S.C. Code Regs. 61-97.100.102 - Licensure. (II)

Current through Register Vol. 46, No. 3, March 25, 2022

A. No person, partnership, corporation, private or public organization, political subdivision or other governmental agency shall establish, operate, maintain, or represent itself (advertise or market) as a Renal Dialysis Facility in South Carolina without first obtaining a License from the Department. The Facility shall not admit Patients prior to the effective date of the License. When it has been determined by the Department that treatment, care, or services are being provided at a location, and the owner has not been issued a license from the Department to provide such treatment, care and services the owner shall cease operation immediately and ensure the safety, health, and well-being of the Patients. Current or previous violations of South Carolina Code or Department regulations may jeopardize the issuance of a License for the Facility or the licensing of any other Facility, or addition to an existing Facility that is owned and/or operated by the Licensee. The Facility shall provide only the treatment, care, and services it is licensed to provide pursuant to the definition in Section 101.QQ. (I)
B. A Renal Dialysis Facility License shall not be required for, nor shall such a License be issued to:
1. Facilities operated by the federal government.
2. Renal dialysis services provided in licensed hospitals (such services remain within the purview of R.61-16, Minimum Standards for Licensing Hospitals and Institutional General Infirmaries).
C. Compliance. An initial License shall not be issued to a proposed Facility until the Licensee applicant has demonstrated to the Department that the proposed Facility is in substantial compliance with this regulation. In the event a Licensee who already has a Facility or activity licensed by the Department makes application for another Facility or an increase in Licensed Capacity, the currently licensed Facility or activity shall be in substantial compliance with the applicable standards prior to the Department issuing a License to the proposed Facility or an amended License to the existing Facility. A copy of licensing standards shall be maintained at the Facility and accessible to all staff members and volunteers. Facilities shall comply with applicable local, state, and federal laws, codes, and regulations.
D. Licensed Dialysis Stations. No Facility that has been authorized to provide a set number of licensed stations, as identified on the face of the License, shall exceed the Licensed Capacity. No Facility shall establish new care or services or occupy additional Stations or renovated space without first obtaining authorization from the Department.
E. Issuance and Terms of License.
1. The License issued by the Department shall be posted in a conspicuous place in a public area within the facility.
2. The issuance of a license does not guarantee adequacy of individual care, services, personal safety, fire safety, or the well-being of any patient or occupant of a facility.
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. A license shall be effective for a specified facility, at a specific location, 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.
5. Facilities owned by the same entity but which are not located on the same adjoining or contiguous property shall be separately licensed. Roads or local streets, except limited access, shall not be considered as dividing otherwise adjoining or contiguous property. For facilities owned by the same entity, separate licenses are not required for separate buildings on the same or adjoining grounds where a single level or type of care is provided.
6. Multiple types of facilities on the same premises shall be licensed separately even though owned by the same entity.
F. Facility Name. No proposed Facility shall be named, nor shall any existing facility have its name changed to, the same or similar name as any other facility licensed in South Carolina.
G. Application. Applicants for a License shall submit to the Department a complete and accurate 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 shall be signed by the owner(s) if an individual or partnership; by two (2) officers if a corporation; or by the head of the governmental department having jurisdiction if a governmental unit. Corporations or limited partnerships, limited liability companies or any other organized business entity shall be registered with the S.C. Secretary of State's Office if required to do so by state law. (II)
H. The application for initial licensure shall include:
1. The application shall set forth the full name and address of the Facility for which the License is sought and of the owner in the event his or her address is different from that of the Facility, and the names of the persons in control of the Facility. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with this regulation;
2. The applicant's oaths assuring that the contents of the application are accurate and true, and that the applicant will comply with this regulation;
3. Proof of ownership of real property in which the Facility is located, or lease agreement allowing the Licensee to occupy the real property in which the Facility is located;
4. Verification of Administrator's qualifications;
5. Name of director of nursing services; and
6. Number of renal dialysis Stations.
I. Licensing Fees. Each applicant shall pay an Annual License fee prior to issuance of a License. The Annual fee shall be two hundred dollars ($200.00) for the first ten (10) Stations and twenty dollars ($20.00) for each additional Station. Annual licensing fees shall also include any outstanding inspection fees. All fees are non-refundable, shall be made payable by check or credit card to the Department or online, and shall be submitted with the application. (II)
J. Licensing Late Fee. Failure to submit a renewal application and fee to the Department by the license expiration date shall result in a late fee of seventy-five dollars ($75.00) or twenty-five percent (25%) of the licensing fee amount, whichever is greater, in addition to the licensing fee. Failure to submit the licensing fee and licensing late fee to the Department within thirty (30) days of the license expiration date shall render the Facility unlicensed. (II)
K. License Renewal. For a License to be renewed, applicants shall submit a complete and accurate application on a form prescribed and furnished by the Department, shall pay the License fee, and shall not have pending enforcement actions by the Department. If the License renewal is delayed due to enforcement actions, the renewal License shall be issued only when the matter has been resolved by the Department, or when the adjudicatory process is completed, whichever is applicable.
L. Amended License. A Facility shall request issuance of an amended license by application to the Department prior to any of the following circumstances:
1. Addition of Renal Dialysis Station or any part thereof; including:
a. Chronic Hemodialysis Stations;
b. Home Hemodialysis Training Stations; or
c. Peritoneal Stations;
2. Change of Facility location from one geographic site to another;
3. Change in Facility name or address (if notified by post office the address has changed)
M. Change of Licensee. A Facility shall request issuance of a new License by application to the Department prior to a change of the legal entity, for example, sole proprietorship to or from a corporation, or partnership to or from a corporation, even if the controlling interest does not change.
N. The licensee shall notify the Department, in a means as determined by the Department, of a change in controlling interest even if, in the case of a corporation or partnership, the legal entity retains its identity and name.
O. Variance. A variance is an alternative method that ensures the equivalent level of compliance with the standards in this regulation. The Facility may request a variance to this regulation in a format as determined by the Department. Variances shall be considered on a case by case basis by the Department. The Department may revoke issued variances as determined to be appropriate by the Department.


S.C. Code Regs. 61-97.100.102
Added by State Register Volume 44, Issue No. 06, eff. 6/26/2020.

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