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The Oregon Administrative Rules contain OARs filed through January 15, 2010

DEPARTMENT OF HUMAN SERVICES, PUBLIC HEALTH DIVISION

DIVISION 64

ACCREDITATION OF LABORATORIES

333-064-0005

Purpose

These rules are for the purpose of implementing Oregon Revised Oregon Statutes (ORS) 438.605 to 438.620, 448.280 and the Oregon Drinking Water Quality Act of 1981. ORS 438.610 states that the Oregon Department of Human Services shall by adopting standards in concurrence with the Accrediting Authority, implement an environmental laboratory accreditation program hereafter referred to as the Oregon Environmental Laboratory Accreditation Program (ORELAP). These rules establish requirements for the accreditation of laboratories analyzing environmental samples under the guidance of the Clean Air Act (CAA), Clean Water Act (CWA), Safe Drinking Water Act (SDWA), and the Resource, Conservation and Recovery Act (RCRA). The Oregon Department of Human Services shall accept ORELAP accreditation for 448.150(1) that states that water samples from public water systems shall be analyzed in a laboratory approved by the Oregon Department of Human Services.

Stat. Auth.: ORS 448.150(1), 448.131, 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620
Stats. Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 &.620
Hist.: OHD 7-1999, f. & cert. ef. 10-26-99; 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

333-064-0010

Scope

(1) These rules apply to environmental laboratories seeking accreditation and performing environmental testing.

(2) Accreditation as described in these rules is required for all environmental laboratories reporting drinking water analysis results to the Oregon Department of Human Services except for Oregon Department of Agriculture Laboratory, Oregon Department of Environmental Quality Laboratory and the Office of Oregon State Public Health Laboratories which must be certified by the United States Environmental Protection Agency for drinking water analysis.

333-064-0015

Adoption by Reference

All standards, listings and publications referred to in these rules are, by those references, made a part of these rules as though fully set forth. Copies are available through the Oregon Department of Human Services, Office of the Oregon State Public Health Laboratories.

333-064-0020

Severability

These rules are severable. If any rule or part thereof or the application of such rule to any person or circumstance is declared invalid, that invalidity shall not affect the validity of any remaining portion of these rules.

Stat. Auth.: ORS 448.150(1) & 448.131, 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620
Stats. Implemented: ORS 448.280(1)(b)(2), 438.605, 438.610, 438.615 & 438.620
Hist.: OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0025

Definitions

As used in these rules, unless the context indicates otherwise:

(1) "Accrediting Authority" means the official accrediting authority for the Oregon Environmental Laboratory Accreditation Program comprised of the Administrator of the Office of Oregon State Public Health Laboratories or designee, the Laboratory Administrator of the Department of Environmental Quality or designee and the Laboratory Administrator of the Department of Agriculture or designee.

(2) "Clean Air Act (CAA)" means the enabling legislation, 42 U.S.C. 7401 et seq. (1974), Public Law 91-604, 84 Stat. 1676 Public Law 95-95, 91 Stat., 685 and Public Law 95-190, 91 Stat., 1399, that empowers the EPA to promulgate air quality standards, monitor and enforce them.

(3) "Clean Water Act (CWA)" means the enabling legislation under 33 U.S.C. 1251 et seq., Public Law 92-50086, Stat. 816 that empowers the EPA to set discharge limitations, write discharge permits, monitor and bring enforcement action for non-compliance.

(4) "Environmental laboratory" means a fixed location or mobile facility that analyzes environmental samples in a controlled and scientific manner.

(5) "National Environmental Laboratory Accreditation Conference (NELAC)" means the voluntary organization of state and federal environmental officials and interest groups purposed primarily to establish mutually acceptable standards for accrediting environmental laboratories.

(6) "National Environmental Laboratory Accreditation Program (NELAP)" means the program established and administered by the EPA to oversee the implementation of the NELAC Standards.

(7) "NELAC Standards" means the adopted June 2003 NELAC Standards (EPA/600/R-04/003), documents describing the elements of laboratory accreditation that was developed and established by the consensus principles of NELAC and meets with the approval requirements of NELAC procedures and policies.

(8) "NELAP approved accrediting authority" means a state or federal department/agency that has been approved by NELAP as being an entity whose accreditation and assessment program meets all of the requirements of the NELAC Standards.

(9) "On-site assessment" means an on-site visit to the environmental laboratory to verify items addressed in the ORELAP application and to evaluate the facility and analytical performance for conformance with the NELAC Standards.

(10) "ORELAP approved assessor" means an assessor whose qualification has been evaluated by ORELAP and found to meet NELAC Standards for laboratory on-site assessors.

(11) "Primary Accreditation" means accreditation by a NELAP approved accrediting authority based on a laboratory's compliance to NELAC Standards after a review of the laboratory's application, Quality Manual, PT results and on-site inspection results as described in the NELAC Standards.

(12) "Proficiency testing (PT)" means the analysis of samples obtained from providers that meet the NELAC standards for PT providers. The composition of the sample is unknown to the laboratory performing the analysis, and is used in part to evaluate the ability of the laboratory to produce precise and accurate results.

(13) "Public water system" means a water system as defined in OAR 333-061-0010.

(14) "Quality Manual (QM)" means a document stating the management policies, objectives, principles, organizational structure and authority, responsibilities, accountability, and implementation of a laboratory to ensure the quality of its product and the utility of its product to its users.

(15) "Resource Conservation and Recovery Act (RCRA)" means the enabling legislation 42 U.S.C. section 6901 et seq. (1976) that requires the EPA to protect human health and protecting and monitoring the environment by regulating hazardous waste disposal practices.

(16) "Safe Drinking Water Act (SDWA)" means the SDWA enacted in 1974 and the Safe Drinking Water Amendments of 1986, 42 U.S.C. 300f et seq., Public Law 93-523, that is the enabling legislation that requires the EPA to protect the quality of drinking water in the U.S. by setting maximum allowable contaminant levels, monitoring, and enforcing violations.

(17) "Secondary Accreditation" means the recognition by reciprocity for the fields of testing, methods and analytes for which the laboratory holds current primary accreditation by another NELAP recognized accrediting authority.

(18) "These rules" means the Oregon Administrative Rules encompassed by OAR 333-064-0005 through 333-064-0065.

(19) "Third party assessor" means an ORELAP approved assessor who has a current contract with the Oregon Department of Human Services to perform on-site assessments of laboratories for ORELAP and is not employed by the state agencies comprising ORELAP's accrediting authority.

(20) "United States Environmental Protection Agency (EPA)" means the federal government agency with the responsibility for protecting public health and safeguarding and improving the natural environment (i.e., air, water, and land) upon which human life depends.

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: ORS 184, 438.605, 438.610, 438.615, 438.620, 448.131, 448.150(1), 448.280(1)(b) & (2)
Stats. Implemented: ORS 438.605, 438.610, 438.615, 438.620, 448.280(1)(b) & (2)
Hist.: 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 5-2003, f. 5-15-03, cert. ef. 7-1-03; 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 23-2004, f. & cert. ef. 7-1-04; PH 8-2005, f. 6-1-05, cert. ef. 7-1-05

333-064-0030

Schedule for Requesting Accreditation, Period of Accreditation

(1) Laboratories in Oregon will be considered to be accredited by ORELAP after the laboratory has requested accreditation, been evaluated by ORELAP and has met all criteria in accordance with OAR 333-064-0035.

(2) The accreditation period for each laboratory is for one year with subsequent accreditation periods beginning from the first day the laboratory is granted accreditation.

(3) Laboratories must reapply for ORELAP approval annually, with the application to be received by ORELAP 120 calendar days prior to the expiration of the current accreditation period.

(4) ORELAP-accredited laboratories may apply for accreditation of additional parameters at any time during their accreditation period with accreditation for such parameters expiring with the current accreditation period.

Stat. Auth.: ORS 448.150(1), 448.131, 448.280(1)(b) & (2), 438.610 & 438.615
Stats. Implemented: ORS 438.605, 438.610 & 438.615
Hist.: 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

333-064-0035

Approval Requirements

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

(2) ORELAP accreditation can be granted, denied, suspended, or revoked in total or in part as described in the NELAC Standards.

(3) In no case shall a laboratory be accredited that does not comply with the NELAC 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 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 NELAC 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 authority.

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

(c) Laboratory's participation in Proficiency Testing (PT) and the obtaining of acceptable PT results according to the NELAC Standards;

(d) A Quality Manual (QM) that includes all elements as set forth in the NELAC Standards;

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

(g) Laboratory's full payment of all appropriate fees as described in section 333-064-0060 of this rule.

Stat. Auth.: ORS 448.150(1), 448.131, 448.280(1)(b)(2), 438.605, 438.610, 438.615 & 438.620
Stats. Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 620
Hist.: 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

333-064-0040

Action Response for Laboratory Drinking Water Analysis Results

(1) The laboratory must notify the water system and, if authorized by the public water system, the Oregon Department of Human Services of all valid sample results that exceed the maximum contaminant levels in OAR 333-061-0030 within one working day.

(2) The laboratory must notify the public water system and, if authorized by the water system, the Oregon Department of Human Services of all unregulated contaminants detected and their concentrations from each specific method used to measure the regulated contaminants.

(3) The laboratory must use report forms that have been approved by the Oregon Department of Human Services for reporting drinking water test results to the Oregon Department of Human Services.

Stat. Auth.: ORS 184, 448.150(1) & 448.131
Stats. Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 &.620
Hist.: OHD 7-1999, f. & cert. ef. 10-26-99; 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

333-064-0045

Procedure for Contesting Actions of ORELAP

The procedure for contesting the actions of ORELAP regarding denial, suspension and revocation of accreditation, or other changes in accreditation status is in accordance with the Administrative Procedures Act, ORS 183.

Stat. Auth.: ORS 131 & 448.150(1) & 448.131, 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620
Stats. Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620
Hist.: OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0050

Accreditation of Out-of-State Laboratories

(1) ORELAP shall accredit out-of-state laboratories that are eligible for reciprocal accreditation provided:

(a) The laboratory is accredited by a state recognized as a NELAP accrediting authority for those fields of testing in which the laboratory is requesting accreditation pursuant to this rule.

(b) The laboratory submits to ORELAP an acceptable application as described in section 333-064-0035(4) of this rule.

(2) ORELAP may accredit out-of-state laboratories which are located in states which do not have NELAP approved accrediting authority for the Fields of Testing and/or Programs in which the laboratory desires accreditation provided that the laboratory complies with all the requirements in section 333-064-0035 of these rules.

Stat. Auth.: ORS 448.150(1) & 448.131, 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620
Stats. Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620
Hist.: OHD 7-1999, f. & cert. ef. 10-26-99

333-064-0055

Display of Certificate

Accredited environmental laboratories shall post or display their most recent ORELAP accreditation certificate and their ORELAP-accredited fields of testing in a prominent place in the laboratory facility.

333-064-0060

Fee Schedule

Fees will be charged to environmental laboratories according to the following schedule.

(1) Payment of a non-refundable application fee must accompany each application.

(a) For laboratories located in Oregon, one of three levels of fees, Tier 1 at $450, Tier 2 at $900 and Tier 3 at $1,600 will be charged. The Tiers will be determined by the total number of points derived from the number of Fields of Testing requested for accreditation listed in section (2)(a) through (c) of this rule.

(A) Each Basic Field of Testing has a multiplier of 1.

(B) Each Moderate Field of Testing has a multiplier of 3.

(D) The total number of points is determined by first summing the number of Fields of Testing within each category (Basic, Moderate or Complex) and then multiplying the sums by their appropriate multiplier as given in this rule. The sum of these results determines the total number of points for each laboratory. Laboratories with a total of 1-10 points are to be considered Tier 1 laboratories, 11 to 25 points are Tier 2 laboratories and 26 or more points are Tier 3 laboratories.

(b) For each out-of-state laboratory requesting primary or secondary accreditation through Oregon, one of three levels of fees, Tier 1 at $1,250, Tier 2 at $2,000 and Tier 3 at $3,000 will be charged with each Tier determined according to section (1)(a) of this rule.

(c) If a laboratory fails to submit an acceptable application after two attempts, the application will be rejected and the laboratory may reapply and must pay a new non-refundable application fee as determined in this rule.

(d) If a new owner acquires the laboratory and wishes the laboratory to remain accredited, the laboratory must submit a new application, pay the application fee and be subject to a new on-site inspection and payment of assessment and on-site fees as described in this rule.

(2) Upon ORELAP's review of a laboratory's application, each laboratory requesting primary accreditation through ORELAP, when ORELAP personnel will be used for the assessment, the laboratory will be charged an assessment fee based on the number Fields of Testing and Programs as follows:

(a) $90 will be charged for each of the following Basic Fields of Testing requested for accreditation:

(A) Gravimetric;

(B) Chromofluorogenic (Microbiology);

(D) Multiple Tube Fermentation/Most Probable Number (MPN) (Microbiology);

(E) Microscopy;

(F) Physical;

(G) Probe.

(b) $350 will be charged for each of the following Moderate Fields of Testing requested for accreditation:

(A) Atomic absorption -- flame;

(B) Atomic absorption -- furnace;

(D) Gas chromatography -- volatiles;

(E) Gas chromatography -- extractables;

(F) High pressure liquid chromatography;

(G) Immunoassay;

(H) Instrumental;

(I) Ion chromatography;

(J) Manual colorimetric;

(K) Radiation;

(L) Toxicity testing.

(A) Gas chromatography/mass spectrometry -- volatiles;

(B) Gas chromatography/mass spectrometry -- extractables;

(D) Inductively coupled plasma/mass spectrometry;

(E) X-ray.

(d) An additional cost of $10 for Basic Fields of Testing, $40 for Moderate Fields of Testing and $75 for Complex Fields of Testing will be charged for each additional Program per Field of Testing for which the laboratory has requested approval. The Programs are:

(A) CAA;

(B) CWA;

(D) RCRA.

(e) Assessment fees must be paid during the accreditation period in which the on-site assessment is to be performed but must be paid before the on-site assessment will be scheduled.

(3) All Oregon environmental laboratories requesting primary accreditation through ORELAP where Oregon state assessor(s) will perform the on-site assessment, must pay an on-site trip fee for each on-site assessment.

(a) On-site trip fees are $350 for Tier 1, $500 for Tier 2 and $1,000 for Tier 3 laboratories with the Tiers determined according to section (1)(a) of this rule.

(b) All laboratories must pay the appropriate on-site trip fee prior to scheduling and performing each required on-site assessment and additional assessments as requested by the laboratory for approval for additional Fields of Testing and/or Program.

(c) All laboratories must pay the appropriate on-site trip fee per on-site assessment performed due to just cause according to NELAC Standards.

(4) All environmental laboratories located in Oregon requesting primary accreditation through ORELAP where ORELAP has determined that third party assessors will be used, must pay all ORELAP assessment fees plus all third party assessors costs. ORELAP may require the laboratory to pay the on-site assessment costs directly to the third party assessor according to the schedule of the assessor for all required on-site assessments.

(5) All out of-state environmental laboratories must pay all on-site assessment costs incurred by ORELAP approved assessors to perform the on-site assessment including but not limited to transportation, per diem and wages during travel. If third party assessors are used, ORELAP may require the lab to pay the on-site assessment costs directly to the assessor according to the schedule of the assessor for all required inspections.

(6) Accredited laboratories requesting additions to their fields of testing during the accreditation period must pay:

(a) The difference in cost of the application fee with a minimum fee of $200;

(b) The difference in cost of the assessment fee;

(c) An on-site trip fee, as described in (3)(a) and (5) of this rule, based only on the additional parameters if ORELAP determines that an on-site assessment is required.

Stat. Auth.: ORS 438.605 - 438.620 & 448.280(1)(b) & (2)
Stats. Implemented: ORS 438.605 - 438.620
Hist.: 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 3-2006(Temp), f. & cert. ef. 2-8-06 thru 7-30-06; PH 5-2006, f. & cert. ef. 4-6-06

333-064-0065

Civil Penalties

(1) In addition to any other penalty provided by law, the Oregon Department of Human Services, in collaboration with the Accrediting Authority, may impose a civil penalty not to exceed $500 per day per violation upon any and all laboratories that willfully or negligently commit any of the following:

(a) Falsely purport to be ORELAP accredited;

(b) Improperly use their ORELAP accreditation status in order to mislead;

(c) Use the NELAC\NELAP logo in catalogs, advertisements, business solicitations, proposals, quotations, laboratory reports and other materials without proper authorization.

(2) The Oregon Department of Human Services reserves the right to pursue other remedies and may take any other disciplinary action against alleged violators.

(3) In establishing the amount of the penalty for each violation, the Oregon Department of Human Services will consider, but not be limited to the following factors:

(a) The gravity and magnitude of the violation;

(b) The laboratory's previous record of complying or failing to comply with this rule.

(c) The laboratory's history in taking all feasible steps or in following all procedures necessary or appropriate to correct the violation; and,

(d) Such other considerations as the Oregon Department of Human Services may consider appropriate.

(4) The Oregon Department of Human Services in collaboration the Accrediting Authority may deny, suspend or revoke accreditation of any laboratory that fails to pay on demand a civil penalty that has become due and payable, provided that it first gives the laboratory an opportunity for a hearing as outlined in ORS 183.

Stat. Auth.: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620
Stats. Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 620
Hist.: OHD 7-1999, f. & cert. ef. 10-26-99; 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

333-064-0070

Effective Date

The effective date or rules 333-064-0005, 333-064-0010, 333-064-0015, 333-064-0030, 333-064-0040, 333-064-0060 and 333-064-0065 shall be October 10, 2002.

Stat. Auth.: ORS 448.280(1)(b) & (2) ,438.605, 438.610, 438.615 & 438.620
Stats. Implemented: ORS 448.150, 448.131 & 448.280(1)(b) & (2)
Hist.: 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 23-2004, f. & cert. ef. 7-1-04; PH 8-2005, f. 6-1-05, cert. ef. 7-1-05

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