2024 Update from SfSAP
SfSAP have been busy in 2024. We want to take a few moments to let you know what has been happening and what we see on the horizon.
Building the Eco System
The SfSAP frameworks will be at the core of the eco system.
The frameworks will create governance and guidance for the different stakeholders and those who are part of the eco system
Learning Frameworks
Learning Frameworks have been a focus of the workstreams for 2024.
The learning frameworks have been updated to allow the
- Learners to have a tiered or domain-based learning approach to there development
- Education Delivery Organizations (EDOs) to structure there training to follow the domain-based approach to learning.
- Health Authorities / Regulators and auditors to have tools to establish a harmonized approach to competency, skills and knowledge.
Domain-based learning pathway.
The frameworks have been adapted to fit within these domains
Learning Frameworks with the Domain Based Learning that will be available in Q1 of 2025 will be:
- Aseptic Processing Sterilization Professional Learning Framework and Outcomes (Revision 2 with Domains)
- Healthcare Products ETO Professional Learning Framework and Outcomes (Revision 2 with Domains)
- Healthcare Products Radiation Sterilization Professional Learning Framework and Outcomes (Revision 2 with Domains)
- Microbiological aspects of sterility assurance for healthcare products Learning Framework and Outcomes (Revision 2 with Domains)
- Moist Heat Sterilization Learning Framework and Outcomes (Revision 1 with Domains)
Packaging & Sterile Barrier Systems Learning Framework and Outcomes (Revision 1 with Domains)
Credentialling
One of the “badges” or recognitions we are wanting to put in place in 2025 is what we are calling Industry Recognized Contributions. This would be awarded to someone who actively participated as a conference speaker, report or guideline contributor, author, or was a professional award recipient. While the detailed process is yet to be worked out, the intent is for someone to fill out a form on the SfSAP website, provide evidence of participation (e.g., the official program, a page from the technical report listing contributors, etc.), and SfSAP would issue the badge with its logo and potentially the logo of the other professional body.
We are still looking for a website or app that would supply just the “portable resume” capabilities.
Educational Delivery Organizations (EDOs)
Members of the steering committee have met with representatives of several EDOs to talk about how the EDOs would use the frameworks. The range of options would be their using the learning frameworks as a guide for developing new courses / modules to re-adjusting their current offerings to match the learning frameworks.
SfSAP Website
The current website is in the final stages of being updated to reflect our current short- and longer-term strategy. This would include being a resource for a number of the documents generated, such as the learning frameworks, guides for using the frameworks, and copies of presentations. The goal is to have this completed in late January 2025.
Meetings / Presentations
Various members of the workstreams and steering committee have been or are scheduled to present virtually or face-to-face at meetings around the world. In some cases, these presentations are fully focused on SfSAP or, in other situations, mention SfSAP work products such as the learning frameworks. Meetings and conferences include:
- GMPs by the Sea (August 2024) – Jim Vesper
- PDA/FDA (September 2024) – Arthur Dumba
- Fermilab regulators meeting (Sept 2024) – Arthur Dumba and Jim Vesper
- IMRP 2024 (Kim Patton, Jim Vesper)
At IMRP 2024, there were several poster presentations that show how the SfSAP Frameworks are being used. Steris had two posters – one with lead author Ginger Zappa and a second one by lead author Niamh Pardy. BD also had a poster developed by Nicola Bench. It was very exciting to see how the learning frameworks are actually being used!
Other steering team or workstream members have submitted abstracts for the 2025 Kilmer Conference and PDA Annual Meeting to continue to build awareness to the SfSAP brand and its work. The new website will list upcoming meetings and also opportunities for others to present. We are creating a “message arc” or list of presentation that build from basic to advanced as a way of communicating what we have done and are planning to do. Hopefully this will help us be a better way to become presenters at meetings.
Pilot Project
We are wanting to start a pilot project with several different EDOs, contract sterilizers, and healthcare product manufacturers as an “ecosystem”. This would involve learning frameworks and how learner competencies can be confirmed and documented. Several organizations have expressed interest in this; the details, including the protocol and evaluation criteria need to be developed. We are anticipating the pilot will be started by early Q2 2025.
Immediate Next Steps – finalizing the Learning Frameworks.
We are asking the lead of each workstream to let Arthur and Jim know the current status of the stream’s frameworks. What we are wanting to see is for each “module” is:
- Module name
- Reference documents that support the module (e.g., regulations, standards, published guidelines)
- Knowledge and skills required – a list of the topics that have been identified by the expert teams that a sterility assurance professional should know or be able to perform. These can help guide learners as they read through the reference documents or select training courses.
- Learning outcomes: Learning outcomes are behavioral statements of how someone would use the knowledge and skills. They can be considered learning objectives. These should be prioritized in terms of when in a person’s development the outcome should be achieved. The three levels are:
- 100 level – foundational outcomes, best associated with a person transitioning from a new hire/novice to competent
- 200 level – advanced outcomes best associated with a person transitioning from competent to proficient
- 300 level / EXP – outcomes derived primarily from experiences, best associated with a person transitioning from proficient to expert