3745-89-03 Procedure for laboratory certification.

(A) General requirements. Laboratories applying for certification to perform analyses to determine compliance with Chapters 3745-81 and 3745-82 and rules 3745-91-06 and 3745-9-09 of the Administrative Code, and with plant control tests for one or more public water system(s), shall meet the following requirements:

(1) The laboratory shall submit, for approval by the director, a detailed laboratory plan including:

(a) The analyses for which certification is sought and the number of individuals proposed to perform each analysis;

(b) The locations of: the areas within the laboratory where microbiological, radiological, and chemical analyses of drinking water will be performed; areas where other analytical determinations will be performed; analytical equipment; adjacent rooms with their functions indicated; bench areas; gas, electric, and vacuum outlets; sinks; refrigerators; cabinets; air conditioning and heating units; doorways; windows; outer and inner walls; fume hoods; safety equipment; floor coverings; ceilings; and lighting;

(c) The equipment proposed to be used in the laboratory including specifications or name(s), description(s), manufacturer(s), and model number(s) for each type of equipment; and

(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 2001" and the "Ohio EPA Laboratory Manual for the Chemical Analyses of Public Drinking Water 2000" 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", dated January 2005 and designated "EPA 815-R-05-004", as supplemented in June 2008 and designated "EPA 815-F-08-006" 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) Sampling procedures that include an example of the written sampling instructions accompanying each sampling kit;

(b) Sample handling procedures, including:

(i) Directions for maintaining the integrity of the samples by tracking samples from receipt to testing to disposal;

(ii) Directions 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 to ensure that adequate sample information is obtained to allow the proper analysis and reporting of results;

(iv) Chain of custody forms, where applicable; and

(v) Directions for rejecting samples that do not meet shipping, minimum reporting information, holding time and/or preservation requirements and for notifying a public water system which submitted a sample that is rejected.

(c) Calibration and standardization procedures for instruments and equipment, including the frequency such procedures will be implemented;

(d) Standard operating procedures including identification of the reference methods used to perform the drinking water analyses approved by the United States environmental protection agency;

(e) Data validation procedures including the conversion of raw data to standard units and the maintenance of accuracy for calculations and transcriptions, where applicable;

(f) Reporting procedures including directions followed to ensure that reporting is completed as specified in rule 3745-89-08 of the Administrative Code;

(g) Standard and reagent procedures including directions followed for preparation and for documentation of the expiration of drinking water standards and reagents;

(h) Quality control procedures as specified by the director or required by each method of analysis;

(i) Preventative maintenance procedures including directions and scheduling for instrumentation servicing;

(j) Routine practices to maintain the precision and accuracy of data as specified by the director or required by each method of analysis;

(k) Corrective action procedures taken when unacceptable results are obtained from the analysis of performance evaluation samples or quality control checks; and

(l) Table of laboratory organization which delineates the responsibilities of all laboratory personnel associated with drinking water analyses and designates the individual(s) responsible for quality assurance of drinking water analyses in the laboratory.

(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 parts listed below:

(a) The name, address and telephone number of the laboratory and of the individual(s) responsible for the laboratory;

(b) A list of analyses for which certification is sought. This list shall designate which analytical method(s) in rule 3745-81-27 of the Administrative Code shall be used for each analysis and shall include the name(s) 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 the "American Association for Laboratory Accreditation (A2LA)", and documentation that proficiency test samples were analyzed at least once during each consecutive twelve month period 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; and

(e) Payment of the appropriate laboratory survey fee established in accordance with section 3745.11 of the Revised Code.

For the purposes of this rule, the "organic chemicals" fee covers all surveys necessary to obtain laboratory certification for the analysis of drinking water for (1) total trihalomethanes, haloacetic acids, and/or volatile organic chemicals, or for (2) pesticides and other organic chemicals; the "inorganic chemical" fee covers all surveys necessary to obtain laboratory certification for the analysis of drinking water for aluminum, antimony, arsenic, barium, beryllium, cadmium, calcium, chromium, copper, iron, lead, magnesium, manganese, mercury, nickel, selenium, silver, sodium, thallium, and zinc; 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, sulfate, total dissolved solids, and plant control tests; and the "limited chemistry" fee covers all surveys necessary to obtain laboratory certification for the analysis of drinking water for

(i) Any two of the analyses included in standard chemistry;

(ii) Asbestos;

(iii) Radioactivity and radioactive chemicals; or

(iv) Lead and copper only.

(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:

(a) Proficiency in appropriate analytical procedures, methodologies, techniques, and use of equipment by analysts participating in the on-site survey;

(b) Analysis of proficiency test samples;

(c) Maintenance of laboratory records for at least thirty days prior to the scheduled on-site survey, with the records documenting that:

(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 approval, and

(v) Acceptable method detection limit (MDL) studies have been completed as required by the director for each method and instrument in accordance with the procedures in appendix A of this rule.

(d) Conformance by the laboratory to the laboratory plan as approved by the director;

(e) Conformance by the laboratory to the analytical reporting limits listed in tables 1, 2, 3, and 4 in appendix B to this rule. Laboratories shall report at a minimum level that they can consistently quantify but shall not have a minimum reporting limit any higher than the level in 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; and

(f) Correction of deviations 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 that are required to be corrected prior to certification of the laboratory. If the survey report notes deviations the director may deny, suspend, or revoke certification in accordance with rule 3745-89-06 of the Administrative Code.

(B) Particular requirements. Each laboratory applying for certification to perform particular drinking water analyses to determine compliance with Chapters 3745-81 and 3745-82 and rule 3745-91-06 of the Administrative Code and plant control tests shall, in addition to the requirements of paragraph (A) of this rule, include with the application the appropriate required reports as described below.

(1) Inorganic chemicals. Applicants for a laboratory certification to perform analyses for inorganic chemicals to determine compliance with Chapter 3745-81 of the Administrative Code shall report results of antimony, arsenic, asbestos, barium, beryllium, cadmium, chromium, copper, lead, mercury, nickel, selenium, thallium, bromate, chlorite, cyanide, fluoride, nitrate, nitrate-nitrite, and nitrite to determine compliance with Chapter 3745-81 of the Administrative Code shall report results of inorganic chemical analyses 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 to determine compliance with paragraphs (A) and (B) of rule 3745-81-12 and rules 3745-81-24 and 3745-81-78 of the Administrative Code shall report results of 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 paragraph (D) of rule 3745-81-12 and rule 3745-81-24 of the Administrative Code shall report results of 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 paragraph (E) of rule 3745-81-12 and rule 3745-81-24 of the Administrative Code shall report results of analysis for pesticides and other organic chemicals in accordance with paragraph (A)(3)(d) of this rule with no unacceptable results.

(5) Microbiological contaminants. Applicants for laboratory certification to perform analyses for microbiological contaminants to determine compliance with rules 3745-81-14 and 3745-81-21 of the Administrative Code shall report results of 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 and rule 3745-89-05 of the Administrative Code 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 and rule 3745-89-05 of the Administrative Code 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 and rule 3745-89-05 of the Administrative Code 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 and rule 3745-89-05 of the Administrative Code 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 and rule 3745-89-05 of the Administrative Code 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 and rule 3745-89-05 of the Administrative Code to perform gross beta particle activity analysis.

(13) Haloacetic acids (five): Applicants for a laboratory certificate of approval to perform analyses for haloacetic acids (five) to determine compliance with paragraph (B) of rule 3745-81-12 and rules 3745-81-24 and 3745-81-78 of the Administrative Code shall report results of 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 a laboratory certificate of approval 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 results of bromate analysis in accordance with paragraph (A)(3)(d) of this rule with no unacceptable results.

(15) Chlorite. Applicants for a laboratory certificate of approval 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 results of 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 approval. If any individual(s) is designated for operational approval, the application shall also designate an individual(s) 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 of approval 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 2001" and "Ohio EPA Laboratory Manual for the Chemical Analyses of Public Drinking Water 2000" by reference. Copies are available at www.epa.ohio.gov/ddagw/labs.aspx and at the Ohio EPA, Lazarus Government Center, 50 West Town Street, Columbus, OH, 43215-3425. Copies can also be obtained by contacting the laboratory certification office at 614-644-4245.]

[Comment: This rule incorporates the "Manual for Certification of Laboratories Analyzing Drinking Water" by reference. Copies are available at www.epa.gov/safewater/methods/laboratorycertification.html and at the Water Resource Center, United States Environmental Protection Agency, EPA West Room 1119, 1301 Constitution Avenue NW, Washington, D.C. (202) 566-1729. Copies can also be obtained by contacting the Safe Drinking Water Hotline at 1-800-426-4791 or www.epa.gov/safewater/hotline/index.html. This document is available for review at Ohio EPA, Lazarus Government Center, 50 West Town Street, Columbus, OH, 43215-3425.]

Effective: 10/31/2010
R.C. 119.032 review dates: 08/16/2010 and 10/31/2015
Promulgated Under: 119.03
Statutory Authority: 6109.03, 6109.04
Rule Amplifies: 6109.03, 6109.04
Prior Effective Dates: 11/26/80, 04/09/90, 09/13/93, 12/01/93, 04/01/99, 01/01/02, 06/28/03, 06/18/04, 1/1/10