Subchapter M. REPORTS

 In addition to incorporation by reference of the requirements in 10 CFR Part 20 (relating to standards for protection against radiation) covering the reporting requirements associated with reports of theft or loss of licensed material, the following reporting requirements apply to radiation-producing machines:

   (1)  Telephone reports. Each licensee or registrant shall report to the Department by telephone immediately, after its occurrence becomes known, a stolen, lost or missing radiation producing machine.

   (2)  Written reports. Each licensee or registrant required to make a report under paragraph (1) shall, within 30 days after making the telephone report, make a written report to the Department setting forth the following information:

     (i)   A description of the licensed or registered source of radiation involved, including, for radiation producing machines, the manufacturer, model and serial number, type and maximum energy of radiation emitted.

     (ii)   A description of the circumstances under which the loss or theft occurred.

     (iii)   A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved.

     (iv)   Exposures of individuals to radiation, circumstances under which the exposures occurred and the possible total effective dose equivalent to persons in unrestricted areas.

     (v)   Actions that have been taken, or will be taken, to recover the source of radiation.

     (vi)   Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.

   (3)  Additional information. Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within 30 days after the licensee or registrant learns of the information.

   (4)  Detachable reports. The licensee or registrant shall prepare a report filed with the Department under this section so that the names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

   The provisions of this §  219.221 amended September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (249266) to (249267) and (204077).

 In addition to incorporation by reference of the requirements in 10 CFR 20.2202 and 20.2203 (relating to notification of incidents; and reports of exposures, radiation levels and concentrations of radioactive material exceeding the constraints or limits), those notification requirements, as well as written 30-day reports under 10 CFR 20.2203(a), also apply to radiation-producing machines and NARM.

   The provisions of this 219.222 amended September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (204077) to (204078).

 If the test for leakage or contamination, required under §  219.61 (relating to testing for leakage or contamination of sealed sources), indicates a sealed source is leaking or contaminated, a report of the test shall be filed within 5 days with the Department describing the equipment involved, the test results and the corrective action taken.

 (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).

 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 therapeutic or diagnostic radiation 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.

   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. Immediately preceeding text appears at serial pages (282381) to (282382).