P03-BrandnameJusification-StrykerSurgicount.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source (Brand Name) 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, VISN 09, James H. Quillen VA Medical Center (JHQVAMC), 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). No options considered. Estimated: REDACTED

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 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.

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

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source (Brand Name) 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

(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.

Market research of past buys for Stryker’s Surgicount system and telephone and email interactions with Stryker sales reps identified two small businesses as authorized resellers of this Stryker product, namely, Trillamed, LLC and Beacon Point Associates, LLC.

5. Price Reasonableness:

Determining that the price is fair and reasonable is based on market research, ccomparisons to similar items in the same or a related industry, and/or a comparison to prices found reasonable on previous purchases.

6. 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.

7/26/2023

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