La. Admin. Code tit. 33 § XV-712

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

Section XV-712 - Notifications, Reports, and Records of Medical Events

A. A licensee shall report any event as a medical event, except for an event that results from patient intervention, in which the administration of byproduct material or radiation from byproduct material, except permanent implant brachytherapy, results in:

1. a dose that differs from the prescribed dose, or the dose that would have resulted from the prescribed dosage, by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin, and:

a. the total dose delivered differs from the prescribed dose by 20 percent or more;

b. the total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or

c. the fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more;

2. a dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following:

a. an administration of a wrong radioactive drug containing byproduct material or the wrong radionuclide for a brachytherapy procedure;

b. an administration of a radioactive drug containing byproduct material by the wrong route of administration;

c. an administration of a dose or dosage to the wrong individual or human research subject;

d. an administration of a dose or dosage delivered by the wrong mode of treatment; or

e. a leaking sealed source; or

3. a dose to the skin or an organ or tissue other than the treatment site that exceeds by:

a. 0.5 Sv (50 rem) or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration; and

b. 50 percent or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration.

B. For permanent implant brachytherapy, the administration of byproduct material or radiation from byproduct material (excluding sources that were implanted in the correct site but migrated outside the treatment site) that results in:

1. the total source strength administered differing by 20 percent or more from the total source strength documented in the post-implantation portion of the written directive;

2. the total source strength administered outside of the treatment site exceeding 20 percent of the total source strength documented in the post-implantation portion of the written directive; or

3. an administration that includes any of the following:

a. the wrong radionuclide;

b. the wrong individual or human research subject;

c. sealed source(s) implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or

d. a leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.

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

D. The following notifications are required for a medical event.

1. The licensee shall notify the Office of Environmental Compliance by telephone at (225) 765-0160 in the manner provided in LAC 33:I.3923 no later than the next calendar day after discovery of the medical event.

2. The licensee shall submit a written report to the Office of Environmental Compliance using the procedures provided in LAC 33:I.3925.B and C within 15 days after discovery of the medical event.

a. The written report shall include:

i. the licensee's name;

ii. the name of the prescribing physician;

iii. a brief description of the event;

iv. why the event occurred;

v. the effect, if any, on the individual(s) who received the administration;

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

vii. certification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not.

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

3. The licensee shall notify the referring physician and also notify the individual who is the subject of the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he or she will inform the individual or that, based on medical judgement, telling the individual would be harmful. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this Paragraph, the notification to the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the licensee shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.

E. Each licensee shall retain a record of each medical event for five years. The record shall contain the names of all individuals involved (including the prescribing physician, allied health personnel, the individual affected by the medical event, and the individual's referring physician), the individual's driver's license or state identification number and the issuing state, a brief description of the medical event, why it occurred, the effect on the individual, what improvements are needed to prevent recurrence, and the actions taken to prevent recurrence.

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

G. A licensee shall:

1. annotate a copy of the report provided to the department with:

a. the name of the individual who is the subject of the event; and

b. the identification number or if no other identification number is available, the social security number of the 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 licensee, no later than 15 days after the discovery of the event.

La. Admin. Code tit. 33, § XV-712

Promulgated by the Department of Environmental Quality, Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 18:34 (January 1992), amended LR 24:2102 (November 1998), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 26:2588 (November 2000), LR 30:1174 (June 2004), LR 30:1679 (August 2004), amended by the Office of Environmental Assessment, LR 30:2804 (December 2004), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 471855 (12/1/2021).

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