Attachment 1 - Epic Plus Heart Valves SOW.docx

DOCX document 27 KB Posted

Attached to
6515--Brand Name Only, EPIC PLUS HEART VALVES, CLE (01/25)
Solicitation number
36C25025Q0350
Issued by

About this file

This Statement of Work (SOW) outlines requirements for Epic Plus Mitral Heart Valves at the Cleveland VA Medical Center. The VA requires a platform change from the previous E100 to the E200 system to maintain continuity of care, specifically needing heart valves in sizes 25m, 27m, 29m, 31m, and 33m. The procurement is a one-time buy for the Surgical Department, where these valves will be used for aortic valve replacements.

The SOW specifies delivery to Cleveland VAMC at 10701 East Blvd, Cleveland, OH 44106. The COR from the Nursing Service section will work with warehouse staff and biomedical engineering to inspect and accept deliveries. No government-furnished equipment is provided, and the contractor will not have access to VA sensitive information. The delivery schedule will be finalized between Cleveland VAMC and the vendor after contract award. Contract number is 541-25-1-783-0185, and this is not a follow-on contract.

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Attachment 2 - Brand name justification.pdf PDF
36C25025Q0350.docx DOCX document

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Text version

STATEMENT OF WORK (SOW)

as of 12/10/2024

Contract Number:
541-25-1-783-0185

Task Order Number:

IFCAP Tracking Number:

Follow-on to Contract and Task Order Number:
Not Applicable

1. Contracting Officer’s Representative (COR).

Name:
To be provided upon award
Section:
Nursing Service
Address:
10701 East Blvd. Cleveland, OH 44106
Phone Number:
To be provided upon award

Fax Number:

E-Mail Address:
To be provided upon award

2. Contract Title. Epic Plus Mitral Heart Valves

3. Background. Cleveland VAMC, Surgical Department is requesting to purchase Epic Plus Mitral Heart Valves, which surgical services have been using the previous platform E100 that are no longer available. The Cleveland VA requires a platform change to the E200 to ensure continuity in our patients. We need to maintain par levels for our inventory. Currently there are no available 25m, 27m, 29m, 31m, 33m, heart valves. Our surgeons are familiar with these valves, and the rest of the supplies and training needed to perform the surgery. Therefore, the surgical services would prefer to purchase the same to keep uniformity

4. Scope.

These heart valves have historically been used by the cardiac department to replace aortic valves in our patients. Our surgeons and their team are very familiar with the Epic Plus Mitral Heart Valves for all sizes.

5. Specific Tasks.

These products will be used in the OR department during replacement of aortic valves in our patients. The inventory has been depleted of the heart valves and needs urgent replacement.

6. Performance Monitoring The COR will work with warehouse staff and biomedical engineering to ensure delivery and incoming inspection to determine for fitness for use.

7. Security Requirements The contractor will not have access to VA sensitive information

8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

Not Applicable

9. Other Pertinent Information or Special Considerations.

None

a. Identification of Possible Follow-on Work.

None

b. Identification of Potential Conflicts of Interest (COI).

None

c. Identification of Non-Disclosure Requirements.

None

d. Packaging, Packing and Shipping Instructions.

Shipping will be determined by the vendor

e. Inspection and Acceptance Criteria.

The COR will monitor delivery and consult with local biomedical staff to determine if the equipment received is suitable for use and meets the specifications of the SOW.

10. Risk Control The Surgical Service will follow any safety recommendations given by the vendor for the equipment.

11. Place of Performance.

Cleveland VAMC 10701 East Blvd Cleveland, OH 44106

12. Period of Performance.

One Time Buy

13. Delivery Schedule.

Details of delivery to be finalized by Cleveland VAMC and vendor after contract have been awarded.

File details come from the government source that posted it. Updated .