October 4, 2004 

Larry E. Guess – Contracting Officer 

Centers for Disease Control and Prevention 

Acquisition and Assistance Field Branch 

Post Office Box 18070 

626 Cochrans Mill Road – B – 140 

Pittsburgh, PA 15236-0070 

Re: Contract No. 200-2004-03805 

Conflict of Interest Plan/Quality Assurance Project Plan 

Dear Mr. Guess: 

S. Cohen & Associates (SC&A) is pleased to submit the revised drafts of the Conflict of Interest 

Plan (revised draft dated October 1, 2004) and the Quality Assurance Project Plan (revised draft 

dated October 1, 2004). These documents, originally submitted on June 29, 2004, incorporate 

the review comments received by the Advisory Board, and have undergone additional internal 

reviews by SC&A. 

The Conflict of Interest (COI) Plan will put into place a formal method to ensure that project 

personnel and companies on the SC&A team avoid potential conflicts of interest. The plan 

codifies practices that the team has employed since the beginning of the project to avoid such 

conflicts. 

The Quality Assurance Project Plan (QAPP) describes the project-specific methods employed 

by SC&A to ensure achievement of quality goals, whereby all work is done in accordance with 

the highest professional standards and in compliance with all applicable regulatory, contractual, 

and other requirements. In addition, all aspects of the project are controlled and documented in a 

transparent and systematic fashion, so that the records can provide a clear picture of how a 

particular project deliverable arose. Adoption of the QAPP will put into place a formal method 

to meet quality goals and to codify practices that the team has employed since the beginning of 

the project to ensure quality. 

Should you have any further questions regarding these documents, please do not hesitate to 

contact me at 732-530-1014. 

John Mauro 

Sincerely yours, 

Project Manager 

cc: S. Ostrow 

Project File (ANIOS/003) 
SCA-PLAN-0001, Rev. 0, October 1, 2004 

ADVISORY BOARD ON RADIATION 

AND WORKER HEALTH 

Quality Assurance Project Plan 

Contract No. 200-2004-03805 

Prepared by 

S. Cohen & Associates 

6858 Old Dominion Drive, Suite 301 

McLean, Virginia 22101 

October 2004 
 

 

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10/01/2004 0 SCA-PLAN-0001 1 of 15 

S. Cohen & Associates: Technical Support for the 

Advisory Board on Radiation & Worker Health Review of 

NIOSH Dose Reconstruction Program 

Document No. SCA-PLAN-0001 

Effective Date: Final draft 

October 1, 2004 

Revision No. 0 

QUALITY ASSURANCE PROJECT PLAN Page 1 of 15 

QA Manager: ______________________Date: _________ 

Stephen Ostrow 

Supersedes: N/A 

Project Manager: ___________________Date: _________ 

John Mauro 
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TABLE OF CONTENTS 

1.0 BACKGROUND .................................................................................................................3 

2.0 PURPOSE ............................................................................................................................4 

3.0 SCOPE .................................................................................................................................4 

4.0 ORGANIZATION ...............................................................................................................4 

5.0 QUALITY PROGRAM RESPONSIBILITIES ...................................................................5 

6.0 PLANS AND PROCEDURES ............................................................................................7 

6.1	 Quality Assurance Project Plan ...............................................................................7 

6.2	 Conflict of Interest Plan ...........................................................................................7 

6.3	 SC&A Procedure to Perform QA Reviews of NIOSH/ORAU Dose 

Reconstruction Procedures.......................................................................................7 

6.4	 A Protocol for the Review of Procedures and Methods Employed by NIOSH 

for Dose Reconstruction ..........................................................................................8 

6.5	 Site Profile Review Procedure.................................................................................8 

6.6	 Deliverables .............................................................................................................8 

7.0	 MANAGEMENT PROCESS ..............................................................................................9 

7.1 Review and Distribution of Task Orders in a Timely Manner ................................9 

7.2 Tracking Progress of Cases and Task Orders ........................................................10 

7.3 Cost Projection Accuracy ......................................................................................10 

7.4	 Subcontractor Management ...................................................................................11 

7.5	 Problem Resolution................................................................................................12 

8.0	 DOCUMENTATION ........................................................................................................12 

9.0	 QAPP TRAINING .............................................................................................................12 

10.0	 CONFIDENTIALITY AND SECURITY OF INFORMATION ......................................13 

10.1 Privacy Act.............................................................................................................13 

10.2 Confidentiality of Information ...............................................................................13 

10.3 Security Safeguards ...............................................................................................13 

11.0 References..........................................................................................................................14 

EXHIBIT A: QUALITY ASSURANCE PROJECT PLAN ACKNOWLEDGMENT FORM ....15
 
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1.0 BACKGROUND 

S. Cohen & Associates (SC&A) holds Contract No. 200-2004-03805 in support of the National 

Institute of Occupational Safety and Health (NIOSH) Advisory Board on Radiation and Worker 

Health (the Advisory Board) to perform an independent review of the NIOSH dose 

reconstruction program under the Energy Employees Occupational Illness Compensation 

Program Act (EEOICPA) of 2000. All work on this project is performed under a highly 

structured quality assurance/quality control and documentation process, which includes 

procedures, plans, audit forms, and checklists that correspond to the requirements of Title 42, 

Parts 81 (Probability of Causation), 82 (Dose Reconstruction), and 83 (Special Exposure 

Cohorts) of the Code of Federal Regulations (42 CFR 81, 82, and 83) and of the NIOSH 

External Dose Reconstruction Implementation Guidelines (OCAS-IG-001) and Internal Dose 

Reconstruction Implementation Guidelines (OCAS-IG-002). 

All projects performed at SC&A are conducted under the guidance of the corporate Quality 

Management Plan (QMP), which ensures adherence to the highest standards of quality and 

project control. SC&A considers the QMP to be an over-arching blueprint for conducting 

quality work on all projects in which SC&A participates. Some basic definitions appearing in 

U.S. Department of Energy Order O 414.1A, “Quality Assurance” (Chg.1, 7-12-01), can help 

clarify what is meant by “quality”: 

• Quality is “the condition achieved when an item, service, or process meets or exceeds the 

user’s requirements and expectations.” 

• Quality Assurance is composed of “all those actions that provide confidence that quality 

is achieved.” 

• Quality Assurance Program is “the overall program (management system) established 

to assign responsibilities and authorities, define policies and requirements, and provide 

for the performance and assessment of work.” 

Individual projects require their own project-specific Quality Assurance Project Plans (QAPPs), 

which reflect project-specific conditions and requirements (e.g., regulatory and contractual). As 

discussed further in Section 6.0, SC&A has prepared a detailed set of Standard Operating 

Procedures (SOPs) and checklists for review of dose reconstruction procedures and methods and 

site profiles, as well as for other purposes. These SOPs (procedures and plans) are tied to the 

Office of Compensation Analysis and Support (OCAS) guidelines for dose reconstruction for 

external and internal exposures and the requirements set forth in 42 CFR 82 and 83, and 

constitute the principal part of the QAPP. 

Specifically, the QAPP and associated SOPs ensure and document that the following has been 

done: 

• Task technical and quality objectives are identified and agreed upon. 

• Activities affecting the achievement of the quality objectives are identified and, via 

SOPs, conducted in a controlled manner. 
 

 

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• SOPs implementing quality requirements are identified and in place prior to the start 

of work. 

• The intended measurements or data acquisition methods are appropriate for achieving 

task objectives; the assessment procedures are sufficient for confirming that data of 

the type and quality needed and expected are obtained; and that any limitations on the 

use of the data can be identified and documented. 

2.0 PURPOSE 

The QAPP describes the project-specific methods employed by the SC&A team to ensure 

achievement of quality goals whereby all work is done in accordance with the highest 

professional standards and in compliance with all applicable regulatory, contractual, and other 

requirements. In addition, all aspects of the project are controlled and documented in a 

transparent and systematic fashion so that the records can provide a clear picture of how a 

particular project deliverable was produced. 

3.0 SCOPE 

The provisions of the QAPP apply to all activities conducted under the SC&A contract (by 

SC&A and its subcontractors on the team) with the Advisory Board. These activities include, 

but are not limited to, site profile and dose reconstruction review, as well as review of 

procedures, plans, and documentation. The QAPP also governs documentation and filing of all 

work, and compliance with any confidentiality and security provisions on information that may 

be gathered, examined, or developed by project personnel. Furthermore, the QAPP outlines the 

process and organization by which the project is managed and controlled. 

4.0 ORGANIZATION 

Figure 1 illustrates the organizational structure of the project team, whose members are drawn 

from SC&A (the prime contractor) and its two primary subcontractors, Saliant, Inc., and the 

Radiation Safety Academy. The team is integrated so that the best qualified to perform a 

specific task is selected to do so. The Project Manager reports to the NIOSH Project 

Officer/Advisory Board Representative and has under him several task managers, the QA 

Manager, the Conflict of Interest Manager, and the Records Management Specialist. Other 

specialized workers from the project team staff the different tasks as required. Although not 

shown on the chart as part of the project organization, within SC&A, the Project Manager reports 

to the company’s Chief Operating Officer and has available a number of staff services. 
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Figure 1: Organizational Chart 

NIOSH Project Officer 

& 

Contracting Officer 

Records Management 

Specialist 

Project Manager 

Deputy PM 

Worker and Site Profile 

Review Managers 

Quality Assurance 

Manager/COI 

Plan Administrator 

Individual Dose 

Reconstruction Case 

Managers 

Specialized Project Staff 

5.0 QUALITY PROGRAM RESPONSIBILITIES 

President of SC&A: The President of SC&A, in consultation with the Project Manager, ensures 

that the project has adequate resources to fulfill its obligations under the contract in support of 

the Advisory Board. The President is also available as a liaison to the Advisory Board to discuss 

any concerns or issues that may arise during the project. 

SC&A Contract Manager: The SC&A Contract Manager ensures that the SC&A team meets all 

of its contractual obligations with respect to project control and reporting, and also oversees the 

subcontracts with the other companies on the SC&A team. 

Project Manager: The Project Manager directs work to accomplish the authorized tasks. The 

Project Manager obtains the necessary SC&A resources, assigns qualified task managers and 

other personnel from SC&A and its subcontractors to the various tasks, oversees their work to 

ensure fulfillment of all requirements and production of quality work products, sets and 

maintains schedules, prepares technical and cost proposals in response to task order request 

packages, and manages expenditures within budget. The Project Manager also coordinates with 

the other organizations in the team to ensure that they comply with all requirements, such as with 

the QAPP. In addition, the Project Manager serves as the principal liaison with the Advisory 

Board for non-contractual matters. 
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Deputy Project Manager: The Deputy Project Manager assists the Project Manager in all aspects 

of the project and will fulfill the project management responsibilities when the Project Manager 

is unavailable. On this project, the Deputy Project Manager also has task management 

responsibilities in the area of Site Profile Reviews. 

Quality Assurance Manager: The Quality Assurance (QA) Manager establishes, oversees the 

implementation of, and revises the project-specific Quality Assurance Project Plan as necessary. 

With the participation of the Project Manager, the QA Manager (1) establishes and implements 

quality policy, (2) develops quality-related procedures, processes, and guidelines, (3) ensures 

that the QAPP is understood and implemented by all project personnel, (4) assesses and 

documents the adequacy of quality systems by reviewing new and revised procedures and 

auditing work products (audit frequency is determined as appropriate to the work product, and 

review and audit findings are documented by memo to the Project Manager and placed in the QA 

files), and (5) determines any corrective actions required to improve quality on the project. 

The QA Manager ensures that all project personnel receive copies of, and are trained in, the 

QAPP and other applicable procedures and plans, and that records of such training are 

maintained in the project files. The QA Manager periodically conducts audits of the work 

products and processes of the SC&A team to verify that work is conducted and documented 

according to established procedures. The QA Manager reports to the Project Manager, but can 

bring any concerns related to the Quality Program directly to the President of SC&A, who is also 

the designated Corporate QA Manager. If any segment of the project is found to be severely 

deficient, the QA Manager documents the deficiency and notifies the Project Manager and 

associated Task Manager. Depending on the severity of the deficiency, the QA Manager may 

stop work until the cited deficiency is resolved. 

COI Plan Administrator: The COI Plan Administrator leads the effort to avoid any real or 

perceived conflict of interest between other work that team members may be doing or have done 

and the scope of work under this contract for the NIOSH Advisory Board. As set forth in greater 

detail in the Conflict of Interest (COI) Plan (discussed in Section 6.2), the COI Plan 

Administrator distributes and revises the COI Plan as required. 

Records Management Specialist: The Records Management Specialist is responsible for keeping 

important documents in the project files to provide a clear record of the process undertaken in 

each work task. As discussed in Section 8.0, records are controlled and kept in a secure location 

in accordance with SC&A practices. The Records Management Specialist receives and 

distributes documents at the direction of the project team. 

Individual Dose Reconstruction Case Managers: Case Managers and others who may report to 

them review individual dose reconstructions at different levels of detail depending on the 

requirements of a particular task order to ensure that all dose reconstructions are done in a fair 

and consistent manner, as described in regulatory and guidance documents. Dose 

reconstructions follow a project procedure, which is discussed in Section 6.3. Assignment of 

Case Managers to closely oversee the review process helps to ensure accountability and 

transparency for each case. 
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Worker and Site Profile Review Managers: Highly qualified individuals from the project team 

perform and lead worker and site profile reviews in which they review selected worker and site 

profiles from NIOSH’s database to ascertain the quality and completeness of the database and to 

support individual dose reconstructions. The review process is governed by a procedure outlined 

in Section 6.5. 

Specialized Project Staff: SC&A and its subcontractors maintain a pool of specialized staff to 

perform different tasks on the project. All individuals on the project review the QAPP (and its 

revisions) and acknowledge their understanding of its provisions to ensure their compliance with 

them via a QAPP Acknowledgment Form. Individuals performing specific tasks review the 

corresponding procedures and acknowledge their understanding of their provisions with an 

appropriate form. 

6.0 PLANS AND PROCEDURES 

Team members perform all work on the project according to approved procedures. Appropriate 

procedures are distributed to each individual working on a particular task, and he or she 

acknowledges receipt and understanding of the procedures by signing an acknowledgement form 

and returning it to the McLean office for inclusion in the project files. The project operates 

under the following plans and procedures; revisions of existing plans and procedures or creation 

of additional ones may occur during the project as conditions warrant. 

6.1 Quality Assurance Project Plan 

This QAPP governs all processes and tasks, and applies to all individuals working on the project. 

It is a high-level document that contains commitments and guidance related to maintaining and 

improving quality in all activities in accordance with the highest professional standards and 

applicable contractual and regulatory requirements. It also establishes training and recordkeeping procedures. 

6.2 Conflict of Interest Plan 

The COI Plan describes the methods employed by SC&A and its team members to detect, avoid, 

and mitigate any potential conflicts of interest on both a corporate and an individual level, 

whereby a company’s or an individual’s current or past work assignments may cause bias or the 

perception of possible bias when performing under this contract. 

6.3 SC&A Procedure to Perform QA Reviews of NIOSH/ORAU Dose Reconstruction 

Procedures 

This procedure specifies how the SC&A team evaluates the approach taken in the NIOSH and 

ORAU documents with respect to Quality Assurance/Quality Control (QA/QC) requirements 

appearing in regulatory and other documents and good practices for the nuclear industry in order 

to provide a high level of assurance that QA/QC requirements, issues, and concerns have been 
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adequately addressed. This procedure applies only to individuals performing QA/QC reviews of 

the NIOSH and ORAU documents. 

6.4 A Protocol for the Review of Procedures and Methods Employed by NIOSH for 

Dose Reconstruction 

This procedure provides a general outline and methodology for conducting independent and 

critical reviews of all relevant procedures identified by the Advisory Board and currently used by 

NIOSH/ORAU for dose reconstructions. The purpose of this procedural protocol is to provide a 

structured and systematic review process that, in broad terms, will (1) determine whether 

procedures are consistent with the philosophy, intent, and statutory directives cited in EEOICPA, 

and (2) determine the extent to which procedures are consistent and comply with the regulatory 

methods and guidelines provided in 42 CFR 82. This procedure applies only to individuals 

reviewing NIOSH dose reconstruction procedures and methods. 

6.5 Site Profile Review Procedure 

The NIOSH Site Profile database is designed to support the conduct of individual dose 

reconstructions by compiling data other than dosimetric information, such as that related to 

facility operations and processes over time; radiological source term characterization; chemical 

and physical forms of the radionuclides; historic workplace conditions and practices; and 

incidents and accidents involving potential exposures. The Site Profile Review Procedure 

provides the structure by which the SC&A team evaluates the approach taken in the NIOSH site 

profiles to gauge the adequacy, completeness, and validity of the information used to determine 

individual eligibility for compensation pursuant to the methods stipulated in 42 CFR 82, OCASIG-001, and OCAS-IG-002. This procedure applies only to individuals performing site profile 

reviews. 

6.6 Deliverables 

The following requirements apply to all deliverable under this contract: 

• All contract deliverables must be signed and dated by the author and assigned a 

revision number. 

• The task manager is required to check, sign, and date all contract deliverables. 

• If the task manager is the author of the deliverable, the Project Manager, or his 

designee, must check, sign, and date the deliverable. 

• The QA Manager must independently audit this process. 
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7.0 MANAGEMENT PROCESS 

The project is conducted in an organized fashion, governed by Standard Operating Plans – plans 

and procedures – to accomplish the tasks to produce a superior work product in accordance with 

contract, regulatory, and other applicable requirements. Sections 7.1 through 7.5 present the 

process that SC&A is implementing to ensure effective management of the contract Statement of 

Work (SOW) areas. 

7.1 Review and Distribution of Task Orders in a Timely Manner 

The contract calls for organizing the overall work by separately tracked, budgeted, and scheduled 

task orders, which are issued by the Advisory Board to the SC&A Project Manager in the form 

of individual Task Order Request Packages (TORPs). The following is accomplished within 

fourteen calendar days after receipt of a TORP: 

• When the Project Manager receives a TORP from the Project Officer, it is logged 

in, date stamped, assigned a Task Order Number, and placed into the dedicated 

project file, which is maintained in a secure location pursuant to SC&A’s records 

management procedure. 

• As a means of tracking performance of each case or task comprising the TORP, 

the TORP may be subdivided into individual cases and/or subtasks. 

• The Project Manger reviews the TORP with the Conflict of Interest (COI) Plan 

Administrator to ascertain whether there may be an actual or perceptual conflict 

of interest. The details of this assessment appear in the Conflict of Interest Plan 

outlined in Section 6.2 

• The Project Manager assesses the requirements of the TORP with other 

knowledgeable members of the team to determine how best to meet its 

requirements without adversely impacting the resources available for ongoing 

tasks. At this point in the process, the Project Manager, in consultation with the 

Deputy Project Manager, sorts the tasks into categories regarding scope and 

effort. 

• After the Project Manager has allocated resources, he selects the task or Case 

Managers, who perform or oversee the work contained in the TORP. 

• If necessary, the Project Manager, Deputy Project Manager, and task or Case 

Managers contact the Project Officer or his designee to clarify any issues that are 

unclear in the TORP and to gain a more complete understanding of the scope of 

work. After that interaction (which may be in person, by telephone, or by e-mail), 

the Project Manager, in consultation with the Deputy Project Manager and the 

designated task or Case Managers, commence preparation of the technical and 

cost proposal for the TORP. 
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7.2 Tracking Progress of Cases and Task Orders 

Once the Project Officer approves the TORP, the Contracting Officer issues a Task Order to the 

SC&A Contracts Manager. The Project Manager oversees the Task Order in accordance with 

established management, QA, procedure, and information system requirements. Technical and 

administrative communications are maintained within the SC&A team and with the Project 

Officer by the SC&A Project Manager, Deputy Project Manager, and/or task or Case Managers, 

under the cognizance and direction of the Project Manager. 

The level of effort for each participant on each task and case and on the overall Task Order is 

stated in the technical and cost proposal for the associated TORP, and each participant is 

informed of the scope of work and the estimated labor commitment made for his or her time. 

Each participant’s actual level of effort is monitored carefully each month through job-cost 

reports by the task or Case Manager and the Project Manager, who hold conferences to discuss 

issues, problems, and potential solutions related to the project. Such conferences are held at least 

weekly. 

SC&A uses its existing automated Project Management System (PMS) and Management 

Information System (MIS) programs to track and control the contract, which may involve 

multiple task orders and multiple cases and/or subtasks within each Task Order. 

7.3 Cost Projection Accuracy 

The SC&A project control system software produces monthly invoices, progress reports, 

projection reports, and deviation reports. This system allows tracking and controlling cost and 

schedule performance for individual task orders at the task, case, and subtask levels. The system 

is supported by input data from the SC&A accounting system. A separate database is used to 

track subcontractor hours and costs. 

At the time a task order is issued, SC&A assigns a job identifier to the project. If necessary, an 

identifier is assigned to each case and/or subtask within the task order. SC&A employee time 

sheets, Associate invoices, and subcontractor invoices are received and posted on a monthly 

basis. Individuals working on the project charge their time to the appropriate job identifiers. For 

quick-response task orders, charges are obtained by the task or Case Managers weekly or even 

daily, if required, for budget control. Project charges on time sheets and Associate invoices are 

certified by the individual and reviewed by the task or Case Managers, the Project Manager, and 

the accounting department. Other direct costs (ODCs) are checked for correct authorization and 

are processed in the same manner. Subcontractors follow similar procedures. 

This system of reporting and approving contract expenditures is used to produce a Cost 

Management Report for comparison to the Cost Plan. The Cost Management Report is used for 

project management and control to determine accrued costs for the current reporting period, to 

forecast costs for subsequent reporting periods, and to project total costs for project completion. 
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The Cost Plan provides a baseline for measuring cost variance on a contract and basic 

information for projecting costs and re-budgeting, if necessary. It also addresses each specific 

task order, case, subtask, project phase, or any other work elements required by the contract. 

The Project Manager checks the actual and projected costs against the Cost Plan to ensure that 

the work is proceeding within budget. Weekly informal review meetings (by telephone, if 

necessary) are held among the Project Manager, Deputy Project Manager, the task or Case 

Managers, and technical staff to discuss technical progress, expenditure rates, and schedule 

progress in order to keep these three aspects of the project in balance. Potential problem areas 

are identified so that they can be dealt with at the earliest possible stage to minimize their impact 

on the project. At least one of the weekly meetings each month includes a formal review of 

progress and budget. 

Under either the accounting system or the MIS, SC&A can provide the Project Officer or 

Contracting Officer with any kind of ad hoc report or cost projection that they might request. 

Although the complete range of such requests may vary, listed below are some of the ad hoc 

reports that may be produced: 

• Estimates of costs and hours to complete 

• Reconciliation of booked versus billed costs for the contract as a whole or for a 

specific task order 

• Schedules of ODCs by cost element 

• Labor costs and ODCs by cost element for specific subcontractors under specific 

task orders, cases, or subtasks 

• List of task orders with ODCs greater than a specified percentage of the total 

estimated cost 

Finally, SC&A has in place an approved Government Property Control System, which governs 

the management of any government-furnished property under this contract. 

7.4 Subcontractor Management 

As the prime contractor, SC&A is responsible for overall project management. In the case of 

task orders with substantial subcontractor participation, SC&A exercises rigorous oversight of 

subcontractor work, closely monitoring costs, schedules, and deliverables. 

SC&A has in place a subcontract with each subcontractor. The subcontracts contain SC&A’s 

standard terms and conditions and any particular clauses required by SC&A’s contract with the 

Centers for Disease Control and Prevention. SC&A’s Contract Manager, in consultation with 

the Project Manager, is responsible for ensuring that the subcontractors follow contract 

requirements. The Project Manager regularly interfaces with the subcontractor Project 

Managers, who assume dual roles ― as subcontractor point-of-contact, responsible for 

subcontractor performance in completing work assignments under the contract, and as technical 

performers on work assignments. 
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For work requiring a specialty niche contractor not already on the team, SC&A searches for the 

capabilities required and solicits proposals from qualified firms. A sole-source award is made if 

the requirement is not excessively large and it is clear that, by virtue of location and capabilities, 

a particular offeror is eminently qualified to perform the work. In this case, a cost proposal is 

solicited from the offeror and a subcontract negotiated and submitted to the Contracting Officer 

for approval (if a fixed price, level-of-effort (LOE) subcontract under $25,000 is negotiated, 

consent is not required from the Contracting Officer). If a sole-source award is not appropriate, a 

competition of a few (probably three) firms is held over a short time period. Proposals are 

evaluated and a subcontract awarded to the firm that offers the most advantageous proposal to 

the government, considering both technical and cost factors. If consent is required, the 

subcontract is submitted to the Contracting Officer prior to its execution by SC&A. 

7.5 Problem Resolution 

SC&A prepares a work plan for every Task Order received from NIOSH. This practice allows 

early identification during the proposal preparation process of potential problems or schedule 

slippages that may arise from each task order and formulation of remedial actions, if needed. 

Close communication among the Project Manager, Deputy Project Manager, and task or Case 

Managers should identify and resolve potential problems early in a task. In addition, the Project 

Manager keeps the Project Officer informed of potential problems and remedial actions taken to 

mitigate the severity of their impact on the project. When a schedule delay is unavoidable, the 

Project Manager works with the Project Officer and Contracting Officer to minimize the impact 

of the delay on the overall project goals. In addition, should a concern arise that a change may 

be needed in task or program direction, the Case Manager immediately informs the Project 

Manager and Deputy Project Manager, who then consult with the Project Officer and 

Contracting Officer. SC&A either continues work or stops work while the issue is being 

resolved. 

8.0 DOCUMENTATION 

Document control is an important aspect of maintaining quality on the project. Documents are 

created, reviewed, approved, distributed, acknowledged, used, revised, and filed in an organized 

fashion according to SC&A standard practices. Specifically, with reference to this plan, the 

QAPP and the QAPP Acknowledgment Forms, signed by the project members, are maintained in 

a secure file at the SC&A Headquarters in McLean, Virginia, under the direction of the Quality 

Assurance Manager, and are available at any time during normal business hours for review by 

the Advisory Board, the Contracting Officer, or their designee. The QAPP is reviewed annually 

for applicability and completeness, and changes are made as necessary and submitted to the 

Project Officer for approval. 

9.0 QAPP TRAINING 

The QA Manager supervises training of each individual working on the contract in the basic 

principles of a quality program upon inception of his or her involvement in the contract and 

retraining thereafter whenever the QAPP is revised. The QA Manager distributes a copy of this 
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QAPP, along with the QAPP Acknowledgement Form, which each team member fills out, signs, 

and returns to project files. The individual certifies on the QAPP Acknowledgement Form that 

he or she understands the provisions of the QAPP and his or her specific responsibilities. This 

process constitutes documentation of QAPP training. 

10.0 CONFIDENTIALITY AND SECURITY OF INFORMATION 

SC&A recognizes the importance of protecting personal, proprietary, and other sensitive 

information to which it may have access under this contract. SC&A has reviewed the provisions 

contained in HHSAR 352.224-70, Confidentiality of Information; FAR 52.224-1, Privacy Act 

Notification; FAR 52.224-2, Privacy Act; and FAR 52.239-1, Privacy or Security Safeguards, 

and is committed to fully complying with all the requirements contained in these documents. All 

obligations with respect to confidentiality and security of information flow down to 

subcontractors at any tier. 

10.1 Privacy Act 

SC&A, its team members, and individuals working on this contract with access to data protected 

by the Privacy Act are aware of and comply with restrictions on disclosure of records maintained 

on individuals and the conditions that must be met in order for disclosure to be permissible under 

the Privacy Act, Section 552a(b)(1)-(12). 

10.2 Confidentiality of Information 

In addition to the requirements of the Privacy Act, the SC&A project team is subject to 

compliance with the provisions of HHSAR 352.224-70. The team obtains written consent from 

any affected individual, institution, or organization prior to disclosing confidential/proprietary 

information or data about that individual, institution, or organization. The team provides the 

Contracting Officer with at least 45 days advance notice in the event that it intends to release 

findings of studies or research that may have adverse effects on the agency. Finally, if the team 

is unsure of the proper handling of material or information under this contract, or if the material 

in question is subject to the Privacy Act or is considered confidential under HHSAR 352.224-70, 

the team contacts the Contracting Officer in writing and obtains a written determination from 

him or her prior to releasing, disclosing, disseminating, or publishing such information or 

material. 

10.3 Security Safeguards 

The SC&A project team does not publish or disclose any safeguards it develops or implements 

under this contract without the prior written consent of the Contracting Officer. Furthermore, the 

team commits to cooperate fully with the government should it be necessary to carry out a 

program of inspection to safeguard against threats and hazards to the security, integrity, and 

confidentiality of government data; SC&A will provide the government reasonable access to its 

facilities, installations, technical capabilities, operations, documentation, records, and databases 

upon request. 
Effective Date: Revision No. Document No. Page No. 

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11.0 REFERENCES 

The following documents constitute the statutory and regulatory bases for the Energy Employees 

Occupational Illness Compensation Program Act (EEOICPA) of 2000, or provide applicable 

QA/QC program information, and have been examined for guidance in designing the Quality 

Assurance Project Plan. The SC&A corporate Quality Management Plan (QMP) was also 

consulted in formulating the QAPP. Outside agency documents, such as the U.S. Department of 

Energy (DOE) “Quality Assurance” order (referenced below), are applied as applicable to the 

NIOSH project using (in the language of the DOE document) “a graded approach”: 

• “Energy Employees Occupational Illness Compensation Program Act of 2000, as 

Amended,” 42 U.S.C. §7384 et seq., October 30, 2000 (Pub. L. 106-398, XXXVI, §3661, 

“The Act”). 

• Executive Order 13179, “Providing Compensation to America’s Nuclear Weapons 

Workers,” Federal Register, Vol. 65, No. 238, December 11, 2000. 

• 42 CFR Part 81, “Guidelines for Determining the Probability of Causation Under the 

Energy Employees Occupational Illness Compensation Program Act of 2000; Final 

Rule,” May 2, 2002. 

• 42 CFR Part 82, “Methods for Radiation Dose Reconstruction Under the Energy 

Employees Occupational Illness Compensation Program Act of 2000; Final Rule,” May 

2, 2002. 

• 42 CFR Part 83, “Procedures for Designating Classes of Employees as Members of the 

Special Exposure Cohort Under the Energy Employees Occupational Illness 

Compensation Program Act of 2000; Final Rule,” May 28, 2004. 

• DOE Order 414.1A, “Quality Assurance,” Chg. 1, July 12, 2001. 

• ORAU contract with Centers for Disease Control (CDC), No. 200-2002-00593. 

• “Quality Assurance Program Plan,” ORAUT-PLAN-0001, Rev. 0, January 30, 2003. 

• “Document Program,” ORAUT-PROC-0001, Rev. 1, October 6, 2003. 

• SC&A, Inc., “Quality Management Plan,” January 2003. 
 

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10/01/2004 0 SCA-PLAN-0001 15 of 15 

EXHIBIT A: QUALITY ASSURANCE PROJECT PLAN 

ACKNOWLEDGMENT FORM 

QUALITY ASSURANCE PROJECT PLAN 

ACKNOWLEDGMENT FORM 

UNDER 

CDC CONTRACT NO. 200-2004-03805 

Plan Name: Quality Assurance Project Plan 

Document No.: SCA-PLAN-0001 

Plan Version: (to be filled in when the Plan is distributed) 

Plan Date: (to be filled in when the Plan is distributed) 

I have read the Quality Assurance Project Plan referenced above and certify that I understand the 

general definition and goal of quality on the project, as well as specific provisions that may apply 

to aspects of the work that I may perform. 

Individual Name 

Signature 

Date 

Company Name