RFQAttachmentNo.6SIPSRequirements.xlsx
XLSX spreadsheet 44 KB Posted
- Attached to
- FDA's Safety Inventory and Protocol System (SIPS) Federal contract opportunity
- Solicitation number
- FDA-RFQ-18-1196672
About this file
RFQ Attachment No. 6: SIPS Requirements
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| RFQAttachmentNo.1SIPSSOWandTerms_AmendmentNo.2.pdf | ||
| RFQAttachmentNo.8_VPAT#U00ae2.1--March2018.pdf | ||
| RFQAttachmentNo.4SmallBusinessPlan.doc | DOC document | |
| RFQAttachmentNo.7ContractorNDA.pdf | ||
| RFQAttachmentNo.1SIPSSOWandTerms.pdf | ||
| RFQAttachmentNo.5SmallBusinessReviewform.pdf | ||
| RFQAttachmentNo.3EPLCArtifacts.pdf |
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Definitions and Instructions
| FDA-RFQ-18-1196672 | |
| RFQ Attachment No. 6 - SIPS Requirements Matrix - Quoters proposing equivalent products must fill out this Attachment | |
| Definitions and Instructions | |
| Instructions: Quoters proposing equivalent products must complete RFP Attachment No. 6 in it's entirety. | |
| Out of the Box (OOTB) | Out-of-the-Box is defined as any functionality that comes shipped directly from the software vendor, works within the product immediately after installation, requires no effort to implement or maintain, and can be utilized by users right away. |
| Configuration | Configuration is defined as any functionality that can be created using built-in workflow tools that are shipped directly from the vendor to tweak or fine-tune product parameters, such as: adding fields, changing field names, modifying drop-down lists, or adding buttons. To be considered configurable, functionality is forward compatible with future vendor software release upgrades. It does not require access to the software code, and can be performed by Information Technology (IT) personnel or business users with limited training or the use of user guides and manuals. The timeframe for configurable items is from a couple of minutes to less than 8 hours. |
| Customization | Customizations are defined as a requirement that does not meet OOTB or by Configuration and requires code/logic changes or modification s to the prodcuct software code, performed by Information Technology personnel. The estimated timeframe for a customizable item is greater than 8 hours. |
High-Level funtionality
| FDA-RFQ-18-1196672 | ||||||||
| RFQ Attachment No. 6 - SIPS Requirements Matrix - Quoters proposing equivalent products must fill out this Attachment | ||||||||
| High-Level Functional Requirements | ||||||||
| Mark one of the following for each row. | ||||||||
| Product Name: (Enter Name Here) | Equivalent Product Name: (Enter Name Here) | Mark one of the following for each row. | ||||||
| High-Level Functional Modules | Module Description | Available Out of the Box (OOTB) | With Minor Configuration | With Custom Coding | If Configuration or Custom Coding Describe Propopsed Approach | Estimated LOE to release module into production | Estimated Release date | Identify Forms Available OOTB for each module |
| Radiation Safety Module | 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. | |||||||
| Chemical Safety Module | 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. It interfaces with PI-Dashboard on different registration types such as radiological, chemical, animal and human subjects and biological for inventory management. | |||||||
| Biological Safety Module | PI Dashboard, 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. | |||||||
| Laboratory 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. | |||||||
| EMR Medical Surveillance Manager | A medical surveillance module specifically designed to help protect employees from nontraditional risks. The EMR/MSM 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. This tool allows for use of employee badges and scanning devices collect and validate immunization data. It also sends confirmation emails, provides a secure patient portal to retrieve copies of formal, signed immunization documentation, and enables the recipient to fill out an electronic survey to provide near-real-time feedback. | |||||||
| Work Incident Management Module | Accidental & Injury, 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. | |||||||
| IRB Module | PI Dashboard, 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. | |||||||
| Data Analytics and Capabilities | Capable to perform data mining, data discovery, signal management (identify, analyze and document signals), reconcile safety data across sources, tailored role-based dashboard, develop and maintain canned and adhoc reports |
Specific Functionality
| FDA-RFQ-18-1196672 |
| RFQ Attachment No. 6 - SIPS Requirements Matrix - Quoters proposing equivalent products must fill out this Attachment |
| Specific Functionality |
| Equivalent Product Name: (Enter Name Here) | Mark one of the following for each row. | |||||
| System Requirements | Available Out of the Box | With Minor Configuration | With Custom Coding | If Configuration or Custom Coding Describe Propopsed Approach | If Configuration or customization identify Estimated LOE (hours) to release specific functionality into production | Estimated Release date |
| Radiation safety and laboratory inspection requirements | ||||||
| Provide the capability to capture, track, retrieve and report on Personnel records which shall include the following attributes: |
o Name, location, contact information of authorized users and workers o Authorizations/Permit levels o Dosimetry records o Training requirements and history The Radioactive Material Inventory & Waste Control functionality shall provide the following capabilities:
o Inventory receipt and disposal records.
o Cradle-to-grave tracking of individual items including automatic decay corrections o Barcode label creation o Tracks radioactive material from a user through a waste stream until final disposal o Enter package inspection information o Displays isotope inventory o Generates Inventory reports including:
- Radioactive Material (RAM) Shipments Received
- Current Inventory by Isotope
- Waste Manifest
- Waste History The Requisition Entry shall provide the following capabilities:
o View/add/edit/delete purchase requisitions for radioactive material o Compare purchase to license limits o Approve purchase o Procurement Reports The Sealed Source inventory functionality shall provide the capatility to capture, track, retrieve and report on the following attributes:
o Location and user name o Enter package inspection information o Activity levels (decay corrected) o Leak test due date o History of leak tests o Sealed Source Reports Maintain records on Survey Instruments including but not limited to:
o Location and user name o Model and serial number o Make and manufacturer o Calibration due date o History of maintenance and calibration o Survey instrument reports Maintain records on radiation-producing devices such as X-Ray machines:
o Location and authorized users o Machine description o Manufacturer, model number and serial number o Calibration and maintenance due dates Maintain records on non-ionizing radiation sources such as lasers and microwaves:
o Machine description o Location and authorized users o Manufacturer, model number and serial number o Calibration and maintenance due dates Maintain records on monthly lab/room contamination surveys and periodic lab/room permit audits/inspections:
o Ability to import wipe test results from survey instruments o Ability to document wipe test history records o Record equipment maintenance and calibration status o Ability to document inspection results o Generate inspection reports o Inspection History
| Track and maintain training course information and requirement |
| Dosimetry exposure history application that allows for viewing and updating of personnel and exposure history information: |
o Ability to import exposure histories from dosimetry service o View exposure data o Archive exposure histories o Adjust badge types o Exposure reporting o Absent Badge Reporting o ALARA Report Provides radiological permit documentation:
o General Information o Personnel involved including PI & worker training & experience o Facilities, building and labs o Isotopes to be used
| Environmental compliance requirements |
| The chemical inventory function will maintain records on chemicals within the White Oak Campus, including: |
o Input and track inventory receipt and disposal records.
o Track individual items by an assigned inventory number. o Ability to determine chemicals that EPCRA reportable along with their current inventory levels on site.
o Ability to upload the latest EPA List of Lists in Excel format for use in EPCRA reporting.
o Allow for input of data at time of chemical material order.
o Assign shipment to user inventory at time of receipt o Documents chemical location within the facility o Views current inventory-facility, P.I., chemical or hazard o Adjusts inventory through disposals or transfers o Track chemical material from a user through a waste stream until final disposal o Bar code Reader integration and label creation o Archive chemical material data as specified by user o Chemical catalog documentation to include:
- Regulatory Information
- Physical /Chemical Characteristics
- Health & Hazard Data
- Fire & Explosion Hazard Data
- Ability to scan SDS for chemicals received and in inventory for viewing by employees
- Reports including but not limited to:
* Chemical Receipts/inventory details, searchable and sortable
* EPCRA's Reportable Chemicals (EHS, CERCLA chemicals, and TRI chemicals)
* Chemical Inventory for CAS and Non-CAS Numbered Chemicals *- TPQ RQ Chemical Listing
* Compressed Gas Cylinder Listing
* Homeland Security Appendix A Reportable Chemicals
* Waste Handling functionality will include the ability to input, track, output the following:
* Waste pickup request
* Waste Pickup Reports
* Removal of chemicals from PI’s inventory
* Maintain Federal/State Identification information:
* Generator information
* State ID
* EPA ID
* Process Drums
* Chemical waste reports
* Chemical waste manifest reports
* Process shipments
* Produce management tracking reports
* Waste stream information
| Biological Safety |
| Provide the ability to capture, track, retrieve and report on the following: |
o Personnel o Name, location, contact information, unique ID number o Registration database integrated with other modules herein o Permits/authorizations o Training history o Medical surveillance status to include:
Record of vaccine history; program details and status o Protocol documentation o Project description o Locations, facilities o Safety procedures and equipment o Inventory o Receipt and disposal records o Assignment to user/PI o Location o Barcode Reader integration and label creation o Chain of custody o Inventory reports o Lab inspection/audits o Equipment maintenance and calibration o Violations, deficiencies o Reports
| Work Incident Management Module |
| Ability to add the following User Stories: |
As an OSHO, I want to log into the Safety Inventory Protocol System (SIPS) and access the Workplace Incident Manager (WIM) module to create new incident reports, delegate reports, review and edit existing incident reports, and digitally sign incident reports.
As an OSHO Surrogate, I want to log into SIPS and access the WIM module to create, review, edit, and digitally sign off on incident reports assigned to me by the OSHO.
As an Employee Supervisor, I want to log into SIPS and access the WIM module to review, edit, and digitally sign an employee incident report.
As a Reporter, I want to log into SIPS and access the WIM module to view incident reports.
The System shall be able to notify Users (OSHOs, OSHO Surrogates, and Employee Supervisors) of incident reports via email.
The System shall use digital signatures for User approval.
The System shall create a new incident report if the Health Unit triggers a incident report during a Health Unit visit by an employee.
The System shall assign a unique ID to incident reports.
The OSHO shall be able to log in to the Workplace Incident Manager (WIM) module.
The OSHO shall be able to initiate a new incident report in the WIM module.
The OSHO shall be able to review and edit an existing incident report.
The OSHO shall be able to delegate and notify via email incident investigation responsibilities to an OSHO Surrogate (includes initiating a new report or investigating a previously-initiated incident).
The OSHO shall be able to digitally sign the incident report.
The OSHO shall be able to notify the Employee Supervisor of an employee incident report via email.
The OSHO shall receive an email notification from the WIM module if an incident report is triggered at a Health Unit.
The OSHO shall be able to access an incident report created by a Health Unit.
The OSHO shall be able to review and edit an incident report initiated by the Health Unit.
The OSHO shall be able to digitally sign the Equipment/Property Damage Form.
The OSHO Surrogate shall be able to initiate a new incident report.
The OSHO Surrogate shall be able to access OSHO-assigned incident reports.
The OSHO Surrogate shall be able to review and edit an existing incident report.
The OSHO Surrogate shall be able to review and edit an OHSO-assigned incident report The OSHO Surrogate shall be able to digitally sign the incident report.
The Employee Supervisor shall be able to log in the WIM module to view an employee incident report.
The Employee Supervisor shall be able to review and edit an employee incident report.
The Employee Supervisor shall be able to digitally sign the completed incident report.
The Employee Supervisor shall be able to digitally sign the Equipment/Property Damage Form.
The Reporter shall be able to access the WIM module to view incident reports.
The OSHO Surrogate shall be able to digitally sign the Equipment/Property Damage Form.
The System shall allow collection of all data included in version 18 of the Incident Reporting Form PDF
Non-Functional Requirements
| FDA-RFQ-18-1196672 | |||||||
| RFQ Attachment No. 6 - SIPS Requirements Matrix - Quoters proposing equivalent products must fill out this Attachmentx - | |||||||
| Non-Functional Requirements | |||||||
| Mark one of the following for each row. | |||||||
| Non-Functional Requirement | Description of Non-Functional Requirement | Available Out of the Box | With Minor Configuration | With Custom Coding | If Configuration or Custom Coding Describe Propopsed Approach | If Configuration or customization identify Estimated LOE (hours) to release specific functionality into production | Estimated Release date |
| Security and Authentication | 5.1 Security Requirements |
The system is used by FDA employee and/or contractors staff with valid PIV card. Authorization to access modules in SIPS is currently provided by the IT Project Manager and/or the module Stakeholders. Each employee must have a ‘need to know’ and the proper level of security clearance issed by the FDA.
5.2 Authentication
Authentication is done with single-sing-on (SSO). Access controls are written into the application and will be administered by system administrators.
User Requirements • System shall provide a work flow process for generate, review, and approval of protocol documents.
• System shall provide a complete lifecycle accounting of the operational parameters of the Radiation Safety Program for management oversight, and; provide critical evidence of compliance with the licensing regulations of the Nuclear Regulatory Commission and any other occupational or environmental regulations.
• System shall create a Chemical Inventory which allows hand bar coding of bottled chemicals when received and removed from the system.
• When bottled chemicals are depleted, the system shall provide the totals of hazardous and flammable chemicals for the individual floors of laboratory buildings that can be used in emergency response as well as ensure that regulatory limits are not exceeded.
• System must demonstate compliance with Federal and State regulations 40 CFR specifically Superfund Amendments and Reauthorization Act (SARA), Emergency Planning and Community Right to Know Sections 303, 311, 312, and 313) by providing the following options:
o A complete annual inventory list of receiving chemicals and wastes (chemical, radiation, and biologic) existing the facility.
o Report and alert when a threshold planing quantity has been exceeded.
o Send a notification within 60 days of newly introduced Extremely Hazardos Chemicals.
• System shall provide and securely track and manage accident and injury. Users can view, edit, close reports or assign reports to safety investigators.
• The system shall be capable of capturing information on laboratories, authorized users and individual users, including training, protocols, monitoring and compliance status. This module will provide linkage between materials, laboratory locations and users in a searchable format.
• The system shall record, maintain, and report the following information for an ongoing laboratory activities:
o Personnel location o Permits o Required training/certification o Vaccination status o Personal Protecting Equipment (PPE) for Biosafety levels I, II, and III).
• The system shall track equipment, consumables (reagents, preparation supplies, etc.), laboratory specimens, and test animals related to ongoing research activities onsite, based on building/laboratory from delivery/assignment to a principal investigator through destruction/disposal.
• The system will also track maintenance service, repair service calls, and operations history for laboratory equipment.
• The System shall record and maintain 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.
• The system shall also record and track incidents including violations of laboratory/safety protocols.
• The system shall have the capability to provide a work flow product for the review and approval of documents describing the proposed research activities, any permits in force (including the name of the issuing agency, expiration date, and conditions stated on the permit), inspections by outside agencies (including the name of the inspecting agency, the inspection date, a list of action items to be addressed, and the next inspection date), by the ESEMB, the Biosafety Officer, Institutional Biosafety Committee (IBC) members and the Institutional Animal Care and Use Committee (IACUC) members.
• The system shall send email notification to FDA researcher or safety officer for any required action or change in status submission of the protocol.
• The system shall support mass of immunization program organize by FDA Clinics.
• The system shall provide individual patient medical records according to role and job title and establishment of compliant.
• The system shall have an ability to link patients with protocol studies.
• The system shall provide an easy scan ID interface for registration (i.e. identify any medical restriction, dosage strength, administration route, etc.) and drug information (i.e. lot number, expiration date, etc.).
System Requirements • The data management system shall be scalable to meet the needs for potential expansion of sites within the FDA enterprise and shall be capable of handling data from several hundred laboratories, several thousand chemicals and several thousand users.
• The data management system shall be a commercially available product that is customizable, but in its basic form meets most of the requirements of the FDA enterprise safety program.
• Access to the system shall be immediate, unlimited and direct via valid PIV card. Access shall be via secure Internet or network-based methods requiring unique SSO login.
• The data management system shall provide a variety of standard and custom reports, the ability to create and store ad-hoc searches/queries, and support the creation (or entry) and review of research protocols.
• In compliance with Occupational Safety and Health Administration, Hazard Communication (OSHA HAZCOM) requirements, the system will also provide the ability to update and view inventoried chemical Safety Data Sheets (SDS) in the main database and the ability for FDA computers to access those SDSs.
• The data management system shall also support the use of handheld devices for laboratory inspections and barcoding of chemicals for inventory management.
• The system but be able to interact with Wireless barcode readers and Barcode printers to provide the ability to track/manage Chemical and other inventory as needed.
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