P01-Statement of Need new tissue processor-Final 02.docx

STATEMENT OF NEED

Pathology and Lab tissue processor VA Pittsburgh Healthcare System

1. Background:

VA Pittsburgh Healthcare Systems requires a tissue processor. The Pathology Department uses tissue processors for preparation of tissue samples for microscopic examinations in histology and pathology laboratories. Tissue processors automate the process of tissue fixation, dehydration, clearing, and impregnation with paraffin wax, providing high-quality tissue sections for staining and analysis.

History of the Requirement: Currently, the facility has one tissue processor which is outdated due to fair wear and tear issues such as hydraulic leaks, worn seals, deteriorated bearings, deteriorated races, worn fittings and stripped wiring.

The impact to the VA Pittsburgh Medical Center, if the machine is not replaced, the lab personnel will have to further scrutinize analysis due to the possibility of inaccuracies. Therefore, the only option to avoid these potential issues, is to replace the current near end of life service platform.

Summary of the Requirement: The purchase of the tissue processor will automate the process of tissue fixation, dehydration, clearing, and impregnation with paraffin wax, providing high-quality tissue sections for staining and analysis.

2. Detailed description of requirement Purchase of the following product:

Pathology Laboratory Tissue processor

Salient Characteristics - Minimum requirements to be considered.

Specific criteria the tissue processor must meet:

· Weigh no more than 363 lbs. empty and no more than 551 lbs. when full (reagents loaded).

· Must have measurements Not To Exceed: 23” length x 28” width x 54” height.

· Power requirements of 100-240 Vac; 50/60 Hz; 1300 VA (max.), 300 VA (typical).

· Monitors status and gives clear visual and audible alarms or warnings in case of problems and provides specimen safety measures.

· Automatic reagent rotation inside the circular chamber.

· Reagents can be pre-heated to up to 35 degrees Celsius to minimize tissue shock and facilitate reagent penetration.

· Alcohol quality measurement using specific gravity of the first alcohol during every run, that enables extension of reagent life.

· Touch screen user interface with intuitive software.

· Downdraft ventilation, with a fan that starts automatically, that reduces user exposure to harmful vapors and through a filter that neutralizes formaldehyde.

· Reaction chamber with three fill levels that allows reduced processing times.

· Tissue processing reagents that are available in 5-liter bottles.

· Easy access wax tank and unique waste wax discard solution.

· Automatic paraffin rotation system discards waste paraffin in a disposable container during processing for easy disposal and enhanced user safety.

· Must be able to order additional baskets and cleaning accessories, external fume extraction adapter kits, filters, and reagent bottles and paraffin kits, if needed.

· Must include installation, assembly, delivery charges, and training needed.

3. Incidental Services:

Contractor installation required and basic training to a superuser designated by the VA Chief of Pathology and Laboratory.

Deliver materials to job in manufacturer's original sealed packaging with brand name marked thereon.

Packaged to prevent damage or deterioration during shipment, handling, storage and installation. Maintain protective covering in place and in good repair until removal is necessary.

Delivery and Installation will be coordinated through the COR.

4. Delivery Instructions:

Pittsburgh VA Medical CTR-University drive, University Drive C Pittsburgh, PA 15240-1003

Facility POC information provide upon award.

Vendor will contact facility POC to coordinate delivery and installation.

5. Training:

Contractor installation required and basic training to a superuser designated by the VA Chief of Pathology and Laboratory.

6. Facility Access:

Vendor will take all instruction from facility POC.

SYMPLR LANGUAGE FOR VA PITTSBURGH HEALTHCARE SYSTEM

(If vendor must be on-site to perform installation, training, etc.)

Vendor Credentialing

Vendor access to the VAPHS is by appointment only and requires credentialing through our vendor credentialing partner, Symplr at https://vcsdatabase.com/login Symplr registration is at cost to the vendor only and VAPHS is not responsible for this.

All on-site contractor representatives agree to follow VA Pittsburgh Policy LD-073 medical center policy (MCP) Vendor Access. This includes all on-site contractor representatives shall be ‘greenlighted’ in VA Pittsburgh’s Vendor Credentialing System Symplr which includes an up-to-date flu vaccination, Tb test, Covid-19 vaccine, and HIPPA certification at a minimum. The government shall not provide any additional compensation for cost to register any subcontractor staff in Symplr. Vendor shall follow most updated guidelines from the Occupational Safety & Health Administration (OSHA), Center for Disease Control (CDC), and Food & Drug Administration (FDA).

All vendors are required to check-in at the Symplr kiosk using their smart phone (University Drive) or desktop check-in with Symplr login (HJH) and obtain a day badge, which will include date, time, and location of approved appointment. Company badge with photo ID is also required to be worn while onsite at any of the VAPHS sites. Vendors are only permitted to visit the location identified on their Symplr generated badge and must exit the facility promptly, checking out via their smart phone once the scheduled appointment has ended.