6515--VACUUM ERECTILE DEVICE FOLLOW-ON AWARD

Award Notice

This is an award notice for Vacuum Erectile Devices (VED) following a competitive process. The Department of Veterans Affairs Strategic Acquisition Center has awarded a contract to LMH Hawthorne Healthcare Inc., doing business as Pisces Healthcare Solutions.

• Award Number: 36C10G26D0014
• Award Amount: $9,000,000.00 (Maximum Aggregate Value)
• Minimum Guaranteed Amount: $1,000.00
• Award Date: June 15, 2026
• Awardee: LMH Hawthorne Healthcare Inc. (DBA Pisces Healthcare Solutions)
• UEI: U4M9XGZW8K11
• Awardee Address: 1660 S FORDHAM ST STE 100, LONGMONT, CO 80503

6515

339113

Service-Disabled Veteran-Owned Small Business (SDVOSB)

U.S. Department of Veterans Affairs, OPAL | Strategic Acquisition Center, Fredericksburg, VA (ZIP: 22408-2697)

This notice is for informational purposes only and is not a request for competitive proposals.

Amendment / Modification

This amendment (Amendment 36C10G26Q0001 0001) modifies the solicitation for Vacuum Erectile Devices (VEDs) with the following key changes:

• Offer Due Date: Extended to January 6, 2026.
• Maximum Aggregate Value: Added a maximum aggregate value of $9,000,000.00.
• Pricing: Clarified that the unit pricing must reflect the price with the 3% Service Level Agreement (SLA) Fee.
• Physical Evaluation Samples: Requires submission of two (2) complete samples each of automatic and manual VEDs, including all associated manuals and supplies.
• Removed Term: "Patient Unique Identifier" has been removed.
• Updated MTRs: Manual and Automatic MTRs 4, 5, 8, 9, and 10 have been updated.

• Offer Due Date

• Contract Maximum Aggregate Value

• Pricing Instructions (Volume III)

• Technical Evaluation (Phase 2)

• Minimum Technical Requirements (MTRs) for Manual and Automatic VEDs

• Bidders must note the new offer due date of January 6, 2026.

• Pricing submissions must explicitly include the 3% SLA Fee.

• Technical proposals must account for the updated sample submission requirements for physical evaluation.

Questions & Answers / Clarifications

This document provides responses to vendor questions regarding the Vacuum Erection Device (VED) solicitation, clarifying key aspects of the requirements, submission process, and contract details.

• Proposal Due Date: The correct proposal submission deadline is January 6, 2026, at 2:00 PM EST, superseding an earlier conflicting date.
• Estimated Quantities: The estimated annual quantity for items in the Schedule of Supplies is 17,700 units.
• Maximum IDIQ Ceiling: The maximum ceiling value for this Indefinite Delivery/Indefinite Quantity (IDIQ) contract is $9,000,000.
• FDA Certification: Proof required is the Premarket 510(k) FDA clearance number.
• Invoice Requirements: A Patient Unique Identifier (PUI) should not be included on invoices as it is not standard for VA Purchase Orders (POs).
• Schedule of Supplies: Serial numbers are not required for Attachment 1. Column O (Unit Price) must include the device price and a 3% Service Level Agreement (SLA) fee.
• Instruction Format: Online videos are acceptable for instructions; QR codes or website links are also acceptable, with written information provided for non-technology users.
• Samples: Offerors must submit two (2) complete samples of both manual and automatic devices, including all associated manuals and supplies. The technical evaluation will be conducted virtually.
• SBA Nonmanufacturer Rule: There is no waiver for the SBA Nonmanufacturer Rule for VEDs. Offerors must comply with FAR clause 52.219-33 and provide employee numbers.
• Customer Service Hours: Required customer service hours have been updated to 8:00 am – 5:00 pm (local time zones) Monday - Friday.
• Ring Ejector Sleeve: A ring ejector sleeve is not required; devices will still be considered without one.

These clarifications address ambiguities regarding deadlines, quantities, pricing, technical requirements, and submission formats, providing essential information for bidders to prepare accurate and compliant proposals.

Form / Attachment / Pricing Sheet

This document, DD FORM 2772, is a Contract Discrepancy Report. It is used to formally document and track discrepancies or problems encountered during contract performance. It also records the contractor's response, corrective actions, and government evaluation and actions.

• Contract Number
• Report Number
• Parties involved (Contractor, QAE, Contracting Officer)
• Dates (Prepared, Returned by Contractor, Action Complete)
• Detailed description of the discrepancy or problem
• Contractor's response, including cause, corrective action, and prevention of recurrence
• Government evaluation and actions taken
• Close-out information for contractor notification, QAE, and ACO

While this form is primarily for internal contract management and tracking issues after award, bidders should be aware of its existence. It signifies a formal process for addressing performance issues. Understanding the types of discrepancies and the required responses can provide insight into potential performance expectations and the government's contract administration process.

Solicitation / RFP / RFQ

This solicitation is for a single-award Indefinite Delivery Indefinite Quantity (IDIQ) contract for Vacuum Erectile Devices (VEDs) and accessories for the Department of Veterans Affairs (VA), Veterans Health Administration (VHA). The acquisition aims to standardize products and reduce costs while ensuring quality.

• Provision of manual and automatic Vacuum Erectile Devices (VEDs) and accessories.

• Devices must be FDA-approved.

• Specific Minimum Technical Requirements (MTRs) are detailed for both manual and automatic VEDs, covering components, instructions, warranty, and accessory options.

• Contractor must guarantee an uninterrupted source of supply and provide a commercial warranty.

• Contractor must have sufficient inventory, warehousing, and supply chain management to handle 100-500 orders daily and avoid "gray market" products.

• Safeguarding of Protected Health Information (PHI) and Personally Identifiable Information (PII) is required.

• Products must be state-of-the-art and FDA-approved.

• Contract Type: Single-award IDIQ, with Firm-Fixed-Price Delivery Orders.

• Period of Performance: One-year base period with four one-year option periods (totaling up to 60 months).

• Minimum Guaranteed Amount: $1,000.00 obligated at award.

• Maximum Aggregate Value: TBD.

• Offers are due by December 29, 2025, 12:00 PM EST.

• Quotes must be submitted electronically in four volumes: Technical, Past Performance, Price, and Solicitation/Award Documents.

• Evaluation will be conducted in three phases: Technical (Literature Review), Technical (Physical Evaluation), and Past Performance & Price.

• Award will be made to the responsible Offeror whose offer is most advantageous to the Government, considering Technical, Past Performance, and Price.

• Key deadlines: Questions due December 15, 2025, 2:00 PM EST.

• This acquisition is a Service-Disabled Veteran Owned Small Business (SDVOSB) set-aside.

• Only certified SDVOSBs listed in the SBA certification database are eligible for award.

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

• Unauthorized, 3rd party resellers are not eligible.

• The acquisition falls under the Buy American Act (BAA).

• A 3.0% Service Level Agreement (SLA) fee must be embedded in all proposed prices.

• Offerors must provide product samples for physical evaluation.

• Attachments include Schedule of Supplies, Pay.gov instructions, reporting tools, and other relevant documents.

Form / Attachment / Pricing Sheet

This document, "Attachment 5 - VED Questions.xlsx", appears to be an Excel spreadsheet containing questions related to a Vacuum Erection Device (VED). It is intended to capture questions from potential bidders regarding specific sections or paragraphs of a solicitation or related document.

• The spreadsheet is structured with columns for 'Question #', 'RFP Section/Paragraph #', and 'Questions'.
• It is a single-sheet document titled 'Sheet1'.
• The document is intended to limit questions to one page.

This attachment serves as a mechanism for bidders to submit their questions about the opportunity. Bidders should review this document to understand the format for submitting questions and to see if their questions have already been addressed or if they need to submit new ones. It is crucial for bidders to use this process to seek necessary clarifications to prepare accurate and compliant proposals.

Form / Attachment / Pricing Sheet

This document is an "Authorized Government Distributor Letter" template. It serves to certify that an offeror is an authorized distributor of specific manufacturer products required for the solicitation.

• Offeror Information: Name, POC, Address.
• Manufacturer: The name of the manufacturer whose products are being distributed.
• Products: Specific Vacuum Erection Devices (VEDs) and accessories covered by the authorization.
• Distribution Authorization: States the geographic area (e.g., specific states, nationwide, including DC, Philippines, Puerto Rico) where the offeror is authorized to distribute.
• Authorized Activities: Confirms the offeror's authority to promote, distribute, sell, and offer technical assistance for the specified products.
• Signatory Authorization: Requires a signature from an officer of the company who is authorized to make these commitments.

Bidders responding to solicitation number 36C10G26Q0001 must provide this letter, completed and signed by an authorized representative, to certify their status as an authorized distributor for the required [Manufacturer Name] Vacuum Erection Devices (VEDs) and accessories. This letter is a required component of the offeror's submission.

Form / Attachment / Pricing Sheet

This document is a sample Letter of Supply required from offerors responding to a solicitation. It serves to assure the government of an uninterrupted source of supply for products from a specific manufacturer if the offeror is awarded a contract.

• Offeror Information: Name, POC, Address.
• Manufacturer Information: Name, Authorized Signatory (Officer), Title, Telephone Number.
• Solicitation Reference: The specific solicitation number the offeror is responding to.
• Product Categories/Brand Names: A list (attached to the letter) specifying the products covered by this supply assurance.
• Commitments: The manufacturer assures sufficient quantities of product for the contract duration, provided the offeror remains in good standing and adheres to OEM Partner Agreements.
• Trade Agreements Act (TAA) Compliance: The manufacturer confirms all supplied products will be TAA compliant and agrees to cooperate with the offeror to support TAA compliance, providing country of origin information and notifying of any changes.

Bidders must obtain and submit this letter from their proposed manufacturer(s) to demonstrate their ability to secure the necessary products for the contract. It is crucial for ensuring compliance with supply chain and trade regulations, specifically the TAA.

Form / Attachment / Pricing Sheet

This document is a Past Performance Questionnaire (PPQ) intended for use by evaluators to assess a contractor's past performance on a previous contract. It is attached to Request for Proposal (RFP) No. 36C10G26Q0001 for Vacuum Erection Devices (VED).

• The questionnaire requests information regarding the contractor's performance in areas such as overall quality, delivery, service quality, problem resolution, and personnel.
• It includes a rating scale from 1 (clearly below standard) to 5 (almost always exceeds standard), with an option for 'Not Applicable'.
• Specific questions address cure notices, terminations, likelihood of re-award, discussions of adverse performance, and the existence of past performance databases.
• Fields are provided for contract period of performance, dollar value, and a description of services provided.

Bidders should be aware that this questionnaire will be used to evaluate their past performance. If this questionnaire is being provided for a subcontractor, both prime and subcontractor names must be included. Completed questionnaires should be sent to Shemika.Wray@va.gov and Brian.Love@va.gov.

Form / Attachment / Pricing Sheet

This document provides detailed instructions for vendors on how to submit payments using the Pay.gov system for the SAC Contract Fee Remittance. It outlines the step-by-step process for completing the required forms and making payments.

• Accessing Pay.gov: Instructions on how to find the "SAC Contract Fee Remittance Form" on the Pay.gov website.
• Form Completion: Details on filling out the "Complete Agency Form" section, including selecting the SAC Contract Number, entering Task or Delivery Order Number (if applicable), Company Name (auto-populates), Company Contact, Sales Quarter, and total quarterly sales.
• MSPV Sales: Instructions for reporting payments related to the MSPV program (selecting "Yes" for MSPV Sale) and non-MSPV sales (selecting "No").
• GSA CRF vs. Assisted Services: Guidance on selecting the appropriate payment type if the contract is off a GSA FSS.
• Payment Information: Instructions for the "Enter Payment Info" step, specifying that only ACH (Automated Clearing House) is accepted. Details on entering Account Holder Name, Account Type, Routing Number, and Account Number.
• Review and Submission: Guidance on reviewing all entered information, opting for email confirmation, agreeing to the authorization statement, and submitting the payment.
• Confirmation: The final step provides payment confirmation.

This document is critical for bidders who are awarded a contract requiring fee remittance through Pay.gov. It provides the necessary procedural steps to ensure timely and correct payment submission, avoiding potential issues or delays. Bidders should familiarize themselves with these instructions to understand their payment obligations and the required process.

Form / Attachment / Pricing Sheet

This Excel file, "Attachment 3 - Quarterly Reporting Tool.xlsx", contains a tool designed for quarterly reporting. It appears to be a template or a system for tracking and reporting on contract performance or sales data on a quarterly basis.

The document contains multiple sheets:

• Sheet2: This sheet appears to contain numerical data organized in rows and columns, potentially representing metrics, codes, or identifiers. It includes columns with numbers, alphanumeric codes, and facility names associated with different VA networks (VISN). This sheet likely serves as a lookup or data input area for reporting.
• Sheet3: This sheet is structured for reporting contract details and sales quantities. It includes fields for Contract Number, Reporting Quarter, CLIN Number, Description/Salient Characteristics, and Price. It also lists VA networks (VISN), facilities, and columns for "Quantity Sold of Item or Performance Description" for 22 line items. It includes summary calculations for total quantities sold, total sales, and SLA (Service Level Agreement) related figures.

Bidders may need to use this tool to understand reporting requirements, track performance metrics, or input sales data if awarded a contract. The structure of Sheet3 suggests that reporting on quantities sold and associated pricing, potentially broken down by CLIN and facility, will be a requirement. The presence of SLA calculations indicates that service level agreements may be a component of the contract performance and reporting.

Form / Attachment / Pricing Sheet

This document is an Excel spreadsheet containing a Schedule of Supplies, detailing line items for a potential contract. It outlines specific medical devices and related components.

• Sheet: Action Line Item Information: Lists "Vacuum Erection Device" (VED) - Automatic and Manual, "Oversized Cylinder," and "Replacement Rings." These are categorized under "Base" and "Option 1" through "Option 4" contract periods.
• Sheet: Items: Provides detailed line item information including ITEM NUMBER, DESCRIPTION, CONTRACT PERIOD (Base, Option 1-4), QUANTITY, UNIT OF MEASURE, UNIT PRICE, and CLINICAL DISCIPLINE (MEDICAL).
• Sheet: RefData: Contains reference data for discount types, options, and receipt types, as well as state codes.
• Sheet: UOMRef: Lists Unit of Measure (UOM) descriptions and their corresponding values.
• Sheet: NAICS: Provides a comprehensive list of North American Industry Classification System (NAICS) codes and their descriptions.
• Sheet: PROD_SVC_CODE: Lists Product/Service Codes (PSC) with their descriptions.
• Sheet: SIC_CODE: Lists Standard Industrial Classification (SIC) codes with their descriptions.
• Sheet: CLINICAL_DISCIPLINE: Lists clinical disciplines and their corresponding codes.
• Sheet: LI_BASE_OR_OPTION: Differentiates between Base and Option periods for line items.
• Sheet: LI_ITEM_TYPE: Categorizes line items by type (e.g., MEDICAL).

This attachment is crucial for bidders as it specifies the exact medical equipment and supplies required, including different configurations and contract options. Bidders must use this information to understand the scope of potential orders, prepare accurate pricing, and ensure their offerings align with the specified CLINICAL DISCIPLINE and item types. The detailed breakdown across contract periods (Base and Options) is essential for long-term planning and proposal development.

Solicitation / RFP / RFQ

This is a Request for Quote (RFQ) for the procurement of battery-operated and manually operated Vacuum Erectile Devices (VED). The Department of Veterans Affairs, Strategic Acquisition Center (SAC) is issuing this RFQ.

• Procurement of battery-operated and manually operated Vacuum Erectile Devices (VED).

• The anticipated period of performance is for a five-year ordering period, consisting of one (1) base year and four (4) one-year option periods.

• The RFQ will be issued mid-November 2025 or after.

• Response Date/Time/Zone: 11-14-2025 3:00 pm EASTERN TIME, NEW YORK, USA.

• No telephone or email questions will be accepted at this time.

• This RFQ is a Total Service-Disabled Veteran Owned Small Business (SDVOSB) Set-Aside.

• NAICS Code: 339113 – Surgical Appliance and Supplies Manufacturing.

• Product Service Code: 6515 – Medical and Surgical Instruments, Equipment, and Supplies.

• Contracting Office Address: U.S. Department of Veterans Affairs, OPAL | Strategic Acquisition Center, 10300 Spotsylvania Ave | STE 400, Fredericksburg VA 22408-2697.

• Contract Specialist: Shemika Wray, Shemika.wray@va.gov.