JA_SAMPosting_Redacted.pdf

CONTROL NUMBER VA-26-00020962

Justification Template_FAR 6_(07-AUG-2024)

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: This proposed sole source action is for a firm-fixed price (FFP) effort for compliance software for Compounded Sterile Products (CSP) and Simplifi MedTrays+ tracking software to Pharmacy OneSource, Inc., 525 Junction Rd Ste 5000, Madison, WI 53717 or UpToDate, Inc. should the novation currently in progress be finalized before award of this proposed effort.

3. Description of the Supplies or Services: The Department of Veterans Affairs, Veterans Health Administration (VHA), Veterans Integrated Service Network (VISN) 2 has a requirement for a turnkey software compounding solution.

The VISN 2 Medical Center Pharmacies have a requirement (USP 797/Joint Commission) for compliance software for their Compounded Sterile Products (CSP).

Simplifi 797 is turnkey pharmacy compliance software that automates operations required to comply with USP chapters 795, 797, and 800. This software is crucial in its role in reducing the risk of errors associated with manual paperwork, must remain to ensure pharmacies do not have to go back to the cumbersome paperwork system and potentially compromise pharmacy operations providing the quality care Veterans need.

The contractor shall provide the following web-based software to be used for all compounding areas and all staff members associated with sterile and nonsterile compounding across Veterans Integrated Services Network (VISN) 2 New York/New Jersey Pharmacy services: Simplifi 797 with Critical point (web-based application);

Simplifi 797 with SoleSource Academy also in compliance with USP 795 and USP 800;

a Compounding Module; and Simplifi+ MedTrays.

The contractor will provide the following:

Installation and implementation of a fully functional Simplifi 797 Software system to all VISN 2 Pharmacy Compounding units to include:

o Simplifi 797 with SoleSource Academy o USP 795 o USP 800 o Compounding Module o Simplifi+ MedTrays o Clinical training for all VISN 2 VA Medical Center Staff (Webex and online) o Technical Training for VISN 2 VA Medical Center Staff (Webex and online)

SoleSource® is the technology platform for deploying the Simplifi+ Compliance branded Suite of applications, including Simplifi 797®, Simplifi+ MedStorage, and Simplifi+ MedTrays. Simplifi 797 is a comprehensive quality management system that helps meet

Simplifi 797 with SoleSource Academy CONTROL NUMBER VA-26-00020962

Justification Template_FAR Part 6_(07 AUG-2024) the requirements of USP Chapters 795, 797, and 800. It facilitates the ongoing compliance of training, procedures, and documentation essential to patient safety and risk mitigation for compounding pharmacies. Simplifi+ MedStorage is a checklist management system that supports organizations by automating and standardizing drug storage best practices across units and healthcare facilities to ensure compliance with The Joint Commission requirements. Simplifi+ MedTrays automates and standardizes medication tray restocking and management, helping pharmacies maintain medication trays accurately and consistently to ensure a constant state of readiness, inventory oversight, and patient safety.

The period of performance consists of a twelve (12) month firm-fixed price (FFP) order with optional tasks for each VISN facility and with four 12-month option periods. The total estimated value of this action, inclusive of all option periods, is

4. Authority:

The statutory authority permitting other than full and open competition is 41 U.S.C.

3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) Overhaul VA Deviation 6.103-1 (b) entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

5. Rationale Supporting Use of Authority Cited Above:

In order to ensure compliance with the stringent United States Pharmacopeia (USP 795, 797, and 800) standards for sterile compounding and to maintain the highest levels of patient safety and regulatory compliance in alignment with Joint Commission standards, the procurement of the Simplifi 797 system is proposed on a sole source basis. This system offers unique capabilities such as real-time environmental monitoring, seamless integration with existing VA workflows, and comprehensive historical data reporting that no other vendor can match. UpToDate, Inc. has deep contextual knowledge of VA’s operational needs and nuances, enabling them to provide highly tailored and effective solutions. Their existing relationship ensures a smoother, faster resolution of any issues that may arise. After conducting thorough market research, it has been determined that no other brand of product meets all of these critical requirements. The cost of the Simplifi 797 system is justified by the significant potential savings from reduced compliance penalties and improved efficiency, making it an essential procurement for maintaining the quality and safety of VA healthcare services. Further market research has determined that other vendors, although providing portions of the requirement, cannot provide all needed capabilities to ensure medication integrity and continued patient safety.

Award of this eventual contract to a vendor that cannot provide all components of Simplifi 797 could lead to significant challenges related to compliance, quality control, documentation, workflow efficiency, staff competency, monitoring, integration, and patient safety. Ensuring the highest standards in sterile compounding is vital for ensuring the highest quality patient care is afforded to Veterans. Ensuring the highest standards in sterile compounding is critical for ensuring positive patient outcomes.

Engaging a new vendor would extend the timeline, resulting in unacceptable risk for

Simplifi 797 with SoleSource Academy CONTROL NUMBER VA-26-00020962

Justification Template_FAR Part 6_(07 AUG-2024) successful deployment in accordance with the mandated schedule by VHA leadership if not awarded to UpToDate, Inc. If a contract is not in place by start of the design milestone, the interfaces listed are under severe risk of not meeting compliance with regulatory requirements of USP chapters 795, 797 and 800.

Specifically, in the event the current contract is allowed to expire, a stopgap solution would return the process of documentation compliance to an archaic paper form, which risks omissions and excursions of data as electronic prompts are absent, decreasing ability in tracking of documentation and risking loss of analytics to provide compliance activities and trends to specific areas. This would lead to increased burden in supervisor oversight and require on-site medical center storage for paper records that must be easily retrievable for regulatory agencies. To be more efficient in this process, VHA personnel would have to design & create documentation in available software such as Google documents, Microsoft Forms, Excel, or Word. Without electronic alerts, manual inspection of documents would need to be performed to track critical omissions or excursions.

The biggest cost to the Government would be in replacement of a web-based training software. Based on market research outlined in Section 8 of this document, the quoted price from an alternative vendor, Discover Software Solutions, which was found not to describe their ability to provide the necessary educational piece nor MedTrays compatible software, was , representing an increase of approximately 72% over historical pricing for the existing Simplifi suite pricing and for the pricing provided by UpToDate in their RFI response. The need for additional MedTrays software and training would mean that the Government would incur additional costs over the existing solutions totaling per year. Additionally, the Government’s analysis is that the procurement of a solution such as this Clinical Compliance Suite offered by an alternative vendor would necessitate the separate procurement of training and software compatible with MedTrays currently in use at VISN 2 facilities, which would require re-training for staff on multiple shifts and incur delays of up to six months, representing an unacceptable delay to mandated VHA timelines.

Furthermore, an alternative solution would interrupt access to comprehensive training, thereby curtailing competency in sterile and nonsterile compounding. Maintaining the Simplifi 797 system avoids the additional costs associated with training, integration, and potential disruptions from switching to a different system or multiple systems performing different operations. For example, if a vendor was to provide quotes for multiple solutions to fulfill this requirement, it could lead to significant delays for VISN 2 Pharmacy personnel to receive training to learn these new solutions and introduce the potential for conflicts between multiple different software solutions operating simultaneously without the seamless cohesion provided by UpToDate’s comprehensive all-in-one offering. One popular company offering web-based training is PharmCon’s Pharmacist CE. These courses are not specifically focused on compounding like the Simplifi suite of products. Additionally, the cost of these courses is based on each individual, not bed sizes per facility as with Simplifi’s offering. Therefore, without group