180 Neb. Admin. Code, ch. 20, § 005

Current through September 17, 2024

Section 180-20-005 - QUALITY MANAGEMENT PROGRAM

Each registrant or applicant subject to 180 NAC 20-006 or 20-007 must develop, implement, and maintain a quality management program to ensure that radiation will be administered as directed by the user.

005.01SCOPE AND APPLICABILITY. The quality management program must address, as a minimum, the following specific objectives.

005.01(A)WRITTEN DIRECTIVES. A written directive must:

(i) Be dated and signed by a user prior to the administration of radiation. If, because of the patient's condition, a delay in the order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented as soon as possible in writing in the patient's record and a revised written directive is signed by a user within 48 hours of the oral revision;

(ii) Contain the patient or human research subject's name, the type and energy of the beam, the total dose, dose per fraction, treatment site, and the number of fractions;

(iii) Be dated and signed by a user prior to the administration of the external beam dose or the next fractional dose for a written revision to an existing written directive; and

(iv) Be retained by the registrant for three years.

005.01(B)PROCEDURES FOR ADMINISTRATION. The registrant must develop, implement, and maintain written procedures to ensure that:

(i) Prior to the administration of each course of radiation treatments, the patient's or human research subject's identity is verified, by more than one method, as the individual named in the written directive;

(ii) Each administration is in according to the written directive;

(iii) Therapeutic radiation machine final plans of treatment and related calculations are in according to the respective written directives by:

(1) Checking both manual and computer generated dose calculations to verify they are correct and in according to the written directive; and

(2) Verifying that any computer-generated calculations are correctly transferred into the consoles of authorized therapeutic medical units;

(iv) Any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken; and

(v) The registrant retains a copy of the procedures for administration for the duration of the registration.

005.02REPORTS AND NOTIFICATIONS OF MISADMINISTRATIONS. The requirements for reports and notifications of misadministrations are as follows.

005.02(A)EVENTS RESULTING FROM PATIENT OR HUMAN RESEARCH SUBJECT INTERVENTION. A registrant must report any event resulting from intervention of a patient or human research subject in which the administration of therapeutic radiation machine radiation results, or will result in, unintended permanent functional damage to an organ or a physiological system as determined by a physician.

005.02(B)OTHER EVENTS. Other than events that result from intervention by a patient or human research subject, a registrant must report any event in which the administration of an external beam radiation dose:

(i) Involves the wrong patient, wrong treatment modality, or wrong treatment site;

(ii) Causes the calculated weekly administered dose to differ from the weekly prescribed dose by more than 30 percent; or

(iii) Causes the calculated total administered dose to differ from the total prescribed dose by more than 20 percent.

005.02(C)TELEPHONE NOTIFICATION. The registrant must notify the Department by telephone no later than the next business day after the discovery of a misadministration.

005.02(D)WRITTEN REPORT. The registrant must submit a written report to the Department within 30 days after the discovery of a misadministration. The written report must include:

(i) The registrant'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) Actions, if any, that have been taken, or are planned to prevent recurrence; and

(vii) Certification that the registrant notified the individual, or the individual's responsible relative or guardian, and if not, why notification was not made.

005.02(E)IDENTIFICATION OF THE INDIVIDUAL PROHIBITED IN REPORT. The report must not contain the individual's name or any other information that could lead to the identification of the individual.

005.02(F)NOTIFICATION TO THE REFERRING PHYSICIAN AND INDIVIDUAL. The registrant must provide notification of the event 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 registrant that they will inform the individual or, based on their medical judgment, telling the individual would be harmful. The 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 registrant must make the appropriate notifications as soon as possible after that. The registrant must 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 20-005.02(E), the notification of the individual who is the subject of the misadministration may be made to that individual's responsible relative or guardian. If a verbal notification is made, the registrant must inform the individual, or responsible relative or guardian that a written description of the event can be obtained from the registrant upon request. The registrant must provide such a written description if requested.

005.02(G)RIGHTS AND DUTIES. Aside from the notification requirement, nothing in this subsection affects any rights or duties of registrants and physicians in relation to each other, to individuals affected by the misadministration, or to that individual's responsible relative or guardians.

005.02(H)COPY OF RECORD TO REFERRING PHYSICIAN. The registrant must retain a record of misadministration according to 180 NAC 20-005.03. A copy of the required record must be provided to the referring physician, if other than the registrant, within 15 days after discovery of the misadministration.

005.03RECORDS OF MISADMINISTRATIONS. A registrant must retain a record of misadministration reported according to 180 NAC 20-005.02 for three years.

180 Neb. Admin. Code, ch. 20, § 005

Amended effective 11/21/2020