August 2009

Minnesota Patient Safety RegistryUser’s Guide

Table of Contents

I. Logging In II. Managing Personal User Information III. Correspondence IV. Managing Hospital/System User Information — Administrative User

(Admin User) OnlyV. What to Report VI. When to Report

VII. How to Bill for Reported Events VIII. How to Report an Event — Cycle Step I : Enter Initial Event Information

IX. How to Report an Event — Cycle Step II : Preparation:X. How to Report an Event — Cycle Step III : RCA/CAP/MOSXI. Review Process

XII. Accessing Event to View Comments XIII. Viewing Comments XIV. Editing an Event in Response to Comments XV. Resubmitting Event for Next Review

XVI. Viewing, Editing and Resubmitting for Subsequent Cycles XVII. Completed Events

XVIII. Measure of Success (MOS) XIX. Event Tracking XX. Data Share Reports

Logging In

On the Minnesota Patient Safety Registry Home Page, enter user name and password.

FAQ: What if I forgot my password?What if I forgot my user name?What if I forgot the Web site 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.

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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.”

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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:

o Password Change: notification that personal password has been changed.

o Data Share Submission – new RCA/CAP is 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.)

o MOS due in 30 days (3 month): reminder that the measure of success for an event is due in 30 days. (Admin user only.)

o 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.”

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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.”

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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.”o Select user roles.o Input user information.o Assign facilities to user.o Click “Create User.”o Provide new user with user

name, password and registry web site address.

o Options for providing access information to user: Click “Create User.”

Within the window displaying the user name 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.

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What to Report

Minnesota Adverse Health Care Events Reporting Act

Under the Minnesota Adverse Health Care Events Reporting Act of 2003 and 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: http://www.mnhospitals.org/inc/data/docs/AHE-clarifications-June2009.doc

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?o 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

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Cycle Step I: Enter Initial Event Information

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

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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.

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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:o Triggering Triage Questionso Registry Screenshotso MDH Review Processo MDH Review Criteriao Hierarchy of Corrective Actionso RCA Action Plan Templateo 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.

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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.

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Step III A: General Information

At the top of the Event Detail Report, click on Step III A: 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.

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Step III B / III C*: RCA/CAP/MOS

1. 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.

2. 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.

* (For events with Best Practice questions, the RCA/CAP/MOS step is IIIC; for all other events the RCA/CAP/MOS step is IIIB.)

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

the State.o Edit or delete the corrective action plan information.

3. Add a New Corrective Action Plano Click on “Add” another Corrective Action Plan for this Root Cause. o Complete each field by choosing from the drop-down menu or entering

information in the text boxes. o 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.

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4. Add New Root Cause Finding or Contributing Factoro Click on “Add” New Root

Cause or Contributing Factor.

o Follow the instructions at the top of the page for selecting a root cause or contributing factor category.

o To select root cause or contributing factor, click on the box next to the correct selection.

o Select the category by clicking on the circle next to the appropriate root cause category.

o Type the findings in the text box below the categories.

o Select “next” to save the information and move to the next section.

5. Submit the RCA/CAP to the Stateo Click on “Return” to Event Detail Report to Submit.o 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.

6. Edit or delete the corrective action plan information

Review Process

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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 event comments can be accessed in two ways:1. Place cursor over “Events.”

Click on “All Events.” Select the event. There are a number of

options for locating the event:a) Change the reporting

year at the top of the report page;

b) Click on the type of event at the top of the report page; or

c) Sort by Facility Name, Facility ID, Event Date or Event Type by clicking on the column headings

2. Place the cursor over “Events.”

Click on “Events By Status.” Click on the fourth tab “Has Comments.”

Viewing Comments

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Click on “View” to access the comments. Only elements that did not meet the review criteria will be listed. For each element listed, click on the + symbol once to view the review specific

criteria element that was not met. Click on the next + symbol to view the data that was submitted and the comments from Stratis Health.

To view previous responses and comments for the review element, click on the third level of + symbol to view the comment history. The comment history will display previous responses and comments.

Editing Event in Response to Comments

Click on “Edit.” The review criteria will

be listed, followed by the MDH comment at the top of the edit box.

The information submitted by the facility will be shown in the edit box. This information can be edited as appropriate within the edit box to provide the information necessary to meet the criteria element.

Click “Update” to save the edited information.Resubmit Event for Next Review

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When all edits have been completed, the event can be re-submitted to the State under the 3rd bullet point at the top of the page: “To re-submit the event, click HERE to return to the event detail and re-submit under cycle step IV.”

Viewing, Editing and Resubmitting for Subsequent Cycles

When notification is received that a subsequent review has been completed and comments added, follow the steps above for viewing comments, editing the event and re-submission.

Completed Events

When the event has met all of the review criteria, the Admin User will receive an automated notification that the event is complete.

Measure of Success (MOS)

If the event is not excluded from the required Measure of Success (MOS), the event MOS needs to be completed within three months of the implementation date that was entered for the corrective action selected as the Measure of Success.

Admin Users will be notified 30 days and 7 days before the MOS is due. Admin Users have the option of “opting out” of the 30-day notification.

Entering MOS information (PDF)

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Place cursor over “Events.” Click on “Events By Status.” Locate event by selecting the fifth tab

“MOS Due.” Click on “Details” next to the event. At the top of the Event Detail Report

click on “RCA/CAP/MOS.” On the Summary Report, click on the

red X on the MOS line. Under the “Measure of Success” tab,

enter “Actual Performance Achieved” in the text box.

Compare to “Threshold” field.

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o If MOS is met or exceeded: Select “Yes” for “MOS Threshold met at 3 months?” Event is complete.

o If MOS is not met: Select “No” for “MOS Threshold met at 3 months?” and submit information

in the “barriers” field and “What change will be made to meet the threshold at 6 months.”

o Select “Update” to save the information.o Return to the MOS prior to the 6-month deadline and complete the “MOS

Threshold met at 6 months?” and, if no, “What were the barriers?”o Select “Update” to save the information.o If the MOS Threshold is met, the event is complete.o If the MOS Threshold is not met, this will trigger follow-up by MDH.

Event Tracking

The event tracking view can be used to find events by stages of completion or to monitor events that need action by the facility.

Accessing the Tracking View Place cursor over “Events.” Click on “Events By Status.” Select the appropriate tab to view the events within an event cycle stage. Click on “Detail” next to events to view the full Event Detail Report.

Data Share Reports

A number of reports based on the Data Share data are available for review and use by registry users from hospitals participating in the Data Share system. To access the reports:

Place cursor over “Data Share” at the top of the registry page. Select the report:

o All Shared Events — access to all of the Data Share event reports Events can be filtered by:

– Selecting reporting year;– Selecting event categories at the top of the page; or– Clicking on the column headers to sort the data.

Click on “View” to access the event details.

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o Custom Reports — create queries for customized reports Show Customization Window option can be used to change the field

included in the report or filter reports.– Click on “Show Customization Window.” – Fields that appear in the customization window can be added to the

report by clicking on the field and dragging over to the report columns.

– Fields can also be removed from the report by dragging them back to the customization window.

– Filter the report by clicking on the arrow in any of the columns and selecting the field options. Multiple fields can be used to filter. For example: Click on “Event Type” and select “Environmental – Falls” and then click on “Injury Severity” and select “Serious Disability.”

To save a created report: click on “Save a Report;” enter a report name; click on “Save Report.”

To access or deleted saved reports: click on “Saved Reports;” select or delete report.

To export a created report: click on “Export to pdf” or “Export to XLS.” Advanced queries can be created by using the “filter control” at the bottom

of the report. This query method is a common querying tool familiar to staff trained in data analysis.– Create the report using the filtering method described above. – Select data ranges for the report by:

o Clicking on “Create Filter.”

o Click on the + sign to display new options

o Click on the first link and select “Event Date” from the drop down options.

o Click on the middle link to select “>” or “=” etc.

o Click on the third link to display the calendar and select the first date of the report date range.

o To select the end date for the report date range, click on “And” and select “and” from the drop-down options.

o Click on the + sign to display new optionso Click on the first link and select “Event Date” from the drop down

options.o Click on the middle link to select “<” or “=” etc.

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o Click on the third link to display the calendar and select the last date of the report date range.

– Select OK– Save the create report by click on “Save a Report,” typing in the

report name, and clicking on “Save Report.”

o Facility Reports — customized facility reports can be created. To create customized facility reports:

Place cursor over “Events.” Click on “Custom Reports.” Follow the steps outlined above under Data Share Reports —

Custom Reports to create facility level reports.

o Trends by Event Type — track event trends across the reporting year. Select a report year by clicking the drop-down. Filter the “Adverse Event Type” by clicking the drop-down and

selecting specific types. Filter the “Year” or “Month” by clicking the drop-down and

selecting specific dates.

o Trends by Category — track root cause analysis category trends across the reporting year.

Select a report year by clicking the drop-down. Filter the “Category” by clicking the drop-down and selecting

specific types. Filter the “Year” or “Month” by clicking the drop-down and

selecting specific dates.

o Key Learnings — access data analysis summary reports Click on the +symbol to expand the Report Year. Filter on individual fields using the tools located on each column

header. Use the ‘Filter Control’ at the bottom of the report to build a custom

query.

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Frequently Asked Questions (FAQs)

What if I forgot my password?o From the log-in page of the registry, click on “forgot your password?”o Follow the instructions to receive a temporary password.

What if I forgot my user name?o If you do not have your user name, you will not be able to reset your password.o Contact your Admin User for assistance.o If you do not know who your Admin User is, contact the Minnesota Hospital

Association.

What if I forgot the Web site address?o Contact your Admin User for assistance.

Where do I go to enter my root cause analysis?o See Cycle III: RCA/CAP/MOS.

Where do I go to enter my corrective action plan?o See Corrective Action Plan.

Where do I go to report on my measure of success?o See Measure of Success.

What is a Measure of Success (MOS)o The MOS is a measure that demonstrates whether the correction action plan was

successfully implemented. If the MOS Threshold measure is met, the MOS is considered to be complete.

Who do I contact for questions regarding:o Access information for the Registry

Contact your Admin User. This will typically be the person who initially set up your user name and password.

If you do not know who your Admin User is, contact the Minnesota Hospital Association.

o Event reviews/comments added Stratis Health

o Conducting a root cause analysis Stratis Health, MDH or MHA

o Whether or not an event is reportable as a Serious Reportable Event MDH; MHA

Contact:

Minnesota Hospital Association (MHA)

Minnesota Department of Health (MDH) Stratis Health, Inc.

Julie Apold(651) 603-3538

japold@mnhospitals.org

Diane Rydrych(651) 201-3564

diane.rydrych@state.mn.us

Kate Peterson(952) 853-8501

kpeterson@stratishealth.org

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