S.C. Code Regs. § § 61-64.V.RHB 5.4

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

Section 61-64.V.RHB 5.4 - Certificates

5.4.1 In order to qualify for a certificate, a facility shall apply to an FDA-approved accreditation body.

5.4.2 Following the Department's receipt of the accreditation body's decision to accredit a facility, the Department may issue a certificate to the facility, or renew an existing certificate, if the Department determines that the facility has satisfied the requirements for certification or recertification.

5.4.3 Provisional Certificates.

5.4.3.1 A new facility is eligible to apply for a provisional certificate. The provisional certificate will enable the facility to perform mammography and to obtain the clinical images needed to complete the accreditation process.

5.4.3.2 Following the Department's receipt of the accreditation body's decision that a facility has submitted the required information, the Department may issue a provisional certificate to a facility upon determination that the facility has satisfied the requirements for provisional certification. A provisional certificate shall be effective for up to six (6) months from the date of issuance. A provisional certificate cannot be renewed, but a facility may apply for a ninety (90)-day extension of the provisional certificate.

5.4.4 Extension of Provisional Certificate.

5.4.4.1 To apply for a ninety (90)-day extension to a provisional certificate, a facility shall submit to its accreditation body a statement of what the facility is doing to obtain certification and evidence that there would be a significant adverse impact on access to mammography in the geographic area served if such facility did not obtain an extension.

5.4.4.2 Following the Department's receipt of the accreditation body's decision that a facility has submitted the required information, the Department may issue a ninety (90)-day extension of the provisional certificate to the facility upon determination that the facility has satisfied the requirements for the ninety (90)-day extension.

5.4.4.3 There can be no renewal of a provisional certificate beyond the ninety (90)-day extension.

5.4.5 Interim Notices. The Department may issue an interim notice of mammography certification by facsimile to a facility if a delay is anticipated in providing a certificate to the facility under one (1) or more of the following circumstances:

5.4.5.1 The Department has been notified by an accreditation body that the facility meets the requirements for a provisional or provisional reinstatement certificate and delivery of the certificate may be delayed;

5.4.5.2 The Department has been notified by an accreditation body that the facility has completed accreditation or reaccreditation and delivery of the certificate to the facility may be delayed; or

5.4.5.3 The Department has been notified by an accreditation body that the facility has timely submitted an application for accreditation or reaccreditation but the completion of the accreditation process may extend beyond the expiration date of a facility's existing certificate through no fault of the facility.

5.4.5.4 An interim notice shall authorize the facility to perform mammography until the facility receives its certificate but in no case for more than forty-five (45) calendar days. No more than one (1) interim notice may be issued to a facility per application for certification.

S.C. Code Regs. § 61-64.V.RHB 5.4

Replaced and amended by State Register Volume 40, Issue No. 06, eff. 6/24/2016; State Register Volume 47, Issue No. 05, eff. 5/26/2023.