WSR 10-17-032

PERMANENT RULES

DEPARTMENT OF ECOLOGY


[ Order 09-09 -- Filed August 9, 2010, 2:21 p.m. , effective September 9, 2010 ]


     Effective Date of Rule: Thirty-one days after filing.

     Purpose: Ecology is revising chapter 173-50 WAC, Accreditation of environmental laboratories, in order to raise lab accreditation fees to cover program costs. Also, due to a budget reduction in the accreditation program, we needed to change some business practices in the rule that will reduce the costs of overseeing accredited labs. This includes decreasing the frequency of on-site audits at nondrinking water labs. To help offset the cost of the fee increase to accredited labs, we are reducing the number of required proficiency testing studies for labs who perform consistently well on such studies. There are also housekeeping amendments and clarification of the grounds for revoking or suspending accreditation.

     Citation of Existing Rules Affected by this Order: Repealing WAC 173-50-160 and 173-50-180; and amending WAC 173-50-020, 173-50-030, 173-50-040, 173-50-050, 173-50-060, 173-50-063, 173-50-067, 173-50-070, 173-50-080, 173-50-090, 173-50-100, 173-50-110, 173-50-120, 173-50-130, 173-50-140, 173-50-150, 173-50-170, 173-50-190, 173-50-210, and 173-50-220.

     Statutory Authority for Adoption: RCW 43.21A.230 allows ecology to accredit environmental laboratories and to assess fees to cover the department's costs. The state department of health (DOH) has delegated to ecology in a memorandum of understanding its RCW 43.20.050 authority to certify drinking water laboratories. In section 301 of ESHB 1244, the 2009 legislature gave ecology authority to raise fees for lab accreditation.

      Adopted under notice filed as WSR 10-07-163 on March 24, 2010.

     Changes Other than Editing from Proposed to Adopted Version: We added two definitions and amended another. We added failure to meet requirements for proficiency testing (PT) as a reason for revoking or suspending accreditation. We removed the option of annual fee adjustments based on the implicit price deflator since that figure no longer exists. We added the conditions under which we waive accreditation fees. In response to comments on the high cost of PT samples, we reduced the requirement for participation in PT studies for laboratories with a history of satisfactory PT results.


WAC 173-50-040 Definitions.


     We added the following definitions:


• "Accreditation year" - the one-year period as stated on the certificate of accreditation.
• "Principal laboratory" - a laboratory designated by the Washington department of health to support the drinking water certification program.

     These are terms added to the rule in response to comments from affected parties.

     We changed the following definition:

     "Procedural manual" - until October 1, 2010, the Department of Ecology Procedural Manual for the Environmental Laboratory Accreditation Program dated November 2002, and beginning October 1, 2010, the Department of Ecology Procedural Manual for the Environmental Laboratory Accreditation Program dated September 2010.

     We plan to complete the revision of the procedural manual by the rule effective date.


WAC 173-50-060 Responsibilities of environmental laboratories.


     We changed the third bullet:


• Submit an initial set of acceptable satisfactory PT ((sample analysis)) sample results (WAC 173-50-070); and

     This change aligns the terminology related to changes in proficiency testing requirements.


WAC 173-50-070 ((Performance audit.)) Proficiency testing (PT).


     We added the second sentence:

     (2) ((Drinking water)) Accredited laboratories must analyze a minimum of one PT sample per applicable microbiology parameter per year and two PT samples for applicable chemistry parameters per year. For chemistry parameters, after an accredited laboratory submits two satisfactory PT sample results and no unsatisfactory results in an accreditation year, the laboratory is required to submit only one satisfactory PT sample result in subsequent accreditation years. This applies as long as there are no intervening unsatisfactory PTs.

     This change was made in response to comments received by interested parties.


WAC 173-50-130 Requirements for maintaining accreditation status.


     We added the parenthetical phrase:

     (1) Accreditation is granted for a one-year period (the accreditation year) and expires one year after the effective date of accreditation.

     This reiterates our definition of "accreditation year" added to WAC 173-50-040.


WAC 173-50-150 Revoking or suspending accreditation.

     We added an additional condition to subsection (3):

     Reports two consecutive unsatisfactory PT sample results.

     This was added to further clarify and align with our changes to WAC 173-50-070.


WAC 173-50-170 Third-party accreditation.


     We changed this bullet:


• A complete set of the most rRecent, satisfactory ((PT)) proficiency test results for the applicable parameters.

     This was added to further clarify and align with our changes to WAC 173-50-070.


WAC 173-50-190 Fee structure.


     We deleted this sentence:

     (((11))) (9) Dollar amounts listed in Table 1 and subsections (((6))) (4), (7), and (8)((, (9), and (10))) of this section may be adjusted every year based on inflation as indicated by the Implicit Price Deflator for State and Local Government Services as published by the economic and revenue forecast council.

     This was done because the implicit price deflator no longer exists.

     We added this new subsection:

     (10) Accreditation fees are waived for laboratories operated by the Washington state departments of ecology and health. Accreditation fees are also waived for drinking water parameters certified by EPA Region 10 at designated principal laboratories.

     This was added to clarify our existing practice for fee waivers.

     A final cost-benefit analysis is available by contacting Stewart Lombard, Department of Ecology, P.O. Box 488, Manchester, WA 98353-0488, phone (360) 895-6148, fax (360) 895-6180, e-mail stew.lombard@ecy.wa.gov.

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 1, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 19, Repealed 2.

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 15, Repealed 2.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 0, Repealed 0.

     Date Adopted: August 9, 2010.

Ted Sturdevant

Director

by Polly Zehm

OTS-3057.4


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-020   Scope.   (1) The Washington state environmental laboratory accreditation program (WA ELAP) applies to laboratories which conduct tests for or prepare analytical data for submittal to any entity requiring the use of an accredited laboratory. This includes laboratories that analyze drinking water. ((This rule also describes how the department of ecology participates in the National Environmental Laboratory Accreditation Program (NELAP) as an accrediting authority once the department is certified by the National Environmental Laboratory Accreditation Conference (NELAC).))

     (2) Accreditation in itself does not authorize use of a specific method for any specific program or project. If such authorization is not granted in documentation governing a program or project within which samples are being analyzed, authorization should be obtained from the laboratory's data user.

     (3) Accreditation does not guarantee validity of analytical data submitted by the accredited laboratory but rather assures that the laboratory has demonstrated its capability to reliably generate and report the analytical data (WAC 173-50-040, definition of "accreditation").

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-020, filed 10/1/02, effective 11/1/02; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-020, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-030   Objectives.   Objectives of the ((accreditation program)) WA ELAP are to:

     • Assure accredited laboratories have a demonstrated capability to accurately and defensibly analyze environmental samples;

     • Assist environmental laboratories in improving their quality assurance/quality control procedures; and

     • Foster cooperation between the state departments of ecology and health, local agencies, other users of environmental data, and operators of environmental laboratories.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-030, filed 10/1/02, effective 11/1/02; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-030, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-040   Definitions.   Definitions in this section apply throughout this chapter, unless context clearly indicates otherwise.

     "Accreditation" - the formal recognition by the department that an environmental laboratory is capable of producing accurate and defensible analytical data. This recognition is signified by issuance of a written certificate accompanied by a scope of accreditation indicating the parameters for which the laboratory is accredited.

     • The term "accredit" as used in this chapter is intended to have the same meaning as the term "certify" as used in RCW 43.21A.230.

     • Any laboratory accredited under this chapter shall be deemed to have been certified under RCW 43.21A.230.

     • The department does not, by accrediting any laboratory pursuant to these rules, vouch for or warrant the accuracy of any particular work done or report issued by that laboratory.

     "Accreditation year" - the one-year period as stated on the certificate of accreditation.

     "Accuracy" - the degree to which an analytical result corresponds to the true or accepted value for the sample being tested. Accuracy is affected by bias and precision.

     "Analyte" - the constituent or property of a sample measured using an analytical method.

     "Analytical data" - the recorded qualitative and/or quantitative results of a chemical, physical, biological, microbiological, radiochemical, or other scientific determination.

     "Analytical method" - a written procedure for acquiring analytical data.

     "Department" - the state of Washington department of ecology when the term is not followed by another state designation.

     "Drinking water certification manual" - the Environmental Protection Agency Manual for the Certification of Laboratories Analyzing Drinking Water, ((4th)) 5th Edition, ((March 1997)) January 2005.

     "Ecology accrediting authority" - the supervisor of the lab accreditation unit of the environmental assessment program of the department of ecology.

     "Environmental laboratory" or "laboratory" - a facility:

     • Under the ownership and technical management of a single entity in a single geographical ((locale)) location;

     • Where scientific ((examinations)) determinations are performed on samples taken from the environment, including drinking water samples; and

     • Where data is submitted to the department of ecology, department of health, or other entity requiring the use of an accredited laboratory under provisions of a regulation, permit, or contractual agreement.

     "Lab accreditation unit" - the lab accreditation unit of the ((environmental assessment program of the)) department of ecology.

     (("Mandatory analytical method" - a recognized written procedure for acquiring analytical data which is required by law or a regulatory agency of the federal, state, or local government.))

     "Matrix" ((means)) - the ((substance from which a)) material to be analyzed ((is extracted)), including, but not limited to, ground or surface water, wastewater, drinking water, air, solid waste, soil, tissue, nuclear waste, and hazardous waste. For the purposes of establishing a fee structure (WAC 173-50-190(4)), matrices are grouped as follows:

     • Nonpotable water;

     • Drinking water;

     • Solid and chemical materials; and

     • Air and emissions.

     ((NELAP accreditations may include other matrices as designated in the NELAC standards.

     "NELAC" - the National Environmental Laboratory Accreditation Conference, a voluntary association of state and federal agencies.

     "NELAC standards" - the standards for laboratory accreditation published by NELAC, September 5, 2001.

     "NELAP" - the National Environmental Laboratory Accreditation Program governed by NELAC.)) "On-site audit" - an on-site inspection and evaluation of laboratory facilities, equipment, records and staff.

     "Out-of-state laboratory" - a laboratory that is not located in the state of Washington.

     "Parameter" - ((a single determination or sampling procedure, or group of related determinations or sampling procedures using a specific written method)) the combination of one or more analytes determined by a specific analytical method. Examples of parameters include:

     • The analyte alkalinity by method SM 2320 B;

     • The analyte zinc by method EPA 200.7;

     • The set of analytes called volatile organic compounds (VOCs) by method EPA 8260; and

     • The analyte Total Coli/Ecoli-count by method SM 9222 B/9221 F.

     "Principal laboratory" - a laboratory designated by the Washington department of health to support the drinking water certification program.

     "Procedural manual" - the Department of Ecology's Procedural Manual for the Environmental Laboratory Accreditation Program dated ((November 2002)) September 2010.

     "Proficiency testing (PT)" - evaluation of the results from the analysis of samples, the true values of which are known to the supplier of the samples but unknown to the laboratory conducting the analyses. PT samples are provided by a source external to the environmental laboratory.

     (("Quality control" - activities designed to assure analytical data produced by an environmental laboratory meet data quality objectives for accuracy and defensibility. Those activities may include routine application of statistically based procedures to evaluate and control the accuracy of analytical results.))

     "Quality assurance (QA)" - activities intended to assure that a quality control program is effective. A QA program is a totally integrated program for assuring reliability of measurement data.

     "Quality assurance (QA) manual" - a written record intended to assure the reliability of measurement data. A QA manual documents policies, organization, objectives, and specific QC and QA activities. Volume and scope of QA manuals vary with complexity of the laboratory mission.

     (("Recognized analytical method" - a documented analytical procedure developed through collaborative studies by organizations or groups recognized by the users of the laboratory's analytical data.)) "Quality control (QC)" - the routine application of statistically based procedures to evaluate and control the accuracy of analytical results.

     "Regulatory program" - a program administered by a federal, state, or other regulatory agency.

     (("On-site assessment" - an on-site inspection of laboratory capabilities.

     "Primary NELAP accreditation" - granting of NELAP accreditation by the ecology accrediting authority after having determined through direct evaluation that the laboratory is in conformance with the NELAC standards.))

     "((Secondary NELAP)) Third-party accreditation" - recognition by the ecology accrediting authority of ((a NELAP)) accreditation ((that was)) granted by another ((NELAP)) accrediting authority.

     "WA ELAP" - Washington state environmental laboratory accreditation program.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-040, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-040, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-040, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-040, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-050   Responsibilities of the department.   (1) The department maintains a procedural manual describing specifics of the accreditation process. As a minimum, the procedural manual describes the procedures for:

     • Submitting an application and fee;

     • Preparing a quality assurance manual;

     • Performing proficiency testing;

     • Conducting on-site ((assessments)) audits;

     • Accrediting out-of-state laboratories;

     • ((Issuing)) Granting, denying, suspending, and revoking accreditation; and

     • Notifying laboratories and authorized government officials of accreditation actions.

     The department will make the procedural manual available to all interested persons.

     (2) Department personnel assigned to assess the capability of drinking water laboratories participating in the ((environmental laboratory accreditation program)) WA ELAP must meet the experience, education, and training requirements established in the ((Environmental Protection Agency)) drinking water certification manual.

     (((3) When granting NELAP accreditations, the ecology accrediting authority is responsible for those actions designated in applicable chapters of the NELAC standards. If a NELAC standard is more stringent than the corresponding standard in this chapter, the NELAC standard applies for laboratories seeking NELAP accreditation.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-050, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-050, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-050, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-050, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-060   Responsibilities of environmental laboratories.   When applying for initial accreditation (see WAC 173-50-130 for maintaining an existing accreditation), managers of environmental laboratories must:

     • Submit an application (WAC 173-50-063) and required fees (WAC 173-50-190) to the department fiscal officer;

     • Submit a copy of the laboratory's quality assurance manual (WAC 173-50-067);

     • Submit an initial set of ((acceptable)) satisfactory PT sample ((analysis)) results (WAC 173-50-070); and

     • Undergo an on-site ((assessment)) audit (WAC 173-50-080).

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-060, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), § 173-50-060, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-060, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-063   Application.   (1) Through the application, laboratory managers:

     • Request accreditation for specific parameters;

     • Calculate fees due to the department; and

     • Provide evidence that sufficient personnel and equipment are available to successfully perform analytical methods as specified in the application.

     (2) Through review of the application submitted by the applicant laboratory, the lab accreditation unit determines if:

     • Requested parameters are eligible for accreditation;

     • The fee calculated by the applicant laboratory is correct; and

     • Personnel and equipment are adequate to support successful performance of requested parameters.

     (3) Following the review, the lab accreditation unit advises the applicant laboratory of any required changes.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-063, filed 10/1/02, effective 11/1/02.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-067   Quality assurance manual.   (1) The lab accreditation unit reviews and approves the laboratory's QA manual prior to the initial on-site ((assessment)) audit. The QA manual submitted concurrently with the application must be in detail and scope commensurate with the size and mission of the laboratory. Guidelines for contents of the QA manual are in the procedural manual.

     (2) The QA manual must address QA and QC requirements of applicable regulatory programs. For drinking water laboratories, such requirements are found in the drinking water certification manual.

     (((3) For laboratories applying for primary NELAP accreditation, QA requirements, including the conduct of specific QC tests, are those designated in the NELAC standards. If a NELAC standard is more stringent than the corresponding standard in this chapter, the NELAC standard applies for laboratories seeking NELAP accreditation.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-067, filed 10/1/02, effective 11/1/02.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-070   ((Performance audit.)) Proficiency testing (PT).   (1) The lab accreditation unit advises applying laboratories of specific requirements for participation in proficiency ((tests. Such tests are completed)) testing (PT) studies for applicable parameters ((no more frequently than twice annually. Current)). Proficiency tests conducted under the provisions of other recognized programs may be used to satisfy ((the accreditation program proficiency testing)) these requirements. The lab accreditation unit determines the sufficiency of such ((audits)) proficiency tests.

     (2) ((Drinking water)) Accredited laboratories must analyze a minimum of one PT sample per applicable microbiology parameter per year and two PT samples for applicable chemistry parameters per year. For chemistry parameters, after an accredited laboratory submits two satisfactory PT sample results and no unsatisfactory results in an accreditation year, the laboratory is required to submit only one satisfactory PT sample result in subsequent accreditation years. This applies as long as there are no intervening unsatisfactory PT sample results.

     (3) The lab accreditation unit may require the laboratory to submit raw data along with the report of analysis of PT samples.

     (4) The lab accreditation unit may waive proficiency tests for certain parameters if PT samples are not readily available or for other valid reasons.

     (5) Applying laboratories are responsible for obtaining PT samples from vendors ((certified by the National Institute of Standards and Technology (NIST) or otherwise)) approved by the lab accreditation unit. No fee shall be charged to the department for the purchase or analysis of PT samples.

     (((6) For laboratories applying for NELAP accreditation, proficiency testing requirements are those designated in the NELAC standards. If the NELAC standard is more stringent than the corresponding standard in this chapter, the NELAC standard applies for laboratories seeking NELAP accreditation.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-070, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-070, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-070, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-070, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-080   On-site ((assessment)) audit.   The laboratory must undergo ((a system)) an on-site audit by the department to assess critical elements and areas of recommended practices. The laboratory must assist/accommodate department of ecology personnel during on-site ((assessments)) audits as required.

     (1) Critical elements for accreditation. Elements of an environmental laboratory's operations which are critical to the consistent generation of accurate and defensible data are critical elements for accreditation. Critical elements are subject ((of)) to intense scrutiny throughout the accreditation process. The ecology accrediting authority may deny, revoke, or suspend accreditation for deficiencies in critical elements. Functional areas including critical elements are:

     (a) Analytical methods. The on-site ((assessment)) audit seeks to determine if documentation of ((mandatory or recognized)) analytical methods:

     • Are present at the laboratory;

     • Readily available to analysts; and

     • Being implemented. If the laboratory is using a locally-developed method, the on-site ((assessment)) audit may include an evaluation of the adequacy of that method.

     (b) Equipment and supplies. The on-site ((assessment)) audit seeks to determine if sufficient equipment and supplies as required by analytical methods are:

     • Available;

     • Being adequately maintained; and

     • In a condition to allow successful performance of applicable analytical procedures.

     To gain and maintain accreditation, laboratories must demonstrate that equipment and supply requirements of applicable regulatory programs are being met.

     (c) QA and QC records. The on-site ((assessment)) audit includes a review of QA and QC records for programs/projects within which the laboratory is generating analytical data for submission to the data user.

     (d) Sample management. The on-site ((assessment)) audit includes a review of applicable procedures for receipt, preservation, transportation, and storage of samples. The laboratory is responsible only for those elements of sample management over which it has direct control. To gain and maintain accreditation, laboratories must demonstrate that sample management requirements of applicable regulatory programs are being met.

     (e) Data management. The on-site ((assessment)) audit includes a review of activities necessary to assure accurate management of laboratory data including:

     • Raw data;

     • Calculations; and

     • Transcription, computer data entry, reports of analytical results.

     To gain and maintain accreditation, laboratories must demonstrate that data management requirements of applicable regulatory programs are being met.

     (2) Recommended practices. Recommended practices are those elements of laboratory operations which might affect efficiency, safety, and other administrative functions, but do not normally affect quality of analytical data. Normally these practices would not be the basis for denial or revocation of accreditation status. Functional areas within which recommended practices may be noted are:

     (a) Personnel. The department seeks to determine if managerial, supervisory, and technical personnel have adequate training and experience to allow satisfactory completion of analytical procedures and compilation of reliable, accurate data. Minimum recommended education and experience criteria for laboratory personnel are specified in the ((program)) procedural manual.

     (b) Facilities. The department seeks to determine if laboratory facilities allow efficient generation of reliable, accurate data in a safe environment.

     (c) Safety. The department may refer serious safety deficiencies to appropriate state or federal agencies.

     (3) ((NELAC requirements. For laboratories applying for NELAP accreditation, on-site assessment requirements are those designated in the NELAC standards. If the NELAC standard is more stringent than the corresponding standard in this chapter, the NELAC standard applies.

     (4))) Drinking water laboratory requirements. For laboratories applying for accreditation of drinking water parameters, on-site ((assessment)) audit requirements are those designated in the drinking water certification manual. If such a standard is more stringent than the corresponding standard in this chapter, the drinking water certification manual applies.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-080, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-080, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-080, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-080, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-090   Evaluation and issuance of certificate.   (1) After preliminary requirements (WAC 173-50-060 through 173-50-080) have been met, the lab accreditation unit submits a report to the affected laboratory concerning the results of the overall accreditation process. The report may:

     • List((s)) findings;

     • ((Assesses)) Assess the importance of each finding; and

     • Make((s)) recommendations concerning actions necessary to assure resolution of problems.

     (2) After completing the accreditation review, the ecology accrediting authority decides whether accreditation should be granted.

     (a) If accreditation is warranted, the department issues a certificate and accompanying scope of accreditation. The certificate remains the property of the department and must be surrendered to the department upon revocation or voluntary termination of accreditation status.

     (b) If accreditation is not warranted, the department issues a report specifying areas of deficiency and steps necessary to upgrade the laboratory to accredited status. In such cases, the laboratory must provide documentation that the specified deficiencies have been corrected. Based on such documentation the ecology accrediting authority decides whether to grant or deny accreditation.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-090, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-090, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-090, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-090, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-100   Interim accreditation.   (((1))) If ((for valid reasons resulting from a deficiency in)) the department ((and not)) is unable to complete the accreditation process through no fault of the laboratory, the ecology accrediting authority may grant interim accreditation ((may be granted)). To be considered for interim accreditation, the laboratory must:

     • Submit an application and applicable fees;

     • Successfully complete applicable proficiency tests; and

     • Submit a QA manual that meets the requirements of WAC 173-050-067.

     The lab accreditation unit may also require the laboratory to submit an analytical data package as evidence of analytical capability.

     (((2) For NELAP accreditation, the only valid reason for granting interim accreditation is the delay of an on-site assessment for reasons beyond the control of the laboratory.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-100, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-100, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-100, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-100, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-110   Provisional accreditation.   (1) The ecology accrediting authority may grant provisional accreditation to laboratories which can consistently produce valid analytical data but have deficiencies requiring corrective action. When the laboratory has corrected such deficiencies, it must provide evidence of correction to the lab accreditation unit, or request a follow-up on-site ((assessment)) audit, as appropriate. If the lab accreditation unit determines the deficiencies have been corrected, the ecology accrediting authority awards full accreditation as in WAC 173-50-090.

     (2) The ecology accrediting authority may renew a provisional accreditation for a subsequent accreditation period if laboratory management has demonstrated that all reasonable measures to correct deficiencies have been exhausted.

     (3) For drinking water laboratories, specific conditions warranting provisional accreditation and specific actions required of the laboratory when provisional accreditation is granted are found in the drinking water certification manual.

     (((4) Provisional accreditation does not apply to NELAP accreditations.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-110, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), § 173-50-110, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-110, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-120   Accreditation categories.   (1) Environmental laboratories are accredited within one or more of the matrix groups defined in WAC 173-50-040. ((Additionally)) Within each matrix group, accreditation is granted within the following broad categories:

     • General chemistry ((I (General)));

     • ((Chemistry II ())Trace metals(()));

     • Organics I (((Gas Chromatography (GC) and High Pressure Liquid Chromatography (HPLC) Methods)));

     • Organics II (((Gas Chromatography/Mass Spectrometry (GC/MS) Methods))) (Category II methods use mass spectrometer detectors);

     ((• Radioactivity;))

     • Microbiology;

     • Radiochemistry;

     • Bioassay((/Toxicity));

     • Immunoassay; and

     • Physical.

     Within these categories, laboratories are specifically accredited for well-defined parameters, such as, but not limited to, those suggested in the procedural manual, using specific((, recognized)) analytical methods or sampling techniques chosen by the applying laboratory.

     (2) The scope of accreditation accompanying the accreditation certificate indicates the parameters for which the laboratory is accredited, and any applicable qualifications, such as interim or provisional accreditation.

     (3) ((For laboratories granted NELAP accreditation,)) The scope of accreditation also indicates the matrix groups within which each parameter applies. Those matrix groups may include, but are not limited to:

     • Nonpotable water;

     • Drinking water;

     • Solid and chemical materials;

     ((• Biological tissue;)) and

     • Air and emissions.

     ((For laboratories granted NELAP accreditation, the scope of accreditation may also indicate the technology, such as gas chromatography/electron capture detection (GC/ECD) or inductively coupled plasma/mass spectrometry (ICP/MS), associated with each parameter.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-120, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-120, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-120, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-120, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-130   Requirements for maintaining accreditation status.   (1) Accreditation is granted for a one-year period (the accreditation year) and expires one year after the effective date of accreditation. ((Except for NELAP accreditation which is limited to one year, exceptions to the one year accreditation may be made for documented cause. In such cases, accreditation may be granted for a period up to two years.))

     (2) Renewal requires the laboratory to submit:

     • An application and appropriate fees;

     • An update of the laboratory's ((quality assurance)) QA manual if applicable; ((and))

     • Evidence of accreditation by a third party when appropriate; and

     • Successful completion of proficiency testing requirements.

     (3) For laboratories accredited for drinking water parameters, on-site ((assessments)) audits are required at periods not to exceed three years from the previous on-site ((assessment)) audit. ((For documented cause, on-site assessments may be extended up to four years from the previous assessment, except for laboratories accredited to analyze drinking water and NELAP accredited laboratories.))

     (4) For laboratories not accredited for drinking water parameters, the schedule of on-site audits will be determined by the ecology accrediting authority.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-130, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-130, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-130, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-130, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-140   Denying accreditation.   (1) The ecology accrediting authority may deny accreditation if the applicant laboratory:

     • Fails to comply with standards for critical elements of the on-site ((assessment)) audit;

     • Misrepresents itself to the department;

     • Fails to disclose pertinent information in the application;

     • Falsifies reports of analysis including ((PT)) proficiency testing results;

     • Engages in unethical or fraudulent practices concerning generation of analytical data;

     • Is deficient in its ability to provide accurate and defensible analytical data; or

     • Fails to render applicable fees.

     (2) A laboratory may be denied accreditation for a specific parameter for unsatisfactory ((analysis of that parameter in)) proficiency ((tests)) testing results.

     (3) Laboratories denied accreditation may appeal under the provisions of WAC 173-50-200. If an appeal does not result in action favorable to the laboratory, and following correction of deficiencies, laboratories denied accreditation may reapply for accreditation to include payment of appropriate fees as determined in WAC 173-50-190.

     (((4) Reasons for denial of NELAP accreditation are as specified in the NELAC standards.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-140, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), § 173-50-140, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-140, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-150   Revoking or suspending accreditation.   (1) Revocation of accreditation is the withdrawal of a previously granted accreditation. Revocation may involve the entire laboratory or one or more individual parameters.

     (2) Suspension of accreditation is for a specified period ((not to exceed six months)) during which the affected laboratory corrects deficiencies that led to the suspension. Suspension may involve the entire laboratory, or one or more individual parameters.

     (((2))) (3) The ecology accrediting authority may suspend or revoke accreditation if the accredited laboratory:

     • Fails to comply with standards for critical elements of an on-site ((assessment)) audit;

     • Violates a state rule relative to the analytical procedures for which it is accredited;

     • Misrepresents itself to the department;

     • Falsifies reports of analysis including ((PT)) proficiency testing results;

     • Engages in unethical or fraudulent practices concerning generation of analytical data;

     • Is deficient in its ability to provide accurate and defensible analytical data; ((or))

     • Refuses to permit entry for enforcement purposes (WAC 173-50-210);

     • Fails to render applicable fees;

     • Fails to maintain third-party accreditation; or

     • Reports two consecutive unsatisfactory PT sample results.

     (((3))) (4) A laboratory having had its accreditation suspended or revoked may appeal under the provisions of WAC 173-50-200. If an appeal does not result in action favorable to the laboratory, and following correction of deficiencies, a laboratory having had its accreditation revoked may reapply for accreditation to include payment of appropriate fees as determined in WAC 173-50-190.

     (((4) Reasons for revocation or suspension of NELAP accreditation are as specified in the NELAC standards.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-150, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), § 173-50-150, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-150, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-170   Third-party accreditation.   (1) The department may recognize accreditation (or certification, registration, licensure, approval) of a laboratory by a third party when the accreditation process is determined to be equivalent to that described in this chapter.

     (2) Laboratories applying for recognition of a third party's accreditation submit:

     • An application and associated fee (WAC 173-50-190(7));

     • A copy of the third party's certificate;

     • A copy of the third party's scope of accreditation;

     • A copy of the third party's most recent on-site ((assessment)) audit report;

     • A copy of the laboratory's corrective action report relative to the on-site ((assessment)) audit, if applicable; and

     • ((A complete set of the most)) Recent ((PT)), satisfactory proficiency test results for the applicable parameters.

     (3) In consideration of a request to recognize a third party's accreditation as the basis for accreditation by the ecology accrediting authority, the lab accreditation unit reviews the application and supporting documentation to assure compliance with minimum accreditation requirements as stated in this chapter. If the review is favorable, a certificate and scope of accreditation are granted as in WAC 173-50-090.

     (4) Laboratories granted third-party accreditation must notify the laboratory accreditation unit immediately of changes in the status of their third-party accreditation.

     (5) Washington laboratories accredited or applying for accreditation in recognition of a third party's accreditation must notify the lab accreditation unit of on-site ((assessments)) audits scheduled by the third party and allow a department observer to attend such on-site ((assessments)) audits.

     (((5) Primary NELAP accreditation cannot be granted in recognition of the accreditation by a third party.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-170, filed 10/1/02, effective 11/1/02; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-170, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-190   Fee structure.   (1) Fees in this chapter are in U.S. dollars and are established to cover costs of administering the ((accreditation program)) WA ELAP. Fees shall be assessed for each parameter or method within each matrix, except as noted in subsection (3) of this section. The fee per parameter or method for each category, and the maximum fee per category ((for each matrix)) where applicable, are identified in Table 1.

     (2) Examples of parameters or methods for each category are published in the procedural manual. Accreditation may be requested for parameters in addition to those listed in the procedural manual.

     (3) When a fee is assessed ((only once)) for a ((given)) specific drinking water parameter ((even though that specific)) or method, the laboratory may be accredited for the same parameter ((may be accredited under more than one matrix)) or method in nonpotable water without paying an additional fee.

TABLE 1 - FEE SCHEDULE

((MATRIX CATEGORY FEE/

PARAMETER

MAX FEE PER CATEGORY
Nonpotable Water Chemistry I $65 $1150
(General)
Chemistry II $65 $975
(Trace Metals)
Organics I $115 $975
(GC/HPLC)
Organics II $345 $1035
(GC/MS)
Radioactivity $145 $1380
Microbiology $175 $520
Bioassay/Toxicity $230 $1435
Immunoassay $65 $390
Physical $65 $260
Drinking Water Chemistry I $60 $305
(General)
Chemistry II $60 $720
Organics I $155 $615
(GC/HPLC)
Organics II $155 $155
(GC/MS)
Microbiology $155 $460
Solid and

Chemical

Materials

Chemistry I $65 $1150
(General)
Chemistry II $65 $975
(Trace Metals)
Organics I $115 $975
(GC/HPLC)
Organics II $345 $1035
(GC/MS)
Radioactivity $145 $1380
Microbiology $175 $520
Immunoassay $65 $390
Physical $65 $260
Air and

Emissions

Chemistry I $65 $1150
(General)
Chemistry II $65 $975
(Trace Metals)
Organics I $115 $975
(GC/HPLC)
Organics II $345 $1035))
(GC/MS)
CATEGORY FEE PER PARAMETER FEE PER METHOD MAX FEE PER CATEGORY
General Chemistry $80 -- $1,600
Trace Metals -- $400 --
Organics I -- $200 --
Organics II -- $500 --
Microbiology $200 -- --
Radiochemistry $250 -- --
Bioassay $300 -- $3,000
Immunoassay $80 -- --
Physical $80 -- --

     (4) The minimum fee for accreditation, either direct or through recognition of a third-party accreditation, is three hundred dollars.

     (5) In addition to paying the fee indicated in Table 1, out-of-state laboratories must pay for the actual cost of travel associated with on-site ((assessments)) audits. The department invoices the laboratory for such costs after completion of the on-site ((assessment)) audit.

     (((5))) (6) The laboratory must pay applicable fees before:

     • Its quality assurance manual is reviewed by the department;

     • The on-site ((assessment)) audit is conducted if applicable; and

     • Interim, provisional, or full accreditation is granted.

     (((6))) (7) The fee for recognition of a third party accreditation (WAC 173-50-170)((, other than NELAP accreditation (WAC 173-50-190(9)), is three hundred forty-five dollars.

     (7) The fee for recognition of a laboratory under a reciprocity agreement (WAC 173-50-160) is three hundred forty-five dollars, or as specified in the reciprocity agreement, but not less than three hundred forty-five dollars.

     (8) The fee for recognition of accreditation by a NELAP accrediting authority for laboratories in Washington is three hundred forty-five dollars. For out-of-state laboratories, the fee for recognition of accreditation by a NELAP accrediting authority is the fee indicated in Table 1.

     (9) For drinking water laboratories, the base fee to defray the extra cost incurred by the department because of the need to coordinate directly with two regulatory agencies is one hundred fifteen dollars.

     (10))) is three-fourths (75%) of the fee indicated in Table 1.

     (8) If a laboratory withdraws from the accreditation process after the application has been processed, but before accreditation is granted, the fee is ((nonrefundable)) refundable, less an amount up to ((an amount of two)) three hundred ((thirty)) dollars as reimbursement for costs of processing the application. If a laboratory withdraws from the accreditation process after the on-site ((assessment)) audit has been completed, the department may retain the entire fee including reimbursement of travel costs if applicable.

     (((11) Dollar amounts listed in Table 1 and subsections (6), (7), (8), (9), and (10) of this section may be adjusted every year based on inflation as indicated by the Implicit Price Deflator for State and Local Government Services as published by the economic and revenue forecast council.)) (9) Dollar amounts listed in Table 1 and subsections (((6), (7),)) (4) and (8)((, (9), and (10))) of this section may be decreased at any time the department determines they are higher than needed to meet accreditation program requirements. The department notifies affected parties of any fee adjustment at least thirty days prior to the effective date of the adjusted fee.

     (10) Accreditation fees are waived for laboratories operated by the Washington state departments of ecology and health. Accreditation fees are also waived for drinking water parameters certified by EPA Region 10 at designated principal laboratories.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-190, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-190, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-190, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-190, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-210   Enforcement.   (1) For the purpose of conducting on-site ((assessments or otherwise enforcing)) audits or inspections to ensure compliance with this chapter, the department may, during regular business hours, enter ((any)) business premises in which analytical data pertaining to accreditation under the provisions of this chapter are generated or stored.

     (2) Refusal to permit entry for such purposes ((shall)) may result in denial((,)) or revocation((, or suspension)) of accreditation ((or registration status)).

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-210, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), § 173-50-210, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-210, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-220   Assistance to laboratories.   Laboratories scheduled to undergo an on-site ((assessment)) audit may request a training session be conducted by department staff in conjunction with that ((assessment)) audit. Accredited laboratories may also request on-site assistance at times other than the on-site ((assessment)) audit. Whether requested as part of the on-site ((assessment)) audit or otherwise, the department will provide such assistance to the extent allowed by staff resources available at the time.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-220, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), § 173-50-220, filed 10/19/90, effective 11/19/90.]


REPEALER

     The following sections of the Washington Administrative Code are repealed:
WAC 173-50-160 Reciprocity.
WAC 173-50-180 Exemptions.

© Washington State Code Reviser's Office