VIII.How to Report an Event Cycle Step I: Enter Initial Event Information

August 2009
Minnesota Patient Safety Registry
User’s Guide
Table of Contents

Logging In
Managing Personal User Information
Correspondence
Managing Hospital/System User Information — Administrative User
(Admin User) Only
What to Report
When to Report
How to Bill for Reported Events

VIII.How to Report an Event — Cycle Step I: Enter Initial Event Information

How to Report an Event — Cycle Step II: Preparation:
How to Report an Event — Cycle Step III: RCA/CAP/MOS
Review Process
Accessing Event to View Comments
Viewing Comments
Editing an Event in Response to Comments
Resubmitting Event for Next Review
Viewing, Editing and Resubmitting for Subsequent Cycles
Completed Events
Measure of Success (MOS)
Event Tracking
Data Share Reports

Logging In
On the Minnesota Patient Safety Registry Home Page, enter username and password.
FAQ:What if I forgot my password?
What if I forgot my username?
What if I forgot the Website
address? /
Managing Personal User Information
Each facility will have a designated Facility Administrative User (Admin User). The Admin User will be responsible for assigning users and user roles for their organization.
There are a number of registry user roles that can be assigned:

Event Reader: User has access to read event information for their assigned facility.
Event Writer: User has access to submit and edit event information for their assigned facility.
Data Share Reader: User has access to read de-identified event information and data sharing reports from other data share facilities — facility must be a data sharing facility.
Facility Admin: User receives automated event correspondence for facility events; manages facility/system users.

The Admin User will assign new users for their facility/system and will assign their designated role(s). Assigning the user will generate a user name and temporary password which the Admin User will communicate to the new user.
The user will use the temporary password to access the registry. When the user accesses the registry, they will be asked to create a secret word and reset their password.
Change Password

Place cursor over “User” and select “User Options.”
Select the “Change Password” tab.
Type in current password.
Type in new password (note password criteria).
Confirm new password.
Select “Change Password.”

/
Update Profile

Place cursor over “User” and select “User Options.”
Select the “Change Profile” tab.

Edit necessary profile information.
Select “Change Profile.”

Correspondence

Place cursor over “User” and select “User Options.”
Select the “Correspondence” tab.
To receive any of the automated email reminders, select from the email options:
Password Change: notification that personal password has been changed.
Data Share Submission – newRCA/CAPis available for review: notification that a data share user has submitted a new root cause analysis and corrective action plan that is available for review by data sharing hospitals. (Data Share user only.)
MOS due in 30 days (3 month): reminder that the measure of success for an event is due in 30 days. (Admin user only.)
MOS due in 60 days (6 month): reminder that the measure of success for an event that has not met the measure of success at
3 months is due in 30 days. (Admin user only.)
Select “Update Correspondence.”

Managing Hospital/System User Information — (Admin User Only)
Admin Users are responsible for managing users within their facility (or system, if serving as Admin User for multiple facilities).
Viewing Users

Place your cursor over “User” to see the three options: “User Options; Manage Users; Add User.”
Select “Manage Users.”
A list of all facility users will be displayed.

Click on “View” next to user’s name to display user information detail.

Unlocking Users
Five incorrect attempts to access the registry will lock the user out of the registry.
To unlock the user:

Click on “View” next to user’s name to display user information detail.
Click on “Edit User Info.”
If the user is “locked-out” of the registry, a check will be displayed next to “Is Locked Out.”
Click on “Unlock User.”
Confirm “OK.”

Deleting Users – Option A
Click on “View” next to user’s name to display user information detail.

Click on “Delete User” button.
Confirm “OK.”

Deleting Users – Option B
From the “Manage Users” Window:

Click on “Delete” next to the user to be deleted.
Confirm “OK.”

Adding Users
Place your cursor over “User” to see the three options: “User Options; Manage Users; Add User.”

Select “Add User.”
Select user roles.
Input user information.
Assign facilities to user.
Click “Create User.”
Provide new user with user name, password and registry website address.
Options for providing access information to user:
Click “Create User.” Within the window displaying the username and password, click “Print/Export User Info.” This will create a document that is auto-populated with the user information and can be sent to the user in different forms:

1) Click on the printer icon at the top of the page to print the document and fax to the user;
2) Click on the disc icon to save the document, edit if necessary, and attach to an email to the user.

Call the user and provide access information via telephone.

What to Report

Minnesota Adverse Health Care Events Reporting Act

Under the Minnesota Adverse Health Care Events Reporting Act of 2003and 2007 revision, Minnesota hospitals, ambulatory surgical centers, behavioral health centers and boards of practice must report to the state the occurrence of any of 28 adverse health events as defined by the National Quality Forum Serious Reportable Events.

Reporting Definition Recommendations and Guidance

The MHA Patient Safety Registry Advisory Council works with the Department of Health on addressing questions about definitions related to the adverse health event reporting law. The purpose of these recommendations is to create more accurate and consistent reporting across organizations:

When to Report

The initial event information must be reported to the State through the web-based registry within 15 working days of the event discovery date.
The findings from the root cause analysis conducted by the organization along with a corresponding corrective action plan must be reported within 60 calendar days of the event discovery date.
What is the discovery date?
The discovery date is the date the organization first becomes aware of the occurrence of a reportable event. Example: a sponge is retained during a procedure (event date) but is not discovered until the patient returns to the emergency department two days later (discovery date).

How to Bill for Reportable Events

Minnesota has a voluntary agreement to not bill for care made necessary by a preventable Serious Reportable Adverse Health Care Event. Minnesota hospitals and payers have worked together to develop recommendations and guidance for implementing the Serious Reportable AHE Billing Policy: [PDF].

How to Report an Event

Reporting of the event information is categorized into four different Cycle Steps within the registry:

Cycle Step I: Initial Event Information
Cycle Step II: Preparation
Cycle Step III: Root Cause Analysis (RCA)/Correction Action Plan (CAP)/Measure of Success (MOS)
Cycle Step IV: Submission

Cycle Step I: Enter Initial Event Information

Log-in to site using assigned user name and password.

Forgot username or password?

Place cursor over “Events” to view options “All Events;” “Events by Status;” and “Add Event.”
Click on “Add Event.”
Select the event category from the drop-down box.

.
Tip: Additional guidance on determining reportability can be found in the Recommendations/Guidance document. Click on the link found in this section of the registry or in the “Resources” tab to access this document.

Click “Continue.”
Complete the initial event information.

The initial event information is comprised of a combination of drop-down menus and text boxes.

To complete a field with a drop-down menu, click on the arrow for that field, and click on the appropriate selection.
To complete a text box, type in the information. There are a number of formatting tools available for each text box, e.g., bold, font size and bullets.

Note: All of the fields in this initial information form are required to be completed. The information won’t be saved until all fields are complete.
When all of the fields have been completed, click on “Update.” This will save the information and will generate an automated notification to the State that a new event has been submitted. This submission must be completed within 15 working days from the event discovery date.
Note: The registry will time-out after 60 minutes with no activity. If you do not complete the required fields and save the event information, the information that you have entered will be lost after 60 minutes of no activity.

Cycle II: Preparation

When the event is submitted, the registry will bring the user to the Event Detail Report page. The Event Detail Report will build the event report as information is entered.
Note: Submitting the initial event information automatically generates a root cause analysis (RCA) due date. The RCA due date can be found on the Event Detail Report page in red below the Event Discovery Date.

There are a number of tools available to prepare for the root cause analysis investigation of this event. The tools can be accessed by clicking on the links under “II. Prepare” section at the top of the page.

Registry Literature— the articles and resources that have been consulted by other organizations submitting events in the category are available for review.
MDH AHE Criteria— the criteria that Stratis Health uses to review each submitted event. Each event must meet all of the MDH AHE Criteria to be considered a completed event by the State.
RCA/CAP Tools:
TriggeringTriage Questions
Registry Screenshots
MDH Review Process
MDH Review Criteria
Hierarchy of Corrective Actions
RCA Action Plan Template
Best Practice Questions — the questions that will need to be completed if the event is under the pressure ulcer, wrong body part, wrong patient, wrong procedure or falls categories.

Tip: Print the Best Practice Questions as a guide in conducting a review of the event and medical record. This information may be useful during the root cause analysis team discussion. Best Practice Questions are available for pressure ulcer, falls and wrong site, procedure and patient events.

Cycle III: RCA/CAP/MOS

The root cause analysis (RCA) and corrective action plan (CAP) need to be submitted within 60 calendar days from the event discovery date.

Accessing the event to add RCA CAP information:

After logging-in to the registry, place cursor over “Events” to view options “All Events;” “Events by Status;” and “Add Event.”
Click on “Events by Status.”
Click on the first tab “In Progress.”
Find the event from the list and click on “Details” next to the event.

Tip: To quickly locate an event, use the sorting tools at the top of the table; sort by: facility (if reporting for a system); facility ID; discovery date; or event type. To use this sorting function either click on the drop-down arrow next to the heading at the top of the column or type the information in the text boxes located beneath the column heading.

Step III A: General Information

At the top of the Event Detail Report, click on
Step IIIA: General Information.
Enter information in the first text box “Information consulted such as clinical literature/other published guidelines.”
Complete the next text box “RCA/CAP Team Members (list by position NOT name).”
Click on “update” to save this information and move to the next step.

Tip: Each of the text boxes can be formatted, e.g., bullets, font size, bolding, by using the icons at the top of each text box.

Step III B: Best Practices

For pressure ulcer, fall, wrong body part, wrong patient or wrong procedure events,
Step III B will be the next screen that needs to be completed. Indicate the correct response to each question by clicking on the response for Yes/No/NA questions, selecting from drop-down lists or typing in responses for text fields as required.
Click on “Update” to save this information and move to the next step.

Step IIIB/IIIC[*]: RCA/CAP/MOS

Root Cause

Follow the instructions at the top of the page for selecting a root cause category, contributing factor category or documenting a finding of “no root cause.”
To select root cause or contributing factor, click on the icon next to the correct selection.
Select the category by clicking on the circle next to the appropriate root cause category.
Type the root cause finding in the text box below the root cause categories.
Select “next” to save the information and move to the next section.

Tip 1: Additional root causes or contributing factors can be entered after all of the information is complete for the current root cause/contributing factor.

Tip 2: For a description of a root cause category, click on the “Definition” help button next to the category.

Tip 3: For questions that can be used to determine if an event finding fits within a particular category, click on the “Questions” help button.

Corrective Action Plan

Follow the instructions at the top of the page for completing the corrective action plan information.
Complete each field by choosing from the drop-down menu or entering information in the text boxes.
All fields are required to be completed. The information on this page cannot be saved until all fields are complete.
When all fields are complete, click on “Update” to save the information and move to the next section.

Note: Each event must have a measure of success (MOS). Exception: Pressure ulcer events do not need a MOS. If you are reporting a pressure ulcer event, select “NO” for the MOS question.

Note: The majority of MOS thresholds should be at or above 90%. If a threshold below 90% is selected, you will be asked to provide a short explanation for the lower threshold, e.g., this is a longer-term action plan that will be implemented over the next year with quarterly thresholds.

The next screen can be used to:

Add a new corrective action plan.
Add another root cause finding or contributing factor.
Return to the Event Summary Report to submit the RCA/CAP information to the State.
Edit or delete the corrective action plan information.

Add a New Corrective Action Plan
Click on “Add”another Corrective Action Plan for this Root Cause.
Complete each field by choosing from the drop-down menu or entering information in the text boxes.
Click on “Update” to save the information.

Tip: Only one MOS can be selected per event. If a new corrective action is added, determine which corrective action should be selected as the MOS.If “Yes” is selected for the field “This is the selected MOS for this Root Cause,” that corrective action plan will become the MOS for that event.

Add NewRoot Cause Finding or Contributing Factor
Click on “Add”NewRoot Cause or Contributing Factor.
Follow the instructions at the top of the page for selecting a root cause or contributing factor category.
To select root cause or contributing factor, click on the box next to the correct selection.
Select the category by clicking on the circle next to the appropriate root cause category.
Type the findings in the text box below the categories.
Select “next” to save the information and move to the next section.

Submit the RCA/CAP to the State
Click on “Return” to Event Detail Report to Submit.
Under Cycle Step IV: Submission, click on “Submit Event.”

Tip: When submitting the event, if an error message appears “The Event is not complete and cannot be submitted. Click here to resolve missing information,”follow the link to the Summary Report and complete information indicated as incomplete.

Edit or delete the corrective action plan information

Review Process

When the RCA/CAP information is submitted, Stratis Health will receive an automated notification. This notification signals Stratis Health to begin their event review process (see PDF). Stratis Health will review the submitted event against established criteria (see PDF) to determine if the event information meets all of the elements.

Editing Event Information

Within 30 days, Stratis Health will complete their review process. When the review process is complete, the Admin User for the facility that submitted the event will receive an automated notification that “comments have been added” for that event.

Accessing Event to View Comments

The eventcomments can be accessed in two ways: