P03-SingleSourceJustification-RetinalCamera-Rev1_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106‐1 For

Over Micro‐Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C249‐24‐AP‐0672

Last Updated: 02/01/22 Page 1 of 4

1. Contracting Activity: Veterans Integrated Service Network (VISN) 09, Network Contracting Office (NCO) 9, Murfreesboro, TN. Tennessee Valley Healthcare System (TVHS), Alvin C. York VA Medical Center, Murfreesboro, TN 37129. PR/2237: 626‐24‐1‐313‐0016

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

Requested equipment is brand name for Topcon Inc., ‐ the original equipment manufacturer (OEM)‐ for the mydriatic retinal camera and associated components/accessories. This system will be used to view and capture image structures of the retina, optic nerve, and external eye then use the ImageNet6 software to transfer and share retinal imaging data between the two TVHS campuses.

Part Number Description Estimated Qty 3700‐36T Topcon Retinal Camera TRC‐50DX system with ImageNet6 software 1 ea

Estimated Amount:

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Brand name is requested to support TVHS standardization efforts to improve workflow processes between Nashville and Murfreesboro campuses eye clinics. Improved data exchange efficiency between the two eye clinics is vital to achieving prompt and proper patient diagnosis and treatment plans, while also minimizing clinical care interruptions, multiple patient cancellations, and increased wait times.

The need for standardizing procedural and diagnostic equipment is critical, as different models have different capabilities, operating procedures, and user interfaces and require additional end user training. A mixture of different models in the patient care area increases the risk of user error, significantly increasing the risk to patient safety. Standardizing patient care equipment is a recognized best‐practice for reducing the risk of errors, increasing uniformity of practice and patient safety. See Zhang, J. et al., Evaluating & Predicting Patient Safety: From Research to Implementation, Vol 2: Concepts and Methodology (Kerm Henriksen et al. eds., Agency for Healthcare Quality and Research 2005).

Staff shortages require the eye clinic residents, physicians, and techs to rotate their work shift between the two campuses on a regular basis and allow both campuses to meet VA mission goals related to Veterans seeking eye care. The Murfreesboro campus is currently

Last Updated: 02/01/22 Page 2 of 4 using an over 15 year old Kowa brand mydriatic system, which is well past its service life of eight years, and does not allow for Digital Imaging and Communications in Medicine (DICOM) integration causing Murfreesboro staff to manually move medical ophthalmic imaging to the computerized patient record system (CPRS) before it can be shared with Nashville campus when peer reviews are sought. Peer reviews happen daily between both campuses. This delays patient diagnosis and treatment options by days, sometimes weeks, depending on availability of staff, and accuracy of data input. The current system at Murfreesboro campus is also unreliable causing clinical care interruption, multiple patient cancellations, or rescheduling with the Nashville campus eye clinic to use their more modern and efficient Topcon mydriatic retinal camera system.

The Nashville campus procured their Topcon TRC‐50Dx system with ImageNet6 software in 2019 at a cost to the Government in the amount of $64,280.00. It is the only mydriatic fundus camera system with all the diagnostic and image capture, transfer, and share functions needed by the eye clinic. Nashville’s current mydriatic fundus camera system with ImageNet6 software went through several months of approval and configuration before being allowed to operate on VA’s medical network architecture.

Furthermore, standardization of equipment reduces the overall cost to the Government as it enables the Government to benefit from strategic, centralized procurement of consumables and components. TVHS eye clinics between Nashville and Murfreesboro campuses are currently using two different makes and models of mydriatic retinal camera systems which, as previously expressed, results in an overall decrease in efficiency in the eye clinic workflow. Acquiring the same Topcon brand and model at the Nashville campus for the Murfreesboro campus is the best means to capitalize on achieving standardized processes between both TVHS campuses.

To purchase items from a different manufacturer brand would require replacement of the Topcon system at the Nashville eye clinic and impede clinical operations as the new equipment gets approved and configured before use on VA’s medical network architecture.

The equipment cost for this action would run in excess of $120,000.00, which considers the loss of the $64,280.00 spent on the current Topcon system plus the cost for a comparable system. The cost in disruption to clinic operations and the impacted Veteran patient is immeasurable. This represents an excessive and unnecessary duplication of costs to the

Last Updated: 02/01/22 Page 3 of 4

Government that would not be recovered through competition for other brands and models.

4. Description of market research conducted and results or statement why it was not conducted: Market research found that the Government attempted to illicit response from domestic suppliers and/or manufacturers through posting of a sources sought notice 36C24924Q0134 from 1/12/2024 through 1/22/2024 via sam.gov’s Contract Opportunities website. The notice clearly stated the Government’s intention of sole sourcing for Topcon Inc.’s mydriatic retinal camera system. The notice yielded three responses from the following vendors: Topcon Medical Systems (TMS), Melling Medical, and KMASK Group. All of whom were interested in selling the Topcon product to the Government. No response for any domestic, American‐made product for the Government to consider was received.

TMS is a large business manufacturer with a domestic office in New Jersey; however, their Topcon products are manufactured in Japan. Melling Medical LLC, is not a manufacturer but a domestic SBA‐certified Service‐Disabled Veteran‐Owned Small Business (SDVOSB) and authorized Topcon distributor/reseller. KMASK Group, is not a manufacturer but a domestic small business reseller/distributor. Talks with Topcon management representative confirmed that KMASK is not an authorized distributor/reseller of their products. Topcon provided a sole source letter and quote. Melling Medical had provided the quote that formed the government’s cost estimate for this requirement.

TVHS eye clinic personnel and market research found that no domestic manufacturers could meet this requirement. Market research only identified mydriatic cameras made by Canon (made in Japan), Kowa (made in Japan), Topcon (made in Japan), and Carl Zeiss (made in Germany). The government looked at Canon’s CX‐1 Hybrid Digital Mydriatic/Non‐Mydriatic Retinal Camera and ZEISS FF 450 Plus Fundus Camera finding it is comparable to the Topcon TRC‐50DX but is not setup – i.e slightly different placement and types of control features ‐ then what they currently have at the Nashville campus, which is the Topcon TRC‐50DX with ImageNet6, part number 3700‐36T. Nashville campus eye clinic’s ImageNet6 software is also not compatible with either Carl Zeiss and Canon’s image capture and sharing software or interoperable with Carl Zeiss and Canon retinal cameras. Kowa’s website did not offer mydriatic retinal camera systems and showed all previous mydriatic models as discontinued.