Or. Admin. Code § 333-024-0335

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-024-0335 - Internal Quality Assurance

(1) Laboratory procedure manuals and relevant texts of appropriate current laboratory methods shall be available for the use of the personnel in the laboratory.

(2) Each instrument system shall be calibrated according to the manufacturer's specifications and the calibrations shall be checked and recorded at intervals compatible with the proper operation of that instrument.

(3) Quality control requirements:

(a) Automated: At least one positive and one negative standard or control shall be included with the frequency recommended by the manufacturer; or at a frequency documented to assure the stability of the analytical method; but no less than once per day of testing.

(b) Manual:

(A) Test kits without positive and negative procedural controls, the laboratory must run at least one positive and one negative standard or control each day of testing for each analyte;

(B) Test kits with positive and negative procedural controls, the laboratory must run at least one positive and one negative standard or control with each lot/shipment and at least once per month for each analyte tested. Results of internal procedural controls must be documented with each sample tested.

(4) A permanent logbook or computer printout shall be kept and include patient/client name or unique identifier, date of test performance, quality control, reagent lot number, temperature, testing analyst, screening result and evidence for referral for confirmation, if applicable.

(5) Each analyst must annually demonstrate testing proficiency and interpretive competency for each analyte tested by proficiency testing internal blind samples.

(6) For each method, the minimum detectable limit for each substance tested must be on the report or in a letter of agreement between the laboratory and the client.

(7) Cutoffs at the minimal detectable range must be verified with a control when there is a lot change or major instrument maintenance.

(8) For each method, whether automated or manual, data shall be recorded and available to document the results on routine precision.

(9) 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. The control limits shall be set so that reliable results are assured. Values for standards shall be clearly stated and recorded.

(10) Quality control results shall be recorded and retained in the laboratory for 2 years.

(11) Solid and liquid reagents, reagent solutions, standards and controls, if prepared in the laboratory, shall be calibrated and dispensed in a manner so as to ensure accuracy of results.

(12) All reagents and solutions shall be labeled to indicate identity, preparation date, expiration date, lot number, and storage conditions. No reagents or solutions may be used beyond their expiration date.

(13) The laboratory shall have a written procedure for chain of custody.

Or. Admin. Code § 333-024-0335

HD 28-1988, f. & cert. ef. 12-7-88; HD 20-1994, f. & cert. ef. 7-20-95; HD 6-1995, f. & cert. ef. 9-13-95; HD 13-1997, f. & cert. ef. 10-16-97; OHD 9-2000, f. & cert. ef. 11-3-00

Stat. Auth.: ORS 438.435

Stats. Implemented: ORS 438.320 & 438.435