either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. The registrant is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within twenty-four (24) hours, the registrant shall make the appropriate notifications as soon as possible thereafter. The registrant may not delay any appropriate medical care for the embryo/fetus, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this paragraph, the notification may be made to the mother's or child's responsible relative or guardian instead of the pregnant individual. If a verbal notification is made, the registrant shall inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the registrant upon request. The registrant shall provide such a written description if requested.

E. A registrant shall:

1. Annotate a copy of the report provided to the Agency with the:

a. Name of the pregnant individual who is the subject of the event; and

b. Identification number or if no other identification number is available, the Social Security Number of the pregnant individual who is the subject of the event; and

2. Provide a copy of the annotated report to the referring physician, if other than the registrant, no later than fifteen (15) days after the discovery of the event.

216 R.I. Code R. 216-RICR-40-20-4.3

Adopted effective 1/1/2019
Amended effective 5/25/2022
Amended effective 11/28/2023