reglab/statecodes huggingface dataset:
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-140 - Method performance criteria

Current through Register Vol. 24-14, July 15, 2024
(1) Accredited
				labs may reference samples for testing by subcontracting fields of testing to
				another accredited laboratory.
(2)
				Laboratories must maintain the integrity of the sample by testing samples on an
				"as is" or "as received" basis before sample prep unless otherwise specified in
				rules.
(3) Laboratories may use
				historical calibrations for high complexity testing as long as it is supported
				by analytical data through quality control results. Historical calibrations
				cannot extend past 30 days.
(4) The
				samples fail quality control testing if the results exceed the limits indicated
				in chapter 314-55 WAC.
(5) Sample
				results are positive for the analyte being tested if their results are greater
				than or equal to the decision point or cutoff limits as indicated in chapter
				314-55 WAC.
(6) Sample results are
				to be reported out in the number of digits and units of measure described in
				chapter 314-55 WAC.
(7)
				Laboratories may be accredited to conduct the following fields of testing:
Field of Testing
Level of
							 Complexity
water activity
low
cannabinoid concentration analysis
high
foreign matter inspection
low
microbiological testing
culture method
moderate
immunoassay method
moderate
polymerase chain reaction (PCR) method
high
residual solvent testing
high
mycotoxin testing
enzyme-linked immunosorbent assay (ELISA)
							 method
moderate
liquid chromatography with tandem mass spectrometry
							 (LC-MS/MS) method
high
pesticide testing
high
heavy metals testing
high
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-150 - Water activity testing

Current through Register Vol. 24-14, July 15, 2024
(1) Water
				activity (aw) analysis is intended to quantitatively
				report out the presence of water in the sample.
The laboratory must run two continuing calibration
				  verifications at levels bracketing the action limit concentration at the
				  beginning of each day of testing.
(2) One sample must be run in duplicate with
				difference in values of 80 percent - 120 percent as a quality control
				specimen.
(3) The laboratory must
				monitor and record temperature and humidity daily or when testing is
				performed.
(4) The laboratory must
				calibrate the aw instrument when:
(a) The instrument has been physically moved
				from one location to another.
(b)
				The instrument has been cleaned.
(c) The manufacturer's instruction manual
				recommends.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-160 - Cannabinoid concentration analysis

Current through Register Vol. 24-14, July 15, 2024
(1)
				Cannabinoid concentration analysis, previously known as potency, is intended to
				quantitate and accurately report cannabinoids above the lower limit of
				quantitation as described in chapter 314-55 WAC.
(2) Laboratories must use a method approved
				by the department to analyze cannabinoids.
(3) Laboratories must limit batch size to 20
				samples in a preparation batch not including quality controls.
(4) ICV, CCV, and surrogate must meet a
				minimum of 80-120 percent recovery for each analyte.
(5) LCS and matrix spike samples must meet a
				minimum of 70-130 percent recovery for each analyte.
(6) Sample and matrix spike duplicates must
				have a relative percent difference (RPD) value of less than 20
				percent.
(7) Chromatographic
				performance must be described in method and must include, but is not limited
				to, the following criteria:
(a) Tailing factor
				less than 2.0;
(b) Column
				performance resolution greater than 1.0;
(c) Retention time shift less than two
				percent.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-170 - Foreign matter inspection

Current through Register Vol. 24-14, July 15, 2024
(1) The
				laboratory must analyze not less than 30 percent of the total representative
				sample of cannabis and cannabis products prior to sample homogenization to
				determine whether foreign material is present.
(2) The laboratory must report the result of
				the foreign material test by indicating "pass" or "fail."
(3) The laboratory must use a microscope with
				photographic capabilities or a camera with magnification or resolution to
				document the presence of foreign matter. Magnification will only be required
				when something is identified and the picture without magnification does not
				allow identification of the foreign matter.
(4) The laboratory must document the
				observation with a detailed description of any foreign matter and photograph
				the sample supporting the report.
(5) The foreign matter inspection must be
				performed in a clean and sanitary location that prevents contamination or
				degradation prior to other testing.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-180 - Microbiological testing

Current through Register Vol. 24-14, July 15, 2024
(1)
				Microbiological testing is intended to accurately measure qualitative,
				semi-quantitative, or quantitate results, and report microorganisms incurred
				through the production and processing of cannabis and cannabis
				products.
(2) The laboratory must
				have a microbiological testing SOP that contains a detailed description of the
				preparation of any material that does not come as a working stock (i.e.,
				culture media, master mix, spiked controls).
(3) The laboratory may use either
				culture-based testing methods, immunoassay methods, molecular assay methods, or
				a combination of culture-based, immunoassay, and molecular assay methods for
				microbiological testing.
(4)
				Quality control must be performed on each new media lot, PCR reagent lot, or
				kit lot used. For molecular assays, DNA controls must be included with each
				analytical run and internal amplification controls (IACs) must be included with
				each individual reaction.
(a) Acceptability
				criteria for all calibration and QC materials such as controls, spikes, and
				blanks, must be defined, as well as the action to be taken when results are
				outside control limits. The laboratory must set controls at relevant limits
				around the decision points for the microbial assay(s) as defined
				above.
(b) Positive and negative
				controls must be included in all microbial assay tests. Quality controls must
				be analyzed in the same manner as samples.
(i)
				The laboratory must use control organisms that represent the target organism.
				Controls for the confirmation of a target, such as salmonella or Shiga
				toxin-producing
E. coli
(STEC), must be as similar as possible
				to the presumptive organism.
(ii)
				The laboratory must maintain documentation of quality control organisms and
				ensure purity of the control organism is maintained by limiting the number of
				cell divisions from the original culture.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-190 - Residual solvent testing

Current through Register Vol. 24-14, July 15, 2024
(1) Residual
				solvent analysis is intended to accurately quantitate and report solvent
				residue left behind from product processing.
(2) Laboratories must use a method approved
				by the department to analyze residual solvents.
(3) Methanol and any other solvent listed in
				chapter 314-55 WAC must not be used in any preparation or analysis procedure
				for residual solvent testing.
(4)
				Upon receipt of a sample at a laboratory, the sample treatment must follow the
				method requirements for preservation and storage.
(5) When an extraction solvent is used in
				method it must be an organic solvent that is capable of accomplishing the
				dilution of the sample while still able to meet the quality control
				requirements of this method and regulatory requirements, and is NOT a required
				analyte per regulations. The selected solvent must be specifically cited in a
				lab's standard operating procedure(s).
(6) Subsampling and homogenization protocols
				must be specified in the approved method(s) to include:
(a) The lab must analyze at least 0.2 grams
				of sample per residual solvents analysis.
(b) Upon receipt of sample, the portion of
				the sample that is to be used for residual solvents analysis must be stored to
				minimize solvent evaporation.
(c)
				Homogenization of residual solvent samples by the lab is prohibited unless
				necessary due to sample composition. If homogenization is necessary, steps must
				be taken to minimize evaporative loss.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-200 - Mycotoxin testing

Current through Register Vol. 24-14, July 15, 2024
(1) Mycotoxin
				testing is intended to accurately measure semi-quantitative or quantitate
				results, and report mycotoxins incurred through the production and processing
				of cannabis and cannabis products.
(2) For semi-quantitative or qualitative
				methods, the laboratory may report negative results. The limit of detection
				must be equal to or less than the analyte limit. Positive detections must be
				confirmed and reported using a quantitative method.
(3) For quantitative methods, the laboratory
				may only report numerical results that are above the limit of quantification
				and below the upper limit of linearity.
(4) The analytical processes for mycotoxin
				testing must include the following:
(a) A
				matrix negative and a matrix positive for each sample matrix tested per
				batch;
(b) Matrix positive controls
				at relevant levels above the decision point;
(c) The laboratory must perform a
				second-source calibration verification (ICV) above the decision point
				concentration.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-210 - Pesticide testing

Current through Register Vol. 24-14, July 15, 2024
(1) Pesticide
				testing is intended to accurately quantitate and report pesticides incurred
				through the production and processing of cannabis and cannabis
				products.
(2) Pesticide standards
				and stock solutions must be prepared in an area separate from
				samples.
(3) Laboratories must use
				a method approved by the department to analyze pesticides.
(4) Laboratories must limit batch size to 20
				samples in a preparation batch not including quality controls.
(5) ICV, CCV, and surrogate must meet a
				minimum of 70-130 percent recovery for each analyte.
(6) LCS and matrix spike samples must meet a
				minimum of 70-130 percent recovery for each analyte.
(7) Sample and matrix duplicates must have a
				relative percent difference (RPD) value of less than 20 percent.
(8) Mass spectrometry confirmation criteria.
(a) A minimum of three structurally
				significant ions (meeting the three to one signal to noise ratio) are required
				for confirmation. If instrument conditions or ionization techniques limit the
				number of ions available, the laboratory may request a deviation from the
				department in order to report results under these conditions.
(b) The confidence limits of the relative
				abundance of structurally significant ions and precursor-to-product ion
				transitions used for single ion monitoring and multiple reaction monitoring
				must be ± 30 percent (relative) when compared to the same relative
				abundances observed from a standard solution injection made during the same
				analytical run.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-220 - Heavy metals testing

Current through Register Vol. 24-14, July 15, 2024
(1) Heavy metals
				testing is intended to accurately quantitate and report metals incurred through
				the production and processing of cannabis and cannabis products.
(2) Analytical standards and solutions must
				be National Institutes of Standards (NIST) traceable or equivalent.
(3) The ICP-MS must be tuned each day of
				analysis using a tuning solution containing elements representing all of the
				mass regions of interest.
(4)
				Instruments must be calibrated every day of testing using a minimum of a
				four-point curve (no blanks can be used as a point).
(5) Laboratories must use a method approved
				by the department to analyze heavy metals.
(6) A stabilizer must be added during sample
				preparation to stabilize mercury through the acid digestion and analysis. The
				stabilizer must be at the same level in the calibration standards as the
				samples.
(7) An internal standard
				(IS) must be added and analyzed in all calibration standards and
				samples.
(8) Spectral interference
				checks (SIC) must be used to verify that the interference levels are corrected
				by the instrument's data system. The SIC must contain known amounts of
				interfering elements that will demonstrate the magnitude of interference and
				test for any corrections.
(9) An
				initial calibration verification (ICV) and initial calibration blank (ICB) must
				be analyzed each day of testing.
(a) The ICB
				is analyzed after the ICV and must not contain target analytes.
(b) The ICV must meet a minimum of 70-130
				percent recovery for each analyte.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-230 - Other analytes

Current through Register Vol. 24-14, July 15, 2024
Should a laboratory test for analytes beyond the analytes
				  required in chapter 314-55 or 246-70 WAC, they must adhere to the following
				  guidelines:
(1) Additional test
				results must be identified as analytes outside the scope of accreditation on
				the certificate of analysis.
(2)
				Additional analytes that are tested using methods that also include required
				analytes for compliance must meet similar requirements for testing and
				reporting.
(3) Additional analytes
				that are tested using methods that do not include required analytes for
				compliance must be validated and tested using standards established in this
				chapter.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-240 - Laboratory computers and information systems

Current through Register Vol. 24-14, July 15, 2024
(1) The laboratory must have computer systems
				and software for sample tracking throughout the laboratory's possession from
				receipt of the samples through testing, reporting, and disposal.
(2) The laboratory must maintain a system
				security plan (SSP) for each information system used, including corporate
				systems and external service provider systems.
(3) The laboratory must have security
				controls (i.e., management, operations, and technical controls) in place to
				protect the confidentiality, integrity, and availability of the system and its
				information.
(4) If the laboratory
				contracts with an external service provider such as a cloud service provider,
				the laboratory must show due diligence in verifying that the service provider
				has procedures in place to protect the confidentiality, integrity, and
				availability of data for the services that they will perform on behalf of the
				laboratory.
(5) The laboratory must
				protect any internal computer systems (e.g., desktops, servers, instrument
				computers) against electrical power interruptions and surges that can
				contribute to data loss.
(6) The
				laboratory must protect any internal computer systems from spyware, viruses,
				malware, and other attacks through the use of firewalls and by maintaining
				software security updates.
(7) The
				laboratory must validate and document changes made to computer systems,
				software, interfaces, calculations, and security measures prior to implementing
				for use on samples.
(8) Software
				testing must include performing manual calculations or checking against another
				software product that has been previously tested, or by analysis of
				standards.
(9) The laboratory must
				have a signed contract or agreement with any external service providers that
				includes the priority elements of physical, technical, and administrative
				safeguards to protect their systems and data.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-250 - Method approvals

Current through Register Vol. 24-14, July 15, 2024
(1) Laboratories
				must use an agency approved method for cannabinoid concentration, pesticides,
				residual solvents, and heavy metals testing. A list of approved analytical and
				preparative methods are available on the agency's website (
https://agr.wa.gov/departments/cannabis/cannabis-lab-analysis-program
).
				If a laboratory wants to use a method not currently on the approved agency list
				of methods, the lab can submit a method for approval.
(2) Laboratories must, at a minimum, do the
				following for a new method approval:
(a)
				Laboratories must submit a method approval form with their required method
				documentation and method validation data emailed to the department at
				cannabis@agr.wa.gov.
(b) Receive
				written approval from the department of the validated method for use on
				customer samples.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-270 - Proficiency testing

Current through Register Vol. 24-14, July 15, 2024
The laboratory must participate in an approved proficiency
				  testing (PT) program that reflects the best available science as determined by
				  the accrediting authority.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-280 - Reports

Current through Register Vol. 24-14, July 15, 2024
(1) All sample test results must be supported
				by analytical data and all analytical data must have a documented review, once
				reviewed by an analyst, and once reviewed by a certifying scientist prior to
				being reported.
(2) Laboratories
				must report results as either "negative," "none detected," "pass/fail," or the
				numeric concentration equal to or above the decision point or cutoff of the
				required analytes tested as indicated in rules.
(3) For the purpose of reporting, decision
				points or cutoff limits have been written in chapter 314-55 WAC to the number
				or significant digits that laboratories are expected to use when reporting
				results.
(4) If the result is above
				the established ULOL, the laboratory must dilute the sample and retest to bring
				the results within the linear range of the test, unless allowed differently in
				the guidelines.
(5) The
				concentration of a diluted primary sample prior to applying the dilution factor
				must be above the concentration of the lowest calibrator or control in the
				batch.
(6) At a minimum, the
				computer generated COA reports for samples going to the customer must contain:
(a) A title: "Certificate of Analysis" or
				"Test Report";
(b) Laboratory name,
				lab ID number, and address;
(c)
				Unique identification of the test report certificate and on each page an
				identification in order to ensure that the page is recognized as a part of the
				COA, and a clear identification of the end of the report;
(d) The name, address, and license number of
				the customer;
(e) Date of sample
				collection;
(f) Sample
				identification number from transportation manifest;
(g) Sample/matrix type (flower, concentrate
				etc.);
(h) Product/sample name and
				category;
(i) Amount of sample
				received;
(j) Date received by
				laboratory;
(k) Name of certifying
				scientist;
(l) Date reported by the
				laboratory;
(m) Results of each
				test performed to include name of test, results, measurands (i.e., mg/g),
				cutoffs, and instrument/method of testing used;
(n) A statement to the effect that the
				results relate only to the items tested.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-290 - Procurement controls

Current through Register Vol. 24-14, July 15, 2024
(1) The
				laboratory must have procedure(s) for the selection and purchasing of services
				and supplies it uses that affect the quality of the tests and/or calibrations.
				Procedures covering reagents and laboratory consumables must exist for the
				purchase, receipt, storage, and disposition of expired materials.
(2) The laboratory must ensure that purchased
				supplies and reagents and consumable materials that affect the quality of tests
				and/or calibrations are inspected or otherwise verified as complying with
				standard specifications or requirements defined in the methods for the tests
				and/or calibrations concerned.
(3)
				New lots or materials received outside of expected environmental conditions
				must be documented and validated before use.
(4) Reagents and standards must be inspected,
				dated, and initialed upon receipt, and upon opening.
(5) Calibration standards and analytical
				reagents must have an expiration or reevaluation date assigned.
(6) Standards and solutions must be
				identified with lot number or other assigned unique identifier to trace back to
				preparation documentation.
(7)
				Prospective suppliers must be evaluated and selected on the basis of specified
				criteria.
(8) Processes to ensure
				that approved suppliers continue to provide acceptable items and services must
				be established and implemented.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-309 - Cannabis laboratory accreditation standards program › Section 16-309-300 - Subcontracting

Current through Register Vol. 24-14, July 15, 2024
(1) The laboratory must notify the customer
				of the subcontract arrangement in writing, including the subcontractors'
				accreditation credentials under chapters 69.50 RCW and 314-55 WAC.
(2) The laboratory must maintain a register
				of all subcontractors that it uses for tests and/or calibrations and a record
				of the evidence of compliance with chapter 314-55 WAC for the work in
				question.
(3) When there are
				indications that subcontractors knowingly supplied items or services of
				substandard quality, this information must be forwarded to laboratory
				management for corrective action.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-010 - Purpose of chapter

Current through Register Vol. 24-14, July 15, 2024
Under the authority of RCW  69.50.348, the department adopts
				  rules to establish a state program for the accreditation of cannabis
				  laboratories in accordance with chapter 16-309 WAC. The purpose of this program
				  is to ensure the laboratory standards described in chapter 16-309 WAC are
				  followed when testing cannabis and cannabis products under chapter 314-55
				  WAC.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-020 - Scope

Current through Register Vol. 24-14, July 15, 2024
(1) This chapter applies to cannabis
				laboratories that conduct tests for or prepare analytical data on cannabis in
				Washington state.
(2) Accreditation
				does not guarantee validity of all analytical data submitted by the accredited
				laboratory but rather assures that the laboratory has demonstrated its
				capability to generate and report the analytical data.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-040 - Accreditation during transition period

Current through Register Vol. 24-14, July 15, 2024
(1)
				Laboratory accreditations issued by the board in 2023 will remain valid through
				their expiration date in 2024.
(2)
				Accreditation issued by the department prior to December 31, 2024, will be
				based on the laboratory standard set forth in chapter 314-55 WAC and be
				considered accreditation renewal. Accreditation will expire in one calendar
				year after issuance.
(3) After
				December 31, 2024, all laboratories must comply with the standard set forth in
				chapter 16-309 WAC in order to maintain accreditation.
(4) Laboratories must submit validation
				studies for their cannabinoid concentration analysis, residual solvent testing,
				pesticide testing, and heavy metals testing to the department for their methods
				prior to November 1, 2024.
(5)
				Laboratories that have not received approval for a validation study by January
				1, 2025, will not be able to test for that parameter until the parameter is
				approved.
(6) Laboratories that
				have been accredited in 2024 to the standard identified in chapter 314-55 WAC
				must fill out an initial accreditation application in order to transfer to the
				department's accreditation program beginning January 1, 2025.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-050 - Laboratory initial accreditation application

Current through Register Vol. 24-14, July 15, 2024
(1) A laboratory that has yet to become
				accredited must complete an initial application provided by the department to
				apply for accreditation to perform cannabis and cannabis product
				testing.
(2) The applying
				laboratory must submit an initial application fee with the application to the
				department before an initial inspection can be scheduled.
(3) Prior to the first audit, the laboratory
				must successfully complete a round of proficiency testing for each parameter
				the laboratory intends to be accredited for. Proficiency testing must come from
				a vendor approved by the department and graded results must be sent to the
				department for review.
(4) The
				laboratory must include the following pre-audit materials with the application:
(a) Current information on its testing
				operation to include a list of analytes tested with method and instrument(s)
				used.
(b) A schedule of its
				operations listing the days and hours for various processes of
				operations.
(c) A list of staff
				along with their qualifications and job function(s).
(d) A map of the facilities and description
				detailing security of the premises along with the location of the lab and
				locations where different types of testing are performed.
(e) A description of the laboratory computer
				systems describing any hardware, software, firewalls, both internal and
				external to the laboratory, that are used in the testing or reporting of
				cannabis. Sufficient information must be available to allow inspectors to
				verify compliance with program requirements.
(f) A copy of the current quality assurance
				manual.
(g) Validation studies for
				each method for which the laboratory is seeking accreditation.
(h) The department may request additional
				documents as necessary.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-060 - Laboratory continued accreditation

Current through Register Vol. 24-14, July 15, 2024
(1)
				Laboratories must apply for accreditation renewal each year after initial
				accreditation to maintain their accreditation status.
(2) Renewal application documents must be
				submitted to the department at least 60 days prior to their accreditation
				expiration date. Documents may be submitted electronically.
(3) The laboratory must include the following
				pre-audit materials with the application:
(a)
				Current information on its testing operation to include a list of analytes
				tested with method and instrument(s) used.
(b) A schedule of its operations listing the
				days and hours for various processes of operations.
(c) A list of staff along with their
				qualifications and job function(s).
(d) A map of the facilities and description
				detailing security of the premises along with the location of the lab and
				locations where different types of testing are performed.
(e) A description of the laboratory computer
				systems describing any hardware, software, firewalls, both internal and
				external to the laboratory, that are used in the testing or reporting of
				cannabis. Sufficient information must be available to allow inspectors to
				verify compliance with program requirements.
(f) A copy of the current quality assurance
				manual.
(g) A complete data pack
				containing all testing performed on designated samples as determined by the
				department during the accreditation period.
(h) Notification of any major changes to
				methods or procedures from the previous audit such as changes in
				instrumentation, new extraction method, software changes, or updates to quality
				assurance procedures.
(i) The
				department may request additional documents as necessary.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-070 - Application review and approval process

Current through Register Vol. 24-14, July 15, 2024
Upon review of the accreditation application and required
				  documents, the department will either:
(1) Notify the applicant laboratory of any
				missing items or amendments necessary to approve the application.
(2) Approve the application, schedule an
				audit, and accredit the laboratory for initial, or renewed status upon
				successful completion of the audit.
(3) Extend a laboratory's current
				accreditation by a maximum of 60 days for the purpose of scheduling.
(4) Deny the application and deny
				accreditation. If the department denies accreditation or denies a subset of
				requested parameters, the department will notify the laboratory of the
				deficiencies.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-080 - Quality assurance manual

Current through Register Vol. 24-14, July 15, 2024
(1) The
				department will review and approve the laboratory's quality assurance (QA)
				manual prior to the department's initial and continued accreditation on-site
				audit of the lab.
(2) The QA manual
				submitted concurrently with the application must be in detail and scope
				commensurate with the size and mission of the laboratory. Instructions for
				contents of the QA manual are in WAC 16-309-120.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-090 - Standard operating procedures

Current through Register Vol. 24-14, July 15, 2024
(1) The
				department will review the laboratory's standard operating procedures (SOP)
				on-site during each audit.
(2) The
				SOP must be in detail sufficient to assure consistent and replicable results by
				any qualified employee at the laboratory.
(3) Guidelines for contents of a standard
				operating procedure are in WAC 16-309-090, the cannabis testing laboratory
				standards manual, and other guidance documents that may be published by the
				department.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-100 - Data and record traceability

Current through Register Vol. 24-14, July 15, 2024
(1) During
				audits and when necessary, the department will ask the lab to demonstrate data
				and record traceability with documentation. To demonstrate this, a cannabis
				laboratory must:
(a) Be able to recreate
				sample results by means of records in entirety, starting at receipt of the
				samples by the laboratory and ending at the final report or certificate of
				analysis, known as a data pack;
(b)
				Document validation of any chemical, reagent, and/or media used by an
				analytical method;
(c) Document
				storage of samples as required by the specific analytical method and
				regulations;
(d) Document that all
				temperature-based equipment such as a refrigerator, oven, or incubator is
				within control at the time of testing. When electronic recordkeeping equipment
				is used, these records must be monitored by lab personnel to verify that
				temperatures meet relevant method and regulatory requirements;
(e) Keep a log for all instruments, including
				documentation of installation, setup, maintenance, and removal from service;
				and
(f) Document preparation and
				quality control (QC) of chemicals, reagents, and media used in support of the
				analyses.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-110 - Proficiency testing

Current through Register Vol. 24-14, July 15, 2024
(1) The
				laboratory must participate in an approved proficiency testing (PT) program on
				an ongoing basis and achieve a passing score for each field of testing
				parameter for which the lab will be or is accredited.
(2) The cost of obtaining and testing PT
				samples is the sole responsibility of the laboratory.
(3) The department will maintain a list of
				approved proficiency tests and proficiency test providers that laboratories can
				use.
(4) A laboratory must
				successfully complete a minimum of one round of PT for each field of testing
				the lab seeks to be accredited for and provide proof of the successful PT
				results to the accrediting authority prior to initial accreditation.
(5) Accredited laboratories must successfully
				analyze a minimum of two PT samples for each parameter per year.
(6) The closing dates of a PT study for a
				particular field of accreditation can be no more than seven months apart, and
				the opening date of a PT study for a particular parameter must be at least
				seven calendar days after the closing date of the previous PT study for the
				same parameter or field of testing.
(7) At least one of the scores must be from a
				round of PT that occurs within six months prior to the laboratory's
				accreditation renewal date.
(8) To
				maintain accreditation, the laboratory must continue to pass each PT and
				parameter for which the lab is accredited.
(9) If the laboratory fails to achieve a pass
				for a parameter, the laboratory must investigate the root cause of the
				laboratory's performance and establish a corrective action plan for each
				unsatisfactory analytical result within five business days and report its
				finding and resolution to the department.
(10) If the corrective action has not
				resolved the analytical deficiency, the laboratory must suspend testing of that
				parameter, even if they have not yet been contacted by the department to do so
				first. The laboratory must then work with the department to resolve the issue
				and must receive authorization from the department before they can restart
				testing for that parameter.
(11)
				The department may require the laboratory to submit raw data along with the
				report of analysis of PT samples.
(12) If the PT provider does not provide
				individual acceptance criteria for each analyte, the following criteria will be
				applied to determine whether the lab achieves a passing score for the round of
				PT:
(a) +/- 30 percent recovery from the
				reference value for residual solvent testing; or
(b) +/- 3 z or 3 standard deviations from the
				reference value for all other fields of testing.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-120 - Audits

Current through Register Vol. 24-14, July 15, 2024
(1) A laboratory must undergo an audit by the
				department to assess critical elements and areas of required standard
				practices.
(a) All accredited laboratories
				will be audited on an annual basis. The laboratory must assist or accommodate
				department personnel and auditors during audits as necessary.
(b) Audits will be performed
				on-site.
(c) Off-site audits will
				only be available at the discretion of the department.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-130 - Audit access

Current through Register Vol. 24-14, July 15, 2024
(1) For the
				purpose of conducting audits, the department may, during regular business
				hours, enter business premises in which analytical data relevant to
				accreditation under the provisions of this chapter are generated or
				stored.
(2) A laboratory's refusal
				to permit the department entry for such audit or inspection purposes may result
				in denial or revocation of accreditation by the department.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-140 - Evaluation and issuance of accreditation

Current through Register Vol. 24-14, July 15, 2024
(1)
				After the department's determination that an applicant laboratory has met the
				requirements in chapter 16-309 WAC and this chapter, the department will grant
				approval of the application and provide the applicant laboratory with proof of
				accreditation and a scope of accreditation listing the accredited
				parameters.
(2) If the department
				grants an interim or provisional accreditation, the department will provide the
				laboratory a report specifying deficiencies and/or missing information
				necessary to upgrade all parameters to accreditation status.
(3) If the department denies the application
				for accreditation in whole, it will provide written notification to the
				applicant laboratory specifying:
(a) Areas of
				deficiency in meeting the requirements in chapter 16-309 WAC or this chapter;
				and
(b) Any missing information the
				department needs to complete the review of the laboratory's
				application.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-150 - Interim accreditation

Current through Register Vol. 24-14, July 15, 2024
(1) The
				department may grant interim accreditation if the laboratory is unable to
				complete an audit for accreditation for a specific parameter, but all other
				requirements of accreditation have been satisfied.
(2) The department may also require the
				laboratory to submit analytical data packages as evidence of analytical
				capability to grant interim accreditation.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-160 - Provisional accreditation

Current through Register Vol. 24-14, July 15, 2024
(1) The
				department may approve an existing laboratory with prior accreditation for
				provisional accreditation when the department determines that the laboratory
				can consistently produce valid analytical data but has deficiencies requiring
				corrective action.
(a) When the laboratory has
				corrected such deficiencies, it must provide documented evidence of correction
				to the department or request a follow-up audit, as appropriate.
(b) If the department determines the
				deficiencies have been corrected, it may approve full accreditation as in WAC
				16-310-140.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-170 - Denying accreditation

Current through Register Vol. 24-14, July 15, 2024
(1) The
				department may deny accreditation for reasons including, but not limited to,
				the following laboratory actions:
(a) Failure
				to comply with standards of this chapter;
(b) Misrepresenting itself to the
				department;
(c) Failure to disclose
				pertinent information in the application;
(d) Falsifying reports of analysis including
				proficiency testing results;
(e)
				Engaging in unethical or fraudulent practices concerning generation of
				analytical data;
(f) Refusing to
				permit entry for department audits as required by WAC 16-310-130;
(g) Failure to pay applicable fees;
				or
(h) Is determined by the
				department or the board to be criminally negligent or not in compliance with
				chapter 69.50 RCW.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-180 - Revoking or suspending accreditation

Current through Register Vol. 24-14, July 15, 2024
The department may suspend or revoke laboratory
				  accreditation.
(1) The department may
				revoke or suspend the entire accreditation and scope of accreditation or one or
				more individual parameters.
(a) Suspension of
				accreditation by the department is for a specified period during which the
				affected laboratory must correct deficiencies that led to the
				suspension.
(b) If the department
				determines deficiencies are not corrected, they may revoke the laboratory's
				accreditation.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-190 - Withdrawal of accreditation

Current through Register Vol. 24-14, July 15, 2024
(1) The
				laboratory may withdraw from the accreditation program by sending a letter to
				the department signed by the laboratory director containing the last date they
				will perform testing under this program.
(2) The laboratory will remain responsible
				for any storage of data acquired during regulated testing for five years from
				the date the testing was performed.
(3) The laboratory must properly dispose of
				any cannabis or cannabis product remaining in the laboratory.
(4) The department may verify compliance with
				these rules even after withdrawal, suspension, or revocation of
				accreditation.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-200 - Fee structure

Current through Register Vol. 24-14, July 15, 2024
(1) The
				laboratory must pay a nonrefundable initial or transfer application fee in the
				amount of $3,200 to the department before the application will be reviewed and
				an audit will be conducted.
(2)
				Audit fees must be paid at least 30 days prior to the initial accreditation
				audit or any continued accreditation audits.
(a) A fee of $7,200 must be paid for on-site
				audits.
(b) A fee of $2,100 must be
				paid for off-site surveillance audits.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-310 - Accreditation of cannabis laboratories › Section 16-310-210 - Appeals

Current through Register Vol. 24-14, July 15, 2024
A laboratory's scientific director may appeal final
				  accreditation actions within 25 days of notification of final action in
				  accordance with chapters 34.05 RCW and 16-08 WAC.
Washington Administrative Code › Title 16 - Agriculture, Department of (See also Titles 24, 60, and 142) › SEEDS AND PLANTING STOCK CERTIFICATION › Chapter 16-319 - Forest tree seed certification › Section 16-319-010 - Forest tree seed certification - Certifying agency

Current through Register Vol. 24-14, July 15, 2024
The Washington State Crop Improvement Association is
				  designated to act as the authorized agent of the director of agriculture for
				  the purpose of assisting in certifying forest tree seeds and shall perform such
				  duties as the director may assign as provided in chapter 15.49 RCW,
				  specifically
				  RCW
				  15.49.370(3).
Order 1028, Regulation 1, filed 8/4/66, effective
					 9/4/66.