Inactive Total Small Business Set-Aside (FAR 19.5)

Human Performance Lab (HPL) Exercise Testing The purpose of this Sources Sought Notice is for market research to obtain information regarding the potential availability and capability of qualified Ser... Human Performance Lab (HPL) Exercise Testing The purpose of this Sources Sought Notice is for market research to obtain information regarding the potential availability and capability of qualified Service-Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), Small Business Manufacturers, other Small Businesses interested and capable of providing items requested. These sources sought is set-aside for small business and seeks providers capable of fulfilling the requirement in accordance with the Statement of work (SOW) The responses received from interested contractors will assist the Government in determining the appropriate set-aside and the appropriate acquisition method. The intended contract is a firm-fixed price service contract. The SBA Non-Manufacturer Rule Waiver will not apply for this requirement. The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 20, VA Portland VA Healthcare System is conducting market research to identify potential contractor sources which can provide the following Service: Human Performance Lab (HPL) to fulfill the specific objectives established in the project entitled Exercise-Induced Hypoalgesia in Women Veterans with Chronic Musculoskeletal Pain: a Comparison of Low, Medium and High Intensity Interval Training. in accordance with the SOW. Potential sources having the capabilities necessary to provide the above commodities which meet all the requirements outlined in the attached Statement of work are invited to respond to this Sources Sought Notice via e-mail to phillip.folger@va.gov no later than noted in this Sources Sought Notice. No telephone inquiries will be accepted. 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 supply the required commodities. 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. Appropriate responses shall include the following information: Company name, address, and business size; point of contact name, phone number, and e-mail address; A capability statement addressing the requirements in the attached Statement of work to include: References for similar commodities currently being provided or previously provided (if any) at the required service levels as outlined in the Statement of work (SOW). Capability Statement. Capability to provide required supplies at VISN 20 in accordance with the Salient Characteristics. NAICS Code 541715 is applicable to determine business size standard. Introduction. Statement of Work The purpose of this Statement of Work is to outline the tasks and responsibilities for the Human Performance Lab (HPL) to fulfill the specific objectives established in the project entitled Exercise-Induced Hypoalgesia in Women Veterans with Chronic Musculoskeletal Pain: a Comparison of Low, Medium and High Intensity Interval Training. This project is funded by the VA s Health Services Research & Development (HSR&D) Pain/Opioid Consortium of Research (CORE) who strive to enhance collaboration and accelerate research related to nondrug interventions for chronic pain. This project will study the effect of various intensities of interval exercise on Women Veterans experience of post-exertional pain. The bouts of exercise are designed to take place in a state-of-the-art exercise physiology lab where participants will exercise on a cycle ergometer while the lab monitors heart rate, exertion, and pain. HPL must be a state-of-the-art physiology lab that has experience in conducting several NIH funded studies pertaining to exercise testing and training. Scope. Twelve participants will be recruited from the VA Portland Healthcare System s Women's Health Clinic (WHC). HPL will provide subjective matter expertise, technical skill and knowledge, and exercise testing capabilities. All tasks related to this project will be initiated by the contractor through strict adherence to the Joint OHSU/VA approved study protocols, approved on 3/19/2024. Specific Tasks. Enrollment of Veterans: Completion and maintenance of necessary trainings relevant to working with Veterans. Completion of screening questions via telephone to quantify duration, persistence, severity, and quality of pain to ensure study eligibility as described in the Joint IRB approved study protocols. Submission of documents to be added to the Joint IRB. Human Performance Lab Testing Collection of pain phenotype questionnaires at the onset of the study as outlined in the Joint IRB-approved protocol. Completion of interval exercise protocols as listed in the Join IRB-approved protocol: The exercise interventions are: (1) a low-intensity interval training protocol consisting of 1:00 rest to 1:00 exercise at 60-65% of estimated maximum heart rate, (2) a medium-intensity interval training protocol consisting of 2:00 rest to 1:00 exercise at 75-80% of estimated maximum heart rate, and (3) a high-intensity interval training protocol consisting of 4:00 rest to 1:00 exercise at 90-95% of estimated maximum heart rate. Maximum heart rate (HR max) will be calculated using the Tanaka equation (208 0.7 × age) HR will be measured with a wearable chest-strap monitor. The participants will be encouraged to pedal the bicycle to maintain HR in goal range, and they may ask the research assistant to adjust the resistance of the cycle ergometer during the intervals if desired, but they will be encouraged to stop if they feel pain or do not feel safe. If they are not able to achieve the heart rate goals, they will be asked to make their best attempt. Collection of pain data: Before and after each intervention; obtain both a self-reported pain level and measure each participant s pressure pain threshold. Administer the well-validated Brief Pain Inventory, Short Form to assess pain severity and pain interference. This measure will be administered at all study assessments and at the beginning of exercise sessions. Ask participants about current pain at the beginning and end of bouts of exercise and at the post-exercise 48-hour follow-up via telephone call. -Collect pressure pain thresholds using a pressure algometer at the rectus femoris and first interosseous muscles. Each site will be measured 3 times; a mean will be used. Pain thresholds will be obtained within 2 to 6 minutes of the completion of exercise. Adverse Event Reporting 3.1 Modifications to the project s protocol will be submitted to the Joint OHSU/VA IRB for review and approval prior to implementation. 3.2 Serious adverse events will be reported to the PI who will notify, in writing, the IRB within 5 business days of becoming aware of the occurrence. 3.3 Nonreportable events and minor protocol deviations will be collected and reported nto the PI within 5 business days of being made aware of the occurrence. Data management: Manage de-identified databases for pain scores. Manage databases to ensure proper storage, safety, and utilization of records. Update databases and modify databases as needed. 5. Performance Monitoring. The Contractor shall meet with the PI at the beginning of the contract award and as needed to review the project s protocol. The PI will be available as needed to the Contractor to discuss the status of enrollment, exercise testing and collection of pain-related data. The PI shall monitor Contractor performance throughout the period of this contract to determine whether they are achieving performance objectives and verifying completion of deliverables. The PI will conduct periodically quality reviews by attending exercise/pain testing sessions to ensure that the Contractor is following correct protocols and documenting data appropriately. The PI shall provide access to the appropriate patient information necessary to fulfill the Contractor s requirements in a timely fashion. The Contractor shall submit final data sets to the PI. The report should include raw data and tables/charts formatted for peer review publication. 6. Security Requirements. The Contractor employees shall not have access to VA sensitive or computer information and will not require routine access to VA Facilities. The Contractor employees shall require intermittent access only and will be escorted by VA employees while at VA Facilities for meetings. No background investigation is required Databases must adhere to VA data security and privacy regulations and must utilize VA-approved software, such as Microsoft Excel. Only IRB- approved study personnel will have access to the data. Contracted personnel must not share data outside of the VA network. All electronic data must reside on VA-owned servers on the VA network behind the firewall. Backup of data must reside on a VA server. VINCI the VA Informatics and Computing Infrastructure can also be used for data analysis and storage. These servers reside at the Austin Information Technology Center (AITC), located in Austin, Texas. To ensure the protection of Veterans data, VINCI maintains compliance with the guidelines set forth by Veterans Health Administration (VHA) Handbook 1200.12, Use of Data and Data Repositories in VHA Research and all other applicable VA and VHA policies and regulations. In addition, VINCI has undergone all security certification activities in support of obtaining an Authorization to Operate (ATO). Access to VINCI resources will be approved in accordance with the requirements of National Data Systems (NDS), VHA Handbook 1200.12, Use of Data and Data Repositories in VHA Research, and all other applicable VA and VHA policies and regulations. The Contractor shall complete Without Compensation all required training. 7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). The Contractor will not use and Government-Furnished Equipment or Information./ 8. Other Pertinent Information or Special Considerations a. Identification of Possible Follow-on Work. There is no anticipated Follow-on Work. b. Identification of Potential Conflicts of Interest (COI). The PI does not anticipate creation of an organizational COI as a result of completion of this project. c. Inspection and Acceptance Criteria. Upon completion of this project, the PI shall submit deliverables to the COTR for review. d. Please see Sole Source Justification 9. Risk Control On enrollment, patients will undergo a health assessment by a physician, and they will be excluded if they are deemed unable to participate in moderate or high intensity interval exercise. As a result, serious risks are not anticipated. If a patient sustained an injury during the exercise training, the PI would be called, and the patient would either be sent to the VA Emergency Department or the PI would facilitate follow-up at the Women s Health primary care clinic within 2 weeks. Any adverse events would be reported to the PI who would notify the IRB within 5 business days of being made aware of the occurrence. The PI would summarize and submit all reportable and nonreportable events to the Joint IRB at Project closure. 10. 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. 11. Place of Performance. Exercise testing will be performed at vendor provided Human Performance Lab (HPL). Meetings will take place at VAPORHCS and/or OHSU and/or virtually via Teams or Webex. De-identified patient data will be kept either within the secure VA VINCI platform workspaces or within user-restricted VAPORHCS Research network folders. No OHSU data will be exchanged through this contract. The VA IRB or VA-OHSU Joint IRB will oversee projects related to this contract.  Deliverable Date Number of test Cost per test Total After award: Potential award date 3/1/2025 36 12. Period of Performance. March 1, 2025, through February 28, 2026. 13. Delivery Schedule Recruitment is estimated to take 6 weeks, starting after contract and IRB approval. After a participant is recruited and scheduled for intake, their exercise, pain testing and follow-up will take place over an 8-week timeline (each bout of exercise and control will be separated by 2 weeks). Within 4 weeks of the completion of the scheduled bouts of exercise for all 12 participants, the Contractor shall deliver documentation in electronic format. Acceptable electronic media formats include: MS Word, MS Excel, MS PowerPoint, MS Access, SPSS, Stata, SAS, R, SQL or other if determined appropriate and approved by the PI. If for any reason, any deliverable cannot be delivered in the timeframe agreed upon, the Contractor shall provide a written explanation to the PI; this written transmittal shall include a firm commitment of when the work shall be completed. This notice needs to cite the reasons for the delay, and the impact on the overall project. Delivery: The vendor must coordinate with the below individuals to coordinate delivery, installation, & other services: TBD 800-949-1004 Station.poc@va.gov 13.2. Hours of Operation Normal tour-of-duty hours at the VAGLAHS are 8:00 am to 4:30 pm, Monday through Friday, excluding Federal holidays. There may be instances in which the Vendor s workday may be outside of this period. The Vendor is required to coordinate these times with the designated Program Manager. In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as Legal Federal official holidays . New Year s Day January 1st Martin Luther King s Birthday Third Monday in January President s Day The third Monday in February Washington's Birthday The third Monday in February Memorial Day The last Monday in May Juneteenth National Independence Day June 19 Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veteran s Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies. Vendor Responsibilities The Vendor shall be responsible for any and all liability actions or suits when the vendor is at fault or negligent in the performance of installation and testing activities. Pecuniary liability is also included for any and all damages to VA buildings and equipment caused by installation activities. The vendor shall comply with all local building and fire codes in addition to VA policy and procedures at the site. The Vendor shall operate under, but not limited, to the following national codes, telecommunications industry standards and practices: National Electric Code (NEC), Building Industry Consulting Service International (BICSI), all standards, Electronic Industries Association/Telecommunications Industry Association EIA/TIA, Americans with Disabilities Act (ADA), National Fire Protection Association (NFPA), Underwriters Laboratories (UL), ITU and IETF and all applicable audio, video, communication, data and control standards. VA Portland Responsibilities The station point of contact will provide access to the appropriate personnel (management, technical, subject matter expertise, etc.) necessary to fulfill the Vendor s requirements in a timely fashion. The station point of contact shall provide the Vendor a list of key personnel associated with the project and contact information for the POC/Project Manager. The station point of contact will ensure that all project staff are up to date on VA training on privacy and security, as well as project specific training. Travel All travel shall be responsibility of the vendor. Whenever possible, conference calls and video conferencing should be used. Completion Date The Vendor shall have services rendered no later than 12 months from the date of Contract Award and receipt of Contract Award (estimated February 28, 2026). Potential contractors: shall provide, at a minimum, the following information to phillip.folger@va.gov a) Company name, address, and point of contact, phone number, e-mail address, and SAM UID. b) Please identify your company s size in comparison to the anticipated North American Industry Classification System (NAICS) code 541715 - Research and Development in the Physical, Engineering, and Life Sciences. To be considered a small business your company must have fewer than 1,000 employees. This notice is to determine the marketplace for this specific requirement. Please check one of the following: [ ] yes [ ] no Service Disabled Veteran Owned Small Business (SDVOSB) [ ] yes [ ] no Veteran Owned Small Business (VOSB) [ ] yes [ ] no Small Business Manufacturers [ ] yes [ ] no All other Small Business (SB) [ ] yes [ ] no Other than Small Business c) The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to these sources sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System Award Management (SAM located on the web at www.sam.gov). It is desirable that any Offeror to have completed their business Online Representations and Certifications Application in the System for Award Management (SAM). d) Any Service-Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov and Veteran Small Business Certification https://veterans.certify.sba.gov/. e) If not a manufacturer, only authorized representatives/providers/distributors of the manufacturer will be considered. Equipment must be new, no used or refurbished equipment accepted. Please provide proof of authorized dealer or reseller letter from manufacturer. f) This is a brand name or equal requirement. As such, the Statement of work reflect the physical, functional, or performance characteristics that equal products must meet to satisfy the Government s needs. To be considered for any potential solicitation, offers of equal products, including equal products of the brand name manufacturer, must: (g) Meet the salient physical, functional, or performance characteristic specified in this source sought; clearly identify the item by Brand name, if any and make/model number. (h) Include descriptive literature such as illustrations, drawings, or a clear reference to descriptive data or information available that identifies that the equal item meets or exceeds the Statement of work required by the Government. Responses are due by 01/23/2025 11:59pm PACIFIC TIME, LOS ANGELES, USA, to the Point of Contact. Shipping Address: Portland VA Healthcare System Vancouver Warehouse 1601 E 4th Plain Blvd Vancouver, WA 98661 Point of Contact: Phillip Folger Contracting Specialist phillip.folger@va.gov