(b) A facility is exempt from the requirement to obtain a license under AS 47.32 and 7 AAC 12.375 - 7 AAC 12.399 if the facility is owned and operated by

1. (1) the United States Indian Health Service; or
2. (2) a tribal organization as defined in 25 U.S.C. 5304(l) under a funding agreement under 25 U.S.C. 5385 (Indian Self-Determination and Education Assistance Act) and P.L.106-260 (Tribal Self-Governance Amendments of 2000 (Title V)).

(c) An applicant shall submit a complete application for an initial license, biennial license renewal, or modification of a previously approved license application on a form provided by the department. The department will return an incomplete application to the applicant for completion and resubmission. An application

1. (1) for an initial license or biennial license renewal

   1. (A) must include

      1. (i) applicable documents and information required under 7 AAC 12.375 - 7 AAC 12.399;
      2. (ii) the name and address of each owner, officer, director, partner, member, or principal of the business organization that owns the entity for which licensure is sought; and
      3. (iii) the fees established under 7 AAC 12.615; and

   2. (B) is subject to an on-site review and inspection conducted by the department; after the inspection is complete, the department will

      1. (i) approve an application that meets the applicable requirements;
      2. (ii) deny an application that does not meet the applicable requirements; or
      3. (iii) extend the application period for not more than 90 days if the center is temporarily unable to comply with the applicable requirements but is taking appropriate steps to achieve compliance;

2. (2) for modification of information included in a previously approved application

   1. (A) must be submitted to the department not fewer than 90 days before the proposed modification date; and
   2. (B) may be subject to an on-site inspection conducted by the department; and

3. (3) may be denied if

   1. (A) the application contains false or fraudulent information;
   2. (B) the applicant fails or refuses to provide required documents or information; or

   3. (C) the center or a center's employee

      1. (i) permitted, aided, or abetted a criminal act related to center operations covered by the license;
      2. (ii) engaged in conduct or practices detrimental to the health, welfare, or safety of patients or employees; or
      3. (iii) participated in, offered to participate in, or implied an offer to participate in a rebate, kickback, or fee-splitting arrangement or a substantially similar arrangement.

(d) The department may approve, deny, or place a condition on a license. If the department

1. (1) denies an application or places a condition on a license, the department will notify the applicant in writing by certified mail; an applicant may appeal a department decision by requesting a hearing on a form provided by the department or in a format approved by the department not more than 15 days after the applicant receives the department's notification; or

2. (2) approves an application, the center shall post

   1. (A) the copy of the approved license in a conspicuous place on the premises where the copy may be readily viewed by patients, staff, and the public; and
   2. (B) notice of a department-issued variance near the approved license, if applicable.

(f) A center shall permit the department to access the center to conduct a standard inspection, investigate a complaint, or investigate a suspected violation of licensing requirements. The center shall allow the department unobstructed and immediate access to

1. (1) inspect and duplicate the facility's records, personnel records, and patient medical records;
2. (2) observe care practices;
3. (3) inspect and photograph the building or the premises; and
4. (4) interview a staff member, contractor, volunteer, patient, patient's legal guardian, chosen representative, family member, or parent of a minor patient.

(h) After inspecting a center, the department will issue a report under AS 47.32.120. If the department issues an inspection report that shows a violation, the center shall submit a plan of correction to the department. For each violation identified in the report, the center's plan of correction must include

1. (1) a description of the center's planned corrective action for patients who were affected by the deficient practice;
2. (2) the method the center will use to identify other patients who may have been affected by the deficient practice;
3. (3) the measures or systemic changes the center will implement to prevent the deficient practice from recurring;
4. (4) the center's plan to monitor the corrective action and evaluate the action's efficacy to prevent the deficient practice from recurring;
5. (5) the center's completion date for each corrective action;
6. (6) the center's designee who will oversee the correction of each violation; and
7. (7) the signature of the center's administrator, or the signature of a person responsible for the center's operation and plan of correction.

(i) After the department reviews a center's plan of correction, the department will either approve the plan or determine that the plan is insufficient. If the department determines that the plan is insufficient, the department may

1. (1) request additional information regarding corrective action described in the center's plan;
2. (2) require the center to amend the plan as the department specifies; or
3. (3) require the center to comply with a directed plan of correction developed under (j) of this section.

(j) If the department develops a directed plan of correction for a center to cure a violation, the department will notify the center in writing. In its notice, the department will include a copy of the directed plan of correction and a description of enforcement action the department may take. A directed plan of correction must include

1. (1) a description of each violation;
2. (2) a description of each action the center shall take to correct each violation; and
3. (3) the deadline for the center to cure the violation.

(k) A center that is licensed under 7 AAC 12.375 - 7 AAC 12.399 may request a waiver of a biennial inspection by the department under AS 47.32.030(a)(3)(D) and 47.32.060 if the center holds a current accreditation from a nationally recognized organization that meets the standards of AS 47.32 and 7 AAC 12.375 - 7 AAC 12.399, as determined by the department. The center shall submit the waiver request on a form provided by the department for each licensing period during which the accrediting organization inspected the center. For each waiver request,

1. (1) the center shall include a copy of the accrediting organization's most recent inspection report, and a plan of correction and proof of corrective action if applicable; and

2. (2) the department

   1. (A) will waive the biennial inspection for the remainder of the licensing period in which the accrediting organization conducted an inspection if the center

      1. (i) passed that inspection; or
      2. (ii) corrected the deficiency in the accrediting organization's inspection report; or
   2. (B) may revoke an approved inspection waiver if the center fails to fulfill a correction plan under this section.