Ala. Admin. Code r. 540-X-11-.04 - Delegation And Supervision

(1) A physician may delegate the performance of non-ablative treatments as defined in these rules through the use of written protocols to a properly trained Level 1 or 2 Delegate.

(2) A delegating physician shall supervise the performance of all non-ablative treatments delegated to a Level 1 or 2 Delegate. This supervision must include:

(a) Ensuring that patients are adequately informed and, prior to treatment, have signed consent forms that outline Risks, Benefits, Alternatives, and Complications, including the disclosure of reasonably foreseeable side effects and complications that may result from the non-ablative treatment, as well as the name of the device and the procedure;

(b) Responsibility for the formulation or approval of a written protocol that meets the requirements of these rules and responsibility for any patient-specific deviation from the protocol;

(c) Substantive review and authorization, at least annually, of the written protocol and any patient-specific deviations from the protocol regarding care provided to a patient under the protocol on a schedule defined in the written protocol;

(d) Ensuring that any Level 1 or 2 Delegate has read and signed the facility's policies and procedures, written protocols for delegation, and these rules regarding the safe use of non-ablative devices;

(e) Prompt receipt of information from the Level 1 or 2 Delegate concerning any problem or complication encountered with any treatment;

(f) On-site or locally remote supervision for non-ablative treatments performed by Level 1 and 2 Delegates consistent with these rules, the training and experience of the delegate performing the procedure, and the risk of harm to the patient;

(g) Personal evaluation and care for complications that arise; and

(h) Evaluation of the technical skills of the Level 1 or 2 Delegate performing non-ablative treatments on an ongoing basis by formally documenting and reviewing at least annually the Level 1 or 2 Delegate's ability to perform the following:

1. To properly operate the devices and provide safe and effective care; and

2. To respond appropriately to concerns, complaints, and complications and untoward effects of the procedures.

Notes

Ala. Admin. Code r. 540-X-11-.04

New Rule: Filed August 16, 2007; effective September 20, 2007. Amended by Alabama Administrative Monthly Volume XLI, Issue No. 08, May 31, 2023, eff. 7/15/2023.

Author: Alabama Board of Medical Examiners

Statutory Authority: Code of Ala. 1975, §§ 34-24-50, 34-24-51, 34-24-53.