Exhibit A FY26.Technical.Specs.AP.Stainer Final 11 July 25.pdf

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Solicitation Amendment H&E Stainer Lease and Reagents Cost Per Test (CPT)
Solicitation number
W81K00-25-Q-A148
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These are Technical Specifications for an Automated Histological H&E Staining System for Martin Army Community Hospital's pathology laboratory. The specifications require an FDA-approved analyzer with medium to high capacity (180+ slides/hour), capable of continuous/batch loading, online and offline drying, and barcode tracking. Key requirements include Windows 10 compatibility, interfaces with Cerner LIS and CoPath Plus, specimen tracking system integration, and compatibility with a water purification system. The system must apply reagents directly to individual slides, perform automated cover slipping, include online venting, and operate without hazardous xylene.

The vendor must provide comprehensive support including on-site technical assistance, installation, validation, training, 24-hour telephonic troubleshooting, and equipment repairs. Reagent requirements include FDA approval, 6-month minimum expiration dates, ready-to-use formulations, and proper temperature-controlled shipping. Additional technical requirements include obtaining DOD Risk Management Framework IT cybersecurity certification within 283 days of award, performing Hematoxylin and Eosin staining, and completing correlation/validation within 120 days of award. The system must fit within 62W x 35D x 80H space constraints and use a combination of wet and dry materials.

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Technical Specifications: Automated Histological H E Staining System PR 12287338

-Provide analyzers that are FDA approved, 100-240V, and use FDA approved software for FDA approved testing reagents.

-Provide medium to high capacity analyzer that can result at least 180 slides or higher per hour.

-Analyzer must have automated programming start, testing and shutdown capability.

-Analyzer should perform continuous loading and or batch loading.

-Analyzer should perform online drying and offline drying.

-Analyzer must have barcode reader and disk drive with read and write and USB port for loading and downloading data and on board operator's/ troubleshooting manuals.

-Ensure that if system requires a water purification/ filtration system it, installation, service, maintenance and supplies required throughout the period of performance to operate the filtration system is included.

-Must include installation of tubing or any other supplies required for water source or waste drain for operation.

-Analyzer Operating system must be compatible with Windows 10 or higher.

-Provides analyzer that interfaces with laboratory information system (LIS) Cerner and/ or anatomical pathology laboratory information system (APLIS) CoPath Plus.

-Provide analyzer that can interface with a specimen tracking system.

-Analyzer must provide capability for data and information storage and data management including maintenance.

-Provide on-site technical support and all reagents and supplies required for installation, validation/correlation of analyzers to bring to a fully operational status is included.

-Provide equipment repairs scheduled and unscheduled as well as preventive maintenance.

-Provide 24 hour telephonic troubleshooting.

-Respond to service calls within four hours or the morning of the next duty day if after 5:00pm

Monday-Friday and correct deficiencies within 24 hours after arrival on-site.

-Provide temporary analyzer until the original analyzer is repaired or permanently if the original analyzer can’t be repaired within 5 days.

-Provide alternate testing and/or validation for extended analyzer downtime/ failure.

-Provide on-site technical support for installation of analyzers to bring to and maintain at fully operational status including required reagents and supplies.

-Provide initial training at vendor’s facility for two personnel and on-site training as needed.

Technical Specifications: Automated Histological H E Staining System PR 12287338

-Ensure proper packaging of reagents, supplies, and equipment and that they are shipped at proper refrigerated or frozen temperatures according to manufacturer environmental specifications.

-Provide FDA approved reagents for use in clinical testing with expiration dates no less than 6 months of delivery date that function properly and pass lot to lot testing.

-Provide ready to use reagents that do not have to be prepared.

-Ensure all shipments arrive Monday through Friday between the hours of 8:00am and 3:00pm EST; excluding holidays and weekends.

-Respond to phone calls regarding shipment discrepancies the same day of notification and discrepancy will be corrected within 24 hours.

-Notify the laboratory if there is a recall on any reagents or equipment within 24 hours.

-Provide customer notification of updates on any reagents in writing within 5 business days and ensure continuity of services and availability of reagents during reagent revision when required.

--Provide all software and part upgrades at no additional cost.

-Must be able to start and obtain DOD Risk Management Framework (RMF) IT cybersecurity certification requirements for analyzer. NLT 283 days from date of award.

-Provide system that is combination of closed and open.

-Provide system that applies reagents/ stains directly to each individual specimen slide and can user programmable for staining protocols not a reagent bath.

-Provide system that performs rinsing and online automated glass cover slipping.

-Provide analyzer that does not require hazardous chemical xylene.

-Analyzer must include online venting for fumes and filters.

-Analyzer must be able to provide the following test menu: Hematoxylin and Eosin staining and coverslipping

Space constraints: 62 W X 35 D X 80 H

Wet/Dry: combination of wet and dry materials.

Correlation/Validation- Due NLT 120 days from award

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