(A) General requirements. Laboratories
applying for certification to perform analyses to determine compliance with
Chapters 3745-81, 3745-82 and 3745-90, and rules
3745-91-06
and
3745-9-09,
and as specified by paragraph (B) of rule
3745-83-01
of the Administrative Code, and with plant control tests for one or more public
water systems, shall meet the following:
(1)
The laboratory shall submit, for approval by the director, a detailed
laboratory plan which includes the following:
(a) The analyses for which certification is
sought and the number of individuals proposed to perform each
analysis.
(b) Plans meeting the
facility requirements as defined in the "Ohio EPA Laboratory Manual for the
Microbiological Analyses of Public Drinking Water
2014
2020" and the
"Ohio EPA Laboratory Manual for the Chemical Analyses of Public Drinking Water
2014
2020."
(c)
The equipment proposed to be used in the laboratory, including specifications
or names, descriptions, manufacturers, and model numbers for each type of
equipment.
(d) The inventory of
standards, reagents and media to be used in analyses for which certification is
sought.
(2) The
laboratory shall submit a quality assurance plan acceptable to the director
when certification is sought for drinking water analysis. The "Ohio EPA
Laboratory Manual for the Microbiological Analyses of Public Drinking Water
2014
2020" and
the "Ohio EPA Laboratory Manual for the Chemical Analyses of Public Drinking
Water
2014
2020" may be used by laboratories seeking
certification for plant control and microbiological testing. Otherwise, an
acceptable quality assurance plan shall be developed by the laboratory as
described in the United States environmental protection agency's "Manual for
the Certification of Laboratories Analyzing Drinking Water" fifth edition,
dated January 2005 (designated "EPA 815-R-05-004"), as supplemented in both
June 2008 (designated "EPA 815-F-08-006") and November 2012 (designated "EPA
815-F-12-006") by "the United States Environmental Protection Agency, Office of
Ground Water and Drinking Water, Cincinnati, OH 45268." The quality assurance
plan shall include at least the following parts:
(a) Table of laboratory organization which
delineates the responsibilities of all laboratory personnel associated with
drinking water analyses and designates the individuals responsible for quality
assurance of drinking water analyses in the laboratory.
(b) Standard operating procedures including
identification of the reference methods used to perform the drinking water
analyses approved by the United States environmental protection
agency.
(c) Sample handling
procedures, including the following:
(i)
Directions
Instructions for maintaining the integrity of the
samples by tracking samples from
collection to
receipt
,
to
and testing to disposal.
(ii)
Directions
Instructions for sample preservation, dechlorination,
etc. as required by the reference method and the documentation used by the
laboratory to verify that proper sample treatment is done.
(iii)
Directions
Instructions to ensure that adequate sample
information is obtained to allow the proper analysis and reporting of
results.
(iv) Chain of custody
forms, where applicable.
(v)
Directions
Instructions for rejecting samples that do not meet
shipping
, minimum
requirements, required reporting information, holding
time or preservation requirements and
instructions for notifying a public water system which
submitted a sample that is rejected
for failing to meet
minimum requirements.
(d) Routine practices to maintain the
precision and accuracy of data as specified by the director or required by each
method of analysis.
(e) Corrective
action procedures taken when unacceptable results are obtained from the
analysis of performance evaluation samples or quality control checks.
(f)
Preventative
Preventive maintenance procedures including directions
and scheduling for instrumentation servicing.
(g) Documentation of the preparation and
expiration of drinking water standards and reagents.
(h) Reporting procedures including directions
followed to ensure that reporting is completed as specified in rule
3745-89-08
of the Administrative Code.
(3) The laboratory shall submit to the
director an application for certification for drinking water analyses required
of public water systems, on a form provided by the director. The application
shall include the following parts:
(a) The
name, address and telephone number of the laboratory and of the individuals
responsible for the laboratory.
(b)
A list of analyses for which certification is sought. This list shall designate
which analytical methods in rule
3745-81-27
or
3745-90-04
of the Administrative Code shall be used for each analysis and shall include
the name of each individual who shall perform each analysis.
(c) Documentation that the laboratory plan in
paragraph (A)(1) of this rule has been accepted by the director.
(d) Documentation that the laboratory has
obtained acceptable results described in paragraph (B) of this rule
and within the acceptance limits described in
appendix C to this rule for analyses performed on all appropriate
proficiency test samples provided by a proficiency testing provider accredited
by a provider of PT samples accredited by a proficiency testing provider
accreditor meeting the "National Environmental Laboratory Accreditation Program
requirement (NELAP)", and documentation that proficiency test samples were
analyzed at least
once during each consecutive
twelve month period
annually for every
contaminant by each method for which the laboratory desires
certification. The director may designate other acceptable providers of
proficiency test samples for analyses to meet this requirement.
(e) Payment of the appropriate laboratory
survey fee established in accordance with section
3745.11 of the Revised Code.
Fees for these surveys shall be paid via a method acceptable to the director.
For the purposes of this rule, fees are as follows:
(i) The "organic chemicals" fee covers all
surveys necessary to obtain laboratory certification for the analysis of
drinking water for either of the following:
(a) Total trihalomethanes, haloacetic acids,
or volatile organic chemicals.
(b)
Pesticides and other organic chemicals.
(ii) The "trace metals" fee covers all
surveys necessary to obtain laboratory certification for the analysis of
drinking water for all metals identified by the United States environmental
protection agency as primary contaminants, secondary contaminants and
contaminants with action levels.
(iii) The "standard chemistry" fee covers all
surveys necessary to obtain laboratory certification for the analysis of
drinking water for bromate, chlorite, cyanide, fluoride, nitrate,
nitrate-nitrite, nitrite,
orthophosphate, total
phosphorus, sulfate, total dissolved solids and plant control
tests.
(iv) The "limited chemistry"
fee covers all surveys necessary to obtain laboratory certification for the
analysis of drinking water for the following:
(a) Any three of the analyses included in
standard chemistry.
(b) Any two of
the analyses included in trace metals.
(c) Asbestos.
(d) Radioactivity and radioactive
chemicals.
(e) Beginning one year
from the effective date of this rule, total microcystins and cyanobacteria
screening.
(v) The
"microbiological" fee covers all surveys necessary to obtain laboratory
certification for the analysis of drinking water for one of the following:
(a) MMO-MUG
(Colilert
or Colisure).
(b)
Membrane Filtration ( MF
).
(c)
Most Probable Number (MPN) by MMO-MUG and
MF.
(4) The director shall return any application
which is not filed in accordance with paragraph (A)(3) of this rule.
(5) Upon the laboratory's successful
completion of the requirements of paragraphs (A)(1), (A)(2) and (A)(3) of this
rule, the laboratory shall demonstrate acceptable levels of performance during
the initial and subsequent on-site surveys, including the following:
(a) Conformance by the laboratory to the
"Ohio EPA Laboratory Manual for the Microbiological Analyses of Public Drinking
Water
2014
2020" and the "Ohio EPA Laboratory Manual for the
Chemical Analyses of Public Drinking Water
2014
2020."
(b) Proficiency in appropriate analytical
procedures, methodologies, techniques, and use of equipment by analysts
participating in the on-site survey.
(c) Analysis of proficiency test
samples.
(d) Maintenance of
laboratory records for at least thirty days prior to the scheduled on-site
survey, with the records documenting the following:
(i) All appropriate laboratory equipment and
auxiliary equipment is operational within prescribed limits.
(ii) Sufficient practice analyses have been
conducted by each analyst participating in the on-site survey to demonstrate
the analyst's proficiency.
(iii) An
acceptable quality assurance plan has been documented and implemented, as
required by paragraph (A)(2) of this rule.
(iv) The analyses, quality control
procedures, and preparation of standards were correctly performed by each
analyst participating in the on-site survey,
except
for analysts to be designated for operational certification
as required for the certification being
requested.
(v) Acceptable
method detection limit studies have been completed as required by the director
for each method and instrument in accordance with the procedures in
appendix A to this rule
the 40 Code of Federal Regulations (C.F.R.) Part
136.
(e)
Conformance by the
The laboratory
conforms
to the laboratory plan as approved by the director.
(f)
Conformance by
the
The laboratory
is able to
meet the
analytical reporting limits listed in tables 1, 2, 3, 4 and 5 in
the appendix
B to this rule. Laboratories shall report
at a
to the
minimum level that they can consistently quantify but shall not have a minimum
reporting limit any higher than the level in
the
appendix
B to this rule. Unless stated in
this rule, the detection limits listed and defined in Chapter 3745-81 of the
Administrative Code shall also be used as reporting limits.
(g) Correction of
deviations
violations
noted in previous survey reports.
(6) The survey report shall be issued to the
applicant by the Ohio environmental protection agency within forty-five days of
any on-site survey, shall indicate the acceptability of the applicant's
performance during the survey, and shall state
deviations
violations
that are required to be corrected prior to certification of the laboratory. If
the survey report notes
deviations
violations the director may deny, suspend, or
revoke certification in accordance with rule
3745-89-06
of the Administrative Code.
(B)
Particular
Specific
requirements
for proficiency testing (PT).
Each laboratory
Laboratories applying for certification to perform
particular drinking water analyses to
determine compliance with Chapters 3745-81 and 3745-82, rules
3745-91-06
and
3745-9-09,
and as specified by paragraph (B) of rule
3745-83-01
of the Administrative Code, as well as plant control tests shall, in addition
to the requirements of paragraph (A) of this rule, include with the application
the appropriate required reports as follows:
(1)
Applicants for
laboratory certification for analytes referenced in paragraphs (C) to (K) of
rule
3745-81-27
of the Administrative Code shall report PT results
Inorganic chemicals. Applicants for laboratory
certification to perform analyses for inorganic chemicals to determine
compliance with Chapter 3745-81 of the Administrative Code shall report
antimony, arsenic, asbestos, barium, beryllium, cadmium, chromium, copper,
lead, mercury, nickel, selenium, thallium, bromate, chlorite, cyanide,
fluoride, nitrate, nitrate-nitrite, and nitrite in accordance with
paragraph (A)(3)(d) of this rule with no unacceptable results.
(2) Total trihalomethanes. Applicants for
laboratory certification to perform analyses for
total trihalomethanes
analytes to determine compliance with rules
3745-81-12
and
3745-81-24
of the Administrative Code shall report bromodichloromethane, bromoform,
chloroform and dibromochloromethane analysis in accordance with paragraph
(A)(3)(d) of this rule with no unacceptable results. Total trihalomethanes
analysis requires reporting all of the compounds established in the definition
of total trihalomethanes in rule
3745-81-01
of the Administrative Code.
(3)
Volatile organic chemicals. Applicants for laboratory certification
to perform analyses for volatile organic chemicals
to determine compliance with
for analytes
referenced in rules
3745-81-12
and
3745-81-24
of the Administrative Code shall report
PT
analyses for volatile organic chemicals with maximum contaminant levels (except
vinyl chloride) in accordance with paragraph (A) (3)(d) of this rule, with not
more than twenty per cent unacceptable results
, and
shall achieve a method detection limit of 0.0005 milligrams per liter for each
of these volatile organic chemicals according to the procedures in appendix A
to this rule.
(4) Pesticides and other organic
chemicals. Applicants for laboratory certification to perform analyses for
pesticides and other organic chemicals to determine compliance with rules
3745-81-12
and
3745-81-24
of the Administrative Code shall report analysis for pesticides and other
organic chemicals in accordance with paragraph (A)(3)(d) of this rule with no
unacceptable results.
(5)
(4) Microbiological
contaminants. Applicants for laboratory certification to perform analyses for
microbiological contaminants
analytes to determine compliance with rules
3745-81-14,
3745-81-21,
and
3745-81-41
to
3745-81-45
of the Administrative Code shall report microbiological contaminants analyses
in accordance with paragraph (A)(3)(d) of this rule with no more than one
unacceptable total coliform result, no more than one unacceptable
fecal coliform/E. coli result, and no false
negative reported values.
(6) Gross alpha particle activity.
Applicants for laboratory certification to perform analyses for gross alpha
particle activity to determine compliance with rules
3745-81-15
and
3745-81-26
of the Administrative Code shall report to the director, within thirty days
after receipt, results of the most recent proficiency test for gross alpha
particle activity analysis in accordance with paragraph (A) (3)(d) of this rule
with no unacceptable results.
(7) Radium-226 and radium-228
radioactivity. Applicants for laboratory certification to perform analyses for
radium-226 and radium-228 radioactivity to determine compliance with rules
3745-81-15
and
3745-81-26
of the Administrative Code shall report to the director, within thirty days
after receipt, results of the most recent proficiency test for radium-226 and
radium-228 analyses in accordance with paragraph (A)(3)(d) of this rule with no
unacceptable results, and shall hold laboratory certification under this rule
to perform gross alpha particle activity analysis.
(8) Gross beta particle activity.
Applicants for laboratory certification to perform analyses for gross beta
particle activity to determine compliance with rules
3745-81-15
and
3745-81-26
of the Administrative Code shall report to the director, within thirty days
after receipt, results of the most recent proficiency test for gross beta
particle activity analyses in accordance with paragraph (A)(3)(d) of this rule
with no unacceptable results, and shall hold laboratory certification under
this rule to perform gross alpha particle activity analysis.
(9) Strontium-89 and strontium-90
radioactivity. Applicants for laboratory certification to perform analyses for
strontium-89 and strontium-90 radioactivity to determine compliance with rules
3745-81-15
and
3745-81-26
of the Administrative Code shall report to the director, within thirty days of
receipt, results of the most recent proficiency test for strontium-89 and
strontium-90 analyses in accordance with paragraph (A)(3)(d) of this rule with
no unacceptable results, and shall hold laboratory certification under this
rule to perform gross beta particle activity analyses.
(10) Iodine-131 radioactivity.
Applicants for laboratory certification to perform analyses for iodine-131
radioactivity to determine compliance with rules
3745-81-15
and
3745-81-26
of the Administrative Code shall report to the director, within thirty days of
receipt, results of the most recent proficiency test for iodine-131
radioactivity analysis in accordance with paragraph (A)(3)(d) of this rule with
no unacceptable results, and shall hold laboratory certification under this
rule to perform gross beta particle activity analysis.
(11) Tritium. Applicants for
laboratory certification to perform analyses for tritium to determine
compliance with rules
3745-81-15
and
3745-81-26
of the Administrative Code shall report to the director, within thirty days of
receipt, results of the most recent proficiency test for tritium analysis in
accordance with paragraph (A)(3)(d) of this rule with no unacceptable results,
and shall hold laboratory certification under this rule for the performance of
gross beta particle activity analysis.
(12) Radioactivity from photon
emitters (excluding iodine-131). Applicants for laboratory certification to
perform analyses for radioactivity from photon emitters (excluding iodine-131)
to determine compliance with rules
3745-81-15
and
3745-81-26
of the Administrative Code shall report to the director, within thirty days
after receipt, results of the most recent proficiency test for radioactivity
from photon emitters (excluding iodine-131) analysis in accordance with
paragraph (A)(3)(d) of this rule with no unacceptable results, and shall hold a
laboratory certification under this rule to perform gross beta particle
activity analysis.
(13)
(5) Haloacetic acids
(five). Applicants for laboratory certification to perform analyses for
haloacetic acids (five)
analytes to determine compliance with rules
3745-81-12
and
3745-81-24
of the Administrative Code shall report haloacetic acids (five) analysis in
accordance with paragraph (A)(3)(d) of this rule with no more than one
unacceptable result. Haloacetic acids (five) analysis requires reporting all of
the compounds listed in the definition of haloacetic acids (five) in rule
3745-81-01
of the Administrative Code.
(14) Bromate. Applicants for
laboratory certification to perform analyses for bromate to determine
compliance with paragraph (C) of rule
3745-81-11
and rule
3745-81-23
of the Administrative Code shall report bromate analysis in accordance with
paragraph (A)(3)(d) of this rule with no unacceptable results.
(15) Chlorite. Applicants for
laboratory certification to perform analyses for chlorite to determine
compliance with paragraph (D) of rule
3745-81-11
and rule
3745-81-23
of the Administrative Code shall report chlorite analysis in accordance with
paragraph (A)(3)(d) of this rule with no unacceptable results.
(16) Plant control tests. Applicants
for laboratory certification to perform plant control tests (except chlorine
residual) required to be reported by rule
3745-83-01
of the Administrative Code may designate individuals for operational
certification. If any individual is designated for operational certification,
the application shall also designate an individual responsible for preparation
of standards and reagents and for the required monthly and quarterly
calibrations and standardizations.
(C) The director may issue, deny, suspend or
revoke a laboratory certificate in accordance with rule
3745-89-06
of the Administrative Code.
[Comment: This rule incorporates the "Ohio EPA Laboratory
Manual for the Microbiological Analyses of Drinking Water
2014
2020" and
"Ohio EPA Laboratory Manual for the Chemical Analyses of Public Drinking Water
2014
2020" by
reference. Copies are available at
www.epa.ohio.gov/ddagw/labcert.aspx
and at the "Ohio EPA, Lazarus Government Center, 50 West Town Street, Suite
700, Columbus, OH, 43215." Copies can also be obtained by contacting the
laboratory certification office at 614-644-4245.]
[Comment: This rule incorporates the United States
environmental protection agency's "Manual for Certification of Laboratories
Analyzing Drinking Water" fifth edition, dated January 2005 (designated "EPA
815-R-05-004"), as supplemented in both June 2008 (designated "EPA
815-F-08-006") and November 2012 (designated "EPA 815-F-12-006) by the United
States environmental protection agency, office of ground water and drinking
water, Cincinnati, OH 45268 by reference. Copies are available at
http://www.epa.gov/dwlabcert
and also at the "Water Resource Center (RC-4100), United States Environmental
Protection Agency, 1200 Pennsylvania Avenue NW, Washington, D.C., 20460, (202)
566-1729." Copies can also be obtained by contacting the "Safe Drinking Water
Hotline" at 1-800-426-4791. This document is available for review at "Ohio EPA,
Lazarus Government Center, 50 West Town Street, Suite 700, Columbus, OH,
43215."]
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