Department of Veterans Affairs Network Contracting Office (NCO) 16 Request For Information (RFI) Page 7 of 7 DISCLAIMER: THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS SYNOPSIS IS NOT A REQUEST FOR QUOTE, PROPOSAL, OR BID. This notice is not a solicitation as defined by FAR 2.101, therefore it shall not be construed as a commitment by the Government to enter a contract, nor does it restrict the Government to an acquisition approach. All information contained in this Request for Information (RFI) is preliminary as well as subject to amendment and is in no way binding on the Government. Information submitted in response to this notice is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. The Government is requesting that restrictive or proprietary markings not be used in response to this notice. If a solicitation is released, it will be synopsized in the Federal Contract Opportunities website or GSA. It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this RFI. 1. Title: Simplifi 797 and Simplifi+Medstorage 2. Purpose: The purpose of this RFI is to identify potential sources which will aid in defining the procurement strategy (e.g., set-aside, sole source, unrestricted) for a solicitation the NCO 16 on behalf of the G.V. (Sonny) Montgomery VA Medical Center (GVSM VAMC) Pharmacy intends on issuing shortly for the following: The anticipated Small Business Administration (SBA) size standard for the North American Industry Classification System (NAICS) code 541519 is $34 Million. 3. Responses Requested: The following questions must be answered in response to this RFI. Answers that are not provided shall be considered non-responsive to the RFI: a. Where are the requested items/equipment manufactured? Vendor must attach documentation of this information to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice b. Are the requested items/equipment manufactured by a small or large business? Is the potential vendor in compliance with the Non-Manufacturer Rule (NMR)? Vendor must attach documentation of this to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice c. Is the Vendor an authorized distributor with access to Original Equipment Manufacturer (OEM) parts which may be required in performance of this requirement? If so, please provide authorized distributor letter. The VA does not accept grey market items and therefore the Vendor must attach evidence of this access (Authorized Distributor letter) to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice. d. Name of potential Contractor that possess the capability to fulfill this requirement. Contractors shall also provide the following: Point(s) of contact name: _______________________________________________ Address: ___________________________________________________ Telephone number: ___________________________________________ Email address: _______________________________________________ Company's business size: ________________________________________________ Data Universal Numbering System (DUNS) #: _______________________________ e. Is your company considered a small business concern, SB, SDVOSB, VOSB, HUBZone, or 8A concern, with the requisite __________________ NAICS code? Please provide proof of qualifications. f. Is your company available under any Government Wide Agency Contract (GWAC), General Services Administration (GSA) Schedule, Indefinite Delivery Indefinite Quantity (IDIQ), and/or Blanket Purchase Agreement (BPA)? If so, please identify the contract number for the Government to review as part of this Market Research. 4. Opportunity/Market Pricing: The G.V. (Sonny) Montgomery VA Medical Center (GVSM VAMC) Pharmacy is seeking information from potential vendors on their ability to provide the required items/equipment. THIS IS A SOURCES SOUGHT REQUEST FOR INFORMATION (RFI) ONLY. Small Business Concerns are encouraged to provide responses to this RFI to assist the G.V. (Sonny) Montgomery VA Medical Center (GVSM VAMC) Pharmacy in determining potential levels of competition and general market pricing available in the industry. Therefore, vendors are requested to submit estimated market research pricing along with their responses to the above. The estimated pricing will be considered when determining the procurement strategy for the forthcoming solicitation. 5. Instructions and Response Guidelines: RFI responses are due by 5:00pm (CST), Friday, 07-26-2024; size is limited to 8.5 x 11 inches, 12-point font, with 1-inch margins in Microsoft Word format via email to caleb.parker@va.gov The subject line shall read: The G.V. (Sonny) Montgomery VA Medical Center (GVSM VAMC) Pharmacy NO SOLICITATION EXISTS AT THIS TIME. There is no page limitation on subparagraphs 3(a) - 3(f). Please provide the information you deem relevant in order to respond to the specific inquiries of the RFI. Information provided will be used solely by The G.V. (Sonny) Montgomery VA Medical Center (GVSM VAMC) Pharmacy as Market Research and will not be released outside of the The G.V. (Sonny) Montgomery VA Medical Center (GVSM VAMC) Pharmacy Purchasing and Contract Team. 7. Contact Information: Caleb Parker caleb.parker@va.gov Your response to this notice is greatly appreciated! DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. End of Document PERFORMANCE WORK STATEMENT Simplifi 797 1) General: The G.V. (Sonny) Montgomery VA Medical Center (GVSM VAMC) Pharmacy requests a subscription purchase agreement for Simplifi 797 w/CriticalPoint, USP 800, USP 795, Compounding Module and Simplifi+MedStorage. This contract is for the Base Year plus four one-year options. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government. 2) Description of Equipment/Services Introduction: Simplifi 797 is turnkey pharmacy compliance software that automates operations required to comply with USP chapters, 795, 797 and 800. The package includes CriticalPoint expert content with policies and procedures, training, task management and alerts to ensure safe and compliant operation. Simplifi+Medstorage is a customizable, mobile and scalable unit inspection management system that helps ensure that clinic staff are following standardized protocols essential to storing and maintaining medications. Users can create checklists to help document patient safety processes taking place before critical events involving regulated protocols. The system-level management capabilities of the platform provide visibility to multiple units and facilities, allowing standardization of policies and procedures across a health system. 3) Background: The GVSM VAMC Pharmacy Services must comply with the U.S. Pharmacopeial Convention (USP) 797 Pharmaceutical Compounding-Sterile Preparations standards. USP 797 is an enforceable federal guideline which provides comprehensive quality standards for the procedures used in sterile compounding areas. USP compounding standards help compounding practitioners adhere to widely acknowledged, scientifically sound procedures and practices, and facilitate the delivery of consistent and good-quality prepared medicines to patients. The failure to adhere to USP 797 standards increases preventable incidents that result in infections or death. GVSM VAMC Pharmacy Department intends to utilize Simplifi 797 -a web based quality management system, to ensure our sterile compounding programs are up to USP 797 standards. The system will assist with policies/procedures, training/competencies, environmental testing, documentation, etc. In addition, GVSM VAMC Pharmacy Services must comply medication storage requirements established by VHA and Joint Commission. The GVSM VAMC plans to use Simplifi+Medstorage to help ensure that clinic staff are following standardized protocols essential to storing and maintaining medications. 4) Objective: The goal of the contract is to acquire and implement Simplifi 797 product applications to assist with compliance to standards for FY 25, and four one-year option periods. 5) Scope: The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified. The Contractor shall provide online access to the web-based application. Simplifi 797 must be user friendly and facilitate the ongoing compliance of training, procedures and documentation imperative to patient safety and risk minimization. The program will document and report on compliance and training to provide to pharmacy inspectors when necessary. The program will also provide needed continuing education to all pharmacy staff members via online ACPE- approved sterile compounding training. The product must provide ACPE accredited sterile compound training continuing education up to 33 hours for all pharmacy staff on both USP 797 and USP 800 standards, requires the most comprehensive sterile compounding training available online. The required product will specifically customize a quality assurance plan including policies and procedure for the GVSMVAMC Pharmacy Service. The product must provide real-time alerts on the facility and system level to assess compliance risks. The Contractor shall provide Simplifi+Medstorage, a single sign-on platform to help track all the tasks and documents required to pass unit inspections both inside and outside of pharmacy through the use of customizable automated checklists in a mobile friendly format. 6) Period of Performance: 10/01/2024 to 09/30/2029. 7) Type of Contract: Firm Fixed 8) Task: The contract will include the program providing product training and ongoing support. As an online application, the product should not require any hardware investment or IT resources.
