JA - MedKnowledge Drug Database_Redacted.pdf

Control Number: VA-22-00013050

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 that will provide the renewal of the existing enterprise MedKnowledge First Databank (FDB) software license, as well as the ability to procure additional clinical module software licenses to First Databank Inc., 500 East 96th Street, Suite 500, Indianapolis, IN 46240.

3. Description of the Supplies or Services: The proposed action is for renewal of the existing FDB commercial clinical knowledge database enterprise software license for the MedKnowledge Information Architecture Framework, as well as enterprise software licenses for associated MedKnowledge clinical modules that are utilized for clinical decision support (CDS) within VA’s Veterans Health Information Systems and Technology Architecture (VistA) Electronic Medical Health Record (EMHR) System, Medication Order Check Healthcare Application (MOCHA) suite of pharmacy software applications. Access to this clinical knowledge database is required for MOCHA medication order checks such as drug-drug interactions, duplicate therapy, and maximum dose checks during provider medication order entry and pharmacy medication order processing.

Optional tasks will be utilized to enhance the current MOCHA system and provide doctors and pharmacists with tools to better support Veterans. There are eight optional tasks including 1.) MedGuide Module, 2.) Hepactic and Renal Dosing Content Bundle, 3.) Order Knowledge Content, Hepactic & Renal Dosing and Rounding, 4.) Opioid Risk Module, 5.) Enhanced Interoperability Module, 6.)

Pharmacogenomics Content & Application Program Interfaces (API) Bundle (Pilot), 7.) Pharmacogenomics Content & API Bundle, and 8.) MEDUCATION Patient Engagement Module, to include all applicable enterprise licenses and APIs which will enable seamless integration and interoperability with the existing VA environment.

The period of performance (PoP) for this effort is one 12-month base period with four 12-month option periods. Additionally, there are eight optional tasks. Each optional task has a 12-month PoP and can be exercised once in the base period and once in each of the option periods. This is a recurring need that is not expected to be change over the next 5 years, therefore the total PoP for this requirement shall not exceed 60 months. The total estimated value of this effort, inclusive of options is $39,234,207.18.

MedKnowledge Drug Database and Decision Control Number: VA-22-00013050 Support Tools

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 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 for this action is FDB, 500 East 96th Street, Suite 500, Indianapolis, IN 46240.

MOCHA applications and FDB’s clinical knowledge database are directly responsible for delivering reliable and efficient order checks within VistA’s Computerized Provider Record System (CPRS) and pharmacy applications.

MOCHA is the innovative centerpiece of the clinical decision support system used by 45,000 providers and 8,000 pharmacists across the Veterans Health Administration (VHA) enterprise, improving the accuracy, safety, and efficacy of 150 million prescriptions per year. MOCHA applications and FDB’s clinical knowledge database are directly responsible for delivering reliable and efficient order checks within VistA’s Computerized Provider Record System (CPRS) and pharmacy applications.

The entire suite of VistA MOCHA applications, (MOCHA, PECS, PPS, MOCHA Server, DATUP), including actual medication order checks, are accomplished by utilizing APIs to access Standard Reference Tables of the current commercial vendor, FDB. These applications are fully dependent and were strictly developed according to the FDB’s database schema, API calls, and algorithms.

In addition, other systems including Consolidated Mail Outpatient Pharmacy and the Clinical Data Repository/Health Data Repository systems have been modified to use FDB data and FDB’s APIs. FDB’s National Drug Code (NDC) and pricing information is used to validate VA’s class of products and to verify that the contractual prices are at or below the open market pricing.

Only FDB can provide seamless integration and interoperability with the existing VistA MOCHA environment and critical VA systems. Specifically, the use of any alternative database would require an extensive process to recode the dependent VistA MOCHA applications, all of which are required by VA to provide patient care and patient safety. This recoding effort would become necessary because each vendor database is unique in the structure and function of its data elements and how those elements interact with VA drug file and associated clinical data in order to generate a meaningful order check. Without this recoding effort, the data elements and clinical data exchanged would be inaccurate and would be unsafe as inaccurate information would have a catastrophic effect on medication order checks such as drug-drug interactions, duplicate therapy, and maximum dose checks which would severely impact Veteran Care.

Additionally, VA’s VistA MOCHA is dependent on FDB’s proprietary APIs. These APIs enable the bidirectional flow of information across an interface from FDB to VA and vice versa. Therefore, transition to any other database would require the redevelopment, reintegration, retesting, conversion of data, retraining, and redeployment not only MOCHA applications, but of APIs as well. Specifically, as FDBs API are proprietary, the use of any alternative database would require VA to redevelop APIs and convert all information contained in these APIs from one format to another, including proprietary project identifiers on over 18,000 entries, such as specific VistA file fields that connect the FDB data tables with the VA National Drug File and with data fields that are required by MOCHA.

VA Government technical experts estimate that a transition from FDB’s clinical knowledge database as detailed above would take, at minimum, 60 million dollars and five years for another vendor to be able to adequately provide current MOCHA functionality and operations. These estimates are based on previous acquisition history and analysis of historical information for similar transitions .

These estimated duplicative costs would not be recovered through competition.

VA must continue to support mission critical services such as drug-drug interactions, duplicate therapy, dosing, patient medication information sheets, and VA-Department of Defense (DoD) interoperability to ensure patient safety. If VA is no longer able to use FDB’s MedKnowledge database, the current deployed versions of these applications, and the support applications would be rendered useless. This would leave pharmacists and providers with no tools to provide order checks. Without means to prevent patient safety issues and harmful drug interactions during the long transition period, there would be a severely negative impact to Veterans’ healthcare.

6. Efforts to Obtain Competition: Market research was conducted, the details of which are in the market research section of this document. 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 contracting opportunities page in accordance with FAR Part 5, and this Justification will be posted to contracting opportunities within 14 days after award in accordance with FAR 6.305(a).

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.

8. Market Research: Government technical experts conducted web-based market research in August 2021. Government technical experts reviewed similar products from alternative sources to include the National Library of Medicine, IBM Micromedex, DrugBank Drug Interaction Checker (DDI), True Pill Safety API, PEPID Drug Information Database, and Cortellis Drug Interactions API.

However, each of these systems was found unable to meet VA’s requirements as the use of any alternative product would require the redevelopment, reintegration, retesting, conversion of data, retraining, and redeployment not only MOCHA applications, but of APIs as well. As such, no alternative product could avoid the duplication of cost and time required as outlined in Section 5 of this justification.

Additionally, VA conducted market research via release of Request for Information (RFI) 36C10B22Q0045 on the Federal Business Opportunities webpage on October 26, 2021 with responses due on November 5, 2021. 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. No responses were received.

The market research revealed that there are not two or more Service Disabled Veteran-Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) sources within the open market or on any existing vehicle that are capable of meeting the Government’s requirements. Therefore, this action cannot be set-aside for SDVOSB/VOSB or any other socio-economic group. In accordance with VA Acquisition Regulation 810.001-70, market research was conducted via the Vendor Information Pages (VIP) database at www.vip.vetbiz.gov. The VIP database was screened for a list of all SDVOSBs and VOSBs under the North American Industry Classification System (NAICS) code 511140. The results of the search found a combined total of 12 SDVOSBs and VOSBs under this NAICS code.

Finally, FDB provided a letter dated December 9, 2021, affirming they are the sole provider of the Licensed Solutions intended for use by the Department of Veterans Affairs. The capabilities sought contain proprietary data elements developed, maintained, and customized exclusively by FDB for VA. Based on the market research, the Government’s technical experts have determined that only FDB is capable of meeting the Government’s requirements 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.

Amy K Norris Date: ______________________

Program Manager Signature: ______________________

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

Heather Utt Date: ______________________

Procuring Contracting Officer Signature:__________________

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

Heather Utt Date: ______________________

Procuring Contracting Officer Signature: __________________

Approval

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

Date:_________ Signature: ____________________________ Michele R. Foster Head of the Contracting Activity Technology Acquisition Center

Office of Procurement, Acquisition, and Logistics