Redacted_LSJ.pdf

LIMITED- SOURCE JUSTIFICATION

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Capital Equipment Division, is the contracting activity.

2. This justification is for the acquisition of brand name products that are essential to VA requirements. The products being acquired are supplied under CareFusion Solutions LLC’s Electronic Catalog (ECAT) Multiple Award Schedule contract, SPE2D1-18-D-0009, which expires December 20, 2022.

3. The Veteran’s Administration (VA) Hospitals in Dallas Texas and Garland Texas have requirements for the following multi-therapy infusion pump system items manufactured by BD CareFusion:

• Part Number: 8015 BD

Item description: BD Alaris PC Unit Model 8015BD (Alaris point of care control unit) Quantity: 507 each Unit price: $2,117.58 Subtotal: $1,073,613.06

• Part number: 8100 BD

Item description: BD Alaris Infusion Pump, Model 8100 BD.

Quantity: 1079 each Unit Price: $1,390.98 Subtotal: $1,500,867.42

• Part number: 8110

Item description: Alaris Syringe Module.

Quantity: 10 each Unit Price: $2,944.00 Subtotal: $29,440.00

• Part number: 8120

Item description: Alaris PCA (Patient Controlled Analgesia) Module.

Quantity: 43 each Unit Price: $3,225.00 Subtotal: $138,675.00

• Part number: 8300

Item description: Alaris EtCO2 (End-tidal Carbon Dioxide) Module Quantity: 20 each Unit Price: $3,230.00 Subtotal: $64,600.00

Total Estimated Dollar Value: $2,807,195.48

4. 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 ordered are unique or highly specialized.

The use of this authority is necessary because the BD CareFusion Alaris multi-therapy infusion pump system is the only infusion pump system that can meet the needs of the VA. The Alaris multi-therapy infusion pump system is used for the delivery of fluids, medications, blood and blood products using continuous or intermittent infusion delivery for adult, pediatric or neonatal patients. The VA’s minimum requirements are as follows:

Infusion Pump

• The multi-therapy infusion pump system shall be compliant with Food and Drug

Administration (FDA) regulations.

• The multi-therapy infusion pump system shall be able to deliver fluid, blood, medications, and total parenteral nutrition (TPN) to a patient over a defined time/period at a specific flow rate.

• The multi-therapy infusion pump system shall be able to connect large volume pump, syringe, patient-controlled analgesia (PCA), and EtCO2 modules to the same point-of-care (PC) pump control unit, with a minimum of four (4) modules in any combination being connected simultaneously.

• The multi-therapy infusion pump PC pump control units shall interface with the Electronic Health Record (EHR) system.

• The multi-therapy infusion pump system shall be capable of Wi-Fi communication

• The multi-therapy infusion pump system shall have a memory of at least 2,500 drugs and fluids that is capable of expansion or be capable of updating the drug library via Wi-Fi.

• The multi-therapy infusion pump system shall include auditory and visual alarms.

• The multi-therapy infusion pump system shall be able to continuously monitor and alert clinical users when air or other blockage is detected in delivery tubing.

• The multi-therapy infusion pump system shall have front/keypad assembly with Color LCD display which displays the drug or IV fluid name, dose, and rate.

• The multi-therapy infusion pump system shall have software that helps to reduce the risk of medication errors by providing a test of reasonableness before the initiation of therapy and to collect automated data to analyze from infusion pump.

• The multi-therapy infusion pump system shall have a battery pack for battery run time up to 6 hours

• The multi-therapy infusion pump system shall support primary and secondary (“piggyback”) delivery.

Syringe Module /PCA Module

• The multi-therapy infusion pump system shall have a syringe infusion pump module and a PCA infusion pump module that can be used on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as Intravenous (IV), Subcutaneous, and Epidural.

• The syringe infusion pump module shall have a flow rate range 0.01-9.99 ml/hr. in 0.01 ml increments to 100-999 ml/hr. in 1 ml increments.

• The syringe infusion pump module shall have pressure sensing disc to accurately monitor in-line pressure, to help reduce start up delays, and to shorten the time to an occlusion alarm.

• The syringe infusion pump module shall accept syringe sizes from 1 to 60 mL, and automatically detect the syringe size.

• The syringe infusion pump/ PCA infusion pump module shall be able to provide continuous electronic monitoring.

EtCO2 Module

• The EtCO2 module shall be able to provide continuous respiratory monitoring during

PCA use and automatic shut-off of the PCA when respiratory rate or CO2 levels drop below set parameters.

• The EtCO2 module shall be able to provide continuous, noninvasive monitoring of end-tidal carbon dioxide, fractional inspired carbon dioxide, and respiratory rate.

• The EtCO2 module shall be able to deliver a sample of the inhaled and exhaled gasses from the ventilator directly from the patient into the monitor for CO2 measurement.

• The EtCO2 module shall be able to provide a sampling gas flow rate nominally 50 mL/min -7.5 +15 mL/min.

The CareFusion Infusion Pump Systems identified above are the only products currently available on ECAT that meet all of the Government’s minimum requirements.

5. DLA Troop Support has determined the prices of supplies under the DLA Troop Support ECAT Contract fair and reasonable based on a favorable comparison to commercial pricing. DLA Troop Support will try to obtain further decreases based on quantity discounts. This acquisition represents the best value to the Government consistent with FAR 8.404(d).

6. The VA performed market research on BD Alaris infusion products and in ECAT in August 2019. The market research revealed that there are no infusion pump systems from other vendors that can meet the minimum requirements.

Market research was also performed in ECAT by the DLA engineer in June 2020 that revealed there are three other manufacturers of infusion pumps available on ECAT as specified below:

• KD Scientific dual syringe infusion pump manufactured by KD Scientific (manufacturer part number: KDS200) and supplied by GSS. This manufacturer does not produce any large volume infusion pumps, PCA pumps, and EtCO2 modules. In addition, this device is a stand-alone dual syringe infusion pump and has no capability for interfacing or bi-directional interoperability with the EHR system. The device is not able to automatically detect the syringe size. The device has no visual alarm and no pressure sensing disc. Therefore, the device does not meet the minimum requirements as specified in paragraph 3.

• Power Infuser Model M100B-3A, manufactured and supplied by Zoll Medical (manufacturer part number: 8700-0600-01). The Power Infuser® Model M100B3-3A is a miniature battery-operated infusion pump designed to deliver IV fluids and blood products to patients in the field, in pre-hospital transport, or in the hospital. However, this device is not intended to support the delivery of pharmaceutical or other medications. This device is a cartridge-type infusion pump and does not work with syringes with various sizes from 1 to 60 mL In addition, this manufacturer does not produce any large volume infusion pumps, PCA infusion pumps, and EtCO2 modules. This device is a stand-alone infusion pump and has no capability for interfacing or bi-directional interoperability with the EHR system. Therefore, the device does not meet the minimum requirements as specified in paragraph 3.

• The M362 syringe infusion pump manufactured by Thermo Fisher Scientific

(manufacturer part number: M362F) and supplied by Government Scientific Source, Inc. (GSS).

This manufacturer does not produce any large volume pumps, PCA infusion pumps, and EtCO2 modules. In addition, this device is a stand-alone syringe infusion pump and has no capability for bi-directional interoperability with the EHR system. The device is not able to automatically detect the syringe size and has no pressure sensing disc. Therefore, the device does not meet the minimum requirements as specified in paragraph 3.

The market research demonstrates that other similar products currently available on ECAT do not meet the VA’s needs, and that the CareFusion Alaris multi-therapy infusion pump system listed in paragraph 3 is unique and highly specialized. The CareFusion Alaris multi-therapy infusion pump system is the only product currently available on ECAT that can meet all of the VA’s minimum requirements.

7. Any ECAT vendor not currently offering the required product will have the opportunity to add the product. Furthermore, ECAT vendors have the opportunity to add new products that fall within the scope of their ECAT contract at any time, enhancing competition for future acquisitions.

8. DLA Troop Support will attempt to locate other acceptable sources for future routine requirements as they arise; however, any new item would be required to meet the VA’s rigorous requirements.

9. As the Contracting Officer, I hereby certify that the information contained in this Limited-Sources Justification is accurate and complete to the best of my knowledge and belief.