36C24419Q0304-001.pdf

VHAPM Part 813.106 Page 1 of 2 Original Date: 08/30/17 Revision 01 Eff Date: 04/23/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C244-19-AP-0696

1. Contracting Activity:

Department of Veterans Affairs, VISN 04, Corporal Michael J. Crescenz VA Medical Center (Philadelphia VAMC) Laboratory Service 3900 Woodland Avenue Philadelphia, PA 19104

642-19-1-025-0327

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The Philadelphia VAMC has a BRAND NAME requirement for Beckman Coulter Aquios reagents. The reagents are used with the Beckman Coulter Aquios Flow Cytometer. The reagents along with the cytometer are used to quantitate the absolute CD4 and CD8 T-lymphocytes of HIV patients receiving treatment at all nine VISN 4 medical centers. The estimated cost of the requirement for a base year and two option years if .

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

The Philadelphia VAMC is currently utilizing Beckman Coulter’s Aquios CL System. This flow cytometer is the only load and go cytometer on the market, and streamlines the lab’s workflow by preparing samples onboard and analyzing them at the same time while preparing subsequent samples. These features reduce operator variability and increase safety for lab personnel by reducing exposure to bio-hazardous material. The system tracks reagents, lot numbers, open and closed container expiration dates, and the number of tests remaining. The built-in barcode reader allows laboratory staff to track all reagents and positions via barcodes, and access the test menus from the Laboratory Information System (LIS). The bi-directional LIS interface means that test results are automatically accessed by the system without needing additional PC systems. The bidirectional interface allows results to automatically be sent to the LIS for review which results in faster and better care for patients. The automatic population of the LIS also results in the elimination of reporting errors that can occur with manual transcription of data into the medical record.

Beckman Coulter’s Aquios CL System also pierces blood tubes and mixes blood specimens automatically. The System also runs two levels of whole blood controls as part of daily Quality Control (QC) and uses that data to verify the function and performance of the System without the use of external standards and fluorescent markers.

VHAPM Part 813.106 Page 2 of 2 Original Date: 08/30/17 Revision 01 Eff Date: 04/23/2018

Changing the cytometer currently being used will result in increased costs in both time and money to the VA. Staff at the Philadelphia VAMC and the other eight VISN 4 medical centers will need to be retrained if the current system is replaced. All lab protocols and Standard Operating Procedures (SOPS) related to using the Beckman Coulter Aquios CL System for collecting and analyzing specimens will need to be revised, which is a timely process.

Finally, using another system would need to be validated against previous testing results and patients would have to be retested to re-establish their baseline based on the new system to validate their treatment.

4. Description of market research conducted and results or statement why it was not conducted:

The GSA e-Library was searched to determine if the required reagents were available on a Federal Supply Schedule (FSS). While Beckman Coulter does have a FSS the Aquios Reagents are not included on the schedule. The contract specialist contacted Beckman Coulter to determine if there are any authorized distributors of the required reagents. The Beckman Coulter representative provided the name of two distributors but was unable to confirm if either distributor sold the Aquios reagents or if those reagents are available on a FSS.

The Contract Specialist posted Sources Sought Notices to GSA E-Buy. No responses were received.

The Contract Specialist searched VetBiz based on the information provided by the Beckman Coulter representative and located both authorized distributors. The Contract Specialist contacted each distributor and confirmed that both distributors are authorized to sell Aquios Reagents. The reagents are sold on the open market by both distributors.

Based on the market research the Request for Quote (RFQ) will be posted to FBO and set aside for Veteran Owned Small Businesses.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name: Ron Kline Name: Shawn E. Smith Title: Contracting Officer Title: Division Chief, NCO4 Date: Date:

2-6-19 2/7/2019

RONALD J.

KLINE 152627

Digitally signed by

RONALD J. KLINE 152627

Date: 2019.02.06 10:12:20 -05'00'

Shawn E.

Smith 346238

Digitally signed by Shawn E. Smith 346238 Date: 2019.02.07 21:00:55 -05'00'