SPECIAL NOTICE
66 -- Roche Cobas 6800 Testing System COVID-19 Support
- Notice Date
- 10/28/2020 6:27:48 AM
- Notice Type
- Justification
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- 250-NETWORK CONTRACT OFFICE 10 (36C250) DAYTON OH 45428 USA
- ZIP Code
- 45428
- Solicitation Number
- 36C25021Q0086
- Archive Date
- 11/27/2020
- Point of Contact
- Jeffrey Rozema, Contracting Officer, Phone: 269-223-6450
- E-Mail Address
-
jeffrey.rozema@va.gov
(jeffrey.rozema@va.gov)
- Award Number
- V797D-70105-36C25021F0120
- Award Date
- 10/26/2020
- Awardee
- ROCHE DIAGNOSTICS CORPORATION INDIANAPOLIS 46256
- Award Amount
- 351000.00000000
- Description
- VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT VHAPM Part 808.405-6 Limiting Sources Page 1 of 4 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C250-21-AP-0171 (1) Contracting Activity: Department of Veterans Affairs, VISN 10, VA Ann Arbor Healthcare System/Network Contracting Office 10, 5500 Armstrong Road, Battle Creek, MI 49037 2237: 506-21-1-1609-0037 (2) Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). New requirement for a Roche Diagnostics Cobas 6800 Molecular Testing Analyzer with Direct Connect Silver IT & Consulting. Order against: FSS Contract Number: V797D-70105 Name of Proposed Contractor: Roche Diagnostics Corporation Street Address: 9115 Hague Rd, P.O. Box 50457 City, State, Zip: Indianapolis, IN 46250-0457 Phone: (317) 521-2000 (3) Description of Supplies or Services: The estimated value of the proposed action is $351,000.00. One (1) Roche Cobas 6800 analyzer with 1-year warranty, Direct Connect Silver IT & Consulting package, and training for VA Ann Arbor Healthcare System PALMS. This system is required for high-throughput COVID-19 testing. (4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor s unique qualifications to provide the required supply or service. FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays: FAR 8.405-6(a)(1)(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: Market research was conducted for high-throughput testing platforms. There are limited vendors who can provide such equipment, with the following equipment models reviewed: Abbott M2000, BD Max, Hologic Panther and Roche 6800. The 6800 and the M2000 can both be considered high-throughput platforms allowing for batches of 96 samples to be loaded at a time. The BD Max is limited to only 24 samples being tested at a time which greatly limits the number of tests that can be performed per shift. The 6800 allows for continuously loaded batches onto the analyzer which allows for the sampling and extraction to be performed simultaneously while the previous batch is amplified and analyzed. The M2000 does not allow for continuous loading of batches. Both the M2000 and BD Max have test menus that overlap with our current methods meaning that they have nothing new to offer. The Hologic Panther is not FDA approved for Sure Path specimen which will be the major test we want to bring in-house. FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. FAR 8.405-6(b): Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: These are direct replacements parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. (5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: Due to COVID-19 testing high volume demand, the Ann Arbor VA requires a high-throughput platform in-house. The Ann Arbor VA currently has two Covid-19 testing methods in the laboratory, the Cepheid and the BioFire. Both methods require hands-on sample preparation and loading of individual test cartridges. These methods are laborious and low throughput resulting in only a dozen or so tests performed each hour. Currently, test volume is roughly 1500 per week, of which 80% is being sent out to a reference laboratory. The turnaround times for sent out testing is 24-48 hours during weekdays. This causes a delay in providing care to our veterans. The Roche 6800 high-throughput platform will generate 400 patient results per 8-hour shift and greatly reduce turnaround time. This will help serve our veterans in timely manner and provide the utmost care they need. In addition to the reasons stated in Paragraph (4) above, the M2000 is due to be phased out soon and it would not be advisable to purchase an instrument which will soon be obsolete. Also, the 6800 has the better test menu, and offers a variety of viral load assays that can be brought in-house for future development. GSA has already determined the prices of supplies to be fair and reasonable. Discounts from FSS pricing were sought from Roche Diagnostics Corporation, with Roche stating that no additional discounts were available on this system. (6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted: Market research was conducted on VIP, AbilityOne, UNICOR, GSA Advantage, VA NAC/SAC, FPDS, and SBA DSBS. The VetBiz search using NAICS Code 334516 and keyword Cobas revealed zero SDVOSB/VOSB s. The VA Rule of Two cannot be met. The Cobas 6800 is not available through any mandatory source. Based on the results of market research, the Government determined that there is only one contractor, Roche Diagnostics Corporation, that can provide the Cobas 6800 Molecular Testing System necessary for patient care. The Cobas 6800 is available on Roche Diagnostic s FSS contract V797D-70105. There are no VOSB s at this time to distribute the supplies needed. The Cobas 6800 Molecular Testing System is only available from the OEM, Roche Diagnostics, and the OEM has provided documentation verifying this. (7) Any Other Facts Supporting the Justification: N/A (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: If a future requirement for the same need is identified, a subsequent acquisition using full and open competition after exclusion of sources shall be promoted amongst Roche Diagnostics Corporation resellers if available. (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.)
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- Record
- SN05839722-F 20201030/201028230147 (samdaily.us)
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