FBODaily.com | FedBizOpps: FILE | 66 | Blood Reagent Test Kits (Combined) - Attachment

FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 28, 2015 FBO #5026
DOCUMENT

66 -- Blood Reagent Test Kits (Combined) - Attachment

Notice Date: 8/26/2015
Notice Type: Attachment
NAICS: 325413 — In-Vitro Diagnostic Substance Manufacturing
Contracting Office: U.S. Department of Veterans Affairs;Strategic Acquisition Center;10300 Spotsylvania Ave;Fredericksburg VA 22408
ZIP Code: 22408
Solicitation Number: VA11915Q0166
Archive Date: 10/27/2015
Point of Contact: Maurice D. Christian
Small Business Set-Aside: N/A
Award Number: VA119-15-A-0146
Award Date: 8/28/2015
Description: FOR OFFICIAL USE ONLY LIMITED SOURCE JUSTIFICATION 1. Contracting Activity The Department of Veterans Affairs (VA) Strategic Acquisition Center (SAC) 10300 Spotsylvania Ave, Suite 400 Fredericksburg VA, 22408 2. Description of Action The proposed action is to acquire blood reagent test kits for the quantitation of Hepatitis-C Virus (HCV) and Human Immunodeficiency Virus Type 1 (HIV-1) under a 12-month firm-fixed priced Blanket Purchase Agreement (BPA) with an option for an additional one month period. This effort is being conducted under the authority of the Multiple Award Schedule Program; the proposed BPA is to be issued under General Services Administration's (GSA) National Acquisition Center (NAC) Federal Supply Schedule (FSS) Contract V797P-7037A with Roche Diagnostics Corporation, 9115 Hague Rd, P.O. Box 50457, Indianapolis, IN 46250-0457. The current NAC FSS contract expires August 14, 2016 allowing BPAs to be issued until the period of performance expires. 3. Description of the Supplies or Services Veterans Health Administration (VHA) has a requirement for real-time polymerase chain reaction (PCR) blood reagent test kits for the quantitation of HCV and HIV-1. Test kits must meet the minimum technical requirements (MTR) for these products including compatibility with Roche Diagnostics Corporation's (Roche) COBAS Ž AmpliPrep Instruments and COBAS Ž TaqMan Ž 48 Analyzer or COBAS Ž TaqMan Ž 96 Analyzer test equipment currently owned or leased by 33 VHA medical facilities. Compatible test kits are COBAS Ž AmpliPrep/COBAS Ž TaqMan Ž HCV Test Kit v2.0 and COBAS Ž AmpliPrep/COBAS Ž TaqMan Ž HIV-1 Test Kit, v2.0. The period of performance for this acquisition is a base year with a one-month option. The total estimated price for the proposed action is $1,986,637.00. 4. Authority Cited The authority permitting limited sources is Federal Acquisition Regulation (FAR) 8.405-6(a)(1)(i)(B), "Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized." 5. Rationale Supporting Use of the Authority Cited Above It is essential for VHA medical facilities to be able to test for HCV and HIV-1 in certain patients. Thirty-three of those medical facilities have made an investment in Roche laboratory test equipment for that purpose. Roche test equipment literature identifies the following HCV & HIV-1 blood reagent test kits as compatible for use: Item #Description05480442190COBAS AmpliPrep/COBAS TaqMan HCV v.2.0 Test Kit05212308190COBAS AmpliPrep/COBAS TaqMan HIV-1 Test v2.0 Only these HCV and HIV-1 test kits are capable of meeting the MTRs because they are unique to Roche Diagnostics Corporation and are highly specialized to conform to the requirements of the test equipment currently owned or leased by multiple VHA medical facilities. The equipment and compatible test kits are proprietary in nature and unique to Roche, the sole manufacturer and distributor of these products. Only brand name Roche test kits can be used since using another product would result in in-compatibility issues. FOR OFFICIAL USE ONLY 6. Efforts to Obtain Competition Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources meeting the Government's requirements. Competition is not anticipated for this acquisition. In accordance with FAR 5.302 and FAR 8.405-6(a)(2), this action will be synopsized at award and justification will be made available within 14 days of award on the Federal Business Opportunities (FBO) Page. 7. Actions to Increase Competition The VA will conduct market research to determine if the current equipment has served its useful life and should be replaced in the future allowing for open competition. Based on various factors such as age, useful life, cost, and capabilities of other equipment and test kits, VA will review the market research data on an annual basis to determine if replacement is needed in the future. 8. Market Research In July 2014 through March 2015, market research was conducted by the technical experts in VHA and the Strategic Acquisition Center (SAC) utilizing MedPDB spend data, internet searches, Subject Matter Expert (SME) research and analysis, contact with Roche, and a search of the Federal Supply Schedule to determine if other companies were capable of providing the test kits that were compatible with Roche Diagnostics equipment. Results of the market research determined that only Roche Diagnostics, the sole supplier and manufacturer of the proprietary items and test kits, had the capability to provide the required test kits that are compatible with Roche Diagnostics' COBAS Ž AmpliPrep/COBAS Ž TaqMan Ž test equipment currently in use at VA medical facilities. Roche Diagnostics' test kits meet all of VHA's minimum technical requirements. The proposed action is a sole-source firm-fixed price VHA-wide Blanket Purchase Agreement (BPA) established under Roche's NAC FSS contract. The option period will be limited to one month based on the duration of the NAC contract expiring in August 2016. Orders placed under this BPA will be de-centralized. By leveraging enterprise-wide quantities, VA anticipates acquiring these products at substantially reduced prices and administrative costs. The North American Industrial Classification System (NAICS) code for this acquisition is 325413, In-Vitro Diagnostic Substance Manufacturing. The Small Business Administration's size standard for this NAICS code is 500 employees. Under this standard, Roche is a large business. There are no small businesses identified for these products by this market research effort. 9. Other Facts Facts applicable to the Contracting Officer's determination that this BPA with Roche for blood reagent test kits for HCV and HIV-1 represents the best value consistent with FAR 8.404(d): a) Accuracy, Safety, and Efficiency - Based on the information previously provided in paragraph 5, the blood reagent test kits to be acquired under this BPA are highly specialized to conform to the requirements of laboratory test equipment used by VHA facilities for the quantitation of HCV and HIV-1 in patients. FOR OFFICIAL USE ONLY FOR OFFICIAL USE ONLY b) Fair and Reasonable Pricing - The blood reagent test kits for HCV and HIV-1 to be supplied under this BPA are currently on Roche's FSS V797P-7037A. In establishing this schedule contract, the NAC made a determination that these prices are fair and reasonable. Additional discounts will be sought in establishing a BPA. Based on anticipated discounts and the pre-determined fair and reasonable pricing of the FSS, it is the determination of the Contracting Officer that the Government will receive fair and reasonable pricing under this BPA. c) Historical data shows that some ordering offices are negotiating additional discounts off the FSS prices, but most purchases are made at the non-discounted schedule price. By consolidating the negotiation of reduced prices, ordering offices will receive the administrative benefit of not needing to negotiate discounts as well as cost savings due to a nationwide discounted price. 10. Technical and Requirements Certification I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief. Date: ______________ Signature: ___________________________ A.J. Swygert Program Manager Office of Procurement and Logistics Department of Veterans Affairs 11. Determination of Best Value I hereby determine that the proposed effort will represent the best value to the Government consistent with FAR 8.404(d).The NAC has already determined that the prices on the FSS contract are fair and reasonable. Further price analysis will be conducted and subsequent negotiations held as necessary. Additionally, price discounts will be sought. Date: ______________Signature: ___________________________ Simone Jackson Contracting Officer Strategic Acquisition Center (SAC) Department of Veterans Affairs 12. Procuring Contracting Officer Certification I certify this justification is accurate and complete to the best of my knowledge and belief. Date: ______________Signature: ___________________________ Simone Jackson Contracting Officer Strategic Acquisition Center (SAC) Department of Veterans Affairs 13. Legal Sufficiency Certification I have reviewed this justification and find it legally sufficient. Date: ______________Signature: ___________________________ Maura Brown Office of General Counsel Department of Veterans Affairs 14. Competition Advocate Certification In my role as Contracting Activity Competition Advocate, based on the foregoing justification, I hereby approve the acquisition of COBAS AmpliPrep/COBAS TaqMan HCV and HIV-1 blood reagent test kits with an estimated amount of $1,986,637.00, pursuant to FAR 8.405-6(a)(1)(i)(B), subject to availability of funds, and provided that the supplies herein described have otherwise been authorized for acquisition. Date: ______________ Signature: ___________________________ Phyllis Bower Head of the Contracting Activity Office of Acquisition Operations FOR OFFICIAL USE ONLY
Web Link: FBO.gov Permalink
(https://www.fbo.gov/notices/a7d3f4faed4f5ad6e80648f1474166cf)
Document(s): Attachment; File Name: VA119-15-A-0146 VA119-15-A-0146.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2277625&FileName=VA119-15-A-0146-000.docx); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2277625&FileName=VA119-15-A-0146-000.docx; File Name: VA119-15-A-0146 LSJ - HCA Approval on HCV Blood Reagent Test Kits.pdf (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2277626&FileName=VA119-15-A-0146-001.pdf); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2277626&FileName=VA119-15-A-0146-001.pdf; Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
Record: SN03858159-W 20150828/150827000959-a7d3f4faed4f5ad6e80648f1474166cf (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

| FSG Index | This Issue's Index | Today's FBO Daily Index Page |

Loren Data's SAM Daily™

66 -- Blood Reagent Test Kits (Combined) - Attachment