Systems to review when using the IHI Global Trigger Tooll

1. A Circumstances or events that have the capacity to cause error.
2. B Any error that did not reach the patient.
3. C An error that reached the patient but did not cause harm.
4. D An error that reached the patient and required monitoring or intervention to confirm that it resulted in no harm to the patient.

1. E Temporary harm to the patient and required intervention.
2. F Temporary harm to the patient and reqquired initial or prolonged hospitalization.
3. G Permanent patient harm.
4. H Intervention required to sustain life.
5. I Patient death.

Expand the Trigger Definitions

History

Conventional attempts to quantify adverse events have included voluntary incident reports, retrospective or concurrent record reviews (sometimes summplemented 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, and refined by Classen by using electronic triggers with an integrated hospital information system.

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. 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 Trigger Tool focuses on identification of harm or injury to the patient.

Definition of an Adverse Event

The Trigger Tool modifies the World Health Organization definition of adverse drug events, but goes beyond medications to include any event in association with medical care. The definition for harm is: unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment or hospitalization, or that results in death.

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 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. The decision is subjective at times and physician input will be critical.
• Was the event an intended result of the care (eg 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 as {other}, 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% of all harms that are detected by the 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.

Commission versus Omission

The 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 Trigger Tool. During reviews, acts of omission may be noticed and can be referred to others as improvement opportunities.

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 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 Trigger Tool because the use of the anticoagulant (commission) caused the event.

Preventability

The Trigger Tool includes all adverse events — that is, events which are unintended consequences of medical care, whether preventable or not. Reviewers should not attempt to determine preventability during a review. If an adverse event occurred it is, by definition, harm. The 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.

Severity Ratings

The Trigger Tool adapts the classification from the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index for Categorizing Errors. Although originally developed for categorizing medication errors, these definitions can be easily applied to any type of error or adverse event. The Tool counts only adverse events: harm to the patient, whether or not the result of an error. Accordingly, the tool excludes the categories A~D because these categories describe errors that do not cause harm.

These categories are not progressive (ie 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.

Trigger Selection

IHI developed the triggers by reviewing the literature on adverse events in various areas of the hospital. IHI then tested these prioritized triggers in hundreds of hospitals. Modules are added, deleted, and adjusted over time to reflect changes in treatments and types of adverse events being identified in the field.

C1 Transfusion of Blood or Use of Blood Products (S19)> (S19)

Procedures can require intra-operative transfusion of blood products for replacement of estimated blood lost, but this has become less common with "bloodless surgery" (keyhole/micro-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 can reflect system problems that include failure to plan changes in anticoagulants prior to surgery and the necessity to reverse quickly in order to do the surgery. These patients have likely experienced an adverse event related to the use of anticoagulants. Surgical procedure Anticoagulant prescriptio Transfusion of blood products Hemoglobin/hematocrit (C6) Diphenhydramine (Benadryl) administration (M7) Surgical operation

• Surgical procedure
• Anticoagulant prescriptio
• Transfusion of blood products
• Hemoglobin/hematocrit (C6)
• Diphenhydramine (Benadryl) administration (M7)
• Surgical operation

C2 Transfusion of Blood or Use of Blood Products (S17)

All "codes", cardiac or pulmonary arrests, and activation of Rapid Response Teams (RRT) 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/RRT 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 anestshesia 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.

• CPR payment
• RRT activation
• Surgical operation

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.

C4 Positive Blood Culture (S20)

A positive blood culture at any time during hospitalization must be investigated as an indicator of an adverse event, specifically a hospital-associated infection (HAI). 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 (eg 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. A surgical site infection is an adverse event.

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 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 medical 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 percent or Greater

Any decrease of 25% 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.

• Anticoagulants prescription
• Aspirin prescription
• Hemoglobin/hematocrit
• Surgical operation

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 advents. 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.

C9 Readmission within 30 Days (S27)

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 could indicate an adverse event.

C11 Healthcare-Associated Infections (S21)

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 (eg prior procedure, urinary catheter at home or in long-term care) versus naturally occurring disease (eg community-acquired pneumonia).

C12 In-Hospital Stroke

Evaluate the cause of the stroke to determine whether it is associated with a procedure (eg 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 (S16)

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 (S14)

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.

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.

 

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 (2.8 IU)

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.

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 hospitalization 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. s

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.

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

OR-only

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 unexpected. The unexpected admissions frequently are related to operative adverse events. For example, admission to intensive care following aortic aneurysm repair may be expected, but admission following knee replacement would be unusual. The reviewer needs to determine why intensive care admission occurred.

S4 Intubation or Reintubation or Use of BiPap in Post Anesthesia Care Unit (PACU)

Anesthesia, sedatives, or pain medications can result in respiratory depression requiring the use of BiPaP or reintubation post-operatively, which would be an adverse event.

S5 X-Ray Intra-Operatively or in Post Anesthesia Care Unit

Imaging of any kind that is not routine for the procedure requires investigaton. An x-ray taken due to suspicion of retained items or incorrect instrument or sponge count would be a positive trigger. The identification of a retained item necessitating an additional procedure is an adverse event. If the retained item is identified and removed without any additional evidence of harm or re-operation to the patient, this is not considered an adverse event.

S6 Intra- or Post-Operative Death

All deaths that occur intra-operatively should be considered adverse events unless death is clearly expected and the surgery was of a heroic nature. Post-operative deaths will require review of the record for specifics, but in general all post-op deaths will be adverse events.

S7 Mechanical Ventilation Greater Than 24 Hours Post-Operatively

Short-term mechanical ventilation post-operatively for cardiac, major thoracic, and certain abdominal procedures is planned. If the patient requires mechanical ventilation beyond 24 hours, an intra-operative or post-operative adverse event should be considered. Patients with pre-existing pulmonary or muscular disease may experience more difficulty in quickly weaning from a ventilator post-operatively, but this should not automatically exclude the possibility of an adverse event. Reviewers must use clinical judgment to determine whether the intra-operative and post-operative care was event free or part of the disease process.

S8 Intra-Operative Administration of Epinephrine, Norepinephrine, Naloxone, or Romazicon

These medications are not routinely administered intra-operatively. Review anesthesia and operative notes to determine the reason for administration. Hypotension caused by bleeding or over-sedation are examples of adverse events that might be treated by these medications.

S9 Post-Operative Increase in Troponin Levels Greater than 1.5 Nanogram/ml

A post-operative increase in troponin levels may indicate a cardiac event. Reviewers will need to use clinical judgment as to whether a cardiac event has occurred.

S10 Injury, Repair, or Removal of Organ During Operative Procedure

Review operative notes and post-operative notes for evidence that the procedure included repair or removal of any organ. The removal or repair must be part of the planned procedure or this is an adverse event and likely the result of surgical misadventure such as an accidental injury.

S11 Occurrence of Any Operative Complication

This refers to any of a number of complications, including but not limited to PE, DVT, decubiti, MI, renal failure, etc.

{S2} Change anesthetic during surgery

Review the anesthesia record for a change in the mode of anesthesia (general, regional block, etc) during the surgery. If found, review notes to determine the reason for the change; exclude an adverse event driving the change of anesthesia. Problems with excessive bleeding, allergic reactions, or other events need to be considered.

{S3} Injury, Repair, or Removal of Organ During Operative Procedure

Review anesthesia records, operating room nursing notes, and PACU notes for evidence that arterial or central lines were inserted intra-operatively. In some cases, this may be a routine part of the procedure, such as in cardiac surgery. However if not routine, it may indicate adverse events intra-operatively, such as bleeding, medication-induced hypotension, anaphylaxis, fluid management, etc.

{S4} Operative time greater than 6 hours

Patients placed in one position for an extended period of time are at greater risk for post-operative complications and adverse events. Examples may include atelectasis, skin breakdown, pressure sores, nerve damage, range of motion, or pain. Look carefully for evidence of these and other events that may arise from being in one position.

{S8} Consult requested in PACU

Consultations ordered post-operatively may indicate an adverse event during surgery, especially if the consultation must be conducted in the PACU. Review the consultation report for the reasons for the consult to determine if an adverse event has occurred.

{S26} Pathology report normal or unrelated to diagnosis

Normal pathology reports may indicate incorrect pre-operative diagnosis and unnecessary surgery, which would be an adverse event. Specimens need to match the preoperative diagnosis. Any deviation, look for possible adverse events.

I1 Pneumonia Onset

Any pneumonia diagnosed in the ICU needs to be looked at carefully. If the evidence suggests the pneumonia started prior to admission to the hospital, there is no adverse event; but if the review suggests initiation in the hospital, it is an adverse event. In general, any infection starting in not only the intensive care unit but in any hospital unit will be considered nosocomial. Readmissions either to the hospital or the intensive care unit could represent a nosocomial infection from a previous hospitalization.

I2 Readmission to the Intensive Care Unit

Refer to trigger S3 — Admission to Intensive Care Post-Operatively

I3 In-Unit Procedure

Any procedure occurring on a patient in the intensive care unit requires investigation. Look at all the bedside procedures and other procedures done while the patient was in the ICU. Complications will commonly not be on the dictated procedure note, but may be evident by the care required, which might indicate an event occurred.

I4 Intubation/Reintubation

Refer to trigger S4 — Intubation or Reintubation or Use of BiPap in Post Anesthesia Care Unit.

P1 Terbutaline Use

Use of terbutaline could result in an unnecessary intervention of a cesarean section that is created by the administration of a medication. Look for complicating factors. Use of terbutaline in pre-term labor is not a positive trigger.

P2 3rd- or 4th Degree Lacerations

By definition a 3rd- or 4th-degree laceration is an adverse event. Also look for additional events to the mother or child associated with the laceration as part of a cascade so appropriate severity can be assessed.

P3 Platelet Count Less Than 50000

Look for adverse events related to bleeding such as strokes, hematomas, and hemorrhage requiring blood transfusions. Look for information about why the platelet count decreased to see if it was as a result of a medication. Usually, a platelet transfusion is an indication that the patient has a low platelet count. Events related to transfusions or bleeding may indicate that an adverse event may have occurred.

P4 Estimated Blood Loss Greater than 500 ml for Vaginal Delivery, or Greater than 1,000 ml for Cesarean Delivery

The accepted limit for "normal" blood loss after vaginal delivery is 500 ml, and a blood loss of 1,000 ml is considered within normal limits after cesarean birth.

P5 Specialty Consult

May be an indicator of injury or other harm.

P6 Administration of Oxytoxic Agents (such as oxytocin, methylergonovine, and 15-methyl-prostaglandin) in the post-partum period

Agents used to control post-partum hemorrhage, defined as blood loss greater than 500 ml for a vaginal delivery and greater than 1,000 ml for a cesarean delivery. If standard administration of oxytocin occurs post-delivery, evaluate for administration amounts greater than 20 units in the immediate post-partum period.

P7 Instrumented Delivery

Instruments may cause injury to the mother, including bruising, trauma, and perineal lacerations.

P8 Administration of General Anesthesia

May be an indicator of harm resulting from poor planning or other sources of harm.

E1 Readmission to the ED within 48 Hours

Look for drug reactions, infections, or other reasons that events may have brought the patient back to the ED and then required admission.

PE Time in ED Greater than 6 Hours

Long ED stays in some cases can represent less than optimal care. Look for complications arising from the ED such as falls, hypotension, or procedure-related complications.

T1 Antihistamines

Antihistamines (eg Chlorpheniramine, Promethzaine (Phenergan), Diphenhydramine) are frequently used for allergic reactions to drugs but can also be ordered as a sleep aid, as a preoperative or preprocedure medication, or for seasonal allergies. If an antihistamine has been administered, review the record to determine if it was ordered for symptoms of an allergic reaction to a drug administered either during the hospitalization or prior to admission.

T2 Vitamin K

Determine whether Vitamin K was used as a response to a prolonged prothrombin time or elevated INR. If either lab value is high, review the record for evidence of bleeding. Look in the lab reports for a drop in hematocrit or for positive fecal occult blodds. Check the progress notes for evidence of excessive bruising or a gastrointestinal (GI) bleed. Less likely, a hemorrhagic stroke or other internal bleeding might have occurred. If any of these is found, it is likely that an ADE has occurred. Bleeding disorders have been reported with selective serotonin reuptake inhibitors (SSRIs).

T3 Flumazenil

Flumazenil reverses benzodiazeipine drugs. Determine why the drug was used. If hypotension or marked, prolonged sedation occurred following benzodiazepine administration, an ADE may have occurred.

T4 Anti-emetics

Anti-emetics (eg Ondanestron, Promethazine, Prochlorperazine, Metoclopramide): Nausea and vomiting can be the result of drug toxicity or overdose, particularly in patients with impaired renal function. Drugs such as lithium and theophylline preparations frequently cause nausea and vomiting when levels get high. SSRIs can cause nausea and vomiting and these symptoms can also be part of an antidepressant withdrawal syndrome. Drugs for dementia commonly cause nausea and sometimes vomiting. Anti-emetics are also commonly administered to patients post-anesthetic or those receiving chemotherapy. Professional judgment must be used in these situations to determine if an ADE has occurred.

T5 Naloxone (Narcan)

Naloxone is a powerful narcotic antagonist. If it has been used, overdosage of narcotics is a frequent finding. If Naloxone was used and the patient's condition changed, excessive narcotic administration, which is an ADE, probably has occurred.

T6 Antidiarrheals

Look for antibiotic-caused Clostridium difficile infections. If the C.difficile was not ordered and significant diarrhea occurred in a patient receiving multiple antibiotics, it is likely that an ADE occurred.

T7 Sodium Polystyrene Sulfonate (SPS)

Used in the treatment of hyperkalemia and aids in the removal of excess potassium from the body. Look for the reason for hyperkalemia and whether the patient had been receiving potassium. Administration of SPS may be in response to an overdose of potassium, which would be an ADE. Drugs which can cause hyperkalemia include potassium-sparing diuretics, NSAIDs, and ACE inhibitors.

T8 Serum glucose < 50

Low serum glucose does not necessarily mean an ADE occurred. Look for evidence of symptoms and administration of glucose (orally or IV). Not all patients will be symptomatic. In addition, look for signs or symptoms in the nursing notes about lethargy, shakiness, etc to help determine if an ADE has occurred.

T9 C.difficile positive stool

If a patient is on multiple antibiotics, this is a likely complication and an indication of an ADE.

T10 Partial Thromboplastin Time (PTT) > 100 seconds

Partial thromboplastin time (PTT) is not an infrequent occurrence when patients are on heparin. As with Vitamin K, look for evidence of bleeding to determine if an ADE has occurred. Use professional judgment for patients with high PTTs receiving heparin during a surgical procedure.

T11 International Normalized Ratio (INR) > 6

International Normalized Ratio (INR) > 6 is not an infrequent occurrence when patients are on warfarin. Look for evidence of bleeding to determine if an ADE has occurred.

T12 White Blood Cell (WBC) count < 3,000

White blood cell count (WBC) < 3,000: In some cases, this will occur in response to drug administration. Follow the WBC counts throughout the admission and see what has happened. If leukopenia is related to drugs such as antipsychotics (especially Clozapine) or Indomethacin, a drop in WBCs should be evident. Don't include patients currently receiving chemotherapy. If a drop in WBC occurs in the absence of medications that may cause this, an ADE has not occurred.

T13 Platelet count < 50,000

Platelet count < 50,000: Certain medications, including antipsychotics (especially Clozapine), can cause the platelet count to drop, placing patients at greater risk for bleeding. Look for adverse events related to bleeding such as strokes, hematomas, and hemorrhage requiring blood transfusions. Look for information about why the platelet count decreased to see if it was as a result of a medication (ie an ADE).

T14 Digoxin level > 2 mg/ml

This cardiac medication provides benefits within a continuous therapeutic range depending on the patient and the condition. When the level exceeds this range, some patients get benefits, but in others, toxicity may occur. The toxicity frequently manifests as arrhythmias or bradycardia, but may also include nausea, vomiting, anorexia, and vision changes even without cardiac symptoms. If the level is greater that the therapeutic range, look for evidence that the patient had complications related to this drug or required other interventions as signs that an ADE may have occurred.

T15 Rising serum creatinine

Certain medications, especially lithium, aminoglycosides, diuretics, and anti-hypertensive medications, can cause renal toxicity, which may become evident when serum creatinine levels start rising. Look at several sequential results to see if levels rose. If they did, check to see if the patient received medications that are known to be nephrotoxic. If interventions were required to correct renal problems, an ADE may have occurred.

T16 Over-sedation/lethargy/falls

Look in the physician progress notes, nursing or multidisciplinary notes for evidence of oversedation, lethargy, and falls. If found, look for a relationship between the event and administration of a sedative (hypnotics and anxiolytics, antipsychotics, sedative antidepressants, antihistamines, etc), analgesic, or muscle relaxant. If over-sedation, lethargy, or falls occurred as a result of administration of a sedative, analgesic, or muscle relaxant, an ADE has occurred. Include falls related to an ADE and resulting in the admission. Do not include intentional overdose by the patient resulting in sedation.

T17 Rash

There are many causes for a rash. To determine if an ADE has occurred, look for evidence that the rash is related to drug administration. For example, a yeast infection may indicate overuse of antibiotics.

T18 Abrupt cessation of medication

In the order sets, whenever "hold" or "stop" medication orders appear, look for the reason. These orders frequently indicate that an ADE has occurred (e.g. discontinuation of penicillin after an allergic reaction, or discontinuation of an antipsychotic due to the development of neuroleptic malignant syndrome).

T19 Abrupt reduction of dose of medication

May indicate that an ADE has occurred but professional judgment is required.

T20 Transfer to a higher level of care

This includes either within the ward (eg to special observation), to another ward (eg PICU or a medical-surgical ward) from your ward, or to your ward from antoher. Transfer of a patient to a higher level of care is only a trigger, a clue that an ADE may have occurred. A higher level of care is indicated when a patient's clinical condition (mental or physical) deteriorates or becomes more serious and this can happen for many reasons. However, in some cases an ADE is the cause of the change in condition. When reviewing this trigger, look for the reasons for the transfer and the change in condition; if the latter is linked to any medication, this may be an indication that an ADE has occurred. For example, transfer following management of respiratory arrest is not an ADE if the respiratory arrest was a complication of an acute asthma attack, but would be an ADE if the respiratory arrest was caused by administraton of intravenous diazepam. If a patient becomes aggressive following commencement of benzodiazepines this could be an ADE as benzodiazepines can cause a paradoxical increase in hostility and aggression. Rapid deterioration in mental state following dose reduction or drug cessation is an ADE, as is a drug withdrawal syndrome.

T21 Unexpected death

Clearly professional judgment will be required but consider the possibility of an ADE, especially if the patient is on antipsychotic medication.

T22 Serum lithium > 1.0 mMol/L

Lithium salts have a narrow therapeutic/toxic ratio and doses are adjusted to achieve a serium lithium concentration of 0.4 to 1.0 mMol/L (lower end of the range for maintenance therapy and elderly patients) on samples taken 12 hours after the preceding does. Common side effects include fine hand tremor, increased thirst, and increased frequency of urination. When the level exceeds the therapeutic range toxicity may occur, and symptoms indicating that harm may have occurred include tremor, ataxia, slurred speech, nystagmus, renal impairment, and convulsions. If the level is greater that the therapeutic range, look for evidence that the patient had complications related to this drug or required other interventions as signs that an ADE may have occurred.

T23 Slow sodium

Used in the treatment of significant hyponatremia. Look for the reason for the hyponatremia (may or may not be drug related) and, in patricular, check if the patient is on antidepressants. Hyponatremia (usually in the elderly and possibly due to the secretion of antidiuretic hormone) has been associated with all types of antidepressants, especially with SSRIs.

T24 Serum sodium < 135 mMol/

Does not necessarily mean an ADE occurred. If the patient is on antidepressants look for evidence of harm (drowsiness, confusion, convulsions) which would indicate that an ADE has occurred.

T25 Laxatives

There are many causes of constipation necessitating the prescription of laxatives. To determine if an ADE is likely to have occurred, look for evidence that the prescription of laxatives is related to drug administration (eg tricyclic antidepressants, antipsychotics (especially clozapine), antimuscarinic drugs). Professional judgment will be necessary.

T26 Antimuscarinic drugs (Benzatropine)

Prescribed for the relief of Parkinsonian symptoms induced by antipsychotic drugs, but there is no justification for giving these drugs routinely in the absence of Parkinsonian side effects. Tardive dyskinesia is not improved by antimuscarinic drugs and may be made worse, which would be considered an ADE. Benzatropine may be given parenterally as emergency treatment for acute drug-induced dystonic reactions which may be severe.

T27 Tetrabenazine

Prescription of this drug does not necessarily mean that an ADE has occurred as it is used for movement disorders such as Huntington's Chorea and other neurological conditions. Look for evidence that the patient has tardive dyskinesia which indicates harm from antipsychotic medication and is an ADE.

T28 Insertion of a urinary catheter for urinary retention

There are many causes of urinary retention, but if it followed commencement/increase in dose of an antimuscarinic drug or a drug with antimuscarinic side effects (eg tricyclic antidepressants, antipsychotic drugs) an ADE has occurred.

T29 Significant weight gain

Look for entries in the record that indicate that prescribed medication is thought to have caused significant weight gain which can occur with, for example, some antipsychotics and lithium. Professional judgment will be required to determine if an ADE has occurred.

T30 Drug combinations not normally recommended

Drug combinations not normally recommended (eg combination of two antidepressants; more than one antipsychotic at the same time; lithium plus a thiazide diuretic; etc): Does not mean that harm has occurred but makes an ADE more likely.

Emergency Department (ED) Module Triggers

S1 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.

S2 Change anesthetic during surgery

Review the anesthesia record for a change in the mode of anesthesia (general, regional block, etc) during the surgery. If found, review notes to determine the reason for the change; exclude an adverse event driving the change of anesthesia. Problems with excessive bleeding, allergic reactions, or other events need to be considered.

S3 Insertion of arterial or central venous line during surgery

Review anesthesia records, operating room nursing notes, and PACU notes for evidence that arterial or central lines were inserted intra-operatively. In some cases, this may be a routine part of the procedure, such as in cardiac surgery. However if not routine, it may indicate adverse events intra-operatively, such as bleeding, medication-induced hypotension, anaphylaxis, fluid management, etc.

S4 Operative time greater than 6 hours

Patients placed in one position for an extended period of time are at greater risk for post-operative complications and adverse events. Examples may include atelectasis, skin breakdown, pressure sores, nerve damage, range of motion, or pain. Look carefully for evidence of these and other events that may arise from being in one position.

S5 Injury, Repair, or Removal of Organ During Operative Procedure

Review operative notes and post-operative notes for evidence that the procedure included repair or removal of any organ. The removal or repair must be part of the planned procedure or this is an adverse event and likely the result of surgical misadventure such as an accidental injury.

S6 Intra-Operative Administration of Epinephrine, Norepinephrine, Naloxone, or Romazicon

These medications are not routinely administered intra-operatively. Review anesthesia and operative notes to determine the reason for administration. Hypotension caused by bleeding or over-sedation are examples of adverse events that might be treated by these medications.

Intraoperative causes (complications during surgery that may have lethal sequelae)

• Bleeding
• Perforation of organs

S7 Intubation or Reintubation or Use of BiPap in Post Anesthesia Care Unit (PACU)

Anesthesia, sedatives, or pain medications can result in respiratory depression requiring the use of BiPaP or reintubation post-operatively, which would be an adverse event.

S8 Consult requested in PACU

Consultations ordered post-operatively may indicate an adverse event during surgery, especially if the consultation must be conducted in the PACU. Review the consultation report for the reasons for the consult to determine if an adverse event has occurred.

S9 X-Ray Intra-Operatively or in Post Anesthesia Care Unit

Imaging of any kind that is not routine for the procedure requires investigaton. An x-ray taken due to suspicion of retained items or incorrect instrument or sponge count would be a positive trigger. The identification of a retained item necessitating an additional procedure is an adverse event. If the retained item is identified and removed without any additional evidence of harm or re-operation to the patient, this is not considered an adverse event.

S10 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 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 medical 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.

S11 Admission to Intensive Care Post-Operatively

Admission to an intensive care unit can be either a normal post-operative journey or it may be unexpected. The unexpected admissions frequently are related to operative adverse events. For example, admission to intensive care following aortic aneurysm repair may be expected, but admission following knee replacement would be unusual. The reviewer needs to determine why intensive care admission occurred.

S12 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.

S13 Mechanical Ventilation Greater Than 24 Hours Post-Operatively

Short-term mechanical ventilation post-operatively for cardiac, major thoracic, and certain abdominal procedures is planned. If the patient requires mechanical ventilation beyond 24 hours, an intra-operative or post-operative adverse event should be considered. Patients with pre-existing pulmonary or muscular disease may experience more difficulty in quickly weaning from a ventilator post-operatively, but this should not automatically exclude the possibility of an adverse event. Reviewers must use clinical judgment to determine whether the intra-operative and post-operative care was event free or part of the disease process.

S14 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.

S15 Occurrence of Any Operative Complication

This refers to any of a number of complications, including but not limited to PE, DVT, decubiti, MI, renal failure, etc.

S16 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.

S17 Code, Cardiac or Pulmonary Arrest, or Rapid Response Team Activation

All "codes", cardiac or pulmonary arrests, and activation of Rapid Response Teams (RRT) 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/RRT 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 anestshesia 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.

S18 Intra- or Post-Operative Death

All deaths that occur intra-operatively should be considered adverse events unless death is clearly expected and the surgery was of a heroic nature. Post-operative deaths will require review of the record for specifics, but in general all post-op deaths will be adverse events.

S19 Transfusion of Blood or Use of Blood Products

Return to Surgery

S20 Positive Blood Culture

A positive blood culture at any time during hospitalization must be investigated as an indicator of an adverse event, specifically a hospital-associated infection (HAI). 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 (eg 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. A surgical site infection is an adverse event.

S21 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 (eg prior procedure, urinary catheter at home or in long-term care) versus naturally occurring disease (eg community-acquired pneumonia).

S22 Post-Operative Increase in Troponin Levels Greater than 1.5 Nanogram/ml

A post-operative increase in troponin levels may indicate a cardiac event. Reviewers will need to use clinical judgment as to whether a cardiac event has occurred.

S23 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.

S24 Romazicon (Flumazenil) Administration

This refers to any of a number of complications, including but not limited to PE, DVT, decubiti, MI, renal failure, etc.

S25 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.

S26 Pathology report normal or unrelated to diagnosis

Normal pathology reports may indicate incorrect pre-operative diagnosis and unnecessary surgery, which would be an adverse event. Specimens need to match the preoperative diagnosis. Any deviation, look for possible adverse events.

S27 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.

S28 Occurrence of Any Operative Complication

This refers to any of a number of complications, including but not limited to PE, DVT, decubiti, MI, renal failure, etc.