Chapter 3745-89 Laboratory Approval

3745-89-01 Definitions.

"Director," "gross alpha particle activity," "gross beta particle activity," "total trihalomethanes," and all other terms defined in rule 3745-81-01 of the Administrative Code have the same definitions in this chapter.

(A) "Certificate of approval" means a document identifying drinking water analyses, identifying the effective period of a laboratory certification for those drinking water analyses, and identifying the individuals approved to perform those drinking water analyses.

(B) "Deviation" means any non-compliance with laboratory certification requirements which cover the physical facility, testing equipment, analytical method, reporting, and all quality control requirements whether they are in the method, the laboratory certification manual, or the Ohio Administrative Code.

(C) "Interim authorization" means granting an analyst operational approval to conduct certain plant control tests pending an on-site approval or, granting a laboratory approval to perform drinking water analyses by using new methods or for new contaminants pending implementation of new or amended regulations.

(D) "Media" means nutrient and mineral complexes used in the growth and identification of microorganisms.

(E) "Method detection limit" or "MDL" means the minimum concentration of a substance that can be measured and reported with ninety-nine per cent confidence that the analyte concentration is greater than zero and is determined from analysis of a sample in a given matrix containing the analyte.

(F) "Operational approval" means approval granted by the director for an analyst to perform one or more of the plant control tests for alkalinity, alkalinity stability, chloride, chlorine, chlorite, chlorine dioxide, fluoride, hardness, pH, or turbidity, including daily calibration and standardization but not including the preparation of standards or reagents nor the required monthly or quarterly calibration and standardization.

(G) "National Institute of Standards and Technology" or "NIST" means the non-regulatory federal agency within the United States commerce department's technology administration.

(H) "On-site survey" means a scheduled or unannounced on-location evaluation and review of a laboratory and its personnel to determine compliance with this chapter.

(I) "Plant control test" means measurement of any or all of the following parameters that are used to monitor or control drinking water plant treatment processes: alkalinity; alkalinity stability; chloride, chlorine, chlorite, chlorine dioxide, and other disinfectants; fluoride; hardness; pH; phosphate; total dissolved solids; turbidity; copper; iron; manganese; and nitrate.

(J) "Proficiency test" (PT) means a sample or a group of samples provided to a laboratory by an American association for laboratory accreditation (A2LA) approved provider used for the purpose of determining the ability of a laboratory and its analysts to successfully perform analyses within acceptable limits specified by the United States environmental protection agency.

(K) "Reporting limit" means the numerical value at and above which a laboratory is required to quantify a contaminant.

(L) "Standard operating procedure" or "SOP" means a document written by a laboratory that details the prescribed techniques and steps necessary for the performance of a specific method by that laboratory.

(M) "State Principal Laboratory" means the laboratory designated by the director as required by the United States environmental protection agency under 40 C.F.R. 142.10 (7/1/2002 edition) and certified by the United States environmental protection agency.

(N) "Subcontract" means an arrangement whereby a laboratory or facility obtains drinking water samples from a public water system and directly provides the samples to a laboratory that is certified to perform the required analyses.

(O) "Water quality parameters" means the following parameters measured in accordance with rule 3745-81-87 of the Administrative Code: pH, temperature, alkalinity, conductivity, calcium, orthophosphate, and silica.

Replaces: Former 3745-89-01

R.C. 119.032 review dates: 08/28/2013 and 08/28/2018
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, 04/01/99, 06/28/03

3745-89-02 Analyses requiring laboratory certification.

For the purpose of determining compliance with Chapters 3745-81 and 3745-82 and rules 3745-91-06 and 3745-9-09 of the Administrative Code, including plant control tests but excluding water quality parameter determinations, or for other analyses required by the director, only those analyses may be acceptable to the director that are performed in:

(A) A laboratory located in the state of Ohio and holding a valid and unexpired laboratory certification under this chapter, and by an individual conducting analyses as designated on the laboratory certificate of approval; or

(B) "The State Principal Laboratory"; or

(C) A laboratory located outside the state of Ohio and owned or operated by a public water system supplying drinking water in the state of Ohio, holding a valid and unexpired laboratory certification under this chapter, and by an individual conducting analyses as designated on the laboratory certificate of approval; or

(D) A laboratory approved by the United States environmental protection agency or by another state to perform required analyses for drinking water contaminants, but only for those contaminants and during those times for which no Ohio laboratory is certified under this chapter for the analyses, or during those times when the director determines there is insufficient capacity.

R.C. 119.032 review dates: 08/28/2013 and 08/28/2018
Promulgated Under: 119.03
Statutory Authority: 6109.03 , 6109.04 , 6109.12
Rule Amplifies: 6109.03 , 6109.04 , 6109.12
Prior Effective Dates: 11/26/80, 04/09/90, 09/13/93, 04/01/99

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

3745-89-04 Renewal of laboratory certification.

(A) The director may renew a laboratory certification for analysis of drinking water upon the laboratory's successful completion of all the requirements in paragraphs (A)(1) to (A)(4) of this rule.

(1) The laboratory shall maintain a valid and unexpired laboratory certification under rule 3745-89-05 of the Administrative Code for the analyses for which renewal is sought.

(2) The laboratory shall submit to the director a completed application for renewal, including the parts described in paragraphs (A)(2) and (A)(3)(a) to (A)(3)(d) of rule 3745-89-03 of the Administrative Code, no sooner than one hundred twenty days and no later than thirty days prior to the expiration date of the currently valid certification. When applications are submitted in accordance with this rule and deemed complete, the laboratory certification will be extended until such time as an onsite survey is completed..

(3) If the applicable laboratory survey fee is not already paid, the laboratory shall submit the appropriate laboratory survey fee in accordance with section 3745.11 of the Revised Code.

Fees for these surveys shall be paid by tendering a certified check payable to "Treasurer, State of Ohio" to the address stated on the invoice and with a copy of the invoice enclosed.

(4) The laboratory shall demonstrate an acceptable level of performance, by all persons to be included in renewal of laboratory certification, during an on-site survey as described in paragraphs (A)(5) and (A)(6) of rule 3745-89-03 of the Administrative Code. An on-site survey shall also include an evaluation of the maintenance of laboratory data. Bacteriological records shall be maintained for at least five years, lead and copper records for at least twelve years, and all other records for at least ten years.

(B) When a valid certification for analysis of drinking water is not renewed in accordance with paragraph (A) of this rule, the certification expires and analyses by the laboratory shall not satisfy the requirements of Chapters 3745-81, 3745-82, 3745-9, and rule 3745-91-06 of the Administrative Code. If the laboratory wishes to be recertified for drinking water analysis, it may apply for certification as required by rule 3745-89-03 of the Administrative Code. Where the physical facility of the laboratory conforms to a laboratory plan which has been previously approved, the requirements of paragraph (A)(1) of rule 3745-89-03 of the Administrative Code may be considered to be satisfied.

(C) The director may approve or deny an application for renewal in accordance with rule 3745-89-06 of the Administrative Code.

R.C. 119.032 review dates: 08/28/2013 and 08/28/2018
Promulgated Under: 119.03
Statutory Authority: 3745.11 , 6109.04
Rule Amplifies: 3745.11 , 6109.04
Prior Effective Dates: 04/09/90, 12/17/93, 04/01/99

3745-89-05 Requirements for maintaining laboratory certification.

(A) The requirements for maintaining laboratory certification include each of the following:

(1) Documentation that all analysts designated on laboratory certificates of approval have participated proportionally in drinking water analyses for which they are designated;

(2) Documentation that only individuals who have interim authorization or have participated acceptably in a recent on-site survey for a laboratory certification and/or are listed on a laboratory certificate of approval have performed drinking water analyses and reported results thereof for the purpose of determining compliance with plant control tests and Chapters 3745-81 and 3745-82 and rule 3745-91-06 of the Administrative Code;

(3) Documentation that drinking water analyses required for the purpose of determining compliance with plant control tests and Chapters 3745-81 and 3745-82 and rule 3745-91-06 of the Administrative Code are performed in accordance with the analytical methods which the laboratory has been certified to use;

(4) Obtaining written approval from the director prior to making any changes in the analytical methodologies or procedures which the laboratory has been certified to use;

(5) Documentation that the laboratory and equipment therein conform to the laboratory plan approved by the director, and that all necessary laboratory equipment is operational;

(6) Notification to the director in writing of any change(s) in personnel or equipment which may affect the laboratory's ability to accurately perform drinking water analyses;

(7) Submitting revised plans and obtaining approval from the director prior to any proposed laboratory remodeling or relocation. During any remodeling or relocation, the director may refuse to accept drinking water analytical results for the purpose of determining compliance with plant control tests and Chapters 3745-81 and 3745-82 and rule 3745-91-06 of the Administrative Code. Upon completion of said remodeling or relocation the laboratory shall notify the director in writing.

(8) Documentation that an acceptable quality assurance plan as described in rule 3745-89-03 of the Administrative Code is being followed;

(9) Maintenance of an acceptable quality assurance plan for drinking water analyses and submittal of revisions to the director prior to implementation of any revisions;

(10) An acceptable level of performance for the reporting of analytical data as described in rule 3745-89-08 of the Administrative Code, including an absence of any falsification in the reports, as well as reporting analytical results in accordance with the reporting limits established in appendix B of rule 3745-89-03 of the Administrative Code;

(11) Obtaining acceptable results within the past twelve months in at least one proficiency test for each regulated contaminant that the laboratory has certification;

(12) Satisfactory performance for analyses included in interlaboratory comparison and verification studies if such are required by the director;

(13) Allowing on-site surveys of the laboratory by certification personnel, including unannounced on-site surveys;

(14) Acceptable performance as described in paragraph (A)(5) of rule 3745-89-03 of the Administrative Code during each on-site survey (including unannounced on-site surveys); and

(15) Correction of deviations noted in survey reports, as set forth in paragraph (A)(6) of rule 3745-89-03 of the Administrative Code, within the time specified by the director; the corrections shall be reported to the director in writing, satisfactorily addressing each individual deviation.

(B) The laboratory may be required to issue notification to its customers, within a specified period of time, explaining deviations noted in the survey. The laboratory may also be required to notify affected customers of unacceptable data, which may include, but not be limited to, a clear, accurate, and easily understood explanation of why the results were unacceptable.

(C) In addition to paragraph (A) of this rule, laboratories holding a valid and unexpired laboratory certification for gross alpha particle activity, radium-226 and radium-228 radioactivity, gross beta particle activity, strontium-89 and strontium-90 radioactivity, tritium, or radioactivity from photon emitters (excluding iodine-131), shall participate in all quality control samples and proficiency test samples. Satisfactory performance in appropriate analyses as described in rule 3745-89-03 of the Administrative Code shall be obtained in at least one proficiency test study per year.

(D) Failure to maintain certification in accordance with this rule may result in suspension or revocation of a laboratory's certification in accordance with rule 3745-89-06 of the Administrative Code.

R.C. 119.032 review dates: 08/28/2013 and 08/28/2018
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, 04/01/99, 06/18/04

3745-89-06 Director's actions for laboratory certification.

(A) The director shall issue or renew a laboratory certificate of approval provided the laboratory has met the laboratory certification requirements as described in this chapter of the Administrative Code.

(1) Laboratory certification shall expire within three years from the effective date of certification. Laboratory certification shall expire within one year from the effective date of certification if the laboratory certification:

(a) Is an initial certification under rule 3745-89-03 of the Administrative Code; or

(b) Directly follows a period of revocation or denial of a former certification under this rule.

(2) The period and provisions of each laboratory certification are summarized on a laboratory certificate of approval which is issued to the laboratory as a record of the certification and its details.

(B) The director may deny, suspend, or revoke a laboratory certification, or all such certifications issued to a laboratory under this chapter, in accordance with Chapter 3745-47 of the Administrative Code, upon finding that:

(1) The laboratory or any laboratory personnel has falsified laboratory data;

(2) The laboratory failed to meet laboratory certification requirements as described in rules 3745-89-03 to 3745-89-05 of the Administrative Code or submitted unacceptable data;

(3) The laboratory has submitted a proficiency test sample to another laboratory for analysis and reported the data as its own;

(4) A person not named on a valid laboratory certificate of approval performed analyses of a water proficiency test sample for purposes of retaining a valid laboratory certification;

(5) The laboratory or any laboratory personnel is performing, reporting, or failing to report drinking water analyses in such a manner as to threaten public health or welfare; or

(6) The laboratory failed to satisfactorily correct deviations.

(C) The director may deny, suspend or revoke an individual's certification to perform laboratory analyses issued under this chapter if the individual is an operator certified under Chapter 3745-7 of the Administrative Code and said certification is suspended or revoked for any reason other than falsification.

(D) The director shall revoke an individual's certification to perform laboratory analyses issued under this chapter if the individual is an operator certified under Chapter 3745-7 of the Administrative Code and said certification is suspended or revoked for actions related to falsification.

(E) During the pendency of an action to suspend or revoke a laboratory certification, the results of performances on a proficiency test shall not be considered by the director in making a determination to suspend or revoke the certification.

(F) The results of drinking water analyses shall not be acceptable for determining compliance with Chapters 3745-81, 3745-82, and 3745-9 or rule 3745-91-06 of the Administrative Code, or for other analyses required by the director, if the results are obtained in violation of rule 3745-81-27 of the Administrative Code or this chapter during the pendency of an action to suspend or revoke a laboratory certification.

(G) Suspension of a laboratory certification shall be for a time period specified by the director but no less than thirty days, and no more than six months, provided a correction statement is submitted in writing to the director addressing each individual deviation within the time period specified by the director and is acceptable to the director in accordance with paragraph (I) of this rule.

(H) The director may notify or require a laboratory to notify its customers, within a specific period of time, of its suspended or revoked certification.

(I) The laboratory shall demonstrate in a manner acceptable to the director that deviations have been addressed to cease suspended certification. The demonstration shall be in writing and may include, but not be limited to, on-site surveys or other means as determined by the director. If the deviations are not satisfactorily addressed within the specified time period, the certificate may remain suspended or be revoked.

(J) Revocation or denial of a new or renewed laboratory certification shall remain in effect for a time period specified by the director of not less than ninety days and not more than one year. Laboratories shall not reapply for certification until the period of denial or revocation expires. After such time, the laboratory may apply for certification as specified in rule 3745-89-03 of the Administrative Code.

(K) All actions under this rule affecting the status of a laboratory's certification shall be in accordance with Chapter 3745-47 of the Administrative Code. The director shall notify the laboratory of any action to deny, suspend, or revoke certification. An action taken by the director under this rule does not preclude the director from pursuing additional civil or criminal enforcement. Suspension or revocation may include any or all laboratory certifications issued by the director under this chapter.

Replaces: Former 3745-89-06

R.C. 119.032 review dates: 08/28/2013 and 08/28/2018
Promulgated Under: 119.03
Statutory Authority: 6109.04
Rule Amplifies: 6109.04
Prior Effective Dates: 11/26/80, 04/09/90, 04/01/99, 06/18/04

3745-89-07 Laboratory certificate property of state; display.

A laboratory certificate of approval issued under this rule remains the property of the state and shall be surrendered to the director upon revocation. The certificate shall be displayed at all times in a prominent location in the laboratory for which it was issued.

R.C. 119.032 review dates: 08/28/2013 and 08/28/2018
Promulgated Under: 119.03
Statutory Authority: 6109.03 , 6109.04
Rule Amplifies: 6109.03 , 6109.04
Prior Effective Dates: 11/26/80

3745-89-08 Reporting of analytical results.

Reporting of analytical data for determining compliance with Chapters 3745-81, 3745-82, and 3745-9 and rule 3745-91-06 of the Administrative Code shall be completed by a laboratory certified by the director to perform drinking water testing, or by a facility acceptable to the director, as follows:

(A) Results shall be reported to the director and to the public water systems by the tenth day following the month in which the chemical analyses are completed and by the tenth day following the month in which a sample is collected for microbiological analysis. All reports required under this rule shall be submitted electronically via a method acceptable to the director.

(B) All positive and all repeat sample results required by rules 3745-81-14 and 3745-81-21 of the Administrative Code, and all microbial monitoring results required by rule 3745-81-42 of the Administrative Code shall be reported to the director electronically via a method acceptable to the director and to the public water systems either by fax, electronically via a method acceptable to the director, or by overnight mail delivery by no later than the end of the next business day after the result was obtained.

(C) All results that exceed any maximum contaminant level specified in rule 3745-81-11 , 3745-81-12 , or 3745-81-15 of the Administrative Code, and all resample results to confirm MCL exceedances, shall be reported to the director electronically via a method acceptable to the director and to the public water systems by fax, electronically via a method acceptable to the director, or by overnight mail delivery by no later than the end of the next business day after the result was obtained.

(D) Reports required under this rule shall be submitted on forms or in a form acceptable to the director and shall be complete and correct. Each report shall include at least the analytical data, the name and certification number of the laboratory performing and/or reporting the analysis, the analytical method type, the dates that the sample was collected and received as well as the date the analysis was completed, the sample identification number as separately assigned by the laboratory for each sample, the certification number(s) of the laboratory analyst(s) who performed the analyses, the sample collector's identification information, and complete sample and public water system identification information including sample location description, sample monitoring point, and sample type. Additional information may be required based on contaminant.

(E) The director may establish reporting limits for any approved analytical method for contaminants listed in Chapter 3745-81 of the Administrative Code. Laboratories shall report analytical results in accordance with the reporting limits established in appendix B to rule 3745-89-03 of the Administrative Code.

(F) Failure by a laboratory to file appropriate, complete, correct, and timely reports of analytical results required by this rule may be considered by the director as failure to meet an acceptable level of performance and as failure to successfully meet the requirements for renewal of its laboratory certification(s).

(G) Analytical results required by rules 3745-81-73 to 3745-81-75 , and 3745-83-01 and Chapter 3745-82 of the Administrative Code, except for paragraph (G)(1) of rule 3745-81-75 of the Administrative Code, shall be reported to the director only when requested by the director.

(H) A laboratory or a facility that subcontracts, as defined in rule 3745-89-01 of the Administrative Code, is responsible for meeting the reporting requirements in this rule. A laboratory or facility may arrange with a subcontracted laboratory to perform this reporting, however, the laboratory retains the ultimate responsibility for these reporting requirements.

R.C. 119.032 review dates: 08/28/2013 and 08/28/2018
Promulgated Under: 119.03
Statutory Authority: 6109.04
Rule Amplifies: 6109.04
Prior Effective Dates: 10/01/95, 04/01/99, 06/28/03, 06/18/09, 09/14/09

3745-89-09 Interim authorization for plant control tests.

(A) A laboratory with a valid and unexpired certification under this chapter may request that the director grant an individual(s) interim authorization to perform for the laboratory one or more of the plant control tests for pH, turbidity, alkalinity, stability, hardness, fluoride, chloride, chlorine dioxide, chlorite, and chlorine according to the following requirements.

(1) The director shall grant interim authorization only to an individual(s) who has performed acceptably during training for performing the same duties as an analyst with operational approval;

(2) The number of individuals requested for interim authorization by the laboratory may not be more than two; and

(3) A laboratory shall submit an application for interim authorization to the director on a form provided by the director. The application shall include the following information:

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

(b) The list of analysts specified on the laboratory's applicable certificate of approval, and the plant control tests which each analyst currently performs;

(c) The list of individuals and the plant control tests for which interim authorization is sought; and

(d) Documentation for each individual on each plant control test requested for interim authorization of at least twenty days of analytical results generated in parallel testing with an analyst included on a certificate of approval for those same plant control tests. The previous approval of an individual to perform plant control tests may be considered for satisfying this requirement.

(B) In order for an individual to be granted interim authorization for any plant control test, the analytical results required by paragraph (A)(3)(d) of this rule shall indicate the individual has an acceptable performance as specified by the director.

(C) The analytical results produced by the individual(s) with interim authorization shall be independently reviewed by an analyst included on a certificate of approval for the same tests as those granted for interim authorization.

(D) Within six months of an interim authorization, an on-site survey will be scheduled. Interim authorization shall remain in effect for a period not to exceed six months, unless an extension is granted or, if an on-site survey is scheduled or has been conducted, until the on-site survey report is issued.

(E) The laboratory shall demonstrate an acceptable level of performance, by all individuals for which interim authorization is sought, during an on-site survey as described in paragraphs (A)(5) and (A)(6) of rule 3745-89-03 of the Administrative Code.

R.C. 119.032 review dates: 08/28/2013 and 08/28/2018
Promulgated Under: 119.03
Statutory Authority: 6109.03 , 6109.04
Rule Amplifies: 6109.03 , 6109.04
Prior Effective Dates: 04/01/99

3745-89-10 Interim authorization for new contaminants and new methods.

The director may grant interim authorization, as defined in rule 3745-89-01 of the Administrative Code, for certified laboratories to perform drinking water analyses by using new methods, or for new contaminants, or both during a transition period necessary for implementation of new or amended regulations. Such authorization shall follow the following procedures:

(A) The director shall notify certified laboratories of the availability of interim authorization and the drinking water analyses to be included.

(B) Interim authorization shall only be available to laboratories which currently have valid certification under this chapter for the same type of drinking water analysis (microbiological contaminants, inorganic, trace metals, etc.) as the drinking water analyses to be included in the interim authorization.

(C) In order to be considered for interim authorization, the laboratory shall submit to the director an application for interim authorization, on a form provided by the director. The application shall include the following information:

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

(2) Statement of the drinking water analyses and methods for which interim authorization is sought and the analysts to be included in the interim authorization to perform the analyses. The analysts shall be individuals already identified on a valid certificate of approval for the laboratory for performing similar analyses or for analyzing the same type of contaminant;

(3) Documentation that the laboratory obtained acceptable results within the past twelve months for at least one proficiency test provided by a proficiency test provider for each drinking water analysis to be included in the interim authorization;

(4) Documentation that method detection limit (MDL) studies have been completed by the laboratory for each drinking water chemistry analysis to be included in the interim authorization; with the MDL studies indicating that the laboratory is capable of meeting any specified analytical reporting requirements; and

(5) Documentation that the director has approved parallel testing between the microbiological methods not approved by the Ohio environmental protection agency and an equivalent microbiological method that is approved by the Ohio environmental protection agency. Parallel testing shall include the following:

(a) The microbiological method not approved by the Ohio environmental protection agency for which interim authorization is being sought shall have been published in the Federal Register as having United States environmental protection agency approval for compliance testing of drinking water;

(b) Three sets of duplicate samples testing during at least one month a quarter for three consecutive quarters. Each set shall consist of twenty-five finished drinking water samples as potential 'negative' samples and ten raw, surface, or non-potable water samples (or dilutions of such) as potential 'positive' samples. Each parallel set shall include the required positive and negative controls. This environmental sample base will simulate what could be encountered when actually testing drinking water in Ohio, including seasonal variations in organisms;

(c) Any method specific quality control procedures required by the laboratory certification office; and

(d) Additionally, one microbiological proficiency test set shall be analyzed from a NIST approved proficiency test supplier with the method not approved by the Ohio environmental protection agency. The test data shall be sent directly to the state proficiency test coordinator from the proficiency test provider. The laboratory shall pass the proficiency test study with the method for which interim authorization is being sought.

(D) When granted, interim authorization shall state the individual(s) and drinking water analyses included in the interim authorization and the length of time that the interim authorization will remain in effect.

(E) An on-site survey shall be scheduled to verify acceptable performance by the laboratory granted interim authorization. Interim authorization shall remain in effect for the length of time specified by the director or until the on-site survey is completed and certification is granted under rule 3745-89-06 of the Administrative Code, whichever occurs first.

Replaces: Former 3745-89-10

R.C. 119.032 review dates: 08/28/2013 and 08/28/2018
Promulgated Under: 119.03
Statutory Authority: 6109.03 , 6109.04
Rule Amplifies: 6109.03 , 6109.04
Prior Effective Dates: 04/01/99

3745-89-11 Approved laboratories for the "Long Term 2 Enhanced Surface Water Treatment Rule".

(A) Cryptosporidium. Systems shall have Cryptosporidium samples analyzed by a laboratory that is approved under "U.S. EPA's Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium in Water" or a laboratory that has been certified for Cryptosporidium analysis by the Ohio environmental protection agency laboratory certification program.

(B) E. coli. Any laboratory certified by the "U.S. Environmental Protection Agency or the National Environmental Laboratory Accreditation Conference (NELAC)" for total coliform or fecal coliform analysis in accordance with 40 C.F.R. 141.74 , is approved for E. coli analysis under this rule when the laboratory uses the same technique for E. coli that the laboratory uses for 40 C.F.R. 141.74 provided that the laboratory obtains acceptable results on a source water proficiency test sample.

(C) Turbidity. Measurements of turbidity shall be made in accordance with paragraph (C)(3) of rule 3745-81-27 of the Administrative Code.

Effective: 01/08/2010
R.C. 119.032 review dates: 01/08/2015
Promulgated Under: 119.03
Statutory Authority: 6109.04
Rule Amplifies: 6109.03, 6109.04