Tenn. Comp. R. & Regs. 0400-20-05-.145

Current through June 26, 2024

Section 0400-20-05-.145 - NOTIFICATIONS, RECORDS, AND REPORTS OF MISADMINISTRATION

(1) Other than events that result from intervention by a patient or human research subject, a licensee or registrant shall report to the Division any event in which the administration of radioactive material, radiation from radioactive material, except permanent implant brachytherapy, or radiation from a radiation producing machine results in:

(a) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sievert (5 rem) effective dose equivalent, 0.5 Sievert (50 rem) to an organ or tissue, or 0.5 Sievert (50 rem) shallow dose equivalent to the skin; and

1. The total dose delivered differs from the prescribed dose by 20 percent or more;

2. The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or

3. The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more.

(b) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following:

1. An administration of a wrong radioactive drug or the wrong radionuclide for a brachytherapy procedure;

2. An administration of a radioactive drug containing radioactive material by the wrong route of administration;

3. An administration of a dose or dosage to the wrong individual or human research subject;

4. An administration of a dose or dosage delivered by the wrong mode of treatment; or

5. A leaking sealed source.

(c) A dose to the skin or an organ or tissue other than the treatment site that exceeds by:

1. 0.5 Sv (50 rem) or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration; and

2. 50 percent or more the expected dose to that site from the procedure if the administration has been given in accordance with the written directive prepared or revised before administration.

(d) A therapeutic radiation machine dose:

1. Involving the wrong individual, wrong mode of treatment, or wrong treatment site;

2. When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than 10 percent of the total prescribed dose;

3. When the calculated weekly administered dose exceeds the weekly prescribed dose by 30 percent or more of the weekly prescribed dose; or

4. When the calculated total administered dose differs from the total prescribed dose by more than 20 percent of the total prescribed dose.

(2) For permanent implant brachytherapy, the administration of radioactive material or radiation from radioactive material (excluding sources that were implanted in the correct site but migrated outside the treatment site) that results in:

(a) The total source strength administered differing by 20 percent or more from the total source strength documented in the post-implantation portion of the written directive;

(b) The total source strength administered outside of the treatment site exceeding 20 percent of the total source strength documented in the post-implantation portion of the written directive; or

(c) An administration that includes any of the following:

1. The wrong radionuclide;

2. The wrong individual or human research subject;

3. Sealed source(s) implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or

4. A leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.

(3) A licensee or registrant shall report to the Division any event resulting from intervention of a patient or human research subject in which the administration of radioactive material or radiation from radioactive material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

(4) A licensee or registrant shall notify the Division at the number given in Rule 0400-20-04-.07 no later than the next calendar day after discovery of the misadministration.

(5) A licensee or registrant shall submit a written report to the Division at the address listed in Rule 0400-20-04-.07 within 15 days after discovery of the misadministration.

(a) The written report must include:

1. The licensee or registrant's name;

2. The name of the prescribing physician;

3. A brief description of the event;

4. Why the event occurred;

5. The effect, if any, on the individual(s) who received the administration;

6. What actions, if any, have been taken or are planned to prevent recurrence; and

7. Certification that the licensee or registrant notified the individual (or the individual's responsible relative or guardian), and if not, an explanation of why not.

(b) The report may not contain the individual's name or any other information that could lead to identification of the individual.

(6) A licensee or registrant shall provide notification of the misadministration to the referring physician and also notify the individual who is the subject of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the licensee or registrant either that they will inform the individual or that, based on medical judgment, telling the individual would be harmful. The licensee or registrant is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the licensee or registrant shall notify the individual as soon as possible thereafter. The licensee or registrant may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the misadministration, because of any delay in notification. To meet the requirements of this rule, the notification of the individual who is the subject of the misadministration may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the licensee or registrant 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 or registrant shall provide a written description if requested.

(7) Aside from the notification requirement, nothing in this rule affects any rights or duties of licensees, registrants, and physicians in relation to each other, to individuals affected by the misadministration, or to that individual's responsible relatives or guardians.

(8) A licensee or registrant shall:

(a) Retain a record of a misadministration in accordance with this rule for three years;

(b) Annotate a copy of the report of a misadministration provided to the Division with:

1. The licensee's or registrant's name;

2. The names of the individuals involved;

3. The identification number, or if no other identification number is available, the social security number of the individual who is the subject of the misadministration;

4. A brief description of the event and why it occurred;

5. The effect, if any, on the individual;

6. The actions, if any, taken, or planned, to prevent recurrence; and

7. Whether the licensee or registrant notified the individual (or the individual's responsible relative or guardian) and, if not, whether such failure to notify was based on guidance from the referring physician.

(c) Provide a copy of the annotated report to the referring physician if other than the licensee or registrant within 15 days after discovery of the misadministration.

Tenn. Comp. R. & Regs. 0400-20-05-.145

Original rule filed February 22, 2012; effective May 22, 2012. Amendments filed December 4, 2023; effective 3/3/2024.

Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.