Attachment_1_Salient_Characteristics_IHC_STAINER.docx

(Attachment 1)

MADIGAN ARMY MEDICAL CENTER

DEPARTMENT OF PATHOLOGY

TACOMA, WA 98431-1100

Salient Characteristics Immunohistochemistry (IHC) Automated Slide Stainer Instrument

1. Instrument must be able to add individual samples/slides continually throughout operation eliminating the requirement to batch samples based on specific antibody stains. Slides, reagents, and self-contained waste system can be simultaneously accessed as the system is processing samples.

2. Instrument shall process at least 100 slides per eight-hour shift.

3. At a minimum, instrument shall be able to stain/process an array of antibodies listed in Attachment 2 Appendix A.

4. Stained slides may remain on the instrument upon completion and do not require immediate removal or restricted run hours based on availability of personnel.

5. Instrument must be able to run testing protocols involving companion diagnostics and ISH.

6. Instrument must be a fully automated system capable of performing baking, deparaffinaization, cell condition, and staining based on the label that is created and affixed to the slide.

7. Instrument must be able to perform IHC, ISH, SISH, immunofluorescence, multiparameter IHC staining (dual, triple), counter stain and titration.

8. Instrument must be able to run paraffin embedded slides, non-paraffin embedded slides, slides using different type 1 cell conditioning and/or type 2 cell conditioning with and without enzyme digestion and enzyme digestion by itself.

9. System must have the ability to use detection that is not polymer and does use AB blocker.

10. System must have a self-contained waste system.

11. System shall utilize flash memory technology and barcodes on dispensers or other similar system to track reagents and for quality control and quality assurance.

12. System should be versatile with the ability to reconfigure modules and scalable to allow for volume increase in throughput.

13. Minimal instrument electrical requirements include: Voltage ~100-230 V; Continuous Amperage 4-6 Amps; Frequency 50/60 Hz.

14. Vendor shall have up to 85% of Madigan’s antibody staining menu in pre-diluted form.

15. Total automation system (two instruments – floor models) shall fit along one wall in an area of 108 in x 48 in x 72 in (Size = W x D x H).

16. Instrument shall provide the ability for technicians to walk away with no additional steps once the staining run is started until complete.

17. Instrument must be an open platform and capable of using third party antibody stains or laboratory developed tests.

18. System must not require remote diagnostics for troubleshooting or required software updates.

19. Vendor will provide initial “operator level” on-site training at no additional cost to the government for up to eight technicians.

20. Vendor will provide two training slots at the contractor’s training site/facility.

21. Vendor will provide all reagents, stains, and supplies, at no cost to the government, for method validation/verification for each assay described in the validation/verification plan signed by the Medical Director, Anatomic Pathology, Madigan Army Medical Center.

22. Instrument must have the capability to establish bidirectional interface with the Anatomic Pathology Laboratory Information System (LIS).

(End of Attachment 1)