Current through Rules and Regulations filed through September 23, 2024
(1) All applications for licenses shall be submitted on forms provided by the Department.
(2) No application shall be considered by the Department unless it is complete, and is accompanied by all required attachments and fee payments.
(3) The Department shall issue an annual license to an applicant if it is determined that the applicant and the facility meet the requirements of these rules.
(4)
Initial License.
(a)
Application for Initial License. The application for the initial license shall be submitted to the Department not later than thirty (30) days prior to the anticipated date of the opening and initiation of operations by the facility, shall be signed by the executive officer of the facility's governing body, and shall be accompanied by:
1. The nonrefundable application fee;
2. The initial license fee as designated on the fee schedule;
3. A narrative description of the services to be offered at the facility, including the number of dialysis stations;
4. The name and contact information of the facility administrator as appointed by the facility's governing body;
5. Evidence that the facility has sufficient staff, qualified as required by these regulations, to meet the needs of patients, with a description of the organizational structure of the staffing; and
6. Proof of facility ownership:
(i) If ownership is a corporation, the application shall be accompanied by a copy of the Certificate of Existence (Good Standing) from the Office of the Secretary of State of Georgia.
(ii) If the facility is non-profit, the application shall be accompanied by legal proof of the organization and the names and addresses of all trustees.
(iii) If ownership is neither a corporation nor a non-profit organization, the name and address of each person with ownership in the facility shall be submitted with the application.
(b)
Temporary Provisional License. The Department may at its discretion issue a temporary provisional license to the facility. The temporary provisional license shall be effective for a period of no more than six (6) months.
1. A temporary provisional license shall be considered for only the following situations:
(i) The facility has applied for an initial license or renewal of a license and cannot demonstrate full compliance with these rules, but has demonstrated satisfactory evidence that it is making progress toward meeting these rules and has submitted an acceptable plan of correction; or
(ii) The facility has applied for a license in order to function as a special purpose facility, meeting the requirements of these rules, with intended operation of no more than the six month period of effectiveness of the license.
2. A temporary provisional license may be issued by the Department only when the facility has demonstrated sufficient compliance with these rules that the health and safety of patients will not be endangered.
3. A 12-month license issued during the period of temporary provisional licensure shall not require an additional license fee.
(c) An end stage renal disease facility in operation at the time these rules initially become effective, and holding certification for participation in the federal Medicare program, shall be granted an initial license upon payment of the applicable license fee, without requiring inspection. This initial license shall be effective for a period of twelve (12) months, unless suspended or revoked as a result of an adverse action, and shall be subject to the renewal process.
(5)
Application for a New Annual License Due to Change in Facility Name, Facility Location, or Facility Ownership.
(a) At least 30 days prior to the change in the facility's name, location, or ownership, a new application for license shall be submitted which shall contain the new name, location, proof of ownership, any changes in the official mailing address and contact telephone numbers, and a description of any organizational changes or changes in key personnel.
(b) The Department, at its discretion, may require an inspection of the facility prior to approval of the new license.
(c) The facility shall return to the Department the license issued under the prior name, location, or ownership, immediately upon the change of same, and it shall be considered revoked.
(6)
Renewal of License. At least 30 days, but no more than 90 days, prior to the expiration of the license, the facility shall submit an application for license renewal on forms provided by the Department, with the applicable renewal fee.
(a) The Department shall conduct an inspection of the facility prior to renewal of the facility license, to ensure continued compliance with these rules and regulations.
(b) The facility shall be permitted to continue operation under the existing license until such time as the inspection has been completed and the renewal of the annual license is issued or denied.
(c) The renewed annual license shall have an effective date at the date of issue or at the expiration date of the previous license, whichever is later, and shall be effective for twelve (12) months from the effective date.
(7)
Denial of License Application or Renewal Application. The Department may refuse to grant a license within the parameters described in "General Licensing and Enforcement Requirements", Chapter 111-8-25.
(a) The Department may refuse to grant an initial annual license without the requirement of holding a hearing prior to the action.
(b) Denial of an application for a new or renewal license from a facility shall be subject to notice and opportunity for a hearing.
(c) An application may be refused or denied if:
1. The facility has failed to demonstrate compliance with these rules and regulations;
2. The applicant has had a license denied, revoked, or suspended within one year of the date of a new application;
3. The applicant has transferred ownership of a facility within one year of the date of a new application in order to avert denial, suspension, or revocation of a permit; or
4. The applicant has knowingly made any verbal or written false statement of material fact in connection with the application for the license.
(8)
Request for Approval for Addition of Services. A facility shall obtain written approval from the Department prior to any addition of services or increase in number of dialysis stations.
(a) At least thirty (30) days prior to the anticipated date of the addition of a new service or an increase in the number of dialysis stations, the facility shall submit a request for approval. The facility shall submit with the request:
1. A description of any modifications to the facility's physical plant to accommodate the change; and
2. Evidence that the facility has reviewed staffing availability and added staff positions if indicated to accommodate the change.
(b) The Department may at its discretion conduct an inspection of the facility prior to action on the request for change.
(c) The Department shall notify the facility of the approval of the request for change, or the reason for disapproval. If disapproved, the Department shall indicate the action or information required for approval of the change.
(9)
Notification of the Discontinuation of a Service. At least thirty (30) days prior to the discontinuation of a facility service, the facility shall notify the Department of the planned discontinuation, and shall provide a description of impact of the change on the care of patients currently served. The facility shall also notify the patients of its planned discontinuation of a facility service.
(10)
Temporary Inactive Status. If the facility is closing temporarily, and plans to reopen under the same ownership and name, the facility may request to have the license placed on temporary inactive status.
(a) Temporary inactive status shall be granted initially for a period of no more than ninety (90) days, and may be granted upon request for only one additional period of ninety (90) days at the discretion of the Department.
(b) When placed on temporary inactive status, the license shall be returned to the Department, and the facility shall not operate until the license has been reactivated.
(c) The facility shall request in writing that the permit be reactivated at least thirty (30) days prior to the desired date of re-opening. Prior to reactivation of the license, the facility shall be subject to inspection by the Department. If the license is not reactivated within six (6) months, the license shall be considered revoked.
O.C.G.A. §§
31-44-2, 31-44-6 and 31-44-11. .
