ML15342A282

From kanterella
Jump to navigation Jump to search
ZS-LT-01, Rev 4 - Quality Assurance Project Plan (for Characterization and Frs)
ML15342A282
Person / Time
Site: Zion  File:ZionSolutions icon.png
Issue date: 12/16/2015
From: Fuller C
ZionSolutions
To:
Office of Nuclear Material Safety and Safeguards
Shared Package
ML15342A256 List:
References
ZS-2015-0160 ZS-LT-01, Rev 4
Download: ML15342A282 (33)


Text

ZS-LT-Ol Revision 4 QUALITY ASSURANCE PROJECT PLAN (for Characterization and FRS)

Procedure No. ZS-LT-OI Revision No.4 Preparer: (Print name / sign): _ _ _ -1.(;,.IJ.IIQ-:;~~J~~~-~~~~====--------IDate:

~harleA FwAller _, L-Secondary Reviewer: (print name / sign): ---id~,~ "",~...JR~'4 CN. 11J.~"~'7T~_ _ _ _~Date:

V JoDi Nascth Regulatory Reqnired Reviews (per AD-ll, "Regulatory Reviews")

Part 72 ISFSI Impact License: 10 CFR 72.48 o YES ~ NO Part 50 License: 10 CFR 50.59 and 50.90 U YES ~ NO Fire Protection: 10 CFR 50.48(f)

DYES IZI NO Conditions of License: E-Plan: 10 CFR 50.54(q) o YES ~ NO QA Review Reqnired? [8J YES 0 ~

I NO LII,J6 A 4/v-_ _

QA Reviewer: ~/lrHlJ 1II<.II 'I Print Nabe / Signature I

Technical Review Required? 0 YES [8J NO Technical Reviewer: _ _ _ _ _ _ --:::-:-'NA~--;-::-:-_ _ _ _ _ _ _ _DATE: _ _ _ __

Print Name / Signature Technical Reviewer: NA'-,-::-:-_ _ __ __ _ __ .DATE:_ _ __ _


:P~n~*n-otN*ame / SigMture Approval Section DEPARTMENT MANAGER: _ _ - - ; ~~~:---,::">!(~..P'

~~I-;-------~DATE: ",;.'\-!r Robert F. ~tter /

DECOMMISSIONING /

PLANT MANAGER*:_ _ _ __ _-::-:---::-:-'NA'=_ __ _ _ _ _ _-'DATE:_ _ __

Print Name I Signature

  • Required for Technical Reviews only Effective Date:

Page 1 of33

ZS-LT-01 Revision 4 Table of Contents

1. INTRODUCTION .................................................................................................................. 5
2. MANAGEMENT .................................................................................................................... 6 2.1. Purpose ............................................................................................................................. 6 2.2. Quality Objectives and Criteria ........................................................................................ 6 2.3. Project Organization ......................................................................................................... 8 2.3.1. Senior Vice President and General Manager ............................................................ 8 2.3.2. Vice President Radiological and Environmental Controls ....................................... 8 2.3.3. Quality Assurance Manager ...................................................................................... 8 2.3.4. Characterization/License Termination Manager....................................................... 9 2.3.5. Radiological Engineer ............................................................................................... 9 2.3.6. Characterization/FRS Supervisor/Engineer .............................................................. 9 2.3.7. Radiological Instrument Supervisor ....................................................................... 10 2.3.8. Radiochemist........................................................................................................... 10 2.3.9. Count Room Technician ......................................................................................... 10 2.3.10. Characterization/FRS Technician ....................................................................... 10 2.4. Training and Qualifications ............................................................................................ 13 2.5. Documents and Records ................................................................................................. 14 2.5.1. Data Base Control ................................................................................................... 14 2.5.2. Quality Assurance (QA) Records ........................................................................... 14 2.5.3. Document Control ................................................................................................... 15 2.5.4. Procurement Quality ............................................................................................... 15 2.5.5. Procedures, Technical Support Documents, Instructions and Drawings ................ 16
3. DATA GENERATION AND ACQUISITION .................................................................... 16 3.1. Survey Planning ............................................................................................................. 16 3.2. Survey Design ................................................................................................................ 17 3.3. Survey Implementation .................................................................................................. 17 3.3.1. Methods for Direct Measurements and Radiological Sample Analysis ................. 18 3.3.2. Types of Media Sampled ........................................................................................ 19 3.3.3. Sample Handling and Custody................................................................................ 20 Page 2 of 33

ZS-LT-01 Revision 4 3.3.4. Analytical Methods for Radiological Contaminants............................................... 21 3.4. Survey Assessment ......................................................................................................... 21

4. QUALITY CONTROL SURVEYS AND SAMPLES ......................................................... 22 4.1. Replicate Measurements and Surveys ............................................................................ 22 4.1.1. Frequency................................................................................................................ 22 4.1.2. Acceptance Criteria ................................................................................................. 23 4.2. Duplicate and Split Samples .......................................................................................... 23 4.2.1. Frequency................................................................................................................ 23 4.2.2. Acceptance Criteria ................................................................................................. 24 4.3. Field Blanks and Spiked Samples .................................................................................. 25 4.3.1. Frequency................................................................................................................ 25 4.3.2. Acceptance Criteria ................................................................................................. 25
5. INSTRUMENT QUALITY .................................................................................................. 26 5.1. Instrument Control ......................................................................................................... 26 5.1.1. Response Checks .................................................................................................... 27 5.1.2. Placing an Instrument Out-of-Service .................................................................... 27 5.2. Instrument/Equipment Calibration and Frequency ........................................................ 27 5.3. Data Management .......................................................................................................... 28
6. DATA VALIDATION AND USABILITY .......................................................................... 28 6.1. Data Review, Verification and Validation ..................................................................... 28 6.2. Verification and Validation Methods ............................................................................. 29 6.2.1. Data Reduction........................................................................................................ 29 6.2.2. Data Validation ....................................................................................................... 29
7. ASSESSMENT AND OVERSIGHT .................................................................................... 31 7.1. Corrective Actions.......................................................................................................... 31 7.2. Reports to Management ................................................................................................. 32
8. REFERENCES ..................................................................................................................... 32 Page 3 of 33

ZS-LT-01 Revision 4 ACRONYMS ANSI American National Standards Institute CoC Chain-of-Custody DCGL Derived Concentration Guideline Level DQA Data Quality Assessment DQO Data Quality Objectives ETMS EnergySolutions Training Management System FPC Flow Proportioned Composite FRS Final Radiation Survey FSA Focused Self-Assessment HPGe High Purity Germanium HTD Hard to Detect ISOCS In Situ Object Counting System LTP License Termination Plan MARLAP Multi-Agency Radiological Laboratory Analytical Protocols Manual MARSSIM Multi-Agency Radiation Survey and Site Investigation Manual MDC Minimum Detectable Concentration NaI Sodium Iodide NIST National Institute of Standards and Technology NRC United States Nuclear Regulatory Commission OJT On-the-Job Training ORAU Oak Ridge Associated Universities QA Quality Assurance QAPP Quality Assurance Project Plan QC Quality Control ROC Radionuclides of Concern TSD Technical Support Document TC Time Composite TCVV Time-Constant/Varying Volume TVCV Time-Varying/Constant Volume WAC Waste Acceptance Criteria WRS Wilcoxan Rank Sum ZNPS Zion Nuclear Power Station ZSRP Zion Station Restoration Project Page 4 of 33

ZS-LT-01 Revision 4

1. INTRODUCTION The Zion Nuclear Power Station (ZNPS) is being decommissioned in accordance with the requirements of 10 CFR 50.82 Termination of License. The objective for the decommissioning of the ZNPS site is to reduce residual radioactivity to levels that permit release of the site for unrestricted use and for termination of the license in accordance with the site release criteria set forth in 10 CFR 20, Subpart E, Radiological Criteria for License Termination. As required by 10 CFR 50.82, and to allow implementation of at risk Final Radiation Survey (FRS) activities, a License Termination Plan (LTP) has been prepared and submitted in accordance with guidance provided in Regulatory Guide 1.179 Standard Format and Content of License Termination Plans for Nuclear Power Reactors (Reference 8.1). The LTP relies on guidance given in NUREG-1575, Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM) (Reference 8.2) and NUREG-1757, Consolidated NMSS Decommissioning Guidance - Characterization, Survey, and Determination of Radiological Criteria, Volume 2, Rev 1 (Reference 8.3) to develop, among other things, a FRS Plan (Section 5 of the LTP).

The MARSSIM guidance also discusses the need for a quality system to ensure the adequacy of data used to demonstrate that site conditions are acceptable for release of the site from the facility license. Laboratory quality for the analysis samples taken to support characterization and FRS is discussed in NUREG-1576, Multi-Agency Radiological Laboratory Analytical Protocols Manual (MARLAP) (Reference 8.4) and Regulatory Guide 4.15, Quality Assurance of Radiological Monitoring Programs (Inception Through Normal Operations to License Termination) - Effluent Streams and the Environment (Reference 8.5). Further, MARSSIM and MARLAP both indicate that a Quality Assurance Project Plan (QAPP) may be used in addition to, or in lieu of, existing quality systems to ensure data quality is achieved.

This QAPP has been prepared to ensure the adequacy of data being developed and used during the site characterization and FRS process. It supplements the quality requirements and quality concepts presented in ZS-QA-10, Quality Assurance Project Plan - Zion Station Restoration Project (Reference 8.6) which adequately encompass other risk-significant decommissioning activities. All characterization and FRS activities essential to data quality will be implemented and performed using approved procedures. Effective implementation of characterization and FRS operations will be verified through audit and surveillance activities, including field walkdowns by Characterization/License Termination management and radiological engineering staff and program self-assessments, as appropriate. Corrective actions are to be prescribed, implemented, and verified in the event any deficiencies are identified. These measures will apply to any applicable services provided by off-site vendors, as well as on-site sub-contractors. Audit and surveillance of off-site vendors may be satisfied by International Laboratory Accreditation Cooperation (ILAC) accreditation as described in the NRC endorsed NEI 14-05, revision 1 guidance.

Page 5 of 33

ZS-LT-01 Revision 4

2. MANAGEMENT ZionSolutions, LLC is responsible for the overall execution of the Zion Station Restoration Project (ZSRP). As the licensee, ZionSolutions is responsible for all licensing activities, safety, radiation protection, environmental safety and health, engineering and design, quality assurance, construction management, environmental management, waste management and financial management. ZionSolutions interfaces directly with the U.S. Nuclear Regulatory Commission (NRC) and other stakeholders on all issues pertaining to decommissioning project activities at ZNPS.

2.1. Purpose This Quality Assurance Project Plan (QAPP) will serve to ensure that site characterization and FRS are performed using approved written procedures by trained individuals and properly calibrated instruments that are sensitive to the potential radiological contaminants. This plan describes the quality assurance requirements and quality controls needed for sampling and analytical methodologies which limit the introduction of errors into analytical data required to support the release of the ZNPS for unrestricted use in accordance with NRC requirements. This QAPP will be used to ensure applicable plans, procedures, and instructions have been followed and documented during the performance of characterization and FRS activities.

2.2. Quality Objectives and Criteria Compliance with this QAPP ensures accuracy and reproducibility when obtaining direct measurements and/or representative samples for the qualification and quantification of radiological contaminants. Data quality must be sufficient to allow comparison with action levels and the unrestricted release criteria for license termination.

The Data Quality Objectives (DQO) process described by MARSSIM is a series of planning steps found to be effective in establishing criteria for data quality and developing survey plans. DQOs are qualitative and quantitative statements derived from outputs of each step of the DQO process that: clarify the study objective, define the most appropriate type of data to collect and determine the most appropriate conditions from which to collect the data. The DQO process allows for systematic planning and is particularly designed to address problems that require a decision between two alternatives. Furthermore, the DQO process is flexible in that the level of effort associated with planning a survey is based on the complexity of the survey and nature of the hazards.

Finally, the DQO process is iterative, allowing the survey designer to incorporate new knowledge and modify the output of previous steps to act as input to subsequent steps.

Page 6 of 33

ZS-LT-01 Revision 4 Each characterization and FRS survey design will incorporate survey specific DQOs.

Using the DQO process to design surveys will allow the survey designer to define specific data requirements and acceptable levels of decision error during planning before any data is collected. It will also ensure that selected instruments and processes will satisfy the intended purpose. This provides confidence that the survey results are accurate and any sources of uncertainty are identified and controlled.

DQOs are based on the seven-step process which is briefly described below.

Step 1: State the Problem - Concisely describe the problem to be studied. Review prior studies and existing information to gain a sufficient understanding to define the problem.

Step 2: Identify the Decision - Identify what questions the study will attempt to resolve, and what actions may result.

Step 3: Identify the Inputs to the Decision - Identify the information that needs to be obtained and the measurements that need to be taken to resolve the decision statement.

Step 4: Define the Study Boundaries - Specify the time periods and spatial area to which decisions will apply. Determine when and where data should be collected.

Step 5: Develop a Decision Rule - Define the statistical parameter of interest, specify the action level, and integrate the previous DQO outputs into a single statement that describes the logical basis for choosing among alternative actions.

Step 6: Specify Tolerable Limits on Decision Errors - Define the decision maker's tolerable decision error rates based on a consideration of the consequences of making an incorrect decision.

Step 7: Optimize the Design - Evaluate information from the previous steps and generate alternative data collection designs. Choose the most resource-effective design that meets all DQOs.

Since the radiological data collected for this project either will or may be used in risk-based corrective actions and remedies, data analytical limits must be set such that applicable federal risk-based action levels and project specific Derived Concentration Guideline Levels (DCGL) or action levels can be met. If project data needs change as work progresses, the DQOs may be modified to meet new project requirements.

Page 7 of 33

ZS-LT-01 Revision 4 2.3. Project Organization ZionSolutions has established the Characterization/License Termination Group (within the Radiological and Environmental Controls organization) with sufficient management and technical resources to fulfill project objectives and goals. The Characterization/License Termination Group is responsible for:

Site characterization; License Termination Plan (LTP) development and implementation; and, The performance of FRS.

Characterization/License Termination encompasses all survey and sampling activities related to the LTP. This includes site characterization surveys and FRS. The duties and responsibilities of key ZionSolutions managers as well as the various key positions within the Characterization/License Termination Group as they pertain to the implementation of this QAPP are described below. Responsibilities for each of the positions described may be assigned to a designee as appropriate. An organizational chart is provided as Figure 2-1.

2.3.1. Senior Vice President and General Manager The Senior Vice President and General Manager is responsible for executing the ZSRP in accordance with site plans and procedures.

2.3.2. Vice President Radiological and Environmental Controls The Vice President Radiological and Environmental Controls is responsible for ensuring sufficient resources are provided for the safe, quality and timely performance of characterization and FRS operations.

2.3.3. Quality Assurance Manager The Quality Assurance (QA) Manager reports to the Senior Vice President and General Manager and is responsible for:

The review, approval, distribution, and implementation of ZS-QA-10, Quality Assurance Project Plan - Zion Station Restoration Project.

Participation in internal planning, technical review, and change control processes.

Verification of facility and site Quality Control (QC) implementation through the auditing and surveillance processes.

Review of FSS/LTP vendors ILAC accreditation and maintain Approved Suppliers List (ASL).

Page 8 of 33

ZS-LT-01 Revision 4 2.3.4. Characterization/License Termination Manager The Characterization/License Termination Manager reports to the Vice President Radiological and Environmental Controls and is responsible for:

The organization, administration, development, and implementation of the characterization and FRS programs.

Ensuring activities conducted as part of the Characterization/FRS are performed in accordance with this QAPP.

The management of personnel assigned to the Characterization/License Termination Group.

Approving characterization survey packages and sample plans, FRS survey packages and sample plans and FRS Release Records.

Approving characterization and FRS Plans and Final Reports.

Ensuring all contractual and licensing obligations, as they pertain to characterization and FRS, are satisfied.

Approving characterization and FRS implementing procedures and other program documents.

Approving personnel access to FRS file cabinets and computer data bases.

For offsite FRS/LTP testing and calibration vendors, review vendor ILAC accreditation to verify technical acceptability for intended scope.

2.3.5. Radiological Engineer The Radiological Engineer reports to the Characterization/License Termination Manager and is responsible for:

The development of all characterization and FRS survey packages and sample plans and providing technical direction in their implementation.

Preparing DQOs for survey design.

Preparing and maintaining survey packages.

Supervising data collection.

Performing data review, verification and validation.

Resolving and documenting any survey design, instruction, or performance discrepancies.

Supporting the preparation of characterization and FRS reports and release records.

2.3.6. Characterization/FRS Supervisor/Engineer The Characterization/FRS Supervisor/Engineer reports to the Characterization/License Termination Manager and is responsible for:

Page 9 of 33

ZS-LT-01 Revision 4 Control and implementation of survey packages and sample plans as received from the Radiological Engineers and to ensure that all quality objectives are achieved.

Coordination of area turnover and survey area preparation.

Maintaining access controls over completed survey areas to ensure data integrity.

Coordinate and schedule Characterization/FSS Technicians to support the schedule.

Ensure all necessary instrumentation and other equipment is available to support survey activities.

2.3.7. Radiological Instrument Supervisor The Radiological Instrument Supervisor is responsible for maintaining the program for the calibration, set-up and repair of the on-site radiological instrumentation and analytical equipment used to support characterization, remedial, and FRS measurements. The Supervisor will also support the review and selection of instrumentation for the Characterization and FRS Programs.

2.3.8. Radiochemist During the performance of characterization and FRS, the Radiochemist will advise the Characterization/License Termination Manager and the Radiological Instrument Supervisor and provide direction and support for project sampling activities, including sample collection, preparation, handling, storage, and shipment and ensure that all requisite instrument QC and Minimum Detectable Concentration (MDC) criteria are met.

2.3.9. Count Room Technician The Count Room Technician will perform radiological sample analysis of volumetric material samples for characterization and FRS. The Technician will operate instrumentation in accordance with all approved procedures and manufacturers recommendations.

2.3.10. Characterization/FRS Technician The Characterization/FRS Technicians are responsible for understanding the requirements included in the LTP, all applicable implementation procedures, and this QAPP. The Characterization/FSS Technicians are responsible for the acquisition and documentation of survey data and collection of samples.

Page 10 of 33

ZS-LT-01 Revision 4 This data and samples will be obtained in accordance with the requirements and instructions provided in the specific sample plans, packages, instructions and guidance provided by the Characterization/FSS Engineers/Supervisors and Radiological Engineers. Through compliance with survey instructions and all applicable program and instrumentation procedures, Characterization/FSS Technicians implement the requirements contained in this QAPP to assure appropriate quality is used in the collection of characterization and FRS data.

Page 11 of 33

ZS-LT-01 Revision 4 FIGURE 2-1 Characterization/LTP/FSS Organization Chart Senior Vice President &

General Manager Quality Assurance Manager VP -

Environmental Safety & Health Characterization/

LTP Manager Radiological Radiological Engineer Radiation Protection Engineer (LTP (Characterization/Final Instrumentation & Laboratory Lead) Status Survey Lead) Organization Support

- Radiological Instrument Supervisor

-Radiochemist

-Count Room Technician Characterization/ -Instrument Technician Radiological FSS Engineer/

Engineer Supervisors Characterization/

FSS Technicians Page 12 of 33

ZS-LT-01 Revision 4 2.4. Training and Qualifications Proper training and qualifications are essential to ensuring effective and consistent performance to make certain that quality data will be acquired during characterization and FRS activities and that the error attributed to human performance is minimized.

Sufficient management and technical resources will be applied to the performance of characterization and FRS activities to ensure project objectives are achieved.

General and specific training requirements applicable for each individual within the Characterization/License Termination Group will be defined, tracked, and periodically updated as project activities progress and responsibilities change. The Characterization/License Termination Manager and the groups designated Training Coordinator will work with the ZionSolutions Training Department to utilize the EnergySolutions Training Management System (ETMS) and other Zion Training Program training, evaluation and documentation processes, as applicable, to support the implementation of a training program for characterization/FRS operations.

Individuals performing field survey and sampling activities and reviewing collected data from field measurements or laboratory data reports will be trained in the use of instruments, devices, and procedures, as applicable to the tasks they will be performing.

The training ensures that the personnel assigned to perform characterization and FRS activities will have sufficient knowledge to perform the work in accordance with the requirements of the Characterization Plan, the LTP and the implementing procedures.

Training will be in the form of attendance at formal classroom training; field observations and guidance provided by Supervision as Technicians start implementing procedures; completion of appropriate on-the-job training (OJT) programs; and/or through reading of certain required procedures. Completion of each type of training will be documented and records will be coordinated with and maintained within the ZionSolutions training department.

At a minimum, personnel assigned to acquire characterization and FRS survey data will be trained on the following:

Initial set-up and pre-use response checks with selected instrumentation and associated detectors.

Proficiency with operating a data-logger instrument and associated detectors.

Downloading of survey data from a data-logger instrument.

Performance of direct static measurements.

Performance of scanning structural surfaces and open land areas.

Performance of volumetric material sampling.

Page 13 of 33

ZS-LT-01 Revision 4 Supervisory and technical support personnel will have sufficient education, experience, training, and certification to appropriately qualify personnel in the performance of their assigned characterization and FRS tasks. Advanced training or experience in MARSSIM implementation will be required for technical personnel developing, reviewing or approving survey unit classifications, characterization and FRS plans, and reports.

2.5. Documents and Records Each characterization and FRS measurement will be identified by date, instrument, location, type of measurement, and mode of operation. Generation, handling, and storage of the original characterization and FRS design and data packages will be controlled. All completed characterization and FRS records will be designated as quality documents and, as such, will be maintained in accordance with ZionSolutions document control procedures.

2.5.1. Data Base Control Data obtained during the performance of characterization and FRS may be analyzed and processed by Excel spreadsheets or more complicated computer data base programs. Access to any established data bases will be controlled and limited to personnel authorized by the Characterization/License Termination Manager. Use of database programs supporting characterization and FRS operations will be in accordance with an approved procedure.

Any computer software used for data reduction, storage or evaluation will be fully documented and certified by the vendor. In addition, appropriate verification and validation performance tests, as necessary, will be performed prior to use of the data base for characterization and FRS data processing. The software will be tested prior to use by an appropriate test data set. Programs developed to assist in calculating characterization/FRS data (i.e. Excel spreadsheets) shall also be tested to verify they are correct.

2.5.2. Quality Assurance (QA) Records Documents that detail the design and performance of characterization and FRS surveys, contain characterization and FRS survey or measurement data, detail custody of samples, or contain other information affecting performance or completion of characterization and FRS are considered QA records when completed. Characterization and FRS records that contain or affect characterization and FRS quality will be maintained in accordance with ZionSolutions document control procedures. In addition:

Page 14 of 33

ZS-LT-01 Revision 4 Direct access to these records will be limited to personnel authorized by the Characterization/License Termination Manager.

A signature file will be maintained of all personnel authorized direct access to these records.

Characterization and FRS records will be signed out (by signature or initials) when they are removed from their storage location (e.g. file cabinet and/or room) where they are maintained.

Positive control is required of characterization and FRS records when they are not secured in the approved storage location.

Positive control is defined as being in the physical possession of an approved individual or placed in a secure locked location where access is controlled to only approved individuals.

2.5.3. Document Control 10 CFR 20.2103(a) requires that records showing the results of surveys and calibrations required by 10 CFR 20.1501 be maintained. These records and other documents that affect characterization and FRS quality will be transmitted to Document Control for processing and retention in accordance with ZionSolutions document control procedures.

2.5.4. Procurement Quality The procurement of materials, equipment, and services for characterization and FRS will be performed in a controlled manner which will ensure compliance with applicable regulatory requirements, procedures, quality assurance standards, and regulations. Service requests will be reviewed for technical adequacy and, in order to assure confidence with services provided. Instrument calibration and laboratory analysis services for FSS/LTP purposes, will be procured as QL-II level services from vendors on the ZionSolutions Approved Supplier List (ASL). Additionally, regular vendor performance reviews, audits and/or surveillances of these contractors may be performed to provide an adequate level of assurance that the quality activities are being effectively performed.

Page 15 of 33

ZS-LT-01 Revision 4 2.5.5. Procedures, Technical Support Documents, Instructions and Drawings The performance of characterization and FRS will require procedures and Technical Support Documents (TSD), as necessary, for personnel training, survey design, survey and sampling implementation, data collection, data review, data reporting, chain of custody, instrument calibration and maintenance, data verification and record storage. These documents will be developed to ensure compliance with the Characterization Plan and/or LTP and will meet applicable quality requirements, including a standardized process for their development, review, approval and revision.

3. DATA GENERATION AND ACQUISITION The characterization and FRS survey process provides data to demonstrate that all radiological parameters satisfy the established guideline values and conditions. The characterization and FRS process consists of four principal elements: planning, design, implementation, and assessment.

3.1. Survey Planning Survey planning is addressed through the implementation of the DQO process. Each survey package will be generated through the development of DQOs specific to the survey area or survey unit that will undergo assessment. Specific decisions will be used to establish the necessary inputs that will be considered for survey design. The following are examples of decisions that may be addressed through the DQO process:

Provide the basis for a non-impacted classification.

Provide the basis for initial classification (e.g. MARSSIM-based Class 1, 2 or 3).

Provide the basis for identification and distribution of Radionuclides of Concern (ROC).

Provide the basis for a surrogate relationship for Hard-to-Detect (HTD) ROCs.

Provide the basis for extent of remediation of surface soils.

Provide the basis for the extent of remediation of subsurface soils.

Provide the basis for the extent of remediation of sub-grade structures.

Evaluate variability of existing residual radioactivity to support FRS survey design.

Evaluate the neutron activation of concrete that is intended for beneficial reuse.

Evaluate the residual radioactivity on concrete that is intended for beneficial reuse.

Provide the basis for the background threshold activity for ROCs.

Provide sufficient radiological data to determine compliance with a Waste Acceptance Criteria (WAC) for a disposal site.

Demonstrate compliance with the dose-based unrestricted release criteria.

Page 16 of 33

ZS-LT-01 Revision 4 3.2. Survey Design During the generation of a characterization or a FRS survey package, specific survey and sampling processes will be designed and established for each survey area or survey unit. Survey design is the element in the process that determines the data and/or information inputs that are necessary to address the decisions for the survey. The survey design will include information relevant to the decision, including (but not limited to) the size of area to be scanned, the number and location of samples, smears and static measurements, and the type(s) of instruments and sampling devices to be used, including required sensitivities or detection levels. Examples of additional types of inputs that may be considered during survey design are:

Survey unit classification and the basis for the classification Historical incidents or accidents involving radioactive material Evidence of previous radioactive material storage or the burial of radioactive material The anticipated ROC Types of media to be sampled Action levels or release criteria Sample frequency, size, and types of measurements (systematic and biased)

Instrumentation and required sensitivity (MDC)

Analytical requirements for physical samples QC Samples Alternate actions based on the decision rule will also be included in the survey design during FRS. Survey designs will identify any check or hold points in the process necessary to ensure the quality of samples or data collected in the field is maintained.

Changes to the survey design will be subject to the same review and approval processes as the original survey design.

3.3. Survey Implementation Characterization and FRS survey packages and sample plans will be implemented in accordance with written, approved procedures that will ensure effective, technically correct and safe operations and data quality. Characterization and FRS procedures will describe the methods and techniques used for the collection of direct measurements and media samples.

Page 17 of 33

ZS-LT-01 Revision 4 3.3.1. Methods for Direct Measurements and Radiological Sample Analysis The type and frequency of direct survey measurements or media samples for analysis are determined by the DQOs in the specific survey package and sample plan. Characterization and FRS measurements include surface scans, direct static surface measurements, and gamma spectroscopy of volumetric materials.

Table 3-1 presents a brief summary of the types of instrumentation that may be used to obtain these measurements.

Table 3-1 Examples of Survey Measurements and Instrumentation Measurement Instrument Type Scanning:

Alpha Gas proportional, Zinc Sulfide scintillation Beta Gas proportional, Geiger-Mueller, Plastic scintillation Gamma NaI (Tl) scintillation In Situ Object Counting System (ISOCS)

Direct (Gross) Activity:

Alpha Gas proportional, Zinc Sulfide scintillation Beta Gas proportional, Geiger-Mueller, Plastic scintillation Radionuclide-specific:

Alpha Radiochemical separation and alpha spectroscopy Beta Liquid Scintillation Gamma HPGe* detector based gamma spectrometer, NaI (Tl) scintillation In Situ Object Counting System (ISOCS)

The on-site radiological laboratory will normally be used for gamma spectroscopy, gas proportional counting and liquid scintillation analysis in accordance with approved procedures. ZionSolutions LLC will also review the quality programs of any off-site vendor laboratories that are used for the receipt, preparation and analysis of characterization or FRS samples to ensure that the same level of quality is provided. In all cases, analytical methods will be established to ensure that required MDC values are achieved. All analytical data will be carefully reviewed prior to its use and incorporation into a characterization or FRS report.

Page 18 of 33

ZS-LT-01 Revision 4 3.3.2. Types of Media Sampled A wide range of media may be sampled and analyzed for characterization and FRS. The types of different media that may be sampled include, but are not limited to the following:

Surface Soil Subsurface Soil Sediment Volumetric Concrete Water Asphalt Grease/Oil Roofing Material Metal Paint Scrapings Surface Wipes There are two methods for the acquisition of volumetric media samples, grab samples and composite samples. Both are defined below. The appropriate sample collection technique will be determined based on the survey package and its DQOs.

3.3.2.1. Grab Sample An individual sample collected from a single location at a specific time or period of time.

3.3.2.2. Composite Samples A sample collected over a temporal or spatial range that typically consists of a series of discrete, equal samples (or aliquots) which are combined or composited. There are four types of composite samples:

Time Composite (TC) - a sample comprised of a varying number of discrete samples (aliquots) collected at equal time intervals during the compositing period. The TC sample is typically used to sample wastewater or streams.

Page 19 of 33

ZS-LT-01 Revision 4 Flow Proportioned Composite (FPC) - a sample collected proportional to the flow during the compositing period by either a time-varying/constant volume (TVCV) or time-constant/varying volume (TCVV) method. The TVCV method is typically used with automatic samplers that are paced by a flow meter. The TCVV method is a manual method that individually proportions a series of discretely collected aliquots. The FPC is typically used when sampling wastewater.

Areal Composite - sample composited from individual, equal aliquots collected on an areal or horizontal cross-sectional basis.

Each aliquot is collected in an identical manner. Examples include sediment composites from quarter-point sampling of streams and soil samples from within grids.

Vertical Composite - a sample composited from individual, equal aliquots collected from a vertical cross section. Each aliquot is collected in an identical manner. Examples include vertical profiles of soil/sediment columns, lakes, and estuaries.

3.3.3. Sample Handling and Custody Responsibility for custody of samples from the point of collection through the determination of the sample analytical results is established by implementing procedures for Sample Identification and Chain-of-Custody (CoC) that will ensure that sample custody is maintained and the validity and control of material samples are intact. Samples (soil, smears, scrapings, etc.) that require measurement or counting (i.e. not a field measurement) shall, at all times, be positively controlled or, have controlled custody by sample log or in accordance with ZS-WM-131, Chain-Of-Custody (Reference 8.10). If the procedure is used, a CoC form should be filled out for all such samples. The person that acquired the sample is responsible for the care and custody of the sample until it is transferred or properly dispatched or, the sample has been placed in secured storage. As few people as possible should handle the sample.

Samples will be labeled with a unique identification number and the date, location, and time of collection. This number will be used for the CoC and for the reporting of counting/measurement data. How samples will be identified will be designated in the survey package or sample plan.

Page 20 of 33

ZS-LT-01 Revision 4 Prior to leaving the positive control of the person taking the sample, samples will be accompanied by a properly completed CoC form or documented in a sample log. When transferring the possession of samples, the individuals relinquishing and receiving will sign, date, and note the time on the CoC form or in a sample tracking log. The CoC form or the log will document transfer of custody of the sample(s) from the sampler to another person, to the on-site radiological laboratory, to an off-site vendor laboratory, or to/from a secure storage area. Secure storage will be provided for archived samples.

Samples sent to an off-site laboratory will be properly packaged for shipment, with a signed CoC form enclosed in each sample box or cooler. Shipping containers will be secured with appropriate custody seals for shipment to the laboratory. The original CoC form will accompany the shipment, and a copy will be retained for the project file. Commercial carriers are not required to sign off on the custody form as long as the CoC forms are sealed inside the sample container and the custody seals remain intact.

3.3.4. Analytical Methods for Radiological Contaminants Samples will be analyzed for radiological contaminants by the on-site radiological laboratory or in some cases, by a qualified off-site radiological laboratory. The analysis of radiological contaminants will use standard approved and generally accepted methodologies or other comparable methodologies.

For radiochemical analyses, the MDC is determined based on normal factors and conditions which influence measurement. The MDC is used to evaluate the capability of a method relative to the required detection limit. Sample size, count duration, tracer recovery, detector background and detector efficiency all contribute to determining the sample MDC. The MDC for a radionuclide by radiochemical measurement is determined from the blank/background variability associated with the appropriate detector, the detector efficiency, sample aliquot size and chemical yield. The background variability is proportional to the sample count time.

3.4. Survey Assessment Data validation is the systematic process of ensuring that the precision and accuracy of direct and analytical data are adequate for their intended use. Validation shall be performed in accordance with written procedures and information gathered during this validation process will be documented.

Page 21 of 33

ZS-LT-01 Revision 4 One hundred percent (100%) of the data generated from all on-site and off-site analytical laboratories shall undergo independent peer review and evaluation. The data review will examine the possible effects on the data that could result from various QC failures. It does not determine data usability, nor does it include assignment of data qualifier flags.

4. QUALITY CONTROL SURVEYS AND SAMPLES Quality Control (QC) surveys and samples are performed primarily as verification that the original characterization or FRS results are valid. QC surveys may include replicate surveys, field blanks and spiked samples, split samples, third party analysis and sample recounts.

Replicate surveys apply to scan and static direct measurements. Field blanks and sample recounts apply to loose surface and material sampling surveys. Spiked samples and split samples apply to material sampling surveys. Third party analysis applies to material samples counted by a different laboratory than normally used. QC survey results are evaluated and compared to the original FRS survey results by the responsible Radiological Engineer in accordance with the appropriate acceptance criteria.

4.1. Replicate Measurements and Surveys A replicate measurement is an independent direct measurement performed by a qualified technician, other than the one who obtained the original characterization or FRS measurement, using a separate but similar instrument. In cases where the instrumentation used is highly specialized or of limited quantity, the same instrument may be used with the approval of the responsible Radiological Engineer. The original technicians may perform the replicate measurement with the approval of the responsible Radiological Engineer in cases where specialized training is required in measurement acquisition or in operation of the instrument. The results of the replicate measurement are directly compared to the result of the original measurement.

The QC replicate surveys only apply to FRS. It entails a repeat survey of the original designed survey in its entirety. QC replicate surveys are designed and modeled in the same manner as the original FRS survey. Any design deviations from the original survey must be approved by the responsible Radiological Engineer. The replicate survey package will be an addendum to the original survey package.

4.1.1. Frequency Replicate measurements will be performed on 5% of the static and scan locations in each characterization and FRS survey package in locations chosen at random. QC replicate surveys, conducted during the FRS phase, will be performed when directed by the Characterization/License Termination Manager.

Page 22 of 33

ZS-LT-01 Revision 4 These frequencies may be increased as directed by the Characterization/License Termination Manager.

Generally, QC replicate surveys will be performed on randomly selected survey units from the known population of survey units. Some circumstances, such as when the survey of a unit may require burdensome support activities, may dictate selecting an alternate survey unit for the QC replicate survey. The responsible Radiological Engineer may also select additional or substitute survey units based on professional judgment.

4.1.2. Acceptance Criteria Replicate static and scan measurement results will be compared to the original measurement results to determine if the acceptance criteria are met. The acceptance criteria for static measurements and scan surveys, based on the professional judgment of the Radiological Engineer, is that the same conclusion is reached for each measurement location and no other locations, greater than the scan investigation level for the area classification, are found. If the same conclusion is not reached or any exceptions are reported that were not reported in the original survey, further evaluations will be performed.

The acceptance criteria for QC replicate surveys is that both data sets either passes or fails the appropriate statistical test [i.e. Sign Test or Wilcoxon Rank Sum (WRS) test] for that survey unit. Agreement is ultimately determined that the same conclusion is reached for each data set. If the same conclusion is not reached or any exceptions are reported that were not reported in the original survey, further evaluations will be performed.

4.2. Duplicate and Split Samples The collection of duplicate samples or split samples will be the primary means of assessing survey precision and accuracy when collecting volumetric and/or material samples for characterization and FRS. A duplicate sample is a second complete sample taken at the same location and same time as the original. A split sample is when the original sample aliquot is separated into two aliquots and analyzed as separate samples.

4.2.1. Frequency For the characterization and FRS of surface and subsurface soils, asphalt, and sediment, a split sample analysis will be performed on 5% of the soil samples taken in a survey unit with the locations selected at random. For all other materials such a volumetric concrete, oils or liquids, the frequency will be determined by the responsible Radiological Engineer.

Page 23 of 33

ZS-LT-01 Revision 4 Duplicate samples will be acquired in accordance with the direction in the specific survey package or sample plan or as directed by the responsible Radiological Engineer.

During the performance of FRS, approximately 5% of the total number of split samples taken will be sent for analysis by a qualified off-site laboratory. If analysis by an off-site laboratory is prohibitive, another option that is acceptable for performing split sample analysis is for the on-site laboratory to analyze the spilt sample using a separate detector. In both cases, this process is performed in order to evaluate the accuracy of the on-site Radiological Laboratory techniques. The two split samples aliquots may be divided between the on-site Radiological Laboratory and off-site laboratory, or both aliquots may be analyzed by both laboratories.

4.2.2. Acceptance Criteria The NRC Inspection Procedure No. 84750 Radioactive Waste Treatment, and Effluent and Environmental Monitoring (Reference 8.9) will be used to determine the acceptability of split and duplicate sample analyses. The sample results will be compared to determine accuracy and precision as follows:

Divide each sample result by its associated uncertainty to obtain the resolution. [Note: the uncertainty is defined as the relative standard deviation ()].

Divide each sample result by the corresponding split or duplicate result to obtain the ratio.

The split or duplicate sample results are in agreement if the value of the ratio falls within the limits shown in Table 4-1 for the corresponding resolution.

Page 24 of 33

ZS-LT-01 Revision 4 Table 4-1 Acceptance Criteria Resolution Acceptable Ratio

<4 0.4-2.5 4-7 0.5-2.0 8-15 0.6-1.66 16-50 0.75-1.33 51-200 0.80-1.25

>200 0.85-1.18 Agreement is ultimately determined when the same conclusion is reached for each compared result. If the split sample or duplicate sample results do not agree, then further evaluations will be performed.

4.3. Field Blanks and Spiked Samples Field blanks are obtained by bringing an adequate volume of uncontaminated material, of the same media as the media being sampled, to the field. A sample will be collected from the uncontaminated material using the standard collection procedures. Field blank samples will be handled as a standard characterization or FRS sample through collection, preparation and analysis.

Spiked samples are procured from and prepared by a radioactive source vendor or laboratory. Spiked samples should be of the same media and same consistency as the on-site media that it is to emulate. The volumetric activity of the spiked sample will be as directed by the Characterization/License Termination Manager.

4.3.1. Frequency Field blanks and spiked samples will not be performed on a routine basis. Field blanks and spiked samples will only be performed when directed by the Characterization/License Termination Manager.

4.3.2. Acceptance Criteria The acceptance criteria for field blank samples are that no plant derived radionuclides are detected. If the analysis of the field blank shows the presence of plant derived radionuclides, then further evaluations will be performed.

Page 25 of 33

ZS-LT-01 Revision 4 Spiked sample results will be compared with the expected results to determine accuracy and precision in the same manner as duplicate or split samples.

Agreement is ultimately determined that the same conclusion is reached for each compared result, based on professional judgment of the Radiological Engineer, on a case by case basis. If the spiked sample results do not agree with the expected results, further evaluations will be performed.

5. INSTRUMENT QUALITY Radiation detection and measurement instrumentation for characterization and FRS is selected to provide both reliable operation and adequate sensitivity to detect the radionuclides identified at the site at levels sufficiently below the action levels or release criteria. Detector selection is based on detection sensitivity, operating characteristics and expected performance in the field.

5.1. Instrument Control The receipt, inspection, issue, control and accountability of portable radiological instrumentation used for characterization and/or FRS will be performed in accordance with an approved procedure. All portable radiological instrumentation and/or detectors addressed by this procedure shall be tracked by means of a serialized inventory system and assigned a unique identification number. An instrument history file shall be established to contain data for each portable radiological instrument or detector that will be and has been used to acquire characterization and/or FRS survey data. The instrument history file will contain a log of the maintenance and use history of the instrument, a copy of all calibration certificates and data sheets and records of daily response checks and control charts.

Instrument accountability will be determined through a sign-out process for all portable instrumentation and/or detectors used for characterization and/or FRS.

Maintenance and repair to characterization and/or FSS portable radiological instrumentation may be performed onsite by qualified personnel with experience in the maintenance and repair of instrumentation or off-site by a qualified vendor. Minor repair is defined as any repair that will not affect the calibration or efficiency of the instrument. Instruments and detectors used for the acquisition of characterization and/or FRS data shall be re-calibrated prior to use in the field if any major maintenance or repairs are performed that could affect the efficiency of the instrument and/or detector.

Portable radiological instrumentation and/or detectors will remain in the custody of the assigned technician, and positive control will be maintained, until collected data has been downloaded and the instrument has been returned to inventory.

Page 26 of 33

ZS-LT-01 Revision 4 Log sheets and other forms used to record field data shall remain in the custody of the responsible individual, and positive control shall be maintained, until returned to secure storage.

5.1.1. Response Checks Response checks shall be performed on all radiological instrumentation and/or detectors used for characterization and/or FRS prior to and following use, not to exceed the end of the shift in which the instrument was used. Response checks that may be performed include but are not limited to ensuring:

The instrument is in good physical condition.

A current and valid calibration label is affixed to the instrument.

The instrument satisfactorily zero adjusts (if applicable).

The instrument satisfactorily battery checks (if applicable).

All detector parameters on the instrument display are correct for the detector in use.

A satisfactory operational response within an acceptable range to a radioactive source of known activity.

If the instrument does not pass the response test, then the instrument will be removed from service. In cases where the failed response test was performed post-use, the Characterization/License Termination Manager or designee will be notified. The data acquired by the instrument since the last response check will be considered as suspect and invalid unless proven otherwise.

5.1.2. Placing an Instrument Out-of-Service Instruments tagged and removed from service for calibration, repair or failure of a response test shall be physically segregated from those instruments available for issue. All instruments removed from service shall be labeled by attaching a "DO NOT USE" tag.

5.2. Instrument/Equipment Calibration and Frequency All portable radiological instruments used for characterization and/or FRS shall be calibrated prior to first use, following any major repair, maintenance, or modifications that could affect calibration, after failure of a performance test requiring adjustments or repairs (that could affect calibration) to correct the failure, and every twelve (12) months.

Page 27 of 33

ZS-LT-01 Revision 4 Instruments will be calibrated using sources traceable to the National Institute of Standards and Technology (NIST) in accordance with approved procedures and instructions. At a minimum, portable radiological instrumentation and/or detectors used for characterization and/or FRS shall be calibrated in accordance with ANSI N323A-1997, Radiation Protection Instrumentation Test and Calibration, Portable Survey Instrumentation (Reference 8.10). This requirement shall be clearly marked on the purchase requisition if an off-site vendor is used for these services. Following calibration, all radiological instrumentation and/or detectors used for characterization and/or FRS shall have a label affixed to the instrument and/or detector indicating current calibration status.

5.3. Data Management Survey data control from the time of collection through evaluation will be specified by procedure and survey package instructions. Manual data entries will be verified by a second individual.

6. DATA VALIDATION AND USABILITY Data validation is the systematic process of ensuring that the precision and accuracy of the analytical data are adequate for their intended use. The Data Quality Assessment (DQA) method is the approach used to perform this process. For FRS, DQA activities will be performed in accordance with an approved procedure.

6.1. Data Review, Verification and Validation The DQA process is an evaluation method used during the assessment phase to ensure the validity of characterization and FRS results and demonstrate achievement of the survey objectives. The decision rule for characterization is the acquisition of the necessary quantity and quality of data to address the decision question. The use of DQA, like the DQO process, is a critical component in ensuring the acquisition of quality data that is accurate and reproducible.

Review the DQOs and Sampling Design Conduct a Preliminary Data Review Select the Statistical Test (for FRS only)

Verify the Assumptions of the Statistical Test (for FRS only)

Draw Conclusions from the Data Review of the DQOs and survey plan designs includes verification and validation of collected data to determine whether or not the quality of the data (accuracy, precision, and sensitivity) satisfies the survey objectives.

Page 28 of 33

ZS-LT-01 Revision 4 The DQA process is the primary evaluation tool to determine that data are of the right type, quality and quantity to demonstrate that the dose from residual radioactivity in each survey unit is less than the annual dose criterion for license termination.

6.2. Verification and Validation Methods Data generated through characterization/FRS field activities or laboratory operations will be reduced and validated prior to reporting. Characterization/FRS analytical data should not be disseminated by the laboratory or considered final until it has been subjected to data validation in accordance with an approved procedure.

6.2.1. Data Reduction The results of all direct measurements will be documented in the applicable specific characterization or FRS Survey Package. All data will be legible. If errors are made, results will be legibly crossed out, initialed and dated by the responsible person(s), and corrected in a space adjacent to the original (erroneous) entry. For material samples, positive control of the sample from the time of acquisition to the time of analysis will be verified.

Typically, the greatest uncertainty in a measurement is often a result of the sampling process and inherent variability in the environmental media rather than the analytical measurement. Therefore, analytical data validation will be performed only to the level necessary to minimize the potential of using false positive or false negative results in the decision-making process.

All calculations will be verified by an independent review. Errors will be noted and corrections will be made, but the original notations will be crossed out legibly. Analytical results for soil samples should be calculated and reported as activity per unit weight (e.g. Ci/g).

Acceptable data will be entered into the applicable specific characterization or FRS survey package closure report. The closure report will also qualify any unacceptable data. Narratives will be prepared which will include information concerning data outside the acceptance limits, and any other anomalous conditions encountered during the analysis of the measurement or sample result.

Quality control data (e.g. split samples) will be compared to the acceptance criteria.

6.2.2. Data Validation Data validation procedures shall be performed for both field and laboratory operations.

Page 29 of 33

ZS-LT-01 Revision 4 Procedures to validate direct field measurement data primarily include checking for transcription errors and review of characterization/FRS Survey Package instructions. For FRS, data validation will be performed in accordance with an approved procedure.

6.2.2.1. Processes Used to Validate Data Processes to validate direct field measurement data primarily include checking for transcription errors and a review of survey package instructions. Upon receiving a survey record or analyses report of data intended for characterization or FRS, the responsible Radiological Engineer will perform a validation of the survey data to ensure that the data results are valid. Each specific sample or measurement result will be assessed individually. Data validation is accomplished through a review and assessment of the following:

Verification that the unique sample identification number for each sample or measurement is consistent between the sample analysis report, the CoC form (if applicable) and the survey package and/or sample plan instructions.

Verification that the recorded sample date and time for each sample or measurement is consistent with the CoC form and the survey record.

Verification that the data is complete and that there are no missing results or supporting data, including but not limited to MDC, uncertainty, background, or methods of analysis.

Verification that the MDC of the instrument used for analysis was adequate to detect all ROC or gross activity at the investigation levels specified in the survey package for that survey unit.

Verification of the absence of anomalies in the sample or measurement results, or in the supporting data, including but not limited to MDC, uncertainty, deviation from established procedure or analysis flags.

For data collected with a data logging instrument, verification that the data has been downloaded with a unique file name.

Verification that survey data results are presented in units appropriate for comparison to the action level or release criteria.

As applicable, convert the units for the reported data to the appropriate units by correcting for survey instrument background, efficiency, geometry, detector area, and/or measurement size.

Page 30 of 33

ZS-LT-01 Revision 4 Once analysis or measurement results have been validated, they can be placed in the survey package for data evaluation. The individual performing the validation will indicate that the data is valid by documenting the validation process in the survey package.

6.2.2.2. Data Reporting Field data reporting will be conducted principally through the execution and completion of survey packages and/or sample plans.

Radiological data from laboratory analysis is not considered official or reportable data until the validation activity has been concluded. The Characterization/License Termination Manager will perform a final review of all report summaries and narratives to determine whether the data meets project requirements.

7. ASSESSMENT AND OVERSIGHT Assessments and oversight will be performed by the QA Department on the characterization and FRS programs to determine if the program is being implemented in accordance with the LTP, regulatory guidance, and approved procedures. In addition, periodic internal assessments (e.g. Focused Self-Assessment Program, FSA) will be performed by ZionSolutions personnel assigned to specific FSA areas of review within the characterization and FRS programs. Radiological Engineers and Characterization/FSS Engineer/Supervisors will perform periodic surveillances and audits of field sampling activities. Aspects to be assessed include, but are not limited to, survey performance, data retrieval, data evaluation, quality control, and document control. All assessment results and any discrepancies found will be documented, tracked to resolution, and reported to project management. Any assessment results showing negative trends, equipment, or performance failures and discrepancies shall warrant a condition report in accordance with AD-8 Corrective Action Program (Reference 8.11). This program will be utilized to identify conditions adverse to quality and to support the development of corrective actions.

7.1. Corrective Actions Corrective action is the process of identifying, recommending, approving and implementing measures to unacceptable procedures or out of quality control performance which can affect data quality. Corrective action can occur during field activities, laboratory analyses, data validation, and data assessment. Any nonconformance with the requirements of the LTP, this QAPP or approved procedures will be identified, corrected, and properly documented.

Page 31 of 33

ZS-LT-01 Revision 4 Corrective action in the field may be necessary when the sample population is changed (e.g. more/less samples, sampling locations other than those specified in the survey package), or when sampling procedures and/or field analytical procedures require modification due to unexpected conditions. Project personnel will be responsible for reporting all suspected technical or quality non-conformances or suspected deficiencies of any activity or issued document by reporting the situation to the responsible Radiological Engineer or Characterization/FSS Engineer/Supervisor. These personnel will be responsible for assessing the suspected problems in consultation with the Characterization/License Termination Manager on making a decision based on the potential for the situation to impact the quality of the data. If it is determined that the situation warrants corrective action, a condition report will be initiated in accordance with AD-8.

Corrective action(s) should only be implemented after approval by the Characterization/License Termination Manager. Any corrective actions will be implemented and documented in the applicable survey package.

7.2. Reports to Management The Characterization/License Termination Manager will be responsible for all reports and deliverables associated with characterization and FRS. Summary level reports of characterization or FRS results, including QA and QC related checks and results will be generated quarterly. These reports will summarize key characterization or FRS tasks accomplished and also communicate the results of field and laboratory reviews, the achievement of specific data quality objectives, and a summary of any corrective actions that were implemented, and its impact on survey quality. Whenever necessary, updates on training provided, changes in key personnel, anticipated problems in the field or laboratory that could affect data quality, along with proposed solutions, will be also be reported. Any ongoing or planned program procedural changes or QAPP modifications will also be highlighted. This report will be distributed to the Vice President, Radiological and Environmental Controls for review and subsequently provided to Senior Management, including and the QA Manager.

8. REFERENCES 8.1. Regulatory Guide 1.179, Rev 1 Standard Format and Content of License Termination Plans for Nuclear Power Reactors - June 2011 8.2. NUREG-1575, Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM) - August 2000 Page 32 of 33

ZS-LT-01 Revision 4 8.3. NUREG-1757, Consolidated NMSS Decommissioning Guidance -

Characterization, Survey, and Determination of Radiological Criteria Volume 2, Revision 1 - September 2002 8.4. NUREG-1576, Multi-Agency Radiological Laboratory Analytical Protocols Manual (MARLAP) - August 2001 8.5. Regulatory Guide 4.15, Quality Assurance or Radiological Monitoring Programs (Inception Through Normal Operations to License Termination) -

Effluent Streams and the Environment - July 2007 8.6. ZS-QA-10, Quality Assurance Project Plan - Zion Station Restoration Project 8.7. Zion Station Restoration Project License Termination Plan - December 2014 8.8. ZS-WM-131, Chain-Of-Custody 8.9. NRC Inspection Procedure No. 84750, Radioactive Waste Treatment, and Effluent and Environmental Monitoring - March 1994 8.10. ANSI N323A-1997, Radiation Protection Instrumentation Test and Calibration, Portable Survey Instrumentation - April 1997 8.11. AD-8, Corrective Action Program Page 33 of 33

ZS-LT-Ol Revision 4 QUALITY ASSURANCE PROJECT PLAN (for Characterization and FRS)

Procedure No. ZS-LT-OI Revision No.4 Preparer: (Print name / sign): _ _ _ -1.(;,.IJ.IIQ-:;~~J~~~-~~~~====--------IDate:

~harleA FwAller _, L-Secondary Reviewer: (print name / sign): ---id~,~ "",~...JR~'4 CN. 11J.~"~'7T~_ _ _ _~Date:

V JoDi Nascth Regulatory Reqnired Reviews (per AD-ll, "Regulatory Reviews")

Part 72 ISFSI Impact License: 10 CFR 72.48 o YES ~ NO Part 50 License: 10 CFR 50.59 and 50.90 U YES ~ NO Fire Protection: 10 CFR 50.48(f)

DYES IZI NO Conditions of License: E-Plan: 10 CFR 50.54(q) o YES ~ NO QA Review Reqnired? [8J YES 0 ~

I NO LII,J6 A 4/v-_ _

QA Reviewer: ~/lrHlJ 1II<.II 'I Print Nabe / Signature I

Technical Review Required? 0 YES [8J NO Technical Reviewer: _ _ _ _ _ _ --:::-:-'NA~--;-::-:-_ _ _ _ _ _ _ _DATE: _ _ _ __

Print Name / Signature Technical Reviewer: NA'-,-::-:-_ _ __ __ _ __ .DATE:_ _ __ _


:P~n~*n-otN*ame / SigMture Approval Section DEPARTMENT MANAGER: _ _ - - ; ~~~:---,::">!(~..P'

~~I-;-------~DATE: ",;.'\-!r Robert F. ~tter /

DECOMMISSIONING /

PLANT MANAGER*:_ _ _ __ _-::-:---::-:-'NA'=_ __ _ _ _ _ _-'DATE:_ _ __

Print Name I Signature

  • Required for Technical Reviews only Effective Date:

Page 1 of33

ZS-LT-01 Revision 4 Table of Contents

1. INTRODUCTION .................................................................................................................. 5
2. MANAGEMENT .................................................................................................................... 6 2.1. Purpose ............................................................................................................................. 6 2.2. Quality Objectives and Criteria ........................................................................................ 6 2.3. Project Organization ......................................................................................................... 8 2.3.1. Senior Vice President and General Manager ............................................................ 8 2.3.2. Vice President Radiological and Environmental Controls ....................................... 8 2.3.3. Quality Assurance Manager ...................................................................................... 8 2.3.4. Characterization/License Termination Manager....................................................... 9 2.3.5. Radiological Engineer ............................................................................................... 9 2.3.6. Characterization/FRS Supervisor/Engineer .............................................................. 9 2.3.7. Radiological Instrument Supervisor ....................................................................... 10 2.3.8. Radiochemist........................................................................................................... 10 2.3.9. Count Room Technician ......................................................................................... 10 2.3.10. Characterization/FRS Technician ....................................................................... 10 2.4. Training and Qualifications ............................................................................................ 13 2.5. Documents and Records ................................................................................................. 14 2.5.1. Data Base Control ................................................................................................... 14 2.5.2. Quality Assurance (QA) Records ........................................................................... 14 2.5.3. Document Control ................................................................................................... 15 2.5.4. Procurement Quality ............................................................................................... 15 2.5.5. Procedures, Technical Support Documents, Instructions and Drawings ................ 16
3. DATA GENERATION AND ACQUISITION .................................................................... 16 3.1. Survey Planning ............................................................................................................. 16 3.2. Survey Design ................................................................................................................ 17 3.3. Survey Implementation .................................................................................................. 17 3.3.1. Methods for Direct Measurements and Radiological Sample Analysis ................. 18 3.3.2. Types of Media Sampled ........................................................................................ 19 3.3.3. Sample Handling and Custody................................................................................ 20 Page 2 of 33

ZS-LT-01 Revision 4 3.3.4. Analytical Methods for Radiological Contaminants............................................... 21 3.4. Survey Assessment ......................................................................................................... 21

4. QUALITY CONTROL SURVEYS AND SAMPLES ......................................................... 22 4.1. Replicate Measurements and Surveys ............................................................................ 22 4.1.1. Frequency................................................................................................................ 22 4.1.2. Acceptance Criteria ................................................................................................. 23 4.2. Duplicate and Split Samples .......................................................................................... 23 4.2.1. Frequency................................................................................................................ 23 4.2.2. Acceptance Criteria ................................................................................................. 24 4.3. Field Blanks and Spiked Samples .................................................................................. 25 4.3.1. Frequency................................................................................................................ 25 4.3.2. Acceptance Criteria ................................................................................................. 25
5. INSTRUMENT QUALITY .................................................................................................. 26 5.1. Instrument Control ......................................................................................................... 26 5.1.1. Response Checks .................................................................................................... 27 5.1.2. Placing an Instrument Out-of-Service .................................................................... 27 5.2. Instrument/Equipment Calibration and Frequency ........................................................ 27 5.3. Data Management .......................................................................................................... 28
6. DATA VALIDATION AND USABILITY .......................................................................... 28 6.1. Data Review, Verification and Validation ..................................................................... 28 6.2. Verification and Validation Methods ............................................................................. 29 6.2.1. Data Reduction........................................................................................................ 29 6.2.2. Data Validation ....................................................................................................... 29
7. ASSESSMENT AND OVERSIGHT .................................................................................... 31 7.1. Corrective Actions.......................................................................................................... 31 7.2. Reports to Management ................................................................................................. 32
8. REFERENCES ..................................................................................................................... 32 Page 3 of 33

ZS-LT-01 Revision 4 ACRONYMS ANSI American National Standards Institute CoC Chain-of-Custody DCGL Derived Concentration Guideline Level DQA Data Quality Assessment DQO Data Quality Objectives ETMS EnergySolutions Training Management System FPC Flow Proportioned Composite FRS Final Radiation Survey FSA Focused Self-Assessment HPGe High Purity Germanium HTD Hard to Detect ISOCS In Situ Object Counting System LTP License Termination Plan MARLAP Multi-Agency Radiological Laboratory Analytical Protocols Manual MARSSIM Multi-Agency Radiation Survey and Site Investigation Manual MDC Minimum Detectable Concentration NaI Sodium Iodide NIST National Institute of Standards and Technology NRC United States Nuclear Regulatory Commission OJT On-the-Job Training ORAU Oak Ridge Associated Universities QA Quality Assurance QAPP Quality Assurance Project Plan QC Quality Control ROC Radionuclides of Concern TSD Technical Support Document TC Time Composite TCVV Time-Constant/Varying Volume TVCV Time-Varying/Constant Volume WAC Waste Acceptance Criteria WRS Wilcoxan Rank Sum ZNPS Zion Nuclear Power Station ZSRP Zion Station Restoration Project Page 4 of 33

ZS-LT-01 Revision 4

1. INTRODUCTION The Zion Nuclear Power Station (ZNPS) is being decommissioned in accordance with the requirements of 10 CFR 50.82 Termination of License. The objective for the decommissioning of the ZNPS site is to reduce residual radioactivity to levels that permit release of the site for unrestricted use and for termination of the license in accordance with the site release criteria set forth in 10 CFR 20, Subpart E, Radiological Criteria for License Termination. As required by 10 CFR 50.82, and to allow implementation of at risk Final Radiation Survey (FRS) activities, a License Termination Plan (LTP) has been prepared and submitted in accordance with guidance provided in Regulatory Guide 1.179 Standard Format and Content of License Termination Plans for Nuclear Power Reactors (Reference 8.1). The LTP relies on guidance given in NUREG-1575, Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM) (Reference 8.2) and NUREG-1757, Consolidated NMSS Decommissioning Guidance - Characterization, Survey, and Determination of Radiological Criteria, Volume 2, Rev 1 (Reference 8.3) to develop, among other things, a FRS Plan (Section 5 of the LTP).

The MARSSIM guidance also discusses the need for a quality system to ensure the adequacy of data used to demonstrate that site conditions are acceptable for release of the site from the facility license. Laboratory quality for the analysis samples taken to support characterization and FRS is discussed in NUREG-1576, Multi-Agency Radiological Laboratory Analytical Protocols Manual (MARLAP) (Reference 8.4) and Regulatory Guide 4.15, Quality Assurance of Radiological Monitoring Programs (Inception Through Normal Operations to License Termination) - Effluent Streams and the Environment (Reference 8.5). Further, MARSSIM and MARLAP both indicate that a Quality Assurance Project Plan (QAPP) may be used in addition to, or in lieu of, existing quality systems to ensure data quality is achieved.

This QAPP has been prepared to ensure the adequacy of data being developed and used during the site characterization and FRS process. It supplements the quality requirements and quality concepts presented in ZS-QA-10, Quality Assurance Project Plan - Zion Station Restoration Project (Reference 8.6) which adequately encompass other risk-significant decommissioning activities. All characterization and FRS activities essential to data quality will be implemented and performed using approved procedures. Effective implementation of characterization and FRS operations will be verified through audit and surveillance activities, including field walkdowns by Characterization/License Termination management and radiological engineering staff and program self-assessments, as appropriate. Corrective actions are to be prescribed, implemented, and verified in the event any deficiencies are identified. These measures will apply to any applicable services provided by off-site vendors, as well as on-site sub-contractors. Audit and surveillance of off-site vendors may be satisfied by International Laboratory Accreditation Cooperation (ILAC) accreditation as described in the NRC endorsed NEI 14-05, revision 1 guidance.

Page 5 of 33

ZS-LT-01 Revision 4

2. MANAGEMENT ZionSolutions, LLC is responsible for the overall execution of the Zion Station Restoration Project (ZSRP). As the licensee, ZionSolutions is responsible for all licensing activities, safety, radiation protection, environmental safety and health, engineering and design, quality assurance, construction management, environmental management, waste management and financial management. ZionSolutions interfaces directly with the U.S. Nuclear Regulatory Commission (NRC) and other stakeholders on all issues pertaining to decommissioning project activities at ZNPS.

2.1. Purpose This Quality Assurance Project Plan (QAPP) will serve to ensure that site characterization and FRS are performed using approved written procedures by trained individuals and properly calibrated instruments that are sensitive to the potential radiological contaminants. This plan describes the quality assurance requirements and quality controls needed for sampling and analytical methodologies which limit the introduction of errors into analytical data required to support the release of the ZNPS for unrestricted use in accordance with NRC requirements. This QAPP will be used to ensure applicable plans, procedures, and instructions have been followed and documented during the performance of characterization and FRS activities.

2.2. Quality Objectives and Criteria Compliance with this QAPP ensures accuracy and reproducibility when obtaining direct measurements and/or representative samples for the qualification and quantification of radiological contaminants. Data quality must be sufficient to allow comparison with action levels and the unrestricted release criteria for license termination.

The Data Quality Objectives (DQO) process described by MARSSIM is a series of planning steps found to be effective in establishing criteria for data quality and developing survey plans. DQOs are qualitative and quantitative statements derived from outputs of each step of the DQO process that: clarify the study objective, define the most appropriate type of data to collect and determine the most appropriate conditions from which to collect the data. The DQO process allows for systematic planning and is particularly designed to address problems that require a decision between two alternatives. Furthermore, the DQO process is flexible in that the level of effort associated with planning a survey is based on the complexity of the survey and nature of the hazards.

Finally, the DQO process is iterative, allowing the survey designer to incorporate new knowledge and modify the output of previous steps to act as input to subsequent steps.

Page 6 of 33

ZS-LT-01 Revision 4 Each characterization and FRS survey design will incorporate survey specific DQOs.

Using the DQO process to design surveys will allow the survey designer to define specific data requirements and acceptable levels of decision error during planning before any data is collected. It will also ensure that selected instruments and processes will satisfy the intended purpose. This provides confidence that the survey results are accurate and any sources of uncertainty are identified and controlled.

DQOs are based on the seven-step process which is briefly described below.

Step 1: State the Problem - Concisely describe the problem to be studied. Review prior studies and existing information to gain a sufficient understanding to define the problem.

Step 2: Identify the Decision - Identify what questions the study will attempt to resolve, and what actions may result.

Step 3: Identify the Inputs to the Decision - Identify the information that needs to be obtained and the measurements that need to be taken to resolve the decision statement.

Step 4: Define the Study Boundaries - Specify the time periods and spatial area to which decisions will apply. Determine when and where data should be collected.

Step 5: Develop a Decision Rule - Define the statistical parameter of interest, specify the action level, and integrate the previous DQO outputs into a single statement that describes the logical basis for choosing among alternative actions.

Step 6: Specify Tolerable Limits on Decision Errors - Define the decision maker's tolerable decision error rates based on a consideration of the consequences of making an incorrect decision.

Step 7: Optimize the Design - Evaluate information from the previous steps and generate alternative data collection designs. Choose the most resource-effective design that meets all DQOs.

Since the radiological data collected for this project either will or may be used in risk-based corrective actions and remedies, data analytical limits must be set such that applicable federal risk-based action levels and project specific Derived Concentration Guideline Levels (DCGL) or action levels can be met. If project data needs change as work progresses, the DQOs may be modified to meet new project requirements.

Page 7 of 33

ZS-LT-01 Revision 4 2.3. Project Organization ZionSolutions has established the Characterization/License Termination Group (within the Radiological and Environmental Controls organization) with sufficient management and technical resources to fulfill project objectives and goals. The Characterization/License Termination Group is responsible for:

Site characterization; License Termination Plan (LTP) development and implementation; and, The performance of FRS.

Characterization/License Termination encompasses all survey and sampling activities related to the LTP. This includes site characterization surveys and FRS. The duties and responsibilities of key ZionSolutions managers as well as the various key positions within the Characterization/License Termination Group as they pertain to the implementation of this QAPP are described below. Responsibilities for each of the positions described may be assigned to a designee as appropriate. An organizational chart is provided as Figure 2-1.

2.3.1. Senior Vice President and General Manager The Senior Vice President and General Manager is responsible for executing the ZSRP in accordance with site plans and procedures.

2.3.2. Vice President Radiological and Environmental Controls The Vice President Radiological and Environmental Controls is responsible for ensuring sufficient resources are provided for the safe, quality and timely performance of characterization and FRS operations.

2.3.3. Quality Assurance Manager The Quality Assurance (QA) Manager reports to the Senior Vice President and General Manager and is responsible for:

The review, approval, distribution, and implementation of ZS-QA-10, Quality Assurance Project Plan - Zion Station Restoration Project.

Participation in internal planning, technical review, and change control processes.

Verification of facility and site Quality Control (QC) implementation through the auditing and surveillance processes.

Review of FSS/LTP vendors ILAC accreditation and maintain Approved Suppliers List (ASL).

Page 8 of 33

ZS-LT-01 Revision 4 2.3.4. Characterization/License Termination Manager The Characterization/License Termination Manager reports to the Vice President Radiological and Environmental Controls and is responsible for:

The organization, administration, development, and implementation of the characterization and FRS programs.

Ensuring activities conducted as part of the Characterization/FRS are performed in accordance with this QAPP.

The management of personnel assigned to the Characterization/License Termination Group.

Approving characterization survey packages and sample plans, FRS survey packages and sample plans and FRS Release Records.

Approving characterization and FRS Plans and Final Reports.

Ensuring all contractual and licensing obligations, as they pertain to characterization and FRS, are satisfied.

Approving characterization and FRS implementing procedures and other program documents.

Approving personnel access to FRS file cabinets and computer data bases.

For offsite FRS/LTP testing and calibration vendors, review vendor ILAC accreditation to verify technical acceptability for intended scope.

2.3.5. Radiological Engineer The Radiological Engineer reports to the Characterization/License Termination Manager and is responsible for:

The development of all characterization and FRS survey packages and sample plans and providing technical direction in their implementation.

Preparing DQOs for survey design.

Preparing and maintaining survey packages.

Supervising data collection.

Performing data review, verification and validation.

Resolving and documenting any survey design, instruction, or performance discrepancies.

Supporting the preparation of characterization and FRS reports and release records.

2.3.6. Characterization/FRS Supervisor/Engineer The Characterization/FRS Supervisor/Engineer reports to the Characterization/License Termination Manager and is responsible for:

Page 9 of 33

ZS-LT-01 Revision 4 Control and implementation of survey packages and sample plans as received from the Radiological Engineers and to ensure that all quality objectives are achieved.

Coordination of area turnover and survey area preparation.

Maintaining access controls over completed survey areas to ensure data integrity.

Coordinate and schedule Characterization/FSS Technicians to support the schedule.

Ensure all necessary instrumentation and other equipment is available to support survey activities.

2.3.7. Radiological Instrument Supervisor The Radiological Instrument Supervisor is responsible for maintaining the program for the calibration, set-up and repair of the on-site radiological instrumentation and analytical equipment used to support characterization, remedial, and FRS measurements. The Supervisor will also support the review and selection of instrumentation for the Characterization and FRS Programs.

2.3.8. Radiochemist During the performance of characterization and FRS, the Radiochemist will advise the Characterization/License Termination Manager and the Radiological Instrument Supervisor and provide direction and support for project sampling activities, including sample collection, preparation, handling, storage, and shipment and ensure that all requisite instrument QC and Minimum Detectable Concentration (MDC) criteria are met.

2.3.9. Count Room Technician The Count Room Technician will perform radiological sample analysis of volumetric material samples for characterization and FRS. The Technician will operate instrumentation in accordance with all approved procedures and manufacturers recommendations.

2.3.10. Characterization/FRS Technician The Characterization/FRS Technicians are responsible for understanding the requirements included in the LTP, all applicable implementation procedures, and this QAPP. The Characterization/FSS Technicians are responsible for the acquisition and documentation of survey data and collection of samples.

Page 10 of 33

ZS-LT-01 Revision 4 This data and samples will be obtained in accordance with the requirements and instructions provided in the specific sample plans, packages, instructions and guidance provided by the Characterization/FSS Engineers/Supervisors and Radiological Engineers. Through compliance with survey instructions and all applicable program and instrumentation procedures, Characterization/FSS Technicians implement the requirements contained in this QAPP to assure appropriate quality is used in the collection of characterization and FRS data.

Page 11 of 33

ZS-LT-01 Revision 4 FIGURE 2-1 Characterization/LTP/FSS Organization Chart Senior Vice President &

General Manager Quality Assurance Manager VP -

Environmental Safety & Health Characterization/

LTP Manager Radiological Radiological Engineer Radiation Protection Engineer (LTP (Characterization/Final Instrumentation & Laboratory Lead) Status Survey Lead) Organization Support

- Radiological Instrument Supervisor

-Radiochemist

-Count Room Technician Characterization/ -Instrument Technician Radiological FSS Engineer/

Engineer Supervisors Characterization/

FSS Technicians Page 12 of 33

ZS-LT-01 Revision 4 2.4. Training and Qualifications Proper training and qualifications are essential to ensuring effective and consistent performance to make certain that quality data will be acquired during characterization and FRS activities and that the error attributed to human performance is minimized.

Sufficient management and technical resources will be applied to the performance of characterization and FRS activities to ensure project objectives are achieved.

General and specific training requirements applicable for each individual within the Characterization/License Termination Group will be defined, tracked, and periodically updated as project activities progress and responsibilities change. The Characterization/License Termination Manager and the groups designated Training Coordinator will work with the ZionSolutions Training Department to utilize the EnergySolutions Training Management System (ETMS) and other Zion Training Program training, evaluation and documentation processes, as applicable, to support the implementation of a training program for characterization/FRS operations.

Individuals performing field survey and sampling activities and reviewing collected data from field measurements or laboratory data reports will be trained in the use of instruments, devices, and procedures, as applicable to the tasks they will be performing.

The training ensures that the personnel assigned to perform characterization and FRS activities will have sufficient knowledge to perform the work in accordance with the requirements of the Characterization Plan, the LTP and the implementing procedures.

Training will be in the form of attendance at formal classroom training; field observations and guidance provided by Supervision as Technicians start implementing procedures; completion of appropriate on-the-job training (OJT) programs; and/or through reading of certain required procedures. Completion of each type of training will be documented and records will be coordinated with and maintained within the ZionSolutions training department.

At a minimum, personnel assigned to acquire characterization and FRS survey data will be trained on the following:

Initial set-up and pre-use response checks with selected instrumentation and associated detectors.

Proficiency with operating a data-logger instrument and associated detectors.

Downloading of survey data from a data-logger instrument.

Performance of direct static measurements.

Performance of scanning structural surfaces and open land areas.

Performance of volumetric material sampling.

Page 13 of 33

ZS-LT-01 Revision 4 Supervisory and technical support personnel will have sufficient education, experience, training, and certification to appropriately qualify personnel in the performance of their assigned characterization and FRS tasks. Advanced training or experience in MARSSIM implementation will be required for technical personnel developing, reviewing or approving survey unit classifications, characterization and FRS plans, and reports.

2.5. Documents and Records Each characterization and FRS measurement will be identified by date, instrument, location, type of measurement, and mode of operation. Generation, handling, and storage of the original characterization and FRS design and data packages will be controlled. All completed characterization and FRS records will be designated as quality documents and, as such, will be maintained in accordance with ZionSolutions document control procedures.

2.5.1. Data Base Control Data obtained during the performance of characterization and FRS may be analyzed and processed by Excel spreadsheets or more complicated computer data base programs. Access to any established data bases will be controlled and limited to personnel authorized by the Characterization/License Termination Manager. Use of database programs supporting characterization and FRS operations will be in accordance with an approved procedure.

Any computer software used for data reduction, storage or evaluation will be fully documented and certified by the vendor. In addition, appropriate verification and validation performance tests, as necessary, will be performed prior to use of the data base for characterization and FRS data processing. The software will be tested prior to use by an appropriate test data set. Programs developed to assist in calculating characterization/FRS data (i.e. Excel spreadsheets) shall also be tested to verify they are correct.

2.5.2. Quality Assurance (QA) Records Documents that detail the design and performance of characterization and FRS surveys, contain characterization and FRS survey or measurement data, detail custody of samples, or contain other information affecting performance or completion of characterization and FRS are considered QA records when completed. Characterization and FRS records that contain or affect characterization and FRS quality will be maintained in accordance with ZionSolutions document control procedures. In addition:

Page 14 of 33

ZS-LT-01 Revision 4 Direct access to these records will be limited to personnel authorized by the Characterization/License Termination Manager.

A signature file will be maintained of all personnel authorized direct access to these records.

Characterization and FRS records will be signed out (by signature or initials) when they are removed from their storage location (e.g. file cabinet and/or room) where they are maintained.

Positive control is required of characterization and FRS records when they are not secured in the approved storage location.

Positive control is defined as being in the physical possession of an approved individual or placed in a secure locked location where access is controlled to only approved individuals.

2.5.3. Document Control 10 CFR 20.2103(a) requires that records showing the results of surveys and calibrations required by 10 CFR 20.1501 be maintained. These records and other documents that affect characterization and FRS quality will be transmitted to Document Control for processing and retention in accordance with ZionSolutions document control procedures.

2.5.4. Procurement Quality The procurement of materials, equipment, and services for characterization and FRS will be performed in a controlled manner which will ensure compliance with applicable regulatory requirements, procedures, quality assurance standards, and regulations. Service requests will be reviewed for technical adequacy and, in order to assure confidence with services provided. Instrument calibration and laboratory analysis services for FSS/LTP purposes, will be procured as QL-II level services from vendors on the ZionSolutions Approved Supplier List (ASL). Additionally, regular vendor performance reviews, audits and/or surveillances of these contractors may be performed to provide an adequate level of assurance that the quality activities are being effectively performed.

Page 15 of 33

ZS-LT-01 Revision 4 2.5.5. Procedures, Technical Support Documents, Instructions and Drawings The performance of characterization and FRS will require procedures and Technical Support Documents (TSD), as necessary, for personnel training, survey design, survey and sampling implementation, data collection, data review, data reporting, chain of custody, instrument calibration and maintenance, data verification and record storage. These documents will be developed to ensure compliance with the Characterization Plan and/or LTP and will meet applicable quality requirements, including a standardized process for their development, review, approval and revision.

3. DATA GENERATION AND ACQUISITION The characterization and FRS survey process provides data to demonstrate that all radiological parameters satisfy the established guideline values and conditions. The characterization and FRS process consists of four principal elements: planning, design, implementation, and assessment.

3.1. Survey Planning Survey planning is addressed through the implementation of the DQO process. Each survey package will be generated through the development of DQOs specific to the survey area or survey unit that will undergo assessment. Specific decisions will be used to establish the necessary inputs that will be considered for survey design. The following are examples of decisions that may be addressed through the DQO process:

Provide the basis for a non-impacted classification.

Provide the basis for initial classification (e.g. MARSSIM-based Class 1, 2 or 3).

Provide the basis for identification and distribution of Radionuclides of Concern (ROC).

Provide the basis for a surrogate relationship for Hard-to-Detect (HTD) ROCs.

Provide the basis for extent of remediation of surface soils.

Provide the basis for the extent of remediation of subsurface soils.

Provide the basis for the extent of remediation of sub-grade structures.

Evaluate variability of existing residual radioactivity to support FRS survey design.

Evaluate the neutron activation of concrete that is intended for beneficial reuse.

Evaluate the residual radioactivity on concrete that is intended for beneficial reuse.

Provide the basis for the background threshold activity for ROCs.

Provide sufficient radiological data to determine compliance with a Waste Acceptance Criteria (WAC) for a disposal site.

Demonstrate compliance with the dose-based unrestricted release criteria.

Page 16 of 33

ZS-LT-01 Revision 4 3.2. Survey Design During the generation of a characterization or a FRS survey package, specific survey and sampling processes will be designed and established for each survey area or survey unit. Survey design is the element in the process that determines the data and/or information inputs that are necessary to address the decisions for the survey. The survey design will include information relevant to the decision, including (but not limited to) the size of area to be scanned, the number and location of samples, smears and static measurements, and the type(s) of instruments and sampling devices to be used, including required sensitivities or detection levels. Examples of additional types of inputs that may be considered during survey design are:

Survey unit classification and the basis for the classification Historical incidents or accidents involving radioactive material Evidence of previous radioactive material storage or the burial of radioactive material The anticipated ROC Types of media to be sampled Action levels or release criteria Sample frequency, size, and types of measurements (systematic and biased)

Instrumentation and required sensitivity (MDC)

Analytical requirements for physical samples QC Samples Alternate actions based on the decision rule will also be included in the survey design during FRS. Survey designs will identify any check or hold points in the process necessary to ensure the quality of samples or data collected in the field is maintained.

Changes to the survey design will be subject to the same review and approval processes as the original survey design.

3.3. Survey Implementation Characterization and FRS survey packages and sample plans will be implemented in accordance with written, approved procedures that will ensure effective, technically correct and safe operations and data quality. Characterization and FRS procedures will describe the methods and techniques used for the collection of direct measurements and media samples.

Page 17 of 33

ZS-LT-01 Revision 4 3.3.1. Methods for Direct Measurements and Radiological Sample Analysis The type and frequency of direct survey measurements or media samples for analysis are determined by the DQOs in the specific survey package and sample plan. Characterization and FRS measurements include surface scans, direct static surface measurements, and gamma spectroscopy of volumetric materials.

Table 3-1 presents a brief summary of the types of instrumentation that may be used to obtain these measurements.

Table 3-1 Examples of Survey Measurements and Instrumentation Measurement Instrument Type Scanning:

Alpha Gas proportional, Zinc Sulfide scintillation Beta Gas proportional, Geiger-Mueller, Plastic scintillation Gamma NaI (Tl) scintillation In Situ Object Counting System (ISOCS)

Direct (Gross) Activity:

Alpha Gas proportional, Zinc Sulfide scintillation Beta Gas proportional, Geiger-Mueller, Plastic scintillation Radionuclide-specific:

Alpha Radiochemical separation and alpha spectroscopy Beta Liquid Scintillation Gamma HPGe* detector based gamma spectrometer, NaI (Tl) scintillation In Situ Object Counting System (ISOCS)

The on-site radiological laboratory will normally be used for gamma spectroscopy, gas proportional counting and liquid scintillation analysis in accordance with approved procedures. ZionSolutions LLC will also review the quality programs of any off-site vendor laboratories that are used for the receipt, preparation and analysis of characterization or FRS samples to ensure that the same level of quality is provided. In all cases, analytical methods will be established to ensure that required MDC values are achieved. All analytical data will be carefully reviewed prior to its use and incorporation into a characterization or FRS report.

Page 18 of 33

ZS-LT-01 Revision 4 3.3.2. Types of Media Sampled A wide range of media may be sampled and analyzed for characterization and FRS. The types of different media that may be sampled include, but are not limited to the following:

Surface Soil Subsurface Soil Sediment Volumetric Concrete Water Asphalt Grease/Oil Roofing Material Metal Paint Scrapings Surface Wipes There are two methods for the acquisition of volumetric media samples, grab samples and composite samples. Both are defined below. The appropriate sample collection technique will be determined based on the survey package and its DQOs.

3.3.2.1. Grab Sample An individual sample collected from a single location at a specific time or period of time.

3.3.2.2. Composite Samples A sample collected over a temporal or spatial range that typically consists of a series of discrete, equal samples (or aliquots) which are combined or composited. There are four types of composite samples:

Time Composite (TC) - a sample comprised of a varying number of discrete samples (aliquots) collected at equal time intervals during the compositing period. The TC sample is typically used to sample wastewater or streams.

Page 19 of 33

ZS-LT-01 Revision 4 Flow Proportioned Composite (FPC) - a sample collected proportional to the flow during the compositing period by either a time-varying/constant volume (TVCV) or time-constant/varying volume (TCVV) method. The TVCV method is typically used with automatic samplers that are paced by a flow meter. The TCVV method is a manual method that individually proportions a series of discretely collected aliquots. The FPC is typically used when sampling wastewater.

Areal Composite - sample composited from individual, equal aliquots collected on an areal or horizontal cross-sectional basis.

Each aliquot is collected in an identical manner. Examples include sediment composites from quarter-point sampling of streams and soil samples from within grids.

Vertical Composite - a sample composited from individual, equal aliquots collected from a vertical cross section. Each aliquot is collected in an identical manner. Examples include vertical profiles of soil/sediment columns, lakes, and estuaries.

3.3.3. Sample Handling and Custody Responsibility for custody of samples from the point of collection through the determination of the sample analytical results is established by implementing procedures for Sample Identification and Chain-of-Custody (CoC) that will ensure that sample custody is maintained and the validity and control of material samples are intact. Samples (soil, smears, scrapings, etc.) that require measurement or counting (i.e. not a field measurement) shall, at all times, be positively controlled or, have controlled custody by sample log or in accordance with ZS-WM-131, Chain-Of-Custody (Reference 8.10). If the procedure is used, a CoC form should be filled out for all such samples. The person that acquired the sample is responsible for the care and custody of the sample until it is transferred or properly dispatched or, the sample has been placed in secured storage. As few people as possible should handle the sample.

Samples will be labeled with a unique identification number and the date, location, and time of collection. This number will be used for the CoC and for the reporting of counting/measurement data. How samples will be identified will be designated in the survey package or sample plan.

Page 20 of 33

ZS-LT-01 Revision 4 Prior to leaving the positive control of the person taking the sample, samples will be accompanied by a properly completed CoC form or documented in a sample log. When transferring the possession of samples, the individuals relinquishing and receiving will sign, date, and note the time on the CoC form or in a sample tracking log. The CoC form or the log will document transfer of custody of the sample(s) from the sampler to another person, to the on-site radiological laboratory, to an off-site vendor laboratory, or to/from a secure storage area. Secure storage will be provided for archived samples.

Samples sent to an off-site laboratory will be properly packaged for shipment, with a signed CoC form enclosed in each sample box or cooler. Shipping containers will be secured with appropriate custody seals for shipment to the laboratory. The original CoC form will accompany the shipment, and a copy will be retained for the project file. Commercial carriers are not required to sign off on the custody form as long as the CoC forms are sealed inside the sample container and the custody seals remain intact.

3.3.4. Analytical Methods for Radiological Contaminants Samples will be analyzed for radiological contaminants by the on-site radiological laboratory or in some cases, by a qualified off-site radiological laboratory. The analysis of radiological contaminants will use standard approved and generally accepted methodologies or other comparable methodologies.

For radiochemical analyses, the MDC is determined based on normal factors and conditions which influence measurement. The MDC is used to evaluate the capability of a method relative to the required detection limit. Sample size, count duration, tracer recovery, detector background and detector efficiency all contribute to determining the sample MDC. The MDC for a radionuclide by radiochemical measurement is determined from the blank/background variability associated with the appropriate detector, the detector efficiency, sample aliquot size and chemical yield. The background variability is proportional to the sample count time.

3.4. Survey Assessment Data validation is the systematic process of ensuring that the precision and accuracy of direct and analytical data are adequate for their intended use. Validation shall be performed in accordance with written procedures and information gathered during this validation process will be documented.

Page 21 of 33

ZS-LT-01 Revision 4 One hundred percent (100%) of the data generated from all on-site and off-site analytical laboratories shall undergo independent peer review and evaluation. The data review will examine the possible effects on the data that could result from various QC failures. It does not determine data usability, nor does it include assignment of data qualifier flags.

4. QUALITY CONTROL SURVEYS AND SAMPLES Quality Control (QC) surveys and samples are performed primarily as verification that the original characterization or FRS results are valid. QC surveys may include replicate surveys, field blanks and spiked samples, split samples, third party analysis and sample recounts.

Replicate surveys apply to scan and static direct measurements. Field blanks and sample recounts apply to loose surface and material sampling surveys. Spiked samples and split samples apply to material sampling surveys. Third party analysis applies to material samples counted by a different laboratory than normally used. QC survey results are evaluated and compared to the original FRS survey results by the responsible Radiological Engineer in accordance with the appropriate acceptance criteria.

4.1. Replicate Measurements and Surveys A replicate measurement is an independent direct measurement performed by a qualified technician, other than the one who obtained the original characterization or FRS measurement, using a separate but similar instrument. In cases where the instrumentation used is highly specialized or of limited quantity, the same instrument may be used with the approval of the responsible Radiological Engineer. The original technicians may perform the replicate measurement with the approval of the responsible Radiological Engineer in cases where specialized training is required in measurement acquisition or in operation of the instrument. The results of the replicate measurement are directly compared to the result of the original measurement.

The QC replicate surveys only apply to FRS. It entails a repeat survey of the original designed survey in its entirety. QC replicate surveys are designed and modeled in the same manner as the original FRS survey. Any design deviations from the original survey must be approved by the responsible Radiological Engineer. The replicate survey package will be an addendum to the original survey package.

4.1.1. Frequency Replicate measurements will be performed on 5% of the static and scan locations in each characterization and FRS survey package in locations chosen at random. QC replicate surveys, conducted during the FRS phase, will be performed when directed by the Characterization/License Termination Manager.

Page 22 of 33

ZS-LT-01 Revision 4 These frequencies may be increased as directed by the Characterization/License Termination Manager.

Generally, QC replicate surveys will be performed on randomly selected survey units from the known population of survey units. Some circumstances, such as when the survey of a unit may require burdensome support activities, may dictate selecting an alternate survey unit for the QC replicate survey. The responsible Radiological Engineer may also select additional or substitute survey units based on professional judgment.

4.1.2. Acceptance Criteria Replicate static and scan measurement results will be compared to the original measurement results to determine if the acceptance criteria are met. The acceptance criteria for static measurements and scan surveys, based on the professional judgment of the Radiological Engineer, is that the same conclusion is reached for each measurement location and no other locations, greater than the scan investigation level for the area classification, are found. If the same conclusion is not reached or any exceptions are reported that were not reported in the original survey, further evaluations will be performed.

The acceptance criteria for QC replicate surveys is that both data sets either passes or fails the appropriate statistical test [i.e. Sign Test or Wilcoxon Rank Sum (WRS) test] for that survey unit. Agreement is ultimately determined that the same conclusion is reached for each data set. If the same conclusion is not reached or any exceptions are reported that were not reported in the original survey, further evaluations will be performed.

4.2. Duplicate and Split Samples The collection of duplicate samples or split samples will be the primary means of assessing survey precision and accuracy when collecting volumetric and/or material samples for characterization and FRS. A duplicate sample is a second complete sample taken at the same location and same time as the original. A split sample is when the original sample aliquot is separated into two aliquots and analyzed as separate samples.

4.2.1. Frequency For the characterization and FRS of surface and subsurface soils, asphalt, and sediment, a split sample analysis will be performed on 5% of the soil samples taken in a survey unit with the locations selected at random. For all other materials such a volumetric concrete, oils or liquids, the frequency will be determined by the responsible Radiological Engineer.

Page 23 of 33

ZS-LT-01 Revision 4 Duplicate samples will be acquired in accordance with the direction in the specific survey package or sample plan or as directed by the responsible Radiological Engineer.

During the performance of FRS, approximately 5% of the total number of split samples taken will be sent for analysis by a qualified off-site laboratory. If analysis by an off-site laboratory is prohibitive, another option that is acceptable for performing split sample analysis is for the on-site laboratory to analyze the spilt sample using a separate detector. In both cases, this process is performed in order to evaluate the accuracy of the on-site Radiological Laboratory techniques. The two split samples aliquots may be divided between the on-site Radiological Laboratory and off-site laboratory, or both aliquots may be analyzed by both laboratories.

4.2.2. Acceptance Criteria The NRC Inspection Procedure No. 84750 Radioactive Waste Treatment, and Effluent and Environmental Monitoring (Reference 8.9) will be used to determine the acceptability of split and duplicate sample analyses. The sample results will be compared to determine accuracy and precision as follows:

Divide each sample result by its associated uncertainty to obtain the resolution. [Note: the uncertainty is defined as the relative standard deviation ()].

Divide each sample result by the corresponding split or duplicate result to obtain the ratio.

The split or duplicate sample results are in agreement if the value of the ratio falls within the limits shown in Table 4-1 for the corresponding resolution.

Page 24 of 33

ZS-LT-01 Revision 4 Table 4-1 Acceptance Criteria Resolution Acceptable Ratio

<4 0.4-2.5 4-7 0.5-2.0 8-15 0.6-1.66 16-50 0.75-1.33 51-200 0.80-1.25

>200 0.85-1.18 Agreement is ultimately determined when the same conclusion is reached for each compared result. If the split sample or duplicate sample results do not agree, then further evaluations will be performed.

4.3. Field Blanks and Spiked Samples Field blanks are obtained by bringing an adequate volume of uncontaminated material, of the same media as the media being sampled, to the field. A sample will be collected from the uncontaminated material using the standard collection procedures. Field blank samples will be handled as a standard characterization or FRS sample through collection, preparation and analysis.

Spiked samples are procured from and prepared by a radioactive source vendor or laboratory. Spiked samples should be of the same media and same consistency as the on-site media that it is to emulate. The volumetric activity of the spiked sample will be as directed by the Characterization/License Termination Manager.

4.3.1. Frequency Field blanks and spiked samples will not be performed on a routine basis. Field blanks and spiked samples will only be performed when directed by the Characterization/License Termination Manager.

4.3.2. Acceptance Criteria The acceptance criteria for field blank samples are that no plant derived radionuclides are detected. If the analysis of the field blank shows the presence of plant derived radionuclides, then further evaluations will be performed.

Page 25 of 33

ZS-LT-01 Revision 4 Spiked sample results will be compared with the expected results to determine accuracy and precision in the same manner as duplicate or split samples.

Agreement is ultimately determined that the same conclusion is reached for each compared result, based on professional judgment of the Radiological Engineer, on a case by case basis. If the spiked sample results do not agree with the expected results, further evaluations will be performed.

5. INSTRUMENT QUALITY Radiation detection and measurement instrumentation for characterization and FRS is selected to provide both reliable operation and adequate sensitivity to detect the radionuclides identified at the site at levels sufficiently below the action levels or release criteria. Detector selection is based on detection sensitivity, operating characteristics and expected performance in the field.

5.1. Instrument Control The receipt, inspection, issue, control and accountability of portable radiological instrumentation used for characterization and/or FRS will be performed in accordance with an approved procedure. All portable radiological instrumentation and/or detectors addressed by this procedure shall be tracked by means of a serialized inventory system and assigned a unique identification number. An instrument history file shall be established to contain data for each portable radiological instrument or detector that will be and has been used to acquire characterization and/or FRS survey data. The instrument history file will contain a log of the maintenance and use history of the instrument, a copy of all calibration certificates and data sheets and records of daily response checks and control charts.

Instrument accountability will be determined through a sign-out process for all portable instrumentation and/or detectors used for characterization and/or FRS.

Maintenance and repair to characterization and/or FSS portable radiological instrumentation may be performed onsite by qualified personnel with experience in the maintenance and repair of instrumentation or off-site by a qualified vendor. Minor repair is defined as any repair that will not affect the calibration or efficiency of the instrument. Instruments and detectors used for the acquisition of characterization and/or FRS data shall be re-calibrated prior to use in the field if any major maintenance or repairs are performed that could affect the efficiency of the instrument and/or detector.

Portable radiological instrumentation and/or detectors will remain in the custody of the assigned technician, and positive control will be maintained, until collected data has been downloaded and the instrument has been returned to inventory.

Page 26 of 33

ZS-LT-01 Revision 4 Log sheets and other forms used to record field data shall remain in the custody of the responsible individual, and positive control shall be maintained, until returned to secure storage.

5.1.1. Response Checks Response checks shall be performed on all radiological instrumentation and/or detectors used for characterization and/or FRS prior to and following use, not to exceed the end of the shift in which the instrument was used. Response checks that may be performed include but are not limited to ensuring:

The instrument is in good physical condition.

A current and valid calibration label is affixed to the instrument.

The instrument satisfactorily zero adjusts (if applicable).

The instrument satisfactorily battery checks (if applicable).

All detector parameters on the instrument display are correct for the detector in use.

A satisfactory operational response within an acceptable range to a radioactive source of known activity.

If the instrument does not pass the response test, then the instrument will be removed from service. In cases where the failed response test was performed post-use, the Characterization/License Termination Manager or designee will be notified. The data acquired by the instrument since the last response check will be considered as suspect and invalid unless proven otherwise.

5.1.2. Placing an Instrument Out-of-Service Instruments tagged and removed from service for calibration, repair or failure of a response test shall be physically segregated from those instruments available for issue. All instruments removed from service shall be labeled by attaching a "DO NOT USE" tag.

5.2. Instrument/Equipment Calibration and Frequency All portable radiological instruments used for characterization and/or FRS shall be calibrated prior to first use, following any major repair, maintenance, or modifications that could affect calibration, after failure of a performance test requiring adjustments or repairs (that could affect calibration) to correct the failure, and every twelve (12) months.

Page 27 of 33

ZS-LT-01 Revision 4 Instruments will be calibrated using sources traceable to the National Institute of Standards and Technology (NIST) in accordance with approved procedures and instructions. At a minimum, portable radiological instrumentation and/or detectors used for characterization and/or FRS shall be calibrated in accordance with ANSI N323A-1997, Radiation Protection Instrumentation Test and Calibration, Portable Survey Instrumentation (Reference 8.10). This requirement shall be clearly marked on the purchase requisition if an off-site vendor is used for these services. Following calibration, all radiological instrumentation and/or detectors used for characterization and/or FRS shall have a label affixed to the instrument and/or detector indicating current calibration status.

5.3. Data Management Survey data control from the time of collection through evaluation will be specified by procedure and survey package instructions. Manual data entries will be verified by a second individual.

6. DATA VALIDATION AND USABILITY Data validation is the systematic process of ensuring that the precision and accuracy of the analytical data are adequate for their intended use. The Data Quality Assessment (DQA) method is the approach used to perform this process. For FRS, DQA activities will be performed in accordance with an approved procedure.

6.1. Data Review, Verification and Validation The DQA process is an evaluation method used during the assessment phase to ensure the validity of characterization and FRS results and demonstrate achievement of the survey objectives. The decision rule for characterization is the acquisition of the necessary quantity and quality of data to address the decision question. The use of DQA, like the DQO process, is a critical component in ensuring the acquisition of quality data that is accurate and reproducible.

Review the DQOs and Sampling Design Conduct a Preliminary Data Review Select the Statistical Test (for FRS only)

Verify the Assumptions of the Statistical Test (for FRS only)

Draw Conclusions from the Data Review of the DQOs and survey plan designs includes verification and validation of collected data to determine whether or not the quality of the data (accuracy, precision, and sensitivity) satisfies the survey objectives.

Page 28 of 33

ZS-LT-01 Revision 4 The DQA process is the primary evaluation tool to determine that data are of the right type, quality and quantity to demonstrate that the dose from residual radioactivity in each survey unit is less than the annual dose criterion for license termination.

6.2. Verification and Validation Methods Data generated through characterization/FRS field activities or laboratory operations will be reduced and validated prior to reporting. Characterization/FRS analytical data should not be disseminated by the laboratory or considered final until it has been subjected to data validation in accordance with an approved procedure.

6.2.1. Data Reduction The results of all direct measurements will be documented in the applicable specific characterization or FRS Survey Package. All data will be legible. If errors are made, results will be legibly crossed out, initialed and dated by the responsible person(s), and corrected in a space adjacent to the original (erroneous) entry. For material samples, positive control of the sample from the time of acquisition to the time of analysis will be verified.

Typically, the greatest uncertainty in a measurement is often a result of the sampling process and inherent variability in the environmental media rather than the analytical measurement. Therefore, analytical data validation will be performed only to the level necessary to minimize the potential of using false positive or false negative results in the decision-making process.

All calculations will be verified by an independent review. Errors will be noted and corrections will be made, but the original notations will be crossed out legibly. Analytical results for soil samples should be calculated and reported as activity per unit weight (e.g. Ci/g).

Acceptable data will be entered into the applicable specific characterization or FRS survey package closure report. The closure report will also qualify any unacceptable data. Narratives will be prepared which will include information concerning data outside the acceptance limits, and any other anomalous conditions encountered during the analysis of the measurement or sample result.

Quality control data (e.g. split samples) will be compared to the acceptance criteria.

6.2.2. Data Validation Data validation procedures shall be performed for both field and laboratory operations.

Page 29 of 33

ZS-LT-01 Revision 4 Procedures to validate direct field measurement data primarily include checking for transcription errors and review of characterization/FRS Survey Package instructions. For FRS, data validation will be performed in accordance with an approved procedure.

6.2.2.1. Processes Used to Validate Data Processes to validate direct field measurement data primarily include checking for transcription errors and a review of survey package instructions. Upon receiving a survey record or analyses report of data intended for characterization or FRS, the responsible Radiological Engineer will perform a validation of the survey data to ensure that the data results are valid. Each specific sample or measurement result will be assessed individually. Data validation is accomplished through a review and assessment of the following:

Verification that the unique sample identification number for each sample or measurement is consistent between the sample analysis report, the CoC form (if applicable) and the survey package and/or sample plan instructions.

Verification that the recorded sample date and time for each sample or measurement is consistent with the CoC form and the survey record.

Verification that the data is complete and that there are no missing results or supporting data, including but not limited to MDC, uncertainty, background, or methods of analysis.

Verification that the MDC of the instrument used for analysis was adequate to detect all ROC or gross activity at the investigation levels specified in the survey package for that survey unit.

Verification of the absence of anomalies in the sample or measurement results, or in the supporting data, including but not limited to MDC, uncertainty, deviation from established procedure or analysis flags.

For data collected with a data logging instrument, verification that the data has been downloaded with a unique file name.

Verification that survey data results are presented in units appropriate for comparison to the action level or release criteria.

As applicable, convert the units for the reported data to the appropriate units by correcting for survey instrument background, efficiency, geometry, detector area, and/or measurement size.

Page 30 of 33

ZS-LT-01 Revision 4 Once analysis or measurement results have been validated, they can be placed in the survey package for data evaluation. The individual performing the validation will indicate that the data is valid by documenting the validation process in the survey package.

6.2.2.2. Data Reporting Field data reporting will be conducted principally through the execution and completion of survey packages and/or sample plans.

Radiological data from laboratory analysis is not considered official or reportable data until the validation activity has been concluded. The Characterization/License Termination Manager will perform a final review of all report summaries and narratives to determine whether the data meets project requirements.

7. ASSESSMENT AND OVERSIGHT Assessments and oversight will be performed by the QA Department on the characterization and FRS programs to determine if the program is being implemented in accordance with the LTP, regulatory guidance, and approved procedures. In addition, periodic internal assessments (e.g. Focused Self-Assessment Program, FSA) will be performed by ZionSolutions personnel assigned to specific FSA areas of review within the characterization and FRS programs. Radiological Engineers and Characterization/FSS Engineer/Supervisors will perform periodic surveillances and audits of field sampling activities. Aspects to be assessed include, but are not limited to, survey performance, data retrieval, data evaluation, quality control, and document control. All assessment results and any discrepancies found will be documented, tracked to resolution, and reported to project management. Any assessment results showing negative trends, equipment, or performance failures and discrepancies shall warrant a condition report in accordance with AD-8 Corrective Action Program (Reference 8.11). This program will be utilized to identify conditions adverse to quality and to support the development of corrective actions.

7.1. Corrective Actions Corrective action is the process of identifying, recommending, approving and implementing measures to unacceptable procedures or out of quality control performance which can affect data quality. Corrective action can occur during field activities, laboratory analyses, data validation, and data assessment. Any nonconformance with the requirements of the LTP, this QAPP or approved procedures will be identified, corrected, and properly documented.

Page 31 of 33

ZS-LT-01 Revision 4 Corrective action in the field may be necessary when the sample population is changed (e.g. more/less samples, sampling locations other than those specified in the survey package), or when sampling procedures and/or field analytical procedures require modification due to unexpected conditions. Project personnel will be responsible for reporting all suspected technical or quality non-conformances or suspected deficiencies of any activity or issued document by reporting the situation to the responsible Radiological Engineer or Characterization/FSS Engineer/Supervisor. These personnel will be responsible for assessing the suspected problems in consultation with the Characterization/License Termination Manager on making a decision based on the potential for the situation to impact the quality of the data. If it is determined that the situation warrants corrective action, a condition report will be initiated in accordance with AD-8.

Corrective action(s) should only be implemented after approval by the Characterization/License Termination Manager. Any corrective actions will be implemented and documented in the applicable survey package.

7.2. Reports to Management The Characterization/License Termination Manager will be responsible for all reports and deliverables associated with characterization and FRS. Summary level reports of characterization or FRS results, including QA and QC related checks and results will be generated quarterly. These reports will summarize key characterization or FRS tasks accomplished and also communicate the results of field and laboratory reviews, the achievement of specific data quality objectives, and a summary of any corrective actions that were implemented, and its impact on survey quality. Whenever necessary, updates on training provided, changes in key personnel, anticipated problems in the field or laboratory that could affect data quality, along with proposed solutions, will be also be reported. Any ongoing or planned program procedural changes or QAPP modifications will also be highlighted. This report will be distributed to the Vice President, Radiological and Environmental Controls for review and subsequently provided to Senior Management, including and the QA Manager.

8. REFERENCES 8.1. Regulatory Guide 1.179, Rev 1 Standard Format and Content of License Termination Plans for Nuclear Power Reactors - June 2011 8.2. NUREG-1575, Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM) - August 2000 Page 32 of 33

ZS-LT-01 Revision 4 8.3. NUREG-1757, Consolidated NMSS Decommissioning Guidance -

Characterization, Survey, and Determination of Radiological Criteria Volume 2, Revision 1 - September 2002 8.4. NUREG-1576, Multi-Agency Radiological Laboratory Analytical Protocols Manual (MARLAP) - August 2001 8.5. Regulatory Guide 4.15, Quality Assurance or Radiological Monitoring Programs (Inception Through Normal Operations to License Termination) -

Effluent Streams and the Environment - July 2007 8.6. ZS-QA-10, Quality Assurance Project Plan - Zion Station Restoration Project 8.7. Zion Station Restoration Project License Termination Plan - December 2014 8.8. ZS-WM-131, Chain-Of-Custody 8.9. NRC Inspection Procedure No. 84750, Radioactive Waste Treatment, and Effluent and Environmental Monitoring - March 1994 8.10. ANSI N323A-1997, Radiation Protection Instrumentation Test and Calibration, Portable Survey Instrumentation - April 1997 8.11. AD-8, Corrective Action Program Page 33 of 33