Conducting an
On-Site Inspection
Timing and communication are very important when conducting the on-site inspection.
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Elements of the on-site inspection include:
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Timing
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Multiple Inspectors
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Completing Your Inspection Assignment
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Dress Attire
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Beginning the Inspection Day
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Program Integration
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Completing the Inspection Checklist
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Maneuvering the Checklist
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Inspection Team Meetings
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Supporting FACT Standards
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Additional Inspection Tips
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Timing
Always remember that the applicant has spent months of hard work preparing for the on-site inspection. You owe them the courtesy of performing a thorough inspection. Do not rush the process. This is where your pre-inspection preparations will pay off. It allows you to identify areas that may require particular attention and plan your time accordingly. You do yourself and FACT a disservice by appearing to rush or cut corners.
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Multiple Inspectors
Where multiple inspectors are assigned to an area, it is crucial to coordinate your efforts to ensure that there is non-repetitive but complete coverage and a thorough interchange of findings between the inspectors. The inspection team divides to conduct the tasks assigned to particular areas. Many inspectors like to tour the entire facility, but we strongly advise you to leave sufficient time for your assigned area. Every area must be seen by someone, but not necessarily by everyone. Some level of cross-checking is advisable, but continual repetition can be aggravating to the applicant and place a strain on your schedule.
Be certain the team leader is aware if you feel you are running short on time. There may be another inspector on the team who can help you complete the work.
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Completing Your
Inspection Assignment
It is necessary to the success of the inspection to complete your checklists as directed by FACT. An incomplete inspection may require a repeat site visit or extensive responses from the applicant. For example, if an inspector assigned to review unrelated and related cord blood banking only reviews unrelated donations, the bank may have to be reinspected or address several standards in its response. As another example, a program may state it does not meet required marrow collection numbers, but a marrow collection inspection must still occur if assigned by FACT.
We understand that inspectors may be told something different on-site than what was originally assigned by FACT. If an applicant asks you to refrain from a certain aspect of an inspection, please take the following steps:
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Remind the applicant that failure to undergo inspection of certain locations or processes may require a reinspection and jeopardize accreditation.
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If the applicant continues to refuse, contact the FACT office immediately for assistance with clarifying accreditation goals.
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If a complete inspection still cannot be performed, clearly document within the inspection report those standards for which you were unable to verify compliance.
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If you observe activities being performed that were not part of the inspection assignment, such as marrow collection or immune effector cell therapy, request permission from the applicant to conduct the inspection to prevent the need for a reinspection. If the applicant objects, offer a reminder of the points above, note the activities you were unable to inspect, and proceed with the inspection as assigned.
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Inspection Day Attire
Because first impressions are so important, the inspection team must arrive at the inspection site on time and wearing business attire and FACT inspector identification. Professional dress instills the applicant’s confidence in your inspection abilities. A suit is not required; however, appropriate business attire does not include any denim. Business attire typically includes slacks or khakis, dress shirt or blouse, open-collar or polo shirt, optional tie or seasonal sport coat, a dress or skirt, a tailored blazer, a knit shirt or sweater, and loafers or closed-toe shoes. Badges are sent to inspectors before the on-site inspection. The identification badge identifies the bearer as a person who is authorized to be in the building.
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Beginning the Inspection Day
The inspection team leader briefly introduces the inspectors and reviews the inspection process and timetable. This is followed by an overview of the organization by the Director. The team leader may request that specific items be addressed in the presentation. Examples include the quality management program, how long the applicant has been in existence and what services it provides, and unique and/or outstanding characteristics of the applicant’s structure. This presentation should not be more than 10-20 minutes.
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Program Integration
A fundamental FACT requirement is that programs function as integrated operational units. This means that there must be evidence of interaction among all of the components. Evidence of this type of exchange is formally required in some of the standards. It is important to look for such interactions when you perform the inspection of your particular area. For example, is the Collection Facility interacting and sharing information with the Clinical Program and the Processing Facility? Do the personnel know how this information is communicated and where to find it?
This type of communication is a particularly important part of the quality management program. Is information being exchanged to ensure real or developing problems can be efficiently identified and remedied? Is the program being reviewed as a whole in addition to an examination of each of its component parts? Is there evidence of ongoing meetings in the form of minutes?
A comparison of notes between the members of the inspection team prior to the exit interview may also help this process.
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Completing the
Inspection Checklist
The inspection checklist is an important tool for inspectors and should be used at all times during the inspection. Not only does it ensure that compliance with each standard is verified, but it also provides a resource for inspectors when writing inspection reports. Furthermore, the FACT Accreditation Coordinators refer to the completed inspection checklists for clarification when needed. The checklist can be completed in the FACT Accreditation Portal. Your accreditation coordinator sends you an exported version of the checklist if you prefer to work with the printed version. Whether you use a printed version or work within the portal, it is very important to take excellent notes.
Complete and accurate information in the inspection checklist directly impacts the ability of the Accreditation Committee to understand the inspector’s findings during an on-site inspection.
If there are ambiguities in the checklist, the FACT Accreditation Coordinator will request clarification.
The following are important reminders for completing the online compliance application:
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Check “compliant” or “non-compliant” for each question: The inspection checklist is the official documentation of compliance with each requirement; therefore, each question must be answered. It is not sufficient to answer only portions of the checklist, because compliance or noncompliance cannot be assumed by the FACT Accreditation Office.
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Select only one answer for each question: Applicants can only be in compliance with a standard if all required elements are met. If only partial compliance can be verified, check “non-compliant” and provide an explanation in the comments field. Provide notes in the comments field: While noncompliance with a requirement is clear for many standards (e.g., the absence of an SOP), it may not be clear for others. For example, if a facility is found to be inadequate for the scope of activities performed, explain why. The online compliance application requires the inspector to include comments for any question or standard marked non-compliant. If the personnel qualifications are considered insufficient for the task assigned, elaborate on what is required to be in compliance with the standards.
These steps will help you remember the deficiencies you found and provide supplemental information for the FACT Accreditation Committee.
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Organizing the Checklist
The checklist is organized by standard number. However, this is not always the order in which information is presented during an inspection. It is crucial to have a plan to ensure every standard has been inspected. It is helpful to double-check your work at the end of the inspection and confirm you have inspected each standard.
It is acceptable to:
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Begin with documentation review, allowing the organization time to gather missing documentation during lunch, or
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Begin with the tour to familiarize yourself with the workflow and check obvious compliance issues, such as cleanliness and safety.
Review your plan with your team to ensure completion and consistency. Always use the checklists. Even if you have inspected many times, the checklist is a great safeguard, especially with the publication of different editions of Standards.
Notes are useful when writing the inspection report and are helpful to review before attending an Accreditation Committee meeting and when answering specific questions from the committee.
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Inspection Team Meetings
The inspection team conducts a working lunch meeting to privately discuss inspection findings from the morning and address particular matters of concern. At this time, the team may re- evaluate the agenda and adjust it as necessary. If you feel that a problem must be addressed during the inspection, use the time at the lunch break to seek advice from the other inspectors or the FACT Accreditation Office. In most cases, issues focus on interpretation of a standard. This is most easily addressed by describing the incident in your report and requesting the Accreditation Committee to make the final decision.
Because cord blood bank inspections are conducted over two days, the inspection team should meet at the end of the first day. This can be done at the bank to allow you time to gather a list of documentation that you would like available for the next day. Alternatively, the team leader may arrange with the FACT Accreditation Office for a room to be made available at your hotel for an evening meeting.
It is important for inspection team members to compare notes before the exit interview and review what information will be presented to the applicant. An applicant should never be cited for deficiencies because the inspectors failed to exchange their findings. This must occur before the exit interview to ensure a unified report is delivered.
The inspection team may also wish to meet after the inspection to coordinate preparation of the report.
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Conduct
During an inspection, personnel are generally very sensitive to an inspector’s behavior and comments. Your conduct during an inspection speaks volumes about FACT and about you.
Be sensitive to the staff’s workload on the day of the inspection. Safe patient care is obviously the priority. If you feel that this is becoming a concern you should request that an individual staff member be assigned to deal with inspection issues. You can then work with him/her to coordinate the best time to tour the facility and meet with other staff if necessary.
Simple things such as politeness, a smile, and constructive suggestions can make a big difference to the inspection process. Applicant personnel are colleagues and the inspection process is supposed to be a collegial and helpful experience, not punitive or condescending.
It is natural that, as a professional of long standing, you will have preferences for how to comply with a standard. Please remember, there are many ways to achieve compliance. As long as the method that the applicant uses satisfies the intent of the standard, it is acceptable (even if you personally prefer a different approach). Alternative approaches may be discussed as part of the ongoing educational efforts if the personnel understand these alternatives are not required.
Differences of opinion should be expressed in a constructive manner. Do not make derogatory comments about findings or express surprise at what you find. Use the inspection checklist and report to record your concerns. When you are uncertain if a particular standard has been met, record your concerns on the inspection checklist and in your report, collect pertinent documents, and return everything to the FACT Accreditation Office. The FACT Accreditation Coordinators will refer any issues requiring further evaluation to the FACT Accreditation Committee and/or FACT Board of Directors.
It is appropriate to discuss your findings with personnel on an ongoing basis throughout the inspection to provide them with an opportunity to provide supplementary information or documentation. Be careful, however, that the tone of these discussions are accurately reflected in your exit interview. There should be no major surprises in the final report. Personnel occasionally complain they had no idea of the depth and scope of deviations until they received the final report from FACT, but instead had finished the inspection feeling they had done very well.
If you feel there are significant problems, or an applicant’s practices are very different from the majority of others’, it is appropriate to suggest alternative approaches that may be more acceptable. Again, these suggestions should be given in a constructive manner and kept within the scope of the FACT Standards. If a staff member is not receptive to your suggestions or argues about a specific point, it is best to move on with the inspection and note the problem on your checklist.
The team leader should address any inappropriate inspector conduct at the time it occurs. If an inspector is not able to complete an inspection due to difficult personnel, or for any other reason, the FACT office should be contacted as soon as possible and the details of the issue should be included in the inspector’s evaluation of the inspection.
Always remember to be the best representation of yourself, your organization, and FACT. An inspector must strive to maintain his or her composure during the entire inspection.
It is desirable to praise personnel for things that are done particularly well. This can include asking them for permission to copy SOPs, labels, or other documents for your own use. The inspection is intended to be collegial and to raise quality as a whole, so this type of activity is an acceptable part of the process. Remember, due to confidentiality reasons you must receive permission from the applicant.
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Supporting FACT Standards
During an inspection you are acting as a FACT representative. You may personally disagree with some of the standards; however, during an inspection you are expected to verify that all standards are being implemented. It is inappropriate to criticize the Standards or FACT during an inspection. Such concerns should be expressed directly to the FACT Board of Directors and/or to the applicable FACT committee(s).
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Additional Inspection Tips
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During the inspection, you have several tools at your disposal. First impressions on entering a facility can indicate the level of organization and management throughout the program. Check for appropriate signage, storage conditions, tidiness, and use of protective equipment. Retrieval times for requested information can also be indicative of overall organization.
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Follow the progress of a product from donor screening to infusion. When questioning staff about procedures, be flexible. Allow the discussion to move into related areas, to ensure you understand the whole process and the personnel’s role in that process. It is not necessary to follow the exact order of the checklist. Determine if you hear the same information from different staff members. Ask about how the patients are followed inpatient (sign-off, transfer to the ICU, etc) and if the BMT Team is involved and to which extent. Request a brief tour simulating how a patient with a complication after transplant will be cared for, starting from the Emergency Department until admission to the BMT designated Unit.
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Ask to see a procedure if one is ongoing, or ask personnel to mock up a procedure. This is a routine component of the inspection process. If a real procedure is being observed, allow the personnel to work without multiple interruptions. Write notes and ask questions later. If a patient is involved, be certain personnel have obtained the patient’s consent to have an observer present. Always follow institutional practices of gowning, limitation on the number of persons allowed in a clean room or other area, or other issues during observation. Do not compromise patient care or product handling by your inspection tasks.
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Double check you have not overlooked something because you have searched in the wrong place. Ask personnel to provide you with the missing documentation – they may have filed it in a different location or system.
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Remember that an additional SOP is not the answer to every deficiency. The Standards do require specific SOPs to be available for certain procedures, e.g., cryopreservation. In other cases, it may be possible to satisfy the intent of the standard by mechanisms other than an SOP.
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An indication of problem areas may be obtained by reviewing variances. Are there repeated occurrences of the same problem, has corrective action been taken, and has it been effective? Remember, variances and audit results are not in of themselves a reason to cite an applicant, but useful to assess whether or not the applicant complies with requirements to detect and correct problems and conduct follow-up.
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If you see a clear deficiency that could be easily and rapidly remedied during your visit, offer the staff the opportunity to make the correction and provide you with evidence the correction has been made. It is not necessary to cite the applicant for that deviation, but you should include the evidence of correction in your report. However, this approach cannot be followed for deficiencies that are serious and require sustained evidence of correction and implementation.
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FACT makes every effort to write Standards that do not conflict with regulatory requirements. However, if national regulations appear to be in conflict with FACT Standards, do not enter into a debate. Simply write a note on the checklist and in your report.
