PM_Part813.106_Atch1_SingleSourceJustification_MPT-SAT - CO SIGNED - Copy_Redacted.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 2 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

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: 36C247-20-AP-2644

1. Contracting Activity: Department of Veterans Affairs, VISN 07, WJB Dorn VA Medical Center

544-20-3-328-0192

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

Automatic endoscope reprocessors are devices used to high level disinfect channeled endoscopes between patient uses. Reusable Medical Equipment (RME) is equipment intended to be by multiple patients. RME has to reprocess on some level based on Spaulding Classifications. There are three levels of RME, critical, semi-critical, and non-critical. Semi critical RME is equipment that comes into contact with mucous membranes, such as an endoscope passed through the throat to examine the stomach or lungs. Semi critical RME does not have to be sterilized, but it does have to be high level disinfected.

- Medivators ADVANTAGE PLUS Automated Endoscope Reprocessor item # ADV-1007.

- INSTALL ADVANTAGE NBD, item # INS-1005.

- ADV PLUS OPERATOR TRAINING, ITEM # OPT-1002.

- Warranty Information- Full coverage for 12 months of date of install or 15 months from date of delivery, which ever comes first. NBD-Advantage install consists of the installation of the machine and includes after hours and or weekend with the available Field Service Engineer.

Estimated amount less than SAT

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

The justification of sole source is because we currently have this product and it has reached its end of life. SPS department in VISN 7 has standardize the use of Medivators AERs. All attachments and connecting equipment to include utilities will remain the same. The manufacturer of an automatic endoscope reprocessor (AER) is responsible for validating that a particular scope can be processed in their system. Medivators has done the appropriate validation that all of the endoscopes we currently use at the Dorn VA Medical Center are indeed compatible in use with this system. In fact, Medivators has validated every flexible endoscope currently on the market, including TEE probes and dilators.

Medivators Advantage Plus is a compact, efficient AER system. The Medivators Advantage Plus can process up to 4 smaller channeled scopes at a time and has a short reprocessing cycle of 23 minutes which will in turn mean we can process more scopes in a shorter amount of time which results in

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VH Part 813.106 Page 2 of 2 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020 cost savings to the VA.

This system also alcohol flushes the scopes while still in the machine, our present process is to remove the scopes from the machine and complete a manual alcohol flush for purposes of drying.

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized. These are “direct replacements” parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed and performing.

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

There are currently three AER systems on government contract. The first is being requested in this procurement. The second is manufactured by Olympus and is only validated for processing Olympus scopes. The third is manufactured by Steris and is currently the AER and will not meet our current system requirements and utilities. It only allows us to process two scopes at a time, the cycle is approximately 50 minutes, the device does not perform an alcohol flush requiring our staff to perform one manually, and though all of our current inventory of scopes is validated in this device, not all scopes on the market are validated in this device which means if we were to procure new scopes we run the risk of buying one that cannot be processed in this device; this not an issue with the Medivators device we are requesting to procure.

Market research revealed authorized distributors of Medivators that could fulfill this requirement.

This action will be set aside 100% small business.

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.

Note: COs are required to make a determination of price reasonableness IAW FAR 13.106-3. See the

S19 Open Market (FAR13) Award Documentation Form with Abstract to document price reasonableness.

Name Date Title