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StafaCT Suite
Workflow-driven software for cell therapy and transplantation centers
Overview Modules Materials

Connecting people and processes across the cell therapy continuum

Across the industry, the cellular therapy and transplantation process is managed with paper documentation, creating challenges in routing patients, donors and products through the process; potential miscommunication between departments; and possible delays.

StafaCT has changed all that with workflow-driven software that eliminates the need for manual and redundant documentation by seamlessly collecting and managing patient, donor and product data throughout the process — from patient referral to post-infusion follow-up.


Developed and implemented in collaboration with leading transplant centers, the StafaCT Suite includes six modules — deployed individually or as a full suite — that support the entire cellular therapy and transplantation continuum:


Stafa Clinical


Captures and manages patient and donor information throughout the cell therapy workflow

  • Integrate and view lab data and test results
  • Obtain electronic approvals at key decision points
  • Schedule and view appointments across departments
  • Input and monitor insurance status and approvals
  • Define disease status and assign treatment protocols
  • Match and manage donors

The Stafa Clinical tracker offers a quick view of all patients and recipients in the pipeline. View, sort, print and share with just a few clicks.



Stafa Apheresis


Guides apheresis procedure workflow and data capture to support quality, traceability and regulatory compliance

  • Import key donor, patient and lab data from electronic health records (EHRs), third-party systems and the Spectra Optia® Apheresis System
  • Transfer data to and from the Stafa Clinical and Stafa Cellular Therapy Lab modules
  • Eliminate the need for a paper-based flow sheet
  • Document and manage collection orders, mobilization regimen and medications
  • Monitor quality and compliance, including deviations
  • Capture product parameters for ISBT 128 label generation
  • Manage equipment, inventory, procedures and protocols
  • Track product transport and confirm product receipt

Stafa Apheresis guides operators through the workflow, prompting data capture along the way.



Stafa Cellular Therapy Lab (CTL)


Enables workflow guidance and comprehensive data capture for product receipt, processing, storage, transport, issue, shipping and infusion

  • Receive products and review product data, including transport temperature and product integrity
  • Access and execute processing protocols for a wide range of cellular therapy needs
  • Scan existing ISBT 128 labels and generate new ones
  • View storage availability and assign storage parameters
  • Track supplies used at any step of the CTL workflow
  • Monitor approvals for product distribution, including infusion orders
  • View complete product manufacturing records and generate reports 

Customizable, built in processes help guide lab technicians through various steps in their workflow.



Stafa ISBT Labeling


Generates ISBT-128-compliant labels on demand and captures scanned label data to support product management

  • Create and print new labels by importing data from EHRs and third-party systems, entering data manually or scanning an existing ISBT label
  • Choose from ISBT-compliant label templates
  • Store labels for reprinting and track unused labels for regulatory compliance
  • Maintain and manage a database of current and archived products
  • Integrate into Stafa Apheresis and Stafa CTL modules or use as a stand-alone module


Stafa Quality and Compliance


Monitors compliance to standards, regulations and internal standard operating procedures (SOPs) through proactive risk mitigation and corrective action across recipient, donor and product workflows

  • Create a centralized and version-controlled repository for standards, regulations, policies and SOPs
  • Leverage an integrated library of current FACT-JACIE standards
  • Perform proactive electronic self-assessments to monitor compliance and improve quality across departments
  • Minimize time spent preparing for audits and accreditations
  • Integrate with other StafaCT modules to save time gathering and preparing data

At-a-glance quality dashboard allows you to track and manage quality indicators such as deviations and alerts.



Stafa Reporting and Analytics


Provides real-time data mining and flexible reporting for quality monitoring, process improvement and research, and simplifies CIBMTR submission and ASTCT request for information (RFI) reporting

  • Map data from other StafaCT modules to registry fields to expedite the reporting process
  • Submit data to registries through a user-friendly interface
  • Access preconfigured reports for products, patients and donors to review workflow and captured data
  • Generate ad hoc reports for analysis, research and improved operational decision-making


ASTCT: American Society for Transplantation and Cellular Therapy; CIBMTR: Center for International Blood & Marrow Transplantation Research®; EBMT: European Society for Blood and Marrow Transplantation; FACT: Foundation for the Accreditation of Cellular Therapy; FDA: U.S. Food and Drug Administration; JACIE: Joint Accreditation Committee ISCT-Europe & EBMT; ISCT: International Society Cell & Gene Therapy

Materials

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