CELLULAR THERAPY APPLICANT GUIDELINES

Print Guidelines download

Accreditation is awarded after successful documentation of compliance with the current Standards. Compliance is determined by evaluation of written documents provided by the organization and by on-site inspection. On-site inspections are carried out by a team of inspectors who are qualified by training and experience, have attended inspector training, and who have a working knowledge of relevant Standards.

Review the steps in the accreditation process and the following information:

Completing the Compliance Application
Preparing for the Data Management Audit
Before the On-Site Inspection
During the On-Site Inspection
After the On-Site Inspection
Data Management Audit Instructions

COMPLETING THE COMPLIANCE APPLICATION

  1. Review the Compliance Application. Assign someone to complete each section.
    • Generate required SOPs if not previously written.
    • Address the areas where you cannot document that you meet the Standard. Ensure that any new protocols or procedures are written or existing protocols/ procedures are revised to document compliance.
  2. The Compliance Application requires document uploads for some standards. Upload the required documents when requested. 
  3. For each standard in the Compliance Application, a checkbox titled “Not Complete” is available to assist you with tracking which standards need additional evidence entered. You may keep a checkmark in this box until all required information has been entered.
  4. The Compliance Application cannot be submitted unless all questions have been answered, all required documents are uploaded, and the application has been signed by the Program Director (or Facility Director for facilities applying independently of a Clinical Program).
  5. Requests for information (RFIs) are generated by your assigned FACT coordinator or inspectors when additional information or documents are required.
  6. When the compliance application is considered complete by the FACT staff, you will be contacted for potential inspection dates. Please be prepared to give several sets of consecutive dates when all key personnel will be available for the inspection.
  7. Organizations applying for accreditation for the first time are given 12 months after submitting their online Eligibility Application to arrange their documentation, adjust processes to be in compliance with the FACT Standards, and submit their Compliance Application. Organizations in the process of renewal accreditation are provided three months to submit their Compliance Application. Timely responses are critical to achieve FACT accreditation.

BEFORE THE ON-SITE INSPECTION

  1. Schedule the on-site inspection for a date when ALL KEY PERSONNEL will be available. At a minimum, this includes the Program Director, the Collection Facility Director and Medical Director, and the Processing Facility Director and Medical Director. In addition, there must be designated personnel available throughout the day to accompany each of the inspectors and assist as needed, and at least one person familiar with charts and data to assist with chart review.
  2. Schedule the on-site inspection on a day that is acceptable for all sites (e.g., hospitals, off-site storage facilities, etc.). The inspectors MUST visit each site to be included in the accredited organization and to talk to key personnel at each of these sites. This may require clearance from an administrator, Director of Nursing, etc.
  3. Provide the FACT Accreditation Office with the name of a convenient reasonable hotel.
  4. The Program Director or designee should communicate the following information to the Team Leader:
    • Provide inspectors information about how to get to the facility. It is acceptable to make arrangements to pick up the inspectors at their hotel. If this is not possible, provide them information about available transportation and estimate the time that will be required to reach your facility.
    • Inform the team of where you want them to meet upon arrival at your facility.
  5. Reserve a room for the inspectors for the entire day where the inspectors 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, key personnel, and others the applicant wishes to invite.
  6. Arrange to provide a modest business lunch for the inspection team. Most teams will want to utilize the lunch hour, at least in part, as a working lunch.
  7. Arrange for a computer(s) with internet access that inspectors can use throughout the inspection day, or, at a minimum, during the lunch hour. Notify the inspection team of the computer arrangements that have been made prior to the inspection.
  8. If inspector travel costs exceed historic averages, your organization may be assessed a travel surcharge.

PREPARING FOR THE DATA MANAGEMENT AUDIT

To document compliance with B9.1, upload CIBMTR Data Management Forms (or MED-A forms, as applicable) into the Compliance Application. From the patient list (see table below), submit the applicable CIBMTR Data Management Forms for each sequential patient selected. These forms will need to be combined into a single file before uploading them to the Compliance Application. If needed, these forms can be found at www.cibmtr.org.

  • TED Only Centers:
    Pre-Transplant Essential Data Form 2400
    100-day Post-Transplant Essential Data Form 2450
  • Comprehensive Report Form Centers:
    Pre-Transplant essential Data Form 2400
    100-day Post-Transplant Essential Data Form 2450 OR 100 Days Post-HSCT Data Form 2100 as applicable for each patient
  • Paper Only Organizations (only for autologous patients or patients of international organizations not submitted to CIBMTR):
    Pre-Transplant Essential Data Form US OMB Control No: 0915-0310
    100-day Post-Transplant Essential Data Form OMB Control No: 0915-0310

DURING THE ON-SITE INSPECTION

  1. The initial interview should include all key personnel of the cellular therapy program and members of the inspection team.
  2. The Program Director should plan to introduce the members of the cellular therapy program to the inspectors, and present information to the inspection team about the program that may be helpful, especially information that was not required on the Compliance Application. It is helpful to review the structure of the organization and the location of the applicant sites, particularly if these issues are complex and/or there are any off-site locations. This presentation should not exceed 10 to 15 minutes.
  3. A knowledgeable personnel member must be available to the inspector at all times to answer questions, find documents or procedures, assist with chart navigation, etc. Appropriate individuals would include a data manager, collection center nurse supervisor, and laboratory supervisor.
  4. The following documents should be immediately available for the inspectors to review:
    • Quality assessment and improvement documents, including internal audits performed by the organization.
    • SOPs for the clinical, collection and processing areas.
    • 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.
    • Documentation of proficiency testing.
    • Documents demonstrating quality improvement and assessment, including audits and validations.
    • IRB approval documentation, if appropriate.
    • The collected source documents for verification of the data included in the submitted CIBMTR Data Management Forms.
    • Validation of computer system if the system is within the control of the facility requesting accreditation and is considered a critical electronic record system (Apheresis and Processing Facilities).
  5. The Inspection Team Leader will provide a schedule for the on-site inspection. If you do not have a detailed schedule one week before the on-site inspection, the Program Director should contact the Team Leader and/or the FACT Office to obtain it. The Program Director is responsible for disseminating the inspection agenda to all key personnel within the program. The Program Director may contact the Team Leader at any time to discuss the schedule or specifics of the inspection.
  6. Be prepared to have someone escort the inspectors to each of the sites. If there are distant sites, be prepared to transport the inspectors there and accompany them at those sites.
  7. Inspectors will need to talk to key personnel at each of the sites. Be certain that they will be available during the scheduled time of the visit for each of the sites. For example, in the Clinical Program, the nurse supervisor, social worker, pharmacy staff, and any additional personnel who are needed to answer specific questions on the checklist need to be available.
  8. Be prepared to gather additional documentation as requested by the team during the time that they are present in your facility. At the discretion of the inspector, the organization may upload specified documents that were reviewed on site by the inspector into the Compliance Application.
  9. Assume that the inspectors will want some closed-session time during the lunch hour, but they may also wish to use a portion of this time to communicate with the applicant. Be available. Be sure to check with the inspection team for questions or concerns related to completing the inspection visit before you leave for your own lunch break.
  10. At the end of the inspection, the inspectors may wish to meet privately with the Program Director and/or designated directors if there are issues to be raised that may be of a sensitive or confidential nature. Be available for this meeting.
  11. The purpose of the Exit Interview is to allow the inspectors to summarize their major findings and to outline the remainder of the accreditation process. Not all citations will be discussed at the Exit Interview. Remember that the citations are reviewed by the FACT Accreditation Coordinators and the Accreditation Committee, and the final decision on accreditation status will be determined by the Board of Directors. The inspectors have specifically been instructed not to speculate on the accreditation status your organization will attain after Accreditation Committee review.
  12. The Program Director and other individuals authorized on your Compliance Application will be notified by email when an Accreditation Committee decision has been reached. Consult the timeline for these processes, and feel free to contact the FACT Accreditation Office if you have questions or need information.
  13. Additional documentation cannot be submitted until the Accreditation Committee has reviewed your organization and a request for information has been initiated in the FACTWeb Accreditation Portal.

AFTER THE ON-SITE INSPECTION

  1. Your program will receive a final inspection summary including the accreditation decision. All citations must be adequately addressed prior to accreditation; some citations contain multiple items that need to be summarized.
  2. Do not make any changes to your organization until you have received the final inspection summary.
  3. If you have any questions regarding a citation, request clarification from your FACT Accreditation Coordinator.
  4. Please complete the evaluations that are included in the email from the FACT Accreditation Office regarding the accreditation outcome. Your comments, suggestions, and observations are important to continued improvement in the inspection and accreditation processes.

DATA MANAGEMENT AUDIT INSTRUCTIONS

Complete the Data Management Audit Form. A link to this form is in the Compliance Application under B9.1. Download the form, complete it according to the instructions, and upload the completed form to the Compliance Application.

  • For an initial application: If the required number of transplants have not been performed in the 12-month period prior to submission of the Compliance Application, but are anticipated to occur prior to accreditation, submit a complete patient list and CIBMTR forms for all patients.  Additional CIBMTR forms may be inspected on-site and uploaded within 48 hours after the on-site inspection at the discretion of the inspector. If the required number of transplants still has not been performed, you will be cited for this and will not receive FACT accreditation unless the required number is performed within 12 months after submitting the Compliance Application. You will be requested to submit an updated data management audit with additional CIBMTR forms submitted after the on-site inspection.
  • For a renewal application: If the required number of transplants have not been performed in the 12-month period prior to submission of the Compliance Application, but are anticipated to occur prior to renewal accreditation, submit a complete patient list and CIBMTR forms for patients that have been transplanted. Additional CIBMTR forms may be inspected on-site and uploaded within 48 hours after the on-site inspection at the discretion of the inspector. If the required number of transplants still has not been performed, you will be cited for this and will not receive renewal accreditation unless the required number is performed by the accreditation expiration date. You will be requested to submit an updated data management audit with additional CIBMTR forms submitted after the on-site inspection.

For each data point on the CIBMTR forms, ensure that you have a primary source document to prove the accuracy of the data. The best method of documentation is to pull the primary records from their location in medical records or elsewhere.  For each data point, put a marker (e.g., yellow “post-it” note) on each primary record.  LABEL the notes with the identity of the data point documented.  Keep all these records readily available for the inspector.

The following table indicates the number of forms to submit based on the transplant population, number of clinical sites, and type of transplant.(Note: It is recognized that some patient characteristics may result in different CIBMTR forms other than those listed above. If so, please contact the FACT office for further direction.)

Transplant
Population
Clinical
Site(s)
Type of
Transplant
Minimum Number of Consecutive Reciepients'
CIBMTR forms to be submitted from Recipient List
Adult OR Pediatric (Only one of these two) Single Clinical Site Allogeneic Only 10 allogeneic
Autologous Only 5 autologous
Allogeneic and Autologous 10 allogeneic
5 autologous
Multiple Clinical Sites Allogeneic only 5 allogeneic from each site
Autologous only 5 autologous from each site
Allogeneic and Autologous 5 allogeneic from each site
5 autologous from each site
Combined Adult AND Pediatric Single Clinical Site Allogeneic Only 5 adult allogeneic
5 pediatric allogeneic
Autologous Only 5 adult autologous
5 pediatric autologous
Allogeneic and Autologous 5 adult allogeneic
5 pediatric allogeneic
5 adult autologous
5 pediatric autologous
Multiple Clinical Sites Allogeneic only 5 adult allogeneic from each site
5 pediatric allogeneic from each site
Autologous Only 5 adult autologous from each site
5 pediatric autologous from each site
Allogeneic and Autologous 5 adult allogeneic from each site
5 pediatric allogeneic from each site
5 adult autologous from each site
5 pediatric autologous from each site
Ask FACT

FAQ

Ask a Peer

As a Matter of FACT

FACT is approved as an accrediting organization by the United States Health Resources Services and Administration (HRSA) for the C.W. Bill Young Cord Blood Transplantation Program.

Accreditation Success Story

Hospital Israelita Albert Einstein (HIAE) in Brazil is the first Bone Marrow Transplantation Center in Latin America to receive FACT accreditation. HIAE is accredited for autologous and allogenic transplantation. Read more