CELLULAR THERAPY ACCREDITATION PROCESS REQUIREMENTS

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This document provides guidelines for the FACT cellular therapy accreditation process. These guidelines pertain to organizations applying for accreditation under the FACT-JACIE Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, the FACT Standards for Immune Effector Cells, and the FACT Common Standards for Cellular Therapies.

Eligibility
Coordinator
Completing the Compliance Application
Before the On-Site Inspection
Preparing On-Site Documentation
During the On-Site Inspection
After the On-Site Inspection
References

ELIGIBILITY

  1. Review the current edition of the applicable Cellular Therapy Standards and Accreditation Manual: http://www.factwebsite.org/Standards/.
  2. Determine eligibility requirements: Cellular Therapy Program eligibility requirements.
  3. Begin the process of applying for FACT accreditation by creating your organization's profile in the Accreditation Portal and the FACT website. After your profile is approved, an email will be sent to the Organization Director that the Eligibility Application is available to complete.
  4. Complete and submit the Eligibility Application that describes your organization and accreditation goals.
  5. Submit a nonrefundable registration fee (initial applicants only). Refer to the FACT accreditation fees page for more details about initial registration and annual accreditation fees.

COORDINATOR

Each organization is assigned a FACT Accreditation Coordinator to assist with questions or concerns you may have throughout the accreditation process

  1. Your FACT Accreditation Coordinator will notify your organization's Director that the Compliance Application has been created. The Organization Director will need to review and approve the organization's accreditation goals and sites to be inspected. Once approved, the Compliance Application will be available to the organization's personnel.

COMPLETING THE COMPLIANCE APPLICATION

  1. Review the Compliance Application. Assign someone to complete each section.  The relevant Self-Assessment Tool contains all Standards and questions in a compliance application and is a useful preparatory resource.   Refer to the REFERENCE section below to access the appropriate document.
    • Identify the areas where no documentation exists.
    • Create new policies or Standard Operating Procedures (SOPs) or update existing policies or SOPs to document compliance.
  2. The Compliance Application in the accreditation portal requires document uploads for some standards.   Required documents for each set of Standards are listed in the relevant Document Submission Requirements form.  Refer to the REFERENCE section below to access the appropriate document.
  3. To assist with tracking which questions need additional evidence, flag questions in the Compliance Application.   You may keep questions flagged until all required information is entered.
  4. The Compliance Application cannot be submitted unless all questions are answered, all required documents are uploaded, all flags are removed, and the application is signed by the Program Director and applicable Facility Directors (or Facility Director for facilities applying independently of a Clinical Program).
  5. Requests for information (RFIs) are generated by your assigned FACT Accreditation Coordinator when additional information or documents are required.
  6. An organization applying for accreditation for the first time is given 12 months after approval of the Eligibility Application to prepare documentation, adjust processes to comply with the FACT Standards, and submit the Compliance Application.  An organization in the process of renewal accreditation must submit the Compliance Application 11 months prior to accreditation expiration.   Timely responses are critical to achieving and maintaining FACT accreditation.
    Note: Inspections are conducted under the current edition of Standards; this may require completion of a new application if a new set of Standards becomes active prior to completion of the Compliance Application.

BEFORE THE ON-SITE INSPECTION

  1. After the FACT Accreditation Coordinator determines the Compliance Application complete, you will be contacted by the Business Manager for potential inspection dates.   Provide the Business Manager several options.  Dates must be at least eight weeks in the future.  Additional inspection day(s) may be required if there are multiple collection sites, or if travel time between sites is lengthy.
    • Provide dates when all key PERSONNEL will be available for the inspection at each site.   At a minimum, this includes the Organization Director, the Collection Facility Director and Medical Director, the Processing Facility Director and Medical Director, and the Quality Manager(s).
    • Send dates that are acceptable for all SITES (e.g., hospitals, off-site storage facilities).   The inspectors MUST visit each site and meet with key personnel.  This may require clearance from an administrator (e.g., Director of Nursing).
    • After an inspection date(s) is selected, notify ALL KEY PERSONNEL and SITES and instruct them to remain available.   In addition, identify designated personnel who must be available throughout the day to accompany each of the inspectors and assist as needed, including one person familiar with charts and data who will be available to assist with chart and data management review.
  2. For inspections in which the documents are not in English, the organization must arrange to have a translator available for EACH inspector during the inspection.
  3. If inspector travel costs exceed historic averages, your organization may be assessed a travel surcharge.
  4. Provide the FACT Office with the name and address of a convenient, reasonably priced, and safe hotel.
  5. The Organization Director or designee should communicate the following information to the Inspection Team Leader:
    • Arrangements to pick up the inspectors at their hotel.   If this is not possible, provide directions to the organization, options for transportation, and the estimated time that will be required to reach your organization.
    • Inform the team of where you want to meet upon arrival at your organization.
  6. Reserve a room for the entire inspection for the inspectors where they can review charts, procedure manuals, and documents.   In addition, for the initial meeting and the exit interview, reserve a room that is adequate in size to accommodate the entire inspection team and key personnel.
  7. Arrange to provide a modest business lunch for the inspection team.  Most teams will use the lunch hour as a working lunch.
  8. Arrange for a computer(s) with internet access that inspectors can use throughout the inspection.
  9. The Inspector Team Leader creates an agenda for the on-site inspection and coordinates with the organization.  If you do not have a detailed agenda one week before the on-site inspection, the Organization Director should contact the Inspection Team Leader and/or the FACT Accreditation Coordinator to obtain the agenda.  The Organization Director is responsible for disseminating the inspection agenda to all key personnel within the organization.
    • The Organization Director may contact the Team Leader at any time to discuss the agenda or specifics of the inspection.

PREPARING ON-SITE DOCUMENTATION

  1. Compile documents and medical records that support compliance for each FACT standard.
  2. Organize and label the documents and records by standard.
  3. Create a crosswalk between each standard and the document(s) and record(s) that support that standard for the inspectors to reference on-site.   This will promote inspection efficiency.
    • The self-assessment tool may be useful for documenting the crosswalk.  Refer to the REFERENCES section below to access the appropriate document.
    • The Compliance Application may be exported to Excel and used as a crosswalk, which includes information regarding document(s) and record(s) entered in the field labeled "Enter applicable document name and page number as evidence of compliance or other comments."
  4. The following documents should be immediately available for the inspectors to review:
    • Quality management documents.
    • SOPs for the clinical, collection and processing.
    • Clinical outcomes requirements as requested by the Clinical Outcomes Improvement Committee, as applicable.
    • Data audit requirements as requested by the FACT - CIBMTR Data Audit Committee, as applicable.
    • Documentation of physician and staff training and continued competency, including documentation of current license(s), contracts, and other documents that have expired between time of submission and the inspection date.
    • Documentation of proficiency testing.
    • Documents demonstrating quality improvement and assessment including audits, corrective actions, validations, qualifications, occurrence reports, and adverse event records.
    • IRB approval documentation, if applicable.
    • Validation of electronic record systems if the system is within the control of the facility requesting accreditation and is considered a critical electronic record system.
  5. Review the FACT website for additional information regarding preparation for the inspection day. Though not required, two webinars are suggested: Quality Organization Virtual Roundtable and Organizational Self-Assessments.

DURING THE ON-SITE INSPECTION

  1. The initial interview should include all key personnel of the cellular therapy organization and members of the inspection team.
    • The Organization Director introduces the members of the cellular therapy organization to the inspectors, and presents information to the inspection team about the organization that may be helpful, especially information that was not required in the Compliance Application.  It is helpful to review the structure of the organization and the location of the sites to be inspected, particularly if these issues are complex and/or there are off-site locations. Slide presentations are helpful but not required. This presentation should not exceed 10 to 15 minutes.
  2. A knowledgeable person must be available for each inspector at all times to answer questions, find documents or Standard Operating Procedures (SOPs), assist with chart navigation, etc.  Appropriate individuals include a quality manager, data manager, collection center nurse supervisor, and processing facility supervisor.
  3. For inspections in which the documents are not in English, the organization must provide a translator to accompany EACH inspector during the inspection.
  4. Be prepared to have someone escort the inspectors to each of the sites.  If there are distant sites, be prepared to transport the inspectors and accompany them at those sites.
  5. Inspectors will meet with key personnel at each of the sites.  Ensure those key personnel are available during the scheduled time of the visit for each of the sites.
  6. Be prepared to gather additional documentation expeditiously, as requested by the inspection team to allow sufficient time for review, before the inspection concludes.
  7. Assume that the inspectors will want a closed-session during the lunch hour, but may wish to use a portion of this time to communicate with your personnel.   Be available to address questions or concerns related to completing the inspection with the inspection team before your lunch break.
  8. At the end of the inspection, the inspectors may wish to meet privately with the Organization Director and/or designated directors if there are issues that may be sensitive or confidential.  Be available for this meeting.
  9. The purpose of the Exit Interview is for the inspectors to summarize their major findings and to outline the remainder of the accreditation process.   Not all citations are discussed at the Exit Interview.  Remember, the FACT Accreditation Coordinator and the Accreditation Committee review citations.  The Board of Directors will determine the final decision on accreditation status.   The inspectors have specifically been instructed not to speculate on the accreditation outcome.

AFTER THE ON-SITE INSPECTION

  1. Additional documentation cannot be submitted after the on-site inspection until the Accreditation Committee reviews your organization’s application and a request for information is initiated in the Accreditation Portal.
  2. Do not make any changes to your organization or processes based on the inspection until you have received the final Accreditation Report.
  3. The inspection team will submit an inspection report to FACT after the on-site inspection.
  4. The Accreditation Coordinator reviews the inspection report and prepares the Accreditation Report for the FACT Cellular Therapy Accreditation Committee.
  5. The FACT Cellular Therapy Accreditation Committee reviews the Accreditation Report and makes a determination regarding the outcome.  Significant questions, problems, and controversial or precedent-setting issues are referred to the Board for resolution.
  6. The Organization Director and designated personnel will be notified by email after an Accreditation Committee decision is achieved.  Refer to the timeline for these processes, and contact your FACT Accreditation Coordinator if you have questions or need information.
  7. Your organization will receive the accreditation decision and the Accreditation Report, which includes citations, variances, and suggestions.
  8. All citations must be adequately addressed prior to accreditation. Responses are reviewed by the FACT Cellular Therapy Accreditation Committee and an accreditation recommendation is submitted to the FACT Board of Directors for final determination.
  9. If you have questions regarding a citation, request clarification from your FACT Accreditation Coordinator.
  10. After accreditation is awarded, the Organization Director will receive a FACT accreditation certificate and the organization will be included on the FACT list of accredited organizations.
  11. Please complete an evaluation regarding the accreditation and inspection process.  Your comments, suggestions, and observations are important for continued improvement in FACT's processes.

REFERENCES

  1. Hematopoietic Cellular Therapy
  2. Immune Effector Cells
  3. Common Standards

 

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