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Approved Methods

SDWA and CWA

Minnesota Department of Health Environmental Laboratory Accreditation Program

Official approved methods for Drinking Water and Clean Water are listed in the 40 Code of Federal Regulations (CFR) 141 and 136

Microbial methods: listed in each rule for which they are to be used (i.e. TCR, SWTR, GWR)

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Safe Drinking Water Act

For compliance samples, laboratories must use only the analytical methodology specified in the

Total Coliform Rule (40 CFR 141.21(f)) Surface Water Treatment Rule (40 CFR 141.74(a)) Groundwater Rule (40 CFR 141.402 (c)(2))

Safe Drinking Water Act

A laboratory must be certified for all analytical methods that it uses for compliance purposes. At a minimum, the laboratory must be certified for one total coliform method and one fecal coliform or E. coli method

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Total Coliform Rule (40 CFR 141.21 (f))

Total Coliform Fermentation (SM 9221 A, B) Total Coliform Membrane Filtration (SM 9222 A, B, C) Presense-Absence (P-A) Coliform Test (SM 9221 D) ONPG-MUG Test (SM 9223) Colisure, E*Colite Test, m-ColiBlue 24, Readycult, Chromocult, and Colitag

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Surface Water Treatment Rule (40 CFR 141.21 (f))

Total Coliform

Fermentation Technique (SM 9221 A, B) Total Coliform Membrane Filter Technique (SM 9222 A, B, C) ONPG-MUG Test (SM 9223)

Fecal Coliform

Fecal Coliform Procedure (SM 9221 E, D)

Heterotrophic bacteria

Pour plate, SimPlate (SM 9215 B)

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Ground Water Rules (40 CFR 141.402 (c)(2))

E.coli

Colilert, Colisure (SM 9223 B) Membrane Filter (EPA 1604, M-ColiBlue) 24, E*Colite, EC MUG, NA MUG (SM 9221 F, 9222 G)

Clean Water Act- Approved Methods for Wastewater and Sewage Sludge (CFR 136.3 Table IA) Total Coliform

MPN (SM 9221 B, EPA 600/8-78-017 p. 114) Membrane Filtration (EPA 600/8-78-017 p.108, SM 9222 B, USGS B-0025-85)

Fecal Coliform

MPN ( EPA 600/8-78-017 p. 132, EPA 1680, 1681, SM 9221 CE Membrane Filtration (EPA 600/8-78-017 p. 124, SM 9222 D, USGS B-0050-85

Enterococci

Multiple Tube (SM9230 B) Membrane Filter (SM 9230 C, EPA 1600) Enterolert

E. coli

MPN (9223 B, USGS 991.15, Colilert, Colilert 18) Membrane Filtration (EPA 1603, mColiBlue 24)

Coliphage

PA (EPA 1602) Single Agar Layer (EPA 1602)

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References

40 CFR Chapters part 136 ­ 149 can be found at: http://www.access.gpo.gov/nara/cfr/waisid x_08/40cfrv22_08.html

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SDWA Coliform Positive

SDWA Actions for Positive Cultures

Minnesota Department of Health Environmental Laboratory Accreditation Program

Each total coliform-positive (TC+) routine sample must be tested for the presence of fecal coliforms or E.coli. If any routine sample is TC+, repeat samples are required

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Repeat Sampling Requirements

Within 24 hours of learning of a TC+ routine sample result, at least 4 repeat samples must be collected and analyzed for total coliforms.

Repeat Sampling Requirements

One repeat sample must be collected from the original site; one within five service connections upstream; one within five service connections downstream and one random sample.

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Repeat Sampling Requirements

If any repeat sample is TC+, the water supply must analzye that TC+ culture for fecal coliforms or E.Coli. The water supply must also collect another set of repeat samples, unless the maximum contaminant level (MCL) has been violated and the system/lab has notified the state, in which case a district engineer will collect the repeat samples.

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Additional Routine Sample Requirements A positive ROUTINE or REPEAT total coliform result requires a minimum of five ROUTINE samples be collected the following month the water supply provides water to the public unless waived by the state.

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SDWA Actions for Positive Cultures

For more information contact: Drinking Water Message Center 651.201.4650 800.818.9318 [email protected]

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Standard Operating Procedure Manual Common Findings

Common Microbiology Findings

Minnesota Department of Health Environmental Laboratory Accreditation Program

Table of Contents Manual must be uniquely identified

Serial number Page numbers and total number of pages Clearly defined end of the manual

Effective Dates

Must maintain a record of the effective dates

Copy to the commissioner

Submit a copy of revised SOPs within 30 days after the effective date of the revision

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Quality Assurance Manual Common Findings

Internal auditing Tracking purity of reagents, standards, media and reagent grade water Failed PTs Training and education of personnel Subcontracting samples Handling client complaints

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Common Micro Findings

Samples not stored separate Chlorinated water sample checks Sterility checks and blanks

Blank on each lot or batch of media (includes chromofluorogenic reagent) Filtration techniques Sample containers Dilution water Membrane filters

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Common Micro Findings, Cont.

Test variability

Reproducibility

Common Micro Findings, Cont.

Documentation of media

None or incomplete

Test Performance

Verification of positives

Autoclaves

Demonstration of sterilization temperature Incomplete records Timing device

Water monitoring

Water used in the prep of media, solutions or buffers

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Common Micro Findings, Cont.

Incubators and water baths

Temp checked 4 hours apart

Labware

Washed and reused

Volumetric equipment

Verified for accuracy

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Sample Handling and Receipt

Sample Handling, Receipt and Acceptance

Minnesota Department of Health Environmental Laboratory Accreditation Program

Transportation, receipt, handling protection, storage, retention and disposal of samples Maintain system of identifying/tracking samples to ensure samples cannot be confused physically or within the laboratory's documentation Identify number and types of containers for each field of testing

EF-6.17.09 1 of 2

EF-6.17.09 2 of 2

Sample Handling and Receipt, Cont.

Condition of sample recorded upon receipt Store standards and samples in separate locations

Sample Handling and Receipt, Cont.

Verify and record thermal and chemical preservation Maintain a chronological list of samples, including the container number and type, received Retain correspondence with client on samples not meeting the sample acceptance criteria

standards

samples

food

EF-6.17.09 1 of 2

EF-6.17.09 2 of 2

Sample Handling and Receipt, Cont.

Chlorine Residual Checks Laboratory shall check chemical preservation prior to or during sample preparation or analysis Microbiological samples from chlorinated water systems do not require an additional chlorine residual check in the lab if the following conditions are met:

· Sufficient sodium thiosulfate is added to each container and · One container per lot is checked to ensure efficacy of sodium thiosulfate, or · Chlorine residual is verified by the collector and is <= 0.1 mg/L

Sample Handling and Collection

Requirements in the Code of Federal Regulations (CFR). 40 CFR 136, Table II.-Required Containers, Preservation Techniques and Holding Times Information in table takes precedence over specific information in methods State agency methods (i.e. performanced based methods such as perfluorinated organic compounds)

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Sample Acceptance and Rejection Policy

Written sample acceptance policy

Made available to sample collection personnel Must outline circumstances that samples will be accepted or rejected

Sample Acceptance Policy

The sample acceptance policy at a minimum must include the following items:

Documentation, including sample identification Sample labeling Use of appropriate sample containers

Retain correspondence and records of conversation concerning decision to dispose of rejected sample or to proceed with analysis

Sample Acceptance Policy, Cont.

Specified holding times Adequate sample volume Procedures to be used when samples show signs of damage, contamination, inadequate preservation, or loss of integrity.

Chain- of-Custody

The procedures and records that document the possession and handling of samples from collection through disposal Chain-of-custody form (legal) Sample submission form (non-legal)

Reference

Electronic Code of Federal Regulations Weblink:

http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&tpl=%2Findex.tpl

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Proficiency Testing (PT)

definition

Is a means to evaluating a laboratory's performance under controlled conditions relative to a given set of criteria through analysis of unknown samples provided by an external source.

Proficiency Testing

Minnesota Department of Health Environmental Laboratory Accreditation Program

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Proficiency Testing Sample

definition

Is a sample, the composition which is unknown to the analyst and is provided to test whether the analyst/laboratory can produce analytical results within specified acceptance criteria

Fields of Proficiency Testing

PT program organized by fields of proficiency testing. The following collectively define fields of proficiency testing

Matrix Technology/method and Analyte/analyte group

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Fields of Proficiency Testing

Laboratories are permitted to analyze one PT sample by multiple methods for a given analyte within a technology. If a laboratory reports more than one method per technology per study, an unacceptable result for any method would be considered a failed study for that technology for that analyte.

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Proficiency Testing Requirements

Initial accreditation

Must successfully complete two PT studies for each requested field of proficiency testing within the most three recent rounds attempted The three recent rounds must have occurred within 18 months of the laboratory's application date The successful PT studies must be at least 15 calendar days apart from the closing date of one study to the shipment date of another study

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Proficiency Testing Requirements

Continuing accreditation

Must complete two PT studies for each field of proficiency testing out of the most recent three Completion dates of successive proficiency rounds for a given field of proficiency testing must be approximately six months apart

Proficiency Testing Requirements

Supplemental PT studies

Laboratory want to add fields of testing to their scope Corrective Action

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Proficiency Testing Requirements

Samples must be analyzed and the results returned to PT Provider no later than 45 calendar days from the opening of the study. PT sample must be analyzed the same as routine samples

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Quality Assurance Manual

defined

SOP vs. QAM

What's the difference???

Minnesota Department of Health Environmental Laboratory Accreditation Program

Commonly referred to as the "QA manual" A written record of the laboratory's plan to ensure that sample integrity is maintained; sample testing is appropriately conducted; and reporting of data is accurate.

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QA Manual Requirements

Standard Operating Procedure Manual

defined

Commonly referred to as "SOPs" or "SOP manual" A written record of procedures used by the laboratory for the analysis of samples. SOPs are the operational backbone of an analytical laboratory.

REVIEW

REVISE

SUBMIT

APPROVE and IMPLEMENT

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Standard Operating Procedure Manual

Key points to consider include: Is there enough information so that the results are repeatable? Is cross-referencing clear enough that analysts can easily obtain all the instructions that they need? SOPs describe in detail all laboratory operations such as preparation of reagents, reagent water, standards, culture media, proper use of balances, sterilization practices, and dishwashing procedures, and corrective actions SOPs are unique to the laboratory

SOP Manual Requirements

REVIEW REVISE

SUBMIT

APPROVE and IMPLEMENT

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QAM vs. SOP

Requirement

Written plan / Table of Contents May include separate procedure or documents by reference Identification on each page/Laboratory Name Clear indication of end of document Revision Number/Date revision effective

QAM vs. SOP

QAM

Yes

SOP

Yes

Requirement

Record of effective dates for all procedures Reviewed periodically and updated when necessary Documentation of the review process must include scope of review, id of the reviewer, date review complete Must submit with application

QAM

No

SOP

Yes

Yes

Yes

Yes

Reviewed annually

Yes

Yes

yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

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QAM vs. SOP

Requirement

Revisions must be submitted in its entirety within 30 days of revision collection and transportation of samples tracking samples (e.g. chain of custody; reporting & records retention) Sample acceptance and rejection criteria Determine continual compliance (internal auditing)

QAM vs. SOP

QAM

Yes

SOP

Yes

Requirement

equipment maintenance & scheduling data accuracy & precision for each certified method /analyte/test category validation of data conversion, transcription, & reporting tracking of standards, reagents, and media correction of unacceptable PT results & performance of quality control checks

QAM

Yes

SOP

No

Yes

No

Yes

Yes

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

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Yes

No

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QAM vs. SOP

Requirement

training & education requirements subcontract testing

Key Points

QAM

Yes

SOP

No

Yes

No

addressing client complaints

Yes

No

Regulations require well-documented plans and activities Lack of documentation leads to inconsistent training and implementation Personalize your instructions to ensure understanding and use

Procedure

No

Yes

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Client Communications

Client Communications

Minnesota Department of Health Environmental Laboratory Accreditation Program

What documents must a lab provide to a client? When does a client need to notified? How does a client need to notified?

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Client Communications

A laboratory must make available its current certificate and corresponding scope of certification upon the request of a client.

Client Communications

Suspension or revocation of laboratory's certification

Upon receiving the notice of suspension or revocation, the laboratory must notify all clients Notification must be in writing and a copy of the notification must be sent to MDH

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Client Communications

Voluntary withdrawal of certification

By the effective date of the withdrawal of certification, the laboratory must notify current clients and regulatory agencies of its intent to withdraw its certification and must indicate the effective date of the withdrawal Notification must be in writing and a copy of the notification must be sent to MDH

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Client Communications

Suitability of a sample for environmental testing

Must consult the client for further instructions Must maintain a written record of the discussion

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Client Communications

Samples analyzed by procedure other than as written

Must have a record that includes

Sample identification traceable to client Modification to the procedure Reason for modification Client's authorization or acknowledgment of the modification

Client Communications

Test Report

Must include deviations from the standard operating procedure, such as failed QC, additions to, or exclusions from the test method Unacceptable instrument calibration Conditions that may have affected the quality of results

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Client Communications, Cont.

Test Report

Definition of data qualifiers Results for which the lab is not certified Signify data reported that was done by a subcontracted laboratory

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Corrective Action

definition

What happens when it fails!?!?!?

Minnesota Department of Health Environmental Laboratory Accreditation Program

An action taken by the laboratory to eliminate or correct the causes of an existing nonconformance and prevent the recurrence of the nonconformance

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Corrective Action Plan

definition

A report which addresses specific items and sets a specific date of completion, generated by the laboratory in response to deficiencies.

Corrective Action Steps

Establish policy and procedure Designate appropriate personnel Root cause Select and implement corrective action Monitor

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Corrective Action

Equipment/Instrument

Not working properly (problem) Instrument is dirty (root cause) Cleaning is necessary due to malfunction (corrective action) Cleaning will be set up on a regular schedule (implement) Continued proper operation (monitor)

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Corrective Action

Calibration not within established acceptance criteria

Corrective action performed and all associated samples reanalyzed If samples can not be reanalyzed data associated with the unacceptable calibration must be qualified on the final report

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Corrective Actions

Quality Control Fails

Not within acceptance criteria Sterility checks/blanks show growth Positive and negative controls

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Corrective Actions

Unacceptable Proficiency Test Results

Within 30 days of notification submit corrective action plan Within 30 days of notification submit the laboratory's request to purchase a PT sample Within 30 days of receiving the results of the PT sample, submit a copy of the results

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Corrective Action

Internal audit finding

Conduct at least annually to determine compliance with the quality system and testing requirements

Corrective Actions

External audit finding

Within 30 days of notification submit corrective action planned and taken If not received within 30 days regulatory action maybe taken upon your lab's certification

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Documentation of Laboratory Personnel Training

Demonstration of Laboratory Personnel

(Training and Documentation)

Minnesota Department of Health Environmental Accreditation Program

Current job descriptions and table of organization Laboratory personnel must have demonstrated capability in the activities for which they are responsible. This must be documented. Initials and signatures of anyone analyzing or reviewing data must be on file Management must ensure and document that laboratory staff maintain capability to perform job functions by the following items:

Documentation of Laboratory Personnel Training, Cont.

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Documentation of Laboratory Personnel Training, Cont.

Evidence that each employee has read, understood and is using the approved revision of the laboratory's QA and SOP manual

2.

Attendance at training or workshops

Documentation of Laboratory Personnel Training, Cont.

3.

Reference

Environmental Laboratory Certification Program

http://www.health.state.mn.us/divs/phl/cert/index.html

Maintain documentation of continued proficiency annually

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Reporting

Reporting must be accurate, legible, objective and unambiguous

Reporting, Records and Data Handling

Minnesota Department of Health Environmental Laboratory Accreditation Program

Modification in the procedure must be documented If your lab issues a DMR Report, a formal test is not required Test report information should include at a minimum the following items:

Test Reports

Title, such as "Test Report", "Laboratory Results" or "Certificate of Results" Name, address and telephone number and name of the contact person Name and address of subcontract laboratory (if applicable)

Test Report, continued

Unique identification of the test report and page numbers (i.e. 1 of 1) The name of the client and the project name (if applicable) Identification of the approved method used A description, the condition of, and unambiguous identification of the sample

Test Report, continued

Date and time of sample collection The date of receipt of the sample (if critical) Time of sample preparation and time of sample analysis (critical)

Test Report, continued

Date of analysis of the environmental test The test results and units of measurement (when appropriate) Identification of the person authorizing the test report

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Test Report, continued

Results relate only to the samples Report reproduction Deviations from standard operating procedures Document test results that do not meet the requirement, or for which the laboratory is not certified

Records

Records must allow for historical reconstruction Records must be kept for five years Electronic records are acceptable as long as you maintain software and hardware to support the records. Records of signatures and initials of analysts

Records, continued

All observations used to calculate the final result must be recorded immediately No erasures, overwritten files, or markings Protect/maintain integrity and security of the data

Data Handling

Maintain work areas for data handling and storage areas Confidential business information/trade secret Retain sufficient raw data for results reconstruction

Data Handling within Lab Procedures

Conversion, transcription, and validation of data Handling out-of-control or unacceptable data Qualifying data on final reports

Contacts and more information

Environmental Laboratory Accreditation Program

Minnesota Department of Health 601 Robert Street North Saint Paul, MN 55155 651-201-5200 http://www.health.state.mn.us/divs/phl/cert/index.html [email protected]

Laboratory Accreditation Program Staff:

Lynn Boysen, [email protected] Stephanie Drier, [email protected] Denise Schumacher, [email protected] Susan Wyatt, [email protected]

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Contacts and more information Environmental Health's Drinking Water Message Center

(651)-201-4650 or toll-free at 1-800-818-9318 [email protected]

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Information

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