1.0 DESCRIPTION The Department of Veterans Affairs (VA) Veterans Health Administration (VHA) National Standardization Medical/Surgical Integrated Product Team (IPT) identified the need to purchase the "Peritoneal Dialysis System" (machine cycler and solution). The Peritoneal Dialysis System is an invaluable device that treats patients with renal failure. The system includes dialysates (also called dialysis fluid), or dialysis solution which is a solution of purified water, electrolytes and salts, such as bicarbonate and sodium. The NAICS code is 334510. This notice is for planning purpose only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This RFI is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes. The SAC in conjunction with VHA is seeking qualified sources to provide Peritoneal Dialysis System on an agency wide basis. Through strategic sourcing, our intent is to continue to reduce costs by standardizing products and the associated sources of supply while simultaneously balancing clinician considerations for obtaining quality products. 2.0 Product Description The Contractor shall provide an uninterrupted source of supply for all Peritoneal Dialysis Systems. The Contractor shall provide items that meet minimum technical requirements (MTRs) listed below and deliver to all VA hospitals. Specifically DVA is seeking MTRs that, at a minimum, meet or exceed the following: Item: Peritoneal Dialysis Cycler MTR 1 Must be FDA approved per: Code of Federal Regulations Title 21 MTR 2 Must have available equipment/supplies to perform continuous ambulatory peritoneal dialysis (CAPD) MTR 3 Must perform continuous cyclic peritoneal dialysis (CCPD) MTR 4 Must have options for programmable treatment modalities of high dose, CCPD, and Tidal therapy; MTR 5 Must be a portable unit that can be transported by the patient MTR 6 Must have a stable power source and emergency backup power source for power outages MTR 7 Must be able to be used in the preferred type of settings: Hospital; dialysis clinic; home MTR 8 Vendor must provide a replacement system with a 24-48 hours turn around MTR 9 Approx. weight (kg): 12-13 MTR 10 Must be able to operate for (hours): 10-12 hours continuously MTR 11 Provide documentation of Electromagnetic Compatibility compliant to the EIC 60601-1-2 standard MTR 12 Must have solution warming capabilities and a safety mechanism to prevent overwarming of solutions. MTR 13 System must have an alarm system that detects maximum/minimum pressures within the internal circuitry, temperature parameters and low/high drain & fill volume. MTR 14 System must have a protective system minimizing air infusion MTR 15 System must have a protective system preventing increased intraperitoneal volume (IIPV) MTR 16 Must have a range fill volume of 0 to 3 liters Item: CAPD solutions MTR 1 Packaging states solution is sterile. MTR 2 Packing states one-time use only. MTR 3 Packaging states expiration date, lot number, and composition. MTR 4 Literature shows FDA approval. MTR 5 2 Liters with 1.5% - 4.25% dextrose MTR 9 2.5 Liters with 1.5% - 4.25% dextrose MTR 11 3 Liters with 1.5% - 4.25% dextrose MTR 14 CAPD bags are prespiked MTR 15 Integrated drain line MTR 16 Low & Standard Calcium Dialysate Item: CCPD solutions MTR 1 Packaging states solution is sterile. MTR 2 Packing states one-time use only. MTR 3 Packaging states expiration date, lot number, and composition. MTR 4 Literature shows FDA approval. MTR 5 2 - 6 liter bags, 1.5% - 4.25% dextrose MTR 6 Low & Standard Calcium Dialysate 3.0 RFI SUBMISSION INSTRUCTIONS Companies are encouraged to respond if they have the capability and capacity to provide the product. However, be advised that generic capability statements are not sufficient for effective analysis of respondents' capacity and capability to provide the required product. If your firm has an interest in responding to the requirement described above, please provide the following: Corporate Capability Statement Information: Corporate Capability Statement; demonstrates capabilities, knowledge and experience related to the Peritoneal Dialysis System described above (please detail if capability exists to meet each spec listed). If significant subcontracting or teaming is anticipated in order to deliver technical capability and scale, organizations should address the administrative and management structure of such arrangements. INSTRUCTIONS: Submit a brief description, five (5) pages or less (including cover letter) that demonstrates how your company can provide Peritoneal Dialysis Systems anywhere in the United States. Provide your past experience in performing these services for other government (federal or states) agencies. Responses should include business size, business type, socio-economic status, identify resellers if you are a manufacturer and capability. Please submit your responses to the following contracting specialist: Tracie Quinn at [email protected]. Responses are due by 2:00 p.m. EST, December 4, 2014. DISCLAIMER: Issuance of this RFI or Sources Sought is to assist the VA in determining sources only and does not commit or bind the Government under any circumstances, nor does it constitute any obligation whatsoever on the part of the Government to procure these services or to issue a solicitation, nor to notify respondents of the results of this notice. No solicitation documents exist at this time; the Department of Veterans Affairs is neither seeking proposals nor accepting unsolicited proposals, and responses to this RFI or Sources Sought cannot be accepted as offers. Any information the vendor considers proprietary should be clearly marked as such. The U.S. Government will not pay for any information or administrative costs incurred in response to this RFI or Sources Sought.

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