29_Attachment_J-19__IHIGlobalTriggerToolWhitePaper2009.pdf

IHI Global Trigger Tool for Measuring Adverse Events Second Edition

Innovation Series 2009

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Copyright © 2009 Institute for Healthcare Improvement

All rights reserved. Individuals may photocopy these materials for educational, not-for-profit uses, provided that the contents are not altered in any way and that proper attribution is given to IHI as the source of the content. These materials may not be reproduced for commercial, for-profit use in any form or by any means, or republished under any circumstances, without the written permission of the Institute for Healthcare Improvement.

The name “Global Trigger Tool” is a common law trademark of the Institute for Healthcare Improvement.

How to cite this paper:

Griffin FA, Resar RK. IHI Global Trigger Tool for Measuring Adverse Events (Second Edition). IHI Innovation Series white paper. Cambridge, Massachusetts: Institute for Healthcare Improvement; 2009.

(Available on www.IHI.org)

Acknowledgements:

The Institute for Healthcare Improvement (IHI) would like to thank the following individuals for their contributions to the work:

David Classen, MD, MS, Senior Partner and Chief Medical Officer, Computer Sciences Corporation Frank A. Federico, RPh, Executive Director, Strategic Partners, IHI Carol Haraden, PhD, Vice President, IHI Terri Simmonds, RN, IHI Faculty John Whittington, MD, IHI Senior Faculty Lee Adler, DO, Vice President, Safety and Quality Innovation and Research, Florida Hospitals/Adventist Health Systems Nancy L. Kimmel, RPh, SSBB, Missouri Baptist Medical Center Margie McKeever, RN, BS, Project Manager, Florida Hospital

IHI also thanks staff members Jane Roessner, PhD, and Val Weber for their editorial review and assistance with this paper.

For reprint requests, please contact:

Institute for Healthcare Improvement, 20 University Road, 7th Floor, Cambridge, MA 02138 Telephone (617) 301-4800, or visit our website at www.ihi.org

The Institute for Healthcare Improvement (IHI) is a not-for-profit organization leading the improvement of health care throughout the world. IHI helps accelerate change by cultivating promising concepts for improving patient care and turning those ideas into action. Thousands of health care providers participate in IHI’s groundbreaking work.

We have developed IHI's Innovation Series white papers as one means for advancing our mission.

The ideas and findings in these white papers represent innovative work by IHI and organizations with whom we collaborate. Our white papers are designed to share the problems IHI is working to address, the ideas we are developing and testing to help organizations make breakthrough improvements, and early results where they exist.

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IHI Global Trigger Tool for Measuring Adverse Events Second Edition

Innovation Series 2009

Authors:

Frances A. Griffin, RRT, MPA: Director, IHI Roger K. Resar, MD: Senior Fellow, IHI

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Innovation Series: IHI Global Trigger Tool for Measuring Adverse Events (Second Edition)1

Executive Summary

Traditional efforts to detect adverse events have focused on voluntary reporting and tracking of errors. However, public health researchers have established that only 10 to 20 percent of errors are ever reported and, of those, 90 to 95 percent cause no harm to patients. Hospitals need a more effective way to identify events that do cause harm to patients in order to quantify the degree and severity of harm, and to select and test changes to reduce harm.

The IHI Global Trigger Tool for Measuring Adverse Events provides an easy-to-use method for accurately identifying adverse events (harm) and measuring the rate of adverse events over time.

Tracking adverse events over time is a useful way to tell if changes being made are improving the safety of the care processes. The Trigger Tool methodology is a retrospective review of a random sample of inpatient hospital records using “triggers” (or clues) to identify possible adverse events.

Many hospitals have used this tool to identify adverse events, to assess the level of harm from each adverse event, and to determine whether adverse events are reduced over time as a result of improvement efforts. It is important to note, however, that the IHI Global Trigger Tool is not meant to identify every single adverse event in an inpatient record. The methodology, recommended time limit for review, and random selection of records are designed to produce a sampling approach that is sufficient to determine harm rates and observe improvement over time.

The Institute for Healthcare Improvement (IHI) formed the Idealized Design of the Medication System (IDMS) Group in May 2000. This group of 30 physicians, pharmacists, nurses, statisticians, and other professionals established an aim to design a medication system that is safer by a factor of 10 and more cost effective than systems currently in use. The Trigger Tool for Measuring Adverse Drug Events was initially developed by this group to assess progress on this safety goal and provided the basis for development of subsequent Trigger Tools.

This white paper is designed to provide comprehensive information on the development and methodology of the IHI Global Trigger Tool, with step-by-step instructions for using the tool to measure adverse events in a hospital.

© 2009 Institute for Healthcare Improvement

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Foreword to Second Edition

Since its development in late 2003, use of the IHI Global Trigger Tool has spread from collaborative projects to large-scale improvement efforts, including IHI’s 5 Million Lives Campaign. The IHI Global Trigger Tool has become a tool that hundreds of hospitals in multiple countries now use to monitor adverse event rates while working to improve patient safety. In 2008, the US Department of Health and Human Services Office of Inspector General completed a pilot study to measure adverse events in Medicare beneficiaries and used the IHI Global Trigger Tool as one method of detection.1 This extensive use of the IHI Global Trigger Tool has provided the opportunity to collect feedback from those using the tool and identify opportunities to clarify definitions and update material.

This Second Edition of the IHI Global Trigger Tool for Measuring Adverse Events white paper contains no substantive changes to the overall methodology or process for review. Clarifications have been made to some text and trigger definitions. References have been added based on recent publications related to Trigger Tools. Experienced reviewers will note that there are changes to the list of triggers. A number of triggers have been removed, particularly in the Surgical module, as these triggers were found over time to not be very useful. The development of a Perinatal Trigger Tool provided the opportunity to update the Perinatal module with additional triggers that will be useful to identify possible adverse events.

Changes to the triggers in the Second Edition will not affect data for organizations that have been using the prior version of the IHI Global Trigger Tool because triggers are not measured; only adverse events are measured. Organizations with months or years of adverse event data from IHI Global Trigger Tool reviews can continue to conduct reviews using the modified trigger list and incorporate the results into the same data set. The triggers listed in the IHI Global Trigger Tool are recommendations only and organizations are encouraged to modify them as needed.

© 2009 Institute for Healthcare Improvement

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© 2009 Institute for Healthcare Improvement

Table of Contents

I. Background A. History B. Harm versus Error C. Definition of an Adverse Event D. Commission versus Omission E. Preventability F. Severity Ratings G. Trigger Selection

II. Rules and Methods A. Review Team B. Sampling Patient Records C. Review Process D. Determination of an Adverse Event E. Data Collection

III. Triggers and Definitions A. Cares Module Triggers B. Medication Module Triggers C. Surgical Module Triggers D. Intensive Care Module Triggers E. Perinatal Module Triggers F. Emergency Department Module Triggers

IV. Training A. General Considerations B. Read the IHI Global Trigger Tool White Paper C. Phase 1: Training Records D. Phase 2: Practice Review

V. Tips for Leadership VI. Stories from Experienced Organizations

A. Florida Hospital B. Mayo Clinic C. OSF Healthcare System D. Tayside Healthcare System (Scotland) E. Missouri Baptist Medical Center

VII. Frequently Asked Questions VIII. Conclusion IX. Appendices

A. References B. IHI Global Trigger Tool Worksheet C. IHI Global Trigger Tool Review Summary Sheet D. Answers to Training Records for IHI Global Trigger Tool

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I. Background

A. History

Conventional attempts to quantify adverse events have included voluntary incident reports, retrospective or concurrent record reviews (sometimes supplemented by “bedside” surveillance), and abstraction of events from observational databases. The concept of a “trigger” (or clue) to identify adverse events in the medical record was introduced by Jick in 1974.2 Classen refined and automated the approach by using electronic triggers with an integrated hospital information system to identify patient records and review the same records for adverse events.3 The use of triggers with manual record reviews was initially developed by the Institute for Healthcare Improvement (IHI) in 1999 to identify only adverse medication events; adaptation of the methodology for other areas of the hospital, such as intensive care, followed. Recent publications describe the use and development of Trigger Tools.4-10

Subsequently, IHI developed the IHI Global Trigger Tool for Measuring Adverse Events to identify adverse events in adult inpatients, with some exclusions, throughout the hospital.

B. Harm versus Error

The overall goal of improved safety in health care is to reduce patient injury or harm, which underscores the importance of distinguishing between errors and harm. Although detection and analysis of errors is important in understanding failure-prone aspects of health care delivery systems and designing strategies to prevent and mitigate these failures, there is special value in quantifying actual harm. Medical errors are failures in processes of care and, while they have the potential to be harmful, numerous reports have shown they are often not linked to the injury of the patient.11 Because events of harm are clear clinical outcomes, they are particularly likely to engage both clinicians and administrators in a thorough review of the system factors that led to the adverse event, with a clear focus on improving patient outcomes. By concentrating on the events actually experienced by patients, a hospital can begin to foster a culture of safety that shifts from individual blame for errors to comprehensive system redesign that reduces patient suffering. To address the clear need to quantify adverse patient outcomes, the IHI Global Trigger Tool focuses on the identification of harm or injury to the patient.

C. Definition of an Adverse Event

Any effort to identify harm requires a clear definition of an adverse event. The World Health Organization (WHO) Collaborating Centers for International Drug Monitoring defines an adverse drug event as follows:

“Noxious and unintended and occurs at doses used in man for prophylaxis, diagnosis, therapy, or modification of physiologic functions.” 12

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The IHI Global Trigger Tool includes these types of events, but goes beyond medications to include any noxious or unintended event occurring in association with medical care.

In the IHI Global Trigger Tool, the definition used for harm is as follows: unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment or hospitalization, or that results in death.

D. Commission versus Omission

The IHI Global Trigger Tool focuses on and includes only those adverse events related to the active delivery of care (commission) and excludes, as much as possible, issues related to substandard care (omission). While adverse events due to omission of evidence-based treatments commonly occur and should be a focus in quality improvement efforts, they are not the focus of measurement with the IHI Global Trigger Tool. For example, a patient not appropriately treated for hypertension who subsequently experienced a stroke certainly has had a medical catastrophe related to poor care, but would not be considered to have suffered an adverse event using the IHI Global Trigger Tool definition because the event is related to omission of evidence-based care. However, a patient to whom anticoagulants were administered who subsequently suffered a stroke from an intra-cerebral bleed would be considered to have suffered an adverse event with the IHI Global Trigger Tool because the use of the anticoagulant (commission) caused the event. During reviews, acts of omission may be noticed and can be referred to others as improvement opportunities.

E. Preventability

The IHI Global Trigger Tool includes all adverse events—that is, events which are unintended consequences of medical care, whether preventable or not. There should be no attempt by the reviewers to determine preventability during a review with the IHI Global Trigger Tool. If an adverse event occurred it is, by definition, harm. One could argue that today’s “unpreventable events” are only an innovation away from being preventable.

The IHI Global Trigger Tool is designed to be a method for measuring harm over time.

If the definition of included events constantly changed depending on what was preventable, the measure over time would become meaningless.

F. Severity Ratings

The IHI Global Trigger Tool adapts the classification from the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index for Categorizing Errors.13 Although originally developed for categorizing medication errors, these definitions can be easily applied to any type of error or adverse event.

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The IHI Global Trigger Tool counts only adverse events: harm to the patient (as defined above), whether or not the result of an error. Accordingly, the tool excludes the following categories from the NCC MERP Index because these categories describe errors that do not cause harm:

Category A: Circumstances or events that have the capacity to cause error

Category B: An error that did not reach the patient

Category C: An error that reached the patient but did not cause harm

Category D: An error that reached the patient and required monitoring or intervention to confirm that it resulted in no harm to the patient

This tool utilizes categories E, F, G, H, and I of the NCC MERP Index because these categories describe harm. (Note that NCC MERP’s “An error that contributed to or resulted in…” has been deleted, since Trigger Tools do not focus on error.)

Category E: Temporary harm to the patient and required intervention

Category F: Temporary harm to the patient and required initial or prolonged hospitalization

Category G: Permanent patient harm

Category H: Intervention required to sustain life

Category I: Patient death

G. Trigger Selection

IHI developed the triggers used in the IHI Global Trigger Tool by reviewing the literature on adverse events in various areas of the hospital. IHI then tested these prioritized triggers in hundreds of hospitals using various Trigger Tools (Adverse Drug Event, Surgical, Perinatal, Intensive Care).14 IHI developed the IHI Global Trigger Tool using modules that correspond to these antecedent Trigger Tools and has added, deleted, and adjusted triggers over time to reflect changes in treatments and types of adverse events being identified in the field.

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II. Rules and Methods

The IHI Global Trigger Tool requires manual review of closed inpatient records (records with completed discharge summaries and coding). This section of the tool explains the processes for selecting and reviewing records and determining whether adverse events have occurred.

A. Review Team

The review team should consist of, at a minimum, three people:

1) Two primary record reviewers who have clinical backgrounds and knowledge about the contents and layout of the hospital’s record, as well as about how care is generally provided in the hospital. Hospitals using the IHI Global Trigger Tool have typically used nurses, pharmacists, and respiratory therapists on their review teams. Experienced nurses have been the best reviewers, but other combinations of team members can be used since each person brings unique expertise.

2) A physician who does not review the records, but authenticates the consensus of the two primary record reviewers. The physician authenticates the findings of the adverse events and the rating of severity, and provides answers to questions the record reviewers have about findings in a specific record.

Using two or more primary record reviewers raises the issue of consistency (intra- and inter-rater reliability) among the reviewers: the greater the number of reviewers on the team, the greater the potential inconsistency. IHI does not recommend that individual hospitals conduct exhaustive studies to measure reliability, but does encourage teams to continually promote consistent, standard record review procedures, use of triggers, and interpretation of events. The review team should remain consistent over time whenever possible. Many hospitals have found that a practical approach is to have a one-year assignment for both primary record reviewers and the physician, with overlapping team members to ensure adequate training of new reviewers. In addition, teams should meet approximately monthly to review all the adverse events identified for that month to detect and resolve variation between the reviewers in adverse event identification and severity rating. This continuous approach to training has been shown to achieve high inter-rater consistency.10 (See section IV for further information regarding training of the review team to enhance consistency.)

B. Sampling Patient Records

The IHI Global Trigger Tool is designed for use with a sampling methodology that utilizes small samples over time.

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8Institute for Healthcare Improvement Cambridge, Massachusetts patients discharged between the 1st and 15th of the month for the first two-week sample and between the 16th and end of the month for the second two-week sample), for a total of 20 records per month. Some hospitals may elect to review all 20 records at one time monthly, but this generates only one data point per month versus the two data points with the two-week samples. Organizations that have the resources to do so may elect to choose a larger sample size, such as 40 records per month, but reviewing more than 40 records per month accrues little additional benefit.

IHI recommends sampling every two weeks and generating two data points each month.

Data from these small samples may show wide variation from sample to sample. However, aggregating these samples over time will increase precision, and plotting this data on control charts will give you useful information about trends and special causes of variation in harm in your organization. (Note that hospitals should use the IHI Global Trigger Tool as one part of a learning system that includes other component measures, such as voluntarily reported errors, surgical site infections, and other outcome measures.)

Because readmission within 30 days is a trigger, select records of patients who were discharged more than 30 days prior to the review date so that readmissions can be checked for the sample. For example, if conducting a review in December, select patient records from those discharged in October.

Use the following guidelines when selecting the records:

• Select 10 patient records for each two-week sampling period, plus a few extra records in case a record is discovered that does not meet review criteria.

• Do not select 20 records for the entire month and divide these 20 records into two 10-record samples; draw each two-week sample independently.

The selection criteria are:

• Closed and completed record (discharge summary and all coding is complete)

• Length of stay at least 24 hours and formally admitted to the hospital

(Note: This is a sampling strategy to avoid outpatient cases. Some hospitals include patients with a one-day stay; however, selected records for review should always be patients that have been classified as inpatient.)

• Patient age 18 years or older

• Excluding inpatient psychiatric and rehabilitation patients

(Note: Triggers are not defined for these populations in this tool.)

If a record does not meet these criteria, do not use it; instead, select one of the “extras.”

The team will review only 10 records, so the extra records will not be used unless this occurs.

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Because the review is based on sampling to discover adverse events, it is critical to use a truly random process for selecting the records. Use any selection method, as long as it is random (i.e., every patient record has an equal opportunity of being chosen). Some valid methods are:

• Generate random numbers between 1 and 9, and select 10 records with record numbers ending in the random number.

• Print out all admissions or discharges (as long as deaths are included), and select every

10th record for review.

If a record selected for review is not available, select the next record in the random list.

In small rural hospitals that have fewer than 10 inpatients per two-week interval, review all records for the interval.

If possible, records of hospital admissions before and after the index record (i.e., the record selected for review) should be made available. The team can consult these to determine cause for admission or readmission. A complete review with the IHI Global Trigger Tool should not be done on these records, only the record identified in the random sample; use the additional records only to investigate the trigger associated with readmission, which should take less than 5 minutes.

C. Review Process

The two primary record reviewers should each review all records independently. During the review, the physician should be available to answer questions that may arise.

Use the following process for the review:

1) The IHI Global Trigger Tool contains six “modules,” or groupings of triggers.

Four of the groupings are designed to reflect adverse events that commonly occur in a particular unit; the Cares and Medication groupings are designed to reflect adverse events that can occur anywhere in the hospital. The six modules are:

• Cares

• Medication

• Surgical

• Intensive Care

• Perinatal

• Emergency Department

All patient records should be reviewed for the triggers in the Cares and Medication modules. The other modules should only be used if applicable; for example, the Intensive Care module should be used when reviewing a record for a patient who spent any part of the hospital stay in an intensive care unit.

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2) The record should only be reviewed to look for the presence of triggers, not to read the record from front page to back page. Experienced reviewers have found the following sections of the record most useful when reviewed in this order:

• Discharge codes, particularly infections, complications, or certain diagnoses

(E-codes, which are used by trained coders to note the presence of certain events and complications, can be found here)

• Discharge summary (look for the specifics of assessment and treatment during the hospital stay)

• Medications administration record

• Laboratory results

• Prescriber orders

• Operative record (operative report and anesthesia record, if applicable)

• Nursing notes

• Physician progress notes

• If time permits, any other areas of the record (such as History & Physical, Consult notes, or Emergency Department notes)

3) Set a 20-minute limit for review of each patient record, once the training period for reviewers has been completed. The “20-minute rule” applies to all records regardless of size. The 20-minute rule was developed in the initial tests of the Trigger Tool because there was a propensity to review the smaller, “easier” patient records (i.e., those with shorter lengths of stay). However, if only shorter stay patient records are reviewed, the sample is no longer random and there will be “selection bias” in the results. It is unlikely that all the events in the larger record will be identified since 20 minutes will not be sufficient time to adequately review the entire record using the Trigger Tool technique. It is important to note that the IHI Global Trigger Tool is not meant to identify every single adverse event in a record. The review time limitation and random selection of records are designed to produce a sampling approach that is sufficient for the design of safety work in the hospital.

4) If a trigger is identified in a record, the “positive trigger” indicates only the presence of a trigger, not necessarily an adverse event. When a positive trigger is found, review only the pertinent portions of the record. The focused review will determine whether an adverse event has occurred (refer to section II-D regarding the Determination of an Adverse Event). If no adverse event is found, the reviewer should then move on and look for other triggers. Reviewers will find many positive triggers, but will identify many fewer adverse events. Occasionally, reviewers will find adverse events with no antecedent trigger. Include these events. Some triggers (nosocomial infections, 3rd- or 4th-degree laceration) are also adverse events by definition. However, a positive trigger most often is not an adverse event in and of itself; rather, it is just a clue that one may have occurred.

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D. Determination of an Adverse Event

When a reviewer identifies a positive trigger, the reviewer should check other relevant portions of the record such as progress notes and orders that were documented in close proximity to the occurrence of the trigger. Documentation that the patient experienced harm from medical care should be present for an adverse event. For example, an INR level greater than 6 would be a positive trigger. The reviewer should look for documentation of bleeding or decreased hemoglobin with need for transfusion and other adverse events that can result from over-anticoagulation.

In determining whether an adverse event has occurred, consider that an adverse event is defined as unintended harm to a patient from the viewpoint of the patient. There are several important aspects:

• Would you be happy if the event happened to you? If the answer is no, then likely there was harm.

• Was the event part of the natural progression of the disease process, or a complication of the treatment related to the disease process? The harm identified should be the result of some medical treatment (review section I-D on Commission versus Omission).

The decision is subjective at times and physician input will be critical.

• Was the event an intended result of the care (e.g., a permanent scar from surgery)?

If so, then this is not considered harm.

• Psychological harm by definition has been excluded as an adverse event.

It is important to emphasize that reviewers may occasionally discover an adverse event without a trigger, while looking for triggers or other details. These events should be included when recording findings, regardless of whether a trigger led the reviewer to the adverse event.

An adverse event that is present on admission to the hospital should be included, provided that it meets the definition of being harm related to medical care. All such adverse events are counted because the measure is what the patient experienced, not what happened within the hospital. Field experience has shown that fewer than 10 percent of all harms that are detected by the IHI Global Trigger Tool will be present on admission. It is useful to keep track of which events occurred outside the hospital so that this can be noted when reporting data. Such data may indicate an opportunity to collaborate with others—office practices, clinics, long-term care facilities—to improve patient safety, even if the events did not result from hospital care itself.

Once reviewers have determined that an adverse event has occurred, assign a category of harm (as defined previously in section I-F on Severity Ratings) as follows:

Category E: Temporary harm to the patient and required intervention

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Category F: Temporary harm to the patient and required initial or prolonged hospitalization

Category G: Permanent patient harm

Category H: Intervention required to sustain life

Category I: Patient death

These categories are not progressive (i.e., an event does not have to first meet the definition of E and F before it can be categorized as G). For category E, some intervention is required. For category H, experienced reviewers have found it helpful to define “lifesaving intervention” as that which must be provided in one hour or less in order to prevent death.

For example, a patient with a surgical site infection requires antibiotic treatment and one could argue that failure to provide it could lead to sepsis and death. While this may be true, it is unlikely that the antibiotic would need to be provided within one hour to prevent death. However, a patient who develops respiratory depression and arrest from a narcotic requires immediate intervention, such as non-invasive or invasive ventilation; this would be an intervention required to sustain life, even if it was only needed for a few hours.

For category I, the event needs only to be contributory to the death.

Primary reviewers should record information on findings while reviewing the patient records. The IHI Global Trigger Tool Worksheet (Appendix B) lists all triggers, categorized into their modules, for use during the review. When a primary reviewer identifies a trigger, the reviewer places a check in the column next to it (the column with +). If the primary reviewer then identifies an adverse event associated with this trigger, the reviewer notes a description and category of harm in the appropriate column. The reverse side of the Worksheet is blank, and reviewers often use this space to make notes for discussion with other members of the review team or to capture questions that need to be reviewed with the physician.

The two primary record reviewers should meet after completing their separate reviews to compare findings and come to consensus, which they record on the IHI Global Trigger Tool Review Summary Sheet (Appendix C).

The physician should review the consensus with the two record reviewers and reach a final agreement on the type, number, and severity of events. The physician does not review the patient records, only the Summary Sheet (Appendix C). Individual Worksheets, notes, and the patient records should be available for the physician’s reference and clarification, if necessary. Adjust the number of adverse events or harm categories, if needed, after review with the physician. The physician is the final arbitrator.

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E. Data Collection

Present the two-week data collections initially in three ways:

• Adverse events per 1,000 patient days (see the example in Figure 1);

• Adverse events per 100 admissions; and

• Percent of admissions with an adverse event.

Each method has certain advantages. “Adverse events per 1,000 patient days” is the traditional measure and is the recommended measure to track the harm rate over time.

Data should be presented in a run chart with “adverse events per 1,000 patient days” on the Y-axis and time in two-week increments on the X-axis.

“Adverse events per 100 admissions” is an alternative presentation of rate. It provides a more easily understood representation of harm for leadership. Data should be presented in a run chart similar to “adverse events per 1,000 patient days.” Note that the conversion from “adverse events per 1,000 days” to “adverse events per 100 admissions” simply entails a switch from number of patient days (1,000) to records reviewed (admissions).

Figure 1. Sample Run Chart of Adverse Events (AEs) per 1,000 Patient Days

AE

s pe r

,0

P at ie nt D ay s

Sample Size = 20 Records per Month

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“Percent of admissions with an adverse event” is a convenient way to present the information to lay leadership, although it diminishes the number of events because some patients may have more than one adverse event during a hospital stay. Thus it is less sensitive to improvement than the two rate measurements.

In addition to the run chart representations, the team should present categories of harm in a bar chart (see Figure 2) depicting the volume of harm in each category (E through I).

Data is also often presented by type of adverse events. The types of events have commonly been defined as infections, medications, and procedural complications. Hospitals have found this categorization to be useful in prioritizing areas for improvement work.

It is also helpful to include a category in the bar chart of those events that occurred prior to admission and were present on arrival. These should not be excluded from the rate or percentage data in run charts, but it will be important to leadership to see the occurrence of these events.

(48 Adverse Events in 100 Patients Over 5 Months)

Figure 2. Distribution of Harm by Category

(48 Adverse Events in 100 Patients over 5 Months)

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III. Triggers and Definitions

This section lists all of the triggers contained in the IHI Global Trigger Tool by module, with descriptions of each trigger and what reviewers should look for to determine the presence of an adverse event.

IMPORTANT NOTE: If a trigger is identified in a record, the “positive trigger” indicates only the presence of a trigger, not necessarily an adverse event. The reviewer must investigate the details to determine whether an adverse event has actually occurred. (For more detail, see section II-C, #4, on the Review Process.)

A. Cares Module Triggers

C1–Transfusion of Blood or Use of Blood Products

Procedures can require intra-operative transfusion of blood products for replacement of estimated blood lost, but this has become less common with “bloodless surgery.” Any transfusion of packed red blood cells or whole blood should be investigated for causation, including excessive bleeding (surgical or anticoagulant-related), unintentional trauma of a blood vessel, etc. Transfusion of many units or beyond expected blood loss within the first 24 hours of surgery, including intra-operatively and post-operatively, will likely be related to a peri-operative adverse event. Cases in which excessive blood loss occurred pre-operatively are typically not adverse events. Patients receiving anticoagulants who require transfusion of fresh frozen plasma and platelets have likely experienced an adverse event related to the use of anticoagulants.

C2–Code, Cardiac or Pulmonary Arrest, or Rapid Response Team Activation

All “codes,” cardiac or pulmonary arrests, and activation of Rapid Response Teams need to be carefully reviewed as this may be the culmination of an adverse event (check for medication-related issues). However, not all codes/arrests/team responses are adverse events as some may be related to progression of a disease process. For example, cardiac or pulmonary arrest intra-operatively or in the post anesthesia care unit should always be considered an adverse event. In the first 24 hours post-operatively, it is also very likely to be an adverse event. Conversely, a sudden cardiac arrhythmia resulting in cardiac arrest may not be an adverse event, but related to cardiac disease. Failure to recognize signs and symptoms would be an example of an error of omission and would not be counted as an adverse event unless the changes in patient condition were the result of some medical intervention.

C3–Acute Dialysis

A new need for dialysis may be the course of a disease process or the result of an adverse event. Examples of adverse events might be drug-induced renal failure or reaction to the administration of a dye for radiological procedures.

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C4–Positive Blood Culture

A positive blood culture at any time during the hospitalization must be investigated as an indicator of an adverse event, specifically a hospital-associated infection. Generally, adverse events associated with this trigger will include infections that are diagnosed 48 hours or more after admission, such as bloodstream line infections, sepsis from other device infections (e.g., catheter-associated urinary tract infection), or any other hospital-associated infection. Patients with positive blood cultures related to other disease (such as community-acquired pneumonia progressing to sepsis) would not be considered to have adverse events.

C5–X-Ray or Doppler Studies for Emboli or Deep Vein Thrombosis

Development of a deep vein thrombosis (DVT) or pulmonary embolism (PE) during a hospital stay in most cases will be an adverse event. Rare exceptions may be those related to disease processes such as cancer or clotting disorders. However, in most patients this is harm related to medical care, even if all appropriate preventive measures appear to have been taken. If the hospitalization occurs due to a DVT or embolism, look for causation prior to admission that could be attributed to medial care such as a prior surgical procedure. The lack of prophylaxis with no DVT or PE is not an adverse event; it is an error of omission.

C6–Decrease in Hemoglobin or Hematocrit of 25% or Greater

Any decrease of 25 percent or greater in hemoglobin (Hg) grams or hematocrit (Hct) should be investigated, especially when occurring in a relatively short period of time such as 72 hours or less. Bleeding events are commonly identified by this trigger and may be related to use of anticoagulants or aspirin or a surgical misadventure. The decrease in Hg or Hct in itself is not an adverse event unless related to some medical treatment. A decrease associated with a disease process is not an adverse event.

C7–Patient Fall

A fall in a care setting represents a failure of care and may be the result of medications, equipment failure, or failure of adequate staffing. Any fall in the care setting that causes injury, regardless of cause, is an adverse event; a fall without injury is not an adverse event.

Falls resulting in injury and admission to the hospital should be reviewed for causation.

A fall that is the result of medical treatment (such as from medications) should be considered an adverse event, even if the fall occurred outside the hospital.

C8–Pressure Ulcers

Pressure or decubitus ulcers are adverse events. Chronic decubiti are adverse events if they occurred during a hospitalization. If the ulcers occurred in the outpatient setting, consider the etiology (over-sedation, etc.) to assess if an adverse event occurred.

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Innovation Series: IHI Global Trigger Tool for Measuring Adverse Events (Second Edition)17

C9–Readmission within 30 Days

Any readmission, particularly within 30 days of discharge, could be an adverse event.

An adverse event may not manifest itself until after the patient has been discharged from the hospital, especially if the length of stay is minimal. Examples of adverse events may include surgical site infection, deep vein thrombosis, or pulmonary embolism.

C10–Restraint Use

Whenever restraints are used, review the documented reasons and evaluate the possible relationship between the use of restraints and confusion from drugs, etc., which would indicate an adverse event.

C11–Healthcare-Associated Infections

Any infection occurring after admission to the hospital is likely an adverse event, especially those related to procedures or devices. Infections that cause admission to the hospital should be reviewed to determine whether they are related to medical care (e.g., prior procedure, urinary catheter at home or in long-term care) versus naturally occurring disease (e.g., community-acquired pneumonia).

C12–In-Hospital Stroke

Evaluate the cause of the stroke to determine whether it is associated with a procedure (e.g., surgical procedure, conversion of atrial fibrillation) or anticoagulation. When procedures or treatments have likely contributed to a stroke, this is an adverse event.

C13–Transfer to Higher Level of Care

Transfers to a higher level of care within the institution, to another institution, or to your institution from another must be reviewed. All transfers are likely to be the result of an adverse event and a patient’s clinical condition may have deteriorated secondary to an adverse event. Look for the reasons for the transfer. For example, in the case of admission to intensive care following respiratory arrest and intubation, if the respiratory arrest was a natural progression of an exacerbation of chronic obstructive pulmonary disease (COPD), then it would not be an adverse event; if it was caused by a pulmonary embolism that developed post-operatively or resulted from over-sedation of a patient with COPD, it would be an adverse event. A higher level of care may include telemetry, intermediate care, or a step-down unit if the patient is transferred from a general medical or surgical nursing unit.

C14–Any Procedure Complication

A complication resulting from any procedure is an adverse event. Procedure notes frequently do not indicate the complications, especially if they occur hours or days after the procedure note has been dictated, so watch for complications noted in coding, the discharge summary, or other progress notes.

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C15–Other

Frequently when the record is reviewed, an adverse event is uncovered that does not fit a trigger. Any such event can be placed under this “Other” trigger. An event does not require a listed trigger to be counted as an event.

B. Medication Module Triggers

M1–Clostridium difficile Positive Stool

A positive C. difficile assay is an adverse event if a history of antibiotic use is present.

M2–Partial Thromboplastin Time (PTT) Greater than 100 Seconds

Elevated PTT measurements occur when patients are on heparin. Look for evidence of bleeding to determine if an adverse event has occurred. Elevated PTT in itself is not an adverse event—there must be manifestation such as bleeding, drop in Hg or Hct, or bruising.

M3–International Normalized Ratio (INR) Greater than 6

Look for evidence of bleeding to determine if an adverse event has occurred. An elevated INR in itself is not an adverse event.

M4–Glucose Less than 50 mg/dl

Review for symptoms such as lethargy and shakiness documented in nursing notes, and the administration of glucose, orange juice, or other intervention. If symptoms are present, look for associated use of insulin or oral hypoglycemics. If the patient is not symptomatic, there is no adverse event.

M5–Rising BUN or Serum Creatinine Two Times (2x) over Baseline

Review laboratory records for rising levels of either BUN or serum creatinine. If a change of two times greater than baseline levels is found, review medication administration records for medications known to cause renal toxicity. Review physician progress notes and the history and physical for other causes of renal failure, such as pre-existing renal disease or diabetes, that could have put the patient at greater risk for renal failure; this would not be an adverse event, but rather the progression of disease.

M6–Vitamin K Administration

If Vitamin K was used as a response to a prolonged INR, review the record for evidence of bleeding. An adverse event has likely occurred if there are laboratory reports indicating a drop in hematocrit or guiac-positive stools. Check the progress notes for evidence of excessive bruising, gastrointestinal (GI) bleed, hemorrhagic stroke, or large hematomas as examples of adverse events.

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Innovation Series: IHI Global Trigger Tool for Measuring Adverse Events (Second Edition)19

M7–Diphenhydramine (Benadryl) Administration

Diphenhydramine is frequently used for allergic reactions to drugs but can also be ordered as a sleep aid, a pre-op/pre-procedure medication, or for seasonal allergies. If the drug has been administered, review the record to determine if it was ordered for symptoms of an allergic reaction to a drug or blood transfusion administered either during the hospital-ization or prior to admission—these are adverse events.

M8–Romazicon (Flumazenil) Administration

Romazicon reverses the effect of benzodiazepine drugs. Determine why the drug was used.

Examples of adverse events are severe hypotension or marked, prolonged sedation.

M9–Naloxone (Narcan) Administration

Naloxone is a powerful narcotic antagonist. Usage likely represents an adverse event except in cases of drug abuse or self-inflicted overdose.

M10–Anti-Emetic Administration

Nausea and vomiting commonly are the result of drug administrations both in surgical and non-surgical settings. Anti-emetics are commonly administered. Nausea and vomiting that interferes with feeding, post-operative recovery, or delayed discharge suggests an adverse event. One or two episodes treated successfully with anti-emetics would suggest no adverse event. Reviewer judgment is needed to determine whether harm occurred.

M11–Over-Sedation/Hypotension

Review the physician progress, nursing, or multidisciplinary notes for evidence of over-sedation and lethargy. Review vital signs records or graphics for episodes of hypotension related to the administration of a sedative, analgesic, or muscle relaxant. Intentional overdose is not considered an adverse event.

M12–Abrupt Medication Stop

Although the discontinuation of medications is a common finding in the record, abruptly stopping medications is a trigger requiring further investigation for cause. A sudden change in patient condition requiring adjustment of medications is often related to an adverse event. “Abrupt” is best described as an unexpected stop or deviation from typical ordering practice; for example, discontinuation of an intravenous antibiotic for switch to oral is not unexpected.

M13–Other

Use this trigger for adverse drug events detected but not related to one of the Medication triggers listed above.

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C. Surgical Module Triggers

S1–Return to Surgery

A return to the operating room can either be planned or unplanned, and both can be a result of an adverse event. An example of an adverse event would be a patient who had internal bleeding following the first surgery and required a second surgery to explore for the cause and to stop the bleeding. Even if the second surgery is exploratory but reveals no defect, this should be considered an adverse event.

S2–Change in Procedure

When the procedure indicated on the post-operative notes is different from the procedure planned in the pre-operative notes or documented in the surgical consent, a reviewer should look for details as to why the change occurred. An unexpected change in procedure due to complications or device or equipment failure should be considered an adverse event, particularly if length of stay increases or obvious injury has occurred.

S3–Admission to Intensive Care Post-Operatively

Admission to an intensive care unit can be either a normal post-operative journey or it may be…