Accreditation Process Requirements
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.
Each organization is assigned a FACT Accreditation Coordinator to assist with questions or concerns you may have throughout the accreditation process
- 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
- 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.
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.
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.
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).
Your assigned FACT Accreditation Coordinator will review the Compliance Application and generate Requests for information (RFIs) when additional information or documents are required.
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.
- Identify the areas where no documentation exists.
- Create new policies or Standard Operating Procedures (SOPs) or update existing policies or SOPs to document compliance.
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
- 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, multiple processing sites, off-site storage sites, and/or marketing sites, or if travel time between sites is lengthy.
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.
If inspector travel costs exceed historic averages, your organization may be assessed a travel surcharge.
Provide the FACT Office with the name and address of a convenient, reasonably priced, and safe hotel.
The Organization Director or designee should communicate the following information to the Inspection Team Leader:
- Provide dates when all key PERSONNEL will be available for the inspection at each site. For CT: 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). For CBB: At a minimum, this includes the CBB Director, CBB Medical Director, CB Collection Director(s), the CB Processing Facility Director, and the Quality Unit Manager.
- Send dates that are acceptable for all SITES (e.g., hospitals, collection sites, 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.
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.
Arrange to provide a modest business lunch for the inspection team on each day of the inspection, including for inspectors that may be off-site. Most teams will use the lunch hour as a working lunch.
Arrange for a computer(s) with internet access that inspectors can use throughout the inspection.
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.
- 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.
- The Organization Director may contact the Team Leader at any time to discuss the agenda or specifics of the inspection.
Preparing On-Site Documentation
- Compile documents and medical records that support compliance for each FACT standard.
- Organize and label the documents and records by standard.
- Create a crosswalk between each standard and the document(s) and record(s) that support that standard for the inspectors to reference on-site. Organization of documents is key to a successful inspection. Use of an electronic software such as OneNote or the equivalent is required. In OneNote, SOPs, policies, and other supporting documents and examples are linked directly to the specific FACT Standard and checklist question, making demonstration of compliance efficient and clear. OneNote can also be used to maintain readiness during the accreditation cycle.
For CT: The following documents should be immediately available for the inspectors to review:
- For information on the use of One Note, see the FACT webinar “Using an electronic Platform for Accreditation Preparation and Continuous Readiness” presented 26 June 2019 and available at: https://www.factweb.org/forms/store/ProductFormPublic/using-an-electronic-platform-for-accreditation-preparation-and-continuous-readiness-webinar
- FACT has provided OneNote templates for each edition of published Standards. These templates can be found on the relevant Standards page.
- 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.”
For CBB: The following documents should be immediately available for the inspectors to review:
- Quality management documents, including meeting minutes, audits, adverse reaction reports, occurrence reports, corrective and preventive actions and effectiveness. Include evidence of quality improvement actions taken.
- SOPs for the clinical, collection, and cell processing areas, as applicable.
- Recipient and donor medical records and product collection or processing records that demonstrate examples of compliance with standards related to management of deviation, products with positive microbial contamination ineligible donors, or adverse reactions.
- Clinical outcomes requirements as requested by the Clinical Outcomes 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.
- Contracts with external facilities including biennial review.
- Documentation of proficiency testing.
- Validation and qualification studies performed.
- 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 to be a critical electronic record system.
- Updated licenses of contracts that expired between application submission and the date of the inspection.
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
- Quality assessment and improvement documents, including internal audits performed by the bank.
- Procedures or work/job instructions for collection, processing, banking, and release.
- Documentation of physician and staff training and continued competency, including documentation of current license, contracts, and other documents that have expired between time of submission and the inspection date.
- Validation studies of key processes.
- Documentation of all steps involved in the collection and receipt of cord blood collections from non-fixed collection sites, including preparation and distribution of collection kits, documentation of collector training, informed consent of the maternal donor, maternal and infant donor history, physical exam, and relevant laboratory test results, and any contracts.
During the On-Site Inspection
- The initial interview should include all key personnel of the cellular therapy organization and members of the inspection team.
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.
For inspections in which the documents are not in English, the organization must provide a translator to accompany EACH inspector during the inspection.
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.
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.
Be prepared to gather additional documentation expeditiously, as requested by the inspection team to allow sufficient time for review, before the inspection concludes.
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.
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.
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.
- 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.
After the On-Site Inspection
- 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.
- Do not make any changes to your organization or processes based on the inspection until you have received the final Accreditation Report.
- The inspection team will submit an inspection report to FACT after the on-site inspection.
- The FACT Accreditation Coordinator reviews the inspection report and prepares the Accreditation Report for the relevant FACT Accreditation Committee.
- The FACT 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.
- 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.
- Your organization will receive the accreditation decision and the Accreditation Report, which includes citations, variances, and suggestions. Refer to the Applicant Response Template for response examples.
- All citations must be adequately addressed prior to accreditation. Responses are reviewed by the FACT Accreditation Committee and an accreditation recommendation is submitted to the FACT Board of Directors for final determination.
- If you have questions regarding a citation, request clarification from your FACT Accreditation Coordinator.
- 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.
- Please complete an evaluation regarding the accreditation and inspection process. Your comments, suggestions, and observations are important for continued improvement in FACT’s processes.
Cord Blood Bank
Immune Effector Cells
- Hematopoietic Cellular Therapy