Attach 01-SON.docx

Statement of Need for Tissue-Tek VIP 6 AI Tissue Processor at

Philadelphia VA Medical Center-P&LMS 3900 Woodland Ave.

Philadelphia, PA 19104-4551

1. Background

1.1. Pathology & Laboratory Medicine Service (P&LMS) requires two (2) Tissue-Tek VIP 6 AI Tissue Processors to be used in the processing of patient tissue specimens for diagnosis. This is required to prepare the patient tissue for sectioning after dissection (grossing) is performed. The tissue processor we are currently using as a primary instrument was acquired in 2003 and 2005 and is used daily without exception.

2. Scope

2.1. P&LMS wishes to obtain a one-time task order to procure the needed equipment.

3. Objectives

3.1. The equipment shall perform according to specifications.

4. Tasks

4.1. To meet the needs of P&LMS

4.1.1.1. Approved for clinical use.

4.1.1.2. Must be able to accommodate a variety of large tissue specimens and biopsy tissues without compromising quality and integrity of the patient tissue specimens.

4.1.1.3. The processor must be able to be used as both a rapid and conventional and processor simultaneously and without microwave assistance.

4.1.1.4. Must have the minimum capacity of no less than 100 cassettes per retort. Must also offer no restrictions or limitations with grossing requirements.

4.1.1.5. Must have the flexibility to be used with Xylene and as a Xylene free processor. The equipment also must be able to use with conventional reagents or proprietary reagents and/or recycled Xylene and Alcohols.

4.1.1.6. Must have a reliable and proven “reagent management system” for maintenance and reagent rotation.

4.1.1.7. Installation and set-up of the instrument.

4.1.1.8. Provide all accessories required for to completely function processors to include UPSs’.

4.1.1.9. Provide reagents required for the initial set up validation/optimization of the instruments

4.1.2. Requirement

4.1.2.1. Salient Characteristics

4.1.2.1.1. 10 mixing modes: Effective yet gentle reagent agitation for excellent reagent penetration

4.1.2.1.2. 2 bulk reservoirs: Convenient additional storage of fresh reagent with each holding up to 10.4 liters

4.1.2.1.3. Automatic onboard mixing of reagents: Mixed reagent solutions enhance dehydration and defatting without extending protocols times, and automatically mixing specified reagents from the 2 bulk reservoirs onboard to create the mixed reagent solutions saves time and reduces opportunities for human error

4.1.2.1.4. Solution Manager: Monitors reagent levels during operation and provides fresh reagent from the 2 bulk reagent reservoirs if needed for safe and worry-free processing

4.1.2.1.5. Automatic solution transfer: Enables in-process transfer of up to two reagents and the paraffin to significantly reduce maintenance, saving both time and money

4.1.2.1.6. Paraffin waste container: Makes the exchange and proper disposal of used paraffin safe, clean, and easy

4.1.2.1.7. Automatic bottle check: Verifies that all bottles are properly connected BEFORE a run starts to prevent errors before they happen

4.1.2.1.8. Tissue-Tek/iSupport: The secure remote service ensures maximum uptime through fast reaction to instrument alerts by Sakura Finetek's professional technical support team

4.1.2.1.9. Fume control system: Advanced filtering combines a fume condenser system and 2 disposable activated carbon filters to eliminate noxious fumes

4.1.2.1.10. Automatic paraffin degassing: Aspirates evaporated clearing agent from the paraffin oven, keeping the paraffin clean while filtering harmful fumes

4.1.2.1.11. Newly designed reagent manifold: Includes new fluid sensors offering an improved solution detecting function that helps safeguard against unexpected user errors

4.1.2.1.12. Color-coded drain & fill ports: Simplifies the safe exchange of reagents onto the instrument

4.1.2.1.13. Ergonomic retort latch with electronic interlock: Seal, lock and protect the retort from being opened during operation simply and operable one-handed

4.1.2.1.14. Heated retort lid: Eliminates retort condensation

4.1.2.1.15. Heated cleaning reagent station: Provides excellent deparaffinization and cleaning of the retort between processes

4.1.2.1.16. High-resolution color touch screen: Easy to see, operate, and monitor the instrument

4.1.2.1.17. LED-lit reagent cabinet: Allows for quick visual observation of reagent levels

4.1.2.1.18. Up to 50 user-defined programs: Offers plenty of versatility to created the processing program that is best suited for the needs of the laboratory

4.1.2.1.19. 3 user-defined cleaning cycles: Provides effective cleaning options for different workflows

4.1.2.1.20. 150- or 300-cassette capacity configurations: Flexible options for both small or large runs for efficient use of reagents

4.1.2.1.21. Two level options for password protection: Complete instrument and information security with admin control over what screens or features are accessible to users

4.1.2.1.22. Optional xylene-free processing: Allows for the use of less hazardous reagent alternatives

4.1.2.2. Specifications

4.1.2.2.1. Power requirement-Single phase, 115 VAC ± 10%, 50/60 Hz, 12 A

4.1.2.2.2. Dimensions:

4.1.2.2.2.1. 24 (W) x 27 (D) x 52 (H) inches 61 (W) x 68 (D) x 133 (H) cm

4.1.2.2.3. Weight: 386 lbs. (175 kg) (without accessories and reagents)

4.1.2.2.4. Capacity: Up to 300 cassettes

4.1.2.2.5. Reagent reservoirs: 13 bottles: up to 4.2 liters (Including cleaning and condensation)

4.1.2.2.6. Paraffin reservoirs:

4.1.2.2.6.1. 3 small: up to 4.2 liters 1 large: up to 5.6 liters

4.1.2.2.9. Level sensors: 4, ultrasonic

4.1.2.2.10. Display:10.4 in., color LCD, touch screen

4.1.2.2.11. External interface:

4.1.2.2.11.1. USB 1.1 connector (only compatible with type of USB supplied) External alarm output terminal UPS signal input terminals (power outage and low battery) LAN terminal

4.1.2.2.12. Certifications: Complies with

4.1.2.2.12.1. IEC 61010-2-010:2014

IEC 61010-2-101:2015

CAN/CSA C22.2 No.61010-1 2nd Ed:2008 CAN/CSA C22.2 No.61010-2-010:2004 CAN/CSA C22.2 No.61010-2-101:2004 UL 61010-1 3rd Ed: 2012

4.1.2.2.13. Regulatory status: IVD, FDA Class I

4.1.2.3. Table

4.2. The vendor must provide training both on site and in their facility for 2 personnel. Assistance with validation/optimization and training of additional persons on site must also be provided during installation of the equipment with no cost to the Medical Center.

5. Delivery

5.1. The equipment must be delivered to the Philadelphia VA Medical Center no later than September 30, 2021.

6. Government Furnished Property

6.1. N/A

7. Security Requirements

7.1. There are no IT security requirements.

8. Place of Performance

8.1. Department of Veterans Affairs

Philadelphia VAMC-P&LMS 3900 Woodland Ave.

Philadelphia, PA 19104-4551

9. Period of Performance

9.1. 30 DAYS ARO