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 16-309-020 - Definitions

Current through Register Vol. 24-14, July 15, 2024
"Accessioning" means the process of receiving and organizing
				  samples for testing in a laboratory.
"Accreditation" means the formal recognition by the
				  accrediting authority that a cannabis 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 the parameters for which the laboratory is accredited.
"Accreditation year" means the one-year period as stated on
				  the certificate of accreditation.
"Accrediting authority" means the recognized agency that has
				  the authority to perform audits and inspections to assure laboratories meet the
				  standards established in rule and will issue, suspend, or revoke accreditation
				  to the laboratory.
"Accuracy" means 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.
"Action level" means the level of concern, decision point,
				  cutoff, or target level for an analyte that must be reliably identified or
				  quantified to be considered positive in a sample.
"Aliquot" means a portion of a larger whole, especially a
				  sample taken for chemical analysis or other treatment.
"Analyte" means the constituent or property of a sample
				  measured using an analytical method.
"Analytical batch" means a group of samples, standards, and
				  blanks which are analyzed together with the same method sequence and same lots
				  of reagents and with the manipulations common to each sample within the same
				  time period usually no more than 24 hours. Batch size is usually limited to
				  instrument loading capacity.
"Analytical data" means the recorded qualitative and/or
				  quantitative results of a chemical, physical, biological, microbiological,
				  radiochemical, or other scientific determination.
"Analytical method" means a written procedure for acquiring
				  analytical data.
"Autoclave" means a steam sterilizer device that is intended
				  for use by a laboratory to sterilize biohazardous products by means of
				  pressurized steam.
"Bias" means the difference between the expectation of the
				  test result and the true value or accepted reference value. Bias is the total
				  systematic error, and there may be one or more systematic error components
				  contributing to the bias.
"Biohazardous" means products that are infectious, and sharps
				  materials such as needles and broken glass.
"Biosafety cabinet (BSC)" means biocontainment equipment used
				  in biological laboratories to provide personnel, environmental, and product
				  protection.
"Blank" means a substance that does not contain the analytes
				  of interest and is subjected to the usual measurement process. Blanks can be
				  further classified as method blanks, matrix blanks, reagent blanks, system
				  blanks, and field blanks. Response for target analytes must be less than 50
				  percent of the limit of quantitation.
"Board" means the Washington state liquor and cannabis
				  board.
"Calibration" means determination of the relationship between
				  the observed analyte signal generated by the measuring/detection system and the
				  quantity of analyte present in the sample measured. Typically, this is
				  accomplished through the use of calibration standards containing known amounts
				  of analyte.
"Calibration curve" means the functional relationship between
				  instrument response and target analyte concentration determined for a series of
				  calibration standards. The calibration curve is obtained by plotting the
				  instrument response versus concentration and performing a regression analysis
				  of the data.
"Calibration standard (CalS)" means a known amount or
				  concentration of analyte used to calibrate the measuring/detection system. May
				  be matrix matched for specific sample matrices.
"Cannabis laboratory analytical standards program (CLASP)"
				  means the interagency coordination team for cannabis laboratory quality
				  standards. The team consists of the department of agriculture (WSDA), the
				  liquor and cannabis board (LCB), and the department of health (DOH). The WSDA
				  is the designated lead agency for the team.
"Cannabis laboratory" or "laboratory" means a
				  facility:
(a) Under the ownership and
				technical management of a single entity in a single geographical
				location;
(b) Where scientific
				determinations are performed on samples taken from cannabis plants and
				products; and
(c) Where data is
				submitted to the customer or regulatory agency, or other entity requiring the
				use of an accredited laboratory under provisions of a regulation, permit, or
				contractual agreement.
"Carryover" means residual analyte from a previous sample or
				  standard which is retained in the analytical system and measured in subsequent
				  samples. Also called memory.
"Certified reference material (CRM)" means a reference
				  material accompanied by documentation (certificate) issued by an authoritative
				  body and providing one or more specified property values with associated
				  uncertainties and traceability, using valid procedures.
Note:
Standard reference material (SRM) is the trademark
							 name of CRMs produced and distributed by the National Institute of Standards
							 and Technology (NIST).
"Certifying scientist" means the person authorized by the
				  scientific director to review the analytical results and issue the certificate
				  of analysis for cannabis samples who has the education, training, and
				  competencies to perform such duties. No certifying duties may be performed by
				  any technical personnel directly involved with the conduct of the analytical
				  findings or testing.
"Clean room" means an isolated environment, strictly
				  controlled with respect to: Airborne particles of viable and nonviable nature,
				  temperature, humidity, air pressure, air flow, air motion, and lighting.
"Continuing calibration verification standard (CCV)" means
				  one of the primary calibration standards used to verify the acceptability of an
				  existing calibration.
"Control" means a sample used to evaluate whether an
				  analytical procedure or test is operating within predefined tolerance
				  limits.
"Corrective action" means the process of identifying and
				  eliminating the cause of a problem to prevent it from happening again.
"Cut-off concentration" means, in qualitative analysis, the
				  concentration of the analyte that is either statistically lower than the level
				  of concern (for limit tests) or at which positive identification ceases (for
				  confirmation of identity methods).
"Decision point" means the level of concern, action level,
				  cutoff, or target level for an analyte that must be reliably identified or
				  quantified to be considered positive in a sample.
"Department" means the state of Washington department of
				  agriculture when the term is not followed by another state designation.
"High complexity testing" means laboratory tests that require
				  a level of expertise to perform the test due to the complexity of the test
				  methodology and the risk of erroneous results. These tests require a higher
				  level of scientific knowledge and experience, troubleshooting skills, and
				  quality control checks.
"Initial calibration blank (ICB)" means an aliquot that
				  consists of the same solvent used for the calibration standards, but without
				  the analytes, analyzed following the initial calibration and prior to
				  quantitating any samples to verify the absence of instrumental
				  interferences.
"Initial calibration verification (ICV)" means a second
				  source standard that is used to verify the correctness of the primary source
				  calibration curve. This standard is initially analyzed prior to sample
				  analysis.
"Incubation" means the act of storing microorganisms at a
				  predetermined temperature, for a predetermined amount of time, to allow for
				  growth of microorganism colonies.
"Inoculation" means the act of introducing microbes into a
				  culture media to induce reproductive growth.
"Interference" means a positive or negative response or
				  effect on response produced by a substance other than the analyte. Includes
				  spectral, physical, and chemical interferences which result in a less certain
				  or accurate measurement of the analyte.
"Intermediate precision" means within-laboratory precision
				  obtained under variable conditions, e.g., different days, different analysts,
				  and/or different instrumentation.
"Internal standard (IS)" means a chemical added to the
				  sample, in known quantity, at a specified stage in the analysis to facilitate
				  quantitation of the analyte. Internal standards are used to correct for matrix
				  effects, incomplete spike recoveries, etc. Analyte concentration is deduced
				  from its response relative to that produced by the internal standard. The
				  internal standard must have similar physio-chemical properties to those of the
				  analyte.
"Laboratory control sample (LCS)" means a portion of
				  respective matrix blank that is spiked with known quantities of target analytes
				  and processed as if it were a sample. The LCS is used to evaluate the accuracy
				  of the methodology.
"Laboratory information management system (LIMS)" means a
				  computer software system that is used to collect information about a sample,
				  track results through the testing process, and disseminate the final results to
				  the customer and regulating agency.
"Limit" means a point or level beyond which something does
				  not or may not exceed or pass. Something that bounds, restrains, or confines to
				  the utmost extent. Limits are used to define a specific concept in analysis.
				  Decision points and action levels are examples of limits.
"Limit of detection (LOD)" means the minimum amount or
				  concentration of analyte that can be reliably distinguished from zero. The term
				  is usually restricted to the response of the detection system and is often
				  referred to as the detection limit. When applied to the instrument capability
				  it is known as an instrument detection limit (IDL) or when applied to the
				  complete analytical method it is often referred to as the method detection
				  limit (MDL).
"Limit of quantitation (LOQ)" means the minimum amount or
				  concentration of analyte in the test sample that can be quantified with
				  acceptable precision and accuracy. Limit of quantitation (or quantification) is
				  variously defined but must be a value greater than the MDL and applies to the
				  complete analytical method.
"Linearity" means the ability of a method, within a certain
				  range, to provide an instrumental response or test results proportional to the
				  quantity of analyte to be determined in the test sample.
"Low complexity testing" means laboratory tests that require
				  little to no expertise to perform the test due to the lack of complexity of the
				  test methodology and the low risk of erroneous results. These tests require a
				  low level of scientific knowledge and experience, troubleshooting skills, and
				  quality control checks.
"Matrix" means the material to be analyzed including, but not
				  limited to, flower, trim, leaves, other plant matter, cannabis concentrate,
				  cannabis infused, and edibles.
"Matrix blank" means a substance that closely matches the
				  samples being analyzed with regard to matrix components. Ideally, the matrix
				  blank does not contain the analyte(s) of interest but is subjected to all
				  sample processing operations including all reagents used to analyze the test
				  samples. The matrix blank is used to determine the absence of significant
				  interference due to matrix, reagents, and equipment used in the
				  analysis.
"Matrix effect" means an influence of one or more components
				  from the sample matrix on the measurement of the analyte concentration or mass.
				  Matrix effects may be observed as increased or decreased detector responses,
				  compared with those produced by simple solvent solutions of the analyte.
"Matrix spike (MS)" means an aliquot of a sample prepared by
				  adding a known amount of analyte(s) to a specified amount of matrix. A matrix
				  spike is subjected to the entire analytical procedure to establish if the
				  method is appropriate for the analysis of a specific analyte(s) in a particular
				  matrix. Also referred to as a laboratory fortified matrix.
"Matrix spike duplicate (MSD)" means a replicate of a sample
				  that has known concentrations of analytes added to it. It is used to evaluate
				  the precision and bias of a method for a specific sample matrix. A matrix spike
				  duplicate is processed along with the same sample batch and follows the same
				  sample preparation and analytical testing.
"Method" means a particular procedure that systematically
				  describes how a cannabis test is performed and analyzed.
"Method validation" means the process of demonstrating or
				  confirming that a method is suitable for its intended purpose. Validation
				  criteria include demonstrating performance characteristics such as accuracy,
				  precision, selectivity, limit of detection, limit of quantitation, linearity,
				  range, ruggedness, and robustness.
"Method validation report" means documentation generated
				  detailing the evidence which established the suitability of the method for its
				  intended use.
"Moderate complexity testing" means laboratory tests that
				  require a level of expertise to perform the test due to the complexity of the
				  test methodology and the risk of erroneous results. These tests require a
				  moderate level of scientific knowledge and experience, troubleshooting skills,
				  and quality control checks.
"Parameter" means the combination of one or more analytes
				  determined by a specific analytical method.
"Performance criteria" means defined, measurable performance
				  characteristics of an analytical method or process-specific requirements for
				  accuracy, precision, recovery, specificity (selectivity), sensitivity (limits
				  of detection), inclusivity, exclusivity, linearity, range, and scope of
				  application. Criteria may also be set by defining process (i.e., method
				  validation protocols).
"Performance-based methods approach" means or conveys "what"
				  needs to be accomplished, but not prescriptively "how" to do it. It is a
				  measurement system based upon established performance criteria for accuracy and
				  precision with use of analytical test methods. Under this measurement system,
				  laboratories must demonstrate that a particular analytical test method is
				  acceptable for demonstrating compliance. Performance-based method criteria may
				  be published in regulations, technical guidance documents, permits, work plans,
				  or enforcement orders.
"Precision" means the closeness of agreement between
				  independent test results obtained under specified conditions. This is described
				  by statistical methods such as a standard deviation or confidence limit of test
				  results. See also "random error." Precision can be further classified as
				  repeatability, intermediate precision, and reproducibility.
"Preparation batch" means samples that are prepared and/or
				  analyzed together with the same process and personnel, using the same lot(s) of
				  reagents. A preparation batch consists of one to 20 samples (not including
				  matrix blanks, LCS, matrix spikes and matrix duplicates) of the same
				  matrix.
"Proficiency testing (PT)" means 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.
"Proficiency testing provider" means a third-party company,
				  organization, or entity not associated with certified laboratories or a
				  laboratory seeking certification that is approved by the department and
				  provides samples for use in PT testing.
"Qualitative analysis/method" means analysis/method in which
				  substances are identified or classified on the basis of their chemical,
				  biological, or physical properties. The test result is either the presence or
				  absence of the analyte(s) in question.
"Quality assurance (QA)" means 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" means a written record
				  intended to assure the reliability of measurement data. A QA manual documents
				  policies, organization, objectives, and specific QC and QA activities.
"Quality control (QC)" means the routine application of
				  statistically based procedures to evaluate and control the accuracy of
				  analytical results.
"Quantitative analysis/method" means analysis/method in which
				  the amount or concentration of an analyte may be determined (or estimated) and
				  expressed as a numerical value in appropriate units with acceptable accuracy
				  and precision.
"Random error" means component of measurement error that in
				  replicate measurements varies in an unpredictable manner. See also
				  "precision."
"Range" means the interval of concentration over which the
				  method provides suitable accuracy and precision.
"Reagent blank" means reagents used in the procedure taken
				  through the entire method. Reagent blanks are used to determine the absence of
				  significant interference due to reagents or equipment used in the
				  analysis.
"Recovery" means the proportion of analyte (incurred or
				  added) remaining at the point of the final determination from the analytical
				  portion of the sample measured. Commonly expressed as a percentage.
"Reference material" means a material, sufficiently
				  homogeneous and stable with respect to one or more specified properties, which
				  has been established to be fit for its intended use in a measurement process or
				  in examination of nominal properties.
"Reference standard" means a standard, generally having the
				  highest metrological quality available at a given location in a given
				  organization, from which measurements are made or derived.
Note:
Generally, this refers to recognized national or
							 international traceable standards provided by a standards producing body such
							 as the National Institute of Standards and Technology (NIST).
"Relative percent difference (RPD)" means the comparison of
				  two quantities while taking into account the size of what is being compared as
				  calculated:
percent RPD=|(sample - duplicate)|/((sample + duplicate)/2) *
				  100
"Repeatability (RSDr)" means precision obtained under
				  observable conditions at a specific concentration/spike level where independent
				  test results are obtained with the same method on identical test items in the
				  same test facility by the same operator using the same equipment within short
				  intervals of time.
"Representative matrix" means a cannabis matrix used to
				  assess probable analytical performance with respect to other matrices, or for
				  matrix-matched calibration, in the analysis of broadly similar cannabis
				  products.
"Reproducibility (RSDR)" means precision obtained at a
				  specific concentration/spike level under observation conditions where
				  independent test results are obtained with the same method on identical test
				  items in different test facilities with different operators using different
				  equipment.
"Ruggedness/robustness" means a measure of the capacity of an
				  analytical procedure to remain unaffected by small but deliberate variations in
				  method parameters and provides an indication of its reliability during normal
				  usage.
"Sample" means representative portion of material taken from
				  a larger quantity of homogenate for the purpose of examination or analysis,
				  which can be used for judging the quality of a larger quantity for the purpose
				  of compliance.
"Sample package" means the sealed, tamper-resistant container
				  (e.g., plastic bag, box, etc.) which contains the quality control sample and
				  transportation manifest from grower or producer collection.
"Scientific director" means the individual with the proper
				  education and training responsible for the overall laboratory operations,
				  compliance, and training of personnel.
"Selectivity" means the extent to which a method can
				  determine particular analyte(s) in a mixture(s) or matrix(ces) without
				  interferences from other components of similar behavior. Also known as
				  specificity.
"Sensitivity" means the change in instrument response which
				  corresponds to a change in the measured quantity (e.g., analyte concentration).
				  Sensitivity is commonly defined as the gradient of the response curve or slope
				  of the calibration curve at a level near the LOQ.
"Shipping container" means the container (e.g., box, mailer,
				  bag) in which the collector, or laboratory has placed one or more sample
				  packages for transport.
"SI" means the international system of units and more
				  commonly known as the metric system. This is the international standard for
				  measurement. Critical laboratory measurements must be traceable to this
				  system.
"Signal to noise ratio (SNR)" means a measure that compares
				  the level of desired signal of an analyte to the level of background noise from
				  the instrument thus establishing the instrument's ability to differentiate
				  between the two.
"Specificity" means the ability of a method to measure
				  analyte(s) in the presence of components which may be expected to be
				  present.
"Spike recovery" means the fraction of analyte remaining at
				  the point of final determination after it is added to a specified amount of
				  matrix and subjected to the entire analytical procedure. Spike recovery is
				  typically expressed as a percentage. Spike recovery must be calculated for the
				  method as written. For example, if the method prescribes using deuterated
				  internal standards or matrix-matched calibration standards, then the reported
				  analyte recoveries must be calculated according to those procedures.
"Spore bioindicators" means a biological indicator that is
				  made up of a carrier material, on which bacterial spores with a defined
				  resistance to the sterilization process have been applied.
"Standard operating procedures (SOP)" means a written
				  document that details the method for an operation, analysis, or action with
				  thoroughly prescribed techniques and steps, and that is officially approved as
				  the method for performing certain routine or repetitive tasks.
"Standard reference material (SRM)" means a certified
				  reference material issued by the National Institutes of Standards and
				  Technology (NIST) in the United States.
"Standard (solution)" means a solution containing a precisely
				  known concentration of an element, analyte, or a substance.
"Sterilization" means a validated process used to render a
				  product free of all forms of viable microorganisms.
"Stock standard" means a concentrated solution of method
				  analyte(s) prepared in the laboratory from referenced and certified analyte
				  standards, where available, or a concentrated solution of method analyte(s)
				  purchased directly from a referenced and certified source, where
				  available.
"Surrogate (SUR)" means a pure compound that shall not be
				  found in any sample but is similar in nature to the compounds of interest. This
				  compound is added to a sample in a known amount before processing to monitor
				  method performance for each sample. It is quantified in a manner analogous to
				  that used for the analytes. The SUR is useful in ensuring that there were no
				  problems in sample preparation.
"Systematic error" means component of measurement error that
				  in replicate measurements remains constant or varies in a predictable manner.
				  This may also be referred to as bias.
"Target analytes" means those analytes required to be tested
				  on samples by the laboratory as defined in chapter 314-55 WAC.
"Testing personnel" means those qualified on the basis of
				  education, training, experience and demonstrated skills to perform analytical
				  testing on cannabis, cannabis concentrates, and cannabis infused
				  products.
"Uncertainty" means nonnegative parameter characterizing the
				  dispersion of the values being attributed to the measured value.
"Unidirectional flow" means performing a standard operating
				  procedure in a single direction to reduce the risk of microbiological
				  contamination.
"Upper level of linearity (ULOL)" means the highest level at
				  which an instrument can measure the concentration of a substance accurately
				  within an acceptable measure of deviation.
"Validated methods" means the methods that have undergone
				  validation.
"Validation (method)" means the process of demonstrating or
				  confirming the performance characteristics through assessments of data quality
				  indicators for a method of analysis.