LSJ_-_Insufflator_redacted.pdf

LIMITED SOURCES JUSTIFICATION

1. The Defense Logistics Agency (DLA) Troop Support, Medical Supplier Operations, Electronic Cataloging (ECAT) Division is the contracting activity.

2. This justification is for the acquisition of brand name product(s) or equal features essential to the Government’s requirements under ECAT.

3. Brook Army Medical Center (BAMC) has a requirement for the following item:

Requisition number: W81NTE-9067-6233

Item Identification: Pneumoclear CO2 Condition Insufflator Kit

Manufacturer: Stryker

Manufacturer part number: 0620-050-002

AMD Supplier P/N: 999300587

AMD Contract Number: SPM2D1-13-D-8211

Beacon Point Associates LLC Supplier P/N: 0620-050-002

Beacon Point Contract Number: SPE2DH-19-D-0010

Estimated unit price: $12,892.00

Quantity: 28 each

Estimated Total Dollar Value: $360,976.00

4. The authority waiving competition requirements is FAR 8.405-6(b) (l), Items Peculiar to one

Manufacturer, and DFARS 208.406-1, Order Placement. Only one source is capable of providing the supplies required at the level of quality required because the supplies are unique or highly specialized. Use of this authority is necessary because the insufflator kit manufactured by Stryker is the only device that can provide unique performance features/ clinical capabilities that meet the US Army’s needs. No other manufacturers can provide insufflators that can meet all of the required unique performance features/ clinical capabilities. The required insufflator shall be

Stryker Pneumoclear CO2 Condition Insufflator Kit for House Gas (manufacturer part number:

0620-050-002) brand name or equal.

The following is the US Army’s minimum requirements for the required insufflator kit:

• The insufflator kit shall have an all in one integrated tube set that can provide heated, humidified, and smoke evacuation all-in-one tube set.

• The insufflator kit shall have a variety of specialty settings to ensure safe and effective pneumopressure that include Standard, Bariatric, Pediatric, Vessel Harvest, Advanced

Flow, and transanal minimally invasive surgery (TAMIS).

• The insufflator kit shall provide a variety of tubing options that include high flow tube set, heated high flow tube set, high flow with smoke evacuation tube set, heated and humidified tube set, and heated, humidified, and smoke evacuation tube set.

After extensive research, the US Army found that the Stryker Insufflator Kit is the only kit on the market that provides an all-in-one insufflation tube set that can heat, humidify, and evacuate the smoke/plume produced during a surgical procedure. The heated and humidified air features are for reduced laparoscope fogging and improved internal moisture. The humidified air is an important feature in maintaining the integrity of the tissue and preventing adhesions after laparoscopic surgical procedures. The smoke evacuation feature is not only for reduced risk of exposure to harmful surgical smoke/ plume but also providing a consistent image by actively removing surgical smoke. These features provide overall better visualization of the surgical site and better outcomes for the patient. This Stryker insufflator integrates the insufflator, the heated air, and smoke evacuator into one-piece equipment. This Stryker insufflator Kit provides for more space in the surgical suite and a more efficient and overall safer procedure while decreasing the risk for complications.

5. DLA Troop Support has already determined the prices of supplies under the ECAT multiple award program fair and reasonable. Price reasonableness is based on a favorable comparison to commercial invoices and best discount off of ECAT vendor’s commercial catalog price.

6. The US Army conducted extensive market research from September through October 2018.

The market research included sources sought from the Internet, ECAT, and GSA. The US Army notified companies that include Beacon Point Associates LLC (Stryker’s distributor), Karl Storz, and Olympus. Beacon Point Associates LLC, ECAT vendor, provided the US Army a quote for the required Stryker Pneumoclear insufflator kit with a trade-in equipment allowance discount.

Karl Storz provided only sales brochures. Olympus did not provide any response. Olympus’ sales brochure was obtained via the vendor’s website. Olympus Intra-abdominal Insufflation

Unit (UHI-4) does not have the required integrated tube set that can provide heated, humidified, and smoke evacuation all-in-one tube set. Therefore, the Olympus Intra-abdominal Insufflation

Unit does not meet all of the minimum requirements as listed in paragraph #4 above. The Karl

Storz’s Endoflator 50 insufflator was the only other insufflator that can provide integrated heating with insufflation. The Karl Storz’s insufflator does have the variety of settings. However, the Karl Storz’s insufflator does not have the smoke evacuation feature integrated with it as the

Stryker Pneumoclear does. Therefore, Karl Storz’s Endoflator 50 insufflator does not meets all of the Army’s minimum requirements. The US Army found that this particular Stryker insufflator is the only one on the market that meets all of the minimum requirements. There are two vendors on ECAT that can supply the required Stryker Pneumoclear CO2 condition

Insufflator kit (Stryker part number: 0620-050-002).

Market research performed in the ECAT system in July of 2019 by the DLA Engineer shows that currently there are only two ECAT vendors that can supply the required Stryker insufflator kit that meet all of the US Army’s needs. The two vendors are AMD and Beacon Point

Associates, LLC.

DLA Troop Support will issue a RFQ to the two ECAT vendors for the required Stryker

Pneumoclear insufflator kit including the optional equipment trade-in discount. Offers from the two vendors will be evaluated by DLA Contracting Officer.

7. ECAT vendors have the opportunity to add products that fall within the scope of the ECAT contract at any time. Any ECAT vendor not currently offering the required item will have the opportunity to add it thereby enhancing competition.

8. DLA Troop Support will attempt to locate other acceptable sources for future routine requirements as they arise; however, any new item would be required to meet the US Army rigorous requirements since there are life and death consequences if the item cannot function in in adverse condition.

9. As the Contracting Officer, I hereby certify that the information contained in this Justification is accurate and complete to the best of my knowledge and belief.