NoticeofIntenttoSoleSource-PrisMax_TherMax_CRRT.pdf

36C24921Q0048

NOTICE OF INTENT TO SOLE SOURCE

PrisMax & TherMax CRRT

1 | P a g e

This procurement is being conducted in accordance with (IAW) 41 USC 3304(a)(1) and FAR subpart

13.5, Simplified Procedures for Certain Commercial Items; therefore, the requirements of FAR Part 6, Competitive Requirements, are not applicable. The resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2020-08, effective 08/31/2020. The

NAICS code is 334510 with a size standard of 1250 employees and PSC 6515.

BACKGROUND: This is a new requirement. to replace an older Grambo ThermaFlex Continuous

Renal Replacement Therapy (CRRT) unit. These units provide renal support and blood purification therapy for patients suffering from acute kidney injury. This equipment is critical in treating COVID-19 patients, in which a significant number of patients are experiencing sudden kidney failure and requiring

CRRT. The current units are over eight years old and nearing the end of their useful life. The

Government seeks the most technologically advanced CRRT system on the market.

The Department of Veterans Affairs (VA) NCO-9, intends to issue a sole source firm-fixed priced purchase order to Baxter Healthcare (Baxter) for Lexington VA Medical Center’s [Facility] Intensive

Care Unit (ICU) Department for the following:

DESCRIPTION OF REQUIREMENT:

qtyQty: 4, PrisMax V2 US, TherMax US, & PrisMax V2 Warmer Arm Kit

Due to travel restrictions currently-in-effect for VHA-wide, the PrisMax Basic Training is an option that can be exercised within one-year of PO award date.

Estimate total price with shipping and handling: $135,700.00

Service Requirement:

Warranty coverage should entail at a minimum the following:

1. One-year coverage

2. Provide repair/replacement options for damaged/defective items

3. Includes parts, labor and travel by the contractor/OEM to facility

Delivery

1. FOB Destination

2. Take no more than 90 days to deliver and install from order receipt.

Salient Characteristics:

a. Integrated blood warmer to warm the patient’s blood prior to returning to the body

b. Easily switch between the following therapies:

• CVVHDF: Continuous Veno-Venous Hemodiafiltration

• CVVHD: Continuous Veno-Venous Hemodialysis

• CVVH: Continuous Veno-Venous Hemofiltration

• SCUF: Slow Continuous Ultrafiltration

c. Effluent management options

• Disposal down a drain

• Captured in an effluent bag

d. Adjustable High-Resolution Screen for clear viewing of system performance

e. Interoperability /compatibility with existing CRRT supplies

ADDITIONAL INFORMATION:

VAAR 819.7003 states that the nonmanufacturer rule (NMR) and the Limitations On Subcontracting (LoS) rule apply to ALL SD/VOSB set-aside and sole source contracts. The LoS and NMR applies to all

36C24921Q0048

NOTICE OF INTENT TO SOLE SOURCE

PrisMax & TherMax CRRT

2 | P a g e socioeconomic characterized small businesses (e.g. SDVOSB, VOSB, WOSB, 8a, HUBzone) under the simplified acquisition threshold (SAT), which for commodities is set at $250,000.00. Below SAT, the LoS and NMR do not apply to a generally classified small business holding none of the previously mentioned socioeconomic characterizations.

Any small business proposing an end product it did not manufacture must meet requirements in 13 C.F.R. 121.406 to be considered a nonmanufacturer and small business.

There is no non-manufacturer class waiver for the given NAICS, PSC and product description.

All responsible sources may submit a bid, proposal, or quotation, which shall be considered by the agency, if it shows they can offer comparable products that meet or exceed the standards described above in accordance with FAR 52.211-6, Brand Name or Equal.

If not identified as manufacturer but determined to be a nonmanufacturer in accordance with 13 CFR 121.406, an authorized distributor letter is required.

QUESTIONS:

1. Do you manufacture any of the like, kind, and quality products sought in this notice?

a. If yes, what is your business size?

2. To fall under the definition of a non-manufacturer for set-aside purposes, answer the following:

a. How many employees do you have?

b. Do you primarily engage in the retail or wholesale trade, normally selling the type of item sought it in this requirement?

c. Do you take ownership or possession of those normally procured items through your personnel, equipment, or facilities until you sell or deliver them?

d. If you don’t manufacture the product, are you authorized and trained to install, troubleshoot, repair, or generally work on the system?

3. Do you offer all the products and services under existing Federal Government contracting vehicles?

a. if yes, please provide the contract number/identifier, and

b. list the contract line items (CLINs) or schedule items (SINs) that would most match the products and services in the Requirement paragraph below.

SCOPE OF WORK: The Facility seeks to award this before November 13, 2020.

Interested parties should submit responses by Tuesday, November 12, 2020 at 10:00am EST to:

sascha.hertslet@va.gov, subject line: 36C24921Q0048-PrisMax_TherMax_CRRT

Responses received will be reviewed; however, a determination by the Government not to compete the proposed procurement based upon responses received to this notice is solely within the discretion of the

Government.

mailto:sascha.hertslet@va.gov