Section 219.228. Reports of medical reportable events for radiation-producing machine therapy

(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.

The provisions of this § 219.228 amended September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3283. Immediately preceding text appears at serial pages (282380) to (282381).

Notation

Cross References

This section cited in 25 Pa. Code § 219.229 (relating to other medical reports); and 25 Pa. Code § 228.35 (relating to operating procedures).