SPECIAL NOTICE
65 -- Detroit Sysmex Hematology BPA
- Notice Date
- 8/5/2020 2:28:58 PM
- 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
- 36C25020Q0899
- Archive Date
- 09/04/2020
- Point of Contact
- Kellie Konopinski, Contracting Officer, Phone: 734-222-4330
- E-Mail Address
-
Kellie.Konopinski@va.gov
(Kellie.Konopinski@va.gov)
- Award Number
- 36C25020A0078
- Award Date
- 08/05/2020
- Awardee
- SYSMEX AMERICA, INC. LINCOLNSHIRE 60069
- Award Amount
- 0
- 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: 36C250-20-AP-3538 (1) Contracting Activity: Department of Veterans Affairs, NCO 10, Detroit VA Medical Center, 553-20-4-058-0973. (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. The proposed action is a Cost Per-Reportable Result BPA with Sysmex Corporation for hematology analyzers. Order against: FSS Contract Number: V797D-40235 (Expires 10/31/2020; CO has confirmed that the NAC CO is in the process of issuing an extension for a period of 1 year, through 6/30/2021, to allow sufficient time to exercise the second option period, which would expire 8/31/2024. A third option period may be exercised effective 9/1/2024. The BPA will be cancelled if either of the option periods is not exercised.) Name of Proposed Contractor: Sysmex America, INC Street Address: 577 Aptakisic Rd. City, State, Zip: Lincolnshire, IL 60069 Phone: 800-379-7639 (3) Description of Supplies or Services: The estimated value of the proposed action is $156,000.00 (base year) and $800,000.00 (base plus 4 option years). The proposed Sysmex package includes the following components: XN9100-201 (2 hematology analyzers), RU-20 (Concentrated reagent delivery system), Slide Maker & Stainer, CellaVision DI-60 with peripheral blood application, advanced RBC application, Body Fluid application, Total Lab Automation Connector, and remote view software (5 licenses), Reagents and Quality Control Material, Monitor, Printer, Cables, Connectors, Sample racks, Interface, Associated Software, 24-7 Technical assistance, Insight real time quality control, Operator manual, Unlimited virtual Instructor Lead Training, On-Line training tutorials, and 2 Advanced Operator Training Classes at Sysmex. Base plus 4 option years, POP: 8/15/2020 8/14/2025 (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; The Detroit VA currently has installed and is using ROCHE Cobas Connection Modules (CCM) which is the automation, interface, and physical track components that will accept the Sysmex Hematology instrumentation and allow samples to be loaded on to the ROCHE CCM and be routed appropriately. According to Roche and Sysmex, the Sysmex XN-9100 Automated Hematology System is the only Hematology system available in the United States that is able to connect to Roche s Cobas® connection modules (CCM) to create an automated workflow. CO has obtained letters from Roche dated July 8, 2020 and from Sysmex. The Sysmex letter documents that Sysmex and Roche have an established agreement allowing connection of the Sysmex XN-9100 to Roche's Total Lab Automated systems with over 20 connections in the US and Canada. The Roche letter documents that the Sysmex XN-9100 is the only system that is able to connect to the Roche Cobas connection modules to create an automated workflow. Sysmex is the only vendor to offer Insight remote real time quality control review of the instrument to assist in monitoring performance. Furthermore, with Remote view software the bench technologist will be able to flag abnormal parameters directly to a Pathologist for review. 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: The proposed Sysmex Hematology package represents the best value for the facility and staff because it is the only equipment that can be incorporated and interfaced into the ROCHE Chemistry sample automation system currently being used at the Detroit VA. The value gained from incorporating Hematology instrumentation into the facility s Chemistry platform is to provide more efficient productivity with limited staffing on all shifts, but especially on afternoons, midnights, and weekends where staffing is reduced to a minimum. This will allow limited staff to provide faster turn-around time from specimen receipt to releasing results to the clinical providers to enhance patient care. Finally, it will allow limited staff to manage acute laboratory situations by allowing a single operator to continue processing and releasing results, while their sole co-worker addresses other clinical needs. Upon installation of the ROCHE Chemistry automation line the facility purposefully incorporated a gate to accommodate the subsequent addition of additional instrumentation. The subsequent efficiency of placing both high volume samples (e.g., Chemistry & Hematology) into one consolidated sample entry point makes better use of limited staff and improves their work ergonomics. Hematology sample review can take place at multiple locations or at the Chemistry Command Center to free up employees to multitask various tasks within the laboratory. By incorporating hematology into Chemistry sample handling workflow, automation software can process and release defined normal samples reducing staffing involvement in managing patient data release. IAW FAR 8.405-4, the ordering activity will seek a price reduction during RFQ phase. (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 by the requesting service. They contacted the two known major hematology vendors (e.g., Sysmex and Beckman Coulter). The result of a review of the information provided by both vendors was that only Sysmex America s system could be integrated and interfaced with the existing ROCHE Chemistry automation package. During evaluation in 2019 of replacement Chemistry Instrumentation packages, the ability to incorporate additional laboratory disciplines (e.g., hematology, coagulation, urinalysis, etc.) was a minimal requirement. This was based on the inability to retain and/or hire qualified laboratory staff to provide acceptable levels of clinical services. The efficiencies created by integrating high sample volume areas was a strong consideration moving forward and anticipating reduced staffing. The ability to more ergonomically utilize staff movement to process and analyze patient samples was also a strong consideration on the off shift and weekends where staffing is further reduced. VIP was queried under NAICS 334516 and 107 concerns were found. A keyword search of Sysmex along with the NAICS code resulted in zero concerns. VA Rule of Two cannot be met. GSA was searched and the requested items were found on Sysmex's NAC contract. Sysmex was contacted directly and they confirmed they have no distributors for this type of contract. Memos from both Sysmex and Roche were received confirming that Sysmex is the only source that can integrate into the current Roche chemistry system at the Detroit VA. (7) Any Other Facts Supporting the Justification: The Sysmex platform is the only product with the capability to be integrated and interfaced with the existing ROCHE Chemistry and Sample Automation Platform (e.g., Cobas Connection Module/CCM). By integrating the Sysmex Hematology package into the ROCHE Chemistry Platform, it will provide the capability to increase laboratory automation and sample turn-around time. It will also allow the staff to consolidate high volume sample processing for Hematology and Chemistry into a single-entry point and to reduce necessary staff movement to perform these functions. Laboratory workflow will be redistributed to make better use of limited staff, both in numbers and expertise. Staffing is limited as there is an inability to hire qualified Technologists and there are reduced levels of staff during the off shift and weekends so this integration will improve the quality, efficiency, productivity and ergonomics of the existing hematology services. (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: For future acquisitions, market research will be performed to determine if there are other sources that can satisfy the Government's needs. (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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