AN12--Yoga Pain Specialist Research Support

THIS IS A SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The purpose of this Sources Sought Notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. The responses received from interested contractors will assist the Government in determining the appropriate acquisition method. The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 20, is conducting market research to identify potential sources which can provide the following in support of the VA Portland Health Care System (VAPHCS): VAPHCS has a need for Yoga Pain Specialist Research Support. STATEMENT OF WORK (SOW) 1. Contract Title. Contract for pain yoga specialist research services for Dr. Travis Lovejoy, a Principal Investigator at the VA Portland Health Care System. 2. Background. The VA Portland Health Care System (VAPORHCS), Research and Development Service, has a need for a base year, firm fixed price contract for pain yoga specialist research services. The contractor will work with VA Principal Investigator Dr. Travis Lovejoy on one of his VA funded research projects, titled Examining the effectiveness of asynchronous versus synchronous yoga for Veterans with chronic pain (Local IRB# 6160). This research project explores the acceptability and viability of asynchronous web-delivered yoga for rural veterans with chronic pain. The nature of the potential asynchronous web-delivered yoga platforms will aim to adhere to the model of the Mindful Yoga Program, developed by Mindful Yoga Works, LLC. This program has been shown in research trials to significantly reduced pain and fatigue in those living with chronic pain. This research support provided by the contractor is beyond what can be met by available research staff and includes services such as project design, as well as development of quality and safety monitoring and reporting protocols, and patient physical readiness assessments. The contractor will be local to the VAPORHCS research station. 3. Scope. VA Principal Investigator, Dr. Travis Lovejoy, requires research services from the Contractor, to support work on a VA-funded research project Examining the effectiveness of asynchronous versus synchronous yoga for Veterans with chronic pain . This project will use deidentified data with strict adherence to the VA approved protocols. This contract governs 1 position per year, with 3 deliverables required for a total cost of $20,000. Deliverable tasks are explained in detail in Section 12 of this document. Cost breakdown by deliverable is explained further in the attached ICGE. The scope of work for the Contractor may include training yoga instructors and face-to-face meetings with PIs. The project PI shall provide access to the appropriate research personnel and materials (management, technical, subject matter expertise, etc.) necessary to fulfill the contractor s requirements in a timely fashion. Contractors will either obtain a VA without compensation (WOC) appointment or be provided with VA data using an approved Data Use Agreement and deidentified data. IRB approval will be obtained prior to the Contractor initiating work with any VA data. The Contractor, in conjunction with the VA PI, shall follow regulations for gaining permission to use data, which may include establishing Data Use Agreements, obtaining IRB approval, and working with data stewards to obtain, understand, and validate data elements. 4. Specific Tasks. The tasks required will be at the discretion and supervision of Dr. Lovejoy. Task 1 Review web yoga platforms. The contractor will review and evaluate online yoga platforms for their content, level of difficulty, and pain area focus, with the outcome of finding 12 online yoga platforms to focus the research efforts on. Given that the suitability of the online yoga platform is largely dependent on adherence to the principles of Mindful Yoga as developed by Mindful Yoga Works, LLC, it is crucial that Mindful Yoga Works, LLC, has input on the review of these online platforms. Additionally, this task requires the contractor to possess the qualifications of an MPH and C-IAYT. Holding a Masters of Public Health (MPH) will ensure the contractor is aware of best public health care practices and ensure they have the qualifications to evaluate existing yoga platforms within the context of the VHA and Veteran care needs. A Certification of Individual Yoga Therapists (C-IAYT) is required to ensure that the contractor s qualifications meet or exceed the peer-reviewed process required to be recognized as a highly trained yoga therapist. Task 2 Develop safety protocols for project The contractor will create a safety SOP document to ensure the safety of participants as they engage in remote yoga exercise. They will also develop and train research assistants on safety and adverse events reporting protocols. This task requires that the contractor possess the qualification of an E-RYT. An Experienced Registered Yoga Teacher Certification (E-RYT) is required to ensure that the contractor has experience providing education workshops. This is important as a significant component of the eventual goal of this project will include Veterans being taught yoga via online learning, and the suitability of these teachings will need to be verified by an E-RYT certified instructor. Task 3 Assess participant readiness to engage in yoga The contractor will develop a protocol to correctly assess participant ability to engage in the remote yoga classes. This will enable the PI and research assistants to triage the research participants into the correct level of yoga class, one that matches their specific pain needs and physical ability. 5. Performance Monitoring. The contractor shall meet with the PI at the beginning of the contract award and as needed to review the research project protocol with the PI, discuss the status of the data and/or other project duties to include, but not limited to, issues, milestones and outstanding actions. Progress Reports shall cover all work completed during the reporting period and work scheduled for the subsequent reporting period. The report shall also identify any problems that arose and a description of how the problems were resolved. If problems have not been completely resolved, the Contractor shall seek guidance from the PI. Fewer than 3 instances of noncompliance for each task will be considered fully successful in an annual evaluation period. 6. Security Requirements. All contractor employees are subject to minimal investigation due to not needing access to PHI or VA facilities. 7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). All contractors will utilize personal devices for use on VA projects as no PHI needs to be accessed for this stage of the project. Software appropriate to the position and available to VA staff will be provided. Project-specific software or other GFE will be provided by the PI for each research study if needed. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor 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 contractor 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 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 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 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 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 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 electronic storage media for restoration in case any electronic equipment or data used by the contractor 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. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. All contracted associates will not need to utilize VA IT equipment. 8. Other Pertinent Information or Special Considerations. a. Identification of Possible Follow-on Work. This contract is for research support of one VHA project. Services may continue to be needed after the expiration of this contract, based on project support needs and funding. b. Identification of Potential Conflicts of Interest (COI). An organizational COI is a situation where because of other relationships or activities a person (company) is unable or potentially unable to render impartial assistance or advice to the Government or cannot objectively perform contract work or has an unfair competitive advantage. FAR 9.502 states that an organization COI may result when factors create an actual or potential conflict of interest on an instant contract, or when the nature of the work to be performed on the instant contract creates an actual or potential COI on a future acquisition. An organizational COI exists when the nature of the work to be performed may, without some restriction on future activities, (1) result in an unfair competitive advantage to the contractor or (2) impair the contractor s objectivity in performing the contract work. In services contracts, it is the latter which may most often occur because of a contractor s access to proprietary information, the evaluation and analysis of products which it may produce, and/or its role as an advocate in contract performance or other situations. The primary burden is on the contractor to identify any organizational COI; however, the Government has the responsibility to identify and evaluate such conflicts. The Contracting Officer is charged with avoiding, neutralizing or mitigating such potential conflicts. It is the VA s responsibility to determine that no organizational COI exists. This is because the customer is more familiar with its requirements and the history of the requirements than the Contracting Officer could ever be. Therefore, the customer must make a determination that no COIs exist or identify any potential COI that may exist prior to the execution of this contract. c. Inspection and Acceptance Criteria. The PI 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. 9. Risk Control Identifiable data will be maintained in secured databases at all times. The contractor shall certify to the Contracting Officer s Technical Representative (COTR) that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes current versions of Internet Explorer and Windows (in Protected Mode on Vista) and future versions, as required. The contractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties. The contractor agrees to: (1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies: (a) The Systems of Records (SOR); and (b) The design, development, or operation work that the contractor is to perform; (2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and (3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency. (1) Operation of a System of Records means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records. (2) Record means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph. (3) System of Records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. 10. Place of Performance. All the contracted work will be done remotely, through a telework agreement. 11. Period of Performance. This contract will begin on 06/01/2024 for one base year, ending at the close of fiscal year on 09/30/2024. We have budgeted for three additional option years, with deliverables to be determined based on project needs. If needed, Option Year 1 would begin on 10/01/24 to 09/31/2025; with Option Year 2 and 3 to follow. Additionally, as discussed with the contractor, we would like to implement a no-cost extension of 6 months to account for possible delays in processing that would hinder work completion. Base Year: 06.01.24 09.30.24 OY1: 10.01.24 09.30.25 OY2: 10.01.25 09.30.26 OY3: 10.01.26 09.30.27 OY4: 10.01.27 09.30.28 12. Delivery Schedule. The contractor will submit deliverables over the course of the contract, with the deadlines to be determined by the PI, Dr. Lovejoy, based on research needs. Below are the agreed upon deliverables for the Base Year. Deliverable 1 Review and evaluate up to 12 online yoga platforms to determine safety and suitability of yoga content for asynchronous delivery to veterans living with chronic pain. Deliverable 2 Create a safety SOP to be utilized in a study evaluating the effectiveness of online yoga for veterans living with chronic pain. Deliverable 3 Create an assessment SOP that identifies veteran readiness to engage in yoga practice. Potential candidates having the capabilities necessary to provide the above stated supplies at a fair and reasonable price are invited to respond to this Sources Sought Notice via e-mail to Nazanin Kreiner at contact@example.gov no later than April 11, 2024, 5:00PM MDT. No telephone inquiries will be accepted. RESPONSES SHOULD INCLUDE THE FOLLOWING INFORMATION: Company name, address, SAM UEI and business size; point of contact name, phone number, and e-mail address; whether services are presently offered on a current GSA Federal Supply Schedule contract. NAICS Code 541715 Size Standard: 1,000 employees is applicable to determine business size standard. Any questions or concerns may also be directed via email to Nazanin Kreiner at contact@example.gov. Disclaimer and Important Notes: This Sources Sought 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. The Government will treat any information received as proprietary and will not share such information with other companies. Any organization responding to this Sources Sought 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. The Government may or may not issue a solicitation as a result of this announcement. There is no solicitation available at this time.