SPECIAL NOTICE
R -- Technical Support for Advisory Board on Radiation Worker Health's Review of NIOSH Dose Reconstruction Program
- Notice Date
- 9/26/2007
- Notice Type
- Special Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Acquisition and Assistance Field Branch (Pittsburgh), Post Office Box 18070 Cochrans Mill Road, Pittsburgh, PA, 15236-0070, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- 2008-N-09682
- Response Due
- 10/31/2007
- Archive Date
- 11/14/2007
- Point of Contact
- Florence Black, Contract Specialist, Phone (412)386-4451, Fax (412)386-6429, - Florence Black, Contract Specialist, Phone (412)386-4451, Fax (412)386-6429
- E-Mail Address
-
fbb4@cdc.gov, fbb4@cdc.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH), has a requirement for a contractor to provide technical assistance to the Advisory Board on Radiation and Worker Health (ABRWH). The purpose of this announcement is to provide a draft statement of work and invite public comments about this requirement. The draft is shown below. Comments should be submitted to Ms. Florence Black at the Contracting Office Address shown above, via email to fpblack@cdc.gov, or via fax at 412-386-6843. Comments are requested by no later than October 31, 2007. The government intends to issue the Request for Proposals (RFP) as a total small business set aside. Although subject to change without advance notice, the projected schedule for posting the formal synopsis is on or about January 7, 2008, and the RFP will be posted on or about March 31, 2008. _________________________________________________________________ Technical Support for the Advisory Board on Radiation and Worker Health?s Review of NIOSH Dose Reconstruction Program Draft Statement of Work dated September, 2007 C.1. Purpose of Contract The Centers for Disease Control (CDC) , National Institute for Occupational Safety and Health (NIOSH) Office of Compensation Analysis and Support (OCAS) is responsible for conducting individual dose reconstructions on employees of the Department of Energy (DOE) and its predecessor agencies, its contractors and subcontractors, and Atomic Weapons Employers (AWEs) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). To support NIOSH?s role under EEOICPA, OCAS has retained the services of a contractor to assist in the implementation of a number of major program elements. Under EEOICPA, the Advisory Board on Radiation and Worker Health (Advisory Board), is required to review a reasonable sample of dose reconstructions for scientific validity and quality, assess the methods for dose reconstruction, and review Special Exposure Cohort (SEC) petitions. To support the Advisory Board, the Department of Health and Human Services (HHS) requires the services of a contractor to assist in the implementation of a number of tasks related to independent review of the dose reconstruction process. C.2. Background and Need In October 2000, Congress and the President enacted EEOICPA, establishing a federal compensation program for employees of the DOE, its 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 CFR Part 30 for lump sum cash benefits of $150,000 and medical benefits. Also, EEOICPA establishes a SEC consisting of employees with 22 specific cancers who worked at three named DOE facilities or participated in certain nuclear tests and who meet certain other requirements. These employees? cancers are presumed to be radiation related. The EEOICPA permits other groups of employees to petition NIOSH to be added to the SEC. For most employees with cancer, EEOICPA and the DOL?s regulation require a determination by DOL that the cancer was ?at least as likely as not? related to the occupational radiation dose incurred by the employee at a facility covered by EEOICPA. Criteria and guidelines for making this determination are established by EEOICPA. On May 2, 2002, the Department of Health and Human Services (HHS) published 42 C.F.R. Part 81, Guidelines for Determining the Probability of Causation. This rule will be used to determine the probability that an employee?s cancer was ?at least as likely as not? related to employment at a DOE or AWE facility. To make this determination, DOL will refer cases to NIOSH for an estimation of the radiation dose received by the employee. EEOICPA also established a federal advisory board, The Advisory Board on Radiation and Worker Health (Advisory Board) which has among its charges the task of reviewing a reasonable sample of the dose reconstructions for scientific validity and quality, assess the methods and procedures for dose reconstruction, review Special Exposure Cohort (SEC) petitions, and advise the Secretary of HHS in these matters. NIOSH and DOL expect a large number of cancer claims under EEOICPA in the initial five to ten years, many of which will require NIOSH dose estimates. More than 650,000 workers have been employed by DOE and its contractors and subcontractors, not including the employees of the AWEs. To date DOL has forwarded to NIOSH approximately 27,000 claims that require dose reconstructions. While the rate of claims receipt varies, about 200 claims each month are referred to NIOSH by the Department of Labor. On May 2, 2002, HHS issued 42 C.F.R. Part 82, The Methods for Radiation Dose Reconstruction, that describes the general methods that NIOSH is using to reconstruct occupational radiation doses under EEOICPA (Federal Register Vol. 67 No. 85). These methods are designed to provide fair and efficient processing of a high volume of dose reconstructions. NIOSH will also seek to obtain dosimetry and relevant records and information on a facility or site-wide basis for DOE sites as well as for AWE sites to reduce the volume of records and information that would need to be collected (at greater expense of time and resources) for each individual claim. NIOSH is establishing a Microsoft SQL Server 2000 relational database management system to house these records. The database will include individual claimant data, ?site profile? data and ?worker profile? data. NIOSH will have a Dose Reconstruction contractor to provide technical support for dose estimation, dose reconstruction and evaluation of SEC petitions submitted in accordance with EEOICPA . The awarded contract will be available on the NIOSH OCAS web site (www.cdc.gov/niosh/ocas) prior to the issuance of the formal Request for Proposals for this procurement. HHS requires technical consultative support for the Advisory Board to conduct the review of the dose reconstruction process. The purpose of this procurement is to continue the services of a contractor to assist the Advisory Board in the review of the NIOSH OCAS dose reconstruction program. C.3. Contract Tasks The Contractor shall provide project staff to direct and manage project activities, document work performed by Contractor personnel, prepare reports documenting progress and problems and interface with the Advisory Board. The Contractor shall document all of the individual steps for each task order performed so that any aspect of a technical review can be evaluated at any point during the course of performance. The Contractor shall maintain a filing system of all material relevant to each technical review undertaken. The filing system shall be cross-referenced in a manner that allows all material to be easily accessed. At the conclusion of a contract task, the Contractor may be required to duplicate all records pertaining to the task order not already held by NIOSH. As an independent organization performing work on behalf of the Government, the Contractor shall provide the support services required to conduct task orders that may include, but not be limited to, the activities listed below. A. Individual dose reconstruction reviews B. NIOSH OCAS ?Site Profile? and ?Procedures? Review C. Review of SEC Petitions The work associated with each of the Government?s anticipated requirements are set forth in general terms as specified below. A. Individual dose reconstructions review The contractor shall evaluate whether or not the reconstruction of dose provides a reasonable estimate of the dose (as needed to adjudicate the claim). The contractor shall evaluate and recommend whether or not the assumptions (individual case assumptions and assumptions applicable to multiple cases) made for dose reconstruction are appropriate and defensible for purposes of this program. The contractor shall evaluate whether or not the data from DOE or other sources is of sufficient quality necessary to obtain a reasonable estimate of dose. The contractor shall evaluate whether or not the dose reconstruction was performed fairly using NIOSH guidelines and in a manner consistent with other cases. The contractor shall review all relevant dose reconstruction methodologies and/or procedures employed by NIOSH / NIOSH contractors in conducting individual dose reconstructions and SEC petitions. The contractor shall evaluate whether methodologies and procedures are consistent with requirements under 42 CFR 82 and whether there are sufficient procedures to achieve consistent application of the requirements in 42 CFR 82. The contractor shall conduct one of three different levels of review on the selected cases: 1) Basic Review, 2) Advanced Review, or 3) Blind Review. The method of review will be determined by the Advisory Board. The number of individual dose reconstruction reviews is estimated to be approximately 62 in the first year. It is expected that there will be approximately 30 Basic Review cases, 30 Advanced Review cases and 2 Blind Review cases. The next four years will also involve a review of approximately 62 cases per year. The breakdown of cases will be the same as described for the first year. The Advisory Board shall determine the cases to be reviewed and the level of review. These percentages are subject to change by the Advisory Board based on experience with the review process. The elements of each type of review are detailed below: 1. Basic Review A. Review Data Collection Evaluate whether NIOSH received all requested data for the DOE or AWE site from any relevant data source or repository Evaluate whether the data used by NIOSH for the case was adequate to make a determination with regard to probability of causation. B. Review Interview and Documentation provided by claimant Evaluate whether NIOSH appropriately addressed all of the reported work history and events represented by the claimant 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 if not, evaluate whether reasonable justification is provided. Review Internal and External Dose Estimates Evaluate whether all assumptions used in the dose determination are appropriate for a remedial compensation program and whether the benefit of the doubt was resolved in favor of the claimant Verify dose calculations are appropriate for purposes of determination of Probability of Causation (POC) Evaluate whether the data were consistent with site radiological monitoring protocols of the time period. Evaluate the treatment of ?missed dose? and/or ?unmonitored dose? if relevant to the case. The review of each dose reconstruction shall include an evaluation of all relevant portions of the methods and/or procedures used by NIOSH. This includes, but is not limited to: Review the internal and external radiation dose reconstruction technical basis documents, Review of 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 is not available or incomplete or otherwise inadequate), Review of the statistical approaches developed for multiple dose reconstructions, Review procedures used for determining whether data are sufficient to make a reasonable dose estimate, Review methods or procedures used for substituting exposure information for unavailable or incomplete information, Review methods for estimating uncertainty in dose and uncertainty distributions surrounding internal and external dose reconstructions on a facility and time specific basis and evaluate whether the benefit of the doubt was resolved in favor of the claimant where there were uncertainties, Review procedures and questionnaire used for work history phone interview, and Review the NIOSH methods, procedures and performance in evaluating, analyzing and validating all contractor work products. 2. Advanced Review The Advanced Review will include all task items in the Basic Review along with the additional tasks listed below: Review Data Gathering Review the entire administrative record to evaluate if relevant information exists which was not considered by NIOSH. Review the relevant aspects of the Site Profile as they apply to the individual case and evaluate the adequacy and completeness of the site profile and evaluate whether the information from the site profile is consistent with the information used for the individual dose estimate. Evaluate whether, to the extent practicable, all relevant sources of data (e.g., DOE, AWE, CDC, Environmental Measurements Laboratory (EML), Nuclear Regulatory Commission ( NRC) , Environmental Protection Agency (EPA), External Health and Safety Regulators, Government Accounting Office (GAO) , Defense Nuclear Facilities Safety Board (DNFSB), Congressional Hearing Records, other research programs, research publications, publications regarding the history of the DOE complex, or administrative/court records) were identified, evaluated and where appropriate, included within the Site Profile database and where appropriate were used in the assessment of the individual dose reconstruction case. Review Work History Interview and Documentation provided by claimant Evaluate the effectiveness of the phone interview in ascertaining relevant work history information. Evaluate whether, for the cases involving survivors, there has been an adequate effort to research co-located workers and other historical records to characterize the individual?s work history. Review Internal and External Dose Estimates Evaluate whether the dose estimate is consistent with relevant radiological information within the NIOSH site profile (e.g. air monitoring, wipe data are consistent with bioassay results) Compare case information and assumptions with relevant co-worker case information and assumptions for consistency 3. Blind Dose Reconstruction Using all raw data available to NIOSH, the independent expert will develop an Interactive RadioEpidemiological Program ( IREP) dose input file that they feel is sufficient to make a determination with regard to POC. B. NIOSH OCAS ?Site Profile? and ?Worker Profile? Review As part of NIOSH?s effort in completing individual dose reconstructions, NIOSH is establishing a ?Site Profile? database for all covered sites. This database includes records relevant to dose reconstruction other than the personnel dosimetry records (e.g. ? process information, characterization information, incident or occurrence reports, summary dosimetric information, etc.). The contractor shall review selected site profiles established by NIOSH to evaluate the quality and completeness of the profiles and the adequacy of the data for purposes of individual dose reconstructions. The contractor shall review the conditions, processes, practices and incidents at selected DOE and AWE facilities covered under EEOICPA to evaluate the adequacy of the information available in the NIOSH Site Profile. The review should focus on whether the approach used by NIOSH assured completeness of data necessary for purposes of determining individual eligibility for compensation. The review should include a evaluation of whether NIOSH identified, evaluated and where appropriate incorporated all relevant data sources (e.g., DOE, AWE, CDC, EML, NRC, EPA, External Health and Safety Regulators, GAO, DNFSB, Congressional Hearing Records, other research programs, research publications, publications regarding the history of the DOE complex, or administrative/court records) within the site profile. One task in evaluating that the data identification and collection process 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 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. As part of NIOSH?s effort in completing individual dose reconstructions and SEC Petition evaluations, NIOSH is establishing a ?Procedures? database to assist in the performance of such efforts. The contractor shall review selected ?Procedures? established by NIOSH to evaluate the quality and completeness of the ?Procedures? and the adequacy of the ?Procedures? for purposes of individual dose reconstructions and SEC Petition evaluations. It is expected that there will be 30 ?Procedures? Reviews and 6 Site Profile Reviews in the first year and in each subsequent year of the contract C. Review of SEC Petitions 42 CFR Part 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 Special Exposure Cohort petitions as requested consistent with the provisions of 83.14 and 83.15. Such reviews may focus on the availability and reliability of documents and monitoring data as well as an analysis of the methods proposed by NIOSH to accomplish individual dose reconstructions for members of a considered class. In cases where a site profile is available for a site in question the contractor will make use of such a document. In cases where no site profile is available the contractor will need to develop the basic information needed to evaluate the SEC Petition. In some cases it may be necessary for the contractor to interview workers and/or site experts to accomplish this task. At the recommendation of the Board, the contractor may be asked to review either the complete SEC Petition or just an aspect of the petition as designated by the Board. In a given year of contract performance, it is anticipated that the contractor will review three complete SEC Petitions and an aspect or aspects of three other petitions.
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- SN01421412-W 20070928/070926223339 (fbodaily.com)
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