NAC459.559. Quality management program.

     1. Each registrant shall establish and maintain a written quality management program to ensure that a radiation therapy system is used as directed by the authorized user. The program must include, without limitation, the following objectives:

     (a) Except where a delay to provide a written directive would jeopardize the health of a patient, a written directive must be prepared before a dose of therapeutic radiation is administered;

     (b) If the emergent nature of the condition of a patient threatens the health of the patient, an oral directive to administer treatment is acceptable, so long as the information contained in the oral directive is documented immediately in the record of the patient and a written directive is prepared within 24 hours;

     (c) If a delay to provide a written revision to an existing written directive jeopardizes the health of a patient, an oral revision to the existing written directive may be given, so long as the oral revision is immediately documented in the record of the patient and a revised written directive is signed by the authorized user within 48 hours;

     (d) A written directive which changes an existing written directive may be made for any therapeutic procedure, so long as the revised directive is signed and dated by an authorized user before the next administration of the electronic brachytherapy dose or fractional dose;

     (e) The identity of the patient as being the person named in the written directive must be verified by more than one method before the administration of any therapeutic radiation;

     (f) The final plans of treatment and any related calculations must be the same as those specified in the written directive;

     (g) Each administration of a dose of therapeutic radiation must comply with the written directive; and

     (h) Any unintended deviation from the written directive must be identified and evaluated, and appropriate action must be taken.

     2. A registrant shall develop procedures for and conduct a review of the program, including, without limitation:

     (a) An evaluation of a representative sample of administrations to patients within the review period through a procedure which must be submitted to the Division;

     (b) An evaluation of all reportable events within the review period; and

     (c) An evaluation of all medical events within the review period to verify that the actions taken comply with the program.

     3. A review of the program must be conducted at least once every 12 months and a record of each review must be maintained for inspection by the Division for at least 3 years. The record must include any evaluations and the findings of the reviews.

     4. A registrant shall evaluate each review to determine the effectiveness of the program and shall make modifications as needed to comply with the provisions of this section.

     5. A registrant shall:

     (a) Within 30 days after the discovery of a reportable event:

          (1) Assemble the relevant facts, including, without limitation, the cause of the reportable event; and

          (2) Identify any corrective action which is required to prevent a reoccurrence of the reportable event; and

     (b) Retain a record of the facts and corrective action taken for at least 3 years.

     6. A registrant shall maintain each written directive for at least 3 years.

     7. A registrant may modify a program specified in subsection 1, so long as the effectiveness of the program is not decreased. Any such modification must be submitted to the Division within 30 days after the modification is made.

     8. Each applicant for a new registration shall submit to the Division a written program specified in subsection 1 as part of the application for registration and shall carry out the program upon issuance of the registration.

     9. A registrant shall keep records of each medical event until the termination of the registration.

     (Added to NAC by Bd. of Health by R185-08, eff. 5-7-2010)