Proposed Text
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 (Repealed.)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 (Repealed.)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.
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(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.
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(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.
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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:
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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.
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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.
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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 for the certification process. The total amount of the fees charged to drinking water laboratories shall be limited to the cost of carrying out the certification program.
B. Drinking water laboratories shall submit a fee with initial certification applications, applications for reciprocal certification, and reinstatement of certification when an on-site assessment is performed following revocation.
C. DCLS shall not consider an application to be complete until the applicant laboratory submits the fee.
D. Once certified under this chapter, drinking water laboratories shall pay the fee annually.
E. 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 Tables.
1. Fees are calculated using the base fees in Table 1.
TABLE 1 - BASE FEES
TESTING CATEGORY |
FEE ($) |
Microbiological testing |
|
1-2 methods |
600 |
3-5 methods |
700 |
6+ methods |
800 |
Inorganic chemistry: non-metals testing |
|
1-2 methods |
650 |
3-5 methods |
850 |
6-8 methods |
1050 |
9+ methods |
1250 |
Inorganic chemistry: metals testing |
|
1-2 methods |
1000 |
3-5 methods |
1200 |
6+ methods |
1400 |
Organic chemistry |
|
1-2 methods |
1050 |
3-5 methods |
1250 |
6-8 methods |
1450 |
9+ methods |
1650 |
Radiochemistry |
|
1-2 methods |
1100 |
3-5 methods |
1300 |
6+ methods |
1500 |
Asbestos |
|
1-2 methods |
900 |
3-5 methods |
1100 |
6+ methods |
1300 |
2. Table 2 shows the relationship between the testing categories for fees and the drinking water laboratory certification categories.
TABLE 2
FEE TESTING CATEGORY |
LABORATORY CERTIFICATION CATEGORY |
Microbiological testing |
Microbiology (includes coliform, e.coli, heterotrophic bacteria) |
Inorganic chemistry, non-metals testing |
Physical/inorganic: aggregate properties (this includes turbidity, alkalinity, total dissolved solids, conductivity and pH) Wet chemistry: (this includes fluoride, nitrate/nitrite, cyanide, sulfate, orthophosphate, pH) Organic aggregate properties: (this includes DOC, TOC, UV254, Surfactants/SUVA) |
Inorganic chemistry, metals testing |
Trace metals (includes lead, copper, chromium, beryllium, mercury, barium, cadmium) |
Organic chemistry (trace) |
Organic chemistry (includes pesticides, herbicides, SOC, PCB, THM, VOC, HAA5, carbamates, fumigants) |
Radiochemistry |
Radiochemistry (includes alpha, beta, radium, gamma, uranium, strontium-89) |
Asbestos |
Asbestos |
H. Calculation of fees - base year fees [year of the effective date of this chapter].
1. DCLS assesses fees based on the number of test methods a laboratory applies for or is certified for within any of six testing categories set out in Table 1.
2. DCLS shall calculate a laboratory's fees by adding the fees for the number of test methods in each category for which the laboratory applies or is certified.
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 fee would be $3600.
I. Calculation of fees - fees beginning [the year following the year of the effective date of this chapter].
1. The amount of the certification fee due under either subsection B or D of this section shall be calculated according to the following formulae:
F = B x C
C = 1 + ∆CPI
∆CPI = (CPI-218.73)÷218.73
where:
F = the fee amount due for the specified calendar year, expressed in dollars.
B = the base fee determined by the calculation specified in subsection G of this section for a laboratory, expressed in dollars.
C = the Consumer Price Index adjustment factor.
∆CPI = the difference between CPI and 218.73 (the average of the Consumer Price Index values for all-urban consumers for the 12-month period ending on the last day of February 2011), expressed as a proportion of 218.73.
CPI = the average of the Consumer Price Index values for all-urban consumers for the 12-month period ending on the last day of February of the calendar year before the specific year when the fee is due. (The Consumer Price Index for all-urban consumers is published by the U.S. Department of Labor, Bureau of Labor Statistics, U.S. All items, CUUR0000SA0.)
For example, if calculating the 2012 certification fee (F):
CPI = 218.73 (the average of CPI values from March 1, 2010, to February 28, 2011, inclusive would be used for the 2011 certification fees).
∆CPI = zero for the 2012 certification fee calculation (i.e, (CPI-218.73)/218.73 = (218.73 - 218.73)/218.73 = 0). [NOTE: ∆CPI for other years would not be zero.]
C = 1.0 for the 2012 certification fee calculation (i.e., 1 + ∆CPI = 1 + 0= 1.0).
B = $3600 [example given in subdivision H 2] (i.e. $3600 x 1.0 = $3600).
2. DCLS shall round certification fees determined under this subsection to the nearest dollar.
J. 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.
3. An hourly charge per reviewer shall be determined by (i) obtaining a yearly cost by multiplying the reviewer's annual salary by 1.35 (accounts for overhead such as taxes and insurance) and then (ii) dividing the yearly cost by 1,642 (number of annual hours established by Fiscal Services, DGS, for billing purposes).
4. The charge per reviewer shall be determined by multiplying the number of hours expended in the review by the reviewer's hourly charge.
5. If an on-site review is required, DCLS shall charge for both travel time and on-site review time. The hourly charge per reviewer shall be the same for travel time as for review time. DCLS shall add travel expenses to the hourly charges.
6. DCLS shall derive any travel expenses charged under subdivision J 5 of this section from the Commonwealth of Virginia reimbursement allowances and rates for lodging, per diem, and mileage.
K. 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.
L. Incomplete payments and late payments.
1. All incomplete payments will be deemed as nonpayments.
2. Interest may be charged for late payments at the underpayment rate set out by the U.S. Internal Revenue Service established pursuant to § 6621(a)(2) of the Internal Revenue Code. This rate is prescribed in § 58.1-15 of the Code of Virginia and is calculated on a monthly basis at the applicable periodic rate.
3. A 10% late payment fee may be charged to any delinquent (over 90 days past due) account.
4. DCLS is entitled to all remedies available under the Code of Virginia in collecting any past due amount and may recover any attorney's fees and other administrative costs incurred in pursuing and collecting any past due amount.
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.