SOURCES SOUGHT
R -- Building Data Infrastructure in the Safety Net to Conduct Patient-Centered Outcomes Research
- Notice Date
- 7/19/2013
- Notice Type
- Sources Sought
- NAICS
- 518210
— Data Processing, Hosting, and Related Services
- Contracting Office
- Department of Health and Human Services, Health Resources and Services Administration, Office of Acquisitions Management and Policy, 5600 Fisher Ln., Room 13A-19, Rockville, Maryland, 20857, United States
- ZIP Code
- 20857
- Solicitation Number
- 13-250-SOL-CHARN
- Point of Contact
- Biji John, Phone: 3014430684
- E-Mail Address
-
bjohn@hrsa.gov
(bjohn@hrsa.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential small businesses (e.g., 8(a), service-disabled veteran-owned small business, HUBZONE small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.102(s) 1. The potential small business will need to demonstrate the ability to (1) provide to build data capacity in the safety net with a special focus on community health centers and (2) maintain strengthen, expand, and extend the reach of a data and research infrastructure which was established under the Community Health Applied Research Network (CHARN). HISTORY: The Affordable Care Act (ACA) of 2010 directs the U.S. Department of Health and Human Services (HHS) to build data capacity for patient-centered outcomes research (PCOR). As a result, the CHARN was established through five (5) cooperative agreement grants in September 2010 under the American Recovery and Reinvestment Act of 2009 to create an infrastructure that has the capacity to pool the experiences of patients across different sites and treatments for the purpose of conducting comparative effectiveness research (CER) observational and interventional studies. CHARN is organized into a data coordinating center at the Center for Health Research at Kaiser Foundation Hospitals and four (4) research nodes: (1) the Association of Pacific Community Health Organizations, (2) Alliance, (3) Fenway Health, and (4) OCHIN, Inc. CHARN database is housed with the data coordinating center and is the property of grantees. It is a practice-based network of community health centers that was established in 2010 to build the capacity for PCOR in the safety net. It fosters data sharing among its participating health centers and the conduct of collaborative research. CHARN has established a centralized clinical data registry with data on 500,000 patients seen in health centers. The CHARN data and research infrastructure can be leveraged to address the data needs of patients and their providers in health centers, as well as the data needs of policy makers who monitor the safety net. CHARN's infrastructure provides (1) data for analytic studies; (2) a platform for conducting observational and interventional studies and accelerating the pace of research dissemination and adoption; and (3) data and research capabilities for quality improvement within participating organizations. The purpose of this requirement is to (1) aggregate data to create a clinical data set in the safety net by linking data from different heath centers; (2) broaden access to the CHARN data and research network; and (3) support the governance structure, creating a reliable and sustainable data source. DESCRIPTION OF WORK: The NAICS code is 518210. The contract will include the following requirements: 1.Maintain and strengthen the exiting data infrastructure for research. 2.Continue to build capacity for collaborative research within and among participating health centers. 3.Create a CHARN database that is usable and available to both CHARN investigators and researchers outside the CHARN network. 4.Develop process to broaden access to CHARN data and infrastructure so that researchers outside of CHARN gain access to the data. 5.Increase sustainability of the network. CONTRACTOR REQUIREMENTS: The contractor must have the ability to access to the CHARN database; collaborate with the four (4) research nodes; and manage the CHARN data coordinating center. The contractor must respond in detail to ALL of the following points by demonstrating your experience and ability to provide: 1. Database in the Safety Net Provide an existing database in the safety net that has a volume of 500,000 or more patient data to conduct patient-centered outcomes research (PCOR). This database shall be IMMEDIATELY ready and primed for the type of analysis needed to make projection for the Affordable Care Act (ACA) program planning as well as monitor the impact of ACA implementation. 2. Impact of ACA on Health Centers Available research capacity developed to monitor the impact of ACA on health centers. 3. Research Quality Clinical Data Registry Develop and manage research quality clinical data registry. 4. Standardized Readily Usable De-identified Analytic Data Sets Create standardized de-identified analytic data files that are ready for analysis using existing CHARN registry data that have already been validated. The first analytic file created should include data that already exist in the CHARN registry at the beginning of this project. This data file will include at a minimum V1 data, or at a maximum all three phases of V2 data. The exact specification of the first analytic file will depend on the scope of the V2 registry at the beginning of project period. Develop technical a code book that will support the use of these de-identified registry data files. 5. Comprehensive CHARN Data Plan Using the current CHARN registry, develop a plan for the extraction of data, submission of data to the CHARN registry, and the creation of analytic files during the project period. The plan shall include an assessment of data that are already in the registry; the frequency and total number of data submissions over the course of the project period; timeline for submissions; number of de-identified analytic data files to be created; and a schedule for the development and completion of de-identified analytic data files. Describe the approach to developing the registry, the content of the registry, data elements to be included, data use policies, registry database design, data submission procedures, and plans and policies for protecting human subjects. 6. Data Aggregation and Validation Immediately adopt the COR-approved comprehensive data plan and the expansion of the current CHARN registry. Develop an expanded registry to include the following: Base Period - registry includes V2 and adds calendar year 2013 data; Option Period 1 - the above plus calendar year 2014 data; and Option Period 2 - all of the above plus calendar year 2015data Data validation shall be completed 10 months from the EDOC of the base period and option periods. Conduct data aggregation and validation of the data submitted by each of the four (4) research nodes for the base period and option periods per the comprehensive data plan. By the end of the option period 2, the registry shall have expanded to include all of V2 data elements from January 2006 until December 2015. Conduct ongoing validation of registry data using methodologically rigorous standards and approaches. In addition, the Contractor shall obtain input from the Steering Committee in the validation of the data, creation of all analytic files, and the development of technical assistance material. Validate the data submitted by during the first 6 months of the project year. 7. Capacity to Conduct PCOR in the Safety Net Support the conduct of research projects that use the CHARN network or registry data for PCOR, quality improvement, and addressing clinically and policy-relevant questions. This research can be conducted by CHARN investigators as well as investigators external to CHARN who are interested in adding to the knowledge base of health care in the safety net. 8. Process for Increasing Access to CHARN Registry Data Develop and implement a plan that addresses the sensitive handling of the data and increases access to CHARN data by external investigators in collaboration with the CHARN Steering Committee (Steering Committee). The plan shall draw on national models of data sharing of sensitive data. Assess the strengths and limitations of existing models for sharing of sensitive data and develop a brief 3-5 page report of findings for discussions at the first Steering Committee Meeting. The contractor submit the report inclusive of comments from the Steering Committee to the COR. Develop, in collaboration with the Steering Committee, a plan (5-10 pages) that includes an approach for developing, implementing, and monitoring a process for external investigators to access and utilize the CHARN data and network. The plan shall also include a strategy for communicating with the intended research audience. The plan shall be submitted to the COR for final approval before implementation. Adopt, implement, and monitor the data access plan and operationalize the COR-approved data access process within one (1) year from EDOC. Monitor operation of data access process and recommend improvements to the process. The contractor shall submit a brief 2-5 page report of recommended improvements. 9. Annual Assessment of Network Conduct an annual assessment of the functioning and effectiveness of the network to include the following: (1) assessing the relationships within the research nodes, among the research nodes and between the research nodes and data coordinating center; (2) reviewing the data extraction, submission, and validation processes; and( 3) evaluation the process of creating de-identified files. Monitor the network to strengthen its functioning. The Contractor shall use the findings of this annual assessment to define and develop the technical assistance support for research nodes and health centers to improve the data-related processes. The Contractor shall also review the performance of the research nodes in meeting the five project objectives as part of this annual assessment. Summarize the findings from this annual assessment in an annual network report. This report shall be 8-10 pages and include recommendations for strengthening the network. The Contractor shall obtain input on this report from CHARN's Steering Committee, prior to submitting its submission to HRSA. The report shall be submitted to the COR. Submit information related to performance metrics to the COR. 10. Technical Assistance to Research Nodes and Health Centers Provide technical assistance to research nodes and health centers to support data extraction and submission to the registry. Technical assistance includes: -Data extraction and encryption protocols consistent with IRB and OMB; -Management and documentation of missing data; -Maintenance of backup files; -Methods for transmitting data electronically consistent with HIPAA guidelines; -Methods of data collection (should the members wish to modify their existing data collection protocols); -IRB clearances; -Data use agreements; -Development of software to facilitate extraction, encryption, or submission of data; and -Submission of data Provide technical assistance and support to health center investigators including participation in all phases of the research cycle-defining a research question, designing a research study, conducting data collection and analysis, and reporting on the results. 11. Support for CHARN Steering Committee, Subcommittees, and Work Groups Provide administrative support for the work of CHARN's Steering Committee (Steering Committee) and any attendant subcommittees and work groups. Convene the Steering Committee two (2) times a year to conduct the work of this project in a city where the research nodes are located. In addition, the Steering Committee may be convened by conference call. The first Steering Committee meeting must be within two (2) months of EDOC. Alterations to the schedule shall be submitted to the COR for approval. 12. Host, coordinate, and staff subcommittee and work group call Work with the Steering Committee to establish meeting dates and agendas. The Contractor shall seek input and approval from the COR prior to finalizing meeting dates and agenda. The Contractor shall submit a steering committee meeting agenda and a logistics plan that includes time frame and budget to the COR for approval. The Contractor shall handle all logistics, including securing and paying for meeting space, equipment rentals, material development and reproduction. Arrange and pay for travel and lodging for up to six (6) members of the data coordinating center and up to three (3) expert members of the steering committee. Within 2 weeks of conducting the meeting, develop and submit a concise and comprehensive meeting report (5-8 pages) to the COR. This report shall include agenda items covered, issues discussed, accepted resolutions, and any other relevant comments or points made during the Steering Committee meeting. Use the existing CHARN communications platform to coordinate the work of the Steering Committee and its subcommittees and ad hoc work groups. This communication platform includes the use of the CHARN intranet site as well as the provision of conference call services. Provide summaries of subcommittee and work group calls to meeting participants with a copy to the COR one (1) week after these meetings. Interested parties that have capabilities necessary to perform the stated requirements may submit capability statements to Mr. Biji John at bjohn@hrsa.gov. CAPABILITY STATEMENTS MUST DEMONSTRATE THE MINIMUM REQUIREMENTS OUTLINE ABOVE. Please address each in the order listed above. TEAMING ARRANGEMENTS: All teaming arrangements shall include the above-cited information and certifications for each entity on the proposed team. Teaming arrangements are encouraged. Responses must be submitted no later than July 24, 2013. Capability statements will not be returned and will NOT be accepted after the due date. This is not an invitation for bid, request for proposal or other solicitation and in no way obligates HRSA to award a contract. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. Please provide the following Business Information: 1. DUNS Number 2. Company Name 3. Company Address 4. Company Point of Contact, phone number, and email address 5. Type of company under NAICS/PSC, as validated via the System for Award Management (SAM). Additional information on the NAICS code can be found at www.sba.gov. 6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.) 7. Current GSA Schedules appropriate to this Sources Sought Notice 8. Current Government Wide Agency Contracts (GWACs) 9. Point of contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. 10. Responders should also include a statement about whether or not they have an approved Federal audited accounting system. If the responder has an approved accounting system, please provide the certification in which the accounting system was deemed adequate (e.g. the name of the audit agency and audit number). You may submit as an attachment. All capability statements can be submitted via e-mail, facsimile, or regular mail to the point of contact listed below. Responses shall be limited to 25 pages. Responses must be submitted no later than 10:00 a.m. Eastern Standard Time, August 2, 2013. NO QUESTIONS WILL BE ENTERTAINED AT THIS TIME. THIS IS FOR MARKET RESEARCH ONLY. Documentation should be sent to: Office of Acquisition Management and Policy ATTN: Biji John 5600 Fishers Lane, 13A-55 Rockville, MD 20857 bjohn@hrsa.gov
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