Statement of Need.docx

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

1700 N. Wheeling Street Aurora, CO 80045

Cardiac Stimulator and Recorder Statement of Need:

Purpose:

The Rocky Mountain Regional VA Medical Center has a requirement to purchase (1) Cardiac Stimulator with an authorized vendor to supply and deliver the items identified in Table 1 below. This is a Brand Name or Equal requirement; refer to the salient characteristics below. Fischer Medical is the basis of design 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 and must have the latest manufacturer’s software/hardware updates installed. 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.

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:

5) Purchase Order:

Period of Performance:

This will be a firm fixed base plus (4) contract.

Base: 1 July 2023 – 30 June 2024 Option Year (1): 1 July 2024 – 30 June 2025 Option Year (2): 1 July 2025 – 30 June 2026 Option Year (3): 1 July 2026 – 30 June 2027 Option Year (4): 1 July 2027 – 30 June 2028

Delivery Instructions:

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

Installation:

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

Training:

The price quoted shall include contractor responsibility for providing on-site orientation and training of using personnel in operation and care of the equipment furnished. This training shall include actual demonstration and operation of the equipment, preventative maintenance, and any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action shall in no way jeopardize the Government's rights under contract guarantee clause. Upon delivery, this training shall be given by qualified contractor representatives on a date to be determined by the using service POC.

Vendor shall submit training materials and training videos (prepared in CD or DVD format) on each piece of equipment for operation and maintenance. Any available training videos shall be for operation and maintenance and shall not be combined. These training materials and videos shall demonstrate the operation and maintenance of the equipment and any adjustments or other actions that may be undertaken by VA operating personnel in the event of failure of equipment. These training materials and videos shall be submitted to the responsible operations official or his designee prior to beginning of training.

The Vendor shall consult with the Point of Contact or person acting in that capacity regarding the time this training will begin. These officials will be responsible for arranging for the presence of personnel to be trained.

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:

Due to the COVID19 situation, the vendor must follow CDC guidelines when on VA property. Any individuals who need to enter the building for installation &/or training may be required to be screened by the site staff prior to entry. Please allow time for this in your schedule.

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

Assembly and 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:

Total Quantity: 1 ☐ Network Required if Checked ☒ Manufacturer Certified Installation Required if Checked ☐ BMET Training Required if Checked ☒ End User Training Required if Checked

Basis of Design is Fischer Medical, MFG P/N: 370000G

· Cardiac Stimulator and Recorder

· Standard (1) Year Manufacturer’s Warranty

· On-Site Training

· Cardiac signal waveform display

· Error messages with clear text explanation

· Ability to save multiple preferred pre-protocol setups that can be recalled at touch of a button

· Touch Screen Display

· Built in battery backup and emergency pace function

· Buttons on keyboard to increment and decrement by touch and sound

· Four channel pacing at 25 mA

· Graphical Console

· Tactile Operator Unit

· Stim unit

· Customized, pre-programmed protocol set-up with ability to instantly adjust settings based on clinical need

· Ability to provide “unrestricted” instant burst pacing

· Actual cardiac signal readback displayed waveforms on any pacing catheter (not manufacturer specific)

· Four channel pacing drives that can withstand ablation and cardioversion pulses that can be independently programmed

· Ethernet connection with other EP equipment

· No menu drill-down

· Small footprint (requires minimal counter space)

· No keyboard or mouse

· Upgradable firmware for pacing drives and controls for future improvements

· Power Source: 100V - 240V, 50Hz – 60Hz

· Power supplies and motors meet UL60601-1; CAN-CSA C22.2 No. 601.1