SPECIAL NOTICE
65 -- Immucor Echo Lumena Blood Bank Analyzer System
- Notice Date
- 7/25/2021 7:58:32 AM
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- 242-NETWORK CONTRACT OFFICE 02 (36C242) ALBANY NY 12208 USA
- ZIP Code
- 12208
- Solicitation Number
- 36C24221Q1211
- Archive Date
- 08/04/2021
- Point of Contact
- Lateisha Robinson, Contract Officer, Phone: 718-584-9000 4334
- E-Mail Address
-
lateisha.robinson@va.gov
(lateisha.robinson@va.gov)
- Awardee
- null
- Description
- TITLE: 65-NOTICE OF INTENT TO AWARD SOLE SOURCE SOL: 36C24221Q1211 DUE: 07/30/2021 SET ASIDE: N/A NAICS:334516 POP STATE: Not specified AGENCY: Department of Veterans Affairs James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx NY 10468-3904 POC: Lateisha Robinson | Lateisha.robinson@va.gov DESCRIPTION: NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT TO. Immucor for Echo Lumena Blood Bank System for the Northport Medical Center. Market research was conducted and determined that Immucor is the only vendor capable of providing supplies necessary that meet the requirements. Statement of Work Echo Lumena Blood Bank System The Northport VA Medical Center is in need of one Echo Lumena Blood Bank System for use in the Transfusion Medicine Service. The Echo Lumena Blood Bank System utilizes Capture Solid Phase Technology for the detection and identification of Red Blood Cell Antibodies. This technology is widely accepted and has been proven through many scientific papers to have superior sensitivity and specificity. The addition of automation to the blood bank offers multiple benefits including standardization of critical processes, improved patient safety (ex, decreased time to transfusion which could impact length of stay metrics), positive impact on Key Performance Indicators (e.g. turnaround Time, Error Reduction) and reduction of manual/hands on labor in the blood bank. Also due to staffing issues and the shortage of non-generalist (a.k.a dedicated) blood bankers in the field the Echo Lumena is like having a full time blood banker who can work 24/7 365 days a year with little down time. DESCRIPTION 1. REQUIREMENTS: a. Contractor shall provide 1 Lumena Echo Blood Bank System with specifications listed below. b. The system shall be capable of producing accurate and reproducible assays on biological samples with FDA approved methods for in vitro diagnostic methods. Model shall provide accurate test assay results up to the manufacturer s defined maximum test per hour without excessive malfunctions, breakdowns, or service calls. c. The model being purchased shall be in current production as of the date the purchase is made. Discontinued models will not be accepted. d. If there is a newer instrument released during the duration of the contract, VA facility should be given opportunity to replace existing instrument with the newer instrument on the same contract. e. The System shall be capable of performing the following: § ABO/Rh § Antibody Screen § Antibody Identification (panel with auto control) § DAT § Crossmatching Blood Units with Patient Samples § ABO and for Rh negative units Rh confirmation typing of donor units § Eluate panel f. The System shall use a combination of hemagglutination and Capture technology in the tests listed above. g. Instrumentation shall include: § Be capable of processing multiple runs simultaneously § Able to prioritize STAT testing § Manual back-up test system § Load many reaction media at one § Traceability of results § Able to load new specimen when instrument is running § Able to perform antibody screen, antigen typing and crossmatch with same sensitivity and specificity using automated and manual back up method. § Interface with the VistA Blood Establishment Software (VBECS) § Electronically connected with predictive service alerts § The analyzer shall have an internal barcode reader for reagents § The reagent barcode reader shall confirm and verify on-board reagents are within expiration dates prior to run § On-board, automatic scanning of patient sample barcodes and manual programming ability § All barcode scanning must support the ISBT128 formats § The system shall have reagent liquid level sensing and an indicator for short sample detection § The reagent low flag shall alert the operator prior to analysis. § The on-board storage shall provide traceability of all reagents/consumables. § Query reports showing patients, reagents/consumables lot numbers and expiration dates. § The system shall monitor and document incubator temperature of antibody screen per patient sample. § The system shall monitor and document lot numbers of each reagent used per patient sample. § Turnaround time for a Type & Screen shall be within 30 minutes. § The system shall have the software capabilities to allow for reflex testing or repeat testing as needed. Example of reflex testing would be: A positive antibody screen can be reflexed to an antibody panel. § The reagents used for ABO/Rh testing shall also be capable of being used with the manual tube testing method. § The vendor shall provide a daily quality control kit that is processed like real patient samples to verify the functionality of the instrument and all required reagents. § The instrument must be able to handle and aspirate directly from the standard 6.0mL K2 EDTA (13x100 mm) and the 4.0mL K2 EDTA (13x75 mm) tubes. § The system must have sample clot detection. § The vendor shall define daily/weekly/monthly maintenance and the time required for the technologist (actual hands on time) and analyzer to perform each maintenance task § The instrument must be furnished with an uninterruptible power supply, capable of a 2-3 hour,15-30 minute back-up. § The UPS to be provided with service/maintenance or replacement as needed per service contract. § The instrument computer screen must have color image analysis to aid in the visual interpretation of reactions. § The instrument must be capable of performing the College of American Pathologists (CAP) Transfusion Medicine Automated Test (JAT) survey directly from the proficiency testing tubes. § The system shall have a design that removes possibility of reagent or sample carryover. § g. Contractor shall: § Provide initial in-depth training for 2 personnel operating the system Provide on-site validation of the equipment. The number of samples required for method validation shall be determined by the Northport VA Medical Center § Define the actual hands on maintenance time required for daily, weekly, monthly, and as needed maintenance. Contractor is to include the analyzer time required to perform each maintenance task and list which tasks are user level and which tasks are service level. § Provide a comprehensive QC program which includes the following options: Ø QC files that cannot be edited or corrected for errors Ø Have on-board quality control data storage and reporting capabilities Ø Ability to alert operator of QC failures § Provide low cost service contract pricing after warranty period § Provide documented evidence confirming the system design removes the possibility of any reagent and sample carryover § Provide a printer. The service contract will include replacement, repair or upgrade if applicable. § provide remote support for the instrument using SSL technology to expedite service, troubleshooting and minimize downtime. The remote support shall only be initiated from the instrument computer via an instrument user request. § Provide instrument service sufficient to meet the needs of the using facility (engineer service support must be available within 24 hours of notification, Monday through Friday). All repairs on instrument must be complete within 24 hours from the time the serviceman arrives. § Provide the necessary Safety Data Sheets (SDSs) and a liquid waste determination based on facility supplied test volumes. § Provide operation manuals at installation in both hard copy and on-line. § Installation must include all evaluation/comparison data sufficient to satisfy CAP requirements. § The vendor must provide all cross-over supplies and reagents. § Remove all equipment within 90 days after notification of the expiration of the terms of the contract but not until the completion of new vendor s equipment installation inclusive of completed cross over studies. § The facility, per their protocol, will be responsible for the removal/erasing of the hard drive at analyzer removal/upgrade. If the Northport VA facility chooses to retain the hard drive, it will be at no additional cost to the VA. § Instruct personnel that they are subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST s Web site at: http://checklists.nist.gov § At installation of new equipment, vendor must provide the physical installation of the equipment. Installation shall include, at a minimum, uncrating and/or un-packaging of all equipment, hardware set-up and hook-up of the system, removal of trash, and documentation that the analyzer is functioning within the correct specifications. § Supply a technical support specialist(s) to assist in equipment installation/set-up, correlation studies (evaluation/comparison of data sufficient to satisfy CAP standards, CLSI and related documents, and Federal Regulations), staff training, in-services to laboratory personnel, methodology problems, and questions. Method Performance/Comparison shall include but is not limited to: accuracy, precision, specificity, sensitivity, and carryover studies on the analyzer. The vendor will state the hours the technical support specialist will be available for installation/set-up/validation studies/training, etc. Delivery: Equipment should be delivered to Building 36 Warehouse. VA Point of Contact: . Inventory List/Invoicing: The VA purchase order (PO) number shall be clearly noted on all invoices and inventory lists for accurate processing. The PO number will start with 632 followed by 5 digits beginning with an A . Ex: 632-AXXXXX.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/7924cd3fb6eb42b6a8a9c38658c1783b/view)
- Record
- SN06072531-F 20210727/210725230108 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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