Section 157.83. Administrative policies and procedures for radiation therapy machines.

 

(1)   Written policies. A registrant shall have written policies and procedures to ensure that radiation will be administered as directed by an authorized user. The policies shall meet all of the following specific objectives:

(a) Prior to administration, a written directive is prepared for any external beam radiation therapy dose or electronic brachytherapy dose. A written revision to an existing written directive may be made prior to beginning treatment, or prior to delivery of a fractional dose, provided that the revision is dated and signed by an authorized user. If, because of the patient's condition, a delay 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 24 hours of the oral revision.

(b) Prior to the administration of each course of radiation treatments, the patient's identity is verified, by more than one method, as the person named in the written directive.

(c) External beam radiation therapy or electronic brachytherapy final plans of treatment and related calculations are according to the respective written directives.

(d) Each administration is according to the written directive.

(e) Any unintended deviation from the written directive is identified, documented, evaluated and appropriate action is taken.

(2)   Development of the operational procedures program. A therapy device registrant shall do all the following:

(a) Develop an operational procedures program that specifies staff duties and responsibilities, and equipment and procedures. The registrant shall implement the program upon issuance of a certificate of registration by the department.

(b) Develop procedures for and conduct a review of the program including, since the last review, an evaluation of a representative sample of patient administrations and all medical events to verify compliance with all aspects of the operational procedures program.

(c) Conduct program reviews at intervals not to exceed 12 months.

(d) Evaluate each of the reviews specified in par. (b) to determine the effectiveness of the program and, if required, make modifications to meet the requirements of par. (b) .

(e) Maintain records of each review specified in par. (b) , including the evaluations and findings of the review, in an auditable form for 3 years.

(3)   Medical events.

(a) A registrant shall report any of the following medical events:

1. A dose that differs from the prescribed dose by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue or 0.5 Sv (50 rem) shallow dose equivalent to the skin and any of the following exist:

a. The total dose delivered differs from the prescribed dose by 20% or more.

b. The fractionated dose delivered exceeds the prescribed dose, for a single fraction, by 50% or more.

2. A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue or 0.5 Sv (50 rem) shallow dose equivalent to the skin under any of the following conditions:

a. An administration of a dose to the wrong patient or human research subject.

b. An administration of a dose delivered by the wrong mode of treatment.

3. A dose to an organ outside the intended treatment volume that exceeds the expected dose to that organ by 0.5 Sv (50 rem) where the excess dose is greater than 50% of the expected dose to that organ.

(b) In response to a medical event, a registrant shall do all of the following:

1. Notify their department head no later than the next calendar day after discovery of the medical event.

2.

a. Submit a written report to the department within 15 working 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; 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 and if not, why not; and if the patient was notified, what information was provided to the patient.

b. The report in subd. 2. a. may not include the patient's name or other information that could lead to identification of the patient.

3. Notify the referring physician and the patient of the medical event no later than 24 hours after the medical event's discovery, unless the referring physician personally informs the registrant either that he or 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 the referring physician. If the referring physician or patient cannot be reached within 24 hours, the registrant shall notify the patient of the medical event as soon as possible. The registrant 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. Retain a record of each medical event for 3 years. The record shall contain all of the following:

a. The names of all persons involved.

b. The patient's unique identification number.

c. A brief description of the event, why it occurred and the effect on the patient.

d. What improvements are needed to prevent recurrence and the actions taken to prevent recurrence.

e. Whether the registrant notified the patient or patient's guardian and if not, why not, and if the patient was notified, what information was provided to the patient.

f. If information was not given to the patient at the direction of the referring physician, the reason why the information was not given to the patient.

5. If the patient was notified, furnish, within 15 working 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 department, or a brief description of both the event and the consequences as they may affect the patient, if a statement is included that the report submitted to the department may be obtained from the registrant.

(4)   Rights. Aside from the notification requirement, nothing in this section affects any rights or duties of registrants and physicians in relation to each other, patients or the patient's responsible relatives or guardians.

CR 01-108 : cr. Register July 2002 No. 559 , eff. 8-1-02; CR 06-021 : am. (2) (b) Register October 2006 No. 610 , eff. 11-1-06; CR 09-062 : am. (1) (a) and (c) Register April 2010 No. 652 , eff. 5-1-10.

Note

Mail the report to the Department at: Department of Health Services, Radiation Protection Section, PO Box 2659, Madison WI 53701-2659. Microsoft Windows NT 6.1.7601 Service Pack 1