JA Simplifi- redacted.pdf

Sterile Compounding Compliance Software Licenses, Maintenance VA-27-00001400 and Support

LIMITED-SOURCES JUSTIFICATION

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 a sole source, firm-fixed price task order to be conducted under the authority of the Federal Supply Schedule (FSS) program awarded under General Services Administration (GSA) Mulitple Award Schedule (MAS) Contract Number 47QTCA20D0034 to UpToDate, Inc (UpToDate), 525 Junction Road, Suite 5000, Madison, WI 53171, for the renewal of brand name Pharmacy OneSource, Inc. (Pharmacy OneSource) Simplifi 797 Sterile Compounding Compliance Software licenses with maintenance and support.

3. Description of the Supplies or Services: VA Health Care Center has a requirement for license renewal of brand name Pharmacy OneSource Simplifi 797 Sterile Compounding Compliance Software for Veterans Integrated Service Network (VISN) 6.

The subscriptions are currently used in the all medical facilities located within VISN 6:

Charles George VA Medical Center (VAMC), also known as (AKA) Asheville VAMC;

Durham VA HCS, AKA Durham VAMC; Fayetteville VAMC; Hampton VAMC; Hunter Homes McGuire VAMC, AKA Richmond VAMC; Salem VAMC; WG Bill Hefner VAMC, AKA Salisbury VAMC. The Contractor shall provide accessibility to the web-based program and assist the VISN 6 Mid-Atlantic Pharmacy staff with connecting to the program. The period of performance shall be a 12-month base period, with 4, 12-month option periods, if exercised. The total estimated value of the proposed action, inclusive of options, is $644,077.45.

4. Authority: This acquisition is conducted under the authority of the Multiple Award Schedule Program. The specific authority providing for a limited source award is Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) General Services Administration Acquisition Regulation (GSAR) 538.7104-3(b)(1)(ii), “Only one source is capable of providing the products, services, or solution required at the level of quality required because the products, services, or solutions are unique or highly specialized.”

5. Rationale Supporting Use of Authority Cited Above: UpToDate is the sole provider of Pharmacy OneSource Simplifi 797 with Sole Source Academy, USP 800 module software. VISN 6 has been using Simplifi 797 since 2020 for pharmacy compliance software that automates operations required to comply with United States Pharmacopeia (USP) chapters 795, 797, and 800. Simplifi 797 is the only closed-loop compliance support software on the market. Simplifi 797 is able to be customized to document and record sterile compounding staff competencies, training, development of policies, and sterile cleanroom operations. The web-based compounding training streamlines staff competency validation and offers easy access to Continuing Education credit. The program is inclusive of Accreditation Council of Pharmacy Education (ACPE) continuing education units (CEUs), standard operating procedures, including 44 hours of ACPE CEUs. Simplifi 797 offers inspection ready reports in minutes, real-time alerts and notification of task out of limits/overdue, up coming competencies and compounding records. The other companies that were researched, Carter Health and 797 Tracker, do not offer the required continuing education units or ability to develop standard operating procedures or pharmacy policies. Additionally, VISN 6 has spent considerable amount of time and investment in customizing the existing Simplifi software to meet the needs of the required sterile compounding reporting for the pharmacy. Resultingly, VISN 6 pharmacies have standardized documentation and recording of sterile compounding. Further, VA requires Simplifi web based portal maintenance, which is the only maintenance compatible with the existing Simplifi web-based infrastructure. No other brand name software is compatible with the existing Simplifi infrastructure. Failure to renew the Simplifi 797 Sterile Compounding Compliance Software licenses would result in gaps in sterile compounding documentation, missed or unverified pharmacy staff competencies, and reduced oversight of USP 795/797/800 compliance. These lapses increase the risk of medication preparation errors, contamination, and compromised sterile compounding practices, which could directly endanger Veterans’ health and safety across VA medical facilities.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in Section 8 of this justification. This effort did not yield any additional sources that can meet the Government's requirements. However, the undersigned VA technical representative determined that limited competition is available among authorized resellers for brand name licenses, as well as software maintenance and support. In accordance with GSAR 538.7104-3(b)(3)(i), this justification will be made publicly available within 14 days of award.

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the market place that would enable future actions to be competed. Specifically, the Government will continue to monitor the marketplace to determine whether other brand software could integrate into VA's existing compliance software that automates operations required to comply with USP chapters 795, 797 and 800.

8. Market Research: In accordance with VA Acquisition Regulation 810.001-70 (Class Deviation), market research was conducted via the Veteran Small Business Certification (VetCert) (by way of Small Business Search) database. In May 2026, the VetCert database was screened for a list of all Service-Disabled Veteran-Owned Small Businesses (SDVOSBs) and Veteran-Owned Small Businesses (VOSBs) under the North American Industry Classification System (NAICS) code 513210, “Software Publishers.” The results of the search found a total of 82 SDVOSBs and VOSBs under the NAICS code 513210. Despite the number of matches, the requirement discussed herein is far more specialized than a simple NAICS code search and therefore more specific market research was necessary, a summary of which is contained below.

In March 2026, the Government’s technical experts conducted market research to ascertain the ability of any other products other than Simplifi 797 that can meet the Government’s requirements. Specifically, the Government’s technical experts conducted web-based searches for alternate software products from Carter Health software, which consists of pre-built required tasks that are not customizable, and 797 Tracker, which only offers month-to-month subscriptions and limits access to reports and management of the software to two logins per pharmacy. Therefore, the Government’s technical experts determined that only Simplifi 797 can meet the Government’s requirements. In April 2026, Wolters Kluwer submitted a letter indicating that Pharmacy OneSource is the sole source provider of Simplifi 797. The Sole Source Letter was uploaded to the contract file. In August 2026, Wolters Kluwer confirmed via email that Pharmacy OneSource is a part of UpToDate, Inc (UpToDate), which is a division of Wolters Kluwer. The email confirmation was uploaded to the contract file.

As a result of the above market research, it has been determined that only Pharmacy OneSource can meet the Government’s requirements for Simplifi 797 Sterile Compounding Compliance Software licenses, maintenance, and support and there are no authorized SDVOSB, VOSB, or Small Business resellers. Therefore, the subject solicitation will be issued on a sole source basis to UpToDate, a large business, under its General Services Administration Multiple Award Schedule contract 47QTCA20D0034, under the NAICS code 513210. A Limited Sources Justification has been completed for this effort.

9. Other Facts: None.

Technical/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.

Tonya Jones Date Administrative Officer Durham VA Health Care System

Best Value Determination I hereby determine that the proposed contract action will represent a fair and reasonable price to the Government consistent with GSAR 538.7102-2(d)(2), Ordering activities are not required to make a fair and reasonable price determination for FSS products, services, or solutions at the order level or BPA level as FSS contract pricing has been determined fair and reasonable. Further price analysis, to include an analysis of proposed level of effort and mix of labor, will be conducted and subsequent negotiations held as necessary. Additionally, price discounts will be sought.

Kimberly Geran Date Contracting Officer Technology Acquisition Center Office of Procurement, Acquisition and Logistics Department of Veterans Affairs

Contracting Officer Certification/Approval I certify that this justification is accurate and complete to the best of my knowledge and belief. The certification required serves as the Contracting Officer’s approval.

Kimberly Geran Date

Contracting Officer Technology Acquisition Center Office of Procurement, Acquisition and Logistics Department of Veterans Affairs