4.0 TASK 4- DOSE RECONSTRUCTION REVIEW TRACKING 


This section presents SC&A's proposal for performing Task 4, Dose Reconstruction Review 

Tracking. 

4.1 	 UNDERSTANDING OF THE TASK AND ITS OBJECTIVES 

It is our understanding that this task requires the development ofa dose reconstruction review 

tracking system that will, at a minimum: 

Collate, track, and maintain all pertinent and necessary parameters provided with a 

data file (e.g., case number, date case was received, cancer type, primary radiation 

exposures type, DOLs Probability ofCausation determination, etc.) to ensure the 

Board-approved sampling strategy for identifying individual cases for review meets 

its design of a random selection process 

Track the status ofthe review process and progress associated with each individual 

case. 

4.2 	 TECHNICAL APPROACH 

To accomplish these objectives, SC&A will develop, manage, update, and maintain a functional 

review tracking system that: 

{1) 	 contains all pertinent data elements and is capable ofsorting and reporting key 

parameters necessary for ensuring that the Board-approved case sampling strategy 

is achieved 

{2) 	 provides an effective method ofdocumenting and tracking all aspects ofthe 

technical review process to ensure that progress can be evaluated at any·point 

during the course ofperformance 

(3) 	 is compatible with the NIOSH relational database management system 

(4) 	 is designed as a flexible tool, which can be expanded to meet the needs ofthe 

Advisory Board 

4.2.1 	 Tracking System Design 

The dose reconstruction review tracking system will consist ofone or more relational databases 

that are compatible with NIOSH's SQL Server 20000 database. It is envisioned that the tracking 

system will be designed as a dynamic tool that can expand and evolve based on project demands. 

This may be best accomplished with the use of multiple, linked relational databases. 

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4.2.2 Data Elements 

Based on the TORP Nos. 1, 2, and 3, SC&A's tracking system will, at a minimum, be populated 

with the following key categories ofinformation as appropriate for each individual case: 

Case Demographics/Board-Provided Data Files (e.g., Task Order number, Case 

number, cancer type, primary radiation exposure type, etc.) 

All Steps ofthe Basic/Advanced/Blind Dose Reconstruction Review Process 

(InternaVExternal Dose Reconstruction, Worker Profile, Interviews, Site Profile) 

Site Profile Reviews 

Dose Reconstruction Procedures and Methods Review 

4.2.2.1 Case Demographics 

The relational database will be populated with all relevant parameters necessary for identifying, 

tracking, and sorting cases by site (e.g., Hanford, Savannah River, etc.), category ofsite (e.g., 

uranium processing facilities, FUSRAP sites, etc.), category of exposure (e.g., external gamma, 

plutonium inhalation), results of audit (e.g., areas where audit identified inconsistences), and any 

other parameters that may serve the Advisory Board's purposes. 

4.2.2.2 Dose Reconstruction Review Process 

Basic Review. As a means of conducting the basic reviews in a systematic, consistent, efficient, 

and transparent manner, SC&A has developed procedures, as described in Task 1, Section 1.3.1.1 

ofthis proposal and a comprehensive checklist, as identified in Appendix A. The procedure and 

checklist were designed to follow guidance specified in U.S. Code ofFederal Regulations (CFR) 

Title 42, Part 82 and External and Internal Dose Reconstruction Implementation Guidelines 

(OCAS-IG-001 and OCAS-IG-002, respectively). The basic individual dose reconstruction 

checklist includes a step-by-step evaluation ofthe following areas: (1) data collection process, (2) 

interview/claimant documentation, (3) external dose reconstruction process, (4) internal dose 

reconstruction process, and (5) applicable portions ofNIOSH procedures and methodologies 

associated with the reconstruction ofdose for each individual case. Each element ofthe checklist 

will be incorporated into the relational database and will serve as a means oftracking and formally 

documenting the individual steps completed throughout the audit process. 

Advanced Review. As with the basic reviews, SC&A has developed a procedure and checklist for 

the advanced reviews, which are described in Task 1, Section 1.3.1.2 and Appendix A, 

respectively, ofthis proposal. The advanced dose reconstruction procedure and checklist include 

all the above-cited elements ofthe basic review as well as steps that allow for a more thorough 

comparison of available data and a more extensive review ofthe (l) data gathering, (2) workhistory interview and documentation provided by claimant, and (2) external/internal dose 

reconstruction processes. The advanced review procedure and checklist is also designed to take 

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into account guidelines established in the 42 Part 82, OCAS-IG-001, and OCAS-IG-002, as well 

as any other technical documents considered relevant. 

Blind Review. A procedure for providing guidance to the auditor who is conducting a blind 

review is included in Task 1, Section 1.3.2 ofthis proposal. Due to the nature of a blind review, 

specific checklists have not been developed. It is assumed that the auditor will have access to all 

available data (i.e., the entire administrative record, worker profile, and site profile) and will also 

follow guidelines established for the basic and advanced reviews (i.e., 42 CFR 82, OCAS-IG-001, 

and OCAS-IG-002). Upon completion of each blind review, the work products will receive the 

same independent advanced review audit procedure as performed for NIOSH dose 

reconstructions to serve as a form ofquality assurance documentation. As with the advanced 

reviews, all elements ofthe review process will be entered into the tracking system. 

Documents Not Included in the Case File. In addition, SC&A's relational database will include a 

listing of all relevant materials identified as part ofthe basic, advanced, or blind reviews that were 

not identified or incorporated into the original case file. These records/documents will also be 

maintained in a filing system and duplicated and provided to NIOSH with the audit report. 

4.2.2.3 Site Profile Reyiew 

Review ofspecific site profiles will be conducted using SC&A-developed, Board-approved 

procedures. A draft framework for a site profile review procedure is presented in Task 2, Section 

2.2.1 ofthis proposal. This draft procedure identifies four areas ofreview, which include (I} 

reviewing the site's operational history, (2) reviewing relevant data sourc·es, (3) conducting 

individual or group interviews, and (4) evaluating worse case doses. When this procedure is 

finalized, it is envisioned that, for each ofthese areas ofreview, a checklist or audit review form 

will be developed. Upon completion and Board approval ofthe checklist/audit form, SC&A will 

incorporate all review parameters into its relational database. 

4.2.2.4 Dose Reconstruction Procedures and Methods Review 

Task 3 ofthe TORP requires a baseline review ofprocedures and methods in place for 

implementing the dose reconstruction program. In order to conduct this review, Task 3 also 

specifies that SC&A will develop a review methodology, which meets the approval ofthe 

Advisory Board. When approved, each item ofthe checklist will be incorporated into SC&A's 

tracking system. 

With the approval ofthe Board, SC&A's plans to use similar review methodology and data 

tracking documents for assessing pertinent components ofthe following dose reconstruction 

process specified in Task 3: 

Internal and External Radiation Dose Reconstruction Technical Basis Documents 

Methods for Estimating "Missed Dose" and "Unmonitored Dose" 

Statistical Approaches for Multiple Dose Reconstructions 

Procedures Used for Determining Whether Sufficient Data Exists to Make a 

Reasonable Dose Estimates 

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Procedures Used for Substituting Exposure Information for 

unavailable/Incomplete Information 

Methods for Estimating Uncertainty Associated with InternaVExternal Dose 

Reconstructions 

Procedures/Questionnaires Used for Interviews 

Quality Assurance Plans and Procedures 

Procedures Used for Data Acquisition 

Procedures Related to Site Profile and Worker Profiles 

Methods, Procedures and Performance in Evaluating, Analyzing, and Validating all 

Contractor Work Products 

4.3 TASK MANAGEMENT 

Database Manager, will be responsible for designing and developing 


SC&A's dose reconstruction review tracking system, which will be compatible with NIOSH's 


SQL Server 2000 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 datahase that 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. 

~IIbe assisted by who will serve in the position of Records 

Management Specialist. She will be the central repository for all documents and records received 

from the Project Officer pertaining to this task order, all project procedures, all project 

deliverables, and all internal and external correspondence. She will establish a hard copy and 

electronic filing system that will maintain information confidential but accessible to authorized 

individuals, in accordance with project SOPs. 

4.4 WORK HOUR ALLOCATION AND SCHEDULE OF DELIVERABLES 

A preliminary case database will be developed within one month from authorization to proceed. 


Upon approval of SC&A' s dose reconstruction tracking system, subsequently quarterly updates 


to this database will be provided to the Board. SC&A will also submit to the Board a written 


monthly update on cases reviewed. 


The hours estimated for Task 4 are presented in Exhibit 4-1