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Preparing
for an On-Site Inspection

Preparing for an on-site inspection in advance is key to successfully completing an inspection including:

Accepting an Inspection Assignment
Communication from the FACT Office
Travel
Meals and Entertainment
Interrupted Travel Plans
International Inspections and Cultural Awareness
Pre-Inspection Review
Communication with Your Inspection Team in Advance
Communication with the Applicant Organization
Pre-Inspection Team Meeting

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Accepting an
Inspection Assignment

The FACT office sends invitations to conduct inspections. The email messages list the program, location, and types of inspectors needed. Please review each of these invitations to determine if you are available for an upcoming inspection. Remember that inspectors ideally perform two inspections per year.

Before accepting an inspection assignment from FACT, double check your calendars to avoid conflicts, and take into account travel time. The date you are given at the time of the request is the date that should be confirmed in your calendar. It is not a tentative date. Although a full team may not have yet been selected, when you confirm availability for an inspection, FACT is planning on your participation. If for any reason the date does happen to change, you will be notified.

Sometimes inspectors provide the FACT office several dates they are available for an inspection. This is a useful approach for accommodating inspectors’ schedules. Please keep all provided dates open until you know the definitive date of the inspection provided by the FACT office.

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Communication from the FACT Office

Before performing a FACT inspection, inspectors are emailed communications from the FACT office that provide specific details about upcoming inspections. It is important to read each email in full because the information provided is critical to performing a specific inspection.

The following are two key emails you should expect after agreeing to perform an inspection:

Inspection Team Assignment Email:

When an inspection is confirmed, all members of the inspection team receive an email with the date and location of the inspection.

This email contains very important logistical information, including:

How to access the compliance application;
Travel arrangements, including hotel recommendations, pricing, and directions;
The name and contact information of your FACT Accreditation Coordinator, inspection team members, and the facility’s key personnel; and
Additional resources.

Inspector Responsibilities Email from Accreditation Coordinator:

You will also receive an email from your FACT accreditation coordinator, which contains instructions to fulfill the inspection team’s responsibilities.

This email contains information including:

How to review documentation in the portal
Reviewing and entering
Documenting compliance with FACT Standards
Team Leader instructions,
Mentor and trainee responsibilities,
Submitting the inspection report, and
Additional resources.

Because you will need to reference these emails as you prepare for an upcoming inspection, the following suggestions may help you keep them easily accessible:

Mark FACT emails as “unread” in your email inbox so they continue to serve as reminders,
Create an email folder in your inbox with the name and date of the inspection and save all FACT emails related to the inspection in that folder, or
Categorize FACT emails with a specific color.

Travel

FACT is a non-profit organization, and one of its largest expenses is travel. We ask that inspectors make airline reservations as soon the inspection date and team are confirmed in order to secure the most economical airfare. FACT contacts with a commercial travel agency, Corporate Travel Management, to assist you in making airline and hotel reservations.

You may contact Corporate Travel Management from 8:00 am to 5:00 pm Central Time at 1-866-363-2903 (international travelers should call 1-402-399-4500). Corporate Travel Management may be contacted after hours at 1-844-378-2955 or 978-326-3143 (outside the US) or by email at na.travelrequest@travelctm.com.

The benefits of using a commercial travel agency include:

FACT will be billed directly for the airfare, eliminating the need for inspectors to initially use personal funds and request reimbursement from the FACT office.
Travel and Transport will apply inspectors’ loyalty reward numbers to any airline so inspectors may continue to accumulate airline miles.
Using Corporate Travel Management can save the inspector time by vetting all flight options to find the right fare at the lowest rate.
Inspectors might encounter difficulties when traveling. A travel agent’s assistance can make travel less stressful.

If Corporate Travel Management is not used, travelers are required to submit an itinerary that includes prices to the FACT office prior to booking. Non-refundable airfares are recommended. If your flight is above $600, please use Corporate Travel Management to book your ticket.

Travel guidelines and reimbursement policy

You must plan on arriving in the city of the on-site inspection the evening before the inspection date to meet with other inspection team members. Departure flights on the final day of the inspection must be after 7:00 pm on the last inspection day to ensure a thorough inspection takes place. Your departure flight must allow for you to complete an entire day’s inspection and be present for the exit interview. This is extremely important, as inspections must not be rushed in order to catch a flight. It also shows courtesy to the applicant who worked diligently in the months leading up to the inspection. Applicants put forth great effort to prepare for an inspection and it is neither fair to them, nor good for FACT’s reputation, to rush an inspection.

Inspectors often find it useful to stay the night after the inspection to complete their inspection report while the information is still fresh in their memory. In this situation, the extra night’s expenses are billable to FACT.

FACT asks applicant organizations to provide suggestions for hotels and for travel to and from the hotel and facility. Make sure you have received an address and/or clear directions to your hotel and to the facility to be inspected in case you have to travel there alone.

FACT only covers your expenses directly associated with the inspection. Please ensure personal arrangements do not interfere with the inspection.

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Meals and Entertainment

FACT allows inspection teams to receive a modest lunch provided by the applicant and other refreshments during the inspection. Alcoholic beverages are not permitted during the inspection day.

Inspectors are discouraged from accepting other invitations of entertainment from the facility. Although such offers of hospitality are appreciated, it can be difficult and uncomfortable for all parties to spend an evening with personnel after an inspection has raised concerns. FACT covers expenses for other meals during the on-site visit.

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Interrupted Travel Plans

Unexpected complications sometimes occur immediately before or during on-site inspections. Examples of such situations include a canceled or delayed flight, heavy traffic the morning of the inspection, or an unexpected illness. When an unforeseeable event occurs, it is important to have a communication strategy with both the applicant organization and the inspection team to preserve the integrity of the inspection.

Inspectors should have the phone numbers and email addresses for the applicant’s key personnel and the FACT inspection team members easily accessible (such as in a printed document, or in a cellular phone contact list).

In case you should need medical attention while on an inspection, or have an existing medical condition, we recommend that you provide emergency contact information to the inspection team. If an emergency does happen, it is the responsibility of the inspector to notify the inspection team and applicant of the situation. It is important to communicate with the applicant and the team as soon as possible to make everyone aware of the issue. Others may need to assist during the inspection.

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International Inspections

One of the many benefits of being a FACT Inspector is traveling internationally. FACT inspectors are often sent to a region of the world where the culture is much different than the inspector’s. What is considered appropriate behavior in one culture may be inappropriate in another one.

Be aware of the cultural variations that exist by learning about the people and the regions of the world you are visiting. It is helpful to acquaint yourself in advance with the country’s basic customs and professional practices before the inspection. Be aware of regulations that may differ from your country. If regulations appear to conflict with FACT Standards, write a note in the checklist and on the report.

Understanding the values, expectations, and beliefs that drive behaviors in different cultures should guide your actions towards an individual, not direct them. For example, gifts are highly valued in Chinese culture and are considered a sign of respect and care. Although such offers of hospitality are appreciated, inspectors are discouraged from accepting gifts and other invitations of entertainment from any applicant.

Another example is the concept of time. Arriving to the inspection at the scheduled time is consider late in Japan and Germany. It is expected that you arrive at least ten minutes early to ensure the inspection can start on time. Doing otherwise may be construed as rude and unprofessional.

Strong communication is the most important tool you have during an inspection. Verbal and non- verbal communication help obtain needed information, diffuse tension, and establish rapport. Knowing how these tend to vary from culture to culture can help you recognize different communication styles and understand and communicate effectively.

If the primary language of the applicant is not English, work with the FACT Accreditation Office and with the applicant to obtain translations of essential documents and to ensure that an adequate number of interpreters will be available at the time of the inspection.

Pre-Inspection Review

Reviewing documentation before an inspection is vital to ensuring the best use of time on-site and improves the quality of the inspection. There is a lot that must be covered on-site and inspectors are encouraged to take advantage of the opportunity for a head start. Please do not wait until you get on the plane to read the information. It is recommended that the documents are reviewed at least 2 times and the findings discussed with the FACT Accreditation Coordinator assigned to the inspection.

Reviewing documents before an inspection reduces stress and anxiety for inspectors and applicants. By reviewing documents in advance you can anticipate future events during the inspection, including incomplete documentation, misunderstanding of the Standards, and unclear structure and services of an organization.

Applicants are required to complete the compliance application and submit documentation to the FACT Accreditation Office prior to the on-site inspection. Sometimes it may be useful to request additional documentation in advance. Requests for documentation should be coordinated with the FACT Accreditation Office to ensure that the applicant does not receive multiple requests for the same information.

Every applicant is different, so make certain you understand how the documentation is organized. Items that you may categorize as procedures may appear in their policies and vice versa. The basic structure of documentation under different quality systems (such as ISO) may be different than that of FACT. Be careful to check that seemingly missing information is not available or presented in a different format. The FACT Accreditation Office requests copies of the Table of Contents from the SOP Manual, which is helpful to determine where to look for information.

The inspector can access the checklist and documents online. Indicate compliance with standards by verifying pre-inspection submissions within the organization’s compliance application. Note questionable items to ensure you address these when you visit. Examples include selection of “not applicable” on the inspection checklist when they are actually relevant to the inspection or the selection of “yes” indicating compliance, despite the lack of supporting documentation. Review the previous inspection report and plan time to verify on-site that past deficiencies have been corrected on-site. The more you complete ahead of time, the more efficient the on-site inspection is likely to be.

A critical issue is the geographical layout and size of the applicant’s facilities. If the facility is large and consists of multiple sites, you may feel that you require assistance from the other team members or additional time. This should be communicated to the inspection team leader and to the FACT Accreditation Office promptly. In the case of cord blood banks, it is especially important to be aware of all the collection sites working with the bank and if there are multiple storage facilities. If you feel you will not be able to complete your inspection in one day (cellular therapy inspections) or two days (cord blood bank inspections), you should notify the team leader and contact the FACT Accreditation Office to make arrangements for an extended stay, additional help, or a return visit as dictated by the situation.

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Advanced Communication
With Your Team

FACT refers to the group of inspectors assigned to a particular on-site inspection as a “team” for a reason. Inspection team members should work together to plan the inspection, divide overlapping tasks, and share initial impressions from submitted documentation. Ongoing discussion with team members in advance of the inspection is strongly encouraged. Scheduling at least one pre-pre-inspection meeting a minimum of two weeks prior to the inspection can help to discuss the initial impressions and to strategize the actual inspection.

The assigned FACT Accreditation Coordinator will schedule an inspection team meeting approximately one month prior to the inspection to:

Ensure the team has access to the application in the Portal.
Communicate any requests from the Clinical Outcomes Improvement or Data Management Committees to the Clinical inspector(s).
Review any issues found when reviewing the application.

The ultimate responsibility for setting the agenda for the inspection day rests with the inspection team leader. The team leader must distribute the agenda to both the applicant and the inspection team. If a team member feels that some tasks can be coordinated or ordered differently, additional feedback to the team leader is welcome.

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Communication with the Applicant Organization

It is critical that the team leader contact the applicant ahead of time to discuss the nature of the inspection, create the agenda, and review items such as the introductory presentation and the exit interview procedure. It is ideal to provide the proposed agenda to the applicant’s director for approval at least two weeks in advance of the inspection. The applicant’s director may have insights into logistics, scheduling, and personnel availability (e.g., transportation, scheduled procedures, distances).

It is important to ensure that key personnel will be available to assist the inspectors. Arrangements should be made to visit all facilities identified as necessary by the FACT Accreditation Office. These arrangements should include transportation and escorts from the facility.

Pre-Inspection Team Meeting

All inspection teams are required to meet the night before the inspection or immediately prior to the inspection. The in-person meeting before the inspection consists of all team members.

The pre-inspection meeting is often the key to a well-organized and efficient inspection. Take time to cover the material in detail and review your plans.

Specifically, this meeting is an important part of the process because it allows the team to:

Review the application together and identify particular concerns or issues that may require additional attention.
Ensure all team members understand the structure and function of the applicant.
Establish initial and exit interview expectations.
Plan the inspection itself. Review the agenda and modify as necessary to ensure appropriate coverage of the entire program.
Allow inspectors who are sharing an area (for example, the Processing Facility) to divide the responsibility to minimize overlap, and to ensure complete coverage and adequate time to compare notes before the exit interview.
Ask and answer any final questions.

The on-site inspection evaluation to be completed after the site visit, asks you and your team members if the pre-inspection meeting took place. The joint preparation by inspection team members is critical to the success of an inspection. Sometimes, extenuating factors may prevent an in-person pre-inspection team meeting at the location of the inspection (flight availability, distance between cord blood collection sites and central bank, etc.). If such factors exist, it is the responsibility of the team leader to plan for a meeting via teleconference. The FACT Accreditation Office will assist with arrangements if requested, including arranging for a teleconference number and/or setting up a meeting time and place.

Preparing
for an On-Site Inspection