Date of Adoption: October 1, 2002.

     Purpose: This amendment will allow ecology to grant accreditation for tests on matrices other than water, for physical tests, and for drinking water tests, and to grant accreditation as a national environmental laboratory accreditation program (NELAP) accrediting authority. Also, the revision will allow collection of sufficient fees to make the accreditation program self supporting.

     Citation of Existing Rules Affected by this Order: Amending chapter 173-50 WAC, Accreditation of environmental laboratories.

     Statutory Authority for Adoption: RCW 43.21A.230.

      Adopted under notice filed as WSR 02-11-151 on May 22, 2002.

     Changes Other than Editing from Proposed to Adopted Version: WAC 173-50-010 Purpose, in this section and elsewhere, the term "data user" was changed to "entities which require the use of accredited laboratories." Reason: Clarity.

     WAC 173-50-040 Definitions, the term "Regulatory program" was revised to eliminate reference to specific federal programs. Reason: Simplicity and clarity.

     WAC 173-50-190, Table 1, in the section on "Drinking Water," those fees per parameter proposed for "Chemistry I and Chemistry II" as $65 were changed to $60. For "Organics I and Organics II," $175 was changed to $155. For "Microbiology," $175 was changed to $155. Maximum fees for Chemistry I, Chemistry II, Organics I, Organics II, and Microbiology were changed from $390, $760, $690, $175, and $520, respectively, were changed to $305, $720, $615, $155, and $460, respectively. Reason: Legal determination that proposed fees violated intent of Initiative 601.

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 24, Repealed 0.

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 24, Repealed 0.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 24, Repealed 0.
     Effective Date of Rule: Thirty-one days after filing.

October 1, 2002

Tom Fitzsimmons

Director

OTS-5693.2

AMENDATORY SECTION(Amending Order 89-1 and 89-1A, filed 4/20/89 and 3/13/90, effective 4/13/90)

WAC 173-50-010   Purpose.   Department of ecology, department of health, and other entities require persons and organizations submitting analytical data under the purview of their programs to use environmental laboratories which are accredited. The purpose of this chapter is to establish a state program for accreditation of environmental laboratories which conduct tests ((for or prepare data for submittal)) and submit data to the department of ecology, the department of health, and other entities which require the use of accredited laboratories. The accreditation program ((implemented under this chapter)) is designed to satisfy the intent of RCW 43.21A.230 and 43.21A.445.

[Statutory Authority: RCW 43.21A.230. 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-010, filed 4/20/89 and 3/13/90, effective 4/13/90.]

     (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. 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.]

     • 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. 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.]

     (((1))) "Accreditation" ((means)) - the formal recognition by the department that an environmental laboratory is capable of producing accurate and defensible analytical data((,)). This recognition is signified by ((the)) issuance of a written certificate accompanied by a scope of accreditation indicating ((those)) the parameters ((and methods)) for which the laboratory ((has been)) 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 ((certifying or)) accrediting any laboratory pursuant to ((this chapter)) these rules, vouch for or warrant the accuracy of any particular work done or report issued by ((the)) that laboratory.

     (((2))) "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.

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

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

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

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

     "Environmental laboratory" ((means any)) - a facility:

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

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

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

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

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

     (((6))) "Matrix" means the substance from which a material to be analyzed is extracted, ((such as)) 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.

     (((7))) "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.

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

     "Parameter" ((means)) - a single determination or sampling procedure, or group of related determinations or sampling procedures using a specific written method ((chosen by an applying laboratory)).

     (((8) "Performance audit" means)) "Procedural manual" - the Procedural Manual for the Environmental Laboratory Accreditation Program dated November 2002.

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

     (9))) "Quality control" ((means those)) - 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.

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

     (((11))) "Quality assurance manual" ((means)) - a written record ((of the)) intended to assure the reliability of measurement data. A QA manual documents policies, organization, objectives, and specific ((quality control)) QC and ((quality assurance)) QA activities ((established for use in an environmental laboratory to assure accuracy of analytical results)). Volume and scope of ((quality assurance)) QA manuals vary with complexity of the laboratory mission.

     (((12))) "Recognized analytical method" ((means)) - a documented analytical procedure ((for analysis of an environmental sample which was)) developed through collaborative studies by organizations or groups recognized by the ((department)) users of the laboratory's analytical data.

     (((13) "System audit" means an on-site inspection of laboratory capabilities by an agency external to the laboratory.

     (14) "Registration" means participation of a laboratory in a program to prepare the laboratory for accreditation, signified by issuance of a written certificate accompanied by a scope of registration indicating those parameters for which the laboratory has achieved registration status.

     (15) "Registered" means the status of continued participation in the preparatory program. Only laboratories owned and operated by municipalities, industries, and other activities which are dischargers as defined in chapter 173-220 or 173-216 WAC shall be eligible for participation in the preparatory program. Such laboratories are also eligible for accreditation. The department does not, by registering any laboratory pursuant to these rules, vouch for or warrant the accuracy of any particular work done or report issued by the laboratory.

Note:

Above referenced chapters are available through the Department of Ecology, P.O. Box 47600, Olympia, WA 98504-7600.))

     "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 accreditation" - recognition by the ecology accrediting authority of a NELAP accreditation that was granted by another NELAP accrediting authority.

[Statutory Authority: RCW 43.21A.230. 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.]

     (4) Managers of environmental laboratories desiring accreditation or registration shall submit an application along with appropriate fees to the department fiscal officer, submit results of performance evaluations, a quality assurance manual and other required documentation to the quality assurance section, and assist/accommodate department personnel during system audits as required.)) (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;

     • Accrediting out-of-state laboratories;

     • Issuing, 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 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. 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.]

     (3) Eligible laboratories shall achieve registration status by submitting a completed application, paying required fees, and submitting a quality assurance manual to the quality assurance section.)) 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 PT sample analysis results (WAC 173-50-070); and

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

[Statutory Authority: RCW 43.21A.230. 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.]

     • Request accreditation for specific parameters;

     • Calculate fees due 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.

[]

     (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.

[]

     (((2) Submission of raw data along with the report of analysis of the performance evaluation sample may be required at the discretion of the quality assurance section.

     (3) Performance audits for certain accreditation parameters may be waived at the discretion of the quality assurance section if performance evaluation samples are not available or for other valid reasons.

     (4) Accredited laboratories and laboratories seeking accreditation which fail to accurately analyze a performance evaluation sample may be allowed a second performance audit. If necessitated by a second failure, a third performance audit may be allowed (as an exception to subsection (1) of this section) only after the laboratory has investigated cause for failure in the preceding audits and completed corrective actions.

     (5) Registered laboratories shall submit results of performance evaluation sample analyses to the quality assurance section. Registration status shall not be denied or revoked solely for failure to accurately analyze performance evaluation samples. Registered laboratories shall investigate causes for errors in performance evaluation sample analysis results which have been identified as unacceptable or otherwise in error. The results of this investigation shall be reported to the quality assurance section within forty-five days of receipt of the performance evaluation report. The report to the quality assurance section shall identify probable causes for error and corrective actions taken to preclude recurrence.

     (6) Applying laboratories shall be responsible for obtaining performance evaluation samples. No fee shall be charged to the department for analysis of performance evaluation samples.)) (2) Drinking water 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.

     (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. 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.]

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

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

     • Are present at the laboratory((,));

     • Readily available to analysts((,)); and

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

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

     • Available((,));

     • Being adequately maintained((,)); and ((are))

     • 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) Quality assurance. The laboratory quality assurance manual shall be reviewed for adequacy prior to the system audit. The system audit shall include a review of quality assurance plans and quality assurance/quality control records for programs/projects within which the laboratory is generating analytical data for submission to the department.)) (c) QA and QC records. The on-site assessment 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 ((system audit shall)) on-site assessment includes a review of applicable procedures for receipt, preservation, transportation, and storage of samples. The laboratory ((shall be held)) 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 ((system audit shall include a review of applicable procedures for checking documentation of)) on-site assessment includes a review of activities necessary to assure accurate management of laboratory data including:

     • Raw data((,));

     • Calculations((,));

     • Transcription ((and)), computer data entry, reports of analytical results((, and other activities necessary to assure accurate management of laboratory data)).

     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((, shall be brought to the attention of laboratory management under the heading of "recommended practices" and individually, shall)). 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 ((system audit shall)) department seeks to determine if managerial, supervisory, and ((analytical)) 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 ((shall be)) are specified in the program procedural manual.

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

     (((c) Safety. When the system audit notes laboratory safety problems, those judged serious shall be referred to appropriate state or federal agencies.

     (3) Registered laboratories shall be advised in a written system audit report prepared by the department of deficiencies in meeting critical element and recommended practice standards. The laboratory must respond in writing to the department within forty-five days of receipt of the system audit report concerning corrective actions taken as a result of the system audit report.)) (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 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. 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.]

     (2) Registration. Registered laboratories shall be issued a certificate and accompanying scope of registration. The certificate shall remain the property of the department of ecology and shall be surrendered to the department upon revocation of the registration status.)) (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:

     • Lists findings;

     • Assesses the importance of each finding; and

     • Makes 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 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. 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.]

     (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. 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.]

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

[Statutory Authority: RCW 43.21A.230. 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.]

     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. 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.]

     (2) Registration shall be granted for a one-year period and shall expire one year after the effective date of registration. Renewal shall require submission of an application and appropriate fees, an update of the laboratory's quality assurance manual, and completion of a new performance audit. System audits shall be required for renewal of registration at periods not to exceed three years from the previous system audit.)) (2) Renewal requires the laboratory to submit:

     • An application and appropriate fees;

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

     • Successful completion of proficiency testing requirements.

     On-site assessments are required at periods not to exceed three years from the previous on-site assessment. 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.

[Statutory Authority: RCW 43.21A.230. 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.]

     (2) A laboratory may be denied registration status only for failure to render appropriate fees, for failing to disclose pertinent information in the application, or for misrepresenting its capabilities.)) (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;

     • Misrepresents itself to the department;

     • Fails to disclose pertinent information in the application;

     • Falsifies reports of analysis including PT 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.

     (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. 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.]

     (2) Registration status may be revoked for failure to submit a renewal application, failure to pay appropriate fees, failure to submit required performance evaluation sample analysis results, failure to report on corrective actions taken if performance evaluation results are unacceptable or otherwise in error, failure to submit to a system audit, failure to report on corrective actions taken on deficiencies identified in a system audit, repeated failure to correct the deficiencies identified in the performance or system audits, or for misrepresenting the capabilities of the registered laboratory.)) (1) Revocation of accreditation is the withdrawal of a previously granted accreditation. Revocation may involve the entire laboratory or one or more individual parameters. 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) 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;

     • 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 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 for enforcement purposes (WAC 173-50-210).

     (3) 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. 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.]

     (4) In granting secondary NELAP accreditation, the ecology accrediting authority must recognize the accreditation of other NELAP accrediting authorities.

[Statutory Authority: RCW 43.21A.230. 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-160, filed 4/20/89 and 3/13/90, effective 4/13/90.]

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

[Statutory Authority: RCW 43.21A.230. 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.]

     (2) Exemption ((shall be)) is granted only for those analytical parameters included in the federal Environmental Protection Agency Quality Assurance Program. The exemption status shall be reviewed annually based upon submittal by the laboratory of a new application and updated evidence of continued participation in a sufficient quality assurance program.

Note:

The federal Environmental Protection Agency does not presently administer a complete quality assurance program for wastewater dischargers in the state of Washington, such as would provide an exemption under subsection (1) of this section. Thus, this exemption is not presently available. The Environmental Protection Agency considers annual analysis of performance evaluation samples to constitute only one element of participation in a quality assurance program. The complete Environmental Protection Agency Quality Assurance Program is described in their Order 5360.1, "Policy and Program Requirements to Implement the Mandatory Quality Assurance Program," which is the basis for exemption requirements stated in subsection (1) of this section.

[Statutory Authority: RCW 43.21A.230. 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-180, filed 4/20/89 and 3/13/90, effective 4/13/90.]

TABLE 1 - FEE SCHEDULE

     (2) Out-of-state laboratories shall coordinate directly with the quality assurance section to determine the anticipated cost of completing the accreditation process. Reimbursement of the cost of travel and per diem shall be added to the normal fee indicated in WAC 173-50-190(1).

     (3) On-site inspections shall not be conducted nor shall interim or provisional or other accreditations be granted until appropriate fees have been received by the department.

     (4) The fee to defray costs to the department recognition of third-party accreditation (WAC 173-50-170) shall be three hundred dollars. The fee for recognition of a laboratory under a reciprocity agreement (WAC 173-50-160) shall be three hundred dollars, or as specified in the reciprocity agreement, but not less than three hundred dollars.

     (5) Apart from the fee process, applicant laboratories shall be required to acquire and analyze performance evaluation (PE) samples for parameters specified by the quality assurance section. The source of PE samples, if other than the federal Environmental Protection Agency, shall be approved by the quality assurance section. To the extent feasible as determined by the quality assurance section, performance evaluation samples already being analyzed by the applicant laboratories, shall be used to fulfill performance audit requirements of this chapter.

     (6) In addition to fees as determined by the number of parameters and methods in WAC 173-50-190(1), laboratories seeking registration status are required to pay an annual fee of six hundred dollars.

     (7) If a laboratory withdraws from the accreditation process after the application has been processed, but before accreditation or registration is granted, the fee will be nonrefundable up to an amount of two hundred dollars as reimbursement for costs of processing the application.

     (8) Dollar amounts listed in subsections (1), (4), (6), and (7) of this section may be adjusted every two years 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. Dollar amounts listed in subsections (1), (4), (6), and (7) of this section may be decreased at any time the department determines they are higher than needed to meet program requirements. The department shall notify affected parties of any fee adjustment at least thirty days prior to making any fee adjustment.)) (1) Fees in this chapter are in U.S. dollars and are established to cover costs of administering the accreditation program. The fee per parameter and maximum fee per category for each matrix are identified in Table 1.

     (2) Examples of parameters 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) A fee is assessed only once for a given parameter even though that specific parameter may be accredited under more than one matrix.

TABLE 1 - FEE SCHEDULE

     (5) The laboratory must pay applicable fees before:

     • Its quality assurance manual is reviewed by the department;

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

     • Interim, provisional, or full accreditation is granted.

     (6) 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) If a laboratory withdraws from the accreditation process after the application has been processed, but before accreditation is granted, the fee is nonrefundable up to an amount of two hundred thirty dollars as reimbursement for costs of processing the application. If a laboratory withdraws from the accreditation process after the on-site assessment 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. Dollar amounts listed in Table 1 and subsections (6), (7), (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.

[Statutory Authority: RCW 43.21A.230. 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.]

[Statutory Authority: RCW 43.21A.230. 93-20-011 (Order 92-53), § 173-50-200, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-200, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-200, filed 4/20/89 and 3/13/90, effective 4/13/90.]

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

[Statutory Authority: RCW 43.21A.230. 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.]

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

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