DA10--**REQUEST FOR INFORMATION** Pharmacy Web-Based Compounding Documentation System VISN 10 Pharmacy Operations

REQUEST FOR INFORMATION (RFI) Comprehensive Web-Based Compounding Documentation System RFI Disclaimer: This Request for Information (RFI) does not create any representation, either express or implied, that if a tender or procurement process does proceed, that the participant s tender or other form of application (if any) will be given any preference or special consideration. Participants are still required to follow any tender or procurement process that may take place in the future. If a solicitation is released, it will be advertised in under Contracting Opportunities in SAM.gov. It is the responsibility of potential offerors/bidders to monitor these sites for the release of any solicitation. This RFI does not indicate a commitment to any particular course of action. Respondents are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party s expense. All businesses are encouraged to respond; however, each respondent must clearly identify their business size and socio-economic category(s) in their capabilities statement. This Request for Information (RFI) is only for the purpose of identifying potential sources as part of market research. No Request for Proposal (RFP), Quote (RFQ), or Invitation for Bid (IFB) exists. Responses to this Request for Information (RFI) are not quotes, proposals, or bids on which the VA can issue any contract. This Notice is issued for information and planning purposes only and does not itself constitute an RFP, RFQ or IFB. The Government does not intend to award a contract based only on responses to this RFI. Responses to the notice will not be returned. Responders are solely responsible for all expenses associated with responding to this Request for Information (RFI). The applicable NAICS code for this requirement is NAICS 513210 Software Publishers, with a Small Business Size Standard of $47.0 Million. The Product Service Code is DA10, IT and Telecom Business Application/Application Development Software As A Service. Background: Veteran Integrated Service Network (VISN) 10 facilities must comply with regulatory standards related to compounded sterile preparations (CSP). United States Pharmacopeia (USP) has developed chapters that provide industry-accepted guidance on this topic which are enforceable by The Joint Commission (TJC), Federal Drug Administration (FDA), and VA Office of Inspector General (OIG). Furthermore, VHA Handbook 1108.12 includes requirements above and beyond those outlined in USP chapters relative to the CSP area regarding cleanliness, quality, competency, and documentation. Additionally, compounding presents a potential for human error. Immediate response to errors is essential to patient safety and outcomes. Overview: VISN 10 Pharmacy Services would like to enter into a 5-year contract (1 base plus 4 option years) to meet their continued need for a comprehensive web-based system that supports documentation, training, and reporting requirements set forth by regulatory bodies on both sterile and non-sterile compounding. The purpose of this sources sought notification is to identify companies that could potentially provide this service and arrange a day(s) for identified vendors to provide a brief overview/demo of the service. This electronic platform shall be web-based, shall already be commercially available, and have the ability to implement multi-factor authentication. The information stored shall be items such as staff activities (i.e., cleanroom tasks, competencies, sampling results), environmental controls (i.e., temperatures, humidity, and pressure differentials), and compounding records (i.e., master formulations, anticipatory compounding). The system shall generate triggers or alerts when trends are identified so pharmacy management can take the appropriate steps to mitigate risk. The service shall maintain a single or multiple system superusers that will grant each employee their own unique access to the site where employees can log-in and see their to-do list of items required for their shift such as remove garbage, decontaminate IV hoods, etc. The vendor shall have a system that: Provides a comprehensive management system that assists with documentation of training and procedures essential to patient safety and risk mitigation related to compounding. System stores task completion status for a period no less than 3 years. Offers ongoing education with accredited continuing education (CE) for pharmacists and pharmacy technicians. Training must include courses that meet the minimum annual training requirements of USP Chapters <795>, <797>, and <800>. Logs quality assurance activities electronically, and digitally documents records for reporting and operational trending. Provides customizable policies and procedures based on current USP guidelines populated with recommendations by field experts. Documents are automatically updated when policy changes are enacted or new best practices are identified. Allows for importing of policies and procedures already developed by the facility. Documents can be uploaded to the system from common formats such as Microsoft Word, Adobe PDF. Provides customizable tasks and competency templates populated with best practice recommendations from subject matter experts. Alerts system users when updates are made. Develops a quality assurance (QA) plan that is based on workflow and data that offers recommendations for improvement. Allows option for scheduling staff for competencies and training. Tracks when staff are overdue on training requirements. Schedules tasks by administrator to staff on a one-time or recurring basis. Customizes workflow based on current practices. Creates customized labels that can be sent to any network printer. Offers wide range of printable reporting functions that can drilled down by user, task, or of specific filter that has been saved. Assigns unique username and password to each user. Completion of tasks associates the users name with that task and applies a digital signature with timestamp. Once completed, signature or time record cannot be modified by the user. Supports up to 100 individual users per facility. Permission levels can be configured by the site administrator. The system must also allow super users to access information, data, and reports from other and/or all VISN 10 facilities. The system shall include the ability to customize the layout of system to meet the user s needs (i.e., add subfolders under main folders, RFI Purpose: The purpose of this RFI is to collaborate with Industry on how best to structure the Request for Proposal (RFP) to ensure: Greater market awareness/participation by relevant and capable suppliers Address quality Address assurance ability to meet technical requirements Address availability of domestic small business suppliers RFI Objectives: Greater market awareness/participation by relevant and capable suppliers: Through this RFI and eventual RFP process, the goal is to have greater engagement and market awareness by potential suppliers who qualify and meet the requirements to fulfill the defined requirements. RFI Question #1: Please let us know your interest in participating in this RFI/RFP process through the undersigned. Please also provide company background information. Address Quality: RFI Question #2: What actions are taken to constantly review and improve the system? RFI Question #3: Provide references for other VA facilities utilizing this system RFI Question #4: What would be best method to ensure there is no disruption in service through implementation? RFI Question #5: Does your system offer access to subject matter expert advice for questions at no additional cost? RFI Question #6: Please describe the process to obtain live customer support for tasks, running reports, and requests for system improvements, including timeliness of response rates. Address assurance ability to meet technical requirements: RFI Question #7: What security measures are in place if PHI were to be uploaded into the system? RFI Question #8: What type of implementation support does your company offer and what does the process look like? RFI Question #9: What other programs and/or platforms for other pharmacy-related tasks outside of compounding (i.e., ward inspections, inventory)? If so, is this included in your system or for an additional cost? RFI Guidelines: Please reference above RFI Question # in structuring your responses. For example for Objective 1: Greater market awareness/participation by relevant and capable suppliers, please reference your response as RFI Question #1: .. . Information from this RFI may lead to one-on-one market research discussions, or other collaborative discussions with industry and other recommended approaches to industry engagement. Although all comments received will be carefully reviewed and considered for inclusion in future RFP and any possible later action, the initiators of this request make no commitment to include any particular recommendations. Your response to this RFI is requested on or before 1:30pm EST on, October 31, 2024. Responses must be submitted electronically addressed to Teri Miller at Teri.Miller@va.gov and Josh Kovar at Joshua.Kovar@VA.gov with the subject line RFI RESPONSE XXXXXXX_(Your Organization name) . Do Not submit pricing information in response to this Request for Information.