Federal contract opportunity for analytical laboratory instrument manufacturing at Clarksburg VAMC Department of Veterans Affairs Medical Center.

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Justification and Approval


Other Than Full and Open Competition

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Louis A. Johnson VA Medical Center

2. Nature and/or Description of the Action Being Processed: This is a request for other than full and open competition for an automated special stains instrument (Benchmark NexES Special Stainer) for the histology laboratory; total estimated cost $50,900.00. Staining menu must include but not limited to acid fast stain, iron stain, mucin stain, trichrome stain, GMS stain and reticulum stain. Instrument must be able to bake and deparaffinize slides on-board. The staining instrument must have independent slide heating for random batch access and bulk fluid/waste sensing capacity. The equipment and testing methodology associated with the instrumentation must be approved by the Food and Drug Administration (FDA) to perform the services/requirements as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the College of American Pathology (CAP)

3. Description of Supplies/Services Required to Meet the Agency's Needs:

" Free Standing installation

" Up to 4 bulk fluids in 3 to 6 liter in-board containers

" Ready to use staining kits

" Up to 25 reagent positions

" 1-20 slides with independent temperature control for each position

" Random access

" Baking and deparaffinization on-board

4. Statutory Authority Permitting Other than Full and Open Competition:

(x ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability

or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4

( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

a. Only One Responsible Source (FAR 6.302-1):

The Ventana BenchMark Special Stain is an up-graded version of the Ventana NexSE staining instrument currently in use. Ventana is the only responsible source, as other vendor's equipment will result in substantial duplication of cost to the government. Please see the following bullets:

" A barcode printer is required for slide identification. The laboratory currently has another model of Ventana stainer in use. The strainers in use and the requested stainer all require a barcode printer for slide identification. The barcode printer being used can easily integrate with this particular stainer.

" Currently purchased consumables, such as deparaffinizer, clearing solution, slide labels and liquid coverslipper, are used by both Ventana model strainers. This would continue with the requested model.

" In summary, a barcode printer will have to be purchased if Ventana is not the chosen vendor at a cost between $1,400.00 and $3,300.00. In addition, two sets of vendor specific consumables will have to be purchased and stocked regularly at an additional annual cost of approximately $3000.00.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Ventana Medical Systems, Inc. is the only source for the Ventana BenchMark Special staining instrument and according to their representative there are no authorized resellers. Ventana Medical Systems, Inc. was awarded GSA Contract #GS-24F-0043M for similar staining equipment.

7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable:

A search of FPDS (Federal Procurement Data System) and eCMS (Electronic Contract Management System) provided information for procurements of similar special strainers for histology. The results identified pricing for similar products were within a reasonable tolerance and were fair based upon the available data; one of the purchases was made by this facility. Ventana Medical Systems, Inc. does have an existing GSA contract for which those prices have been deemed reasonable for similar products. In addition, Ventana Medical Systems, Inc. has proposed a trade-in of the current stainer and 20% discount on bulks and ancillaries.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Ventana Medical Systems, Inc. is the only source for the Ventana BenchMark Special staining instrument.

Market research was conducted on GSA and NAC to establish the product or similar items were not available on government contract. There were no resellers found in the open market to provide the item as well.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

In accordance with VHA Directive 2009-31, the replacement of the current Ventana stainer with the new one ensures consistency and uniformity in the product safety aspect of employee knowledge (use, cleaning, maintenance, etc.) and reusable medical equipment (reagents, chemicals, etc.).

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: NA

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: NA