Attach 05 SSJ Redacted.pdf

36C22-23-AP-1516 | Delivery of Medtronic M5 Microbrider | VA Pittsburgh Healthcare System, University Drive Campus

Single Source Justification

Last Updated: 02/01/22 Page 2 of 4

2 MICRODEBRIDER 1899200 M5 ROHS 1899200 EA 1 Included Included 3 INSTRUMENT TRAY 1899076 M5 1899076 EA 1 Included Included

The estimated value of the proposed action is

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

Currently the operating room (OR) at the Pittsburgh VA Healthcare System, University Drive is outfitted with the Medtronic multispecialty Integrated Power Console (IPC) system. This system powers the handpieces used for ENT surgeries. The new handpieces must be compatible with the Medtronic multispecialty Integrated Power Console system to function. The Medtronic M5 Microdebriders are the only compatible handpieces and therefore are the required brand.

The Pittsburgh VA Healthcare System, University Drive ENT and OR have four M4 microdebriders in use to provide for our Veteran needs when it comes to surgically having to remove any type of sinus blockage that is impeding the airways. As of last week, two of our M4 Units on stations have been deemed out of service an sent out for repair with no know estimated date of return. The use of these microdebriders during routine everyday surgery are becoming an everyday practice here at the Pittsburgh VA.

When preforming certainly sinus procedures we must follow Hospital guidelines by having a primary and secondary unit present during the surgery. We have routinely been able to conduct 3 maybe sometime 4 surgical procedures a day that might require the use of a microdebrider. Our surgical staff will not know if a microdebrider will be necessary to complete a surgical case until they are in the practice of the case.

Being down to one set impedes our current practice of schedule multiple possible endoscopic case daily due to the turn around time with the sterile processing time needed with each unit. Currently we have procedures that are booked out months in advance and without have an additional set of microdebriders we run the risk of doing our aging veterans a disservice by not having the tools required to make their life easier.

This ENT/OR equipment request is an emergency requirement to avoid disruptions in Veteran care and Veterans having to be cancelled because of not having the needed equipment to care for such ENT needs, as our current equipment has failed. This is an Unusual and Compelling Urgency. We will have to cancel patients needing care or put Veterans at risk of injury if physicians are expected to use the current equipment, which they are not.

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

NCO4 conducted the following market research for this requirement.

Vendor Information Page (VIP) Database. NCO4 consulted the VIP database using NAICS Code 334510 and Key Words Medtronic M5 Microdebrider with one result, .

is not an authorized distributor of Medtronic. CS verified with

36C22-23-AP-1516 | Delivery of Medtronic M5 Microbrider | VA Pittsburgh Healthcare System, University Drive Campus

Single Source Justification

Last Updated: 02/01/22 Page 3 of 4 uploaded to the BC. NCO4 further validated SDVOSB/VOSB status in the Small Business

VISN4 Procurement SharePoint Database. NCO confirmed, through NCO-4 procurement history, that the OEM (Medtronic, Large) is the sole manufacture for the Medtronic M5 Microdebrider.

listing and , is also uploaded to BC.

VA Strategic Acquisition Center (SAC) Contract Database. NCO4 consulted Existing Surgical Equipment for any Medtronic M5 Microdebrider contracts for any of the items required for this procurement (01-25-2023). The search yielded no results.

VA National Acquisition Center (NAC) Contract Catalog Search Tool (CCST). NCO4 searched the NAC for Medtronic M5 Microdebrider contracts for any of the items required for this procurement (01- 25-2023). The search yielded no results.

Federal Procurement Data System (FPDS). onic M5 in NAICS 339112 (01-25-2023). NCO4 has determined that NAICS Code 334510 (Five (5) instances were reported in FPDS) for this procurement more accurately represents the requirement. The M5 Microdebrider is used in Endoscopic sinus surgeries. NAICS Descriptor for 334510 includes Electromedical Endoscopic Equipment. (Included as attachment to Market Research Report) and is s Waiver for this NAICS. The National Institute of Health further https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3696152/).

General Service Administration (GSA) Advantage website search engines. NCO4 search the GSA results (01-25-2023).

NCO4 Correspondence with the OEM. Following an NCO4 query, OEM responded with the following (01-26-2023). OEM Medtronic answered email questionnaire that Medtronic is the sole m

Veterans Health Administration (VHA) Procurement Guide (PG) Nonmanufacturer Rule (NMR) Decision Tree. NCO4 determined that this procurement meets the criteria of a SD/VOSB Set Aside using the matrix provided (included as attachment to Market Research Report). Small Business Administration (SBA) remains in full force and effect and emphasizes the endoscopic requirement as essentially a large business endeavor. Vendors have been vetted for all criteria required and the