-18651.doc

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >$250K to $700K

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 3C260-20-AP-0501

1. Contracting Activity: Department of Veterans Affairs, RPO West, NCO 20, Portland VA Medical Center. 2237: 648-20-1-9961-0023.

2. Nature and/or Description of the Action Being Processed:

New firm-fixed price contract for replacement of entire fleet of 18 aged dialysis equipment. All units are no longer economical to repair. In addition, equipment repairs have been escalating recently, and 9 of the 18 units failed over the weekend (on 11/10/19). This resulted in the facility going on “dialysis divert” and sending patients out into the community for dialysis. This wide-scale equipment failure, risk to patient care, and risk of adverse event to patients necessitate emergency procurement of replacement units.

FAR13.5 Simplified Procedures for Certain Commercial Items:

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Replacement of the entire fleet of 18 dialysis equipment with new units that also have in-line hematocrit capabilities costs $16,000.00 each. Adding additional back up units, for a total need of 22 units, results in a cost estimate of $355,659.00. Some trade-in value for the existing unit will occur, so total costs will be less. Delivery of the units is dependent on manufacturing timelines but is expected to be under 30 days. Partial orders and expedited shipping are being sought to mitigate the urgent condition.

4. Statutory Authority Permitting Other than Full and Open Competition:

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per FAR 6.302-1;

(X) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4

( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

FAR13.5 Simplified Procedures for Certain Commercial Items:

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

a) Unusual and Compelling Urgency

· Dialysis equipment is utilized on patients with End Stage Renal Failure (ESRF) three times a week for approximately 4 hours. This equates to over 7,000 patient dialyses annually at the Portland VA Dialysis section. The patient load is so heavy that two shifts need to be run per day to accommodate all the patients. This has aged the equipment more rapidly than other patient care equipment.

· The total amount of labor hours and parts spent to date make them now uneconomical to repair. However, they had been operating well and we had planned for a replacement in FY20 (the units are on the approved FY20 list).

· Due to recent increased failures in the costly main sensor board, replacement was becoming critical. With the failure of nine (9) blood pumps on Sunday, November 10th, 50% of the existing dialysis units are unusable for patient care. As a result, the facility is now on dialysis divert, and our patients are being sent out to the community for dialysis. Our healthcare delivery capabilities are cut in half, and we are failing the performance of the mission to provide renal dialysis to our veterans. It is critical to note that unlike other diseases, patients with ESRF cannot have their appointments postponed for any length of time. After about a week, potassium and internal bodily waste products (toxins to the body normally removed by the kidneys) can reach lethal levels.

· Due to the factors stated above, the need to replace these units is now an emergency and they must be replaced as soon as possible.

· Purchase of Fresenius units will ensure there is no learning curve or risk of use errors. The dialysis equipment currently in use are manufactured by Fresenius, and the operator GUI and software of the new units will result in a seamless transition, no training learning curve, and no slowdown in patient care. (Use errors can result in adverse patient outcomes, up to and including death, and costly litigation. Training learning curves for new equipment will result in decreased patient throughput and increased outsourcing.)

· Other vendors on the market do not have the functions, features, capabilities or software to meet the agency’s need. In particular, The Baxter/Gambro units are not allowed to be used at Portland due to past history with thrombus formation in the patient lines.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: No alternative sources were investigated due to the emergent nature of the situation.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: When compared to other purchases of Hemodialysis supplies the price is considered fair and reasonable. On 10/26/2018 award # 36C26219C0009 was purchased for hemodialysis supplies to Fresenius for the amount of $331,699.51. The exact number of machines purchased under this award is unknown, however, the scope and scale appear to be similar to the current prospective requirement.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: VIP was searched using NAICS code 334510 which populated 177 potential SDVOSB/VOSB vendors. However, market research was limited due to the unusual and compelling urgency of this requirement IAW FAR 6.302-2(a)(2). The delay in receiving the requested supplies could have adverse of affects on Veteran health and safety.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Manufacturer only.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The use of better forecasting to determine when the current machines will need to be replaced, so that competition can be used.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

___Gordon Hosoda___________ __11/13/19______________________

Name: Gordon Hosoda Date

Title: Chief, Biomedical Engineering Facility: 648 Portland

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

Name: Robert Hamilton

Title: Contract Officer Facility: NCO 20

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Name: Brian Corey

Title: Chief, Supply Branch 1

Facility: NCO 20

RPOW Log #: 2019-11-13T05:13:23

OFOC SOP Revision 08

Original Date: 03/22/11

Revision 08 Date: 04/18/2018