P03 JOFOC 36C242-21-AP-2788_BBraun Hemodialysi-ALB-s - Redacted.pdf

Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format >SAT

VHAPM Part 819.7007/7008 Page 1 of 5 Original Date: 08/30/2017 Revision 03 Eff Date: 04/03/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-21-AP-2788

1. Contracting Activity: Department of Veterans Affairs, VISN 2

Network Contracting Activity 2 (NCO2) FDR Campus VA Hudson Valley Healthcare System 2094 Albany Post Rd Montrose, New York 10548

Organizational Activity:

Albany Stratton VA Medical Center VA Western New York Healthcare System (VAWNYHS) 113 Holland Ave Albany, NY 12208

Purchase request (i.e. 2237) number: 528-21-4-8085-0184

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

The VA Healthcare Network Upstate New York at Albany Stratton VA Medical Center requires the purchase of twenty-six (26) hemodialysis machines to replace the current fleet of machines that are beyond their lifecycle replacement date. The hemodialysis machines will be used as an artificial kidney to filter and remove waste product as well as excess fluid from the blood. Albany Stratton Dialysis Department requires a hemodialysis unit capable of continuously measuring the KT/V or URR during the dialysis treatment as well as the capability to perform Sustained Low-Efficiency Daily Dialysis (SLEDD) treatments for the more critically ill patients.

This action will be awarded as a new firm-fixed-price contract.

VHAPM Part 819.7007/7008 Page 2 of 5

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

The action requested will be a brand name only purchase of 26 B Braun Dialog+ with Adimea hemodialysis machines. Exact product and quantities are detailed below:

Item # Description Unit Qty Price Extended 710200L Dialog+

Evolution Hemodialysis System

PK 26

7102233 Adimea PK 26 7107218 Dialog

Computer interface Hardware

PK 26

Technician Training

EA 2

The estimated value of the proposed action is $

Delivery: 90 Days ARO

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S.

Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7007 or 819.7008 up to $5,000,000. Check the specific VAAR clause used below:

(X) 819.7007 Sole source awards to a verified service-disabled veteran-owned small business; or ( ) 819.7008 Sole source awards to a verified veteran-owned small business

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

Marathon Medical Corporation is an authorized distributor of B. Braun Medical Inc. Marathon Medical Corporation is a Service-Disabled, Veteran-Owned, Small Business medical supply distribution company. B.Braun will only sell their Dialog “Evolution” Hemodialysis System to the VA through their SDVOSB distributor partner, Marathon Medical Corporation.

819.7007 allows sole source awards to SDVOSB based on 38 U.S.C. 8127(c) and SDVOSB Marathon Medical Corporation has been determined to be a responsible source with respect to performance as per FedDataCheck. Additionally, Marathon Medical Corporation meets the eligibility requirements in 819.7003.

Additional searches were conducted in the VIP database for more eligible verified SDVOSBs. None were identified.

VHAPM Part 819.7007/7008 Page 3 of 5

B.Braun Rationale:

Albany Stratton is seeking brand name only as the specifications the clinical staff are requesting are peculiar to only one manufacturer. Only B Braun Dialog+ Evolution machines with Adimea have all of the capabilities that the clinicians are seeking to allow for more accurate real time Kt/V measurement by using UV light to measure the change in concentration of uremic substances in spent dialysate, average flow rates slow enough to perform SLEDD treatments, utilization of a bicart canister for bicarbonate solutions, and Streamline blood tubings which eliminate the air/blood gap in patient blood tubing sets.

Reviews of available Hemodialysis systems and manufactures were done to include machines. Neither model machine has all of the clinical capabilities that the Nephrologists and Hemodialysis staff are seeking to obtain. As no other Hemodialysis machine on the market came close to meeting the staff needs, no other models were considered.

Costs for these machines were compared against quotes that other VA’s obtained for these products as well as procurement costs for machines via previous National Contract that is no longer in affect. The B Braun Dialog + Evolution machines procurement costs were lower or equal to other machines on a per machine basis. This ensures that the procurement cost is fair and reasonable.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by subpart

5.2 and, if not, which exception under 5.202 applies:

Published Special Notice 36C24221Q1323 – INTENT TO SOLE SOURCE B Braun Dialog+ with Adimea Hemodialysis Machines to Marathon Medical Corporation on beta.SAM.gov from September 1, 2021 through September 8, 2021. No responses were received.

See Section 8 for market research

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

This is a sole source request. The Government will use various analyses and conduct price comparison based on historical data in accordance with FAR 15, 404-1 to ensure market fairness;

and acquisition at reasonable, cost-effective val

VHAPM Part 819.7007/7008 Page 4 of 5

Revision 03 Eff Date: 04/03/2020

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Received a copy of a letter from Scott Koehler, Director, Distribution Services, B. Braun Medical Inc.

stating that Marathon Medical Corporation is an authorized distributor of B. Braun Medical Inc., and that Marathon Medical Corporation is a Service-Disabled Veteran-Owned Small Business medical supply distribution company.

Received a copy of a letter from Jamie Keiper, Vice President of Sales, B.Braun Medical Inc. to Leslie McGee, Buffalo VA Medical Center stating that B.Braun will only sell the Dialog “Evolution” Hemodialysis System to the VA through their SDVOSB distributor partner, Marathon Medical Corporation.

Confirmed through the VIP database that marathon Medical Corporation is a verified SDVOSB.

Published Special Notice 36C24221Q1323 – INTENT TO SOLE SOURCE B Braun Dialog+ with Adimea Hemodialysis Machines to Marathon Medical Corporation on beta.SAM.gov from September 1, 2021 through September 8, 2021. No responses were received.

Conducted additional searches on the VIP database using NAICS Code 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing), and keywords BBraun, Dialog, Evolution, and Dialysis.

No vendors were identified using BBraun or Dialog. Two vendors were identified using Evolution and Dialysis. Evolution Medical Logistics LLC was disqualified because Evolution is in the name of the company and they do not sell Evolution dialysis equipment. QSF & Associates was disqualified because they do not sell BBraun Dialog hemodialysis machines.

Conducted searches on the SBA DSBS database using NAICS Code 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing), and keywords BBraun, Dialog, Evolution, and Dialysis.

One vendor was identified using BBraun. Marathon Medical Corporation, the BBraun authorized SDVOSB. No vendors were identified using Dialog or Evolution. Eight vendors were identified using Dialysis. All eight vendors were contacted, none of which sells BBraun products.

Conducted searches on GSA Advantage using keywords BBraun and Dialysis, Dialog and Dialysis, Evolution and Dialysis, and Dialysis and BBraun. No products were found.

The VA Rule of Two cannot be met.

Marathon Medical Corporation meets the eligibility criteria outlined in VAAR 819.7003, they are verified in VIP and the action is below the $5M threshold.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

None. Authority of 819.7007 Sole source awards to a verified service-disabled veteran-owned small business.