Section 1591. General and administrative requirements

A. Radiation safety requirements. The registrant shall be responsible for directing the operation of the x-ray system under his administrative control. The registrant or the registrant's agent shall assure that the requirements of this chapter are met in the operation of the x-ray system or systems.

1. An x-ray system that does not meet the provisions of this chapter shall not be operated for diagnostic purposes.

2. Individuals who will be operating the x-ray systems shall meet the qualifications of this part to conduct the practice of radiologic technology.

3. A chart shall be provided in the vicinity of the diagnostic x-ray system's control panel that specifies, for all examinations performed with that system, the following information:

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

b. Type and size of the image receptor to be used;

c. Type and size of the image receptor combination to be used, if any;

d. Source to image receptor distance to be used (except for dental intraoral radiography);

e. Type and location of placement of patient shielding (e.g., gonad, etc.) to be used; and

f. For mammography, indication of kVp/target/filter combination.

4. 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.

5. Except for patients who cannot be moved out of the room, only the staff, ancillary personnel, or other persons 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 not less than 0.5 mm lead equivalent material;

b. The x-ray operator, other staff, ancillary personnel, and other persons required for the medical procedure shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 mm lead equivalent material. However, when distances provide sufficient protection from scatter radiation, or for low dose rate devices such as bone densitometry equipment, no protective devices may be necessary; and

c. Human patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 mm lead equivalent material or shall be so positioned that the nearest portion of the body is at least two meters from both the tube head and the nearest edge of the image receptor.

6. Gonad shielding of not less than 0.5 mm lead equivalent material shall be used for human 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.

7. 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 deliberate exposure for the following purposes:

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

b. Exposure of an individual for the purpose of healing arts screening except as authorized by subdivision 11 of this subsection.

8. When a patient or image receptor must be provided with auxiliary support during a radiation exposure:

a. Mechanical holding devices shall be used when the technique permits. The written safety procedures, as required by subdivision 4 of this subsection, shall list individual projections where holding devices cannot be utilized;

b. Written safety procedures, as required by subdivision 4 of this subsection, 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 subdivision 5 of this subsection. Caregivers who stay in the room to assist with imaging of patients shall be positioned and instructed to keep the protective apron between themselves and the patient;

d. No individual shall be used routinely to hold image receptors or patients;

e. 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 mm lead equivalent material; and

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

9. Procedures 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 routine 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.

c. Portable or mobile radiographic (exclude fluoroscopic) x-ray equipment shall be used only for examinations where it is impractical to transfer the patient to a stationary x-ray installation.

d. X-ray systems subject to 12VAC5-481-1621 shall not be utilized in procedures where the source to patient distance is less than 30 cm, except for veterinary systems.

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

(1) Be positioned properly, that is, tube side facing the right direction, and grid centered to the central ray; and

(2) If the grid is of the focused type, be of the proper focal distance for the SIDs being used.

10. All individuals who are associated with the operation of an x-ray system are subject to the requirements of 12VAC5-481-640, 12VAC5-481-700, and 12VAC5-481-710.

11. Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the agency. If any information submitted to the agency becomes invalid or outdated, the agency shall be immediately notified. Persons requesting that the agency approve a healing arts screening program shall submit the following information and evaluation:

a. Name and address of the applicant and, where applicable, the names and addresses of agents within this state;

b. Diseases or conditions for which the x-ray examinations are to be used in diagnoses;

c. A description of the x-ray examinations proposed in the screening program, that is, type and number of views;

d. Description of the population to be examined in the screening program, that is, age range, sex, physical condition, and other appropriate information;

e. An evaluation of any known alternate methods not involving ionizing radiation that could achieve the goals of the screening program and why these methods are not used instead of the x-ray examinations;

f. An evaluation by a qualified medical physicist of the x-ray system or systems to be used in the screening program. The evaluation shall include the following:

(1) Documentation that such systems satisfy all requirements of this chapter; and

(2) Measurement of patient exposures from the x-ray examinations to be performed;

g. A description of the diagnostic x-ray quality control program;

h. A copy of the technique chart for the x-ray examination procedures to be used;

i. The qualifications of each individual who will be operating the x-ray system or systems;

j. The qualifications of the individual who will be supervising the operators of the x-ray system or systems. The extent of supervision and the method of work performance evaluation shall be specified;

k. The name and address of the practitioner licensed in the state who will interpret the radiograph;

l. Procedures to be used in advising the individuals screened and their practitioners of the healing arts or health care providers of the results of the screening procedure and any further medical needs indicated;

m. Procedures for the retention or disposition of the radiographs and other records pertaining to the x-ray examinations;

n. Frequency of screening of individuals; and

o. The duration of the screening program.

12. The registrant shall maintain the following information and maintenance record for each x-ray system for inspection by the agency:

a. Model and serial numbers of all major components, and user's manuals for those components;

b. Tube rating charts and cooling curves;

c. Records of surveys, calibrations, maintenance, and modifications performed on the x-ray system or systems; and

d. A copy of all correspondence with the agency regarding that x-ray system.

13. Except for veterinary facilities, each facility shall maintain an x-ray utilization log containing the patient's name, the type of examination, and the date the examination was performed.

14. The registrant shall maintain a list of x-ray operators for each facility. Operators must be licensed by the Department of Health Professions where x-rays are used within the scope of practice or be certified by the American Registry of Radiological Technologists (ARRT), or be an individual enrolled, or was enrolled within the past three months, in an accredited program for radiologic technology and under the supervision of a licensed or certified radiological technologist, or if a dental assistant, comply with the Board of Dentistry's radiation certification requirements in 18VAC60-20-195.

B. X-ray film processing facilities and practices.

1. Each installation using a radiographic x-ray system and analog image receptors (e.g., radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions:

a. Manually developed film.

(1) Processing tanks shall be constructed of mechanically rigid, corrosion resistant material; and

(2) 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	°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

(3) Devices shall be utilized that will indicate the actual temperature of the developer and signal the passage of a preset time appropriate to the developing time required.

b. Automatic processors and other closed processing systems. 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:

	Developer Temperature		Minimum Immersion Time*
	°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
	*Immersion time only, no crossover time included.

Processing deviations from the requirements of this subdivision 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).

2. Other requirements.

a. 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.

b. The darkroom shall be light tight 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 to two when processed shall not suffer an increase in density greater than 0.1 (0.05 for mammography) when exposed in the darkroom for two minutes with all safelights on. If used, daylight film handling boxes shall preclude fogging of the film.

c. 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.

d. 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.

e. 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.

f. Outdated x-ray film shall not be used for 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 plus fog and speed.

g. 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.

h. Living and deceased patients' diagnostic images shall be maintained for a minimum of five years. Diagnostic images for minors shall be maintained for a minimum of five years beyond their 18th birthday.

C. The registrant shall submit to the agency a copy of all surveys, calibrations, and inspections performed by a private inspector within 30 days of completion of the survey, calibration, or inspection.

D. The private inspector shall provide the inspection report to the registrant within 14 days of the completion of the inspection. A summary or recommendation shall be included with this report. The inspector shall notify the registrant of any noncompliances that need corrective action.

E. Violations identified as "serious" must be corrected within 30 days. Certification of the unit will not be issued until the violation is corrected. Violations identified as "non-serious" shall be corrected before the next inspection cycle. Uncorrected "non-serious" violations will become "serious" and require immediate correction.

Historical Notes

Derived from Volume 31, Issue 24, eff. August 27, 2015.

Statutory Authority

§ 32.1-229 of the Code of Virginia.