6 Colo. Code Regs. § 1007-1-24.6

Current through Register Vol. 47, No. 11, June 10, 2024

Section 6 CCR 1007-1-24.6 - Quality Management Program

24.6.1 Each registrant or applicant subject to 24.7, 24.8, 24.13, or 24.14 shall develop, implement, and maintain a quality management program to ensure that radiation will be administered as directed by the authorized user.

24.6.2 The quality management program shall include provisions for written directives and procedures for administration of radiation.

24.6.2.1 A written directive:

(1) Shall be dated and signed by a radiation therapy authorized user prior to the administration of radiation;

(2) Shall contain the human patient or human research subject's name, the type and energy of the beam, the total dose, dose per fraction, treatment site, and number of fractions;

(3) May be revised at the discretion of the authorized user, provided that the revision is written, dated and signed by the authorized user prior to administration of the next fraction;

(4) May be subject to oral revision, if because of the patient's condition, a delay in the order to provide a written revision to an existing written directive would jeopardize the patient's health, and provided that:

(a) The oral revision is documented as soon as possible in writing in the patient's record; and

(b) A revised written directive is signed by an authorized user within 48 hours of the oral revision; and

(5) Shall be retained (a copy is acceptable) for 3 years.

24.6.2.2 The registrant shall develop, implement, and maintain written procedures to ensure that:

(1) Prior to the administration of each course of radiation treatments, the human patient's or human research subject's identity is verified by more than one method as the individual named in the written directive;

(2) Each administration is in accordance with the written directive;

(3) Radiation therapy final plans of treatment and related calculations are in accordance with the respective written directives by:

(a) Checking both manual and computer generated dose calculations to verify they are correct and in accordance with the written directive; and

(b) Verifying that any computer-generated calculations are correctly transferred into the consoles of therapeutic medical units;

(4) Any unintended deviation from the written directive is identified, evaluated and appropriate action is taken; and

(5) The registrant retains a copy of the treatment administration procedures for the duration of the registration.

24.6.3 Reports and Notifications of Reportable Medical Events.

24.6.3.1 A registrant shall report any event resulting from intervention of a human patient or human research subject in which the administration of any beam radiotherapy results, or will result in, unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

24.6.3.2 Other than events that result from intervention by a human patient or human research subject, a registrant shall report any event in which the delivered dose to the prescribed point or volume:

(1) Involved the wrong individual or the wrong treatment site; or

(2) Involved:

(a) A calculated administered dose that differs from the:

(i) Total prescribed dose by more than 10 percent of the total prescribed dose, for a total prescribed dose consisting of three (3) or fewer fractions; or

(ii) Total prescribed dose by more than 20 percent of the total prescribed dose; or

(iii) Weekly prescribed dose by more than 30 percent.

24.6.3.3 The registrant shall notify the Department by telephone no later than the next calendar day after discovery of the reportable medical event.

24.6.3.4 The registrant shall submit a written report to the Department within 15 calendar days after discovery of the reportable medical event pursuant to 24.6, to include:

(1) The registrant or licensee's name;

(2) The name of the authorized user who signed the written directive and/or who supervised delivery of the prescribed dose;

(3) The name(s) of the Registered Medical Physicist(s);

(4) The name(s) of the radiation therapist(s);

(5) A brief description of the event;

(6) Why the event occurred;

(7) The room the event occurred in;

(8) The type of radiotherapy equipment involved in the event;

(9) Copies of written protocols;

(10) The effect, if any, on the individual who received the dose;

(11) Actions, if any, that have been taken, or are planned, to prevent recurrence; and

(12) Certification that the registrant notified the individual who received the dose (or the individual's responsible relative or guardian) or, if not, the reason notification was not provided.

24.6.3.5 The report shall not contain the affected individual's name or any other information that could lead to identification of the individual who received the dose.

24.6.3.6 The registrant shall provide notification of the reportable medical event, no later than 24 hours after its discovery, to the authorized user (and to the referring physician if other than the authorized user).

24.6.3.7 The registrant shall notify the affected individual no later than 24 hours after the reportable medical event is discovered, unless, based on medical judgment, the authorized user informs the registrant in writing that telling the individual would be harmful.

(1) The registrant shall notify the affected individual as soon as possible if the authorized user cannot be reached within 24 hours.

(2) The registrant shall not delay any appropriate medical care for the affected individual, including any necessary remedial care as a result of the reportable medical event, because of any delay in notification.

(3) To meet the requirements of this section, the notification of the affected individual may be made instead to that individual's responsible relative or guardian.

(4) If a verbal notification is made, the registrant shall inform the affected individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the registrant upon request. The registrant shall provide such a written description if requested.

24.6.3.8 Aside from the notification requirement, nothing in this section affects any rights or duties of registrants, licensees, and physicians in relation to each other, to an individual affected by the reportable medical event, or to that individual's responsible relatives or guardians.

24.6.3.9 A registrant shall retain a record of a reportable medical event for 3 years, containing:

(1) The registrant's or licensee's name;

(2) The name of each individual involved;

(3) The medical records number or equivalent means to identify the individual who is the subject of the reportable medical event;

(4) A brief description of the event and why it occurred;

(5) The effect, if any, on any individual who received the dose;

(6) The actions, if any, taken, or planned, to prevent recurrence; and

(7) Whether the registrant notified the individual (or the individual's responsible relative or guardian) or, if not, the reason notification was not provided.

24.6.3.10 A copy of the record required under 24.6.3.9 shall be provided to the authorized user(s), if other than the registrant or licensee, within 15 calendar days after discovery of the reportable medical event.

6 CCR 1007-1-24.6

Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/2014

38 CR 02, January 25, 2015, effective 2/14/2015

38 CR 05, March 10, 2015, effective 3/30/2015

38 CR 12, June 25, 2015, effective 7/15/2015

38 CR 14, July 25, 2015, effective 8/14/2015

39 CR 02, January 25, 2016, effective 2/14/2016

39 CR 16, August 25, 2016, effective 9/14/2016

39 CR 22, November 25, 2016, effective 12/15/2016

40 CR 11, June 10, 2017, effective 6/30/2017

40 CR 20, October 25, 2017, effective 11/14/2017

42 CR 24, December 25, 2019, effective 1/14/2020

43 CR 14, July 25, 2020, effective 8/14/2020

43 CR 18, September 25, 2020, effective 10/15/2020

44 CR 11, June 10, 2021, effective 7/15/2021

44 CR 14, July 25, 2021, effective 8/14/2021

45 CR 22, November 25, 2022, effective 12/15/2022