Sterilization Systems

This is a notice of intent to sole source a contract under the authority of FAR 13.106-1(b)(2), only one source being available to meet the Government’s need. The contract is estimated for delivery 120 days after receipt of order. The North American Industrial Classification System (NAICS) code for this procurement is 339113, Surgical Appliance and Supplies Manufacturing, with a small business size standard of 800 employees. The PSC is 6515 – Medical and Surgical Instruments, Equipment and Supplies.

The Department of Veterans Affairs intends to solicit and award a sole source contract, firm fixed price, for service and maintenance of two (2) ST100NX ALL CLEAR 1-DR DUO Sterilization Systems to ADVANCED STERILIZATION PRODUCTS SERVICES INC, 33 TECHNOLOGY DR, IRVINE, CA 92618. There are no other sources of service that will satisfy agency requirements.

Items Required: Two (2) ALL CLEAR 1-DR DUO, Product Number: 10104-007-50, to include OEM installation, one year OEM warranty, two (2) preventative maintenance and corrective maintenance visits (not incurred by facility error) with OEM labor, parts and travel, two (2) user manuals per unit, technical services help desk and in service education as needed. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.

The STERRAD Sterilization Process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to safely sterilize medical instruments and materials without leaving toxic residue. Because the cycle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat (less than 250 degrees F/ 120 degrees C) and/ or moisture.

Advanced Sterilization Products has no authorized distributors for the necessary model of sterilization system. No other sterilizers are known to meet the salient characteristics necessary. Several additional pieces of equipment at the VA Southern Nevada Health Care System are speced to ASP equipment, creating compatibility issues if another manufacturer product was utilized. Current chemical indicators and sterilant would have to be repurchased at an increased cost if alternative devices were selected.

Any responsible source that feels it is capable in performing this requirement may submit a quote for the above listed items and describe and/or submit documentation to support your capabilities. The response will be considered by the agency. If you are not the Original Equipment Manufacturer (OEM), you must submit an authorized distributor letter signed by the OEM as well as proof of ability to supply OEM warranty and services.

If you are not the OEM and a small business, you must indicate in your response how you will comply with limitations on subcontracting and/or the non-manufacturer rule. Responses should be submitted to Leah Smith at leah.smith@va.gov no later than Friday, June 7th, at 11:00 AM Pacific Time to be considered. The Government will not pay for information submitted.

Any responses received will only be considered for the purposes of determining whether to conduct a competitive procurement in lieu of sole source contract described in this notice, and such determination shall be made at the sole discretion of the Government. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the requirement. If no responses are received, the government will proceed with the Sole Source acquisition.