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FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 24, 2014 FBO #4717
DOCUMENT

Q -- CPRT HIV-HCV Bio Molecular Test - Justification and Approval (J&A)

Notice Date

10/22/2014
 

Notice Type

Justification and Approval (J&A)
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;VA Caribbean Healthcare System;Administrative Building;#10 Calle Casia Suite #4M440;San Juan PR 00921-3201
 

ZIP Code

00921-3201
 

Archive Date

10/6/2014
 

Point of Contact

Israel Rodriguez
 

E-Mail Address

641-7582,
 

Small Business Set-Aside

N/A
 

Award Number

V797P7037A VA248-15-F-0006
 

Award Date

10/1/2014
 

Description

LIMITED SOURCES JUSTIFICATION ORDER >$3,000 FAR PART 8.405-6 2237 Transaction # or Vista Equipment Transaction #: 672-15-1-045-0006 This acquisition is conducted under the authority of the Multiple Award Schedule Program. The material or service listed in par. 3 below is sole source, therefore, consideration of the number of contractors required by FAR Subpart 8.4 - Federal Supply Schedules, is precluded for the reasons indicated below. Restricted to the following source: Provide original manufacturer's name for material or contractor's name for service. (If a sole source manufacturer distributes via dealers, ALSO provide dealer information.) Manufacturer/Contractor: Roche Diagnostics Corporation Manufacturer/Contractor POC & phone number: Tele: 1-800-428-5076 Mfgr/Contractor Address: 9115 Hague Road, PO BOX 50457, Indianapolis, IN. 46250-0457____________ Dealer/Rep address/phone number: Mariela Alemañy - mobile 787-672-9846 / VM 1-800-845-7355 X26845 0 The requested material or service represents the minimum requirements of the Government. (1) AGENCY AND CONTRACTING ACTIVITY:Department of Veterans Affairs VA Caribbean Healthcare System______ 10 Casia Street ___________________ San Juan, PR 00926 VISN:08 (2) NATURE AND/OR DESCRIPTION OF ACTION BEING APPROVED: This limited source justification is a request for other than Full and open competition and only one responsible source and no will satisfy agency, requirements per FAR 6.302-1 for a Cost per reportable test contract for the automation of HIV and HCV Viral Load PCR testing for VA Caribbean Healthcare System. This procurement is a Delivery Order against NAC Contract V797P-7037A, Source 66 III. The equipment at the installation is a COBAS AmpliPrep/COBAS TaqMan System. (3)(a)A DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY'S NEED: Work includes HIV and HCV Viral Load PCR testing and equipment, including: (a) consumables supplies, standards, controls, reagents and disposables, (b) preventive maintenance, routine repairs, emergency repairs services to VA Caribbean Healthcare System (VACHS), San Juan, P.R. All consumables supplies (reagents, standards, controls, disposables, etc) required for the proper operation of the contractor's equipment and necessary to perform tests on the equipment provided shall be included. (b)ESTIMATED DOLLAR VALUE: $146,119.36 (c)REQUIRED DELIVERY DATE: October 1st 2014. (4)IDENTIFICATION OF THE JUSTIFICATION RATIONALE (SEE FAR 8.405-6), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR'S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE. 1Specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources. The COBAS AmpliPrep/COBAS TaqMan System is from Roche Diagnostics and all the reagents, columns, calibrators and controls to be use for analysis must be from the same company. No other company produce comparable laboratory supplies for this equipment. Therefore, the Joint Commission and the College of American Pathologist (CAP) would not accredit the Instrument if we use other companies' reagents. A market research was performed and this evaluation was compare with the same type or instrument from another company. The research demonstrated that Roche instrument kits and equipment is FDA approved. Also, Roche instrument have the capability to add other test to the platform. These two major elements make a different in meet the standards and add the capability to cross reference by executing other test as necessary. (5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.4 TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: The anticipated price to the Government is $147,119.00 for one (1) year of testing based on historical data of previous years. The price is fair and reasonable in comparison with other equipment of the same quality with the advantage or the two major capabilities previously mentioned. This order represents the best price in the market and it greatly increases laboratory efficiency and productivity according to our specific needs with this technology. The durability of equipment, maintenance, repairs and support service provided makes a different in productivity. (6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED: The market research for this action evaluated two companies: Roche Diagnostics and other company. No other companies were capable to provide equipment with the technology to meet the capability and qualification. (7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: This product is a more efficient system available. The equipment is capable to process more tests per hour with very little hands-on time which increase productive. Keeping the current technology would eliminate any assay due to changes in methodology on our patient historical data. Staff is already trained with Taqman 48/AmpliPrep instrument. The evaluations for Roche Diagnostic's performance during the last years had been excellent. The company service and technical support has been outstanding. (8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE: None (9) REQUIREMENTS CERTIFICATION: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor's supervisor, fund control point official, chief of service or someone with responsibility and accountability.) // SIGNED // 9/19/2014 SIGNATUREDATE Inocencia Pena, Ph.D., MT (ASCP) Microbiology Supervisor Pathology and Laboratory NAMETITLESERVICE LINE/SECTION VA Caribbean Healthcare System, San Juan, PR FACILITY (10) APPROVALS IN ACCORDANCE WITH FAR 8.405-6(d): a. CONTRACTING OFFICER'S CERTIFICATION (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. // SIGNED // 09/20/2014 CONTRACTING SPECIALIST SIGNATUREDATE ISRAEL RODRIGUEZ VA CHS, San Juan, PR NAME AND TITLEFACILITY b. PRODUCT LINE SUPERVISOR (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. // SIGNED // 09/22/2014 PLS SIGNATUREDATE JOSE I. HERNANDEZ VA CHS, San Juan, PR NAME AND TITLEFACILITY c. CONCUR / NON-CONCUR (over $150,000 to $650,000) NCO8 QA SIGNATUREDATE NAME AND TITLE d. DOC (over $150,000 to $650,000): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. SIGNATUREDATE NAME VISN 8 DOC
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/9e58f3cb68ebb98c2d88856ca2444119)
 

Document(s)

Justification and Approval (J&A)
 

File Name: V797P7037A VA248-15-F-0006 V797P7037A VA248-15-F-0006_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1693156&FileName=V797P7037A-001.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1693156&FileName=V797P7037A-001.docx

 

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

Record

SN03555651-W 20141024/141022234048-9e58f3cb68ebb98c2d88856ca2444119 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
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