La. Admin. Code tit. 33 § XV-603

Current through Register Vol. 50, No. 11, November 20, 2024

Section XV-603 - General and Administrative Requirements

A. Radiation Safety Requirements. The registrant shall be responsible for directing the operation of the X-ray system(s) under his or her administrative control. The registrant or his or her agent shall assure that the requirements of LAC 33:XV are met in the operation of the X-ray system(s).

1. An X-ray system that does not meet the provisions of LAC 33:XV shall not be operated for diagnostic or therapeutic purposes unless approved by the department.

2. Individuals who will be operating the X-ray systems shall be adequately instructed in the safe operating procedures and be competent in the safe use of the equipment.

3. The qualified expert, if required in this Section, shall complete initial and routine compliance evaluations following nationally recognized procedures. These evaluations shall include a review of the required quality control tests.

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

5. 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:

a. patient's (adult and pediatric, if appropriate) body part and anatomical size;

b. technique factors;

c. type of image receptor used;

d. source to image receptor distance used (except for dental intraoral radiography); and

e. type of grid, if any.

6. At the request of the department, the registrant shall create and make available written safety procedures to each individual operating X-ray equipment, including 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.

7. Except for human patients who cannot be moved out of the room, only the staff and ancillary personnel, including parents or guardians, required for the medical procedure or training shall be in the room during the radiographic exposure. The following conditions shall be met for those 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 millimeter lead equivalent;

b. the X-ray operator, other professional staff, and ancillary personnel shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 millimeter lead equivalent material; 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 millimeter lead equivalent material or shall be so positioned that the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the image receptor.

8. 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. Any diagnostic information obtained from each exposure shall be reviewed 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 without prior written approval of the department.

9. 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:

a. written safety procedures, as required by LAC 33:XV.603.A.19, shall indicate the requirements for selecting a holder and the procedure the holder shall follow;

b. the human holder shall be instructed in personal radiation safety and protected as required by LAC 33:XV.603.A.6;

c. no individual shall be used routinely to hold the image receptor or patients;

d. 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;

e. when an animal must be held by an individual during an exposure, that individual shall be protected with appropriate shielding devices, such as lead equivalent aprons and gloves, and shall be positioned such that no part of his or her body shall be struck by the useful beam.

10. Each facility shall have lead equivalent aprons and gloves available in sufficient numbers to provide protection to all personnel who are involved in X-ray operations and who are otherwise not shielded.

11. All protective apparel and auxiliary shields shall be evaluated at intervals of no less than 12 months, and no more than 14 months, for integrity and clearly labeled with their lead equivalence.

12. Each 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.

13. Nationally recognized diagnostic reference levels (DRLs) shall be utilized when applicable.

14. The registrant shall use auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information.

15. 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.

16. Neither the X-ray tube housing nor the collimating device shall be held during an exposure. Exceptions are allowed for department approved devices specifically designed to be hand-held.

17. The useful X-ray beam shall be limited to the area of clinical interest.

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

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

20. Each registrant, except for veterinarians, covered under this Chapter shall establish written standards for the proper performance of each diagnostic X-ray imaging system under the control of the registrant, and shall document by routine test record that the system is performing in accordance with these standards (quality control). Copies of this documentation shall be retained for at least six months and be available for inspection by the department. If a test interval is greater than six months, then a copy of the most recent test record shall be retained.

21. All individuals who are associated with the operation of an X-ray system are subject to the requirements of LAC 33:XV.410 and 411. In addition, when protective clothing or devices are worn on portions of the body and a personnel monitoring device or devices are required in accordance with LAC 33:XV.431, monitoring devices shall be used as follows:

a. when a protective apron is worn, at least one such monitoring device shall be worn at the collar outside of the protective apron;

b. the dose to the whole body based on the maximum dose attributed to the most critical organ shall be recorded in the reports required by LAC 33:XV.476. If more than one 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; and

c. deliberate exposure to an individual's personnel monitoring device is prohibited.

22. 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 LAC 33:XV.699. Appendix C to the Office of Environmental Compliance. If any information submitted to the department becomes invalid or outdated, the Office of Environmental Compliance shall be immediately notified. See the definition of healing arts screening in LAC 33:XV.602.

23. Any person proposing to conduct a diagnostic or screening mammography program shall not initiate such a program without having a complete mammography facility survey performed by a mammography physicist initially and at intervals of no less than 12 months, and no more than 14 months thereafter.

B. X-Ray Film Processing Facilities and Practices. See Appendix D.

C. 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. Facilities shall establish and follow an image quality control program in accordance with the recommendations of a qualified expert, the system manufacturer, or a nationally recognized organization.

D. Exemptions

1. Dental Facilities. Dental facilities performing only intraoral, panoramic, or cephalometric imaging are exempt from following the provisions of LAC 33:XV.603.A.12.

2. Podiatry Facilities. Podiatry facilities are exempt from following the provisions of LAC 33:XV.603.A.12.

3. Veterinary Facilities. Veterinary facilities are exempt from following the provisions of LAC 33:XV.603.A.12-14, LAC 33:XV.603.A.19-20, and LAC 33:XV.603.A.22.

E. Plans Review

1. Except for dedicated mammography radiographic systems, podiatric radiographic systems, panoramic dental radiographic systems, intraoral dental radiographic systems, and bone density radiographic systems prior to construction, the floor plans and equipment arrangement of all new installations, or modifications of existing installations, utilizing X-rays for diagnostic or therapeutic purposes shall be submitted to the Office of Environmental Compliance for review and approval. The required information is specified in LAC 33:XV.699. Appendices A and B.

2. The floor plans and equipment arrangement for all new, or modifications of existing, installations for veterinary and dental CBCT X-ray systems shall be reviewed for adequacy by the department on a case-by-case basis.

3. The department may require the applicant to utilize the services of a qualified expert to determine the shielding requirements prior to the plans review and approval.

4. The approval of such plans shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in LAC 33:XV.410, 416, and 421.

F. Quality Assurance

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:

a. maintain documentation of minimum qualifications for practitioners, medical physicists, and X-ray equipment operators;

b. designate an individual to manage the QA program;

c. establish and maintain written QA and quality control (QC) procedures, including evaluation frequencies and tolerances;

d. complete preventative maintenance on the X-ray systems in accordance with manufacturer specifications. In lieu of manufacturer's specifications, maintenance shall be completed at intervals of no less than 12 months, and no more than 14 months;

e. complete and document an annual review of the QA program; and

f. retain QA/QC records of evaluations and reviews for three years.

La. Admin. Code tit. 33, § XV-603

Promulgated by the Department of Environmental Quality, Nuclear Energy Division, LR 13:569 (October 1987), amended by the Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 19:1421 (November 1993), LR 22:976 (October 1996), LR 23:1139 (September 1997), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 26:2585 (November 2000), amended by the Office of the Secretary, Legal Affairs Division, LR 31:2532 (October 2005), LR 33:2184 (October 2007), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 482933 (12/1/2022).

AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq. and 2104.B.