Titles of Regulations: 1VAC30-45. Certification for Noncommercial Environmental Laboratories (amending 1VAC30-45-40, 1VAC30-45-95, 1VAC30-45-100, 1VAC30-45-130, 1VAC30-45-520, 1VAC30-45-650, 1VAC30-45-730, 1VAC30-45-750, 1VAC30-45-760, 1VAC30-45-771).

1VAC30-46. Accreditation for Commercial Environmental Laboratories (amending 1VAC30-46-15, 1VAC30-46-40, 1VAC30-46-70, 1VAC30-46-95, 1VAC30-46-100, 1VAC30-46-140, 1VAC30-46-150, 1VAC30-46-200, 1VAC30-46-210, 1VAC30-46-220).

Statutory Authority: § 2.2-1105 of the Code of Virginia.

Effective Date: April 1, 2022.

Agency Contact: Rhonda Bishton, Director's Executive Administrative Assistant, Department of General Services, 1100 Bank Street, Suite 420, Richmond, VA 23219, telephone (804) 786-3311, FAX (804) 371-8305, or email rhonda.bishton@dgs.virginia.gov.

Summary:

The amendments update the regulations to the 2016 TNI standards, including adding (i) as a cause for suspension, laboratory failure to submit an acceptable corrective action plan after two opportunities; (ii) as a reason to withdraw accreditation or certification, laboratory failure to correct the causes for suspension within the term of suspension; (iii) as a reason to withdraw accreditation in part or in total, when a laboratory fails three consecutive proficiency testing (PT) studies; (iv) as a reason to withdraw accreditation or certification, when a laboratory fails to meet the provisions concerning communicating with other laboratories with regard to proficiency testing; (v) a statement that the agency will regularly review its budget to determine if the fees charged under the program offset its costs; and (vi) a provision requiring a laboratory to pay the cost of compliance determination when the agency has suspended accreditation or certification in total and the laboratory wishes to demonstrate that reasons for suspension have been resolved.

In 1VAC30-45, the amendments revise the time between PT supplemental studies, delete the requirement for an access log to archived records, require a successful performance of the demonstration of capability procedure when the laboratory has not performed this procedure within 12 months, and conform to the U.S. Environmental Protection Agency's 2017 Methods Update Rule.

Changes since the proposed regulation (i) clarify decertification and withdrawal of accreditation when a laboratory has failed PT studies three times in succession and (ii) make technical edits to make the regulation more understandable.

Summary of Public Comments and Agency's Response: A summary of comments made by the public and the agency's response may be obtained from the promulgating agency or viewed at the office of the Registrar of Regulations.

1VAC30-45-40. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise.

"Acceptance criteria" means specified limits placed on characteristics of an item, process, or service defined in requirement documents.

"Accuracy" means the degree of agreement between an observed value and an accepted reference value. Accuracy includes a combination of random error (precision) and systematic error (bias) components that are due to sampling and analytical operations. Accuracy is an indicator of data quality.

"Algae" means simple single-celled, colonial, or multicelled, mostly aquatic plants, containing chlorophyll and lacking roots, stems and leaves that are either suspended in water (phytoplankton) or attached to rocks and other substrates (periphyton).

"Aliquot" means a portion of a sample taken for analysis.

"Analyte" means the substance or physical property to be determined in samples examined, organism, physical parameter, or chemical constituent for which an environmental sample is being analyzed.

"Analytical method" means a technical procedure for providing analysis of a sample, defined by a body such as the Environmental Protection Agency or the American Society for Testing and Materials [ , ] that may not include the sample preparation method.

"Assessment" means the evaluation process used to measure or establish the performance, effectiveness, and conformance of an organization and its systems or both to defined criteria (i.e., to the standards and requirements of laboratory certification).

"Assessor" means the person assigned by DCLS to perform, alone or as part of an assessment team, an assessment of an environmental laboratory.

"Audit" means a systematic evaluation to determine the conformance to quantitative and qualitative specifications of some operational function or activity.

"Authority" means, in the context of a governmental body or local government, an authority created under the provisions of the Virginia Water and Waste Authorities Act, Chapter 51 (§ 15.2-5100 et seq.) of Title 15.2 of the Code of Virginia.

"Batch" means environmental samples that are prepared together or analyzed together or both with the same process and personnel, using the same lot or lots of reagents. "Analytical batch" means a batch composed of prepared environmental samples (extracts, digestates, or concentrates) that are analyzed together as a group. An analytical batch can include prepared samples originating from various environmental matrices and can exceed 20 samples. "Preparation batch" means a batch composed of one to 20 environmental samples of the same matrix that meets the criteria in this definition for "batch" and with a maximum time between the start of processing of the first and last sample in the batch to be 24 hours.

"Benthic macroinvertebrates" means bottom dwelling animals without backbones that live at least part of their life cycles within or upon available substrates within a body of water.

"Blank" means a sample that has not been exposed to the analyzed sample stream in order to monitor contamination during sampling, transport, storage or analysis. The blank is subjected to the usual analytical and measurement process to establish a zero baseline or background value and is sometimes used to adjust or correct routine analytical results. Blanks include the following types:

1. Field blank. A blank prepared in the field by filling a clean container with pure deionized water and appropriate preservative, if any, for the specific sampling activity being undertaken.

2. Method blank. A sample of a matrix similar to the batch of associated samples (when available) that is free from the analytes of interest and is processed simultaneously with and under the same conditions as samples through all steps of the analytical procedures, and in which no target analytes or interferences are present at concentrations that impact the analytical results for sample analyses.

"Calibration" means to determine, by measurement or comparison with a standard, the correct value of each scale reading on a meter, instrument or other device. The levels of the applied calibration standard should bracket the range of planned or expected sample measurements.

"Calibration curve" means the graphical relationship between the known values, such as concentrations, of a series of calibration standards and their instrument response.

"Calibration standard" means a substance or reference material used to calibrate an instrument.

"Certified reference material" means a reference material one or more of whose property values are certified by a technically valid procedure, accompanied by or traceable to a certificate or other documentation that is issued by a certifying body.

"Client" or "customer" means the Department of Environmental Quality (DEQ) when used in the context of quality assurance and specific quality control provisions.

"Commercial environmental laboratory" means an environmental laboratory where environmental analysis is performed for another person.

"Corrective action" means the action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent recurrence.

"DCLS" means the Division of Consolidated Laboratory Services of the Department of General Services.

"Demonstration of capability" means the procedure to establish the ability of the analyst to generate data of acceptable accuracy and precision.

"Detection limit" means the lowest concentration or amount of the target analyte that can be determined to be different from zero by a single measurement at a stated degree of confidence.

"Environmental analysis" or "environmental analyses" means any test, analysis, measurement, or monitoring used for the purposes of the Virginia Air Pollution Control Law, the Virginia Waste Management Act or the State Water Control Law (§ 10.1-1300 et seq., § 10.1-1400 et seq., and § 62.1-44.2 et seq., respectively, of the Code of Virginia). For the purposes of these regulations, any test, analysis, measurement, or monitoring required pursuant to the regulations promulgated under these three laws, or by any permit or order issued under the authority of any of these laws or regulations is "used for the purposes" of these laws. The term shall not include the following:

1. Sampling of water, solid and chemical materials, biological tissue, or air and emissions.

2. Field testing and measurement of water, solid and chemical materials, biological tissue, or air and emissions, except when performed in an environmental laboratory rather than at the site where the sample was taken.

3. Taxonomic identification of samples for which there is no national accreditation standard such as algae, benthic macroinvertebrates, macrophytes, vertebrates, and zooplankton.

4. Protocols used pursuant to § 10.1-104.2 of the Code of Virginia to determine soil fertility, animal manure nutrient content, or plant tissue nutrient uptake for the purposes of nutrient management.

5. Geochemical and permeability testing for solid waste compliance.

6. Materials specification for air quality compliance when product certifications specify the data required by an air permit such as fuel type, Btu content, sulfur content, or VOC content.

"Environmental laboratory" or "laboratory" means a facility or a defined area within a facility where environmental analysis is performed. A structure built solely to shelter field personnel and equipment from inclement weather shall not be considered an environmental laboratory.

"Establishment date" means the date set for the accreditation program under 1VAC30-46 and the certification program to be established under this chapter.

"Establishment of certification program" or "established program" means that DCLS has completed the initial accreditation of environmental laboratories covered by 1VAC30-46 and the initial certification of environmental laboratories covered by 1VAC30-45.

"Facility" means something that is built or installed to serve a particular function.

"Field of certification" or "FoC" means those matrix, technology/method, and analyte combinations for which DCLS offers certification.

"Field of proficiency testing" or "FoPT" means analytes for which a laboratory is required to successfully analyze a PT sample in order to obtain or maintain certification, collectively defined as the matrix, technology/method, and analyte combinations for which the composition spike concentration ranges and acceptance criteria have been established by the Proficiency Testing Program Executive Committee of TNI.

"Field testing and measurement" means any of the following:

1. Any test for parameters under 40 CFR Part 136 for which the holding time indicated for the sample requires immediate analysis; or

2. Any test defined as a field test in federal regulation.

The following is a limited list of currently recognized field tests or measures that is not intended to be inclusive: continuous emissions monitoring; online monitoring; flow monitoring; tests for pH, residual chlorine, temperature and dissolved oxygen; and field analysis for soil gas.

"Finding" means an assessment conclusion referenced to a laboratory certification standard and supported by objective evidence that identifies a deviation from a laboratory certification standard requirement.

"Governmental body" means any department, agency, bureau, authority, or district of the United States government, of the government of the Commonwealth of Virginia, or of any local government within the Commonwealth of Virginia.

"Holding time" means the maximum time that can elapse between two specified activities.

"International System of Units (SI)" means the coherent system of units adopted and recommended by the General Conference on Weights and Measures.

"Laboratory control sample" or "LCS" means a sample matrix, free from the analytes of interest, spiked with verified known amounts of analytes or a material containing known and verified amounts of analytes. It is generally used to establish intra-laboratory or analyst specific precision and bias or to assess the performance of all or a portion of the measurement system. "Laboratory control sample" or "LCS" may also be named laboratory fortified blank, spiked blank, or QC check sample.

"Laboratory manager" means the person who has overall responsibility for the technical operation of the environmental laboratory and who exercises actual day-to-day supervision of laboratory operation for the appropriate fields of testing and reporting of results. The title of this person may include but is not limited to laboratory director, technical director, laboratory supervisor, or laboratory manager.

"Legal entity" means an entity, other than a natural person, who that has sufficient existence in legal contemplation that it can function legally, be sued or sue, and make decisions through agents as in the case of corporations.

"Limit of detection" or "LOD" means an estimate of the minimum amount of a substance that an analytical process can reliably detect. An LOD is analyte and matrix specific and may be laboratory dependent.

"Limit of quantitation" or "LOQ" means the minimum levels, concentrations, or quantities of a target variable (e.g., target analyte) that can be reported with a specified degree of confidence.

"Local government" means a municipality (city or town), county, sanitation district, or authority.

"Macrophytes" means any aquatic or terrestrial plant species that can be identified and observed with the eye, unaided by magnification.

"Matrix" means the component or substrate that may contain the analyte of interest. A matrix can be a field of certification matrix or a quality system matrix.

1. Field of certification matrix. These matrix definitions shall be used when certifying a laboratory.

a. Nonpotable water. Any aqueous sample that has not been designated a potable or potential potable water source. Includes surface water, groundwater, effluents, water treatment chemicals, and TCLP or other extracts.

b. Solid and chemical materials. Includes soils, sediments, sludges, products, and byproducts of an industrial process that results in a matrix not previously defined.

c. Biological tissue. Any sample of a biological origin such as fish tissue, shellfish, or plant material. Such samples shall be grouped according to origin.

d. Air and emissions. Whole gas or vapor samples including those contained in flexible or rigid wall containers and the extracted concentrated analytes of interest from a gas or vapor that are collected with a sorbent tube, impinger solution, filter or other device.

2. Quality system matrix. For purposes of batch and quality control requirement determinations, the following matrix types shall be used:

a. Drinking water. Any aqueous sample that has been designated a potable or potential potable water source.

b. Aqueous. Any aqueous sample excluded from the definition of drinking water matrix or saline/estuarine source. Includes surface water, groundwater, effluents, and TCLP or other extracts.

c. Saline/estuarine. Any aqueous sample from an ocean or estuary, or other salt water source.

d. Nonaqueous liquid. Any organic liquid with less than 15% settleable solids.

e. Biological tissue. Any sample of a biological origin such as fish tissue, shellfish, or plant material. Such samples shall be grouped according to origin.

f. Solids. Includes soils, sediments, sludges, and other matrices with more than 15% settleable solids.

g. Chemical waste. A product or byproduct of an industrial process that results in a matrix not previously defined.

h. Air and emissions. Whole gas or vapor samples including those contained in flexible or rigid wall containers and the extracted concentrated analytes of interest from a gas or vapor that are collected with a sorbent tube, impinger solution, filter, or other device.

"Matrix spike (spiked sample or fortified sample)" means a sample prepared by adding a known mass of target analyte to a specified amount of matrix sample for which an independent estimate of target analyte concentration is available. Matrix spikes are used, for example, to determine the effect of the matrix on a method's recovery efficiency.

"Matrix spike duplicate (spiked sample or fortified sample duplicate)" means a second replicate matrix spike prepared in the laboratory and analyzed to obtain a measure of the precision of the recovery for each analyte.

"National Environmental Laboratory Accreditation Conference (NELAC)" or "NELAC" means a voluntary organization of state and federal environmental officials and interest groups with the primary purpose to establish mutually acceptable standards for accrediting environmental laboratories. NELAC preceded the formation of The NELAC Institute or TNI.

"National Institute of Standards and Technology" or "NIST" means an agency of the U.S. Department of Commerce's Technology Administration that is working with EPA, states, NELAC, and other public and commercial entities to establish a system under which private sector companies and interested states can be certified by NIST to provide NIST-traceable proficiency testing (PT) samples.

"Negative control" means measures taken to ensure that a test, its components, or the environment do not cause undesired effects, or produce incorrect test results.

"Noncommercial environmental laboratory" means either of the following:

1. An environmental laboratory where environmental analysis is performed solely for the owner of the laboratory.

2. An environmental laboratory where the only performance of environmental analysis for another person is one of the following:

a. Environmental analysis performed by an environmental laboratory owned by a local government for an owner of a small wastewater treatment system treating domestic sewage at a flow rate of less than or equal to 1,000 gallons per day.

b. Environmental analysis performed by an environmental laboratory operated by a corporation as part of a general contract issued by a local government to operate and maintain a wastewater treatment system or a waterworks.

c. Environmental analysis performed by an environmental laboratory owned by a corporation as part of the prequalification process or to confirm the identity or characteristics of material supplied by a potential or existing customer or generator as required by a hazardous waste management permit under 9VAC20-60.

d. Environmental analysis performed by an environmental laboratory owned by a Publicly Owned Treatment Works (POTW) for an industrial source of wastewater under a permit issued by the POTW to the industrial source as part of the requirements of a pretreatment program under Part VII (9VAC25-31-730 et seq.) of 9VAC25-31.

e. Environmental analysis performed by an environmental laboratory owned by a county authority for any municipality within the county's geographic jurisdiction when the environmental analysis pertains solely to the purpose for which the authority was created.

f. Environmental analysis performed by an environmental laboratory owned by an authority or a sanitation district for any participating local government of the authority or sanitation district when the environmental analysis pertains solely to the purpose for which the authority or sanitation district was created.

"Owner" means any person who owns, operates, leases, or controls an environmental laboratory.

"Person" means an individual, corporation, partnership, association, company, business, trust, joint venture, or other legal entity.

"Physical," for the purposes of fee test categories, means the tests to determine the physical properties of a sample. Tests for solids, turbidity, and color are examples of physical tests.

"Positive control" means measures taken to ensure that a test or its components are working properly and producing correct or expected results from positive test subjects.

"Precision" means the degree to which a set of observations or measurements of the same property, obtained under similar conditions, conform to themselves. Precision is an indicator of data quality. Precision is expressed usually as standard deviation, variance, or range, in either absolute or relative terms.

"Primary accreditation body" means the accreditation body responsible for assessing a laboratory's total quality system, on-site assessment, and PT performance tracking for fields of accreditation.

"Proficiency test or testing (PT)" or "PT" means evaluating a process to evaluate a laboratory's performance under controlled conditions relative to a given set of criteria through analysis of unknown samples provided by an external source.

"Proficiency test (PT) sample" means a sample, the composition of which is unknown to the laboratory and is provided to test whether the laboratory can produce analytical results within specified acceptance criteria.

"Proficiency testing (PT) program" means the aggregate of providing rigorously controlled and standardized environmental samples to a laboratory for analysis, reporting of results, statistical evaluation of the results, and the collective demographics and results summary of all participating laboratories.

"Program," in the context of a regulatory program, means the relevant U.S. Environmental Protection Agency program such as the water program under the Clean Water Act (CWA), the air program under the Clean Air Act (CAA), the waste program under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA or Superfund), or the waste program under the Resource Conservation and Recovery Act (RCRA).

"Publicly Owned Treatment Works (POTW)" or "POTW" means a treatment works as defined by § 212 of the CWA, which is owned by a state or municipality (as defined by § 502(4) of the CWA). This definition includes any devices and systems used in the storage, treatment, recycling, and reclamation of municipal sewage or industrial wastes of a liquid nature. It also includes sewers, pipes, and other conveyances only if they convey wastewater to a POTW treatment plant. The term also means the municipality as defined in § 502(4) of the CWA, which has jurisdiction over the indirect discharges to and the discharges from such a treatment works.

"Quality assurance" or "QA" means an integrated system of management activities involving planning, implementation, assessment, reporting, and quality improvement to ensure that a process, item, or service is of the type and quality needed and expected by the client.

"Quality assurance officer" means the person who has responsibility for the quality system and its implementation. Where staffing is limited, the quality assurance officer may also be the laboratory manager.

"Quality control" or "QC" means the overall system of technical activities that measures the attributes and performance of a process, item, or service against defined standards to verify that they meet the stated requirements established by the customer; operational techniques and activities that are used to fulfill requirements for quality; and also the system of activities and checks used to ensure that measurement systems are maintained within prescribed limits, providing protection against "out of control" conditions and ensuring that the results are of acceptable quality.

"Quality manual" means a document stating the management policies, objectives, principles, organizational structure and authority, responsibilities, accountability, and implementation of an agency, organization, or laboratory, to ensure the quality of its product and the utility of its product to its users.

"Quality system" means a structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The quality system provides the framework for planning, implementing, and assessing work performed by the organization and for carrying out required quality assurance and quality control activities.

"Range" means the difference between the minimum and maximum of a set of values.

"Reference material" means a material or substance one or more properties of which are sufficiently well established to be used for the calibration of an apparatus, the assessment of a measurement test method, or for assigning values to materials.

"Reference standard" means a standard, generally of the highest metrological quality available at a given location, from which measurements made at that location are derived.

"Responsible official" means one of the following, as appropriate:

1. If the laboratory is owned or operated by a private corporation, "responsible official" means (i) a president, secretary, treasurer, or a vice-president of the corporation in charge of a principal business function, or any other person who performs similar policy-making or decision-making functions for the corporation or (ii) the manager of one or more manufacturing, production, or operating facilities employing more than 250 persons or having gross annual sales or expenditures exceeding $25 million (in second-quarter 1980 dollars), if authority to sign documents has been assigned or delegated in accordance with corporate procedures.

2. If the laboratory is owned or operated by a partnership, association, or a sole proprietor, "responsible official" means a general partner, officer of the association, or the proprietor, respectively.

3. If the laboratory is owned or operated by a governmental body, "responsible official" means a director or highest official appointed or designated to oversee the operation and performance of the activities of the environmental laboratory.

4. Any person designated as the responsible official by an individual described in subdivision 1, 2, or 3 of this definition, provided the designation is in writing, the designation specifies an individual or position with responsibility for the overall operation of the environmental laboratory, and the designation is submitted to DCLS.

"Sampling" means the act of collection for the purpose of analysis an activity related to obtaining a representative sample of the object of conformity assessment, according to a procedure.

"Sanitation district" means a sanitation district created under the provisions of Chapters 3 (§ 21-141 et seq.) through 5 (§ 21-291 et seq.) of Title 21 of the Code of Virginia.

"Selectivity" means the ability to analyze, distinguish, and determine a specific analyte from another component that may be a potential interferent or that may behave similarly to the target analyte within the measurement system.

"Sewage" means the water-carried human wastes from residences, buildings, industrial establishments, or other places together with such industrial wastes and underground, surface, storm, or other water as may be present.

"Simple test procedures" or "STP" means any of the following:

1. Field testing and measurement performed in an environmental laboratory.

2. The test procedures to determine:

a. Biochemical oxygen demand (BOD) or carbonaceous BOD (CBOD);

b. Fecal coliform;

c. Total coliform;

d. Fecal streptococci;

e. E. coli;

f. Enterococci;

g. Settleable solids (SS);

h. Total dissolved solids (TDS);

i. Total solids (TS);

j. Total suspended solids (TSS);

k. Total volatile solids (TVS); and

l. Total volatile suspended solids (TVSS).

"Standard operating procedure" or "SOP" means a written document that details the method for an operation, analysis, or action with thoroughly prescribed techniques and steps. An SOP is officially approved as the method for performing certain routine or repetitive tasks.

"Standardized reference material" or "SRM" means a certified reference material produced by the U.S. National Institute of Standards and Technology or other equivalent organization and characterized for absolute content, independent of analytical method.

"System laboratory" means a noncommercial laboratory that analyzes samples from multiple facilities having the same owner.

"Test" means a technical operation that consists of the determination of one or more characteristics or performance of a given product, material, equipment, organism, physical phenomenon, process, or service according to a specified procedure.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Air Pollution Control Law" means any method of analysis required by the Virginia Air Pollution Control Law (§ 10.1-1300 et seq.); by the regulations promulgated under this law (9VAC5) including any method of analysis listed either in the definition of "reference method" in 9VAC5-10-20, or listed or adopted by reference in 9VAC5; or by any permit or order issued under and in accordance with this law and these regulations.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Waste Management Act" means any method of analysis required by the Virginia Waste Management Act (§ 10.1-1400 et seq.); by the regulations promulgated under this law (9VAC20), including any method of analysis listed or adopted by reference in 9VAC20; or by any permit or order issued under and in accordance with this law and these regulations.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Water Control Law" means any method of analysis required by the Virginia Water Control Law (§ 62.1-44.2 et seq.); by the regulations promulgated under this law (9VAC25), including any method of analysis listed or adopted by reference in 9VAC25; or by any permit or order issued under and in accordance with this law and these regulations.

"Test method" means an adoption of a scientific technique for performing a specific measurement as documented in a laboratory standard operating procedure or as published by a recognized authority.

"The NELAC Institute" or "TNI" means the organization whose standards environmental laboratories must meet to become accredited under 1VAC30-46, the regulation governing commercial environmental laboratories in Virginia.

"Toxicity characteristic leachate procedure" or "TCLP" means Test Method 1311 in "Test Methods for Evaluating Solid Waste, Physical/Chemical Methods," EPA Publication SW-846, as incorporated by reference in 40 CFR 260.11. This method is used to determine whether a solid waste exhibits the characteristic of toxicity (see 40 CFR 261.24).

"Traceability" means the property of a result of a measurement whereby it can be related to appropriate standards, generally international or national standards, through an unbroken chain of comparisons.

"U.S. Environmental Protection Agency" or "EPA" means the federal government agency with responsibility for protecting, safeguarding, and improving the natural environment (i.e., air, water, and land) upon which human life depends.

"Virginia Air Pollution Control Law" means Chapter 13 (§ 10.1-1300 et seq.) of Title 10.1 of the Code of Virginia, which is titled "Air Pollution Control Board."

"Virginia Environmental Laboratory Accreditation Program" or "VELAP" means the program DCLS operates to certify environmental laboratories under this chapter.

"Wastewater" means liquid and water-carried industrial wastes and domestic sewage from residential dwellings, commercial buildings, industrial and manufacturing facilities, and institutions.

"Waterworks" means each system of structures and appliances used in connection with the collection, storage, purification, and treatment of water for drinking or domestic use and the distribution thereof to the public, except distribution piping.

"Zooplankton" means microscopic animals that float freely with voluntary movement in a body of water.

1VAC30-45-95. Suspension of certification.

A. DCLS may suspend certification from an environmental laboratory in total or in part to allow the laboratory time to correct the reason for which DCLS may withdraw certification. Suspension is limited to the reasons listed in subsection B of this section.

B. DCLS may suspend certification from an environmental laboratory in part or in total when the laboratory has failed to do any of the following:

1. Participate in the proficiency testing program as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

2. Satisfactorily complete proficiency testing studies as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

3. Submit an acceptable corrective action plan after two opportunities as specified in 1VAC30-45-390.

4. Maintain a quality system as defined in Article 4 (1VAC30-45-600 et seq.) of Part II of this chapter.

4. 5. Employ staff that meets the personnel qualifications of Article 1 (1VAC30-45-200 et seq.) of Part II of this chapter.

5. 6. Notify DCLS of any changes in key certification criteria as set forth in 1VAC30-45-90.

C. Process to suspend certification.

1. When DCLS becomes aware of a cause to suspend a laboratory, the agency shall send notification to the responsible official and the laboratory manager stating it appears to DCLS that the laboratory has failed to meet the 1VAC30-45 standards for one or more of the reasons listed in subsection B of this section. DCLS shall send the notification by certified mail.

2. The DCLS notification shall do the following:

a. Require the laboratory to provide DCLS with documentation of the corrective action already taken with regard to its failure to meet a standard under subsection B of this section.

b. State the corrective action the laboratory must take and the time allowed for this corrective action to be completed in order to retain certification.

3. The environmental laboratory may proceed to correct the deficiencies for which DCLS may suspend the laboratory's certification.

4. Alternatively the laboratory may state in writing that DCLS is incorrect in its observations regarding potential suspension and give specific reasons why the laboratory believes DCLS should not suspend certification. The laboratory has the right to due process as set forth in 1VAC30-45-110, the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia), and Part 2A of the Rules of the Supreme Court of Virginia.

5. With the exception of subdivision B 4 of this section, DCLS may allow the laboratory up to 60 days to correct the problem for which it may have its certification suspended.

6. DCLS shall set a date for suspension that follows the period provided under subdivision 5 of this subsection to restore certification.

7. If the laboratory does not correct its deficiencies within the time period allowed or pursue options under subdivision 4 of this subsection, DCLS may suspend a laboratory in part or in total.

8. DCLS shall notify the laboratory by letter if the laboratory's certification is suspended in part or in total. DCLS shall send the notification by certified mail. DCLS shall also notify the pertinent Virginia state agency of the laboratory's suspension status.

9. The laboratory may provide information demonstrating why suspension is not warranted in accordance with subdivision 4 of this subsection.

D. Responsibilities of the environmental laboratory and DCLS when certification has been suspended.

1. The term of suspension shall be limited to six months or the period of certification whichever is longer.

2. The environmental laboratory shall not continue to analyze samples or report analysis for the fields of certification for which DCLS has suspended certification.

3. The environmental laboratory shall retain certification for the fields of certification, methods, and analytes where it continues to meet the requirements of this chapter.

4. The laboratory's suspended certification status shall change to certified when the laboratory demonstrates to DCLS that the laboratory has corrected the deficiency or deficiencies for which its certification was suspended.

5. An environmental laboratory with suspended certification shall not have to reapply for certification if the cause or causes for suspension are corrected within the term of suspension.

6. An environmental laboratory that DCLS has suspended in total shall pay the cost of any necessary follow-up on-site assessments or data review or both to determine compliance. This cost shall be calculated under the provisions of 1VAC30-45-130 F and G.

7. If the laboratory fails to correct the causes of suspension within the term of suspension, DCLS shall decertify the laboratory in total or in part.

1VAC30-45-100. Decertification.

A. DCLS shall decertify an environmental laboratory in total if the laboratory is found to be falsifying any data or providing false information to support certification.

B. DCLS may decertify an environmental laboratory in part or in total when the laboratory has failed to do any of the following:

1. Participate in the proficiency testing program as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

2. Satisfactorily complete proficiency testing studies as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

[ 3. Successfully complete three consecutive PT studies, either by failure to participate in the required PT study or by failure to obtain acceptable results for the same field of certification. ]

[ 4. 3. ] Maintain a quality system as defined in Article 4 (1VAC30-45-600 et seq.) of Part II of this chapter.

[ 4. 5. ] Employ staff that meets the personnel qualifications in Article 1 (1VAC30-45-200 et seq.) of Part II of this chapter.

[ 5. 6. ] Submit an acceptable corrective action plan after two opportunities as specified in 1VAC30-45-390.

[ 6. 7. ] Implement corrective action specified in the laboratory's corrective action plan as set out under 1VAC30-45-390.

[ 7. 8. ] Correct the causes of suspension within the term of suspension.

[ 9. 8. ] Notify DCLS of any changes in key certification criteria as set forth in 1VAC30-45-90.

[ 8. 10. 9. ] Use accurate references to the laboratory's certification status in the laboratory's documentation.

[ 9. 11. 10. ] Allow a DCLS assessment team entry during normal business hours to conduct an on-site assessment required by Article 2 (1VAC30-45-300 et seq.) of Part II of this chapter.

[ 10. 12. 11. ] Pay the required fees specified in 1VAC30-45-130.

[ 13. 12. ] Meet the provisions regarding communication with others in 1VAC30-45-510 C.

C. [ DCLS may decertify an environmental laboratory in part or in total when the laboratory has failed three consecutive proficiency testing studies for the same field of certification either by failure to participate in the proficiency testing study or by failure to obtain acceptable results.

D. ] DCLS shall follow the process specified in 1VAC30-45-110 when decertifying an environmental laboratory.

[ D. E. ] Responsibilities of the environmental laboratory and DCLS when certification has been withdrawn.

1. Laboratories that lose their certification in full shall return their certificate to DCLS.

2. If a laboratory loses certification in part, DCLS shall issue a revised certificate to the laboratory.

3. When the environmental laboratory has lost certification in full or in part, the laboratory shall not continue to analyze samples or report analyses for the fields of certification that DCLS has decertified.

[ E. F. ] After correcting the reason or cause for decertification under subsection A or B of this section, the laboratory owner may reapply for certification under 1VAC30-45-70.

1VAC30-45-130. Fees.

A. General.

1. Environmental laboratories shall pay a fee with all applications, including reapplications, for certification. DCLS shall not designate an application as complete until it receives payment of the fee.

2. Each certified environmental laboratory shall pay an annual fee to maintain its certification. DCLS shall send an invoice to the certified environmental laboratory.

3. Fees shall be nonrefundable.

4. DCLS, as part of its regular budgetary review of the program, shall determine whether the fees charged under this section offset the program costs as required under § 2.2-1105 of the Code of Virginia.

B. Environmental laboratories performing only simple test procedures shall pay an annual fee of $690.

C. Fee computation for general environmental laboratories.

1. Fees shall be applied on an annual basis.

2. Environmental laboratories shall pay the total of the base fee and the test category fees set out in subsections D and E of this section.

D. Base fees for general environmental laboratories.

1. DCLS determines the base fee for a laboratory by taking into account both the total number of methods and the total number of field of certification matrices for which the laboratory would be certified.

2. DCLS shall charge the base fees set out in Table 1. The base fee for a laboratory is located by first finding the row for the total number of methods to be certified and then finding the box on that row located in the column headed by the total number of matrices to be certified. For example, DCLS charges a base fee of $1495 to a laboratory performing a total of eight methods for one matrix.

	TABLE 1: BASE FEES
	Number of Methods	1 Matrix	2 Matrices
	1 - 9	$1495	$1645
	10 - 29	$1610	$1811
	30 - 99	$1783	$2099

E. Test category fees for general environmental laboratories.

1. The test category fees cover the types of testing for which a laboratory may be certified as specified in the laboratory's application or as certified at the time of annual billing.

2. Fees shall be charged for each category of tests to be certified.

3. Fees shall be charged for the total number of field of certification matrices to be certified under the specific test category. For example, if a laboratory is performing inorganic chemistry for both nonpotable water and solid and chemical materials matrices, the fee for this test category would be found in the column for two matrices.

4. The fee for each category includes one or more analytical methods unless otherwise specified.

5. DCLS shall charge the test category fees set out in Table 2. The test category fees for a laboratory are located by first finding the row with the total number of test methods for the test category to be certified. The fee to be charged for the test category will be found on that row in the column headed by the total number of matrices to be certified. A laboratory performing four test methods for inorganic chemistry in nonpotable water and solid and chemical materials (two matrices) would be charged a test category fee of $431.

6. Noncommercial environmental laboratories that perform toxicity, radiochemical, or asbestos testing shall pay the test category fees established for these types of testing in 1VAC30-46-150.

	TABLE 2: TEST CATEGORY FEES
	Test Category	Fees by Number of Matrices
		One	Two
	Oxygen demand	$259	$385
	Bacteriology, 1 - 3 total methods	$201	$305
	Bacteriology, 4 or more total methods	$253	$380
	Physical, 1 - 5 total methods	$201	$305
	Physical, 6 - 10 total methods	$253	$380
	Inorganic chemistry, 1 - 10 total methods	$288	$431
	Inorganic chemistry, 11 - 20 total methods	$362	$546
	Inorganic chemistry, 21 - 49 total methods	$453	$679
	Chemistry metals, 1 - 5 total methods	$374	$564
	Chemistry metals, 6 - 20 total methods	$472	$707
	Organic chemistry, 1 - 5 total methods	$460	$690
	Organic chemistry, 6 - 20 total methods	$575	$863

7. Fee examples. Three examples are provided.

a. Example 1:

	Base Fee	One matrix and four test methods	$1495
	Test Category Fees
	One Matrix
	Nonpotable Water	Bacteriology (2 methods)	$201
	Nonpotable Water	Oxygen demand (1 method)	$259
	Nonpotable Water	Physical (1)	$201
	TOTAL		$2156

b. Example 2:

	Base Fee	One matrix and 15 test methods	$1610
	Test Category Fees
	One Matrix
	Nonpotable Water	Bacteriology (2 methods)	$201
	Nonpotable Water	Inorganic chemistry (9 methods)	$288
	Nonpotable Water	Chemistry metals (2 methods)	$374
	Nonpotable Water	Oxygen demand (1 method)	$259
	Nonpotable Water	Physical (1)	$201
	TOTAL		$2933

c. Example 3:

	Base Fee	Two matrices and 27 test methods	$1811
	Test Category Fees
	One Matrix
	Nonpotable Water	Bacteriology (4 methods)	$253
	Nonpotable Water	Oxygen demand (1 method)	$259
	Solid and Chemical Materials	Chemistry metals (1 method)	$374
	Two Matrices
	Nonpotable Water and Solid and Chemical Materials	Inorganic chemistry (13 methods)	$546
	Nonpotable Water and Solid and Chemical Materials	Physical (7 methods)	$380
	TOTAL		$3623

F. Additional fees. Additional fees shall be charged to laboratories applying for the following: (i) modification to scope of certification under 1VAC30-45-90 B, (ii) transfer of ownership under 1VAC30-45-90 C, (iii) review of compliance following total suspension, (iv) exemption under 1VAC30-45-120, or (iv) (v) petition for a variance under 1VAC30-45-140.

1. For any certified environmental laboratory that applies to modify its scope of certification as specified under 1VAC30-45-90 B, DCLS shall assess a fee determined by the method in subsection G of this section.

2. Under 1VAC30-45-90 C, DCLS may charge a transfer fee to a certified laboratory that transfers ownership. A fee shall be charged if DCLS (i) needs to review documentation sent by the laboratory about the transfer of ownership or (ii) determines that an on-site assessment is necessary to evaluate the effect of the transfer of ownership. DCLS shall assess a fee determined by the method in subsection G of this section. If, under 1VAC30-45-90 C, DCLS determines that the change of ownership or location of laboratory requires recertification of or reapplication by the laboratory, the laboratory shall pay the application fees required under this section.

3. Under 1VAC30-45-95 D 6, an environmental laboratory that DCLS has suspended in total shall be charged the cost of any necessary follow-up on-site assessments or data review or both to determine compliance. This charge shall be calculated under the method specified in subsection G of this section.

4. General environmental laboratories applying for an exemption under 1VAC30-45-120 shall pay an initial application fee of $700 plus an additional fee based on the actual time needed for DCLS to assess the exemption request. The total fee shall not exceed the actual time DCLS takes to assess the exemption request. Laboratories performing only simple test procedures applying for an exemption under 1VAC30-45-120 shall pay an initial application fee of $300 plus an additional fee based on the actual time needed for DCLS to assess the exemption request. The total fee shall not exceed the actual time DCLS takes to assess the exemption request. The fee assessed shall be calculated using the method in subsection G of this section.

4. 5. Under 1VAC30-45-140, any person regulated by this chapter may petition the director to grant a variance from any requirement of this chapter. DCLS shall charge an initial fee of $700 plus an additional fee based on the actual time needed for DCLS to review the petition, including any on-site assessment required. The total fee shall not exceed the actual time DCLS takes to review and make a determination on the request for a variance. The fee shall be determined by the method specified in subsection G of this section.

G. Fee determination.

1. The fee shall be the sum of the total hourly charges for all reviewers plus any on-site review costs incurred.

2. An hourly charge per reviewer shall be determined by (i) obtaining a yearly cost by multiplying the reviewer's annual salary by 1.35 (accounts for overhead such as taxes and insurance) and then (ii) dividing the yearly cost by 1,642 (number of annual hours established by Fiscal Services, the Department of General Services, for billing purposes).

3. The charge per reviewer shall be determined by multiplying the number of hours expended in the review by the reviewer's hourly charge.

4. If an on-site review is required, travel time and on-site review time shall be charged at the same hourly charge per reviewer, and any travel expenses shall be added.

H. Out-of-state laboratories - travel costs. The owner of an environmental laboratory located in another state who applies for certification under this chapter shall also pay a fee equal to the reasonable travel costs associated with conducting an on-site assessment at the laboratory. Reasonable travel costs include transportation, lodging, per diem, and telephone and duplication charges.

I. DCLS shall derive the travel costs charged under subsections G and H of this section from the Commonwealth of Virginia reimbursement allowances and rates for lodging, per diem, and mileage.

1VAC30-45-520. PT criteria for laboratory certification.

A. Result categories.

1. The criteria described in this section apply individually to each FoPT, as defined by the laboratory seeking to obtain or maintain certification in its certification request. These criteria apply only to the PT portion of the overall certification standard.

2. There are two PT result categories: "acceptable" and "not acceptable."

B. Initial and continuing certification.

1. A laboratory seeking to obtain or maintain certification shall successfully complete one PT study for each requested FoC.

2. Once a laboratory has been granted certification status, it shall continue to complete PT studies for each FoPT and maintain a history of at least one acceptable PT study each calendar year. The laboratory shall complete its PT studies by September 30 of each calendar year.

3. When the PT sample used for initial certification was analyzed by the laboratory prior to the date of application, the analysis date of the PT sample shall be no more than 12 months prior to the application date of certification.

4. For a laboratory performing supplemental testing, the PT studies shall be at least 15 seven calendar days apart from the closing date of one study to the shipment opening date of another study for the same FoPT.

5. When the PT study result is reported by the PT provider as "acceptable" the environmental laboratory has satisfied the PT requirement.

6. When the PT study result is "not acceptable," the environmental laboratory shall follow the procedure in subsection C of this section.

7. DCLS shall consider a laboratory's analytical result for a FoPT not acceptable when the laboratory makes any reporting error or omission that results in a nonspecific match between the analytical result for the FoPT and any criterion that identifies the laboratory or the field of certification for which the PT sample was analyzed for the purpose of initial or continued certification.

C. Procedure and requirements for "not acceptable" PT study results.

1. When a laboratory receives a PT study result of "not acceptable," the laboratory shall determine the cause for the failure and perform and document corrective action. The corrective action documentation shall be completed within 30 days of receiving the "not acceptable" PT study result and be submitted to DCLS upon request. DCLS may extend the time for corrective action and documentation.

2. Upon completion of the corrective action the laboratory shall perform another PT study for each FoPT that had a "not acceptable" result.

3. If the laboratory successfully completes the makeup PT study by receiving an "acceptable" result before December 31, DCLS shall not suspend the laboratory's certification for the pertinent FoC.

4. If the laboratory receives a "not acceptable" result on the makeup PT study, DCLS shall notify the laboratory that there is cause to suspend the laboratory's certification for the FoC for which the PT study was "not acceptable."

5. DCLS shall not extend the period for annual PT study completion beyond December 31 each year. Failure to satisfactorily complete a PT study, including any corrective action and makeup PT study, by December 31 shall result in suspension of certification in total or in part.

6. If the laboratory receives a "not acceptable" result on three successive PT studies, DCLS shall decertify the laboratory for the pertinent FoC until such time that the laboratory:

a. Completes corrective action for all failed studies and submits its corrective action report to DCLS;

b. Obtains an "acceptable" result for the PT studies; and

c. Applies for a change to its scope of certification and pays applicable fees required by 1VAC30-45-90 B and 1VAC30-45-130 F.

7. DCLS shall follow the provisions of 1VAC30-45-110 in decertifying the laboratory.

D. Withdrawal from PT studies. A laboratory may withdraw from a PT study for any FoPT on or before the close date of the study. Withdrawing from a study shall not exempt the laboratory from meeting the annual analysis requirements necessary for continued certification.

1VAC30-45-650. Records management and storage.

A. The laboratory shall keep all records, certificates, and reports as required by applicable state and federal recordkeeping laws and regulations. The laboratory shall safely store these records and hold them secure.

B. The laboratory shall retain all records for a minimum of three years from generation of the last entry in the records, or longer, if required by an applicable regulatory program, whichever is greater. The laboratory shall maintain all information necessary for the historical reconstruction of data, including all original observations, calculations and derived data, calibration records and a copy of the test report.

C. Records that are stored only on electronic media shall be supported by the hardware and software necessary for their retrieval. Records that are stored or generated by computers or personal computers shall have hard copy or write-protected backup copies.

D. The laboratory shall establish a record management system for control of laboratory notebooks, instrument logbooks, standards logbooks, and records for data reduction, validation storage and reporting.

E. Access to archived information shall be documented with an access log. The laboratory shall protect these records against fire, theft, loss, environmental deterioration, vermin and, in the case of electronic records, electronic or magnetic sources.

F. The laboratory shall have a plan to ensure that the records are maintained or transferred in the event that a laboratory transfers ownership or goes out of business. In addition, in cases of bankruptcy, the laboratory shall follow appropriate regulatory and state legal requirements concerning laboratory records.

1VAC30-45-730. Test methods and standard operating procedures.

A. Methods documentation.

1. The laboratory shall have documented instructions on the use and operation of all relevant equipment, on the handling and preparation of samples, and for calibration or testing, where the absence of such instructions could jeopardize the calibrations or tests.

2. All instructions, standards, manuals, and reference data relevant to the work of the laboratory shall be maintained up to date and be readily available to the staff.

B. Standard operating procedures (SOPs).

1. Laboratories shall maintain SOPs that accurately reflect all phases of current laboratory activities such as assessing data integrity, corrective actions, handling customer complaints, and all test methods. These documents, for example, may be equipment manuals provided by the manufacturer or internally written documents. The test methods may be copies of published methods as long as any changes or selected options in the methods are documented and included in the laboratory methods manual.

2. The SOPs shall be organized. Each SOP shall clearly indicate the effective date of the document, the revision number, and the signature or signatures of the responsible laboratory manager or managers.

3. Copies of all SOPs shall be accessible to all personnel.

C. SOPs for laboratory methods.

1. The laboratory shall have and maintain an SOP for each certified analyte or test method.

2. This SOP may be a copy of a published or referenced method or may be written by the laboratory. In cases where modifications to the published method have been made by the laboratory or where the referenced test method is ambiguous or provides insufficient detail, these changes or clarifications shall be clearly described. Each test method shall include or reference where applicable:

a. Identification of the test method;

b. Applicable matrix or matrices;

c. Limits of detection or quantitation;

d. Scope and application, including parameters to be analyzed;

e. Summary of the test method;

f. Definitions;

g. Interferences;

h. Safety;

i. Equipment and supplies;

j. Reagents and standards;

k. Sample collection, preservation, shipment, and storage;

l. Quality control;

m. Calibration and standardization;

n. Procedure;

o. Data analysis and calculations;

p. Method performance;

q. Pollution prevention;

r. Data assessment and acceptance criteria for quality control measures;

s. Corrective actions for out-of-control data;

t. Contingencies for handling out-of-control or unacceptable data;

u. Waste management;

v. References; and

w. Any tables, diagrams, flowcharts, and validation data.

D. Test methods.

1. Laboratories shall use (i) promulgated test methods in accordance with the Code of Federal Regulations; (ii) test methods stated in any current permit issued by the State Air Pollution Control Board, the Virginia Waste Management Board, or the State Water Control Board; or (iii) alternate test procedures approved by the board issuing the permit or the Department of Environmental Quality, including applicable quality assurance requirements, and sample preservation, container, storage, and holding time requirements.

2. The laboratory shall use appropriate test methods and procedures for all tests and related activities within its responsibility (including sample handling, transport and storage, preparation, and analysis). The method and procedures shall be consistent with the accuracy required and with any standard specifications relevant to the calibrations or tests concerned.

3. When the use of reference test methods for a sample analysis is mandated, only those methods shall be used.

4. Where test methods are employed that are not required, as in the Performance Based Measurement System approach, the methods shall be fully documented and validated (see subsection E of this section).

E. Demonstration of capability.

1. Prior to acceptance and institution of any test method, satisfactory initial demonstration of method capability is required. In general, this demonstration does not test the performance of the method in real world samples, but in the applicable and available clean quality system matrix sample (a quality system matrix in which no target analytes or interferences are present at concentrations that impact the results of a specific test method), for example, drinking water, solids, biological tissue, and air. Laboratories shall follow the procedure in subsection F of this section to demonstrate capability.

2. Thereafter, ongoing demonstration of method performance, such as laboratory control samples, is required.

3. In cases where a laboratory analyzes samples using a test method that has been in use by the laboratory for at least one year prior to applying for certification, and there have been no significant changes in instrument type, personnel or test method, the continuing demonstration of method performance and the analyst's documentation of continued proficiency shall be acceptable. The laboratory shall have records on file to demonstrate that an initial demonstration of capability is not required.

4. In cases where a laboratory analyzes samples using a test method that has not been in use by an individual in the laboratory for at least one 12-month period, another successful demonstration of capability in accordance with subsection F of this section shall be required for that individual to resume testing by the method.

5. In all cases, the laboratory shall document each demonstration of capability as required by subsection G of this section.

5. 6. The laboratory shall complete a demonstration of capability each time there is a change in instrument type, personnel or test method, including the addition of an analyte to a certified test method.

F. Procedure for demonstration of capability. The following steps shall be performed for mandated test methods. However, before any results are reported using this method, actual sample spike results may be used to meet this standard (i.e., at least four consecutive matrix spikes within the last 12 months). For analytes that do not lend themselves to spiking (e.g., TSS) the demonstration of capability may be performed using quality control samples. The laboratory may document that other approaches to demonstration of capability are adequate. This documentation shall be included in the laboratory's quality manual:

1. A quality control (QC) sample may be obtained from an outside source or may be prepared by the laboratory using alternate source stock standards that are prepared independently from those used in instrument calibration.

2. The analyte or analytes shall be diluted in a volume of clean quality system matrix sufficient to prepare four aliquots at the concentration specified, or if unspecified, to a concentration of 1-4 times the limit of quantitation.

3. At least four aliquots shall be prepared and analyzed according to the test method either concurrently or over a period of days.

4. Using all of the results, calculate the mean recovery in the appropriate reporting units (such as g/L) and the standard deviations of the population sample (n-1) (in the same units) for each parameter of interest. When it is not possible to determine mean and standard deviations, such as for presence or absence of the analyte and logarithmic values, the laboratory shall assess performance against established and documented criteria.

5. Compare the information from subdivision 4 of this subsection to the corresponding acceptance criteria for precision and accuracy in the test method (if applicable) or in laboratory-generated acceptance criteria (if there are not established mandatory criteria). If all parameters meet the acceptance criteria, the analysis of actual samples may begin. If any one of the parameters do not meet the acceptance criteria, the performance is unacceptable for that parameter.

6. When one or more of the tested parameters fail at least one of the acceptance criteria, the analyst shall proceed according to either subdivision 6 a or 6 b of this subsection.

a. Locate and correct the source of the problem and repeat the test for all parameters of interest beginning with subdivision 3 of this subsection.

b. Beginning with subdivision 3 of this subsection, repeat the test for all parameters that failed to meet criteria. Repeated failure, however, confirms a general problem with the measurement system. If this occurs, locate and correct the source of the problem and repeat the test for all compounds of interest beginning with subdivision 3 of this subsection.

G. Documentation of demonstration of capability. The laboratory shall document each demonstration of capability so that the following information shall be readily available for each employee:

1. Analyst or analysts involved in preparation and analysis.

2. Matrix.

3. Analytes, class of analytes, measured parameters, or organisms.

4. Identification of methods performed.

5. Identification of laboratory-specific SOP used for analysis, including revision number.

6. Date or dates of analysis.

7. All raw data necessary to reconstruct and validate the analyses.

8. Data evaluation required by subsection F of this section.

H. Sample aliquots. Where sampling (as in obtaining sample aliquots from a submitted sample) is carried out as part of the test method, the laboratory shall use documented procedures and appropriate techniques to obtain representative subsamples.

I. Data verification. Calculations and data transfers shall be subject to appropriate checks. The laboratory shall establish standard operating procedures to ensure that (i) the reported data are free from transcription and calculation errors and (ii) all quality control measures are reviewed and evaluated before data are reported. The laboratory also shall establish standard operating procedures addressing manual calculations including manual integrations.

J. Documentation and labeling of standards and reagents. Documented procedures shall exist for the reception and storage of consumable materials used for the technical operations of the laboratory.

1. The laboratory shall retain records for all standards, reagents, reference materials, and media including the manufacturer/vendor, the manufacturer's Certificate of Analysis or purity (if available), the date of receipt, recommended storage conditions, and an expiration date after which the material shall not be used unless its reliability is verified by the laboratory.

2. Original containers (such as provided by the manufacturer or vendor) shall be labeled with an expiration date if this date is provided by the manufacturer or vendor.

3. Records shall be maintained on standard and reference material preparation. These records shall indicate traceability to purchased stocks or neat compounds, reference to the method of preparation, date of preparation, expiration date and preparer's initials.

4. Sufficient identification of containers of prepared reagents and standards shall be provided to ensure proper performance of tests.

K. Computers and electronic data related requirements. Where computers, automated equipment or microprocessors are used for the capture, processing, manipulation, recording, reporting, storage or retrieval of test data, the laboratory shall ensure the following:

1. Computer software developed by the user is documented in sufficient detail and is suitably validated as being adequate for use.

2. Procedures are established and implemented for protecting the integrity of data, such as integrity of data entry or capture, data storage, data transmission and data processing.

3. Computer and automated equipment are maintained to ensure proper functioning and provided with the environmental and operating conditions necessary to maintain the integrity of calibration and test data.

4. Appropriate procedures are established and implemented for the maintenance of security of data including the prevention of unauthorized access to, and the unauthorized amendment of, computer records.

1VAC30-45-750. Quality assurance.

A. General. The laboratory shall have quality control procedures for monitoring the validity of environmental tests undertaken. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results. This monitoring shall be planned and reviewed and may include, but not be limited to, the following:

1. Regular use of certified reference materials or internal quality control using secondary reference materials or both.

2. Participation in interlaboratory comparison or proficiency testing program.

3. Replicate tests using the same or different methods.

4. Retesting of retained samples.

5. Correlation of results for different characteristics of a sample (e.g., total phosphate should be greater than or equal to orthophosphate).

B. Essential quality control procedures. The general quality control principles in subsection C of this section shall apply, where applicable, to all environmental laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory. 1VAC30-45-770 through 1VAC30-45-775, 1VAC30-45-790 through 1VAC30-45-798, and 1VAC30-45-810 through 1VAC30-45-818 specify quality control requirements for chemical testing, microbiological testing, and air testing, respectively. Noncommercial environmental laboratories that analyze environmental samples using other types of testing such as toxicity, radiochemical, or asbestos testing shall meet the quality control standards for the specific method and the specific type of testing in the 2009 Modules 3, 6, and 7 of Volume 1 of the 2016 TNI Standards for Environmental Laboratories. The standards for any given test type shall assure that the applicable principles are addressed.

C. All laboratories shall have detailed written protocols in place to monitor the following quality controls:

1. Positive and negative controls to monitor tests such as blanks, spikes, reference toxicants.

2. Tests to define the variability or repeatability of the laboratory results or both such as replicates.

3. Measures to assure the accuracy of the test method including calibration or continuing calibrations or both, use of certified reference materials, proficiency test samples, or other measures.

4. Measures to evaluate test method capability, such as method detection limits and quantitation limits or range of applicability such as linearity.

5. Selection of appropriate formulae to reduce raw data to final results such as regression analysis, comparison to internal and external standard calculations, and statistical analyses.

6. Selection and use of reagents and standards of appropriate quality.

7. Measures to assure the selectivity of the test for its intended purpose.

8. Measures to assure constant and consistent test conditions (both instrumental and environmental) where required by the test method such as temperature, humidity, light, or specific instrument conditions.

1VAC30-45-760. Quality control requirements.

A. General.

1. The quality control protocols specified by the laboratory's SOPs shall be followed (1VAC30-45-730 C). The laboratory shall ensure that either the (i) applicable essential standards outlined in this section through 1VAC30-45-775, 1VAC30-45-790 through 1VAC30-45-798, and 1VAC30-45-810 through 1VAC30-45-818 or (ii) mandated methods or regulations, whichever are more stringent, are incorporated into their method SOPs. When it is not apparent which is more stringent, the quality controls in the mandated method or regulations are to be followed.

2. All quality control measures shall be assessed and evaluated on an ongoing basis and quality control acceptance criteria shall be used to determine the validity of the data. The laboratory shall have procedures for the development of acceptance/rejection criteria where no method or regulatory criteria exists.

B. Initial test method evaluation. For all test methods other than microbiology, the requirements of subdivisions 1 and 2 of this subsection apply. For microbiology testing, the initial test method evaluation requirements are contained in 1VAC30-45-790 through 1VAC30-45-798. For the evaluation of precision and bias (subdivision 3 of this subsection), the requirements of subdivision 3 a of this subsection apply to standard methods. The requirements of subdivision 3 b of this subsection apply to the methods referenced in that subdivision.

1. Limit of detection (LOD).

a. The laboratory shall determine the LOD for the method for each target analyte of concern in the quality system matrices. All when the testing is [ done in accordance with the federal Clean Water Act conducted ] using approved methods listed in 40 CFR Part 136 [ for a program under the federal Clean Water Act ], except when the procedure for Determination of Method Detection Limit at 40 CFR Part 136 Appendix B states the procedure is not applicable to a measurement.

b. The laboratory shall determine the LOD for the method for each target analyte of concern in the quality system matrices when test results are to be reported to the LOD (versus the limit of quantitation or working range of instrument calibration), according to 1VAC30-45-771 and 1VAC30-45-814. Where an LOD study is not performed, the laboratory may not report a value below the limit of quantitation.

c. When the LOD is required under subdivision 1 a or 1 b of this subsection, all sample processing steps of the analytical method shall be included in the determination of the LOD.

b. d. The validity of the LOD shall be confirmed as described in 40 CFR Part 136 Appendix B as applicable, or by qualitative identification of the analyte or analytes in a quality control sample in each quality system matrix containing the analyte at no more than two to three times the LOD for single analyte tests and one to four times the LOD for multiple analyte tests. This verification shall be performed on every instrument that is to be used for analysis of samples and reporting of data.

c. An LOD study is not required for any component for which spiking solutions or quality control samples are not available such as temperature, or, when test results are not to be reported to the LOD (versus the limit of quantitation or working range of instrument calibration), according to 1VAC30-45-771 and 1VAC30-45-814. Where an LOD study is not performed, the laboratory may not report a value below the limit of quantitation.

2. Limit of quantitation (LOQ).

a. The laboratory shall determine the LOQ for each analyte of concern according to a defined, documented procedure.

b. The LOQ study is not required for any component or property for which spiking solutions or quality control samples are not commercially available or otherwise inappropriate (e.g., pH).

c. The validity of the LOQ shall be confirmed by successful analysis of a QC sample containing the analytes of concern in each quality system matrix one to at a concentration at or below the LOQ or no more than two times the concentration of the claimed LOQ. A successful analysis is one where the recovery of each analyte is within the established test method acceptance criteria or client data quality objectives for accuracy. This single analysis is not required if the bias and precision of the measurement system is evaluated at the LOQ.

3. Evaluation of precision and bias.

a. Standard methods. The laboratory shall evaluate the precision and bias of a standard method for each analyte of concern for each quality system matrix according to either of the following:

(1) The single-concentration four-replicate recovery study procedures in 1VAC30-45-730 F; or

(2) An alternate procedure documented in the quality manual when the analyte cannot be spiked into the sample matrix and quality control samples are not commercially available.

b. Nonstandard methods.

(1) For laboratory-developed test methods or nonstandard test methods that were not in use by the laboratory before July 2003, the laboratory shall have a documented procedure to evaluate precision and bias. The laboratory shall also compare results of the precision and bias measurements with criteria given in the reference method or criteria established by the laboratory.

(2) Precision and bias measurements shall evaluate the method across the analytical calibration range of the method. The laboratory shall also evaluate precision and bias in the relevant quality system matrices and shall process the samples through the entire measurement system for each analyte of interest.

(3) The following are examples of a systematic approach to evaluate precision and bias:

(a) Example 1. Analyze QC samples in triplicate containing the analytes of concern at or near the limit of quantitation, at the upper-range of the calibration (upper 20%) and at a mid-range concentration. Process these samples on different days as three sets of samples through the entire measurement system for each analyte of interest. Each day one QC sample at each concentration is analyzed. A separate method blank shall be subjected to the analytical method along with the QC samples on each of the three days. (Note that the three samples at the LOQ concentration can demonstrate sensitivity as well.) For each analyte, calculate the mean recovery for each day, for each level over days, and for all nine samples. Calculate the relative standard deviation for each of the separate means obtained. Compare the standard deviations for the different days and the standard deviations for the different concentrations. If the different standard deviations are all statistically insignificant (e.g., F-test), then compare the overall mean and standard deviation with the established criteria from above.

(b) Example 2. A validation protocol such as the Tier I, Tier II, and Tier III requirements in U.S. EPA Office of Water's Alternate Test Procedure (ATP) approval process.

4. Evaluation of selectivity. The laboratory shall evaluate selectivity by following the checks established within the method. These checks may include mass spectral tuning, second column confirmation, ICP inter-element interference checks, chromatography retention time windows, sample blanks, spectrochemical absorption or fluorescence profiles, co-precipitation evaluations, and electrode response factors.

1VAC30-45-771. Chemical testing: limit of detection and limit of quantitation.

A. General. All procedures used shall be documented. Documentation shall include the quality system matrix type. All supporting data shall be retained.

B. Limit of detection (LOD). The laboratory shall utilize a test method that provides an LOD that is appropriate and relevant for the intended use of the data. An LOD is not required for a test method when test results are not reported outside of the calibration range. LOD determination and validation are required as specified by 1VAC3045-760 B 1. LODs shall be determined by the protocol in the mandated test method or applicable regulation. If the protocol for determining LODs is not specified, the selection of the procedure shall reflect instrument limitations and the intended application of the test method.

1. The LOD shall be initially determined for the compounds of interest in each test method in a quality system matrix in which there are no target analytes or interferences at a concentration that would impact the results. Alternatively the LOD shall be determined in the quality system matrix of interest (see definition of matrix).

2. LODs shall be determined each time there is a change in the test method that affects how the test is performed, or when a change in instrumentation occurs that affects the sensitivity of the analysis.

3. The LOD shall be verified annually for each quality system matrix, method and analyte according to the procedure as specified in 1VAC30-45-760 B 1.

C. Limit of quantitation (LOQ).

1. Any established LOQ shall be above the LOD.

2. The LOQ shall be verified annually for each quality system matrix, method and analyte according to the procedure specified in 1VAC30-45-760 B 2. Alternatively, the annual LOQ verification is not required if the LOD is reevaluated or verified according to subdivision B 3 of this section.

FORMS (1VAC30-45)

Application for Certification of Environmental Laboratories DGS-21-156 (eff. 1/2009) (Application for Certification Laboratories applying for certification under 1VAC30-45 must be obtained obtain the application from DCLS program staff at Lab_Cert@dgs.virginia.gov)

DOCUMENTS INCORPORATED BY REFERENCE (1VAC30-45)

The Standards for Environmental Laboratories and Accreditation Bodies, 2009 2016, The NELAC Institute (TNI), P.O. Box 2439, Weatherford, TX 76086; www.nelac-institute.org:

Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (EL-V1-2009)

Volume 2: General Requirements for Accreditation Bodies Accrediting Environmental Laboratories (EL-V2-2009)

Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (EL-V1-2016, rev. 2.1). Modules 3, 6, and 7 only

1VAC30-46-15. Standards for accreditation transition.

A. Commercial environmental laboratories are accredited under the standards of the National Environmental Laboratory Accreditation Conference (NELAC), now The NELAC Institute (TNI).

B. DCLS shall accredit commercial environmental laboratories under the 2003 NELAC 2009 TNI Standards as specified by the provisions of this chapter that became effective on January 1, 2009 November 1, 2015, for the first 10 six months following November 1, 2015 [ (insert the effective date of this chapter) April 1, 2022 ].

C. DCLS shall accredit commercial environmental laboratories under the 2009 2016 TNI Standards as specified by the provisions of this chapter effective on November 1, 2015 [ (insert the effective date of this chapter) April 1, 2022 ], beginning on the first day of the 11th seventh month following November 1, 2015 [ (insert the effective date of this chapter) April 1, 2022 ].

1VAC30-46-40. Definitions.

A. The definitions contained in the 2009 2016 TNI Standards are incorporated by reference into this section. Some of these definitions are included in this section because the terms are used throughout this chapter.

B. The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Acceptance criteria" means specified limits placed on characteristics of an item, process, or service defined in requirement documents.

"Accreditation" means the process by which an agency or organization evaluates and recognizes a laboratory as meeting certain predetermined qualifications or standards, thereby accrediting the laboratory. "Accreditation" is the term used as a substitute for the term "certification" under this chapter.

"Accreditation body" or "AB" means the territorial, state, or federal agency having responsibility and accountability for environmental laboratory accreditation and which grants accreditation.

"Algae" means simple single-celled, colonial, or multicelled, mostly aquatic plants, containing chlorophyll and lacking roots, stems and leaves that are either suspended in water (phytoplankton) or attached to rocks and other substrates (periphyton).

"Analyte" means the substance or physical property to be determined in samples examined, organism, physical parameter, or chemical constituent for which an environmental sample is being analyzed.

"Analytical method" means a technical procedure for providing analysis of a sample, defined by a body such as the Environmental Protection Agency or the American Society for Testing and Materials, that may not include the sample preparation method.

"Assessment" means the evaluation process used to measure or establish the performance, effectiveness, and conformance of an organization and its systems or both to defined criteria (i.e., to the standards and requirements of laboratory accreditation).

"Assessor" means the person assigned by DCLS to perform, alone or as part of an assessment team, an assessment of an environmental laboratory.

"Authority" means, in the context of a governmental body or local government, an authority created under the provisions of the Virginia Water and Waste Authorities Act, Chapter 51 (§ 15.2-5100 et seq.) of Title 15.2 of the Code of Virginia.

"Benthic macroinvertebrates" means bottom dwelling animals without backbones that live at least part of their life cycles within or upon available substrates within a body of water.

"Commercial environmental laboratory" means an environmental laboratory where environmental analysis is performed for another person.

"Corrective action" means the action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent recurrence.

"DCLS" means the Division of Consolidated Laboratory Services of the Department of General Services.

"Environmental analysis" or "environmental analyses" means any test, analysis, measurement, or monitoring used for the purposes of the Virginia Air Pollution Control Law, the Virginia Waste Management Act or the State Water Control Law (§ 10.1-1300 et seq., § 10.1-1400 et seq., and § 62.1-44.2 et seq., respectively, of the Code of Virginia). For the purposes of these regulations, any test, analysis, measurement, or monitoring required pursuant to the regulations promulgated under these three laws, or by any permit or order issued under the authority of any of these laws or regulations is "used for the purposes" of these laws. The term shall not include the following:

1. Sampling of water, solid and chemical materials, biological tissue, or air and emissions.

2. Field testing and measurement of water, solid and chemical materials, biological tissue, or air and emissions, except when performed in an environmental laboratory rather than at the site where the sample was taken.

3. Taxonomic identification of samples for which there is no national accreditation standard such as algae, benthic macroinvertebrates, macrophytes, vertebrates, and zooplankton.

4. Protocols used pursuant to § 10.1-104.2 of the Code of Virginia to determine soil fertility, animal manure nutrient content, or plant tissue nutrient uptake for the purposes of nutrient management.

5. Geochemical and permeability testing for solid waste compliance.

6. Materials specification for air quality compliance when product certifications specify the data required by an air permit such as fuel type, Btu content, sulfur content, or volatile organic chemical (VOC) content.

"Environmental laboratory" or "laboratory" means a facility or a defined area within a facility where environmental analysis is performed. A structure built solely to shelter field personnel and equipment from inclement weather shall not be considered an environmental laboratory.

"Establishment date" means the date set for the accreditation program under this chapter and the certification program under 1VAC30-45 to be established.

"Establishment of accreditation program" or "established program" means that DCLS has completed the initial accreditation of environmental laboratories covered by this chapter and the initial certification of environmental laboratories covered by 1VAC30-45.

"Facility" means something that is built or installed to serve a particular function.

"Field of accreditation" means those matrix, technology/method, and analyte combinations for which DCLS offers accreditation.

"Field of accreditation matrix" means the following when accrediting a laboratory:

1. Drinking water. Any aqueous sample that has been designated a potable or potential potable water source.

2. Nonpotable water. Any aqueous sample excluded from the definition of drinking water matrix. Includes surface water, groundwater, effluents, water treatment chemicals, and TCLP or other extracts.

3. Solid and chemical materials. Includes soils, sediments, sludges, products and byproducts of an industrial process that results in a matrix not previously defined.

4. Biological tissue. Any sample of a biological origin such as fish tissue, shellfish, or plant material. Such samples shall be grouped according to origin (i.e., by species).

5. Air and emissions. Whole gas or vapor samples including those contained in flexible or rigid wall containers and the extracted concentrated analytes of interest from a gas or vapor that are collected with a sorbent tube, impinger solution, filter or other device.

"Field of proficiency testing" or "FoPT" means analytes for which a laboratory is required to successfully analyze a PT sample in order to obtain or maintain accreditation, collectively defined as: the matrix, technology/method, and analyte combinations for which the composition spike concentration ranges and acceptance criteria have been established by the Proficiency Testing Program Executive Committee of TNI.

"Field testing and measurement" means any of the following:

1. Any test for parameters under 40 CFR Part 136 for which the holding time indicated for the sample requires immediate analysis; or

2. Any test defined as a field test in federal regulation.

The following is a limited list of currently recognized field tests or measures that is not intended to be inclusive: continuous emissions monitoring; online monitoring; flow monitoring; tests for pH, residual chlorine, temperature and dissolved oxygen; and field analysis for soil gas.

"Finding" means an assessment conclusion referenced to a laboratory accreditation standard incorporated by reference or contained in this chapter and supported by objective evidence that identifies a deviation from a laboratory accreditation standard requirement.

"Governmental body" means any department, agency, bureau, authority, or district of the United States government, of the government of the Commonwealth of Virginia, or of any local government within the Commonwealth of Virginia.

"Holding time" means the maximum time that can elapse between two specified activities.

"Legal entity" means an entity, other than a natural person, who has sufficient existence in legal contemplation that it can function legally, be sued or sue and make decisions through agents as in the case of corporations.

"Local government" means a municipality (city or town), county, sanitation district, or authority.

"Macrophytes" means any aquatic or terrestrial plant species that can be identified and observed with the eye, unaided by magnification.

"Matrix" means the substrate of a test sample.

"National Environmental Laboratory Accreditation Conference (NELAC)" or "NELAC" means a voluntary organization of state and federal environmental officials and interest groups with the primary purpose to establish mutually acceptable standards for accrediting environmental laboratories. NELAC preceded the formation of The NELAC Institute or TNI.

"National Environmental Laboratory Accreditation Program" or "NELAP" means the program under TNI the purpose of which is to establish and implement a program for the accreditation of environmental laboratories. This program is comprised in part of NELAP Accreditation Bodies which are recognized and approved under the program to implement the TNI standards. The NELAP accreditation bodies currently are state programs such as the one in Virginia.

"Noncommercial environmental laboratory" means either of the following:

1. An environmental laboratory where environmental analysis is performed solely for the owner of the laboratory.

2. An environmental laboratory where the only performance of environmental analysis for another person is one of the following:

a. Environmental analysis performed by an environmental laboratory owned by a local government for an owner of a small wastewater treatment system treating domestic sewage at a flow rate of less than or equal to 1,000 gallons per day.

b. Environmental analysis performed by an environmental laboratory operated by a corporation as part of a general contract issued by a local government to operate and maintain a wastewater treatment system or a waterworks.

c. Environmental analysis performed by an environmental laboratory owned by a corporation as part of the prequalification process or to confirm the identity or characteristics of material supplied by a potential or existing customer or generator as required by a hazardous waste management permit under 9VAC20-60.

d. Environmental analysis performed by an environmental laboratory owned by a Publicly Owned Treatment Works (POTW) for an industrial source of wastewater under a permit issued by the POTW to the industrial source as part of the requirements of a pretreatment program under Part VII (9VAC25-31-730 et seq.) of 9VAC25-31.

e. Environmental analysis performed by an environmental laboratory owned by a county authority for any municipality within the county's geographic jurisdiction when the environmental analysis pertains solely to the purpose for which the authority was created.

f. Environmental analysis performed by an environmental laboratory owned by an authority or a sanitation district for any participating local government of the authority or sanitation district when the environmental analysis pertains solely to the purpose for which the authority or sanitation district was created.

"Owner" means any person who owns, operates, leases, or controls an environmental laboratory.

"Person" means an individual, corporation, partnership, association, company, business, trust, joint venture or other legal entity.

"Physical," for the purposes of fee test categories, means the tests to determine the physical properties of a sample. Tests for solids, turbidity, and color are examples of physical tests.

"Pretreatment requirements" means any requirements arising under Part VII (9VAC25-31-730 et seq.) of 9VAC25-31 including the duty to allow or carry out inspections, entry, or monitoring activities; any rules, regulations, or orders issued by the owner of a POTW; or any reporting requirements imposed by the owner of a POTW or by the regulations of the State Water Control Board. Pretreatment requirements do not include the requirements of a national pretreatment standard.

"Primary accreditation body" or "primary AB" means the accreditation body responsible for assessing a laboratory's total quality system, on-site assessment, and PT performance tracking for fields of accreditation.

"Proficiency test," "proficiency testing," or "PT" means evaluating a process to evaluate a laboratory's performance under controlled conditions relative to a given set of criteria through analysis of unknown samples provided by an external source.

"Proficiency test sample" or "PT sample" means a sample, the composition of which is unknown to the laboratory and is provided to test whether the laboratory can produce analytical results within specified acceptance criteria.

"Proficiency testing program" or "PT program" means the aggregate of providing rigorously controlled and standardized environmental samples to a laboratory for analysis, reporting of results, statistical evaluation of the results and the collective demographics and results summary of all participating laboratories.

"Publicly Owned Treatment Works" or "POTW" means a treatment works as defined by § 212 of the CWA, which is owned by a state or municipality (as defined by § 502(4) of the CWA). This definition includes any devices and systems used in the storage, treatment, recycling, and reclamation of municipal sewage or industrial wastes of a liquid nature. It also includes sewers, pipes, and other conveyances only if they convey wastewater to a POTW treatment plant. The term also means the municipality as defined in § 502(4) of the CWA, which has jurisdiction over the indirect discharges to and the discharges from such a treatment works.

"Quality assurance" or "QA" means an integrated system of management activities involving planning, implementation, assessment, reporting, and quality improvement to ensure that a process, item, or service is of the type and quality needed and expected by the client.

"Quality assurance officer" means the person who has responsibility for the quality system and its implementation. Where staffing is limited, the quality assurance officer may also be the technical manager.

"Quality control" or "QC" means the (i) overall system of technical activities that measures the attributes and performance of a process, item, or service against defined standards to verify that they meet the stated requirements established by the customer; (ii) operational techniques and activities that are used to fulfill requirements for quality; and (iii) system of activities and checks used to ensure that measurement systems are maintained within prescribed limits, providing protection against "out of control" conditions and ensuring that the results are of acceptable quality.

"Quality manual" means a document stating the management policies, objectives, principles, organizational structure and authority, responsibilities, accountability, and implementation of an agency, organization, or laboratory, to ensure the quality of its product and the utility of its product to its users.

"Quality system" means a structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The quality system provides the framework for planning, implementing, and assessing work performed by the organization and for carrying out required quality assurance and quality control activities.

"Quality system matrix," for purposes of batch and quality control requirements, means the following:

1. Air and emissions. Whole gas or vapor samples, including those contained in flexible or rigid wall containers and the extracted concentrated analytes of interest from a gas or vapor that are collected with a sorbent tube, impinger solution, filter, or other device.

2. Aqueous. Any aqueous sample excluded from the definition of drinking water matrix or saline/estuarine source. Includes surface water, groundwater, effluents, and TCLP or other extracts.

3. Biological tissue. Any sample of a biological origin such as fish tissue, shellfish, or plant material. Such samples shall be grouped according to origin.

4. Chemical waste. A product or byproduct of an industrial process that results in a matrix not previously defined.

5. Drinking water. Any aqueous sample that has been designated a potable or potential potable water source.

6. Non-aqueous liquid. Any organic liquid with less than 15% settleable solids.

7. Saline/estuarine. Any aqueous sample from an ocean or estuary, or other salt water source such as the Great Salt Lake.

8. Solids. Includes soils, sediments, sludges, and other matrices with more than 15% settleable solids.

"Responsible official" means one of the following, as appropriate:

1. If the laboratory is owned or operated by a private corporation, "responsible official" means (i) a president, secretary, treasurer, or a vice-president of the corporation in charge of a principal business function, or any other person who performs similar policy-making or decision-making functions for the corporation or (ii) the manager of one or more manufacturing, production, or operating facilities employing more than 250 persons or having gross annual sales or expenditures exceeding $25 million (in second-quarter 1980 dollars), if authority to sign documents has been assigned or delegated in accordance with corporate procedures.

2. If the laboratory is owned or operated by a partnership, association, or a sole proprietor, "responsible official" means a general partner, officer of the association, or the proprietor, respectively.

3. If the laboratory is owned or operated by a governmental body, "responsible official" means a director or highest official appointed or designated to oversee the operation and performance of the activities of the governmental laboratory.

4. Any person designated as the responsible official by an individual described in subdivision 1, 2, or 3 of this definition provided the designation is in writing, the designation specifies an individual or position with responsibility for the overall operation of the laboratory, and the designation is submitted to DCLS.

"Sampling" means the act of collection for the purpose of analysis an activity related to obtaining a representative sample of the object of conformity assessment, according to a procedure.

"Sanitation district" means a sanitation district created under the provisions of Chapters 3 (§ 21-141 et seq.) through 5 (§ 21-291 et seq.) of Title 21 of the Code of Virginia.

"Secondary accreditation body" or "secondary AB" means the accreditation body that grants TNI accreditation to laboratories based on their accreditation by a TNI-recognized primary accreditation body laboratory accreditation for a field of accreditation based on recognition of accreditation from a primary accreditation body for the same field of accreditation.

"Sewage" means the water-carried human wastes from residences, buildings, industrial establishments, or other places together with such industrial wastes and underground, surface, storm, or other water as may be present.

"Standard operating procedure" or "SOP" means a written document that details the method for an operation, analysis, or action with thoroughly prescribed techniques and steps. An SOP is officially approved as the method for performing certain routine or repetitive tasks.

"TCLP" or "toxicity characteristic leachate procedure" means Test Method 1311 in "Test Methods for Evaluating Solid Waste, Physical/Chemical Methods," EPA Publication SW-846, as incorporated by reference in 40 CFR 260.11. This method is used to determine whether a solid waste exhibits the characteristic of toxicity (see 40 CFR 261.24).

"Technical manager (however named)" means the person who has overall responsibility for the technical operation of the environmental laboratory and who exercises actual day-to-day supervision of laboratory operation for the appropriate fields of testing and reporting of results. The title of this person may include but is not limited to laboratory director, technical manager, laboratory supervisor, or laboratory manager.

"Technology" means a specific arrangement of analytical instruments, detection systems, or preparation techniques, or any combination of these elements.

"Test" means a technical operation that consists of the determination of one or more characteristics or performance of a given product, material, equipment, organism, physical phenomenon, process, or service according to a specified procedure.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Air Pollution Control Law" means any method of analysis required by the Virginia Air Pollution Control Law (§ 10.1-1300 et seq. of the Code of Virginia); by the regulations promulgated under this law (9VAC5), including any method of analysis listed either in the definition of "reference method" in 9VAC5-10-20, or listed or adopted by reference in 9VAC5; or by any permit or order issued under and in accordance with this law and these regulations.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Waste Management Act" means any method of analysis required by the Virginia Waste Management Act (§ 10.1-1400 et seq. of the Code of Virginia); by the regulations promulgated under this law (9VAC20), including any method of analysis listed or adopted by reference in 9VAC20; or by any permit or order issued under and in accordance with this law and these regulations.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Water Control Law" means any method of analysis required by the Virginia Water Control Law (§ 62.1-44.2 et seq. of the Code of Virginia); by the regulations promulgated under this law (9VAC25), including any method of analysis listed or adopted by reference in 9VAC25; or by any permit or order issued under and in accordance with this law and these regulations.

"Test method" means an adoption of a scientific technique for performing a specific measurement, as documented in a laboratory standard operating procedure or as published by a recognized authority.

"The NELAC Institute (TNI)" or "TNI" means the organization whose standards environmental laboratories must meet to be accredited in Virginia.

"TNI standards" means the 2009 2016 Standards for Environmental Laboratories and Accreditation Bodies approved by TNI.

"Virginia Air Pollution Control Law" means Chapter 13 (§ 10.1-1300 et seq.) of Title 10.1 of the Code of Virginia that is titled "Air Pollution Control Board."

"Virginia Environmental Laboratory Accreditation Program" or "VELAP" means the program DCLS operates to accredit environmental laboratories under this chapter.

"Wastewater" means liquid and water-carried industrial wastes and domestic sewage from residential dwellings, commercial buildings, industrial and manufacturing facilities, and institutions.

"Waterworks" means each system of structures and appliances used in connection with the collection, storage, purification, and treatment of water for drinking or domestic use and the distribution thereof to the public, except distribution piping.

"Zooplankton" means microscopic animals that float freely with voluntary movement in a body of water.

1VAC30-46-70. Process to apply and obtain accreditation.

A. Duty to apply. All owners of (i) commercial environmental laboratories and (ii) TNI-accredited commercial environmental laboratories applying for secondary accreditation shall apply for accreditation as specified by the provisions of this section. Applications for accreditation must be obtained from DCLS program staff by email at Lab_Cert@dgs.virginia.gov.

B. Initial applications. Owners of commercial environmental laboratories applying for accreditation under this chapter for the first time shall submit an application to DCLS as specified under subsection F of this section.

C. Renewal and reassessment.

1. DCLS shall renew accreditation annually for the accredited laboratory provided the laboratory does the following:

a. Maintains compliance with this chapter.

b. Attests to this compliance by signing the certificate of compliance provided under subdivision F 3 of this section.

c. Reports acceptable proficiency test values as required by 1VAC30-46-210 B.

d. Pays the fee required by 1VAC30-46-150.

2. DCLS shall reassess the accredited environmental laboratory during an on-site assessment as required by 1VAC30-46-220.

D. Responsibilities of the owner and operator when the laboratory is owned by one person and operated by another person.

1. When an environmental laboratory is owned by one person but is operated by another person, the operator may submit the application for the owner.

2. If the operator fails to submit the application, the owner is not relieved of his responsibility to apply for accreditation.

3. While DCLS may notify environmental laboratories of the date their applications are due, failure of DCLS to notify does not relieve the owner of his obligation to apply under this chapter.

E. Submission of applications for modifications to accreditation. An owner of an accredited environmental laboratory shall follow the process set out in 1VAC30-46-90 B to modify the laboratory's scope of accreditation.

F. Contents of application.

1. Applications shall include but not be limited to the following information and documents:

a. Legal name of laboratory;

b. Name of owner of laboratory;

c. Name of operator of laboratory, if different than owner;

d. Street address and description of location of laboratory;

e. Mailing address of laboratory, if different from street address;

f. Address of owner, if different from laboratory address;

g. Name, address, telephone number, facsimile number, and email, as applicable, of responsible official;

h. Name, address, telephone number, facsimile number, and email, as applicable, of technical manager;

i. Name, address, telephone number, facsimile number, and email, as applicable, of designated quality assurance officer;

j. Name and telephone number of laboratory contact person;

k. Laboratory type (e.g., commercial, public wastewater system, mobile);

l. Laboratory hours of operation;

m. Fields of accreditation for which the laboratory is seeking accreditation;

n. The results of two successful unique TNI-compliant PT studies for each accreditation field of proficiency testing as required by 1VAC30-46-210 B (for primary accreditation only);

o. Quality assurance manual (for primary accreditation only);

p. Copy of the primary certificate of accreditation for secondary accreditation applications; and

q. For mobile laboratories, a unique vehicle identification number, such as a manufacturer's vehicle identification number (VIN #), serial number, or license number.

2. Fee. The application shall include payment of the fee as specified in 1VAC30-46-150.

3. Certification of compliance.

a. The application shall include a "Certification of Compliance" statement signed and dated by (i) the quality assurance officer, and (ii) the responsible official or the technical manager, or both.

b. The certification of compliance shall state: "The applicant understands and acknowledges that the laboratory is required to be continually in compliance with the Virginia environmental laboratory accreditation program regulation (1VAC30 Chapter 46) and is subject to the provisions of 1VAC30-46-100 in the event of noncompliance. Specifically the applicant:

(1) Shall commit to fulfill continually the requirements for accreditation set by DCLS for the areas where accreditation is sought or granted.

(2) When requested, shall afford such accommodation and cooperation as is necessary to enable DCLS to verify fulfillment of requirements for accreditation. This applies to all premises where laboratory services take place.

(3) Shall provide access to information, documents, and records as necessary for the assessment and maintenance of the accreditation.

(4) Shall provide access to those documents that provide insight into the level of independence and impartiality of the laboratory from its related bodies, where applicable.

(5) Shall arrange the witnessing of laboratory services when requested by DCLS.

(6) Shall claim accreditation only with respect to the scope for which it has been granted accreditation.

(7) Shall pay fees as shall be determined by the accreditation body.

(8) Shall have access to a copy of the TNI standards incorporated by reference into this chapter.

I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate the information submitted. Based on my inquiry of the person or persons who manage the laboratory or those persons directly responsible for gathering and evaluating the information, the information submitted is, to the best of my knowledge and belief, true, accurate and complete. Submitting false information or data shall result in denial or withdrawal of accreditation. I further certify that I am authorized to sign this application."

G. Completeness determination.

1. DCLS shall determine whether an application is complete and notify the laboratory of the result of such determination. DCLS shall provide this notice within 90 calendar days of its receipt of the application.

2. An application shall be determined complete if it contains all the information required pursuant to subsection F of this section and is sufficient to evaluate the laboratory prior to the on-site assessment. Designating an application complete does not preclude DCLS from requesting or accepting additional information.

3. If DCLS determines that an application is incomplete, the DCLS notification of such determination shall explain why the application is incomplete and specify the additional information needed to make the application complete.

4. If DCLS makes no determination within 90 calendar days of its receipt of either (i) the application or (ii) additional information, in the case of an application determined to be incomplete, the application shall be determined to be complete.

5. If the laboratory has not submitted the required additional information within 90 days of receiving a notice from DCLS requesting additional information, DCLS may inform the laboratory that the application cannot be processed. The laboratory may then submit a new application.

H. Grant of interim accreditation pending final determination on application.

1. DCLS shall grant interim accreditation status to laboratories applying initially under the following conditions:

a. The laboratory's application is determined to be complete;

b. The laboratory has satisfied all the requirements for accreditation, including all requests for additional information, with the exception of on-site assessment; and

c. DCLS is unable to schedule the on-site assessment within 120 days of its determination that the application is complete.

2. A laboratory with interim accreditation status shall have the same rights and status as a laboratory that has been granted accreditation by DCLS.

3. Interim accreditation status shall not exceed 12 months.

I. On-site assessment. An on-site assessment shall be performed and the follow-up and reporting procedures for such assessments shall be completed in accordance with 1VAC30-46-220 prior to issuance of a final determination on accreditation.

J. Final determination on accreditation. Upon completion of the accreditation review process and corrective action, if any, DCLS shall grant accreditation in accordance with subsection K of this section or deny accreditation in accordance with subsection L of this section.

K. Grant of accreditation.

1. When a laboratory meets the requirements specified for receiving accreditation, DCLS shall issue a certificate to the laboratory. The certificate shall be sent to the technical manager, and the responsible official shall be notified.

2. The director of DCLS or his designee shall sign the certificate.

3. The certificate shall include the following information:

a. Name of owner of laboratory;

b. Name of operator of laboratory, if different from owner;

c. Name of responsible official;

d. Address and location of laboratory;

e. Laboratory identification number;

f. Fields of accreditation (matrix, technology/method, and analyte) for which accreditation is granted;

g. Any addenda or attachments; and

h. Issuance date and expiration date.

4. TNI accreditation status.

a. Laboratories accredited under this chapter are accredited under the standards of TNI.

b. The certificate of accreditation shall contain the TNI insignia.

c. Accredited laboratories shall comply with the provisions of 1VAC30-46-130 with regard to the use of these certificates and their status as TNI-accredited laboratories.

5. The laboratory shall post the most recent certificate of accreditation and any addenda to the certificate issued by DCLS in a prominent place in the laboratory facility.

6. Accreditation shall expire one year after the date on which accreditation is granted.

L. Denial of accreditation.

1. DCLS shall deny accreditation to an environmental laboratory in total if the laboratory is found to be falsifying any data or providing false information to support accreditation.

2. Denial of accreditation in total or in part.

a. DCLS may deny accreditation to an environmental laboratory in total or in part if the laboratory fails to do any of the following:

(1) Pay the required fees;

(2) Employ laboratory staff to meet the personnel qualifications as required by 1VAC30-46-210 A;

(3) Successfully analyze and report proficiency testing samples as required by 1VAC30-46-210 B;

(4) Submit a corrective action plan in accordance with 1VAC30-46-220 in response to a deficiency report from the on-site assessment team within the required 30 calendar days;

(5) Implement the corrective actions detailed in the corrective action plan within the time frame specified by DCLS;

(6) Pass required on-site assessment as specified in 1VAC30-46-220; or

(7) Implement a quality system as defined in 1VAC30-46-210 C.

b. DCLS may deny accreditation to an environmental laboratory in total or in part if the laboratory's application is not determined to be complete within 90 days following notification of incompleteness because the laboratory is delinquent in submitting information required by DCLS in accordance with this chapter.

c. DCLS may deny accreditation to an environmental laboratory in total or in part if the DCLS on-site assessment team is unable to carry out the on-site assessment pursuant to 1VAC30-46-220 because a representative of the environmental laboratory denied the team entry during the laboratory's normal business hours that it specified in the laboratory application.

3. DCLS shall follow the process specified in 1VAC30-46-110 when denying accreditation to an environmental laboratory.

M. Reapplication following denial of accreditation. DCLS shall not waive application fees for a laboratory reapplying for accreditation.

1VAC30-46-95. Suspension of accreditation.

A. Before withdrawing accreditation, DCLS may suspend accreditation from an environmental laboratory in total or in part to allow the laboratory time to correct the reason for which DCLS may withdraw accreditation. Suspension is limited to the reasons listed in subsection B of this section.

B. DCLS may suspend accreditation from an environmental laboratory in part or in total when the laboratory has failed to do any of the following:

1. Participate in the proficiency testing program as required by 1VAC30-46-210 B.

2. Complete proficiency testing studies and maintain a history of at least two successful proficiency testing studies for each accredited field of testing out of the three most recent proficiency testing studies as defined in 1VAC30-46-210 B.

3. Submit an acceptable corrective action plan after two opportunities as specified in 1VAC30-46-220 L.

4. Maintain a quality system as defined in 1VAC30-46-210 C.

4. 5. Employ staff that meets the personnel qualifications of 1VAC30-46-210 A.

5. 6. Notify DCLS of any changes in key accreditation criteria as set forth in 1VAC30-46-90.

C. Process to suspend accreditation.

1. When DCLS determines that cause exists to suspend a laboratory, the agency shall send notification to the responsible official and the technical manager stating the agency's determination that the laboratory has failed to meet the 1VAC30-46 standards for one or more of the reasons listed in subsection B of this section. DCLS shall send the notification by certified mail.

2. In its notice, DCLS shall request the laboratory to notify DCLS in writing if the laboratory believes the agency is incorrect in its determination.

3. The notification shall state that the laboratory is required to take corrective action whenever a failure occurs and to document the corrective action. The notification shall require the laboratory to provide DCLS with documentation of the corrective action taken with regard to its failure to meet a standard under this chapter.

4. The notification shall state what the laboratory is required to do to restore its accreditation status and the time allowed to do so.

5. The environmental laboratory may proceed to correct the deficiencies for which DCLS has suspended the laboratory's accreditation.

6. Alternatively the laboratory may state in writing that DCLS is incorrect in its determination regarding suspension, giving specific reasons why the laboratory believes DCLS should not suspend accreditation.

7. With the exception of subdivision B 4 of this section, DCLS may allow the laboratory up to 60 days to correct the problem for which it may have its accreditation suspended.

8. DCLS shall set a date for suspension that follows the period provided under subdivision 7 of this subsection to restore accreditation.

9. If the laboratory does not correct its deficiencies within the time period allowed, DCLS shall suspend a laboratory in part or in total.

10. DCLS shall notify the laboratory by letter of its suspension status. DCLS shall send the notification by certified mail. DCLS shall also notify the pertinent Virginia state agency of the laboratory's suspension status.

11. The laboratory may provide information demonstrating why suspension is not warranted in accordance with the standard referenced in the initial DCLS notification. If such information is not provided prior to the suspension date, the laboratory accepts the DCLS decision to suspend.

12. The laboratory has the right to due process as set forth in 1VAC30-46-110.

D. Responsibilities of the environmental laboratory and DCLS when accreditation has been suspended.

1. The term of suspension shall be limited to six months or the period of accreditation whichever is longer.

2. The environmental laboratory shall not continue to analyze samples or report analysis for the fields of accreditation for which DCLS has suspended accreditation.

3. The environmental laboratory shall retain accreditation for the fields of accreditation, methods, and analytes where it continues to meet the requirements of this chapter.

4. The laboratory's suspended accreditation status shall change to accredited when the laboratory demonstrates to DCLS that the laboratory has corrected the deficiency or deficiencies for which its accreditation was suspended.

5. An environmental laboratory with suspended accreditation shall not have to reapply for accreditation if the cause or causes for suspension are corrected within the term of suspension.

6. An environmental laboratory that DCLS has suspended in total shall pay the cost of any necessary follow-up on-site assessments or data review or both to determine compliance. This cost shall be calculated under the provisions of 1VAC30-46-150 E and F.

7. If the laboratory fails to correct the causes of suspension within the term of suspension, DCLS shall withdraw the laboratory's accreditation in total or in part.

1VAC30-46-100. Withdrawal of accreditation.

A. DCLS shall withdraw accreditation from an environmental laboratory in total if the laboratory is found to be falsifying any data or providing false information to support accreditation.

B. DCLS may withdraw accreditation from an environmental laboratory in part or in total when the laboratory has failed to do any of the following:

1. Participate in the proficiency testing program as required by 1VAC30-46-210 B.

2. Complete proficiency testing studies and maintain a history of at least two successful proficiency testing studies for each affected accredited field of testing out of the three most recent proficiency testing studies as defined in 1VAC30-46-210 B.

[ 3. Successfully complete three consecutive PT studies, either by failure to participate in the required PT study or by failure to obtain acceptable results for the same field of accreditation. ]

[ 4. 3. ] Maintain a quality system as defined in 1VAC30-46-210 C.

[ 4. 5. ] Employ staff that meets the personnel qualifications of 1VAC30-46-210 A.

[ 5. 6. ] Submit an acceptable corrective action plan after two opportunities as specified in 1VAC30-46-220.

[ 6. 7. ] Implement corrective action specified in the laboratory's corrective action plan as set out under 1VAC30-46-220.

[ 7. 8. ] Correct the causes of suspension within the term of suspension.

[ 9. 8. ] Notify DCLS of any changes in key accreditation criteria as set forth in 1VAC30-46-90.

[ 8. 10. 9. ] Use correct and authorized references to the laboratory's accreditation status or that of DCLS in the laboratory's documentation and advertising as set forth in 1VAC30-46-130.

[ 9. 11. 10. ] Allow a DCLS assessment team entry during normal business hours to conduct an on-site assessment required by 1VAC30-46-220.

[ 10. 12. 11. ] Pay required fees specified in 1VAC30-46-150.

[ 13. 12. ] Meet the provisions regarding communication with others in Volume 1, Module 1, Section 4.1.5 of the 2016 TNI Standards.

C. [ DCLS may withdraw accreditation from an environmental laboratory in part or in total when the laboratory has failed three consecutive proficiency testing studies for the same field of accreditation either by failure to participate in the proficiency testing study or by failure to obtain acceptable results.

D. ] DCLS shall follow the process specified in 1VAC30-46-110 when withdrawing accreditation from an environmental laboratory.

[ D. E. ] Responsibilities of the environmental laboratory and DCLS when accreditation has been withdrawn.

1. Laboratories that lose their accreditation in full shall return their certificate to DCLS.

2. If a laboratory loses accreditation in part, DCLS shall issue a revised certificate to the laboratory.

3. The laboratory shall discontinue the use of all materials that contain either a reference to the environmental laboratory's past accreditation status or that display the TNI logo. These materials may include catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical reports, or other materials.

4. The environmental laboratory shall not continue to analyze samples or report analyses for the fields of accreditation for which DCLS has withdrawn accreditation.

[ E. F. ] After correcting the reason or cause for the withdrawal of accreditation under 1VAC30-46-100 A or B, the laboratory owner may reapply for accreditation under 1VAC30-46-70 B and E.

1VAC30-46-140. Secondary accreditation.

A. DCLS may grant secondary accreditation to an environmental laboratory that holds a current accreditation from another TNI-recognized NELAP-recognized primary accreditation body.

B. The owner of a TNI-accredited environmental laboratory that seeks accreditation under this chapter shall apply as specified in 1VAC30-46-70 with the exception of 1VAC30-46-70 F 1 n and o.

C. The owner of the applicant laboratory shall pay the fee required by 1VAC30-46-150.

D. DCLS shall not require a TNI-accredited environmental laboratory that seeks accreditation under this section to meet any additional proficiency testing, quality assurance, or on-site assessment requirements for the fields of accreditation for which the laboratory holds primary TNI accreditation.

E. DCLS shall consider only the current certificate of accreditation issued by the TNI-recognized primary accreditation body.

F. DCLS shall grant secondary accreditation for only the fields of accreditation offered under this chapter for which the laboratory holds current primary TNI accreditation.

1VAC30-46-150. Fees.

A. General.

1. Environmental laboratories shall pay a fee with all applications, including reapplications, for accreditation. DCLS shall not designate an application as complete until it receives payment of the fee.

2. Each accredited environmental laboratory shall pay an annual fee to maintain its accreditation. DCLS shall send an invoice to the accredited environmental laboratory.

3. An environmental laboratory applying for secondary accreditation under 1VAC30-46-140 shall pay the same fee as other laboratories subject to this chapter.

4. Fees shall be nonrefundable.

5. DCLS, as part of its regular budgetary review of the program, shall determine whether the fees charged under this section offset the program costs as required under § 2.2-1105 of the Code of Virginia.

B. Fee computation.

1. Fees shall be applied on an annual basis.

2. Environmental laboratories shall pay the total of the base fee and the test category fees set out in subsections C and D of this section.

C. Base fee.

1. DCLS determines the base fee for a laboratory by taking into account both the total number of methods and the total number of field of accreditation matrices for which the laboratory would be accredited.

2. DCLS shall charge the base fees set out in Table 1. The base fee for a laboratory is located by first finding the row for the total number of methods to be accredited and then finding the box on that row located in the column headed by the total number of matrices to be accredited. For example, DCLS charges a base fee of $1625 to a laboratory performing a total of eight methods for one matrix.

TABLE 1: BASE FEES
Number of Methods	One Matrix	Two Matrices	Three Matrices	Four or more Matrices
1 - 9	$1625	$1788	$1969	$2163
10 - 29	$1750	$1969	$2188	$2438
30 - 99	$1938	$2281	$2688	$3188
100 - 149	$2063	$2475	$2969	$3563
150+	$2250	$2813	$3531	$4406

D. Test category fees.

1. The test category fees cover the types of testing for which a laboratory may be accredited as specified in the laboratory's application or as accredited at the time of annual billing.

2. Fees shall be charged for each category of tests to be accredited.

3. Fees shall be charged for the total number of field of accreditation matrices to be accredited under the specific test category. For example, if a laboratory is performing inorganic chemistry for both nonpotable water and solid and chemical matrices, the fee for this test category would be found in the column for two matrices.

4. The fee for each category includes one or more analytical methods unless otherwise specified.

5. Test category fees. DCLS shall charge the test category fees set out in Table 2. The test category fees for a laboratory are located by first finding the row with the total number of test methods for the test category to be accredited. The fee to be charged for the test category will be found on that row in the column headed by the total number of matrices to be accredited. A laboratory performing four test methods for bacteriology in both nonpotable and drinking water (two matrices) would be charged a test category fee of $413.

TABLE 2: TEST CATEGORY FEES
	Fees by Number of Matrices
Test Category	One	Two		Three or More
Aquatic toxicity, acute methods only	$740	N/A		N/A
Aquatic toxicity, acute and chronic methods	$990	N/A		N/A
Oxygen demand	$281	$419		$544
Bacteriology, 1 - 3 total methods	$219	$331		$431
Bacteriology, 4 or more total methods	$275	$413		$538
Physical, 1 - 5 total methods	$219	$331		$431
Physical, 6 - 10 total methods	$275	$413		$538
Physical, 11 or more total methods	$344	$519		$675
Inorganic chemistry, 1 - 10 total methods	$313	$469		$613
Inorganic chemistry, 11 - 20 total methods	$394	$594		$775
Inorganic chemistry, 21 - 49 total methods	$493	$738		$959
Inorganic chemistry, 50 or more total methods	$615	$925		$1203
Chemistry metals, 1 - 5 total methods	$406	$613		$796
Chemistry metals, 6 - 20 total methods	$513	$769		$1000
Chemistry metals, 21 or more total methods	$640	$963		$1250
Organic chemistry, 1 - 5 total methods	$1020	$1270		$1495
Organic chemistry, 6 - 20 total methods	$1145	$1458		$1739
Organic chemistry, 21 - 40 total methods	$1301	$1695		$2048
Organic chemistry, 41 or more total methods	$1495	$1983		$2420
Radiochemical, 1 - 10 total methods	$990	$1365		$1703
Radiochemical, 11 or more total methods	$1146	$1603		$2015
Asbestos	$1146	$1603		$2015

6. Fee examples. Three examples are provided.

a. Example 1:

Base Fee	One matrix and four test methods	$1625
Test Category Fees
One Matrix
Nonpotable Water	Bacteriology (2 methods)	$219
Nonpotable Water	Oxygen demand (1 method)	$281
Nonpotable Water	Physical (1 method)	$219
TOTAL		$2344

b. Example 2:

Base Fee	One matrix and 15 test methods	$1750
Test Category Fees
One Matrix
Nonpotable Water	Bacteriology (2 methods)	$219
Nonpotable Water	Inorganic chemistry (9 methods)	$313
Nonpotable Water	Metals (2 methods)	$406
Nonpotable Water	Oxygen demand (1 method)	$281
Nonpotable Water	Physical (1 method)	$219
TOTAL		$3188

c. Example 3:

Base Fee	Two matrices and 27 test methods	$1969
Test Category Fees
One Matrix
Nonpotable Water	Bacteriology (4 methods)	$275
Nonpotable Water	Oxygen demand (1 method)	$281
Solid and Chemical Materials	Metals (1 method)	$406
Two Matrices
Nonpotable Water and Solid and Chemical Materials	Inorganic chemistry (13 methods)	$594
Nonpotable Water and Solid and Chemical Materials	Physical (7 methods)	$413
TOTAL		$3938

E. Additional fees. Additional fees shall be charged to laboratories applying for the following: (i) modification to scope of accreditation under 1VAC30-46-90 B, (ii) transfer of ownership under 1VAC30-46-90 C, (iii) review of compliance following total suspension, or (iii) (iv) petition for a variance under 1VAC30-46-160.

1. For any accredited environmental laboratory that applies to modify its scope of accreditation as specified under 1VAC30-46-90 B, DCLS shall assess a fee determined by the method in subsection F of this section.

2. Under 1VAC30-46-90 C, DCLS may charge a transfer fee to a certified laboratory that transfers ownership. A fee shall be charged if DCLS (i) needs to review documentation sent by the laboratory about the transfer of ownership or (ii) determines that an on-site assessment is necessary to evaluate the effect of the transfer of ownership. DCLS shall assess a fee determined by the method in subsection F of this section. If, under 1VAC30-46-90 C, DCLS determines that the change of ownership or location of laboratory requires reaccreditation of or reapplication by the laboratory, the laboratory shall pay the application fee required under this section.

3. Under 1VAC30-46-95 D 6, an environmental laboratory that DCLS has suspended in total shall be charged the cost of any necessary follow-up on-site assessments or data review or both to determine compliance. This charge shall be calculated under the method specified in subsection F of this section.

4. Under 1VAC30-46-160, any person regulated by this chapter may petition the director to grant a variance from any requirement of this chapter. DCLS shall charge a fee for the time needed to review the petition, including any on-site assessment required. The fee shall be determined by the method specified in subsection F of this section.

F. Additional fees determination.

1. The fee shall be the sum of the total hourly charges for all reviewers plus any on-site review costs incurred.

2. An hourly charge per reviewer shall be determined by (i) obtaining a yearly cost by multiplying the reviewer's annual salary by 1.35 (accounts for overhead such as taxes and insurance) and then (ii) dividing the yearly cost by 1,642 (number of annual hours established by Fiscal Services, Department of General Services, for billing purposes).

3. The charge per reviewer shall be determined by multiplying the number of hours expended in the review by the reviewer's hourly charge.

4. If an on-site review is required, travel time and on-site review time shall be charged at the same hourly charge per reviewer, and any travel expenses shall be added.

G. Out-of-state laboratories applying for primary accreditation.

1. The owner of an environmental laboratory located in another state who applies for primary accreditation under this chapter shall pay a surcharge of $5000 plus the labor costs of the on-site assessment and reasonable travel costs associated with conducting an on-site assessment at the laboratory. Reasonable travel costs include transportation, lodging, per diem, and telephone and duplication charges. These charges shall be in addition to the fees charged under subdivision A 1 and subsections B through D of this section.

2. Once the laboratory is accredited, DCLS shall charge the annual fee specified in subdivision A 2 and subsections B through D of this section, the labor costs for the on-site assessment, and reasonable travel costs associated with conducting the on-site assessment.

H. DCLS shall derive the travel costs charged under subsections F and G of this section from the Commonwealth of Virginia reimbursement allowances and rates for lodging, per diem, and mileage.

1VAC30-46-200. Incorporation by reference of TNI standards.

A. The following TNI standards are incorporated by reference into this chapter: The Standards for Environmental Laboratories and Accreditation Bodies, 2009 2016 (The NELAC Institute (TNI)), Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis, and Volume 2: General Requirements for Accreditation Bodies Accrediting Environmental Laboratories, except for section Section 6.6 of Module 3 concerning confidential business information.

B. Environmental laboratories applying for accreditation and accredited under this chapter shall comply with the TNI standards incorporated by reference into subsection A of this section. For convenience these standards are specified by accreditation component in 1VAC30-46-210 and 1VAC30-46-220.

C. The TNI standards are organized by volume and module.

1. Volume 1 - Management and Technical Requirements for Laboratories Performing Environmental Analysis includes the following modules:

a. Proficiency Testing.

b. Quality Systems General Requirements.

c. Quality Systems for Asbestos Testing.

d. Quality Systems for Chemical Testing.

e. Quality Systems for Microbiological Testing.

f. Quality Systems for Radiochemical Testing.

g. Quality Systems for Toxicity Testing.

2. Volume 2 - General Requirements for Accreditation Bodies Accrediting Environmental Laboratories includes the following modules:

a. General Requirements.

b. Proficiency Testing.

c. On-Site Assessment.

1VAC30-46-210. Standards for accreditation.

A. Standards for personnel. The standards for personnel are found in Section 5.2 of Volume 1, Module 2 of the TNI standards.

B. Standards for proficiency testing.

1. The standards for proficiency testing are found in (i) Module 1 and (ii) section 4.11 of Module 2 of Volume 1 of the TNI standards.

2. Additional requirements from Volume 2, Module 2 of the TNI standards.

a. A laboratory shall perform two proficiency test studies each calendar year for each FoPT. These proficiency testing studies shall be performed at least five months apart and no longer than seven months apart within the calendar year.

b. The following proficiency testing studies shall not apply when meeting the requirements of subdivision 2 a of this subsection:

(1) Studies used for corrective action to reestablish successful history in order to maintain accreditation; and

(2) Studies used to reinstate accreditation after DCLS suspends accreditation.

c. DCLS shall consider a laboratory's analytical result for a FoPT not acceptable for the following reasons:

(1) When the laboratory does not report the results within the time frames specified in Volume 1, Module 1 of the TNI standards.

(2) When the laboratory makes any reporting error or omission that results in a nonspecific match between the analytical result for the FoPT and any criterion that identifies the laboratory or the field of accreditation for which the PT sample was analyzed for the purpose of initial or continued accreditation.

d. If DCLS requests a corrective action plan from a laboratory, the laboratory shall provide the plan within 30 calendar days of the request.

e. A laboratory may withdraw from a study for any FoPT on or before the close date of the study. Withdrawing from a study shall not exempt the laboratory from meeting the semiannual analysis requirements necessary for continued accreditation.

C. Standards for quality systems.

1. General requirements for all environmental laboratories are found in Volume 1, Module 2 of the TNI standards.

2. Requirements for the specific types of testing that may be performed by an individual environmental laboratory are found in Volume 1, Modules 3 through 7 of the TNI standards.

3. Drinking water laboratories obtaining certification under this chapter shall meet the reporting requirements set out in 1VAC30-41 for compliance with 12VAC5-590-530 and 12VAC5-590-540.

1VAC30-46-220. On-site assessment.

A. The standards for on-site assessment are found in Volume 2, Module 3 of the TNI standards. The requirements specific to environmental laboratories are set out in this section.

B. DCLS shall conduct a comprehensive on-site assessment of an environmental laboratory prior to granting final primary accreditation to the laboratory.

C. Frequency of on-site assessment.

1. DCLS shall reassess each accredited laboratory every two years starting from the date of the previous assessment plus or minus six months.

2. Other on-site assessments.

a. If DCLS identified a deficiency on a previous on-site assessment, the agency may conduct a follow-up on-site assessment.

b. DCLS may conduct an on-site assessment under the following circumstances:

(1) A laboratory applies to modify its scope of accreditation;

(2) A transfer of ownership occurs that affects personnel, equipment, or the laboratory facilities; or

(3) A laboratory applies for an exemption or a variance.

c. Any other change occurring in a laboratory's operations that might reasonably be expected to alter or impair analytical capability and quality may trigger an on-site assessment.

D. Announced and unannounced on-site assessments. DCLS, at its discretion, may conduct either announced or unannounced on-site assessments. Advance notice of an assessment shall not be necessary.

E. Preparation for the on-site assessment.

1. Prior to the actual site visit, DCLS may request in writing from a laboratory those records required to be maintained by this chapter.

2. DCLS may opt not to proceed with an on-site assessment based on nonconformities found during document and record review.

F. Areas to be assessed.

1. DCLS shall assess the laboratory against the standards incorporated by reference and specified in 1VAC30-46-200 and 1VAC30-46-210.

2. The laboratory shall ensure that its quality manual, analytical methods, quality control data, proficiency test data, laboratory SOPs, and all records needed to verify compliance with the standards specified in 1VAC30-46-200 and 1VAC30-46-210 are available for review during the on-site assessment.

G. National security considerations.

1. Assessments at facilities owned or operated by federal agencies or contractors may require security clearances, appropriate badging, or a security briefing before the assessment begins.

2. The laboratory shall notify DCLS in writing of any information that is controlled for national security reasons and cannot be released to the public.

H. Arrival, admittance, and opening conference.

1. Arrival. DCLS and the laboratory shall agree to the date and schedule for announced on-site assessments.

2. Admittance of assessment personnel. A laboratory's refusal to admit the assessment personnel for an on-site assessment shall result in an automatic failure of the laboratory to receive accreditation or loss of an existing accreditation by the laboratory, unless there are extenuating circumstances that are accepted and documented by DCLS.

3. Health and safety. Under no circumstance, and especially as a precondition to gain access to a laboratory, shall assessment personnel be required or even allowed to sign any waiver of responsibility on the part of the laboratory for injuries incurred during an assessment.

4. Opening conference. An opening conference shall be conducted and shall address the following topics:

a. The purpose of the assessment;

b. The identification of assessment personnel;

c. The test methods that will be examined;

d. Any pertinent records and procedures to be examined during the assessment and the names of the individuals in the laboratory responsible for providing assessment personnel with such records;

e. The roles and responsibilities of laboratory staff and managers;

f. Any special safety procedures that the laboratory may think necessary for the protection of assessment personnel;

g. The standards and criteria that will be used in judging the adequacy of the laboratory operation;

h. Confirmation of the tentative time for the exit conference; and

i. Discussion of any questions the laboratory may have about the assessment process.

I. On-site laboratory records review and collection.

1. Records shall be reviewed by assessment personnel for accuracy, completeness, and the use of proper methodology for each analyte and test method to be evaluated.

2. Records required to be maintained pursuant to this chapter shall be examined as part of an assessment for accreditation.

J. Observations of and interviews with laboratory personnel.

1. As an element of the assessment process, the assessment team shall evaluate an analysis regimen by requesting that the analyst normally conducting the procedure give a step-by-step description of exactly what is done and what equipment and supplies are needed to complete the regimen. Any deficiencies shall be noted and discussed with the analyst. In addition, the deficiencies shall be discussed in the closing conference.

2. Assessment personnel may conduct interviews with appropriate laboratory personnel.

3. Calculations, data transfers, calibration procedures, quality control, and quality assurance practices, adherence to test methods, and report preparation shall be assessed for the complete scope of accreditation with appropriate laboratory analysts.

K. Closing conference.

1. Assessment personnel shall meet with representatives of the laboratory following the assessment for a closing conference.

2. During the closing conference, assessment personnel shall inform the laboratory of the preliminary findings and the basis for such findings. The laboratory shall have an opportunity to provide further explanation or clarification relevant to the preliminary findings. If the laboratory objects to the preliminary findings during the closing conference, all objections shall be documented by the assessment personnel and included in the final report to DCLS.

3. Additional problem areas may be identified in the final report.

L. Follow-up and reporting procedures.

1. DCLS shall provide an on-site assessment report to the laboratory documenting any deficiencies found by DCLS within 30 calendar days of the last day of the on-site assessment.

2. When deficiencies are identified in the assessment report, the laboratory shall have 30 calendar days from the date of its receipt of the on-site assessment report to provide a corrective action plan to DCLS.

3. The laboratory's corrective action plan shall include the following:

a. Any objections that the laboratory has with regard to the on-site assessment report;

b. The action that the laboratory proposes to correct each deficiency identified in the assessment report;

c. The time period required to accomplish the corrective action; and

d. Documentation of corrective action that the laboratory has already completed at the time the corrective action plan is submitted.

4. If the corrective action plan, or a portion of the plan, is determined to be unacceptable to remedy the deficiency, DCLS shall provide written notification to the responsible official and technical manager of the laboratory, including a detailed explanation of the basis for such determination. Following receipt of such notification, the laboratory shall have an additional 30 calendar days to submit a revised corrective action plan acceptable to DCLS.

5. DCLS may suspend accreditation from a laboratory under 1VAC30-46-95 B 3 or withdraw accreditation from a laboratory under 1VAC30-46-100 B 5 if DCLS finds the second revised corrective action plan to be unacceptable.

6. The laboratory shall submit documentation to DCLS that the corrective action set out in its plan has been completed within the time period specified in the plan.

7. DCLS, under 1VAC30-46-100 B 6, may withdraw accreditation from a laboratory if the laboratory fails to implement the corrective actions set out in its corrective action plan.

8. DCLS shall grant final accreditation as specified in 1VAC30-46-70 K upon successful completion of any required corrective action following the on-site assessment.

DOCUMENTS INCORPORATED BY REFERENCE (1VAC30-46)

The Standards for Environmental Laboratories and Accreditation Bodies, 2009 2016, The NELAC Institute (TNI), P.O. Box 2439, Weatherford, TX 76086; www.nelac-institute.org:

Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (EL-V1-2009)

Volume 2: General Requirements for Accreditation Bodies Accrediting Environmental Laboratories (EL-V2-2009)

Volume 2: General Requirements for Accreditation Bodies Accrediting Environmental Laboratories (EL-V2-2016, rev. 2.0)