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Ohio Laws and Rules
(A) Except as provided in paragraphs (H) and (I) of this rule, and except for the performance of real time analysis of lead content in paint film, no person shall provide or offer to provide analysis of lead content in air, dust, soil, paint film or other substances, for the purposes of meeting the requirements set forth in Chapter 3742. of the Revised Code and the rules adopted thereunder, unless that person is approved by the director as an environmental lead analytical laboratory or employed by an environmental lead analytical laboratory approved by the director.
(B) The director shall not approve an application for environmental lead analytical laboratory approval unless the applicant meets all the following criteria:
(1) The applicant submits an application for approval as an environmental lead analytical laboratory on a form prescribed by the director;
(2) The applicant demonstrates successful quarterly performance in the “Environmental lead proficiency analytical testing” (ELPAT) program and is currently accredited by an accrediting organization that participates in the “National lead laboratory accreditation program” (NLLAP) as provided for in P.L. 102-550;
(3) The applicant has paid the approval or annual renewal fee of three hundred dollars;
(4) The applicant demonstrates compliance with the record-keeping and reporting requirements of rule 3701-32-14 of the Administrative Code; and
(5) The applicant certifies that the laboratory will comply with all the requirements of its NLLAP recognition.
(C) If an approved environmental lead analytical laboratory has its NLLAP recognition denied, revoked, suspended or limited, the laboratory shall notify the director within twenty-four hours of that action. The laboratory shall also notify the director within five business days each time the laboratory’s NLLAP accreditation as an environmental lead analytical laboratory is renewed or modified.
(D) An approved environmental lead analytical laboratory shall implement the use of documented methodologies that incorporate adequate control measures when analyzing environmental samples.
(E) Except as provided in paragraph (G) of this rule, no person shall provide or offer to provide analysis of lead content in blood, for the purpose of meeting the requirements set forth in Chapter 3742. of the Revised Code and the rules adopted thereunder, unless that person is approved by the director as a clinical laboratory or employed by a clinical laboratory approved by the director.
(F) The director shall not approve an application for a clinical laboratory unless the applicant meets all the following criteria:
(1) The applicant submits an application for approval as a clinical laboratory on a form prescribed by the director;
(2) The applicant demonstrates possession of a current “Clinical laboratory improvement amendments of 1988” (CLIA) certification by the U.S. department of health and human services as set forth in P.L. 100-578 to perform blood lead testing;
(3) The applicant has paid the approval or annual renewal fee of three hundred dollars;
(4) The applicant demonstrates compliance with the record-keeping and reporting requirements set forth in rules 3701-30-05 and 3701-32-14 of the Administrative Code; and
(5) The applicant certifies that the laboratory will comply with all the requirements of its CLIA accreditation.
(G) If an approved clinical laboratory has its CLIA accreditation revoked, suspended or limited, the laboratory shall notify the director within twenty-four hours of that action. The laboratory shall also notify the director within five business days each time the laboratory’s CLIA certification as a clinical laboratory is renewed or modified.
(H) A laboratory operated by the federal government is exempt from approval by the director as an environmental lead analytical laboratory or a clinical lead laboratory.
(I) A laboratory certified to analyze lead in drinking water by the Ohio environmental protection agency (OEPA) pursuant to Chapter 3745-89 of the Administrative Code is exempt from the requirements of this rule for the purposes of analyzing lead in drinking water.
(J) Approval of an environmental lead analytical laboratory or clinical lead laboratory expires twelve months from the date of issuance.
(K) If at any time an environmental lead analytical laboratory or clinical laboratory does not meet the requirements set forth in Chapter 3742. of the Revised Code or of this rule, the director, in accordance with Chapter 119. of the Revised Code may:
(1) Provided the director has received a complete application for approval, refuse to issue or renew an approval of an environmental lead analytical laboratory or clinical laboratory; or
(2) Suspend or revoke the approval of an environmental lead analytical laboratory or clinical laboratory.
Expiration of approval is not subject to appeal.
(L) For the purposes of this rule, an application is considered complete when the applicant:
(1) Submits a complete application;
(2) Submits all required documentation to the director; and
(3) Pays the application fee.
HISTORY: Replaces former 3701-82-02; Eff 12-30-94 (Emer.); 3-30-95; 3-26-98; 4-15-04
Rule promulgated under: RC 119.03
Rule authorized by: RC 3742.09
Rule amplifies: RC 3742.04, 3742.06, 3742.10, 3742.15, 3742.16, 3742.19
RC 119.032 review dates: 3/26/03, 4/15/09