R313-30-5. Quality Management Program

(1) In addition to the definitions in R313-30-2, the following definitions are applicable to a quality management program:

"Course" means the entire treatment consisting of multiple fractions as prescribed in the written directive.

"Misadministration" means the administration of an external beam radiation therapy dose:

(a) Involving the wrong patient, wrong treatment modality, or wrong treatment site;

(b) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than ten percent of the total prescribed dose;

(c) When the calculated weekly administered dose differs from the weekly prescribed dose by more than 30 percent; or

(d) When the calculated total administered dose differs from the total prescribed dose by more than 20 percent of the total prescribed dose;

"Prescribed dose" means the total dose and dose per fraction as documented in the written directive.

"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;

"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. Applicants or registrants subject to R313-30-6 or R313-30-7 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 an external beam radiation therapy dose;

(i) Notwithstanding R313-30-5(2)(a), 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;

(ii) Notwithstanding R313-30-5(2)(a), 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;

(iii) Notwithstanding R313-30-5(2)(a), 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 a 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) An administration is in accordance with the written directive; and

(e) Unintended deviations from the written directive is identified and evaluated, and appropriate action are taken.

(3) Development of Quality Management Program.

(a) An application for registration subject to R313-30-6 or R313-30-7 shall include a quality management program that specifies staff, duties and responsibilities, and equipment and procedures as part of the application required by R313-16 of these rules. The registrant shall implement the program upon issuance of a Certificate of Registration by the Director;

(b) Existing registrants subject to R313-30-6 or R313-30-7 shall submit to the Director a written certification that a quality management program has been implemented by December 31, 1994.

(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, recordable events, and misadministrations to verify compliance with the quality management program;

(b) Conduct these reviews annually. The intervals should not exceed 12 months and shall not exceed 13 months;

(c) Evaluate these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the requirements of R313-30-5(2); and

(d) Maintain records of these reviews, including the evaluations and findings of the reviews, in a form that can be readily audited, for three years.

(5) The registrant shall evaluate and respond, within 30 days after discovery of the recordable event, to recordable events by:

(a) Assembling the relevant facts including the cause;

(b) Identifying what corrective actions are required to prevent recurrence; and

(c) Retaining a record, in a form that can be readily audited, for three years, of the relevant facts and what corrective actions were taken.

(6) The registrant shall retain:

(a) Written directives; and

(b) A record of administered radiation doses, in a form that can be readily audited, 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 misadministrations and shall take the following actions in response to a misadministration:

(a) Notify the Director by telephone no later than the next calendar day after discovery of the misadministration;

(b) Submit a written report to the Director within 15 days after discovery of the misadministration. 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 misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the registrant either that the physician 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 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 thereafter. The registrant shall not delay appropriate medical care for the patient, including necessary remedial care as a result of the misadministration, because of a delay in notification;

(d) Retain a record of misadministrations for five years. The record shall contain the names of 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 misadministration, a written report to the patient by sending either a copy of the report that was submitted to the Director, or a brief description of both the event and the consequences as they may effect the patient, provided a statement is included that the report submitted to the Director can be obtained from the registrant;

(9) Aside from the notification requirement, nothing in R313-30-5(8) affects the rights or duties of registrants and physicians in relation to patients, the patient's responsible relatives or guardians, or to others.