64E-5.345. Reports of Exposures, Radiation Levels, Concentrations of Radioactive Material Exceeding the Constraints or Limits, Medical Events and Dose to an Embryo/Fetus or a Nursing Child

(1) Reportable Events. In addition to the notification required by Rule 64E-5.344, F.A.C., each licensee or registrant shall submit a written report within 30 days after learning of any of the following occurrences:

(a) Incidents for which notification is required by Rule 64E-5.344, F.A.C.; or

(b) Doses in excess of any of the following:

1. The occupational dose limits for adults in Rule 64E-5.304, F.A.C.;

2. The occupational dose limits for a minor in Rule 64E-5.310, F.A.C.;

3. The limits for an embryo or fetus of a declared pregnant woman in Rule 64E-5.311, F.A.C.;

4. The limits for an individual member of the public in Rule 64E-5.312, F.A.C.;

5. Any applicable limit in the license or registration;

6. The ALARA constraints for air emissions specified in subsection 64E-5.303(5), F.A.C.; or

(c) Levels of radiation or concentrations of radioactive material in:

1. A restricted area in excess of applicable limits in the license or registration; or

2. An unrestricted area in excess of 10 times the applicable limit set forth in this part or in the license or registration, whether or not involving exposure of any individual in excess of the limits in Rule 64E-5.312, F.A.C.; or

(d) For licensees subject to the provisions of U.S. Environmental Protection Agency’s generally applicable environmental radiation standards in 40 CFR 190, levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those standards.

(2) Contents of Reports.

(a) Each report required by subsection 64E-5.345(1), F.A.C., shall describe the extent of exposure of individuals to radiation and radioactive material, including as appropriate:

1. Estimates of each individual’s dose;

2. The levels of radiation and concentrations of radioactive material involved;

3. The cause of the elevated exposures, dose rates, or concentrations; and

4. Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license or registration conditions.

(b) Each report filed as specified in subsection 64E-5.345(1), F.A.C., shall include for each occupationally overexposed individual: the name, social security account number, and date of birth. With respect to the limit for the embryo or fetus in Rule 64E-5.311, F.A.C., the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable portion of the report.

(3) All licensees or registrants who make reports as specified in subsection 64E-5.345(1), F.A.C., shall submit the report in writing to the department.

(4) Reports of Medical Events.

(a) The licensee or registrant shall notify the department by telephone no later than the next calendar day after the discovery of the medical event. The licensee or registrant shall also notify the referring physician of the affected individual and the individual or a responsible relative or guardian, unless the referring physician personally informs the licensee either that he will inform the individual or believes, based on medical judgment, that telling the individual or the individual’s responsible relative or guardian would be harmful to either. These notifications shall be made within 24 hours after the licensee or registrant discovers the medical event. If the referring physician, individual or the individual’s responsible relative or guardian cannot be reached within 24 hours, the licensee or registrant shall notify them as soon as practicable. The licensee is not required to notify the individual or the individual’s responsible relative or guardian without first consulting the referring physician; however, the licensee or registrant shall not delay medical care for the individual because of this. If a verbal notification is made, the licensee shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.

(b) Written Report. Within 15 days after the medical event report to the department, the licensee or registrant shall report in writing to the department and to the referring physician and furnish a copy of the report to the individual or the individual’s responsible relative or guardian if either was previously notified by the licensee or registrant as specified in (4)(a), above, or a brief description of both event and consequences as they affect the individual or the individual’s responsible relative or guardian if a statement is included that the report submitted to the department can be obtained from the licensee or registrant. The written report shall include the licensee’s or registrant’s name; the prescribing physician’s name; the referring physician’s name; a brief description of the event; why the event occurred; the effect on the individual; the action taken to prevent recurrence; whether the licensee or registrant informed the individual or the individual’s responsible relative or guardian and what information was provided to the individual or individual’s responsible relative or guardian, and if not, a written medical justification. The report shall not include the individual’s name or other information that could lead to identification of the individual.

(5) Records of medical event. Each licensee or registrant shall retain a record of each medical event for 20 years. The record shall contain the names of all individuals involved in the event, including the prescribing physician, the allied health personnel, the individual, and the individual’s referring physician, the individual’s identification number if one has been assigned, a brief description of the event, why it occurred, the effect on the individual, what improvements are needed to prevent recurrence, and the actions taken, if any, to prevent recurrence.

(6) Rights and Duties of Licensees or Registrants. Aside from the notification requirement, nothing in this section shall affect any rights or duties of licensees, registrants or physicians in relation to each other, the individual, or responsible relatives or guardians.

(7) Reports of a dose to an embryo/fetus or a nursing child.

(a) The licensee shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours after discovery of an event that would require reporting under paragraph 64E-5.344(7)(e) or (f), F.A.C., unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. The licensee is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, the licensee shall make the appropriate notifications as soon as possible thereafter. The licensee may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this subsection, the notification may be made to the mother or child's responsible relative or guardian instead of the mother. If a verbal notification is made, the licensee shall inform the mother, or the mother or child’s responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.

(b) Written Report. 

1. Within 15 days after the discovery of an event that would require reporting under paragraph 64E-5.344(7)(e) or (f), F.A.C., the licensee or registrant shall report in writing as described below, to the department and to the referring physician.

2. Within 15 days after the discovery of an event that would require reporting under paragraph 64E-5.344(7)(e) or (f), F.A.C., the licensee or registrant shall also furnish a copy of the report or a brief description of both the event and the consequences of the event as they affect the embryo/fetus or nursing child, to the mother, or the mother or child’s responsible relative or guardian if either was previously notified by the licensee or registrant as specified in paragraph (7)(a), above. If a brief description of both the event and consequences of the event is provided in lieu of the report, such description shall include a statement that the report submitted to the department can be obtained from the licensee or registrant. 

3. The written report shall include the licensee's or registrant's name, the prescribing physician’s name, the referring physician's name, a brief description of the event, why the event occurred, the effect on the embryo/fetus or nursing child, the action taken to prevent recurrence, whether the licensee or registrant informed the pregnant individual or mother or the mother’s or child’s responsible relative or guardian and what information was provided to the individual or individual’s responsible relative or guardian, and if not, a written medical justification. The report shall not include the individual’s or child’s name or other information that could lead to identification of the individual or child.

(8) Records of reports of dose to an embryo/fetus or a nursing child. Each licensee or registrant shall retain a record of each report of dose to an embryo/fetus or a nursing child for 20 years. The record shall contain the names of all individuals involved in the event, including the prescribing physician, the allied health personnel, mother or the nursing child’s name, and the mother or nursing child’s referring physician, the social security number of the mother, the nursing child’s social security number or identification number if either has been assigned, a brief description of the event, why it occurred, the effect on the individual, what improvements are needed to prevent recurrence, and the actions taken, if any, to prevent recurrence.

Rulemaking Authority 404.051, 404.081 FS. Law Implemented 404.022, 404.051(1), (4), 404.081 FS. History–New 1-1-94, Formerly 10D-91.482, Amended 10-8-00, 2-11-10.