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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 11, 2018 FBO #5952
DOCUMENT

66 -- IMMUNOHEMATOLOGY ANALYZER for Martinsburg VA Medical Center - Attachment

Notice Date

3/9/2018
 

Notice Type

Attachment
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;VAMC (613);VISN 5 Contract Satellite Office;510 Butler Avenue, Building 306A;Martinsburg WV 25405
 

ZIP Code

25405
 

Solicitation Number

36C24518Q0132
 

Response Due

3/14/2018
 

Archive Date

4/13/2018
 

Point of Contact

Rhett Bohling rhett.bohling@va.gov
 

Small Business Set-Aside

N/A
 

Description

Pathology & Laboratory Medicine Service VA Medical Center 510 Butler Avenue Martinsburg, WV 25405 sow 082616 Page 1 of 4 STATEMENT OF WORK IMMUNOHEMATOLOGY ANALYZER Introduction and Overview An automated blood bank analyzer is needed which performs the full range of immunohematology testing, including crossmatches, cell panels, antigen testing and serial dilutions for titration studies. The analyzer must automate blood bank test processes including liquid pipetting, reagent handling, incubation, centrifugation, reaction grading and interpretation. Scope of Work Delivery of ORTHO VISION for the purpose of automated pre-transfusion testing of patient and donor specimens. Full range of immunohematology testing must include the following test menu: ABO/RH Group Antibody Screen Antibody Identification Antigen Typing Cell Panels Crossmatch (AHG) DAT (IgG and Polyspecific) Eluates RH Phentotype Serial Dilutions for Titration Studies Performance Specifications System must use column agglutination technology Instrument must be capable of fully automated serial dilutions Testing system must not utilize proprietary system liquids Instrument must offer up to 24 hours walkaway time When operational, the instrument must always be in a ready mode and at no time go into a hibernation or sleep state Testing system must have capability for a minimum of three pre-diluted antibody identification panels FDA cleared for use in conjunction with the instrument Instrument must be able to run selected antibody identification panels Supplier s pre-diluted reagent red blood cells must utilize United States based donors. Reagent red blood cells and column agglutination technology cards must use United States based manufacturing Vendor must supply an analyzer capable of bench top installation Instrument system must have a pipette conditioning (e.g. dead) volume <20 µl Vendor must have a demonstrated ability to supply automated and non-automated FDA licensed reagents for blood bank or transfusion service testing under their own brand Fully loaded waste containers shall each not weigh more than 11 lbs. and be accessible at waste height Optical resolution of the on-board camera must be at least 5 megapixel resolution down to 32 x 32 microns, and store a digital image of both the front and back of each gel card to record test results System must have capability to interface to the laboratory information system (LIS) Performance Specifications with Detail System must use agglutination technology ORTHO VISION Analyzer utilizes IDMTS Gel, a column agglutination technology Instrument must be capable of fully automated serial dilutions 1) The ORTHO VISION ® Analyzer is an FDA cleared blood bank analyzer on the market that is capable of performing fully automated serial dilutions for titration studies with no manual dilution steps. Titration studies historically have been highly manual and laborious exercises prone to opportunity for error and tech to-tech variability. Fully automated serial dilutions allow for less hands-on time and less opportunity for human error. Serial dilutions are performed for disease monitoring, pregnancy, and transplant workups and ongoing evaluation. c. Testing system must not utilize proprietary system liquids The ORTHO VISION ® Analyzer uses readily available, non-proprietary, system liquids. The ORTHO VISION ® uses normal blood bank saline and distilled water both of which are standard BB items d. Instrument must offer up to 24 hours walkaway time The ORTHO VISION ® Analyzer is proven to have up to 24 hours of walkaway capability. Operator only has to interface with the system to load patient samples. The analyzer always has the capacity of reagents and waste storage on board to sustain for up to 24 hours of testing (and a minimum of 4 hours). e. When operational, the instrument must always be in a ready mode and at no time go into hibernation or sleep state The ORTHO VISION ® Analyzer does not need to be routinely interacted with when not in use to keep it ready for testing. It is always in a state in which testing can begin without a warm up period. f. Testing system must have capability for a minimum of three pre-diluted antibody identification panels The ORTHO VISION ® Analyzer is the only column agglutination system to offer three fully pre-diluted, ready to run, and FDA cleared reagent red cells panels for automated antibody identifications; Associated ORTHO Reagent 0.8% Red Blood Cells Panels A, B and C. g. Instrument must be able to run selected antibody identification panels 1) The ORTHO VISION ® can run selected cell antibody identification panels and run a true auto control h. Supplier s pre-diluted reagent red blood cells must utilize United States based donors. Reagent red blood cells and column agglutination technology cards must use United States based manufacturing All ORTHO ID-MTS Gel cards and pre-diluted Reagent Red Blood Cells are MADE IN THE USA in Raritan, NJ and Pompano Beach, FL. Additionally, all ORTHO pre-diluted reagent red blood cells are sourced from donors based in the United Stated. Vendor must supply an analyzer capable of bench top installation The ORTHO VISION ® Analyzer is a bench top analyzer and can be used either on an existing lab bench top or with the optional instrument cart. j. Instrument system must have a pipette conditioning (e.g. dead) volume <20 µl 1) The ORTHO VISION ® Analyzer has < 20 µl dead volume for the pipette probe. This translates into reagent savings (less dead volume = less waste). k. Vendor must have a demonstrated ability to supply automated and non-automated FDA licensed reagents for blood bank or transfusion service testing under their own brand 1) ORTHO supplies automated and traditional reagents as a one stop shop under the Ortho Clinical Diagnostics brand name. Fully loaded waste containers shall each not weigh more than 11 lbs. and be accessible at waste height Minimizing the handling of heavy waste containers should always be an ergonomic and operator safety consideration. All fluid containers, as measured when they are full, on the ORTHO VISION ® Analyzer weigh less than 11lbs and are located at waist level to ease ergonomic concerns. m. Optical resolution of the on-board camera must be at least 5 megapixel resolutions down to 32 x 32 microns, and store a digital image of both the front and back of each gel card to record test results 1) The digital camera for ORTHO VISION ® Analyzer has a Full color resolution of 5 megapixels down to 32 x 32 microns and stores all images digitally for ease of reference and operator interpretation of test results. The ORTHO VISION ® Analyzer also takes pictures of both sides of the ID-MTS Gel card Deliverables ORTHO VISION ® Analyzer Six sample racks included with analyzer One off-site training slot and training sessions for staff on-site Tasks Deliver to Martinsburg VA Medical Center, Blood Bank Department, Building 500, 510 Butler Avenue, Martinsburg, WV, 25405. Assembly and validation of performance within 30 days. Training of staff. Schedules/Milestones Delivery within 30 days of purchase. Validation of performance within 30 days of delivery.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/MaVAMC613/MaVAMC613/36C24518Q0132/listing.html)
 

Document(s)

Attachment
 

File Name: 36C24518Q0132 36C24518Q0132.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4138464&FileName=36C24518Q0132-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4138464&FileName=36C24518Q0132-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Martinsburg VA Medical Center;Blood Bank Department;Building 500, 510 Butler Avenue;Martinsburg, WV

Zip Code: 25405
 

Record

SN04850186-W 20180311/180309231551-49412c7b9a49d1b5893a5a7f4f4a2159 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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