SOURCES SOUGHT
A -- United States Renal Data System Coordinating Center (USRDS CC)
- Notice Date
- 1/18/2018
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6710B Rockledge Dr., Suite 1124, MSC7000, Bethesda, Maryland, 20892-7510, United States
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NIDDK-KUH-SBSS-2019-2
- Point of Contact
- Usha Raman, Phone: 301-443-5228, Pamela Nevels, Phone: 301-827-0845
- E-Mail Address
-
ramanu2@mail.nih.gov, pamela.nevels@nih.gov
(ramanu2@mail.nih.gov, pamela.nevels@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Synopsis : This is a R&D Small Business Sources Sought (SBSS) notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The primary purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether there are small businesses; HUBZone small businesses; service-disabled, veteran owned small businesses; 8(a) small businesses, women-owned small businesses, or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a small business set aside is possible or to identify potential sources for a full and open competition. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a North American Industry Classification System (NAICS) code of 541715 and the small business standard is 1,000 employees. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) is seeking an organization to continue supporting the functions of the United States Renal Data System Coordinating Center (USRDS CC). Background : The mission of National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support research on many of the most serious diseases affecting public health. The institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields, as well as many basic science disciplines. Among these diseases are end-stage kidney diseases. End stage renal disease (ESRD) is a major public health concern in the United States and around the world leading to enormous financial and personal costs. The United States Renal Data System (USRDS) is a national data system that collects, analyzes, and distributes information about chronic kidney disease (CKD) and end-stage renal disease (ESRD) in the United States. The USRDS is funded directly by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). USRDS staff collaborate with members of Centers for Medicare & Medicaid Services (CMS), the United Network for Organ Sharing (UNOS), and the ESRD networks, sharing datasets and actively working to improve the accuracy of ESRD patient information. The USRDS was created in 1988 in order to collect and analyze information on the incidence, prevalence, morbidity, and mortality of ESRD in the United States. The CC contract was awarded during the second phase of the USRDS project. Although the CMS previously maintained a data collection system, gathering information on Medicare beneficiary-specific entitlement, demographic, cost, and utilization data, and Medicare facility-specific certification data, a comprehensive ESRD database was not available. The USRDS fulfilled this unmet need. The current USRDS CC contract is held by the University of Michigan under contract number HHSN276201400001C. The period of performance of the current contract is from February 8, 2014 through February 7, 2019. Along with producing the Annual Data Report on ESRD & Chronic Kidney Disease (CKD) in the United States, the USRDS CC also fulfills data requests, provides standard analysis files and specialized datasets to researchers, produces the Researcher's Guide, and presents the results of its research at national conferences and in peer-reviewed journals. Six central goals define the mission of the USRDS: to characterize the ESRD population; to describe the prevalence and incidence of ESRD along with trends in mortality and disease rates; to investigate relationships among patient demographics, treatment modalities, and morbidity; to report the costs of ESRD treatments and total burden of ESRD program in the United States; to identify new areas for special renal studies and support investigator-initiated research. Purpose and Objectives: The USRDS has a primary objective of making data readily available to the renal community. In many cases, these requests can be answered by providing data currently published in the Annual Data Report (ADR) or elsewhere. Questions and data requests that are not answered directly by the ADR can be addressed to the Coordinating Center; all USRDS inquiries and requests are processed free of charge. Requests for data not available in the Annual Data Reports are evaluated on a case-by-case basis. Project Requirements: NIDDK is seeking an organization or institution to serve as the Coordinating Center (CC) for the United States Renal Data System (USRDS). The CC, in collaboration with the NIH and the Centers for Medicare and Medicaid Services (CMS), provides the biostatistical, epidemiological, data management and analytical expertise necessary to maintain and update the existing USRDS database. The CC also coordinates, scientifically manages, develops and expands the database; prepares and releases subsets of the database to support investigator-initiated research; publishes papers and reports of scientific findings based on USRDS data. To be deemed capable of performing this requirement, the offeror must submit a written capability statement that clearly demonstrates its experience and ability to support the USRDS project which consists of the following major objectives during its next cycle: TASK ONE: Transition Support The objective of this task is to ensure that the USRDS database, documentations and all related software can be transitioned seamlessly between the incumbent Contractor and the new Contractor, without impacting the USRDS operations. In order to reduce the risk to the USRDS operations during transition, the Government requires the development and implementation of transition plans at the beginning, interim and final stages of the newly awarded contract. Initial Transition-in Activities: The Contractor shall perform the following activities during the Transition-In Period of the Base year of the contract. • coordinate all communications and activities with the predecessor contractor; • transfer (from the predecessor contractor or the Government) and inventory all Government furnished equipment (GFE, if applicable), Government furnished material (GFM), Government provided data (GPD), and Government acquired data (GAD); • transfer the USRDS database from the predecessor contractor and set-up the database at the Contractor's facilities; • Coordinate the transfer of all software (source code and object code) for the website, database scripts, and other USRDS software; and • become proficient with all USRDS database systems by the end of the Transition Period. • Within 60 days of start of contract, provide to the NIDDK COR a draft report on the status of transition-in activities. Provide final report incorporating input from NIDDK COR within 90 days of start of contract. Interim Transition-out Activities: The Contractor shall, from the date of award, develop and document all systems and processes to ensure that there is an archived record of actions and practices. All records and information systems shall employ systematic version control, ongoing tracking and monitoring to enhance quality and ensure survivability. At least two months prior to the completion date of the Base Period, the Contractor shall provide to the NIDDK COR a draft transition-out plan that details the potential close-out or transfer of all contract related tasks to a potential successor Contractor. This document shall be organized and catalogued in sufficient detail to support an orderly transition to ensure continuity of the USRDS and its activities. The Contractor shall work with the COR and the Contracting Officer to refine and complete this plan. During each of the following Option Periods of the contract, this transition-out plan will be revised to reflect changes in the USRDS database, documents and software to facilitate smooth hand-off to any future contractor. The revised transition plans shall be will be updated and provide to the NIDDK COR at least 2 months prior to the end of each Option Period. The Final Transition Plan will be due either 1 month after notification by CO (that the next option is not being exercised) or 2 months before the end of Option Period 4. Final Transition-out activities: During the final Option Period, the current/incumbent contractor shall collaborate with the COR and the subsequent contractor to coordinate the handoff of USRDS operations, database, software and all related activities. In accordance with the COR and the new Contractor, the incumbent contractor shall provide support to meet the milestones and activities as per the COR-approved transition schedule. The incumbent contractor shall perform the transfer of all databases, data management systems, website software, all publications and documentation, and files to the government and/or subsequent Contractor. All data files and software systems shall be provided in electronic format and transferred in a secure manner that meets NIH FISMA guidelines. The incumbent contractor shall provide support for all transition activities till the end of the period of performance. The incumbent Contractor shall maintain full operational capacity during the transition period until the subsequent Contractor has taken full control with the approval of the COR. TASK TWO: PROVIDE LOGISTICAL SUPPORT FOR ALL MEETINGS AND CORRESPONDENCE: The USRDS will have a steering committee (SC) to oversee activities of the USRDS. The Steering committee will be composed of 2 representatives of the NIDDK, 1 representative from CMS, and the PI and Co-PI(s) from the USRDS CC. In addition, the USRDS will have an external expert panel (the EEP) which generally consist of 12 standing members (sufficient for at least one member per chapter in the ADR) with expertise in biostatistics, in renal disease representing dialysis, transplantation, epidemiology, economics, and other areas as may be defined by the PO. This group will meet at least annually as below. The CC will pay for consulting time and travel for members of the EEP and provide a pre-meeting summary including agenda, invitee roster and travel status NLT one week prior to meeting date. The contractor will provide logistical support for meetings involving the SC and EEP. The SC will have monthly phone calls concerning USRDS issues. The contractor will provide for the phone arrangements and will provide written minutes of each meeting to be supplied to the PO within one week of the phone calls. There will be at least one annual face-to-face meeting of the CC and the government POs at the CC site, typically in mid-September of each year, exact date to be determined between the CC and PO. The CC will provide logistical support for this meeting including the preparation of minutes, which will be provided to the PO within one week of the meeting. There will be at least one initial face-to-face meeting of the EEP with CC staff and government POs. This will take place at the NIH campus, with the exact date determined by CC, EEP membership and PO. Subsequent meetings can be held by teleconference at the discretion of the NIDDK PO. NIDDK will arrange for the meeting room, however the CC will pay for travel of the EEP. The CC will provide other logistical support for the meeting including minutes which will be made available to the PO within one week of the meeting date. When applicable, the Contractor shall consider Federal facilities first for hotels, conference centers, private sector businesses or other locations considered as an alternative location if deemed necessary through discussion between the Contractor and the COR. TASK THREE: PREPARATION OF ANALYSIS PLAN FOR THE ADR: Within two months of the award date, the contractor will provide the government PO a detailed plan for the creation of the following year's ADR. This plan will include a brief description of the previous ADR chapters and a plan for updating each chapter. The ADR analysis plan will be updated annually within two months after the publication of the ADR. The analysis plan will be submitted to the PO for review and approval and work on the ADR will not commence until PO approval is obtained. Each year's analysis plan will include responses to comments received from the government PO, the external expert panel, and others in the renal community. TASK FOUR: PREPARATION OF THE ADR: Annually, the contractor will publish the ADR. Drafts of the ADR will be provided to the government PO and EEP members by June of each calendar year (via email). Based on comments from the government PO and EEP the ADR will be published via the Internet by October of each calendar year. Assessment of all outcomes below shall include all ages (including children, which will require access to non-Medicare data as above) and, for non-fatal outcomes, shall include both inpatient and outpatient sources of information. The CKD/AKI chapters will include the following (although chapters may be added or deleted at the discretion of the NIDDK PO): 1. CKD in the General Population 2. Identification and Care of Patients with CKD 3. Morbidity and Mortality in Patients with CKD 4. Cardiovascular Disease in Patients with CKD 5. Acute Kidney Injury/Acute Kidney Disease (including acute presentations of kidney disease) 6. Health Care Expenditures for Persons with CKD (including both acute and chronic presentations of kidney disease) 7. Prescription Drug use in Patients with CKD 8. Transition of Care in Chronic Kidney Disease The ESRD volume will have the following chapters, although chapters may be added or deleted at the discretion of the NIDDK PO: 1. Incidence, prevalence, patient characteristics, and treatment modalities 2. Clinical indicators and preventive care, including Healthy People 2020/2030 goals 3. Vascular Access 4. Hospitalization 5. Mortality 6. Transplantation 7. Pediatric ESRD population 8. Cardiovascular Disease 9. Healthcare Expenditures for persons with ESRD 10. Prescription drug use in patients with ESRD 11. International comparisons of ESRD 12. CKD Analytical Methods The reference tables will include the following, although tables may be added, deleted, or modified at the discretion of the NIDDK project officer. Volume 1 - CKD: B. Prevalence K. Economic Costs of CKD Volume 2 - ESRD: A. Incidence B. Prevalence C. Patient Characteristics D. Treatment Modalities E. Transplantation: Process F. Transplantation: Outcomes G. Morbidity and Hospitalization H. Mortality and Causes of Death I. Patient Survival J. Provider Characteristics K. Economic Costs of ESRD L. Vascular Access M. Census Populations N. International Comparisons O. ESRD Analytical Methods In volume 2 - ESRD the following reference tables will contain both unadjusted and adjusted rates, A - incidence, B - prevalence, G - morbidity and hospitalization, H - Mortality and causes of death, and I - patient survival. The adjustment methods will include adjustment for age, sex, race and Hispanic ethnicity. The ADR will also include, as appropriate, maps showing the geographical dispersion of CKD and ESRD rates and outcomes. The maps will include the "hover" feature that displays the underlying statistics as viewers use the computer mouse to illustrate the data. TASK FIVE: Support for Government Data Requests At the direction of the Program Official and Project Scientist, the Contractor shall aggregate, analyze and release data for the use of the Government. Such data requests may require greater than two hours of personnel time. Ten (10) such requests are expected each year. TASK SIX: Support for Renal Community Data Requests The Contractor shall aggregate, analyze and release data to the renal community. Such data requests are limited to two hours or less of personnel time. One hundred (100) such requests are expected each year. Many of these requests are expected to be extracts of data already available in the ADR reference tables or chapters. These data releases will not require specific prior approval from the Program Official and Project Scientist. The Contractor shall track the number of such requests and report this information in the Quarterly Technical Progress Report TASK SEVEN: Preparation of Standard Analysis Files Preparation of Standard Analysis Files (SAFS). By January of each calendar year, the contractor will update the SAFs at the CC for release to the renal community (under tasks eight and nine below). A description of the SAFs can be found at: https://www.usrds.org/Products.aspx. In December of each year, drafts of the SAF's shall be disseminated to the PO for review via secure electronic transmission. A detailed cost report will be prepared each year concerning the costs of preparation of the SAFs. TASK EIGHT: Support for Standard Analysis Files Data Release At the approval of the Program Official and Project Scientist, the Contractor shall make available SAFs to investigators for the support of biomedical and/or economic research. Such data release shall conform to the prescribed "Policy on USRDS Data Release to Investigators" (see Appendix B of the 2016 ADR). The CC will report to the NIDDK PO monthly on the number of SAF requests will details of the costs incurred in supplying the data. As stated in the Policy, the Contractor shall only provide the requested data. CC personnel shall not be involved in further analysis of such data. However, the Contractor shall assist investigator(s) needing special technical assistance in utilization of the data in the database. It is expected that 50 such requests shall occur each year, although this does not constitute a binding limit. In addition, the contractor shall establish a web based portal for processing/evaluation of such requests by the NIDDK program officer, including a dashboard to assess progress of current requests and keeping all needed documents (Data use agreements (DUA), IRB approval memos, research protocols, and NIDDK DUA approval memos) mutually accessible to both NIDDK and the CC in a secure fashion, and allow seamless communication with the requestor. The contractor shall establish a separate portal for the corresponding processing of requests to approve manuscripts prepared from SAF analysis. An additional component of this web-based portal will be tracking submission and approval of manuscripts produced from analysis of the USRDS as approved DUA's TASK NINE: Support for Complex Data Release Requests The contractor will be responsible for performing more complex data requests, usually in the form of linkages with non USRDS data sources. These approved requests will entail individual programming efforts. The contractor will be responsible for performing up to 20 such data requests per contract year (with an option for additional requests in increments of five). The CC will report to the NIDDK PO quarterly on the number of SAF requests will details of the costs incurred in supplying the data. As stated in the Policy, the Contractor shall only provide the requested data. CC personnel shall not be involved in further analysis of such data. However, the Contractor shall assist investigator(s) needing special technical assistance in utilization of the data in the database. TASK TEN: Preparation of Data Analysis Publication Manuscripts The Contractor shall prepare manuscripts (deliverables of data analysis) for publication in peer reviewed medical/scientific journals in collaboration with the NIDDK staff, describing the research findings from the existing data studies. A minimum of three manuscripts are expected annually. The Contractor shall prepare all manuscripts in accordance with the USRDS Publication Policy (revised 2015, https://www.usrds.org/2017/view/Default.aspx). TASK ELEVEN: Transition of care CKD cohort study The Contractor shall, using appropriate data sources as above, develop a large cohort of patients at substantially decreased kidney function (eGFR of <=30 ml/min/1.73 m2, or stage 4 CKD) for whom the clinical course is followed until various outcomes of interest (death, renal replacement therapy, or custodial care (inpatient or outpatient, hospice etc.). Among key questions to be posed would be optimal timing of vascular access preparation/placement, appropriate provider counseling and education, changes in patterns of medication use through the continuum of chronic kidney disease to end stage renal disease or death. Note : The Government plans to have the USRDS website migrate from its current ".org" domain to a ".gov" domain over the next 12 months. Organizations should have the demonstrated capability of operating and maintaining computer systems, database applications and a website in a ".gov" domain. Anticipated period of performance: It is anticipated that the period of performance will be for five years from February 8, 2019 to February 7, 2024. Capability Statement Requirements: The intention of this announcement is to survey the market for potential offerors among small businesses including veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business and women-owned small business concerns. No large businesses should respond to this announcement. Interested small businesses that believe they possess the capabilities to perform the project requirements described above must submit electronic copies of their capability statements to Ms. Usha Raman at ramanu2@mail.nih.gov and to Ms. Pamela Nevels @ pamela.nevels@nih.gov Capability Statements should be received by the Contracting Officer by 1 pm ET Friday, February 2nd, 2018. Respondents must send capability statements via electronic submission only. Each response should include the following business information: • DUNS number. • Company Name. • Company Address. • Company Point of Contact, phone and Email address. • Whether the Organization has an approved accounting system, and if so, the agency that approved the system. • Company size and type (i.e., small business, 8(a), woman-owned, veteran owned, etc.) pursuant to the applicable NAICS code, as validated via the system for Award Management (SAM). All offerors must be registered on SAM at https://www.sam.gov The content of the capability statements shall be limited to fifteen pages describing the organization's experience and ability to perform this effort. Information submitted should be pertinent and specific in the technical area under consideration, on each of the following qualifications (1) Experience: an outline of previous projects, specific work previously performed or being performed and any in-house research and development effort;(2) Personnel: Name, professional qualifications and specific experience of scientist, engineers and technical personnel who may be assigned as principal investigator and/or project officer: (3) Facilities: Availability and description of special facilities required to perform in the technical areas under consideration, and a statement regarding industrial security clearance. Any other specific and pertinent information as pertains to this particular area of procurement that would enhance our consideration and evaluation of the information submitted. Resumes may be included in an Appendix which does not count in the fifteen (15) total page limit. The Appendix, which may only include resumes, is limited to an additional fifteen (15) pages. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. The Government reserves to 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 to provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to any forthcoming solicitation. 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(s). Information in the anticipated RFP supersedes any information in this Sources Sought notice announcement. Any enquiries regarding this sources sought notice should be directed to both, Ms. Usha Raman at ramanu2@mail.nih.gov and Ms. Pamela Nevels at pamela.nevels@nih.gov. Ms. Usha Raman Contracting Officer Acquisition Services Branch Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH 6710B Rockledge Drive; Room: 1161B MSC 7000 Bethesda MD 20892 Phone: 301-443-5228 Email: ramanu2@mail.nih.gov
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- Place of Performance
- Address: TBD, United States
- Record
- SN04792908-W 20180120/180118231107-30c768a0f79aebdbd5a31ec2adf98c10 (fbodaily.com)
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