P09_Statement of Need_AesculapContainers.docx

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

1700 N. Wheeling Street Aurora, CO 80045

Aesculap Containers - Sterile Processing Service Statement of Need:

Purpose:

The Rocky Mountain Regional VA Medical Center has a requirement to purchase an Aesculap Sterilization Container system, and deliver the items identified in Table 1 below. This is a Brand Name or Equal requirement; refer to the salient characteristics below.

Table 1 – Package Item(s) Summary

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. 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.

Tracking information will be emailed to the following Point of Contact (POC):

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

1) Ship To:

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

3) Mark For:

4) Contract Number: N/A

5) Purchase Order: N/A

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.

Delivery will be coordinated through the On-Site Point of Contacts (POCs):

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:

Assembly and Installation Required (Yes ☐ No ☒) Training Required (Yes ☐ No ☒)

Basis of Design is to be able to securely store and transport Emergency Management deployable equipment.

· Aesculap Containers.

· FDA-cleared containers for use in sterilization methods including PreVac Terminal, PreVac IUSS, Gravity Steam, EtO, and STERRAD, STERIS, and STERIZONE low-temperature.

· Ergonomic container handles stop at 90 degrees

· Single-step latch system allowing rapid assembly of sets and increasing department efficiency.

· Secure padlock design which assures sterilization integrity.

· Single-motion filter retention plate with audible click.

· Lifting points on each end of containers allow SPD staff to close and OR staff to open aseptically.

· Stackable Containers during sterilization and storage.

· Rigid containers are accompanied by an IFU adhering to and compliant with current processes and sterilization equipment utilized within the SPS Department of the Rocky Mountain Regional VA Medical Center

· FDA-cleared Steam sterilization dry time of 15 Minutes while still allowing for items to be stored for later use.

· FDA clearance to maintain sterility of contents for up to 360 days for PreVac Terminal, PreVac IUSS, Gravity Steam, EtO, and STERRAD, STERIS, and STERIZONE low-temperature sterilization methods.

· Item numbers for each container product allowing users to order lids, bottoms, baskets individually.

· OEM-owned mobile repair service validated to repair the containers

· Lifetime warranty on manufacturing defects and minimum 3-year warranty on gaskets.

· A comprehensive Instrument Organization System (IOS) is available including baskets, instrument brackets, and mats for care and handling.

· Shelf life of 10+ years.