FACTWEB INSPECTOR HELP  

A. QUICK REFERENCE GUIDE:

I.   INTRODUCTION

II.  ACCESSING THE COMPLIANCE APPLICATION

III. REVIEWING THE COMPLIANCE APPLICATION

IV. ENTERING INSPECTION FINDINGS

V.  COMPLETING THE INSPECTION REPORT

VI. USING FACTWEB FOR TRAINING INSPECTIONS

VII. TROUBLESHOOTING

B. ADDITIONAL FACTWEB INSPECTOR TOOLS:

            I.  COMPREHENSIVE GUIDE

            II. ONLINE TUTORIAL [additional login required]

D. HOW TOs:

            I. DOWNLOAD THE FACTWeb INSPECTOR WEBINAR   


 I. QUICK REFERENCE GUIDE: INTRODUCTION  

This guide provides quick references for conducting FACT inspections in the FACTWeb accreditation portal. Inspectors must familiarize themselves with this online system in order to maintain the thoroughness and consistency of FACT inspections. Elements to be verified are based on the FACT Standards, and inspectors are responsible for assessing each requirement, documenting their findings, and generating a detailed report.  

II.  ACCESSING THE COMPLIANCE APPLICATION

 1. Directly access FACTWeb by visiting www.factweb.org and logging in with your username and password.
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 The inspector submenucontains the following menu items:

  • Current Inspections: List of the inspector’s upcoming inspections (and the organizations’ current applications).
  • Evaluation Forms: Link to a webpage containing evaluation forms for providing feedback regarding the on-site inspection.
  • Inspector Tools: Resources for inspectors, such as guides and examples.
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 2. Select “Current Inspections” to access the Inspection Dashboard and view the applications for upcoming inspections.

KEY INSPECTION DASHBOARD COLUMNS:

  • Application: Select link to access the application to review. The link’s name will reflect the type of application (CT Clinical Program, CT Collection Facility, CT Processing Facility, or Cord Blood Bank) and will take the user to the checklists.
  • Inspection Report: Select the link to access the inspection report form that details the observations from the on-site inspection. This column also displays the due date of the finished report.  
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III. REVIEWING THE COMPLIANCE APPLICATION

1. Select the appropriate link under “Application” on the Inspection Dashboard. A set of tabs will allow you to view various aspects of the application. This view also provides a link to the Inspection Report. 
2. Select the Application tab to access the checklists.  
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3. Select the assigned checklist to review that specific site’s pre-inspection submission. Initially all statuses appear as ‘Reviewed’, showing that they have been reviewed by the FACT Office. The inspector’s responsibility is to mark them ‘Compliant’ or ‘Not Compliant’ following the on-site inspection.
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4. Review the application by using the Help6 symbol to expand the standards and view the details of the checklist.
5. Open each standard from the checklist by clicking on the text of the standard and view all of the applicant’s responses (including answers to the compliance questions and uploaded documents). Use the Help7 button to quickly navigate the checklist.
6. If compliance can be verified solely by the pre-inspection documentation, inspectors may mark the standard as compliant or not compliant at this time.
7. To make a note in the system that should not be included on the inspection report, click ‘Review Notes’.

IV. ENTERING INSPECTION FINDINGS

Inspectors may enter their findings into the Compliance Application during the inspection or immediately afterwards. The FACT Accreditation Coordinator at the FACT office provides inspectors the checklists in a printable Excel file for use throughout the inspection day to make handwritten notes. Inspectors may export the checklists themselves by accessing the applicable checklist (see Chapter III) and selecting ‘Export to Excel’. 
1. Access the Inspector Quick View by clicking ‘Review this Part’ on the checklist.
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The Inspector Quick View allows entire parts (for example, Part B) or individual sections (for example, Section B1) to be marked compliant with one click. 
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2. Mark either an entire part or individual section as compliant. Note: If any standards in a section are already marked non-compliant, the system will not allow that section to be marked compliant. For those sections, compliance will have to be indicated for each individual standard.
3. Use notes written throughout the inspection to mark the ‘Not Compliant’ standards.
4. When a standard is marked as “Not Compliant”, a dialogue box appears requiring inspectors to describe the deficiency. These notes will populate the Inspection Report. Select ‘Update Note’ to save the entry. Note: If ‘Update Note’ is not selected, the note will be lost.
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5. To enter a suggestion, select the purple button 'Suggestions'. Enter the suggestion in the dialogue box and click 'Update Suggestion'.  This information will appear on the inspection report as a suggestion.

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V. COMPLETING THE INSPECTION REPORT

An inspection report is automatically generated using data from the Compliance Application. The inspector will need to enter some additional information for certain sections of the report as described below.

1. Access the inspection report through one of the following pages:

  • Inspector Dashboard - see Chapter II, step 2.
  • Standard – by Standard View – see Chapter III, step 4.
  • Inspector Quick View – see Chaper IV, step 1. 
2. Review and edit the following sections of the report:
  • Description of Organization: This section is pre-populated with descriptions entered by the FACT Accreditation Coordinator. Inspectors should review this information following the on-site inspection for accuracy. Make corrections and add other pertinent information as necessary by selecting the blue ‘Edit’ button below the area. Save your edits by selecting the ‘Save’ menu button.
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  • Inspectors’ Overall Impression: Enter the overall impression of the applicant organization. by selecting the blue ‘Edit’ button below the window. Save your edits by selecting the ‘Save’ menu button.  
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  • Inspection Notes: Review citations, variances, and suggestions, which are automatically populated in the report based on data in the Compliance Application. Follow the steps below to make edits in the Compliance Application. Edits are also automatically made to the inspection report.
  • Citations and Variances: This area is automatically populated based on the standards marked “Not Compliant” in the Compliance Application. To edit the description of the deficiency, or to remove the citation or variance, select the standard number. This will open the Compliance Application for that standard and allow the information to be edited.
  • Suggestions: To edit the suggestion, select the hyperlink ‘Suggestion:’ which opens the standard that contains the suggestion. Edit the text in the 'Suggestions' dialogue box and select ‘Update Suggestions’. To remove the suggestion, delete the text in the Suggestions dialogue box.

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  • File Attachments: Upload files to the inspection report as required, such as the data management form completed by the clinical inspector. To upload the data management form required for the clinical inspections, download the form from the compliance application in B9, complete it and then upload it in the inspection report.

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Inspector Signatures: Type your name in the signature box to sign the report electronically. Each inspector must sign the inspection report online as soon as his/her part is completed. The inspection team leader will be notified via email when the team members sign the inspection report. Once all reports are signed, the team leader reviews the final report and submits it to the FACT office.

All standards have to be marked as ‘Compliant’ or ‘Not Compliant’ for the inspector team leader to be able to submit the inspection report to FACT. If a standard is not marked accordingly, the following message will be displayed on the screen:

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STATUS CHECK: STATUS VIEW
Inspectors may quickly check which Standards are not marked ‘Compliant’ or ‘Not Compliant’ using the Status View.
Access the Status View by clicking on the link on the checklist page (see Chapter III). Filters based on the standard statuses are on the right side of the status view screen to allow inspectors to sort standards and access various types of information. 
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VI. USING FACTWEB FOR TRAINING INSPECTIONS

Trainee inspectors attend on-site inspections to observe how an inspection is performed, how to request and review information, and how to interview facility staff. During the inspection, the trainee completes the applicable inspection checklist and describes the deficiency for each standard cited.

The training inspection is facilitated in FACTWeb. Trainee inspectors are able to view all information entered by the applicant and active inspection team. To keep the trainee’s practice checklist and report separate from the actual inspection findings, he/she completes an exported version of the applicable checklist and writes the report in a separate document.
Note: Trainee inspectors should not mark standards as compliant or not compliant in the Compliance Application, but observe the active inspectors perform this step. Indicating noncompliance with a standard should be achieved using the exported checklist.

1. Export the applicable checklist to Excel (see Chapter IV). Format the checklist to the preferred layout (for example, make the column titled “Comment” wider and delete standards not applicable to the training inspection).  

2. Prepare for the inspection by reviewing the applicant’s documentation and FACT’s review notes in advance.  

3. During the inspection, note on the exported checklist which standards are compliant or not compliant.  

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4. Clinical trainee inspectors: download the data management form uploaded by the applicant for Cellular Therapy Standard B9.1. Using the applicant’s data, complete the inspector portion. 

5. During or after the inspection, write a clear description of the deficiency for each standard that is cited. The trainee inspector may choose to do this within the exported checklist or on a separate document. The description must be typed and clearly state the inspector’s findings and demonstrate the trainee understands the type of information that must be submitted in the Inspection Report Notes dialogue box.

6. Send the completed checklist and, if applicable, the data management form (clinical trainee inspectors only) to the mentor for review.

MENTOR RESPONSIBILITY: 
  
7. After the mentor reviews the trainee inspector’s checklist and descriptions of deficiencies, and the data management form if applicable, he/she uploads the file(s) to the inspection report.
Note: The mentor must submit the inspection report only after he/she receives the trainee inspector’s file(s).  

VII. TROUBLESHOOTING

PROBLEM SOLUTION
Slow Speed.
  • Use the Chrome browser with FACTWeb. Chrome is free to download at http://www.google.com/chrome.
  • The application’s performance speed is 5 to 8 seconds for loading pages. If you encounter slower performance, please contact FACT at 402.559.1950.
Unable to sign the inspection report.
  • Verify that all standards are marked either ‘Compliant’ or ‘Not Compliant’.
  • Check the inspector report due date. If the due date has passed, contact your FACT Accreditation Coordinator.
Need Further Assistance?

If you have additional questions or need further assistance, contact FACT at:

  • Telephone: 402.559.1950
  • Your FACT Accreditation Coordinator
  • ASK FACT button on the FACT website:
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