Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part X - THERAPEUTIC RADIATION MACHINES › Appendix 144-220-X-B - QUALITY MANAGEMENT PROGRAM

Current through 2024-29, July 17, 2024
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