H265--INR Patient Self Testing - VHA VISN 10 VA Medical Centers

The Network Contracting Office (NCO-10) is seeking to identify Services Disabled Veteran Owned Small Businesses (SDVOSB) and/or Veteran Owned Small Businesses (VOSB) vendors to perform the following services, INR Patient Self Testing. This is a Request for Information (RFI) to seek capable sources and request industry feedback ONLY. This notice does not constitute a commitment by the Government. Interested parties are asked to submit capability statement that clearly and convincingly identifies their ability to fulfill the requirements. Industry feedback to the information below is requested to ensure the VA has not created a defacto sole source requirement. The Government may use the responses to this RFI for information and planning purposes. VISN 10 has identified the need to have an International Normalized Ratio (INR) Patient Self Testing (PST) option available for Veterans Affairs (VA) beneficiaries seen at VA facilities and Community Based Outpatient Clinics (CBOCs) who are receiving the anticoagulant warfarin (Coumadin). The VISN will contract with an Independent Diagnostic Testing Facility (IDTF) to facilitate PST services for multiple locations within the VISN 10 catchment area, including Ohio, Michigan and Indiana. The requirement will include patient education and support services, testing supplies and materials, reporting services, quality control, and customer service. Each individual VA will utilize IDTF services in the provision of warfarin management. Vendor must provide and devices to the VA Facilities for initial validation. The device must be FDA-approved for CLIA-waived testing and have documented research on its utilization in the role of patient self-testing, and must include all accessories required for long-term use, such as rechargeable battery, charging cord, etc. Vendor shall also provide testing supplies, which includes, but is not limited to test strips, lancets, ancillary supplies, and quality control materials. Vendor to provide patient education in a face-to-face setting to allow the patient to view the demonstration and provide certificate of completion of training. INR results are to be electronically transferred to the vendor. Test results should be sent via encrypted email, fax, and/or phone to the VA facility POC or group by same day COB. All test results must be available via an online portal that specified VA facility users can access 24/7. SaaS approval is required for portal once vendor is selected. Vendor shall provide a report to the facility and VISN POC s monthly including patient adoption, break down of cost, and Time in Therapeutic Range (TTR) of each individual patient. In addition to answering the below questions 1-3, respondents are also requested to provide their capability statement, including company name, address, and point of contact information. Capabilities statement shall provide a detailed overview, experience, and qualifications to perform the requirement. Question #1: Response, are you interested in providing a quote for this requirement? Yes / No (choose one) Question #2: Response: If your firm is a SVOSB and/or VOSB? If so, please provide a copy of VETCERT certification. Please provide current scope of operations and locations of service/capability: Where is your business located and where is your main scope of operations? Please provide any additional certifications regarding the socio-economic status of your company including, WOSB, EDWOSB, HUB, 8a, Small Disadvantage Business, Small Business, etc. Question #3: Response: Does your company have the ability to perform this contract while complying with the Limitations on Subcontracting, if applicable, rules per FAR 52.219-14, 13 CFR 125.6 and VAAR 852.219-75. If so, please briefly explain how your firm will accomplish this, include any potential teaming arrangements or subcontractors. To Note: The CO shall conduct periodic checks with the vendor to ensure that Limitations on Subcontracting compliance is maintained during the period of performance, if applicable, if this requirement is set-aside for any small business entities. In accordance with 13 CFR § 125.6(g), Whoever violates the requirements set forth in paragraph (a) of this section shall be subject to the penalties prescribed in 15 U.S.C. 645(d), except that the fine shall be treated as the greater of $500,000 or the dollar amount spent, in excess of permitted levels, by the entity on subcontractors. A party's failure to comply with the spirit and intent of a subcontract with a similarly situated entity may be considered a basis for debarment on the grounds, including but not limited to, that the parties have violated the terms of a government contract or subcontract pursuant to far 9.406-2(b)(1)(i) (48 CFR 9.406-2(b)(1)(i). The applicable NAICS code for this requirement is NAICS 541380 Testing Laboratory and Services with a Small Business Size Standard of $19.0 Million Dollars. The Product Service Code is H265 Equipment and Materials Testing Medical, Dental, and Veterinary Equipment and Supplies For informational purposes only, Wage Determinations shall apply to this contract. All businesses are encouraged to respond; however, each respondent must clearly identify their business size and socio-economic category(s) in their capabilities statement. This Request for Information (RFI) is only for the purpose of identifying potential sources as part of market research. No Request for Proposal (RFP), Quote (RFQ), or Invitation for Bid (IFB) exists. Responses to this Request for Information (RFI) are not quotes, proposals, or bids on which the VA can issue any contract. This Notice is issued for information and planning purposes only and does not itself constitute an RFP, RFQ or IFB. The Government does not intend to award a contract based only on responses to this RFI. Responses to the notice will not be returned. Responders are solely responsible for all expenses associated with responding to this Request for Information (RFI). The VA will not pay for information received in response to this Request for Information. Do not submit pricing information in response to this Request for Information. Detailed capabilities statements and answers to questions 1-3 must be submitted by email to Contract Specialist Teri Miller at contact@example.gov in an electronic format, no later than 1:30 PM EST on April 10, 2024. As part of market research, this Request for Information / Sources Sought is to determine if there exists an adequate number of qualified interested contractors capable of providing services for this requirement.