3701-32-14 Record keeping and reporting requirements for environmental lead analytical and clinical laboratories.

(A) An environmental lead analytical laboratory shall send to the director, by first class mail or electronic transfer, a copy of its quarterly proficiency testing results from the ELPAT program within five business days of receiving the results.

(B) A clinical laboratory shall send to the director, by first class mail or electronic transfer, a copy of its proficiency testing results performed pursuant to the CLIA program within five business days of receiving the results.

(C) For the purposes of meeting the requirements of this rule and the requirements in rule 3701-30-05 of the Administrative Code, any clinical laboratory that performs any analysis of human blood, urine or other bodily substance of an Ohio resident to detect or determine levels of lead, cadmium, mercury, or arsenic for each specimen shall collect all of the following information shall submit to the director by electronic transfer, unless otherwise authorized by the director, within seven days of obtaining the results:

(1) Resident's name and parent's or the guardian's name if the resident is less than sixteen years old;

(2) Resident's street and mailing address, including the city, state, county and zip code;

(3) Resident's date of birth, gender, race and ethnicity;

(4) Telephone number, with area code, where the resident can be reached;

(5) Specimen matrix for blood, urine, or other bodily substance;

(6) Analyte for lead, cadmium, mercury, or arsenic;

(7) Procedure used to obtain the specimen and the date it was obtained;

(8) Physician's or healthcare provider's first name, last name, address, telephone number, and national provider identifier, if applicable;

(9) If the resident is employed, employer's name and address;

(10) Resident's medicaid number, if any;

(11) If the resident is under six years of age, the resident's social security number;

(12) CLIA number of the laboratory performing the analysis; and

(13) The accession number, the date the sample was analyzed, and the test result and appropriate units of measurement.

(D) Any physician or healthcare provider requesting analysis of blood, urine, or other bodily substance of an Ohio resident to detect or determine levels of lead, cadmium, mercury, or arsenic shall complete each request for analysis with the information required in paragraphs (C)(1) to (C)(11) of this rule and paragraph (A) of rule 3701-30-05 of the Administrative Code.

Effective: 08/04/2014
R.C. 119.032 review dates: 04/01/2014 and 04/01/2019
Promulgated Under: 119.03
Statutory Authority: 3742.03
Rule Amplifies: 3742.03
Prior Effective Dates: 12/30/1994 (Emer.), 4/9/95, 3/21/98, 6/19/03, 4/1/04, 7/5/09