SECTION 310:638-5-6. Records and procedure manual

(a)   Records. The drug screen testing facility shall maintain and make available for at least two (2) years documentation of all aspects of the testing process.

(1)   The required documentation shall include:

(A)   personnel files on all individuals authorized to have access to specimens;

(B)   chain of custody documents;

(C)   quality assurance/quality control records;

(D)   procedure manuals;

(E)   all test data, including calibration curves and any calculations used in determining test results;

(F)   reports;

(G)   performance records on proficiency testing;

(H)   performance on certification inspections; and

(I)   hard copies of computer-generated data or another read-only computerized data storage system that produces exact duplicates of the reported result.

(2)   The drug screen testing facility shall maintain documents for any specimen under legal challenge for an indefinite period.

(b)   Procedure manual. Each drug screen testing facility shall have a procedure manual which includes the principles of each test, preparation of reagents, standards and controls, calibration procedures, derivation of results, linearity of methods, sensitivity of the methods, cutoff values, mechanisms for reporting results, controls, criteria for unacceptable specimens and results, remedial actions to be taken when the test systems are outside of acceptable limits, reagents and expiration dates, and references. Copies of all procedures and dates on which they are in effect shall be maintained as part of the manual.

[Source: Added at 11 Ok Reg 4339, eff 7-14-94 (emergency); Added at 12 Ok Reg 517, eff 12-12-94 (emergency); Added at 12 Ok Reg 3069, eff 7-27-95; Amended at 17 Ok Reg 381, eff 11-1-99 (emergency); Amended at 17 Ok Reg 2045, eff 6-12-00]