Okla. Admin. Code § 252:307-3-3

Current through Vol. 42, No. 6, December 2, 2024

Section 252:307-3-3 - Operational information

The application for primary accreditation shall include the following:

(1) A report of an onsite assessment conducted by the DEQ or a DEQ approved assessor within the eighteen (18) months prior to the date of filing or, for in-state laboratories only, a letter requesting the DEQ to conduct an on-site assessment. The assessment report shall verify data submitted in an application, list any deficiencies and be signed by the DEQ or DEQ approved assessor.

(2) A listing of equipment to be used for sample analysis, storage and reporting.

(3) Standard Operating Procedures (SOPs) for every analyte or method performed by the laboratory. An SOP may be a copy of a published or referenced method or may be written by the laboratory. Each SOP shall include or reference the following topics, as applicable:

(A) Identification of the method;

(B) Applicable matrix or matrices;

(C) Limits of detection and quantitation;

(D) Scope and application, including parameters to be analyzed;

(E) Summary of the method;

(F) Definitions;

(G) Interferences;

(H) Safety;

(I) Equipment and supplies;

(J) Reagents and standards;

(K) Sample collection, preservation, shipment and storage;

(L) Quality control;

(M) Calibration and standardization;

(N) Procedure;

(O) Data analysis and calculations;

(P) Method performance;

(Q) Pollution prevention;

(R) Data assessment and acceptance criteria for quality control measures;

(S) Corrective actions for out-of-control data;

(T) Contingencies for handling out-of-control or unacceptable data;

(U) Waste management;

(V) References; and

(W) Any tables, diagrams, flowcharts and validation data.

(4) A written quality manual which shall meet all requirements, for inclusion or reference, of the TNI Standard.

(5) A statement of personnel qualifications showing that laboratory employees meet the applicable personnel requirements of the TNI Standard. Educational requirements will be considered only if awarded by an accredited institution of higher education.

(6) Results of laboratory's two most recent proficiency testing rounds, at least 15 calendar days apart. All PT laboratory records shall be made readily available prior to and during on-site assessments of the laboratory.

(7) If deficiencies are listed in an assessment report, the applicant shall submit a corrective action plan which specifies deadlines for implementation and completion of the plan. The DEQ may establish conditions, including compliance schedules, for the applicant's corrective action plan.

Okla. Admin. Code § 252:307-3-3

Adopted by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 9/15/2015