§19–304.

(a) A hospital or related institution shall:

(1) Report an unexpected occurrence related to an individual’s medical treatment that results in death or serious disability that is not related to the natural course of the individual’s illness or underlying disease condition; and

(2) Submit the report to the Department within 5 days of the hospital’s or related institution’s knowledge of the occurrence.

(b) A hospital or related institution may report to the Department an unexpected occurrence or other incident related to an individual’s medical treatment that does not result in death or serious disability.

(c) A hospital or related institution shall:

(1) Conduct a root cause analysis of an occurrence required to be reported under subsection (a) of this section; and

(2) Unless the Department approves a longer time period, submit the root cause analysis to the Department within 60 days of the hospital’s or related institution’s knowledge of the occurrence.

(d) If a hospital or related institution fails to comply with subsection (a) or (c) of this section, the Secretary may impose a fine of $500 per day for each day the violation continues.

(e) The Secretary shall adopt regulations to implement this section.