(1) Every person, firm or corporation operating or maintaining a laboratory in which body fluids, secretions or excretions are examined for the determination of the presence or absence of an infectious agent in the material examined or in the person or animal from which it was secured shall register annually with the department, giving the name of such laboratory, its location and the name of the person or persons owning or operating the same.

(2) All laboratories doing public health work in the state of Montana shall register with the department. Such laboratories which meet the standards of the department shall be designated as approved laboratories.

(1) Laboratories which, after inspection, are found to conform to the standards required by the department will be given a certificate of approval, and such laboratories will thereafter be designated as approved laboratories.

(1) An authorized representative of the state laboratory shall make an annual inspection of all registered laboratories, and at such other times as he or the department may deem advisable.

For the purpose of this subchapter:

(1) "Accuracy" means the degree of agreement between an observed value and an accepted reference value.

(2) "Analyte" means the substance or thing for which a water sample is analyzed to determine its presence or quantity.

(3) "Bachelor degree or equivalent" means a college degree with the equivalent of 30 semester hours in a biological or physical science program or at least four years of experience in a specific related scientific discipline.

(4) "Certification officer" means a representative of the department who conducts assessments of laboratories to determine if they should be approved for licensure. The representative may be a third party contractor who acts under the authority of the department.

(5) "Chemical hygiene plan" means a document written by a laboratory that describes the procedures used to store, handle, and dispose of chemicals in the laboratory.

(6) "Conditional licensure" refers to a laboratory applying for a license for the first time that is in compliance with most requirements for licensure but has not yet met all of the requirements of this subchapter, but whose deficiencies do not affect the capability of the laboratory to perform valid analyses.

(7) "Contaminated" means exceeding a maximum contaminant level established in ARM Title 17, chapter 38, subchapter 2.

(8) "Department" means the Department of Public Health and Human Services.

(9) "Environmental laboratory" means the environmental laboratory of the Department of Public Health and Human Services that is responsible for the licensing of laboratories performing drinking water analyses in Montana.

(10) "Environmental Protection Agency (EPA)" means the United States Environmental Protection Agency.

(11) "EPA laboratory certification manual" means the EPA publication entitled "Manual for the Certification of Laboratories Analyzing Drinking Water," January 2005, 5th edition (EPA 815-R-05-004).

(12) "Holding time" means the maximum time that a sample may be held prior to preparation or analysis.

(13) "Initial demonstration of analytical capability" means the procedure described in the method cited in 40 CFR part 136, appendix A, as amended August 28, 2017, for chemistry analysis, used to determine a laboratory's accuracy and precision in applying an analytical method.

(14) "Interdependent analyte group" means a group of analytes, as determined by the department, for which the ability to correctly identify and quantify a single analyte in the group indicates the ability to correctly identify and quantify other analytes in the group.

(15) "Interim licensure" refers to a status that may be granted by the certifying agency to a fully licensed laboratory without an on-site inspection for a particular analyte or interdependent analyte group if the certifying agency determines with appropriate documentation that the laboratory has the appropriate instrumentation, is using a previously approved method, has adequately trained personnel to perform the analyses, and has satisfactorily analyzed PT samples, if available for the analytes in question.

(16) "Key personnel" means a laboratory's director, supervisor, and quality assurance officer, all of whom meet the requirements of the EPA laboratory certification manual.

(17) "Method detection limit" means the minimum concentration of a substance that can be measured and reported with 99% confidence that the analyte concentration is greater than zero as determined from analysis of a sample containing the analyte in a given matrix as described in 40 CFR part 136, appendix B, as amended August 28, 2017.

(18) "Performance evaluation (PE) sample" means a sample obtained through a source approved by the environmental laboratory whose composition is unknown to the laboratory performing the analysis and which is used to evaluate the ability of the laboratory to produce precise and accurate results.

(19) "Precision" means the degree to which a set of observations or measurements of the same property, usually obtained under similar conditions, conform to themselves. Precision is usually expressed as standard deviation, variance or range, in either absolute or relative terms.

(20) "Proficiency testing (PT)" refers to testing an unknown sample to evaluate the ability of the laboratory to produce precise and accurate results and is used interchangeably with performance evaluation (PE).

(21) "Provisional licensure" refers to the downgraded status of a laboratory previously holding full certification due to noted deficiencies, but in the opinion of the certifying agency the laboratory can still demonstrate their ability to consistently produce valid data.

(22) "Quality assurance plan" means a document written by a laboratory that describes the procedures used to ensure that routinely generated analytical data are scientifically valid and that their precision and accuracy are within defined limits.

(23) "Safe Drinking Water Act" means the federal law set out in 42 USC 300f through 300j-11, governing drinking water programs.

(24) "Standard operating procedures (SOPs)" means a laboratory's written document which details the steps of an operation, analysis, or action whose techniques and procedures are thoroughly prescribed and is accepted by the laboratory as the procedure for performing certain routine or repetitive tasks.

(25) "Variance" means written approval from the environmental laboratory allowing a laboratory to use a method, procedure, or equipment other than that required by these rules that meets the purpose and intent of these rules and that has been shown to have no adverse material effects on the accuracy of analyses.

(26) "Waiver" means written approval from the environmental laboratory exempting a laboratory from a requirement of these rules if the environmental laboratory finds that the requirement is inapplicable to the particular practice of that laboratory.

(1) A laboratory that conducts analyses of water from public water supplies must meet the licensure requirements of these rules before the analyses or reports of the analyses may be accepted by the Department of Environmental Quality (DEQ) for the purpose of meeting the requirements of Title 75, chapter 6, MCA, and rules of the DEQ concerning public water supplies.

(2) A laboratory may be licensed to perform microbiology testing, chemical testing, or both. Microbiology testing and chemical testing are separate licensure categories. If a laboratory requests licensure for both categories, it must submit to the department a separate license application and undergo a separate inspection for each category, and it will receive a separate license for each category for which it qualifies.

(3) A license granted by the department constitutes permission to perform only those analyses of analytes and using only those methods for which the laboratory requests the licensure to cover and that the department finds the laboratory is capable of performing in accordance with the provisions of this subchapter.

(1) Any laboratory not currently licensed but desiring licensure under this subchapter must:

(a) submit a completed application to the Department of Public Health and Human Services, Laboratory Services Bureau, 1400 Broadway, Cogswell Building, P.O. Box 4369, Helena, MT 59604-4369, on forms provided by the department. The application must include:

(i) the legal name of the laboratory;

(ii) the name of the laboratory owner;

(iii) the laboratory mailing address;

(iv) the full address of the physical location of the laboratory;

(v) the laboratory hours of operation;

(vi) a description of qualifications of key personnel and technical employees;

(vii) the name and daytime phone number of the laboratory director;

(viii) the name and daytime phone number of the laboratory's quality assurance officer;

(ix) the name and daytime phone number of the laboratory contact person; and

(x) the laboratory's quality assurance plan and documentation of the laboratory's implementation and adherence to the quality assurance plan.

(b) be enrolled in a proficiency testing program;

(c) apply for approval to analyze at least one analyte or interdependent analyte group by a method the department approves under ARM 37.12.333;

(d) pay all applicable fees prescribed by ARM 37.12.310 prior to the department's processing of the application; and

(e) submit a statement of assurance of compliance signed and dated by the laboratory owner, director, and quality assurance officer, which shall include:

(i) an acknowledgment that the applicant understands that, once licensed, the laboratory must continually comply with the requirements for licensure in this subchapter in order to remain licensed;

(ii) an acknowledgment that the department may make unannounced inspections of the laboratory for the purpose of assessing compliance with these rules and that a refusal to allow entry to the laboratory premises by the department's authorized representatives is grounds for denial or revocation of its license;

(iii) a statement that the applicant laboratory will perform all proficiency testing audits according to acceptable methods, in accordance with department requirements, and at their own expense; and

(iv) a statement that there is no misrepresentation in the information provided in the application.

(2) When the laboratory submits the documentation required by ARM 37.12.333, the department shall conduct an on-site assessment at a date and time agreed to by the laboratory director to determine whether the laboratory complies with the minimum requirements of this subchapter and that the laboratory can produce valid results.

(3) At the time of scheduling the assessment, the department's certification officer shall specify what staff, equipment, and supplies need to be on hand during the evaluation and what tests need to be run in order to determine whether the laboratory can meet the licensure requirements set out in this subchapter.

(4) If possible, the evaluations will be scheduled to occur within 45 days after the department determines the application is complete, except in the case of applications received in May, June, July, or August, which will be scheduled for evaluation no later than October 31 of the same year.

(5) The certification officer shall provide the laboratory director with a written report of the department's findings from the on-site assessment.

(6) If the department determines that the laboratory does not meet the requirements for licensure:

(a) the department will send the laboratory written notice of that fact, the grounds for the decision, and the right to submit a plan of correction within 30 days after receipt of the notice for minor deficiencies and within 15 days after receipt of the notice for major deficiencies;

(b) if a plan of correction is not received by the deadline or if the plan of correction is inadequate to correct the deficiencies, the department will issue a written denial of the license, the grounds for denial, and the right to an appeal pursuant to the Montana Administrative Procedure Act.

(7) If the on-site assessment is satisfactory or, if it is not, if implementation of the plan of correction successfully eliminates the deficiencies cited, the department shall issue a final decision in writing granting the type of license requested and stating which analyte(s) or interdependent analyte group(s) the laboratory is approved to analyze.

(8) A license expires on the expiration date listed on the license, unless revoked earlier. To avoid a lapse in licensure, a laboratory must submit, on a form provided by the department, a completed application for renewal and the required fee for licensure prior to the expiration of the license.

(1) In order to be licensed, a laboratory must:

(a) meet all of the applicable personnel, equipment, training, and facility requirements of this subchapter;

(b) at least once during the three-year term of its license, pass an on-site inspection by an agent of the environmental laboratory that shows compliance with the requirements of these rules for the license category in question;

(c) if the laboratory performs chemical analyses, have performed analyses on at least two performance evaluation (PE) samples for each analyte or interdependent analyte group and each method each year during the term of its license; and

(d) if the laboratory performs microbiological analyses, have successfully performed analyses on at least two performance evaluation (PE) samples for each analyte and method each year during the term of its license.

(1) The following fees calculated on a flat fee yearly schedule, must be submitted to the department, under the circumstances noted, by laboratories conducting analyses of public water supplies. All licensure fees are due January 1 of each calendar year. New laboratories that wish to be licensed prior to July 1 will pay full licensure fees; after July 1 of the fiscal year the licensure fees will be prorated 50%:

(a) $250 with an application for an initial microbiology, inorganic chemistry, or organic chemistry license. This application fee will only be charged when issuing a first-time license or issuing a new license after a license has lapsed;

(b) $550 licensure fee for an organic chemistry license for an in-state laboratory;

(c) $990 licensure fee for an organic chemistry license for a laboratory licensed by reciprocity;

(d) $350 licensure fee for an inorganic chemistry license for an in-state laboratory;

(e) $600 licensure fee for an inorganic chemistry license for a laboratory licensed by reciprocity;

(f) $350 licensure fee for a microbiology license for an in-state laboratory;

(g) $600 licensure fee for a microbiology license for a laboratory licensed by reciprocity;

(h) $300 plus travel expenses for an inspection to determine if the holder of a conditional license qualifies for a full license or for a second inspection during the three-year term of a license that is necessary for approval of a new laboratory location; there is no charge for one inspection during the term of the license;

(i) $125 per day for training in the environmental laboratory;

(j) $300 per day, plus travel expenses of environmental laboratory staff, for on-site training and technical assistance outside of licensure inspections by the Laboratory Services Bureau staff.

(a) all of the requirements of this subchapter continue to be met for the type of license granted;

(b) the laboratory completes annual questionnaires from the department designed to update the department on personnel and procedures; and

(c) the laboratory remits to the department the appropriate annual licensure fee and any other fees due pursuant to ARM 37.12.310.

(2) A reciprocal license granted to an out-of-state laboratory is for the same period as the license, certification or other approval granted by the approving authority, provided that:

(a) all of the requirements of ARM 37.12.313 continue to be met;

(b) the laboratory completes annual questionnaires designed to update the department on personnel and procedures; and

(c) the laboratory remits to the department the appropriate annual licensure fee or fees due pursuant to ARM  37.12.310.

(1) In the case of a laboratory applying for a license for the first time, the department may grant a conditional license to a laboratory that:

(a) is in compliance with all requirements for licensure but has not yet analyzed a second PE sample or does not have records of historical performance; or

(b) does not comply with all of the requirements of this subchapter, but whose deficiencies do not affect the capability of the laboratory to perform valid analyses.

(2) Conditional licensure will be granted only after an on-site inspection and is in effect for one year or until full licensure is granted under provisions of ARM 37.12.311, whichever is earlier.

(3) In order for a laboratory applying for a chemistry license for the first time to upgrade from conditional licensure status to fully licensed status, it must perform analyses of a minimum of two PE samples over the course of a year that indicate at least two successful analyses of each analyte or interdependent analyte group and method for which they seek licensure to analyze, and undergo a second on-site inspection that shows full compliance with licensure standards.

(4) In order for a laboratory applying for a microbiology license for the first time to upgrade from conditional licensure status to fully licensed status, a microbiology laboratory must be in continual operation for one year, analyze and successfully pass at least two performance evaluation (PE) sets for each analyte and method, and undergo a second on-site inspection to verify that its methodologies and quality control meet the standards of this subchapter.

(1) The department may issue a license to an out-of-state laboratory to perform analyses for public drinking water systems in Montana provided that the laboratory:

(a) applies for licensure and is currently approved by the Environmental Protection Agency or the state in which the laboratory is located if that state has a certification program approved by EPA for laboratories analyzing water from public water supplies;

(b) the EPA or the state's certifying authority, whichever is appropriate, provides the department with a copy of the laboratory's current certification and most recent inspection report;

(c) the requirements for certification in the approving state are no less stringent than the requirements for resident laboratories in the state of Montana;

(d) the laboratory submits qualification information for all key personnel and provides the department with a current copy of the laboratory's quality assurance plan;

(e) the laboratory performs, analyzes, and successfully passes PE audits for analytes from sources approved by the department. The provider of the PE samples shall report results of the analyses directly to the department; and

(f) the laboratory complies with the notification requirements of ARM 37.12.324, 37.12.325, and 37.12.326.

(2) The department may license a laboratory that is accredited by the National Environmental Laboratory Accreditation Program (NELAP) if:

(a) it provides evidence of its accreditation and applies for licensure on that basis;

(b) it obtains approval from the department of the testing procedures for each analyte or interdependent analyte group and method and meets the approval requirements of this rule; and

(c) the methods are approved by EPA for drinking water analysis.

(1) The department may downgrade a laboratory to provisional status and place conditions upon the license of a laboratory. The provisionally licensed laboratory must notify clients of its downgraded status in writing, on any applicable report. The department will notify the Department of Environmental Quality of any laboratories that have been downgraded to provisional status. Downgrading to provisional status may occur under the following circumstances:

(a) the laboratory reports results of an analysis of PE samples that are outside acceptable limits, and does not successfully perform analysis on a second set of PE samples within 90 days of receipt of the original report, or it fails to report results of a PE sample analysis for any analyte that the laboratory is approved to analyze. In this case:

(i) the laboratory's license is provisional only in regard to the laboratory's approval to conduct analyses of the particular analyte or method involved;

(ii) the provisional status remains in effect until the next available PE results are reported to the department, at which time:

(A) the conditions will be removed if acceptable PE results are reported to the department; or

(B) approval to conduct the analysis in question will be revoked if unacceptable PE results are reported to the department.

(b) the laboratory notifies the department, after the fact, of changes in personnel, equipment, or a change in location that have a material effect on the analyses of analytes for which it is approved. In this case, provisional approval will remain in effect until:

(i) the department has re-evaluated the laboratory; and

(ii) those analyses affected by the changes are conducted on PE samples and the results are evaluated by the department, at which time the conditions may be removed if the analyses meet the standards of these rules or approval to do those tests may be revoked if the standards are not met.

(1) The department may deny or revoke a license at any time that a laboratory is not in compliance with the requirements for licensure under this subchapter, including if the laboratory:

(a) fails to analyze and report results of at least two PE samples per year;

(b) reports unacceptable results or fails to report the results of analyses of two consecutive PE samples for an analyte for which the laboratory is approved;

(c) fails to correct cited deficiencies within the time specified by the department or fails to adhere to conditions of a waiver or variance;

(d) no longer employs a director or analysts who have satisfied the requirements of this subchapter;

(e) does not use EPA-approved methods to perform analyses;

(f) does not perform required quality control procedures;

(g) falsifies data or engages in deceptive practices such as reporting another laboratory's data without giving credit on the report to the laboratory which performed the analysis;

(h) reports data that were obtained using equipment, procedures, analysts, methods, or facilities that are not approved by the department;

(i) fails to report to the Department of Environmental Quality within the time frames described in ARM 37.12.341 the results of any sample required under ARM Title 17, chapter 38, subchapter 2, and accepted by the laboratory for analysis, that exceeds a maximum contaminant level (MCL) or triggers additional actions; or

(j) fails to report results on forms or formats acceptable to the Department of Environmental Quality.

(2) The department will send the laboratory written notice of the denial or revocation of a license that indicates the grounds for the revocation or denial and the right to an appeal of the decision pursuant to the Montana Administrative Procedure Act.

(1) The department will issue a license to a laboratory whose license has been denied or revoked when the laboratory demonstrates to the department that all appropriate requirements listed in the EPA laboratory certification manual are satisfied and when a compliance schedule has been set to meet all additional requirements of this subchapter.

(2) If the laboratory does not fulfill the terms of the compliance plan, the license will again be revoked pursuant to ARM 37.12.315.

(3) A laboratory may request technical assistance from the department to remediate any deficiencies. The department shall provide the technical assistance as soon as is practical.

(4) The department adopts and incorporates by reference the EPA laboratory certification manual (EPA 815-R-05-004, "Manual for the Certification of Laboratories Analyzing Drinking Water," January 2005), which contains criteria, procedures, and quality assurance standards required by the EPA that must be met by laboratories analyzing drinking water to determine compliance with the federal Clean Water Act and its rules. A copy of the manual may be obtained from the Department of Public Health and Human Services, Laboratory Services Bureau, 1400 Broadway, Cogswell Building, P.O. Box 4369, Helena, MT 59604-4369, telephone (406)444-3444, or may be downloaded at the EPA web site: https://www.epa.gov/dwlabcert/laboratory-certification-manual-drinking-water.

(1) For a laboratory to become approved and to maintain approval for conducting analyses for an analyte or an interdependent analyte group by a specific method, the laboratory must, at its own expense, meet the proficiency testing requirements of this rule.

(2) In order to initially obtain and to maintain approval, the laboratory must:

(a) whenever required by the EPA, enroll and participate in a proficiency testing program approved by the environmental laboratory for each analyte or interdependent analyte group, or, for each analyte or interdependent analyte group and method for which proficiency testing is not available or required, the laboratory must establish, maintain, and document the accuracy and reliability of its procedures through a quality assurance plan;

(b) successfully participate in at least two proficiency tests annually;

(c) prior to obtaining approval, notify the department of the authorized proficiency testing program or programs in which it has enrolled for each analyte or interdependent analyte group and method approved under its license to analyze;

(d) follow the proficiency testing provider's instructions for preparing the proficiency testing sample and must analyze the proficiency testing sample as if it were a client sample;

(e) direct the proficiency testing provider to send, either in hard copy or electronically, a copy of each evaluation of the laboratory's proficiency testing audit results to the department; and

(f) authorize the proficiency testing provider to release to the department all information necessary for the department to assess the laboratory's compliance with this rule.

(3) In addition to the requirements of (2), in order to remain approved for testing an analyte or interdependent analyte group, a laboratory must:

(a) in each calendar year, successfully complete at least two separate proficiency testing audits for each analyte or interdependent analyte group and method;

(b) maintain a paper or electronic copy of all proficiency testing records, including analytical data and worksheets and a copy of the proficiency testing provider report forms authorized by the environmental laboratory and used by the laboratory to record proficiency testing results for a period of five years;

(c) for every proficiency test, ensure that the director of the laboratory signs and retains an attestation statement stating that the laboratory followed the proficiency sample provider's instructions for preparing the proficiency sample and analyzed the proficiency testing sample as if it were a client sample; and

(d) analyze and report to the provider the results of the proficiency test by the deadline set by the proficiency testing provider.

(4) A laboratory may not:

(a) perform multiple analyses (such as replicates or duplicates) that are not normally performed in the course of analysis of a routine sample;

(b) average the results of multiple analyses for reporting when not specifically required to do so by the analytic method in question;

(c) permit anyone other than bona fide laboratory employees who perform the analyses on a day-to-day basis for the laboratory to participate in the generation of data or reporting of results;

(d) discuss the results of a proficiency testing audit with any other laboratory until after the deadline set for receipt of results by the proficiency testing provider;

(e) if the laboratory has multiple testing sites or separate locations, discuss the results of a proficiency testing audit across sites or locations until after the deadline set for receipt of results by the proficiency testing provider;

(f) send proficiency testing samples or portions of samples to another laboratory to be tested; or

(g) knowingly receive a proficiency testing sample from another laboratory for analysis and fail to notify the department of the receipt of the other laboratory’s sample within five business days of discovery.

(5) Results of proficiency tests must be within the control limits established by the EPA as specified in the EPA laboratory certification manual (EPA 815-R-05-004) "Manual for the Certification of Laboratories Analyzing Drinking Water," January 2005) for each analysis for which the laboratory requests approval.

(a) Specific chemistry acceptance criteria are listed in Table IV-10. "MCL and Proficiency Testing Sample Acceptance Criteria in the CFR, Primary and Secondary Drinking Water Regulations" of the EPA laboratory certification manual.

(b) Specific microbiology acceptance criteria is correctly analyzing a minimum of nine of ten samples, with no false negative result (i.e., a single false positive result would be considered acceptable).

(6) The department may require the testing of other samples, such as blind samples or split samples, as needed to evaluate laboratory performance.

(7) The laboratory must participate in an authorized proficiency testing program for at least 12 months before changing to another proficiency testing provider for the analyte or interdependent analyte group, unless there are extenuating circumstances.

(8) A laboratory must notify and have approval from the department before changing enrollment in an authorized proficiency testing program, and if the reason for changing providers is a result of extenuating circumstances, the laboratory must also delineate the reasons for the requested change.

(9) The department adopts and incorporates by reference the acceptance limits for regulated parameters in chapter IV of the EPA laboratory certification manual (EPA 815-R-05-004, "Manual for the Certification of Laboratories Analyzing Drinking Water," January 2005), which contains the critical elements for chemistry that a laboratory must meet, including the acceptance limits required by the EPA for metals, inorganics, volatile organic compounds and synthetic organics in drinking water samples. A copy of chapter IV may be obtained from the Department of Public Health and Human Services, Laboratory Services Bureau, 1400 Broadway, Cogswell Building, P.O. Box 4369, Helena, MT 59604-4369, telephone (406)444-3444, or may be downloaded at the EPA web site: https://www.epa.gov/dwlabcert/laboratory-certification-manual-drinking-water.

(1) Whenever a laboratory makes any change in personnel or equipment that has a material effect on the analysis of analytes, the laboratory must notify the department of that fact within 30 days after making the change, but prior to reporting results of tests used in regulatory compliance. A change in personnel is defined as the loss or replacement of the laboratory supervisor or a situation in which a trained and experienced analyst is no longer available to analyze a particular parameter for which licensure has been granted.

(2) After receiving the notification, the department may place conditions upon the laboratory's license pursuant to ARM 37.12.314.

(1) A licensed laboratory that changes its name or business organizational status must report the change in writing to the department within 30 days of the change.

(1) A licensed laboratory which intends to change its physical location shall notify the department 90 days prior to the relocation. The notification shall include the following:

(a) the full physical address of the new location;

(b) a notification of any personnel, equipment, or analytic method changes which will occur as a result of the relocation; and

(c) a signed statement either that the laboratory quality assurance plan will not be affected by the relocation, or, if it will be, that the plan will be revised to address the necessary changes.

(2) If, in view of the information received pursuant to (1), the department is satisfied that the laboratory can produce valid results at the new location, it shall place conditions on the laboratory license as specified in ARM 37.12.314.

(3) The department shall conduct an on-site inspection at the new location within 60 days after the relocation is completed.

(4) Within 30 days after the on-site inspection, the department shall issue a determination either that the laboratory license is:

(a) revoked;

(b) its provisional status is retained; or

(c) the conditions are removed.

(5) If the department's decision is to revoke the license, the procedure followed will be that set out in ARM 37.12.315.

(6) The term of the license remains the same as it was for the original site.

(2) Whenever possible, inspections will be scheduled in advance so that they do not interfere with routine laboratory operations. However, whenever necessary to protect public health, unannounced inspections will be conducted.

(3) If an unannounced inspection causes a business hardship or may result in harm to laboratory clients, the laboratory director will give the department notice of that fact at the time of inspection and the department will make whatever accommodations may be made to alleviate the hardship or harm while still protecting public health.

(1) Analyses must be conducted using current EPA approved methods in accordance with the analytical requirements set forth in 40 CFR 141.

(2) Alternate analytical procedures are not permitted unless such procedures satisfy 40 CFR 141.27 and have been approved by the EPA.

(3) An applicant laboratory must request approval to analyze for an analyte or interdependent analyte group and the method(s) used as part of its application for licensure or renewal of a license.

(4) Approval for such analyses will be granted only after an on-site assessment. The applicant laboratory shall submit:

(a) documentation that it has the necessary equipment and qualified technical employees to preform the tests;

(b) for chemistry analysis, documentation that the laboratory has successfully passed two proficiency testing audits for the analyte and method in question from an approved proficiency testing program;

(c) its standard operating procedure for the method used to analyze for the analyte in question;

(d) documentation of its initial demonstration of analytical capability; and

(e) documentation establishing the laboratory's method detection limit for each chemical analyte.

(5) If the department is satisfied from its assessment that the applicant laboratory can produce valid results, it shall grant approval for the analyte or interdependent analyte group by a specific method.

(6) At a time other than when applying for a license renewal, a licensed laboratory may request approval to analyze for an additional analyte or interdependent analyte group by submitting a written request together with the documentation required in (1).

(a) If the analyte for which approval is requested is an addition to, or a group similar to, analytes that have already received approval, the certifying agency may grant interim approval for the analyte which shall remain in effect until the next review for license renewal as long as the laboratory continues to successfully complete proficiency testing on the analyte.

(b) If the analyte for which approval is requested is unrelated to previously approved analytes, or requires specialized equipment and/or personnel training, the certifying agency shall require a new application packet and an application fee to be submitted, as well as an update of the laboratory licensure file, and shall perform an on-site assessment prior to approval.

(1) A licensed laboratory must develop and implement a quality assurance program that is an integrated system of activities involving planning, quality control, quality assessment, reporting, and quality improvement to ensure that its services meet its standards of quality with its stated level of confidence.

(2) The quality assurance program must address the type of testing activities the licensed laboratory undertakes and how quality assurance activities may change with changes in sample volumes. The quality assurance program must include a quality assurance plan and documentation of quality assurance activities.

(3) As part of its quality assurance program, each licensed laboratory must develop and adhere to a quality assurance plan. The laboratory must include and address the following essential items in the quality assurance plan:

(a) listing of key individuals, laboratory organization and lines of responsibility;

(b) position descriptions;

(c) evaluation of staff competency;

(d) staff training;

(e) general quality control procedures;

(f) frequency of proficiency testing;

(g) proficiency testing audit handling;

(h) reporting of proficiency testing results;

(i) analytical methods and SOPs with annual reviews and dates of revisions of the methods and SOPs;

(j) sample handling procedures;

(k) data reduction, validation, reporting, and verification (an SOP may be referenced);

(l) record keeping, quality assurance review of data, and reporting of results;

(m) equipment operation and calibration;

(n) physical facility factors that may affect quality;

(o) corrective action policy and procedures;

(p) definitions of terms used in the quality assurance plan;

(q) frequency and procedure of quality reviews and the content of reports to the laboratory director; and

(r) frequency, procedure, and documentation of preventive maintenance.

(4) For chemistry laboratories the plan must also include:

(a) calibration procedures for chemistry (an SOP may be referenced);

(b) instrument performance checks;

(c) laboratory reagent blanks, and field or trip blanks;

(d) field or laboratory matrix replicates;

(e) reference samples;

(f) laboratory fortified blanks and laboratory fortified matrix spikes;

(g) initial demonstration of method capability and use of control charts; and

(h) qualitative identification and confirmation of contaminants.

(5) As part of the quality assurance program, the laboratory must document and retain records for a period of five years demonstrating that it has maintained compliance with its quality assurance program. The laboratory may be requested by the department to provide quality assurance data to monitor compliance.

(1) A laboratory shall develop and maintain a safety program, including an education-based safety program, which meets the requirements of the Montana Safety Culture Act, Title 39, chapter 71, part 15, MCA, and ARM 24.30.2501 through 24.30.2558 implementing that act and adopted by the Department of Labor and Industry.

(a) The department adopts and incorporates by reference those portions of ARM 24.30.2501 through 24.30.2558, which contain requirements that employers must meet concerning the establishment of educational safety programs and safety programs for employers who employ more than five employees. A copy of those rules may be obtained from the Department of Public Health and Human Services, Office of Legal Affairs, 111 North Sanders, Sanders Building, P.O. Box 4210, Helena, MT 59604-4210.

(2) The laboratory shall develop and maintain a chemical hygiene plan.

(3) Where safety methods are included in an analytic method approved by the department, they must be included in the method's SOP and adhered to by the laboratory's analysts performing the procedure.

(1) A laboratory must have, at a minimum, the equipment and supplies necessary to perform an approved analytical method for each contaminant analysis for which approval is requested pursuant to ARM 37.12.305.

(2) The equipment and supplies must meet the specifications required by the approved analytical method used and the specifications specified in the EPA laboratory certification manual for that method.

(3) Analytical reagent (AR) grade chemicals or better must be used for analyses.

(4) The laboratory must have a source of distilled, deionized, or reagent grade water that meets all the requirements listed in the EPA laboratory certification manual and the requirements of the analytical method being used.

(5) The department adopts and incorporates by reference the standards contained in the EPA laboratory certification manual (EPA 815-R-05-004, "Manual for the Certification of Laboratories Analyzing Drinking Water," January 2005) for sources of distilled, deionized water, or reagent grade water. A copy of the manual may be obtained from the Department of Public Health and Human Services, Laboratory Services Bureau, 1400 Broadway, Cogswell Building, P.O. Box 4369, Helena, MT 59604-4369, telephone (406)444-3444, or may be downloaded at the EPA web site: https://wwwepa.gov/dwlabcert/laboratory-certification-manual-drinking-water.

(1) All results of samples collected from a public water supply system and accepted by the laboratory for analysis that exceed a maximum contaminant level (MCL) or that trigger additional actions under ARM Title 17, chapter 38, subchapter 2 must be promptly, on the day the result is determined or no later than noon the next working day, reported by the laboratory to the Montana Department of Environmental Quality (MDEQ). Results must be reported to the Public Water Supply Section of the MDEQ either electronically to dpws@mt.gov or by telephone to (406) 444-1947. The written sample result must be submitted to MDEQ on forms and in formats approved by the MDEQ within 48 hours of completion of the analysis. When a maximum contaminant level as set out in ARM Title 17, chapter 38, subchapter 2 is found to be exceeded in any sample, the reporting laboratory accepting the sample for analysis from the water supplier must notify the water supplier of that result within 24 hours after the analysis is completed.

(2) The analytical result of all microbiological or chemical samples accepted by the laboratory for analysis, other than those which are defined in ARM 37.12.341(1), must be reported to the MDEQ within a week after completion of the analysis. The results must be submitted on forms and in formats approved by the MDEQ.

(1) If a laboratory refers testing to another laboratory, that referral laboratory must be licensed in Montana to perform drinking water analysis for that analyte and method.

(2) A laboratory that reports analyses performed by other laboratories is required to report all analyte results that are used for regulatory compliance, to the Montana Department of Environmental Quality.

(1) In order to be licensed to perform chemical analyses, a laboratory must meet the standards contained in this rule.

(2) Analysts in training must be supervised by an experienced analyst who meets all of the requirements of this rule.

(3) Supervising analysts must verify all results of testing performed by analysts in training and cosign those results.

(4) The laboratory's analysts must:

(a) meet all of the qualifications and conditions set forth in chapter IV of the EPA laboratory certification manual, and if responsible for the operation of analytical instrumentation, complete specialized training offered by the manufacturer or another qualified training facility approved by the department, or served a period of apprenticeship under an experienced analyst. The duration of this apprenticeship should be proportional to the sophistication of the instrument; and

(b) provide certification and/or training and experience documentation to the department for review and approval as part of the laboratory licensure and inspection process.

(5) The department adopts and incorporates by reference chapter IV of the EPA laboratory certification manual (EPA 815-R-05-004, "Manual for the Certification of Laboratories Analyzing Drinking Water," January 2005), which establishes qualifications for staff training and experience and conditions for approval of laboratories conducting chemical analyses of public drinking water. A copy of chapter IV may be obtained from the Department of Public Health and Human Services, Laboratory Services Bureau, 1400 Broadway, Cogswell Building, P.O. Box 4369, Helena, MT 59604-4369, telephone (406) 444-3444, or may be downloaded at the EPA web site:  https://www.epa.gov/dwlabcert/laboratory-certification-manual-drinking-water.

(1) In order to be licensed to perform microbiological analyses, a laboratory must meet the standards contained in this rule.

(2) Individual analysts must be approved by the state as meeting the standards of this rule in order to perform microbiological analysis of drinking water samples.

(3) Analysts in training must be supervised by an experienced analyst who meets all of the requirements of this rule.

(4) Supervising analysts must verify all results of testing performed by analysts in training and co-sign those results.

(5) A laboratory must meet all of the qualifications and conditions set forth in chapter V of the EPA laboratory certification manual.

(a) Analysts must have a minimum of two days of training at the environmental laboratory with a successful evaluation from the state training personnel. Documentation of independent certification or prior experience and training as approved by the department may be substituted for this training.

(6) The department adopts and incorporates by reference chapter V of the EPA laboratory certification manual (EPA 815-R-05-004, "Manual for the Certification of Laboratories Analyzing Drinking Water," January 2005), which establishes qualifications for staff training and experience and conditions for

approval of laboratories conducting microbiological analyses of public drinking water. A copy of the above chapter V may be obtained from the Department of Public Health and Human Services, Laboratory Services Bureau, 1400 Broadway, Cogswell Building, P.O. Box 4369, Helena, MT 59604-4369, telephone: (406) 444-3444, or may be downloaded at the EPA web site: https://www.epa.gov/dwlabcert/laboratory-certification-manual-drinking-water.

(1) Fees for clinical and environmental analyses performed by the laboratory of the department are set to reflect the actual costs of the tests and services provided.

(2) The department will maintain a list of all tests available from the lab and the price of each test. The department adopts and incorporates by reference the Public Health Laboratory Testing Fee Schedule and the Environmental Laboratory Testing Fee Schedule effective December 1, 2023, which are available on the web site of the Department of Public Health and Human Services at https://dphhs.mt.gov/publichealth/LaboratoryServices/index, and by mail upon request to the lab at the Department of Public Health and Human Services, Public Health and Safety Division, P.O. Box 6489, Helena, MT 59604-6489.

(3) The fee for a specific lab test will be lowered by the department to a level not exceeding the cost to the department of the test in question whenever a change of analysis method warrants lower fees.

(4) Fees for analyses other than those listed will be established at the level of comparable analyses.

This rule has been repealed.

This rule has been repealed.

This rule has been repealed.