Or. Admin. R. 333-024-0360 - Special Category Laboratories

Current through Register Vol. 61, No. 4, April 1, 2022

(1) The rules in this section set standards for special category screening laboratories, as authorized in ORS 438.435(4), (6) and (7). These rules apply to the testing of inmates within state and local correctional facilities and to the testing of offenders on parole, probation, or under post-prison supervision.
(2) Special category laboratories as defined in this rule must use only manual or automated substance of abuse screening methods approved by the U.S. Food and Drug Administration. Any alcohol screening test must meet the requirements of the conforming products list found in the United States Department of Transportation National Highway Traffic Safety Administration Docket No. 94-004 and meets the standards of the United States Department of Transportation Alcohol Testing Procedure, 49 C.F.R. part 40, in effect on October 23,1999.
(3) Individuals who perform screening tests for substances of abuse must complete a training course offered by the manufacturer or provider of the test, an educational facility, or training provided by the Department of Corrections Drug Control Unit with curriculum acceptable to the Public Health Division. No testing is to be performed prior to the completion of this training. A certificate of satisfactory completion, including the dates and hours of training completed, shall be kept by the SOA testing program manager at each facility and parole office. A copy shall also be on file with the Drug Control Manager at the Department of Corrections.
(4) Protocols, procedures, and records of all testing shall be maintained as described in this section and shall be followed:
(a) Each local and state correctional facility or parole office shall have a designated substance of abuse program manager who shall assure that:
(A) Written policies established by the Department of Corrections are followed regarding specimen collection, specimen identification, and chain of custody, as defined in OAR 333-024-0310(2);
(B) Written procedure manuals are available to testing individuals, and that the written procedures require following the manufacturer's testing protocol. The written procedures must describe the test limitations and the use of approved standards and quality control, as defined in OAR 333-024-0310(4) and (21).
(C) There is a written record of the:
(i) Date and time the specimen was obtained;
(ii) Date and time the test was performed;
(iii) Lot number of the test kit used, test results, including the results of controls;
(iv) Signature or initials of the analyst.
(b) Quality control procedures as described in this subsection shall be followed:
(A) Each instrument shall be calibrated according to the manufacturer's specifications, with each new lot or shipment of reagents, and after major maintenance;
(B) For manual methods, known positive and negative controls, as defined in OAR 333-024-0310(4), shall be included with each batch of tests or with every ten samples for each analyte of each kit. Known positive and negative controls must be run with each lot shipment, and at least once per month, if internal procedural controls are included with each test;
(C) For automated instruments, a positive and negative control, as defined in OAR 333-024-0310(4) shall be included at least once per day of use, or following each tenth sample analyzed;
(D) All calibration and control data shall be recorded;
(E) The minimum detectable limit of the analytical method for each substance tested shall be available;
(F) Limits for controls shall be clearly stated and recorded. The corrective action taken when analyses are outside these control limits shall be clearly stated and recorded;
(G) No reagent shall be used beyond its expiration date;
(H) A record shall be kept of each testing individuals' quality control performance. This record will be reviewed by the SOA program manager at least every six months;
(I) Each local and state correctional facility, parole, probation, and post prison program shall be required to participate satisfactorily in a proficiency testing program, as defined in OAR 333-024-0310(16). The proficiency testing programs available from the College of American Pathologists, or the American Association of Bioanalysts, or other proficiency testing program acceptable to the Public Health Division may be used;
(J) Proficiency testing results and control data shall be reviewed every six months by the SOA program testing manager, and corrective action shall be taken and documented when appropriate. A copy of the report and corrective action must be sent to the Drug Control Manager of the Department of Corrections for review.
(c) If an initial test shows a result indicating the presence of a substance of abuse in the body, a confirmatory test shall be conducted in a licensed clinical laboratory, or a laboratory certified for that testing under the Clinical Laboratory Improvement Amendments of 1988, Code of Federal Regulations Part 493 -- Laboratory Requirements, or an equivalent out of state laboratory, if the results are to be used to deprive or deny any person of any benefit, probation, or parole except as described in ORS 438.435(7).
(d) If any test for substances of abuse is performed outside this state the results of which are used to deprive or deny any person any benefit, the person desiring to use the test shall have the burden to show that the testing procedure used meets or exceeds the testing standards of this state.

Notes

Or. Admin. R. 333-024-0360
HD 5-1992, f. & cert. ef. 5-15-92; HD 5-1995, f. & cert. ef. 9-13-95; OHD 4-2000, f. & cert. ef. 4-27-00; OHD 9-2000, f. & cert. ef. 11-3-00

Stat. Auth.: ORS 438.050, 438.130, 438.435(4), 438.435(5) & 438.435(6)

Stats. Implemented: ORS 438.435

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