S.C. Code Regs. § § 61-64.V.RHB 5.5

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

Section 61-64.V.RHB 5.5 - Suspension or Revocation of Certificates

5.5.1 Except as provided in RHB 5.5.2, the Department may suspend or revoke a certificate if the Department finds that the owner, operator, or any employee of the facility:

5.5.1.1 Has been guilty of misrepresentation in obtaining the certificate;

5.5.1.2 Has failed to comply with the standards of RHB 5.2 through 5.24;

5.5.1.3 Has failed to comply with reasonable requests of the Department or the accreditation body for records, information, reports, or materials that the Department believes are necessary to determine the continued eligibility of the facility for a certificate or continued compliance with the standards of RHB 5.2 through 5.24;

5.5.1.4 Has refused a reasonable request of a duly designated FDA inspector, Department inspector, or accreditation body representative for permission to inspect the facility or the operations and pertinent records of the facility;

5.5.1.5 Has violated or aided and abetted in the violation of any provision of this regulation;

5.5.1.6 Has failed to comply with prior sanctions imposed by the Department; or

5.5.1.7 Has failed to pay any required fees.

5.5.2 The Department may summarily suspend the certificate of a facility if the Department makes a finding described in RHB 5.5.1 and also determines that:

5.5.2.1 The failure to comply with required standards presents a serious risk to human health;

5.5.2.2 The refusal to permit inspection makes immediate suspension necessary;

5.5.2.3 There is a reason to believe that the violation or aiding and abetting of the violation was intentional or associated with fraud; or

5.5.2.4 Makes other finding that public health, safety, or welfare imperatively requires emergency action.

5.5.3 If the Department summarily suspends a certificate in accordance with RHB 5.5.2:

5.5.3.1 Any person to whom an order is issued may appeal it pursuant to applicable law, including S.C. Code Title 44, Chapter 1; and Title 1, Chapter 23;

5.5.3.2 The suspension shall remain in effect until the Department determines that:

5.5.3.2.1 Allegations of violations or misconduct were not substantiated;

5.5.3.2.2 Violations of required standards have been corrected to the Department's satisfaction; or

5.5.3.2.3 The facility's certificate is revoked in accordance with RHB 5.5.4. 5.5.4 The Department may revoke the facility's certificate if the Department determines that the facility:

5.5.4.1 Is unwilling or unable to correct violations that were the basis for suspension; or

5.5.4.2 Has engaged in fraudulent activity to obtain or continue certification.

S.C. Code Regs. § 61-64.V.RHB 5.5

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.