Statement of Need Pro Lab for RMR.docx

Eastern Colorado Healthcare System (ECHCS) Rocky Mountain Regional (RMR) VA Medical Center

1700 N. Wheeling Street Aurora, CO 80045

EasyOne Pro LAB Statement of Need: This portable pulmonary function testing system is needed for both clinical and research-based testing at the Floyd Lindstrom VA Clinic in Colorado Springs, Colorado. Currently, we do not have capability to do a wide variety of pulmonary function testing such as spirometry, diffusion capacity for carbon monoxide testing, lung clearance index (LCI) testing via multiple breath washout, and bronchoprovocation testing. Requests for these diagnostic procedures are being funneled through our community care system. We have previously purchased the EasyOne Pro Lab Respiratory Unit that is currently used in Dr. Krefft’s research protocol VA study/COMIRB ID#19-1853 (Clinical Markers and Monitoring of Deployment Lung Disease) and with expansion of both research and clinical testing to Colorado Springs to become more veteran-centric and prevent burdensome travel to the RMR VAMC, purchase of this equipment would allow us to have comparable data and minimize differences in instrument measurement variability with other devices, especially to maintain research quality integrity. Furthermore, for the multiple breath washout function of this device, the LCI measurement is FDA-approved for clinical use and would be helpful for both research and clinical care measurements to improve longitudinal monitoring in our Veteran population.

Purpose:

The Rocky Mountain Regional VA Medical Center has a requirement to purchase one EasyOne Pro Lab Respiratory Unit with an authorized vendor to supply and deliver the items identified in Table 1 below.

Table 1 – Package Item(s) Summary

Salient Characteristics:

· Standard (1) Year Manufacturer’s Warranty.

· Must export files and raw data.

· Must have connection for O2 gas supply system.

· Must have flexible HL7 and XML interface for easy EMR integration.

· Must measure Spirometry, DLCO and provide provocation testing.

· Must measure the FRC (Functional Residual Capacity) based on the Multiple Breath Nitrogen (N2) Washout method.

· Must measure lung clearance index (LCI) based on the Multiple Breath Nitrogen (N2) Washout method.

· Must be compact with smooth surfaces for easy and thorough cleaning.

Scope of Work:

Equipment will be shipped in original OEM packaging and will be inspected upon receipt to ensure equipment is free of defect and/or damage. The equipment will ship complete, no partial shipments will be accepted.

Date of manufacture must not be greater than 2 years before the purchase order date. The equipment must not be used or refurbished and must have the latest manufacturer’s software/hardware updates installed; if applicable. Any batteries provided with the unit will not be manufactured more than 12 months before the purchase order issue date.

The vendor will provide all applicable service manuals that includes theory of operation, maintenance requirements, repair information, schematics, part lists and troubleshooting information in electronic format for use by the VA Biomedical Engineering Department.

Period of Performance:

This will be a firm fixed contract and items should be received within 30 days from time of award.

Inspection:

Prior to acceptance of the goods or services provided under this contract, inspection and testing will be performed by the government.

Warranty:

The Contractor shall provide all manufacturer’s warranty with products upon delivery. Warranty shall commence upon acceptance by VA representative and verification of operational functionality.

The warranties shall include all travel and shipping costs associated with any warranty repair.

Deliverables:

Operation and Maintenance Manuals Invoicing and Supporting Documentation:

The supporting documentation and invoice shall be submitted within 30 days at the end of each month. Subsequent changes or corrections shall be submitted by a separate invoice. In addition to information required for submission of a ‘proper’ invoice in accordance with FAR 52.212-4 (g), all invoices must include the following information:

a. Name and Address of Contractor

b. Contractor’s Tax Identification Number

c. Date of Invoice

d. Invoice Number

e. Contract Number

f. Purchase Order Number

g. Date of Service

h. Contract Line Item Number (CLIN)

i. Description, Quantity, Unit of Measure, Unit Price, and Extended Price of the items delivered

j. Total Price Recalls:

The Vendor shall immediately notify all affected VA Medical Centers and designated POC in the event of a device recall, removal, required adjustment, or required modification that is suggested or mandated by the Vendor, distributor, manufacturer, or any regulatory or government agency. The following information shall be included in this notification:

A complete item description and identification (to include lot or serial numbers where applicable); administrative identification data including order numbers and order date; reasons for recall, removal, adjustment, or modification; and Instructions for appropriate corrective action.

Confidentiality and Non-Disclosure:

This equipment does not connect to a VA network. Therefore, in accordance with Appendix A, Handbook 6500.6 Checklist, Block 6, the C&A requirements do not apply to this requirement, and a Security and Accreditation Package in not required.

This equipment does not hold or store patient information. Therefore, in accordance with Appendix A, Handbook 6500.6 Checklist, Block 7, Appendix B and C provisions do not apply.