Nebraska Administrative Code
Topic - HEALTH AND HUMAN SERVICES SYSTEM
Title 180 - CONTROL OF RADIATION
Chapter 7 - MEDICAL USE OF RADIOACTIVE MATERIAL
Section 180-7-115 - REPORT AND NOTIFICATION OF MISADMINISTRATION

Universal Citation: 180 NE Admin Rules and Regs ch 7 ยง 115

Current through September 17, 2024

115.01 MISADMINISTRATION REPORTING. A licensee must report any event as a misadministration, other than events that result from patient intervention, where:

(A) The administration of radioactive material or radiation from radioactive material, except permanent implant brachytherapy, results in:
(i) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 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; and either
(1) The total dose delivered differs from the prescribed dose by twenty percent or more;

(2)The total dosage delivered differs from the prescribed dosage by twenty 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 fifty percent or more;

(ii) 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 containing radioactive material 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; or

(iii) 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 according to the written directive prepared or revised before administration; and

(2) Fifty percent or more the expected dose to that site from the procedure if the administration had been given according to the written directive prepared or revised before administration.

(B) 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, which results in:
(i) The total source strength administered differing by twenty percent or more from the total source strength documented in the post-implantation portion of the written directive;

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

(iii) An administration that includes any of the following:
(1) The wrong radionuclide;

(2) The wrong individual or human research subject;

(3) Sealed source or sources 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.

115.02 REPORTING. A licensee must report 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.

115.03 DEPARTMENT NOTIFICATION. The licensee must notify the Department by telephone, no later than the next business day after the discovery of a misadministration.

115.04 REPORT REQUIREMENTS. The licensee must submit a written report to the Department within 15 days after discovery of the misadministration.

(A) The written report must include:
(i) The licensee's name;

(ii) The name of the prescribing physician;

(iii) A brief description of the event;

(iv) Why the event occurred;

(v) The effect, if any, on the individual or individuals who received the administration;

(vi) What actions, if any, have been taken or are planned to prevent recurrence; and

(vii) Certification that the licensee notified the individual, or the individual's responsible relative or guardian, and if not, why not; and

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

115.05 REFERRING PHYSICIAN NOTIFICATION. The licensee must 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 either that they will inform the individual or that, based on medical judgment, telling the individual would be harmful. The licensee 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 must make the appropriate notifications as soon as possible thereafter. The licensee 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 180 NAC 7-115.05, 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 must 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 must provide such a written description if requested.

115.06 RIGHTS AND DUTIES. Aside from the notification requirement, nothing in 180 NAC 7-115 affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the misadministration, or to that individual's responsible relatives or guardians.

115.07 RECORDS. A licensee must retain a record of a misadministration according to 180 NAC 7-089. A copy of the record required under 180 NAC 7-089 must be provided to the referring physician if other than the licensee, within 15 days after discovery of the misadministration.

Disclaimer: These regulations may not be the most recent version. Nebraska may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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