Draft Product Description _Lexicomp Drug Database Brand Name or Equal.docx

Drug Database Subscription TAC Number: VA-24-00040873

PRODUCT DESCRIPTION (PD)

DEPARTMENT OF VETERANS AFFAIRS

Veterans Health Administration Veteran Integrated System Network (VISN) 5 Clinical Point of Care Drug Information & Interaction Knowledge Product Lexicomp Drug Database Brand Name or Equal Date: May 5, 2024

VA-24-00040873

PD Version Number: 1.0

Contents

PRODUCT REQUIREMENTS

The Department of Veteran Affairs (VA), Veterans Health Administration (VHA), Veteran Integrated System Network (VISN) 5 requires an existing commercial off-the-shelf web-based/online access, Clinical Point of Care Drug Information & interaction Knowledge Product that will be made available throughout VA Capitol Health Care Network (VISN 5) with emphasis on Pharmacy. VISN 5 includes six main VA Medical Center/Health Care Systems that includes: Beckley VA Medical Center, Clarksburg VA Medical Center, Huntington VA Medical Center, Martinsburg VA Medical Center, Washington DC VA Medical Center & VA Maryland Health Care System and all their Clinical Based Outpatient Clinics and affiliated campuses.

VA offices access Wolters Kluwer Lexicomp to obtain comprehensive drug information to assist healthcare providers theirclinical decision-making and drug information needs. VA Pharmacy Administrators require an easily accessible source of information about thousands of prescription and over-thecounter medications to inform their practice. The platform provides pharmacists and pharmacy residents access to key information about brand name and generic drugs. Key data points obtained from the platform include mechanism of action, dosing, drug and food interactions, and contraindications and warnings.

For the purpose of this solicitation, this product’s emphasis is on drug database subscription (DDB) to assist with drug identification and drug interactions. This database will serve to assist health care providers in their clinical decision making and drug information needs.

VISN 5’s goal is to ensure uniform availability of high quality, clinical point of care drug information to our Pharmacy and across the system to improve clinical decision making. The following is needed by the contractor:

a. The contractor shall provide all resources necessary to meet the requirements described in this statement of work for an online, commercial, off-the-shelf, drug database subscription (DDB).

b. The contractor shall provide 24/7 online web access to the DDB subscription as stated herein for staff at facilities in the VISN 5 (via IP), to their mobile devices (via Apps or mobile websites), or to their remote work areas (via IP or OpenAthens). Remote access must include access via OpenAthens and mobile platforms including various popular hand-held devices, for all healthcare providers across VISN 5.

c. An unrestricted number of simultaneous users are to have immediate access from any web-enabled computer within VISN 5 VA. It is required that all authorized remote users with VPN access have access to the product.

Required Ddb Subscription Requirements & Salient Characteristics

The contractor shall provide a DDB Subscription which addresses the following requirements and salient characteristics:

a) Provides up-to-date drug information [prescription, over the counter (OTC), alternative medicine];

b) Determines dosing, side effects/adverse events, and interactions, both drug-drug and drug-food; drug-OTC, drug-alternative medicine

c) Provides full-text databases on chemical, pharmaceutical, and related biological substances used in clinical patient care;

d) Includes drug reviews, guidelines, clinical reviews, and information from package inserts and drug texts;

e) Contains calculators (dosing, clinical, measurement, laboratory values, etc.);

f) Provides access to Black-Box warnings;

g) Provides drug formulary information;

h) Contains a clinical teaching section to assist in communicating information to patients;

i) Provides comparison tables to compare drugs within a class for features like half-life or other valuable information;

j) Comprehensive medication monographs which include information regarding FDA and non-FDA indications, with literature citations for the evidence base;

k) Summaries of clinically relevant primary literature within the resource (more than just a reference to a source;

l) Provide primary literature references and summary data in the resource for comparative efficacy and off-label indications;

m) Contain references to abstracts, tertiary electronic sources and full text articles;

n) Provide a uniform search tool and user interface throughout the product;

o) Updated on a daily basis by a review board of allied health professionals; contains a date of last review/update for each section;

p) Provides content on acute care, alternative medicine, drug information, toxicology, teratogenic medications, patient education, and occupational health and safety including material safety data sheets;

q) Ability to "brand" both web and printed materials with practice site logos and contact information;

r) Provide drug assessments to the user based on manufacturer monographs and peer reviews of primary literature;

s) Provide references to primary literature to support recommendations and/or indications for therapy.

t) Provides side-by-side comparative drug evaluations with primary literature summaries to allow time effective comparison of more than one agent with one search. Includes concise reviews of trials or case reports including key characteristics of study design such (number of patients, p-values, population included);

u) Provide users with a multitude of web-based calculators designed to meet the needs of all healthcare providers;

v) Comprehensive information available about drug use in special populations including renal impairment, hepatic impairment, geriatrics, dialysis, obesity and other relevant disease states that will vary by drug;

w) Provide consumer appropriate printable health information on medications, procedures, and disease states. This health information should be available in at least English and Spanish languages;

x) Provide a drug interaction tool that can enter multiple drugs and allergies for a given patient with output of entry that includes drug-drug, drug-allergy, drug-ethanol, drug-lab, drug-food, drug-tobacco, drug-pregnancy and drug-lactation interactions;

y) Drug Interaction tool will provide severity of interaction;

Adverse drug reactions will include percentages of patients affected by the interaction where available and include case reports;

z) Provide a tool for medication identification based on any information available to the provider (i.e. color, imprint, formulation, etc.);

aa) Provide administration with tracking tools to include stats on particular components used by the organization;

ab) Exportable to an iPhone, blackberry, iPad or android device for point of care decisions;

ac) Provide an IV compatibility database that is comprehensive, searchable, and which may be drilled to obtain more information or references;

ad) Provide pharmacy compounding stability information;

ae) Components of the clinical topic review for drug information shall include the following fields:

a. Medical Safety Issues/Alerts.

b. Brand Names.

c. Pharmacologic Category.

d. Dosing (Adults, Elderly, Pediatric, etc.) and Forms (capsule, tablet, liquid, etc.).

e. Generic Alternative availability.

f. Administration, Use, Contraindications, Warnings/Precautions.

g. Specific Populations (Pregnancy Risk Factor/Lactation/Breast Feeding, Pediatric, Geriatric, etc.).

h. Dietary Considerations.

i. Mechanism of Action.

j. Metabolism/Interactions.

k. Pharmacodynamics/Kinetics.

l. References section.

m. Graphics (figures, pictures, graphics, tables, etc.) integrated into record/review that can be printed or exported.

n. Hyperlinks to related record/review topics.

af) The contractor shall provide users an intuitive navigation interface for searching, navigating, and reading through database content and the results of a database search; and,

ag) Poison control information including antidote and supportive care recommendations.

ah) Information on Handling of hazardous medications (NIOSH)

Users shall be able to:

1. Enter a search phrase consisting of one or more terms or select a term from drop down menu of potential matches after typing the first few characters of the term.

2. Enter names of diseases, symptoms, laboratory abnormalities, procedures, drugs, classes of drugs, etc. to retrieve topical reviews.

3. Enter common synonyms, abbreviations, and acronyms that will be mapped to the appropriate topical review(s) in display results.

4. Search for drug information and retrieve topic reviews containing information about the drug.

5. Search for drug information by retrieving the drug record.

6. Search for drug interactions by entering drug name to display a complete list of interactions for the drug.

7. Choose and use medical specialty calculators interactively by entering required values/units of information to determine mathematical calculation.

8. Sort search results for display through the use of categorization options such as adult, pediatric, etc.

9. Find specific text within a topic review using the product’s find tool.

10. Select among various output options, including printing all or selected portions of the topical review

Additional Customer Support Requirements

a. A single point of contact for customer service issues is named, available by both phone and email, and assigned to VISN 5 Program Manager or its representative. At least one alternative contact is provided for absences of the provided single point of contact. A single point of contact shall be supplied for the database, and shall follow all of the following terms:

b. The single point of contact should be available via telephone and email during normal business hours and should not have excessive business travel or all day training commitments. Any scheduled out of office time must be notified to the VISN 5 Program Manager with a minimum of two (2) week notice.

c. The VISN 5 Program Manager reserves the right to request and be provided a replacement single point of contact representative within 60 days after request. This request can be made for any reason or no reason at all, with no additional cost necessary or reason provided. The number of these requests is made at the discretion of the LNO Program Manager.

d. It is the responsibility of the VA specified customer service contact to be fully educated and familiar with the physical and administrative structure of the VA system.

e. The contractor shall provide monthly reports to the VISN 5 Program Manager of technical service requests provided to VISN 5 customers. The contractor’s point of contact shall meet with the VISN 5 Program Manager via conference call to review reports as required.

f. Each report shall provide at a minimum the following columns in Excel format with:

1. Reference #.

2. Date Created.

3. First Assigned Technical Service Representative.

4. Customer Full Name.

5. Email Address of customer.

6. Issue/Request Statement.

7. Status.

8. Result.

9. Other information per Contractor choice.

NOTICE OF THE FEDERAL ACCESSIBILITY LAW AFFECTING ALL INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) PROCUREMENTS (SECTION 508)

On January 18, 2017, the Architectural and Transportation Barriers Compliance Board (Access Board) revised and updated, in a single rulemaking, standards for electronic and information technology developed, procured, maintained, or used by Federal agencies covered by Section 508 of the Rehabilitation Act of 1973, as well as our guidelines for telecommunications equipment and customer premises equipment covered by Section 255 of the Communications Act of 1934. The revisions and updates to the Section 508-based standards and Section 255-based guidelines are intended to ensure that information and communication technology (ICT) covered by the respective statutes is accessible to and usable by individuals with disabilities.

SECTION 508 – INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) STANDARDS

The Section 508 standards established by the Access Board are incorporated into, and made part of all VA orders, solicitations and purchase orders developed to procure ICT. These standards are found in their entirety at: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines. A printed copy of the standards will be supplied upon request.

Federal agencies must comply with the updated Section 508 Standards beginning on January 18, 2018. The Final Rule as published in the Federal Register is available from the Access Board: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule.

The Contractor shall comply with “508 Chapter 2: Scoping Requirements” for all electronic ICT and content delivered under this contract. Specifically, as appropriate for the technology and its functionality, the Contractor shall comply with the technical standards marked here:

COMPATABILITY WITH ASSISTIVE TECHNOLOGY

The standards do not require installation of specific accessibility-related software or attachment of an assistive technology device. Section 508 requires that ICT be compatible with such software and devices so that ICT can be accessible to and usable by individuals using assistive technology, including but not limited to screen readers, screen magnifiers, and speech recognition software.

ACCEPTANCE AND ACCEPTANCE TESTING

Deliverables resulting from this solicitation will be accepted based in part on satisfaction of the Section 508 Chapter 2: Scoping Requirements standards identified above.

The Government reserves the right to test for Section 508 Compliance before delivery. The Contractor shall be able to demonstrate Section 508 Compliance upon delivery.

INFORMATION TECHNOLOGY USING ENERGY-EFFICIENT PRODUCTS

Not Applicable

EPEAT

EPEAT product compliance is not required in this acquisition.

ENERGY STAR

Energy Star compliance is not required in this acquisition.

FEMP

FEMP or FEMP low standby power product compliance is not required in this acquisition.

SYSTEM ACCEPTANCE (PRE-PRODUCTION) TESTING

Not Applicable

SHIPMENT OF HARDWARE OR EQUIPMENT

Inspection: Destination Acceptance: Destination Free on Board (FOB): Destination

Ship To and Mark For:

Primary

Alternate

Address:

Address:

Voice:

Voice:

Email:

Email:

SPECIAL SHIPPING INSTRUCTIONS

Not Applicable

NATIONAL ACQUISITIONS

Not Applicable

GENERAL REQUIREMENTS

VA TECHNICAL REFERENCE MODEL

The Contractor shall support the VA enterprise management framework. In association with the framework, the Contractor shall comply with OIT Technical Reference Model (VA TRM). The VA TRM is one component within the overall Enterprise Architecture (EA) that establishes a common vocabulary and structure for describing the information technology used to develop, operate, and maintain enterprise applications. Moreover, the VA TRM, which includes the Standards Profile and Product List, serves as a technology roadmap and tool for supporting OIT. Architecture & Engineering Services (AES) has overall responsibility for the VA TRM.

SOCIAL SECURITY NUMBER (SSN) REDUCTION

The Contractor solution shall support the Social Security Number (SSN) Fraud Prevention Act (FPA) of 2017 which prohibits the inclusion of SSNs on any document sent by mail. The Contractor support shall also be performed in accordance with Section 240 of the Consolidated Appropriations Act (CAA) 2018, enacted March 23, 2018, which mandates VA to discontinue using SSNs to identify individuals in all VA information systems as the Primary Identifier. The Contractor shall ensure that any new IT solution discontinues the use of SSN as the Primary Identifier to replace the SSN with the Integrated Control Number (ICN) in all VA information systems for all individuals. The Contractor shall ensure that all Contractor delivered applications and systems integrate with the VA Master Person Index (MPI) for identity traits to include the use of the ICN as the Primary Identifier. The Contractor solution may only use a Social Security Number to identify an individual in an information system if and only if the use of such number is required to obtain information VA requires from an information system that is not under the jurisdiction of VA.

INTERNET PROTOCOL VERSION 6 (IPV6)

The Contractor solution shall support Internet Protocol Version 6 (IPv6) based upon the memo issued by the Office of Management and Budget (OMB) on November 19, 2020 (https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf). IPv6 technology, in accordance with the USGv6 Program (https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1), NIST Special Publication (SP) 500-267B Revision 1 “USGv6 Profile” (https://doi.org/10.6028/NIST.SP.500-267Br1), and NIST SP 800-119 “Guidelines for the Secure Deployment of IPv6” (https://doi.org/10.6028/NIST.SP.800-119), compliance shall be included in all IT infrastructures, application designs, application development, operational systems and sub-systems, and their integration. In addition to the above requirements, all devices shall support native IPv6 and dual stack (IPv6 / IPv4) connectivity without additional memory or other resources being provided by the Government, so that they can function in a mixed environment. All public/external facing servers and services (e.g. web, email, DNS, ISP services, etc.) shall support native IPv6 and dual stack (IPv6 / IPv4) users and all internal infrastructure and applications shall communicate using native IPv6 and dual stack (IPv6 / IPv4) operations.

SOFTWARE AND LICENSING REQUIREMENTS

The Contractor shall be responsible for the provision of all software licenses and any associated licensing maintenance required for any development, delivery, integration, operation, and/or maintenance associated with its proposed application(s), software products, software solution, and/or system including, but not limited to, any and all application(s), software and/or software products that comprise, are a part of, or integrate with the Contractor’s proposed application(s), software products, software solution, and/or system for the life of any resulting contract.

POINTS OF CONTACT:

VA Program Managers:

Contracting Officer:

Name: Newton Maloba Title: Contracting Officer E-Mail Address: Newton.Maloba@va.gov

Contract Specialist:

Name: Tiarrah Turner Title: Contract Specialist E-Mail Address: Tiarrah.Turner@va.gov

INFORMATION SECURITY CONSIDERATIONS:

The Assessment and Authorization (A&A) requirements do not apply and a Security Accreditation Package is not required

All VA sensitive information shall be protected at all times in accordance with local security field office System Security Plans (SSP’s) and Authority to Operate (ATO)’s for all systems/LAN’s accessed while performing the tasks detailed in this Product Description.

Product Description _JUL_21_2021

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