Inactive

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The Center for Disease Control and Prevention (CDC), National Institute for Occupational S... This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The Center for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), is seeking information on a potential requirement for " Technical Support for the Advisory Board on Radiation and Worker Health." The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the NAICS code 541690 for the potential acquisition. Responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. 1. Purpose The purpose of this acquisition is to provide technical support to the Board to fulfill its obligations under its HHS Charter to review the scientific validity and quality of radiation dose reconstructions conducted by NIOSH and to advise the Secretary of HHS on whether doses can be estimated with sufficient accuracy for classes of employees at DOE and AWE facilities petitioning to be added to the SEC. More specifically, the objectives are to perform the following activities in support of the Board, using review methods and criteria consistent with relevant statutes and the HHS regulations cited above, as interpreted by HHS, and conforming to the current policies, procedures, and precedents of completed Board reviews: • Evaluate the scientific validity and quality of a sample of dose reconstructions completed by NIOSH under EEOICPA; • Evaluate the scientific validity and quality of procedures and methods by which NIOSH conducts dose reconstructions under EEOICPA, including but not limited to the review of site profiles, implementation guidelines, technical basis documents, technical information bulletins, workbooks, and other forms of dose reconstruction procedures; and • Evaluate the technical merits of SEC petitions and NIOSH evaluations of these petitions. 2. Background and Need In October 2000, President Clinton signed into law the Energy Employees Occupational Illness Compensation Act of 2000 (EEOICPA), establishing a federal compensation program for employees of the Department of Energy (DOE), its predecessor agencies and their contractors and subcontractors, and Atomic Weapons Employers (AWEs). On July 31, 2001, covered employees with cancer, beryllium disease, or silicosis that may be related to work at nuclear weapons production programs of DOE and its predecessor agencies began applying to the Department of Labor (DOL) under the procedures and requirements of 20 C.F.R. pt. 30. Under Part B of EEOICPA, a covered employee with cancer may submit a claim for a lump sum monetary compensation of $150,000 and medical benefits by either obtaining a probability of causation determination or becoming a member of the Special Exposure Cohort (SEC). EEOICPA established an SEC consisting of classes of employees who have one or more of 22 specific cancers and have worked for a specific period of time at one of the SEC work sites. These employees’ cancers are presumed to be radiogenic and a dose reconstruction is not required. The EEOICPA permits individuals to petition the Secretary of HHS on behalf of a class of employees to be added to the SEC. For most employees with cancer, EEOICPA requires a probability of causation determination that the cancer was “at least as likely as not” caused by the occupational radiation dose incurred by the employee. Specifically, EEOICPA mandates that guidelines for determining the probability of causation should be based on the radiation dose received by the employee (or a group of employees performing similar work) at such facility and the upper 99 percent confidence interval of the probability of causation in the radioepidemiological tables published by the National Cancer Institute. The radiation dose would then be incorporated into the dose reconstruction methods established by the Department of Health and Human Services (HHS), while taking into consideration the type of cancer, past health-related activities (such as smoking), information on the risk of developing a radiation-related cancer from workplace exposure, and other relevant factors. On May 2, 2002, HHS published 42 C.F.R. pt. 81, “Guidelines for Determining the Probability of Causation,” and 42 C.F.R. pt. 82, “Methods for Radiation Dose Reconstruction under the Employees Occupational Illness Compensation Program Act of 2000,” as final rules in the Federal Register (Vol. 67, No. 85). 42 C.F.R. pt. 81 is used by DOL to determine the probability of causation for a claimant’s cancer; while 42 C.F.R. pt. 82 is used by NIOSH to provide DOL with dose estimates for claimants who submitted Part B claims for dose reconstructions. The dose reconstruction rule describes the general methods that NIOSH uses in estimating occupational radiation doses under EEOICPA. These methods are designed to provide fair and efficient processing of a high volume of dose reconstructions. Specifically, once DOL receives a Part B claim, it forwards the claims to NIOSH and requests it to provide an estimate of the radiation dose received by the employee. NIOSH uses the dose reconstruction guidelines to reconstruct the occupational radiation doses incurred by the employee. As discussed in the rule, the radiation dose estimates will first take into account information from personnel monitoring records (for example dosimeter badge readings and bioassay sample analyses) and then apply dose reconstruction methods as necessary. DOL then uses the radiation dose and the HHS probability of causation guidelines to determine the probability of causation for a claimant’s cancer. DOL has referred more than 56,983 claims to NIOSH for dose reconstruction through November 24, 2023. DOL continues to refer new and rework cases to NIOSH at the rate of about 275 per month. As stated above, EEOICPA established an SEC consisting of classes of employees who have at least one of the 22 specific cancers and have worked for a specific period of time at one of the SEC work sites. Congress also allowed for additional groups, or classes of, employees to be added to the SEC, and this task is delegated to HHS per Executive Order 13179. On May 28, 2004, HHS issued 42 CFR 83 as a final rule (Federal Register Vol. 69, No. 104). This rule describes the procedures HHS will use to designate additional classes of employees as members of the SEC. Classes are added to the SEC when HHS determines that radiation dose reconstruction is not feasible because the information available is not adequate to allow doses to be reconstructed with sufficient accuracy. The SEC petition process is administered by NIOSH on behalf of HHS. There are two ways to initiate an SEC petition for adding a class of workers to the SEC. Individuals may initiate the evaluation of a class by submitting a petition to NIOSH documenting reasons why dose reconstruction is not feasible (as described in 42 C.F.R. § 83.13); or NIOSH may initiate the addition of a class on its own, based upon its research into the potential exposures at a covered facility (as described in 42 CFR . § 83.14). When NIOSH initiates the addition of a class, a simplified petition is obtained from a representative claimant from the class. Regardless who initiates the SEC petition, NIOSH prepares a petition evaluation report, which describes the information available for reconstructing doses, reaches a conclusion about the feasibility of dose reconstruction, and determines if there was a potential for harm to the members of the class. EEOICPA also established the Advisory Board on Radiation and Worker Health (referred to hereafter as “ABRWH” or “the Board”) to provide independent review of the scientific validity and quality of the NIOSH dose reconstruction program and to recommend to the Secretary of HHS whether it is feasible to “estimate doses with sufficient accuracy” for each class of employees petitioning to be added to the SEC. The Board is also charged more specifically under its dose reconstruction review function to review a sample of dose reconstruction cases, as an element of evaluating scientific validity and quality. The scope of the sample is unspecified by EEOICPA and the Board’s charter but the Board has a target of reviewing up to 2 percent of the total number adjudicated dose reconstruction cases. For the evaluation of SEC petitions, the Board begins its work once NIOSH has presented its evaluation report providing its recommendations for the disposition of the petition. The Board evaluates the NIOSH evaluation report but also independently evaluates the petition and any other information it deems pertinent to establishing its recommendation for the disposition of the petition. The Board is supported technically in all of its abovementioned functions by a contractor, which is the subject of this contract solicitation. The contractor is responsible for providing a variety of evaluative work products (technical reports), as specified below, that the Board considers in performing its various types of reviews and producing its recommendations. These work products are heavily dependent on health physics science and practices, related disciplines (e.g., statistics, ionizing radiation physics, nuclear engineering), and extensive informational research and analysis relying on NIOSH-accumulated reports as well as de-novo data collection from DOE and its site contractors, and other sources. The contractor is also responsible for providing technical support to the Board (and its subcommittees and work groups) as it works to resolve findings of its technical support contractor with the determinations of the NIOSH Division of Compensation Analysis and Support (DCAS), which operates the NIOSH dose reconstruction program. The NIOSH DCAS Web page at: www.cdc.gov/niosh/ocas includes detailed information on the legal infrastructure of the dose reconstruction program, its policies and technical procedures (both generic and specific to individual DOE and Atomic Weapons Employer [“AWE”] facilities), Board policies and procedures, SEC recommendations and final HHS designations and determinations, transcripts and minutes from the Board and its work groups and subcommittees, as well as the work products of its current technical support contractor. Careful review of this information would provide a thorough grounding in the nature, methods, and conditions of technical support of the Board described here, and it would also be instructive on the scope and content of this support. C.3. Contract Tasks The support services that the contractor will provide are listed below. It is expected that the level of support required during the base year and during each option year will vary. The contractor providing technical support to the Board will have access to all NIOSH documentation, procedures, and data used in dose reconstruction and in the evaluation of SEC petitions. This includes the following: (1) 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 Data Base (SRDB) and/or Virtual Volumes. The SRDB and/or Virtual Volumes contain documents that relate to DOE and AWE facilities. 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 SRDB and/or Virtual Volumes to develop and write Site Profiles, TBDs and TIBs, as well as to perform dose reconstructions. (2) 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. The contractor will also need to conduct data captures from DOE and employees of DOE and AWEs to fulfill this requirement, which will be governed by existing Board policy and procedures to ensure national security (see Board “Data Access and Interview Procedures, Proc-010” on the NIOSH DCAS Web page) and appropriate stewardship of Federal records. The contractor will be required to submit to NIOSH immediately upon release to the contractor all data, reports, and other information it acquires during its data captures from DOE and AWE facilities, other sources of documentation accessed, and completed (DOE cleared – as applicable) interviews of current and former employees of these facilities. NIOSH will maintain these submissions as require by law and Federal regulations under the NIOSH system of records associated with the EEOICPA dose reconstruction program, which is organized as described above. NIOSH recordkeeping will ensure these submissions remain available to the contractor as needed. Support Services Requirements 1.0 Dose Reconstruction Case Reviews It is anticipated that the contractor will complete up to 30 dose reconstruction case reviews annually. A. OBJECTIVES A.1 For full internal and external (i.e., “best estimate”) dose reconstructions (up to 24 annually), reviews must: • Report on compliance with DCAS dose reconstruction procedures (current at the time of the dose reconstruction) including site specific and generic procedures. • Report on defects of procedures employed in the dose reconstruction that underestimate dose or improperly overestimate dose OR have the potential to result in such errors for other cases not reviewed. • Report on data employed in or omitted from the dose reconstruction that by use, misapplication, or omission, inaccurately underestimate dose or improperly overestimate dose OR have the potential to result in errors for other cases not reviewed. • Report on errors or patterns of errors when such are indicative of a potential deficiency in quality management. • Characterize errors with respect to their consequence for the compensability of the review case and their likely consequence for other cases not reviewed. • Specify whether assumptions conferring claimant favorability were applied to uncertain information employed in estimating doses. • Report on the extent to which claimant-provided information is acknowledged and addressed in dose reconstruction report to the claimant. • With respect to the appropriateness and adequacy of procedures and data sources used in the dose reconstruction, reviews must be fully consistent with decisions produced from the Board’s issue resolution process from its reviews of site profiles, SEC petitions, and dose reconstruction procedures. However, reviews should re-raise resolved issues if the review produces a new perspective on the resolved matter not previously considered by the Board that substantially calls into question the agreed upon resolution. Further, reviews should identify any issues brought to light by the individual case that have not been addressed by the Board through prior reviews of relevant dose reconstruction procedures, the site profile, or SEC petitions. A.2 For dose reconstruction cases representing efficiency-driven overestimates and underestimates (up to 6 annually) , reviews must: • Report on compliance with DCAS dose reconstruction procedures (current at the time of the dose reconstruction) including site specific and generic procedures, specifying instances of non-compliance that result in errors in the estimation of dose. • Report on the appropriateness of the efficiency processes applied in the case. • Report on procedures employed to underestimate or overestimate dose if such procedure may not have underestimated or overestimated dose (as intended) in the specific case or may not consistently underestimate or overestimate dose (as intended) for other cases not reviewed. • Report on data incorrectly employed in or omitted from the dose reconstruction. • Report on errors or patterns of errors when such are indicative of a potential deficiency in quality management. • Characterize errors with respect to their consequence for the compensability of the review case and their likely consequence for other cases not reviewed. • Specify whether “worst case” assumptions and/or assumptions conferring claimant favorability were consistently applied as appropriate in place of further research in cases that are non-compensable “overestimates”. • Report on the extent to which claimant-provided information is acknowledged and addressed in dose reconstruction report to the claimant. • With respect to the appropriateness and adequacy of procedures and data sources used in the dose reconstruction, reviews must be fully consistent with decisions produced from the Board’s issue resolution process from its reviews of site profiles, SEC petitions, and dose reconstruction procedures. However, reviews should re-raise resolved issues if the review produces a new perspective on the resolved matter not previously considered by the Board that substantially calls into question the agreed upon resolution. Further, reviews should identify any issues brought to light by the individual case that have not been addressed by the Board through prior reviews of relevant dose reconstruction procedures, the site profile, or SEC petitions. B. REQUIRED PROCEDURES The procedure for the review of dose reconstructions should include (but is not limited to) the following elements, as appropriate: B.1. Review Data Collection • Evaluate whether NIOSH received all requested data for the DOE or AWE site from any relevant data source or repository and whether all relevant data sources, including sources maintained by NIOSH, were appropriately queried and applied to the case (not necessary for compensable cases). • Review the entire administrative record to evaluate whether all relevant information was considered by NIOSH (not necessary for compensable cases) • Review the relevant data elements of the Site Profile, Technical Basis Document, and other dose reconstruction procedures, as they apply to the individual case, to evaluate the adequacy and completeness of the data used in the case and to evaluate whether the information from the procedures is consistent with the information used for the case. B.2. Review Claimant Interview and Documentation • Evaluate whether NIOSH appropriately addressed all documentation and reported work history and events submitted by the claimants including but not limited to a) incidents or occurrences, b) actual monitoring practices, c) personal protection practices, and d) work practices. • Assure that interview information is consistent with data used for the dose estimate, and when not, evaluate whether there is appropriate justification for inconsistencies. B.3. Review Internal and External Dose Estimates • Evaluate whether the data were appropriately adjusted, as necessary, to reflect limitations of site radiological monitoring protocols of the time period (not necessary for efficiency-driven underestimates). • Evaluate the treatment of ‘missed dose’ and/or ‘unmonitored dose’ when relevant to the case. • Evaluate whether the dose estimate is consistent with relevant radiological information in the NIOSH site profile (e.g.evaluate whether air monitoring or swipe data are consistent with bioassay results, to the extent expected in light of work and safety practices and other factors). • Evaluate whether appropriate doses from co-worker models were derived and applied, when relevant to the case. B.4. Evaluate relevant portions of the methods and/or procedures used by NIOSH This includes, but is not limited to: • Evaluate methods for estimating each component of dose (internal, external, ambient, medical) relevant to the case. • Evaluate methods for estimating ‘missed dose’ and ‘un-monitored dose’ (for cases related to monitoring technology and for cases where monitoring was not performed, monitoring data are not available, incomplete, or otherwise inadequate). • Evaluate the statistical approaches developed for multiple dose reconstructions. • Evaluate methods or procedures used for substituting exposure information (area monitoring, swipe samples, source term and process analyses) for unavailable or incomplete personal monitoring information, • Evaluate methods for accounting for uncertainty in dose distributions and uncertainty distributions around internal and external dose estimates on a facility and time specific basis and evaluate whether the uncertainties were addressed by a claimant favorable approach. • Review the relevant aspects of the Site Profile, Technical Basis Document, and other dose reconstruction procedures, as they apply to the individual case, to evaluate their appropriate application to the case and their adequacy for estimating all doses associated with the case. Review should also reflect the current status of reviews of relevant procedures by the Board, taking into account the Board’s approval of procedures as well as any unresolved consideration by the Board of procedures that remain under review. B.5. Evaluate Effectiveness of Quality Control Identify any quality control failures as evidenced by defects in cases that represent non-compliance with established dose reconstruction procedure and characterize the seriousness of the defects as they impact the case or potentially impact other cases not reviewed. B.6. Provide Case Reports Summarize the findings of individual cases reviewed, present summary findings to Board member teams (assigned to each case by the Board Chair), incorporate any changes arising from this consultation with Board members, and produce and distribute a written report. C. BLIND DOSE RECONSTRUCTION CASE REVIEWS It is estimated that the contractor will complete up to 6 “blind dose reconstructions reviews” annually in which the contractor independently conducts dose reconstructions on cases already completed by NIOSH (without information on the results of the NIOSH dose reconstruction) to examine the scientific validity of dose reconstruction procedures, the adequacy of available data, and the degree of professional judgment implicit in the procedures and its impact on dose reconstruction results. Blind dose reconstructions will: • Use all raw data available to NIOSH, • Follow all NIOSH dose reconstruction procedures reviewed and approved by the Board but use independent discretion in applying or diverging from procedures not yet approved by the Board, • Apply independent professional judgment on all matters left by dose reconstruction procedures to be determined by professional judgment, • Formulate and apply procedures to address any matters not addressed by approved NIOSH procedures, • Estimate radiation doses and apply IREP to the results, • Compare the resulting dose reconstructions to that completed by NIOSH, identify and characterize the causes and consequences of any differences, and discuss the acceptability or potential problems associated with these findings. • Propose follow-up evaluations or actions, as necessary, based on the findings. D. ISSUE RESOLUTION The contractor will provide technical support to the Subcommittee on Dose Reconstruction Review in the resolution of findings from its own reviews and from those of members of the Board or the Subcommittee that may be questioned or disputed by NIOSH or by members of the Board or Subcommittee. This existing resolution process is documented in the transcripts of the Subcommittee, which can be found at www.cdc.gov/niosh/ocas. It will include producing matrix-style reports summarizing the findings of individual and groups of dose reconstruction case reviews, as directed, and updating these reports as findings are resolved. 2.0 Dose Reconstruction Procedures Reviews As part of NIOSH’s program of completing individual dose reconstructions, NIOSH has established and is routinely updating and improving dose reconstruction procedures that include site-specific procedures, guidance, and data, such as “site profiles,” and “technical basis documents”, and related “work books” (programmed implementation tools), as well as generic multi-site and universal procedures, such as “technical information bulletins -- TIBs”, “implementation guidelines IGs”, “program evaluation reports “PERs”, and other reports. These various procedures, as well as past reviews of such procedures by the Board’s technical support contractor can be found at www.cdc.gov/niosh/ocas. NIOSH also maintains a “Site Research Data Base” (“SRDB”) which includes extensive records and reports that provide some of the bases for these dose reconstruction procedures as well as data applied by these procedures for completing individual dose reconstructions. The contractor shall review selected procedures and related implementation tools and data established by NIOSH to evaluate their scientific validity and quality as applied for purposes of individual dose reconstructions under EEOICPA. A. Scope It is estimated that the contractor will complete annually up to 3 site profile reviews, up to 3 reviews of generic dose reconstruction procedures, and up to 4 reviews of program evaluation reports. Actual activity annually may vary from these estimates, which are provided to facilitate analysis of the proposal costs, personnel, and other elements. B. Review Approach Reviews will focus on whether the procedures and related data used by NIOSH are scientifically valid and of adequate quality for correctly determining individual eligibility for compensation. The review should include a close evaluation of the health physics, statistical treatments, and other dose reconstruction methods employed and an evaluation of whether NIOSH identified, evaluated, and where appropriate, incorporated all available and necessary data sources (from the NIOSH SRDB, DOE, and other sources as applicable) within the procedure. In some instances, evaluating whether the data identification, collection, and evaluation processes were adequate may require the contractor to conduct interviews (one-on-one or group) with employees, employee representatives, advocacy organizations, health and academic researchers and other site ‘experts’ (those with long standing knowledge of processes, materials, events, and exposures). The contractor may be required to conduct meetings with these individuals or groups at locations near the facilities of interest. It will frequently be important for the contractor to examine the availability of dosimetrically relevant information in relation to scope, characteristics, and times and locations of radiological exposures. This information will often be relevant in evaluating the adequacy of related dose reconstruction procedures. For certain procedure reviews, such as select PER reviews, the contractor may also be directed to review a small number of individual dose reconstructions completed under the procedure to examine the adequacy of the procedure and its implementation. C. Issue Resolution The contractor will provide technical support to the Subcommittee on Procedure Reviews, Board work groups (many of which are site-specific), and the Board in the resolution of findings from its own reviews or Board member reviews that may be questioned or disputed by NIOSH or by other members of the Board, the Subcommittee, or Board work groups. This existing resolution process is documented in the transcripts of the Subcommittee, the Board work groups, and the Board, which can be found at www.cdc.gov/niosh/ocas. The process will include producing a matrix-style report summarizing findings of the procedure review and updating the report as findings are resolved. It may also include producing “white papers” and other limited analyses required to examine, verify, and/or validate findings and or approaches proposed by NIOSH, Board members, or the Board’s contractor to resolve findings. The volume of this resolution work may vary widely from one procedure review to another. The offeror should assume that resolution work for a procedure review will require 10 percent of the effort involved in producing its initial review report. 3.0 Review of SEC Petitions 42 C.F.R. pt. 83, Procedures for Designating Classes of Employees as Members of the Special Exposure Cohort under EEOICPA of 2000, describes the general procedures to be followed in the review of SEC Petitions. Section 83.15 describes how the Board will consider and advise the Secretary of HHS on a petition. The contractor shall evaluate SEC petitions and associated NIOSH Evaluation Reports as requested, consistent with the provisions of sections 83.13, 83.14, 83.15, and in accordance with related NIOSH and Board Procedures. These and other relevant materials, including past reviews of the Board’s technical support contractor, can be found at www.cdc.gov/niosh/ocas. A. Scope It is estimated that the contractor will review annually up to 6 SEC Petitions and associated NIOSH Evaluation reports, or review parts thereof as directed. The extent of original research, data capture, and interviews of experts and site employees and retirees required of the contractor will vary. It will depend on the extent to which this information has already been captured by NIOSH and the Board’s technical support contractor and is available through the SRDB or in holdings set aside for NIOSH and the Board at DOE. At the recommendation of the Board, the contractor may be asked to review the complete SEC petition and NIOSH Evaluation Report or specified elements of these. B. Review Approach Reviews will focus on the adequacy and reliability of available documents and monitoring data as well as an analysis of the scientific validity and quality of methods proposed by NIOSH to accomplish individual dose reconstructions for all members of a petitioning class. The review will examine whether all radiological doses associated with the class can be bounded or estimated more precisely using approved methods and adequate data. The central concern of reviews will be to support the Board with technical information and analyses by which it can deliberate and recommend to the Secretary whether, in its view, doses can be reconstructed with sufficient accuracy. Complete reviews of petitions will typically involve the following: • some original data capture and interviews of petitioners, site experts, employees, and/or retirees; • analysis of proposed procedures and available monitoring, process, and source term data and information in comparison to information indicating actual and potential radiological conditions; • statistical analyses to assess data completeness and representativeness; • assessment of the pedigree and reliability of essential data; • evaluation of the appropriateness of any use of surrogate data in light of Board and NIOSH criteria for such use; and • consideration of illustrative dose reconstructions examples provided by NIOSH to demonstrate the f...