La. Admin. Code tit. 33 § XV-613

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

Section XV-613 - Notifications, Reports, and Records of Medical Events

A. A registrant shall report any medical event, except for an event that results from patient intervention, in which the administration of radiation involves the wrong patient, a procedure different than that which was authorized by the licensed practitioner of the healing arts, or a body site different from that which was authorized and intended to be exposed by the authorized X-ray procedure that results in:

1. unintended skin dose to the same area in a single procedure greater than two Gy (200 rad);

2. unintended dose other than skin dose in a single procedure greater than:

a. five times the facilitys established protocol, and >0.5 Gy (50 rad) to any organ, or

b. five times the facilitys established protocol, and >0.02 Sv (2 rem) effective dose;

3. exposure to the wrong patient or wrong site for the entire procedure when the resultant dose is:

a. greater than 0.5 Gy (50 rad) to any organ; or

b. an effective dose greater than 0.02 Sv (2 rem); or

4. a total effective dose that exceeds 0.02 Gy (2 rads) that involves any equipment failure, personnel error, accident, abnormal or other unusual occurrence with the administration of ionizing radiation.

B. Any administration of radiation involving a wrong patient, a procedure different than that which was authorized by a licensed practitioner, or a wrong body site imaged, including those reported in Subsection A of this Section, shall be internally reported, investigated, documented, and addressed within the facility. Each registrant shall retain a record of these occurrences for five years.

C. A registrant shall report any event resulting from intervention of a patient or human research subject in which the administration of radiation results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

D. All reports, notifications, and records shall be in accordance with LAC 33:XV.712.D, E, and G.

E. Aside from the notification requirement, nothing in this Section affects any rights or duties of registrants and physicians in relation to each other, the individual, or the individual's responsible relatives or guardians.

La. Admin. Code tit. 33, § XV-613

Promulgated by the Department of Environmental Quality, Office of Environmental Assessment, LR 31:1064 (May 2005), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 45751 (6/1/2019), Amended LR 451758 (12/1/2019), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 471854 (12/1/2021).

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