PERMANENT RULES
Effective Date of Rule: Thirty-one days after filing.
Purpose: Ecology is revising chapter 173-50 WAC, Accreditation of environmental laboratories, in order to raise lab accreditation fees to cover program costs. Also, due to a budget reduction in the accreditation program, we needed to change some business practices in the rule that will reduce the costs of overseeing accredited labs. This includes decreasing the frequency of on-site audits at nondrinking water labs. To help offset the cost of the fee increase to accredited labs, we are reducing the number of required proficiency testing studies for labs who perform consistently well on such studies. There are also housekeeping amendments and clarification of the grounds for revoking or suspending accreditation.
Citation of Existing Rules Affected by this Order: Repealing WAC 173-50-160 and 173-50-180; and amending WAC 173-50-020, 173-50-030, 173-50-040, 173-50-050, 173-50-060, 173-50-063, 173-50-067, 173-50-070, 173-50-080, 173-50-090, 173-50-100, 173-50-110, 173-50-120, 173-50-130, 173-50-140, 173-50-150, 173-50-170, 173-50-190, 173-50-210, and 173-50-220.
Statutory Authority for Adoption: RCW 43.21A.230 allows ecology to accredit environmental laboratories and to assess fees to cover the department's costs. The state department of health (DOH) has delegated to ecology in a memorandum of understanding its RCW 43.20.050 authority to certify drinking water laboratories. In section 301 of ESHB 1244, the 2009 legislature gave ecology authority to raise fees for lab accreditation.
Adopted under notice filed as WSR 10-07-163 on March 24, 2010.
Changes Other than Editing from Proposed to Adopted Version: We added two definitions and amended another. We added failure to meet requirements for proficiency testing (PT) as a reason for revoking or suspending accreditation. We removed the option of annual fee adjustments based on the implicit price deflator since that figure no longer exists. We added the conditions under which we waive accreditation fees. In response to comments on the high cost of PT samples, we reduced the requirement for participation in PT studies for laboratories with a history of satisfactory PT results.
WAC 173-50-040 Definitions.
We added the following definitions:
| | "Accreditation year" - the one-year period as stated on the certificate of accreditation. |
| | "Principal laboratory" - a laboratory designated by the Washington department of health to support the drinking water certification program. |
We changed the following definition:
"Procedural manual" - until October 1, 2010, the
Department of Ecology Procedural Manual for the Environmental
Laboratory Accreditation Program dated November 2002, and
beginning October 1, 2010, the Department of Ecology
Procedural Manual for the Environmental Laboratory
Accreditation Program dated September 2010.
We plan to complete the revision of the procedural manual by the rule effective date.
WAC 173-50-060 Responsibilities of environmental laboratories.
We changed the third bullet:
| | Submit an initial set of |
WAC 173-50-070 ((Performance audit.)) Proficiency testing
(PT).
We added the second sentence:
(2) ((Drinking water)) Accredited laboratories must
analyze a minimum of one PT sample per applicable microbiology
parameter per year and two PT samples for applicable chemistry
parameters per year. For chemistry parameters, after an
accredited laboratory submits two satisfactory PT sample
results and no unsatisfactory results in an accreditation
year, the laboratory is required to submit only one
satisfactory PT sample result in subsequent accreditation
years. This applies as long as there are no intervening
unsatisfactory PTs.
This change was made in response to comments received by interested parties.
WAC 173-50-130 Requirements for maintaining accreditation
status.
We added the parenthetical phrase:
(1) Accreditation is granted for a one-year period (the accreditation year) and expires one year after the effective date of accreditation.
This reiterates our definition of "accreditation year" added to WAC 173-50-040.
WAC 173-50-150 Revoking or suspending accreditation.
We added an additional condition to subsection (3):
Reports two consecutive unsatisfactory PT sample results.
This was added to further clarify and align with our changes to WAC 173-50-070.
WAC 173-50-170 Third-party accreditation.
We changed this bullet:
| |
WAC 173-50-190 Fee structure.
We deleted this sentence:
(((11))) (9) Dollar amounts listed in Table 1 and
subsections (((6))) (4), (7), and (8)((, (9), and (10))) of
this section may be adjusted every year based on inflation as
indicated by the Implicit Price Deflator for State and Local
Government Services as published by the economic and revenue
forecast council.
This was done because the implicit price deflator no longer exists.
We added this new subsection:
(10) Accreditation fees are waived for laboratories operated by the Washington state departments of ecology and health. Accreditation fees are also waived for drinking water parameters certified by EPA Region 10 at designated principal laboratories.
This was added to clarify our existing practice for fee waivers.
A final cost-benefit analysis is available by contacting Stewart Lombard, Department of Ecology, P.O. Box 488, Manchester, WA 98353-0488, phone (360) 895-6148, fax (360) 895-6180, e-mail stew.lombard@ecy.wa.gov.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 1, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 19, Repealed 2.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 15, Repealed 2.
Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 0, Repealed 0.
Date Adopted: August 9, 2010.
Ted Sturdevant
Director
by Polly Zehm
OTS-3057.4
AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02,
effective 11/1/02)
WAC 173-50-020
Scope.
(1) The Washington state
environmental laboratory accreditation program (WA ELAP)
applies to laboratories which conduct tests for or prepare
analytical data for submittal to any entity requiring the use
of an accredited laboratory. This includes laboratories that
analyze drinking water. ((This rule also describes how the
department of ecology participates in the National
Environmental Laboratory Accreditation Program (NELAP) as an
accrediting authority once the department is certified by the
National Environmental Laboratory Accreditation Conference
(NELAC).))
(2) Accreditation in itself does not authorize use of a specific method for any specific program or project. If such authorization is not granted in documentation governing a program or project within which samples are being analyzed, authorization should be obtained from the laboratory's data user.
(3) Accreditation does not guarantee validity of analytical data submitted by the accredited laboratory but rather assures that the laboratory has demonstrated its capability to reliably generate and report the analytical data (WAC 173-50-040, definition of "accreditation").
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-020, filed 10/1/02, effective 11/1/02; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-020, filed 4/20/89 and 3/13/90, effective 4/13/90.]
Assure accredited laboratories have a demonstrated capability to accurately and defensibly analyze environmental samples;
Assist environmental laboratories in improving their quality assurance/quality control procedures; and
Foster cooperation between the state departments of ecology and health, local agencies, other users of environmental data, and operators of environmental laboratories.
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-030, filed 10/1/02, effective 11/1/02; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-030, filed 4/20/89 and 3/13/90, effective 4/13/90.]
"Accreditation" - the formal recognition by the department that an environmental laboratory is capable of producing accurate and defensible analytical data. This recognition is signified by issuance of a written certificate accompanied by a scope of accreditation indicating the parameters for which the laboratory is accredited.
The term "accredit" as used in this chapter is intended to have the same meaning as the term "certify" as used in RCW 43.21A.230.
Any laboratory accredited under this chapter shall be deemed to have been certified under RCW 43.21A.230.
The department does not, by accrediting any laboratory pursuant to these rules, vouch for or warrant the accuracy of any particular work done or report issued by that laboratory.
"Accreditation year" - the one-year period as stated on the certificate of accreditation.
"Accuracy" - the degree to which an analytical result corresponds to the true or accepted value for the sample being tested. Accuracy is affected by bias and precision.
"Analyte" - the constituent or property of a sample measured using an analytical method.
"Analytical data" - the recorded qualitative and/or quantitative results of a chemical, physical, biological, microbiological, radiochemical, or other scientific determination.
"Analytical method" - a written procedure for acquiring analytical data.
"Department" - the state of Washington department of ecology when the term is not followed by another state designation.
"Drinking water certification manual" - the Environmental
Protection Agency Manual for the Certification of Laboratories
Analyzing Drinking Water, ((4th)) 5th Edition, ((March 1997))
January 2005.
"Ecology accrediting authority" - the supervisor of the lab accreditation unit of the environmental assessment program of the department of ecology.
"Environmental laboratory" or "laboratory" - a facility:
Under the ownership and technical management of a
single entity in a single geographical ((locale)) location;
Where scientific ((examinations)) determinations are
performed on samples taken from the environment, including
drinking water samples; and
Where data is submitted to the department of ecology, department of health, or other entity requiring the use of an accredited laboratory under provisions of a regulation, permit, or contractual agreement.
"Lab accreditation unit" - the lab accreditation unit of
the ((environmental assessment program of the)) department of
ecology.
(("Mandatory analytical method" - a recognized written
procedure for acquiring analytical data which is required by
law or a regulatory agency of the federal, state, or local
government.))
"Matrix" ((means)) - the ((substance from which a))
material to be analyzed ((is extracted)), including, but not
limited to, ground or surface water, wastewater, drinking
water, air, solid waste, soil, tissue, nuclear waste, and
hazardous waste. For the purposes of establishing a fee
structure (WAC 173-50-190(4)), matrices are grouped as
follows:
Nonpotable water;
Drinking water;
Solid and chemical materials; and
Air and emissions.
((NELAP accreditations may include other matrices as
designated in the NELAC standards.
"NELAC" - the National Environmental Laboratory Accreditation Conference, a voluntary association of state and federal agencies.
"NELAC standards" - the standards for laboratory accreditation published by NELAC, September 5, 2001.
"NELAP" - the National Environmental Laboratory Accreditation Program governed by NELAC.)) "On-site audit" - an on-site inspection and evaluation of laboratory facilities, equipment, records and staff.
"Out-of-state laboratory" - a laboratory that is not located in the state of Washington.
"Parameter" - ((a single determination or sampling
procedure, or group of related determinations or sampling
procedures using a specific written method)) the combination
of one or more analytes determined by a specific analytical
method. Examples of parameters include:
The analyte alkalinity by method SM 2320 B;
The analyte zinc by method EPA 200.7;
The set of analytes called volatile organic compounds (VOCs) by method EPA 8260; and
The analyte Total Coli/Ecoli-count by method SM 9222 B/9221 F.
"Principal laboratory" - a laboratory designated by the Washington department of health to support the drinking water certification program.
"Procedural manual" - the Department of Ecology's
Procedural Manual for the Environmental Laboratory
Accreditation Program dated ((November 2002)) September 2010.
"Proficiency testing (PT)" - evaluation of the results from the analysis of samples, the true values of which are known to the supplier of the samples but unknown to the laboratory conducting the analyses. PT samples are provided by a source external to the environmental laboratory.
(("Quality control" - activities designed to assure
analytical data produced by an environmental laboratory meet
data quality objectives for accuracy and defensibility. Those
activities may include routine application of statistically
based procedures to evaluate and control the accuracy of
analytical results.))
"Quality assurance (QA)" - activities intended to assure that a quality control program is effective. A QA program is a totally integrated program for assuring reliability of measurement data.
"Quality assurance (QA) manual" - a written record intended to assure the reliability of measurement data. A QA manual documents policies, organization, objectives, and specific QC and QA activities. Volume and scope of QA manuals vary with complexity of the laboratory mission.
(("Recognized analytical method" - a documented
analytical procedure developed through collaborative studies
by organizations or groups recognized by the users of the
laboratory's analytical data.)) "Quality control (QC)" - the
routine application of statistically based procedures to
evaluate and control the accuracy of analytical results.
"Regulatory program" - a program administered by a federal, state, or other regulatory agency.
(("On-site assessment" - an on-site inspection of
laboratory capabilities.
"Primary NELAP accreditation" - granting of NELAP accreditation by the ecology accrediting authority after having determined through direct evaluation that the laboratory is in conformance with the NELAC standards.))
"((Secondary NELAP)) Third-party accreditation" - recognition by the ecology accrediting authority of ((a
NELAP)) accreditation ((that was)) granted by another
((NELAP)) accrediting authority.
"WA ELAP" - Washington state environmental laboratory accreditation program.
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-040, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-040, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-040, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-040, filed 4/20/89 and 3/13/90, effective 4/13/90.]
Submitting an application and fee;
Preparing a quality assurance manual;
Performing proficiency testing;
Conducting on-site ((assessments)) audits;
Accrediting out-of-state laboratories;
((Issuing)) Granting, denying, suspending, and revoking
accreditation; and
Notifying laboratories and authorized government officials of accreditation actions.
The department will make the procedural manual available to all interested persons.
(2) Department personnel assigned to assess the
capability of drinking water laboratories participating in the
((environmental laboratory accreditation program)) WA ELAP
must meet the experience, education, and training requirements
established in the ((Environmental Protection Agency))
drinking water certification manual.
(((3) When granting NELAP accreditations, the ecology
accrediting authority is responsible for those actions
designated in applicable chapters of the NELAC standards. If
a NELAC standard is more stringent than the corresponding
standard in this chapter, the NELAC standard applies for
laboratories seeking NELAP accreditation.))
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-050, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-050, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-050, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-050, filed 4/20/89 and 3/13/90, effective 4/13/90.]
Submit an application (WAC 173-50-063) and required fees (WAC 173-50-190) to the department fiscal officer;
Submit a copy of the laboratory's quality assurance manual (WAC 173-50-067);
Submit an initial set of ((acceptable)) satisfactory PT
sample ((analysis)) results (WAC 173-50-070); and
Undergo an on-site ((assessment)) audit (WAC 173-50-080).
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-060, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), § 173-50-060, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-060, filed 4/20/89 and 3/13/90, effective 4/13/90.]
Request accreditation for specific parameters;
Calculate fees due to the department; and
Provide evidence that sufficient personnel and equipment are available to successfully perform analytical methods as specified in the application.
(2) Through review of the application submitted by the applicant laboratory, the lab accreditation unit determines if:
Requested parameters are eligible for accreditation;
The fee calculated by the applicant laboratory is correct; and
Personnel and equipment are adequate to support successful performance of requested parameters.
(3) Following the review, the lab accreditation unit advises the applicant laboratory of any required changes.
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-063, filed 10/1/02, effective 11/1/02.]
(2) The QA manual must address QA and QC requirements of applicable regulatory programs. For drinking water laboratories, such requirements are found in the drinking water certification manual.
(((3) For laboratories applying for primary NELAP
accreditation, QA requirements, including the conduct of
specific QC tests, are those designated in the NELAC
standards. If a NELAC standard is more stringent than the
corresponding standard in this chapter, the NELAC standard
applies for laboratories seeking NELAP accreditation.))
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-067, filed 10/1/02, effective 11/1/02.]
(2) ((Drinking water)) Accredited laboratories must
analyze a minimum of one PT sample per applicable microbiology
parameter per year and two PT samples for applicable chemistry
parameters per year. For chemistry parameters, after an
accredited laboratory submits two satisfactory PT sample
results and no unsatisfactory results in an accreditation
year, the laboratory is required to submit only one
satisfactory PT sample result in subsequent accreditation
years. This applies as long as there are no intervening
unsatisfactory PT sample results.
(3) The lab accreditation unit may require the laboratory to submit raw data along with the report of analysis of PT samples.
(4) The lab accreditation unit may waive proficiency tests for certain parameters if PT samples are not readily available or for other valid reasons.
(5) Applying laboratories are responsible for obtaining
PT samples from vendors ((certified by the National Institute
of Standards and Technology (NIST) or otherwise)) approved by
the lab accreditation unit. No fee shall be charged to the
department for the purchase or analysis of PT samples.
(((6) For laboratories applying for NELAP accreditation,
proficiency testing requirements are those designated in the
NELAC standards. If the NELAC standard is more stringent than
the corresponding standard in this chapter, the NELAC standard
applies for laboratories seeking NELAP accreditation.))
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-070, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-070, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-070, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-070, filed 4/20/89 and 3/13/90, effective 4/13/90.]
(1) Critical elements for accreditation. Elements of an
environmental laboratory's operations which are critical to
the consistent generation of accurate and defensible data are
critical elements for accreditation. Critical elements are
subject ((of)) to intense scrutiny throughout the
accreditation process. The ecology accrediting authority may
deny, revoke, or suspend accreditation for deficiencies in
critical elements. Functional areas including critical
elements are:
(a) Analytical methods. The on-site ((assessment)) audit
seeks to determine if documentation of ((mandatory or
recognized)) analytical methods:
Are present at the laboratory;
Readily available to analysts; and
Being implemented. If the laboratory is using a
locally-developed method, the on-site ((assessment)) audit may
include an evaluation of the adequacy of that method.
(b) Equipment and supplies. The on-site ((assessment))
audit seeks to determine if sufficient equipment and supplies
as required by analytical methods are:
Available;
Being adequately maintained; and
In a condition to allow successful performance of applicable analytical procedures.
To gain and maintain accreditation, laboratories must demonstrate that equipment and supply requirements of applicable regulatory programs are being met.
(c) QA and QC records. The on-site ((assessment)) audit
includes a review of QA and QC records for programs/projects
within which the laboratory is generating analytical data for
submission to the data user.
(d) Sample management. The on-site ((assessment)) audit
includes a review of applicable procedures for receipt,
preservation, transportation, and storage of samples. The
laboratory is responsible only for those elements of sample
management over which it has direct control. To gain and
maintain accreditation, laboratories must demonstrate that
sample management requirements of applicable regulatory
programs are being met.
(e) Data management. The on-site ((assessment)) audit
includes a review of activities necessary to assure accurate
management of laboratory data including:
Raw data;
Calculations; and
Transcription, computer data entry, reports of analytical results.
To gain and maintain accreditation, laboratories must demonstrate that data management requirements of applicable regulatory programs are being met.
(2) Recommended practices. Recommended practices are those elements of laboratory operations which might affect efficiency, safety, and other administrative functions, but do not normally affect quality of analytical data. Normally these practices would not be the basis for denial or revocation of accreditation status. Functional areas within which recommended practices may be noted are:
(a) Personnel. The department seeks to determine if
managerial, supervisory, and technical personnel have adequate
training and experience to allow satisfactory completion of
analytical procedures and compilation of reliable, accurate
data. Minimum recommended education and experience criteria
for laboratory personnel are specified in the ((program))
procedural manual.
(b) Facilities. The department seeks to determine if laboratory facilities allow efficient generation of reliable, accurate data in a safe environment.
(c) Safety. The department may refer serious safety deficiencies to appropriate state or federal agencies.
(3) ((NELAC requirements. For laboratories applying for
NELAP accreditation, on-site assessment requirements are those
designated in the NELAC standards. If the NELAC standard is
more stringent than the corresponding standard in this
chapter, the NELAC standard applies.
(4))) Drinking water laboratory requirements. For
laboratories applying for accreditation of drinking water
parameters, on-site ((assessment)) audit requirements are
those designated in the drinking water certification manual. If such a standard is more stringent than the corresponding
standard in this chapter, the drinking water certification
manual applies.
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-080, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-080, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-080, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-080, filed 4/20/89 and 3/13/90, effective 4/13/90.]
List((s)) findings;
((Assesses)) Assess the importance of each finding; and
Make((s)) recommendations concerning actions necessary
to assure resolution of problems.
(2) After completing the accreditation review, the ecology accrediting authority decides whether accreditation should be granted.
(a) If accreditation is warranted, the department issues a certificate and accompanying scope of accreditation. The certificate remains the property of the department and must be surrendered to the department upon revocation or voluntary termination of accreditation status.
(b) If accreditation is not warranted, the department issues a report specifying areas of deficiency and steps necessary to upgrade the laboratory to accredited status. In such cases, the laboratory must provide documentation that the specified deficiencies have been corrected. Based on such documentation the ecology accrediting authority decides whether to grant or deny accreditation.
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-090, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-090, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-090, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-090, filed 4/20/89 and 3/13/90, effective 4/13/90.]
Submit an application and applicable fees;
Successfully complete applicable proficiency tests; and
Submit a QA manual that meets the requirements of WAC 173-050-067.
The lab accreditation unit may also require the laboratory to submit an analytical data package as evidence of analytical capability.
(((2) For NELAP accreditation, the only valid reason for
granting interim accreditation is the delay of an on-site
assessment for reasons beyond the control of the laboratory.))
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-100, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-100, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-100, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-100, filed 4/20/89 and 3/13/90, effective 4/13/90.]
(2) The ecology accrediting authority may renew a provisional accreditation for a subsequent accreditation period if laboratory management has demonstrated that all reasonable measures to correct deficiencies have been exhausted.
(3) For drinking water laboratories, specific conditions warranting provisional accreditation and specific actions required of the laboratory when provisional accreditation is granted are found in the drinking water certification manual.
(((4) Provisional accreditation does not apply to NELAP
accreditations.))
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-110, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), § 173-50-110, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-110, filed 4/20/89 and 3/13/90, effective 4/13/90.]
General chemistry ((I (General)));
((Chemistry II ())Trace metals(()));
Organics I (((Gas Chromatography (GC) and High Pressure
Liquid Chromatography (HPLC) Methods)));
Organics II (((Gas Chromatography/Mass Spectrometry
(GC/MS) Methods))) (Category II methods use mass spectrometer
detectors);
(( Radioactivity;))
Microbiology;
Radiochemistry;
Bioassay((/Toxicity));
Immunoassay; and
Physical.
Within these categories, laboratories are specifically
accredited for well-defined parameters, such as, but not
limited to, those suggested in the procedural manual, using
specific((, recognized)) analytical methods or sampling
techniques chosen by the applying laboratory.
(2) The scope of accreditation accompanying the accreditation certificate indicates the parameters for which the laboratory is accredited, and any applicable qualifications, such as interim or provisional accreditation.
(3) ((For laboratories granted NELAP accreditation,)) The
scope of accreditation also indicates the matrix groups within
which each parameter applies. Those matrix groups may
include, but are not limited to:
Nonpotable water;
Drinking water;
Solid and chemical materials;
(( Biological tissue;)) and
Air and emissions.
((For laboratories granted NELAP accreditation, the scope
of accreditation may also indicate the technology, such as gas
chromatography/electron capture detection (GC/ECD) or
inductively coupled plasma/mass spectrometry (ICP/MS),
associated with each parameter.))
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-120, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-120, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-120, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-120, filed 4/20/89 and 3/13/90, effective 4/13/90.]
(2) Renewal requires the laboratory to submit:
An application and appropriate fees;
An update of the laboratory's ((quality assurance)) QA
manual if applicable; ((and))
Evidence of accreditation by a third party when appropriate; and
Successful completion of proficiency testing requirements.
(3) For laboratories accredited for drinking water
parameters, on-site ((assessments)) audits are required at
periods not to exceed three years from the previous on-site
((assessment)) audit. ((For documented cause, on-site
assessments may be extended up to four years from the previous
assessment, except for laboratories accredited to analyze
drinking water and NELAP accredited laboratories.))
(4) For laboratories not accredited for drinking water parameters, the schedule of on-site audits will be determined by the ecology accrediting authority.
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-130, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-130, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-130, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-130, filed 4/20/89 and 3/13/90, effective 4/13/90.]
Fails to comply with standards for critical elements of
the on-site ((assessment)) audit;
Misrepresents itself to the department;
Fails to disclose pertinent information in the application;
Falsifies reports of analysis including ((PT))
proficiency testing results;
Engages in unethical or fraudulent practices concerning generation of analytical data;
Is deficient in its ability to provide accurate and defensible analytical data; or
Fails to render applicable fees.
(2) A laboratory may be denied accreditation for a
specific parameter for unsatisfactory ((analysis of that
parameter in)) proficiency ((tests)) testing results.
(3) Laboratories denied accreditation may appeal under the provisions of WAC 173-50-200. If an appeal does not result in action favorable to the laboratory, and following correction of deficiencies, laboratories denied accreditation may reapply for accreditation to include payment of appropriate fees as determined in WAC 173-50-190.
(((4) Reasons for denial of NELAP accreditation are as
specified in the NELAC standards.))
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-140, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), § 173-50-140, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-140, filed 4/20/89 and 3/13/90, effective 4/13/90.]
(2) Suspension of accreditation is for a specified period
((not to exceed six months)) during which the affected
laboratory corrects deficiencies that led to the suspension.
Suspension may involve the entire laboratory, or one or more
individual parameters.
(((2))) (3) The ecology accrediting authority may suspend
or revoke accreditation if the accredited laboratory:
Fails to comply with standards for critical elements of
an on-site ((assessment)) audit;
Violates a state rule relative to the analytical procedures for which it is accredited;
Misrepresents itself to the department;
Falsifies reports of analysis including ((PT))
proficiency testing results;
Engages in unethical or fraudulent practices concerning generation of analytical data;
Is deficient in its ability to provide accurate and
defensible analytical data; ((or))
Refuses to permit entry for enforcement purposes (WAC 173-50-210);
Fails to render applicable fees;
Fails to maintain third-party accreditation; or
Reports two consecutive unsatisfactory PT sample results.
(((3))) (4) A laboratory having had its accreditation
suspended or revoked may appeal under the provisions of WAC 173-50-200. If an appeal does not result in action favorable
to the laboratory, and following correction of deficiencies, a
laboratory having had its accreditation revoked may reapply
for accreditation to include payment of appropriate fees as
determined in WAC 173-50-190.
(((4) Reasons for revocation or suspension of NELAP
accreditation are as specified in the NELAC standards.))
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-150, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), § 173-50-150, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-150, filed 4/20/89 and 3/13/90, effective 4/13/90.]
(2) Laboratories applying for recognition of a third party's accreditation submit:
An application and associated fee (WAC 173-50-190(7));
A copy of the third party's certificate;
A copy of the third party's scope of accreditation;
A copy of the third party's most recent on-site
((assessment)) audit report;
A copy of the laboratory's corrective action report
relative to the on-site ((assessment)) audit, if applicable;
and
((A complete set of the most)) Recent ((PT)),
satisfactory proficiency test results for the applicable
parameters.
(3) In consideration of a request to recognize a third party's accreditation as the basis for accreditation by the ecology accrediting authority, the lab accreditation unit reviews the application and supporting documentation to assure compliance with minimum accreditation requirements as stated in this chapter. If the review is favorable, a certificate and scope of accreditation are granted as in WAC 173-50-090.
(4) Laboratories granted third-party accreditation must notify the laboratory accreditation unit immediately of changes in the status of their third-party accreditation.
(5) Washington laboratories accredited or applying for
accreditation in recognition of a third party's accreditation
must notify the lab accreditation unit of on-site
((assessments)) audits scheduled by the third party and allow
a department observer to attend such on-site ((assessments))
audits.
(((5) Primary NELAP accreditation cannot be granted in
recognition of the accreditation by a third party.))
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-170, filed 10/1/02, effective 11/1/02; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-170, filed 4/20/89 and 3/13/90, effective 4/13/90.]
(2) Examples of parameters or methods for each category are published in the procedural manual. Accreditation may be requested for parameters in addition to those listed in the procedural manual.
(3) When a fee is assessed ((only once)) for a ((given))
specific drinking water parameter ((even though that
specific)) or method, the laboratory may be accredited for the
same parameter ((may be accredited under more than one
matrix)) or method in nonpotable water without paying an
additional fee.
| (( |
PARAMETER |
||||||
Chemical Materials |
|||||||
Emissions |
|||||||
| CATEGORY | FEE PER PARAMETER | FEE PER METHOD | MAX FEE PER CATEGORY | |||||||
| General Chemistry | $80 | -- | $1,600 | |||||||
| Trace Metals | -- | $400 | -- | |||||||
| Organics I | -- | $200 | -- | |||||||
| Organics II | -- | $500 | -- | |||||||
| Microbiology | $200 | -- | -- | |||||||
| Radiochemistry | $250 | -- | -- | |||||||
| Bioassay | $300 | -- | $3,000 | |||||||
| Immunoassay | $80 | -- | -- | |||||||
| Physical | $80 | -- | -- | |||||||
(5) In addition to paying the fee indicated in Table 1,
out-of-state laboratories must pay for the actual cost of
travel associated with on-site ((assessments)) audits. The
department invoices the laboratory for such costs after
completion of the on-site ((assessment)) audit.
(((5))) (6) The laboratory must pay applicable fees
before:
Its quality assurance manual is reviewed by the department;
The on-site ((assessment)) audit is conducted if
applicable; and
Interim, provisional, or full accreditation is granted.
(((6))) (7) The fee for recognition of a third party
accreditation (WAC 173-50-170)((, other than NELAP
accreditation (WAC 173-50-190(9)), is three hundred forty-five
dollars.
(7) The fee for recognition of a laboratory under a reciprocity agreement (WAC 173-50-160) is three hundred forty-five dollars, or as specified in the reciprocity agreement, but not less than three hundred forty-five dollars.
(8) The fee for recognition of accreditation by a NELAP accrediting authority for laboratories in Washington is three hundred forty-five dollars. For out-of-state laboratories, the fee for recognition of accreditation by a NELAP accrediting authority is the fee indicated in Table 1.
(9) For drinking water laboratories, the base fee to defray the extra cost incurred by the department because of the need to coordinate directly with two regulatory agencies is one hundred fifteen dollars.
(10))) is three-fourths (75%) of the fee indicated in Table 1.
(8) If a laboratory withdraws from the accreditation
process after the application has been processed, but before
accreditation is granted, the fee is ((nonrefundable))
refundable, less an amount up to ((an amount of two)) three
hundred ((thirty)) dollars as reimbursement for costs of
processing the application. If a laboratory withdraws from
the accreditation process after the on-site ((assessment))
audit has been completed, the department may retain the entire
fee including reimbursement of travel costs if applicable.
(((11) Dollar amounts listed in Table 1 and subsections
(6), (7), (8), (9), and (10) of this section may be adjusted
every year based on inflation as indicated by the Implicit
Price Deflator for State and Local Government Services as
published by the economic and revenue forecast council.)) (9)
Dollar amounts listed in Table 1 and subsections (((6), (7),))
(4) and (8)((, (9), and (10))) of this section may be
decreased at any time the department determines they are
higher than needed to meet accreditation program requirements.
The department notifies affected parties of any fee
adjustment at least thirty days prior to the effective date of
the adjusted fee.
(10) Accreditation fees are waived for laboratories operated by the Washington state departments of ecology and health. Accreditation fees are also waived for drinking water parameters certified by EPA Region 10 at designated principal laboratories.
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-190, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), § 173-50-190, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-190, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-190, filed 4/20/89 and 3/13/90, effective 4/13/90.]
(2) Refusal to permit entry for such purposes ((shall))
may result in denial((,)) or revocation((, or suspension)) of
accreditation ((or registration status)).
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-210, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), § 173-50-210, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-210, filed 4/20/89 and 3/13/90, effective 4/13/90.]
[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), § 173-50-220, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), § 173-50-220, filed 10/19/90, effective 11/19/90.]
The following sections of the Washington Administrative Code are repealed:
| WAC 173-50-160 | Reciprocity. |
| WAC 173-50-180 | Exemptions. |