Extracorporeal Shock Wave Therapy (ESWT) System for Winn Army Community Hospital and Martin Army Community Hospital

This document is a federal solicitation and contract form, specifically Standard Form 1449 (REV. 11/2021), used for the acquisition of commercial products and commercial services. Issued by the Defense Health Agency (DHA) HCD Southeast located in Frederick, Maryland, the solicitation is designated under the Women-Owned Small Business (WOSB) program. The form serves as a template for Solicitations, Contracts, or Orders, and outlines the standard fields required to process federal acquisitions. This includes administrative information such as the solicitation number, issue date, offer due date, and contact details for the contracting officer, Heather Clipson. It also contains sections for the schedule of supplies or services, pricing, terms of delivery, and set-aside classifications (including Small Business, HUBZone, SDVOSB, and EDWOSB). Additionally, the document incorporates standard Federal Acquisition Regulation (FAR) clauses by reference, such as FAR 52.212-1 and 52.212-4, which govern instructions to offerors and contract terms and conditions. The form requires signatures from both the offering contractor and the United States contracting officer to execute a binding agreement upon award.

This Statement of Work outlines the requirements for procurement, installation, training, and support of Extracorporeal Shock Wave Therapy (ESWT) systems at two military treatment facilities: Martin Army Community Hospital (MACH) at Fort Benning, Georgia, and Winn Army Community Hospital (WACH) at Fort Stewart, Georgia. The selected contractor must be an Original Equipment Manufacturer (OEM) authorized vendor. For MACH, the contractor will deliver a dual-unit system comprising a Storz Medical radial pressure wave unit, a vibration therapy unit, a focused shockwave unit, and dedicated support carts. For WACH, the contractor will provide an integrated, modular tower system combining both radial and focused shockwave therapy modalities on a single mobile trolley. All equipment must meet FDA and built-in safety regulatory standards. Additionally, the contractor is required to provide on-site clinical operator training and technical training for biomedical engineering staff. The procurement includes a minimum two-year warranty for main consoles, a one-year (or pulse limit) warranty for handpieces, one annual preventive maintenance service visit during the first year, and defined remote and on-site technical support response times.

This document is "Attachment 2 - Contractor Past Performance Self-Certification Worksheet," a government solicitation form requiring offerors to self-certify their performance history regarding Extracorporeal Shockwave Therapy (ESWT) systems over the past three years. To complete the worksheet, vendors must provide basic company details—including company name, CAGE Code or Unique Entity Identifier (UEI), and point of contact information—along with a brief overview of the volume and scope of Storz Shockwave Therapy Systems they currently provide to commercial or government clients. Additionally, the form requires offerors to answer three self-certification questions regarding their performance over the past three years: 1. Whether they or their products have been subject to any FDA Class I, II, or III recalls. 2. If they have experienced any infection control issues, FDA observations, or customer complaints related to ESWT devices or applicators. 3. Whether they have had any contracts terminated early for cause. For any "Yes" responses, vendors must submit a brief narrative explaining the cause and the corrective actions implemented. Finally, the worksheet must be signed and dated by an authorized representative to certify that all provided information is current, accurate, and complete.