Current through Register Vol. 54, No. 44, November 2, 2024
(a) For a
medical reportable event for radiation-producing machine therapy, the licensee
or registrant shall do the following:
(1)
Notify the Department by telephone within 24 hours after discovery of the
event.
(2) Submit a written report
to the Department within 15 days after discovery of the event. The written
report shall include the licensee's or registrant'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 or registrant
notified the patient, or the patient's responsible relative or guardian (for
notification purposes under this section, this person will be included in
subsequent references to "the patient"), and if not, why not; and if the
patient was notified, what information was provided to the patient. The report
may not include the patient's name or other information that could lead to
identification of the patient.
(3)
Notify the referring physician and also notify the patient of the event within
24 hours after its discovery, unless the referring physician personally informs
the licensee either that he will inform the patient or that, based on medical
judgment, telling the patient would be harmful. The licensee or registrant is
not required to notify the patient without first consulting the referring
physician. If the referring physician or patient cannot be reached within 24
hours, the licensee or registrant shall notify the patient as soon as possible
thereafter. The licensee or registrant may not delay appropriate medical care
for the patient, including necessary remedial care, because of delay in
notification.
(4) If the patient
was notified, the licensee or registrant shall also furnish, within 15 days
after discovery of the event, a written report to the patient by sending one of
the following:
(i) A copy of the report that
was submitted to the Department.
(ii) A brief description of both the event
and the consequences, as they may affect the patient, if a statement is
included that the report submitted to the Department can be obtained from the
licensee or registrant.
(b) The licensee or registrant shall retain a
record of each medical reportable event for radiation-producing machine therapy
for 5 years. The record shall contain the names of the 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
event, why it occurred, the effect on the patient, what improvements are needed
to prevent recurrence and the actions taken to prevent recurrence.
(c) Aside from the notification requirement,
this section does not affect rights or duties of licensees or registrants and
physicians in relation to each other, patients or the patient's responsible
relatives or guardians.
This section cited in 25 Pa. Code §
219.229 (relating to diagnostic or
interventional procedure medical reports); and 25 Pa. Code §
228.35 (relating to operating
procedures).
