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

§ 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.

Source

   The provisions of this §  219.229 adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3283; amended October 26, 2018, effective January 24, 2019, 48 Pa.B. 6791. Immediately preceeding text appears at serial page (304470).

Cross References

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

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