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VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

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: 36C256-19-AP-2198

1. Contracting Activity: Department of Veterans Affairs Michael E. DeBakey VA Medical Center (MEDVAMC) Network Contracting Office 16 2002 Holcombe Boulevard Houston, TX 77030

PR#: 598-19-3-5701-0041

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

The CAVHS Pharmacogenomics Analysis Laboratory requires a Preventative Maintenance and Repair service contract for its MassARRAY Analyzer 4 System and RS-1000 Nanodispenser. The equipment will be utilized in clinical research laboratory testing for Genotype analyses to test for low level somatic mutation detection. The MassARRAY 4 Mass Spectrometer will require a five (5) year maintenance plan ($84,750.00); whereas the Nanodispense will only require an additional one (1) year maintenance plan ($11,370.00). The total estimated value of a 5-year contract is $96,120.00.

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

The Agena Bioscience MassArray® System is a Matrix Assisted Laser Desorption/Ionization Time-of- Flight (MALDI-TOF) Mass Spectroscopy instrument, for precise determinations in clinical research laboratory testing. The Agena Bioscience technology is a complete platform with Maldi-TOF Mass Spec, a Nanodispensor, and software which can perform the following applications on the same instrument:

a. Genotyping analyses includes:

Low level somatic mutation detection Multiplexed Single Nucleotide Polymorphisms (SNP) genotyping economically

b. Methylation analyses using a MassCLEAVE chemistry for quantitative results

c. Quantitative gene Expression

Allele specific expression Copy Number Variation

d. Comparative sequence analysis of microbial, viral, and other haloid organism genomes May include Nosocomial infections

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

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

The Agena Bioscience MassARRY 4 Mass Spectrometer and the Agena Bioscience NanoDispenser are critical to patient care. In addition to routine preventative maintenance, this instrument requires regular software updates that only Agena Bioscience engineers can perform. Agena has provided a sole source letter stating they are “the sole source manufacturer and proprietary owner of this equipment”. Additionally, “no other legal entity or agent has authorization for commercial distribution of the MassARRAY System, its liquid handler accessories, and SpectroCHIP Arrays in the United States”. “Only Field Service Engineers employed by Agena Bioscience have the appropriate training and approval to conduct installation, troubleshooting, repairs and preventive maintenance on the MassARRAY System and its liquid handler accessories in the United States”.

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

A query of VIP was performed, resulting in 189 SDVOSBs and 42 VOSBs in the market who have the requisite 811219 NAICS code. Additionally, RFI 36C25619Q0923 was issued/posted to FBO on May 28, 2019 as a Notice of Intent (NOI) to Sole Source to Agena Bioscience, Inc., The NOI provided a closing/response date of June 4, 2019. The notice stated, “any response to this notice must show clear, compelling, and convincing evidence that competition will be advantageous to the government”. As of the closing/response date, not a single contractor responded to the NOI nor challenged the sole source status. Based on Market Research results, it is recommended this J&A be approved for Single Source award to Agena Bioscience, Inc.

5. Prepared By:

6. 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.