J&A_Redacted.pdf

Control No: JA17084

"For Official Use Only”

Sole Source Justification (SSJ) in accordance with FAR subpart 13.5 using Simplified Acquisitions Procedures (SAP)

Mammography Reporting System 7 (MRS7 Reporting) Software

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

Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Ft Detrick, MD, 21702.

2. Requiring Activity: The Requiring Activity responsible for this action is the U.S.

Army Medical Materiel Agency (USAMMA), 693 Neiman Street, Ft Detrick, MD, 21702.

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a) ** See FAR 12.207(b).

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price: ________

**Time & Materials: ________

* Cost: ________

Funds: RDT&E Operations and Maintenance, Army (OMA)

Other Funds: Defense Health Program, Procurement

Fiscal Year of Funds: _FY2015/2016/2017_____

Estimated Total Dollar Value including Options: $ __

4. Contractor Name:

Name of Proposed Contractor: Mammography Reporting System Inc.

Attn:

Street Address: 19000 33rd Ave W, Suite 130 City, State, Zip: Lynnwood, WA 98036 Phone: (800) 253-4827, ext. 1746

DUNS: 787948405

Cage Code: 1BTF5

"For Official Use Only”

5. Description of Supplies/Services: The Army Radiology Picture Archive and Communication Systems (PACS) office within the U.S. Army Medical Materiel Agency (USAMMA) is seeking the Mammography Reporting System 7 (MRS7 Reporting) reporting software. MRS7 Reporting is a software database that tracks the Food and Drug Administration (FDA) mandatory requirements for passing the Mammography Quality Standards Act annual inspection and keeping track of patient past medical history related to breast imaging. The Army PACS Office centrally manages the procurement of Radiology PACS and software products that operate in conjunction with the PACS Systems. The Army Medical Department (AMEDD) has 26 facilities which are operating on different versions of MRS. The goal is to bring all facilities to the same version and to procure MRS7 Reporting for those facilities that are not using a tracking and reporting software system. The period of performance for this contract will include a one (1) 12-month base period with four (4) 12-month option periods to allow for annual software maintenance and support.

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: Only one responsible source and no other supplies or services will satisfy agency requirements. This requirement is for the purchase, installation, training, and annual maintenance of commercial software. MRS, Inc. is the only company in the marketplace to offer an approved Government bi-directional Health Level Seven (HL7) feed to the Composite Health Care System (CHCS). This is crucial for the documentation of medical information into the patient medical record, which will follow a patient from DoD facility to DoD facility. The process time for this and other companies to complete and obtain approval to connect to CHCS will take approximately two years, which is outside the time line for implementation for upgrades to existing facilities and for new installations. Additionally, with the implementation of the new electronic health records, this range may increase given the many unknowns with connecting new systems. MRS, Inc. is the only vendor that has met and passed requirements for Defense Information Assurance Certification and Accreditation

(DIACAP).

MRS is currently operational at 26 hospitals that provide mammography services.

Software upgrades will offer a continuity of medical information; reduce the learning curve of learning a new system as well as training costs, therefore offering savings to the Government while standardizing the remaining facilities across the AMEDD.

There are many of the features of MRS7 Reporting software that are unique and are not found in any other software available in the commercial market place. For example, MRS7 Reporting offers a user interface integration that seamlessly integrates, and operates within both AGFA Impax and Fuji Synapse PACS environments without logging out of one program into another. AGFA and Fuji are the two PACS systems deployed throughout the AMEDD and concurrent integration is of paramount importance; the close integrations with the PACS ensures providers are able to work within both software environments simultaneously while information and images are passed between systems without manual intervention. The automatic transmission of images enables a seamless workflow to the provider ensuring urgent patient exams are completed in a timely manner, and interpretations provided by the radiologists are captured in both the PACS and the Radiology Information System (CHCS).

If MRS7 Reporting is not procured, the impact to the Government’s ability to stay in compliance with FDA mandates may be jeopardized. In order for a AMEDD facility to practice mammography, the facility must pass a yearly FDA inspection to insure compliance with documentation, notification, tracking, safety, and Quality Assurance (QA)/Quality Control (QC). This software enables facilities to meet these mandates in a matter consistent throughout the enterprise. Without the MRS7 Reporting software, the Army will continue to use pen/pencil and paper to document these data requirements which places the facility at increased risk of human error. On average a AMEDD facility completes approximately 400-900 mammography exams a month. A facility that fails Mammography Quality Safety Act inspection is rendered unable to perform exams and these exams will have to be sent to a civilian medical facility at a premium cost to the Government.

8. Efforts to obtain Competition: A sources sought synopsis was posted on FedBizOpps (FBO) for a similar requirement awarded on 4 March 2016 (contract number W81XWH-16-P-0097). This Sources Sought Notice was posted on 22 October 2015 under solicitation number W81XWH-16-T-0008 and no responses were received.

This posting included the Statement of Need and Minimum Essential Characteristics (MECs) for the required mammography reporting software. The intent was to find as many potential sources as possible that would be able to fulfill the requirement.

Therefore, as this previous market research failed to locate any additional sources, the Government intends to negotiate directly with MRS, Inc. for the purchase, installation, and annual maintenance of the MRS7 Reporting software.

a. Effective competition. Based on results of the Sources Sought Notice, the expectation is there are no sources capable of providing a solution that would meet

USAMMA’s requirement. Therefore, this procurement action will be accomplished on a sole source basis.

b. Subcontracting competition. Not applicable; as this is a supply-type requirement, the Government does not anticipate subcontracting competition opportunities.

9. Actions to remove or overcome barriers Competition: USAMMA will continue to monitor the commercial market and will also consider open competition for future procurement actions if the opportunity is possible. Additionally, the Government may post a Request for Information (RFI) for any future procurement to FedBizOpps to determine if there are sources available in the market place that can meet the Government’s need. If responses from an RFI posting show that there are competitors in the marketplace, future acquisitions may be competed.

10. Market Survey: USAMMA has conducted market research during the period of October and November 2016 through Internet searches and review of manufacturer brochures. One of the specific manufacturers reviewed during the market research efforts is MagView which is a company that offers a similar product. The MagView software does not have the required DIACAP nor is it approved by Medical Health Systems to operate in conjunction with CHCS. MagView would be required to meet and pass DIACAP which takes approximately one (1) year, which again is outside the timeframe for the upgrades to existing facilities and for new installations. MagView has installed its software at some facilities with the hopes of completing the DIACAP, which has not occurred to date. Therefore, MagView’s software does not currently meet all of the MECs for this requirement.

Additional market research was completed via Medical Health Systems for all Mammography Reporting Companies Authorized connection to CHCS and Information Assurance CIOs for approved companies, and there is no other vendor that offers the aforementioned benefits.

Finally, market research efforts were completed by the USAMRAA Contract Specialist.

For example, the USAMRAA Contract Specialist reviewed similar requirements for previously purchased MRS7 Reporting software under the aforementioned contract number W81XWH-16-P-0097. This previous acquisition was accomplished on a sole source basis as the manufacturer does not have agreements with any third party distributors to sell or license its software. This contract file also includes the results of an Air Force (AF) awarded contract (contract number: FA7000-16-C-0012) for MRS7 Reporting Software for various AF base medical facilities. There were slight differences as FA7000-16-C-0012 included Agfa Talk and MRSQuest Touch licenses however, a review of the Federal Procurement Data System – Next Generation (FPDS-NG) Report for this AF contract reflects this procurement action was also competed on a sole source basis.

Finally, the USAMRAA Contract Specialist completed a review of the General Services

Administration (GSA) Advantage! and GSA eLibrary websites on 30 January 2017. The Contract Specialist searched for the MRS7 Reporting software through a keyword search on GSA Advantage! which revealed no results for this specific software.

Additionally, the Contract Specialist searched GSA eLibrary to determine if the manufacturer has a GSA contract and the results of the search also revealed no results.

Therefore, the Contract Specialist has determined the required items and related services are not available through GSA.

11. Interested Sources: In accordance with FAR 5.102, a Notice of Intent to Sole Source will be posted to FedBizOpps. This announcement will detail the Government’s intent to purchase the MRS7 Reporting software, training, and annual maintenance on a non-competitive basis, directly from Mammography Reporting System, Inc. However, any responses received from interested sources will be reviewed to determine if a competitive acquisition is in the Government’s best interest.

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number: As stated above, a similar contract was awarded by USAMRAA for MRS7 Reporting software in support of USAMMA.

Contract Number W81XWH-16-P-0097 was awarded to Mammography Reporting System, Inc. on 4 March 2016 for a total contract value of $950,405.00.

Previously competed? Contract number W81XWH-16-P-0097 was completed on a sole source basis.

Previous authority for less than Full & Open Competition: The previous authority cited in the Sole Source Justification for W81XWH-16-P-0097 (control #: JA16027) is FAR 13.501(a)(1)(i): Only one source reasonably available.

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

Submitted by Signature:

Printed name:

Agency/Position/Title: USAMMA/ Product Manager, Image Management Systems

E-Mail Address:

Date:

Approval

Based on the foregoing justification, I hereby approve the procurement of MRS7 software, training, and annual maintenance on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901, as implemented by FAR subpart FAR 13.501(a)(1)(ii), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Date: ___________________ Signature:

3/02/2017

Special Advocate for Competition