A.02.04_W81K02-17-T-0228_JandA_SP_5649_EU,KO,Legal,_and_PAC_REDACTED.pdf

For Official Use Only (See FAR 2.101 and 3.104-4)

(25 February 2016)

Control Number: 17‐RHCO‐P‐425

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: W40M PACIFIC RGNL CNTRG US MEDCOM HCAA JBLM

HCC, 673 WOODLAND SQUARE LOOP SE, SUITE 101 LACEY WA 98503-1066

2. Description of Action: Approval is being requested for new contract for Madigan Army Medical Center (MAMC) to requisition under LOA the medical equipment supply order listed below.

3. Description of Supplies/Services: Hermes Nuclear Medicine Imaging and Retrieval System

4. Authority Cited: The statutory authority permitting other than full and open competition is 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: MAMC seeks the procurement of nuclear medicine hardware, processing software, and storage solutions— the reasons for choosing HERMES as the sole source of supply is as follow:

a. Nuclear Medicine Image Management System provided by Hermes Medical Solutions will unify our image management capabilities allowing us to utilize a single vendor software package to process and view all nuclear medicine studies. In addition, Hermes provides dedicated nuclear medicine image storage and retrieval. Hermes will enable us to electronically store raw data on a local server and reprocess as needed in a more expedient and efficient manner. Currently the Nuclear Medicine Department must back up raw data from several modalities to optical disc. Clinic personnel must then fetch large PET-CT studies from long term storage archive and then import these large data sets to a remote Picture Archiving and Communication System (PACS) server which is then made available to a third party system that is aligned with our current PACS. Other vendors providing similar products do not have a dedicated storage and retrieval medium, but instead must collaborate with an additional vendor for storage and retrieval. This unified system prevents diagnostic medical errors and data corruption.

b. The Hermes system includes Positron Emission Tomography-Computerized Tomography (PET-CT) processing, displaying, and reporting software which will be compatible with the PACS system that will be installed in the coming months.

MAMC has been advised that the current software will not be compatible with the new PACS system coming online. Other vendors offer upgrades of their systems to include this capability, but not to the standard of Hermes’ system.

(25 February 2016)

Control Number: 17-RHCO-P-425

Nuclear Medicine Imaging and Retrieval System

c. Hermes equipment and hardware meets the Digital Imaging and Communications DICOM conformance standards for all nuclear medicine and radiologic modalities. This is an important feature because without DICOM conformance standardization anexam that is performed on acamera with image files which are incompatible will also mean that the doctor will be unable to view the image(s). DICOM standardization enables us to receive Computerized Tomography (CT) for attenuation correction, mapping, and fusion to a CT, or MRI to a SPECT scan done in other facilities. This will significantly reduce additional workload for the Nuclear Medicine Department. Additionally, DICOM conformance reduces radiation exposure to our patients because Hermes utilizes a half-dose reconstruction method (Hybrid Recon) to lessen radiation exposure to the patient. This feature is notavailable through other vendors.

d. The Hermes system is compatible with the Genesis Electronic Health Record (EHR) System being implemented and Hermes meets the cyber security compliance required to operate in a Government facility. Hermes products are installed and used at several other DoD medical facilities and Hermes has a DoD Information Certificate of Net worthiness. As an example, the Hermes system is currently installed and effectively working within the Nuclear Medicine Section of Walter Reed Army Medical Center and Fort Belvoir Community Hospital with CAC authentication and data sharing capabilities between the two facilities enhancing their ability to provide improved patient care. Other vendors do offer this feature, but not in tandem with the other features.

In conclusion, no other vendor provides the combination of features identified in bullets a-d above. Hermes is the only vendor on the market which will provide dedicated nuclear medicine processing and storage capabilities; that is compatible with the incoming PACS system; conforms to DICOM standards; and is compatible with Genesis EHR system while being both secure and net-worthy. If the system is not purchased: 1. There will be an increased possibility of the need to refer patients to facilities off the installation. 2. There will be increased costs to the organization as the current system will be incompatible with the incoming PACS system. 3. The quality of patient care will be degraded as a result of longer appointment times and strain on medical personnel dealing with cumbersome systems. 4. There is a greater risk of loss and/or corruption of patient data. 5.

Joint Outpatient Experience Survey (JOES) scores for the department and facility will suffer.

The requested delivery date is 15 June 2017. This date is flexible as the Department of Nuclear Medicine is also expecting a new PACS system installation. PACS must be online before Hermes Equipment can be installed. Finalization of the delivery date will be coordinated with the Department Chief.

(25 February 2016)

6. Efforts to Obtain Competition: Other competitors were researched but none could provide the combination of supplies and software required. Other competitor’s equipment was either incompatible with existing systems and/or incompatible with incoming PACS and EHR Systems that are being integrated.

A sources sought notice was posted to FBO on 18 Apr 2017 and no responses were received.

a. Effective competition. Other competitors were researched but none could provide the combination of supplies and software required.

b. Subcontracting competition. There are no subcontracting possibilities. All products and ancillary services will be provided by Hermes Medical Solutions exclusively.

7. Actions to Increase Competition: Developmental software is always in the horizon, especially as it applies to medical modalities. MAMC will always be in the lookout for newer, fresher, more powerful technological advances that can potentially in the future extend the margins of our EHR capabilities and Nuclear Medicine. Should new and more advanced software engineering emerge, published, and be available for testing, MAMC as it relates to Nuclear Medicine software, will afford opportunities to manufacturers and companies to showcase their product in concert with applicable regulations and policies.

8. Market Research: Research conducted suggested that other companies provided similar products. A quote for the Oasis Nuclear Medicine Solution from the Segami Cooperation was reviewed, but does not meet all of the requirements. No other vendor provides the combination of features identified.

9. Interested Sources: No other company other than HERMES has expressed, verbal or written interest in providing the required medical Image processing software application that meets MAMC Nuclear Medicine Department’s mission essential needs.

Notices required by FAR 5.201 shall be published, and any bids or proposals received shall be considered.

10. Other Facts: Other than those previously mentioned in this document, no other facts are being provided herein. Additional thoughts to consider: The development of software to link the intended electronic record process in unique to the Medical Department. Developmental software will not work in this case for it does not meet the lead time associated with the project or accurately produce the intended results. Most manufacturers will insist that their product can communicate with our Electronic Health Record (EHR),PACS etc.…to the contrary, presentations clearly show that their software still in the developmental process and therefore does not propel the MAMC

(25 February 2016)

EHR project forward. HERMES is the only solution available in today’s market which can in fact link the incorporated modalities and accurately communicate with MAMC EHR Initiative.

a. Procurement history. This is a new requirement.

(1) N/A

(2) N/A

(3) N/A

(4) N/A

(5) N/A

(6) N/A

(7) N/A

b. Other facts. N/A

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.

DAVISON.JONATH

AN.M.1035994625

Digitally signed by

DAVISON.JONATHAN.M.1035994625

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=DAVISON.JONATHAN.M.1035994625

Signature: Date: 2017.04.26 14:24:31 ‐07'00' Date: 26 April 2017

Typed Name: LTC(P) Jonathan M Davison, MD Title: Chief of Nuclear Medicine

12. Requirements 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.

DAVISON.JONATH

Digitally signed by

DAVISON.JONATHAN.M.1035994625

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, Signature:

AN.M.1035994625 cn=DAVISON.JONATHAN.M.1035994625

Date: 2017.04.26 14:24:56 ‐07'00' Date: 26 April 2017

Typed Name: LTC(P) Jonathan M Davison, MD Title: Chief of Nuclear Medicine

(25 February 2016)

Typed Name: 893 Date:

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

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

Quotes from other companies were obtained using concerted efforts to ensure the equipment selected is precisely what the organization requires to conduct the medical mission. The pricing associated therein lists the most up-to-date information compatible in the nuclear medicine medical practice. Pricing was given careful consideration to ensure all available sources carrying government contracts (when available) with similar equipment was reviewed. Purchase of an image management system, has been approved by Technology Basement Requirements Analysis (TARA) through MEDCOM.

Certified cost or pricing data is not required per FAR 15.403-1(b) (3).

Signature: BRADBURY.LARR Y.A.1164241951

Digitally signed by

BRADBURY.LARRY.A.1164241951

DN: c=US, o=U.S. GoveDrnmaetnet,:ou=DoD, ou=PKI, ou=USA, cn=BRADBURY.LARRY.A.1164241951

Typed Name: Date: 2017.04.27 08:2T3:i0t8le‐0:7_'00'

14. Contracting Officer Certification:

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

Digitally signed by BRADBURY.LARRY.DA.1a16t4e24:1951 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, Typed Name: Y.A.1164241951 ou=USA, cn=BRADBURY.LARRY.A.1164241951

Date: 2017.04.27T08i:t2l4e:0:5_‐07'00'

15. Legal Review: I have reviewed this justification and approval and it is deemed to be legally sufficient.

HUDSON.RODNEY.

EDWARD.1162645

HUDSON.RODNEY.EDWARD.1162645893

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=HUDSON.RODNEY.EDWARD.1162645893 Date: 2017.04.27 13:40:59 ‐05'00'

Title: Signature:

Signature: BRADBURY.LARR

(25 February 2016)

Approval

Based on the foregoing justification, I hereby approve the procurement of Nuclear Medicine Imaging and Retrieval System for MAMC in the amount of $749,500.00 on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

PECK.JOSEPH.SAMUEL.1165787150

DN: c=US, o=U.S. Government, ou=DoD, Signature:

UEL.1165787150

ou=PKI, ou=USA, cn=PECK.JOSEPH.SAMUEL.1165787150 Date: 2017.05.02 10:37:55 ‐05'00'

Date:

2 May 2017

Typed Name: Mr. Joseph S. Peck Title: Special Advocate for Competition

PECK.JOSEPH.SAM