Current through Register Vol. 48, No. 38, September 20, 2024
a) Primary
Accreditation. The Agency shall issue initial or renewal primary accreditation
if the laboratory has met the following criteria:
1) completed the application process as
specified in Section
186.130;
2) paid the fees required by 35 Ill. Adm.
Code 185;
3) employs qualified
personnel, as required by the TNI Standard;
4) implemented and maintains a quality
system, as required by the TNI Standard;
5) successfully analyzed proficiency testing
samples, as required by this Part and the TNI Standard;
6) passed an on-site assessment, as required
by this Part and the TNI Standard; and
7) implemented corrective action detailed in
a corrective action report, if any.
b) Secondary Accreditation. The Agency will
issue initial or renewal secondary accreditation if the laboratory has met the
following criteria:
1) completed the
application process as specified in Section 186.130;
2) paid the fee required by 35 Ill. Adm. Code
185; and
3) submitted evidence of
primary accreditation from a NELAP accreditation body.
c) Laboratory accreditation issued pursuant
to this Part is valid for one year and may be renewed on an annual
basis.
d) When an accredited
laboratory has made a timely and complete application for the renewal of
accreditation pursuant to this Section, the existing accreditation shall
continue in full force and effect until the final Agency decision on the
application has been made, unless a later date is fixed by order of the Board
or a reviewing court. An application will be considered timely only when
received by the Agency prior to the expiration of the laboratory's
accreditation.
e) Accreditation
remains in effect until:
1) suspended or
revoked by the Agency according to the TNI Standard;
2) withdrawn at the written request of the
accredited laboratory; or
3) the
accreditation expires.
f) An accredited laboratory may make a
written request to add to its scope of accreditation. The Agency will conduct
an on-site assessment if the additional fields of testing or test methods
require the use of a chemical process, an analytical process, instrument or
piece of equipment that the laboratory has not been previously accredited to
use.
g) Laboratories shall post or
display their most recent certificate of accreditation and scope of
accreditation in a prominent place in the laboratory facility.
h) A laboratory shall notify the Agency in
writing within 30 days after a change of any matter that may affect the ability
of the laboratory to fulfill the requirements for accreditation, including, but
not limited to, any change in the following:
1) its legal, commercial, ownership or
organizational status;
2) the
organization, top management and key personnel, including, but not limited to,
laboratory director, quality assurance officer, supervisor, analyst;
3) main policies, including, but not limited
to, its quality system;
4)
resources and premises, including, but not limited to, a major remodeling of a
laboratory or relocation of the physical facility.
i) Transfer of Accreditation
1) Accreditation shall be transferrable when
the following conditions are in effect:
A) the
transferring owner agrees in writing with the transferee, before the transfer
of ownership takes place, to be accountable and liable for any analyses, data
and reports generated up to the time of legal transfer of ownership;
and
B) the transferee agrees in
writing with the transferring owner to be accountable and liable for any
analyses, data and reports generated after the legal transfer of ownership
occurs.
2) The
laboratory shall submit a copy of the agreement entered under subsection (i)(1)
to the Agency prior to transfer of ownership.
3) Transfer of accreditation pursuant to this
subsection (i) will not alter the laboratory's accreditation status or scope of
accreditation.
4) If ownership is
transferred, the transferee will not be responsible for payment of fees to the
Agency during the remainder of the yearly period, provided that the
transferring owner has fully paid the required fees to the Agency pursuant to
35 Ill. Adm. Code 185.
