Current through Register Vol. 47, No. 52, December 29, 2023
a) Except as otherwise provided in subsection
(b)(1)(C) and Section
370.40, a certificate
issued by the Agency is required for lawful operation of all mammography
facilities subject to the provisions of this Part. Facilities performing
mammography shall meet the requirements of Sections
370.70,
370.80,
370.90,
370.100,
370.110,
370.120
and
370.130
and be accredited by an FDA-approved accreditation body. Each mammography unit
shall be accredited by or have an application pending for accreditation with an
FDA-approved accrediting body.
AGENCY NOTE: Currently, the only FDA-approved accrediting body
in Illinois is the American College of Radiology.
AGENCY NOTE: Except for provisional certificates and interim
notices, the term of certificates issued under this Section shall be for 3
years.
b) Application.
1) Certificates.
A) In order to qualify for a certificate, a
facility shall apply to an accreditation body.
B) Following the Agency's receipt of the
accreditation body's decision to accredit a facility, the Agency may issue a
certificate to the facility, or renew an existing certificate, if the Agency
determines that the facility has satisfied the requirements for certification
or recertification.
C) An interim
notice authorizes the facility to perform mammography until the facility
receives its certificate but in no case for more than 45 days. No more than one
interim notice may be issued to a facility per application for certification.
The Agency 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 or more of the following circumstances:
i) The Agency 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
take more than 24 hours;
ii) The
Agency has been notified by an accreditation body that the facility has
completed accreditation or reaccreditation and delivery of the certificate to
the facility may take more than 24 hours; or
iii) The Agency 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.
2) Provisional certificates. 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.
A) To receive a provisional certificate, a
facility shall apply and submit the required information to an FDA-approved
accreditation body.
B) Following
the Agency's receipt of the accreditation body's decision that a facility has
submitted the required information, the Agency 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 6 months from the date of issuance. A provisional
certificate cannot be renewed, but a facility may apply for a 90 day extension
of the provisional certificate.
C)
In the event the facility is denied accreditation by the accrediting body with
time remaining on the provisional certificate, the provisional certificate
expires immediately with the denial and the facility must stop performing
mammography.
3)
Extension of provisional certificate.
A) To
apply for a 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.
B)
Following the Agency's receipt of the accreditation body's decision that a
facility has submitted the required information, the Agency may issue a 90 day
extension of the provisional certificate to the facility upon determination
that the facility has satisfied the requirements for the 90 day
extension.
C) There can be no
renewal of a provisional certificate beyond the 90-day extension.
c) Reinstatement
policy. A previously certified facility that has allowed its certificate to
expire, that has been refused a renewal of its certificate by FDA or the
Agency, or that has had its certificate suspended or revoked by FDA or the
Agency, may apply for reinstatement. If reinstated, the facility will be
eligible for a provisional certificate.
1)
Unless prohibited from reinstatement under subsection (c)(4), a facility
applying for reinstatement shall:
A) Contact
an FDA-approved accreditation body to determine the requirements for
reapplication for accreditation;
B)
Fully document its history as a previously provisionally certified or certified
mammography facility, including the following information:
i) Name and address of the facility under
which it was previously provisionally certified or certified;
ii) Name of previous owner/lessor;
iii) Facility identification number assigned
to the facility under its previous certification; and
iv) Expiration date of the most recent
provisional certificate or certificate; and
C) Justify application for reinstatement of
accreditation by submitting to the accreditation body a corrective action plan
that details how the facility has corrected deficiencies that contributed to
the lapse, denial of renewal or revocation of its certificate.
2) The Agency may issue a
provisional certificate to a previously certified facility:
A) Following the Agency's receipt of the
accreditation body's decision that a facility has adequately corrected, or is
in the process of correcting, pertinent deficiencies at the facility;
and
B) The Agency determines that
the facility has taken sufficient corrective action since the lapse, denial of
renewal or revocation of its previous certificate.
3) After receiving the provisional
certificate, the facility may lawfully resume performing mammography services
while completing the requirements for certification.
4) If a facility's certificate was revoked on
the basis of an act described in Section
370.160,
no person who owned or operated that facility at the time the act occurred may
own or operate a mammography facility within 2 years after the date of
revocation.
d) Appeals
of adverse accreditation or reaccreditation decisions. The appeals procedures
described in this subsection (d) are available only for adverse accreditation
or reaccreditation decisions that preclude certification or recertification by
the Agency.
1) Upon learning that a facility
has failed to become accredited or reaccredited, the Agency will notify the
facility that the Agency is unable to certify that facility without proof of
accreditation.
2) A facility that
has been denied accreditation or reaccreditation is entitled to an appeals
process from the accreditation body. A facility shall avail itself of the
accreditation body's appeal process before appealing that decision to the
FDA.
3) In the event that a
facility, after availing itself of the accreditation body's appeal process,
receives an adverse accreditation or reaccreditation decision, the facility may
appeal that decision to the FDA. In order to appeal, the facility shall send a
request for reconsideration to the FDA
Amended at 36 Ill. Reg. 17392, effective November 30,
2012
