JA - Cook Medical_Redacted.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Cook Medical Cardiovascular Products and Accessories

Electronic Catalog (ECAT) Manufacturer Direct Program

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, is the contracting activity.

2. The action being approved is the ability to solicit for DLA requirements on an other than full and open competition basis.

3. The supplies to be acquired are various types of Cook Medical cardiovascular products that fall into the following product categories: Stents and Non-Biliary Stents, Abdominal Stents, Balloon-Expanding Stents, Drug Eluting Stents, Self-Expanding Stents, Thoracic, and Visceral.

Along with these products or products in these categories the vendor must be capable of supplying the ancillary accessories (such as needles for entry and guide wire) and instrumentation that are necessary for the physician to perform cardiovascular surgery. These products will be delivered Just-in-Time (JIT) for surgery, Direct Vendor Delivery (DVD) or Consignment. Under the JIT delivery method, the Medical Treatment Facility (MTF) calls the Sales Representative when a surgery is scheduled to discuss the case, make a product selection, and set the surgery date and time. The Sales Representative will transport the “procedural package” to the designated site at the scheduled time. Under the DVD method, the products are shipped direct to the customer via a transportation carrier. Under the Consignment method, “procedural packages” are pre-positioned at the MTFs, which pay only for the products that are used during the surgery. These “procedural packages” include Cardiovascular Implants, Instrumentation Sets and Ancillary Products (such as needles for entry, guide wire, etc.) that are necessary for the cardiovascular surgery. DLA Troop Support is establishing and will provide for all of the delivery methods (JIT, DVD and Consignment).

The proposed contract will be a fixed price with economic price adjustment, Indefinite Delivery/ Indefinite Quantity contract with a one (1) year base period and four (4) one (1) year option periods. The estimated dollar value for DLA’s requirements in support of DoD activities is approximately over the five (5) year life of the contract, as shown in the table below:

The maximum dollar value of the proposed procurement is $13,700,204.00.

4. The applicable statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(1), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, as implemented by FAR 6.302-1.

5. The use of this authority is necessary because the current cardiovascular marketplace consists of manufacturers that produce their own line of cardiovascular products. Unlike many other industries, product selection in the cardiovascular industry is not based solely on price and is

CUI

Electronic Catalog (ECAT) Manufacturer Direct Program overshadowed by physician preference/experience and highly specialized training on use of specific surgical items. A physician’s training with a particular manufacturer’s product increases their aptitude and familiarity with the technical characteristics of the implantable products that are expected to produce a higher quality of life for their patients or achieve certain therapeutic results. Cook Medical implantable products are unique and proprietary, as is the industry standard, and require highly specialized training on the part of the physician. Once trained and comfortable with a particular manufacturer’s products and the surgical procedure, the physician will likely use that manufacturer’s products consistently thereafter.

In addition, the Cook Medical representatives are experts on the vendor’s products and are a vital part of helping to ensure that the patient is getting the necessary treatment. At the request of MTFs, Cook Medical will have a qualified representative on site at the MTF within the timeframe specified by the facility necessary to meet their requirements. The representative provides technical advice and guidance to the physician before, during, and after implantation.

Furthermore, technical support is available twenty-four (24) hours a day, seven (7) days a week.

As noted above, Cook Medical’s cardiovascular products are provided in procedural packages that include the proprietary Cook Medical’s cardiovascular products, instrumentation sets and ancillary accessories that are essential for the surgical procedures involving the implant products.

The instruments and ancillary accessories are available individually from sources other than Cook Medical, but the overall requirement for a complete surgical package ready for immediate use makes separate competitive buys of these instruments and ancillary accessories impractical and such buys would not satisfy the requirement.

There are no known manufacturers or distributors other than Cook Medical that can provide requiring medical facilities with the complete procedural package under all three delivery methods and have the ability to provide support with regard to Cook Medical’s cardiovascular products and surgical procedures. As technology advances or further product lines are required by the MTFs, additional cardiovascular products determined to be sole source to Cook Medical may be added to the contract. All product lines added to the contract must be within the scope of the solicitation. Separate technical certification(s) supporting an amendment to this Justification for Other Than Full and Open Competition will be prepared and approved prior to addition to the contract. All items proposed for addition to the contract will be synopsized and the prices will be determined fair and reasonable prior to placement on the contract.

6. A Sources Sought Notice (SSN) was issued to ensure that offers are solicited from as many sources as is practicable. The SSN was issued on March 5, 2021, via the Beta.SAM.gov website seeking sources capable of providing Cook Medical cardiovascular products and closed on April 6, 2021. Cook Medical was the only company that expressed interest in the proposed acquisition.

As required by FAR 5.2, the acquisition was synopsized on March 20, 2020, in Contract Opportunities (Beta.SAM.GOV). In addition, this justification will be published with the solicitation in accordance with FAR 6.305(c).

CUI

Electronic Catalog (ECAT) Manufacturer Direct Program

I have reviewed this justification and recommend approval.

Date EILEEN MOTTA

Chief, ECAT Division

I have reviewed this justification and recommend approval.

Date DANIEL KEEFE

Director, Supplier Operations Medical Supply Chain

I have reviewed this justification for legal sufficiency.

Date

DLA Counsel -Troop Support

I have reviewed this justification and recommend approval.

Date ROBERT J. PANICHELLE

DLA Troop Support Competition Advocate

CUI

PANICHELLE.ROB

ERT.J.1229157139

Digitally signed by

PANICHELLE.ROBERT.J.122915

Date: 2021.08.11 14:11:23 -04'00'