IC 25-22.5-12.5-6: Reporting of serious adverse events

Sec. 6. (a) As used in this section, "serious adverse event" means any negative medical occurrence associated with the use of a prescription medication or treatment provided that results in, based on a reasonable medical judgment, jeopardy to an individual's health resulting in medical or surgical intervention or any of the following outcomes:

(1) Death.

(2) A life threatening medical occurrence.

(3) Inpatient hospitalization or prolonging of an existing hospitalization.

(b) A medical spa shall notify the board in the manner prescribed by the board not later than fifteen (15) days after the occurrence of a patient's serious adverse event. The notice must include, to the extent that the information may be obtained or reasonably available from the source, the following:

(1) The name of the patient, the prescription medication treatment involved, and the date of the serious adverse event.

(2) The nature and location of the serious adverse event.

(3) The medical records for the patient concerning the serious adverse event.