§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.

 

(Source:  Amended at 29 Ill. Reg. 20963, effective December 16, 2005)