6515--Upper Artificial Limbs

Amendment / Modification

• The Response Date/Time/Zone for Solicitation 36S79725R0001 has been extended to April 2, 2026, at 16:00 Central Time, Chicago, USA.

• The document includes "Questions Answered" and "PWS updates."

• Updates to the Performance Work Statement (PWS) address:

  • Minimum technical requirements for Upper Extremity Artificial Limbs.
  • Contract Product Training, including options for virtual or in-person training at government medical centers, contractor facilities, or via electronic means. A minimum of two seats for DLC personnel must be reserved for in-person training.
  • Clarification that fabrication and assembly services, particularly for partial hand prostheses, are an opportunity.
  • Confirmation that a satisfaction period is a mandatory requirement, not a warranty policy.
  • Exceptions to the standard 5-day delivery timeline for products with numerous SKUs can be made on a case-by-case basis with CO/COR approval.
  • ISO 9001 and/or ISO 13485 certification is mandatory for FDA-regulated medical devices.
  • Devices with both terminal device and wrist in one part number should be listed under the terminal device tab.
  • There is no anticipated volume of orders for this new national contract; historical data only includes dollar sales figures, not order volume.
  • Annual training at the DLC can be conducted virtually.

• Solicitation response deadline.

• Performance Work Statement (PWS) details regarding training, fabrication, delivery, and technical requirements.

• The deadline for submitting offers has been extended to April 2, 2026, 16:00 CDT.

Amendment / Modification

This document is Amendment 0001 to Solicitation 36S79725R0001. It modifies the contract/order as described in Item 14.

Key changes include:

• The hour and date specified for receipt of Offers is extended. (Specific extension details are not provided in the text, but the amendment indicates it is not extended in one instance and is extended in another, requiring careful review of the full document for precise timing).

• It clarifies that the solicitation is amended as set forth in Item 14.

• It provides instructions for acknowledging receipt of the amendment, including options for returning copies, acknowledging on the offer, or separate communication. Failure to acknowledge properly may result in offer rejection.

• It states that if an offeror desires to change an offer already submitted due to this amendment, the change must be made by letter or electronic communication referencing the solicitation and amendment, and received prior to the opening hour and date.

• The amendment affects the deadline for receipt of offers.

• It impacts the process for acknowledging receipt of amendments.

• The deadline for submitting offers has been extended.

• Offerors must ensure proper acknowledgment of this amendment to avoid rejection.

• Offerors may modify submitted offers in response to this amendment, provided they meet the specified timing and referencing requirements.

Amendment / Modification

This document is an amendment to the original solicitation for Upper Artificial Limbs.

• The primary change is the amendment itself, referencing the original solicitation number 36S79725R0001.
• The attached document "36S79725R0001 0001" contains the details of the amendment.

Bidders should refer to the attached amendment document for any changes to requirements, deadlines, or submission instructions related to solicitation 36S79725R0001.

Form / Attachment / Pricing Sheet

This document is a Past Performance Questionnaire used to gather feedback on a contractor's performance. It is intended to be completed by entities that have previously contracted with the vendor being evaluated.

• Sections for the Name of Contractor being Evaluated, Company Providing Reference, Contract Number, Nature of Contract, and Contract Period of Performance.
• Fields for the Name and Title of the Person Completing the Questionnaire, their Company/Organization, and contact information (Phone Number/E-mail Address).
• A section to describe the nature of the contract and products purchased.
• Adjectival rating definitions (Excellent, Very Good, Good, Fair, Poor, Neutral).
• Specific questions related to past performance, including how well contract requirements were met, adherence to schedule, responsiveness, effectiveness in addressing issues, and overall satisfaction.
• A question regarding adherence to a small business subcontracting plan, if applicable.
• An "Additional Comments" section.

This questionnaire is a tool for the government to assess a bidder's past performance. Bidders should be aware that their past performance will be evaluated using this form, and the feedback provided will influence the evaluation of their proposal. The document also provides the mailing address and email for submission: VA National Acquisition Center Commodities and Services Acquisition Service Attn: Michelle Williams Solicitation 36S79725R0001, michelle.williams4@va.gov.

Form / Attachment / Pricing Sheet

This document is a template for a Memorandum of Understanding (MOU) and Interconnection Security Agreement (ISA) between a VA Organization and a non-VA organization. It outlines the terms and conditions for sharing data and information resources securely through system interconnections.

• MOU: Defines the purpose of the interconnection, authorities, responsibilities of both parties, cost apportionment, and termination terms.
• ISA: Details technical aspects of the interconnection, including system descriptions, hardware/software requirements, security considerations (data types, FIPS categorization, data flow), security assessments, services offered, points of contact, and audit trail responsibilities.
• Appendices: Include Points of Contact, Definitions of Sensitive Information Types, and Interconnection Ports and Protocols.
• Document Control: Tracks revisions and updates to the MOU/ISA.

Bidders may need to understand and potentially complete sections of this template if their proposed solution involves interconnecting with VA systems. It details the security requirements, data handling protocols, and responsibilities that will govern the relationship. Specifically, bidders should pay attention to sections on:

• Data types transmitted and their FIPS sensitivity categorization.
• Security assessment requirements for their systems.
• Information exchange security, including FIPS 140-2 compliance if VA sensitive data is involved.
• Trusted behavior expectations and formal security policies.
• Audit trail responsibilities.
• Specific security parameters and controls implemented by both parties.
• Topological drawing requirements.
• Points of contact for communication and incident reporting.

Solicitation / RFP / RFQ

This solicitation is for the Department of Veterans Affairs (VA) National Acquisition Center (NAC) to establish multiple Firm Fixed Price (FFP) Indefinite-Delivery Indefinite-Quantity (IDIQ) contracts for prosthetic limb components. The goal is to consolidate and streamline the acquisition of these items for VA prosthetic clinics nationwide, ensuring enterprise-scale consistency, quality, and cost savings. The program aims to provide preferred products for consolidated contracting, including Prosthetic Terminal Devices (PTD), Prosthetic Wrist Units (PWU), Prosthetic Elbow Units (PEU), Prosthetic Limb Suspensions (PLS), Prosthetic Components & Accessories (PCA), and Partial Hand Components & Accessories (PHCA).

• Product Categories: PTD, PWU, PEU, PLS, PCA, PHCA.

• Technical Requirements: Products must be commercial, meet specific technical specifications (e.g., grip strength, battery capacity, compatibility), and be ready for operational use upon receipt. Materials in contact with skin must be hypoallergenic.

• Documentation: Product literature, packaging lists, patient education materials, and clinician instructions are required.

• ISO Certification: Facilities must be ISO 9001 and/or ISO 13485 certified.

• Training: Contractors must offer training programs on contract items.

• Customer Service: Direct technical and fitting assistance must be provided.

• Contract Type: Firm Fixed Price, Indefinite-Delivery Indefinite-Quantity (IDIQ).

• Contract Period: Base year with four (4) one-year options.

• Guaranteed Minimum: $1,000.00 per contract.

• Contract Ceiling: $37,000,000.00.

• Delivery: FOB destination, USA and its territories. Delivery within 5 calendar days ARO for CONUS, 7 calendar days for OCONUS.

• Submission: Proposals are due by the date specified in Block 8 of SF 1449. Proposals must be submitted in two volumes: Business and Technical.

• Evaluation: Lowest Price Technically Acceptable (LPTA) source selection process. Evaluation factors include Price, Technical Acceptability, and Past Performance.

• Key Deadlines: Questions due by February 6, 2026.

• This acquisition is unrestricted.

• Offerors must be registered and active in the System for Award Management (SAM).

• Orders will be placed electronically via the Remote Order Entry System (ROES).

• No orders will require items to be sent directly to a patient.

• A 60-calendar day satisfaction period is required for devices.

Form / Attachment / Pricing Sheet

This document details the electronic exchange of commercial transactions between the Denver Logistics Center (DLC) and contractors supplying artificial limbs, upper extremities products, and related fabrication materials. It outlines the specifications for purchase orders (POs), acknowledgements, cancellations, returns, return authorizations, invoices, invoice rejects, corrected invoices, and contracted item lists.

• Purchase Orders (POs): Exchanged via secure file transfer (SFTP/FTP/SSL). Files are named using a specific format (e.g., Contractor_Name_AL_PO_date_time.TXT). POs do not contain PII or PHI.
• Purchase Order Acknowledgements: Contractor must acknowledge receipt of POs via file transfer.
• Purchase Order Cancels/Returns: Procedures for cancelling POs or returning items within 60 days of the PO date.
• Return Authorizations: Contractor must transmit return authorization numbers within 48 hours of cancel-return transaction receipt.
• Invoices: Submitted daily in a batch format via SFTP. Specific naming conventions and deadlines apply (10 am Mountain Time).
• Invoice Rejects: Error files returned to the contractor's SFTP server for correction.
• Corrected Invoices: Contractors must submit corrected invoices via SFTP by 10 am Mountain Time.
• Contracted Item List: Contractors must submit product data according to specified formats and rules.
• Electronic Data Interchange / SFTP: Mandates the use of SFTP/FTP/SSL for secure file exchange, requiring a Memorandum of Understanding / Interconnection Security Agreement (MOU/ISA).
• Customer Engagement Portal (CEP): A portal for vendors to view PO and payment activity and submit vendor setup forms (VA Form 10091).

This document is critical for understanding the operational and technical requirements for doing business with the DLC for artificial limbs and related products. Bidders must be prepared to implement secure file transfer protocols, adhere to strict file naming conventions, and manage electronic transactions for orders, acknowledgements, returns, and invoicing. Familiarity with the Customer Engagement Portal is also required.

Form / Attachment / Pricing Sheet

This document is an Excel workbook containing pricing schedules for various groups of prosthetic devices and components. Bidders must use this template to provide detailed pricing for their offers.

• The workbook contains separate sheets for six distinct groups: Prosthetic Terminal Devices (PTD), Prosthetic Wrist Units (PWU), Prosthetic Elbow Units (PEU), Prosthetic Limb Suspensions (PLS), Prosthetic Components and Accessories (PCA), and Partial Hand Components and Accessories (PHCA).
• For each item, bidders must fill in Unit Prices for the Base Year and all Option Years (I through IV).
• Bidders must also provide their commercially published list price, estimated quantities, and total prices for each period.
• Required columns for each item include: "Item Name", "Item Description", "HCPC", "Model/Manufacturer", "Part Number", "Item location/page number", "Place of Manufacture", "Warranty Period", and "Manufacturer's Suggested Retail Price (MSRP)".
• Bidders must ensure product names are consistent across all submitted documents.
• Identifying the country of origin in the "Place of Manufacture" column fulfills certification requirements.

This document is critical for bidders to accurately price their proposals. It outlines the specific format and required information for cost submissions across all product categories. Bidders must complete this schedule in its entirety for the base and option years to be considered for award. Failure to provide complete pricing information may result in disqualification.

Solicitation / RFP / RFQ

The Department of Veterans Affairs (VA) is seeking to establish consolidated contracting for Prosthetic Terminal Device (PTD), Prosthetic Wrist Unit (PWU), Prosthetic Elbow Unit (PEU), Prosthetic Limb Suspension (PLS), Prosthetic Components & Accessories (PCA), and Partial Hand Components and Accessories (PHCA) for use with prosthetic (artificial) limbs. The goal is to achieve enterprise-scale consistency in fabrication and obtain quality products at reduced prices.

• Procurement of Prosthetic Terminal Device (PTD), Prosthetic Wrist Unit (PWU), Prosthetic Elbow Unit (PEU), Prosthetic Limb Suspension (PLS), Prosthetic Components & Accessories (PCA), and Partial Hand Components and Accessories (PHCA).

• Customized products for prosthetic limbs.

• Product Service Code: 6515

• NAICS Code: 339113

• Contracting Office ZIP Code: 60141

• Place of Performance: Not specified in this section, but VA NAC is the contracting office.

• Questions Due: By Close of Business (COB) on February 6, 2026.

• Proposal Due: March 27, 2026, at 4:00 PM Central Time (Chicago, USA).

• All questions and proposals should be submitted via email to michelle.williams4@va.gov.

• Not specified in the provided text.

• This solicitation number is 36S79725R0001.

• The point of contact for this solicitation is Michelle Williams (michelle.williams4@va.gov, 708.786.7565).

• Referenced attachments include: 36S79725R0001, Attachment D.1 Price Schedule, ATTACHMENT D.2- PAST PERFORMANCE QUESTIONAIRE, Attachment D.3_Secure File Transfer and Electronic Data Interchange, and Attachment D.4_VA MOU ISA Approved Final Template-09092020.