Sources Sought Only This sources sought is issued solely for information and planning purposes – it does not constitute a Request for Proposal (RFP) or a promise to issue a RFP in the future. This sources sought does not commit the Government to contract for any supply or service. The Government is not currently seeking proposals. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. The sources sought responses are advised that the Government will not pay for any information or costs incurred in response to this sources sought; all costs associated with responding to this sources sought will be solely at the interested party’s expense. Not responding to this sources sought does not preclude participation in any future RFP, if any is issued. If a solicitation is released, it will be synopsized on beta.sam.gov. It is the responsibility of the potential offerors to monitor this site for additional information pertaining to this requirement, if any. Purpose and Objective: The Centers for Disease Control and Prevention (CDC), National Center on Birth Defects and Developmental Disabilities (NCBDDD), Birth Defects Monitoring and Research Branch (BDMRB) is seeking to determine the availability of potential large and small business vendors (e.g. 8 (a), veteran-owned small business, service-disabled veteran owned small business, HUBZone small business, small disadvantage business, and women-owned small business) for the following project. BDMRB, NCBDDD, CDC has an immediate need for the acquisition and configuration of new database software and infrastructure for MACDP to expedite the process by which congenital defects data are collected, reviewed, analyzed, and disseminated for public health action. Migration to a web-based system that can ultimately facilitate electronic health records (EHR) interoperability and is expected to substantially improve data timeliness and system performance. Timely data are critical for CDC to respond to emerging threats, such as Zika and COVID-19. A new system will also improve other uses of MACDP data, including the transfer to case information to CDC’s existing case-control study, the Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS) and to the Congenital Heart Defects Surveillance Across Time And Regions (CHD-STAR). The new MACDP database must be web-based and centralized and should include any necessary add-ons for data visualization and reporting functionality. The application should also have in place all necessary licenses, personnel, materials, and equipment to begin configuration of the OpenClinica® data entry and management software for the new MACDP database. Description of Tasks: Task 1: Configuration and Customization of OpenClinica® The contractor shall customize and configure OpenClinica® using an iterative development approach in regular communication with the COR and technical monitors. Development will include all necessary data elements and functional requirements, such as user-friendly data entry forms, tracking case completion/abstraction status (e.g., vital record identified, clinical review complete), business rules and data quality checks, automatic case processing (e.g., routing record back to the field if missing birth hospitalization details), and robust record search capabilities. The contractor shall ensure long-term maintenance of systems operations, including external interface management, data integrity validation, operation reporting, database administration, network monitoring, performance tuning, backup and disaster recovery, upgrades and maintenance, monitoring and performance. The contractor shall ensure modifications are made as necessary. Assigning priority to maintenance tasks will be done in consultation with the COR. Task 2: Data Management The contractor shall securely maintain, manage, and transmit data using a secure method of data transfer and storage consistent with CDC Information Technology Security protocols, such as full data encryption at rest and in transit to be approved by COR. The contractor shall provide database version control and records retention. Task 3: Data Extract Delivery The contractor shall develop a routine in-tool report that provides key data elements and metrics in real-time to summarize the following: Cases in Process by current stage (e.g. Vital records check, Birth address check, Non-clinical review, Clinical review, Return to Field, Hold and Finished cases). The in-tool report shall require COR approval. The contractor shall also develop a report or data extract that program staff can execute as needed which includes key variables (e.g., contact information) for BD-STEPS eligible patients from finalized records. In lieu of an in-tool report, a weekly dataset may be provided to meet the criteria described, and should be transmitted using a secure method of data transfer consistent with CDC Information Technology Security protocols: Possible mechanisms include a secure FTP (file transfer protocol) or S3 transfer. Estimated Period of Performance: Base Year + 4 Option Periods Responses: Interested parties believing that they possess the expertise and experience to meet the Government's needs described above are invited to submit a capability statement with their technical and management capabilities addressing the requirements. Specifically, vendors must demonstrate experiences with configuring similar surveillance database projects (OpenClinica ®). NCBDDD is looking for a company with current access to an OpenClinica license. Any current or recent experience with OpenClinica customization, implementation, and operation would be a good attribute for a prospective bidder. NCHHSTP currently does not have the time nor resources to custom build a new database. Interested parties are requested to include the following information in their response: 1. Company name, address, phone number; 2. UEI number and CAGE Code, as registered in the System for Award Management (SAM) at http://www.betaSam.gov/ 3. Business size and Classification (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code of 541611. 4. Small Business Administration Business Opportunity Specialist (name, email address, phone number) if applicable. 5. Point(s) of contact including e-mail addresses and telephone numbers for contacts 6. Current Federal Government-Wide contract vehicles for your company that would be appropriate for this sources sought notice. For example, GSA Federal Supply Schedule, NITAAC, NASA SEWP, GSA Alliant, GSA OASIS, etc. Submission Instructions: Responses are due via email on or before Thursday, May 26, 2022, at 1:00 p.m., Eastern Time, to Sheenum Gupta, email address:
[email protected] and must include the information requested below. Only emailed responses will be accepted. Copy and paste into subject line: Response to Sources Sought for NCHHSTP MACDP Database for (insert your company name). Responses are limited to 10 pages, 11pt Times New Roman font. Responses greater than 10 one-sided pages will not be considered. Late responses will not be accepted. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in the response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). This is strictly market research, and the Government will not entertain any questions or phone calls.