JA_Updated_SH1_III_Redacted_Redacted.pdf

LOG # 15-10169

Form 02.4G.AB RCP # N6264514RCP3001 1 Nov 2012

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD to meet the requirements of the US Army, US Navy, US Air Force, Defense Health Agency (DHA) and the Veterans Administration (VA).

2. Nature and/or description of the action.

The requirement is for five (5) radiation dose monitoring systems. The Government intends on awarding a Firm Fixed Price contract. The proposed manufacturer is Bayer Healthcare LLC, 100

Bayer Blvd, Whippany, NJ 07981-1544. There are multiple distributors capable of providing the equipment that meets the minimum government requirements.

3. Description of the supplies/services required.

The requirement is for five (5) radiation dose monitoring systems. One system is required by the

US Army, one system is required by the US Navy, and one system is required by the US Air

Force. One (1) system will be included for DHA and one (1) system will be included for the

VA, both as an option. These systems shall be installed throughout various US Army, US Navy, US Air Force, DHA and VA (if the options are exercised) sites. See attached list. The system shall be capable of monitoring and managing patient radiation exposure across imaging modalities including radiography, computed tomography, angiography, fluoroscopy, and mammography. The system shall be capable of determining radiation dose based on

International Commission on Radiological Protection (ICRP) definitions. The system shall be capable of using both Computed Tomography Dose Index (CTDI) and Dose Length Product

(DLP). The system shall be capable of tracking patient size specific dose estimates (SSDEs).

The system shall allow the user to select effective diameter or water-equivalent diameter for

SSDE estimation. The system shall be capable of tracking patient-specific organ doses. The system shall support Digital Imaging and Communications in Medicine (DICOM) standards, Health Level Seven (HL7) standards, and Integrating Healthcare Enterprise (IHE) Radiation

Exposure Monitoring (REM) Profile standards. The system shall provide functionality to support flexible reporting without scripting, multiple data filtration settings, data visualization and interface, and alert setting and notification. The system shall be compatible with the installed base of Picture Archiving and Communication Systems (PACS), as outlined in the attached site list. The system shall support both local and remote access to all patient exposure data and should provide a web-based application. The systems for the Army, Navy, and Air

Force shall be deployed at the sites listed in the attached site list with the capability of processing the procedure volume indicated. Options for additional site and system implementation shall be included as indicated in the attached site list.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized maintenance contractor for the proposed equipment/systems such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The systems shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America; even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

Navy Other Procurement (OP), Defense Health Program (DHP) funds in the amount of

, Army OP, DHP funds in the amount of , and Air Force OP, DHP funds in the amount of will be used to procure the equipment. Funding for the DHA option and VA option is currently unavailable. However, the estimated cost for the DHA option is and the VA option is . The total award value including options is .

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

The statutory exception permitting other than full and open competition for this acquisition is 10

USC 2304(c)(1) and FAR 13.501(a), Sole Source (including brand name) Acquisitions. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-Cohen Act of

1996). There are multiple distributors capable of providing the equipment that meets the minimum government requirements.

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

The dose monitoring system manufactured by Bayer Healthcare is the only product which can meet the minimum requirements of the government. Bayer is the only vendor that can provide a radiation dose monitoring system capable of tracking patient-specific organ dose. Accurate dose monitoring capability is critical to ensuring patient radiation safety in compliance with The Joint

Commission (TJC) Performance Improvement (PI) standard 02.01.01. Currently, the US Army, US Navy, and US Air Force do not comply, thus the acquisition of a dose monitoring system is mission essential. Organ-specific dose monitoring capability is necessary for physiologically meaningful patient radiation dose information. Organ specific dose monitoring is also an essential tool for analyzing and improving radiology department workflow and imaging protocols. Other available radiation dose monitoring systems are capable of tracking rough whole body dose estimates or estimates specific to patient body size or region, but not organ-specific dose and thus do not meet the minimum requirements. No other products besides those manufactured by Bayer are capable of meeting the minimum requirements.

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

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to FedBizOpps in accordance with FAR 5.202. The government will evaluate any responses received.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

Market research was conducted in November – December 2014. The market research conducted included research conducted by the internet, and review of product literature. The internet search was done using Google, Bing, GSA Advantage, and the ECRI Sourcebook. Vendors which can provide radiation dose monitoring systems of the scope and complexity required to meet most of the minimum requirements include Agfa, Bayer, GE, and PHS Technologies. The radiation dose monitoring systems offered by Agfa, GE, and PHS are not capable of tracking patient organ-specific dose and thus do not meet the minimum requirements. Only the radiation dose monitoring system offered by Bayer is capable of tracking patient organ-specific dose. Bayer is the only manufacturer whose products can meet the minimum requirements of the government.

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

None

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on

FedBizOpps in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of 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.

Future requirements will be synopsized in accordance with FAR 5.203.

12. Point of Contact

The point of contact at the Naval Medical Logistics Command, Fort Detrick, Frederick, MD, regarding the contents of the Justification and Approval is , who may be reached at

SITE INFORMATION

US Navy Sites MTF PACS Vendor VR Product CT Count (2013) RF Count Other X-ray

NMC Portsmouth Fuji Synapse 4.1 PowerScribe 5.0 17,144

5,206 148,636

NMC San Diego Carestream PACS 11.4 Carestream Native

Reporting

22,635 5,100 152,703

NH Beaufort Agfa Impax 6.3 0 None 1,826 267 19,662

NH Bremerton Fuji Synapse 3.2.1 PowerScribe 5.0 6,233

385 27,355

NH Camp Lejeune Agfa Impax 6.4 Talk Technology 4.0 12,465 1761 72,954

NH Camp Pendleton McKesson Radiology

PowerScribe 5.0 6,731 962 64,847

NH Jacksonville Agfa Impax 6.5 PowerScribe 5.0 6,777 698 49,141

NH Lemoore Fuji Synapse 3.2.1 PowerScribe 5.0 1,384 68 11,136

NH Pensacola Agfa Impax 6.5 Talk Technology 4.0 4,968 265 44,022

NH 29 Palms Agfa Impax 6.3 Talk Technology 4.0 2,018 162 13,428

USNH Guam Fuji Synapse 3.2.1 PowerScribe 5.0 2,396 194 12,922

UNSH Okinawa Fuji Synapse 3.2.1 PowerScribe 5.0 6,917 470 27,402

USNH Yokosuka Fuji Synapse 3.2.1 PowerScribe 5.0 1400 177 21,100

USNH Naples Agfa Impax 6.4 None 883 87 5,348

USNH Rota Agfa Impax 6.4 None 469 46 3,111

USNH Sigonella Agfa Impax 6.4 None 464 16 4,987

NHC Charleston Fuji Synapse 3.2.1 None 840 0 8,035

NHC Cherry Point Agfa Impax 6.4 Talk Technology 4.0 462 152 12,388

NHC Corpus Christi Fuji Synapse 3.2.1 PowerScribe 5.0 0 34 4,478

NHC New England Agfa Impax 6.4 Talk Technology 4.0 0 0 17,410

96,012 16,050 721,065

US Army Sites MTF PACS Vendor VR Product CT Count Other X-ray

Brooke AMC Ft Sam Houston TX AGFA IMPAX 6.5 PowerScribe 360 41,000 130,000

Blanchfield ACH - Ft Campbell, KY AGFA IMPAX 6.5 PowerScribe 360 11,488 64,274

Eisenhower AMC - Ft Gordon, GA AGFA IMPAX 6.5 PowerScribe 360 14,754 73,528

Moncrief ACH - Ft. Jackson, SC AGFA IMPAX 6.5 PowerScribe 360 3,882 32,206

Winn ACH - Ft Stewart, GA AGFA IMPAX 6.5 PowerScribe 360 5,728 46,346

Lyster ACH - Ft Rucker, AL AGFA IMPAX 6.5 No Servers 822 9,320

Martin ACH - Ft Benning, GA AGFA IMPAX 6.5 PowerScribe 360 10,886 63,291

Reynolds ACH - Fort Sill, OK AGFA IMPAX 6.5 PowerScribe 360 8,630 38,834

Madigan AMC - JB Lewis-McCord, WA Pending selection of new system

PowerScribe 360 27,000 104,000

Bassett ACH - Ft Wainwright, AK Pending selection of new system

(No Servers) 9,100 24,700

Weed ACH - Ft Irwin, CA AGFA IMPAX 6.5 (No Servers) 1,600 8,000

William Beaumont AMC - Ft Bliss, TX AGFA IMPAX 6.5 PowerScribe 360 16,000 77,000

Evans ACH - Ft Carson, CO AGFA IMPAX 6.5 PowerScribe 360 11,500 57,200

General Leonard Wood ACH - Ft

Leonard Wood, MO

AGFA IMPAX 6.5 PowerScribe 360 7,500 39,300

Irwin ACH - Ft Riley, KS AGFA IMPAX 6.5 PowerScribe 360 4,500 33,500

Tripler AMC, Hawaii Fuji Synapse 4.2 PowerScribe 360 13,917 110,732

Brian Allgood ACH - Seoul S. Korea Fuji Synapse 4.3 PowerScribe 360 1,765 27,140

Landstuhl RMC, Germany Fuji Synapse 4.3 PowerScribe 360 7,900 40,000

Womack AMC - Ft Bragg, NC AGFA IMPAX 6.3 PowerScribe 360 18,465 113,453

Ireland ACH - Ft Knox, KY AGFA IMPAX 6.3 PowerScribe 360 6,781 35,194

Keller ACH - West Point, NY AGFA IMPAX 6.3 PowerScribe 360 1,554 9,538

McDonald ACH - Ft Eustis, VA AGFA IMPAX 6.3 PowerScribe 360 1,090 17,471

Kimbrough AHCC - Ft Meade, MD AGFA IMPAX 6.3 PowerScribe 360 1,627 13,322

Carl R Darnall AMC, Ft Hood TX AGFA IMPAX 6.3 PowerScribe 360 13,000 65,000

Munson AHC - Ft Leavenworth KS AGFA IMPAX 6.5 (No Servers) 0 13,000

RW Bliss AHC- Ft Huachuca AZ AGFA IMPAX 6.5 (No Servers) 0 8,000

Guthrie AHC - Ft Drum NY AGFA IMPAX 6.3 PowerScribe 360 0 12,000

Kenner AHC - Ft Lee VA AGFA IMPAX 6.3 PowerScribe 360 0 20,000

224,807 1,286,349

US Air Force Sites

Davis Monthan IMPAX 6.3 Talk 3.2 7,90 9,290

Langley IMPAX 6.3 Talk 3.2 3,902 27,404

Mountain Home IMPAX 6.3 Talk 4.1 549 3,272

Nellis IMPAX 6.3 Talk 3.2 7,672 35,904

Offutt Fuji 3.2 Talk 4.1 1,979 13,090

Tyndall IMPAX 6.3 Talk 3.2 1,020 6,478

Keesler IMPAX 6.3 Talk 3.2 9,470 36,298

Lackland IMPAX 6.3 Powerscribe 5.0 4,987 48,950

Luke IMPAX 6.3 Talk 4.1 2,114 15,776

Maxwell IMPAX 6.3 Not a reading site 844 5,104

Sheppard IMPAX 6.3 Not a reading site 627 4,618

Andrews IMPAX 6.3 Talk 4.1 4,747 23,909

Barksdale IMPAX 6.3 Not a reading site 582 7,057

Eglin IMPAX 6.3 Talk 4.1 7,500 44,031

Wright-Patterson Fuji 3.2 Talk 4.1 9,791 40,581

MacDill IMPAX 6.6 Talk 4.1 1,850 22,198

Scott IMPAX 6.3 Talk 3.2 1,420 10,709

Travis IMPAX 6.3 Talk 4.1 10,018 43,472

Misawa Fuji 3.2 Talk 4.1 667 3,548

Osan Fuji 3.2 Talk 4.1 1,322 9,520

Yokota Fuji 3.2 Talk 4.1 567 3,420

AF Academy IMPAX 6.3 Talk 4.1 2,414 20,958

Aviano IMPAX 6.3 Talk 4.1 180 3,167

RAF Lakenheath IMPAX 6.3 Powerscribe to Talk 4.1 2,258 14,550

Elmendorf Fuji 3.2 Powerscribe 5.0 4,307 70,396

80,787 523,700

Defense Health Agency Site

Fort Belvoir ACH, Ft Belvoir, VA AGFA IMPAX 6.4 Talk Technology 4.1 20,000 70,000

Veterans Administration Site MTF PACS Vendor VR Product CT Count (2013) RF Count Other X-ray

CAPT James A. Lovell

FHCC

Agfa Impax 6.5 Talk Technology 4.0 N/A

0 20,605