Ohio Admin. Code 3701-53-07 - Laboratory requirements

(A) Chain of custody and the test results for evidential alcohol, controlled substances, metabolites of a controlled substance and drugs of abuse shall be identified and retained for not less than three years, after which time the documents may be discarded unless otherwise directed in writing from a court. All positive blood, urine, oral fluid and other bodily substances shall be retained according to the laboratory procedure manual for a period of not less than one year from the report date, after which time the specimens may be discarded unless otherwise directed in writing from a court or the submitting agency.

(B) The laboratory shall successfully complete a national proficiency testing program using the applicable techniques or methods for which the laboratory personnel seek a permit under rule 3701-53-10 of the Administrative Code. The designated laboratory director or designee will submit a copy of the proficiency test results to the director or their designee.

(C) The laboratory will have a written procedure manual of all analytical techniques or methods used for testing of alcohol or drugs of abuse in bodily substances. Textbooks and package inserts or operator manuals from the manufacturer may be used to supplement but may not be used in lieu of the laboratory's own procedure manual for testing specimens.

(D) The designated laboratory director will review, sign, and date the procedure manual to certify that the manual is in compliance with this rule. The designated laboratory director will ensure that:

(1) Any changes in a procedure be approved, signed, and dated by the designated laboratory director(s);

(2) The date the procedure was first used and the date the procedure was revised or discontinued is recorded;

(3) A procedure shall be retained for not less than three years after the procedure was revised or discontinued, or in accordance with a written order issued by any court to the laboratory to save a specimen that was analyzed under that procedure;

(4) Laboratory personnel are adequately trained and experienced to perform testing of blood, urine, oral fluid and other bodily substances for alcohol and drugs of abuse and shall ensure, maintain and document the competency of laboratory personnel. The designated laboratory director(s) shall also monitor the work performance and verify the skills of laboratory personnel;

(5) The procedure manual includes the criteria the laboratory shall use in developing standards, controls, and calibrations for the techniques or methods involved; and

(6) At least one copy of the current procedure manual specified in paragraph (C) of this rule for performing blood, urine, oral fluid, or other bodily substance tests shall be available in the area where the analytical tests are performed and followed by laboratory personnel.

(7) Each testing day, the analytical techniques or methods used in rule 3701-53-04 of the Administrative Code will be checked for proper calibration.

(E) Any time the designated laboratory director ceases to serve in that capacity the laboratory will notify the director and another permitted laboratory director or applicant will be designated and approved by the director. If the new designated laboratory director does not hold a valid permit, they will apply for a permit as outlined in rule 3701-53-10 of the Administrative Code.

(F) Tests for alcohol in blood, urine, and other bodily substances shall be performed in a laboratory by a laboratory director or by a laboratory technician. Laboratory personnel shall not perform a technique or method of analysis that is not listed on the laboratory director's permit.

(G) Tests for drugs of abuse in blood, urine, oral fluid and other bodily substances shall be performed in a laboratory by a laboratory director or by a laboratory technician. Laboratory personnel shall not perform a technique or method of analysis that is not listed on the laboratory director's permit.

Replaces: 3701-53-07

Notes

Ohio Admin. Code 3701-53-07

Effective: 1/23/2023
Five Year Review (FYR) Dates: 01/23/2028
Promulgated Under: 119.03
Statutory Authority: 3701.143, 4511.19, 1547.11
Rule Amplifies: 4511.19, 1547.11
Prior Effective Dates: 03/01/1968, 01/01/1987, 05/05/1990, 07/07/1997, 09/14/1997 (Emer.), 12/12/1997, 09/30/2002, 01/08/2009