JA_Analysis_of_CWA_Contaminated_Swine_Original,Amd_0001_FBO_Redacted.pdf

Defense Threat Reduction Agency and

United States Strategic Command Center for Combating Weapons of Mass Destruction

8725 John J. Kingman Road, Sto p 6201 Fort Belvoir, VA 22060-6201

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Amendment 0001

1. Nature and/or Description of Action

The Defense Threat Reduction Agency (DTRA) proposes to issue Amendment 0001 against the Justification for Other Than Full and Open Competition for the requirement entitled “Analysis of Chemical Warfare Agent (CWA) Contaminated Swine Remains.”

Battelle is the only contractor able to provide the required technical effort. The purpose of Amendment 0001 is to revise the previously approved ceiling of $700,275.80 to $845,714.00 and address the contributing factors associated with this revision. The original Justification for Other than Full and Open Competition is attached.

2. Description of the Supplies/Services Required

Amendment 0001 pertains to the revision of the ceiling of the original justification. During the time between the approval of the J&A (November 2015) and the receipt of the proposal from the Contractor (10 May 2016), the Joint Mortuary Affairs Center changed their requirement for the methods and timing of decontamination at a mortuary affairs contaminated human remains mitigation site (MACRMS). The requirement change was based on the scientific results of a previous effort and updated Concepts of Operation and Tactics, Techniques and Procedures. These changes resulted in the addition of a 28-day waiting period between two steps of the technical work being added to each set of agent exposures. This additional time increased the cost of the proposed effort above that in the approved J&A due to the added costs of laboratory space, personnel, safety and surety for each 28-day period.

3. Statutory Authority

The statutory authority for this non-competitive action is: 10 United States Code (U.S.C.) 2304(c)(1) or 41 U.S.C. 253(c)(1), as implemented by FAR 6.302-1, Only One Responsible Source. The statutory authority remains unchanged for Amendment 0001.

4. Applicability of Authority

The applicability of authority for Amendment 0001 remains unchanged from the original Justification for Other Than Full and Open Competition. As noted in the original justification, the previous two efforts (Tasks 6 and 9 under contract W81XWH-11-D-0002) were envisioned by DTRA J9CBS as a means to assess the hazard posed to mortuary affairs (MA) personnel by chemically contaminated remains.

The Government-owned equipment for the above efforts is currently being stored at Battelle’s facilities from previous use. The costs associated with decontaminating, handling and shipping to a separate contractor are estimated to be approximately $450,000. The testing and reports from Tasks 6 and 9 could be passed on to another contractor, however this would not incur any savings. It is the industry standard for labs to confirm the original results to ensure lab-to-lab consistency and worker safety. This would incur costs of approximately $460,000 (the combined costs of the Tasks 6 and 9).

Awarding this new requirement to a different contractor would result in a significant delay and cost to the government due to the need to decontaminate, handle and ship all equipment previously used by Battelle for previous efforts, as well as repeat all testing previously accomplished under the tasks noted above. Sole-sourcing to Battelle is a logical follow-on and will save the Government approximately $910,000.

5. Effort to Solicit Potential Sources

In accordance with FAR 5.201, a notice of intent to execute a sole source contract based on the original Justification for Other Than Full and Open Competition was synopsized in Federal Business Opportunities (FedBizOpps) on November 17, 2015. There were no sources that expressed an interest in proposing on this requirement. An updated notice of intent is not considered necessary for Amendment 0001 as the Contracting Officer has determined that the factors contributing to the ceiling increase are consistent with the rationale outlined in the original Justification for Other Than Full and Open Competition.

6. Fair and Reasonable Costs

The anticipated cost/price of this contract action to the Government will be determined to be fair and reasonable based on technical evaluations from the DTRA Program Office, analysis of cost and pricing data, field pricing support from Defense Contract Management Agency (DCMA) and/or Defense Contract Audit Agency (DCAA) as required, and an analysis of the proposed costs against historical program cost data and information.

7. Market Research

In accordance with Federal Acquisition Regulation (FAR) part 10, market research has been conducted. Continuous market surveillance of the capabilities, expertise, and development experience of the many performers currently doing work for DTRA J9CBS is ongoing, as well as the effectiveness of the Standard Operating Procedure regarding decontamination and return home of contaminated human remains.

Based on the results of the research outlined in the original J&A, it is determined that the most efficient and expedient method to meet this requirement is to continue the requirement as a sole source contract to Battelle Memorial Institute because this is a logical follow-on to work previously performed by Battelle in support of DTRA and JMAC requirements under W81XWH-11-D-0002, Tasks 0006 and 0009. Changing the performer would result in significant additional funds, time, and materials which would significantly delay the deliverable and meeting DTRA and Stakeholder requirements.

Based on continuous market surveillance and the original competitive process, it is determined that no new evidence exists, nor is there any reason to believe, that a greater value source could be obtained by issuing a new solicitation nor is there any reason to believe the marketplace has changed for this type of specific work. The market research conducted supported the acquisition strategy to award a follow-on contract to continue the research with Battelle, as this would provide the government the desired animal model in both the most expedient and cost effective manner.

8. Other Facts

None

9. Interested Sources

The only known source is Battelle. As indicated in paragraph 5, there were no sources who expressed interest regarding the notice of intent posted in FedBizOpps.

10. Subsequent Actions

Should any further development be required, the technical data, computer software, and software documentation created during this program would be used to support the new procurement and opportunities for interested parties.

Technical Certification

I certify that the data and information forming the basis for this justification are accurate and complete to the best of my knowledge and belief.

Project Manager

Contracting Officer Certification

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

Contracting Officer

General Counsel Coordination

This justification is legally sufficient.

Attorney

Approval

Based on the above justification, I hereby approve accomplishment of this acquisition by means other than using full and open competition.

Competition Advocate

BRAXTON.ELIZAB

ETH.R.1231040222

Digitally signed by

BRAXTON.ELIZABETH.R.1231040222

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=DTRA, cn=BRAXTON.ELIZABETH.R.1231040222 Date: 2016.06.22 13:30:38 -04'00'

Defense Threat Reduction Agency and

United States Strategic Command Center for Combating Weapons of Mass Destruction

8725 John J. Kingman Road, Sto p 6201 Fort Belvoir, VA 22060-6201

Analysis of CWA Contaminated Swine Remains

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Nature and/or Description of Action

The Defense Threat Reduction Agency contracting activity proposes to procure without using full and open competition a follow-on effort entitled “Analysis of CWA1

Contaminated Swine Remains.” Battelle will be the only contractor solicited to provide the required technical effort.

2. Description of the Supplies/Services Required

The proposed effort is for the purpose of testing decontamination procedures in a large animal in order to support the return home of battlefield contaminated human remains.

Policy as stated in Department of Defense Directive (DODD) 1300.22, Mortuary Affairs Policy, is that the human remains of all members of the Armed Forces of the United States will be returned for permanent disposition. In order to comply with this policy in a Joint Publication 4-06 describes Mortuary Affairs (MA) and Chapter VII of this Joint Publication outlines MA operations in a chemical, biological, radiological, and nuclear (CBRN) environment to include roles and responsibilities, planning factors, and personnel, equipment, and support requirements. The Tactics, Techniques and Procedures for MA in a CBRN contaminated environment are developed by the Joint Mortuary Affairs Center (JMAC). In order to ascertain the effectiveness of the Mortuary Affairs Contaminated Remains Mitigation Site (MACRMS) Concept and Proposed Tactics, Techniques, and Procedures Version 2.0 Standard Operating Procedure regarding decontamination and return home of contaminated human remains, the Defense Threat Reduction Agency has initiated a research program to investigate the procedure. This task is in support of the JMAC and the Contaminated Human Remains – Tiger Team (CHR-TT) Program and will test 4 agents and a revised set of decontamination procedures to assess the hazard remaining after decontamination to ensure that it is safe to return previously contaminated remains home for final disposition.

The proposed 12 month effort will be a logical follow-on to the work performed at Battelle Memorial Institute (BMI) under W81XWH-11-D-0002, Tasks 0006 and 0009. The previous contract, W81XWH-11-D-0002, was a single-vendor Indefinite Delivery Indefinite Quantity (IDIQ) contract issued under full and open competition out of the contracting offices at United States Army Medical Research Acquisition Activity (USAMRAA) in support of United States Army Medical Research Institute of Chemical Defense (USAMRICD), The Joint Program Executive Office Medical Chemical Systems (JPEO MCS) and DTRA/J9CB. W81XWH-11-D-0002 Task 0006 determined the hazard remaining after gross contamination with selected chemicals without any decontamination.

W81XWH-11-D-0002 Task 0009 determined the hazard remaining after gross

1 chemical warfare agent contamination with VX both with and without following the MACRMS protocols for decontaminating chemically contaminated remains. While both efforts were successfully completed and reports delivered, the efforts demonstrated the need for additional research to decrease the hazard posed to mortuary affairs staff and others handling contaminated remains.

The proposed effort is estimated to cost $700,275.80 based on an independent government cost estimate (IGCE) performed by the DTRA/J9CBS PM and support team. This cost was estimated based upon previous similar studies under W81XWH-11-D-0002, Tasks 0006 and 0009, as well as animal studies at other performing agencies such as Edgewood Chemical Biological (ECBC) and United States Army Medical Research Institute of Chemical Defense (USAMRICD) under CB3281 and CB3949.

3. Statutory Authority

The statutory authority for this non-competitive action is: 10 United States Code (U.S.C.) 2304(c)(1) or 41 U.S.C. 253(c)(1), as implemented by FAR 6.302-1, Only One Responsible Source.

4. Applicability of Authority

Battelle Memorial Institute (BMI) served as the contractor for the previous two efforts (Tasks 6 and 9 under contract W81XWH-11-D-0002) to assess the hazard posed to mortuary affairs (MA) personnel by chemically contaminated remains. Awarding this new requirement to a different contractor would result in a significant delay and cost to the government due to the need to decontaminate, handle and ship all equipment previously used by Battelle for previous efforts, as well as repeat all testing previously accomplished under the tasks noted above.

The equipment noted above is owned by the Government, however it is currently being stored at BMI’s facilities from previous use. The costs associated with decontaminating, handling and shipping to a separate contractor are estimated to be approximately $450,000.

The testing and reports from Tasks 6 and 9 could be passed on to another contractor, however this would not incur any savings. It is the industry standard for labs to confirm the original results to ensure lab-to-lab consistency and worker safety. This would incur costs of approximately $460,000 (the combined costs of the Tasks 6 and 9).

Based on the information above, the Government would incur significant and unreasonable costs if this requirement was competed. Sole-sourcing to BMI would be a logical follow-on and save the Government approximately $910,000. In accordance with the authority cited in paragraph 3 above, BMI is the only responsible source for this procurement. This prevents a substantial duplication of costs and prevents unacceptable delays of approximately 8-12 months.

5. Effort to Solicit Potential Sources

The prior IDIQ contract, W81XWH-11-D-0002, was the result of a full and open competition under a request for proposal (RFP) through USAMRAA. The single awardee of this IDIQ contract was Battelle Memorial Institute (BMI). Because the prior contract was based on the unique solutions proposed by BMI and because this effort will represent a logical follow-on to the work previously completed by BMI under Tasks 0006 and 0009 of IDIQ Contract W81XWH-11-D-0002, no other sources will be solicited. However, as outlined in Section 7 below, DTRA/J9CBS conducts continuous market surveillance to ensure that its current and planned projects are represented by state-of-the-art scientific and technical approaches.

Further, a notice of intent to award a sole source contract will be posted to FedBizOpps, which will allow another opportunity for other potential sources to present their capabilities, which will then be considered.

6. Fair and Reasonable Costs

Once a in receipt of Battelle’s proposal, DTRA will analyze cost and pricing to ensure a fair and reasonable cost to the Government. This will be accomplished by performing a price analysis on labor, materials and other direct costs, as well as utilizing DCMA and DCAA for any available information with respect to the contractor's indirect rates. A technical evaluation will be performed to determine the reasonableness of proposed labor hours, materials, travel, and certain other direct costs.

7. Market Research

In accordance with Federal Acquisition Regulation (FAR) part 10, market research has been conducted. Continuous market surveillance of the capabilities, expertise, and development experience of the many performers currently doing work for DTRA J9-CBS is ongoing, as well as the effectiveness of the Standard Operating Procedure regarding decontamination and return home of contaminated human remains. In addition, the following actions were taken to query the current market.

Meetings, industry days, or pre-solicitation conferences with potential offers were conducted.

• DTRA Advanced and Emerging threat Division Project Level Science and Technology (S&T) Review - August 13-17th, 2012 (Arlington, VA); July 23-25th, 2013 (Lorton, VA);

July 29-August 1, 2014 (Edgewood, MD); and July 20-24th, August 12-13th, 2015 (Lorton, VA).

• Technical Conferences (e.g. Society of Toxicology (2011, 2012, 2015), and DTRA CB Conferences (2008, 2009, 2010, 2011, 2015)).

• NTA2 Deep Dives (Deep Dive 2: 7-8 February 2011; Deep Dive 3: 18-19 October 2011; Deep Dive 4: 13-14 December 2011; Deep Dive 5: 17-18 April 2012; Deep Dive 6:

2 non-traditional agent

7-8 August 2012; Deep Dive 7: 8-9 January 2013; Deep Dive 8: 19 June 2013 (Arlington, VA; Falls Church, VA; Edgewood, MD)).

Requests for Information on (RFI) were posted on FedBizOpps.

• HDTRA1-12-ETADEF-RFI, November 2011

• HDTRA1-14-WMD-RFI-CBS-0001, May 2014

HDTRA1-12-ETADEF-RFI was issued in November 2011 as a supplement to the COR’s existing knowledge of the marketplace from attendance at scientific, technical and programmatic meetings, as well as previous BAAs, to determine whether any unknown providers of the desired capabilities may exist, and 11 businesses were identified as capable of handling chemical threat agents, including non-traditional agents, and also handling, generating and storing classified material. A review of the responses indicates that most of the respondents failed to demonstrate sufficient knowledge of requirements, failed to address required capabilities or did not appear capable of performing all of the required tasks. Furthermore, additional time to train new performers would greatly hinder time-sensitive work.

Market research was performed for potential businesses that can perform work with classified agents. Such businesses must have cleared personnel, secure facilities, and laboratories certified by government authorities for hazardous work. Only a handful of businesses have this capability, and among them is Battelle Memorial Institute. The businesses identified are as follows:

No new small businesses were identified which are capable of performing work with classified agents. These RFI results from 2011 should still be considered current because the COR has maintained knowledge of the marketplace and there have not been additional performers in this space that have presented at national or international meetings. Additionally, the RFI discussed below did not identify any additional performers. Finally, while these results demonstrate that there are performers who are qualified to complete this follow-on effort, as indicated above, changing from Battelle to a new contractor for the follow-on effort would result in a substantial duplication of time, 12 months, and cost, (approximately, $460,000.00). If another contractor would take over study design, set up and implementation as well as agent synthesis and transport, this would result in a significant cost to the Government in delaying deliverables and technical capabilities, as well as equipment, procurement and training costs.

As another market research action, RFI HDTRA1-14-WMD-RFI-CBS-0001 was issued in May 2014 to assess if any of the prime contractors and their teams on the DTRA WMD IDIQ had the existing capabilities, infrastructure and personnel resources for performing both theoretical and practical hazardous material defense related research, development, test and evaluation (RDT&E) in support of the goals of the Threat Agent Characterization and

Countermeasure Branch. If the RFI results were to indicate that the IDIQ performer teams did possess the requisite technical capabilities, a further inquiry could be made to assess the estimated cost for completing this follow-on effort to determine whether another viable source may exist. A review of the responses to this RFI determined that 4 of the prime contractors had capability to do such research, but only because of the subcontractors on their teams. It was also determined that because of the nature of the research required by the Threat Agent Characterization and Countermeasure Branch, the prime contractors, largely serving in a “pass-through” capacity, were not value added and therefore did not demonstrate a need-to-know about the requirements or the compounds of interest and could not be informed of them without violating the USG Protect and Suppress Policy. The memorandum documenting this policy is classified SECRET and can be supplied on a need-to-know basis to appropriately cleared personnel. Therefore, it was determined by the COR and the Contracting Officer that the requirement could not be met via the DTRA WMD IDIQ, irrespective of cost considerations.

Based on the results of the above research, it is determined that the most efficient and expedient method to meet this requirement is to continue the requirement as a sole source contract to Battelle Memorial Institute because this is a logical follow-on to work previously performed by Battelle in support of DTRA and JMAC requirements under W81XWH-11-D- 0002, Tasks 0006 and 0009. Changing the performer would result in significant additional funds, time, and materials which would significantly delay the deliverable and meeting DTRA and Stakeholder requirements.

8. Other Facts

None

9. Interested Sources

As addressed above, Battelle is currently the source planned to be solicited for this follow-on effort; however, a notice of intent to award a sole source contract will be posted to FedBizOpps, which will allow other interested sources to present their capabilities.

10. Subsequent Actions

During the course of the proposed follow-on effort, the program manager will continue market surveillance of the work being done in the area of investigating the decontamination procedures. Should future agency needs require additional work in the area of decontamination into a similar area, the ongoing market surveillance will provide insight into the appropriate acquisition strategy. The deliverables of technical data, and documentation developed during this follow-on effort will be used to sufficiently describe the science and technology and methods used, such that future work could reasonably be performed by other qualified performers. Should any further development be required, the technical data, computer software, and software documentation created during this program would be used to support the new procurement and opportunities for interested parties.

11. Approvals

Technical Certification

I certify that the data and information forming the basis for this justification are accurate and complete to the best of my knowledge and belief.

Project Manager

Contracting Officer Certification

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

Contracting Officer (<$550K)

General Counsel Coordination

This justification is legally sufficient.

Attorney

Approval

Based on the above justification, I hereby approve accomplishment of this acquisition by means other than using full and open competition.

Competition Advocate

NUCKOLS.BRIAN

.D.1280774452

Digitally signed by

NUCKOLS.BRIAN.D.1280774452

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=DTRA, cn=NUCKOLS.BRIAN.D.1280774452 Date: 2015.11.05 09:52:12 -05'00'