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GxP Lifeline

Designing a Learning and Performance Program in Tissue and Organ Banking


For Blood & Biologics

Keeping up with the changes and the training in tissue and organ banking is an ongoing process. We know what works well and what doesn't. We know with a field-based staff that classroom training is difficult to pull off when trying to coordinate everyone's schedules and of course working around the case load. What we have found is that online learning or on-demand learning does work. This allows all of the staff to access training when and where they need it. We currently offer the following types of training:

Most of our training was either classroom-based or on-the-job training and not tied to appraisals.

  • SOPs - new, revised and annual review
  • Department meeting trainings
  • Professional development training
  • New hire orientation
  • Core curriculum
  • On-the-job training

When we first starting looking at how we could improve our learning and development program we were also looking at how to improve our performance management program. The two programs are tied together and should be looked at together. We decided to move from training to performance. When we started we were a paper-based, classroom-delivery training program. Working though this process, we identified documentation issues and training gaps which needed to be closed.

With any paper-based system, there will be documentation gaps. We found that not everything was recorded when it needed to be, paper went missing, and there was a lack of accountability as everyone had a hand in the training folders. While we had already started to centralize the training function, we still had too much autonomy for documenting training within the departments.

The next set of issues addressed was the training gaps. Most of our training was either classroom-based or on-the-job training. The challenge here was that learning wasn't tied to appraisals. We didn't use development plans to track the progress of the learning and there was no formal method of goal setting.

Identifying the Drivers to Learning and Performance

Once the gaps were identified, we needed to recognize the drivers that would help reach our goals and improve our process. We identified two sets of drivers, the first being business drivers and the second being regulatory drivers. Our business drivers included:

  • Standardization of learning
  • SCORM compliant courses
  • Data retrieval and reporting
  • Usability factors
  • Easy and quick to deploy
  • Cost

Being accountable to many different regulatory agencies was a challenge since we are responsible for learning and development for both tissue and organ staff. Keeping track of which requirements were due for which agency was a challenge. Each agency looked at a different department and had different requirements. We needed to streamline this process so we would have a consistent and standardized approach to audits.

According to AATB and FDA standards, being able to show that staff members are qualified to perform their functions, that appropriate staff training occurs, and their competency is assessed/evaluated by a responsible person, are all part of the requirements. AOPO offers 14 different standards relating to training and documentation. The first interpretive guideline for AOPO states ""A system that is documented should be in place which states the types of training courses, seminars or other programs that provide this staff development.""

As a result, we determined that we wanted a system that would take care of the following components:

Automation
  • Registrations
  • Notifications
  • Automating the completion of the course
  • Metrics
Flexibility
  • Easy access of information and a variety of information
  • Staff can take the courses when they want
  • Strategic decisions can be made quickly and regularly based on reporting data
  • Data is available when needed by both managers and staff
  • We can change/update courses on the fly
  • Staff and managers can view all the performance management information in one place
  • Focused development opportunities can be assigned and completed as needed
  • Competencies can be assigned as needed
  • Development issues can be addressed much more quickly
    Data Retrieval
    • Integrated reporting available to users and managers
    • Easy access of information
    • Training metrics automated
    • The data that we decided to measure at least initially is:
      • The time it takes for staff to complete SOP reviews
      • How many SOPs were launched
      • How many courses based on clinical skills and non-clinical skills were launched
    • Data is readily available for staff, managers and auditors
    • Additional courses both online and classroom that align to critical skills and can be tracked back to competencies and reported on
    • Improve what we can measure
    • Meaningful development data can be reported to senior management
    • Data is incorporated into the quality program
    Compliance Requirements
    • SCORM compliant
    • Meets all nine regulatory agency and our internal standards and requirements
    • We always know where we are in terms of compliance by employee
    • We can address compliance issues quickly by assigning development plans
    Developmental Focus
    • Allow us to create courses as needed and assign them as needed, not a one-size-fits-all training methodology
    • Development plans are updated on a regular basis.

    Performance Cycle for Development Plans

    Once we knew what we wanted, we needed to determine how to incorporate that into our performance management cycle. As stated earlier, performance and learning are closely tied as the diagram (Figure 1) shows. We added in the component of goal setting and competencies as well as development plans as part of the ongoing meetings between staff and managers. We will constantly be moving to improve the performance management cycle. The constant improvement cycle will take place each year at the end of the annual review process or as other things change for us. This is on the organizational level and moves down to the individual level which we will see next.

    Figure 1

    While Figure 1 displays how performance management works on an organizational and departmental level, we wanted to make it more relevant and clearer to the staff. Figure 2 (below) displays how that looks.

    Figure 2

    Walking through each of the components illustrates how they tie together and how this will help guide our learning needs. Goals are what an employee is going to do for us. These can be and should incorporate organizational, departmental and individual goals that will drive the organization to meet its mission. Development Plans are what we can do for an employee. This is where we have the tools and resources that we can offer the employees to help them meet their goals.

    Learning units are the actual courses that we run. These roll up into the development plans. All learning units will be part of a development plan but not all development plans will have learning units. An example of this may be a development plan to attend a seminar or conference, which wouldn't necessarily have a learning unit assigned.

    Creating Development Plans

    Many of the learning and performance requests come from the departments we support. As each department looks at data, L&D will meet with them to determine if a developmental plan would be useful and appropriate. We look at data from many different departments to determine if L&D can help by putting together a program to help improve their goals and outcomes. We look at processes for continuous improvement as well as updated SOPs. We conduct a needs assessment on a regular schedule which helps us determine where additional needs may be.

    We also build our programs using a module approach so we can reuse pieces of content over again in other programs. This cuts down on our development time and allows us to present a consistent look and feel to our programs, as well as launching a program in much less time.

    Gauging Success

    There are two areas where we want to measure success; first on the L&D and performance level and the organizational level. The second area of measurement is on the departmental and individual level. As with any other measure of success, it is best to use metrics or data that is meaningful and important versus measurements just for the sake of measuring. We track much of our learning data and criteria and measure the improvements. As with all of our processes, what we track may change based on the current situation. In other words, we remain flexible in what is measured and how often. We don't keep measuring something just because we always have measured that outcome. If it's not important now, don't measure it. Move on to what is important.

    On the departmental and individual level, managers and staff can also decide what is important to them at the current time and assign relevant goals, development plans and learning units and then measure pre- and post-accomplishments.

    Keeping learning current with all the changes on the business side as well as the changes on the learning side is always a challenge. Being flexible, automated, data-driven and user-driven makes it much more manageable. Keeping up with changes and designing an individualized program will allow much more effective learning and much better performance. While keeping in mind the importance of the regulatory requirements, don't forget about the business side of the requirements. Both need to work in concert together.


    David Hoffstetter, MS, is the Manager, Learning and Development at New England Organ Bank. His current role involves him in coaching, performance management and learning and development. He holds a Master of Science degree in Organizational Psychology from Capella University, a Bachelor of Science in Business Management from Northeastern University and a Certificate in Training and Development from Boston University. David has been involved in corporate learning and development as well as performance management consulting prior to his current role. He is a member of American Society of Training and Development, the International Society of Performance Improvement and American Association of Tissue Banks (AATB). He currently sits on the Education Committee of AATB. David can be reached at david_hofstetter@neob.org.


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