No. The purpose of Patient Safety Leadership WalkRounds™ should be to discuss issues about patient safety only. Senior leaders may want to talk about other issues, such as budget, but this will only dilute the message that safety is a high priority. Other forums, even additional rounds, should be scheduled to discuss these other important issues. However, to promote open communication senior leaders should try to answer any question from a staff member that may come up.

The frequency should vary depending on the size of the unit or department. On large, busy units, where the staff and patients change often, Safety Briefings should be daily. However, on a small unit where the staff on duty or the patients may not vary much, weekly may work better. Talk with the staff and get their input as to a frequency for Briefings that is useful.

First, the manager should not have to routinely attend Safety Briefings. The briefings should be designed for staff to conduct on their own. However, whether a manager attends or not, there are several ways to collect information. Use a form to write down issues or suggestions, and have a staff member complete the form, perhaps rotating the task among all staff. Another alternative is to use 3x5 index cards, on which each staff member can write items down themselves. Allow people to remain anonymous with either option.

Before making a change to a process, estimate what you predict the new Risk Priority Number (RPN) will be. This will help you decide whether or not the change will be an improvement. Be sure to test the change first on a small scale to see if your predictions are correct. Once you decide to implement the change permanently, recalculate the RPN and report it in your data.

The interactive FMEA Tool is particularly useful in evaluating a new process prior to implementation and in assessing the impact of a proposed change to an existing process.

If the FMEA is complete, you should have a total Risk Priority Number (RPN) for each failure mode identified. Each step in the process may have more than one failure mode, so total the RPNs from each failure mode to determine the RPN for each step. Start with the steps that have the highest RPN, as they pose the greatest risk. Within each step, start first on the failure modes that have the highest individual RPN.

We do not have a specific tool for measuring heparin ADEs. However, some organizations have conducted baseline reviews using what are called "drill-down" triggers that focus on a specific medication or topic. Here are some tips for creating your own list of triggers to identify heparin ADEs:

• Meet with the team of hospital staff, including at minimum a nurse, a pharmacist, and a physician who work with heparin routinely.
• Make a list of the types of harm that could come to patients on heparin, e.g., bleeding and thrombosis.
• List occurrences that might be "clues" that one of these kinds of harm has occurred or almost occurred — these are your triggers. Examples are certain lab values or administration of vitamin K or blood products. Keep in mind that triggers are only attention grabbers; they do not always denote ADEs.
• Once you have your list of triggers, select a random sample of 20 records of patients who received heparin during their stay. Billing information from financial systems can often help you find heparin recipients.
• Use the same general guidelines as in the Trigger Tool for Measuring Adverse Drug Events, but review the patient records only for the triggers on your list.
• Count every ADE causing harm that is related to heparin, whether a trigger identifies the ADE or not. Do not count ADEs related to other medications.
• Track the data either per admission or per 1,000 doses of heparin.

As you implement improvements to reduce heparin ADEs, you can repeat this review and track the data over time. These steps can create drill-down triggers for both medication and non-medication issues.

The ADE measures in the Trigger Tool for Measuring Adverse Drug Events provide information about the level of medication-related harm occurring across an entire organization. In order to achieve a significant reduction in harm, the hospital needs to work on multiple changes simultaneously. It can conduct small tests of change on one or more pilot units and collect specific measures to assess success. For example, one pilot unit may test a sliding scale for insulin and measure something specific to that test, while another unit may be testing a different change and collecting different measures. While pilot units are testing various changes, the organization should continue to monitor its overall rate of harmful ADEs to assess whether or not the changes being tested are actually reducing harm.

The Trigger Tool for Measuring Adverse Drug Events is not designed to identify every harmful ADE that occurs, nor should it be expected to do so. A comprehensive list of triggers would be enormous and probably unworkable. The triggers listed in the ADE Trigger Tool represent only some of the clues associated with the most common harmful ADEs. You are encouraged to modify the list for your organization’s needs, deleting triggers that are never found and adding new ones based on your own data).

There are guidelines on how to obtain data on reconciliation errors from your patient records. Some of the errors you will find with these guidelines will have resulted in ADEs, but not all. Errors from reconciliation should be tracked as a separate measure from ADEs. When using the ADE Trigger Tool, it will help you measure your organization’s overall rate of medication harm. The harm you will find using the ADE Trigger Tool will have many root causes, including reconciliation errors. When collecting data for ADE measures, include all ADEs that you find, including those related to reconciliation errors.

Yes. Some medications have frequent and expected side effects. For example, narcotics commonly cause constipation. This known side effect can be prevented, or at least mitigated. Therefore, it should be classified as minor harm, which is Category E on the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index for Categorizing Medication Errors. Whether or not an ADE causes harm does not depend on whether or not it is expected. Narcotic-induced constipation may seem minor to a clinician but not to a patient.

We do not have a specific tool for measuring heparin ADEs. However, some organizations have conducted baseline reviews using what are called "drill-down" triggers that focus on a specific medication or topic. Here are some tips for creating your own list of triggers to identify heparin ADEs:

• Meet with the team of hospital staff, including at minimum a nurse, a pharmacist, and a physician who work with heparin routinely.
• Make a list of the types of harm that could come to patients on heparin, e.g., bleeding and thrombosis.
• List occurrences that might be "clues" that one of these kinds of harm has occurred or almost occurred — these are your triggers. Examples are certain lab values or administration of vitamin K or blood products. Keep in mind that triggers are only attention grabbers; they do not always denote ADEs.
• Once you have your list of triggers, select a random sample of 20 records of patients who received heparin during their stay. Billing information from financial systems can often help you find heparin recipients.
• Use the same general guidelines as in the Trigger Tool for Measuring Adverse Drug Events, but review the patient records only for the triggers on your list.
• Count every ADE causing harm that is related to heparin, whether a trigger identifies the ADE or not. Do not count ADEs related to other medications.
• Track the data either per admission or per 1,000 doses of heparin.

As you implement improvements to reduce heparin ADEs, you can repeat this review and track the data over time. These steps can create drill-down triggers for both medication and non-medication issues.

The pediatric age range includes children up to 18 years of age. The Pediatric ADE Patient Record Review Sheet was created with advice from pediatric hospitals and lists nine triggers. The pediatric triggers are identical to the triggers in the Trigger Tool for Measuring Adverse Drug Events except there are fewer of them because some adult triggers do not apply to the pediatric population.

Remember that the trigger itself is a signal or clue that helps to identify potential ADEs. Count events as ADEs only if they cause harm. It is not critical which triggers you use. Organizations can choose to modify the triggers to suit their patient populations.

Adverse drug events are outcome measures, while voluntarily reported errors are not. Data on the number of medication errors should be collected for qualitative learning since the error-reporting rate itself may be a reflection of the culture of reporting. Reviewing patient records alone to determine an error rate will not identify all errors, although more errors are identified with record reviews than by relying solely on voluntary reports. If your institution likes the current method of reporting and analyzing errors, it is fine to continue using it as long as you understand its limitations and interpret the data accordingly.

One tested method is monitoring the administration of glucose tablets, glucagons, or ampules of 50 percent dextrose. These treatments are often indicators of hypoglycemic events, which are sometimes ADEs. Automated reports from dispensing machines are handy monitoring documents. Another trigger is a laboratory blood glucose value of less than or equal to 50, which might also be reported automatically by a laboratory information system.

The review of patient records for ADEs and reconciliation can happen at the same time, or records can be reviewed first and then reconciled. The two reviews do not have to happen simultaneously, but sometimes it is easier to select one set of patient records and use them for both reviews. Also, the same group of staff does not have to review the records for both ADEs and reconciliation. If a pilot unit will be working on reconciliation, then a team with staff from that unit may want to participate in the reconciliation review.

Yes, an adverse drug event (ADE) identified without a trigger does count when calculating the ADE measures. Triggers help to identify some of the more common ADEs but will never identify all of them. Since the purpose of the measure is to monitor overall harm from medications in the organization, every ADE discovered should be included, regardless of how it was found.

Data collected with the ADE Trigger Tool should be from a small, random sample that comes from your overall population, so it may not identify a specific area of harm. It is best to start with one high-hazard medication, so consider first reviewing self-reported adverse drug events from the previous six months to see if any one medication stands out. If not, just start with the high hazard medication used most frequently or in the greatest volume in your organization.

The review of patient records for ADEs and reconciliation can happen at the same time, or records can be reviewed first and then reconciled. The two reviews do not have to happen simultaneously, but sometimes it is easier to select one set of patient records and use them for both reviews. Also, the same group of staff does not have to review the records for both ADEs and reconciliation. If a pilot unit will be working on reconciliation, then a team with staff from that unit may want to participate in the reconciliation review.

The reconciliation review methods currently included on IHI.org focus only on reconciliation of prescription medications. Once you have clearly established your reconciliation review process for prescribed medications, you can then add herbals, vitamins, and other supplements to the review process. Provide a separate space on the admission medication order form to list these types of drugs, perhaps with a default order not to continue them so that these drugs are considered reconciled without a call to the physician.

Not necessarily. When comparing admission orders to medications a patient was taking at home prior to admission, it is critical to take into account not only what was omitted, but why. Deliberate omission of a medication is not a reconciliation error. For example, if a patient is admitted to the hospital due to drug toxicity or a complication from a drug taken at home, that is a valid clinical reason why it is not included in the admission orders. To determine whether there was a reconciliation error, see if there was adequate documentation in the patient record so that the nurse or pharmacist did not have to contact the physician for clarification about the missing drug. If the physician had to be contacted, then this should be counted as a reconciliation error, but if the documentation was clear, it is not an error.

Ideally, all medications that the patient takes at home and will need in the hospital should be included with the initial admitting orders. However, with multiple physicians caring for the patient, that is not always the case. This process should not be considered an error as long as all staff clearly understand what the process is and follow it. However, if nurses need to call and remind physicians to order a medication, then considered this a reconciliation problem and count it as an error in your reconciliation review.

There are guidelines on how to obtain data on reconciliation errors from your patient records. Some of the errors you will find with these guidelines will have resulted in ADEs, but not all. Errors from reconciliation should be tracked as a separate measure from ADEs. When using the Trigger Tool for Measuring Adverse Drug Events, it will help you measure your organization’s overall rate of medication harm. The harm you will find using the ADE Trigger Tool will have many root causes, including reconciliation errors. When collecting data for ADE measures, include all ADEs that you find, including those related to reconciliation errors.

The process for reconciling medications in outpatient settings (including the Emergency Department for patients who are not admitted) is a bit different than the process for inpatient transitions.

First, a medication list must be collected. It is important to know what medications the patient has been taking or receiving prior to the outpatient visit in order to provide quality care. This applies regardless of the setting from which the patient came — home, long-term care, assisted living, etc.

The medication list should include all medications (prescriptions, over-the-counter, herbals, supplements, etc.) with dose, frequency, route, and reason for taking it. It is also important to verify whether the patient is actually taking the medication as prescribed or instructed, as sometimes this is not the case.

At the end of the outpatient visit, a clinician needs to verify two questions:

1. Based on what occurred in the visit, should any medication that the patient was taking or receiving prior to the visit be discontinued, altered, or held pending consultation with the prescriber?
2. Have any new prescriptions been added today?

These questions should be reviewed by the physician who completed the procedure when one occurs, or the physician who evaluated and treated the patient.

If the answer to both questions is “no,” the process is complete.

If the answer to either question is “yes,” the patient needs to receive clear instructions about what to do — all changes, holds, and discontinuations of medications should be specifically noted. Include any follow-up required, such as calling or making appointments with other practitioners and a timeframe for doing so.

When patients are recurring outpatients, a medication list can be kept on file rather than re-created on every visit. Each time the patient comes for a visit, the list should be re-verified for any additions, deletions or changes to medications, doses, frequencies, routes and alterations from original prescription or instructions.