36C10B19C0021-001.pdf

Control Number: TAC-19-51006

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition and Logistics

Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

2. Description of Action: The proposed action is for award of a Firm-Fixed Price (FFP) contract for renewal of existing enterprise software licenses and associated software maintenance, as well as additional enterprise licenses, for a comprehensive pharmacy drug database source and associated decision support tools from First Databank Inc. (FDB).

3. Description of the Supplies or Services: VA Veterans Health Administration (VHA), Pharmacy Service has a requirement for the renewal of existing enterprise FDB MedKnowledge software licenses and maintenance, as well as the procurement of additional enterprise licenses. Specifically, VHA requires renewal of the FDB brand name enterprise licenses for MedKnowledge Information Architecture (inclusive of MedKnowledge Framework), Cloud Connector (up to 1,000,000 hits), the Patient Education Modules (Spanish), and VA Custom Monthly Update. The current system provides a mechanism to cross check several critical factors in relation to patient safety, such as Patient Medication Information Sheets (PMIS), auxiliary warning labels, drug-drug interactions, duplicate drug order checks and max single dose checks.

Additionally, as part of this requirement, VA requires the procurement of additional FDB brand name enterprise licenses for the following modules:

AlertSpace, Drug Formulary Management Module, Go-Live Med Orders, Medguide Module, Medicare Module, MedTeach Module, MedsTracker, Meducation, State Controlled Substance Module, Enhanced Interoperability Module, Image/Imprint Modules, Drug-Drug Interaction for Consumers Module, and Cloud Connector (Greater than 1,000,000 hits) applications. These additional licenses are to expand the utilities and tools to provide better, more accurate patient care for Veterans. The maintainence and support shall include updates of any changes to the architecture, framework and any modules daily, or on another recurring schedule determined by VA, not to exceed daily. Support needed will be in a form of telephone and online support for VA personnel and VA Contractors as needed. The period of performance for this effort consists of a 12-month base period, with two 12-month option periods, and 12 optional tasks for additional licenses. The total estimated value of this effort, inclusive of options, is .

4. Statutory Authority: The statutory permitting other than full and open competition is 41 U.S.C 3304(a)(1) as implemented by the Federal Acquisition

MedKnowledge Drug Database and Decision Control Number: TAC-19-51006 Support Tools

Regulation (FAR) Subpart 6.302-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements."

5. Rationale Supporting Use of Authority Cited Above: The proposed source is FDB, located at 500 East 96th Street, Suite 500, Indianapolis, IN 46240. In May 2018 VA awarded a sole source contract to Cerner Corporation for a new electronic health record (EHR) system that will replace VistA. The rollout to Cerner will be done in phases and, until it is complete, VA will be required to work in VistA. The transition to the Cerner EHR System will take approximately 10 years. In the interim, VA must maintain the existing licenses with FDB within VistA. Currently VistA systems Pharmacy Enterprise Customization System (PECS), Medication Order Check Healthcare Application (MOCHA), and Pharmacy Product System (PPS) interoperate with and have been customized to use only the FDB drug database source. Conversion to any other brand name drug database would require extensive information technology changes for a new database to interface with VistA, including reconfiguration of both a new database and the VistA applications currently interoperating with FDB. There are multiple applications and servers within VA EHR system that utilize FDB drug database source as a key part of their software in performing the necessary cross checks to ensure patient safety. The three main systems, which are fully deployed, nationally operated systems, are PECS, MOCHA, and PPS. These systems utilize only FDB drug database source to perform the necessary drug-drug interactions checks, duplicate therapy checks, dosing, patient medication information sheets, and provide VA and Department of Defense (DoD) interoperability. Each of these three production systems have servers and software which are fully deployed and are operating in direct support of clinicians at all VA facilities. These applications have been specifically developed for use with the proprietary FDB drug database source. Conversion to any other brand name drug database would require the aforementioned extensive redevelopment of these applications to ensure seamless performance. These efforts would result in extensive delivery delays of approximately two years and duplicated costs of $3 million that would not be recovered through competition. These estimates are based on previous efforts for similar development.

In addition, market research conducted, and detailed in section eight of this justification, highlighted that only FDB can provide a seamless integration and interoperability with the existing environment, a functional requirement for VA.

VA utilizes several proprietary technologies in its current environment which would have to interact with any alternate solution. Introducing new technology would require a process to recode these dependent applications, which include but are not limited to, Patient Medication Information (PMI), drug-drug interactions, auxiliary warning labels, duplicate drug therapy, and dosing, all of which are required by VA to have a safe healthcare application. VA requires a seamless integration to provide patient care and patient safety. Additionally, all of VA’s current systems are dependent on proprietary Application Programming

Interfaces (APIs); transition to another proprietary API would require VA to convert all information from one format to another, including proprietary product identifiers on over 18,000 entries. This would result in further delivery delays of two years and estimated duplicated costs of $3 million, that would not be recovered through competition.

In addition, VA has a requirement for additional licenses to expand the current FDB system and pharmacist’s tools to better support Veterans. The additional licences are part of the FDB suite of applications, therefore, these licenses will seamlessly integrate and interoperate with the existing VA environment. No other brand name licenses can meet VA’s interoperability and compatability requirments with the exisiting licesnes due to the proprietary constraints of the licesnes. Specifically, use of another brand name license would not communicate with the deployed FDB licenses.

Also, only FDB can provide the software maintenance since access to FDB’s proprietary code is required to ensure all the services provided are properly configured.

Furthermore, VA has an immediate need to ensure seamless continuation of operation of the drug database system as the current FDB drug database source contract expires on January 17, 2019. Even if VA could overcome the technical issues stated above, only FDB drug database source can meet the Governments requirement to continue performance of this function uninterrupted. VA estimates that it would take a minimum of two years for another vendor to be able to provide for seamless integration/operations. This estimate is based on historical information for the integration, testing, and deployment of the current FDB system. VA must continue to support mission critical services such as drug-drug interactions, duplicate therapy, dosing, patient medication information sheets, and VA-DoD interoperability to ensure patient safety. If VA is no longer able to use FDB database source, the already deployed versions of these applications, and the support applications and features would be rendered useless. This would leave clinicians with no tools to assist in order checks to prevent patient safety issues and harmful drug interactions during the long transition period, which would have a severe negative impact to Veterans’ healthcare.

6. Efforts to Obtain Competition: Market research was conducted, the details of which are in section eight below. The market research conducted did not yield any capable sources, other than FDB, who could meet all of the Government’s requirements. As a result, there is no competition anticipated for this acquisition. Additionally, the proposed action will be synopsized on the Federal Business Opportunities Page (FBO) in accordance with FAR Part 5.201, and this Justification will be posted FBO within 14 days after award.

7. Actions to Increase Competition: In order to remove or overcome barriers to competition in future acquisitions for this requirement, the agency will work with the program office to perform additional market research so that other solutions can be considered. VA has recently signed a contract with the Cerner corporation. A request to convert VistA to the Cerner/Multum platform has been entered;, however, funding has not been approved for the new project. Using Cerner/Multum is the most logical system. Furthermore, within the next 10 years, VA intends to transition from FDB to Cerner Multum drug database source.

Using Cerner Multum will bring consistency between VisTA, the new EHR, and DoD, in regard to order checks and patient information

8. Market Research: Market research was conducted via release of a Request for Information (RFI) 36C10B19Q0044, along with a draft Product Description, on the Federal Business Opportunities webpage on October 5, 2018 with responses due on October 15, 2018. In the RFI, the Government requested capability statements from vendors that could demonstrate their current ability to provide a comprehensive pharmacy drug database and associated decision support tools. One response was received from the incumbent contractor, FDB. After review of the information received, the Governments technical experts determined that only FDB was technically capable to execute the requirements detailed in Justification for Other than Full and Open Competition prepared in support of this acquisition. In addition to the RFI, the Government’s technical experts conducted additional market research in December 2018 by looking at similar software from WoltersKluwer-MediSpan and Cerner-Multum After reviewing the product information from these items, the Government’s technical experts determined that these items could not meet all of VA’s requirements as outlined in Section 5 of this Justification.

Finally, in discussions with FDB, FDB stated that there are no resellers of their software and/or maintenance support, and provided a sole source letter.

Furthermore, on December 14, 2018, the Government contacted FDB to see if they would consider selling the rights to the FDB product; FDB responded stating that they would not sell the rights to its products. Based on this market research, the Government’s technical experts have determined that only FDB can meet all of VA’s needs, and that competition is not expected for this requirement.

9. Other Facts: None.

10. Technical and Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

11. Determination of Best Value: I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonbale based on price analysis to include comparison of negotiated prices to the Independent Government Cost Estimate.

12. Procuring Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

13. Legal Sufficiency Certification: I have reviewed this justification and find it adequate to support a limited source award and deem it legally sufficient.

Approval

In my role as Advocate for Competition, based on the foregoing justification, I approve the acquisition for the renewal of existing enterprise FDB MedKnowledge software licenses and maintenance, as well as the procurement of additional enterprise licenses, on an other than full and open competition basis, pursuant to the authority cited in section 4 herein, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition.