P03 ULRICH INJECTOR 36C260-24-AP-1606_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval

For

Exception to Fair Opportunity Memo

Acquisition Plan Action ID:36C260-24-AP-1606

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Healthcare Administration

(HVA), Regional Procurement Office West (RPO-W), Network Contracting Office (NCO) 20, on behalf of VA Sierra Pacific Network (VISN) 20, Seattle VA Medical Center (VAMC).

2237 # 663-24-2-9961-0091

2. Description of Action: The proposed sole source is for firm-fixed price (FFP) delivery order against Indefinite Delivery/Indefinite Quantity (IDIQ) contract Number VA797H17D0024 for a Computed Tomography (CT) scanner with contrast.

3. Description of Supplies or Services: The Ulrich INJECT CT motion is a contrast media management system that is indicated for the controlled automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in CT applications, and Radiation Therapy CT scans for accurate Target Delineation. The total estimated value of the proposed action is .

4. Statutory Authority: The statutory authority permitting an exception to fair opportunity is Section 41 U.S.C. 4106(c) as implemented by the Federal Acquisition Regulation (FAR) 16.505(b)(2)(i):

(X) FAR 16.505(b)(2)(i)(B): Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

5. Rationale Supporting Use of Authority Cited Above:

The use of CT contrast media is for the purpose of Radiation Therapy Treatment Planning. This helps the Radiation Oncologist to accurately delineate tumors especially adjacent to critical Organs at Risk (OAR). Therefore, producing a better dose coverage to the Target (s) and sparing the OAR.

- Compatible with all CT scanners including GE Discovery RT scanner

- Uses GE Healthcare contrast media as supplied in single dose bottles

- The Radiology Department at Seattle VA has an Ulrich Injector identical to this one. Thus, in case their scanner is down, they can use ours as a backup

- Unique syringeless design

- GE maintains exclusive licensing rights for the GE CT Motion.

6. 6. Efforts to Obtain Competition: Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

8. Market Research: Based on the market research, no two or more VIP verified and capable SDVOSBs or VOSBs were identified and appeared capable of performing the requirement. In addition, no small business in any of the other targeted socio-economic groups appeared to qualify for a set-aside or sole source procurement. The market research identified that this requirement is a commercial product available through VA NAC HTME IDIQ Contract VA797H17D0024. GE Precision Healthcare does not have authorized Service-Disabled Veteran Owned Small businesses or other small business distributors and retains full proprietary rights to the distribution and service which is common within the industry.

9. Other Facts:

Unique characteristics that limit availability to only one source, with the reason no other suppliers or services can be used:

The CT Motion pulls contrast directly from the bulk contrast bottle, so we save money converting from single use to bulk.

a. Reduce contrast and saline waste. Only use however much contrast you need. Any leftover contrast is saved for your next patient.

b. Higher through-put (up to 6 additional patients a day) allows the department to schedule additional patients on the same day.

c. Syringeless - Time- No syringes to fill and prime. Approx. 30 seconds set up time between patients.

d. Elimination of syringe waste (and potential reduction in medical waste disposal costs)

e. Reduced consumables spend (significantly less storage space needed).

f. Improves safety with delivery of contrast in CT multiple automated air detectors built into the injector.

g. Pedestal injector is cableless and cordless via Bluetooth and powered by lithium battery.

h. Eliminates all construction costs & time associated with ceiling mount injector.

i. For use with Omnipaque contrast media (Imaging Bulk Pack).

10. Technical and Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

Name: Adam Tazi, PhD. DABR Date: 09/05/2024 Title: Chief Therapeutic Medical Physicist Facility: VA PSHCS, Radiation Oncology, Seattle, WA

11. Determination that Anticipated Cost is Fair and Reasonable: A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable: The item is available via HTME IDIQ. Price reasonableness was determined at the time of award.

12. Contracting Officer's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Approvals in accordance with VHAPG Part 816.505 Indefinite Delivery Contracts: Ordering, and local requirements.

I certify the justification meets requirements for other than full and open competition.

Gregory G. Watson Contracting Officer

Krystal Weeks Branch Chief

RPOW JA Tracker #: FY24-NCO 20-2778