(a) The following actions shall be taken for
a misadministration by the licensee:
(1) The
licensee shall notify the department by telephone no later than twenty-four
hours after discovery of the misadministration.
(2) The licensee shall submit a written
report to the department within fifteen days after discovery of the
misadministration. The written report shall include the licensee's name; the
prescribing physician's name; a brief description of the event; why the event
occurred; the effect on the patient; what improvements are needed to prevent
recurrence; actions taken to prevent recurrence; whether the licensee notified
the patient; or the patient's responsible relative or guardian, and if not, why
not, and if the patient was notified, what information was provided to the
patient. The report shall not include the patient's name or other information
that could lead to identification of the patient.
(3) The licensee shall notify the referring
physician and also notify the patient of the misadministration not later than
twenty-four hours after its discovery, unless the referring physician
personally informs the licensee either that he or she shall inform the patient
or that, based on medical judgment, telling the patient would be harmful. The
licensee is not required to notify the patient without first consulting the
referring physician. If the referring physician or patient cannot be reached
within twenty-four hours, the licensee shall notify the patient as soon as
possible thereafter. The licensee may not delay any appropriate medical care
for the patient, including any necessary remedial care as a result of the
misadministration, because of any delay in notification.
(4) If the patient was notified, the licensee
shall also furnish, within fifteen days after discovery of the
misadministration, a written report to the patient by sending either:
(A) A copy of the report that was submitted
to the department, or
(B) A brief
description of both the event and the consequences, as they may affect the
patient, provided a statement is included that the report submitted to the
department can be obtained from the licensee.
(b) Each licensee shall retain a record of
each misadministration. The record shall contain the names of all individuals
involved including the prescribing physician, allied health personnel, the
patient, and the patient's referring physician, the patient's social security
number or identification number if one has been assigned, a brief description
of the misadministration, why it occurred, the effect on the patient, what
improvements are needed to prevent recurrence, and the action taken to prevent
recurrence.
(c) Aside from the
notification requirement, nothing in subsections (a) and (b) shall affect any
rights or duties of licensees, and physicians in relation to each other,
patients, or patient's responsible relatives or guardians.