Current through Register Vol. 48, No. 9, September 27, 2024
5.4.1 In order to
qualify for a certificate, a facility shall apply to an FDA-approved
accreditation body.
5.4.2 Following
the Department's receipt of the accreditation body's decision to accredit a
facility, the Department may issue a certificate to the facility, or renew an
existing certificate, if the Department determines that the facility has
satisfied the requirements for certification or recertification.
5.4.3 Provisional Certificates.
5.4.3.1 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.
5.4.3.2 Following the Department's receipt of
the accreditation body's decision that a facility has submitted the required
information, the Department 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 six (6) months from the date of issuance. A provisional certificate cannot
be renewed, but a facility may apply for a ninety (90)-day extension of the
provisional certificate.
5.4.4 Extension of Provisional Certificate.
5.4.4.1 To apply for a ninety (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.
5.4.4.2
Following the Department's receipt of the accreditation body's decision that a
facility has submitted the required information, the Department may issue a
ninety (90)-day extension of the provisional certificate to the facility upon
determination that the facility has satisfied the requirements for the ninety
(90)-day extension.
5.4.4.3 There
can be no renewal of a provisional certificate beyond the ninety (90)-day
extension.
5.4.5 Interim
Notices. The Department 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 (1) or more of the following
circumstances:
5.4.5.1 The Department 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 be delayed;
5.4.5.2
The Department has been notified by an accreditation body that the facility has
completed accreditation or reaccreditation and delivery of the certificate to
the facility may be delayed; or
5.4.5.3 The Department 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.
5.4.5.4 An interim notice shall authorize the
facility to perform mammography until the facility receives its certificate but
in no case for more than forty-five (45) calendar days. No more than one (1)
interim notice may be issued to a facility per application for
certification.
