Health Rx Nexus Licenses or Equivalent

THIS IS A SOURCES SOUGHT NOTICE FOR INFORMATION AND ACQUISITION PLANNING PURPOSES ONLY. This is not a request for quote or proposal. This notice does not constitute a commitment by the Government to issue an RFP, RFQ, contract, or order. The Government will not pay for any effort expended or any material provided in response to this announcement. Requests for a solicitation will not receive a response. This Sources Sought is being issued by the Food and Drug Administration (FDA) to seek companies capable of providing renewal of Health Rx Nexus v.4 Commercial-Off-The-Shelf (COTS) software licenses, maintenance, and enhancement services or equivalent Safety and Compliance COTS software licenses, maintenance, and enhancements. The current Health Rx suite of Nexus v. 4 term licenses and products utilized by the FDA is as follows: NAIC-001-A - Nexus Application Container - Qty 1 PID-001-A: PI Dashboard - Qty - 1 PID-001-8: PI-Dashboard Add-on Domain (IRB, Biology, Animal Care and Use Committee (ACUC), Chemical, Radiation) - Qty 2 LSM-001-A Laboratory Safety Mangaer - Qty1 INV-001-A Inventory Manager - Qty 1 DAR-001-A: Data Analytics and Reporting - Qty 1 ESM-001-A: Electronic Surveillance Manager PID Connector - Qty 1 EMR-001-A: Electronic Medical Record - Qty 1 CAM-0001-A: Clinical Access Manager - Qty 1 VIM-001-A: Vaccine Manager - Qty 1 FDA's Safety Inventory Protocol System (SIPS) is comprised of the current Health Rx Nexus v.4 licenses listed above. SIPS is FDA's primary repository for storing safety researcher registrations and researcher safety protocol listing data across the FDA. SIPS tracks incidents within agency locations; tracks chemical, biological, and radiological research protocols; and tracks employee health and medical records. SIPS supports the following business needs: - Internal Review Board (IRB) Protocol Registration - Health Physics Assistance (Radiation Safety Database) - Chemical Safety Assistance (The Environmental protection data systems Chemical Inventory System) - Biological Safety Assistance - Complaince Assistance (Lab Safety) - Animal & Inventory Assistance - Accidental & Injury Assistance - Occupational Heath Assistance SIPs assists FDA's Employee Safety and Environment Management (ESEM) staff within the Office of Commissioner (OC), manage integrated Occupational Safety and Health programs for the entire agency. Programs supported include Occupational Medicine, Radiation Safety, Biological Safety, Environmental Protection, Chemical Inventory, and Occupational Safety and Health regulations. The functional areas listed below comprise the modules that are currently included within FDA's SIPS: 1) Laboratory Safety and Compliance Module: Surfaces all active laboratory space, protocols and materials to EHS to drive lab inspections and compliance. Enables view of research activity multiple ways including by floor, lab, PI, associated researcher, safety inspector, and material. Initiate a lab inspection by selecting pre-defined forms appropriate to work being done in lab, quickly conduct inspection, checking off deficiencies and adding notes documents, and pictures, manage resolution of deficiencies, and issue final inspection report. Data is used to produce many compliance and tracking reports. 2) The Institutional Review Board (IRB) module, implemented in 2015, provides tracking of the status of the research protocols using human subjects. The IRB module is used by Research Involving Human Subject Committee (RIHSC) for the creation, submission, review, and approval of all research packages for RIHSC. This module provides electronic record keeping in which FDA sponsors maintain accurate and complete study records to include the current and archived versions of the protocol, consent form, and study amendments; establishes the location where original source materials and records or data are generated over the course of study, and assure the confidentiality of all records. 3) The Vaccine Manager module has been operational since October 2016 and is an immunization management tool that augments medical surveillance programs. This module allows for use of employee badges and scanning devices collect and validate immunization data. In addition, this module will send confirmation emails, provide a secure patient portal to retrieve copies of formal, signed immunization documentation, and enables the recipient to fill out an electronic survey to pride near real-time feedback. 4) The Radiation Safety module- PI Dashboard, implemented in 2017, performs two essential functions: it provides a complete lifecycle accounting of the operational parameters of the radiation safety program for management oversight, and; provides critical evidence of compliance with the licensing regulations of the Nuclear Regulatory Commission and any other occupational or environmental regulations. 5) The Chemical Safety module - PI Dashboard, implemented in 2017, supports the FDA chemical inventory. This module allows for hand bar-coding of bottled chemicals when received and removed from the FDA. When bottled chemicals are depleted, the module provides the totals of hazardous and flammable chemicals for the individual floors of laboratory buildings that could be used in emergency response situations. As well, this module ensures that regulatory limits are not exceeded. The chemical inventory module complies with numerous Federal and State regulations. 6) The Biological Safety module, implemented in 2017, records, maintains, and reports information to support ongoing laboratory activities. This includes personnel location and suitability- certifications, permits, required training, vaccination status, and equipment ratings relevant for personnel working in Biosafety levels I, II, and III. In addition, the biological module tracks equipment, consumables, cradle-to-grave laboratory specimens, and test animals related to ongoing research activities onsite, based on building/laboratory. The laboratory specimens included in tracking laboratory specimens includes select agents, from delivery/assignment to a principal investigator through destruction/disposal. The Biological Safety module also tracks maintenance service, repair service calls, and operations history for laboratory equipment, and quantities/usage of laboratory consumables (reagents, preparation supplies, etc). The Biological Safety module also records and maintains version control for all laboratory and safety protocols, consistent with Biosafety in Microbiological and Biomedical Laboratories, 5th Ed. (BMBL) requirements for Biosafety levels I, II, and III. 7) The Animal Inventory module, implemented in 2017, is closely linked to the Biological module. This module provides inventory of research animals and compliance with requirements of the Institutional Animal Care and Use Committee (IACUC). 8) The Workplace Incidents Management module, implemented in 2017, captures, records, and tracks incidents that are violations of laboratory and safety protocols. This module provides linkages to the eComp program for reporting workplace injury and illness for investigation by the FDA Safety Staff. The Workplace Incidents Management module provides custom reporting and analytical features for OSHA and Department of Labor forms and reporting. 9) The Employee Medical Record (EMR) module, has been fully operational since September 2017, and is a medical surveillance module specifically designed to help protect employees from nontraditional risks. The EMR was configured to support various styles of medical practice and includes specialized Occupational Medicine templates. This module allows an FDA's Occupational Medical Service clinic to recall patients into the clinic for surveillance appointments based on workplace risks. The Clinical Access Manager (CAM) in this module is a tool for patient and provider scheduling, automatic charge capture, and analysis of utilization and outcomes. The Vaccine Manager in this module is an immunization management tool that augments medical surveillance programs. 10) The Employee Medical Record/Medical Surveillance Manager (EMR/MSM) module, has been operational since September 2017, combines electronic medical record and medical surveillance programs. It is specifically designed to integrate OHS policies across all clinics to proactively monitor and recall patients into the clinic for surveillance appointments based on workplace risks as defined by registered research protocols in an effort protect the employees from nontraditional risks. The EMR was also configured to support documentation of various styles of medical practice and includes specialized Occupational Medicine templates. 11) The Clinical Access Manager (CAM) module has been operational since April 2017 and is a tool for patient and provider scheduling, and analysis of utilization and outcomes. A secure patient portal will allow self-scheduling, cancellation, and a view of past and future appointments. MAINTENANCE SUPPORT: Maintenance support includes but is not limited to: - External help desk and online services including tips and tricks, computer based end user training, user guides, sample reports and views. - Software patches and upgrades For more detail on SIPS requirements please see Attachments No. 1 and 2. SUBMISSION INSTRUCTIONS Interested companies must submit the following information: 1. Capability Statement limited to 10 pages addressing at a minimum the following: - What Safety and Compliance COTs tool does your company recommend and why? - Can the recommended tool be hosted on FDA's Technical Environment? Please note, the FDA is not seeking a Cloud or web based tool. - Are you an authorized reseller or authorized agent to service this COTS tool? - Please describe and give examples of the capabilities of the proposed COTS solution. Please note, equivalent COTs solutions must at a minimum contain the following functional areas Out of the Box (OOTB) or equivalent functional areas: o Laboratory Safety o Data Analytics and Reporting o Workplace Incident Management o Electronic Medical Records o Electronic Medical Surveillance o Compliance and Safety (Radiation, ACUC, Chemical, Biology, IRB) o Clinical Access Manager o Vaccine Manager - Interested Offerors recommending an equivalent product, provide a detailed explanation of how the product can provide the same or better functionality than FDA's current Health Rx Nexus v.4 suite of products listed in this Sources Sought Notice. - Does your company have a corporate experience in providing Safety and Compliance IT Support and Enhancement Services for the commercial industry or Government? If yes, please explain. - Does your company have experience implementing the recommended Safety and Compliance COTs tool? If so, did your company perform services as a prime or subcontractor? Explain your company's role in more detail. - Does the proposed product meet the 508 standards below for new products and usability? Usability Standards ? C203 Electronic Content ? C202 Functional Performance Criteria ? C205 Software ? C206 Support Documentation and Service Standards for New Software: ? E203 Access to Functionality ? E204 Functional Performance Criteria ? E205 Electronic Content 2. Interested companies shall provide the following Business Information for both the seller and manufacturer of the product (if different)(2 pages): - DUNS Number - Company Name - Company Address. - Company Point of Contact, phone number and email address - Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp. - Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); - Current GSA Schedules appropriate to this Sources Sought - Current Government Wide Agency Contracts (GWACs) - Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. - Any applicable Socio-Economical Classification(s): 8(a), HUBZone, Service-Disabled Veteran-owned, Veteran-Owned, Women-Owned and Small Disadvantaged Business. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email. Responses shall be limited to 15 pages. Responses must be received in writing, by no later than Monday, June 25, 2018, 1:30 PM, Eastern Time. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Jody OKash at Jody.OKash@fda.hhs.gov. The title of the email shall include the FBO Sources Sought Number, Project title, and Company Name_Capability Statement (for example: FDA-SS-18-1196672, Safety and Compliance COTS Solution, and ABC Company Capability Statement).