C.M.R. 10, 144, ch. 220, pt. X, app 144-220-X-B
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. Prescribed dose means the total dose and dose per fraction as documented in the written directive. The prescribed dose is an estimation from measured data from a specified therapeutic radiation machine using assumptions that are clinically acceptable for that treatment technique and historically consistent with the clinical calculations previously used for patients treated with the same clinical technique;
C. 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;
D. 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. Scope and applicability. Each applicant or registrant subject to X.6 or X.7 shall establish and maintain a written quality management program to provide high confidence that radiation will be administered as directed by the authorized user. The quality management program shall include written policies and procedures to meet the following specific objectives:
A. Prior to administration, a written directive is prepared for any external beam radiation therapy dose;
(1) 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 administration of the external beam radiation therapy dose or the next external beam radiation therapy fractional dose;
(2) If, because of the patient's condition, a delay in 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 shall be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by an authorized user within 48 hours of the oral revision;
(3) If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive shall be acceptable, provided that the information contained in the oral directive is documented immediately in the patient's record and a written directive is prepared and signed by an authorized user within 24 hours of the oral directive.
B. Prior to the administration of each course of radiation treatments, the patient's identity is verified, by more than one method, as the individual named in the written directive;
C. External beam radiation therapy final plans of treatment and related calculations are in accordance with the respective written directives;
D. Each administration is in accordance with the written directive; and
E. Any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.
3. Development of quality management program.
A. Each application for registration subject to X.6 or X.7 shall include a quality management program that specifies staff, duties and responsibilities, and equipment and procedures as part of the application required by Part B of this rule . The registrant shall implement the program upon issuance of a registration certificate
B. Each existing registrant subject to X.6 or X.7 shall submit to the Agency a written certification that a quality management program has been implemented.
4. As a part of the quality management program, the registrant shall:
A. Develop procedures for, and conduct a review of, the quality management program including, since the last review, an evaluation of a representative sample of patient administrations, all recordable events, and all medical events to verify compliance with all aspects of the quality management program;
B. Conduct these reviews at intervals not to exceed 12 months;
C. Evaluate each of these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the requirements; and
D. Maintain records of each review, including the evaluations and findings of the review, in an auditable form, for three years.
5. The registrant shall evaluate and respond, within 30 days after discovery of the recordable event, to each recordable event by:
A. Assembling the relevant facts including the cause;
B. Identifying what, if any, corrective action is required to prevent recurrence; and
C. Retaining a record, in an auditable form, for three years, of the relevant facts and what corrective action, if any, was taken.
6. The registrant shall retain:
A. Each written directive; and
B. A record of each administered radiation dose, in an auditable form, for three years after the date of administration.
7. The registrant may make modifications to the quality management program to increase the program's efficiency provided the program's effectiveness is not decreased.
8. The registrant shall evaluate each medical event and shall take the following actions in response to a medical event:
A. Notify the Agency by telephone no later than the next calendar day after discovery of the medical event;
B. Submit a written report to the Agency within 15 days after discovery of the medical event. The written report shall include: the registrant's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the patient; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the registrant notified the patient or the patient's responsible relative or guardian (this person will subsequently be referred to as the patient), and if not, why not, and if the patient was notified, what information was provided to the patient. The report shall not include the patient's name or other information that could lead to identification of the patient;
C. 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 registrant either that he/she will inform the patient or that, based on medical judgment, telling the patient would be harmful. The registrant is not required to notify the patient without first consulting with the referring physician. If the referring physician or patient cannot be reached within 24 hours, the registrant shall notify the patient as soon as possible . The registrant shall 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;
D. Retain a record of each medical event for five years. The record shall 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 event, why it occurred, the effect on the patient, what improvements are needed to prevent recurrence, and the actions taken to prevent recurrence; and
E. If the patient was notified, furnish, within 15 days after discovery of the medical event, a written report to the patient by sending either a copy of the report that was submitted to the Agency, or 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 registrant;
9. Aside from the notification requirement, nothing in X.5.H. affects any rights or duties of registrants and physicians in relation to each other, patients, or the patient's responsible relatives or guardians
C.M.R. 10, 144, ch. 220, pt. X, app 144-220-X-B