SPECIAL NOTICE
66 -- NEW - STX Electrophoresis Upgrade
- Notice Date
- 9/17/2021 7:18:31 AM
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- 257-NETWORK CONTRACT OFFICE 17 (36C257) ARLINGTON TX 76006 USA
- ZIP Code
- 76006
- Solicitation Number
- 36C25721Q1447
- Archive Date
- 10/17/2021
- Point of Contact
- joseph.miller20@va.gov, Joe Miller, Phone: 240-215-8899
- E-Mail Address
-
Joseph.Miller20@va.gov
(Joseph.Miller20@va.gov)
- Awardee
- null
- Description
- Page 4 of 4 Special Notice Notice of Intent to Award a Sole Source Procurement The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office 17, intends to award a firm-fixed priced contract/order to Sebia, Inc. for procurement of a fully automated, gel electrophoresis instrument that can perform both serum and urine electrophoresis (SPEP/UPEP), immunofixation (SIFE/UIFE) and Immunotyping (IT) to identify monoclonal and polyclonal gammopathies. Required Technical Specifications of an instrument similar to the Sebia System: SEBIA OR EQUAL Hydrasys 2 or equal system for automated agarose gel electrophoresis. Capillarys 3 Octa or equal system When considering the specified workload pricing is based on cartridge price plus add on. Add on is figured by equipment at the facility divided by the average monthly test volume and includes service. This also includes calibrators and controls (where applicable) to be included in the cost per test pricing. The STVHCS shall be responsible for submitting their test counts each month to the awarded Contractor. The Government estimates the volumes as listed on Attachment A but does not guarantee volumes as listed. These monthly testing numbers provided by The STVHCS are best estimates only derived from past patient care numbers. The instrumentation must be approved by the Food and Drug Administration (FDA). Multi-parameter semi-automated agarose gel electrophoresis instrument for SPEP, UPEP, IFE, IT. Walk away after sample inoculation. Sequenced sample application, migration, incubation, staining, destaining, and drying. High voltage protein separation and direct protein detection of the following five protein zones: Albumin, Alpha-1, Alpha-2, Beta, and Gamma. Scanner required for the identification of protein fractions. Independent and separate self-contained assay kits. Software compatible with instrumentation to provide the software features to complete patient demographic, curve editing, modification of the baseline, fraction identification, and curve overlay. Software to provide a comprehensive patient report with electrophoretic curve, immunofixation pattern, and quantitively specific protein results. A comprehensive quality control program with two levels of quality control to include Levy-Jennings charts. Hardware Features- The instrumentation shall have the following Hardware Features: A total equipment footprint that when installed in the Laboratories shall not impact the functionality and or operations Laboratory. Contractor shall supply a printer, replacement printers if required, and toner cartridges as part of their cost per test pricing. Equipment must be able to support multiple barcode formats with a minimum of ten characters in the specimen identifier. Ability to store and retransmit records in case of interface outage. The flexibility to set multiple units of measurements. Method Performance and Validation Requirements: Method performance and comparison will be at the expense of the Contractor and shall include the following: all reagents consumables and replacement parts, assayed quality control material, calibration material, and linearity material every six months. Linearity material and reagents, and results shall be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards, and Federal Regulations. The Contractor shall perform method validation to include correlation study, crossover studies, sensitivity, linearity, reproducibility, and any additional test workup required to demonstrate satisfactory instrument performance consistent with CLSI Standards. Carryover Studies Successful carryover studies, demonstrating absence of any clinically significant carryover, shall be completed by the Contractor on the analyzers during installation. These studies shall be performed using either Contractor developed programs or programs developed by a third party (CAP/CLSI). The programs shall be provided to each Laboratory at no charge. This notice is not to be considered a request for quotations or proposals. A contract will not be awarded based on an offer received in response to this notice; however, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Proposals or offers received will be used to determine if a comparable source is available and more advantageous to the government. If no affirmative written response is received within 7 days from the publication of this notice, to joseph.miller20@va.gov, a contract/order will be issued to Sebia, Inc. without any further notice. The proposed contract actions are for supplies, which the government intends to negotiate with only one source. The anticipated statutory authorities permitting other than full and open competition for the requirement is 41 U.S.C. 3304(a)(1), as implemented by FAR 13.5. The proposed sole source procurement will be made by a pricing agreement with Sebia, Inc.
- Web Link
-
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- Record
- SN06136692-F 20210919/210917230116 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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