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Hospital receipt sample for Quality Assurance

welcome to module 2 conducting an fmea before beginning we would like to acknowledge the assistance of ismp canada for their contributions in developing this presentation which includes material from the 2007 canadian failure mode and effects analysis framework upon completing this module you will be able to identify and reduce risks in your practice setting using fmea enhance patient safety and prevent harm from reaching your patients identify processes in pharmacy practice settings that are suitable for analysis using fmea and participate as a team member in an fmea and with experience be able to lead a team yourself an fmea is conducted in a systematic step-wise manner a typical fmea includes eight steps as shown on this slide we will go through each of these steps in this learning module the first step in an fmea is to select the process for analysis and assemble a team fmea can be very resource intensive so it is typically used for processes that represent a substantial risk to the organization it is important to clearly define the topic and specific processes for analysis a topic that is too broad can become overwhelming conversely if the focus is too narrow the project can fail to achieve the desired improvement outcomes what exactly do we mean by a high risk process this is a process that if it fails represents a significant risk in health care we generally consider this to be a risk of harming a patient high risk processes also include those that represent risk to staff or risks to the organization itself such as financial liability or damage to reputation how do you decide which high risk processes require an fmea there are often many places where organizations and individual practitioners know there are vulnerabilities this information may come from internal data such as medication incident reports or concerns expressed in a department or by a staff group organizations may also choose to undertake an fmea based on a follow-up to a risk identified externally such as through an ismp canada safety bulletin or news report of harm to a patient some examples of high-risk processes in health care include medication use operative procedures use of blood products restraint and seclusion care provided to vulnerable population groups such as children the elderly those with compromised immune systems such as cancer patients and any kind of emergency or resuscitation care in thinking about these broad categories you can probably think of specific processes within them that would present a high potential for harm if a failure occurred some examples of high-risk processes in pharmacy practice include the process for ensuring correct patient identification use of high alert medications such as anticoagulants opioids and others dispensing medications for children and assessing patients clinical needs related to ensuring a prescribed medication is appropriate or assessing the need for pharmacists initiated prescribing now take a moment to consider some examples of high risk processes in your own practice setting once you have determined the topic for analysis you can assemble your team it is important that the team be interdisciplinary including front line staff and leadership with representation from all the disciplines involved in or directly impacted by the process under analysis some teams may be smaller or larger depending on the scope of the project and whether there are staff performing multiple roles within a pharmacy sometimes there may be as many as six to eight people on a team especially in a hospital pharmacy however in community pharmacy the team is likely to be smaller it is helpful to include people who are naive or unfamiliar with the specific process being analyzed but have some general knowledge about the area under analysis in a community pharmacy french shop staff understand the overall process but are not directly involved and may have observed interactions with patients that may be important to the analysis in a hospital setting information technology or biomedical staff may have some involvement in the process and will be able to offer a higher level perspective typically the team has a leader a facilitator or advisor process experts a naive person and a recorder the leader is usually someone in a management position who has a stake in the analysis in community pharmacy this might be the dispensary manager or the licensee in a hospital pharmacy the dispensary manager or the director of the department might take on this role a facilitator or advisor is a person who can guide the team through the fmea process this is usually a person who has received training in fmea and understands the rationale for the stepwise process of fmea this could even be a staff pharmacist who has reviewed the system's approach to quality assurance for pharmacy practice a framework for mitigating risk teams often start trying to work on solutions as soon as the gaps become visible during process mapping without working through the process step by step a facilitator who understands how to conduct an fmea will help to keep the team on track so that important steps are not missed all teams require process experts these are frontline staff who understand how the process works on a daily basis and can speak to problems in the current process and comment on the proposed changes where possible include people from the organization who are able to take on a system level view in a community pharmacy you may want to consider inviting a community physician or a nurse practitioner depending on the process under analysis you may also want to consider including a patient representative to ensure process changes consider the patient perspective this might even be a non-pharmacy staff member who has been a patient in his or her community at some point in time and can provide the patient perspective lastly it can be helpful to designate someone to be the recorder an individual with good computer skills who can facilitate record keeping from the meetings the amount of time required to complete an fmea will vary with the scope of the project for a straightforward topic in a community pharmacy an fmea could be completed in one or two meetings of one to two hours for example a licensee identified that his patient population has very similar if not identical spelling of names the names also sound similar although he did not have any incidents related to dispensing the wrong drug to the wrong patient he prospectively reviewed the problem and implemented preventative measures he implemented the verification of the patient health care number against the hard copy prescription into his process a more complex fmea will take longer ismp canada is aware of an ambulatory case pharmacy that worked on a complex topic through weekly meetings for several months and the united states veterans affairs national center for patient safety estimates an average fmea in one of their hospitals requires 100 to 150 person hours to put this in perspective this will be six to ten hour meetings for an eight member team this would probably be typical for a hospital project involving multiple disciplines and departments once you have decided on a topic and assembled the team the next step is to diagram the process and sub processes related to your topic why do we do this as a diagram because diagramming helps all team members to see the process in the same way diagrams also provide a visual perspective and a picture truly is worth a thousand words a diagram also provides a visual focus helping to keep the team on track and prevent digression to other side topics how do you create a diagram of a process start by creating a flowchart using sticky notes first place a sticky note at each end describing the beginning and end of the process for analysis then add a sticky note for each additional component of the process it is important to chart the process as it is usually done not the way it is outlined in the policy and procedure manual for example think about the basic dispensing process it begins with a patient presenting at the pharmacy with the prescription and ends with the filled prescription being provided to the patient it is important to start with a high level overview of the process typically five to seven steps or components as shown here between the receipt of the prescription at the pharmacy and releasing it to the patient several other processes must take place the prescription must be entered into the computer system filled and labeled and stored for pickup while these components may seem obvious at this point when we break them down further as shown in the subsequent slides the complexity of various processes and opportunities for error become apparent in order to help keep track as you go through the analysis process number the processes and sub processes as you go along you will see in this slide that the process components have been numbered from one to five the next step is to select a component of the process to diagram in more detail the team conducting this analysis recently had a near-miss incident in which a prescription was almost given to the wrong patient so they had planned to focus on component 5 prescription is released to the patient now we can diagram the components of the sub process 5a patient request medication at pickup area 5b pharmacy staff member verbally repeats patient name 5c pharmacy staff member retrieves prescription from storage area 5d pharmacy staff member request second identifier 5e pharmacy staff member confirms two identifiers against prescription receipt 5f prescription is released to patient note that it is not uncommon for process diagrams to be more complex than illustrated in this example possibly including branching in addition to the main linear flow for example sub-processes of sub-processes here are some process tips to keep you on track label and number all process and subprocess components use different colored sticky notes as you move through the analysis steps when doing an fmea it is best to start with a simple topic first these beginning steps are often very eye-opening for first-time team members as they start to see just how complex their processes are if you pick a simple topic your diagramming should also be simple if you realize that the topic is too large consider redefining the selected topic to something more manageable your initial diagram will still be useful for seeing the interrelationships between different parts of the process the next step is to work as a team to brainstorm potential failure modes failure modes can be described as the whats that could go wrong potential failure modes or error modes can relate to people materials equipment methods and the environment examples of failure mode categories include quantity too little too much or partial for example only the patient's pharmacy profile or patient interview is used for patient assessment and net care was not reviewed availability missing or none for example it was out of stock timing too early too late for example it was a drug related problem not resolved at point of care quality the wrong element for example a patient or drug and effectiveness the desired outcome was not achieved for example the therapy does not work as well as intended how do you know what failure modes are possible this is where your process experts come in frontline staff will be able to tell you about their experience with the process and organizational leaders will be aware of department and organization-wide data you can also consider published literature including ismp canada and other safety bulletins and newsletters consider failures in other industries and try to think out of the box focus on plausible worst case scenarios while in theory death is the worst case outcome in reality this does not occur most of the time this slide shows a failure mode diagram with potential failure modes listed underneath each sub-process component in our example of the patient identification process the team has identified several possible failure modes under component 5a patient request medication at pickup area the team identified two possible failure modes number one the patient goes by more than one name such as a nickname or is usually called by their middle name and two the pharmacy staff member mishears the patient's name there were also two potential failures associated with the second component of this process in which the pharmacy staff member is expected to verbally repeat the patient's name these were number one the pharmacy staff member does not verbally repeat the patient's name and number two the patient does not identify the incorrect name used by the pharmacy staff member you can see from the diagram that not all components have the same number of failure modes again the failure modes are numbered this time with an alphabetic identifier it is important to number the failure modes to keep track later in the fmea but the order of the numbering is not important when thinking about failure modes it is helpful to remember that they are the whats that can go wrong in a process [Music] at this point you can transfer the failure modes from the diagram to an fmea spreadsheet the next steps use that spreadsheet and the spreadsheet can be a word or excel program projected on a screen or wall for the team to follow together or can be printed on large or small sheets of paper and handwritten we have now reached step four identifying the effects and causes of the potential failure modes in other words if the failure happened what would be the result or effect and what would cause a failure to occur [Music] let's start with the effects of the failure review each failure mode and ask if this failure occurred what would the effect be enter the results of the team's discussion into the spreadsheet as shown on the next slide this spreadsheet is what we use in an fmea for example for failure mode 5d1 pharmacy member does not request second identifier the team determined the effect to be incorrect prescription release to patient leading to the risk of harm for patient receiving incorrect prescription and loss of confidentiality for other patient remedication prescribed the second failure mode identified 5d2 patients with similar names at the same address was identified as having the same effect as 5d1 you can work across the spreadsheet one failure mode at a time or complete the effects for all the failure modes for one sub-process component and then move on to the failure mode causes and prioritization this part of the process is often quite fluid once the potential effects of a failure mode have been identified the next step is to consider why might the failure occur for each potential failure mode listed you and your team should be able to identify one or more causes of the failure this is sometimes referred to as prospective root cause analysis thinking about how particular adverse events might occur it is important to consider human factors principles when identifying causes this will help teams to identify design problems and or design features that could conflict with known human factors principles and therefore can lead to the failure modes while it is human nature to focus on the actions of practitioners at the point where they are providing direct care to patients the goal of fmea is to push the team to move towards the underlying system factors that could contribute to an incident but are not under the direct control of the practitioners caring for the patient ask questions such as why or how would this happen what could cause this how often could this happen this slide lists the causes that the team has identified for failure modes 5d1 and 5d2 in 5d1 pharmacy member does not request second identifier the team has identified the failure mode cause as identification is incomplete note in fact that this is the cause of the effect not the cause of the failure a possible cause of the failure might have been something like staff member distracted by another patient at the counter failure modes effects and causes can be tricky for 5d2 patients with similar names at same address the identified failure mode cause is that the second identifier used was not unique [Music] in summary failure modes are the what's that could go wrong and failure mode causes are the whys step 5 is about prioritizing in an ideal world you would be able to address all of the potential failures identified but in reality this is not possible we need a mechanism to identify those that are the most important teams should plan to act on sixty to seventy percent of the identified failure modes the following slides will show you how to decide which ones require priority action to prioritize failure modes assess each failure mode and assign them a numerical score for severity frequency and detectability multiply these three scores together to generate a criticality score this criticality score is also sometimes called a risk priority number beginning with severity this is a one to five score ranging from no effect to a severe or catastrophic effect frequency is an assessment of the likelihood that a specific failure will occur this is also a one to five score ranging from yearly to hourly frequency can be determined based on known data or may be based on the expertise of team members lastly consider detectability this is a tricky concept detectability assesses the likelihood that the failure would be detectable before the effect is known here are a couple of examples to help you understand this concept an everyday example of a detectability safeguard is a low battery alarm on a laptop computer in addition to a visual display of battery power the device sends a warning before the battery power falls below a critical level providing the user with an opportunity to save data before the operating system fails a pharmacy specific example would be the freezer sensors placed in shipping containers that are used to transport medications that are sensitive to temperature such as insulin and vaccines these products should not be used if it is possible that they have been frozen during transport while a failure has occurred in that the temperature has not been appropriately maintained during transport the sensor provides a warning to avoid the greater failure of administering the potentially ineffective product to a patient this slide shows the prioritization section completed both of these failure modes generated the same ratings for severity frequency and detectability resulting in criticality scores of 24 for both there are two important considerations related to the prioritization step first any failure mode with a severity score of five requires action regardless of the total criticality score if a failure could result in a catastrophic event action is required regardless of the frequency with which this might occur second once you have calculated the criticality scores for all the relevant sub-process components determine a cut-off criticality score the cutoff is based on an intention to take action on 60 to 70 percent of the identified failure modes with the highest criticality scores and cannot be determined in advance as the criticality scores will be different in every fmea this approach takes into account the fact that the risk is inherent in almost every process the key is to identify the risks that are unacceptable and have the greatest potential to cause patient harm so that the team can focus actions on areas where they will achieve the greatest benefit it is important to understand that criticality scores are unique to each fmea and they cannot be compared from one to another so if the highest scores generated in one fmea are in the 70s and in another they're in the 40s this does not indicate that one topic is necessarily more important or riskier than the other [Music] here are some process tips use the expertise of all of the team members and remember to consider a reasonable or plausible worst case scenario because the ratings are multiplied one or two points will have a significant impact on the criticality score if your team is not able to reach consensus you should always assign the higher rating fmea is a safety assessment so it is always better to overestimate than underestimate a failure mode and if you have trouble assigning ratings remember that it's okay to use your gut feeling or your expert judgment [Music] we are now getting to the purpose for conducting the fmea in the first place step 6 is about redesigning the process to address the potential failure modes as a reminder ing to solp 6.7 the licensee has a duty to make changes or take preventative measures promptly in response to a drug error if the protection of the public requires it preventative measures should also be undertaken if a potential risk has been identified regardless of whether an incident has occurred this can be addressed in three ways first mitigate harm or decrease the severity of the effect of a particular failure mode practically this is difficult to do if the failure occurs the harm is the harm secondly reduce or eliminate the failures that cause error this is about decreasing the frequency of the occurrence and lastly make the failure or error visible this is where the opportunity to mitigate harm comes in if the failure is detectable ideally before reaching a patient there is opportunity to change the patient outcome and ultimate effect of the failure when considering process redesign options it is important to consider the likelihood of long-term success this hierarchy of effectiveness illustrates the most and least effective strategies for change examples of forcing functions and constraints are found in pharmacy computer systems which will not allow you to process a prescription unless all the required fields have been filled in for example the allergy field automation and computerization are important supports for information management and for completion of repetitive tasks automated dispensing from pre-loaded dispensing machines into unit dose strip packages or vials is now also common vastly improving efficiency as well as accurate dispensing hospital pharmacists are more involved in simplification and standardization projects than community pharmacists examples include pre-printed or electronic order sets for common diagnosis such as pneumonia reminders checklists and double checks refer to the need for redundancies in systems to ensure safety checklists are helpful for complex processes to ensure that all the required steps have been completed for example the process for loading medications into an automated dispensing machine might be supported with a checklist posted on the machine lastly pharmacists and pharmacy technicians are all familiar with the need for double checks for example some pharmacies double count narcotics to verify the quantity dispensed in healthcare we have often focused on policy development in education and information without realizing that when used alone these are low leverage strategies for change because they don't change the underlying conditions that lead to error opportunities instead relying on individuals to remember the correct way to do something in redesigning processes attempt to use higher leverage strategies whenever possible also consider relevant literature and ensure that you are meeting practice standards when developing risk reduction strategies it is helpful to educate the team about this hierarchy as part of the fmea orientation and encourage team members to recommend the most effective solution that is reasonable and or possible given the circumstances this slide shows the actions proposed by the fmea team for the failure mode pharmacy staff member request second identifier for failure mode 5d1 pharmacy staff member does not request second identifier the team has suggested educating all pharmacy staff on the importance of correct patient identification and the need to follow proper procedures it is estimated that this could be completed within a month developing a standardized process requiring documentation of the second identifier used to verify the patient's identity is estimated to take one to three months posting information for patients explaining the identity verification process and the rationale and requesting their assistance in ensuring it takes place is also expected to take one to three months implementing a photo identification process for selected high alert medications for example methadone will likely take three to six months as a long-term goal the team has suggested assessing the opportunity to implement an automated double check of patient id such as bar coding if we look at these suggestions and compare them to the hierarchy of effectiveness you will see that these different strategies fall in different levels on the hierarchy of effectiveness for example automation through barcoding is a high leverage solution while education on following procedures is a low leverage solution when considering redesign options look for permanent fixes whenever possible recognizing that sometimes an interim solution may be required it may be possible to completely eliminate a component and this is a very strong action it is important to recognize that most actions are really controls on the system it is important that actions target the underlying problems offer long-term solutions and have a greater positive than negative impact on other processes and resources as well actions should be objective and measurable and achievable and reasonable actions should be clear and concise provide a long-term solution be objective and there should be a way of assessing their effectiveness once completed for example they should be measurable the smart acronym developed by george doran provides a quick way to evaluate actions specific measurable attainable realistic and timely to support monitoring of progress with implementation of recommended actions a summary table indicating the time frame for implementation individuals responsible and a measurement plan to assess success is helpful this table also ranks the strength of the action on the hierarchy of effectiveness you may or may not have the resources to implement all recommended actions remember to consider the strength of the action and how it may be related to best practices that should be implemented in the pharmacy [Music] step 7 is focused on analyzing and testing a new process to minimize the possibility of unintended consequences before implementing the recommended actions it is important to assess the impact of the proposed changes on the calculated criticality scores looking at an individual redesign option you can recalculate the criticality score to assess if implementing it would decrease the calculated criticality score there are a number of ways to analyze and test proposed changes if substantial changes are proposed to a process it is best to conduct an fmea of the redesign process simulation or usability testing are human factors tools to assess processes for unanticipated problems pilot testing is helpful to ensure a redesigned process will work as intended before moving to widespread implementation the model for improvement uses a plan do study act cycle also called small cycles of change to evaluate an improvement in a practice setting and make enhancements based on feedback that is received plan means to identify the underlying causes that result in the need for changes in processes and developing an action plan to implement the revised processes do refers to carrying out your action plan for your revised processes and documenting your observations act looks at identifying additional measures or changes that might be needed to your process study focuses on analyzing the results checking patient satisfaction and reviewing what worked and what didn't work with your new process once you figure this out you can repeat the plan do study act cycle again we have reached the final step of the fm ea process implementing and monitoring the redesign processes when developing and implementing an action plan with redesign processes it is important to consider how you will know you have been successful quarterly review of drug incidents is necessary to ensure changes implemented were successful in advancing patient safety and whether further safety strategies must be implemented to prevent future drug errors fmea provides a mechanism for assessing the error potential of strategies intended to enhance the safety of the system and can be used in response to an incident that has occurred or prospectively based on identified areas of potential concern the drug incident quarterly review report available on the acp website under practice resources drug error management should be used to document this quarterly review licensees are encouraged to review ismp canada safety bulletins as part of their quarterly review in order to gain insight into how to prevent similar errors from happening full implementation of a new process will take time and measuring for sustained improvement is critical to long-term success it is important to consider change management principles when planning and implementing changes including communicating the reasons for process changes and finding change agents to champion the new process it is vital to share results and celebrate successes and lastly monitor changes over time to ensure that changes are sustained monitoring is important for several reasons it provides feedback on whether the actions have achieved their objective and also provides a mechanism to ensure changes are maintained over time various strategies can be used to monitor process and assess impact drug error reports are one measurement strategy but since many drug errors are low frequency events lack of similar occurrences is not necessarily evidence of success proxy measures such as auditing compliance with implemented changes will also suggest ongoing vulnerabilities in systems for example auditing documentation of the second identifier and having the licensee or dispensary manager observe the process for releasing prescriptions to patients will identify if the changes are being maintained if not the team can meet to review the reasons why or take another look at the process to see if there is a different strategy that would work better acp requires that a quarterly review report be completed for drug incidents this same report can also be used to document whether actions have achieved their objectives as part of drug incident analysis or as part of an fmea that was initiated to prevent a drug incident from happening results from monitoring efforts also provide data that can be shared with staff about the impact of patient safety efforts it is also important to recognize it sometimes as changes are introduced for the purpose of reducing risk new risk may be inadvertently introduced ongoing monitoring is required because the new risk may not be identifiable until after the team implements the strategy additionally monitoring will help to identify process changes that are not a good fit resulting in workarounds with the potential to cause new errors you can see that fmea is a logical stepwise method of analyzing a process to identify and correct system vulnerabilities to reduce the potential for air and harm to patients it can be used on projects with wide-ranging scopes in any setting fmea goals and processes align with the standards for the operation of licensed pharmacies and the standards of practice for pharmacists and pharmacy technicians in alberta this slide illustrates a one-page summary of the fmea process that may be helpful for reference during fmea team meetings you can find this guide on page 22 of the system's approach to quality assurance for pharmacy practice a framework for mitigating risks to be successful fm ea teams should focus on high profile safety critical areas this creates the most impact from limited resources start with smaller projects and get success if you need to tackle a large safety initiative try to break it into manageable chunks fmea provides a real opportunity to engage frontline staff including team members with different perspectives and expertise is invaluable to success it also provides a great opportunity to encourage creative thinking undertaking fmea will assist pharmacy teams to meet the quality assurance objectives of the practice and operations standards the use of fmea creates many gains for organizations including fostering a safety minded culture and supporting prospective problem resolution to create fault tolerant systems fm ea also identifies opportunities to increase efficiency as well as quality last but not least fmea helps to engage frontline staff and improves team communication we hope you have enjoyed this presentation and will find fmea to be a useful tool for pharmacists pharmacy technicians and support staff in your practice setting working together we can proactively change processes to make them safer