Attachment 1 - Statement of Work - 28 Aug.pdf

Contract Title: Point-of-Care Clinical Decision Support Tool

Requiring Activity Name: DHA Medical Libraries Organizational Management Office Branch (DML OMO)/ Executive Skills, Continuing Education, and Libraries Division (EXCEL)/ J-7, Education and Training Directorate, Falls Church, VA

1. Scope and Background

1.1. Scope

This is a statement of work (SOW) for a commercial-of-the-shelf (COTS) clinical decision support (CDS) tool to be used at the point of care (chairside). This clinical tool is required as a first-line, comprehensive, and primary source of clinical information and guidance for Department of Defense (DoD) Medicine and the Military Health System (MHS), which include and consist of medical and clinical support functions, all medical-related personnel regardless of location (CONUS, OCONUS, Military Treatment Facilities (MTFs), shipboard, submarine, forward deployed, or other operational settings), and components located within and belonging to the organizations specified below (here-in known as supported organizations):

• MHS

• Defense Health Agency (DHA)

• DoD Medical Laboratories

• DoD Medical Research Organizations

• Air Force Medicine

• Army Medicine

• Navy Medicine

• United States Air Force

• United States Army

• United States Navy

Although part of the Military Health System, Uniformed Services University of the Health Sciences and Coast Guard Medicine are not covered in the scope of this SOW.

The contract period of performance will be a base year plus four (4) Option years with extension.

1.2. Background

The Department of Defense Medicine and Military Health System health care providers require access to a comprehensive, current, evidence-based, and peer-reviewed CDS tool to be used at the point of care to assist in answering patient-specific, clinical foreground questions that inform patient care. Regardless of location (e.g., CONUS, OCONUS, Military Treatment Facilities (MTFs), shipboard, submarine, forward deployed, or other operational settings), it is imperative to have up-to-date, evidenced-based information and guidance readily available. This CDS tool will be used by DHA providers with a wide range of education, training, and experience, from young medics or corpsmen to physicians who are recognized experts in their clinical subspecialties. While the CDS tool will be used by DHA expert physicians, it is a particularly critical resource for junior physicians, medics, and corpsmen who are often the sole health care provider in remote locations, such as ships and small military bases far removed from population centers.

Medics and corpsmen have significant clinical responsibility, despite having substantially less training than physicians. Providers in remote environments do not have immediate access to colleagues for consultation and guidance when unsure of the management of a patient. The CDS tool is critical to the delivery of safe, effective, and timely health care.

The CDS tool shall cover a broad range of medical disorders and diseases and provide recommendations, guidance, and advice to providers in identifying, treating, and managing the disease, disorder, or issue at hand. The CDS tool shall be evidence-based, referencing filtered information (e.g., clinical practice guidelines, systematic reviews, meta-analyses, etc.) and unfiltered information (e.g., published clinical studies and trials) and providing expert recommendation or advice on the approach to medical management and expected outcomes. The last point—providing expert recommendation—is particularly important given the above comments about the many junior physicians, medics, and corpsmen in remote locations. Three

(3) studies, over a period of nine (9) years, arrived at nearly the identical conclusions: a little over half of clinical decisions are supported by strong evidence, a third were based on non-experimental evidence, and nearly 20% by no evidence at all.1,2,3 Within the DHA Enterprise, thousands, if not tens of thousands, of clinical decisions are made every day by DHA providers based on non-experimental evidence or no evidence at all. With the scale of this issue, the CDS tool will need to make recommendations for clinical questions based on non-experimental evidence, conflicting evidence, or no evidence at all. The clinical provider must still make a decision in these scenarios, and the CDS tool will serve as the immediately available expert.

1.3. Place of Performance: The work to be performed under this contract will be performed at the vendor’s facilities.

1.4. Period of Performance

Base Year Period of Performance

Service Branch Period of Performance Army (prorated) November 19, 2024 – August 31, 2025

Navy (prorated) November 19, 2024 – August 31, 2025

Air Force November 1, 2024 – August 31, 2025

Option Years Periods of Performance

Option Year Period of Performance

Option Year 1 September 1, 2025 – August 31, 2026

Option Year 2 September 1, 2026 – August 31, 2027

Option Year 3 September 1, 2027 – August 31, 2028

Option Year 4 September 1, 2028 – August 31, 2029

52.217-8 September 1, 2029 – January 31, 2030

1.5. The vendor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, technical support, supervision, and other items and non-personal services necessary to provide and maintain access to the CDS tool for supported organizations as defined in this SOW.

1.6. Contracting Officer Representative (COR): The COR will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the vendor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the vendor’s concerning technical aspects of the contract; monitor vendor’s performance and notify both the Contracting Office and vendor of any deficiencies; and provide site entry of vender personnel. A letter of designation issued to the COR, a copy of which is sent to the vender, states the responsibilities and limitations of the COR, especially regarding to changes in cost or price, estimates, or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

2. Requirements

2.1. Content Requirements

2.1.1. The product shall provide evidence-based, comprehensive, in-depth topical medical reviews on the medical management of the full gamut of medical diseases, disorders, and conditions to assist in answering patient-specific, clinical foreground questions to inform patient care.

2.1.2. The topic reviews shall reference clinical practice guidelines from a wide range of medical societies and published meta-analyses, systematic reviews, and clinical studies and trials.

References to published literature shall hyperlink to PubMed citations.

2.1.3. The topic reviews shall include clinical algorithms and decision trees as appropriate.

2.1.4. The topic reviews shall describe atypical presentations of common diseases, disorders, and conditions at least 50% of the time.

2.1.5. The topic reviews shall include expert recommendation, guidance, and advice from the author/writer to assist providers with the practice of medicine. The expert topic author/writer shall apply clinical gestalt and clinical experience to guide and advise providers on diagnosis, treatment, and management of diseases, disorders, and conditions and on interpretation and application of guidelines, published studies, and other evidence.

2.1.5.1. When medical society guidelines and/or published research are conflicting or inconclusive, the expert author/writer shall make a specific management recommendation at least 75% of the time. For example, some medical societies recommend treating hypertension with beta blockers and others do not. In this example, the expert author/writer shall recommend when beta blockers should and/or should not be used to treat hypertension.

2.1.5.2. When there is only poorly conducted experimental studies, non-experimental studies, and/or no published evidence for a particular clinical question, the expert author/writer shall make a specific management recommendation at least 75% of the time.

2.1.5.3. The expert author/writer shall recommend drug dosages or therapeutic regimens in the absence of practice guidelines, algorithms, and published evidence.

2.1.6. The topic reviews shall answer clinical background questions about the topic. Clinical background questions ask the who, what, when, where, how, and why of the disease, disorder, or condition at hand.

2.1.7. The topic reviews shall include information about laboratory tests including normative values, contraindications, and risks.

2.1.8. The product shall include interactive medical specialty calculators (e.g., cardiac output, peak expiratory flow), sorted by specialty and name.

2.1.9. The product shall include a fully integrated drug database including drug to drug interaction information.

2.1.10. The product shall provide content that is based on the current/latest published evidence and society guidelines. This includes being reviewed with major content updates at least three (3) times per year, with additional updates when new evidence emerges.

2.1.11. The product shall be written at the medical provider level.

2.1.12. The product shall provide content that covers (at a minimum):

2.1.12.1. Adult and Pediatric Emergency Medicine

2.1.12.2. Adult Primary Care and Internal Medicine

2.1.12.3. Allergy

2.1.12.4. Aviation Medicine

2.1.12.5. Cardiovascular Medicine

2.1.12.6. Dermatology

2.1.12.7. Drug Information

2.1.12.8. Endocrinology

2.1.12.9. Family Medicine

2.1.12.10. Gastroenterology

2.1.12.11. Hematology

2.1.12.12. Hypertension

2.1.12.13. Immunology

2.1.12.14. Infectious Diseases

2.1.12.15. Nephrology

2.1.12.16. Neurology

2.1.12.17. Obstetrics, Gynecology and Women’s Health

2.1.12.18. Oncology

2.1.12.19. Pediatrics

2.1.12.20. Psychiatry

2.1.12.21. Pulmonary Critical Care and Sleep Medicine

2.1.12.22. Rheumatology

2.1.12.23. Surgery

2.1.12.24. Undersea Medicine

2.1.13. The product shall provide content that covers the pathophysiology, clinical manifestations, diagnosis, prognosis, etiology, diagnostics, laboratory tests, prevention, management, and recommended treatment (pharmacologic and non-pharmacologic) of medical disease, disorder, or condition at hand, with levels of evidence and grades of recommendations, if appropriate.

2.1.14. The product shall address all the issues a clinician must understand, evaluate, and manage in the coverage of the topic, such as (but not limited to):

2.1.14.1. Evaluation of symptoms or findings via the initial evaluation and targeted evaluation, considerations for special populations, etc.

2.1.14.2. Clinical presentation, including the most common symptoms and signs, atypical (rare) symptom and signs, major findings, variance with respect to specific patient populations, common lab findings, complex presentations, etc.

2.1.14.3. Diagnosis, including evaluation and diagnostic options, progression of testing, what to do with a positive or negative test, differential diagnosis, etc.

2.1.14.4. Treatment, including indications for therapy, options for therapy, procedures, monitoring and measuring response, duration, relapse and resistant disease, risks of treatment, etc.

2.1.14.5. Natural history of disease or condition and prognosis relative to treatment options, such as impact on survival, disease course, factors impacting expected course, etc.

2.1.15. The product shall provide content that is synthesized into clear and concise recommendations.

2.1.16. The product shall provide content that includes infant, pediatric, and adult/geriatric topics and the ability to sort content by age group.

2.1.17. The product shall include a drug monograph, pharmacodynamics, pharmacokinetics, mechanism of action, prescribing, dosing, administration, contraindications, warnings/precautions, pregnancy implications, breastfeeding considerations, dietary considerations, drug interactions checker, labeled and off-labeled use, brand names and generic equivalents, and adverse drug effects guidance that is consistent with the guidance of the enterprise drug database.

2.1.18. The product shall include information about diagnostics, including indications, contraindications, precautions, techniques, safety, society guidelines, summary, and recommendations.

2.1.19. The lead or primary author/writer of each topic shall be an expert in the clinical subspecialty. Each topic shall be peer reviewed by experts in the clinical subspecialty.

2.1.19.1. The product shall state who wrote or authored each topic. An editor is not considered a writer or author.

2.1.19.2. Author and reviewer credentials and affiliations shall be included in the topic.

Credentials and affiliations shall clearly demonstrate specific relevance to the topic subspecialty.

2.1.19.3. Author and reviewer clinical subspecialties must match the clinical topic. For example, the author(s) for Crohn’s disease in children must be a pediatric gastroenterologist. A general pediatrician would not be acceptable, as the expert for this disease is a pediatric gastroenterologist.

2.1.19.4. Authors and reviewers with an academic appointment must, at least 75% of the time, be at the associate professorship level or higher in the clinical subspecialty.

2.1.19.5. Authors and reviewers with an academic appointment must, at least 50% of the time, be at the Professor level, as they are the most experienced.

2.2. Functionality Requirements

2.2.1. The product shall have search tools enabling users to find/retrieve all medical topic reviews on search topics in one interface, including drop-down menus of possible matches and topics after typing the first few characters (auto-suggest).

2.2.2. The product shall map from common synonyms, abbreviations, and acronyms.

2.2.3. The product shall ensure users have the capability to print, email, and download full-text topic reviews.

2.2.4. The product shall have a search interface that is customer-friendly and effective at retrieving relevant content quickly and easily.

2.2.5. The product shall provide date of last content review or update.

2.2.6. The product shall provide a stand-alone, complete database that does not require a subscription to other products to retrieve a complete medical topic review.

2.2.7. The product shall provide alerting features to notify users of new content since the last update. Alert content shall focus on information that is patient-oriented and with the potential to change current practice of health care providers.

2.2.8. The product shall ensure content is searchable with words or phrases in titles and content and by subject.

2.2.9. The product shall provide cross links to other relevant information in the database, including pictures, figures, tables, graphs, algorithms, and videos.

2.2.10. The product shall provide references that link to PubMed and to subscribed content through an Open URL Resolver.

2.2.11. The product shall include patient education handouts within the database.

2.2.12. The product shall allow providers to earn continuing education (CE)/continuing medical education (CME) credits, including AMA Category 1 PRA credits and credits that satisfy ABMS Maintenance of Certification (MOC) and ABMS Continuing Certification requirements such as MOC II or Self-assessment Activities, as well as American Association of Nurse Practitioners (AANP) NP Contact Hours for continuing professional development (CPD) at no additional cost. The product shall allow providers to accrue, track, and redeem credits after establishing a personal account. Transcripts shall be owned by the provider.

2.2.13. The product shall allow authorized users to register for personal accounts while accessing the database from the MHS Medical Community of Interest (Med-COI) Network (DHA network) or through authorized authentication systems such as OpenAthens Single Sign-

On, Command Access Card (CAC) and Public Key Infrastructure (PKI) technologies, or proxy service.

2.2.14. The product shall require authorized users to reverify or recertify affiliation/registration credentials no more than one (1) time per 180 days, if periodic reverification is required.

Reverification shall be performed by logging into the personal profile while accessing the database on the DHA network or through OpenAthens Single Sign-On, CAC and PKI technologies, or proxy service.

2.3. Accessibility Requirements

2.3.1. The vendor shall provide direct access to the product over the Med-COI Network Internet protocol (IP) architecture.

2.3.2. The product shall be capable of unlimited, simultaneous access by authorized users.

2.3.3. The vendor shall allow remote access through COTS authentication solutions, including but not limited to OpenAthens Single Sign-On and EZproxy, and other Government-approved, secure methods that prevent unauthorized access.

2.3.4. The vendor shall allow all authorized users access to the product from any computer, tablet, or mobile device with an Internet connection (mobile web).

2.3.5. The vendor shall provide a fully tested, functional, and of commercial-quality DVD containing all the same content as the online version in its entirety. Due to the lack of Internet connectivity on ships and deployed, remote locations, this requirement is of utmost importance. The DVD is also critical for use when, for operation security, providers are prohibiting from carrying devices that can emit a “ping” or location signal (e.g., smart phone). The DVD shall be updated at a minimum three (3) times per year and be in alignment with the online updates.

2.3.6. The vendor shall make all online content and features accessible in their entirety on iOS and Android devices through a single mobile app downloadable from the Apple Store and Google Play.

2.3.7. The vendor shall allow CE/CME to be accrued, tracked, and claimed through desktop, laptop, tablet, mobile web, and mobile app platforms at no additional cost.

2.3.8. The product shall synchronize user accounts, including tracking of CE/CME, across access via desktop, laptop, tablet, mobile web, or mobile app and provide a consistent user experience across these access platforms.

2.3.9. The vendor shall make all online content and features downloadable and accessible in their entirety for use offline (i.e., without Internet or Wi-Fi connection) on iOS and Android devices through a single mobile app downloadable from the Apple Store and Google Play.

The vendor shall provide updates in alignment with online updates. Wi-Fi or network connection will be made available for initial download and full content updates.

2.3.10. System downtime resulting from upgrade or other electronic maintenance requirements shall be minimal, and the vendor shall notify the COR and the DML OMO at dha.ncr.education-trng.mbx.mhs-medical-library@health.mil 10-15 calendar days prior to a scheduled maintenance start date. The vendor shall notify the COR and the DML OMO a minimum of 24 hours before an unplanned system downtime occurs or as soon as a system outage occurs or is noticed.

2.4. Support Requirements

2.4.1. The vendor shall provide up to three (3) live onsite training sessions total per year for CONUS MTFs by request at no additional cost. The vendor shall provide unlimited live online training by request for CONUS and/or OCONUS MTFs at no additional cost. The vendor shall produce and provide instructional, informational, and promotional brochures and flyers upon request at no additional cost.

2.4.2. The vendor shall accept and manage up to 2.5 million IP addresses. The vendor shall have the documented ability to support the Military Health System (MHS) operational networking environment and multiple physical sites within this environment who access content electronically.

2.4.3. The vendor shall activate or update Med-COI IP ranges within 48 hours of notification by the COR or other designated Government civilian(s) in the DML OMO; the vendor shall activate or update access information for other authorized authentication solutions within 48 hours of notification by the COR or other designated Government civilian(s) in the

DML OMO.

2.4.4. The vendor shall support access through CAC and PKI technologies; COTS authentication solutions, including but not limited to OpenAthens Single Sign-On and EZproxy; and other Government-approved, secure methods that prevent unauthorized access.

2.4.5. The vendor shall provide telephone and email technical support 24/7/365 for authorized personnel worldwide. All site content and support of the website is the responsibility of the vendor. Technical issues unresolved within one 24 hours shall be reported via email to both the COR and the DML OMO at dha.ncr.education-trng.mbx.mhs-medical-library@health.mil.

2.4.6. The vendor shall provide and support integration throughout the Med-COI network via the current and future DOD Electronic Health Record portal.

2.4.7. The vendor shall send a monthly metrics report by the fifteenth (15th) day of the month and an annual metrics report for the previous fiscal year by November 15 to the COR and/or designated Government civilian(s) in the DML OMO. The metrics shall include the following at a minimum:

2.4.7.1. Trending search topics Total # of user accounts

2.4.7.2. Total number of topics viewed by device or access method (computer, tablet, mobile web device)

2.4.7.3. Total number of registered users

2.4.7.4. Total number of continuing education credit units claimed

2.4.8. The vendor shall send ad-hoc metrics reports on demand as requested by the COR and/or other designated Government civilian(s) in the DML OMO within five (5) business days of request.

2.4.9. The vendor shall provide monthly reports of technical service requests from users to the COR and/or designated Government civilian(s) by the fifteenth (15th) day of the month.

Each report shall provide the following data in Excel format:

2.4.9.1. Ticket number

2.4.9.2. Date of creation

2.4.9.3. Assigned representative

2.4.9.4. Customer name

2.4.9.5. Customer email address

2.4.9.6. Issue/request statement

2.4.9.7. Status

2.4.9.8. Result

3. Deliverables

3.1. (Deliverable #1) The vendor shall activate or update Med-COI IP ranges and activate or update access information for other authorized authentication solutions per section 2.4.3 of the Statement of Work (SOW).

3.2. (Deliverable #2) The vendor shall provide a fully tested, functional, and of commercial-quality DVD per the section 2.3.5 of the SOW.

3.3. (Deliverable #3) The vendor shall send monthly and annual metrics reports per section 2.4.7 of the

SOW.

3.4. (Deliverable #4) The vendor shall send ad-hoc metrics reports per section 2.4.8 of the SOW.

3.5. (Deliverable #5) The vendor shall provide telephone and email technical support 24/7/365 for authorized personnel worldwide per section 2.4.5 of the SOW.

3.6. (Deliverable #6) The vendor shall provide system downtown notifications per section 2.3.10 of the

SOW.

3.7. (Deliverable #7) The vendor shall send monthly reports of technical service requests per section

2.4.9 of the SOW.

References

1. Ayre S, Walters G. Are therapeutic decisions made on the medical admissions unit any more evidence-based than they used to be?. J Eval Clin Pract. 2009;15(6):1180-1186. doi:10.1111/j.1365-2753.2009.01345.x

2. Michaud G, McGowan JL, van der Jagt R, Wells G, Tugwell P. Are therapeutic decisions supported by evidence from health care research? Arch Intern Med. 1998;158(15):1665-1668. doi:10.1001/archinte.158.15.16653

3. Nordin-Johansson A, Asplund K. Randomized controlled trials and consensus as a basis for interventions in internal medicine. J Intern Med. 2000;247(1):94-104. doi:10.1046/j.1365-2796.2000.00583.x