6640--Protein Electrophoresis System (Ann Arbor VA Medical Center)

This is a SOURCES SOUGHT only for the Ann Arbor VA Medical Center. Information collected during this Sources Sought may be used in a set aside. If a solicitation is issued, the Government will do so in accordance with Federal Acquisition Circular (FAC) 2024-03. The North American Industry Classification System (NAICS) number is 325413. The NAICS size is 1,500 employees. Preliminary contract scope will be a 5-year Blanket Purchase Agreement with four option years.

Any contractor that believes they are capable of meeting the requirements below, and desire to claim preference for small business status, must be registered with the SBA and be able to be located through SBA - Dynamic Small Business Search. Any contractor that believes they are capable and desires to claim preference for veteran owned small business status must be registered with in VetCert at Veteran Small Business Certification (sba.gov) as an SDVOSB or VOSB.

All contractors that deem themselves capable of meeting the requirement shall provide the below information to James Howard, Contracting Officer, at james.howard3@va.gov no-later-than Tuesday, February 18, 2025, at 12:00PM, EDT, and referencing RFI #36C25025Q0148. Responses shall include: (1) Business Name and Address, (2) Contract Number items are covered under, if applicable (3) Point of Contact Name, Phone Number and E-mail Address (4) SAM UEI and NAICS code (5) Business Size SMALL or LARGE (6) Type of Business: service disabled veteran owned, veteran owned small business, 8a, HUBZone, woman-owned, etc. (7) Information for the product you would propose and which, if any, of the salient characteristics below it does not meet. (8) Where the proposed product(s) are manufactured. (9) A concern that is not a manufacturer of the commodity shall provide the manufacturer s name and size standard, along with an authorized distributor letter. (10) If the concern is the manufacture and the sole distributor, please provide documentation to that effect. If the concern is the manufacturer and has authorized distributors, please provide a list of the authorized distributors as well. (11) Current lead time of equipment that will be proposed.

Contractor must be registered with https://www.sam.gov

To be considered SDVOSB/VOSB, must be registered in VetCert at Veteran Small Business Certification (sba.gov).

FOB is Destination.

Delivery is to:

Ann Arbor VAMC (Chemistry Laboratory)

2215 Fuller Rd.

Ann Arbor, MI 48105

SALIENT CHARACTERISTICS

PROTEIN ELECTROPHORESIS SYSTEM

SYSTEM & CONSUMABLE REQUIREMENTS:

Test Menu MUST include test kits for the various assays involved in:

Serum Protein Electrophoresis (SPEP): Fractionation of various proteins in serum.

Immunotyping (IT): Identification of abnormal proteins in serum and urine

Immunofixation (I-Fix): Identification of abnormal proteins in human serum, urine and/or other biological fluids.

Urine Protein Electrophoresis (UPEP): Fractionation of various proteins in urine- Qualitative analysis

Detection and identification of gammopathies in human sera and other biological fluids.

Detection and identification of Bence Jones protein in human urine or of free light chains in human serum

High Resolution (HR) multifractionation of proteins in neat or diluted human serum, urine, or concentrated cerebrospinal fluid.

Provide upgrades for new tests as available.

Capillary/Gel system must have automatic delimiting of curves and identification of fractions to minimize operator editing.

Capillary/Gel system must have the ability to import quantitative specific protein results with correct measuring unit required to provide a comprehensive chartable report. System must have patient s demographic information available.

Capillary/Gel system must be able to import comment(s) from a word processor for unlimited comment entry.

Capillary/Gel system must allow for customized, compressed printouts of results and curves.

The Capillary/Gel electrophoresis is the technique employed in the separation of proteins. Proteins are detected directly at a precise wavelength providing a high degree of precision and accuracy.

The Capillary/Gel system must have eight capillary tubes, which will increase throughput.

The Capillary/Gel system must provide walk-away technology from start to finish. System must have the capability to read barcodes and provide for a continuous feed of samples. The system must have Positive Sample Identification (PSI) capability for full traceability from primary tube placement to final result recovery.

The Capillary/Gel system must have a system that controls the temperature during sample migration for consistent reproducibility from analysis-to-analysis and from capillary to-capillary.

The Capillary/Gel system must process approximately 80 samples per hour.

The Capillary/Gel system must have reagent traceability technology.

An interpretive software package must be available to facilitate reporting of results.

A Personal Computer (PC), keyboard, mouse, monitor, imaging scanner and high-definition color printer must be provided with connection cables for communication between the Capillary and agarose gel electrophoresis systems. This will allow for importing and storage of immunofixation scans and Capillary/Gel results and images.

The automated multiparametric agarose gel electrophoresis instrument must have high resolution and clarity of the electrophoresis bands for easy interpretation. The densitometry system is integrated into the instrument. The software provides editing and quantification of results, customization of reports, archival and recall of patient results. The system must have a color LCD touch-screen display. Vendor must update the latest version of software as available to the customers free of charge.

The automated multiparametric agarose gel electrophoresis system must provide a sequential processing of each electrophoresis step from application, migration, incubation, staining, destaining, drying, and final reading allowing for walk-away operation.

The automated multiparametric agarose gel electrophoresis system throughput should be at least 80 protein samples per hour and at least 15 Immunofixation samples per hour.

The automated multiparametric agarose gel electrophoresis system must automatically regulate voltage, current, power and volt hour, and stable temperature for consistent results from agarose gel to agarose gel.

The automated multiparametric agarose gel electrophoresis system must have an easy-to-use keyboard and screen with up to 40 migration programs available.

The automated multiparametric agarose gel electrophoresis system must have at least 8 different reagents on-line that are available at once. Reagents need to be water based.

The system must have a processing system for sample preparation and dilution designed to complement the automated multiparametric agarose gel electrophoresis system. A processing system must deliver precise micro-volumes of sample directly from primary tubes to the sample applicators, therefore allowing accurate and precise delivery of sample to agarose gel.

Automated multiparametric agarose gel electrophoresis system must compress printouts of results and curves and allow the operator to customize the report(s).

Automated multiparametric agarose gel electrophoresis system must be able to import comments from a word processor for customizable comment entry. Report options should include item such as patient history, immunofixation image, UID, name, age, ordering physician, specimen collection date and time.

Automated multiparametric agarose gel electrophoresis system must have a three-level quality control per analysis program, and Levey-Jennings statistical program.

The Capillary/Gel and Automated multiparametric agarose gel electrophoresis system must have bidirectional (broadcast download & host query) Laboratory Information System (LIS) capabilities.

Automated multiparametric agarose gel electrophoresis system must have software to allow for extensive curve editing capabilities, including deletion of minima and fractions, baseline modifications, fraction identification, and curve overlay. System must also have automatic alignment, centering of the electrophoretic pattern during reading, and automatic demarcation of the electrophoretic patterns.

An auto-sampler is a must for full standardization of all pre-analytical steps associated with the agarose gel electrophoresis system. The auto sampler must have Positive Sample Identification (PSI) capabilities.

All systems that have Positive Sample Identification (PSI) must be able to utilize and read barcode type: Code 128.

All systems must be compatible with 110 120 Volt power outlets.

Must have adequate Uninterruptible Power System (UPS) to support each analyzer system.

Each system must have an on-board type of waste disposable system for liquid output with options of connecting to floor drains.

Sampling systems must accommodate primary sample tubes sizes of 13mm x 75mm; 13 mm x 100 mm; and 16 mm x 100 mm; 5, 7, 10 mL tubes, and micro tubes. Systems must be able to accept plastic tubes meeting current safety requirements.

System and tests must meet College of America Pathologists (CAP), Clinical Laboratory Improvement Act of 1988 (CLIA 88), Clinical and Laboratory Standards Institute (CLSI; formerly NCCLS) standards and demonstrate satisfactory performance on CAP peer group comparisons.

System must be able to analyze serum, urine, and cerebrospinal fluid (CSF) when applicable/dependent on the electrophoresis process.

System must have cap piercing mechanism.

System must be capable of integrating the workstation to pathologist s desk.

Projected Test Volumes