8. Quality Assurance

L. W. McMahon, J. L. Miranda, and L. D. Welch

ABSTRACT

The overall goal of a well-designed and well-implemented sampling and analysis program is to measure accurately what is really there. Environmental decisions are made on the assumption that analytical results are, within known limits of accuracy and precision, representative of site conditions. Many sources of error exist that could affect the analytical results. Factors to consider as sources of error include improper sample collection, handling, preservation, and transport; inadequate personnel training; and poor analytical methods, data reporting, and record keeping. A quality assurance (QA) program is designed to minimize these sources of error and to control all phases of the monitoring process.

8.1 INTRODUCTION

The application of a quality assurance/quality control (QA/QC) program for environmental monitoring activities at the ORR is essential to generating data of known and defensible quality. Each aspect of the environmental monitoring program, from sample collection to data management, must address and meet applicable quality standards.

The 1995 QA/QC results for the three sites have been compiled into a summary that represents the performance of the reservation as a whole. In past years, the results were reported separately for each of the three site analytical laboratories. The three laboratories were recently combined into a single entity, the Analytical Services Organization. The 1995 results are based on data from the Analytical Services Organization, the ORNL Environmental Sciences Division, the ORNL Industrial Hygiene Department and the K-25 Site Technical Division.

8.2 FIELD SAMPLING QUALITY ASSURANCE

Field sampling QA encompasses many practices that minimize error and evaluate sampling performance. Some key quality practices include the following:

use of standard operating procedures (SOPs) for sample collection and analysis;
use of chain-of-custody and sample-identification procedures;
instrument standardization, calibration, and verification;
technician and analyst training;
sample preservation, handling, and decontamination; and
use of QC samples such as field and trip blanks, duplicates, and equipment rinses.

Preparation of SOPs is a continually evolving process. In 1988, the Environmental Surveillance Procedures QC Program was issued for use by Energy Systems, with oversight by DOE-ORO and the EPA.

A process is in place for continuous improvement in the field sampling QA program and for incorporation of new procedures to reflect changing technologies and regulatory protocols. An Environmental Surveillance Procedures QC Committee is tasked with updating the field sampling and QC procedures. Membership in the committee includes representatives from each of the five Energy Systems facilities, DOE, ER, Central Waste Management, and the Analytical Services Organization. The committee ensures that requirements from relevant federal and state regulations are incorporated into the procedures and that new procedures are incorporated only after appropriate review and approval. In addition, site specific procedures are reviewed internally.

Because of changing technologies and regulatory protocols, training of field personnel is a continuing process. To ensure that qualified personnel are available for the array of sampling tasks within Energy Systems, training programs by EPA as well as private contractors have been used to supplement internal training. Examples of topics addressed include the following:

planning, preparation, and record keeping for field sampling;
well construction and groundwater sampling;
surface water, leachate, and sediment sampling;
soil sampling;
stack sampling;
decontamination procedures; and
health and safety considerations.

8.3 ANALYTICAL QUALITY ASSURANCE

The Energy Systems analytical laboratories have well-established QA/QC programs, well-trained and highly qualified staff, and excellent equipment and facilities. Current, approved analytical methodologies employing good laboratory and measurement control practices are used routinely to ensure analytical reliability. The analytical laboratories conduct extensive internal QC programs with a high degree of accuracy, participate in several external QC programs, and use statistics to evaluate and to continuously improve performance. Thus, QA and QC are daily responsibilities of all employees.

8.3.1 Internal Quality Control

Analytical activities are supported by the use of standard materials or reference materials (e.g., materials of known composition that are used in the calibration of instruments, methods standardization, spike additions for recovery tests, and other practices). Certified standards from the National Institute of Standards and Technology (NIST), EPA , or other DOE laboratories are used for such work. The laboratories operate under specific QA/QC criteria at each installation. Additionally, separate QA/QC documents relating to analysis of environmental samples associated with regulatory requirements are developed.

QA/QC measurement control programs external to the sample analysis groups have single-blind control samples submitted to the analytical laboratories to monitor performance. The results of such periodic measurement programs are statistically evaluated and reported to the laboratories and their customers. Most reports are issued quarterly, and some laboratories compile annual summary reports. These reports assist in evaluating the adequacy of analytical support programs and procedures. If serious deviations are noted by the QC groups, the operating laboratories are promptly notified so that corrective actions can be initiated and problems can be resolved. QC data are stored in an easily retrievable manner so that they can be related to the analytical results they support.

8.3.2 External Quality Control

In addition to the internal programs, all Energy Systems analytical laboratories are directed by DOE and are expected by EPA to participate in external QA programs. The QA programs generate data that are readily recognizable as objective packets of results. The external QA programs typically consist of the Energy Systems laboratories analyzing a sample of unknown composition provided by various QA organizations. The organizations know the true composition of the sample and provide the Energy Systems laboratories with a data report on their analytical performance. The sources of these programs are laboratories in EPA, DOE, and the commercial sector. Energy Systems participates in ten such programs (Table 8.1). The following sections describe the external QA programs in which Energy Systems participates.

8.3.2.1 Environmental Protection Agency Contract Laboratory Program (CLP)

The Contract Laboratory Program (CLP) is an EPA-administered QA element used to evaluate laboratory analytical proficiency in comparison with analyte and the current state of work. The program operates from the Contract Laboratory Analytical Services Support office at Alexandria, Virginia, in cooperation with the EPA regional offices. This program evaluates laboratories for the determination of organic and inorganic contaminants in aqueous and solid hazardous waste materials and enforces stringent QA/QC requirements to ensure comparable data. This program scores on additional criteria other than an ``acceptable-unacceptable'' evaluation of the measurement result. By the CLP scoring algorithm, performance of 75% or better indicates acceptable performance. Values below this score indicate that deficiencies exist and that the participant has failed to demonstrate the capability to meet the contract requirements.

8.3.2.2 Water Supply Laboratory Performance Quality Control Program

This program is administered by EPA and is used by the state of Tennessee to certify laboratories for drinking water analysis. To maintain a certification, a laboratory must meet a specified set of criteria relating to technical personnel, equipment, work areas, QA/QC operating procedures, and successful analysis of QA samples. In addition, inclusion on the state of Tennessee's UST approved listing may be granted as a result of successful participation in this program.

8.3.2.3 Water Pollution Performance Evaluation Quality Control Program

This program is used by DOE to evaluate laboratories engaged in analysis of polluted water samples at existing and former DOE sites. It is administered by EPA in Cincinnati, Ohio (Region V). It is also used by some states as part of their laboratory certification process.

8.3.2.4 American Industrial Hygiene Association Proficiency Analytical Testing Program

The American Industrial Hygiene Association (AIHA) administers the Proficiency Analytical Testing (PAT) Program as part of its AIHA accreditation process for laboratories performing analyses of industrial hygiene air samples.

8.3.2.5 EPA Discharge Monitoring Report Quality Assurance Study

EPA conducts a national QA program in support of the NPDES permits, and it is mandatory for major permit holders. The EPA supplies the QA samples and furnishes the evaluated results to the permittee, who is required to report the results and any necessary corrective actions to the state or regional coordinator.

8.3.2.6 EPA Intercomparison Radionuclide Control Program

The EPA Intercomparison Radionuclide Control Program is administered by NERL-LV. Samples include water, air filters, and milk. The state of Tennessee requires participation for drinking-water certification of radionuclide analysis, and all sites are involved. The NERL-LV program calculates a normalized standard deviation for each laboratory based on all reported results. By their criteria, any reported value above three standard deviations is considered unacceptable.

8.3.2.7 Environmental Lead Proficiency Analytical Testing (ELPAT) Program

This program was established by AIHA in 1992 to evaluate analysis of environmental lead samples in different matrices. The matrices evaluated are paint, soil, and dust wipes. The participating laboratory analyzes each matrix at four levels. In addition, a laboratory may request to become accredited for lead analysis in this program. The Environmental Lead Proficiency Analytical Testing Program (ELPAT) is administered by AIHA.

8.3.2.8 Mixed Analyte Performance Evaluation Program (MAPEP)

The Mixed Analyte Performance Evaluation Program (MAPEP ) is a program set up by the DOE Radiological and Environmental Sciences Laboratory in conjunction with the Laboratory Management Division of the Office of Technology Development to evaluate analysis of mixed-waste samples. The program is evaluated by Argonne National Laboratory.

8.3.2.9 DOE Environmental Measurements Laboratory (EML) Quality Assessment Program

Participation in the radionuclide Quality Assessment Program, administered by DOE Environmental Measurements Laboratory (EML) in New York, is required by DOE Order 5400.1. Various matrices, such as soil, water, air filters, and vegetation, are submitted semiannually for analysis of a variety of radioactive isotopes. All matrices, except air filters, are actual materials obtained from the environment at a DOE facility. A statistical report is submitted to the sites by EML for each period.

8.3.2.10 Proficiency Environmental Testing (PET) Program

The Proficiency Environmental Testing (PET) program is a service purchased from an outside vendor and is used by all five Energy Systems analytical laboratories and the DOE laboratory at the Fernald, Ohio, facility, to meet the need for a QA program for all environmental analyses. The samples are supplied by the commercial company at two concentration levels (high and low). All data from each of the six laboratories are reported to the supplier. The commercial supplier provides a report on the evaluated data to the site QA/QC managers. The report includes a percentage recovery of the referenced value, deviation from the mean of all reported data, specific problems in a site lab, and other statistical information. A corporate report is also provided that compares the data from the Energy Systems laboratories with those of other corporate laboratories.

8.3.2.11 Quality Assessment Program for Subcontracted Laboratories

Requirements for QC of Analytical Data for the ER Program (Energy Systems 1992b ) defines the basic requirements that laboratories must satisfy in providing support to ORR ER projects. Oversight of subcontracted commercial laboratories is performed by Technical Subcontracting Office (TSO) personnel, who conduct on-site laboratory reviews and monitor the performance of all subcontracted laboratories.

The components of the review process are as follows.

Laboratory Quality Assurance Plan (LQAP) -A review of the LQAP is performed by the TSO prior to an initial audit of the laboratory. Each laboratory is required to have an LQAP in place and to correct any deficiencies noted by the TSO review.
Performance evaluation samples-Each laboratory is required to successfully participate in an external performance evaluation program for analytes representative of those anticipated in the environmental samples. Participation is reviewed before samples are submitted to the laboratory and as part of the initial audit and periodic audits.
Initial audit-After the laboratory has satisfactorily responded to LQAP comments and submitted the required performance evaluation data, an audit is conducted to verify that conditions of Requirements for QC of Analytical Data for the ER Program (Energy Systems 1992b ) are being implemented.
Periodic audits-Audits of laboratories participating in the TSO pricing agreement are conducted every 6 to 12 months to verify continuing compliance with requirements.
Monthly progress reports-Reports are submitted to the TSO by each laboratory to maintain communication so that changes in certification status, personnel, or facilities may be monitored.
Project-specific surveillances-Surveillances are conducted as required to monitor specific project data quality.

8.4 DATA MANAGEMENT, VERIFICATION, AND VALIDATION

Verification and validation of environmental data are performed as components of the data collection process, which includes planning, sampling, analysis, and data review. Verification and validation of field and analytical data collected for environmental monitoring and restoration programs are necessary to ensure that data conform with applicable regulatory and contractual requirements. Validation of field and analytical data is a technical review performed to compare data with established quality criteria to ensure that data are adequate for intended use. The extent of project data verification and validation activities is based upon project-specific requirements.

Over the years, the environmental data verification and data validation processes used by ORR environmental programs have evolved to meet continuing regulatory changes and monitoring objectives. Procedures have been written to document the processes. For routine environmental effluent monitoring and surveillance monitoring, data verification activities may include processes of checking whether (1) data have been accurately transcribed and recorded, (2) appropriate procedures have been followed, (3) electronic and hard-copy data show one-to-one correspondence, and (4) data are consistent with expected trends. For example, the requirements for self-monitoring of surface-water and wastewater effluents under the terms of an NPDES permit require the permittee to conduct the analyses as defined in 40 CFR 136 and to certify that the data reported in the monthly discharge monitoring report are true and accurate.

Typically, routine data verification actions alone are sufficient to document the truthfulness and accuracy of the discharge monitoring report. For ER projects, routine verification activities are more contractually oriented and include checks for data completeness, consistency, and compliance against a predetermined standard or contract.

Certain projects may perform a more thorough technical validation of the data as mandated by the project's data quality objectives. For example, sampling and analyses conducted as part of a remedial investigation to support the CERCLA process may generate data that are needed to evaluate risk to human health and the environment, to document that no further remediation is necessary, or to support a multimillion-dollar construction activity and treatment alternative. In that case, the data quality objectives of the project may mandate a more thorough technical evaluation of the data against predetermined criteria. For example, EPA has established functional guidelines for validation of organic and inorganic data collected under the protocol of the EPA's CLP. These guidelines are used to offer assistance to the data user in evaluating and interpreting the data generated from monitoring activities that require CLP performance.

The validation process may result in identifying data that do not meet predetermined QC criteria (in flagging quantitative data that must be considered qualitative only) or in the ultimate rejection of data from its intended use. Typical criteria evaluated in the validation of CLP data include the percentage of surrogate recoveries, spike recoveries, method blanks, instrument tuning, instrument calibration, continuing calibration verifications, internal standard response, comparison of duplicate samples, and sample holding times.

Electronic data transfers from portable computers in the field and from laboratory information management systems used by on-site and commercial analytical laboratories to environmental data management systems have greatly enhanced the efficiency of the review process. In addition, the ongoing development of data-review software applications continues to provide necessary tools for data review. For example, as groundwater monitoring data are compiled, computer capabilities accomplish the following tasks:

calculate charge balance;
calculate conductivity and compare the data with field and laboratory measurements of conductivity;
compare alkalinities and pH, field-duplicate measurements, results of filtered and unfiltered samples for elemental analyses, and current data with historical data to note results that are statistical outliers from established patterns;
generate a summary of holding times for volatile organics; and
screen volatile-organic results from samples against volatile-organic results from laboratory blanks.

Irregularities in the laboratory results that are discovered through this program are flagged and reviewed with the laboratory. If corrections need to be made, the laboratory provides a revised laboratory report. If a data point is found to be an outlier, it remains flagged in the data base as information for the data user.

Continuing improvements are being made to computerized environmental data management systems maintained by the Y-12 Plant, ORNL, and the K-25 Site to improve the functionality of the systems, to allow access by a wide range of data users, and to integrate the mapping capabilities of a geographic information system (GIS) with the data bases containing results of environmental monitoring activities.

Integration of compliance-monitoring data for the ORR with sampling and analysis results from remedial investigations by the ER Division is a function of the Oak Ridge Environmental Information System (OREIS). OREIS is necessary to fulfill requirements prescribed in both the FFA and TOA and to support data management activities for all five facilities managed by Energy Systems. The FFA, a tripartite agreement between DOE, EPA Region IV, and the state of Tennessee, requires DOE to maintain one consolidated data base for environmental data generated at DOE facilities on the ORR. According to the FFA, the consolidated data base is to include data generated pursuant to the FFA as well as data generated under federal and state environmental permits. The TOA further defines DOE staff obligations to develop a quality assured, consolidated data base of monitoring information that will be shared electronically on a near-real-time basis with the state staff.

OREIS is the primary component of the data management program for the ER Program, providing consolidated, consistent, and well documented environmental data and data products to support planning, decision making, and reporting activities. OREIS provides a direct electronic link of ORR monitoring and remedial investigation results to EPA Region IV and the state of Tennessee DOE Oversight Division.

Contents REFERENCES