QUALITY ASSURANCE PLAN - Basic Lab

Basic Laboratory, Inc.QAP, Revision 15.0, January 20121.5 The Quality Assurance Director/Officer (QAO) assists the LaboratoryDirector in assuring the production of accurate, valid, and reliable data bycontinuously monitoring the implementation of the laboratory qualityassurance program. The QAO administers all inter-laboratory QA efforts,schedules and reviews performance evaluation results, takes correctiveactions, and prepares quality assurance reports for management. He alsoconducts annual audits of the overall laboratory operation, and isresponsible for the management and annual review of this QA manual. The Department Managers and/or Supervisors are responsible foreach task identified in their scope of work. They are responsible fororganizing and directing the technical activities within their assignedsections(s). They are involved in daily laboratory operations and areresponsible for verifying that laboratory QC and analytical procedures arebeing followed as specified for each project. They are responsible fororganizing, assembling, disseminating, and filing all documents pertinentto the analysis for each set of samples. They may be responsible for thereview of data generated in their departments for accuracy. They alsoadvise the Laboratory Director of progress, needs, and potential problemsof their assigned section(s). The Analysts or Technical Staff are responsible for sample analysis, dataprocessing and recording in accordance with this laboratory QAP andestablished SOPs. They are responsible for calibration and preventivemaintenance of instrumentation, data reduction, data review, andreporting of all out-of-control situations, as well as for initial correctiveactions whenever necessary. Well documented training records are kepton file for each Analyst in order to provide proof of proper training foreach method they perform. The Sample Custodians are responsible for the proper preparation,shipment and receipt of sampling kits. When the samples are receivedinto the laboratory, the sample custodian is responsible for checking anddocumenting the chain-of-custody by checking sample descriptions,labels, and parameters requested against the chain of custody record. Ifany discrepancies are noted, the sample custodian informs theLaboratory Director who coordinates corrections with clients. Thisinformation is recorded into a sample logbook and into the LaboratoryInformation Management System (LIMS). All samples are logged into theLIMS and are tracked within the LIMS for the remainder of their journeythrough the laboratory. Audit trails are available for each sample.Personnel QualificationsSee Appendix A – Key Personnel Resumes.1.6Personnel TrainingTo ensure that all personnel involved in analytical activities are able to carry outPage 9 of 99

Basic Laboratory, Inc.QAP, Revision 15.0, January 2012their duties, they are required to undergo a training program. Training isadministered by trainers designated by the Laboratory Director or by the QAOfficer, and is normally a senior analyst.The program is presented to new employees upon employment and must becompleted prior to assumption of assigned duties. It includes orientation, reviewof the job description and how the position integrates with the overallorganization, overview of the QA program, overview of the safety program, andinitial on-the-job training on the employee’s initial job assignment. Eachemployee has read, understood, and is using the latest version of thelaboratory’s QAP and the SOPs that relate to their job responsibilities.The readiness of the new employee to assume initial job assignment is assessedby the area supervisor. Acceptable performance is determined by conducting anInitial Demonstration of Capability (IDC). Each acceptable performance ofanalysis is noted on the employee’s training record. After final approval by theQAO, the employee is allowed to begin initial assignments. All completeddocumentation is kept in the employees permanent training records.1.7Laboratory CapabilitiesBasic Laboratory is capable of testing water and soil samples for a wide varietyof parameters. See Appendix B for a complete listing of all certified methods.2.0Quality Assurance ObjectivesThe overall QA objectives for Basic Laboratory are to develop and implementprocedures for laboratory analysis, chain-of-custody, and reporting that will provideresults which are of known and documented quality. Data Quality Indicators (DQIs) areused as qualitative and quantitative descriptors in interpreting the degree of acceptabilityor utility of data. The principal DQIs are precision, bias (accuracy), representativeness,comparability, completeness and detection limits. DQIs are used as quantitative goalsfor the quality of data generated in the analytical measurement process. This sectionsummarizes how specific QA objectives are achieved. The specific application of thesevarious activities are contained in the method SOPs.The laboratory’s quality assurance objectives of precision, accuracy, and completenessare listed in Appendix C and D. These objectives are based on the laboratory’scapabilities as indicated by historical data or results of validation studies. Wheresufficient data is not available, EPA CLP control criteria are used. The fish toxicitybioassay QA/QC objectives along with a report format are listed in Appendix E.2.1PrecisionPrecision is a measure of the degree to which two or more measurements are inagreement. Precision is assessed through the calculation of relative percentdifferences (RPD) and/or relative standard deviations (RSD) for replicatesamples. For inorganic analyses, laboratory precision is usually assessedthrough the analysis of a sample/sample duplicate pair, although some methodsrequire the use of matrix spike/matrix spike duplicate. For organic analyses,precision is usually assessed through the analysis of matrix spike/matrix spikePage 10 of 99

Basic Laboratory, Inc.QAP, Revision 15.0, January 2012duplicate (MS/MSD) and field duplicate samples.Precision is a measurement of the mutual agreement among individualmeasurements of the same parameters under prescribed similar conditions.If calculated from duplicate measurements:(C1 - C2) x 100RPD (C1 C2) /2where: RPD relative percent differenceC1 larger of the two observed valuesC2 smaller of the two observed valuesIf calculated from three or more replicates, use relative standard deviation (RSD)rather than RPD:RSD (s/y) x 100%where: s standard deviationy mean of replicate analysisStandard deviation(s) is defined as follows:s n (yi - y)2i 1n-1where:yi measured value of the ith replicatey mean of replicate measurementsn number of replicates2.2AccuracyAccuracy is the degree of agreement between an observed value and anaccepted reference or true value. Accuracy is first assessed by the analysis ofblanks and through the adherence to all sample handling, preservation andholding times. Laboratory accuracy is further assessed through the analysis ofMS/MSD, quality control check samples, laboratory control samples (LCS) andsurrogate compound spikes.For measurements where matrix spikes are used, the percent recovery (%R) iscalculated:Page 11 of 99

Basic Laboratory, Inc.QAP, Revision 15.0, January 2012S-U%R 100 xCsawhere: S measured concentration in spiked aliquotU measured concentration in un-spiked aliquotCsa actual concentration of spike addedFor situations where a standard reference material (SRM) is used instead of, orin addition to, a matrix spike, the percent recovery (%R) is calculated:Cm%R 100 xCsrmwhere: Cm measured concentration of SRMCsrm actual concentration of SRM2.3RepresentativenessRepresentativeness expresses the degree to which data accurately and preciselyrepresent a characteristic of a population, parameter variations at a samplingpoint, a process condition, or an environmental condition within a defined spatialand/or temporal boundary. Representativeness is ensured by using the properanalytical procedures, appropriate methods, meeting sample holding times andanalyzing field duplicate samples.2.4CompletenessCompleteness is a measure of the amount of valid data obtained from ameasurement system compared to the amount that was expected to be obtainedunder normal conditions. Laboratory completeness is a measure of the amount ofvalid measurements obtained from all the measurements taken in the project.No. of Acceptable parameters%C x 100Total number analyzed2.5ComparabilityComparability is an expression of the confidence with which one data set can becompared to another. Comparability is achieved by the use of routine analyticalmethods, achieving holding times, reporting results in common units, use ofconsistent detection levels, and consistent rules for reporting data.2.6Detection LimitsMethod Detection Limits (MDLs) are determined for all analytes as specified byrecognized EPA standards. From these, a Reporting Limit (RL), normally aroundPage 12 of 99

Basic Laboratory, Inc.QAP, Revision 15.0, January 20125 times the MDL, is also established. The RL is the minimum concentration of ananalyte that can be identified and quantified within specified limits of precisionand bias during routine analytical operating conditions. The RL is never lowerthan the lowest standard in the calibration curve, unless the method specificallyrequires it.3.0Sample Collection Procedures3.1Sample CollectionSpecial consideration is given to the procurement, storage, and transportation ofsamples to be analyzed. Procedures ensure that the analyte(s) originally presentin the sample matrix has not undergone degradation or concentration, and thatcontaminants which might interfere with the analysis have not been added.Plastic containers are not used for samples to be analyzed by electron capturedetector. Use of metal containers is discouraged since they may contain traceimpurities such as oil films, lacquers, or rosin from soldered joints, which causeinterference during gas chromatographic analysis. In general, glass jars orbottles with Teflon-lined lids or aluminum foil are the most suitable samplecontainers. In certain cases, the analyte of interest may be unstable because ofits chemical nature and/or interaction with the sample matrix, and specialpreservatives need to be added during sample collection. Appendix Fsummarizes the requirements for sample containers, preservation procedures,and holding times according to the Federal Register, 40CFR Part 136.It is the responsibility of the client to ensure the proper collection and delivery oftheir sample. Basic Laboratory will provide whatever support possible to assistthe client in this endeavor, such as providing proper supplies and instructions.3.2Sampling Kit PreparationSampling kits to be used by client field personnel are prepared by BasicLaboratory sample custodians following instructions indicated on the Bottle OrderForm (BOF). The BOF (shown in Appendix G) is generated when the clientcontacts a Basic Laboratory representative about analyzing samples. Theinstructions on the BOF are therefore unique to the client’s requirements.If required, preservatives are added to the sample containers by the samplecustodians according to the instructions on the BOF. These preservatives areprepared by various laboratory personnel according to the appropriate writtenStandard Operating Procedure, or bottles are purchases pre-preserved andcertified from an outside supply company. The type of preservative added isindicated on the sample container labels (shown in Appendix G). Sampling kitsare then assembled in appropriately sized ice chests for shipping ortransportation4.0Sample Custody4.1Sample TrackingBasic Laboratory uniquely identifies each sample to be tested to ensure thatPage 13 of 99

Basic Laboratory, Inc.QAP, Revision 15.0, January 2012there is no confusion regarding identity. The sample identification systemincludes identification for all samples, sub-samples, and subsequent extracts ordigestates. A unique identification code is placed on each sample container. Theidentifier used by Basic Laboratory is referred to as the Work Order number, andis trackable at all time using the LIMS. Each analyst is also required to maintainlaboratory benchsheets to provide sufficient detail to enable others to reconstructthe analysis should the analyst not be available to do so.In summary, the system for tracking samples consists of the Chain of Custody,the LIMS work order, laboratory benchsheets, laboratory notebooks, instrumentoperation logbooks, instrument printouts (raw data), and final analytical reports.This tracking system ensures that the Laboratory’s records can be used as validevidence should such data become the subject of litigation or any other type ofreview or investigation.4.2Sample AcceptanceBasic Laboratory has a written sample acceptance policy that outlines thecircumstances under which samples will be accepted. Samples that do not meetthe policy are noted on the COC defining the nature and substance of thevariation. The policy requires proper, full, and complete documentation, includingthe sample identification, the location, date and time of collection, collector'sname, preservation type, sample type and any special remarks concerning thesample; Unique identification of samples using durable labels completed inindelible ink; use of appropriate sample containers; receipt within holding times;adequate sample volume; and procedures that are used when samples showsigns of damage.4.3Sample Receipt and LoginAll samples submitted to Basic Laboratory are delivered to the laboratory’scentral sample receiving area and are received by the sample custodians. Thetemperature (and pH when required) of the sample are checked and recorded onthe Chain of Custody and in the LIMS. The sample custodian compares thesamples received against the Chain of Custody (shown in Appendix G).If a sample discrepancy, such as a broken or missing sample is observed atcheck-in by the sample custodian, a statement to that effect is written in theremarks section of the Chain of Custody. The client must be notified and approveof any changes made. At this time, the Laboratory Manager, the ProjectManager, or the QAO should be notified so that any technical problems can beaddressed.All samples received are recorded into the LIMS with the following minimuminformation: client name, client address, analytical parameters requested, samplecollection date and time, and laboratory work order number. The laboratory workorder number is a sequential number that is unique to each sample. Samplesare processed through the laboratory by their unique laboratory Work Ordernumbers. Special instructions about the samples are written onto the Chain ofCustody (COC) and are entered into the LIMS in the comments section. A copyof the COC and work order is given to each laboratory section.Page 14 of 99

Basic Laboratory, Inc.QAP, Revision 15.0, January 2012Samples are taken by the sample custodian to the designated storage areas.Access to these areas is limited to authorized laboratory personnel only.4.4Sample PreservationSamples that require preservation by the laboratory are preserved aftercompletion of the login process, but before transfer to the laboratories. Thepreservatives used by the sample custodians are prepared by the respectivelaboratories and are analyzed before use to ensure that they are free fromcontamination. After preservation, the sample custodian verifies the pH of eachsample to ensure that an adequate amount of preservative has been added tothe sample.4.5Sample StorageSamples which require thermal preservation are stored under refrigeration.Storage at a temperature above the freezing point of water to 6oC is consideredacceptable. Samples are stored in a manner that prevents cross contamination.Laboratory standards and reagents are never stored in the same refrigerationunits as client samples.4.6Sample DisposalAll original samples, digestates, leachates and extracts or other samplepreparation products are disposed of in accordance with Federal and State lawsand regulations. If the sample is part of litigation, disposal of the physical sampleoccurs only with the concurrence of the affected legal authority, sample data userand/or submitter of the sample. Otherwise, all samples are disposed of 30 daysafter the final report is mailed to the client, unless prior arrangements are madeto maintain the samples for a longer period.5.0Calibration Procedures and FrequencyThis section deals with the systems that are in place in the laboratory to ensure that allconditions are in a state of control at the time of analytical data generation. Theoperation of each system is documented in written Standard Operating Procedures(SOPs) to ensure consistent execution and compliance at all times. Analyticalprocedures used are based on approved and published methods. All StandardOperating Procedures are readily available at the analysts’ bench.5.1TraceabilityWherever applicable, calibration of analytical support equipment and instrumentsis traceable to national standards of measurement.5.2Reference StandardsReference standards of measurement, such as Class S or higher weights, ortraceable thermometers, are used for calibration only. Reference standards aresubjected to in-service checks between calibrations and verifications.Page 15 of 99

Basic Laboratory, Inc.QAP, Revision 15.0, January 20125.3General RequirementsEach calibration is dated and labeled with or traceable to the method, instrument,analysis date, and each analyte name, concentration and response (or responsefactor). Sufficient information is recorded to permit reconstruction of thecalibration. Acceptance criteria for calibrations comply with method requirementsor are established and documented.5.4Analytical Support EquipmentAnalytical support equipment include, but are not limited to: balances, ovens,refrigerators, freezers, incubators, water baths, temperature measuring devicesand volumetric dispensing devices (if quantitative results are dependent on theiraccuracy, as in standard preparation and dispensing or dilution into a specifiedvolume). All such support equipment is maintained in proper working order. Therecords of all activities including service calls are kept. Re-calibration occurs atleast annually, using NIST traceable references whenever available, over theentire range of use. The results of such calibration must be within thespecifications required of the application for which the equipment is used;otherwise the equipment is removed from service until repaired.Prior to use on each working day, balances, ovens, refrigerators, freezers,incubators and water baths are checked with NIST traceable referencethermometers (where possible) in the expected use range. The acceptability foruse or continued use is according to the needs of the analysis or application forwhich the equipment is being used. (The acceptance limits for each piece ofequipment is located in the front of the daily logbook associated with it.)Mechanical volumetric dispensing devices (except Class A glassware) arechecked for accuracy semi-annually and documented.5.5Instrument CalibrationCalibration procedures for a specific laboratory instrument will consist of an initialcalibration and secondary source calibration verification. The SOP for eachanalysis performed in the laboratory describes the calibration procedures, theirfrequency, acceptance criteria and the conditions that will require recalibration. Inall cases, the initial calibration is verified using an independently preparedcalibration verification solution. Basic Laboratory maintains a log for eachinstrument which contains the following information: instrument identification,seria

A. Key Personnel Resumes B. Laboratory Certification and Capabilities C. Quality Assurance Objectives Summary for Water Samples D. Quality Assurance Objectives Summary for Soil / Sediment Samples E. Quality Assurance Ob