Sole_Source_Justification_Redacted.docx

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

1. Contracting Activity: The Contracting Activity responsible for this action is the US Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Ft Detrick, MD, 21702.

1. Requiring Activity: The Requiring Activity responsible for this action is the US Army Medical Materiel Agency (USAMMA), 693 Neiman Street, Ft Detrick, MD, 21702.

1. Nature of Action:

Mod to Existing Purchase Order/Contract Number __________________

Pricing: Firm-Fixed Price Time & Materials Cost

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

Fiscal Year of Funds: FY15, 3 Year

Estimated Total Dollar Value including Options:

1. Contractor Name:

Contractor: Mammography Reporting System Inc.

Street Address: 19000 33rd Ave W, Suite 130 City, State, Zip: Lynnwood, WA 98036

DUNS: 787948405

Cage Code: 1BTF5

1. Description of Supplies/Services: The Army PACS office is seeking MRS7 software. MRS7 is a software database that tracks FDA mandatory requirements for the passing Mammography Quality Standards Act annual inspection and keep 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 MRS for those facilities that are not using a tracking and reporting software system. Period of performance will be a 12-month base period with four 12-month option periods.

1. 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

(a) 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

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

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

1. Reason for Authority Cited: Only one responsible source and no other supplies or services will satisfy agency requirements for purchasing a commercial item under $7 million. MRS is the only company to offer an approved government bidirectional 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 get approval to connect to CHCS will take approximately two years, which is outside the time line for implementation. MRS is the only vendor that has met and passed requirements for Defense Information Assurance Certification and Accreditation.

MRS is currently operational at 13 of 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 some savings to the government while standardizing the remaining facilities across the AMEDD.

MRS 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.

If MRS is not procured, the effects for the government’s ability to stay in compliance with FDA mandates may be jeopardized. In order for a facility to practice mammography, the facility must pass a yearly FDA inspection to insure compliance with documentation, notification, tracking, safety, and QA/QC. This software enables facilities to meet these mandates in a matter consistent throughout the enterprise. Without the 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 site completes anywhere from 400-900 mammography exams a month. A facility that fails Mammography Quality Safety Act inspection is render unable to perform exams and these exams will have to be sent to a civilian medical facility at a premium cost to the government.

1. Efforts to Obtain Competition: A sources sought synopsis was posted on FedBizOpps (FBO) and no responses were received. The synopsis included the Statement of Need (SON) and Minimum Essential Characteristics (MECs). The intent was to find as many potential sources as possible that would be able to fulfill the requirement.

7. Effective Competition: Based on these findings, it is not expected that there are multiple sources that would be able to provide a solution that would meet the requirement.

7. Subcontracting Competition: MRS is the only source that can provide the requested product and is proprietary. MRS will be performing all of the work under the contract as no subcontracting possibilities exist.

1. Actions to remove or overcome barriers to Competition: USAMMA will continue to monitor the commercial market and will also consider open competition for future procurement actions if the opportunity is possible.

1. Market Survey: MagView is a company that offers a similar product; however it does not currently have a Defense Information Assurance Certification and Accreditation, 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 a year, which again is outside the timeframe for purchase and implementation. MagView has installed its software at some facilities with the hopes of completing a DIACAP, which has not occurred to date.

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.

1. Interested Sources: To date, there have been no other vendors that expressed interest/ capability in fulfilling the requirement.

1. Procurement History and any Other Facts:

Previous Contract or Purchase Order Number: Not applicable

Previous competed: Not applicable

Previous authority for less than Full and Open Competition: Not applicable