A.02.04_JA__Sole_Source_PRN_Heart_Kits_Redacted.pdf

Control No: 18-RHCO-C-613

For Official Use Only

(See FAR 2.101 and 3.104-4)

(25 February 2016)

Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: Regional Health Contracting-Central, Joint Base San Antonio—Fort Sam

Houston, Texas.

2. Description of Action: Regional Health Contracting Office -Central intends to issue a sole source contract to Perfusion Resources Network (PRN) for in Trace Cart - Rev #13. These customized kits are used in the Department of Cardiovascular located at San Antonio Military Medical Center (SAMMC), Joint Base San Antonio, Fort Sam Houston, Texas. This action will be accomplished through the use of a

Firm Fixed Price contract, utilizing Defense Health Program Operation and Maintenance funds.

3. Description of Supplies/Services: The Department of Cardiovascular requires Perfusion Resources

Network (PRN) Custom Carmeda Coated H-L Kit in Trace Cart - Rev #13, which are used for heart surgeries at the San Antonio Military Medical Center (SAMMC), Joint Base San Antonio – Fort Sam

Houston, Texas. The base amount is $210,000.00 and each option period is $210,000.00. The total with option years is $630,000.00. The Period of Performance will be 1 October 2018 through 30 September

2019, with two (2) 12 month option periods. The shelf-life of the existing Government-owned equipment is approximately 8 years. The basis for the contract estimate, i.e., historical data based on the number of heart surgeries performed under the previous contract.

4. Authority Cited: The statutory authority permitting other than full and open competition is 41 United

States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: PRN is the only vendor that provides these Custom Carmeda kits that are specifically designed to fit the equipment at SAMMC. Currently SAMMC owns over $350,000 in equipment that is only compatible with the Custom Carmeda kits that are provided by PRN. Without these kits, the Cardiovascular Department would not be able to run the Government owned Heart-lung machines and many patients would need to be deferred to other non-Government facilities for care.

Market Reseach shows that PRN is the only vendor that provides the Custom Carmeda kits required.

They do not have any distributors and are the sole proprietor of the Custom Carmeda Coated H-L Kit in

Trace Cart - Rev #13 required by the Government.

6. Efforts to Obtain Competition: A Sources Sought was issued on 25 June 2018. It closed on 3 July

2018. No interested sources responded. The Government has tried to obtain competition in the past, but has only received proposals from PRN.

a. Effective competition. SAMMC has Government-owned equipment that is only compatible with the Carmeda Coated H-L Customized kits. To change to another manufacturer would require a large new equipment purchase (easily in excess of $350,000.00). See 5 & 8.

b. Subcontracting competition. The requirement does not yield itself to any subcontracting opportunities based on the nature of the required product(s), results of the sources sought along with the historical data of procuring supplies of the type required.

Custom Carmeda Coated H-L Customized Kit

For the Department Cardiovascular

San Antonio Military Medical Center, Fort Sam Houston, TX

7. Actions to Increase Competition: After contract award, this justification will be available at the

Government Point of Entry, www.fedbizopps.gov. If in the future other compatible products become available market research will be performed to consider other sources that meet or exceed the current requirement. Pricing, availability and any alternative solutions will be the focus of that research. The contract file will be properly documented with any findings.

8. Market Research: Market research via the Internet, Federal Business Opportunities, and e-mail indicates that there are no other companies other than PRN that make a custom kit that is compatible with the existing Government-owned equipment.

9. Interested Sources: To date, no other sources have written to express an interest. The notices required by FAR 5.201 and 5.203(a) have been published and that any bids or proposals received shall be considered. See 6

10. Other Facts: The kitting of multiple vendors products into one “ship in. ship out” container has not only been a huge convenience for SAMMC logistics and the clinical users in the operating room, but it also greatly reduces shipping costs and reduces the cost of disposing cardboard shipping and packing materials

a. Procurement history.

a. Procurement history. Reasonable efforts to retrieve information from the following computer records, contract files, competition advocate office files or other sources:

(1) Contract numbers and dates of the last several contracts for these same/similar requirements:

W81K00-15-D-0003 – Perfusion Resource Network $597,240.00

W81K00-12-D-0010 – Perfusion Resource Network $397,136.00

(2) The competitive status of these actions.

W81K00-15-D-0003 – Competitive (only one offer received)

W81K00-12-D-0010 – Competitive (only one offer received)

(3) Authority previously cited if less than full and open competition was used. N/A

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. N/A

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. N/A

(6) An explanation of any unusual patterns which may be revealed by the history, e.g., several consecutive, urgent buys. N/A

11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signature: Date: _____________

Typed Name: Edwin Sierra Title: Logistics

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signature: Date:

Typed Name: Rex Incledon Title: Chief, Cardiovascular

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

The IGE, historical procurement data and market research will be used to determine that the price was fair and reasonable. Certified cost or pricing data is not required per FAR 15.403-1(b)(3).

Signature Date

Typed Name: Jamie M. Brunner Title: Contracting Officer

14. Contracting Officer Certification

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature: _____________________ Date:

APPROVAL

Based on the foregoing justification, I hereby approve the procurement of Perfusion Resource Network

(PRN), Inc., for Custom Carmeda Coated H-L Kits for use in the Department of Cardiovascular. Total dollar $630,000.00 on an other than full and open competition basis pursuant to the authority of 41 U.S.C.

1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the supplies and property herein described have otherwise been authorized for acquisition.

Signature: ___________________________ Date: __________