Attach 01 SON.docx

STATEMENT OF NEED FOR

CARL ZEISS CIRRUS HD- OCT MODEL 5000 AT

ERIE VA MEDICAL CENTER

ATTN: DISTRIBUTION CENTER

135 E. 38TH STREET

ERIE, PA 16504

End-User/Facility POC: Francine Maney Acquisition Utilization Specialist: Scott Burick

1. Background: The Department of Veterans Affairs, Erie VA Medical Center, has a “brand name” requirement for one (1) ZEISS OS Cirrus HD-OCT Model 5000 with AngioPlex OCT Angiography. The OCT (Ocular Coherence Tomographer) scans the layers of the back of the eye, showing normal and abnormal structures at the microscopic level. It gives baseline information as to effectiveness of treatment on the structural changes in common diseases such as clinically significant macular edema, cystoid macular edema and glaucoma. In many cases it has replaced the invasive procedure intravenous fluorescein angiograms (IVFAs). It has become the standard of care for monitoring these conditions and is becoming the standard of care for patients on the medication hydroxychloroquine (plaquenil).

2. Salient Features (Brand Name): ZEISS OS:

2.1 This equipment must have the capability to capture and provide OCT Angiography.

2.2 This equipment must have exact Macular Scan Pattern of 512 x 128 for retina scan with exact scanning speed of 27,000 A-scans a second within a 6mm x 6mm.

2.3 This equipment must have exact scan pattern of 200 x 200 in a 6mm x 6mm cube for Glaucoma Scan with exact scanning speed of 27,000 A-scans a second. The scan pattern must be able to capture and provide RNFL, ONH, Neuro Retinal Rim Tissue, and 3-D cube capabilities all in one scan.

2.4 This equipment must utilize an LSO Fundus Camera (Line Scanning Laser Ophthalmoscope).

2.5 Equipment must be able to automatically track prior to scan. This must be achievable without the technician needing to align to prior scan. Anterior Segment scan has a minimal 15.5 mm x 5.8 mm in depth with full view of the Anterior Chamber.

2.6 Axial resolution – 5 um.

2.7 Hard drive / internal storage has to equal 750 GB or 80,000 scans

2.8 USB ports – 6 ports

2.9 At a minimum the Display must be an integrated 19inch color flat panel display.

3. Training and Installation:

Contractor shall provide installation services for this procurement. Contractor shall install all applicable software and configure all network connections on the equipment. Contractor shall perform a full functionality test on the equipment to ensure that the equipment is properly sending data either directly to the Zeiss Forum or to its client PC and then to the Zeiss Forum. Contractor shall ensure any bi-directional communication is tested fully, allowing for sending and retrieval of data. Contractor shall provide Biomedical Engineering with all back up discs, licensure, software keys and passwords necessary to fully maintain the equipment.

4. SECURITY & PRIVACY CONTROL: (This language is not required for all equipment purchases. Refer to Appendix A 6500 comments section to verify if security and privacy language is to be included per ISO and Privacy Officer).

4.1 If vendor will be on station:

4.1.1 Contractor will be on station to provide service and therefore required to take the generalized privacy training: Privacy Training for Personnel Without Access to VA Computer Systems or Direct Access to or the Use of VA Sensitive Information

4.1.2 Training is required upon hire and annually thereafter as long as the contract is in place.

4.1.3 Contractor can self-enroll in TMS, take VA Privacy Training course # VA20939, and provide a copy of the completed training certificate to the government point of contact or COR if applicable. Alternatively, the contractor can read the text version and provide a copy of the completed training certificate to the government point of contact or COR if applicable.

5. Delivery:

All items must be FOB Destination, 30 Days ARO, to the following location:

Erie VA Medical Center Attn: Distribution Center 135 E. 38th Street Erie, PA 16504

Monday – Friday from 8:00am – 4:00pm