Statement of Work.docx

STATEMENT OF WORK (SOW)

1. Background. The Cincinnati Veterans Affairs Medical Center (CVAMC) currently has brand name reusable manometry probes compatible with existing specialized high-resolution manometry (HRM) systems that are at end of lifecycle and require replacement.

2. Scope. This is a new one-time request for a firm-fixed price contract to procure a supply of brand name reusable manometry probes that are compatible in all aspects with existing HRM systems.

3. Specific Tasks. The Contractor will supply new brand name manometry probes to replace the facility’s existing manometry probes. The Contractor will submit reprocessing guidelines for reusable probes. The Contractor will verify packaging integrity and sterility. The Contractor will assist with initial setup and calibration. The Contractor will conduct staff training on probe handling, usage, and troubleshooting. The CVAMC staff will follow validated cleaning and sterilization protocols.

4. Equipment Salient Characteristics.

I. Sensor & Catheter Specifications

a. 36 pressure channels with 12 measurement points per sensor, totaling 432 pressure data points, combined with 18 impedance channels to track bolus transit

b. Catheter diameter: 4.2 mm with true circumferential sensors

II. Coverage & Mapping Capabilities

a. Captures pressure and impedance continuously from pharynx to stomach in a single catheter insertion

b. Provides circumferential pressure mapping of bolus movement and esophageal motor function

III. Diagnostic Enhancements

a. Combines High-Resolution Manometry (HRM) with impedance measurements, improving evaluation of bolus passage success and esophageal motility disorders such as achalasia, dysphagia, reflux, and hiatal hernia

b. Maps utility includes enhanced sensitivity for diagnosing post-antireflux surgery dysphagia and helps predict bolus clearance

IV. Software Functions

a. Provides tools for analysis, graphical identification of key landmarks (LES, UES, PIP), eSleeve for sphincter pressure, and both high-res and conventional display modes

b. Includes Chicago Classification algorithm integration with automatic interpretation

c. Supports HIS/HL7 interoperability aligning with meaningful use standards

V. Efficiency & Training

a. Procedures take ≤10 minutes and require minimal specialized training

b. Visual data output via spatiotemporal contour maps (Clouse plots) simplifies interpretation

5. Performance Monitoring. CVAMC Sterile Processing Service (SPS) will be responsible for monitoring the manometry probes.

6. Security Requirements. The C&A requirements do not apply, and a security accreditation package is not required. A signed copy of the VA Handbook 6500.6 is on file.

7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). No GFE/GFI will be provided for this requirement.

8. Other Pertinent Information or Special Considerations.

a) Identification of Possible Follow-on Work. Not Applicable

b) Identification of Potential Conflicts of Interest (COI). There are no known potential conflicts of interest identified.

c) Identification of Non-Disclosure Requirements. There are no non-disclosure requirements for this requirement.

d) Packaging, Packing and Shipping Instructions. Contractor must ensure packing is complete, sealed, and without damage before shipping equipment. The purchase order number must be included on all shipping labels/documents.

e) Inspection and Acceptance Criteria. The CVAMC Warehouse Logistics staff will receive the equipment. If damages are discovered, the equipment will not be accepted. The Contractor will be contacted for replacement equipment. If the equipment is accepted, Biomedical Engineering Service (Biomed) will conduct a safety inspection. If damages are discovered, the equipment will not be accepted. The Contractor will be contacted for replacement equipment. If accepted, the equipment will be delivered to the end user.

If replacement equipment is required, the Government will not be responsible for the cost of additional shipping and handling charges.

9. Risk Control. Biomed will conduct safety inspection. SPS will sterilize equipment prior to patient use.

10. Place of Performance. Cincinnati VA Medical Center, 3200 Vine St, Cincinnati, Ohio 45220 -2213

11. Delivery Schedule. All supplies will be shipped to the CVAMC Warehouse within 30 days after receipt of order (ARO). Any unexpected delays must be communicated in writing to the Contracting Officer. FOB Destination. Hours of operation are Monday – Friday, 6:00AM – 3PM EST. No deliveries are accepted on the following Federal holidays:

· New Year’s Day – January 1

· Martin Luther King, Jr.’s birthday – 3rd Monday in January

· President’s Day – 3rd Monday in February

· Memorial Day - Last Monday in May

· Juneteenth National Independence Day - June 19

· Independence Day - July 4

· Labor Day - 1st Monday in September

· Columbus Day (Indigenous People’s Day) - 2nd Monday in October

· Veterans Day - November 11

· Thanksgiving Day - 4th Thursday in November

· Christmas Day – December 25th

The President of the United States of America may declare additional days as a federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.