8_-_Redacted_Sole_Source_J&A.pdf

ARMD Hardware Refresh, Tri-Service J&A #17-10071

JUSTIFICATION AND APPROVAL FOR

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification for other than full and open competition is executed by the Naval Medical Logistics Command, Fort Detrick, Maryland in order to meet Department of Defense requirements.

2. Nature and/or description of the action being approved.

The government intends to award a sole source contract to Draeger, Inc. (Draeger) for an Anesthesia Recording and Monitoring Device (ARMD) hardware and ancillary software (not application software) refresh at military treatment facilities on behalf of the Department of Air Force, Department of Army, Department of Navy, and the Defense Health Agency National Capital Region Medical Directorate.

3. Description of the supplies or services required to meet the agency’s needs.

The Department of Defense (DoD) requires software and hardware for the Innovian ARMD system. The Innovian software and clinical workstations, which support the ARMD program mission within the DoD, are located at 66 facilities worldwide. The current system hardware and ancillary software (organic operating systems) need to be replaced due to the servers and MDS-IT workstations reaching end-of-life. The current system was purchased from North American Draeger, Inc., now Draeger, Inc., under Blanket Purchase Agreement N62645-08-A-0020.

Innovian is a commercially available off-the-shelf, Food and Drug Administration (FDA) regulated medical device that provides electronic intraoperative anesthesia documentation through collection of input from patient monitors, anesthesia machines, ventilators, vaporizers, drug documentation, and provider comments. It also provides reporting and detailed analysis of the intraoperative patient record database to document and improve quality, patient safety, workload, productivity, and cost. The software provides users with important data, such as patient demographics, text integration, patient allergies, problem lists, care status and delivery, laboratory results, medication administration, and information regarding surgeries. The ARMD system replaces paper anesthesia records used in operating rooms (ORs) and other anesthetizing or moderate sedation locations to manage patient information and critical information during procedures.

The hardware refresh will include replacing approximately 800 MDS-IT medical device workstations and 200 servers, including updated organic operating systems and recertifying the system using the DoD’s new Risk Management Framework (RMF) process. The Government intends to award an indefinite delivery indefinite quantity contract for the required services with an ordering period from 01 August 2017 (estimated) through 26 July 2019. The total estimated dollar value of the resultant contract is $6,890,000.00. It is anticipated that Fiscal Year 17 Defense Health Program funding will be utilized for the initial task orders.

4. Identification of the statutory authority permitting other than full and open competition.

FAR § 13.106-1(b)(1)(i) Soliciting from a single source.

The procedures in FAR subpart 13.5 will be used in accordance with 41 U.S.C. 1901.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The proposed source for this effort is Draeger, located at 3135 Quarry Road, Telford, PA 18969-1042. Draeger is the sole original designer and creator of the Innovian ARMD system, which is a FDA 510(k) cleared Class 1 medical device. Draeger holds all copyrights to the Innovian software and no other entity has the right to reengineer, modify, or provide technical support for, or enhancements to this system. Draeger licensed the software for use by the DoD in September 2008. Since then, it has invested heavily in the engineering efforts required to make the system (software, workstations, and servers) compliant with DoD cybersecurity requirements. Draeger has also provided continual sustainment services since that time; however, they formally stated that they will no longer be able to provide sustainment past 31 July 2019 for the current ARMD hardware due to the non-availability of spare parts. The DoD in in process of deployment of a new Electronic Health Record (EHR) from Cerner Corporation (MHS Genesis) that will replace all current ARMD hardware and software. The MHS Genesis product will not be fully deployed across the MHS until 2022 according to current timelines. Since the current ARMD hardware is not supportable past July 2019, an interim solution is required until MHS Genesis is at full operational capability. The Draeger hardware and supporting organic operating systems must be upgraded or the Government must procure a new intraoperative anesthesia record keeping system. The estimated cost to replace Innovian ARMD with another anesthesia record keeping system that includes hardware, organic operating systems, and the Innovian application software to include training of anesthesia providers, is approximately $17,000,000.00.

Accordingly, Draeger is the only qualified source for this technology refresh contract and therefore, it is in the best interest of the Government to proceed with the refresh contract compared to replacement of the entire system.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable.

A notice of intent to sole source was posted to FedBizOpps on 25 August 2017 with a closing date of 9 September 2017. If any responses are received, this J&A and supporting documents will be updated.

7. Determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

Prior to award, the Contracting Officer will make a determination that the award price(s) are fair and reasonable. It is anticipated that the price analysis conducted will utilize the Government’s independent cost estimate or comparison of proposed prices with prices obtained through market research for the same or similar items

8. Description of the market research conducted and the results or a statement of the reason market research was not conducted.

Market research was not conducted as the requirement represents a valid sole source.

9. Any other facts supporting the use of other than full and open competition.

None

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

None

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

In the event an entirely new ARMD system is needed in the future, market research will be conducted to determine if the requirement can be competed. The BPA that is referenced above was awarded using full and open competition and three quotes were received.

12. Point of contact.

Nicholas J. Carroll, Contracting Officer

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED BY NAVSUPINST 4200.83H

I certify that the facts and representations under my cognizance which are included in this justification and its supporting acquisition planning documents, except as noted herein are complete and accurate to the best of my knowledge and belief.

TECHNICAL/REQUIREMENTS COGNIZANCE

David Baker 301-619-7487 Date Chief, Clinical Engineering

AFMOS/SGALE

LEGAL SUFFICIENCY AND CONCURRENCE

I have determined this justification is legally sufficient.

Office of Counsel Code 00L Date

CONTRACTING OFFICER/APPROVING OFFICIAL below $650,000

12. Contracting Officer Certification.

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

Nicholas J. Carroll Code 05 301-619-9361 Date Contracting Officer

COMPETITION ADVOCATE/APPROVING OFFICIAL $650,000 or above

Upon the basis of the above justification, I hereby approve, as Competition Advocate, the solicitation of the proposed procurements described herein using other than full and open competition, pursuant to the authority of 10 U.S.C 2304(C)(1)

Darin L. Callahan Code 00 301-619-3095 Date Competition Advocate