SoleSource-FARpart13-SpongeCounter.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)

Last Updated: 02/01/22 Page 1 of 2

Acquisition Plan Action ID:_36C249-23-AP-3073_

1. Contracting Activity: Department of Veterans Affairs (VA), VISN 09, Tennessee Valley

Healthcare System (TVHS), Nashville Campus Medical Center, Network Contracting Office

(NCO) 9. PR/2237: 626-23-3-313-0216

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

Qty: 9 units, Stryker brand, Surgicount+ with pole mount kit and software license for use in the operating rooms (OR). Estimated Amount: $111,625.65. No option considered.

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

Stryker reps provided a sole source document attesting that they are the sole manufacturer and distributor of the Surgicount+ system. They have a post on their website for a competitive comparison between Surgicount and Situate [https://www.stryker.com/us/en/surgical-technologies/products/surgicount-safety-sponge-system/surgicount-index/surgicount-safety-sponge-system/competitive-comparison-.html] and also responded via email to their uniqueness from ORLocate and Situate with the following:

Stryker Surgicount+ is the only device on the market that offers proof of correct count.

Stryker Surgicount+ is the only system that aligns with Associate of periOperative Registered Nurses (AORN) standards for OR count guidelines running adjunct to the manual count.

Stryker Surgicount+ has a cordless reader that can help locate missing sponges.

Stryker Surgicount+ has a $5 million risk sharing promise should a sponge be retained with the use of their device.

Stryker surgicount+ has been put to the test with over 500 US customers, over 210 million sponges used in over 9 million procedures, and still ZERO retained surgical sponges since its launch in 2009.

Surgicount+ digital ledger gives real-time reconciliations throughout the OR case, plus permanent database metrics for additional post-op accounting, compliance and reporting.

Lastly, this requirement falls under North American Industry Classification System (NAICS) 339113, Surgical Appliance and Supplies Manufacturing, where the Small Business Administration (SBA) has not issued a non-manufacturer rule (NMR) class waiver. With no NMR class waiver, the Government can only procure direct from one of the three large business manufacturers identified for this requirement.

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)

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

4. Description of market research conducted and results or statement why it was not conducted: Market research consisted of search of VA’s VetBiz database; contacting knowledgeable individuals in Government and industry regarding market capabilities to meet requirements; querying the Government-wide database of contracts and other procurement instruments intended for use by multiple agencies available at www.contractdirectory.gov and other Government and commercial databases that provide information relevant to agency acquisitions; reviewing catalogs and other generally available product literature published by manufacturers, distributors, and dealers or available on-line; and, conducting interchange meetings or holding presolicitation conferences to involve potential offerors early in the acquisition process.

Safety considerations using input from other nurse managers at other VA medical centers familiar with ORLocate, Situate, or Surgicount, and data mined from the Food and Drug Administration’s (FDA) Total Product Life Cycle (TPLC) database supported Stryker sales rep comments for the safety record associated with the Surgicount unit.

An FDA search for product code LWH for Counter, Sponge, Surgical of medical device reports (MDR) for incidents like foreign body in patients from 2018-2023 found 11 instances total where 10 were from Medtronic/Covidien’s Situate device and one from Steris’s ORLocate Sponge unit. Same search of FDA TPLC showed 167 incidents for False Positive Results only for the Medtronic/Covidien Situate unit.

Results of the market research effort by a workgroup of staff members and OR leadership narrowed down the options to Medtronic Situate and Stryker Surgicount+. In-service trials of one-week each per device were conducted by both the Medtronic sales representatives and the Stryker sales representatives. It was determined that Stryker Surgicount+ is the product that offers all the options required in the OR to locate and count uniquely identified surgical sponges with added post-operative administrative value for accounting, compliance, and reporting that Situate was unable to meet or be modified to meet.

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.

7/14/2023

X Sascha Hertslet, CFCM NCO9, Contracting Officer, Supply East Signed by: SASCHA HERTSLET