LSJ_W25MWY80720084_RD.pdf

LIMITED-SOURCES JUSTIFICATION

1 The Defense Logistics Agency (DLA) Troop Support, Medical Supplier Operations, Electronic Catalog (ECAT) Division, is the contracting activity.

2 The action submitted for approval is the acquisition of a brand named Medical Vital Signs Simulator (MVSS) of Fluke Biomedical Corporation.

3 The Government has the following requirement:

Item Description/Brand Name: ProSim 8 Vital Signs Simulator Manufacturer: Fluke Biomedical Corporation MFR Part number: 4530092

NSN: 6515016560420

Quantity: 40 Estimated Total Dollar Value:

4 This action is being conducted under the authority of the ECAT Multiple Award Schedule Program. The authority waiving the competition requirements is FAR 8.405-6(a)(1)(i)(B) – Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized. As explained below, this particular brand name product is essential to the Government’s requirements, and market research has established that other companies’ similar products do not meet the Government’s needs.

The use of this authority is necessary because the United States Medical Materiel Agency (USAMMA) requires Fluke Biomedical’s ProSim 8 Vital Signs Simulator to increase inventory level to support deployed medical units and contingency operations. Fluke Biomedical Corporation is only Approved Manufacturer by the Government for NSN, 6515016560420; Simulator Kit, Patient Vital Sign.

The required MVSS shall satisfy the following minimum requirements that were established by USAMMA

1. Non-Invasive Blood Pressure (NIBP) Simulator Capability

2. Medical Functions Simulator Capability

3. Pulse Oximetry Simulator Capability

4. FDA Approved

5. All functions consolidated into one unit

6. Must be able to be calibrated and maintained at a depot level

7. Masimo Rainbow Technology

(Masimo Rainbow Set is a breakthrough noninvasive blood constituent monitoring platform that has the promise of measuring many blood constituents that previously required invasive procedures.)

The Simulator Kit, Patient Vital Sign is available on ECAT.

5 DLA Troop Support has already determined the prices of the supplies under the ECAT Multiple Award Schedule

Program fair and reasonable based on a favorable comparison to Federal Supply Schedule (FSS) pricing and discounts from commercial price lists.

Request for Quotation (RFQ) will be sent to all Laboratory ECAT contract holders prior to placement of the delivery order in an effort to obtain better pricing. This acquisition represents the best value to the Government consistent with FAR 8.404(d).

6. Market research was performed by the DLA Contracting Officer utilizing ECAT, WEBFLIS internet and by the United States Medical Materiel Agency between May/June 2018. The market research revealed other MVSS products are available, however, none of the other MVSS products meet all of the USAMMA’s minimum requirements. The results of the market research are summarized in the chart the next page.

6 ECAT vendors have the opportunity to add products, including MVSS’ and similar items, that fall within the scope of the ECAT contract at any time. Likewise, DLA Troop Support will continue to attempt to locate new vendors to join the ECAT program. The ongoing addition of new vendors and products to ECAT will enhance competition for future acquisitions. However, any new items available for future acquisitions would need to meet USAMMA’s minimum requirements.

7 As the Contracting Officer, I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.

ID# Model

NIBP

Simulator Capability

Medical Functions Simulator

Pulse Oximetry Simulator

FDA

Approved

Consolidation into one unit

Calibrated and Maintained at a

Depot level

Masimo Rainbow

Technology

Fluke Biomedical Pro-Sim 8 Vital Signs Simulator

Y Y Y Y Y Y Y

BC Marketplace Biomedical NIBP1030 Kit (SpO2 in separate device)

Y N Y

Separate Device N N N N

Pronk SimCube Patient 5+ OxSlim Kit (set of three separate devices) y y Y

Separate Device N N N Y

Clinical Dynamics AccuSim Total Patient Simulator

Y Y Y N Y N Y

Rigel Medical UNI- SIM Vital Signs Simulator

Y Y Y

Separate Device N N N N

Fluke Biomedical Pro-Sim 4 Vital Signs Simulator

Y Y N Y Y Y N