WSR 02-20-090

PERMANENT RULES

DEPARTMENT OF ECOLOGY


[ Order 01-12 -- Filed October 1, 2002, 11:10 a.m. ]

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Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 24, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 24, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 24, Repealed 0.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.]


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

WAC 173-50-020   Scope.   ((The environmental laboratory accreditation program applies to laboratories, within or outside the state, which conduct tests for or prepare analytical data for submittal to the department. Federal laboratories may participate in the accreditation program on a voluntary basis.)) (1) The environmental laboratory accreditation program 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. 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 89-1 and 89-1A, filed 4/20/89 and 3/13/90, effective 4/13/90)

WAC 173-50-030   Objectives.   ((The primary objective of the accreditation program is to assure accredited laboratories have a demonstrated capability to accurately analyze environmental samples. A secondary objective is to assist environmental laboratories in improving their quality assurance/quality control procedures. Accreditation does not guarantee validity of analytical data submitted by the laboratory subsequent to accreditation.)) Objectives of the accreditation program 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. 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 92-53, filed 9/22/93, effective 10/23/93)

WAC 173-50-040   Definitions.   Definitions ((set forth)) in this section ((shall)) apply throughout this chapter, unless context clearly indicates otherwise.

(((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.]


AMENDATORY SECTION(Amending Order 92-53, filed 9/22/93, effective 10/23/93)

WAC 173-50-050   Responsibilities of the department.   (((1) The department shall require persons and organizations submitting analytical data to the department under the purview of department programs to use environmental laboratories which are accredited or registered under the provisions of this chapter.

(2) The department shall not require use of accredited or registered laboratories for determination of analytical parameters for which no suitable accreditation process can be reasonably devised as determined by the quality assurance section.

(3) The department shall develop a procedural manual describing specifics of the accreditation process. As a minimum, the procedural manual shall describe in detail the procedures to be followed for: Submitting an application; preparing a quality assurance manual; system (on-site) audits; performance audits; accreditation of out-of-state laboratories; determination and payment of fees; issuance, denial, suspension, and revocation of accreditation or registration; and methods for notifying laboratories and authorized department officials of accreditation actions. The procedural manual shall be made available to all interested persons.

(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.]


AMENDATORY SECTION(Amending Order 90-21, filed 10/19/90, effective 11/19/90)

WAC 173-50-060   ((Requirements for accreditation and registration.)) Responsibilities of environmental laboratories.   (((1) Managers of environmental laboratories desiring accreditation or registration shall submit to the department fiscal officer an application and pay required fees as predetermined by coordination with the quality assurance section. Concurrently, the laboratory manager shall submit a copy of their laboratory quality assurance manual to the quality assurance section and arrange with the quality assurance section for completion of a performance audit and system audit.

(2) Through the application, laboratory managers shall request accreditation or registration in applicable parameters and provide evidence that sufficient personnel, equipment, and facilities are available to successfully perform analytical methods as specified in the application. The quality assurance manual submitted concurrently with the application shall be in detail and scope commensurate with the size and mission of the laboratory.

(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.]


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

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.

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NEW SECTION
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. 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.

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AMENDATORY SECTION(Amending Order 92-53, filed 9/22/93, effective 10/23/93)

WAC 173-50-070   Performance audit.   (1) The ((quality assurance section shall)) lab accreditation unit advises applying laboratories of specific requirements for ((performance audits which shall be)) proficiency tests. Such tests are completed for applicable parameters no more frequently than twice annually (((see exception in subsection (4) of this section))). Current ((performance audits)) proficiency tests conducted under the provisions of other recognized programs may be used to satisfy the accreditation program ((performance audit)) proficiency testing requirement. The lab accreditation unit determines the sufficiency of such audits ((shall be determined by the quality assurance section)).

(((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.]


AMENDATORY SECTION(Amending Order 92-53, filed 9/22/93, effective 10/23/93)

WAC 173-50-080   ((System audit.)) On-site assessment.   The laboratory ((shall)) must undergo a system 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 as required.

(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.]


AMENDATORY SECTION(Amending Order 92-53, filed 9/22/93, effective 10/23/93)

WAC 173-50-090   Evaluation and issuance of certificate.   (((1) Accreditation. Following receipt of an application and completion of a performance audit and system audit, the quality assurance section shall submit a report to the affected laboratory concerning the results of the overall accreditation process. The report shall list findings, assess the importance of each finding, and make recommendations concerning actions necessary to ensure resolution of problems. After completing the accreditation review, the quality assurance section shall decide, based on information in the application and results of the system audit, performance audit, and review of the quality assurance manual, whether accreditation should be granted. If this decision is affirmative, a certificate shall be issued authorizing the affected laboratory to submit analytical data to the department as specified on an accompanying scope of accreditation. The certificate shall remain the property of the department and shall be surrendered to the department upon revocation of accreditation status. If accreditation is not justified, the department shall issue a report specifying areas of deficiency and steps necessary to upgrade the laboratory to accredited status. In such cases, the laboratory shall provide documentation that the specified deficiencies have been corrected. Based on such documentation the department shall decide whether to grant, renew, deny, or revoke accreditation.

(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.]


AMENDATORY SECTION(Amending Order 92-53, filed 9/22/93, effective 10/23/93)

WAC 173-50-100   Interim accreditation.   ((If for valid reasons based on a deficiency in the department and not the laboratory, the quality assurance section cannot conduct a complete assessment of laboratory capabilities in a timely manner, an interim accreditation may be granted. The accreditation shall be based on submission of an application and fees by the laboratory, successful completion of a performance audit where appropriate, and department approval of the laboratory's quality assurance manual.)) (1) If for valid reasons resulting from a deficiency in the department and not the laboratory, 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. 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 90-21, filed 10/19/90, effective 11/19/90)

WAC 173-50-110   Provisional accreditation.   ((Laboratories which have deficiencies requiring corrective action but can produce valid analytical data as determined by the quality assurance section may be given a provisional accreditation. When the laboratory has corrected such deficiencies, it may provide evidence of correction to the quality assurance section, or request reaudit, as appropriate. Upon determining deficiencies have been corrected, the quality assurance section shall take action to award full accreditation as in WAC 173-50-090. Provisional accreditation shall not be renewed for a subsequent accreditation period unless laboratory management can demonstrate that all reasonable measures to correct deficiencies noted during the initial capability assessment have been exhausted.)) (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, 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. 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 92-53, filed 9/22/93, effective 10/23/93)

WAC 173-50-120   Accreditation ((and registration)) categories.   ((Environmental laboratories shall be accredited or registered within the broad categories Chemistry I (general), Chemistry II (trace metals), Organics I (gas chromatography (GC), high pressure liquid chromatography (HPLC) methods), Organics II (gas chromatography/mass spectrometry (GC/MS) methods), Radioactivity, Microbiology, and Bioassay/Toxicity. Within those broad categories, laboratories shall specifically be accredited or registered to perform within the well-defined parameters identified in WAC 173-50-190 or as requested by the applying laboratory, using specific, recognized analytical methods chosen by the applying laboratory. Additional parameters may be designated in the program procedural manual without amendment of this chapter if required to allow more efficient execution of the accreditation program.)) (1) Environmental laboratories are accredited within one or more of the matrix groups defined in WAC 173-50-040. Additionally, accreditation is granted within the following broad categories:

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);

Radioactivity;

Microbiology;

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. 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 92-53, filed 9/22/93, effective 10/23/93)

WAC 173-50-130   Requirements for maintaining accreditation ((and registration)) status.   (1) Accreditation ((shall be)) is granted for a one-year period and ((shall)) 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. ((Renewal shall require submission of an application and appropriate fees, an update of the laboratory's quality assurance manual, and successful completion of performance audit requirements. System audits shall be required for renewal of accreditation at periods not to exceed three years from the previous system audit. For documented cause, system audits can be extended up to four years from the previous audit.

(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.]


AMENDATORY SECTION(Amending Order 90-21, filed 10/19/90, effective 11/19/90)

WAC 173-50-140   Denying accreditation ((and registration status)).   (((1) A laboratory may be denied accreditation for failing to comply with standards for critical elements of the system audit, for misrepresenting its capabilities or failing to disclose pertinent information in the application, for falsifying analytical data, or for failing to render appropriate fees. Additionally, a laboratory may be denied accreditation for a specific parameter for unsatisfactory analysis of that parameter in the performance audit. Laboratories denied accreditation may appeal under the provisions of WAC 173-50-200 or, following correction of deficiencies, may reapply for accreditation to include payment of appropriate fees as determined in WAC 173-50-190.

(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.]


AMENDATORY SECTION(Amending Order 90-21, filed 10/19/90, effective 11/19/90)

WAC 173-50-150   Revoking or suspending accreditation ((and registration status)).   (((1) Accreditation status may be suspended or revoked if the laboratory violates a state rule relative to the analytical procedures for which it is accredited, misrepresents itself to the department, fails to submit an application and associated fees for renewal, falsifies reports of analysis, or engages in unethical or fraudulent practices concerning the generation of analytical data. Additionally, an accredited laboratory may be reaudited for cause and, if found to be deficient in its ability to provide accurate analytical data, may have its accreditation suspended or revoked.

(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.]


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

WAC 173-50-160   Reciprocity.   ((The department may recognize accreditation (or certification, registration, licensure, approval) of an out-of-state laboratory by another state with which the department has established a reciprocity agreement. In such cases, the out-of-state laboratory shall submit an application and associated fee to offset administrative costs of processing its application (see WAC 173-50-190(5)), and a copy of their accreditation documentation including scope of accreditation. After review of the application and accreditation to assure compliance with minimum accreditation requirements as stated in this chapter, the laboratory may be recognized as authorized to submit analytical data to the department.)) (1) The department may recognize accreditation (or certification, registration, licensure, approval) of an out-of-state laboratory by the laboratory's home state with which the department has established a reciprocity agreement.

(2) The out-of-state laboratory must submit:

An application and associated fee (WAC 173-50-190(8));

A copy of the other state's certificate;

A copy of the other state's scope of accreditation;

A copy of the other state's most recent on-site assessment report;

A copy of the laboratory's corrective action report relative to the on-site assessment; and

A complete set of the most recent PT results for applicable parameters.

(3) In consideration of a request to recognize a reciprocity agreement 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) 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.]


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

WAC 173-50-170   Third-party accreditation.   ((The department may recognize accreditation (or certification, registration, licensure, approval) of a laboratory, including in-state laboratories, by a third party when the accreditation is determined to be equivalent to that described in this chapter. Laboratories applying for recognition of third-party accreditation shall submit an application and associated fee to offset administrative costs (see WAC 173-50-190(5)), and provide documented information demonstrating requirements for accreditation have been fulfilled as a result of accreditation carried out by a third party. After review of the application and accreditation to ensure compliance with minimum accreditation requirements as stated in this chapter, the laboratory may be recognized as authorized to submit analytical data to the department.)) (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 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 report;

A copy of the laboratory's corrective action report relative to the on-site assessment; and

A complete set of the most recent PT 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) 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 scheduled by the third party and allow a department observer to attend such on-site assessments.

(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.]


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

WAC 173-50-180   Exemptions.   (1) The application form ((shall)) provides for wastewater dischargers whose laboratories meet the exemption qualifications of RCW 43.21A.230 to request exemption from the accreditation program. Those laboratories shall be required to submit evidence that they are participating in a federal Environmental Protection Agency Administered Quality Assurance Program including as a minimum the following elements: Current QA program/project plans; performance evaluation audits; system audits; corrective action for audit deficiencies; quality control guidelines and records; and training in quality assurance for laboratory management personnel. The department shall grant exemption from accreditation requirements of this chapter upon receipt of confirmation from Region ((X)) 10 of the federal Environmental Protection Agency of such participation by a laboratory.

(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.]


AMENDATORY SECTION(Amending Order 92-53, filed 9/22/93, effective 10/23/93)

WAC 173-50-190   Fee structure.   (((1) Fees in this chapter are established to cover costs of administering the accreditation program. The fee per parameter and maximum fee per category are identified in Table 1. Laboratory directors may request addition of parameters within given categories.

TABLE 1 - FEE SCHEDULE

CATEGORY PARAMETER MAX FEE

PER FEE/

PARAMETER CATEGORY

Chemistry I

(General)

Calcium $55 $1000
Chloride
Fluoride
Magnesium
pH
Potassium
Sodium
Specific Conductance
Sulfate
Total Alkalinity
Total Dissolved Solids (TDS)
Total Hardness
Ammonia (NH3-N)
Kjeldahl Nitrogen
Nitrate (NO3-N)
Nitrate-Nitrite (NO3-NO2)
Nitrite (NO2-N)
Orthophosphate
Phosphorous (total)
Biochemical Oxygen Demand

(BOD)/Carbonaceous

BOD (CBOD)

Chemical Oxygen Demand

(COD)

Total Organic Carbon

(TOC)

Acidity
Anionic Surfactants (LAS)
Bromide
Color
Cyanide (total)
Dissolved Oxygen (DO)
Nonfilterable Residue/

Total Suspended

Solids (TSS)

Total Solids
Volatile Solids
Oil/grease
Phenolics (total)
Salinity
Silica
Sulfide
Sulfite
Total Organic Halides
Total Petroleum Hydrocarbons
Total Residual Chlorine
Turbidity
Chemistry II

(Trace Metals)

Aluminum $55 $850
Antimony
Arsenic
Barium
Beryllium
Cadmium
Chromium
Chromium (hexavalent)
Cobalt
Copper
Iron
Lead
Manganese
Mercury
Molybdenum
Nickel
Selenium
Silver
Strontium
Thallium
Tin
Titanium
Vanadium
Zinc
Organics I

(GC, HPLC

methods)

Acrolein/Acrylonitrile $100 $850
Phenols
Purgeable (volatile)

Halocarbons

Purgeable (volatile)

Aromatics

Benzidines
Phthalate Esters
Nitrosamines
Organochlorine Pesticides
Polychlorinated Biphenyls (PCBs)
Nitroaromatics/Isophorone
Polycyclic Aromatic

Hydrocarbons

Haloethers
Chlorinated Hydrocarbons
Organophosphorus Pesticides
Chlorinated Herbicides
Gasoline
Diesel Fuel
Organics II

(GC/MS

Methods)

Purgeable (volatile) Organics $300 $900
Extractable Base/Neutral

and Acid (Semivolatile)

Organics

Dioxin (2,3,7,8-Tetra-

chlorodibenzo-p-dioxin)

Radioactivity Gross Alpha $125 $1200
Gross Beta
Cesium 134
Cesium 137
Cobalt 60
Radium 226
Radium 228
Tritium
Total Uranium
Iodine 131
Strontium 89
Strontium 90
Microbiology Coliform (fecal) $205 $600
Coliform (total)
Enterococci/Fecal

Streptococci

E. coli
Bioassay/Toxicity Fish $200 $1250
Rat
Amphipod
Bivalve Larvae
Chromosomal abnormality
Microtox
Daphnid
Echinoderm
Mysid
Algae
Sediment Antimony $100 $500
Arsenic
Cadmium
Copper
Lead
Mercury
Nickel
Silver
Zinc
Polycyclic Aromatic

Hydrocarbons

Extractable Base/Neutral

and Acid (semivolatile)

Organics

(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

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)

(4) 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. The department invoices the laboratory for such costs after completion of the on-site assessment.

(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.]


AMENDATORY SECTION(Amending Order 92-53, filed 9/22/93, effective 10/23/93)

WAC 173-50-200   Appeals.   An environmental laboratory manager may appeal final accreditation ((and registration)) actions within thirty days of notification of final action in accordance with chapter 43.21B RCW.

[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.]


AMENDATORY SECTION(Amending Order 90-21, filed 10/19/90, effective 11/19/90)

WAC 173-50-210   Enforcement.   (1) For the purpose of conducting on-site assessments or otherwise enforcing this chapter, the department may enter any premises in which analytical data pertaining to accreditation ((and registration)) under the provisions of this chapter are generated or stored((, for the purpose of conducting system audits or otherwise enforcing this chapter)).

(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.]


AMENDATORY SECTION(Amending Order 90-21, filed 10/19/90, effective 11/19/90)

WAC 173-50-220   Assistance to laboratories.   ((During those calendar years in which a system audit is not required, registered laboratories may request a visit by quality assurance section personnel for the purpose of providing assistance in correcting deficiencies and improving practices for those tests covered by the scope of registration. These visits will be for the purpose of technical assistance and will not result in preparation of a corrective action report by the registered laboratory.)) Laboratories scheduled to undergo an on-site assessment may request a training session be conducted by department staff in conjunction with that assessment. Accredited laboratories may also request on-site assistance at times other than the on-site assessment. Whether requested as part of the on-site assessment 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. 90-21-090 (Order 90-21), 173-50-220, filed 10/19/90, effective 11/19/90.]

Washington State Code Reviser's Office