The Veteran s Administration (VA) Office of Research and Development, Regional Procurement Office East in Pittsburgh, PA intends to negotiate on a sole source basis with Solellis Data, LLC based in Seattle, WA on behalf of the VA Puget Sound Healthcare System. The requirement is to The planned studies follow preliminary studies based on the same subject. The specific work to be performed includes: Background This procurement is to provide technical services to several ongoing medical study projects. This is a follow-on to a contract for like services. Scope The required services will be used to support a VA-funded research study (VAPSHCS MIRB# 00467 and 01703), administered through the VAPSHSC Rehabilitation Research & Development (RR&D) Center for Limb Loss and Mobility (CLiMB). The contractor shall provide technical services to several projects for both AMPREDICT PRO grants and the ankle arthroplasty study. This will include database troubleshooting and modifications, generation of summary tables and figures, website modifications, and database management of deidentified data. The contractor shall undergo all background checks, finger printing, and issued a badge. The contractor will have no supervisory role, will not be considered study staff engaged in human subjects research and will not have access to identifiable data. Specific Tasks Ankle study comparing arthrodesis to arthroplasty in patients with end stage ankle arthritis Trouble shoot and modify study database periodically per needs of the study. Manage study database of deidentified data that has been entered by study staff. This will include weekly checking/querying data and sending out queries to site study coordinators. Produce monthly follow-up summary tables for coordinator meetings. Assist in data analyses for papers or grants by ensuring study database is prepared for analysis and producing summary tables. Dysvascular amputation studies Continue to modify AMPREDICT Decision Support Tool website after physician usability testing which is a demonstration website of the prediction models and contains no study data. Participate as consultant in the transition from the current AMPREDICT website to integration with a larger website when we hire a web development team for the AMPDECIDE portal. Trouble shoot and modify the Redcap databases as needed and assist in producing summary tables of deidentified study data. 6. Performance Monitoring The VA Principle Investigator will provide direct oversight and supervision of work provided by the VA study team and will monitor/certify receipt of all deliverables. The preliminary and final deliverables and all associated working papers and other materials deemed relevant by the VA which have been generated by the contractor in the performance of these tasks are the exclusive property of the U.S. government and shall remain the property of the U.S. government upon completion of the contract. 7. Security Requirements Security Training Contractor is subject to all relevant VA National and local Medical Center security policies that exist, including 38 CFR 16 (Federal Policy for the Protection of Human Subjects (Common Rule). All contractor employees will complete the VA's on-line Security Awareness Training Course, the VA Cyber Security Awareness Course, and the Privacy Awareness Training Course and will do so annually. Contractors have and will continue to provide signed certifications of completion to the POC during each year of the contract. This requirement is in addition to any other training that may be required of the contractor and subcontractor(s) as they are considered Without Compensation staff and must meet all VA employee training requirements. The contractor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation. Contractor must also abide by the Standards for Privacy of Individually Identifiable Health Information, known as the HIPAA Privacy Rule. The HIPAA privacy rule and related information can be found on the Health and Human Services (HHS) and NIH websites: http://www.hhs.gov/ocr/hipaa/finalreg.html http://aspe.hhs.gov/admnsimp/, http://privacyruleandresearch.nih.gov/. Internet/Intranet The contractor will also comply with Department of Veterans Affairs (VA) Directive 6102 and VA Handbook 6102 (Internet/Intranet Services). VA Directive 6102 sets forth policies and responsibilities for the planning, design, maintenance support, and any other functions related to the administration of a VA Internet/Intranet Service Site or related service (hereinafter referred to as Internet). This directive applies to all organizational elements in the Department. This policy applies to all individuals designing and/or maintaining VA Internet Service Sites; including but not limited to full time and part time employees, contractors, interns, and volunteers. This policy applies to all VA Internet/Intranet domains and servers that utilize VA resources. This includes but is not limited to va.gov and other extensions such as, .com, .edu, .mil, .net, .org, and personal Internet service pages managed from individual workstations. VA Handbook 6102 establishes Department-wide procedures for managing, maintaining, establishing, and presenting VA Internet/Intranet Service Sites or related services (hereafter referred to as Internet ). The handbook implements the policies contained in VA Directive 6102, Internet/Intranet Services. This includes, but is not limited to, File Transfer Protocol (FTP), Hypertext Markup Language (HTML), Simple Mail Transfer Protocol (SMTP), Web pages, Active Server Pages (ASP), e-mail forums, and list servers. VA Directive 6102 and VA Handbook 6102 are available at: Internet/Intranet Services Directive 6102 http://www.va.gov/pubs/directives/Information-Resources-Management-(IRM)/6102d.doc Internet/Intranet Services Handbook 6102 http://www.va.gov/pubs/handbooks/Information-Resources-Management-(IRM)/6102h.doc Internet/Intranet Services Handbook 6102 Change 1 updates VA's cookie use policy, Section 508 guidelines, guidance on posting of Hot Topics, approved warning notices, and minor editorial errors. http://www.va.gov/pubs/handbooks/Information-Resources-Management-(IRM)/61021h.doc All contractor employees who require access to the Department of Veterans Affairs' computer systems have been subject to a background investigation and have received a favorable adjudication from the VA Security and Investigations Center (07C). This requirement will be applied to all new contractor or subcontractor personnel requiring access to the Department of Veterans Affairs computer systems. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed, but the contractor 8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). All equipment and software will be provided by the Department of VA. If there is ever any contractor supplied equipment, of any type, it must meet all security requirements that apply to Government Furnished Equipment and Government Owned Equipment as identified in VA Handbook 6500. will be responsible for the actions of those individuals they provide to perform work for the VA. 9. Other Pertinent Information or Special Considerations. The required services are highly specialized. Expertise is required in both data management and unique computer programming is necessary for the timely completion of the projects. a. Identification of Possible Follow-on Work. If data management is not completed within the final contract period, it is possible that an additional contract will be necessary to continue the work. Any work that increases the cost to the Government shall be approved, in writing, by the Contracting Officer prior to performance. b. Identification of Potential Conflicts of Interest (COI). No conflicts of interest to report. c. Identification of Non-Disclosure Requirements. The contractor will work with deidentified data and will work on site as VA Without Compensation (WOC) staff. Therefore, non-disclosure agreements are not required. d. Packaging, Packing and Shipping Instructions. None. e. Inspection and Acceptance Criteria. The POC is responsible for certifying that the work done under the contract is performed to time and standard. They are also responsible to assure the inspection and acceptance of products provided incidental to services. A demo period or trial is not inspection of a product. 10. Risk Control Staff will be working on site in VA designated space and will meet the requirements of Without Compensation staff. They will also be listed as study team members on the Internal Review Board (IRB) applications for specific projects they are working on; therefore, the security risk level is low. 11. Place of Performance. The work specified in this statement will be performed at VA Puget Sound Health Care System, 1660 South Columbian Way, Seattle WA 98108. 12. Period of Performance. The Government anticipates a firm-fixed price contract. The period of performance shall be: One Base Period of twelve months from 9/30/2021 9/29/2022 One Option Period of twelve months: 9/30/2022 - 9/29/2023 Privacy Officer Language Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data- General, FAR 52.227-14(d) (1). VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. Records Management Language for Contracts Required The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. The requirement will take place at a VA facility Seattle, WA. The sole source is pursuant to FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This notice of intent is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement and supporting documentation to the contracting office no later than Friday, Sept 24, 2021, (10:00 AM, EST). Interest/capability statements may be sent to Michael Haydo at
[email protected]. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.