17RHCOP70_Sole_Source_Justification_under_13.501.doc

For Official Use Only (See FAR 2.101 and 3.104-4) (25 February 2016)

Control Number: 17-RCHO-P-70

Sole Source Justification and Approval Under FAR 13.501

Contracting Activity: Joint Base Lewis McChord Health Contracting Cell

Description of Action: This Justification and Approval is for a new contract for an approximate 10-month base period and two 12-month options starting 12DEC2016. This will be a firm fixed priced contract using FY17 OMA funding.

Description of Supplies/Services: This requirement is for fortified human breast milk for the Maternal Child Health/Neonatal Intensive Care Unit at Madigan Army Medical Center at Joint Base Lewis-McChord, WA. The period of performance is from 12DEC2016 – 30SEP2017, with two option years, ending in 30SEP2019. Clause 52.217-9 Option to Extend the Term of the Contract will be added to the contract. The value of this acquisition is $1,085,726.88. NAICS: 325414 Biological Product (except Diagnostic) Manufacturing. PSC: 6505 Drugs and Biologicals.

Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

Reason for Authority Cited: These items are unique to Prolacta Biosciences, and are not provided by any other company. Market Research has found no other company that provides fortified human breast milk that is made entirely from human breast milk and fortified for pre-term infants weighing 1250g or less at birth.

Efforts to Obtain Competition: Market research was conducted to determine availability of fortified human breast milk for very low birth weigh pre-term infants in the market place. As the Market Research Reports shows, the products from Prolacta are the only products in the market place that are made entirely from human breast milk and fortified for pre-term infants with a very low birth weight. There are other products that can be added to human breast milk but are based upon cow milk. There is also human breast milk that is offered by other companies but are not fortified for these low birth weight infants. Until another company develops a similar product, Prolacta is the only company that can provide these items. At that time, the hospital intends to review other sources.

Brooke Army Medical Center did a similar acquisition for these items on 9JUN2015 and only received one offer – Prolacta. That contract is W81K00-15-P-0361

A sources sought notice was posted to www.fbo.gov on 14NOV2016 requesting information from any company that can provide these items. There were no responses to the notice.

Control Number: 17-RHCO-P-70 Fortified Human Breast Milk for Madigan Army Medical Center at Joint Base Lewis-McChord, WA

Effective competition. N/A. As there are no other vendors for this item, there is no chance for competition.

Subcontracting competition. In accordance with FAR 19.702(b)(1), a Subcontracting Plan is not required from small business concerns.

Actions to Increase Competition: It is not possible to compete the current acquisition. The Notice required by FAR 5.201 will be published. No action on the part of this office will decrease this type of barrier to competition available.

Market Research: Market Research has found no other company that provides fortified human breast milk that is made entirely from human breast milk and fortified for pre-term infants weighing 1250g or less at birth. Other formulas were found for pre-term infants, however none were made solely from human breast milk. As stated in the Market Research Report, the American Academy of Pediatrics recommends the use of only human milk to prevent Necrotizing Enterocolitis (NEC), Broncho Pulmonary Dysplasia, and sepsis. All other products in the market place use cow milk in whole or in part in their formulas. Fortified human breast milk is recommended for pre-term infants to ensure adequate nutrient intake. The use of fortified human breast milk has been shown to save over $8000 per infant assuming no complications arise. Studies have shown that the use of the fortified human breast milk reduce the odd of developing NEC by 77% which if NEC occurs can cost an additional $74,000 - $200,000 per infant in addition to reducing infant mortality.

The Small Business Administration’s Dynamic Small Business Search was reviewed as well as the Federal Supply Schedules were also searched vendors who can provide this service. However the suggested source, Prolacta Bioscience, has indicated in their System for Award Management that they are a small business.

A Sources Sought was posted on 14NOV2016 closes on 28NOV2016. No responses were received as a result of this notice.

Interested Sources: Aside from the suggested source, no other vendors have expressed interest in this action. The notice required by FAR 5.201 will be published and bids or proposals received shall be considered.

Other Facts:

a. Procurement history.

Contract numbers and dates of the last several contracts for these same requirements: This is a new contract. There are no previous awards for these products.

The competitive status of these actions: N/A

Authority previously cited if less than full and open competition was used: N/A

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

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

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

If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. N/A

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:

.1153060564

Digitally signed by.1153060564 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=.1153060564 Date: 2016.12.05 09:47:09 -08'00'

Typed Name: Title: Chief, Maternal Child Health Nursing

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: .1153060564

Digitallysigned by.1153060564 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=.1153060564 Date: 2016.12.05 09:47:47 -08'00' Typed Name: Title: Chief, Maternal Child Health Nursing

Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. Based on the Independent Cost Estimate provided by the requiring activity and historical contract pricing available for the same or similar requirements, the anticipated cost to the Government will be fair and reasonable.

.1284448126 Digitally signed by .1284448126 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=.1284448126 Date: 2016.12.05 10:44:03 -08'00' Certified Cost or Pricing Data will not be required in accordance with FAR 15.403- 1(b)(3).

Typed Name: Title: Contracting Officer

Contracting Officer Certification:

.1284448126 Digitally signed by .1284448126 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=.1284448126 Date: 2016.12.05 10:44:21-08'00' I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Title: Contracting Officer

Approval

Based on the foregoing justification, I hereby approve the $1,085,726.88 procurement of fortified human breast milk for the Maternal Child Health/Neonatal Intensive Care Unit at Madigan Army Medical Center at Joint Base Lewis-McChord, WA 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 herein described have otherwise been authorized for acquisition.

Digitally signed by.1165787150 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=.1165787150 Signature:.1165787150 Date: 2016.12.07 16:03:50 -06'00'

Typed Name: Title: Special Advocate for Competition