Redacted_JA_BMJ.docx

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Nature and/or Description of Action

The Defense Threat Reduction Agency/SCC-WMD contracting activity proposes to procure, without using full and open competition, a sole source contract to adapt an existing commercially-available platform to deliver training on infectious diseases related to the US Department of Health and Human Services (HHS) and US Department of Agriculture’s (USDA) list of Select Agents and Toxins for clinicians in the Cooperative Biological Engagement Program’s (CBEP) partner- countries.

2. Description of the Supplies/Services Required

Correct clinical diagnosis of infectious dieases caused by Select Agents is critical for early disease detection. Given that symptoms of infectious diseases caused by Select Agents often present as common endemic clinical conditions, there is a mission need to deploy clinical/medical training programs that help our partner nations to identify and differentially diagnose diseases of security concern. This will ultimately improve the accuracy of diagnoses and downstream reporting, therefore providing fidelity to decision making in the event that a disease of security concern emerges.

The current CBEP training model requires contractor personnel to travel OCONUS for several days in order to conduct classroom-based training events. Based on recent studies conducted by National Center for Biotechnology Information (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1480097/), National Institute of Health (NIH) and United States Agency for International Development (https://www.usaidassist.org/sites/assist/files/computer-based_training.pdf), this type of training is not indicative of effective information uptake especially for practicing clinicians who are limited in their schedule availability. The same studies have recommended distance learning and on-the-job training as a much more effective tool to stay abreast of the most recent medical developments for accurate diagnoses. As a result, CBEP is initiating a new training paradigm by utilizing an existing distance-learning platform to supplement practicing clinicians’ medical knowledge and training them in how to properly diagnose infectious diseases of security concern.

The British Medical Journal (BMJ) has developed a commercially available platform that provides training to clinical practitioners and specialists in the form of online modules to supplement their existing medical training with the best available, world-renowned, and peer- reviewed clinical data. This procurement is intended to acquire the services of the BMJ to adapt their existing system to complete their comprehensive offering of training material on Select Agents and Toxins, which already contains approximately 30% of Select Agent data. Since Defense Threat Reduction Agency and United States Strategic Command Center for Combating Weapons of Mass Destruction 8725 John J. Kingman Road, Stop 6201 Fort Belvoir, VA 22060-6201

CBEP is adapting their platform, the BMJ is expected to absorb the cost of updating all of the material once development is complete. In addition, CBEP plans to procure standalone standardized educational material which will be considered Government Furnished Information (GFI) that may be distributed to partner nations.

The nature of this work is new as CBEP has not adapted an existing platform in this manner before. The total period of performance is 3 years with no optional tasks. The estimated total contract dollar value is $3.7M. It is likely that the base period of performance will begin in late FY16. CBEB expects to use a combination of FY16 and FY17 funds for the base period.

3. Statutory Authority

The statutory authority for this non-competitive action is:

10 United States Code (U.S.C.) 2304(c)(1) or 41 U.S.C. 253(c)(1), as implemented by FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements, as further defined by FAR 6.302-1(a)(2); when the supplies or services required by the agency are available from only one responsible source, or for DoD, NASA, and the Coast Guard, fron only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

4. Applicability of Authority

In accordance with 10 U.S.C 2304(c)(1), DTRA has determined that the British Medical Journal is uniquely qualified and is the only responsible source to complete this work for the following reasons:

1. The BMJ has an existing well-developed platform that specifically meets the needs of partner nations. This platform has been cited numerous times in Journal of Medical Internet Research (http://www.jmir.org/2016/1/e15/) as an essential tool that will significantly improve clinician continuing medical education programs in relation to infectious disease diagnosesThere was a Case study on weighted decision criteria of the tender process for the Norwegian Electronic Health Library, part of the Norwegian Knowledge Centre for Health Services (NOKC). Through NEHL portal (www.helsebibliteket.no) national clinicians have access to medical journals, indexes, point-of-care reference tools and other medical information resources. The highest score was for BMJ Best Practice from BMJ (0, 9604) and the second highest score was for UpToDate from UpToDate Inc. (0, 7092). (mentioned in Market Research Report)

2. The response to the Sources Sought demonstrated that only BMJ was fully compliant with all specific requirments such as tutorial videos, personalization, and a testing mechanisms for training on Select Agents and Toxins.

3. The BMJ is globally-recognized with expertise in the areas of medical education, clinical decision support, data analytics and healthcare quality improvement to enhance decision- making. Their well-established distance learning platform is regularly updated with peer reviewed and evidence based technical content.

4. The BMJ has experience working with various governments across the world, including US government agencies. This level of experience will be essential when the training program is transitioned to the partner nation to fully support.

5. The BMJ has demonstrated a willingness to work within resource constrained international settings, which is applicable to CBEP’s mission space.

6. A majority of medical institutions in partnering countries follow British medicine training methodology. This familiarity with the BMJ methodology will enhance the partner nation’s confidence in taking ownership of the training program once it is transitioned to them.

7. BMJ has successfully integrated and merged the following unique components into a single platform: differential diagnosis support, personalized training modules, and individualized credit tracking.

5. Effort to Solicit Potential Sources

Market research was conducted and subject matter experts within the government were consulted to determine potential sources. As required by FAR 5.2, CBEP published a sources sought notice on FedBizOpps on August 13, 2015. Four responses were receieved from Metabiota, Battelle, University of Washington , and the British Medical Journal.

6. Fair and Reasonable Costs

The estimated cost of this contract action is $3.7M for a 36 month period of performance. The final cost of this action will be determined to be fair and reasonable based on an Independent Government Cost Estimate (IGCE) and an in-country price analysis developed during a Collaborative Proposal Development effort with the British Medical Journal.

7. Market Research

In accordance with FAR Part 10, market research was conducted for this acquisition. The methods used for this research were:

· Issuance of a Sources Sought notice;

· In-depth discussions with experts in the field from multiple global health organizations;

· Clarifying discussions with all responders to the Sources Sought

In accordance with FAR Part 10, a review of the market place, in addition to the sources sought notice, produced one additional competitor to BMJ. However, during a pre-solitication meeting with this company, they specifically expressed no interest to work with DTRA.

Although there were responses from potential offerers, none, except the British Medical Journal, addressed all the requirements within the notice. The results of the sources sought notice were as follows:.

British Medical Journal (BMJ) BMJ submitted a very well written response addressing all elements requested. They have a globally recognized reputation with expertise in the areas of medical education providing clinical diagnostic and treatment guidelines, integrated drug database and case histories. In addition, they also provide an opportunity to discuss less common presentations along with access to full range of content in 16 different languages. Over 5 million users visit BMJ’s web-based resources and sites each month. They have a total of 19,682 active institutional subscriptions globally across all of their available products. Of these, they have 930 active institutional subscriptions specifically across the countries CBEP is engaged with. In addition, they have 26,221 active individual subscriptions; of these, 635 are specifically across CBEP engaged countries. Of their 1,000+ topics, they have 28 BMJ Best Practice topics which are relevant and match against 10 Select Agents; this comprises of 7 BMJ Best Practice topics which fully match the HHS and USDA select agents list: Avian influenza virus, Coxiella burnetii, Bacillus anthracis, Brucella abortus, Brucella melitensis, Brucella suis, Ebola virus, Francisella tularensis, SARS associated coronavirus, and Yersinia pestis. A further 21 BMJ Best Practice topics which are relevant and also partially match against the 10 select agents include: Acute pharyngitis, Influenza infection, Atypical pneumonia, Infectious mononucleosis, Infective endocarditis, Rhabdomyolysis, Food poisoning, Assessment of fevers of unknown origins, Lymphogranuloma venereum, Legionella infection, Encephalitis, Necrotising fasciitis, Assessment of lymphadenopathy, Yellow fever, Sporotrichosis, Hantavirus cardiopulmonary syndrome, Babesiosis, Assessment of acute motor deficit, Overview of pneumonia, and Bartonella infection.

To further develop any new training material or content, BMJ provided a timeframe of approximately 4-6 months and approximately 5 weeks for translation of a new topic, with the ability for this work to run concurrently. BMJ has extensive experience of translating complex content into numerous languages, including non-romanic languages. Therefore, they have a thorough understanding of the challenges, requirements, processes, timelines and costs involved. In addition, BMJ has a long-standing relationship with a translation house (Lionbridge), who understands the particular complexities of translating clinical content; BMJ is also in discussions with Ukrainian company, Fragola Government Services, who have experience in translating to Russian, Azerbaijani, Armenian and Kazakh.

BMJ’s web-based clinical decision support that is available online is BMJ Learning, BMJ On Examination and BMJ Best Practice. BMJ Best Practice topics are fully updated at least once a year; however there is a continuous review of guidelines, evidence and drug alerts and urgent updates are made when necessary. These updates are overseen by dedicated expert contributors; who review the new body of evidence, relevant drug and device alerts, and any new or significantly changed guidelines for key information that is then prioritized, synthesized and incorporated into the content. Users can sign up for regular alerts via RSS and email to stay informed of the latest updates. BMJ Best Practice PDFs can be downloaded directly from the website when a user clicks on the PDF icon. Therefore, they are automatically updated, as and when the website content is updated. PDFs are version-controlled with a "last updated" date on the front cover and every page of the PDF thereafter. The BMJ Best Practice App is also updated at the same time as the website. When users are in a Wi-Fi zone and open the app, it will start to update automatically. BMJ internally tracks all changes and updates to content and can provide change reports, as required.

In addition to having an existing well-developed platform that is regularly updated with peer- reviewed and evidence-based technical content, BMJ involves partner country clinical experts as authors, reviewers and contributors on content, thus supplementing the partner country individual’s clinical expertise.

To measure user competency and proficiency, BMJ provides pre and post-tests that form the basis for personalized learning recommendations, that lead to suggestions for additional trainings that are delivered and tracked at the user-level. Upon completion of personalized trainings, an assessment known as BMJ On Examination is available which is fully tracked and can be reported at user and cohort level. BMJ also provides an anonymized peer comparison on the assessment and testing part platform. This enables end users to compare themselves against their peers who have completed the same test at either their regional, country, or global level. BMJ has the capability to report peer comparisons and performance for specific regions and countries to DTRA or partner countries. Furthermore, BMJ has a significant amount of experience in dealing with accreditation authorities internationally and are actively seeking accreditation in 7 additional countries. This effort will further assist partner countries to establish a valid and robust accreditation system, which has been identified as a priority in some CBEP partner countries.

BMJ is currently engaged in Africa, Asia, the Former Soviet Union, Middle East and working with various DoD medical centers and Veteran Affairs Hospitals. Their experience working with various Governments across the globe, including the USG and notable international organizations will be essential for the transition of sustainable training to partner countries. Some of the partnerships that BMJ has with international organizations include the World Health Organization (WHO), UK Department for International Development (DfID), Centre for Disease Control (CDC), World Bank, US Agency for International Development (USAID), NICE International, BRAC (www.brac.net), CABI (www.cabi.org), Institute of Healthcare Improvement (IHI) (www.ihi.org), Alliance for Continuing Education in the Health Professions (ACEHP), US (www.acehp.org), and the European Association of Hospital Pharmacy. They also have healthcare partnerships and relationships with a number of Ministries of Health, Royal Colleges, Medical Associations and Societies, including with the Brazilian Ministry of Health, China Medical Association, Government Ministries in the Kingdom of Saudi, Oman and United Arab Emirates, Iraq and Jordan, the Association of American Medical Colleges in the U.S., the U.S.Consulate General Ho Chi Minh City, Vietnam, University of Cape Town and University of Witwatersand, South Africa, Cochrane, Guidelines International Network (GIN), Centre for Evidence Based Medicine, UK and Emory University, Atlanta.

BMJ has received interest from a number of countries. The most notable recent expression of interest has been from the Republic of Georgia. BMJ has received exceptional feedback from users, who regard their resources as highly relevant, informative, accessible and trustworthy. The National Centre for Disease Control and Public Health (NCDC&PH) and the Ministry and State Regulatory Agency have expressed unequivocal support to the plan of working in partnership with BMJ to implement their resources across Georgia. In addition, the ECDC (with whom BMJ has links) Medpiet, the Mediterranean Program for Intervention Epidemiology Training, have expressed an interest in working with BMJ in Georgia, where they are already working with the NCDC&PH. BMJ also has a long-standing relationship with Emory University School of Medicine (Ken Walker, Professor of Medicine) in Atlanta, who has been working in Georgia for a number of years and is supportive of BMJs proposals to support implementation and accreditation. Countries relevant to DTRA / CBEP, which have expressed an interest in working with BMJ are Ministry of Health and Makerere University, Kampala, Uganda; Ministry and State Regulatory Agency and NCDC&PH, Georgia (as above), Ministry of Health (Malaysia Society for Quality and Health), Malaysia; Delhi Medical Council, Kerala state, and All India Institute for Hygiene and Public Health, India.

Furthermore, BMJ is committed to supporting low-resource countries and ensuring that access and support continues beyond the DTRA funding period. They aim to ensure sustainability by making their resources financially affordable. A large element of their cost is upfront, on implementation. Therefore, on transition, they are able to offer significant discounts. BMJ would apply tiered discounts on annual subscription prices for a minimum of 3 years. Discounts range from 15% for countries such as South Africa, 40% to countries such as Georgia, Kazakhstan, Vietnam and Malaysia, 70% for countries such as Iraq, Cameroon and Djibouti and 90% discount for countries such as Afghanistan and Uzbekistan. On transition, they would also absorb all content updating costs associated with any newly created select agents training, so these would not be passed on to partner countries. Over the course of their relationship with DTRA, BMJ would also seek to absorb any costs associated with marketing, raising awareness and usage support. They also aim to incorporate their resources within the clinical and educational infrastructure by working with partner country medical schools to map BMJ content against curricula; work with relevant bodies to seek accreditation for their resources so that users can attain recognized CME/CPD. This effort will further enable partner countries to establish a valid and robust accreditation system. BMJ also intends to identify local champions and trainers and develop local train the trainer programs at hospitals and public health organizations, to build understanding and embed the resources within local practice. BMJ believes that in-country advocacy and influence is critical for sustainability; hence they plan to engage and build networks with key influencers and leaders to ensure ongoing support for their resources as well. Furthermore, BMJ wants to demonstrate the value and impact gained from use of their resources. They will therefore work with DTRA and partner countries to demonstrate value through case studies/vignettes and showcase impact both in-country and internationally, using their reach and particularly, International Quality Forums which are attended by a global audience of around 3,000 delegates.

After reviewing BMJ’s initial submission, we conducted additional follow-up to gain further clarification on their responses. Responses were received in a timely manner and were satisfactory, which have been incorporated into the content above. BMJ has demonstrated a willingness to collaborate in resource-constrained international settings by offering tiered-pricing based on gross domestic product (GDP). They are also willing to consider any further suggestions from DTRA to ensure long-term sustainability.

University of Washington (UW) UW collaborates with Ministries of Health to develop curriculum materials and engages in the reform of educational degree programs and integration of evidence based information on infectious diseases into existing courses. It implements distance learning across countries with resource limited technology and low bandwidth. UW developed a digital textbook application, to enhance self-directed learning by embedding interactive quizzes, tutorials and learning exercises with full color photos and videos, which is available via tablet and WhatsApp mobile in 17 different languages. Using interactive video, UW launched ECHO in 2012 to offer weekly online clinics thus providing real time clinical consultation in remote, underserved areas in the US. They are currently engaged in 30 + countries with registered offices in 11 countries. Although UW has unique capabilities and experience in US, it is unclear if current engagements provide clinician-specific trainings. In addition, their willingness to provide incentives to resource constrained partner countries was not provided in their response. After reviewing UW’s initial submission, we reached out and conducted additional follow-up to gain further clarification on their responses, however, no additional information was received from the offerer within the given response timeframe. As such, we have determined that UW is not an appropriate implementer for this effort.

Metabiota Metabiota has stated that the current marketplace does not have a comprehensive peer-reviewed clinician-training platform that provides personalized responsive training with a tracking mechanism, which fundamentally conflicts with DTRA’s analysis. Metabiota proposed to develop a differential diagnosis platform that allows users to input patient information, and review treatment options by probability and country data. Their training would be coupled with additional user input (geographic location, experience, clinical role) and prior performance on assessment testing; based on prior performance and areas of strengths and weaknesses, a personalized training path would then be developed. Metabiota has a global presence has experience working with CBEP. As part of their engagements, Metabiota states that they provide necessary resources, expertise and global network to support resource constrained partners, however, no specifics about incentives are mentioned in their response. After reviewing Metabiota’s initial submission to the RFI, we conducted additional follow-up to gain further clarification on their responses however, no additional information was received.

Battelle Battelle follows an interactive "learn by doing" approach by proposing to utilize an inter- disciplinary team that meets the training needs of global one health approach, which was not responsive to the notice requesting information on an adaptable platform. They are currently engaged in Eastern Europe, Africa, the Middle east, and Southeast Asia with over 800 contracts with a wide variety of defense and civilian government agencies. Their response to the RFI states that they provide incentives to partner countries by paying for travel and per diem to support attendance at training events, compensate certified trainers and Training of Trainers for their training time and support attendance at international conferences, which is completely unrelated to the scope of this effort. Upon reviewing Battelle’s submission and cross-walking it against the RFI and CBEP requirements, we concluded that the information provided was not sufficient nor in the format requested. We also conducted additional follow-up to gain further clarification on their responses and we received no additional information from the offerer.

See attached Market Resesarch Report for additional information.

8. Other Facts

None.

9. Interested Sources

Interested sources include: the British Medical Journal, Metabiota, Battelle, and the University of Washington (UW).

10. Subsequent Actions

As the DTRA CBEP effort evolves, the Program Office will continue to monitor the marketplace to identify any additional sources that may develop the specific services required for this effort in the future.

Technical Certification

I certify that the data and information forming the basis for this justification are accurate and complete to the best of my knowledge and belief.

Digitally signed by MISHULIN.DENIS.I.1397122162MISHULIN.DENI

DN: c=US, o=U.S. Government, S.I.1397122162 ou=DoD, ou=PKI, ou=DTRA, cn=MISHULIN.DENIS.I.1397122162

05/26/16

Date: 2016.05.26 16:10:05 -04'00'

Project Manager Date

Contracting Officer Certification

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

Digitally signed by BUTLER.DEBRA.A.1412343987BUTLER.DEBRA

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=DTRA, cn=BUTLER.DEBRA.A.1412343987 Date: 2016.05.27 10:11:20 -04'00'.A.1412343987

Contracting Officer Date

General Counsel Coordination

This justification is/is not legally sufficient.

Digitally signed by HAWORTH.DEBRA.B.1192536886HAWORTH.DEBRA.

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, B.1192536886 ou=DTRA, cn=HAWORTH.DEBRA.B.1192536886 Date: 2016.05.31 06:17:26 -06'00'

Attorney Date

Approval

Based on the above justification, I hereby approve accomplishment of this acquisition by means other than using full and open competition.

MILLER.DAVID. E.1229162850

Digitally signed by MILLER.DAVID.E.1229162850 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=DTRA, cn=MILLER.DAVID.E.1229162850

Date: 2016.05.31 13:58:29 -04'00'

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