Dose Reconstruction and Related Activities for Energy Employees Occupational Illness Compensation Program Act (EEOICPA)
"Dose Reconstruction and Related Activities for Energy Employees Occupational Illness Compensation Program Act (EEOICPA)."
The Centers for Disease Control and Prevention (CDC), National Institute of Occupational Safety and Health (NIOSH), Cincinnati, OH has a requirement for a base year, plus four (4) option years, Cost Plus Award Fee, Performance Based contract for "Dose Reconstruction and Related Activities for Energy Employees Occupational Illness Compensation Program Act (EEOICPA)."
The objective of this acquisition is to allow National Institute for Occupational Safety and Health (NIOSH), through its Division of Compensation Analysis and Support (DCAS), to fulfill its obligations under the Energy Employees Occupational Illness Compensation Act (EEOICPA), performing dose reconstructions for claims referred by DOL (Department of Labor) and evaluating petitions for additions of classes to the SEC (Special Exposure Cohort). More specifically, the objectives are to obtain assistance in performing the following activities:
• Identify data relevant to reconstructing radiation doses and evaluating SEC petitions
• Claimant Communications
• Dose estimation and reporting
• Prepare Special Exposure Cohort petition evaluations
• Technical and program management support
2. References.
Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), Radiation Dose Reconstruction website: http://www.cdc.gov/niosh/OCAS/ocasppg.html
The Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA or The Act), as Amended, established a compensation program for the civilian men and women who, over the past 50 years, have performed duties uniquely related to the nuclear weapons production and testing programs of the Department of Energy (DOE) and its predecessor agencies. http://www.cdc.gov/niosh/OCAS/pdfs/theact/eeoicpaall.pdf
The Act (42 U.S.C. 7384 et seq.) was originally passed on October 30, 2000, and became effective on July 31, 2001. The National Defense Authorization Act for Fiscal Year 2002 (Public Law 107-107; Section 3151(b)) and the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 (Public Law 108-375; Section 3161) made several amendments to The Act.
Other references can be located on the Web such as:
42 CFR 81 (http://www.cdc.gov/niosh/OCAS/pdfs/42cfr81/frcll020612.pdf),
42 CFR 82 (http://www.cdc.gov/niosh/OCAS/pdfs/42cfr82/42cfr82.pdf), and
42 CFR 83 (http://www.cdc.gov/niosh/OCAS/pdfs/42cfr83/42cfr83b.pdf).
DRAFT PERFORMANCE WORK STATEMENT
The support services that the dose reconstruction contractor will be expected to provide are listed below. It is expected that this level of support will be required during the base year and during each option year. While the number of cases to be processed on an annual basis is subject to fluctuation, offerors should prepare their proposals assuming that 3,120 dose reconstructions will be required each year (60 per week for 52 weeks). Additionally, the contractor will be required to review previously completed dose reconstruction reports to determine if changes made in methodology or new data affects the outcome of the case. These reviews do not require a fully documented dose reconstruction unless the claim's compensability decision is likely to switch from non-compensable to compensable. It should be assumed that a weekly average of approximately 25 such evaluations need to be completed. It should be understood that this is not a guarantee of this level of effort, but a target value that will facilitate comparison of proposals. Offerors should assume that, for each year of the contract, 5 SEC petitions will be filed, and claims will be received from 5 sites with no claims previously submitted. Site research will be required for those situations. Technical approaches and some calculational tools from sites that have been researched prior to this award will be made available to the successful offeror by NIOSH.
All documents that describe radiation exposures, radiological operations, radiological conditions, and other information useful to performing dose reconstruction, evaluating SEC petitions, or performing other functions of the project will be stored in the Site Research Database (SRD). The SRD contains documents that relate to U.S. DOE and AWE sites. These documents can include, but are not limited to, general overview documents, publications for a site that describe a particular process or operation, or reports from a site addressing particular issues such as specific contaminants to which some workers might have been exposed. Project personnel populate and use the database to develop and write a wide variety of technical documents, as well as to perform dose reconstructions.
Information relevant to individual claims will be stored in the NIOSH OCAS Claims Tracking System (NOCTS). NOCTS was developed to track the claims made under EEOICPA. The NOCTS application tracks claimant data and documents, and is thus a central repository for all information related to each claim. The web-based interface allows the application to be accessed by any computer equipped with Internet connection and browser software. The primary goal of NOCTS is to facilitate the processing of claims in an efficient and accurate manner. The application also provides an instrument for effective and timely communications with claimants during this process. Another goal is to establish and maintain interagency communications among all the parties involved in the claims process.
1.0 Identify data relevant to reconstructing radiation doses and evaluating SEC petitions
1.1 Data collection related to claims and petitions: The contractor will collect all known sources of recorded dosimetry, radiation data, and relevant information applicable to completing dose reconstructions for individual claimants and evaluating SEC petitions for classes of employees. This task will include the following:
1.1.1 NIOSH will request from DOE and provide to the contractor individual exposure information for claimants. In coordination with NIOSH and with the cooperation of DOE, the contractor will request from DOE (as necessary) and other entities supplemental information applicable to individual claims or petitions to supplement any such information in the NIOSH claims database. The collection of this information will be conducted under a Memorandum of Understanding that has been established between HHS and DOE (http://www.cdc.gov/niosh/OCAS/ocasdoe.html#mou or
http://www.cdc.gov/niosh/OCAS/pdfs/misc/moudoe.pdf).
1.1.2 The contractor will synthesize information related to dose reconstruction feasibility into Professional Judgment Papers and Petition Evaluation Reports, providing the basis for the feasibility or infeasibility of reconstructing radiation dose. Professional Judgment Papers evaluate the bases provided with the SEC petition to determine if they meet the criteria in 42 CFR 83 for a valid petition, i.e. to determine if the petition qualifies. Petition Evaluation Reports are prepared once petitions are qualified and they evaluate the existing information to determine if it is sufficient to perform dose reconstructions for the proposed class. Additional information about the SEC process and examples of Petition Evaluation Reports can be found at http://www.cdc.gov/niosh/ocas/ocassec.html.
1.1.3 The contractor will maintain a local office in Cincinnati, Ohio to abstract, enter, or migrate necessary information from DOE and other records into the Site Research Database or NIOSH OCAS Claims Tracking System for use in dose reconstructions or other purposes.
1.1.4 The contractor will monitor the completeness and timeliness of record/information acquisition from DOE and other sources, inform NIOSH, on a monthly basis, of delays, their causes, and involve NIOSH as necessary to obtain their timely resolution.
1.2 Dose reconstruction research: The contractor will research the conditions, processes, practices, and incidents at DOE and AWE facilities relevant to conducting dose reconstructions. This task will include the following:
1.2.1 The contractor will review and analyze records from DOE and AWEs, which will be useful to interpret recorded dosimetry information, to evaluate the adequacy and completeness of dosimetry information, and to substitute for unavailable or incomplete dosimetry information. Plans for site visits and the research to be performed during a site visit must be approved by NIOSH. It is likely that 50 site data capture visits may be required each year.
1.2.2 With the cooperation of DOE and assistance of worker representatives and others, the contractor will identify and interview current and former DOE/AWE facility line managers, radiation protection personnel, individual workers, and others as appropriate, and analyze the results of these interviews to interpret recorded dosimetry information, to evaluate the adequacy and completeness of dosimetry information, and to substitute for unavailable or incomplete dosimetry information. The extent of these efforts shall be coordinated with and approved by NIOSH prior to initiation of contact with DOE or DOE contractor personnel.
1.2.3 As agreed upon between NIOSH and the contractor, the contractor will develop statistical procedures and assumptions based on dose reconstruction research that can be applied in multiple dose reconstructions, including but not limited to dose reconstructions for employees in specific jobs, performing specific tasks, employed in specific facilities or sites, and related to specific time periods of employment. These statistical procedures will include methods to estimate the uncertainty distributions surrounding internal and external dose reconstructions on a facility specific and time-dependent basis. NIOSH will review and approve such procedures and assumptions. Technical information bulletins ORAUT-OTIB-0019 Rev-01, "Analysis of Coworker Bioassay Data for Internal Dose Assignment," and ORAUT-OTIB--0020 Re-03, "Use of Coworker Dosimetry Date for External Dose Assignment," describe these techniques (https://www.cdc.gov/niosh/OCAS/tibsnum.html).
1.2.4 The contractor will produce and submit to NIOSH reports summarizing methods, data sources, and findings of research on facilities on a schedule specified by NIOSH as the need for the report is identified.
1.2.5 The contractor will research and analyze information pertaining to sites, claims, and dose reconstruction processes in response to questions and technical issues raised about the EEOICPA program by the Advisory Board on Radiation and Worker Health. Results of these efforts will be provided as scheduled by NIOSH.
2.0 Claimant Communications
2.1 As directed under 42 CFR 82 and consistent with NIOSH technical guides and procedures, conduct, record, transmit to NIOSH, and report to claimants the results of computer assisted telephone interviews (CATIs) with claimants and, as appropriate, with co-workers and other potential witnesses. Three scripts that cover interviews with claimants who are covered employees, survivors, or co-workers have been prepared. They are provided in Attachment C. Since these scripts have been reviewed and approved by the Office of Management and Budget (OMB) under the requirements of the Paperwork Reduction Act of 1995, any substantive changes will require approval by OMB. NIOSH will provide a usable computerized version of these scripts. The contractor may, however, with review and approval from NIOSH, convert these scripts to a computer program that facilitates more efficient data storage and retrieval.
2.2 The contractor will produce and provide for review by the claimant/interviewee reports of interviews, and enter final reports and their elements as a case file into the claims database no less frequently than weekly.
2.3 The contractor will obtain and enter into the claimant interview case file and research database additional information as may be provided by the claimant in writing to supplement the claim record.
2.4 The contractor will conduct close-out interviews with claimants once they have received their draft dose reconstruction reports in order to answer questions about the dose reconstruction and to explain the next steps in the claim process.
2.5 Although not part of the interview process, the contractor must provide a toll free telephone line to address claimants' questions within 30 days of award. This will be in addition to the claimant telephone support service that NIOSH is currently offering.
2.6 The contractor will correspond with claimants informing them that their dose reconstruction has been scheduled once all the information necessary to perform the dose reconstruction has been received, but not before.
2.7 The contractor will designate a point of contact within its organization who is responsible for resolving issues and answering questions from communications with claimants by either NIOSH or the contractor. This point of contact shall have the organizational authority necessary to resolve issues between sub-organizations within the contractor's organization in order to provide resolutions and answers.
2.8 When the contractor receives information from a claimant that affects the normal progress of the claim (e.g., identifies an additional cancer not listed on the claim, provides information that affects the draft dose reconstruction, etc.) the contractor shall notify NIOSH's Claimant Information and Communication Team of the reason for the interruption in claim progress. Information of this nature that is received by NIOSH will be communicated promptly to the contractor. In all cases the contractor will communicate the resolution to the claimant.
2.9 Contractor shall provide CATI and close out interview for every claimant for whom a dose reconstruction is performed unless claimant declines to participate. Some claims have multiple claimants, so the number of claimants is larger than the number of dose reconstructions that must be completed. Contractor should plan to complete 1.5 CATIs and close out interviews per dose reconstruction, or 96 CATIs and close out interviews per week.
3.0 Dose Estimation and reporting
3.1 As directed under 42 CFR Part 82 and consistent with NIOSH Implementation Guides for Internal and External Dose Reconstruction (located at https://www.cdc.gov/niosh/ocas/drmethods.html ), and technical information bulletins and procedures (http://www.cdc.gov/niosh/OCAS/ocastbds.html ,
http://www.cdc.gov/niosh/OCAS/ocasppg.html ), the contractor will produce and report timely dose estimates, supporting methodology, and factual basis for each claim received by NIOSH from DOL under EEOICPA and for claims requiring re-work because of changes in claim information or changes in dose reconstruction policy (estimated at 3000 dose reconstructions and re-works annually).
3.2 The contractor will collect and analyze all available information relevant to dose estimation/reconstruction for each individual claim and produce and transmit to NIOSH a draft report providing dose estimates, methods, and the factual basis upon which the doses were estimated, including a narrative explanation of this information understandable by claimants with a high school education. An example dose reconstruction report will be included as an attachment under Section J.
3.2.1 Internal and external radiation dose estimates will be calculated for each organ that the claimant presents with a primary cancer. The annual dose to each organ will be calculated from the time of first exposure at a covered facility to the date of cancer diagnosis. As appropriate, a separate dose will be computed for each type of radiation exposure received by the individual, using the exposure types provide for in the NIOSH-Interactive Radio Epidemiological Program (IREP) program. These doses will be reported as equivalent dose using the weighting factors provided in the NIOSH technical guides. As part of NIOSH's ongoing Quality Assurance (QA) program, the contractor may be provided blind test claims on a periodic basis.
3.2.2 Internal dose calculations will be performed using standard metabolic models published by the International Commission on Radiological Protection (ICRP). These calculations will be performed using a NIOSH supplied computer program entitled Integrated Module for Bioassay Analysis (IMBA) or other NIOSH approved programs. IMBA was specially created for NIOSH to perform internal dose calculations using the most recent physiologically based biokinetic models such as those contained in ICRP publications 56, 67, and 69. Inhalation intakes will be evaluated using the respiratory tract model contained in ICRP publication 66. The contractor will not have access to the source code. Any contractor developed software used for calculating internal dose must be approved by NIOSH prior to its use in dose reconstructions and NIOSH must have access to the program and source code. Any contractor purchased software used for calculating internal dose must be approved by NIOSH prior to its use in dose reconstructions.
Within 30 days of award, NIOSH will provide training on the IMBA software for key contractor personnel who are not familiar with the software. Within 30 days after receiving training from NIOSH, the contractor will be responsible for providing and documenting training to members of its technical team who will be involved in conducting dose reconstructions and are not already familiar with the software.
3.2.3 Estimates of missed dose, due to technical limitations in monitoring technology, will be evaluated and included in the energy employee's dose reconstruction for both internal and external sources of exposure. In addition, any exposure to diagnostic x rays that were required as a condition of employment and that were performed at an EEOICPA-covered facility will be estimated and included in the energy employee's total organ dose.
3.3 The contractor will review with NIOSH and revise dose reconstructions, as necessary, subject to NIOSH oversight of the dose reconstruction program.
3.4 The contractor will develop statistical procedures and assumptions that may have application for multiple dose reconstructions, including but not limited to dose reconstructions for employees in specific jobs, performing specific tasks, employed in specific facilities or sites, and related to specific time periods of employment. NIOSH will review and approve these procedures and assumptions before they are used to complete dose reconstructions.
4.0 Prepare Special Exposure Cohort petition evaluations
4.1 In accordance with 42 CFR 83 and procedure OCAS-PR-004, "Internal Procedures for the Evaluation of Special Exposure Cohort Petitions,"
(http://www.cdc.gov/niosh/ocas/secmisc.html) the contractor will process and evaluate petitions received from individuals for the addition of classes to the SEC, and will initiate the addition of classes when there is not adequate information to reconstruct radiation doses with sufficient accuracy.
4.2 The contractor will process and evaluate petitions received from individuals for additions of classes to the SEC (the 83.13 process).
4.2.1 With the approval of NIOSH, the contractor will communicate with the petition submitter as necessary in order to obtain the information required in 42 CFR 83 for a petition. Some petitions may be sufficient upon initial receipt, but NIOSH expects that every petition will require communication of this type to obtain information required by 42 CFR 83.
4.2.2 The contractor will determine whether the information ultimately submitted with a petition meets the requirements in 42 CFR 83 and therefore qualifies for evaluation. Contractor will document the basis for this determination in a professional judgment and submit it to NIOSH.
4.2.3 For petitions that qualify for evaluation, the contractor shall provide a list of the types of apparent data deficiencies that could potentially make dose reconstructions infeasible, along with the research efforts that the contractor will pursue to remedy each apparent data deficiency, and shall submit the list to NIOSH for review and approval. The schedule for delivering the list will be established by NIOSH upon qualification of a petition, depending on the complexity of the petition.
4.2.4 For petitions that qualify for evaluation, provide a draft professional judgment that includes a preliminary qualification determination based on the petition and supporting documentation received. NIOSH recognizes this may have to be revised based on the petitioner's response.
4.2.5 The contractor shall research information relevant to the feasibility of the dose reconstruction for members of the class; reach determinations about the feasibility of reconstructing doses for members of the class and the potential that members of the class were harmed by their exposure; document those determinations in a petition evaluation report; and submit the petition evaluation report to NIOSH for review and approval. The petition evaluation report must be completed and approved by NIOSH within 180 days from the date the petition was originally submitted to NIOSH, not counting days when NIOSH and the contractor are awaiting additional information from the submitter in order to fulfill the petition qualification requirements of 42 CFR 83.
4.2.6 The contractor will provide additional research and revision to petition evaluation reports to respond to questions raised by the Advisory Board on Radiation and Worker Health ("the Board"). NIOSH anticipates that every petition evaluation report will prompt questions from the Board. Such questions have required detailed follow-up analysis of complex issues such as monitoring program adequacy, technical performance of internal and external dosimetry systems, and characterization of the radiation fields present at sites being evaluated.
4.3 The contractor will identify classes of workers for whom there is inadequate information to perform dose reconstruction with sufficient accuracy, and initiate adding those classes to the SEC (the 83.14 process).
4.3.1 The contractor will identify potential classes for whom dose reconstruction is not feasible, and will document the basis for that determination. Classes may comprise any portion of the employees at a covered facility and any portion of the duration of the covered period. The class definition and basis for finding it infeasible to reconstruct radiation doses will be submitted to NIOSH for review and approval.
4.3.2 The contractor will propose a representative claimant from each 83.14 class for NIOSH approval. Upon NIOSH approval of a representative claimant, contractor will prepare communications to that claimant about the infeasibility of dose reconstruction and the 83.14 SEC process.
4.3.3 The contractor will prepare a petition evaluation report that documents the basis for finding dose reconstruction infeasible for members of the class and submit the petition evaluation report to NIOSH for review and approval.
4.3.4 The contractor will provide additional research and revision to petition evaluation reports to respond to questions raised by the Advisory Board on Radiation and Worker Health. NIOSH expects that every petition evaluation report will prompt questions from the Board.
4.4 The contractor will produce Basis of Decision documents when petitioners request an Administrative Review of SEC petitions that have completed the review cycle. These documents will detail the processes and evidence used in making key decisions in defining or declining addition of a SEC class.
5.0 Technical and program management support
5.1 Technical support: Provide information and analyses to NIOSH to review individual dose reconstructions, dose reconstruction procedures and practices, or SEC petition evaluations, or to respond to requests by DOL, the Advisory Board on Radiation and Worker Health, Congress, or other stakeholders, and to support NIOSH management in the dose reconstruction and SEC petition evaluation program. This task will include the following:
5.1.1 The contractor will prepare and provide analyses, information and reports to NIOSH in response to reviews of individual dose reconstructions requested by DOL in the adjudication of claims. NIOSH expects four of these requests per year.
5.1.2 The contractor will prepare and provide analyses, information, and reports to NIOSH in response to reviews of dose reconstructions, dose reconstruction procedures, technical documents such as technical information bulletins or technical basis documents, or SEC petition evaluations under EEOICPA by the Advisory Board and other external organizations that may conduct scientific or technical reviews, such as the National Academy of Sciences and the Government Accountability Office. NIOSH expects that the Advisory Board will review and comment on 60 dose reconstruction reports, 8 technical basis documents, and 15 procedures and technical information bulletins (combined) each year. Total requests from other bodies is expected to be four per year.
5.1.3 The contractor will prepare and provide analyses, information, and reports to NIOSH in support of Congressional briefings and in response to Congressional inquiries. NIOSH expects to request contractor assistance for responding to one Congressional inquiry per week and six briefings per year. Inquiries address individual cases, while briefings address program status and site specific information for a single or few sites (e.g., those from a single state).
5.1.4 Within 30 days of award, the contractor will establish practices for using the NIOSH OCAS Claims Tracking System (NOCTS). Any supplementary tracking system established by the contractor must be compatible with and provide current information to NOCTS to support reporting of dose reconstruction process status to claimants.
5.1.5 The contractor will provide records to NIOSH such that NIOSH can comply with requests for records under the Freedom of Information Act and Privacy Act. NIOSH expects to request contractor assistance in approximately twelve such requests per year.
5.2 Program management support: The contractor shall provide comprehensive program management support to NIOSH. This task will include the following:
5.2.1 Within 60 days of award, the contractor will develop and implement a written project management plan and submit it to NIOSH for review and approval. The project management plan will define the organizational structure, management approach, requirements, and tools for planning, implementing, and monitoring work practices which will be used to complete radiation dose reconstructions and to evaluate submissions and petitions for the addition of classes to the SEC.
5.2.2 Within 90 days of award, the contractor will develop, implement and maintain a written quality assurance program for the overall project. The quality assurance program documentation will describe the organizational structure, functional responsibilities, levels of authority, and interfaces for those personnel managing, performing, and assessing the adequacy of work performed as part of this contract.
5.2.3 Within 90 days of award, the contractor will develop and enact procedures for implementing "NIOSH Policy on the Appearance of Bias for the EEOICPA Program & General Conflict of Interest Requirements,"(http://www.cdc.gov/niosh/OCAS/ocascobs.html or
https://www.cdc.gov/niosh/ocas/pdfs/dr/cobpolicy-r3.pdf ). Copies of those procedures will be provided to NIOSH at that time.
5.2.4 The contractor will prepare and submit to NIOSH monthly performance reports and quarterly cost reports covering all tasks under this contract. The monthly performance report shall include but need not be limited to: the number of dose reconstruction reports submitted to NIOSH for approval; a list of the procedures, technical information bulletins, technical basis documents, or other documents submitted to NIOSH for approval; A list of SEC professional judgment papers and petition evaluation reports submitted to NIOSH for approval; any other products delivered; a status report of information gathering efforts (those completed, underway, and planned), to include document capture efforts, site visits, worker and site expert interviews; a description of issues that must be addressed in order to complete required activities; and a description of the work accomplished and work in progress under the contract.
5.2.5 The contractor will participate in person or by teleconference in project status meetings with DCAS and other topical meetings convened by DCAS. Project status meetings will be scheduled at mutually agreeable times but will be no less frequent than bi-monthly. Status updates to individual line items on the master project plan will be provided weekly for active tasks.
5.2.6 The contractor will conduct semiannual program reviews and provide the results of these reviews to NIOSH.
6.0 EEOICPA Performance Objectives
Performance objectives will be used to measure contractor performance for work performed under this contract in accordance with the PWS and the Performance Based Award Fee Plan found under attachments in Section J. The Performance Based Award Fee Plan may cover a specific period and may also be subject to revision as the performance needs under this contract change.
Performance Objective Performance Threshold Surveillance Method
Completion and Submission of Dose Reconstruction Reports Dose Reconstruction Reports that are accurate and complete so that they are approved by DCAS without the need for revision or without comment 95% of the time. 100% inspection
Submit First Draft of the text for consultation phone call, or DOL employment/survivor verification request for SEC process. Within 10 working days of receipt of Form B SEC submission, 90% of the time. 100% inspection
Schedule of initial consultation phone call for a Form B SEC submission Within 10 working days of receipt of approval by DCAS of the consultation phone call text, 90% of the time. 100% inspection
Submit draft professional judgment of SEC. Within 20 working day from the receipt of a SEC petition, 90% of the time. 100% inspection
Submit detailed evaluation plan in an SEC production Gantt chart. Within 10 working days of from the qualification of a petition, 90% of the time. 100% inspection
Submit high quality draft SEC petition evaluation report and completed evaluation issues matrix. In accordance with SEC petition Gantt chart, 90% of the time. 100% inspection
7.0 Reporting Schedule
Contractor shall provide monthly performance reports to NIOSH covering all tasks under this contract. The monthly performance report shall include but need not be limited to: the number of dose reconstruction reports submitted to NIOSH for approval; a list of the procedures, technical information bulletins, technical basis documents, or other documents submitted to NIOSH for approval; A list of SEC professional judgment papers and petition evaluation reports submitted to NIOSH for approval; any other products delivered; a status report of information gathering efforts (those completed, underway, and planned), to include document capture efforts, site visits, worker and site expert interviews; a description of issues that must be addressed in order to complete required activities; and a description of the work accomplished and work in progress under the contract.
Contractor shall provide either with the monthly invoice or within a week of submitting the invoice a Monthly Financial Report breaking out costs by budget category for each Work Breakdown Structure element (e.g., for each task) listing costs by reporting period and cumulatively for the contract.
8.0 Special Considerations
Much of the information obtained and generated during this project is protected by the Privacy Act. All personnel on the project with access to such information must receive Privacy Act training before being allowed access to such information. The Privacy Act training shall include the information described in corresonding attachments in Section J.
All work and work assignments on the project must conform to NIOSH's Conflict of Interest Policy.
On occasion the contractor's work will influence, and will be influenced by, the work of other NIOSH contractors. This will be particularly true regarding the technical support contractor for the Advisory Board on Radiation and Worker Health (ABRWH). Interaction with other NIOSH contractors should occur in the presence of NIOSH unless NIOSH specifically authorizes the separate contact.
The contractor must demonstrate its ability to comply with all HHS and CDC IT security policies. The contractor must provide among its staff a reasonable number of individuals with the proper level of Department of Energy (DOE) security clearances ("Q clearances") to complete the work envisioned under this contract. All contractor staff must comply with applicable HHS and CDC policies for safeguarding information retrieved from HHS, DOE, and other government and non-government information, including any NIOSH Security Plan with DOE that may be implemented.
9.0 Government Furnished Property
The Government will furnish office furniture, computer servers, personal computers, and accessories, which are currently located at 4850 Smith Road, Suite 200, Cincinnati, Ohio. An inventory of the servers and summary of the personal computers that will be available is included under Attachments in Section J. However, the personal computers will be at or near their expected replacement time at the start of this contract, so the contractor should anticipate procuring replacement items during this contract.
10.0 Section 508
HHSAR Provision, 352.239-73: Electronic and Information Technology Accessibility Notice
(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.
(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.
(c) The Section 508 accessibility standards applicable to this contract are:
205 WCAG 2.0 Level A & AA Success Criteria
302 Functional Performance Criteria
502 Inoperability with Assistive Technology
504 Authoring Tools
602 Support Documentation
603 Support Services
In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.
In order to facilitate the Government's determination whether proposed EIT services meet applicable Section /508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.
(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.
11.0 Privacy and Security Safeguards
A. Baseline Security Requirements
1) Applicability. The requirements herein apply whether the entire contract or order (hereafter "contract"), or portion thereof, includes either or both of the following:
a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.
b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.
2) Safeguarding Information and Information Systems. In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:
a. Protect government information and information systems in order to ensure:
• Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;
• Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and
• Availability, which means ensuring timely and reliable access to and use of information.
b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.
c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.
d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.
3) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:
Confidentiality: [ ] Low [X] Moderate [ ] High
Integrity: [ ] Low [X] Moderate [ ] High
Availability: [X] Low [ ] Moderate [ ] High
Overall Risk Level: [ ] Low [X] Moderate [ ] High
Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:
[ ] No PII [X] Yes PII
Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-130, "PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother‘s maiden name, biometric records, etc.
PII Confidentiality Impact Level has been determined to be: [ ] Low [X] Moderate [ ] High
4) Controlled Unclassified Information (CUI). CUI is defined as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term "handling" refers to "...any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:
a. marked appropriately;
b. disclosed to authorized personnel on a Need-To-Know basis;
c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and
d. returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.
5) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.
6) Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.
The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and CDC policies. Unauthorized disclosure of information will be subject to the HHS/CDC sanction policies and/or governed by the following laws and regulations:
a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);
b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and
c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).
7) Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).
8) Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.
9) Contract Documentation. The Contractor shall use provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.
10) Standard for Encryption. The Contractor (and/or any subcontractor) shall:
a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.
b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.
c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and OpDiv-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).
d. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the COR prior to performing any work on behalf of HHS.
e. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.
11) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the CDC non-disclosure agreement. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.
12) Privacy Impact Assessment (PIA) - The Contractor shall assist the CDC Senior Official for Privacy (SOP) or designee with conducting a PIA for the information system and/or information handled under this contract.
a. The Contractor shall assist the CDC SOP or designee with completing a PIA for the system or information within prior to performing any work on behalf of HHS in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.
b. The Contractor shall assist the CDC SOP or designee in reviewing the PIA at least every year throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.
B. Training
1) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/OpDiv Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees shall complete CDC Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS training policies.
2) Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum.
3) Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.
C. Rules of Behavior
1) The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, and CDC Implementation of the HHS Rules of Behavior for Use of HHS Information Technology Resources.
2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual OpDiv Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.
D. Incident Response
The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by CDC Computer Security Incident Response Team (CSIRT) within 24 hours, whether the response is positive or negative.
FISMA defines an incident as "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.
A privacy breach is a type of incident and is defined by Federal Information Security Modernization Act (FISMA) as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as "a suspected or confirmed incident involving PII" .
In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:
1) Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.
2) NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send CDC approved notifications to affected individuals within 30 days.
3) Report all suspected and confirmed information security and privacy incidents and breaches to the CDC Computer Security Incident Response Team (CSIRT) at 866-655-2245 and CSIRT@cdc.gov, COR, CO, OpDiv SOP (or his or her designee), and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable CDC and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:
a. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;
b. not include any sensitive information in the subject or body of any reporting e-mail; and
c. encrypt sensitive information in attachments to email, media, etc.
4) Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, HHS and CDC incident response policies when handling PII breaches.
5) Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation.
E. Position Sensitivity Designations
All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:
[ ] Level 6C: Sensitive - High Risk
[X] Level 5C: Sensitive -Moderate Risk
F. Homeland Security Presidential Directive (HSPD)-12
The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.
Roster. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within 14 of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within 14 of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.
If the employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level.
G. Contract Initiation and Expiration
1) General Security Requirements. The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology and in accordance with the HHS Contract Closeout Guide (2012).
2) System Documentation. Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.
3) Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.
4) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO within 14 days before an employee stops working under this contract.
5) Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or CDC policies.
6) The Contractor (and/or any subcontractor) shall perform and document the actions identified in the CDC Contractor Employee Separation Checklist when an employee terminates work under this contract within 1 days of the employee's exit from the contract. All documentation shall be made available to the CO and/or COR upon request.
H. Records Management and Retention
The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/CDC policies and shall not dispose of any records unless authorized by HHS/CDC.
In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/CDC policies.
HHSAR "Privacy Act" clause, 352.224-70):
PII means information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual. OMB Circular A-130, Managing Information as a Strategic Resource (July 28, 2016). Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother`s maiden name, biometric records, etc.
The E-Government Act of 2002 Section 208 (E-Government Act) and Office of Management and Budget (OMB) Memorandum M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government of 2002, form the core of the Privacy Impact Assessment (PIA) requirement. Together, they state that a PIA is an assessment of how information is handled within certain electronic systems. Each PIA should consider: 1) Whether the system complies with legal, regulatory, and policy requirements related to privacy; 2) The risks and effects of how that system handles personally identifiable information (PII); and 3) How the system could be changed to mitigate potential privacy risks. The Department of Health and Human Service (HHS) has chosen to evaluate the privacy implications of all electronic systems regardless of whether the E-Government
Act or OMB M-03-22 requires a PIA.
Privacy or Security Safeguards (FAR Clause 48 CFR § 52.239-1)
1. The Contractor shall not publish or disclose in any manner, without the Contracting Officer's written consent, the details of any safeguards either designed or developed by the Contractor under this contract or otherwise provided by the Government.
2. To the extent required to carry out a program of inspection to safeguard against threats and hazards to the security, confidentiality, integrity, and availability of Government data, the Contractor shall afford the Government access to the Contractor's facilities, installations, technical capabilities, operations, documentation, records, and databases.
3. If new or unanticipated threats or hazards are discovered by either the Government or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party.
Confidential Information (HHSAR Clause 48 CFR § 352.224-71)
1. Confidential Information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.
2. Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this contract to identify Confidential Information from time to time during performance.
3. Confidential Information or records shall not be disclosed by the Contractor until:
a. Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency.
b. For information provided by or on behalf of the government,
i. The publication or dissemination of the following types of information are restricted under this contract: NONE
ii. The reason(s) for restricting the types of information identified in subparagraph (i) is/are: None
c. Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to disseminate or publish information identified in subparagraph (2)(i). The contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.
d. Whenever the Contractor is uncertain with deciding if information is confidential under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication of that information.
Privacy Threshold Analysis (PTA) - due within 45 days after contract award
1. The Contractor shall assist the Senior Agency Official for Privacy (SAOP) (or his or her designee) with conducting a PTA (using the Privacy Impact Assessment [PIA] form) for the information system and/or information collection project to determine whether or not a full PIA needs to be completed.
a
