64E-5.611. Quality Management Program and Notifications, Records and Reports of Medical Events

(1) Each applicant or licensee under this part, as applicable, shall establish and maintain a written quality management program to provide a high confidence that radioactive material or radiation from radioactive material will be administered as directed by the authorized user. The quality management program must include written policies and procedures to meet the following objectives:

(a) Except where a delay to provide a written directive would jeopardize the patient’s health as specified in paragraphs (b) and (c) of this section, a written directive is prepared prior to administration for the following:

1. Any teletherapy radiation dose;

2. Any gamma stereotactic radiosurgery radiation dose;

3. Any brachytherapy radiation dose;

4. Any administration of iodine 131 as sodium iodide in quantities greater than 30 microcuries (1.11 megabecquerels);

5. Any therapeutic administration of a radiopharmaceutical other than iodine 131 as sodium iodide; or

6. Any high dose rate remote afterloader radiation dose.

(b) An oral directive is acceptable when a delay to provide a written directive would jeopardize the patient’s health because of the emergent nature of the patient’s condition. The information contained in the oral directive must be documented immediately in the patient’s record and a written directive prepared within 48 hours of the oral directive.

(c) An oral revision to an existing written directive is acceptable when a delay to provide a written revision to an existing written directive would jeopardize the patient’s health. The oral revision must be documented immediately in the patient’s record and a revised written directive must be signed by the authorized user within 48 hours of the oral revision.

(d) A written directive which changes an existing written directive can be made for any diagnostic or therapeutic procedure if the revision is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery dose, high dose rate remote afterloader dose, the teletherapy dose, or the next fractional dose.

(e) The patient’s or human research subject’s identity is verified by more than one method as the individual named in the written directive prior to administration;

(f) The final plans of treatment and related dose calculations, manually or computer generated, for brachytherapy, teletherapy, high dose rate remote afterloader, and gamma stereotactic radiosurgery agree with the respective written directives:

(g) Verify that any computer-generated calculations are correctly transferred into the consoles of therapeutic medical units authorized by Rule 64E-5.634, F.A.C.;

(h) Each administration agrees with the written directive; and

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

(2) The licensee shall develop procedures for and conduct a review of the quality management program including an evaluation of the following:

(a) A representative sample of patient administrations within the review period;

(b) All recordable events within the review period; and

(c) All medical events within the review period to verify compliance with all aspects of the quality management program.

(3) The review of the quality management program specified in (2) above shall be conducted at intervals not to exceed 12 months. A record of each review shall be maintained for inspection by the department in an auditable form for 3 years and shall include evaluations and findings of the review.

(4) The licensee shall evaluate each of these reviews to determine the effectiveness of the quality management program and make modifications to meet the objectives in subsection 64E-5.611(1), F.A.C.

(5) Within 30 days of discovery of each recordable event, the licensee shall:

(a) Assemble the relevant facts including the cause;

(b) Identify any corrective action required to prevent recurrence;

(c) Retain a record in an auditable form for 3 years of the relevant facts and any corrective action taken.

(6) The licensee shall retain in an auditable form for 3 years each written directive and a record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required by subsection 64E-5.611(1), F.A.C.

(7) Each applicant for a new license shall submit to the department a quality management program as part of the application for a license and implement the program upon issuance of the license by the department.

(8) Each licensee shall maintain copies of the quality management program for the duration of the license.

(9) Each licensee shall submit and maintain records and reports of medical events as required by subsections 64E-5.345(4) and (5), F.A.C.

Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History–New 8-25-91, Amended 1-1-94, Formerly 10D-91.717, Amended 2-11-10.