Statement of Need Temp Controlled Cabinet.pdf

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

1700 N. Wheeling Street

Aurora, CO 80045

Statement of Need:

Purpose:

The Rocky Mountain Regional VA Medical Center (RMRVAMC) has an identified a requirement to procure temperature controlled sterile storage cabinets to support Sterile Processing Service operations.

Our directive was recently updated to have more stringent storage duration for Reusable Medical Device (RMD) to every 24 hours from 72 hours. This is part of our action plan to address our findings during our VISN 19 CSPO annual survey to gain compliance with the updated directive.

Refer to the salient characteristics below.

Table 1 – Package Item(s) Summary

Description Qty Sterile storage cabinet 1 Installation and in-servicing. 1

Scope of Work:

The Sterile Processing Service at the RMRVAMC requires a one-time procurement of a Sterile storage cabinet that is temperature and humidity controlled to meet Directive 1116, AAMI ST79 sterile storage requirements. The storage cabinet system must be able to provide the necessary capability to regulate temperature, pressure, cleanliness, and humidity to prevent decay and increase the shelf life of stored goods. This cabinet system will help us meet our need to maintain sterile conditions for stored sterilized implements, equipment, and inventory, bringing us back into compliance with the updated SPS Directive.

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. 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, maintenance requirements, and part lists.

The shipping label and packing slip will contain the following information for ease of receipt:

FY26 Temperature Controlled Instrument Cabinet – Sterile Processing

Service

1) Ship To:

2) Rocky Mountain Regional VA Medical Center, 1700 N Wheeling Street, Aurora, CO 80045

Delivery:

Delivery shall be within 30 days from time of award.

Equipment shall be delivered to the Rocky Mountain Regional VA Medical Center located at 1700 N.

Wheeling Street, Aurora, CO 80045.

Delivery Hours of Operation: Monday – Friday; 0700hrs – 1500hrs; excluding all Federal Holidays.

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.

Special Work Requirements:

The removal/disposal of waste and/or excess material shall be the responsibility of the vendor.

Installation Required (Yes ☐ No ☒)

Training Required (Yes ☐ No ☒)

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.

Salient Characteristics:

Minimum Salient Characteristics

1. Must have Overall Exterior Dimensions: 30.5” W x 32” D x 77.5” H

2. Not to exceed Weight: 450 lbs.

3. Must have Shelfs, Qty & Dimensions: Five (5) -27.75” W x 18” D.

4. Overall Payload Dimensions must be: 28” W x 19”D x 42” H.

5. Must maintain 66°F to 72°F Temperature.

6. Must maintain Humidity at 20% to 60% RH.

7. Must maintain positive pressure +0.03”WC.

8. Must meet IEC 60601-1 Medical Standard for Power Supplies.

9. Must have a HEPA Filtration designed to exceed ISO 4 Cleanliness or better.

10. Capable of 230 air changes per hour.

11. Must have an Integrated condensate control system.

12. Must have a Onboard custom control system with digital display for monitoring temperature, humidity, pressure and status.

13. Must have Integral pressure monitoring with alarm.

14. Must have Steam humidification utilizing standard demineralized water.

15. Must have Integral 3/4 gallon reservoir filled through front spout access.

16. Must have 120V hospital grade 10ft long plug-in-cord.

17. Must have 55-59 DBA at 3 feet (1 meter).

18. Must have capability to interface with VA network environmental monitoring system via an access port.