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-C - ALTERNATIVE 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.
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.