SOLICITATION NOTICE
R -- Administrative Support For Chernobyl Projects: Thyroid Screening Follow-up and Leukemia/Thyroid Cancer in Clean-up Workers in Ukraine - Statement of Work
- Notice Date
- 8/27/2018
- Notice Type
- Cancellation
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CP85030-45
- Archive Date
- 9/15/2018
- Point of Contact
- Miguel Diaz, Phone: 2402765439
- E-Mail Address
-
miguel.diaz@nih.gov
(miguel.diaz@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- N02CP85030-45 SF1449 N02CP85030-45 Statement of Work Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive Room 1E144 Bethesda, MD 20892 This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1(a)(2) and 13.501(a) using simplified acquisition procedures for commercial acquisitions. Any contract(s) awarded from this solicitation will contain FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items. The North American Industry Classification System code is 541611 and the business size standard is $14 Million. Only one (1) award will be made as a result of this combined synopsis/solicitation. This will be awarded as a severable firm fixed price type contract. The anticipated period of performance for this requirement is 7.5 months, with one 12-month option period. It has been determined that there is no opportunity to acquire green products or services under this procurement. DESCRIPTION The National Institute of Cancer (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Radiation Epidemiology Branch (REB), is anticipating awarding a contract to implement the continuation of the partner project agreements between the Research Center for Radiation Medicine (RCRM) of the Academy of Medical Sciences of Ukraine and the National Cancer Institute (NCI) of the United States and between the Institute of Endocrinology and Metabolism (IEM) of the Academy of Medical Sciences of Ukraine and the NCI to provide financial management oversight for three NCI supported projects in Ukraine: follow-up for thyroid cancer and related activities in individuals exposed to radioactive fallout from the Chernobyl accident; field work for the case-control study of thyroid cancer in Chernobyl clean-up workers; and data collection for the case-control study of leukemia. This work is currently being conducted under contract HHSN261201600298P held by the Science and Technology Center in Ukraine (STCU). The Chernobyl Research Unit (CRU), DCEG REB sponsors joint U.S.-Ukraine studies of health effects of the Chernobyl Accident. Currently, there are two partnership agreements supporting three collaborative U.S.-Ukraine epidemiological projects in Ukraine. These projects are 1) "Thyroid Cancer and Other Thyroid Diseases in Ukraine Following the Chernobyl Accident" (P004) undertaken at the Institute of Endocrinology and Metabolism (IEM), Kiev; 2) "Leukemia and Other Hematologic Diseases Among Clean-up Workers in Ukraine Following the Chernobyl Accident" (P003) at the Research Center for Radiation Medicine (RCRM), Kiev; and 3) "Thyroid Cancer among Chernobyl Cleanup Workers in Ukraine" (P003A) undertaken as a variation of the project name, "Leukemia and Other Hematologic Diseases Among Clean-up Workers in Ukraine Following the Chernobyl Accident" (see below) also at RCRM. The partnership agreement for "Thyroid Cancer and Other Thyroid Diseases in Ukraine Following the Chernobyl Accident" (P004) involves thyroid screening and other related tasks in a cohort of about 13,000 people who were exposed to post-Chernobyl radioactive fallout under age 20 years. The aim of this project is to assess early and late morphologic and functional changes in the thyroid glands of persons exposed at young ages to radiation from radioactive materials released as a consequence of the Chernobyl nuclear power plant accident. The cohort members have been undergoing diagnostic thyroid examinations since 1998. Under a rigid protocol approved by NCI, IEM staff carries out the field work to maintain contact with the cohort members and invite them to diagnostic thyroid examinations, which may include palpation, ultrasound scanning, thyroid hormone and other laboratory tests. These examinations are done at IEM or by a mobile team. If deemed necessary by the protocol, cohort members are referred to an expert endocrinologist at IEM for a fine-needle aspiration biopsy for diagnostic confirmation. Interview information collected by IEM regarding residential, health, diet and lifestyle history has been used for estimating radiation doses by an international expert group involving NCI. Follow-up is also performed on all subjects for thyroid cancer morbidity and mortality through linkage with the national cancer registry in Ukraine. The IEM is responsible for the tracing of cohort subjects, recording medical and other data, data processing, and database management and organizing analytical data for NCI. IEM collects fresh and/or archived samples for study by NCI genetic and genomic investigations. IEM also provides data management and quality control, services needed for radiation dose reconstruction to be undertaken by NCI and other dosimetry experts and assist data analysis and manuscript preparations for NCI. The partnership project agreement for "Leukemia and Other Hematologic Diseases among Clean-up Workers in Ukraine Following the Chernobyl Accident" (P003) involves a case-control study of leukemia among clean-up workers carried out by RCRM staff. The objective of this study is to assess the risk of leukemia and other hematological cancers related to radiation exposure that the clean-up workers received during the recovery and clean-up operations after the accident. Data collection undertaken by RCRM is nearly completed, and major study results showing a significant risk of leukemia associated with radiation exposure have been published. The RCRM continues to provide additional data and/or biological samples for analyses performed by NCI. Recently, an amendment has been made to the above agreement with RCRM to add a case-control study of thyroid cancer in the same clean-up worker population, "Thyroid Cancer among Chernobyl Cleanup Workers in Ukraine" (P003A). Under the protocol approved by NCI, RCRM staff conducts field work to identify cases with thyroid cancer and non-cancer controls, interview them for radiation exposure information, and collect saliva samples for future genetic studies. In addition, under the protocol approved by NCI, RCRM acquire and store archival thyroid tumor tissues and other biological samples for NCI genetic research ("Tissue Archiving"). The RCRM also provides data management and quality control, services needed for radiation dose reconstruction to be undertaken by NCI and other dosimetry experts and assist data analysis and manuscript preparations for NCI. In all three projects, NCI is responsible for study design and methodologies while the Contractor shall implement an un-interrupted continuation of these projects under a Partner Project Agreement, providing technical and financial management for the projects in Ukraine. As set forth in the agreement signed by the United States, Canada, Sweden and Ukraine, funds received by the Recipients (RCRM and IEM) in Ukraine from the NCI, in connection with the contractors projects, shall be excluded in determining the profits of the contractor for the purpose of tax liability and funds received by persons shall not be included in these persons taxable incomes. The allocation of intellectual property arising from the agreement and the responsibilities for protecting and exploiting such intellectual property have been negotiated between the Recipient and the Partner. Exploitation of results shall be limited to applications for peaceful purposes, and the Recipient and the NCI shall ensure that any results that could result in concerns over proliferations of weapons technology and transfer of sensitive technologies will be protected in accordance with Ukrainian laws and international agreements. PURPOSE AND OBJECTIVE OF PROCUREMENT The objective of this procurement is to obtain severable support services to provide technical and financial management oversight for the four NCI supported projects in Ukraine: (1) follow-up for thyroid cancer and related activities projects/activities (including genomic and in utero studies) in individuals exposed to radioactive fallout from the Chernobyl accident; and (2) leukemia and other hematologic diseases among clean-up workers in Ukraine following the Chernobyl accident and related studies and activities, including data collection and analysis for the leukemia study and thyroid cancer study in Chernobyl clean-up workers; tissue archiving; evaluation of human factor uncertainties; and field work and collection of blood and other biological samples and dosimetry for the TRIO study. The projects are performed by the Partner organizations (IEM and RCRM) and the administration and support tasks are handled by the Contractor. The project tasks are broken down as follows: Core Project Tasks performed by the Partner Organizations (IEM and RCRM) for administration and financial management by the Contractor during Base Period and Option Period, if exercised: Continue follow-up activities (cohort maintenance, follow-up through linkage to national registers, data collection and management for the 16,000 cohort subjects); provide data to NCI and assist NCI in analysis of data and manuscript preparation. Conducting field work, acquire blood and other biological samples from the trios and estimate doses for the parents for the study of Paternal irradiation of Ukrainian clean-up workers and germline mutations in their offspring (TRIO study); provide biological samples and data to NCI for genomic research to be conducted in collaboration with NCI; data collection/ management related to the case-control studies of leukemia and thyroid cancer in cleanup workers and tissue archiving; provide data to NCI and assist NCI in analysis of data and manuscript preparation. CONTRACTOR REQUIREMENTS The Contractor shall perform administrative duties to support collaboration among the study personnel at NCI and the NCI collaborating institutions as specified in the study protocols listed in the attached Statement of Work (SOW) for two NCI supported projects: Cleanup Workers (Appendix A) and Thyroid Cohort (Appendix B) as stated below: •Assisting the NCI with maintaining agreements with NCI collaborating institutions. •Providing financial and administrative oversight of the studies conducted by NCI collaborating institutions. This will include evaluation and verification of the progress of project activities, materials, supplies, personnel and services, auditing the costs, if deemed necessary. •Reporting to the NCI COR if there are any significant managerial issues or problems and provide advice in resolving them. •Providing support in procuring materials and supplies, and compensation to study subjects as needed by RCRM and IEM in performance of the tasks outlined in Appendices A & B and approved by the NCI COR. •Providing support in procuring equipment including customs clearance assistance to support performance of the tasks outlined in Appendices A & B. A Terason uSmart3300 NextGen system is required for the tasks under Appendix B. PERIOD OF PERFORMANCE Services provided for all projects listed in the attached SOW during the period of September 16, 2018 - April 30, 2019, with an additional one-year option period and option tasks. Base Period: September 17, 2018 - April 30, 2019 (Appendix A: TRIO and Dosimetry in Clean-up workers; Appendix B: Nodular Screening, Cohort Maintenance, Thyroid Dosimetry, and Breast Cancer Feasibility) Option Period 1: May 1, 2019 - April 30, 2020 (Appendix B: Nodule Screening, Cohort Maintenance) 1) Option Task 1: Appendix A: TRIO: August 1, 2019 - April 30, 2020 2)Option Task 2: Appendix A: Dosimetry for Cohort of Clean-up Workers: August 1, 2019 - April 30, 2020 3) Option Task 3: Appendix B: Breast Cancer Feasibility: August 1, 2019 - April 30, 2020 PLACE OF PERFORMANCE Kiev, Ukraine BASIS FOR AWARD: Selection of a Quoter for award will be based on an evaluation of quotes against four factors. The factors, in order of importance are: Technical Capability, Organizational Experience, Key Personnel, and Price, subject to available funding and Quoter responsibility. All evaluation factors, other than cost or price, when combined are significantly more important than cost or price. However, cost/price may become a critical factor in source selection in the event that two or more Quoters are determined to be essentially equal following the evaluation of all factors other than cost or price. In any event, the Government reserves the right to make an award to that Quoter whose response provides the best overall value to the Government. The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs set forth in the RFQ. The merits of each proposal will be evaluated carefully. Each quote must document the feasibility of successful implementation of the requirements of the RFQ. Quoters must submit information sufficient to evaluate their quotes based on the detailed factors listed below. The Evaluation Process: The Government will award a contract resulting from this quotation to the responsible contractor whose quote conforming to the quotation will be the most advantageous to the Government, price and other factors considered. The following evaluation factors shall be used to evaluate the prospective contractors and are listed in order of importance. 1.Technical Capability (50 points) 2.Key Personnel (30 points) 3.Organizational Experience (20 points) 4.Past Performance 5.Price 1.Technical Capability (50 Points): The technical response should clearly and fully demonstrate the Quoter's full understanding of the capabilities, knowledge, and personnel requirements, as stated in the statement of work. Failure to respond explicitly to each of the categories may result in the Quoter's offer/quotation being deemed technically unacceptable. The Government will evaluate the Quoter's technical capabilities based on feasibility of methodologies and services provided for successfully supporting the major initiatives described in the Statement of Work. The technical proposal should describe, in detail, justify and document procedures and qualifications that meet the following criteria: •Demonstrated capability of, or an approach for, establishing a United States-Ukrainian binational project agreement for the two ongoing NCI support post-Chernobyl projects described in the SOW; •Demonstrated experience of successfully establishing and managing similar projects in size and scope to those outlined in the SOW. •Demonstrated experience in managing and administering projects funded by US government agencies; 2.Key Personnel (30 Points) Responses should detail how the Quoter will provide the necessary project administration, organization and staff to ensure compliance with tasks as described in the Statement of Work. Responses should describe the key personnel who will be assigned to manage performance and supervise the work. Resumes and/or Biographies shall be provided that demonstrate how the key personnel meet the criteria required below: •Demonstrated capability of, or an approach for, providing on-site managerial oversight for the two ongoing NCI supported post-Chernobyl projects described in the SOW; •Demonstrated capability of, or an approach for, communicating in English, Ukrainian, and Russian; 3.Organizational Experience (20 Points) The Government will evaluate the Quoter's organizational experience based on information obtained from references provided by the Quoter, other relevant information obtained from other sources known to the Government, and any information supplied by the Quoter on organization experience to contracts similar in nature described in this procurement. The Government will evaluate the Quoter's technical capabilities based on demonstrated relevant examples of organizational experience and expertise. The technical proposal should describe, in detail, the organization experience that meets the following criterion: •Demonstrated experience negotiating with medical institutions and international and/or local governments. 4.Past Performance (Past Performance will be evaluated separately for reasonableness but not scored). Quoter's shall submit the following Past Performance information as part of their response: List of the last three (3) contracts/agreements held during the past ten years and all contracts currently in process that are similar in nature to the solicitation. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Quoters that are newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel. Include the following information for each contract or subcontract: 1.Name of Contracting Organization 2.Contract Number (for subcontracts, provide the prime contract number and the subcontract number) 3.Contract Type 4.Total Contract Value 5.Brief description of Requirement 6.Contracting Officer's Name and Telephone Number 7.COR/Program Manager's Name and Telephone Number 8.North American Industry Classification Code (NAICS) The Quoter may provide information on problems encountered on the identified contracts and the Quoter's corrective actions. Each Quoter will be evaluated on its performance under existing and prior contracts or similar products or services. The Government is not required to contact all references Provided by the Quoter. Also, references other than those identified by the Quoter may be contacted by the Government to obtain additional information that will be used in the evaluation of the Quoter's Past Performance. The Government will evaluate the Quoter's past performance based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken. The Government will assess the relative risks associated with each offeror. Performance risks are those associated with a Quoter's likelihood of success in performing the acquisition requirements as indicated by that Quoter's record of past performance. The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the Quoter's performance. The lack of a performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror. The past performance sub-factors are listed below in order of relative importance. These sub-factors will be used to evaluate the quality of past performance. 5.Price (Price will be evaluated separately for reasonableness but not scored). EVALUATION OF OPTIONS It is anticipated that any contract(s) awarded from this solicitation will contain option provision(s) and period(s) in accordance with FAR Clauses 52.217-6, 52.217-7, 52.217-8, and 52.217-9. In accordance with FAR Clause 52.217-5, Evaluation of Options, (July 1990), the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement, except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests. Evaluation of options will not obligate the Government to exercise the option(s). FORMAT AND INFORMATION FOR SUBMITTING A QUOTATION Quoters shall submit Quotation Package responses in two (2) separate files; one (1) SF1449 and one (1) technical proposal response as specified in FAR 52.212-1 Instructions to Offerors - Commercial Items. Quotation Packages shall be emailed directly to Miguel Diaz, Contracting Officer, at miguel.diaz@nih.gov. Quotation Packages must be received in the NCI-OA contracting office by 3:00 PM EST on August 31, 2018. Please refer to solicitation number N02CP85030-45 on all correspondence. Faxed quotations will NOT be accepted. Quotations may be submitted via email to Miguel Diaz, Contracting Officer, at miguel.diaz@nih.gov. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management through SAM.gov. CONTRACT AND PRICING DOCUMENTS •Signed SF1449 (page 1, blocks 12, 17a, 24, 30a, 30b and 30c and other pricing information, if applicable). •Acknowledgement of amendments (if applicable). •A completed copy of provisions at FAR 52.212-3 Offerors Representation and Certifications of Commercial Items must be included which can be found online at System for Award Management (SAM) https://www.sam.gov or be registered on SAM with the complete Representations and Certifications. By submission of an offer, the Quoter acknowledges the requirement that a prospective awardee shall be registered in the SAM database prior to award and during the performance of the required supply or services resulting from this solicitation. Note: Lack of registration in SAM will make a Quoter ineligible for award. DISCLAIMER This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. CONFIDENTIALITY No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
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