OAR 333-024-0335
Testing for Substances of Abuse: 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.

Source: Rule 333-024-0335 — Testing for Substances of Abuse: Internal Quality Assurance, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0335.

333–024–0005
Purpose 333–024–0010
Definitions 333–024–0012
Licensure 333–024–0016
Licensure Categories 333–024–0020
Licensure for Performance of Laboratory Specialties 333–024–0021
Qualifications and Responsibilities of Directors for High Complexity Laboratories 333–024–0022
Qualifications and Responsibilities for Director of Moderate Complexity Laboratories 333–024–0023
Qualifications and Responsibilities of Consultants, Supervisors and Testing Personnel for Moderate and High Complexity Laboratories 333–024–0026
Equipment and Facilities 333–024–0035
Internal Quality Control for Moderate and High Complexity Laboratories 333–024–0037
Specialty and Subspecialty Quality Control 333–024–0040
External Quality Control (Proficiency Testing Programs and On-Site Inspections) 333–024–0043
Quality Assurance 333–024–0045
Venereal Disease Testing 333–024–0050
Records and Reports 333–024–0053
Accreditation Organizations and Accredited Laboratories 333–024–0055
Incompetence 333–024–0260
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Purpose 333–024–0265
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Procedure 333–024–0305
Testing for Substances of Abuse: Purpose and Scope 333–024–0310
Testing for Substances of Abuse: Definitions 333–024–0315
Testing for Substances of Abuse: Licensure 333–024–0320
Testing for Substances of Abuse: Qualifications and Responsibilities of Directors 333–024–0325
Testing for Substances of Abuse: Incompetence 333–024–0330
Testing for Substances of Abuse: Specimen Collection, Chain of Custody, Records, and Reports 333–024–0335
Testing for Substances of Abuse: Internal Quality Assurance 333–024–0340
Testing for Substances of Abuse: External Quality Control (Proficiency Testing Program and On-Site Inspections) 333–024–0345
Testing for Substances of Abuse: Confirmatory Testing 333–024–0350
Testing for Substances of Abuse: Equipment and Facilities 333–024–0360
Testing for Substances of Abuse: Special Category Laboratories 333–024–0365
Testing for Substances of Abuse: Substance of Abuse Registration 333–024–0370
Health Screen Testing: Purpose 333–024–0375
Health Screen Testing: Definitions 333–024–0380
Health Screen Testing: Permits 333–024–0385
Health Screen Testing: Testing Site Schedule 333–024–0390
Health Screen Testing: Personnel Qualifications and Responsibilities 333–024–0395
Health Screen Testing: Tests Performed 333–024–0400
Health Screen Testing: Quality Assurance 333–024–1000
Newborn Screening: Purpose 333–024–1010
Newborn Screening: Definitions 333–024–1020
Newborn Screening: Persons Responsible for Ensuring that First Specimens are Collected and Submitted 333–024–1025
Newborn Screening: Persons Responsible for Ensuring that Second, Third and Repeat Specimens are Collected and Submitted 333–024–1030
Newborn Screening: Timing for Collecting Specimens 333–024–1040
Newborn Screening: Manner of Submitting Specimens 333–024–1050
Newborn Screening: Religious Exemption from Newborn Testing 333–024–1060
Newborn Screening: Improperly Collected Specimens 333–024–1070
Newborn Screening: The Newborn Screening Panel and Methods of Testing 333–024–1080
Newborn Screening: Result Reporting and Follow-up 333–024–1090
Newborn Screening: Use, Release and Retention of Residual Specimens 333–024–1100
Newborn Screening: Ordering Specimen Collection Kits and Fees 333–024–1110
Newborn Screening: Failure to Comply 333–024–2000
Fees for Communicable Disease Tests Performed in the State Laboratory
Last Updated

Jun. 8, 2021

Rule 333-024-0335’s source at or​.us