Electrophoresis Testing Reagents & Equipment Rental & Service. See attached justification and approval.

A. SCOPE OF PROCUREMENT

The Corporal Michael J. Crescenz VA Medical Center s Pathology & Laboratory Medicine Service, Chemistry section (P&LMS), is seeking to purchase reagents/gels for Serum/Urine Protein Electrophoresis and Serum/Urine Immunofixation to include the lease of the equipment to perform testing and the densitometer and software to complete the patient reportable results.

P&LMS intends to award a contract on a sole source basis to Helena Laboratories Corporation to utilize the latest and most current state of the art technology to perform this testing with the absolute minimum amount of technologist hands on time.

Estimated annual volumes are:

Serum Protein Electrophoresis 3000

Urine Protein Electrophoresis 600

Immunofixation (Serum and Urine) 600

Equipment must include testing system, any workstation (computer), UPS (uninterruptable power system), Software and Electronic procedure manual(s).

The system must be a Fully Automated Agarose Gel Electrophoresis system to perform serum/urine protein electrophoresis (SPEP/UPEP) and serum/urine immunofixation (SIFE/UIFE). The system must have an on-board, positive patient identification system with primary tube sampling. The system must meet the complete profile as described below.

B. DEFINITIONS

SPEP - Serum Protein Electrophoresis

UPEP - Urine Protein Electrophoresis

SIFE - Serum Immunofixation

UIFE - Urine Immunofixation

C. GENERAL REQUIREMENTS FOR EQUIPMENT

1. Operational Features - The instrumentation offered must have:

The capability of being a fully automated agarose gel (zone) electrophoresis system with minimal set up time or hands-on technologist time.

Must have on-board, positive patient identification system to track sample from primary tube, to gel, to scanned image on densitometer and final reports for comments and interpretation. Must utilize a bi-directional LIS interface compatible with Data Innovations. (Instrument must be able to import patient demographics and upload result to the LIS) with liquid level sensing for samples.



Must have an on-board integrated sample handling (pipetting) system.



Must have an integrated sample dilution system.



Must be able to delineate status of each gel in process.



Must have on screen system alerts.



Must have on-board staining, drying and scanning with no gel transfers.



Must have the ability to store color coded antisera s on board, ready to use. Antisera must be applied using a rigid template to eliminate crossover.



Must have automated immunofixation with Autopress and Autoblot capabilities.



Must have automatic pairing of patient protein and IFE results.



Must have the ability to print out the patient paired protein and IFE results on one report form.



Must have a customizable auto interpretation feature.



Must be able to load ten (10) agarose gels prior to onset of operation.



Must be able to pipette a minimum of 28 samples per gel for protein electrophoresis with a maximum of 756 patients in an 8 hour day.



Must be able to pipette a minimum of 4 samples per gel for IFE with a maximum of 100 patients in an 8 hour day.



Must be able to perform SPEP and IFE s together in the same run setup.





Training - The vendor must provide an on-site instrument training program for up to ten (10) staff members at no additional charge. This will include training on the operation of the system, data manipulation, and basic troubleshooting and repair.



Vendor must work with P&LMS on validation and correlation.



Vendor must provide the reagents necessary for a minimum of 40 patients for correlation, validation and training at no additional charge.



Vendor must provide a 1 year renewable contract with up to 4 additional renewals.



Vendor is required to provide delivery, installation and removal of equipment (when required) at no additional charge.