6515--NX EQ Negative Pressure Wound Therapy Systems (VA-23-00059623)

Sources Sought Notice Sources Sought Notice Page 7 of 7 Sources Sought Notice *= Required Field Sources Sought Notice Page 1 of 7 REQUEST FOR INFORMATION 1.0 DESCRIPTION The Veterans Health Administration (VHA) Equipment Life Cycle Management (ELCM) Program identified 3M Vacuum Assisted Closure (V.A.C.) Ulta® Negative Pressure Wound Therapy (NPWT) is a candidate for a Veteran Administration (VA) wide (otherwise referred to as national ) single award Requirements contract. The Department of Veterans Affairs (DVA) Office of Procurement, Acquisition, and Logistics (OPAL) Strategic Acquisition Center (SAC) on behalf of VHA is issuing this Request for Information (RFI) by the FAR 10.002(b)(2) to determine the availability and technical capabilities of qualified sources. The period of performance will consist of a base of 12 months with four 12-month option periods from the date of award. The associated North American Industrial Classification System (NAICS) code for this procurement code

for NPWT is 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies, and the associated size standard is 1250 employees. The FAR Provision found at 52.204-7(b)(1) requires that All interested Offerors must be registered in SAM before submitting an offer or quotation. You may access the SAM website at https://www.sam.gov/portal/public/SAM/. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the Veteran Small Business Certification (VetCert) database, at https://veterans.certify.sba.gov/ at the time of offerors submission. This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This RFI is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes. 1. SCOPE OF WORK: The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the 3M V.A.C. Ulta® Negative Pressure Wound Therapy Systems product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award. This activity proposes to negotiate a non-competitive award (sole source) with 3M Healthcare (UEI: NYZ3A8USQ3X9), for the procurement of 3M V.A.C. Ulta® Negative Pressure Wound Therapy Systems manufactured by 3M Healthcare under the issuance of a Requirements Contract. The 3M V.A.C. ULTA® is the only NPWT system that includes an integrated roller pump for instilling the wound bed with a discrete volume of topical wound cleansers (requires V.A.C. VERAFLO supplies). V.A.C. VeraFlo Instillation therapy cleans contaminated wounds with the installation of topical wound cleansers, removing infection materials and treats the wound with appropriate topical antimicrobial and antiseptic solutions. This treatment controls infections and promotes healing. This could impact saving a limb, possibly reducing further surgery if the wound is not on a limb but rather on the trunk of the body. Sensa T.R.A.C. System which is incorporated with the V.A.C. ® Vera T.R.A.C. Pad and Vera T.R.A.C. Duo tube set, monitors and maintains target pressure at the wound site. The V.A.C. ® ULTA provides dynamic pressure control and intermittent therapy that maintains a minimum negative pressure level between cycles which helps to prevent leaks and fluid accumulation that can occur when there is no negative pressure at the wound site and helps prevent patient discomfort from foam expansion and compression between cycles. The self-adjusting pressure compensation automatically compensates for viscosity, volume, leakage, and machine height to wound changes. Pressure can be set from 25mmhg to 200mmhg and is adjustable in increments of 25mmhg. A unique capability of the 3M V.A.C. ULTA® is that it can manage open abdominal wounds with exposed viscera (intestinal content, bowels, etc.) including, but not limited to, abdominal compartment syndrome in the setting of a closely monitored area within the hospital such as the ICU. They have a unique abdominal dressing that will most often be applied in the operating theater. This pulls fluid out of the wound cavity in situations where the surgeon feels that surgical wound closure would not be appropriate due to swelling of the abdomen and rather chooses to delay closure until the swelling is gone. Without this capability, these types of wounds would force the surgeon to fill the wound cavity with moist dressings necessitating several dressing changes until closure increasing the risk of infection. In addition, the patient would have to remain bed-bound to minimize evisceration (bowels falling out). In addition, the 3M V.A.C. ULTA® wound imaging feature allows the physician to upload digital images of the wound to record the wound healing process over time. The 3M V.A.C. ULTA® is also uniquely capable of monitoring and maintaining pressure at the wound site (with optional SENSAT.R.A.C. supplies). 2. REQUIREMENT The SAC in conjunction with VHA is seeking a qualified source to manufacture NPWT on an agency-wide basis. VA intends to award a single award Requirement Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, and FAR 6.302-1 Only One Responsible Source And No Other Supplies Or Services Will Satisfy Agency Requirements. Vendors will be required to deliver NPWT to VA medical centers and facilities throughout the United States The type of NPWT required for this program has been identified as most advantageous to the Government to be incorporated into a national Requirements Contract. For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the Request for Information. First, the SC table below shall be included at the beginning of the technical volume with a cross-reference column of the page number(s) identifying where in the proposal the requirement is met. Next, the offeror must clearly identify the item by brand name (if any) and make/model number. Finally, the offeror must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the contracting officer, and clearly describe any modifications it plans to make to a product to make it conform to the Request for Information requirements. The Government's intent for this Requirements contract is to include all ancillary items to ensure the equipment can function as designed by the original equipment manufacturer (OEM) and as clinically required. The Government may through bilateral modification, add or remove items to this contract that are determined to be within the scope of the solicited product line, not limited to the original items awarded. Additionally, any discontinued items may be replaced via future contract modification by the replacement part identified by the OEM, so long as the replacement part serves the same clinical purpose and function as the originally awarded item. Furthermore, any new technology that is presented during the performance of this contract may be evaluated by the Government for inclusion into the contract, via bilateral modification. This new technology must be determined to be within the scope of the original contract. Table 1: Line Items CONTRACT LINE ITEM# BRAND PART NUMBER DESCRIPTION BASE YR OY 1 OY 2 OY 3 OY 4 0001 3M CAPULTDEV01/US.S V.A.C. Ulta Therapy Unit 49 46 39 42 26 0002 3M 4-Year Extended Warranty 4-Year Extended Warranty 49 46 39 42 26 The Department of Veterans Affairs is seeking vendors who can provide 3M V.A.C. Ulta® Negative Pressure Wound Therapy System as listed above which meets all the salient characteristics below. Table 2: Salient Characteristics SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION APPLICABLE CLINS Vendor s Provide Page # Where Each SC Is Met in Your Technical Literature SC 1 Integrated wound management system that provides negative pressure wound therapy with an instillation option. Literature Review 0001 SC 2 Instillation mode must be capable of automatically determining the volume of topical wound solution to instill. Literature Review 0001 SC 3 The unit must be capable of providing automatic cleansing cycles. Delivering automatic and repetitive wound cleansing without dressing removal Literature Review 0001 SC 4 Capable of monitoring and maintaining pressure at the wound Literature Review 0001 SC 5 Must be capable of providing wound care for closed surgical incisions. Literature Review 0001 SC 6 Must be capable of providing wound care for Open abdomen wounds. Literature Review 0001 SC 7 Must be capable of providing wound care for open wounds Literature Review 0001 The Department of Veterans Affairs is seeking vendors who can provide 3M V.A.C. ULTA® Negative Pressure Wound Therapy System, as listed above, which meets all the following salient characteristics. The type of Intensive Care Ventilator required for this program has been identified as most advantageous to the Government to be incorporated into a national Requirements Contract. The salient characteristics (SC) for these commercial items are identified in the NPWT. Responses to this Sources Sought Notice shall include the following: Full name and address of the company DUNS number/ CAGE Code/ SAM UIE Business Size Manufacturer or Distributor If the distributor provides the full name, business size, and address of the manufacturer. Country of Origin designation for all products. Ability to provide an uninterrupted supply of products on a national scale. Technical Literature that clearly shows the product(s) meet the identified salient characteristics (if submitting an or-equal item). Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified. All small business, VOSB, and SDVOSB distributors shall provide a valid letter of authorization from the manufacturer of the product/brand that you intend to offer. The letter shall be printed on the manufacturer s letterhead and be no older than 6 months old. The letter shall also clearly state how long your agreement is in place with the manufacturer, e.g., 6 months, 4 years, expires 4 years from XXX, end of 2025, etc. The letter shall also be signed by a legally, authorized representative of the manufacturer. Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.