1. (1) Generally. This rule applies to any material change other than a change in ownership, which is governed by Rule 538-X-4-.16. For purposes of this rule, a material change includes:

   1. (a) A change in the licensee's management, including any director, officer, or other individual with responsibilities for the licensee's day-to-day operations, but not resulting in a change of ownership;
   2. (b) A change in the location of any facility utilized by a licensee pursuant to its license; or
   3. (c) Any other change that would render an applicant ineligible for a license under Rule 538-X-3-.14 or other provision of law.
2. (2) Procedure for Reporting Material Change. Licensees shall seek prior approval for any material change under this rule, except where prior approval is not feasible due to death or other circumstances beyond the control of the licensee, in which case the Commission shall be notified in writing as soon as practicable, but in no event more than thirty (30) days following the material change, in accordance with the procedures and documentation for doing so set forth in these Rules. Without limiting the foregoing, a request to relocate a facility under paragraph (1) of this rule must provide the address of the facility requested to be relocated as well as the site where the facility is proposed for relocation; photographs from all sides of the proposed location, including aerial and street views; the reasons for the proposed relocation; proof of authorization for the licensee proposing the facility relocation to occupy the proposed facility;  verification that the proposed site will be in compliance with all local laws, the Act and these Rules; and a detailed explanation of the expected impact on patients, the community, and the general public.
3. (3) Commission Evaluation of Reported Material Change. The Commission may conduct such investigation as it deems necessary to determine if a proposed material change should be approved or, in the case of a prior material change, violates a condition of licensure or should otherwise result in the initiation of license revocation proceedings or other enforcement action.
4. (4) Self-Reporting. A licensee's duty to report is mandatory in the event of "injury," "loss," or a "material breach" of the licensee's policies and procedures as affirmed to the Commission in the application or any amendment thereto; reports should be made promptly to the Commission, and, as applicable, law enforcement, in no event more than 24 hours after its occurrence or discovery, to allow for swift investigation and remediation.
5. (5) Waivers. The licensee may request a waiver to excuse it from noncompliance with its verified plans as previously communicated to the Commission (as opposed to noncompliance with the Rules, warranting a variance (see below)) where the requested change is needed only for a temporary period due to an identifiable reason, after which the licensee expects to return to operations as set forth in its previously provided documentation, the licensee may seek a waiver, identifying the reason for the difference and a specific period of time (no longer than six (6) months, renewable once for good cause shown for an additional six (6) months) during which operations must return to compliance with documentation previously provided. The Commission shall rule on a requested waiver within 14 days of its submission.
6. (6) Amendment. The licensee may request an Amendment to previously provided documentation where the identified change is expected to be permanent; if not in contravention of the Act or these Rules, Amendments should be quickly and routinely granted.
7. (7) Temporary Variance. A licensee may request a temporary variance pursuant to the procedures of 538-X-1-.08-1. When seeking a temporary variance under these Rules, Licensees should also, when applicable, notify the Commission of a material change in circumstances as defined herein.
8. (8) Permanent Variance. A licensee may request a permanent variance pursuant to the procedures of 538-X-1-.08-2. When seeking a permanent variance under these Rules, Licensees should also, when applicable, notify the Commission of a material change in circumstances as defined herein.

9. (9) Consequences. Except in the case of self-reporting as delineated above, a licensee's timely discharge of this duty, by filing amended documentation, seeking a waiver or variance, should not result in sanctions:

   1. (a) in the absence of clear and convincing evidence that the licensee's request was fraudulent, frivolous or a subterfuge for willful non-compliance, or
   2. (b) where the circumstances necessitating the self-report or giving rise to a material change were accompanied by a substantial risk of harm to individuals or property and occurred due to the negligent, reckless, willful or deliberate conduct (whether an act or omission) of the licensee or its representatives.

Author: William H. Webster; Mark D. Wilkerson; Justin C. Aday

Statutory Authority: Code of Ala. 1975, §§20-2A-22, as amended.

History: New Rule: Published August 31, 2022; effective October 15, 2022. Amended: Published April 30, 2026; effective June 14, 2026.