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FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 29, 2017 FBO #5819
DOCUMENT

66 -- IHC REAGENTS SALISBURY VAMC - Justification and Approval (J&A)

Notice Date

10/27/2017
 

Notice Type

Justification and Approval (J&A)
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 6;100 Emancipation Drive;Hampton VA 23667
 

ZIP Code

23667
 

Archive Date

10/15/2017
 

Point of Contact

Darla J Hurlock
 

E-Mail Address

8-3120<br
 

Small Business Set-Aside

N/A
 

Award Number

VA246-17-D-0367
 

Award Date

9/30/2017
 

Description

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>$150K) ALL APPROVAL SIGNATURES REDACTED. DJH. Acquisition Plan Action ID: VA246-17-AP-9608 Contracting Activity: Department of Veterans Affairs, Network Contracting Office 6 (NCO 6), on behalf of the Veterans Affairs Medical Center (VAMC) in Salisbury, North Carolina in support of purchase request number 659-18-1-064-0012. Nature and/or Description of the Action Being Processed: This Justification provides the rationale for contracting by other than full and open competition for an FY18 standing order for consumables (reagents, test kits) to be used in antibody-tagging testing at VAMC Salisbury s Pathology and Laboratory Service. This procurement is for consumables specified above is conducted in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. Description of Supplies/Services Required to Meet the Agency s Needs: VAMC Salisbury recently purchased a Roche Diagnostics brand pathology analyzing equipment: Benchmark ULTRA fully automated slide preparation system; Ventana HE600 analyzer; Vantage analyzer; and V-Connect software. The equipment requires consumables (reagents, antibodies, and supplies) to process the tests. The estimated annual FY18 cost of the consumables is $250,000.00. This procurement will be awarded to Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN 46256. 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; The authority for applying the Simplified Procedures for Commercial Items of FAR 12.5 is 41 U.S.C. 1901 and is implemented by restricting competition on this procurement via FAR 13.106(b)(2). Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Roche Diagnostics Corporation is the sole manufacturer and distributor of the stated slide preparation equipment and all associated consumables (reagents and test kits). This equipment is highly specialized and the consumables are extremely sensitive to transportation, heat, and time. To guarantee the reagents quality integrity is maintained, Roche Diagnostics Corporation does not use distributors. This allows for the replacement of any consumable directly and expeditiously if performance is not maintained at 100% acceptability. Additionally, these consumables are specifically designed for the stated equipment; use of any other type of consumables may result in standardization errors and misdiagnosis of tissue samples. Use of other type of consumables would also void all equipment warranties and product liability regulations. As such, only Roche Diagnostics Corporation can satisfy the requirement. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An Intent to Sole Source Notice will be published on FedBizOpps; however, no responses are anticipated. Due to the organic/chemical composition and sensitivity of the consumables, Roche Diagnostics Corporation does not allow distribution rights in effort to maintain quality assurance. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The estimated cost to the Government for this requirement is $250,000.00 for an annual supply of consumables; Roche Diagnostics Corporation has previously provided quantity discounts to the Government and is anticipated to provide the same for this requirement. Previous procurements for this requirement have been reviewed and compared to the current estimated cost, and it is therefore determined the cost to the Government for this requirement is fair and reasonable. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Internet searches, along with FSS Schedule 66 searches, indicate Roche Diagnostics Corporation is the only distributor of the required consumables. Additionally, a search of NAICS 325413 provided 18 SD/VOSBs, however, Roche Diagnostics Corporation provided a written statement of their policy regarding not using distributors regardless of socio-economic status. Any Other Facts Supporting the Use of Other than Full and Open Competition: There are no other facts supporting this request for Justification other than those previously stated. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: See Section 6 above. 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: There are no actions which may be taken to overcome barriers to competition for this requirement.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/3f21c47228730ad7ba65ab214ac2013a)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA246-17-D-0367 VA246-17-D-0367_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3875977&FileName=VA246-17-D-0367-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3875977&FileName=VA246-17-D-0367-000.docx

 

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

Record

SN04725487-W 20171029/171027231140-3f21c47228730ad7ba65ab214ac2013a (fbodaily.com)
 

Source

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

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