SOW for CS Medical TEE Probe HLD Unit rev 2.doc

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Attached to
6515--Intent to Sole Source: TD-100 TEE Probe HLD Unit Federal contract opportunity
Solicitation number
36C24225Q0416
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 2

About this file

This Statement of Work outlines requirements for procurement of a CS Medical TD-100 TEE Probe High Level Disinfection (HLD) Unit for the Buffalo VA Medical Center. The equipment must include specific components: pre-installation kit, starter kit, vapor management filter, HLD tracker, disinfectant, neutralization station, electrical lead, master spill kit, and web-based training with 5 user licenses.

The contract specifies brand name or equal procurement from CS Medical, LLC, with delivery required within 30 days of award. Key requirements include FDA clearance, compliance with AAMI standards (ST-79 and ST-108), ISO 9001 certification, and VA SPS standards. The vendor must provide technical documentation, conduct a facility walkthrough with VA Engineering, deliver mandatory staff training, and include a minimum one-year warranty for parts and labor. This procurement is being handled as a sole source acquisition by the Department of Veterans Affairs Veterans Health Administration VISN 2 for the Buffalo VAMC facility located at 3495 Bailey Avenue, Buffalo, NY.

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Other files attached to 6515--Intent to Sole Source: TD-100 TEE Probe HLD Unit, newest first.
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Intent To Sole Source - TD 100 TEE Probe HLD Unit.docx DOCX document
36C24225Q0416.docx DOCX document

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Text version

STATEMENT OF WORK (SOW)

As of 3/3/2025

1. Point of Contact (POC):

Name:

Section:
SPS
Address:
3495 Bailey Ave., Buffalo NY 14215

Phone Number:

Fax Number:

E-Mail Address:

2. Contract Title: Tee Probe High Level Disinfection Unit for VHAWNYHS Procurement for Buffalo VAMC.

3. Background: The AutoCAD drawing is attached below of the equipment layout. There is 1 TEE Probe HLD Unit in the diagram that we wish to purchase from CS Medical.

4. Scope:

4.1 The Buffalo VAMC is seeking a brand name or equal (CS Medical), to purchase the addition of:

· CS Medical TD 100 TEE Probe HLD Unit (1 each),

· The TEE Probe HLD Unit must meet the following salient characteristics (1 each):

1. Pre-Installation Kit

2. Starter Kit

3. Vapor Management Filter

4. HLD Tracker

5. Disinfectant (cs)

6. Neutralization Station

7. Electrical Lead

8. Master Spill Kit

9. Web-based In-Service Training (5 user license)

This sterile processing equipment Probe Disinfection System must meet the non-clinical, functional, and performance specifications specified in this Statement of Work (SOW). Devices must have FDA clearance for utilization in the United States of America.

5. Specific Technical Elements:

5.1 The proposed unit shall meet the following Buffalo VA Medical Center technical requirements: Brand Name or equal- CS Medical.

5.2 The processing equipment must have the following General Salient Characteristics:

· A walkthrough with VA Facility and Engineering must be done with vendor before consideration for approval, due to utility needs.

· Training of SPS staff is mandatory for operational and user needs.

· The vendor shall provide complete technical information sheets and owners/user’s manual.

· The vendor will supply specs and pictures of the sterile processing equipment TEE Probe HLD Disinfector.

· The vendor shall supply the IFU for cleaning and maintaining of the sterile processing equipment TEE Probe HLD Disinfector.

· TEE Probe HLD unit must have at least a full, 1 year warranty for parts and labor.

6. Technical Terms and Conditions: The offering vendor shall meet the following Buffalo VA Medical Center Terms and Conditions.

6.1 The Vendor certifies that the device meets or exceeds AAMI (including ST-79 and ST-108 and others), ISO 9001 and VA SPS standards and design requirements.

6.2 The Vendor to must deliver the equipment and applicable accessories in new condition. Any equipment damaged in shipping or delivery must be the responsibility of the Vendor.

6.3 The Vendor will provide the VA with all service publications that are used to inform or update SPS and Biomed personnel on RMD issues, i.e., newsletters, alerts, recalls and/or procedure changes or upgrade enhancements. Such publications will be sent to the VA when they become available to the Vendor’s field service personnel.

7. Place of Performance:

The place of performance for this contract is the Buffalo VAMC; 3495 Bailey Avenue, Buffalo, NY 14215

8. Delivery Schedule: All items must be delivered to the Buffalo VAMC NTL 30 days from date of award.

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