Attachment B.docx

Attachment B Brand Name or Equal Description/Requirements:

The below items are for use in Microbiology. See Attachment A for associated annual volumes required by the facility.

Salient characteristics –

1. Must be FDA Approved for IVD use.

2. Reagents must be compatible with systems already in use.

3. Reagents are used for the identification of organisms in patient samples.

4. Control strains of organisms are recommended by automated system manufacturers, Clinical Laboratory Standards Institute, other reagent manufacturers.

5. Consumables are recommended by manufacturers of instruments that they are used with.

The below items are for use in blood bank testing. See Attachment A for associated annual volumes required by the facility.

1. Buffered saline is used in all aspects of blood bank tube and automated testing. Buffered saline maintains Ph balance and prevents lysis of red cells during testing, washing, preparations, etc.

2. 0.1 Normal sodium hydroxide is required for instrument maintenance on the Ortho VISION automated analyzer.

The below items are for use in Hematology. See Attachment A for associated annual volumes required by the facility.

1. #177 VT87139 Kova Caps, for use in combination with line item number 181, Kova tubes.

2. #178 11-996 S/P lens paper is required to manually clean microscope lenses.

3. #179 22600100 Incyto C-Chip Hemocytometer Neubauer are disposable devices validated for manually counting cells in a body fluid. They are not associated with any equipment. Substitution not acceptable.

4. #180 BTP4015 Medix Thrombotic is a manual back up method for counting platelets in peripheral blood. Not associated with any equipment.

5. #181 BLT4013 Test kit WBC count Leuko Tic is a manual backup method for counting WBC in peripheral blood and body fluids. It is not associated with any equipment.

6. #182 K717M-5 Linearity set D-Dimer, is for checking D-dimer linearity on the coagulation analyzer (Stago) although it is not analyzer specific.

7. #183 667035 is for cleaning purposes and not specific for any analyzer or testing system. It is a liquid barrier 4x4 wipe.

8. #184 10323320 Tubing underplaten is specific to our backup slide stainer and must physically fit the Siemens Hematek slide stainer EE93720. Substitution not acceptable.

9. #185 10312656 Pump tubing set for Hema-tek is specific to our back up stainer and must physically fit the Siemens Hematek slide stainer EE93720. Substitution not acceptable.

10. #186 10316256 Cannula set for Hematek is specific to our back up stainer and must physically fit the Siemens Hematek slide stainer EE93720. Substitution not acceptable.

11. #187 Cyto Filter paper, one time use filter paper that must physically fit the Sakura Cyto-tek funnels. Substitution not acceptable.

12. #188 02-707-467 Maxi pipet tips fits our large volume pipet for body fluid dilutions.

13. #189 23176172 Coagulation Reference plasma for use in Coagulation mixing studies on the Stago although not analyzer specific.

14. #190 NC0343944 Qwik check qc beads are for quality control for manual semen analysis. Not associated with any equipment.

15. #243 240360 Streck 1.2 ml vacuum tubes are a manual method and specific for our backup ESR method. It has been validated and correlated to our primary method the iSED automated method. Two boxes used per year. Substitution not acceptable.

16. #244 22-250-937 Typenex Smear Safe Blood Dispenser, For preparation of manual peripheral blood slides. Allows the user to dispense a single drop of blood from a draw tube to be spread on the slide. Two boxes used per year.

17. #245 M6006-16 Oil immersion Track 300 is for use with the Cellavision and is a specific requirement for the Cellavision microscopy system and cannot be substituted. Two bottles used per year. Substitution not acceptable.

The Brand Name for the below reagents is Zeptometrix/Antylia Scientific. See Attachment A for associated annual volumes required by the facility.

1. Supplies must be compatible with all features and not void the warranty of VA’s existing cleared IVD analyzer or its testing components.

2. Quality control must physically fit and be compatible with the VA-owned systems without alteration.

3. Must be FDA Approved for IVD use.

4. Controls must be able to test DNA for Chlamydia, Influenza A & B, and Neisseria gonorrhoeae

The below items are used with our ThermoFisher Scientific Clearvue Automated Coverslipper to coverslip stainer Histology microscope slides, per manufacturer requirements.

1. The items must be compatible with current, validated instrument SOP.

The below items are used in the automated internal decontamination system of our ThermoFisher Scientific Cryostar NX50 Cryostats, per manufacturer requirements.

The below items are used in countertop Fume Hoods, per manufacturer requirements.

The below items are used for fixation of patient tissue specimens and testing of fluids used for fixation.

The below items are used in the performance of intra-operative frozen section procedures.

The below items are used by Pathology Residents during gross examination of patient tissue specimens.

The below items are used by Pathologists and Cytotechnologists during microscopic examination of patient pathology slides.

1. Permanent marking/dotting pen – alcohol resistant.

The below items are used with Histology’s Cole & Parmer Accumet Basic AB15 ph Meter, per manufacturer’s requirements.

The below item is used with Histology’s Leica Peloris II Tissue Processor for testing of reagent concentrations, per instrument manufacturer requirements.

The below item is used with Histology’s Leica Peloris II Tissue Processor, Sakura Tissue-Tek VIP5 Tissue Processor, and Sakura Tissue Tek Embedding Stations to monitor accuracy of the temperature maintained in the heated paraffin stations, per instrument manufacturer requirements.

The below item is used on lab work surfaces to absorb spilled liquids and protect the work surface.

1. Waterproof polyethylene backing

The below item is used for shipping temperature sensitive items such as Histology paraffin blocks to other locations.

The below items are used in slide staining and tissue processing procedures.

1. Ethyl Alcohol, Pure Ethanol, and 80% Dehydrant are specified in Pathology validated staining and tissue processing procedures. These items must be compatible with current, validated equipment SOPs.

2. Bluing Reagent and Clarifier 2 are specified in Pathology validated staining and tissue processing procedures. These items must be compatible with current, validated equipment SOPs.