VigilentLABS

CLIA Waived Lab Quality

AssurancePlan

Laboratory Location

74 Truxtun Ave, North Charleston, SC

Todd A. Ritter, Lab Director                   _________________           Date____  

TableofContents

Introduction………………………………………………………………………………………………………………….. 3

Quality Assurance PolicyStatement………………………………………………………………………………… 3

ConfidentialityPolicy Statement……………………………………………………………………………………… 3

Code of Ethics/Conduct…………………………………………………………………………………………………. 3

DataIntegrity, Fraud Prevention&Detection…………………………………………………………………… 3

PolicyonWaste,FraudandAbuse……………………………………………………………………………………… 4

CustomerService……………………………………………………………………………………………………………. 4

NewWork Requests and Contracts………………………………………………………………………………… 4

Quality AssuranceProgram Management andImplementation…………………………………………. 5

QA Committee……………………………………………………………………………………………………………. 5

QA Officer…………………………………………………………………………………………………………………. 5

LaboratoryOrganization, PositionResponsibilities…………………………………………………………… 5

and Personnel Qualifications………………………………………………………………………………………….. 5

LaboratoryDirector………………………………………………………………………………………………………. 5

LaboratoryManager……………………………………………………………………………………………………… 6

QA Officer…………………………………………………………………………………………………………………. 6

TechnicalStaff(Chemists,Lab Technicians, etc.)……………………………………………………………….. 6

Staff…………………………………………………………………………………………………………………………… 6

Sample Procedures………………………………………………………………………………………………………… 7

(SampleCollection, Storage, Handling and Acceptability)………………………………………………… 7

Collection……………………………………………………………………………………………………………………. 7

Sample Acceptability……………………………………………………………………………………………………. 7

Collection……………………………………………………………………………………………………………………. 8

AnalyticalProcedures…………………………………………………………………………………………………….. 8

InternalQuality Control…………………………………………………………………………………………………. 8

Precision……………………………………………………………………………………………………………………… 9

Accuracy…………………………………………………………………………………………………………………….. 9

Completeness…………………………………………………………………………………………………………….. 10

Introduction

Vigilent Labs is a private, CLIA Waived Testing laboratory. We are committed to providing thehighest quality environmental, residential, and industrial testing services in a timely and cost-effectivemanner.We have established quality systems to ensure the quality and integrity of our work, and we are committedto enacting these quality measures and ensuring compliance with applicable National Environmental LaboratoryAccreditationProgram(NELAP)/TheNELACInstitute(TNI) standards.

Vigilent Labs has integrated many Quality Assurance (QA) practices into its measurement activities.These QApracticesaredesignedtogeneratehighqualitydatainanefficientandcost-effectivemanner.VigilentLabsemploysa laboratory-wide Quality Assurance Program designed to assess and monitor the ongoing quality of the testingperformed in its facility.Its purpose is to identify and correct problems as they occur and, if possible, to determinein advance potential problem areas and institute measures for their resolution.The Quality Assurance Committeewill oversee all QA activities to assure the accurate, reliable, and prompt reporting of testing results.This documentdescribes VigilentLabs’ QualityAssurance Planas it relates tooperations withinthe laboratory.While thisdocument strives to be inclusive, much of the Vigilent Labs quality plan is incorporated in the laboratory and methodStandardOperating Procedures (SOPs)referencedintheAppendix.

This QA Plan addresses all the minimum required elements described in the Guidelines and Specifications forPreparing Quality Assurance Program Plans (QAMS-004 / 80), Interim Guidelines and Specifications for PreparingQuality Assurance Project Plans (QAMS-005 / 80) and Guidance on Preparation of Laboratory Quality AssurancePlans(EPA910/9-92-0332).

QualityAssurancePolicyStatement

It is the policy of Vigilent Labs that there shall be sufficient quality assurance activities conducted to ensure that alldata generated, processed, and reported will be scientifically valid and of known and documented quality.Inaddition, the use of all aspects of this quality system will continually improve the effectiveness of the laboratory andthe quality system. All data generated by Vigilent Labs, unless acknowledged and authorized by the submitting party,will be of known precision and accuracy and legally defensible.   Quality assurance activities are designed in themost cost-effective fashion possible without compromising data quality objectives.The laboratory staff adheres tothe requirements and specifications stated in this Quality Assurance Plan.All data reported meets the applicablerequirements for TNI, Environmental Protection Agency (EPA) and/or any State specific methods used. For specificmethodrequirementsrefertoSOPs,currentEPAmethods,themostcurrenteditionofStandardMethods,and/orstatespecificmethods.

Allemployeesmustread,understand,andfollowtheprovisionsofthisQualityAssurancePlan.

ConfidentialityPolicyStatement

All client information at Vigilent Labs is considered confidential.No information will be given out without theexpress verbal or written permission of the client.   All reports generated will be held in the strictest of confidenceand issued only to the client.The exceptions to this policy would be those mandated by law (e.g., positive E. coli inpublic water systems that are required to be reported to State Regulatory Agencies).All employees of Vigilent Labswillat all times adhere tothis policy.

CodeofEthics/Conduct

The Vigilent Organization is a team, and each team member is expected to maintain a high level of professionalism.Each employee is responsible for his or her work, and that work must be conducted ethically, legally, and inaccordance with standard operating procedures and applicable methods and regulations.Employees are expected toperform their duties with excellence, and to contribute to an environment where their co-workers can efficientlyperform their duties and maintain focus on the overall benefit of the Vigilent team, our customers, public health, andtheenvironment.ThepenaltiesforviolatingtheCodeofEthicscanrangefromverbalreprimandstolossof

position.No person at Vigilent Labs will in any way be put under undue pressure, financial or other, to completetheirassigned tasks inviolationofthis code.

DataIntegrity,FraudPrevention&Detection

Vigilent Labs actively works to ensure that the data produced is of the highest quality and legally defensible. The dataintegritysystemincludesdataintegritytrainingforallnewemployeesandannualrefreshertrainingforallemployees, signed data integrity documentation, in-depth monitoring and review of data, and proficiency testingsamples.

PolicyonWaste,FraudandAbuse

Under no circumstances is the willful change or fraudulent manipulation of analytical data condoned.Such acts areto be reported immediately to management for appropriate corrective action.Reported acts will be assessed on anindividualbasis andresultingactionswillbeconsistentwithVigilentpoliciesandcouldresultindismissal.

Falsification of data in any form will not be tolerated.While much analytical data is subject to professionaljudgment and interpretation, outright falsification, whenever observed or discovered, will be documented andappropriateremediesandpunitivemeasureswillbetakentowardthoseindividualsresponsible.

CustomerService

Vigilent’s reputation has been built upon service to the customer.The laboratory is always willing to communicateand cooperate with customers to ensure their requirements are met, provided confidentiality to other customers canbeensured.Feedbackfromcustomers,includingcomplaints,isusedtoimprovelaboratoryoperationsandservices.

QualityAssuranceProgramManagementandImplementation

Overall responsibility for quality assurance lies with the Laboratory Director.The primary QA management of thelaboratory rests with the Laboratory Manager.To provide technical assistance to the Laboratory Manager, a QAOfficer is appointed by the Laboratory Director.The QA Officer is granted sufficient resources to ensure the properexecution of the QA Plan and to recommend and implement specific QA policies and procedures.A QualityAssuranceCommitteeexiststofurtherfacilitateadherenceanddevelopmentofQApoliciesandprocedures.

QACommittee

The Quality Assurance Committee is comprised of the QA Officer, Laboratory Manager, Laboratory Director, andLaboratory Supervisors.The QA Committee is responsible for overseeing lab-wide QA Plan implementation andaddressingQAcomplaintsorconcernsbroughttoitsattentionfrominternalorexternalsources.TheQACommittee directs the efforts of the QA Officer and enforces any necessary corrective actions.The QA Committeeshall convene if needed to assess and/or address laboratory QA concerns and any actions taken by the QA Officer.Any QA complaints or problems that are received from outside the laboratory will be referred to the committee inordertoresolve suchissues.

QAOfficer

The QA Officer is appointed by the Laboratory Director to oversee specific QA policy and procedure development,implementation, and adherence at Vigilent Labs. The QA Officer is responsible for auditing internal operations andensuring compliance with QA criteria established by this QA Plan and other documented policies and procedures.The QA Officer assesses all QA systems on an annual basis.Results of all findings are documented and correctiveaction recommendations, if any, are submittedtothe QA Committee, Laboratory Manager and affected staffmembers.

The QA Officer is responsible for documentation and evaluation of specific policies and procedures.StandardOperatingProceduresarekeptonfiledocumentingspecificproceduresemployedtoensurethevalidityandacceptability of data generated at Vigilent Labs.Materials purchased for quality control purposes are received with aCertificate of Analysis from the manufacturer.Certificates are kept on file for review if necessary.The QA Officeris responsible for coordinating and reporting for all performance evaluation samples, maintaining and updatingcertificationsand accreditations,andmonitoring correctiveactions.

LaboratoryOrganization,PositionResponsibilitiesandPersonnelQualifications

All employees maintain a copy of all training certificates and diplomas on file with certificates of capability for eachmethod they perform.Job descriptions are maintained in employee training files.Organizational charts for VigilentLabsare shown intheAppendices.

LaboratoryDirector

The Laboratory Director is responsible for overall technical direction and business leadership of Vigilent Labs. TheLaboratory Director oversees laboratory operations and appoints a Laboratory Manager and Quality AssuranceManagertoimplementlaboratoryprocedures,basedonthecurrentmarket,technologicaladvancesinequipment,andmethods.

The Laboratory Director is responsible for assuring that the provisions of this QA Plan are met, and that adequateresourcesareavailable fortechnicaloperationsandqualitysystems oversight.

The Laboratory Director is a direct liaison to the Corporation’s Board of Directors (BOD) and must attend a BODmeeting at least once a year, or as necessary to discuss equipment purchases, managerial changes, contracts, andmajorSOPandQA changes.

AllLaboratoryManagersandQAOfficersreportdirectlytotheLaboratoryDirector.

The Laboratory Director may serve as Laboratory Manager, Technical Director, Systems Manager, and/or Analyst ifthesepositionsarenot filledfor anyreason.

The Laboratory Director must have a minimum BS in a science or engineering field and 5 years of managerialexperiencein an environmentallaboratoryoran equivalentcombinationofeducationandexperience.

LaboratoryManager

TheLaboratoryManagerisresponsibleforoverseeingthedailyoperationsofVigilentLabs.TheLaboratoryManager, in conjunction with the Technical Directors, is responsible for coordinating laboratory activities with theoverall goal of efficiently producing high quality data in a reasonable time.The Laboratory Manager is responsibleformonitoringthevalidityoftheanalysesperformedanddatageneratedandformonitoringstandardsofperformancein quality controlandquality assurance.

TheLaboratoryManagerreportsdirectlytotheLaboratoryDirectorandmayactasInterimDirectorduringextendedabsence of theLaboratoryDirector.

Additionally, the Laboratory Manager will provide technical support to customers and coordinate projects to meetspecificcustomer needs.

The Laboratory Manager is responsible for the maintenance of standards and materials in accordance with the QAPlan,toensure uninterruptedoperationof the laboratory.

All Section Managers and Analysts not reporting to the Technical Directors report directly to the LaboratoryManager.

In events where employee scheduling or current workload is such that new work cannot be incorporated withoutmissing holding times or data quality objectives, the Laboratory Manager has authority to refuse samples, modifyemployeescheduling,orre-scheduleprojects.

The Laboratory Manager, in coordination with the area Supervisors, QA personnel, and Technical Directors, isresponsible for determining in which QA proficiency testing programs the laboratory will participate, and whichaccreditations the laboratory will pursue.It is the responsibility of the Laboratory Manager to ensure that thelaboratory sections perform the tasks necessary to complete the proficiency testing required to maintain certificationandaccreditation

TheLaboratoryManagerwillattendmanagerialand/orstaffmeetingsatwhichthetopicofQAisdiscussed.

The Laboratory Manager can act as Analyst, Supervisor, or Technical Director if, for any reason, the positions arenotfilled.

The Laboratory Manager is responsible for all human resource decisions within the laboratory except for employeesreportingdirectly tothe LaboratoryDirector.

If the Laboratory Manager is to be absent for more than 15 days, a Technical Director (or other supervisor) will benamedtoserveas thetemporaryLaboratoryManager.

The Laboratory Manager must have a minimum BS in a science or engineering field and 5 years of managerialexperienceinanaccreditedenvironmentallaboratory,oranequivalentcombinationofeducationandexperience.

QAOfficer

The QA Officer is designated by the Laboratory Director.The QA Officer serves as the focal point for QA/QC andis responsible for the oversight and/or review of quality control data.The QA Officer functions independently fromlaboratory operations (answering directly to the Lab Director)and can evaluate data objectively withoutmanagerial influence.   The QA Officer is responsible for conducting internal audits, and for notifying managementof any deficiencies in the quality system, and for monitoring corrective actions. The QA Officer is responsible formaintaining the currency of this QA Plan, and will help develop, implement, and maintain Standard OperatingProcedures appropriate to the procedures employed within Vigilent Labs. The QA Officer is responsible for ensuringallapplicableregulatory agencyrequirements are met.

The QA Officer must have a minimum BS in a science or engineering field and two years experience in QA/QC oranequivalentcombinationofeducationandexperience.

SampleProcedures

(SampleCollection,Storage, HandlingandAcceptability)

All samples collected atVigilent Labs are logged in and tested immediately. If needed, Corrective measures to ensure proper specimen collection and/or handling on future sample sets willrequire training of sample collection procedures.

Collection

Samples must adhere to requirements for collection.  Consult the Standard Operating Procedure.

Tracking

Samplesaretrackedbytheirindividuallog-innumbers.Astestingiscompletedthev.Passisupdatedandthedataarchived.

Collection

Allsamplesshouldbecollectedusingstandardfieldsamplingtechniques.Thesamplecontainershouldbelabeledwith thefollowinginformation:

1. Dateandtimeofcollection
2. Nameofpersoncollectingsample
3. SampleIDandprojectname

Pertinentdataconcerningeachsampleshouldbeenteredintoafieldlogbookoronthechainofcustody.

Verification/Validation

Someproceduresutilizeadditionalvisualconfirmationandvalidationofvaluesobtainedelectronicallyintheformofstripchartsorotherprintouts.

Data quality indicators such as blank results, duplicate reproducibility (precision), matrix spike, and quality controlsample recoveries (accuracy), and known sample or project histories are checked to verify result validity.Refer totheindividualmethodSOPsfor acceptabilitycriteria.

TimelyReporting

Samplesaretypicallytestedconsecutivelyasreceivedunlessholdingtimesorspecialarrangementsrequireexpeditedtestingschedules.Alltestingisscheduledso thatacceptedholdingtimescanbemet.

ReportingResults

After sample analysis, analysts post test results to the customer.Prior to reporting, entered data are validated.A final report is generated after all testing for a particular sample is completed, andreportsaredistributed totheclientandanyregulatoryagencyrequiringcopies.

InternalQualityControl

AnInternalQualityControlprogramhasbeendesignedtoensuresystematicin-houseproductionofhighqualityanalyticaldata.  Theobjectives of this programare:

1. Toprovideameasureoftheprecisionofanalytical methods.
2. Tomaintainacontinuingassessmentoftheaccuracy,precisionandcompletenessofindividualanalysesperformedinthe laboratory.
3.  
4.  
5.  
6.  

Precision

Precision is the ability of an analytical method or instrument to reproduce its own measurement.It is a measure ofthe variability or random error in sampling, sample handling and in laboratory analysis.The American Society ofTesting and Materials (ASTM) recognizes two levels of precision:1) repeatability – the random error associatedwithmeasurementsmadebyasingletestoperatoronidenticalaliquotsoftestmaterialinagivenlaboratory,withthe same apparatus, under constant operating conditions, and 2) reproducibility – the random error associated withmeasurementsmadebydifferenttestoperatorsindifferentlaboratories,usingthesamemethod butdifferentequipment to analyze identical samples of test material.

Accuracy

Accuracy is a measure of the closeness of an individual measurement (or an average of multiple measurements) tothe true or expected value.

QualityDocumentControl

All Standard Operating Procedures and Quality Assurance Plans are maintained under the control of the QA Officer.The QA Officer is responsible for maintaining all official/authorized versions of all Standard Operating Proceduresand Quality Assurance Plans.The master version of each Standard Operating Procedure is maintained by the QAOfficer.Copies of SOPs are available to analysts and other personnel via PDF links on each computer workstation.This QA Plan is maintained in the possession of the QA Officer and a copy is distributed to the Laboratory Manager.All original signatures are maintained on the QA Officer’s master copy.Any copies or versions of these documentsthataredistributedoutsidethe laboratory are notcontrolledor updated.

Additional quality systems documents (bench sheets, facilities maintenance forms, etc.) are tracked in a Master ListofQualitySystemsDocuments,whichrecordstherevisionnumberandeffectivedateofapprovedforms.

Analytical and support records, both electronic and hard copy, are retained in accordance with Vigilent Labs dataarchiving SOPs.

StandardOperatingProcedures(SOPs)andLaboratoryNotebooks

Vigilent Labs maintains a database of SOPs for use in both technical and administrative functions.SOPs are writtenfollowing the format and content requirements described in the SOP for preparation of SOPs (ALI-01).Each SOPhas been reviewed and approved by a minimum of two authorities, the Laboratory Manager, and the QA Officer. AllSOPs undergo a documented annual review to make sure current practices are described.The QA Officer maintainsa comprehensive list of current SOPs.The document control process ensures that only the most currently preparedversion of SOP is being used for guidance and instruction.The QA Manual, SOPs, standards preparation logbooks,runlogbooks,etc.,areallconsideredcrucialtoconsistentoperationsatVigilentLabsandallanalystsareinstructedon the proper usage of each.Vigilent Labs maintains a current file, accessible to all laboratory staff, of thepromulgated methodology (EPA, Standard Methods, etc.) used to perform analyses as well as this QA Plan andapplicableStandardOperatingProcedures.(ForspecificIALproceduresrefertoSOPALI-15.)

Deviationfrom Standard Operating Procedures

Vigilent Labs recognizes that occasionally a deviation from a Standard Operating Procedure may be necessary.Insuch cases, a written record of the deviation is retained with the sample data and if the deviation affects the dataintegrityanappropriatedataqualifiercommentisnotedontheanalyticalreport.Anexampleofthiswouldincludeaspecialpreparativesteporprocedurenotnormallyperformedbutperhapsmandatedbyspecialmatrixconcerns.

ModifiedProcedures

Vigilent Labs strives to perform published methods as described in the referenced documents.If there is a materialdeviationfromthepublishedmethod,themethodiscitedasa“Modified”methodintheanalyticalreport.Modificationstothepublishedmethodsarelistedinthestandardoperatingprocedure.Standardoperatingprocedures are available to analysts and are also available to our clients for review, especially those for “Modified”methods.Clientapprovalisobtainedfor theuseof“Modified” methodsprior to analysis.

CorrectiveAction

Corrective action is initiated when deviations or non-conformances with laboratory or regulatory practices areidentified.Some examples include unacceptable PT results, internal or external audit findings, data or record reviewfindings,andcustomer complaints.

Corrective action may take several forms.Some findings (for example, matrix spike recoveries that fail recoverylimits)mayonlyrequireanexplanationonthedataorthefinalreport,whileotherfindingswillinitiateadocumented Corrective Action Report.Corrective action reports identify the problem noted, an investigation, a rootcauseanalysisoftheproblem,anyactionstakentocorrectorpreventtheproblem,and follow-upactivities.

Customer complaints will be directed to the Laboratory Manager, QA Manager, and/or section supervisors.Everyreasonableeffortshouldbemadetoaddress(andcorrect,ifnecessary)customercomplaints.Ifthelabisfoundtobeatfault,a correctiveactionformshouldbeinitiatedandcompleted.

PreventativeAction

Vigilent Labs and its personnel strive to improve the laboratory procedures, including analysis, record-keeping, andcustomer service.Preventative action is a proactive process to identify opportunities for improvement rather than areactiontotheidentificationofproblemsorcomplaints.Whenimprovementopportunitiesorpreventativeactionsare identified, action plans will be developed, implemented, and evaluated for effectiveness.All Vigilent employeesareencouragedtolookforandidentifypotentialimprovementstolabsafety,efficiency,andcustomerservice.

Training&PersonnelQualifications

All personnel involved in any function affecting data quality will have sufficient training and technical expertise to effectively execute their job requirements. The laboratory evaluates all prospective job applicants for scientificknowledgeandexperienceasnotedinthejobdescriptionsforthepositionconsidered.

New employees receive documented training on the Quality Assurance Plan, laboratory safety, standard operating procedures, and data integrity, as well as method-specific training. A record of specialized training received by or given by the staff is kept in the Personnel Training folders.

In addition to prior work and educational experience, Vigilent Labs actively encourages its employees to expand and refine their job skills and knowledge through participation in educational programs. Time off is granted to attend seminars and training sessions put on by instrument manufacturers, regulatory agencies, professional business, and scientific organizations, etc. Additionally, Vigilent Labs conducts in-house training on related topics.

Analysts perform an Initial Demonstration of Capability (IDOC) when performing a new method or a method they have not performed in a 12-month period.

Servicesand Supplies

Vigilent Labs purchases services and supplies from reputable vendors and ensures that supplies meet or exceed standards established in the analytical methods. A list of approved vendors is maintained and updated annually.