Notice of Intent to Sole Source.docx

NOTICE OF INTENT TO SOLE SOURCE

In accordance with FAR 13.106-1(b)(1)(i), Network Contracting Office 9 intends to award a sole source purchase order to Baxter Healthcare Corporation, located at One Baxter Parkway, DF6-5W, Deerfield, IL 60015. The basis for a sole source award is that Baxter Healthcare Corporation is the sole manufacturer of the PrisMax V3 Renal Care System, which is required for hospital standardization and continuity of patient care. The following items will be purchased:

The anticipated statutory authority for limiting competition is FAR 13.106-1(b)(1)(i); only one source is capable of providing supplies required at the level of quality required because the supplies are unique or highly specialized. The NAICS code is 339113 with a size standard of 750 employees.

Any capability statements received by the closing date of this Notice will be considered by the Government. A determination by the Government not to compete based on responses to this Notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

Capability statements shall be submitted by email to Angela Tucker at angela.tucker2@va.gov, and are due no later than January 4, 2022 at 10:00AM CT. Phone calls will not be accepted.

NOTE: capability statements for Brand Name products must include a letter directly from the manufacturer that your company is an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller of the exact equipment listed above.

Salient Characteristics

· Loads and primes the Prismaflex disposable set automatically

· Pumps blood through the blood flow path of the Prismaflex disposable set

· Delivers anticoagulant solution into the blood flow path

· Pumps sterile infusion solutions into the blood flow path of the Prismaflex disposable set, according to the therapy in use

· Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies

· Controls the patient fluid removal or plasma loss, according to the therapy in use

· Monitors the system and alerts the operator to abnormal situations through alarms

· Access line: the access line connects the patient catheter to the inlet of the blood pump segment. It includes an access pressure pod. The PBP pump output line is connected to the access line just after the blood flow enters the access line.

· Blood pump segment: the blood pump segment is inserted in a peristaltic pump which pumps blood through the disposable set

· Pre-filter line: the pre-filter line connects the outlet of the blood pump segment to the filter or cartridge blood inlet. It includes a filter pressure pod. In between, the pre infusion and systemic anticoagulation lines connect to the pre filter line.

· Filter blood compartment: blood flows in the hollow fiber membrane, which constitute the blood compartment of the filter, from bottom to top to minimize air trapping. The output of the blood compartment connects to the deaeration chamber.

· Deaeration chamber: the deaeration chamber is connected to the return line section downward the filter, the monitor line and the return line. It also connects with the post infusion line. Blood flows in and partially fills the chamber. Due to the centrifuge flow, air that might be in the blood flowing out of the filter travels upwards out of the fluid to the air-filled portion. The monitor line connects to the return pressure port and permit to measure the return pressure. Degassed blood flows in the return line

· Return line: the return line connects the deaeration chamber to the patient catheter. It passes through the air bubble detector and return clamp.

· Pre-blood pump fluid line: this connects the pre-blood pump (PBP) from the pre-blood bag to the access line connection.

· Systemic syringe line: this connects the anticoagulant being delivered from the systemic syringe into the pre-filter line.

· Pre-filter replacement line: this line connects from the fluid in the bag on the replacement scale to the pre-filter line

· Dialysate line: this line connects from the fluid in the bag on the dialysate scale to the filter fluid compartment input.

· Filter fluid compartment: the dialysate line connects to the input of the filter fluid compartment. Conversely to the blood path, the filter fluid compartment flows from top to bottom. It gives the fluid the chance to meet with the blood through the fiber membrane and transport impurities from the blood to the fluid filter compartment. The output of the filter fluid compartment connects to the input of the effluent line.

· Effluent line: the fluid coming out of the filter fluid compartment flows into the input of the effluent line. It flows through a pressure pod, the discharger ring, and the blood leak detector. The output of the effluent line is either the effluent catch bag on the effluent scale, or the input to the auto-effluent accessory.

· Post-filter replacement line: this line connects fluid from the bag on the replacement scale to the deaeration chamber.

· Auto Effluent line: when used, the effluent line described above connects to the auto effluent accessory and the auto effluent bags. The auto effluent drain line routes fluid from the auto effluent bags to the clinical drain.

· The machine also uses the pressure data to calculate filter pressure drop (∆P), and transmembrane pressure (TMP) or access transmembrane pressure (TMPa). These calculated pressures are used to tell when clotting has begun in the filter or when the filter has clotted, and the set must be changed

· Weight Approximately 75–80 kg (165–176 lb) without fluid bags or disposable set, depending on installed options.

· Height Approximately 140–170 cm (55–67 in.)

· Width Approximately 51 cm (20 in.)

· Base Approximately 70 × 70 cm (27.5 × 27.5 in.)

· Stability The control unit complies with IEC 60601-1 [ed3.0].

· Microprocessors The primary CPU (control processor, CP) runs at 600 MHz. Secondary CPUs include:

· Safety processor (SP) runs at 96 MHz

· Power system controller (PSC) runs at 24 MHz

· Display control processor (DCP) runs at 24 MHz

· NAND flash memory and 512 MB of SD RAM.

· 32-GB capacity SDHC card for data storage in a Microsoft Windows-compatible format.

· Display Integral 1024 × 768 16-bit color LCD monitor

· Line voltage 100–240 VAC, 50/60 Hz

· Power cord Length: 3.5 m (11.5 ft), including plug

· Power interruptions the system comes standard with a lithium battery that will power the system for at least 30 minutes without AC power.

· USB port Communicates with an external USB 1.0 storage devices

· Upgraded 3.1 software