Section 3410. Quality management program

Each registrant or applicant subject to 12VAC5-481-3420 and 12VAC5-481-3430 shall develop, implement, and maintain a quality management program to provide high confidence that radiation will be administered as directed by the authorized user.

A. Scope and applicability. The quality management program shall address, at a minimum, the following specific objectives:

1. Written directives.

a. A written directive shall be dated and signed by an authorized user prior to the administration of radiation. If because of the patient's condition a delay caused by providing 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 an authorized user within 48 hours of the oral revision.

b. The written directive shall contain the patient's or human research subject's name, type and energy of the beam, total dose, dose per fraction, treatment site, and number of fractions.

c. A written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized user prior to the administration of the therapeutic radiation machine dose or the next fractional dose.

d. The registrant shall retain a copy of the written directive for three years.

2. Procedures for administrations. The registrant shall develop, implement, and maintain written procedures to provide high confidence that:

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

b. Each administration is in accordance with the written directive;

c. Therapeutic radiation machine final plans of treatment and related calculations are in accordance with the respective written directives by:

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

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

d. Any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken; and

e. The registrant retains a copy of the procedures for administrations for the duration of the registration.

B. Reports and notifications of misadministrations.

1. A registrant shall report any event resulting from the treatment 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.

2. Other than events that result from the treatment of a patient or human research subject, a registrant shall report any event in which the administration of a therapeutic radiation machine therapy dose:

a. Involves the wrong patient, wrong treatment modality, or wrong treatment site;

b. The calculated weekly administered dose differs from the weekly prescribed dose by more than 30%; or

c. The calculated total administered dose differs from the total prescribed dose by more than 20% of the total prescribed dose.

3. The registrant shall notify the agency by telephone no later than the next calendar day after the discovery of a misadministration.

4. The registrant shall submit a written report to the agency within 15 days after the discovery of a misadministration. The written report shall include:

a. The registrant's name;

b. The name of the prescribing physician;

c. A brief description of the event;

d. Why the event occurred;

e. The effect, if any, on the individual who received the misadministration;

f. Actions, if any, that have been taken or are planned to prevent recurrence; and

g. Certification that the registrant notified the individual, or the individual's responsible relative or guardian, and if not, why not.

5. The report shall not contain the individual's name or any other information that could lead to the identification of the individual.

6. The registrant shall 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 either that he will inform the individual or that, based on 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 shall notify the individual as soon as possible thereafter. The 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 subdivision, 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 registrant shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the registrant upon request. The registrant shall provide such a written description if requested.

7. Aside from the notification requirement, nothing in this section 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 relatives or guardians.

8. The registrant shall retain a record of a misadministration in accordance with subsection C of this section. A copy of the required record shall be provided to the referring physician if other than the registrant within 15 days after discovery of the misadministration.

C. Records of misadministrations. A registrant shall retain a record of misadministrations reported in accordance with subsection B of this section for three years. The record shall contain the following:

1. The registrant's name and the names of the individuals involved;

2. The social security number or other identification number, if one has been assigned, of the individual who is the subject of the misadministration;

3. A brief description of the event; why it occurred; and the effect, if any, on the individual;

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

5. Whether the 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.

Historical Notes

Derived from Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 32, Issue 17, eff. June 5, 2016.

Statutory Authority

§§ 32.1-12 and 32.1-229 of the Code of Virginia.