Transitioning to New and Revised FACT Standards: Advice from the Quality Committee

Posted in :: 2018 Volume 1 :: Thursday, February 15th, 2018

Managing change is a difficult task we are faced with on a daily basis. FACT provides guidance and resources to help navigate changes from one edition of Standards to the next. With an enthusiastic staff, a thorough plan, and the right resources, your program will be able to proactively address the changes and avoid feeling overwhelmed. The purpose of this article is to provide tips and references for transitioning to new Standards editions.

FACT releases new editions of Standards on a three-year cycle, issuing interim standards as needed. The public comment period is your first opportunity to preview changes that will be made.  The draft Standards and Accreditation Manuals are made available to the public for review and comment nine months in advance of final publication.  Even though the Standards are not finalized, the drafts released at this time allow your program to begin a preliminary assessment of the new edition’s potential impact on its policies and processes.

On March 1, 2018, the 7th edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration (the Standards) will be published.  Immediately following publication, begin assessing the new and revised requirements and implementing changes as necessary to become in  compliance before these Standards become effective on May 30, 2018.

Operational changes for FACT compliance are often most efficient if leadership-driven; therefore, the first step is to assign a leader or group within your organization who will be responsible for implementation (e.g., Program Director, Administrator, or Quality Committee).  Next, a point person or group should be identified to facilitate review of existing and proposed standards along with the summary of changes provided by FACT. The Accreditation Manual should be referenced for guidance.  The focus of a preliminary review will be on the intent of the new edition of the Standards.

Next, perform a gap analysis, which compares specific requirements against existing policies and procedures. Evaluate how changes in the Standards will affect current processes and determine new methods for compliance. Use the FACT self-assessment tool to effectively and efficiently track new or revised standards, gap analysis information, and follow-up plans.  Developing a crosswalk between the new Standards and an organization’s relevant SOPs, forms, worksheets, and labels will assist the program with identifying deficiencies in compliance with the new edition.  This gap analysis will flag concerns that will require review and discussion at an organizational level.

A gap analysis should not focus solely on the new or revised standards but also include unaffected standards.  This is an excellent opportunity to proactively evaluate overall compliance with the FACT Standards and further prepare your program for future inspections.  Furthermore, the program must verify that implementation of policies and procedures for new or revised standards does not adversely affect its compliance with existing standards.

Feedback from all critical stakeholders should be addressed. Ways to accomplish this is to tap into existing committee structures or by chartering working group(s) with delineated scope and schedules. Key personnel from all facilities (i.e., clinical, collection, processing, and cord blood banks) should collaborate to identify issues relevant to the group including, but not limited to:

  • Which documents in each facility will need to be created or revised?
  • Which personnel within each facility will be impacted (e.g., will require training and competency)?
  • How will the change affect work processes?
  • Are dedicated meeting(s) with affected staff required?

Some methodologies for assessing compliance and identifying noncompliance (or predicting the risk of non-compliance) with new or revised standards include procedural review, audits, and  mock inspections.  To evaluate potential impact on policies and processes for high-risk activities, conducting a predictive failure analysis, using a tool such as Failure Mode Effects Analysis (FMEA), may be warranted.

Effective meetings will result in the best outcomes.  If possible, group members should schedule time for meetings, recognizing that regular attendance and active participation are essential.  Members of each facility should prepare and present an agenda for common discussion, circulating it and any handouts for review in advance.  Discussion items should be summarized with conclusions and action items should be assigned both a responsible party and a target date for completion.

Participants are responsible for identifying change(s) in the standards they are assigned, ensuring these revisions are tracked in the crosswalk with facility and organization policies and procedures.  Prior to presenting at larger organizational meetings, smaller working group meetings may be helpful to agree on the plan for the standards to be discussed.

It is helpful to develop and manage an implementation plan for needed changes identified by the gap analysis.  This is a dynamic activity that addresses logistical concerns and changes required, solutions to new issues, action items with due dates, and staff assignments.  Again, crosswalks developed using the FACT self-assessment tool can help with organizing these activities; however, for particularly complicated action plans, a separate tool(s) may be necessary.

In addition to assistance provided by FACT staff, FACT provides a variety of useful and practical resources that may support organizations’ compliance with new, revised, and current standards.  Organizations can prepare early by regularly reviewing FACT resources, including, but not limited to:

Additionally, the online FACT Cellular Therapy Library and FACT Cord Blood Library include tools for organizations including the self-assessment tool mentioned earlier, Document Submission Requirements, Summary of Changes, and numerical crosswalks between old and new Standards editions. In-person events are also offered to facilitate the Standards transition process and allow opportunities for interaction with FACT leaders. Check the FACT website’s calendar frequently, as FACT’s educational events include many sessions throughout the year such as webinars, workshops, and Quality Boot Camps. FACT recommends using multiple sources of educational resources based on your organization’s learning style and focus.

Once transition changes are identified and proposed solutions are discussed and agreed upon, these solutions must be implemented in accordance with the program’s quality management plan.  Policy and procedure revisions must be documented and approved with defined effective dates.   The change process must involve all affected personnel, providing them with associated documents and other resources in advance of the change to allow them time to complete required training prior to implementation.  To help error-proof the process change, retired documents must be archived appropriately and outdated documents must be removed from use.

Once changes are deployed, it is prudent to review and analyze the impact of the changes on the quality management systems.  Some methods to accomplish this are:

  • performance of an audit for effectiveness,
  • review of staff training records and/or competency testing, and
  • assessing the availability of current documents at all relevant sites.

To close the loop on implemented changes, it is essential to provide feedback to responsible groups and personnel.

Armed with your plan, engaged staff, and FACT resources, the transition to the new edition of Standards will be efficient and effective. Please contact the FACT Office with any questions. The staff can refer you to the right resource to solve your problem. We all recognize that change is inevitable, but with the right resources, change can be managed.

Article written by Therese Dodd BA, MBA, RN, CPHQ, FNAHQ