Or. Admin. Code § 333-064-0035

Current through Register Vol. 63, No. 11, November 1, 2024

Section 333-064-0035 - Approval Requirements

(1) This rule and the TNI Standards describe the procedure for obtaining and maintaining accreditation.

(2) Oregon Environmental Laboratory Accreditation Program (ORELAP) accreditation can be granted, denied, suspended, or revoked in total or in part as described in the TNI Standards.

(a) Reasons to deny an initial application shall include, but are not limited to:

(A) Failure to submit a completed application;

(B) Failure to pay fees;

(C) Failure of laboratory staff to meet the personnel qualifications of education, training, and experience as required by the TNI Standards;

(D) Failure to successfully analyze and report proficiency testing (PT) samples as required by the TNI Standards and these rules;

(E) Failure to respond to an assessment report from an on-site assessment with a corrective action report within 30 calendar days, or failure to respond to deficiencies identified in the first corrective action report review within 30 calendar days, as required by the TNI Standards;

(F) Failure to implement the corrective actions detailed in the corrective action report within the agreed upon time frame;

(G) Failure to implement a quality system as defined in the TNI Standards;

(H) Failure to pass required on-site assessments;

(I) Misrepresentation of any fact pertinent to receiving or maintaining accreditation; or

(J) Denial of entry during the laboratory's normal business hours for an on-site assessment.

(b) Reasons for suspension or revocation in total or in part shall include but are not limited to:

(A) If the accreditation body finds, during the on-site assessment, that the public interest, safety or welfare imperatively requires emergency action;

(B) Failure to complete proficiency testing studies as required by the TNI Standards and these rules;

(C) Failure to notify the accreditation body of any changes in key accreditation criteria defined in the TNI Standards within 35 calendar days of the effective change, including:

(i) General features of the laboratory, including corporate entity, name, addresses, legal status, technical directors and quality managers, and technical resources;

(ii) General information concerning the laboratory such as its activities, its relationship in a larger corporate entity if any, and addresses of all its physical location(s) to be covered by the scope of accreditation;

(D) Failure to maintain a quality system as required by the TNI Standards;

(E) Failure of the laboratory to employ staff that meets qualifications for education, training, and experience as required by the TNI Standards;

(F) Misrepresentation of any fact pertinent to receiving or maintaining accreditation;

(G) Denial of entry to an accreditation body's assessment team during the laboratory's normal business hours for the purpose of conducting an on-site assessment;

(H) Failure to pass an on-site assessment conducted by an accreditation body;

(I) Failure to respond to an assessment report from an on-site assessment with a corrective action report within 30 calendar days, or failure to respond to deficiencies identified in the first corrective action report review within 30 calendar days, as required by the TNI Standards;

(J) Failure to implement the corrective actions detailed in the corrective action report within the agreed upon time frame;

(K) Failure to pay fees;

(L) Failure to maintain licensure by the Oregon Liquor and Cannabis Commission (Commission) under ORS 475C.548 if the laboratory is accredited under ORS 475C.560 for sampling and laboratory testing of marijuana items and industrial hemp-derived vapor items required under ORS 475C.544; or

(M) Failure to maintain licensure by Oregon Psilocybin Services under ORS 475A.594 if the laboratory is accredited under ORS 475A.606 for sampling and laboratory testing of psilocybin products required under ORS 475A.590.

(3) In no case shall a laboratory be accredited that does not comply with the TNI Standards as specified in this rule.

(4) The elements for accreditation shall include but are not restricted to:

(a) Application for accreditation:

(A) ORELAP will make online, electronic applications available to all laboratories requesting an application.

(B) The laboratory must request ORELAP accreditation by completing and submitting to ORELAP an acceptable application that includes all elements as required by the TNI Standards. For primary accreditation this includes a completed application with all required documents. For secondary accreditation this includes a completed application with all of the required documents plus proof of accreditation from a primary accrediting body.

(b) The laboratory's participation in a biennial on-site assessment(s) as required by the TNI Standards. Environmental testing laboratories seeking initial, primary ORELAP accreditation shall not be granted accreditation prior to an acceptable on-site assessment;

(c) The laboratory's participation in PT and the obtaining of acceptable PT results according to the TNI Standards and these rules;

(d) A quality manual (QM) that includes all elements as set forth in the TNI Standards;

(e) Laboratory staff members that meet the TNI Standards for training and experience for their responsibilities within the laboratory;

(f) Creation and retention of all records pertaining to samples and analyses, including chain of custody documents, log books, work sheets, raw data, calculations, quality assurance data, and reports according to TNI Standards; and

(g) The laboratory's full payment of all appropriate fees as described in OAR 333-064-0060.

(5) Laboratories accredited under ORS 475C.560 that fail to obtain licensure with the Commission under ORS 475C.548 in accordance with subsection (5)(a) below, become unlicensed pursuant to subsection (5)(b) below, or otherwise become unlicensed under ORS 475C.548, shall have their accreditation denied or revoked in accordance with ORS chapter 183.

(a) Laboratories that obtain initial accreditation under ORS 475C.560 must submit a complete application for licensure under ORS 475C.548 with the Commission within 30 days of accreditation by ORELAP and must obtain licensure within six months of accreditation. The Oregon Health Authority (Authority) may in its discretion extend the time to obtain initial licensure under ORS 475C.548 by six months upon request by an accredited laboratory due to processing delays with the Commission that are outside the control of the laboratory.

(b) The Authority shall deny accreditation renewal or revoke accreditation of a laboratory that surrenders its license, has its license revoked, is denied renewal of its license, or is otherwise no longer licensed under ORS 475C.548.

(6) Laboratories accredited under ORS 475A.606 that fail to become licensed by the Oregon Psilocybin Services program under ORS 475A.594 in accordance with subsection (6)(a) below, become unlicensed pursuant to subsection (6)(b) below, or otherwise become unlicensed under ORS 475A.594, shall have their accreditation denied or revoked in accordance with ORS chapter 183.

(a) Laboratories that obtain initial accreditation under ORS 475A.606 must submit a complete application for licensure under ORS 475A.594 with Oregon Psilocybin Services within 30 days of accreditation by ORELAP and must obtain licensure within six months of accreditation. The Authority may in its discretion extend the time to obtain initial licensure under ORS 475A.594 by six months upon request by an accredited laboratory due to processing delays with Oregon Psilocybin Services that are outside the control of the laboratory.

(b) The Authority shall deny accreditation renewal or revoke accreditation of a laboratory that surrenders its license, has its license revoked, is denied renewal of its license, or is otherwise no longer licensed under ORS 475A.594.

Or. Admin. Code § 333-064-0035

OHD 7-1999, f. & cert. ef. 10-26-99; OHD 1-2001, f. & cert. ef. 1-17-01; OHD 16-2002, f. & cert. ef. 10-10-02; PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04; PH 20-2003, f. 12-02-03, cert. ef. 12-08-03; PH 8-2005, f. 6-1-05, cert. ef. 7-1-05; PH 6-2011, f. & cert. ef. 8-9-11; PH 37-2020, minor correction filed 05/07/2020, effective 5/7/2020; PH 54-2020, temporary amend filed 06/05/2020, effective 6/5/2020 through 12/1/2020; PH 85-2020, amend filed 12/23/2020, effective 1/1/2021; PH 39-2022, minor correction filed 04/26/2022, effective 4/26/2022; PH 207-2022, amend filed 12/27/2022, effective 12/27/2022; PH 68-2024, amend filed 07/09/2024, effective 7/23/2024

Statutory/Other Authority: ORS 448.150, 448.131, 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560, 475A.590 & 475A.606

Statutes/Other Implemented: ORS 448.280, 438.605, 438.610, 438.615, 438.620, 475C.544, 475C.560, 475A.590 & 475A.606