Pathology Special Stainer SOW Amend 003.doc

Statement of Work Department of Veterans Affairs

James Mountain Inhofe VA Medical Center

Background Information

Special stains in pathology are used to highlight specific components within tissue sections that are not easily distinguishable with routine staining methods, such as Hematoxylin and Eosin (H&E). These stains employ various chemical reactions to bind selectively to a particular cellular or extracellular component, allowing pathologists to identify and analyze specific structures, elements, and microorganisms present in tissue samples. Automation of special staining provides a higher level of quality control/consistency in stain quality than manual methods using pour off reagents and manual timers which make it time and labor intensive. Space constraints are a limiting factor, and the automated special stains instrument will allow for multiple tests to be run simultaneously without occupying large areas of countertop space. Pathology is requesting a cost per kit (CPK) equipment reagent rental agreement for automated special stains instrument to enable faster and more consistent analysis of tissue samples to be installed at James Mountain Inhofe VA Medical Center (JMIVAMC).

A. Scope:

Operational features:

1. Function as a stand-alone automated instrument for staining of anatomic pathology fixed tissue slides.

2. Must be fully automated capability of baking, deparaffinization, and staining of special stains

3. Must be capable of holding between 1-20 slides per slide carousel

4. Must be capable of independent temperature control for each position and regulate between 37°C–75°C (98°F–167°F)

5. Must have minimum 25 reagent positions

6. Must be capable of staining slides sizes: 25 mm x 75 mm, 26 mm x 76 mm

7. Bulk fluids: Up to four bulk fluids in 3–6 L onboard containers

8. Must be CSA, EMC and CE compliant

9. Due to space constraints, allowable instrument dimensions (WxDxH) are approximately: 20in W x 25in D x 53.3in H (50.8 cm x 63 cm x 135.4 cm)

10. Instrument must be able to process following special stains:

a. AFB

b. Alcian Blue

c. Congo Red

d. Elastic

e. Giemsa

f. GMS

g. Gram

h. Iron

i. Mucicarmine

j. PAS

k. Reticulum

l. Trichrome Blue

m. Pap Stain (Optional)

n. Stiener II

o. Jones H&E B. Applicable Documents:

ISO documents.

C. Contractor Requirements: The contractor will provide all equipment, parts, service, and maintenance necessary for cost per kit reagent/instrument rental operation of the equipment and shall pay routine shipping fees for such. This includes required provision of workstations and hard drives, replacement, shipping and service on workstations and hard drives. Maintenance/service is also required to allow operation and appropriate validation in the new hospital, JMIVAMC.

D. Instrumentation and manuals:

1. Required hardware and software upgrades, as well as necessary training, shall be provided at no additional expense.

2. The contractor shall provide on-site support to assist with performance of validation studies. Vendor shall perform all required statistical analyses and report data in an organized, clearly comprehensible format. The contractor shall ensure that installation of equipment, validation studies and all other tasks that are necessary for implementation of this agreement are completed prior to July 1, 2026.

3. Vendors shall provide a list or otherwise specify all maintenance requirements/tasks to be performed by the analyzer operator(s) as well as the service engineers.

4. Vendors shall provide commercial literature, other information describing compliance with technical specifications, and all customer references from successful installations over the past year.

E. Technical support services: Technical support services shall be provided at no additional charge. Technical support by telephone shall be available 24 hours a day, 7 days per week. On-site technical support shall be available 8:00 a.m. – 5:00 p.m. central time, Monday through Friday, excluding Federal holidays. Technical support shall return all downtime calls within one hour. Should on-site service be required, the contractor’s field service organization shall provide on-site service response within 24 hours after being contacted. The repair person shall also, prior to departure, provide the visited site with written documentation of services performed. The contractor shall provide, at no charge, all labor, travel, and parts necessary to make repairs. Repair service is expected to be provided 8:00 a.m. – 5:00 p.m. central time, Monday through Friday, excluding Federal holidays.

F. Operator Training: Contractor shall provide operator training for up to two (2) persons per analyzer the first year at no additional cost. Contractor shall provide all tuition, training materials, airfare, lodging, and meals. Additional on-site training shall be provided as needed at no additional costs as per Contractor’s training schedule.

G. Value-added Items: All value-added items provided by the Contractor shall be the property of Eastern Oklahoma VAHCS and will not be returned at the end of the agreement unless Eastern Oklahoma VAHCS ends the agreement prior to five-year ordering period. Contractor shall provide the following value-added items at no additional costs:

1. Uninterruptible Power Supply (UPS) for each system. Systems shall be installed and maintained by the contractor. Preventive maintenance shall be performed in accordance with manufacturer’s recommended guidelines. Batteries should be replaced prior to expiration date provided by the manufacturer.

2. All ancillary equipment/furniture needed to support instrumentation, including desktop workstations, monitors, keyboards, and other computer accessories.

H. Computer Hard Drives: Per Eastern Oklahoma VAHCS Information Security Policies, no hard drives or computer disks containing VA patient information will be removed from VA facilities. At the time of turn-in or removal due to failure, the VA facility will remove all sensitive data from information systems storage devices or render the data from these systems unreadable. No Federal Information Processing equipment will be discontinued from rental/lease or exchange without compliance with this requirement. No charge will be incurred by Eastern Oklahoma VAHCS for any hard drive that is removed from the instrument.

I. Government Requirements: N/A J. Deliverables:

James Mountain Inhofe Veterans Affairs Medical Center (JMIVAMC)

440 S Houston Avenue, Tulsa, OK, 74127

We request that the equipment be installed and operational by July 1, 2026.

(End of Statement of Work)