P03 JA NX EQ NPWTS 6.302-5 Public Law 109 - Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Office of Procurement, Acquisition and Logistics (OPAL)

Strategic Acquisition Center (SAC) 10300 Spotsylvania Ave Suite 400

Fredericksburg, VA 22408

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

PURSUANT TO FAR 6.302- 5

“AUTHORIZED OR REQUIRED BY STATUTE”

Non-Expendable (NX) Equipment (EQ) Negative Pressure Wound Therapy (NPWT) System

3M™ V.A.C. ULTA® THERAPY SYSTEMS

(1) Contracting Activity:

Department of Veterans Affairs (VA)

Strategic Acquisition Center (SAC) Spotsylvania Ave, STE 400 Fredericksburg, VA 224

(2) Description of Action:

This activity proposes to negotiate a non-competitive sole source Firm-Fixed-Price Requirements contract with Marathon Medical Corporation, a Service-Disabled Veteran- Owned Small Business (SDVOSB), for the 3M V.A.C.® ULTA Negative Pressure Wound Therapy (NPWT) Systems and its associated equipment. The period of performance will be for one (1) base period with two (2) 12-month option periods.

(3) Description of Supplies or Services:

The 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 by installing topical wound cleansers, removing infection materials, and treating 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 a wound is not on a limb but rather the body's trunk. Sensa T.R.A.C.™ System, which is incorporated with the V.A.C. ® VeraT.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 prevent leaks and fluid accumulation 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 adjusts 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.

Strategic Acquisition Center (SAC) 10300 Spotsylvania Ave Suite 400

A unique capability of the 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 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).

The total estimated value of the proposed action is $4,440,956.28, inclusive of a 12-month base and two option years.

(4) Statutory Authority Permitting Other Than Full and Open Competition:

The statutory authority permitting other than full and open competition is 41 U.S.C.

§ 3304(a)(5) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302- 5 entitled, “Authorized or required by statute”. The applicable statute is Public Law 109- 461: “Veterans Benefits, Health Care, and Information Technology Act of 2006” specifically, the “Veterans First Contracting Program” outlined in 38 U.S.C § 8127(c).

(5) Rationale Justifying Use of Cited Statutory Authority:

Marathon Medical Corporation is a registered and verified SDVOSB that can immediately support this need as they are an authorized distributor of the 3M V.A.C.® ULTA Negative Pressure Wound Therapy (NPWT) Systems and its associated equipment.

Marathon Medical Corporation is a registered Small Business Administration (SBA) Veteran-certified SDVOSB. This was verified on 08/07/2024 and saved to the contracting file.

The Government will not make an award unless price is found fair and reasonable and brings the best value to the Government. The rates will be verified using the Independent Government Cost Estimate (IGCE), current market conditions, historical

Strategic Acquisition Center (SAC) 10300 Spotsylvania Ave Suite 400 pricing, and technical expertise. A fair and reasonable price determination will be made prior to award.

VA Acquisition Regulation (VAAR) 819.7008 states explicitly, “A determination that only one SDVOSB can meet the requirement is not required,” and that using this authority, the following must be verified:

i. The anticipated award price of the contract (including options) will not exceed $5 million. The estimated value is $4,40,956.28.

ii. The justification prepared pursuant to FAR 6.302-5(c)(2)(ii) shall be posted in accordance with FAR subpart 5.301(d);

iii. The SDVOSB concern has been determined to be a responsible source based of FPDS historical contracts with the VA.

iv. Marathon Medical Corporation is a registered and verified Service- Disabled Veteran- Owned Small Business (SDVOSB).

v. In the estimation of the Contracting Officer, contract award can be made at a fair and reasonable price that offers best value to the Government. Historical prices along with market research for similar services shall assist with making a fair and reasonable price determination prior to award.

vi. The Contracting Officer has determined that the use of this authority is in the best interest of the Government based upon the fact that Marathon Medical Corporation is a SDVOSB vendor that possesses authorization to be a distributor for the 3M™ V.A.C.

ULTA® THERAPY SYSTEMS.

(6) Description of Efforts to Solicit Offers from as Many Sources as Practicable:

The contracting officer has determined that the use of this authority is in the best interest of the government based upon the fact that Marathon Medical Corporation is an SDVOSB which has a satisfactory performance history with the Department of Veterans Affairs in providing quality supplies at a fair and reasonable price and has the necessary working knowledge of the VA negative pressure wound therapy systems, programs and policies to provide the needed deliverables within the timeline required.

In accordance with VAAR 819.7008(b), the determination to make a sole source award to an SDVOSB is a business decision wholly within the discretion of the contracting officer; therefore, the requirement to ensure that offers are solicited from as many potential sources as practicable is not applicable to this procurement. In addition, VAAR 819.7008(c) further authorizes the contracting officer to make the award without

Strategic Acquisition Center (SAC) 10300 Spotsylvania Ave Suite 400 first determining that only one SDVOSB source can meet the requirement. Marathon Medical submitted their authorized agreement with 3M KCI manufacturer. This acquisition for services/supplies is not readily available on an existing purchasing vehicle (such as a GWAC, Internal IDIQ, GSA FSS, etc.).

A notice of the proposed action will be synopsized via the Government Point of Entry (GPE) in accordance with FAR Section 5.201, and the agency will make publicly available the justification required by FAR 6.305(a) within 14 days after contract award.

(7) Fair and Reasonable Price Determination:

No award shall be made until the Contracting Officer determines the price to the Government to be fair and reasonable. This determination will be based on a comparison of current contract pricing, an IGCE, past proposal submissions (if available), and other information as made available.

(8) Market Research:

Based on current market research, specifically the RFI results and the manufacturer of the 3M™ V.A.C. ULTA® THERAPY SYSTEMS, stated extended to SDV Office Systems LLC is determined to be a responsible source. They are registered and verified in VetCert as a SDVOSB with the North American Industry Classification System code (NAICS) 339113 (Surgical Appliance and Supplies Manufacturing) for this requirement, which is in accordance with Public Law 109-461, Section 502(c) meets the requirements of this statute to allow a sole source to a SDVOSB. A review of their Representations and Certifications was conducted in the System Award Management (SAM.gov) and Marathon Medical represented that they are an SDVOSB.

In addition, the SAM Responsibility/Qualification Summary was reviewed and shows no reports for Marathon Medical Corporation that would indicate defective pricing, instances of contractor fault or recipient not-qualified, terminations for cause, default, or material failure to comply, or non-responsibility of the contractor.

(9) Other Facts:

Marathon Medical Corporation is performing satisfactorily under their current contracts.

In accordance with Public Law 109-461, codified at 38 U.S.C § 8127 (c), in order to increase contracting opportunities for small business concerns owned and controlled by veterans and small business concerns owned and controlled by veterans with service-connected disabilities, contracting officers of the VA are given specific statutory authority to award a contract to a small business concern owned and controlled by veterans using procedures other than competitive procedures (i.e., a “sole source”

Strategic Acquisition Center (SAC) 10300 Spotsylvania Ave Suite 400 contract). The contracting officer may do so in accordance with VAAR 819.7007. The contracting officer may do so if:

(1) Such concern is determined to be a responsible source with respect to performance of such contract opportunity.

(2) The anticipated award price of the contract (including options) will exceed the simplified acquisition threshold (as defined in section 134 of title 41) but will not exceed $5,000,000.00; and In the contracting officer's estimation, the contract award can be made at a fair and reasonable price that offers the best value to the United States.

The Contracting Officer has determined that this proposed action meets all the requirements of 38 U.S.C. 8127(c).

(10) Sources Expressing Interest:

Name of Contractor: MARATHON MEDICAL CORPORATION Street Address: 3251 Lewiston ST Suite 16 City, State, Zip: Aurora, Colorado 80011-1530 Phone: 303-339-4305

Name of Contractor: Beacon Point Associates Street Address: 1216 SW 4th Street, Suite 4 City, State, Zip: Cape Coral, FL 33991 Phone: 239-673-6965

(11) Actions to Remove Barriers to Future Competition:

The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

All future requirements will be handled on a case-by-case basis. Toward the expiration of this contract, consideration will be given as to whether the future acquisition should be competitive.

Strategic Acquisition Center (SAC) 10300 Spotsylvania Ave Suite 400

(12) Technical and Requirements Certification:

Technical and Requirements Certification:

I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

Digitally signed by ANNETTE

ANNETTE HOLLAND HOLLAND

Signature:

Annette Holland

Date: 2024.08.16 12:00:44 -06'00'

Deputy Program Manager Lifecycle Management Logistic

Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Digitally signed by SARA VICKROY Date: 2024.08.16 14:15:08 -04'00'

Signature: Date:

Sara Vickroy Contracting Officer Strategic Acquisition Center

Approval

In my role as Contracting Activity Competition Advocate, based on the foregoing justification, I hereby approve this acquisition on an “other than full and open competition” basis pursuant to the statutory authority cited in paragraph four above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition. As this action does not exceed $15M, the certification below required by FAR 6.304 serves as approval.

Signature:

Adam M. Spacht

Digitally signed by ADAM

SPACHT

Date: 2024.08.16 14:26:03 -04'00'

Director, Compliance, and Internal Control Service Procuring Activity Advocate for Competition (SAC-Fredericksburg) Strategic Acquisition Center

SARA VICKROY