C.M.R. 10, 144, ch. 220, pt. X, app 144-220-X-C
1. In addition to the definitions in X.2, the following definitions are applicable to a quality management program:
A. Medical event" means the administration of an external beam radiation therapy dose:
(1) Involving the wrong patient, wrong treatment modality, or wrong treatment site; or,
(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; or
(3) When the calculated weekly administered dose differs from the weekly prescribed dose by more than 30 percent; or
(4) When the calculated total administered dose differs from the total prescribed dose by more than 20 percent of the total prescribed dose;
B. Recordable event means the administration of an external beam radiation therapy dose when the calculated weekly administered dose differs by 15 percent or more from the weekly prescribed dose;
C. Written directive means an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of radiation, containing the following information: total dose, dose per fraction, treatment site and overall treatment period.
2. Each registrant shall establish and maintain a written program to provide assurance that radiation is administered to humans as directed by the authorized user. The program shall include the following elements:
A. Procedure for preparing written directives for the administration of radiation, however, a written directive is not required when an authorized user personally administers a dosage provided the pertinent facts are documented as otherwise required;
B. Procedure for verifying by more than one method the identity of the individual to be administered radiation;
C. Procedure for updating the therapy operating and emergency procedures manual;
D. Procedure for verifying that final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the respective written directives;
E. Procedures assuring that administration of radiation is carried out as specified in the written directive or the therapy operating and emergency procedures manual;
F. Procedures for identifying and evaluating unintended deviations from the written directive or the therapy operating and emergency procedures manual including taking appropriate action for recordable events and medical event;
3. Each registrant shall evaluate and respond to medical events as follows:
A. For a medical event:
(1) The licensee shall notify by telephone the Agency no later than the next calendar day after discovery of the medical event.
(2) The licensee shall submit a written report to the Agency within 15 days after discovery of the medical event. The written report must include the licensee's name; a brief description of the event; why the event occurred; the effect on the patient; what improvements are needed to prevent recurrence; whether the licensee notified the patient, or the patient's responsible relative or guardian (this person will be subsequently referred to as the patient in this section), and if not, why not, and if the patient was notified, what information was provided to the patient. The report must not include the patient's name or other information that could lead to identification of the patient.
(3) The licensee shall notify the referring physician and also notify the patient of the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he will inform the patient or that, based on medical judgment, telling the patient would be harmful. The licensee is not required to notify the patient without first consulting the referring physician. If the referring physician or patient cannot be reached within 24 hours, the licensee shall notify the patient as soon as possible thereafter. The licensee may not delay any appropriate medical care for the patient, including any necessary remedial care as a result of the medical event, because of any delay in notification.
(4) If the patient was notified, the licensee shall also furnish, within 15 days after discovery of the medical event, a written report to the patient by sending either:
(a) A copy of the report that was submitted to the Agency; or
(b) A brief description of both the event and the consequences as they may affect the patient, provided a statement is included that the report submitted to the Agency can be obtained from the licensee.
B. Each licensee shall retain a record of each medical event for five years. The record must contain the names of all individuals involved (including the prescribing physician, allied health personnel, the patient, and the patient's referring physician), the patient's social security number or identification number if one has been assigned, a brief description of the medical event, why it occurred, the effect on the patient, what improvements are needed to prevent recurrence, and the actions taken to prevent recurrence.
C. Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, patients, or the patient's responsible relatives or guardians.
4. Each registrant shall evaluate and respond to recordable events within 30 days after discovery by assembling the relevant facts, identifying the cause of the recordable event, and taking appropriate action, if any is required, to prevent recurrence.
5. Each registrant shall conduct an annual evaluation of the human administration program including any recommendations for changes to be made as well as any modifications made since the last evaluation and, if required, revise procedures to assure that the radiation is administered as directed by the authorized user. Modifications made to the program shall not decrease the effectiveness of the program.
6. Each registrant shall retain, in auditable form, for three years:
A. Each written directive;
B. A record of each administered radiation dose where a written directive is required;
C. A record of each annual review of the program including the evaluations and findings of the review;
D. A record of each recordable event, the relevant facts, and any corrective actions taken.
C.M.R. 10, 144, ch. 220, pt. X, app 144-220-X-C