AWARD
66 -- CPRR - Hematology Analyzer/Slide Maker/Stainers - 13 VISN 10 Facilities
- Notice Date
- 10/1/2023 5:58:11 AM
- Notice Type
- Award Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- 250-NETWORK CONTRACT OFFICE 10 (36C250) DAYTON OH 45428 USA
- ZIP Code
- 45428
- Solicitation Number
- 36C25023Q0996
- Archive Date
- 11/30/2023
- Point of Contact
- Kellie Konopinski, Contracting Officer, Phone: 734-222-4330
- E-Mail Address
-
Kellie.Konopinski@va.gov
(Kellie.Konopinski@va.gov)
- Award Number
- 36C25024A0003
- Award Date
- 10/01/2023
- Awardee
- Sysmex America, Inc. LINCOLNSHIRE 60069
- Award Amount
- 0
- Description
- Hematology CPRR 36C250-23-AP-4549 VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT Effective Date: 02/01/2022 Page 1 of 4 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C250-23-AP-4549 (1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10, located at 24 Frank Lloyd Wright Drive, Suite M2200, Ann Arbor, MI 48105, in support of the VISN 10 VA Health Care System facilities below. 2237: 506-24-1-1030-0006 VA Ann Arbor Healthcare System 2215 Fuller Rd. Ann Arbor, MI 48105 Northern Indiana Healthcare System (VANIHCS) Marion Campus 1700 E. 38th Street Marion, IN 46953 Battle Creek VA Medical Center 5500 Armstrong Road Battle Creek, MI 49037 Aleda E. Lutz VA Medical Center 1500 Weiss Street Saginaw, MI 48602 Northern Indiana Healthcare System (VANIHCS) Ft. Wayne Campus 2121 Lake Avenue Fort Wayne, IN 46805 Chalmers P. Wylie Ambulatory Care Clinic Central Ohio VA 420 North James Rd. Columbus, OH 43119 Northern Indiana Healthcare System (VANIHCS) St. Joseph/Mishawaka Campus 1540 Trinity Place Mishawaka, IN 46545-5006 Dayton VA Medical Center 4100 W. Third St. Dayton, OH 45428 Richard L. Roudebush Veterans Affair Medical Center 1481 West 10th Street Indianapolis, IN 46202 Louis Stokes Cleveland VA Medical Center Pathology & Laboratory Medicine Service 113(W) 10701 East Blvd. Cleveland, Ohio 44106 Toledo Community Based Outpatient Clinic 1200 South Detroit Avenue Toledo, OH 43614 Chillicothe Veterans Affairs Medical Center 17273 State Route 104 Chillicothe, Ohio 45601 Wyoming VA Health Care Center 5838 Metro Way Wyoming, MI 49519 (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). This procurement will result in a new FSS BPA with a base year and four one-year option periods for Hematology Cost Per Reportable Result (CPRR) for 13 VISN 10 facilities. Order against: FSS Contract Number: V797D-40235 (expires 8/31/2034 inclusive of options) Name of Proposed Contractor: Sysmex America, Inc. Street Address: 577 Aptakisic Road City, State, Zip: Lincolnshire, IL 60069 Phone: 224-543-9376 (3) Description of Supplies or Services: Period of Performance: 10/1/2023 9/30/2028 (base year with four one-year option periods). This acquisition is for a CPRR BPA for hematology analyzers, slide-maker/stainers and cell imaging systems per the requirements requested by each facility (see table below). The hematology analyzers must be FDA approved analyzers/systems to allow for optimized efficiency of workflow, staffing, and space. The analyzers should provide clinical utility through the most advanced technologies. The analyzers/systems must be a modular analytical unit that offers scalability and standardization to labs of all sizes. Site Number of analyzers XN20 Analyzer Slide maker/Stainer Cell Image (CellaVision) Dilution system QC Storage VANIHCS Ft. Wayne 2 Yes Yes No No No VANIHCS Marion 2 Yes No No No No VANIHCS SJ CBOC 2 Yes No No No No Toledo CBOC LAB 1 No No No No No Aleda E. Lutz Saginaw VA Medical Center 2 Yes No No No No Battle Creek VAMC 2 No No Yes No No Wyoming Health Care Center 1 No No Yes No No Ann Arbor VAMC 2 Yes Yes Yes Yes Yes, if space allows Richard L. Roudebush VA Medical Center 2 Yes Yes Yes Yes Yes Chalmers P. Wylie Ambulatory Care Clinic Columbus Ohio 2 Yes Yes Yes Yes No Dayton, OH 2 Yes Yes No Yes No Cleveland, OH 3 Yes Yes Yes Yes Yes, and Specimen Storage System Chillicothe VA Medical Center 2 Yes Yes No Yes No (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; Sysmex is the only vendor that meets the following requirements for the requesting facilities: Sysmex is the only vendor that meets the requirement of a having a Complete Blood Count (CBC) and White Blood Cell (WBC) Automated Differential (DIFF) and Reticulocyte Enumeration which also includes the 6-part differential. Sysmex Body Fluid parameters are, the Total Nucleated Count (TNC) [i.e., White Blood Cell (WBC) + Nucleated Cells], WBC only (not including non-WBC cells), and a Red Blood Cell (RBC) count. The requirement of having TNC and a WBC is necessary for the technologist who is performing the testing and to the provider who is interpreting the results. The TNC should be equal to or greater than the WBC. When there is a difference, this lets the tech and provider know how many large cells are present compared to normal size WBC. These large cells are either tissue cells (normal findings) or malignant cells (abnormal findings). The differentiation of WBC from TNC gives flexibility in reporting only the WBC and completing a differential that only includes the WBC parameters or reporting out the TNC and completing a differential that includes both WBC and non-WBC nucleated cells. This requirement allows the providers to rule out sepsis where the majority of the cells would be WBC. Sysmex has a 6-part differential, which includes immature granulocytes (IG). This parameter is required for the reliable detection and quantification of circulating immature granulocytes. This may help to reduce the number of manual differentials required. An immature granulocyte count informs the provider of possible left shift (infection) or a possible hematopoietic disorder since the normal population doesn t have immature granulocytes circulating in the peripheral blood. Detection of elevated levels of immature granulocytes can indicate overproduction in the bone marrow (Leukemia), infection, allergic reactions, or inflammation. Early detection of these elements will allow providers take prompt action towards treatment or further diagnostic testing. Sysmex meets the requirement of advanced clinical parameters such as Immature Granulocytes, Retic-He, and Immature Platelet Fraction (IPF). This is a requirement of the VA for the following reasons: Immature Granulocyte (IG) count informs the provider of possible left shift (infection) or a possible hematopoietic disorder since the normal population doesn t have immature granulocytes circulating in the peripheral blood. Immature Platelet Fraction (IPF) informs the provider of how many immature platelets are present in blood. This helps determine if the bone marrow is a possible problem with platelet production or if platelets are being destroyed in circulation. Immature Platelet Fraction (IPF) helps the physicians to understand the pathophysiology behind thrombocytopenia. This advanced parameter helps to determine if the FboNotice cause of low platelet counts is due to decreased production in the bone marrow, or increased consumption/destruction in the peripheral blood. Reticulocyte Hemoglobin (RET-HE) is a parameter in the diagnosis and treatment of anemia. It informs the providers if the bone marrow is producing RBCs. RET-HE is a measurement of the hemoglobin content of the developing reticulocyte population. RET-HE is measured at the cellular level, reflects hemoglobinization changes within 3-5 days of therapy, and is not impacted by inflammatory processes. This advanced parameter is beneficial to patient care because it indicates the efficacy of treatment for patients with iron deficiency anemia. Sysmex is the only vendor that meets the requirement for two different technologies in identifying and enumerating platelets. This allows problematic samples to be automatically reflexed with more sensitive technology, PLT-F. The PLT-F includes the Immature Platelet Fraction which is a direct cellular measurement of thrombopoiesis. Sysmex provides an XN20 analyzer which meets the requirement for separation of blast cells and abnormal lymphocytes from normal, mature cells to provide more accurate differential flagging, reduce manual slide review and allows for auto verification. If the flag is identified on the XN10 model, the analyzer will auto reflex the specimen on the XN20. No intervention is required. Sysmex meets the requirement of an automated line which allows for the analyzer, slide maker/stainer, and Cell Imaging system to be fully connected to allow technologists to walk away and return with the capability to perform review, edit, and complete differential results. This increases efficiency and is crucial with reduced staffing and expected turnaround times for patient care and treatment. Sysmex meets the requirement of all reportable parameters for the Quality Control (QC) materials and CAP survey samples, including Basophils. This requirement allows quality control and CAP proficiency samples to monitor all reportable parameters on an analyzer to ensure the analyzer is capable of measuring and differentiating all cell types. This is vital for reliable result reporting which could affect result interpretation. Joint Commission standard QSA.02.10.01 15 states For quantitative tests, the laboratory tests quality control materials across the clinically significant values of the reportable test results during a 24-hour period. The reference range for basophil cells is 0.0 to 0.2x103. The lack of QC material that spans across this range at a minimum, if not broader, is unacceptable and could cause future regulatory compliance issues. Sysmex meets the requirement of automatic background checks prior to body fluid testing. Background checks are automatically executed when switching from whole blood mode to the body fluid mode on the Sysmex. It is necessary to make certain all lysing fluids and diluents are free of contaminates and this is done through running a background count before body fluids are analyzed. The changing of modes, by the technologist, automatically performs this task which eliminates the possibility of the background being forgotten and possibly erroneous results being released. The action from Sysmex is completed without technologist intervention. Sysmex s CellaVision meets the requirement of an Advanced RBC Application and Advanced Body Fluid Application Software. The Advanced Applications on the CellaVision aid the technologist in grading/differentiating cells in a standardized capacity. This helps to ensure more consistent reporting. The advanced RBC application allows for differentiation of the RBC morphology and platelet morphology for a complete assessment of patient blood composition. The Body Fluid advanced application software allows for assessment of Body Fluid specimens using the CellaVision imaging software. This will save technologist time and allow for greater accuracy at identifying cells in body fluid by giving technologists the ability to share images with pathology for further identification without the need to carry a slide to pathologist and locate the cell on the slide again. Sysmex meets the requirement of a QC Storage system connected to the analyzer with the following features: Able to have onboard QC storage. This saves space in laboratory-owned refrigeration and keeps QC material at manufacturer recommended refrigeration limits. Provide an automated solution for storage and handling of QC material by performing QC initial analysis and cleaning procedures automatically through a standardized process determined by Laboratory s policies. This saves technologist time by removing the need to program, warm, mix, and run QC and cleaning maintenance. Provide a solution for monitoring lot information, expiration date and remaining volume of QC material. This reduces the need for oversight of QC inventory allowing for more accurate ordering and usage, saving the VA time and money. Availability of automated QC Analysis with onboard storage and scheduled run times. This saves technologist time by removing the need to program, warm, mix, and run QC. Availability of automated cleaning routines with onboard storage of clean material. This reduces the amount of space needed to properly store this cleaning material. Also, this saves technologist time by removing the need to program obtain and run daily cleaning maintenance on each analyzer and completing this daily maintenance automatically. Sysmex meets the requirement that QC peer group data must have real time, automatic electronic data upload capability to analyzer quality control. It is automatically uploaded/transmitted (with an approved VA MOU) to Sysmex Insight via the System Network Communication System (SNCS) connection. This automatic update eliminates need to manually export data and monitors QC in real time. Insight is Sysmex s web-based Inter-laboratory Quality Assessment Program (IQAP) designed to facilitate evaluation of analyzer performance. Insight is integrated into the BeyondCare Quality Monitor (BCQM) application. Sysmex meets the requirement that the equipment must store the data for up to 2 years. There is no need to print out data or save on a USB because 2 years of data is saved within the analyzer. This allows greater storage capacity and allows redundancy in the case of lost files or inability to access files stored on the drive. Sysmex allows for the connection of the TOSOH HgbA1C to the XN-9100 Hematology line. Cleveland OH requires the ability to connect the TOSOH to the line once they obtain the Sysmex Hematology line. Based on the market research conducted, Sysmex is the only vendor that has equipment that meets the Government s requirements. 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: It has been determined to be the equipment that provides the best value for the VISN 10 facilities for the reasons stated above in section 4. Sysmex will provide the VA with FDA approved parameters meeting all the VA s requirements. The many technologically advanced features will allow for a complete streamlined hematology system that will require less technologist time for routine tasks that will allow the technologist to perform other duties. The system will be able to accurately obtain results on Immature Granulocytes, RET-HE, and IPF parameters needed to provide excellent patient care in a package that is reliable and easy to use. The advanced WBC, PLT, and RETIC parameters will provide the most complete hematological analysis possible, providing the veteran with the best care available. The additional benefits of the BCQM cloud-ware, tri-level control material that covers all parameters, remote calibration verification, and FDA approval means the analyzer can be trusted to perform as expected with a high degree of reliability. On board reagent dilution unit, QC storage, and clean material storage will decrease the amount of technologist time needed to maintain and perform quality measures on the instrument. The integrated slide maker stainer and cell imaging system are also time saving solutions. This type of system is crucial in today s work environment where there is a constant shortage of qualified medical technologists/medical laboratory scientists. GSA has already determined the prices for the FSS contract to be fair and reasonable. However, in accordance with FAR 8.405-4, the contracting officer shall seek a price reduction. (6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. VetCert was queried under NAICS 334516 and 191 concerns were found. DSBS was searched selecting self-certified SDVOSB/VOSB s, NAICS 334516 and keyword Sysmex and no concerns were found. An additional DSBS search with NAICS 334516 and keyword Sysmex resulted in zero concerns. Sysmex America, Inc. was contacted and they confirmed they do not currently have any distributors for this type of CPRR procurement. Cost Per Reportable Result procurements are covered under Sysmex America, Inc. s NAC Contract V797D-40235. The Analyzers must be able to perform and report the clinical parameters to meet the Government s requirements for each site listed. The requesting service did in-depth market research on the Sysmex equipment and Beckman Coulter equipment. Beckman Coulter did not meet all the technical requirements. Siemens also provides Hematology equipment, however, they were contacted during market research and said they would not be participating/providing information for their equipment. NAICS 334516 has an NMR Class Waiver; however, hematology equipment is not specified. Furthermore, there are no possible SDVOSB/VOSB distributors. The manufacturer, Sysmex America, Inc., is a large business. The VA Rule of Two and SBA Rule of Two cannot be met. The FSS contract includes FAR 52.225-5 Trade Agreements, and equipment is manufactured in TAA-designated countries of Japan and Sweden (or USA). Because this is a national contract, any BAA/TAA issues regarding the items on contract and use of the contract were addressed at time of award and any subsequent delivery orders would thereby be covered as a result. (7) Any Other Facts Supporting the Justification: An ERA (Enterprise Risk Analysis), which is required for a major software version or operating system updates, has been completed for this equipment. VA Directive 6550 documents have been completed by the vendor and each facility is routing them to their respective Biomed/Area Manager/ISSO departments. FITARA approval is not required. CellaVision and Hematology Analyzers are both listed in Appendix A: Medical Equipment Categorized by Medical Product Service Codes (PSC) and do NOT Require FITARA Approval in the FITARA VHA Guide dated 4/20/21. (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 any forthcoming procurements of this nature, market research will be conducted to identify comparable and competitive products in the commercial marketplace.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/6991e8fa8cfe482b8a64351a961f326b/view)
- Record
- SN06850454-F 20231003/231001230052 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |