Ill. Admin. Code tit. 32, § 370.160 - Suspension, Revocation or Denial of Certificates
a) The Agency may suspend, revoke or deny a
certificate if the Agency finds that the owner, operator or any employee of the
facility:
1) Has been guilty of
misrepresentation in obtaining the certificate;
2) Has failed to comply with the standards of
Sections
370.70,
370.80,
370.90,
370.100,
370.110,
370.120
and
370.130
of this Part;
3) Has failed to
comply with reasonable requests of the Agency or the accreditation body for
records, information, reports, or materials that the Agency believes are
necessary to determine the continued eligibility of the facility for a
certificate or continued compliance with the standards of Sections 370.70,
370.80, 370.90, 370.100, 370.110, 370.120, 370.130 and 370.140 of this
Part;
4) Has refused a reasonable
request of a duly designated FDA inspector, Agency inspector, or accreditation
body representative for permission to inspect the facility or the operations
and pertinent records of the facility;
5) Has violated or aided and abetted in the
violation of any provision of this Part;
6) Has failed to comply with prior sanctions
imposed by the Agency; and
7) Has
failed to pay any required fees.
b) If, based upon any of the grounds in
subsection (a) of this Section, the Agency determines that action to suspend,
revoke or deny certification is warranted, the Agency shall notify the owner or
operator of a facility and shall provide an opportunity for hearing in
accordance with 32 Ill. Adm. Code 200.
c) The Agency may suspend the certificate of
a facility before holding a hearing if the Agency determines that:
1) The failure to comply with required
standards presents a serious risk to human health;
2) The refusal to permit inspection makes
immediate suspension necessary; or
3) There is reason to believe that the
violation or aiding and abetting of the violation was intentional or associated
with fraud.
d) If the
Agency suspends a certificate in accordance with subsection (c) of this
Section:
1) The Agency shall provide the
facility with an opportunity for a hearing under 32 Ill. Adm. Code 200 not
later than 30 days after the effective date of the suspension;
2) The suspension shall remain in effect
until the Agency determines that:
A)
Allegations of violations or misconduct were not substantiated;
B) Violations of required standards have been
corrected to the Agency's satisfaction; or
C) The facility's certificate is revoked in
accordance with subsection (e) of this Section.
e) After providing a hearing in accordance
with subsection (d)(1) of this Section, the Agency may revoke the facility's
certificate if the Agency determines that the facility:
1) Is unwilling or unable to correct
violations that were the basis for suspension; or
2) Has engaged in fraudulent activity to
obtain or continue certification.
Notes
Amended at 29 Ill. Reg. 20963, effective December 16, 2005
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