4.0 TASK 4 DOSE RECONSTRUCTION REVIEW TRACKING
This sectionpresentsSC&A's proposal for performing Task 4, Dose ReconstructionReview Tracking.
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UNDERSTANDINGOF THE TASK AND ITS OBJECTIVES
It is our understandingthat this task requiresthe developmentof a dosereconstructionreview tracking systemthat will, at a minimum: Collate, track, and maintain all pertinent and necessary parameters provided with a data file (e.g., casenumber, date casewas received,cancertype, primary radiation exposurestype, DOLs Probability of Causationdetermination,etc.) to ensurethe Board-approvedsampling strategyfor identifying individual casesfor review meets its design of a random selectionprocess Track the statusof the review processand progressassociated with eachindividual case. 4.2
TECHNICAL APPROACH
To accomplishtheseobjectives, SC&A will develop, manage,update,and maintain a functional review tracking systemthat: (1) contains all pertinent data elementsand is capableof sorting and reporting key parametersnecessaryfor ensuringthat the Board-approvedcasesampling strategy is achieved provides an effective method of documentingand tracking all aspectsof the technical review processto ensurethat progresscan be evaluatedat anY'point during the courseof performance is compatible with the NIOSH relational database management system is designedas a flexible tool, which can be expandedto meet the needsof the Advisory Board
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4.2.1 Tracking System Design The dosereconstructionreview tracking systemwill consist of one or more relational databases that are compatible with NIOSH's SQL Server20000 database. It is envisionedthat the tracking systemwill be designedas a dynamic tool that can expandand evolve basedon project demands. This may be best accomplishedwith the use of multiple, linked relational databases.
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4.2.2 Data Elements Basedon the TORP Nos. 1,2, and 3, SC&A's tracking systemwill, at a minimum, be populated with the following key categoriesof information as appropriatefor eachindividual case: CaseDemographics/Board-Provided Data Files (e.g., Task Order number, Case number, cancertype, primary radiation exposuretype, etc.) All Stepsof the Basic/Advanced/Blind Dose ReconstructionReview Process (IntemaVExtemal Dose Reconstruction,Worker Profile, Interviews, Site Profile) Site Profile Reviews Dose ReconstructionProceduresand Methods Review 4.2.2.1 CaseDemographics
The relational database will be populated with all relevant parameters necessary identifying, for tracking, and sorting casesby site (e.g., Hanford, Savannah River, etc.), categoryof site (e.g., uranium processingfacilities, FUSRAP sites, etc.), categoryof exposure(e.g., external gamma, plutonium inhalation), results of audit (e.g., areaswhere audit identified inconsistences), and any other parameters that may servethe Advisory Board's purposes. 4.2.2.2 Dose ReconstructionReview Process
Basic Review. As a meansof conducting the basic reviews in a systematic,consistent,efficient, and transparentmanner, SC&A has developedprocedures,as describedin Task 1, Section 1.3.1.1 of this proposal and a comprehensivechecklist, as identified in Appendix A. The procedureand checklist were designedto follow guidancespecified in u.s. CodeofFedera/Regu/ations (CFR) Title 42, Part 82 and External and Internal Dose ReconstructionImplementation Guidelines (OCAS-IG-OOIand OCAS-IG-OO2, respectively). The basic individual dosereconstruction checklist includes a step-by-stepevaluation of the following areas:(I) data collection process,(2) interview/claimant documentation,(3) external dose reconstructionprocess,(4) internal dose reconstructionprocess,and (5) applicable portions ofNIOSH proceduresand methodologies associated with the reconstructionof dose for each individual case. Each elementof the checklist will be incorporatedinto the relational database and will serveas a meansof tracking and formally documentingthe individual stepscompletedthroughout the audit process. Advanced Review. As with the basic reviews, SC&A has developeda procedureand checklist for the advancedreviews, which are describedin Task I, Section 1.3.1.2and Appendix A, respectively,of this proposal. The advanceddosereconstructionprocedureand checklist include all the above-citedelementsof the basic review as well as stepsthat allow for a more thorough comparisonof available data and a more extensivereview of the (I) data gathering, (2) workhistory interview and documentationprovided by claimant, and (2) external/internal dose reconstructionprocesses.The advancedreview procedureand checklist is also designedto take
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into account guidelines establishedin the 42 Part 82, .OCAS-IG-OOI,and OCAS-IG-OO2, well as as any other technical documentsconsideredrelevant. Blind Review. A procedurefor providing guidanceto the auditor who is conducting a blind review is included in Task l, Section 1.3.2of this proposal. Due to the nature of a blind review, specific checklistshave not been developed. It is assumed that the auditor will have accessto all available data (i.e., the entire administrative record, worker profile, and site profile) and will also follow guidelines establishedfor the basic and advancedreviews (i.e., 42 CFR 82, OCAS-IG-OOl, and OCAS-IG-OO2).Upon completion of eachblind review, the work products will receive the sameindependentadvancedreview audit procedureas performed for NIOSH dose reconstructionsto serveas a form of quality assurance documentation. As with the advanced reviews, all elementsof the review processwill be enteredinto the tracking system. DocumentsNot Included in the CaseFile. In addition, SC&A's relational database will include a listing of all relevant materials identified as part of the basic, advanced,or blind reviews that were not identified or incorporatedinto the original casefile. Theserecords/documents will also be maintainedin a filing systemand duplicated and provided to NIOSH with the audit report. 4.2.2.3 Site Profile Review
Review of specific site profiles will be conductedusing SC&A-developed,Board-approved procedures. A draft framework for a site profile review procedureis presentedin Task 2, Section 2.2.1 of this proposal. This draft procedureidentifies four areasof review, which include (1) reviewing the site's operationalhistory, (2) reviewing relevant data sources,(3) conducting individual or group interviews, and (4) evaluatingworse casedoses. When this procedureis finalized, it is envisionedthat, for eachof theseareasof review, a checklist or audit review fonD will be developed. Upon completion and Board approval of the checklist/audit fonD, SC&A will incorporateall review parametersinto its relational database.
4.2.2.4
Dose ReconstructionProcedures and Methods Review
Task 3 of the TORP requires a baselinereview of proceduresand methodsin place for implementing the dosereconstructionprogram. In order to conduct this review, Task 3 also specifiesthat SC&A will develop a review methodology,which meetsthe approval of the Advisory Board. When approved,eachitem of the checklist will be incorporatedinto SC&A's tracking system. With the approval of the Board, SC&A's plans to use similar review methodology and data tracking documentsfor assessing pertinent componentsof the following dosereconstruction processspecified in Task 3: Internal and External Radiation Dose ReconstructionTechnical Basis Documents Methods for Estimating "Missed Dose" and "Unmonitored Dose" Statistical Approachesfor Multiple Dose Reconstructions ProceduresUsed for Detennining Whether Sufficient Data Exists to Make a Reasonable Dose Estimates
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Procedures Used for Substituting ExposureInfonnation for unavailable/lncompleteInfonnation Methods for Estimating Uncertainty Associatedwith IntemaVExtemalDose Reconstructions Procedures/Questionnaires Used for Interviews Quality AssurancePlansand Procedures Procedures Used for Data Acquisition Procedures Relatedto Site Profile and Worker Profiles Methods, Procedures and Perfonnancein Evaluating, Analyzing, and Validating all Contractor Work Products 4.3
TASK MANAGEMENT
Database Manager, will be responsiblefor designing and developing SC&A's dosereconstructionreview tracking system,which will be compatible withNIOSH's SQL Server2000 database. -.
has over 20 years experience in designing and developing databases, including recent experience with Access, SQL Server 2000. Among other projects, -. aided in designing a dataBasethat tracked documents supporting a CDC dose reconstruction document collection effort, designed and developed a LIMS system that has been in operational use for over 5 years by a radiological lab, designed and developed an dose tracking system used by EPA Headquarters, and has supported the programming and database needs of numerous dose modeling programs.
be assisted who will servein the position of Records ManagementSpecialist. Shewill be the central repository for all documentsand recordsreceived from the Project Officer pertaining to this task order, all project procedures,all project deliverables,and all internal and external correspondence.Shewill establisha hard copy and electronic filing systemthat will maintain information confidential but accessibleto authorized individuals, in accordance with project SOPs.
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WORK HOUR ALLOCA nON AND SCHEDULE OF DELIVERABLES
A preliminary casedatabase will be developedwithin one month from authorizationto proceed. Upon approval of SC&A' s dosereconstructiontracking system,subsequentlyquarterly updates to this database will be provided to the Board. SC&A will also submit to the Board a written monthly updateon casesreviewed. The hours estimatedfor Task 4 are presentedin Exhibit 4-1
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