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FBO DAILY ISSUE OF DECEMBER 07, 2012 FBO #4031
DOCUMENT

66 -- Rapid Point Blood Bank Test Supplies - Justification and Approval (J&A)

Notice Date

12/5/2012
 

Notice Type

Justification and Approval (J&A)
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN 1 Network Contracting Office;Acquisitions-90;421 North Main Street;Leeds MA 01053-9764
 

ZIP Code

01053-9764
 

Solicitation Number

VA24113Q0076
 

Archive Date

3/14/2013
 

Point of Contact

Teresa J Cutty
 

E-Mail Address

4-4040
 

Small Business Set-Aside

N/A
 

Award Number

VA241-13-P-0190
 

Award Date

12/5/2012
 

Description

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1.Contracting Activity: Department of Veterans Affairs, VISN 1, VA Connecticut Healthcare System & VA Manchester, Pathology & Laboratory Medicine Service, Transfusion Medicine Department. Transaction # (CT) Transaction # (Manchester) Justification for other than full and open competition 2.Nature and/or Description of the Action Being Processed: Other than full and open competition as authorized by statute - Yearly firm fixed price purchase order is requested for Blood Bank reagent cells, panel cells and other reagents required for transfusion medicine testing at the VA West Haven Lab, Blood Bank Department, and the VA Manchester Lab, Blood Bank Department. A separate yearly purchase order is required for each site until a BPA for VISN 1 has been negotiated and put into place. Some of these products are specific for the gel testing systems that are used at the VISN 1 Blood Bank labs and produce the best results based on their quality and their predilution for use. The 0.8% Surgiscreen, 0.8% Affirmagen, 0.8% Resolve A, 0.8% Resolve B, and 0.8% Resolve Panel C are sole source items and can only be obtained from Ortho and used on their automated and semi-automated Gel Systems. No other manufacturer offers this product with the specific characteristics that are required for use on the Gel systems in the VISN 1 Blood Bank Labs. The other items have some substitutes available from Company A and CompanyB but their products do not meet the same quality standards as the Ortho as determined by all the Blood Bank Labs within VISN 1. All the Ortho products have been validated already at all VISN 1 sites including the Connecticut and Manchester sites. The other products are not prediluted and do not work as well as the Ortho reagents and cells specifically engineered for use on the Gel automation and semi automation systems. The tech time required to make the dilutions and chance for error do not make this a practical solution and would cost the government more in the long run. Both the Company A and Company B are only validated for use using the slide and tube method and not the automated method of testing. Validation studies would require a lot of time and expense to complete in order to meet the standards of the accreditation agency that oversees the VISN 1 Labs and FDA specifically for Blood Bank Labs. Ortho's reputation is also superior with far fewer FDA reagent recalls in the past several years. Critical Blood Bank testing services become compromised with any recall of products which in turn puts the patient's well being in jeopardy. Ortho's customer service is very good and they are always responsive to the customer's needs. This has been demonstrated over several years in all of the VISN 1 labs. 3.Description of Supplies/Services Required to Meet the Agency's Needs: Products for this CT (689) purchase order along with the yearly estimated quantity and delivery are: Product Product # Yearly QtyUnitCost/each Confidence System690209626 kit A2 Cells71931013ea Resolve Panel B71952013kit Panel C (ficin treated)71941013kit Coombs Control71981078ea Affirmagen71921052kit Surgiscreen71910052kit 0.8% Surgiscreen690231678kit 0.8% Affirmagen71920178kit 0.8% Resolve Panel C690231913kit Products for this Manchester (608) purchase order along with the yearly estimated quantity and delivery are: Product Product # Yearly QtyUnitCost/each Confidence System690209613 kit A2 Cells71931012ea 0.8% Resolve A690231712kit 0.8% Resolve B 690231812kit Coombs Control71981012ea Affirmagen71921012kit Surgiscreen71910012kit 0.8% Surgiscreen690231624kit 0.8% Affirmagen71920124kit Anti A Bioclone 69019341ea Anti B Bioclone69019351ea Anti A1 Lectin7118301ea 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; 5.Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority Ortho Clinical diagnostics is the manufacturer of the automated and semi-automated gel blood bank testing system used at the Blood Bank Lab in the VA Connecticut Healthcare System and the Manchester VA. Some of the products are sole source products and can only be obtained from the manufacturer Ortho. No other manufacturer or vendor can provide these products. These products are specifically made for the automated and semi-automated gel testing systems. They are compatible with these systems and no other product can be used. They do not require any preparation because they are prediluted and ready to use. Ortho offers the only class of reagents that are gel compatible with their systems. Ortho is the preferred vendor for the open market items because they too are prediluted and ready to use for testing. This eliminates technique variables and incorporates minimal handling of reagents and samples making the testing safer for the techs performing the work. Ortho offers the only class of reagents that are gel compatible with their systems. Ortho has proven quality products utilized in all the sites within VISN 1. They are reliable and cost effective. Switching to any other brand would require many comparison and validation studies and other vendor's reagents are not as sensitive or specific with the gel testing system. Other vendor's products would also require more time for the testing and increase variability while decreasing standardization and quality of work potentially putting our veterans at risk. 6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: All sites within VISN 1 are very satisfied with the performance, reliability and cost of the Ortho products and they are compatible with the automated and semi-automated gel systems in our Blood Bank Labs. All sites have expressed that Ortho products are the only product that they would use based on past experience and a switch to another product would be very costly and not work properly with the gel systems. All sites are currently standardized with these systems throughout VISN 1. They use the most compatible, sensitive and specific reagents and cells that work with the new gel systems in their labs. Both Company A and Company B are methods for slide and tube testing according to the manufacturer's instructions. These methods require more steps and tech intervention and do not produce the same sensitivity, specificity and standardization as do the Ortho products in conjunction with the Ortho gel systems. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer determines that the anticipated price will be fair and reasonable based upon the fact that the pricing provided is the commercial price for these supplies and based on prior year's pricing. 8.Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Ortho Clinical diagnostics is the manufacturer of the automated and semi-automated gel blood bank testing systems used throughout VISN 1 and at VA West Haven and VA Manchester Blood Bank Labs. The requested products are not on Ortho's Federal Supply Schedule but are compatible with the systems. They do not require any preparation because they are prediluted and ready to use. They are also more specific and sensitive than the alternate vendor products. They have proven themselves to be quality products since all sites currently use them and find them reliable and cost effective. Switching to any other brand would require many studies and would not work properly on the gel system automation. Technical market research concluded that both Company A and Company B are methods for slide and tube testing only according to their manufacturer's instructions. These methods require more steps and tech intervention and do not produce the same sensitivity, specificity and standardization as do the Ortho products in conjunction with the Ortho gel systems. 9.Any Other Facts Supporting the Use of Other than Full and Open Competition: Vendor is the sole manufacturer and distributor of the supplies used on the automated and semi-automated analyzers and they are compatible with existing VA CT & VA Manchester equipment. These tests provide rapid and accurate results utilizing the equipment already in place in Labs within VISN 1. This system already provides a cost savings in tech time with minimum handling and is safer for the techs since there is less sample handing as well. Along with this their product is more sensitive and specific in detection of antibodies and typing. They have proven over time to be reliable and of best value to our Blood Bank labs. 10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None 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: Contracting activity will continue to encourage brand name or equivalent specifications. VISN 1 Network Labs will continue to monitor new products to identify products that may meet our specialized needs.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/NoVAMC/VAMCCO80220/VA24113Q0076/listing.html)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA241-13-P-0190 VA241-13-P-0190 RAPID POINT BLOOD BANK SUPPLIES.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=543535&FileName=-1829.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=543535&FileName=-1829.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN02943254-W 20121207/121205234525-d59508dcef3c15329bff902bba40de07 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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