3701-53-06 Laboratory requirements.

(A) Chain of custody and the test results for evidential alcohol 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 and other bodily substances shall be retained in accordance with rule 3701-53-05 of the Administrative Code for a period of not less than one year, after which time the specimens may be discarded unless otherwise directed in writing from a court.

(B) The laboratory shall successfully complete a national proficiency testing program using the applicable technique or method for which the laboratory personnel seek a permit under rule 3701-53-09 of the Administrative Code.

(C) The laboratory shall 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 shall review, sign, and date the procedure manual as certifying that the manual is in compliance with this rule. The designated laboratory director shall ensure that:

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

(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 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 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 technique or method involved; and

(6) A complete and timely procedure manual is available and followed by laboratory personnel.

(E) Any time the designated laboratory director is replaced, another permitted laboratory director or applicant shall be designated and approved by the director.

Effective: 01/08/2009
R.C. 119.032 review dates: 10/22/2008 and 01/01/2014
Promulgated Under: 119.03
Statutory Authority: 3701.143
Rule Amplifies: 3701.143
Prior Effective Dates: 7/7/1997, 9/30/02