CORD BLOOD BANK APPLICANT GUIDELINES

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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
Before the On-Site Inspection
During the On-Site Inspection
After the On-Site Inspection

COMPLETING THE COMPLIANCE APPLICATION

  1. Review the Compliance Application. Assign someone to complete each section.
    • Generate missing procedures or work/job instructions. 
    • 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 Cord Blood Bank Director.
  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 two-day inspection. If more than four collection sites are to be inspected and/or if there is a long travel time between collection sites, an additional day may be required for the collection site inspection.
  7. Banks 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. Banks 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 CBB Director, CBB Medical Director, CB Collection Site Director(s), the CB Processing Facility Director, and the Quality Manager. In addition, there must be designated personnel available throughout the day to accompany each of the inspectors, assist as needed, and act as a translator for the inspector if required.
  2. Schedule the on-site inspection on days that are acceptable for all sites (e.g., bank, collection sites, processing facilities, off-site storage facilities, etc.). The inspectors MUST visit each site that has been chosen to be included in the inspection and talk to key personnel at 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 for the inspection team members.
  4. The Bank Director or designee should communicate the following information to the Inspection Team Leader:
    • Provide inspectors with directions to the facility. It is acceptable to arrange 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 inspection team of where you want them to meet you upon arrival at your facility.
  5. For the days of the inspection, reserve a room for the inspectors where they can review 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 on each day of the inspection. 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, 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 bank may be assessed a travel surcharge.

DURING THE ON-SITE INSPECTION

  1. The initial interview should include all key personnel of the cord blood bank and members of the inspection team.
  2. The Bank Director should plan to introduce the members of the applicant cord blood bank to the inspectors, and present information to the inspection team about the bank that may be helpful, especially information that was not required on the Compliance Application. It is helpful to review the structure of the bank 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. Knowledgeable personnel must be available to the inspectors at all times to answer questions, find documents or procedures, provide translation services, etc. Appropriate individuals would be a quality manager, collection site nurse supervisor, or processing facility supervisor.
  4. The following documents should be immediately available for the inspectors to review:
    •  Quality assessment and improvement documents, including any internal audits performed by the program. 
    •  Procedures or work /job instructions for collection, processing, banking, and release. 
    •  Documentation of 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 for key processes. 
  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 Cord Blood Bank Director should contact the Inspection Team Leader and/or the FACT Office to obtain it. The Bank Director is responsible for disseminating the inspection agenda to all key personnel within the program. The Bank Director may contact the Team Leader at any time to discuss the schedule or specifics of 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 there and accompany them at those sites. 
    • 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. 
  6. Be prepared to gather additional documentation requested by the team during the time that they are present in your Cord Blood Bank. At the discretion of the inspector, the bank may upload specified documents that were reviewed on site by the inspector into the Compliance Application.
  7. 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.
  8. At the end of the inspection, the inspectors may wish to meet privately with the Cord Blood Bank 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.
  9. 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 program will attain after Accreditation Committee review.
  10. The Cord Blood Bank 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.
  11. Additional documentation cannot be submitted until the Accreditation Committee has reviewed your Cord Blood Bank and a request for information has been initiated in the FACTWeb Accreditation Portal.

AFTER THE ON-SITE INSPECTION

  1. Your Cord Blood Bank 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 Cord Blood Bank 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.
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