Histology Automated H&E, IHC, and Special Staining System
This is a Sources Sought Notice, THIS IS NOT A SOLICITATION. The Government seeks a vendor that can provide one (1) Automated H&E staining system capable of providing continuous loading of up to 500 s... This is a Sources Sought Notice, THIS IS NOT A SOLICITATION. The Government seeks a vendor that can provide one (1) Automated H&E staining system capable of providing continuous loading of up to 500 slides at a time with a throughput of 16-200 slides per hour, and a slide tracking system supporting multiple barcode formats. Shall be able to simultaneous process multiple slide trays including drying, de- paraffinization, staining, and coverslipping. Shall be capable of random access slide processing with STAT availability at any point in the process. Shall be capable of simultaneous processing of multiple protocols. All solutions shall be sealed, pre-packaged, pre-diluted and monitored via RFID for inventory management. Fresh solution shall be used for each slide, and the system shall allow for solutions to be changed without shutting down or stopping. System shall be xylene and alcohol free and not be required to be hooked up to any water systems. System shall offer automated remote support that does require access to TAMC’s network. The H&E staining system shall include, 1 UPS Backup system, 2 operator manuals, on-site Technical Service Specialist assistance (instrument setup and method validation), 1 system training including travel, tuition, room and board. The H&E staining system shall be FDA approved to use the kits to be included in this reagent rental agreement contract. The contractor shall provide all trained personnel, labor, travel, tools, diagnostic equipment, software, hardware, firmware, test phantoms, materials, supplies, repair parts, and test equipment not government furnished, necessary to keep the unit operational to manufacturer’s specifications, five (5) days per week excluding federal holidays. The contractor shall provide troubleshooting assistance via email or on-site as determined by the Government representative, and replacement parts by mail as requested. The contractor shall provide and install hardware and software updates. The contractor shall provide new or updates for user manuals when changes are made. New and refurbished parts shall be certified and documented to meet OEM (Original Equipment Manufacturers) specifications. All equipment shall be in compliance with the Joint Commission (JC) standards, HIPAA and the NFPA 99 Standard for Health Care Facilities. The contractor will furnish and install all manufacturer mandatory modifications and apply recalls by FDA. The contractor shall provide a minimum of two (2) preventive maintenance services per year to include lubrications, cleaning (other than operators), calibrations, parts replacement, and unlimited repairs. The contractor shall provide one (1) Immunohistochemical (IHC) Automated Slide Preparation and Staining System. The system shall be capable of automated baking, deparaffinization, cell condition and staining for IHC. The IHC staining system shall have a slide carousel holding 1-30 slides with independent processing/functionality and temperature control for each position and reagent carousel with at least 35 reagent positions. System shall offer random access allowing samples to be added at any time without the need to batch. The system shall accept slides 25x75 mm, 1x 3 inches, or 26x76 mm. System shall be capable of holding up to 7 different bulk reagents in 3 to 6 liter on-board containers. System shall be xylene-free and not be required to be hooked up to any water systems. System shall offer automated remote support that does require access to TAMC’s network. The IHC staining system shall include, 2 operator manuals, on-site Technical Service Specialist assistance (instrument setup and method validation), 1 system training including travel, tuition, room and board. The IHC Staining System shall be FDA approved to use the kits to be included in this reagent rental agreement contract. The contractor shall provide all trained personnel, labor, travel, tools, diagnostic equipment, software, hardware, firmware, test phantoms, materials, supplies, repair parts, and test equipment not government furnished, necessary to keep the unit operational to manufacturer’s specifications, five (5) days per week excluding federal holidays. The contractor shall provide troubleshooting assistance via email or on-site as determined by the Government representative, and replacement parts by mail as requested. The contractor shall provide and install hardware and software updates. The contractor shall provide new or updates for user manuals when changes are made. New and refurbished parts shall be certified and documented to meet OEM (Original Equipment Manufacturers) specifications. All equipment shall be in compliance with the Joint Commission (JC) standards, HIPAA and the NFPA 99 Standard for Health Care Facilities. The contractor will furnish and install all manufacturer mandatory modifications and apply recalls by FDA. The contractor shall provide a minimum of two (2) preventive maintenance services per year to include lubrications, cleaning (other than operators), calibrations, parts replacement, and unlimited repairs. The IHC staining system shall have FDA approved vendor supplied kits for the following (no analyte specific reagent); P16 AE1/AE3 (Pan-Keratin) CD3 Synaptophysin P63 Melan-A CD117 CK34BE12 CD20 CD34 Chromogranin H. Pylori TTF-1 E-Cadherin Contract will include all kits and ancillary reagents required to perform the above IHC stains. If a change in one of the above IHC’s requires additional or different ancillary reagent, this reagent will be added as an administrative mod to the contract with no additional cost. The contractor shall provide one (1) Automated Special Staining System. The system shall be fully automated to include baking, deparafinization and staining of special stains, it shall have slide carousel capable of 1-20 slides with independent temperature control for each position and a reagent carousel capable of at least 25 positions. The system shall hold up to 4 bulk fluids in 3 to 6 liter on-board containers. System shall be xylene-free and not be required to be hooked up to any water systems. System shall offer automated remote support that does require access to TAMC’s network. The Automated Special Staining System shall include, 2 operator manuals, on-site Technical Service Specialist assistance (instrument setup and method validation), 1 system training including travel, tuition, room and board. The Automated Special Staining System shall be FDA approved to use the kits to be included in this reagent rental agreement contract. The contractor shall provide all trained personnel, labor, travel, tools, diagnostic equipment, software, hardware, firmware, test phantoms, materials, supplies, repair parts, and test equipment not government furnished, necessary to keep the unit operational to manufacturer’s specifications, five (5) days per week excluding federal holidays. The contractor shall provide troubleshooting assistance via email or on-site as determined by the Government representative, and replacement parts by mail as requested. The contractor shall provide and install hardware and software updates. The contractor shall provide new or updates for user manuals when changes are made. New and refurbished parts shall be certified and documented to meet OEM (Original Equipment Manufacturers) specifications. All equipment shall be in compliance with the Joint Commission (JC) standards, HIPAA and the NFPA 99 Standard for Health Care Facilities. The contractor will furnish and install all manufacturer mandatory modifications and apply recalls by FDA. The contractor shall provide a minimum of two (2) preventive maintenance services per year to include lubrications, cleaning (other than operators), calibrations, parts replacement, and unlimited repairs. The Special Stains staining system shall have FDA approved vendor supplied kits for the following (no analyte specific reagent): AFB Alcian Blue PAS with and without diastase Elastic Giemsa GMS II Iron Mucicarmine Trichrome Reticulin Amyloid Contract will include all kits and ancillary reagents required to perform the above special stains. If a change in one of the above stains requires additional or different ancillary reagent, this reagent will be added as an administrative mod to the contract with no additional cost. The IHC and Special Staining System shall be able to operate off of one computer. All 3 systems shall be supported and serviced by one division of one company. Temperature dependent reagents (reagents required to be kept at 8°C or colder) will be shipped in insulated containers with appropriate gel packs or dry ice (for frozen reagents). Uptime is defined as the time during which a piece of equipment is functioning or able to function. The contract shall provide both scheduled (PMCS) and unscheduled services to repair and/or maintain the equipment listed above, and components if any, to a fully functional condition with a ninety-eight (98%) uptime guarantee (calculated on a quarterly basis). PMCS will be conducted no less than once every 12 months on each piece of equipment unless the Manufacturer’s Service Manual states this should be done more often. PMCS may be requested sooner than 12 months if problems are encountered. Once a PMCS is requested, it shall be scheduled and performed within 30 days. Service will be available M-F 24 hours per day to allow for PMCS to be conducted during section downtime. Interested parties shall reply to Regional Health Contracting Office - Pacific VIA EMAIL to tae.h.kim76.civ@mail.mil. TELEPHONE REQUESTS WILL NOT BE HONORED. Please indicate your interest and ability to provide the requested items by providing a current copy of your price list and capabilities statement NO LATER THAN 4 June 2021, 10:00 AM Hawaii Standard Time.
Data sourced from SAM.gov.
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