S.C. Code Regs. § § 61-108.100.103

Current through Register Vol. 48, No. 10, October 25, 2024

Section 61-108.100.103 - License Requirements (II)

A. Compliance. An initial license shall not be issued to an owner/operator who has not been previously and continuously licensed under Department regulations until the licensee has demonstrated to the Department that the proposed equipment is in substantial compliance with the licensing standards. In the event a licensee who already has a facility/activity/freestanding or mobile technology licensed by the Department makes application for another facility/activity/freestanding or mobile technology or increase in licensed capacity of a facility, the currently licensed facility/activity/freestanding or mobile technology shall be in substantial compliance with the applicable standards prior to the Department issuing a license to the proposed facility/activity/freestanding or mobile technology.

B. A copy of the licensing standards shall be maintained by the licensee and accessible to all staff members.

C. No licensee who has been issued a license for a particular type of equipment shall establish new care, treatment, procedures, and/or services without first obtaining authorization from the Department. (I)

D. Issuance and Terms of License.

1. A license is issued by the Department and shall be posted in a conspicuous place near the licensed equipment.

2. The issuance of a license does not guarantee adequacy of individual care, treatment, procedures, and/or services, personal safety, fire safety or the well-being of any patient.

3. A license is not assignable or transferable and is subject to revocation at any time by the Department for the licensee's failure to comply with the laws and regulations of this State.

4. Equipment that is licensed pursuant to this regulation and is acquired by a licensed health care facility through purchase, contract, lease, or assuming/obtaining possession, shall be included as a part of the health care facility's license, and the original equipment license shall become null and void.

5. A license shall be effective for specified equipment at a specific location(s) for a specified period following the date of issue as determined by the Department. A license shall remain in effect until the Department notifies the licensee of a change in that status.

6. Equipment owned by the same entity but not located on the same adjoining or contiguous property shall be separately licensed. Roads or local streets, except limited access, e.g., interstate highways, shall not be considered as dividing otherwise adjoining or contiguous property.

7. Multiple types of equipment on the same premises may be licensed separately even though owned by the same entity.

E. Application. Applicants for a license shall submit to the Department a completed application on a form prescribed and furnished by the Department prior to initial licensing and periodically thereafter at intervals determined by the Department. The application includes the applicant's oath, assuring that the contents of the application are accurate and true, and that the applicant will comply with this regulation. The application shall be signed by the owner(s) of the equipment if an individual or partnership; in the case of a corporation, by two of its officers; or in the case of a governmental unit, by the head of the governmental department having jurisdiction. The application shall set forth the type of equipment, including the year, model of equipment, all equipment upgrades, location of the equipment for which the license is sought and of the owner in the event his or her address is different from that of the location of the equipment, and the names of the persons in control of the equipment. A copy of the nonapplicability, exemption, or Certificate of Need shall be included as part of the initial application. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with these regulations. Corporations or limited partnerships shall be registered with the S.C. Office of the Secretary of State.

F. Licensing Fees. The initial and annual license fee shall be $600.00. Such fees shall be made payable by check or money order to the Department and are not refundable. The Department may charge an additional amount, if necessary, to cover the cost of inspection or investigation.

G. Late Fee. Failure to submit a renewal application or fee after the license expiration date may result in a late fee of 25% of the licensing fee amount, in addition to the licensing fee. Continual failure to submit completed and accurate renewal applications and/or fees by the time period specified by the Department may result in an enforcement action.

H. License Renewal. To renew a license an applicant shall file an application with the Department and pay a license fee. If the license renewal is delayed due to enforcement action, the renewal license shall be issued only when the matter has been resolved satisfactorily by the Department or when the adjudicatory process is completed, whichever is applicable. If an application is denied, a portion of the fee shall be refunded based upon the remaining months of the licensure period.

I. Registered Equipment. Licensees utilizing equipment that is required to be registered by the Department's Bureau of Radiological Health shall not be licensed until such equipment is properly registered.

J. Change of License.

1. A licensee shall request issuance of a new or amended license by application to the Department prior to any of the following circumstances:

a. Change of ownership of equipment;

b. Change of types of equipment as shown on the license;

c. Change of equipment location from one geographic site to another.

2. Changes in address (as notified by the post office) shall be accomplished by application or by letter from the licensee.

3. Replacement of equipment shall be accomplished by letter from the licensee.

K. A freestanding or mobile technology license shall not be required for, nor shall such a license be issued to, equipment operated by the federal government.

L. Exceptions to Licensing Standards. The Department has the authority to make exceptions to these standards where it is determined that the health, safety, and well-being of the patients are not compromised and provided the standard is not specifically required by statute.

S.C. Code Regs. § 61-108.100.103

Added by State Register Volume 28, Issue No. 5, eff May 28, 2004.