25 Pa. Code § 219.229 - Diagnostic or interventional procedure medical reports

(a) Within 30 days of the determination by a physician of either actual or suspected acute or long-term functional damage to an organ or a physiological system of a patient exposed to radiation from a diagnostic or interventional procedure from a radiation-producing machine, the registrant or licensee shall document the finding and provide a report to the Department and provide a clinical summary to the prescribing physician and the patient. The report shall be retained for at least 5 years. Exempt from this reporting requirement are any events already reported under § 219.228 (relating to reports of medical reportable events for radiation-producing machine therapy) and any functional damage to a patient organ or a physiological system that was an expected outcome when the causative procedures were prescribed.

(b) Upon discovery of a medical reportable event, the registrant or licensee shall:

(1) Notify the Department regarding the medical reportable event within 1 business day.

(2) Provide a written report, including the analysis of the medical reportable event, by the qualified medical physicist, as defined in § 221.2 (relating to definitions), to the Department within 15 business days.

(3) Provide a clinical summary to the prescribing physician and patient within 15 business days.

(4) Maintain a record of the medical reportable event as part of the patient's permanent medical record.

Notes

25 Pa. Code § 219.229

The provisions of this § 219.229 adopted September 14, 2001, effective 9/15/2001, 31 Pa.B. 5239; amended July 16, 2004, effective 7/17/2004, 34 Pa.B. 3283; amended October 26, 2018, effective 1/24/2019, 48 Pa.B. 6791.

This section cited in 25 Pa. Code § 221.11 (relating to registrant responsibilities).