South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-64 - X-Rays (Title B)
Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY
Section 61-64.V.RHB 5.5 - Suspension or Revocation of Certificates
Universal Citation: SC Code Regs 61-64.V.RHB 5.5
Current through Register Vol. 48, No. 9, September 27, 2024
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.
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