(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 2020" and the "Ohio EPA Laboratory Manual for the
Chemical Analyses of Public Drinking Water 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 2020" and the
"Ohio EPA Laboratory Manual for the Chemical Analyses of Public Drinking
Water 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) Instructions for
maintaining the integrity of the samples by tracking samples from collection to
receipt, and testing to disposal.
(ii) 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) 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) Instructions for
rejecting samples that do not meet shipping 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) 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 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 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
2020" and the "Ohio EPA Laboratory Manual for the Chemical Analyses
of Public Drinking Water 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, 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 the 40 Code of
Federal Regulations (C.F.R.) Part 136.
(e) The laboratory conforms to the laboratory plan as approved
by the director.
(f) The laboratory is able to meet the analytical reporting
limits listed in tables 1, 2, 3, 4 and 5 in the appendix to this rule.
Laboratories shall report 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 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 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
violations that are required to be corrected prior to certification of the
laboratory. If the survey report notes violations the director may deny,
suspend, or revoke certification in accordance with rule 3745-89-06 of the
Administrative Code.
(B) Specific requirements for
proficiency testing (PT). Laboratories applying for certification to perform
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 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 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 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.
(4) Microbiological contaminants.
Applicants for laboratory certification to perform analyses for 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 E. coli
result, and no false negative reported values.
(5) Haloacetic acids (five). Applicants
for laboratory certification to perform analyses for 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.
(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
2020" and "Ohio EPA Laboratory Manual for the Chemical Analyses of
Public Drinking Water 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."]