216 R.I. Code R. 216-RICR-40-20-5.5

Current through December 26, 2024

Section 216-RICR-40-20-5.5 - Quality Management Program

5.5.1Scope and Applicability

A. Each applicant or registrant subject to §§ 5.6, 5.7 or 5.11 of this Part shall develop, implement, and maintain a written quality management program to provide high confidence that radiation will be administered as directed by the Authorized Physician. The quality management program must address, as a minimum, the following specific objectives:

1. Written Directives:

a. A written directive must be dated and signed by an Authorized Physician prior to the administration of radiation;

b. Notwithstanding §5.5.1(A)(1)(a) of this Part, if, because of the patient's/human research subject's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's/human research subject's health, an oral revision to an existing written directive must be acceptable, provided that the oral revision is documented immediately in writing in the patient's/human research subject's record and a revised written directive is signed by an Authorized Physician within forty-eight (48) hours of the oral revision;

c. The written directive must contain the patient or human research subject's name, the type and energy of the beam, the total dose, dose per fraction, treatment site, treatment technique, treatment frequency, and number of fractions.

d. A written revision to an existing written directive may be made provided that the revision is dated and signed by an Authorized Physician prior to the administration of the therapeutic radiation machine dose, or the next fractional dose.

e. The registrant must retain a copy of each written directive, in an auditable form, for in accordance with medical record retention requirements for comparable documents after the date of administration.

2. Procedures for Administrations. The registrant must develop, implement, and maintain documented policies, procedures, and rules to provide high confidence that:

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

b. Therapeutic radiation machine final plans of treatment and related calculations are in accordance with the respective written directives by:

(1) Checking the parameters and the results of the primary calculation with a secondary method to verify they are correct and in accordance with the written directive; and

(2) Verifying the planned parameters are correctly displayed on the consoles of therapeutic radiation machines;

c. Each administration is in accordance with the written directive; and

d. Any unintended treatment deviation from the written directive, or final plan of treatment utilized as a written directive, is identified, and evaluated, and appropriate action is taken.

e. At least two (2) radiation therapists per patient are required when non-emergent external beam radiation therapy is being delivered.

3. A registrant must retain a copy of the procedures required by §5.5.1(A)(2) of this Part for the duration of the registration.

5.5.2Notifications of Medical Events

A. A registrant must report any medical event, except for a medical event resulting from intervention by a patient or human research subject, in which the administration of therapeutic radiation machine radiation results or will likely result in unintended permanent functional damage to an organ or a physiological system as determined by an Authorized Physician as defined in §5.3.3 of this Part.

B. Other than events that result from intervention by a patient or human research subject, a registrant must report any event in which the administration of a therapeutic radiation machine therapy dose:

1. Involves the wrong patient, wrong treatment modality, wrong treatment technique, wrong treatment site; or

2. The administered dose differs from the prescribed dose as stated in the written directive by more than fifty percent (50%) for treatment courses consisting of a single fraction; or

3. The administered dose differs from the prescribed dose as stated in the written directive by more than ten percent (10%) for treatment courses consisting of five (5) fractions or less; or

4. The administered dose over any five (5) consecutive fractions differs from the prescribed dose by more than thirty percent (30%); or

5. The administered dose over the entire treatment course consisting of more than five (5) fractions differs from the prescribed dose by more than twenty percent (20%).

C. The registrant must notify the Agency no later than the next business day after the registrant ascertains that a medical event occurred.

1. All required notifications must use Agency contact information specified in § 1.4 of this Subchapter.

D. The registrant must submit a written report to the Agency within fifteen (15) days after the initial notification of a medical event. The written report must include:

1. The registrant's name and registration number;

2. The name of the prescribing physician;

3. A brief description of the event;

4. Why the event occurred;

5. The effect, if any, on the individual(s);

6. Actions, if any, that have been taken, or are planned, to prevent recurrence; and

7. Certification that the registrant notified the individual (or the individual's responsible relative or guardian), and if not, why not.

E. The report must not contain the individual's name or any other information that could lead to the identification of the individual.

F. The prescribing Authorized Physician must provide notification of the event to the individual who is the subject of the medical event no later than twenty-four (24) hours after initial notification by the registrant to the Agency, unless the prescribing Authorized Physician determines that, based on medical judgement, telling the individual would be harmful. The prescribing Authorized Physician will also notify any other physician health care providers actively involved in the patient's care for the disease that is being treated. If the health care providers or the affected individual cannot be reached within twenty-four (24) hours, the prescribing Authorized Physician must notify each as soon as possible thereafter. The registrant may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification.

G. To meet the requirements of §5.5.2 of this Part, the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If an oral notification is made, the registrant must inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the registrant upon request. The registrant must provide such a written description if requested.

H. Aside from the notification requirement, nothing in §5.5.2 of this Part affects any rights or duties of registrants and physicians in relation to each other, to individuals affected by the medical event, or to that individual's responsible relatives or guardians.

I. The registrant must retain a record of each medical event report with an identification link to the individual who is the subject of the medical event in accordance with §5.5.3 of this Part.

5.5.3Records of Medical Events

A. A registrant must retain a record of medical events reported in accordance with §5.5.2 of this Part for the duration of the registration. The identification link must include, as a minimum:

1. The name of the individual who is the subject of the medical event; and

2. The social security number or other identification number, if one has been assigned, of the individual who is the subject of the medical event.

B. A registrant must provide a copy of the annotated report to the referring physician, if other than the registrant, no later than fifteen (15) days after the registrant ascertains that a medical event occurred.

5.5.4Implementation of Quality Management Program

A. As a part of the quality management program, the registrant must:

1. 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/human research subject administrations, and all medical events to verify compliance with all aspects of the quality management program.

2. Conduct these reviews at intervals not to exceed twelve (12) months.

3. Evaluate each of these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the requirements of §5.5.1 of this Part; and

4. Maintain records of each review, including the evaluations and findings of the review, in an auditable form, for three (3) years.

5.5.5[RESERVED]

5.5.6Modifications

The registrant may make modifications to the quality management program to increase the program's efficiency provided the program's effectiveness is not decreased.

216 R.I. Code R. 216-RICR-40-20-5.5

Adopted effective 1/1/2019
Amended effective 5/25/2022
Amended effective 11/27/2023