S.D. Admin. R. 44:03:01:10

Current through Register Vol. 51, page 67, December 16, 2024

Section 44:03:01:10 - General safety provisions to protect persons from radiation exposures

The licensee shall be responsible for directing the operation of any X ray system under the licensee's administrative control. The licensee or the licensee's agent shall provide that:

(1) No X ray system may be operated for diagnostic purpose unless the system meets the provisions of this chapter;

(2) Any person who is operating the X ray system is adequately instructed in the safe operating procedures and competent in the safe use of the equipment commensurate with the size, scope, and nature of the service. Any such person shall be instructed and demonstrate competence in subjects outlined in § 44:03:01:14.01;

(3) Procedures and auxiliary equipment utilized produce images of good diagnostic quality with minimum patient radiation exposure;

(4) Digital imaging equipment is consistent with the diagnostic objective of the examination;

(5) The film screen combinations shall be the fastest speed consistent with the diagnostic objective of the examination;

(6) A technique chart or manual is located in the vicinity of the control panel of each machine that specifies, for all diagnostic examinations performed with that system, the following:

(a) The technique factors to be used that are specific to a patient's anatomical part, size, or age (for pediatrics), except for any system that has only automatic X ray exposure controls;

(b) The type of film-screen combination to be used;

(c) The type of grid to be used, if any;

(d) The SID to be used, except for dental and all other fixed SID radiographic equipment;

(e) The type and placement of patient shielding to be used;

(f) The routine views for all procedures done with each machine; and

(g) For mammography, an indication of kVp/target/filter combination;

(7) A written operating and safety procedure must be available to each individual who operates radiation machines that includes restrictions for the safe operation of each radiation machine. The operator must be able to demonstrate familiarity with these procedures;

(8) Except for veterinary facilities, each facility maintains a record containing the patient's name, the type of examination, the date the examination was performed, and equipment operator;

(9) Except for patients who cannot be moved out of the room, only the staff, ancillary personnel or other persons required for the medical procedure shall be in the room during the radiographic exposure;

(10) Each licensee of the radiation source must supply the following personnel with appropriate individual monitoring devices and require the personnel to wear the monitoring devices:

(a) Adults likely to receive in one year, a dose in excess of ten percent of the limits in subsection (13) of this section;

(b) Declared pregnant women likely to receive, during the entire pregnancy, a dose in excess of 0.1 rem (one mSv);

(c) Each individual who enters a high radiation area or very high radiation area; and

(d) Minors likely to receive in one year a dose in excess of 0.1 rem (one mSv);

(11) Each individual monitoring device must be assigned to and worn by only one individual;

(12) Each licensee of the radiation source must ensure that individuals who are required to be monitored for occupational doses according to this part wear individual monitoring devices as follows:

(a) An individual monitoring device used for monitoring the dose to the whole body must be worn on the trunk of the body or at the unshielded location of the whole body likely to receive the highest exposure;

(b) When a protective apron is worn, the individual monitoring device must be worn at the collar outside of the protective apron;

(c) When more than one individual monitoring device is used, the record must identify the location of the monitor on the body and must state whether it was worn outside or under the protective clothing. The effective dose equivalent must be recorded in the reports required by this part; and

(d) When a woman declares her pregnancy, a dosimeter must be worn at the level of the abdomen and under any lead shielding;

(13) The licensee of the radiation source must obtain a control device that accompanies individual personal monitoring devices during shipment. The control device must be kept in an area of natural background radiation at the facility between shipments;

(14) The licensee of the radiation source must maintain clear and legible records showing the radiation doses of all individuals for whom individual monitoring is required according to this part;

(15) The licensee of the radiation source must control the occupational dose to individual adults, except for planned special exposures, to the following annual dose limit, which is the more limiting of:

(a) The total effective dose equivalent being equal to five rem (0.05 Sv); or

(b) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to fifty rem (0.5 Sv); and

(c) The annual limits to the lens of the eye, to the skin, and to the extremities, which are:

(i) A lens dose equivalent of fifteen rem (0.15 Sv); and

(ii) A shallow dose equivalent of fifty rem (0.5 Sv) to the skin or to any extremity;

(16) When a woman declares her pregnancy in writing, the licensee of the radiation source must ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (five mSv);

(17) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, must be subtracted from the limits for planned special exposures that the individual may receive during the current year;

(18) To determine dose equivalent:

(a) The assigned deep dose equivalent and shallow dose equivalent must be for the portion of the body receiving the highest exposure;

(b) The deep dose equivalent, lens dose equivalent, and shallow dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits if the individual monitoring device was not in the region of highest potential exposure or the results of individual monitoring are unavailable;

(c) When a protective apron is worn while working with fluoroscopic equipment and monitoring is conducted as specified in subdivision (10) of this section, the effective dose equivalent for external radiation must be determined as follows:

(i) When only one individual monitoring device is used and it is located at the neck (collar) outside the protective apron, the reported deep dose equivalent must be the effective dose equivalent for external radiation; or

(ii) When only one individual monitoring device is used and it is located at the neck (collar) outside the protective apron, the reported deep dose equivalent value multiplied by 0.3 must be the effective dose equivalent for external radiation; or

(iii) When individual monitoring devices are worn, both under the protective apron at the waist and outside the protective apron at the neck, the effective dose equivalent for external radiation must be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04;

(d) Any alternative method of determining dose must be approved by the department; and

(19) Radiation sources shall be labeled and caution signs posted to provide a warning to all persons within the exposure area.

S.D. Admin. R. 44:03:01:10

SL 1975, ch 16; 50 SDR 041, effective 10/11/2023

General Authority: SDCL 34-21-4.1, 34-21-15.

Law Implemented: SDCL 34-21-4.1, 34-21-25, 34-21-26.