DBSS_JA_Other_Than_Full__Openv1_Signed.pdf

Justification and Approval

For Other than Full and Open Competition

Log Number

1. Contracting Activity:

Tricare Management Activity (TMA) Contract Operations Division (COD)

7700 Arlington Blvd, Suite 5101

Arlington, Virginia 22042-5101

ATTN: Mr. Robert Leblanc

The Requiring Activity for this action is: TRICARE Management Activity, Defense Health

Clinical Systems (DHCS) Program Office, 5109 Leesburg Pike, Suite 319

Falls Church, VA 22041

2. Description of Action.

Approval is being requested by the TRICARE Management Activity, DHCS Program Office for a Defense Blood Standard System (DBSS) Sustainment Support contract. The type of contract is a firm fixed price for labor and cost-type for ODCs. The estimated total value, including all options, is $9,034,235.52. The Period of Performance for this effort will be one (1) four- month base year with three (3) six-month option periods, as well as a two (2) month optional transition out period. The Contract Management Information Database (CMID) number for this action is

CMID 21168.

3. Description of Supplies or Services.

The services that are to be provided are operational support and sustainment for the Department of Defense’s (DOD) Defense Blood Standard System (DBSS). DBSS v3.04 WIN2K is a Blood

Establishment Computer Software (BECS) that is required by law to be sustained under the Code of Federal Regulations (CFR), Title 21, Series 800 to 899. The FDA requires compliance to current Good Manufacturing Practices (cGMP) by qualified medical device suppliers to meet industry standards of care.

DBSS v3.04WIN2K provides procedures for collecting, manufacturing, testing, processing, freezing, storing, shipping, and distributing blood components and substitutes. The DBSS v3.04WIN2K supports the tracking of blood components and substitutes, as well as, the tracking of blood donors and recipients (look-back) for infectious disease (e.g. Human Immunodeficiency

Virus (HIV) and Hepatitis), and provides a deferral list of donors prohibited from donating blood. The DBSS v3.04WIN2K is operated by the Military Departments at Blood Transfusion facilities on military installations both in the Continental United States (CONUS) and Outside the Continental United States (OCONUS).

4. Authority Cited.

10 U.S.C.2304(c)(1) as implemented by FAR 6.302-1 -- Only One Responsible Source and No

Other Supplies or Services Will Satisfy Agency Requirements and

10 U.S.C.2304(c)(2) as implemented by FAR 6.302-2 -- Unusual and Compelling Urgency.

5. Reason for Authority Cited.

The Food and Drug Administration (FDA) has declared that the DBSS is a Class II medical device and is subject to special controls called the Quality System Regulations (21 Code of

Federal Regulations (CFR) Section 820). The FDA classification as a Class II medical device is because the DBSS makes life and death clinical decisions without human intervention. This is the only FDA regulated medical device manufactured by the Department of Defense. The incumbent vendor, in accordance with the above listed CFR reference, has an established Quality

System that has safeguarded DBSS for over nine years. The vendor’s established Quality System enhances and supports the DBSS Project Office FDA mandated Quality Management System.

The mature quality systems of both vendor and DBSS Program Office, in-tandem, have successfully passed two FDA audits without notable discrepancies. Introduction of another vendor to sustain DBSS operations at over 58 DOD sites will increase the risk of properly maintaining the system for its intended use.

Failure to maintain this contractual agreement will result in new or additional repeat findings from the FDA that will lead to harsher restrictions including recall of software or legal liability.

This will require the DBSS sites to depend on a manual system (paper-based) and blood donations and transfusions will be subject to a higher probability of error that may lead to a patient’s death or irreversible harm. Failure to retain this vital contract source will show lack of intent to maintain Management Control as outlined within 21 CFR, Part 820.50, Purchasing

Controls within the established DBSS PO quality system.

5D Information Management, Haemonetics- Software Solutions (HSS) Division has been the designated source for this effort since 2004.

6. Efforts to Obtain Competition.

Due to the proprietary nature of 5D’s commercial software, the fact that the Department of

Defense is planning on sun setting (closing down) this Commercial off the Shelf (COTS) product within the next 24 months, 5D’s applicable source code, and the potential increased costs of having another contractor invest time, materials, funding and effort to come on board and understand the current maintenance and sustainment requirements, no efforts were made to obtain competition for maintenance services for this automated information system.

7. Actions to Increase Competition.

It is anticipated that further efforts to generate competition will not be effective prior to award of this requirement due to the proprietary nature of the commercial software.

8. Market Survey.

Market research was conducted in May 2013 for this action to be a small business set –aside through FedBizOpps. It has been concluded that no small business could satisfy the requirement for sustainment of this DOD Blood Commercial-off-the-Shelf (COTS) product without the current contractor, 5D Information Management, who are the proprietors of the current product.

This market survey revealed that 5D is the only contractor that can provide proprietary services and equipment for the Defense Blood Standard System (DBSS) since they have not licensed the right to maintain this software to any other contractors. The proposed contractor for this action, 5D Information Management, has certified that: (a) they have not granted any third party maintenance and support contractor any license or right to use or access the proprietary source code for any purpose or use, including, without limitation, for engineering development of software updates changes necessary to correct software problems, produce software enhancements or implement critical IA security software changes; (b) 5D does not permit any third party access to the dedicated DOD maintenance and support enclave at their headquarters nor has it granted anyone one else the right to use any of the GFE, which they are required to maintain to comply with requirements for the DBSS and (c) 5D has not licensed or granted to any third party the right to provide maintenance and support services for the software.

9. Interested Sources.

To date, no other sources with legal access to 5D’s Commercial off the Shelf (COTS) source code or software maintenance capability have expressed written interest in the proposed acquisition.

10. Other Factors.

a. Procurement History.

(1) Contract numbers and dates of the last several awards:

a. DBSS Sustainment, Contract # GS-35F-0543T, Order # DO W81XWH-09-F-

0628, Date of Base Award: 1 May 2009.

b. DBSS Sustainment, Contract # GS-35F-0543T, Order # DO W81XWH-11-F-

0183, Date of Base Award: 1 July 2011.

(2) Competitive status of these actions:

a. Full and Open Competition under the General Service Administration’s (GSA)

Information Technology (IT) 70 Schedule through the United States Army

Medical Research Acquisition Activity (USAMRAA)

b. Full and Open Competition under the General Service Administration’s (GSA)

Information Technology (IT) 70 Schedule through the United States Army

Medical Research Acquisition Activity (USAMRAA)

11. Technical Certification.

I justify 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.

NAME: Chester Alexander _______________ DATE: ____________________________

TITLE: DBSS Product Manager/COR SIGNATURE: _______________________

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.

NAME: Joseph McMullin_______________ DATE: ____________________________

TITLE: _Director, DHCS Resource Management SIGNATURE:

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 basis for this determination is historical cost and price analysis used to develop the

Independent Government Cost Estimate. Certified cost or pricing data was not required because of the prohibition at FAR 15.403-1(b)(1).

calexan1 Typewritten Text 13 September 2013

14. Contracting Officer Certification

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

NAME: Robert Leblanc______________ DATE: ____________________________

TITLE: Contracting Officer SIGNATURE: ______________________

15. Legal Sufficiency Review. I have reviewed the foregoing justification and approval and deem it legally sufficient.

NAME: David Smith____________________ DATE: ____________________________

TITLE: Legal Counsel SIGNATURE:

APPROVAL

Based on the foregoing justification, I hereby approve the procurement of Defense Blood

Standard System (DBSS) Sustainment Support contract on an other than full and open competition basis pursuant to the authority of FAR 6.302-1 -- Only One Responsible Source and

No Other Supplies or Services Will Satisfy Agency Requirement.

Approval is granted subject to the availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

NAME: Genesta S. Belton DATE: ____________________________

TITLE: Competition Advocate SIGNATURE: ______________________