Virtual Inspections Lead to Accreditation Process Improvements

Posted in :: 2021 Volume 4, Uncategorized :: Wednesday, July 14th, 2021

By Suzanne Birnley, MS, MBA, FACT Accreditation Services Manager

It has been a very busy few months at FACT between the implementation of virtual inspections and publishing the eighth edition of the FACT-JACE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration.  These developments have led to some changes and improvements to the FACT Accreditation Process.

  1. Although initially developed for virtual inspections, some changes to submission requirements will continue to be part of the accreditation process moving forward. All applicant programs and banks are now required to submit additional documentation in preparation for their FACT inspection. For applicants currently waiting for their inspection to be scheduled, these documents can be uploaded in the FACT Accreditation Portal Document Library under the Virtual Inspection Documents tab.  These documents are expected to be submitted a minimum of 4 weeks prior to the inspection. These additional submissions have been included with the Eighth Edition Hematopoietic Cellular Therapy (HCT) Compliance Application, and will be included in other Standards as new editions are published. These include:
    • A copy of all policies and Standard Operating Procedures referenced in the Quality Management Plan.
    • The most recently completed Annual Report on the Effectiveness of the Quality Management Program.
  1. Whether for a virtual inspection or on-site, beginning July 1, 2021, all programs are required to use OneNote or the equivalent to organize documents for their inspection. This can be accomplished in several ways:
    • Use the OneNote template provided by FACT.
    • Use a software developed within the organization or a commercially available software.
    • Use the FACT Self-Assessment Tool or checklist from your completed application in the FACT Accreditation Portal, and add additional columns for links to documents and information regarding where to find documentation of compliance for each standard.
    • For on-site inspections, use the binder method. Match each standard to the documentation of compliance in paper form, all organized by standard in three-ring binders.
  1. For virtual inspections, beginning July 1, 2021, all programs are required to use a document camera to display documentation that exists in paper format. This is particularly important in collection or processing facilities that use paper records.

Finally, it is very important that inspectors have access to any updated documents, especially if the Compliance Application was completed a year ago.  FACT Accreditation Coordinators will send Requests for Information (RFIs) to update documentation known to be out of date, such as medical licenses and continuing education.  It is your responsibility to let your coordinator know if there are any other policies or SOPs that were submitted that have since been revised.  If inspectors do not have access to these documents, it is a risk that they may not see evidence of compliance, resulting in deficiencies cited on the Accreditation Report.

FACT greatly appreciates the hard work of the inspectors and applicants as we transition through this challenging time.  We do intend to return to on-site inspections as soon as it is safe to do so.  We are actively seeking and welcoming feedback on both the virtual inspection process and these process changes.  If you have any questions or concerns, please contact your Accreditation Coordinator or the Manager of Accreditation Services, Suzanne Birnley.

 

 

 


Learning from Each Other: Accredited Organizations’ Advice for Preparing for FACT Inspections (Part 3)

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021

By Stacy Freeburg, FACT Accreditation Coordinator

How do you maintain audits, various consent forms, and other documentation?

Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service

Our quality management system, Q-Pulse, has been fantastic for maintaining audits, documents, non-conformances, supplies, equipment, and now training courses.  We are a central system overseeing 2 pediatric FACT-accredited sites and 12 nationally accredited sites (National Association of Testing Authorities, Australia/National Pathology Accreditation Advisory Council [NATA/NPAAC]). Without this tool, we would not exist. It automates actions, creates workflows, and emails notifications. I really like how easy it is to modify drop downs to meet our requirements without information technology upgrades or database changes. It is also very intuitive for staff, which makes training and day-to-day use very easy. I used to work for the national body, NATA, and I saw a lot of very complicated software packages-at accredited sites. Many were not well used!

Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute
and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital

Maintenance of audits, consent forms, and labeling is assigned to various quality designees, as applicable. Our programmatic Standard Operating Procedures (SOPs) describe established processes for follow-up and reporting to ensure the audits are completed in a timely manner. SOPs dictate processes for consent updating and review. Check-off and time-out processes ensure labeling is completed per standards and regulatory guidance. The quality designees work with physicians, supervisors, and clinicians to maintain compliance with FACT standards impacting the daily duties of staff members. The integration into daily practice creates a quality-focused program, with built-in and evolving checks and balances throughout the program’s departments to ensure consistency of processes and procedures.

Share strategies for staying up to date on upcoming changes to the Standards and what tools you use to communicate those upcoming changes within your organization.

Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service

Generally, this is done via Q-Pulse. We have had specific training sessions across our network, which have focused on donor work-up, ISBT 128 labelling, and GMP requirements.

An Immune Effector Cell (IEC) Quality Manager focuses purely on IEC rather than both Hematopoietic Progenitor Cell (HPC) and IEC. This has assisted in developing IEC-specific SOPs and processes. This is such a growing area that I believe it needs individual attention.

Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute
and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital

Monthly meetings are conducted to discuss regulatory topics, including any updates to the FACT Standards. Key personnel from the clinical, collection, and processing facilities participate in the monthly meetings. Consistent monitoring of the FACT newsletter and disseminating pertinent updates occurs during these meetings. Note, our programmatic SOPs outline how updates need to be conveyed to the program, reviewed with the FACT Program Director, and distributed to the program through an appropriate conduit based on the impact and urgency of the change.

Stacy Freeburg, FACT Accreditation Coordinator, FACT Accreditation

Maintain a spreadsheet or utilize OneNote or a similar tool that crosswalks the FACT Standards to your SOPs. FACT provides an Excel download of all standards and related questions, called the Self-Assessment Tool, in the portal that can be used to prepare for the accreditation process. If a new edition of Standards is finalized during the organization’s accreditation cycle, organizations can use the crosswalk FACT provides to update its internal crosswalk to SOPs (available on the FACT website).

For additional information, download and view the educational recording, QM Series 8: The Document Control Process From Start to Finish (and Back Again!) (FACT), September 13, 2017.

Thank you to the following contributors for sharing their tips and lessons learned from their experiences at a FACT accredited program:

Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute
and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital

Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service

Elisha Nixon, Quality Program Manager, Walter Reed National Military Medical Center, Murtha Cancer Center Research Program, Uniformed Services University of the Health Sciences, The Henry M. Jackson Foundation


Learning from Each Other: Accredited Organizations’ Advice for Preparing for FACT Inspections (Part 2)

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

By Stacy Freeburg, FACT Accreditation Coordinator

FACT-accredited organizations voluntarily seek and maintain FACT accreditation via a rigorous process, demonstrating their commitment to quality and their belief that patient needs are paramount. Obtaining and maintaining FACT Accreditation is a major undertaking.

Recognizing that we are a peer-driven organization, we invited a few organizations who are currently FACT accredited to share their suggestions for how to maintain many of the documents required for FACT Accreditation.

How does your program organize various documents so that they are readily available, such as current licenses, specialty certificates, or CVs?

Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service

This is a challenge. For large education sessions that are renewable (e.g., Risk Management Program (RMP) training), we have started using the Training Courses module in our Q-Pulse quality management software. This allows for central management and electronic record keeping.

Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital

This information is reviewed on an annual basis to ensure documents are up to date and organized for each employee in our employees’ FACT folders. If updates are needed, the information is requested directly from the employee or obtained though administrative staff. The timing of the annual review of the employees’ FACT folders corresponds with our hospital’s annual employee evaluations. Copies of licensure and certificates for key personnel are stored in a shared electronic folder to allow access to those who may require it throughout the year.

How does your program compile and maintain the educational activities list?

Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service

For the last six to seven years, we have been providing a “BMT Masterclass”. The schedule of topics is based on the FACT requirements. This is a virtual presentation or prerecording. These are recorded and subtitled and placed on our website at https://aci.health.nsw.gov.au/networks/blood-and-marrow-transplant/resources. All members of BMT Nurses, Scientist, Physicians, and Pharmacists in New South Wales (NSW) and across Australia have access. We also run a “Introduction to BMT” session once a year, a scientific forum, and senior nurses’ day.  We use a basic template for recording.

Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital

Our program utilizes the FACT Educational Activities Form throughout the program departments to document cellular therapy education on an annual basis. Key team members maintain their own educational activities form, and the form is part of the annual audit of the individual employees’ FACT folder.

Stacy Freeburg, FACT Accreditation Coordinator, FACT Accreditation

When I worked in direct health care, a sign-in sheet was provided for all internal training to document educational activities. Information gathered included training title, date and length of the training, title of the training, and attendees’ name. In addition, staff were expected to submit documentation of any external training to a central location. This information was compiled onto a word document for each staff member (similar to the FACT Educational Activities Form). The sign in sheets also provided documentation that the organization provided opportunities for staff for educational activities.

 Staff also were required to update their educational activities in a system tied to the Human Resources department’s intranet. Information gathered included the activities’ titles and dates and length of training. Activities could be webinars, reading an article, etc. Staff were then able to print out a summary form. All staff were required to turn in a copy during their annual personnel evaluation, which demonstrated compliance with requirements and made it readily available for submission for accreditations.

Benefits of Documenting Educational Activities

Documentation is not only a way to document educational activities for FACT Accreditation, but can also be a resource for planning future training needs. To maximize the usefulness of educational activity records, it is important that they be up to date, organized for easy retrieval, and have a mechanism to for review. By reviewing the types of educational activities staff have attended, programs can determine what education is needed. For example, the program may wish to expand opportunities to include tumor board discussions, review of peer reviewed articles, or ensuring that staff have the opportunity to attend various professional conferences.

As noted above, gathering licenses and educational activities is challenging. Tying the submission to annual performance evaluations or having an annual audit to verify it is complete are two methods to avoid a panic when you need to submit the information.

Download the FACT Educational Activities Form