36C26318Q0527-001.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under $150K

VHAPM Part 813.106 Page 1 of 2 Original Date: 08/30/17

DEPARTMENT OF VETERANS AFFAIRS

Justification for Brand Name Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($150K)

Acquisition Plan Action ID: VA-18-00006442

1. Contracting Activity: Department of Veterans Affairs, VISN 23, VA Black Hills Health Care System, 113 Comanche Road, Fort Meade, SD 57741; 2237 # 568-18-2-2021-0062

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

This requirement is for the replacement/upgrade to an existing equipment that is becoming too old to be reasonably serviced and maintained.

The Zeiss Optical Coherence Tomography OCT HD 5000 with AngioPlex OCT Angiography Version 9.5 is an automated device used by clinical staff to help diagnose and manage a variety of patient ocular diseases, such as glaucoma retinal disease and cataracts. The unit must have the ability to scan at the speed and scan patterns outlined in the Functional Specifications document. The unit must also have the ability to produce the reports and or analytics as outlined in the Functional Specifications document.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The new device will replace the older Cirrus HD OCT 4000 and must be able to accept the data and patient records stored on the older device’s proprietary software/database to allow for uninterrupted continuity of care to veterans with data gathering for research.

a. This would be done so that practice can continue on with analytics and quantitative analysis of the GPA and Macular change analysis reports using the Cirrus 4000 past scans with past baselines in the report shown on the Cirrus 5000. The data must be interchangeable between the Cirrus 4000 and Cirrus 5000 unit. No other brand has this capability due to proprietary software.

b. Must be on the Approved Medical Device List for Vista Imaging. See link attached. See page 22 on link below titled Optical Coherence Tomography (Ophthalmology use only) http://www.va.gov/health/imaging/docs/VistA_Imaging_DICOM_Modality_Interfaces.pdf

4. Description of market research conducted and results or statement why it was not conducted:

An internet search turns up several distributors for this model of OCT. There are only 4 manufacturers listed for the approved list of Approved Medical Device List for VISTA imaging. These devices are compatible with the VA’s internal patient database, the only one capable of working with the current Zeiss Cirrus HD OCT 4000 without losing patient baseline images is the model 5000. Market research confirms that other manufacturer’s software is incompatible with proprietary software.

https://www.acquisition.gov/?q=/browse/far/13 http://www.va.gov/health/imaging/docs/VistA_Imaging_DICOM_Modality_Interfaces.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under $150K

VHAPM Part 813.106 Page 2 of 2 Original Date: 08/30/17

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Chris Skaggs Date Contracting Officer https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466