36C25918Q0202-001.docx

Statement of Work GI Lab Manometry System VA Eastern Colorado Health Care System Statement of Work GI Lab Manometry System

Version 1 12/01/2016

Introduction Veteran Affairs Eastern Colorado Health Care System (VA ECHCS) wishes to enter into an agreement to replace and upgrade exisiting Sandhill G3 Manometry System. The system will be utilized by GI Lab and Clinic for esophageal manometry testing and anorectal manometry testing.

General Conditions Intent of Proposal All hardware and software will become the property of the Government upon contract award. The Government is not entering into an agreement where any items are leased or vendor owned.

Address The address of the VA ECHCS is provided below.

VA ECHCS

1055 Clermont Street Denver, CO 80220 Schedule and Order Management Post-award the vendor will coordinate delivery and the completion of any services identified in this document with the VA ECHCS POC prior to beginning any work. Once the dates have been confirmed, modifications to the schedule are subject to written approval by VA ECHCS and the vendor.

Use of Premises During the performance of this contract, work will be carried out on VA ECHCS premises. The vendor will perform all work in such a manner that will cause a minimum interference with VA ECHCS operations and the operations of other vendors on the premises.

The vendor will coordinate and cooperate with VA ECHCS’s Contract Officer Representative (COR) for all activities related to the deployment of the new system.

Operation and Service Documentation Operators and service manuals shall be provided by the vendor. Electronic copy is preferred.

Functional and Technical Specifications Functional Requirements

3.1.1 Manometry System (QTY: 1)

· All-in-one system, to include data processing central unit, display, mobile cart, printer, software, and any necessary cables and accessories to complete impedience manometry studies, as well as anorectal manometry studies.

· Callibration kits shall also be included for between use calibration of catheter and system.

· Impedence Manometry Catheter and Module (QTY: 1)

· Catheter shall have 32 circumferential pressure channels

· Catheter shall have 16 impedence channels

· Catheter shall be able to be cleaned, and reprossed for repeated use.

· Cleaning standard operating procedure (SOP) shall be approved by Sterile Processing Service (SPS), Infection Control (IC), and Associate Director of Patient Care Services (ADPCS)

· Anorectal Manometry Catheter and Module (QTY: 1)

· Catheter shall have 23 circumferential pressure channels

· Catheter shall be able to be cleaned, and reprossed for repeated use.

· Cleaning standard operating procedure (SOP) shall be approved by Sterile Processing Service (SPS), Infection Control (IC), and Associate Director of Patient Care Services (ADPCS)

· Shall be able to perform the following diagnostic tests:

· Push and Squeeze Manuvers

· Recto-Anal Inhibitory Reflex (RAIR)

· Compliance Testing

· Sensation

3.1.3 Software Requirements

· A review software shall be available to review data from the swallow studies and anorectal studies conducted

· Reports shall be able to be generated, and printed directly to cart or network printers, or network storage.

· Software System shall be approved by VA Office of Information and Technology (OI&T), Biomedical Engineering, and VA Information Security Officer (ISO) via 6550 form attached.

· Software Functionality:

· Shall be able to create automated Chicago Classification 3.0 scoring

· Shall be able to create customizable views

· Shall be able to be software locked, with login

· Shall have customizable views based on user login

Professional Services Requirements

Training Requirements Training requirements for these items are detailed below, and are representative of the minimal amount of information the VA requires for the specific audiences identified. Vendor shall provide a flexible training credits option for VA ECHCS team to manage during the project implementation phase.

Table 1 – Training Details by Audience

Warranty/Guarantee Requirement Warranty shall commence upon acceptance by VA representative and verification of operational functionality.

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