TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH SUBCHAPTER d: LABORATORIES AND BLOOD BANKS PART 465 CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES SECTION 465.130 CERTIFICATION PROCEDURE
Section 465.130 Certification Procedure
a) An environmental laboratory that meets or exceeds the minimum criteria for certification may receive certification from the Department for any microbiological parameter for which a methodology has been specified in this Part or for which an alternative methodology has been approved in accordance with the provisions of this Part.
b) The operational aspects of an environmental laboratory that will be evaluated in considering a request for certification are:
1) laboratory facilities,
2) personnel,
3) methodology and instrumentation,
4) data handling, and
5) quality assurance program.
c) In seeking initial certification, whether a new laboratory or a certified laboratory requesting to analyze additional or newly regulated contaminants, the petitioning environmental laboratory shall:
1) Submit a formal request for certification to the Department;
2) File with the Department on the applicable administrative questionnaires furnished by the Department, if available, or otherwise in a form approved by the Department, complete information on the five categories listed in subsection (b);
3) Analyze all proficiency testing samples (PTs) required in accordance with the applicable Sections of this Part and report the results of those analyses to the Department; and
4) Permit and cooperate in an on-site visit by Department-authorized certification officers. Certification officers shall provide the environmental laboratory with official identification and credentials. The initial visit will be arranged at the mutual convenience of both parties. The Department reserves the right to make subsequent visits without prior notice during regular working hours.
d) Initial approval or denial of certification may be made only after the procedure described in subsection (c) has been completed. If all requirements of subsection (c) are satisfactory, initial approval will be granted followed by a written narrative report. Denial of certification shall be in the form of a written narrative, giving information as to how deficiencies may be corrected, along with a completed survey form on which all deficiencies are clearly identified.
e) Biennial audit approval or denial of certification may be made only after the requirements described in subsection (b) have been assessed. If all requirements of subsection (b) are satisfactory, approval will be granted followed by a written narrative report. Denial of certification shall be in the form of a written narrative, giving information as to how deficiencies may be corrected, along with a completed survey form on which all deficiencies are clearly identified.
f) Environmental laboratories in jurisdictions not having reciprocal agreements with the Department under Section 465.240 may receive certification from the Department under this Part and shall pay all of the expenses to be incurred by the Department, including travel expenses.
(Source: Amended at 46 Ill. Reg. 19150, effective November 17, 2022) |