Part I
General Provisions

1VAC30-40-10. Introduction. (Repealed.)

The Safe Drinking Water Act (SDWA) of December 16, 1974, mandated the establishment of drinking water regulations. The United States Environmental Protection Agency (USEPA) was authorized to set the national drinking water regulations and oversee the implementation of the SDWA. State governments through their health departments or environmental agencies were to accept the responsibility for the implementation and enforcement of the SDWA'S provisions.

The Virginia Department of Health, Office of Drinking Water (VDH-ODW) has accepted and maintains the primary enforcement responsibility (primacy) under the SDWA and the requirements of the National Primary Drinking Water Regulations (NPDWR) 40 CFR 141, 142 and 143 (2009).

The Department of General Services, Division of Consolidated Laboratory Services (DGS-DCLS) has been designated by VDH-ODW as the principal state laboratory. Pursuant to regulation 40 CFR 142.10(b)(3)(i) (2009), DGS-DCLS has established and maintains the state program for the certification of laboratories conducting analytical measurements of drinking water contaminants.

This chapter provides the mechanism to assure that laboratories are capable of providing valid data for compliance under the SDWA.

1VAC30-40-20. Definitions. (Repealed.)

The following words and terms, when used in this chapter, shall have the following meanings, unless the context already indicates otherwise:

"Analyst" means a chemist, microbiologist, physicist, or technician who actually performs a test. The analyst may carry out the complete test or participate jointly with other analysts. The qualifications an analyst needs depend greatly on functions being performed.

"Certifying team" means experienced DGS-DCLS professionals to perform laboratory on-site evaluations under the SDWA.

"CFR" means Code of Federal Regulations.

"Compliance sample" means any sample required by the Virginia Department of Health to determine that the water quality does not exceed the maximum contaminant level (MCL) for each specified parameter.

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

"EMSL-LV" means the Environmental Monitoring Systems Laboratory in Las Vegas, Nevada.

"Maximum contaminant level (MCL)" means the maximum permissible level of a contaminant in water which is delivered to the free flowing outlet of the ultimate user of a waterworks.

"Minimum requirements" means criteria which are critical to the generation of valid data. These criteria describe the lowest level of capability at which the analyses can be successfully performed.

"NPDWR" means the National Primary Drinking Water Regulations (40 CFR 141 et seq.) (2009).

"Performance evaluation sample" means annual sample to be analyzed by a laboratory on certain parameters for which certification has been requested or granted. This annual sample is a form of documentation of a laboratory's capabilities in conjunction with on-site inspection evaluations of the laboratory by the certifying team.

"Primary enforcement responsibility (Primacy)" means the primary responsibility for administration and enforcement of primary drinking water regulations and related requirements applicable to public water systems within a state.

"Quality Assurance (QA) Plan" means a written description of a laboratory's quality assurance activities.

"SDWA" means the Safe Drinking Water Act (42 USC § 300 f et seq.).

"TTHM" means Total Trihalomethanes.

"USEPA" means the United States Environmental Protection Agency.

"VDH-ODW" means the Virginia Department of Health - Office of Drinking Water.

"Virginia laboratory officer" means the DGS-DCLS coordinator of drinking water laboratory certification activities.

1VAC30-40-30. Public notification for exceeded MCL. (Repealed.)

The public notification regulations require that a laboratory analyzing compliance samples immediately notify the VDH-ODW of all results which exceed an MCL in accordance with Virginia Waterworks Regulations, 12VAC5-590-530 and 12VAC5-590-540.

1VAC30-40-40. Compliance data report. (Repealed.)

A. A waterworks with an on-site certified laboratory shall follow the reporting requirements outlined in Virginia Waterworks Regulations, 12VAC5-590-530.

B. A contract laboratory analyzing compliance samples shall complete the appropriate VDH-ODW Sample Input Form in accordance with the instructions for compliance under the SDWA. The contract laboratory shall report the analysis result to the VDH-ODW within three days of completion date of sample analysis.

1VAC30-40-50. Laboratory Quality Assurance Plan. (Repealed.)

A certified laboratory shall establish a QA Plan complying with USEPA and state standards. The QA Plan may be a separately prepared QA document or may incorporate by reference already available standard operating procedures. Documentation for the items listed below can be made by reference to the laboratory's standard operating procedures or to other literature.

1. Laboratory Organization, Personnel Qualifications, Training and Responsibility.

2. Sample Collection, Handling, Preservation and Rejection.

3. Instrument and Equipment Calibration, Standardization, and Temperature Checks.

4. Maintenance Procedures.

5. Standards, Reagents, Laboratory Pure Water, Media and Glassware.

6. A current working manual of procedures shall be available to the working analyst. The procedures shall be written as they are exactly performed in the laboratory, not ideally how they should be performed.

7. Data Reduction, Validation, Reporting and Review.

8. Internal and External Quality Control.

9. Precision, Accuracy, Quantitation and Detection Levels.

10. Corrective Action Contingencies.

1VAC30-40-60. Fees. (Repealed.)

A fee shall be charged by DGS-DCLS for the certification process. Fees are currently waived for state, local, and federal government laboratories. The annual fee shall be based on the current schedule, the location of the laboratory and the categories for which the laboratory requests certification. The fee shall be payable at the time the application is filed with DGS-DCLS, and is nonrefundable. The categories are microbiology, inorganic chemicals, organic chemicals and radiochemicals.

1VAC30-40-70. Reciprocity. (Repealed.)

An out-of-state laboratory shall be granted reciprocal certification provided the laboratory demonstrates the need to serve customers in Virginia and is certified by USEPA or another state under equivalent certification criteria.

The laboratory's certificate, current performance evaluation study report, most recent on-site evaluation report, personnel qualifications and QA Plan shall be received by DGS-DCLS prior to consideration for certification. An annual fee is charged per category. The categories are microbiology, inorganic chemicals, organic chemicals and radiochemicals.

1VAC30-40-80. Update on regulations. (Repealed.)

Whenever USEPA adopts a new manual for the "Certification of Laboratories Analyzing Drinking Water," EPA-814B-92-002, September 1992, the Virginia laboratory officer shall inform local laboratories of the availability of the manual. Local laboratories shall comply with the updated manual. DGS-DCLS may update this chapter to be equivalent or more stringent than the USEPA Manual. DGS-DCLS, as necessary, may adopt in this chapter new NPDWR on or before their effective date.

1VAC30-40-85. Incorporation by reference.(Repealed.)

A. The sampling, analytical methodology, and laboratory certification requirements of 40 CFR 141 and 143 (2009) are incorporated by reference into this chapter.

B. The specific sampling, analytical methodology, and laboratory certification requirements incorporated by reference are listed below by category:

1. Inorganic chemistry: 40 CFR 141.23, 40 CFR 141.89, and 40 CFR 141.131.

2. Organic chemistry: 40 CFR 141.24 and 40 CFR 141.131.

3. Microbiology: 40 CFR 141.21, 40 CFR 141.74, 40 CFR 141.174, 40 CFR 141.704, and 40 CFR 141.705. 40 CFR 136.3 (a) for e. coli requirements under 40 CFR 141.704.

4. Radiochemistry: 40 CFR 141.25.

5. Alternative testing methods: 40 CFR Part 141, Subpart C, Appendix A.

6. Test methods specified for secondary maximum contaminant levels: 40 CFR 143.4.

C. The exceptions to the requirements for laboratory certification in 40 CFR 141.28, 40 CFR 141.74(a), 40 CFR 141.89(a)(1), 40 CFR 141.131(b)(3), and 40 CFR 141.131(c)(3) are incorporated by reference into this chapter. Laboratory testing for alkalinity, calcium, conductivity, disinfectant residual, orthophosphate, pH, silica, temperature, and turbidity for compliance purposes may be performed by laboratories or persons not certified under this chapter but acceptable to VDH-ODW.

Part II
Certification of Laboratories

1VAC30-40-90. Application for certification. (Repealed.)

A. A laboratory shall request the application form from DGS-DCLS.

B. An application packet consisting of the application form; forms for personnel, equipment and methodology; this chapter; and pertinent information regarding the SDWA shall be provided to the laboratory.

C. DGS-DCLS shall administratively review the application packet when received.

D. DGS-DCLS shall provide a performance evaluation sample or enroll the laboratory in the USEPA Performance Evaluation Study, if applicable.

E. DGS-DCLS shall schedule an on-site evaluation for in-state laboratories. For chemical certification, the laboratory shall obtain acceptable results on the performance evaluation study (or EMSL-LV Cross Check Samples) before an on-site evaluation is scheduled.

1VAC30-40-100. Evaluation procedure. (Repealed.)

A. DGS-DCLS shall notify a laboratory three weeks before the on-site evaluation.

B. During the on-site evaluation, the certifying team shall evaluate the laboratory on its equipment and supplies, general laboratory practices, sample collection, handling and preservation, methodology and quality assurance. A laboratory may be required to analyze an unknown sample or perform analysis on a parameter during the evaluation.

Survey forms may be used as guidelines for complete coverage of the laboratory's activities. Each deviation observed during the laboratory evaluation shall be discussed at the time it is observed. The certifying team shall make an oral report to the laboratory staff at the end of the evaluation.

C. The certifying team shall prepare a narrative and action report for the Virginia laboratory officer. This report shall contain information pertinent to the evaluation. The report shall recommend the parameters in a category for which certification can be granted.

D. DGS-DCLS shall obtain from VDH-ODW an identification number for a newly certified laboratory. DGS-DCLS shall inform VDH-ODW of the certification status of a laboratory.

E. The Virginia laboratory officer shall advise the laboratory within 30 days after the on-site evaluation of its certification status and forward the certifying team's complete report.

F. Each laboratory found to be in noncompliance with this chapter, as indicated in the certifying team report, shall submit documentation of the corrective actions at the time specified by DGS-DCLS.

G. Additional actions toward certification shall be determined based on the specific circumstances.

1VAC30-40-110. Levels of certification. (Repealed.)

Certification is granted for individual parameters in a category except for the volatile organic chemicals (VOC's). The VOC's are certified as a group based on the method employed and successful completion of the performance evaluation study.

1. "Certified" means a laboratory that meets the minimum requirements as determined by the certifying team using this chapter. The certification shall be valid for up to three years.

2. "Provisionally certified" means a laboratory which has deficiencies but can still produce valid data. The laboratory can continue to report compliance data to VDH-ODW. A laboratory shall be permitted up to six months for correction of deficiencies. The certifying team may perform an announced or unannounced on-site evaluation to determine the adequacy of documented corrective actions. The certifying team shall recommend to the Virginia laboratory officer to upgrade the laboratory's certification status.

3. "Not certified" means a laboratory that does not meet the minimum requirements as determined by the certifying team using this chapter.

1VAC30-40-120. Notice of appeal. (Repealed.)

A laboratory may appeal its not certified status and make a request for an on-site reevaluation to the Virginia laboratory officer. A different certifying team shall perform the reevaluation. The reevaluation report shall be sent to the laboratory within 30 days. Should the reevaluation confirm the not certified status, the laboratory shall correct the deficiencies and reapply for certification.

1VAC30-40-130. Maintenance of certified status. (Repealed.)

To maintain its certified status, a laboratory shall:

1. Continue to meet the requirements listed in this chapter based on the on-site evaluation.

2. Pass performance evaluation samples on an annual basis (for radiochemistry pass additional two cross-check samples).

3. Perform a minimum of five water analyses for each chemical parameter per month. Refer to 1VAC30-40-330 for the minimum number of microbiology analyses. This shall ensure that the laboratory maintains expertise in the certified categories.

4. Notify DGS-DCLS within 30 days of changes in personnel, equipment or laboratory location which may change the laboratory's analytical capability.

5. Use approved methodology incorporated by reference at 1VAC30-40-85.

6. Notify VDH-ODW in accordance with 1VAC30-40-30.

1VAC30-40-140. Downgrading of certified status. (Repealed.)

A laboratory's certified status shall be downgraded to a provisionally certified status for:

1. Failure to meet the requirements listed under 1VAC30-40-130.

2. Failure to successfully analyze the same parameter on two consecutive performance evaluation studies.

3. Failure to submit documentation of corrective actions on the failed parameters on a performance evaluation study.

1VAC30-40-150. Revocation of certified status. (Repealed.)

A laboratory shall be downgraded from certified or provisionally certified to not certified status for:

1. Failure to employ USEPA approved methods incorporated by reference at 1VAC30-40-85.

2. Failure to submit report for the performance evaluation study at the specified time limit unless a waiver is approved by DGS-DCLS.

3. Failure to successfully analyze a parameter that is provisionally certified.

4. Submission of a performance evaluation sample to another laboratory for analysis and reporting the data as its own.

5. Failure to correct identified deficiencies based on an on-site visit.

6. Permitting persons other than qualified personnel to perform and report results for drinking water analysis.

7. Falsification of data or use of other deceptive practices.

8. Failure to notify the VDH-ODW in accordance with 1VAC30-40-30.

1VAC30-40-160. Action to downgrade or revoke certification. (Repealed.)

The laboratory shall be notified by certified mail of the circumstances which form the basis of downgrading or revocation of certified status.

1VAC30-40-170. Reinstatement of certification. (Repealed.)

Certification shall be reinstated when the laboratory can demonstrate that the deficiencies which produced the downgrading or revocation of certified status have been corrected. An on-site evaluation or successful completion of a performance evaluation study or both may be required.

1VAC30-40-180. Certification for additional parameters. (Repealed.)

A laboratory shall submit a request for additional parameters to DGS-DCLS. To obtain certification, the laboratory, when applicable, shall pass the performance evaluation study and be subjected to an on-site evaluation. If the laboratory's capability and proficiency has been established for similar parameters in a category, an on-site evaluation may not be required.

1VAC30-40-190. Recertification process. (Repealed.)

DGS-DCLS shall notify and mail recertification forms to the laboratory at least 30 days before the expiration of certification. The continuing on-site evaluations shall be performed as in the initial evaluation with emphasis on past deficiencies and their corrections.

Part III
Chemistry

1VAC30-40-200. Personnel. (Repealed.)

The laboratory shall provide a curriculum vitae on each analyst involved in analyzing drinking water with sufficient information to show that personnel are adequately trained and experienced to perform the specific analyses for the categories being considered for certification. Whenever there is a change of personnel, DCLS shall be notified and provided with data on the status change of present personnel or curriculum vitae for new personnel within 30 days of the change.

1VAC30-40-210. Laboratory facilities. (Repealed.)

The laboratory facilities shall be clean, have controlled temperature and humidity and have adequate lighting at the bench top.

The laboratory shall provide for the disposal of chemical wastes. Exhaust hoods are required for preparation, extraction and analysis, where applicable, of drinking water inorganic and organic parameters.

It is recommended that inorganic and organic facilities be in separate rooms. Sample storage shall be isolated for protection from sources of contamination.

1VAC30-40-220. Laboratory equipment and instrumentation. (Repealed.)

The laboratory is only required to have those instruments that are needed to perform the approved methods for which certification has been requested. Those instruments shall meet the following specifications:

1. General.

a. Analytical balance. Each analytical balance shall have a sensitivity of 0.1 mg. The balance shall be seated on a steady base to prevent interference from vibration and protection from sudden drafts and humidity changes.

b. pH meter. pH meter shall be accurate within ±0.05 pH units. Scale readability of the pH meter shall be ±0.1 pH units. Glass electrodes shall be either immersed in distilled water or stored according to the manufacturer's recommendations during periods of inactivity. pH meter may be usable with specific ion electrode.

c. Magnetic stirrer. Variable speed with inert material coated stir bar.

d. Conductivity meter. Suitable for checking distilled water quality, readable in ohms or mhos with a range from 2 ohms to 2 megohms.

e. Hot plate. Hot plate shall have selectable temperature control.

f. Refrigerator. Standard refrigerator for storage of aqueous reagents and samples. An explosion-proof type of refrigerator for organic storage.

g. Drying oven. Gravity or convection units with selectable temperature control from room temperature to 180°C or higher (± 2°C). To 400°C for cleaning organic glassware.

h. Thermometer. Any good grade mercury-filled centigrade thermometer with 1°C or finer subdivisions calibrated to 180°C or higher.

i. Centrifuge. Centrifuge to 3000 rpm which can handle 4 X 50 mL tubes.

j. Glassware. All volumetric glassware shall be marked Class A, denoting that it meets federal specifications and need not be calibrated before use. Borosilicate glass which is more resistant than regular soft glass to damage by heat, chemicals, and physical abuse, is recommended.

k. Waterbath. Electric or steam heated capable of temperature control to within 5°C to 100°C.

l. Pipets and tips. Microliter capacity 5 to 100 microliters with metal-free disposable tips.

m. Desiccator. Glass or plastic models depending on particular application.

2. Inorganic contaminants.

a. Photometer.

(1) Spectrophotometer. Usable wavelength range, 400 to 700 nm. Maximum spectral band width, no more than 20 nm. Several sizes and shapes of absorption cells providing a sample path length from approximately 1 to 5 cm.

(2) Filter photometer (abridged spectrophotometer). Capable of measuring radiant energy in range of 400 to 700 nm. Relatively broad bands (10 to 75 nm) of this radiant energy are isolated by absorption of the colorimetric methods. Photometer shall be capable of using several sizes and shapes of absorption cells providing a sample path length varying from approximately 1 to 5 cm.

(3) Color standards. To verify wavelength on photometer. Shall cover 200-800 nanometers.

b. Automated analysis systems. Exact equipment used is specified by the individual methods and includes:

(1) Sampler

(2) Proportioning pump

(3) Manifold of analytical cartridge

(4) Heating bath

(5) Heating bath with distillation head

(6) Continuous filter

(7) Colorimeter with filters

(8) Ion selective electrode detector with electrodes

(9) Recorder

c. Arsine generator and absorption system. A Gutzeit generator or equivalent used in conjunction with an absorber tube or assembly.

d. Atomic absorption spectrophotometer. Single-channel, single- or double-beam instrument having a grating monochromator, photomultiplier detector, adjustable slits, and a wave-length range of least 190 to 800 nm.

(1) Readout system. An appropriate readout system that has a response time capable of measuring the atomic absorption signal generated is required. This includes the capability to detect positive interference on the signal from intense nonspecific absorption. In furnace analysis a strip chart recorder shall be used for verification of adequate background correction if a CRT video readout or hard copy plotter is not available.

(2) Fuel and oxidant. Commercial grade acetylene is generally acceptable. Air may be supplied from a compressed air line, a laboratory compressor, or from a cylinder of compressed air. Reagent grade nitrous oxide is also required for certain determinations. Standard commercially available argon or nitrogen or both are required for furnace work, and hydrogen is required for the flame hydride systems. The supplies of fuel and oxidant shall be maintained at pressures somewhat higher than the controlled operating pressure of the instrument.

(3) Burner. The burner recommended by the particular instrument manufacturer and consistent with the approved method shall be used. For certain elements the nitrous oxide burner is required.

(4) Hollow cathode lamps. Single element lamps are preferred but multi-element lamps may be used. Electrodeless discharge lamps may also be used.

(5) Graphite furnace. Any furnace device capable of reaching the specified temperatures is satisfactory.

(6) Background corrector. A background correction system or provision for a subsequent analysis using a nonabsorbing line is required for furnace analysis.

(7) Hydride generation system. Any gaseous hydride system used in conjunction with an atomic absorption spectrophotometer equipped for direct aspiration analysis.

e. Mercury cold vapor analyzer. Commercially available vapor mercury analyzer can be substituted for the equipment listed below.

(1) Absorption cell. Standard 10 cm quartz cell with end windows or 11.5 cm plexiglass cell with an inside diameter of 2.5 cm.

(2) Air pump. Peristaltic pump with an air flow of 1 L per minute.

(3) Flowmeter. Capable of measuring an air flow of 1 L per minute.

(4) Spectrophotometer. Atomic absorption spectrophotometer equipped with a mercury hollow cathode lamp.

(5) Aeration tube. A straight glass frit having a coarse porosity.

(6) Drying unit. A 6-inch drying tube containing 20 grams of magnesium perchlorate or a heating device is required to prevent condensation of moisture.

f. Inductively Coupled Plasma. Computer control, background correction, radio frequency generator and argon gas supply.

g. Inductively Coupled Plasma-Mass Spectrometer. Capable of scanning the mass range 5 - 250 amu with a minimum resolution capability of 1 amu peak width at 5.0% peak height.

h. Ion Chromatograph. Conductivity detector or UV detector, suppressor column and separator column.

3. Organic contaminants.

a. Gas chromatograph. A commercial or custom-designed gas chromatograph (GC) with a column oven capable of isothermal temperature control ±0.2°C to at least 220°C. Additional accessories and specifications are listed below.

(1) Chlorinated hydrocarbons. Equipped with a glass-lined injection port suitable for chlorinated hydrocarbon pesticides with a minimum of decomposition, and equipped with either an electron capture detector or electrolytic conductivity detector.

(2) Chlorophenoxys. Equipped with a glass-lined injection port and either an electron capture detector or electrolytic conductivity detector.

(3) Volatile organic compounds. Equipped with electrolytic conductivity detector and photoionization detector.

(4) VOC's by gas chromatography/mass spectrometry (GC/MS). The gas chromatograph, which shall be temperature programmable, shall be interfaced to the mass spectrometer with an all-glass enrichment device and an all-glass transfer line. Mass spectral data are to be obtained with electron-impact ionization at a nominal electron energy of 70 eV.

The mass spectrometer shall be capable of producing a spectrum that meets all criteria below when 50 ng of p-bromofluorobenzene(BFB) is introduced into the gas chromatograph. An interfaced data system is necessary to acquire, store, reduce and output mass spectral data.

(5) Synthetic Organic Chemicals (SOC's) by GC/MS. The gas chromatograph, which shall be temperature programmable, shall be equipped with splitless/split or on column capillary injection. The mass spectrometer shall be capable of electron ionization at a nominal electron energy of 70 eV. The mass spectrometer shall be capable of producing a spectrum that meets all criteria below when 5 ng or less of decafluorotriphenylphosphine (DFTPP) is introduced into the gas chromatograph. An interfaced data system is necessary to acquire, store, reduce and output mass spectral data.

(6) GC/MS interface. It is recommended that the interface between the end of the chromatographic column and the ion source of the mass spectrometer be constructed with deactivated glass or glass-lined materials. The GC/MS interface can use any separator, transfer line or other interface part, provided it is demonstrated that the system meets BFB and DFTPP performance specifications.

(7) GC/MS data system. It is desirable that the data system shall have the ability to perform automatic quantitative analysis using integrated specific ion abundances and either a single internal or external standard. The data system shall also have the ability to perform automatic quantitative analysis using integrated specific ion abundances and regression analysis with multiple internal or external standards.

b. Recorder for gas chromatograph. Strip chart recorder with a full scale response time of 1 second or less, 1 mV (-0.05 to 1.05) signal to match the instrument, and a chart speed of 0.25 to 0.5 in/min or appropriate data system.

c. High Performance Liquid Chromatograph.

(1) With Post Column Reactor (PCR) equipped with a fluorescence detector.

(2) Equipped with a photodiode array detector.

d. Purge and trap system. A commercial or custom-designed system containing three separate elements.

(1) Purging device. Designed for a 5 ml or 25 ml sample volume dependent on methodology.

(2) Trapping device. Shall be at least 25 cm long and have an inside diameter of at least 0.105 inch.

(3) Desorber assembly. Capable of heating the trapping device to 180°C.

e. Kuderna-Danish glassware. Sets of tapered glassware, each consisting of a three ball Snyder Column, evaporative flask, and calibrated tube.

f. Separatory funnels. For extraction with organic solvents, 250 ml or larger.

1VAC30-40-230. General laboratory practices. (Repealed.)

A. General.

1. Chemicals/reagents. "Analytical reagent grade" (AR) chemicals shall be used for most analyses required of water; however, certain analytical procedures may require special reagents.

2. Laboratory safety. While safety criteria are not aspects of laboratory certification, each laboratory is encouraged to have a safety plan. Where safety practices are included in an approved method, they shall be strictly followed.

B. Inorganic contaminants.

1. Glassware preparation. All glassware shall be washed in warm detergent solution and thoroughly rinsed first in tap water and then distilled water. Individual procedures shall be referred to for more elaborate precautions to be taken against contamination of glassware.

2. Reagent water. The laboratory water source shall at least have a resistivity value of 0.5 megohms (less than 2.0 micromhos/cm) at 25°C. Quality water meeting such specifications can be purchased from commercial suppliers. Quality of reagent water is best maintained by sealing from the atmosphere. Quality checks to meet specifications above shall be made and documented at planned intervals not to exceed one month.

C. Organic contaminants.

1. Glassware preparation. Glassware and sample bottles shall be washed in a warm detergent solution and thoroughly rinsed first in tap water and then in distilled water. Glassware shall have a final organic solvent rinse or baked at 400°C for 30 minutes and then air dried or cooled in an area free of organic contamination. Glassware shall be covered with organic-free aluminum foil during storage. Bottles and cap liners used for collection of samples for the determination of VOCs shall be dried at 105°C for one hour, sealed, and stored in an area free of volatile organics.

2. Reagent water. Reagent water for organic analysis shall be free of interferences that coelute from the gas chromatograph with the compound being measured. It may be necessary to treat distilled water with activated carbon to eliminate all interferences.

1VAC30-40-240. Analytical methodology. (Repealed.)

A. Laboratories shall meet the sampling and analytical methodology requirements incorporated by reference at 1VAC30-40-85 B 1 for primary inorganic contaminants, 1VAC30-40-85 B 2 for primary organic contaminants, 1VAC30-40-85 B 5 for alternative testing methods, and 1VAC30-40-85 B 6 for secondary maximum contaminant levels.

B. DPD Colorimetric Test Kit and FACTS Colorimetric Test Kit are the only acceptable prepackaged kits for free chlorine residual.

C. Measurement for residual disinfectant, turbidity, pH and temperature need not be made in certified laboratories but may be performed by any persons acceptable by the VDH-ODW. The following are the critical elements of these tests:

1. Sealed liquid turbidity standards purchased from the instrument manufacturer shall be calibrated against properly prepared and diluted formazin or styrene divinylbenzene polymer standards at least every four months in order to monitor for any eventual deterioration. This calibration shall be documented. The standards shall be replaced when they do not fall within 15% of the assigned value of the standard. Solid turbidity standards composed of plastic, glass, or other materials shall not be used.

2. Calibration interval for color wheels, sealed ampules, and other visual standards for free chlorine residual at least every six months. These calibrations shall be documented. By comparing standards and plotting such a comparison on graph paper, a correction factor can be derived and applied to all future results obtained on the now calibrated apparatus.

3. Additional criteria. The following criteria shall be used by persons for performing free chlorine residual, turbidity, pH and temperature measurements.

a. Free chlorine residual. Samples shall be collected in plastic or glass. Samples are not preserved; analyses are made within 15 minutes. A DPD or FACTS Colorimetric Test Kit, spectrophotometer or photometer is required.

b. Turbidity. Samples shall be collected in plastic or glass. Samples are not preserved; analyses are to be made within 15 minutes. Nephelometer is needed with light source for illuminating the sample and one or more photoelectric detectors with a readout device to indicate the intensity of light scattered at right angles to the path of the incident light. Unit may be line/bench or battery/portable operated.

c. pH. Samples shall be collected in plastic or glass. Samples are not preserved. Analyses are to be made within 15 minutes. A pH meter is necessary.

d. Temperature. Samples shall be analyzed immediately. A good grade mercury-filled or dial-type centigrade thermometer, or thermistor is required.

1VAC30-40-250. Sample collection, handling, and preservation. (Repealed.)

A. A written sampling procedure with specified sampling instructions shall be made available to sample collectors. The laboratory shall require strict adherence to correct sampling procedures, complete identification of a sample and prompt transfer of the sample to the laboratory.

B. The collector shall be trained in sampling procedures.

C. The sample needs to be representative of the potable water system. The water tap shall be sampled after maintaining a steady water flow for two or three minutes to clear service line unless otherwise specified by the method, as an example, lead and copper. The tap shall be free of any attachments or water purification devices.

D. The sample report form shall be completed immediately after collection with location, date and time of collection, collector's name, preservative added and any remarks concerning the sample. Indelible ink shall be used.

E. The sample container, required preservation, and maximum holding time requirements for sampling and analyzing inorganic contaminants are incorporated by reference at 1VAC30-40-85 B 1.

F. The sample container, required preservation, and maximum holding time requirements for sampling and analyzing organic contaminants are incorporated by reference at 1VAC30-40-85 B 2.

G. The sample container, required preservation, and maximum holding time requirements for alternative test methods are incorporated by reference at 1VAC30-40-85 B 5.

H. The laboratory shall reject any sample not meeting the above criteria and notify the system or individual requesting the analyses.

1VAC30-40-260. Quality assurance. (Repealed.)

A. All quality control (QC) information shall be made available for inspection by the certifying team.

B. General.

1. The laboratory shall adhere to the written Quality Assurance (QA) Plan.

2. A manual of analytical methods and the laboratory's QA Plan shall be available to the analysts.

3. The laboratory shall analyze an unknown water supply performance evaluation sample once per year for all contaminants for which that laboratory is certified. Results shall be within the control limits established by USEPA.

4. At least once each quarter, the laboratory shall analyze a known QC sample. If errors exceed limits specified, corrective action is to be taken and documented and a follow-up quality control standard analyzed as soon as possible to demonstrate the problem has been corrected.

5. The laboratory shall perform an initial demonstration of capability to generate acceptable precision and accuracy data.

6. The laboratory shall develop and maintain QC charts for each analyte. Since percent recovery may not be a constant, the percent recovery data may have to be separated into concentration intervals before control limits are calculated for each interval.

7. The laboratory shall determine initially and at least annually their method detection limit (except when the method specifies a different frequency).

8. The laboratory shall calibrate pH meters for each use period with fresh standard buffers at pH 7.0 and at the pH appropriate for the test being performed.

9. The laboratory shall have a current service contract and a written maintenance calibration procedure on all balances. The laboratory shall calibrate balance(s) monthly using Class S or S-1 reference weights. This calibration(s) shall be documented.

10. The laboratory shall calibrate the conductivity meter monthly with a 0.01 M KCl solution.

11. The wavelength setting on the spectrophotometer shall be verified with color standards covering 200-800 nanometers every quarter.

12. The laboratory shall check calibration of in-use glass/mercury thermometers annually at the temperature used, against a reference National Institute of Standards Technology, (NIST) thermometer.

13. Refrigerator shall maintain a temperature of 1° to 5°C. Thermometer shall be graduated in at least 1°C increments with the thermometer bulb immersed in liquid. The laboratory shall record temperatures for days in use at least once per day.

14. The laboratory shall record oven temperatures for days in use at least once per day.

15. The laboratory shall test new pipets before use. A pipet shall be checked for accuracy after any maintenance or trouble shooting. All pipets shall be checked for accuracy every six months. Pipets with capacity of less than 500 uL shall be checked for accuracy every quarter. Tips shall be metal free.

16. Chemicals shall be dated upon receipt. Chemicals whose shelf life has been exceeded shall be discarded in a safe manner. Reagents shall be dated when prepared.

17. The laboratory shall perform instrument maintenance according to maintenance procedures and schedules. The laboratory instrument maintenance shall be documented.

C. Inorganic contaminants. In addition to specific quality controls inherent to a method, the following are necessary for each analyte for which the laboratory is certified:

1. A standard reagent curve composed of a minimum of a reagent blank and three standards covering the sample concentration range shall be prepared. The reagent blank shall be carried through the entire analytical procedure. The reagent blank shall not exceed the method detection limit (MDL).

2. Calibration for some methods is so time-consuming that subdivision 1 of this subsection is impractical. For these methods, the standard curve shall be initially developed as in subdivision 1 of this subsection. Thereafter, each day on which analyses are performed, the standard curve shall be verified by use of at least a reagent blank and one standard near or at the MCL. Daily checks shall be within ± 10% of the original curve.

3. If 20 or more samples are analyzed per day, the working standard curve shall be verified by running an additional standard near or at the MCL every 20 samples. Each check shall be within ± 10% of the original curve.

4. The laboratory shall add a known spike to a minimum of 10% of the routine samples (except when the method specifies a different percentage, i.e., furnace methods) to determine if the entire analytical system is in control. The spike concentration shall not be substantially less than the background concentration of the sample selected for spiking. These checks shall be evenly spaced and one check shall be at the end of the day's analyses. Over time, samples from all routine sample sources shall be spiked. If any of these checks are not within the control limits, a standard shall be analyzed to determine if the "out of control" condition was due to sample matrix or system operation. This standard is to be analyzed through the complete analytical system. Corrective action is to be taken in accordance with the laboratory's QA Plan.

D. Organic contaminants. In addition to specific quality controls inherent to a method, the following are necessary for each analyte for which the laboratory is certified:

1. Documentation of acceptable calibration is required before any samples are analyzed. Any of the following calibration procedures shall be employed.

a. Internal Standard Calibration. Prepare calibration standards at a minimum of three concentration levels for each analyte of interest. To each calibration standard, add a known constant amount of one or more of the internal standards and surrogate compounds. The lowest standard shall represent analyte concentrations near, but above, their respective MDLs.

The remaining standards shall correspond to the range of concentrations expected in the sample concentrates, or shall define the working range of the detector. The calibration standards shall bracket the analyte concentrations found in the sample extracts.

b. External Standard Calibration. Prepare calibration standards at a minimum of three concentration levels for each analyte of interest. To each calibration standard add a known constant amount of one or more surrogate compounds. The lowest standard shall represent analyte concentrations near, but above, their respective MDLs. The other concentrations shall correspond to the range of concentrations expected in the sample concentrates, or shall define the working range of the detector. The calibration standards shall bracket analyte concentrations found in the sample extracts.

c. Single point calibration is a viable alternative to the internal and external standard or calibration. Add to the standard a known constant amount of one or more surrogate compounds. The single point standard shall be prepared at a concentration that produces a response that deviates from the sample extract response by no more than 20%.

d. The working calibration curve or calibration factor shall be verified on each working day by the measurement of a minimum of two calibration check standards, one at the beginning and one at the end of the analysis day. These check standards shall be at two different concentration levels to verify the calibration curve. For extended periods of analysis (greater than eight hours), it is strongly recommended that check standards be interspersed with samples at regular intervals during the course of the analyses. If the response for any analyte varies from the predicted response by more than ± 20%, the test shall be repeated using a fresh calibration standard. If the results still do not agree, generate a new calibration curve.

2. Laboratory Reagent Blanks (LRB). Before processing any samples, the analyst shall demonstrate that all glassware and reagent interferences are under control. Each time a set of samples is extracted or reagents are changed, a laboratory reagent blank shall be analyzed.

3. Laboratory Fortified Blank (LFB). The laboratory shall analyze at least one laboratory fortified blank (LFB) sample with every 20 samples or one per sample set (all samples extracted within a 24-hour period) whichever is greater. The fortified concentration of each analyte in the LFB shall be 10 times MDL or at the MCL, whichever is less.

4. Laboratory Fortified Sample Matrix (LFSM). The laboratory shall add a known concentration to a minimum of 10% of the routine samples or one sample concentration per set, whichever is greater. The added concentration shall not be less than the background concentration of the sample selected for fortification. Ideally, the fortified analyte concentrations shall be the same as that used for the LFB. Over time, samples from all routine sample sources shall be fortified.

5. Laboratory Performance Check Sample (LPCS): Instrument performance shall be monitored on a daily basis by analysis of the LPC sample. The LPC sample contains compounds designed to indicate appropriate instrument sensitivity, column performance (primary column) and chromatographic performance. Inability to demonstrate acceptable instrument performance indicates the need for reevaluation of the instrument system.

6. It is essential that the laboratory analyze a field blank for TTHM or VOC or both with each sample set. If reportable levels of TTHM or VOC or both are demonstrated to have contaminated the field blank, resampling is essential.

7. The laboratory is to analyze 10% of all samples for TTHM or VOC's or both in duplicate. A continuing record of results and subsequent action taken shall be retained.

8. On a weekly basis, the laboratory shall demonstrate the ability to analyze low level samples for THMM and VOC's. Prepare a low level laboratory performance check sample. For each analyte, the recovery shall be between 60% and 140% of the expected value.

9. It is essential that laboratories that analyze for TTHM by liquid-liquid extraction and VOC's by Purge and Trap can demonstrate that raw source waters do not contain interferences under the chromatographic conditions selected.

10. If a mass spectrometer detector is used for TTHM or VOC analyses, it is essential that the mass spectrometer performance tests described under equipment specifications using BFB be conducted once during each eight-hour work shift. Records of satisfactory performance and corrective action shall be maintained.

11. Each time an analytical system undergoes a major modification or prolonged period of inactivity, the precision of the system shall be demonstrated by the analysis of replicate laboratory performance check samples.

1VAC30-40-270. Records and data reporting. (Repealed.)

A. Records of chemical analyses shall be kept by the laboratory for three years. This includes all raw data, calculations, and quality control data.

B. The data shall contain the following information:

1. Date, place and time of sampling and name of person who collected the sample.

2. Identification of sample as to what type:

a. Routine distribution system sample.

b. Check sample.

c. Raw or process water sample.

d. Private well sample.

e. Special purpose sample.

3. Date of receipt of sample and date of analysis.

4. Laboratory and persons responsible for performing analysis.

5. Analytical technique and method used.

6. Result of analysis.

1VAC30-40-280. Action response to laboratory results. (Repealed.)

When the action response is a designated laboratory responsibility, the laboratory shall notify the proper authority of noncompliance sample results and request resampling from the same sampling point immediately.

Part IV
Microbiology

1VAC30-40-290. Personnel. (Repealed.)

Each laboratory shall provide a resume from each analyst involved in analyzing drinking water with sufficient information to show that personnel are adequately trained and experienced to perform the specific analyses for the categories being considered for certification. Whenever there is a change of personnel, DGS-DCLS shall be notified and provided with the new personnel data within 30 days of the change.

1VAC30-40-300. Laboratory facilities. (Repealed.)

The laboratory facilities shall include sufficient space to process and examine samples proportionate with the total work load. Laboratory facilities shall be clean and have controlled temperature and humidity and have adequate lighting at bench tops. Laboratory facilities shall include sufficient bench top area for processing samples; storage space for media, glassware, and portable equipment; floorspace for stationary equipment; and areas for cleaning glassware and sterilizing materials. The laboratory shall have provisions for decontamination and disposal of microbiological waste. Office areas for clerical work and record keeping shall be segregated from laboratory work areas.

1VAC30-40-310. Laboratory equipment and supplies. (Repealed.)

The laboratory shall have available or have access to the items required for Membrane Filter Technique, Fermentation Technique, Presence-Absence Test or ONPG-MUG Test procedures as listed below. All quality control procedures (marked "QC") must be documented.

Equipment shall be in good working order. Maintenance or service on any equipment shall be documented.

1. pH Meter shall be clean and accurate to ± 0.1 pH units. Scale graduated in at least 0.1 pH units. Store electrodes according to manufacturer's recommendations. Use pH buffer aliquot only once.

QC - Standardize pH meter each use period with pH 7.0 and pH 4.0 buffers. Standardize at least quarterly with pH 10.0 buffer.

QC - Date commercial buffer solution container upon receipt and when opened. Discard buffers before manufacturer's expiration date or one year from date of opening, whichever comes first.

2. Balance (top loader or pan) shall be clean, not corroded and able to detect 100 mg at a 150 g load.

QC - Calibrate balance monthly using Class S or S-1 reference weights. Use a minimum of three traceable weights which bracket the low, middle and high ranges of laboratory weighing needs.

QC - Maintain a service contract or internal maintenance protocol and maintenance records. Conduct maintenance at least annually.

3. Temperature monitoring devices. Use glass thermometers, dial thermometers or continuous recording devices for incubators, water baths, ovens and refrigerators. Thermometers for total coliform incubators shall be graduated in at least 0.5°C increments. Thermometers for fecal coliform water baths/incubators shall be graduated in at least 0.2°C increments. Liquid column in glass thermometers shall not be separated.

QC - Check calibration of glass mercury thermometers and continuous recording devices annually and check calibration of dial thermometers quarterly, at the temperature used. Use an NIST (formerly NBS) reference thermometer or one that meets the requirements of NBS monograph SP 250-23 for these calibrations. NIST reference thermometer must be graduated in 0.2°C increments or less.

4. Total coliform incubator shall maintain an internal temperature of 35° ± 0.5°C. Place thermometers on the top and bottom shelves of the use area with the thermometer bulb immersed in liquid. If aluminum block incubator is used, culture dishes and tubes shall be snug-fitting in block.

QC - Record temperature for days in use at least twice per day with readings at least four hours apart.

5. Fecal coliform water bath/incubator shall maintain a temperature of 44.5° ± 0.2°C. If aluminum block incubator is used, culture dishes and tubes shall be snug-fitting in block.

An incubation temperature of 44.5° ± 0.2°C can best be maintained with a water bath equipped with a gable cover.

QC - Record temperature for days in use at least twice per day with readings at least four hours apart.

6. Autoclave shall be in good operating condition and have a temperature gauge with a sensor on the exhaust, a pressure gauge and an operational safety valve. Vertical autoclaves and pressure cookers are not acceptable. For most efficient operation, a double-walled autoclave constructed of stainless steel is recommended. Autoclave maintains sterilization temperature (121°C) during the sterilization period and completes an entire cycle within 45 minutes when a 12-15 minute sterilization period is used. Autoclave depressurizes slowly to ensure media do not boil over and bubbles do not form in inverted tubes.

QC - Record date, contents, sterilization time and temperature for each cycle.

QC - Record the time media is placed in the autoclave and the time it is removed.

QC - Use maximum registering thermometer, heat sensitive tape, spore strips or ampoules during each autoclave cycle and record temperature. Avoid overcrowding.

QC - Check automatic timing mechanism with a stopwatch quarterly. Establish a service contract or internal maintenance protocol and maintain records.

7. Hot air oven shall maintain a stable sterilization temperature of 170 °C to 180°C. Its use is optional for sterilization of glass pipets, bottles, flasks, culture dishes and other dry items. Items shall be sterilized for at least two hours. Oven thermometer is graduated in 10°C increments or less with the bulb placed in sand during use. Oven thermometer can be read from outside of oven.

QC - Record date, time, temperature and contents of each sterilization cycle.

8. Colony counter. Use a dark field model colony counter to count Heterotrophic Plate Count (HPC) colonies.

Fully automatic colony counters are not suitable because of the size and small number of colonies observed when lab pure water or potable water are analyzed for HPC.

9. Conductivity or resistivity meter. Suitable for checking lab pure water. Readable in ohms or mhos, with a range from at least 2 ohms to 2 megohms ± 2% or equivalent micromhos. Unit may be in-line/bench or portable/battery operated.

QC - Conductivity meter shall be calibrated monthly with a 0.01 N or lower KCl solution as described in Standard Methods for the Examination of Water and Wastewater, 18th Ed., 1992, Part 2510. Preferably, calibrate meter in the range that it is used. A commercial conductivity or resistivity standard may be used.

10. Refrigerator maintains a temperature of 1-5°C (34- 40°F). Refrigerator thermometer shall be graduated in at least 1° increments and have the bulb immersed in water.

QC - Record temperature for days in use at least once per day.

11. Inoculating equipment. Inoculating loops shall have a diameter of at least 3 mm. Metal loops or needles shall be made of 22 to 24 gauge nickel alloy or platinum-iridium wire. Single-service metal loops or presterilized plastic loops may be used. Hardwood applicator sticks shall be dry heat sterilized. Swabs used for swabbing membrane filters shall be made of sterile cotton.

12. Membrane filtration equipment. MF funnels shall be stainless steel, glass or autoclavable plastic, not leak and not be scratched or corroded. Funnels shall be calibrated with a 100 mL Class A graduated cylinder and etched or otherwise marked at the calibrated 100 mL level. Field equipment is acceptable for coliform detection only when standard laboratory MF procedures are followed.

13. Membrane filters and pads. Membrane filters shall be those recommended by the manufacturer for water analysis. The recommendation shall be based on data relating to ink toxicity, recovery, retention, and absence of growth-promoting substances. Membrane filters shall be manufactured from cellulose ester materials, white, grid marked, 47 mm diameter with 0.45 um pore size or alternate pore size if manufacturer provides performance data equal to or better than the 0.45 um pore size. Membrane filters may be purchased presterilized or autoclaved before use.

QC - Record the lot number and date received for membrane filters.

QC - Check the sterility of each lot number of membrane filters by placing one membrane in 50 mL of single strength TSB and check for growth after 24 hours incubation at 35°C ± 0.5°C.

14. Optical/counting/lighting equipment for MF. Low power (10X - 15X) magnification device (preferably binocular microscope) with fluorescent light source shall be used for observing sheen colonies on membrane filters.

15. Culture dishes (loose or tight fitting lid). Use presterilized plastic or sterilizable glass culture dishes. To maintain sterility of glass culture dishes, use stainless steel or aluminum canisters, or wrap dishes in heavy aluminum foil or char-resistant paper. Incubate loose-lid dishes in a tight-fitting container, e.g., plastic vegetable crisper, to prevent dehydration of membrane filter and medium. Reseal opened packs of disposable culture dishes between use periods.

16. Culture tubes/bottles and closures. Culture tubes/bottles shall be made of borosilicate glass or other corrosion resistant glass and shall be large enough to contain the culture medium as well as the sample portions without being more than ¾ full. After sterilization, the fermentation vial shall be completely filled with medium and at least ⅓ to ½ submerged in medium. Closures shall be snug-fitting stainless steel or plastic caps, loose fitting aluminum caps, or screw caps with nontoxic liners.

17. Pipets/measuring equipment. Sterile glass or plastic pipets shall be used for measuring 10 mL or less. Pipets shall deliver the required volume quickly and accurately within a 2.5% tolerance. Pipets shall not be etched, mouthpiece or delivery tips shall not be chipped and graduation marks shall be legible. Pipet containers shall be aluminum or stainless steel, or wrap individual pipets in char-resistant paper or aluminum foil. Opened packs of disposable sterile pipets shall be resealed between use periods. Graduated cylinders are recommended for samples larger than 10 mL.

18. Sample containers. Sample bottles shall be wide mouth plastic or noncorrosive glass with a nonleaking ground glass stopper or a cap with a nontoxic liner which will withstand repeated sterilization, or other approved disposable, presterilized sample containers (e.g., Whirl-pak bags). Glass-stoppered bottle closures shall be covered with aluminum foil or char-resistant paper for sterilization. Capacity of sample containers shall be at least 120 mL.

Add sodium thiosulfate (Na2S2O3; anhydrous, 100 mg/L) to sample container before sterilization (0.1 mL of 10% Na2S2O3 solution per 120 mL capacity). Disposable, presterilized sample containers shall contain sodium thiosulfate.

QC - Check sterility of at least one bottle per batch of laboratory-sterilized sample bottles by adding 25 mL of sterile single strength TSB to each bottle. Incubate at 35° ± 0.5°C for 24 hours and check for growth.

QC - Check sterility of one Whirl-pak bag or other presterilized sample container from lot number in use every month. Use same procedure as for sterile bottles.

19. Glassware, plasticware and metal utensils. Except for disposable plasticware, items shall be resistant to effects of corrosion, high temperature and vigorous cleaning operations. Metal utensils shall be made of stainless steel. Flasks, beakers, pipets, dilution bottles, culture dishes, culture tubes/bottles, and other glassware shall be made of borosilicate glass and free of chips, cracks, or excessive etching. Volumetric glassware shall be Class A, denoting that it meets federal specifications and need not be calibrated before use. Graduated cylinders for measurement of sample volumes shall have a tolerance of 2.5% or less. Markings on graduated cylinders and pipets are legible. Plastic items shall be clear, inert and nontoxic and retain accurate, readable calibration marks after repeated autoclaving.

20. Ultraviolet lamp. Disconnect unit monthly and clean lamps by wiping with a soft cloth moistened with ethanol.

QC - If UV lamp is used for sanitization, test lamp quarterly with UV light meter and replace if it emits less than 70% of initial output or if agar spread plates containing 200 to 250 microorganisms, exposed to the UV light for two minutes, do not show a count reduction of 99%.

1VAC30-40-320. General laboratory practices. (Repealed.)

A. Sterilization procedures.

1. Media, membrane filters and pads shall be removed immediately after completion of sterilization cycle.

2. Membrane filter assemblies shall be sterilized between sample filtration series. A filtration series ends when 30 minutes or longer elapse between individual sample filtrations.

B. Laboratory pure water.

1. Use only satisfactorily tested reagent water from stills or deionization units to prepare media, reagents and dilution/rinse water for microbiological analyses.

2. QC - Test the quality of the lab pure water or have it tested by a certified lab to assure it meets these criteria:

C. Dilution/rinse water.

1. Prepare stock buffer solution according to Standard Methods, 18th Ed., 1992, Part 9050 C.1.a. Autoclave or filter sterilize stock buffer, label and date container and store in refrigerator. Ensure stored stock buffer solution is free of turbidity.

2. Prepare rinse/dilution water by adding 1.25 mL of stock buffer solution and 5 mL of magnesium chloride (MgCl₂) solution to one liter of lab pure water. Make magnesium chloride solution by adding 81.1 g MgCl₂. 6H₂O or 38g of anhydrous MgCl₂ to one liter of lab pure water. Autoclave rinse/dilution water according to Table IV-1 of this chapter.

3. QC - Check each batch of dilution/rinse water for sterility by adding 50 mL of dilution/rinse water to 50 mL of double strength TSB. Incubate at 35° ± 0.5°C for 24 hours and check for growth.

D. Glassware washing.

1. Washing processes shall provide clean glassware with no stains or spotting. Glassware shall be washed in a warm detergent solution and thoroughly rinsed initially in tap water. Use distilled or deionized water for final rinse.

2. QC - Perform the Inhibitory Residue Test (Standard Methods, 18th Ed., 1992, Part 9020 B.3.a.2)) on the initial use of a washing compound and whenever a different formulation of washing compound, or washing procedure, is used to ensure glassware is free of toxic residue.

E. Media; general requirements.

1. Use dehydrated or ready to use media manufactured commercially. Store dehydrated media in a cool, dry location away from direct sunlight and discard caked or discolored dehydrated media.

2. Date bottles of dehydrated media when received and when opened. Discard dehydrated media six months after opening; if stored in a desiccator from the time of opening, storage is extended to 12 months. Discard dehydrated media that has passed the manufacturer's expiration date. Unopened dehydrated media should be used within two years of date of receipt.

3. QC - Record the date of preparation, type of medium, manufacturer's lot number, sterilization time and temperature, final pH and technician's initials for media prepared in the laboratory. Store prepared media as described in Table IV-3.

4. QC - Check each batch of laboratory-prepared media and each lot number of commercially prepared (ready to use) media before use with a known positive and a known negative culture control. These control organisms can be stock cultures (periodically checked for purity) or commercially available disks impregnated with the organism.

5. Incubate refrigerated broth in culture tubes and bottles with fermentation vials overnight at 35°C before use. Discard tubes and bottles showing growth or bubbles.

6. Check tubes and bottles of broth before use and discard if evaporation exceeds 10% of original volume.

7. QC - For commercially prepared (ready to use) liquid media and agars, record the date received, lot number and pH verification. Discard media by manufacturer's expiration date.

1VAC30-40-330. Analytical methodology. (Repealed.)

A. Laboratories shall meet the sampling and analytical methodology requirements incorporated by reference at 1VAC30-40-85 B 3 for microbiology and 1VAC30-40-85 B 5 for alternative test methods.

B. A laboratory shall be certified for all analytical methods that it uses. At minimum, the laboratory shall be certified for one total coliform method, one fecal coliform or E. coli method, and the Pour Plate Method for heterotrophic bacteria.

C. Laboratories shall perform a minimum of 20 coliform analyses monthly by each coliform method for which it is certified in order to maintain certification status or qualify for initial certification. The minimum number of coliform analyses (20) may be performed on a variety of water sample types collected from different stages of the water treatment process, raw source water, surface or ground water, as well as drinking water samples collected from a distribution system or private wells.

1VAC30-40-340. Sample collection, handling and preservation (Repealed.)

A. If a laboratory does not collect samples and has no control over sample collection, handling, preservation and identification, the laboratory director must reject any samples not meeting sampling criteria and notify the authority requesting the analyses. The laboratory shall have a written sample rejection policy covering those samples that do not meet sampling requirements.

B. Sample collector shall be trained in sampling procedures and, if required, approved by the VDH-ODW.

C. Samples shall be representative of the potable water distribution system. Samples collected from public water supplies shall be collected in accordance with a sample siting report approved by the VDH-ODW. Water taps used for sampling are free of aerators, strainers, hose attachments, mixing type faucets and purification devices. Maintain a steady water flow for at least two minutes to clear the service line before sampling. Collect at least a 100 mL sample volume and allow at least 1/2 inch of space in the sample container to facilitate mixing of sample by shaking.

D. Laboratories that collect as well as analyze samples shall ice samples immediately after collection and deliver the samples directly to the laboratory.

E. The sample container, required preservation, and maximum holding time requirements for sampling and analyzing microbiological contaminants are incorporated by reference at 1VAC30-40-85 B 3.

F. Sample report.

1. Immediately after collection, enter on the sample report form the sample site location, sample type (e.g. regular, repeat, etc.), date and time of collection, free chlorine residual, collector's name and any remarks.

2. Record the date and time of sample arrival at the laboratory and the date and time analysis begins.

1VAC30-40-350. Records and data reporting. (Repealed.)

Records of microbiological analyses shall be kept by the laboratory or be accessible to the laboratory for at least five years. If reports are entered into a computer storage system, a printout of the data shall be returned to the laboratory for verification from the bench worksheets. Summary reports shall contain all of the information required on individual sample records. Where applicable, standard Virginia State Health Department forms shall be used; where not applicable, sample report forms shall include the following:

1. Date, place, and time of sampling and sample collector's name.

2. Identification of sample as to whether it is a chlorinated or nonchlorinated sample, regular distribution system sample, repeat sample, raw or plant tap sample, well-water sample, or other special purpose sample.

3. Date and time of receipt of sample into the laboratory and date of analysis.

4. Laboratory and persons responsible for performing analysis.

5. Analytical procedure/method used.

6. Analysis results.

1VAC30-40-360. Action response to laboratory results. (Repealed.)

A. Immediately notify the appropriate field office of the VDH-ODW of any coliform-positive samples from public water supplies.

B. All analytical results for compliance shall be reported directly to the VDH-ODW as described in 1VAC30-40-40.

C. Repeat sampling shall be initiated on the basis of coliform presence in either the Fermentation Technique confirmed test, unverified MF Test, P-A confirmed test, or ONPG-MUG Test. Data used to determine monthly compliance may be adjusted by using the Fermentation Technique completed test, verified MF Test results or P- A completed test results.

D. Notify the appropriate field office of the VDH-ODW when samples from public water supplies are invalidated due to interference from noncoliforms.

Part V
Radiochemistry

1VAC30-40-370. Radiochemistry. (Repealed.)

A. Laboratories shall meet the sampling and analytical methodology requirements incorporated by reference at 1VAC30-40-85 B 4 for radiochemistry and 1VAC30-40-85 B 5 for alternative testing methods.

B. For radiochemistry certification of laboratories, DGS-DCLS shall require conformance to USEPA "Manual for the Certification of Laboratories Analyzing Drinking Water," EPA-814B-92-002 Chapter VI, Radiochemistry, September 1992. Appropriate revisions of the manual shall become effective upon issuance.

FORMS (1VAC30-40) (Repealed.)

Application for Certification, Safe Drinking Water Act (rev. 2/94).

Safe Drinking Water Program Laboratory Personnel List.

CHAPTER 41

REGULATION FOR THE CERTIFICATION OF LABORATORIES ANALYZING DRINKING WATER

PART I

GENERAL PROVISIONS

1VAC30-41-10. Purpose.

A.  This chapter establishes the requirements for certification of drinking water laboratories.

B.  The federal Safe Drinking Water Act (SDWA) mandates the establishment of a national drinking water program to protect public health. The U.S. Environmental Protection Agency (EPA) at 40 CFR 141.28 requires that laboratories be certified to analyze samples of drinking water for compliance purposes.   EPA at 40 CFR 142.10(b)(3)(i) requires states to establish and maintain programs for the certification of drinking water laboratories.

C.  The Virginia Department of Health, Office of Drinking Water (VDH-ODW) maintains primary enforcement responsibility (primacy) under the SDWA and the federal SDWA regulations for the Commonwealth of Virginia.  The VDH-ODW at 12VAC5-590-340 requires that all analyses done to demonstrate compliance with primary and secondary maximum contaminant levels or action levels be performed by the Division of Consolidated Laboratory Services of the Department of General Services (DCLS) or by laboratories certified by DCLS.  VDH-ODW at 12VAC5-590-440 further requires that laboratories seeking certification to perform drinking water analyses shall comply with this chapter.

1VAC30-41-20. Applicability.

A.  This chapter applies to the following:

 1.  Owners of drinking water laboratories in Virginia.

 2.  Owners of drinking water laboratories located outside Virginia who seek reciprocal certification under1VAC30-41-90.

B.  Covered contaminants.

1.  This chapter covers the contaminants regulated in 40 CFR Parts 141 and 143 as specified in the VDH-ODW Waterworks Regulations, 12VAC5-590.

2.  Exceptions.

Laboratory testing for alkalinity, calcium, chlorite, conductivity, disinfectant residual, orthophosphate, pH, silica, temperature, and turbidity for compliance purposes may be performed by laboratories or persons not certified under this chapter but acceptable to VDH-ODW.

1VAC30-41-30. Alternative certification for drinking water laboratories.

Drinking water laboratories may become certified by meeting the requirements for accreditation set out in 1VAC30-46.

1VAC30-41-40. Definitions.

The following words and terms, when used in this chapter, shall have the following meanings, unless the context already indicates otherwise:

"Analyst" means a chemist, microbiologist, physicist, or technician who actually performs a test. The analyst may carry out the complete test or participate jointly with other analysts.

"Certification officer" means a DCLS employee who has the responsibility for evaluating drinking water laboratories for certification.

"Contaminant" means any objectionable or hazardous physical, chemical, biological or radiological substance or matter in water.  Contaminants are the analytes that drinking water laboratories test for in the drinking water samples they analyze.

"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.

"Drinking water laboratory" or "laboratory" means a laboratory that performs analyses to demonstrate compliance with primary or secondary maximum contaminant levels or action levels or any combination of these specified in 12VAC5-590.

"EPA" means the United States Environmental Protection Agency.

"Findings" means factual, objective statements that provide evidence of deficiencies in meeting the requirements of this chapter.

"Laboratory director" or "laboratory supervisor" means the person who directs the operation of the drinking water laboratory on a day to day basis.

 "Manual" means the EPA Office of Water, Manual for the Certification of Laboratories Analyzing Drinking Water - Criteria and Procedures Quality Assurance, Fifth Edition, EPA 815-R-05-004 (January 2005).

"Manual supplement" means the EPA Office of Water, Supplement 1 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water, EPA 815-F-08-006 (June 2008).

"Maximum contaminant level (MCL)" means the maximum permissible level of a contaminant in water which is delivered to any user of a waterworks, except in the cases of turbidity and VOCs, where the maximum permissible level is measured at each entry point to the distribution system.  Contaminants added to the water under circumstances controlled by the user, except those resulting from corrosion of piping and plumbing caused by water quality, are excluded from this definition.  Maximum contaminant levels may be either "primary" (PMCL), meaning based on health considerations or "secondary" (SMCL) meaning based on aesthetic considerations.

"Owner" means any person who owns, operates, leases or controls a drinking water laboratory.

"Persistent" means to continue an activity without change in spite of opposition or warning. 

"Private laboratory" means a laboratory that is or is part of a commercial entity.

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

"Public laboratory" means a laboratory that is or is part of a local, state, or U.S. governmental agency.

"Quality assurance" means an integrated system of management activities involving planning, quality control, quality assessment, reporting and quality improvement to ensure that a product or service meets defined standards of quality with a stated level of confidence.

"Quality assurance (QA) plan" means a comprehensive plan detailing the aspects of quality assurance needed to adequately fulfill the data needs of a program.

"Quality control" means

(1)  The overall system of technical activities whose purpose is to measure and control the quality of a product or service so that it meets the needs of the users.

(2)  The operational techniques and activities that are used to fulfill requirements for quality.

"SDWA" means the Safe Drinking Water Act (42 USC § 300 f et seq.).

"VDH-ODW" means the Virginia Department of Health - Office of Drinking Water.

1VAC30-41-50. Incorporation by reference - EPA Guidance.

A.  The following EPA guidance documents are incorporated by reference into this chapter:

1.  The Manual for the Certification of Laboratories Analyzing Drinking Water, Fifth Edition, EPA 815-R-05-004 (January 2005) [Manual].

2.  Supplement 1 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water, EPA 815-F-08-006 (June 2008) [Manual Supplement].

B.  The federal regulatory requirements incorporated by reference into 1VAC30-41-55 shall govern if a conflict is found between the requirements of the Manual or the Manual Supplement and the requirements incorporated by reference into 1VAC30-41-55.

1VAC30-41-55. Incorporation by reference - Code of Federal Regulations.

A. The sampling, analytical methodology, and laboratory certification requirements of 40 CFR 141 and 143 (2011) in effect as of July 1, 2011, are incorporated by reference into this chapter.

B. The specific sampling, analytical methodology, and laboratory certification requirements incorporated by reference are listed below by category for information purposes:

1. Inorganic chemistry: 40 CFR 141.23, 40 CFR 141.89, and 40 CFR 141.131.

2. Organic chemistry: 40 CFR 141.24 and 40 CFR 141.131.

3. Microbiology: 40 CFR 141.21, 40 CFR 141.74, 40 CFR 141.174, 40 CFR 141.704, and 40 CFR 141.705. 40 CFR 136.3 (a) for e. coli requirements under 40 CFR 141.704.

4. Radiochemistry: 40 CFR 141.25.

5. Alternative testing methods: 40 CFR Part 141, Subpart C, Appendix A.

6. Test methods specified for secondary maximum contaminant levels: 40 CFR 143.4.

C. The exceptions to the requirements for laboratory certification in 40 CFR 141.28, 40 CFR 141.74(a), 40 CFR 141.89(a)(1), 40 CFR 141.131(b)(3), and 40 CFR 141.131(c)(3) are incorporated by reference into this chapter.

PART II

CERTIFICATION OF LABORATORIES - GENERAL REQUIREMENTS

1VAC30-41-60. Categories of certification.

A.  Laboratories may apply to be certified for inorganic chemistry, organic chemistry, microbiology, radiochemistry, or any combination of these four categories of certification. 

B.  Within each category, laboratories may be certified for specific contaminants or contaminant groups and for one or more methods used to determine the levels of these contaminants.

1VAC30-41-70. Initial certification application.

A.  Application for initial certification.

Drinking water laboratories applying under this chapter shall submit a completed Application for Certification, obtained by contacting the DCLS Laboratory Certification office.  A complete application contains:

1. Specific laboratory information, including name of organization, name of laboratory director, and contact information.

2. Identification of public water systems served by the laboratory.

3. Identification of the drinking water certification contaminants or contaminant groups and related methods for which the laboratory requests certification.

4. A quality assurance plan that meets Chapter III, Section 11 of the Manual and Manual Supplement to Chapter III, Section 2 as required by 1VAC30-41-120.

5. A satisfactory report of at least one proficiency test performed within the last 12 months for each method and contaminant for which the laboratory seeks certification.

6. Laboratory personnel list.

7. Requested laboratory data, which includes, at a minimum:

a. For microbiology applications:

(1)  Equipment and supply list.

(2)  Sampling information and test results for at least 20 analyses for each method and contaminant for which the laboratory seeks certification.

b. For chemistry applications:

(1)  Instrumentation and equipment list.

(2)  Method Detection Limit (MDL) documentation for each requested method and contaminant for which the laboratory seeks certification.

(3)  Initial Demonstration of Capability (IDC) documentation for each requested method and contaminant for which the laboratory seeks certification.

c. For radiochemistry applications:

(1)  Instrumentation and equipment list.

(2)  Minimum Detectable Activity (MDA) documentation for each requested method and contaminant for which the laboratory seeks certification.

(3)  Initial Demonstration of Capability (IDC) documentation for each requested method and contaminant for which the laboratory seeks certification.

8.  Payment of the fee required by 1VAC30-41-270.

B.  DCLS review of application submittal. 

1.  DCLS shall administratively review the application submittal and respond to the applicant laboratory within 60 calendar days. 

2.  If DCLS finds that the application submittal is complete, a certification officer shall arrange a mutually agreeable time and date with the laboratory for an on-site assessment.

3.  If DCLS finds that the application submittal is incomplete, a certification officer shall request the applicant laboratory to submit the additional information or documentation required within 90 days.

4.  If the laboratory has not submitted the required additional information within 90 days of the DCLS request for information, DCLS may return the incomplete application and inform the laboratory that the application cannot be processed.  The laboratory may then submit a new application.  

1VAC30-41-80. Certification requirements.

To become certified, a laboratory shall meet or successfully complete the following:

1.  Requirements for a quality assurance plan in 1VAC30-41-120.

2.  Analysis of a proficiency test (PT) sample for each contaminant and each method for which certification is sought.  Proficiency testing requirements are set out in 1VAC30-41-130.

3.  Specific requirements for chemistry, microbiology, or radiochemistry that are pertinent to the specific laboratory's application for certification.  These requirements are set out in Parts III through V of this chapter.

4.  On-site assessment by DCLS certification officers at least once every three years.  On-site assessment requirements are set out in 1VAC30-41-150.

5.  The laboratory ethics and fraud detection and deterrence requirements set out in 1VAC30-41-140.

6.  Payment of the fee required by 1VAC30-41-270.

1VAC30-41-90. Reciprocity.

A. DCLS may grant reciprocal certification to a drinking water laboratory located outside Virginia provided the laboratory demonstrates the need to serve customers in Virginia and is certified by EPA or another state under equivalent certification criteria.

B. To be considered for certification, the applicant laboratory shall send DCLS the following:

1. A copy of the certificate and scope of certification issued by the laboratory's primary certifying or accrediting authority.

2. A list of the methods and the contaminants tested under each method for which the laboratory is requesting certification.

3. The most recent PT report for each method and contaminant combination listed by the laboratory under subdivision B 2 of this section.

4. The fee required under 1VAC30-41-270.

5. Confirmation that Virginia has been added to the PT provider's list of certifying authorities to whom the laboratory's PT results will be reported.

C. Out-of-state laboratories holding NELAC accreditation for drinking water that seek reciprocal accreditation for drinking water in Virginia shall apply for that accreditation under 1VAC30-46.

1VAC30-41-100. Renewal of certification.

DCLS shall renew the certification for a drinking water laboratory if the laboratory maintains its certified status as required by 1VAC30-41-180, and pays the annual fee as required by 1VAC30-41-270.

1VAC30-41-110. Modification of certification.

A.  To request the addition of contaminants or methods to its certification, the drinking water laboratory shall submit the following to DCLS:

1.  A completed DCLS drinking water certification application form.

2.  An acceptable PT report for each requested method and contaminant, performed within the last 12 months.

3.  The standard operating procedures for the requested methods.

4.  The current quality assurance plan, if requested.

5.  For chemistry:

a.   Method Detection Limit (MDL) documentation for each requested method and contaminant for which the laboratory seeks certification.

b.   Initial Demonstration of Capability (IDC) documentation for each requested method and contaminant for which the laboratory seeks certification.

6.  For microbiology, sampling information and test results for at least 20 analyses by the requested method and contaminant combination.

7. Applicable fees as required by 1VAC30-41-270.

B.  To drop a contaminant or a method from the laboratory's certification, the laboratory shall submit a request in writing to the DCLS certification office.

1VAC30-41-120. Quality assurance plan.

A drinking water laboratory shall develop and maintain a quality assurance plan that meets the requirements of (i) Chapter III, Section 11 of the Manual and (ii) the Manual Supplement to Chapter III, Section 2.

1VAC30-41-130. Proficiency testing.

A.  A drinking water laboratory shall meet the following requirements pertaining to proficiency testing:

1.  The requirements of this section.

2.  The requirements of Chapter III, section 13.1 of the Manual.

3.  The specific requirements of the Manual for chemistry in Chapter IV, Section 7.2.1, for microbiology in Chapter V, section 7.2, and for radiochemistry in Chapter VI, section 7.4 that are pertinent to the laboratory.

B.  A drinking water laboratory shall successfully participate in at least one Water Supply (WS) PT study per calendar year for each contaminant and by each method for which the laboratory seeks or wants to maintain certification.

C.  Drinking water laboratories shall obtain WS PT studies from PT providers approved by the American Association for Laboratory Accreditation utilizing the "National Standards for Water Proficiency Testing Studies."

D.  Drinking water laboratories shall instruct the PT providers to send the results of the WS PT studies to the DCLS Laboratory Certification Office.

E.  WS PT study results.

1.  DCLS shall certify or maintain certification for a drinking water laboratory for which WS PT study results are reported by the proficiency test provider as "acceptable."

2.  A drinking water laboratory for which some or all WS PT study results are reported as "not acceptable" shall follow the procedure in subsection F of this section.

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

1.  When a laboratory receives a PT study result of "not acceptable," the laboratory shall perform and document corrective action.  The corrective action documentation shall be submitted to DCLS within 30 days of receiving the "not acceptable" PT study result.

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

3.  If the result of the laboratory's makeup PT study is "acceptable," DCLS shall not downgrade the laboratory.

4. If the laboratory fails the makeup PT study, DCLS shall downgrade the laboratory to provisionally certified status for the contaminant or contaminants for which the PT study was "not acceptable."

5.  When DCLS becomes aware of a failure to comply with PT study requirements DCLS shall notify the laboratory of its downgraded status within 14 days of the downgrade.  DCLS shall send the notification by certified mail or an equivalent mailing service.

6.  The laboratory shall correct the problems that caused the downgrade and satisfactorily analyze another PT study within three months.  A laboratory may not be provisionally certified for more than three months.

7.  If the result of the second makeup PT study is "acceptable," the laboratory can request DCLS in writing to restore its certified status.

8.  If the result of the second makeup PT is "not acceptable," DCLS shall revoke certification for the contaminant or contaminants for which the PT study was unsuccessful.

9.  DCLS shall follow the provisions of 1VAC30-41-240 in revoking the laboratory's certification.

1VAC30-41-140. Laboratory ethics and fraud detection and deterrence.

Drinking water laboratories shall meet the requirements of the Manual Supplement to Chapter III of the Manual concerning laboratory ethics and fraud detection and deterrence.

1VAC30-41-150. On-site laboratory assessment.

A.  Frequency of on-site laboratory assessments.

1.  DCLS shall assess a drinking water laboratory when the laboratory owner initially applies for certification and at least once every three years after initial certification is granted.

2.  DCLS may perform an on-site assessment if major changes in personnel or equipment occur at the laboratory or if the location of the laboratory changes.

3.  DCLS may perform interim on-site assessments to confirm that a laboratory has carried out a corrective action plan.

4.  DCLS may perform unannounced on-site assessments.

B.  Action prior to a scheduled on-site assessment.

1.  DCLS shall arrange a mutually agreeable date and time for the on-site assessment with the drinking water laboratory's management.

2.  Prior to the on-site audit, DCLS shall request and the laboratory shall provide current records and information that are necessary to evaluate the laboratory.  These records and information may include the following:

a.  Quality manual.

b.  Personnel list.

c.  Instrument list or equipment list or both.

d.  Standard operating procedure (SOP) for each method to be evaluated.

e.  A data package specified by the certification officer.

f.  For chemistry, the most recent MDL study for each regulated contaminant  to which the MDL requirement applies.

C.  Opening conference. 

The DCLS on-site assessor or team shall begin the process of the on-site assessment by holding a conference to state the purpose of the assessment, identify the assessment team, and set out the tasks to be done during the assessment.

D.  Assessment process.

1.  The DCLS on-site assessment team shall evaluate  laboratory personnel qualifications and training, operations, equipment, supplies, general laboratory practices, sample  handling procedures, methodology, written procedures, and records.  The team shall perform the assessment for those specific methods and contaminants for which the laboratory has requested certification.

2.  DCLS may require a laboratory to demonstrate drinking water methods during the assessment.

3.  The DCLS on-site assessment team shall perform a data audit on at least one sample and on one PT sample for at least one method.

4.  The DCLS on-site assessment team shall discuss observed deviations at the time they are observed.

5.  Findings or deviations are considered preliminary until the final report is issued.

E.  Closing conference. 

1.  The on-site assessment team shall conduct a closing conference to review the results of the assessment with laboratory staff and management. 

2.  The on-site assessment team shall discuss the following:

a.  Any deviations in the observed procedures and records.

b.  The time frame for any corrective actions needed and the response.

c.  Recommendations, if necessary, for changes in equipment and supplies, staffing, and facility.

F.   Within 30 calendar days after the on-site assessment, DCLS shall notify the laboratory of its certification status and send the laboratory the final on-site assessment report.

G.  Final report.

In its final on-site report, DCLS:

1. Shall list the certification status for each contaminant or, if applicable, each class of contaminants evaluated as determined by DCLS as a result of the on-site assessment.

2.  Shall list and describe each finding, providing a reference to the underlying requirement.

3. May recommend changes to correct the problems described in the findings that have resulted in the laboratory not obtaining certification for a particular contaminant.

4.  May recommend improvements to laboratory operation, recognize outstanding performance, and provide other information of use to the laboratory.

H.  Results of the on-site assessment.

1.  DCLS shall certify the laboratory when the on-site assessment shows that the laboratory has established or is maintaining the standards of quality required under this chapter.

2.  When DCLS finds during the on-site assessment that the laboratory is not maintaining the standards of quality required under this chapter, the laboratory shall follow the procedure in subsection I of this section.

I.  Procedures and requirements when findings are reported.

1.  The laboratory shall respond with a corrective action plan for all findings issued in the report within 60 calendar days.  This corrective action plan shall specify what immediate corrective actions are being taken and any proposed actions that need the concurrence of DCLS.

2. DCLS shall review the corrective action plan.  If DCLS finds that any aspect of the laboratory's corrective action plan is inadequate, it shall notify the laboratory director in writing by certified mail or other equivalent mailing service of its intent to downgrade the laboratory.

3.  The laboratory director shall respond within 30 calendar days with an additional corrective action plan.  If the additional corrective action plan is still deficient, DCLS shall not issue a certificate for the initial application or shall downgrade the laboratory to provisionally certified status.

4.  DCLS shall respond within 14 days of determining the laboratory's letter and corrective action plan are deficient.

5.  The laboratory shall correct the problems cited in the initial notification letter within three months of the date the laboratory was downgraded.

6.  If within three months the laboratory has not corrected the problems for which DCLS downgraded the laboratory to provisionally certified status, DCLS shall revoke the laboratory's certification status. 

7.  DCLS shall revoke certification only for the contaminants and methods for which the laboratory was initially cited.

8.  DCLS shall follow the provisions of 1VAC30-41-240 in revoking the laboratory's certification. 

9.  When DCLS reports a finding that had been identified in the previous tri-annual on- site assessment where the laboratory had not implemented corrective action, DCLS shall downgrade the laboratory to provisionally certified.

10.  A provisionally certified laboratory may continue to analyze samples for compliance purposes but shall notify its clients of its downgraded status and provide that information in writing on any report.

1VAC30-41-160. Levels of certification.

A. "Certified."  DCLS shall certify a laboratory that meets the criteria set out in this chapter.

B. "Interim certification."  DCLS may issue an interim certification when it finds that performing an on-site assessment is unnecessary or when the on-site assessment cannot be scheduled within a reasonable time.  This may occur when DCLS reviews a laboratory application for an addition to its certification status or when a laboratory notifies DCLS that its location is changing.  The laboratory shall maintain the requirements for certification while awaiting the on-site assessment.  DCLS shall perform the on-site assessment as soon as possible.  Interim certification status is equivalent to certified status.

C. "Provisionally certified."  DCLS shall provisionally certify a laboratory that has deficiencies as a preliminary stage prior to revocation.  A provisionally certified laboratory may continue to analyze drinking water samples for compliance purposes.  The laboratory shall notify its clients of the downgraded status in writing and indicate the status on reports.  A laboratory may not be provisionally certified for more than three months. 

D.  "Not certified."  DCLS shall not certify a laboratory that possesses deficiencies and, in the opinion of DCLS, cannot consistently produce valid data.  A laboratory that has had its certification revoked in whole or in part shall notify its clients of its revoked status in writing.

1VAC30-41-170. Term of certification.

DCLS shall certify drinking water laboratories for a period of one year.

1VAC30-41-180. Maintenance of certified status.

To maintain its certified status, a laboratory shall:

1.  Continue to meet the requirements for certification listed in 1VAC30-41-80.

2.  Successfully pass WS PT studies annually as required by1VAC30-41-130.

3.  Notify DCLS in writing within 30 calendar days of major changes in personnel, equipment or laboratory location as specified in 1VAC30-41-200.

4.  Use approved methodology as required by this chapter and incorporated by reference into 1VAC30-41-55.

5.  Comply with the reporting requirements specified in 1VAC30-41-190.  

1VAC30-41-190. Reporting requirements.

A.  To maintain certification, drinking water laboratories shall comply with the reporting requirements set out in the VDH-ODW regulations specified below: 

1.  Compliance, monitoring, and exceedances, 12VAC5-590-530. 

2.  Public notices, 12VAC5-590-540. 

B.    Drinking water laboratories shall report the results of analyses to the VDH-ODW within three days of completion unless 12VAC5-590-530 or 12VAC5-590-540 requires a different time limit.

1VAC30-41-200. Major changes in personnel or equipment or a change of laboratory location.

A.  Major change in personnel.

1.  The drinking water laboratory shall notify DCLS of a major change in the laboratory's personnel in writing within 30 calendar days of the change.

2.   A major change in personnel is defined as (i) the loss or replacement of the laboratory director or laboratory supervisor or (ii) the loss of all the trained and experienced analysts that had been available to analyze a particular contaminant for which certification has been granted.

3.  DCLS shall follow the procedure in 1VAC30-41-220 to downgrade the laboratory to provisionally certified status if the laboratory fails to notify DCLS within 30 calendar days of a major change in personnel. 

B.  Change of laboratory location.

1.   The laboratory shall notify DCLS of a change in the laboratory's location in writing at least 30 calendar days prior to the location change.

2.  DCLS may perform an on-site assessment of the new facility when a laboratory changes location.

3.  DCLS shall follow the procedure in 1VAC30-41-220 to downgrade the laboratory to provisionally certified status if the laboratory fails to notify DCLS of a change in the laboratory's location at least 30 days prior to the location change.

C.  Equipment.

1.  A drinking water laboratory shall notify DCLS in writing within 30 calendar days of a major change in equipment.

2.  A drinking water laboratory shall provide the following information to DCLS about new equipment:

a.  Make and model of the new instrument.

b.  Date of installation and training.

c.  Initial demonstration of capability (IDC) and minimum detection limit (MDL).

d.  Updated standard operating procedure (SOP).

e.  Methods and contaminants for which the instrument will be used.

f.  Successful PT analyzed on the new instrument.

g.  Date the instrument was put into service analyzing compliance samples.

3.   DCLS shall follow the procedure in 1VAC30-41-220 to downgrade the laboratory to provisionally certified status if the laboratory fails to notify DCLS within 30 calendar days of any major change in equipment.

D.  Laboratory action to address major changes to personnel or equipment or a change of location.

1.  When a major change to laboratory personnel or equipment or a change of location occurs, the laboratory shall establish a schedule to address the change and provide the schedule in writing to DCLS.   The laboratory shall submit the schedule to DCLS along with the notification of the change.

2.  If DCLS determines that the laboratory can no longer produce valid data because of the major change in personnel or equipment or the change of location, DCLS shall follow the procedure in 1VAC 30-41-240 to revoke certification for the contaminants in question.

1VAC30-41-210. Downgrading to provisionally certified status.

DCLS shall downgrade a certified drinking water laboratory's status to provisionally certified for each contaminant and by each method for any of the following reasons:

1.  Failure to analyze a PT sample each calendar year during the period defined by DCLS and within the acceptance limits specified in the regulations incorporated by reference in 1VAC30-41-55.

2.  Failure to successfully analyze a PT sample for a contaminant after participating in two successive PT studies.

3.   Failure to notify DCLS within 30 calendar days of major changes in personnel or equipment or a change in laboratory location as required by 1VAC30-41-200.

4.  Failure to satisfy DCLS that the laboratory is maintaining the required standard of quality based upon the on-site assessment requirements in 1VAC30-41-150.

5.  Failure to comply with the reporting requirements of 1VAC30-41-190 in a timely manner.

1VAC30-41-220. Procedure to downgrade to provisionally certified status.

A. DCLS shall notify the laboratory director in writing that DCLS intends to downgrade the laboratory to provisionally certified status.  DCLS shall send this notification within 14 days of becoming aware of the cause for the downgrade.  DCLS shall send the notification by certified mail or other equivalent mailing service.

B.  The laboratory director shall review the problems cited in the notice.  Within 30 days of receiving the notice, the laboratory director shall send DCLS a letter specifying what immediate corrective actions are being taken and any proposed actions that need the concurrence of DCLS.

C.  DCLS shall consider the adequacy of the laboratory's response and notify the laboratory director in writing by certified mail or other equivalent mailing service of the laboratory's certification status.  DCLS shall respond within 14 days of receiving the laboratory's letter and corrective action plan.

D.  The laboratory shall correct the problems cited in the initial notification letter from DCLS within three months of the date of the DCLS response to the laboratory's corrective action plan.

E.  If within three months the laboratory has not corrected the problems for which DCLS downgraded the laboratory to provisionally certified status, DCLS shall revoke the laboratory's certification status.  This revocation shall apply only to the contaminants and methods for which the laboratory was initially cited in the DCLS downgrade notification.

F.  DCLS shall follow the provisions of 1VAC30-41-240 in revoking the laboratory's certification.

G.  A provisionally certified laboratory may continue to analyze samples for compliance purposes but shall notify its clients in writing of its downgraded status and shall provide that information in writing on any report.

1VAC30-41-230. Revocation of certified status.

DCLS shall downgrade a drinking water laboratory's status to not certified from certified or provisionally certified or interim certified status for each contaminant and by each method for any of the following reasons:

1.  Falsification of data or use of other deceptive practices.

2.  Reporting PT data from another laboratory as its own.

3.  Failure to use the Federally-approved methods incorporated by reference into this chapter at 1VAC30-41-55.

4.  Refusal to participate in an on-site assessment conducted by DCLS.

5.  Failure to pay the annual fee to DCLS.

6.  For provisionally certified laboratories, failure to successfully analyze a PT sample or any other unknown test sample for a particular contaminant within the specified acceptance limits.

7.  For provisionally certified laboratories, failure to satisfy DCLS that the laboratory has corrected identified deficiencies based on an on-site assessment.

8.  For provisionally certified laboratories, persistent failure to comply with the reporting requirements specified in 1VAC30-41-190.

1VAC30-41-240. Procedure to revoke certification.

A.  DCLS shall notify the laboratory owner in writing of its intent to revoke certification.  DCLS shall describe in detail the reasons and circumstances that form the basis for revoking certified status in this notice.   DCLS shall send the notification by certified mail or an equivalent mailing service.

B.  DCLS shall provide an opportunity for an Informal Fact Finding Conference pursuant to § 2.2-4019 of the Administrative Process Act prior to making a final decision to revoke certification.

C.  A drinking water laboratory that has had its certification revoked for methods and contaminants under the methods shall do the following:

1.  Stop analyzing SDWA compliance samples for these contaminants and methods.

2.  Send the samples to a laboratory that is certified to perform the analyses.

3.  Notify its clients of its revoked status in writing.

1VAC30-41-250. Appeal procedure.

A laboratory may appeal a final decision to revoke certification by DCLS pursuant to the Administrative Process Act (§ 2.2-4000 et seq.).

1VAC30-41-260. Reinstatement of certification.

A.  A drinking water laboratory may request in writing to have its certification status upgraded or reinstated. 

B.  DCLS shall upgrade or reinstate certification when the laboratory can demonstrate that it has corrected the deficiencies that produced the downgrading or revocation of certified status. 

C.  DCLS may require an on-site assessment or successful completion of a WS PT study or both before upgrading or reinstating a drinking water laboratory.   If the on-site assessment is necessary, the laboratory shall pay the fees set out in 1VAC30-41-270 H.

1VAC30-41-270. Fees.

A.    DCLS shall charge a fee to certify drinking water laboratories.  This fee shall be limited to the cost of administering the certification program. 

B.  Required fees.

1.  Drinking water laboratories shall submit payment of the fee with their initial applications for certification.

2.  Drinking water laboratories located out-of-state and applying for reciprocal certification shall submit payment of the fee with their initial application.

3.  Once certified under this chapter, drinking water laboratories shall pay the fee annually.  DCLS shall send an invoice to the certified drinking water laboratory.

4. Additional fees may apply under 1VAC30-41-270 K when changes to the laboratory's certification require DCLS staff time to administer the change.

C.  DCLS shall not consider an application to be complete until the applicant laboratory submits payment of the certification fee.

D.  All incomplete payments shall be deemed as nonpayment.   Nonpayment of fees shall result in denial or revocation of certification.

E.  Payment of fees shall be nonrefundable.

F. DCLS, under 1VAC30-41-230, may revoke the certification of any certified laboratory that does not pay its annual fee.

G.  Fee computation.

1.  Fees for certification of drinking water laboratories shall be applied on an annual basis.

2.  Drinking water laboratories shall pay the total of the base year fees as required by 1VAC30-41-270 H and J for the first twelve months following [the effective date of this chapter].

3.  Beginning [the thirteenth month following the effective date of this chapter], drinking  water laboratories shall pay the total of the base year fees required by 1VAC30-41-270 H  and J (Table 1) as adjusted by the method set out in 1VAC30-41-270 I. 

 H.  Calculation of fees - base year fees [year of the effective date of this chapter].

1.    DCLS charges a fee for the review and certification of the drinking water laboratory's quality system.  This includes a review of the test methods for which the drinking water laboratory requests or holds certification.  The fees are based on the number of test methods for which the laboratory would be certified within each of the six testing categories set out in Table 1 of 1VAC30-41-270 J.

2.  DCLS shall calculate a laboratory's fees by adding the  fees for the number of test methods in each category as set out in Table 1 of 1VAC30-41-270 J for which the laboratory applies or is certified.

3.  For example, a laboratory may be certified for three microbiological methods ($700); five inorganic chemistry, non-metals methods ($850); two inorganic chemistry, metals methods ($1000); and two organic chemistry methods ($1050).  The total annual fee would be $3600.

I.  Calculation of fees - fees beginning [the thirteenth month following the effective date of this chapter].

1.  DCLS shall revise the base year fees after the first twelve months following the effective date of this chapter and every twelve-month period thereafter.

2.  DCLS shall increase or decrease the fees set out in Table 1 of 1VAC30-41-270 J using the Consumer Price Index-Urban (CPI-U) percentage change, average-average for the previous calendar year.  (The CPI-U for all urban consumers is published by the U.S. Department of Labor, Bureau of Labor Statistics, U.S.) 

3.  DCLS shall revise each previous year's Table 1 of 1VAC30-41-270 J so that the revisions will be cumulative, reflecting the changes in the CPI-U over time.

4.  DCLS shall round the revised fees to the nearest whole dollar.

5.  DCLS shall publish the revised fee table annually on the VELAP website.

J.  Fee Tables.

 1.  Fees are calculated using the base year fees in Table 1.

TABLE 1 - BASE YEAR FEES

2.  Table 2 shows the relationship between the testing categories for fees and the drinking water laboratory certification categories.

TABLE 2

K.  Additional fees 

1.  An additional fee shall be charged to a laboratory:

a.   Applying for modification of certification under 1VAC30-41-110.

b.   Moving its location when the move requires DCLS to perform an on-site assessment.

c.   Requesting reinstatement of certification when DCLS requires an on-site assessment.

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

a.    An hourly charge per reviewer shall be $61 as of the effective date of this chapter.  DCLS shall revise the hourly charge after the first twelve months following [the effective date of this chapter] and every twelve-month period thereafter.  The hourly charge shall increase or decrease using the Consumer Price Index-Urban (CPI-U) percentage change, average-average for the previous calendar year.   

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

c.     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.

L.  Method of payment.

Fees shall be paid by check, draft or postal money order payable to the Treasurer, Commonwealth of Virginia, or submitted electronically (if available), and must be in U.S. currency, except that agencies and institutions of the Commonwealth of Virginia may submit interagency transfers for the amount of the fee. All fees shall be sent to the following address (or submitted electronically, if available): Attn:  Lab Certification, DCLS, 600 North 5th Street, Richmond, VA, 23219.  Laboratories may also pay fees using credit cards.  Laboratories shall fill out the DCLS Fee Payment Form for Virginia Laboratory Certification Programs and send the completed form with the fee.

PART III

CHEMISTRY

1VAC30-41-300. Personnel.

Drinking water laboratories shall meet the requirements of Chapter III, Section 10 and Chapter IV, Section 1 of the Manual.

1VAC30-41-310. Laboratory facilities.

Drinking water laboratories shall meet the requirements of Chapter IV, Section 2 of the Manual.

1VAC30-41-320. Laboratory equipment and instrumentation.

A.  Drinking water laboratories shall meet the requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

B.  Drinking water laboratories shall meet the requirements of Chapter IV, Section 3 of the Manual.

1VAC30-41-330. General laboratory practices.

A.  Drinking water laboratories shall meet the requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

B.   Drinking water laboratories shall meet the requirements of Chapter IV, Section 4 of the Manual with the exception of Table IV-1.

1VAC30-41-340. Analytical methodology.

A. Laboratories shall meet the sampling and analytical methodology requirements incorporated by reference at 1VAC30-41-55 for primary inorganic chemical contaminants, primary organic chemical contaminants, alternative testing methods for chemistry, and secondary maximum contaminant levels.

B.  Laboratories shall meet the requirements of Chapter IV, Subsection 5.1 of the Manual with the exception of Tables IV-2 through IV-5.

C.  A drinking water laboratory shall perform a minimum of five water analyses monthly for each chemical contaminant for which the laboratory is certified in order to maintain certification status or qualify for initial certification.

D.  Exceptions to laboratory certification under 1VAC30-41-20 B 2.

1.  Laboratory testing for alkalinity, calcium, chlorite, conductivity, disinfectant residual, orthophosphate, pH, silica, temperature, and turbidity for compliance purposes may be performed by laboratories or persons not certified under this chapter but acceptable to VDH-ODW.

2.  This testing shall be performed using approved sampling and analytical methodology as incorporated by reference into 1VAC30-41-55 C.

3.  Laboratories performing this testing shall meet the requirements of Chapter IV, Section 5.2 of the Manual, with the exception of Tables IV-2 through IV-5.

1VAC30-41-350. Sample collection, handling, and preservation.

A.  Drinking water laboratories shall meet the sample container, required preservation, and maximum holding time requirements incorporated by reference at 1VAC30-41-55 for primary inorganic chemical contaminants, primary organic chemical contaminants, alternative testing methods for chemistry, and secondary maximum contaminant levels.

B.  Drinking water laboratories shall meet the requirements of Chapter IV, Section 6 of the Manual with the exception of Table IV-6, and the Manual Supplement to Chapter IV, Section 6 of the Manual.

C. Drinking water laboratories shall reject any sample not meeting the above criteria and notify the system or individual requesting the analyses.

D.  The laboratory shall have a written sample rejection policy covering those samples that do not meet sampling requirements.

1VAC30-41-360. Quality assurance.

Drinking water laboratories shall meet the quality assurance and quality control requirements of the following:

1.  The approved test methods and associated quality assurance and quality control requirements incorporated by reference into 1VAC30-41-55.

2.  Chapter III, Section 11 of the Manual.

3.  Chapter IV, Section 7 of the Manual with the exception of Tables IV-7 through IV-10.

4.  The Manual Supplement to Chapter III, Section 2 of the Manual.

1VAC30-41-370. Records and data reporting.

Drinking water laboratories shall meet the record keeping and data reporting requirements of the following:

1.  The approved test methods incorporated by reference into 1VAC30-41-55.

2.  Chapter IV, Section 8 of the Manual.

1VAC30-41-380. Action response to laboratory results.

Drinking water laboratories shall meet the action response requirement of Chapter IV, Section 9 of the Manual and the requirements of 1VAC30-41-190.

PART IV

MICROBIOLOGY

1VAC30-41-400. Personnel.

Drinking water laboratories shall meet the requirements of Chapter III, Section 10 and Chapter V, Section 1 of the Manual.

1VAC30-41-410. Laboratory facilities.

A.  Drinking water laboratories shall meet the requirements of Chapter V, Section 2 of the Manual.

B.  The laboratory facilities shall include sufficient space to process and examine samples proportionate with the total work load.

C.  The laboratory shall have provisions for decontamination and disposal of microbiological waste.

D.  Office areas for clerical work and record keeping shall be segregated from laboratory work areas.

1VAC30-41-420. Laboratory equipment and supplies.

Drinking water laboratories shall meet the following requirements:

1.  The requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

2.  The requirements of Chapter V, Section 3 of the Manual.

1VAC30-41-430. General laboratory practices.

Drinking water laboratories shall meet general laboratory practices of the following:

1.  The requirements set out in the approved methods incorporated by reference into 1VAC30-41-55 and in use by the laboratory.

2.  The requirements of Chapter V, Section 4 of the Manual.

1VAC30-41-440. Analytical methodology.

A. Drinking water laboratories shall meet the sampling and analytical methodology requirements incorporated by reference at 1VAC30-41-55 for microbiology and alternative testing methods for microbiology.

B. Drinking water laboratories shall meet the requirements of Chapter V, Section 5 of the Manual and the Manual Supplement to Chapter V, Section 5 of the Manual unless these requirements conflict with the requirements specified in subsection A of this section.

C. A drinking water laboratory shall perform a minimum of 20 coliform analyses monthly by each coliform method for which it is certified in order to maintain certification status or qualify for initial certification. The minimum number of coliform analyses (20) may be performed on a variety of water sample types collected from different stages of the water treatment process, raw source water, surface or ground water, as well as drinking water samples collected from a distribution system or private wells.

1VAC30-41-450. Sample collection, handling, and preservation.

A.  Laboratories that perform sampling shall meet the sample container, required preservation, and maximum holding time requirements incorporated by reference at 1VAC30-41-55 for microbiology and alternative testing methods for microbiology.

B.  Laboratories that perform sampling shall meet the requirements of Chapter V, Section 6 of the Manual and the Manual Supplement to Chapter V, Section 6 of the Manual unless these requirements conflict with the requirements specified in subdivision A 1of this section.

C.  Drinking water laboratories shall reject any sample not meeting the above sampling criteria and notify the system or individual requesting the analyses.

D.  The laboratory shall have a written sample rejection policy covering those samples that do not meet sampling requirements.

1VAC30-41-460. Quality assurance.

Drinking water laboratories shall meet the quality assurance and quality control requirements of the following:

1.  The approved test methods and associated quality assurance and quality control requirements incorporated by reference into 1VAC30-41-55.

2.  Chapter III, Section 11 and Chapter V, Section 7 of the Manual.

3.  The Manual Supplement to Chapter III, Section 2 of the Manual.

1VAC30-41-470. Records and data reporting.

Laboratories shall meet the record keeping and data reporting requirements of the following:

1.  The approved test methods incorporated by reference into 1VAC30-41-55.

2.  Chapter V, Section 8 of the Manual.

1VAC30-41-480. Action response to laboratory results.

Drinking water laboratories shall meet the requirements of Chapter V, Section 9 of the Manual and the requirements of 1VAC30-41-190.

PART V

RADIOCHEMISTRY

1VAC30-41-500. Radiochemistry.

A. Drinking water laboratories shall meet the sampling and analytical methodology requirements incorporated by reference at 1VAC30-41-55 for radiochemistry and alternative testing methods for radiochemistry.

B. Drinking water laboratories shall meet the requirements of Chapters III and VI of the Manual as follows:

1.  Personnel:  Chapter III, Section 10 and Chapter VI, Section 1 of the Manual.

2.  Laboratory facilities:  Chapter VI, Section 2.

3.  Laboratory equipment and instrumentation:  Chapter VI, Section 3.

4.  General laboratory practices:  Chapter VI, Section 4.

5.  Analytical methods:  Chapter VI, Section 5, with the exception of Table VI-1.

6.  Sample collection, handling, and preservation:  Chapter VI, Section 6, with the exception of Table VI-2.

7.  Quality assurance:  Chapter III, Section 11 and Chapter VI, Section 7.

8.  Records and data reporting:  Chapter VI, Section 8.

9.  Action response to laboratory results:  Chapter VI, Section 9 and the requirements of 1VAC30-41-190.