ProteinSimple SSJ_signed.pdf
PDF 371 KB Posted
- Attached to
- Lab Instrument Service Plan
- Solicitation number
- 1140969
About this file
This document is a Single Source or Brand Name Justification for a contract to provide maintenance and support services for two Jess instruments used by the USDA's Animal and Plant Health Inspection Service (APHIS) at the National Veterinary Services Laboratories (NVSL) and Center for Veterinary Biologics (CVB).
The justification states that ProteinSimple (Biotechne) is the sole manufacturer of the Jess instruments and the only approved provider of the required maintenance and support services. These services include calibration, annual preventive maintenance, software upgrades, on-site repair, and phone/remote support. The total estimated cost for the annual contract is $27,824. The justification cites the critical need for the Jess instruments to evaluate and test animal biologics in order to uphold the Virus Serum Toxin Act, and that loss of the instruments would significantly impact CVB's testing capabilities and product approvals. The contracting officer has determined that ProteinSimple is the only responsible source available to meet the agency's requirements.
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Text version
Section 1: Single Source or Brand Name Justification
1.1 Identification of the Agency and Contracting Activity
Requesting Agency:
USDA, APHIS, NVSL and CVB 1800 Dayton Avenue Ames, IA 50010
Contracting Activity:
USDA, APHIS, MRPBS, ASD
Minneapolis Procurement Branch Butler Square, Fifth Floor 100 North 6th Street Minneapolis, MN 55403
1.2 Description of the Supplies or Services Required to Meet the Agency’s Needs
This procurement includes the purchase of the Biotechne-ProteinSimple maintenance/service plan (Jess-3549; Jess- 3995).
The services to be performed include: calibration services for the system; annual preventive maintenance for the system;
software up-grade/instrument updates; unlimited on-site service, Repair Service - Non-consumable Parts, Labor, Travel;
Phone/Remote Support, and use of loaner instrument if on-site repair cannot be achieved.
The total estimated cost for this annual contract is $27,824.00. The cost is inclusive of the service as well as travel for the technician to the lab, all parts, shipping, and technical assistance by field application scientists related to troubleshooting errors.
1.3 Circumstances and Rationale for Limiting Competition
ProteinSimple (Biotechne) is the sole manufacturer of the instrument and the only company in the market approved to perform the maintenance on Jess machines. The Jess equipment are used to qualitatively and quantitively analyze antigen in master seed viruses and/or master seed cell lines. Jess instruments are also used to confirm potency of our Stakeholder’s pre-license serials. The Jess instrument allows CVB to uphold the mission of the Virus Serum Toxin Act and the 9CFR by evaluating and interrogating characteristics of antigens that are used to produce animal biologics. Without servicing and calibration of the instrument, CVB personnel do not have confidence that results of carefully thought-out experiments, are accurate. This could put industries’ animal biologic products at risk for licensure, delaying prevention or treatment of relevant animal diseases. Loss of the Jess instrumentation would increase CVB testing times, therefore, increasing time to licensure and availability of products to the veterinary community.
Maintenance of the instruments include software updates. Due to the above described sensitivity, only OEM issues software can be used and the OEM is the only provider of the software.
1.4 Description of the Market Research Conducted Among Schedule Holders and the Results or a
Statement of the Reason Market Research Was Not Conducted
A search in accordance with FAR Part 8 resulted in finding no other source for servicing the ProteinSimple Jess and Maurice instruments. Market research revealed that truly the only vendor capable of furnishing the requirements.
1.5 Estimated Price, Including All Options, If Applicable
$27,824.00
1.6 Recommended Source(s)
Only one responsible source and no other supplies or services will satisfy agency requirements. Biotechne-ProteinSimple is the sole source and vendor of these services.
Section 2: Certifications and Approvals
2.1 Program or Technical Personnel
Supporting data which form the basis for and included in this justification are certified accurate and complete.
Anna Dash CVB-Vir Technician
2.2 Contracting Officer
The information contained in this justification is accurate and complete to the best of my knowledge and belief and in accordance with Federal Acquisition Regulation 13.106-1(b)(1), I hereby determine the circumstances described above deem only one source, or limited sources, reasonably available and competition is precluded for the reasons indicated in this document.
Caroline Russell Contracting Officer
| Section 1: Single Source or Brand Name Justification |
| 1.1 Identification of the Agency and Contracting Activity |
| 1.2 Description of the Supplies or Services Required to Meet the Agency’s Needs |
| 1.3 Circumstances and Rationale for Limiting Competition |
| 1.4 Description of the Market Research Conducted Among Schedule Holders and the Results or a Statement of the Reason Market Research Was Not Conducted |
| 1.5 Estimated Price, Including All Options, If Applicable |
| 1.6 Recommended Source(s) |
| Section 2: Certifications and Approvals |
| 2 |
| 2.1 Program or Technical Personnel |
| 2.2 Contracting Officer |
| 2024-10-29T14:33:54-0500 | |
| ANNA DASH |
| 2024-10-30T10:23:25-0400 | |
| CAROLINE RUSSELL |
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