A03-Redacted_JA17147_18-D-0019.pdf

Control Number: JA17147

FOR OFFICIAL USE ONLY| P a g e

Justification Review Document for Other Than Full and Open Competition

Program/Equipment: Datatron(Datatron EXT System), an environmental monitoring system which includes providing the hardware and software solutions

Authority: FAR 6.302-1(a) (2) (iii) (A), Only One Responsible Source

Amount: $2.0 Million

Prepared by:

Typed Name: _Mr. Timothy Cannon_

Title: _Contracting Officer Representative

Phone: 301-319-9083

Date: 14 August 2017

E-Mail: timothy.w.cannon3.civ@mail.mil

Contracting Officer:

Typed Name: _Laura A. Tomitz Phone: 301-319-2051

E-mail: laura.a.tomitz.civ@mail.mil Date: 14 August 2017

Technical Representative:

Typed Name: Mr. Timothy Cannon Phone: 301-319-9083

Title: Contracting Officer Representative Date: 14 August 2017

Requirements Representative:

Typed Name: __Mr. Bruce Davis_____ Phone: __ 301-319-9397_______

Title: _Director, IMO, WRAIR Date: 23 August 2017

CANNON.TIMOTHY.WAYNE.1045029928 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=CANNON.TIMOTHY.WAYNE.1045029928Signature: Date: 14 August 2017

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Contracting Officer Representative:

Typed Name: Mr. Timothy Cannon Phone: _301-319-9083

Digitally signed by CANNON.TIMOTHY.WAYNE.1045029928

Legal Counsel:

Typed Name: CPT Scott Luu Phone:301-619-9879

Signature:

Digitally signed by LUU.SCOTT.1384974984

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=LUU.SCOTT.1384974984

Date: 2017.08.18 09:39:29 ‐04'00' Date: 18 August 2017_

LUU.SCOTT.1384974984

Justification and Approval for Other than Full and Open Competition

Justification

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD on behalf of the Walter Reed Army Institute of Research, WRAIR.

2. Description of Action: Approval is requested for a sole source, Indefinite Delivery / Indefinite Quantity (IDIQ) contract for a period of performance of one 12-month base and four

(4) 12- month options to R&D Scientific. R&D Scientific is the current contractor providing WRAIR and the Naval Medical Research Center (NMRC) with an environmental monitoring system (Datatron EXT System) which includes providing the hardware and software solutions, as well as installation, calibration, validation, and maintenance of the temperature, humidity, CO2, a n d pressure monitoring in freezers and refrigerators. The environmental monitoring system is required in order for the WRAIR / NMRC’s ongoing studies to maintain Food and Drug Administration (FDA) compliance as well as academic integrity. This is a follow-on requirement of environmental monitoring services currently provided by R&D Scientific under contract W81XWH-13-D-0012. RDT&E funds shall be used to award task orders.

3. Description of Supplies/Services:

The contractor performs 24x7 365 days per year Original Equipment Manufacturer (OEM)-recommended preventive, remedial, and emergency maintenance service required on a Government owned Datatron EXT System, SN: 18ZY9F1 and all components thereof, in accordance with the Original Equipment Manufacturers (OEM) instructions. This includes the purchase of various temperature, humidity, CO2, and pressure probes and nodes for installation and calibration. The equipment is currently located at WRAIR/NMRC, buildings 500, 501, 503,508, 509 and 511, on the Forest Glen annex, in Silver Spring, Maryland. Buildings 501 and 511 are currently under renovation but are expected to be a part of this award in the outyears. The contractor provides a 24 hour hotline and response to request for repair service within 48 hours of request.

In accordance with FDA regulations, WRAIR/NMRC must have an environmental monitoring system in place to monitor and protect Temperature Sensitive Materials (TSM) for various research efforts and bio production initiatives. If a monitoring lapse occurs, activities requiring Good Manufacturing Processes (GMP), as outlined in the Federal Food, Drug, and Cosmetic Act (FD&C Act), section 501(a)(2)(B), Good Laboratory Processes (GLP), as outlined in 21 CFR 58, and Good Clinical Practices (GCP), as outlined in ISO 14155, involving TSM would be compromised.

It is estimated that the contractor will be required to install new points (calibration monitoring units, also called probes) for the WRAIR / NRMC facilities at a rate of approximately 40 points per quarter. This number is based on the historical information of installed points.

The estimated cost of this contract will be $2 million for the base plus 4 year period.

4. Authority Cited: The statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c) (1). The FAR citation is 6.302-1(a) (2) (iii) (A), and the FAR c i tat ion title is only one responsible source and no other supplies or services will satisfy a g e n c y requirements.

5. Reason for Authority Cited:

The WRAIR/NMRC currently has R&D Scientific’s Datatron environmental monitoring system installed throughout the center to monitor TSM in accordance with regulatory compliance and DOD’s cyber security requirements. There are currently 1082 data points (with increases up to approximately 1100 data points / channels) active in WRAIR / NMRC.

R&D Scientific’s environmental monitoring system must be maintained at WRAIR/ NMRC for the following reasons:

A.COST DUPLICATION

This 12-month base period and four (4)12-month option periods contract award is necessary for the efficiency and cost effectiveness of the environmental monitoring system for the Government. The Datatron (EXT) system is essentially a capital asset and systems investment of hardware, software, and maintenance. The annual cost of maintaining the current system is approximately $400k/year or $2.0M for 5 years.

The Government has made an investment in the components of this system. There are basically four elements where cost duplication cannot be recovered through competition:

a) cost of probes—sunk cost of inventory; There are eleven different probes and nodes that proprietary to R&D Scientific. They cannot be used with other environmental monitoring systems which have their own probes and nodes. The current inventory of 1082 probes has a value of approximately $700,000 which cannot be recouped.

b) sunk cost of maintenance, installation, and calibration is valued at approximately $200,000 which has already occurred for this year. These services would restart with a new contractor and reflect a loss to the Government which cannot be recouped.

c) purchase of a new system would be approximately $1.7 million in the first year. This is the base cost not including the phase in cost. A competitive action could have of the effect of potentially having a new contractor. A new contractor would require the removal of the current 1082 R&D Scientific probes, installation of new probes, and calibration of all newly installed probes, and annual maintenance of said probes. A complete new contract to a different contractor would require one year to changeover to include running two systems side by side as one system is phased out and another one comes on line and is validated.

d) necessary time to change over inclusive of running two systems concurrently for one year (Phase in – Phase out) valued at approximately $600,000.

e) life cycle of software and hardware is approximately 10 years of useful life and return on investment. WRAIR has additional TSM requirements which to date, are in the market research phase. These needs are discussed below. They are only factored into this requirement as they represent the totality of WRAIR’s TSM needs and are part of the changing environmental monitoring landscape. The Government is not exercising the 4th

Option period on the current Datatron contract due to scope issues.

Total cost to bring on a new system in the first year $2,300,000. (c+d)

Loss to the government in the first year $1,500,000 (a+b+d)

Duplicative cost to the Government in the first year $3,800,000 ($2,300,000 + $1,500,000)

B. OWNERSHIP OF PROPRIETARY DATA AND PROBES

All components of the R&D Scientific Datatron EXT system are proprietary. In order to be operational, all components (software and hardware) must be compatible with each other. R&D Scientific Corporation, 272 Route 206, Flanders, NJ 07836-9163 has proprietary rights of the installed Datatron EXT System that uses company owned methods allowing for the maintenance of the system. All system program files and database files are proprietary information and password protected. R&D Scientific Corporation has not authorized other vendors to do this work nor have they issued factory passwords outside of R&D Scientific.

The Datatron system is also compliant with Risk Management Framework (RMF) requirements outlined in NIST Special Publication 800-53 Security and Privacy Controls for Federal Information Systems and Organization. Meeting RMF standards is a requirement of DOD network systems.

C. FDA REQUIRING FOR PROTECTING TSM

A lapse in service would be in violation of the required F D A regulatory practices. It is estimated that there could be as much as $10M of material related to Research and Development efforts lost should WRAIR suffer a lapse in monitoring. Current estimates predict that there would be in excess of $10M lost in our regulated laboratories should a lapse in monitoring happen. A lapse would also place research animals at risk, since the system is used to monitor the temperature and humidity of animal storage areas. It is not possible to measure the dollar amount associated with the many years of research that would have to be recreated to continue moving forward with new science. Some samples are unable to be recreated or replicated and will therefore be irreplaceable in the event of a failure that was due to a lapse in monitoring. It is also not possible to place a price on the credibility WRAIR would lose with external partners (some commercial) who have paid the Institute to produce materials for use in clinical trials.

D. WRAIR / NMRC CHANGING REQUIREMENTS

A 12-month base period and 4 12-month option periods sole source contract will allow WRAIR /NMRC to insure the full return on investment of the current system, develop and mature the full TSM requirement, and insure sufficient time to phase in a new system. WRAIR TSM requirements now include the need to inventory and mark all its refrigerated and frozen samples and reduce its Building 503 power draw by off-siting as much of their refrigerated /frozen specimens.

In accordance with TSM changing requirements, WRAIR is developing its need for a freezer farm outside of WRAIR’s Forest Glen Annex site. An off-site freezer farm facility will accomplish two benefits, namely it will serve to reduce the number of specimens needing to be held in the WRAIR facility to a reduced and necessary level; and it will reduce the energy consumption for freezer/refrigerator needs as the power draw is beyond the building capacity.

WRAIR’s requirements also include the need to tag each of its specimens for inventory purposes as directed by DOD.

Each one of these services is tied to the new environmental monitoring requirement. They represent the totality of TSM monitoring and cause a ripple effect for a new environmental monitoring system, which would need to include these separate components for the total change of the requirement.

6. Efforts to Obtain Competition:

No efforts have been taken to obtain competition since the competitive award of W81XWH-13- D-0012. R&D Scientific has full rights to the system and no other vendor can provide services to R&D’. This contract was previously competed; however, a needed surge increased the number of points needed significantly, which consequently caused the accelerated use of the maximum quantities and the elimination of the fourth option period.

A Request for Information (RFI) was published in Federal Business Opportunities on 1 May 2017 announcing the Government’s requirement for these monitoring services.

Responses to the announcement were due on 8 May 2017. Only 1 vendor, Barca Strategy submitted a Capability Statement. The COR reviewed and found the capability statement as unacceptable as they did not specifically discuss or address requirements for temperature sensitive medical procedures storage and handling of SB-875-11, or being capable of full validation to the desired Good Manufacturing Practice(GMP)/FDA/Good Laboratory Practices, (GLP) standards.

a. Effective Competition. The follow-on award for this IDIQ shall be competed.

b. Subcontracting competition. Subcontracting is not anticipated as R&D Scientific is a Small Business, therefore, subcontracting is not required.

7. Actions to Increase Competition:

An industry assessment will continue to determine potential products and offerors. An industry day may be considered to aid in this process.

Additional time is needed to assess the needs of WRAIR’s two major building renovation projects and with the establishment of an off-site freezer farm. Renovations in Building 501 (Pilot Bioproduction Facility) will be completed in April 2019 and Building 511 (Veterinary Services-Animal Holding Facility) will be completed in January 2019. It is estimated that 192 points will be installed and calibrated between the two buildings.

8. Market Research:

It has become clear there are other TSM monitoring products that may meet the WRAIR requirements that did not respond to the RFP when W81XWH-13-D-0012 was competed.

WRAIR has identified Mesalabs, REES, and VaLogic, LLC which would potentially meet the requirements in the future. It is unknown if any of these systems can meet RMF.

Market research is still being conducted using internet searches, discussions with sister research facilities and multiple vendor representatives.

9. Interested Sources:

A notice was published in Federal Business Opportunities on announcing the Government’s intent to procure via sole source to provide environmental monitoring hardware and software that is currently installed throughout the Walter Reed Army Institute of Research (WRAIR)/ Naval Research Medical Command (NMRC) campus for the monitoring of Temperature Sensitive Materials (TSM). Responses to the announcement were due on 25 May 2017. There were no responses from any companies or institutions.

10. Other facts: Discuss any other facts supporting the use of other than full and open competition, such as the following:

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

(1) The following contract numbers and dates represent individual WRAIR departmental one-time buys:

W81WXH-08-P-0506 – 1 June 2008 – 31 Jul 2008 Calibration only W81XWH-11-P-0490 – 9 Sep 2011 – Installed 10 points in Experimental Therapeutics;

W81XWH-11-P-0502 – 15 Aug 2011 – 14 Sep 2011 – Installed Datatron at Pilot

Bioproduction Facility;

W81XWH-11-P-0614 – 01 SEP 2011 to 31 Aug 2013 – Maintenance and

Calibration;

W81XWH-13-P-0627 - 01 OCT 2013 to 31 DEC 2013- Calibration only;

W81XWH-13-D-0012 - 01 JAN 2014 – Current contract; WRAIR’ s first attempt at a comprehensive contract award for all of WRAIR ’ s departmental needs

(2) Competitive status of these actions.

The only contract mentioned above that was competed as Full and Open Competition was W81XWH-13-D-0012 while the rest were competed as Other than Full and Open Competition

(3) Authority previously used for less than full and open competition.

Awards W81XWH-08-P-0506, W81XWH-11-P-0490, W81XWH-11-P-0502, W81XWH-11-P- 0614, and W81XWH-13-P-0627 were awarded under FAR 6.302.1 (only one responsible source and no other supplies or services will satisfy agency requirements). The current award (W81XWH-13-D-0012) was competed Full and Open Competition in 2013.

(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.

Not Applicable

(5) If any prior award was accomplished by full and open competition, a detailed explanation of the changed circumstances.

When W81XWH-13-D-0012 was competed and awarded, the WRAIR did not know that buildings 501 and 511 would have MILCON awards made to renovate and expand mission. Additionally, the WRAIR was not intending to create an off-site freezer farm.

After a substantial loss of TSMP material during option year one of W81XWH-13-D-0012, the Command mandated that all TSMP material be placed on electronic monitoring to prevent future losses. The original contract requirements awarded on this contract were based upon a study which captured the growth, needs needed to support the WRAIR\NMRC mission of the previous seven years and the known requirements for the next five. The estimated quantities ended up being greatly outpaced by actual needs to the point where the CLIN quantities were used up before the period of performance ended. This was due to a large loss of product when it was realized that there was insufficient monitoring occurring.

WRAIR is also in the process of defining the scope of an off-site freezer farm to be established in FY18. This effort began with the award of W81XWH-11-D-0021-0107 with a Period of Performance of March 23, 2015 to June 5, 2015 to provide a full inventory of current TSMP storage devices. This was the first step taken to support the implementation of the TSMP.

Program at WRAIR that is compliant with DA SB 8-75-11 (20 NOV 2013). An engineering analysis was conducted by WRAIR Facilities division to determine heat signatures and power draws in each of the equipment rooms housing these units. This process is currently ongoing, and upon completion, WRAIR can finalize the number of temperature sensitive samples capacity in building 503 to determine not only what level of samples can remain but to determine the level of off-site freezer space required.

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

None

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the buy and whether there have been any significant changes.

The current contract was not sole sourced.

b. Other facts. Provide any other facts necessary to justify limiting competition that were not previously discussed.

None

11. Technical Certification: Include the following statement:

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.

Timothy Cannon Date Information Management Division

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.

Timothy Cannon Date Information Management Division

13. Fair and Reasonable Cost Determination: Include the following determination:

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

R&D is the incumbent vendor for the Datatron EXT system utilized throughout WRAIR/NRMC. This system is proprietary. This new total is anticipated to be commensurate, with a reasonable escalation, to the costs of the past and current awards. This increase is a standard and acceptable business practice given the economy and the type of preventative maintenance, multiple calibration and installation service being provided. Based on historical data and price analysis, the anticipated cost is determined to be fair and reasonable. These are commercial products and services. Certified cost and pricing data is not required.

Digitally signed by TOMITZ.LAURA.A.1016349271

TOMITZ.LAURA.A.1016349271 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=TOMITZ.LAURA.A.1016349271

Date: 2017.08.14 10:52:56 ‐04'00'

Laura A. Tomitz Date Contracting Officer

14. Contracting Officer Certification. This certification shall be made by the Contracting Officer from this justification and approval. Include the following statement:

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

TOMITZ.LAURA.A.1016349271

Digitally signed by TOMITZ.LAURA.A.1016349271

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=TOMITZ.LAURA.A.1016349271 Date: 2017.08.14 10:53:26 ‐04'00'

Laura A. Tomitz Date Contracting Officer

15. Legal Sufficiency Review:

Based on the information provided in this document, I hereby determine this justification for other than full and open competition to be legally sufficient.

Typed Name: CPT_Scott Luu Date:

Title: _Contract_and Procurement Fraud Attorney Signature:

LUU.SCOTT.1384974984

Digitally signed by LUU.SCOTT.1384974984

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=LUU.SCOTT.1384974984

Date: 2017.08.18 09:40:37 ‐04'00'

Approval Special Advocate for Competition

Based on the foregoing justification, I hereby approve the procurement of Datatron(Datatron EXT System), an environmental monitoring system which includes providing the hardware and software solutions on an other than full and open competition basis pursuant to the authority of 10 U.S.C.2304(c)(1), FAR 6.302-1(a) (2) (iii)(A), Only One Responsible Source, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Date: Signature:

Chris.sherman Typewritten Text

Chris.sherman Typewritten Text Christopher E. Sherman Special Advocate for Competition

Chris.sherman Typewritten Text 08/23/2017