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Protection Through Prevention –
A Study in Root Cause Analysis of Patient Safety Events 1
Protection Through Prevention –
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Protection Through Prevention –
A Study in Root Cause Analysis of Patient Safety Events 2
3) Building Corrective and Preve...
Protection Through Prevention –
A Study in Root Cause Analysis of Patient Safety Events 3
we know for sure is our Event (w...
Protection Through Prevention –
A Study in Root Cause Analysis of Patient Safety Events 4
patient care, and to understand ...
Protection Through Prevention –
A Study in Root Cause Analysis of Patient Safety Events 5
	
Examining to Find “Why” the Ev...
Protection Through Prevention –
A Study in Root Cause Analysis of Patient Safety Events 6
So in this first step we are loo...
Protection Through Prevention –
A Study in Root Cause Analysis of Patient Safety Events 7
same patient and medication. Lab...
Protection Through Prevention –
A Study in Root Cause Analysis of Patient Safety Events 8
Determining What Root Causes Rel...
Protection Through Prevention –
A Study in Root Cause Analysis of Patient Safety Events 9
preventative measures. There are...
Protection Through Prevention –
A Study in Root Cause Analysis of Patient Safety Events 10
Quality for adherence to the ne...
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Protection through Prevention - A Study in Root Cause Analysis of Patient Safety Events

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In this case study, a medication error is examined that affected one patient, could have affected two patients (due to swapped medications) but the quick response by the treatment team stopped the second error before it occurred, to understand the needs of both the RCA itself and those performing the analysis.

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Protection through Prevention - A Study in Root Cause Analysis of Patient Safety Events

  1. 1. Protection Through Prevention – A Study in Root Cause Analysis of Patient Safety Events 1 Protection Through Prevention – A Study in Root Cause Analysis of Patient Safety Events Edward Skompski VP, TapRooT® PURPOSE: As we on focus patient safety during this week I though it prudent to examine one of the more important aspects of providing a safe environment of care for our patients, the use of Root Cause Analysis (RCA) to prevent future events. If we perform very thorough objective analysis, we can build corrective and preventative measures that will improve our systems and reduce or remove the chances for future similar events. In this case study we will examine a medication error that affected one patient, could have affected two patients (due to swapped medications) but the quick response by the treatment team stopped the second error before it occurred, to understand the needs of both the RCA itself and those performing the analysis. My goal with this example is to provoke thought, raise questions, and provide guidance with some solutions that will ultimately help you perform better analysis in the future and thus create a safer environment for your patients, staff, and community. I will be using the TapRooT® methodology in this case study as this is the process I have used for over 20 years and is the one process that I know that provides the most objective, consistent and thorough analysis. If you would like more information on our process, the techniques mentioned below, or the overall TapRooT® process you can visit www.taproot.com or contact me at skompski@taproot.com or (865) 696-0329 and I will be more than glad to help you improve your analysis program. BASIC CASE DESCRIPTON: The case I am using today is a situation where we had a medication error (wrong medication, wrong patient). The situation deals with many aspects of medication administration from orders from practitioners, storage of the medica- tions (two medications were stored together), the labeling used on medications along with the patient IDs and other possible issues that impact the situation. This case did not end up in permanent harm but the wrong medication did reach a patient thus providing this hospital with a Sentinel event. This required an analysis to determine the causes. Within the case there are many threads that impacted performance yet could go undetected if the correct ques- tions were not asked and the correct information is not collected. This case study is a real incident with information changed to protect the location and identities of those involved. ROOT CAUSE ANALYSIS: I would like to begin my looking at the needs of the RCA practitioner and of the RCA process before we dive into the study itself. When looking at investigations as a whole there are truly three phases that are used during any analysis: 1) Understanding “What” Happened – This is the data gathering phase where we start with a basic understanding of the situation, most times beginning with a lack of information, and have to find out the other details that tell the entire story. 2) Examining to Find “Why” the Event Happened – This phase is for analysis only. We should have all the pertinent information gathered and organized before entering this phase. Once here we begin the process of determine what the Causal Factors and Root Causes are for the event. This is where the investigator has to perform a very objective, thorough and credible analysis.
  2. 2. Protection Through Prevention – A Study in Root Cause Analysis of Patient Safety Events 2 3) Building Corrective and Preventative Measures to “Fix” the Root Causes – This phase requires a laser focus to- wards the root causes being fixed and the overall bigger picture of the organization and its systems. If we leave any one root cause in the system, we allow for the chance for future occurrence of the same type of event. As the RCA practitioner works through the process of investigating any event there needs to be a thorough and objective process for addressing each of these above. In the following sections we will dive into each “Phase” and demonstrate how we should approach each to ensure that our analysis will help us identify the true root causes and build better fixes and measures to create a safer environment of care. Understanding “What” Happened Let’s first look at the summary of the incident as reported to the hospital: On 3/31/15 at 1645 the incorrect medication was administered to Patient Sandy Smith, 60-year-old Female, DOB June 18, 1954. Medication provides was Clonidine .1mg. Proper medication should have been Klonipin 1mg. The medication provided was for patient Sarah Smith, 60-year-old Female, DOB July 18, 1954. The nurse returned to medication room, noticed Nurse 2 searching for Clonidine, immediately returned to the room of patient, noted the wrong medication, medication was discontinued immediately. The nurse states that both medications appeared to be for the same patient as doses and multiple administration are not uncommon. The incident was reported to the treating Physician. From this report we can begin to get a picture of the situation but I believe it is clear that there is a lot of missing in- formation. The first step in this phase of the investigation is to prepare for data collection and begin organizing what we need, what we know, and what we do not know. This level of organization is key to success in the later phases. If we began to look for root causes with only this information there is no way to ensure that our analysis is thorough, credible or objective. First let me introduce a simple tool we use called SnapCharT® which is a flowcharting tool we use to organize data. We use shapes to represent differing types of information and to organize the data so that it makes since in the con- text of the event. Below you will see an initial Planning SnapCharT® based on the initial report above. This chart will show that we have many gaps in information due to the limited information provided. Those gaps are represented with the gray “dashed” shapes throughout the chart. You will note in the sequence of actions at the top we have a some “dashed” box representing missing information about the steps in the process. There are multiple “dashed” ovals representing areas where we need more descriptive information about an action. One of the items
  3. 3. Protection Through Prevention – A Study in Root Cause Analysis of Patient Safety Events 3 we know for sure is our Event (which is represented by the circle or target). This has a solid line around it noting that we have confirmation that this happened. All of this information, what we know and what we do not know helps us organize and develop our plans for data collection. From this basic understanding of the event we can now start to determine who would we want to interview and what data we need to collect to determine what happened. Our initial list might look something like this: The first question raised in my mind is, “Is this enough?”. The answer is likely a strong no. We are only scratching the surface if we focus only on the obvious answer based on the report. To thoroughly address all aspects of this event let’s look at a philosophy I call “Working Your Way Around the Target”. This concept has always helped me determine a full list of those people that have influence or knowledge of the situation. Each concentric ring on this target represents a layer of information that can be gathered to truly understand the bigger picture. By taking a slice through this tar- get we can gather all the information necessary to adequately examine the situation and draw very objective conclusions regarding “What” happened. Each layer provides different information: Those Involved (Bullseye) – This group of individual will have direct knowledge of the event and can provide you with the most accurate data direct data. This group needs to be interviewed or be given the opportunity to write a state- ment as soon as possible (without putting the patient or staffer at further risk) Those Near the Event (Second Ring) – These people can provide knowledge of what they may have witnessed, heard, seen, felt, smelled, or otherwise noticed at the time of the event. This should not be considered “direct” knowledge of the event, but can used to either disprove or confirm information provided by those involved. Subject Matter Experts (Third Ring) – Individuals in this area will not be providing any information about the actual event. Interviewing or talking with this group will provide information regarding how a situation “should have been handled” or how things “can be done”. These could be other practitioners, nurses, doctors, technicians or anyone with knowledge of the process. Again this data is used to better understand the processes around an event. Administration and Management (Outer “Dotted” Ring) – I know many of you noticed the “dotted” nature of this ring. There is a specific reason I put this into a “dotted” line. In our organizational process (will be discussed shortly) we use a “dotted” line to represent Assumptions or Unconfirmed Data. With that in mind, when I mention talking to Administration or Management we are looking to determine their “Expectations” for work, their “Beliefs” regarding 1) Nurse 1 2) Nurse 2 3) Patient 1 4) Treating Physician
  4. 4. Protection Through Prevention – A Study in Root Cause Analysis of Patient Safety Events 4 patient care, and to understand what messages are being sent from the top to those involved in the situation. Many times the messages sent, the expectations communicated can be very different from those communicating the mes- sage and those hearing the message. Based on this model, let’s reexamine our list of interviewees: The list now shows more depth and covers the entire process not simply the medication administration. Now by gathering this information we begin to see the bigger picture and examine all possible things that impact the situa- tion. Please note that during the process of interviewing and gather information we will likely expand this list based on the input. This list is not fixed but can be fluid. In addition to the interviews above we will likely have a list of other information to collect. This could include (but not be limited to): a) Any rules, policies or documents that govern medicine administration b) Copies of the EMR or Doctors orders and treatment documentation c) Examining the processes in the Pharmacy d) Examining the processes around medications at the treatment site e) Training information around all staff involved f) And any other relevant documentation or information It is clear to see that if we simply focus on those directly involved we in no way can see the overall big picture. All of this data is used to paint a thorough picture of the situation and to remove any “dotted” lines from our Snap- CharT®. Below you will find the example of a finished SnapCharT® for this situation. With this chart completed we now understand “What happened” and can move into the “Why” phase of the investigation. 1) Patient 1 2) Patient 2 3) Nurse 1 4) Nurse 2 5) Patient Family 6) Other patients (if this was not a single patient room) 7) Other nurses on shift at same ward or station 8) Pharmacist 9) Pharmacy Tech 10) Doctor (treating physician) 11) Other Nurses (who work in same area) 12) Charge Nurse 13) Hospital Administrator
  5. 5. Protection Through Prevention – A Study in Root Cause Analysis of Patient Safety Events 5 Examining to Find “Why” the Event Happened Causal Factors As we enter this analysis phase we are looking at determining two things, first what are the Causal or Contributing Factors to the event, then secondly determining the root causes of those factors. The basic premise here is if we identify all Causal or Contributing Factors, then determine the root causes for those factors and eliminate them, we in turn eliminate the event from occurring in the future.
  6. 6. Protection Through Prevention – A Study in Root Cause Analysis of Patient Safety Events 6 So in this first step we are looking to examine our SnapCharT® to determine what information that led directly to the event or made it more severe (or did not mitigate the situation). Not all information is going to have a direct impact on the event, we will find positive things that happened, we will find out information that provides clarity but has zero impact on the event or outcome. But there will be things identified that will stand out as having a direct impact on the event happening or being more severe. Examining the chart above, I have identified three items (with a Triangle) as being direct causal or contributing factors to the event (I also included the other information attached to each item): 1) Medication labels misidentified as the same patient and medication. Labels both read S. Smith, one had DOB Jun 18, 1954, one had DOB Jul 18, 1954, One Clonidine .1mg, one Klonipin 1mg 2) Nurse 1 retrieved the wrong medication. There was no second check of labels, this is common practice during high census and has become accepted by supervision. Also the assumption was made that multiple medications in same bin were extra doses (common). 3) Nurse did not complete the 5 rights, required by policy, also a common practice accepted by supervision with no observations provided by management to ensure use of policy. So to check, I can ask a simple question about each of these items; If I remove the issues above, could we keep this event from happening? So If the labels could have been easily identified as separate patients and medications could we have prevented the error? If the nurse had retrieved the correct medication could we have prevented the event? If the nurse had performed the 5 rights (even after selection of the medication) could she have caught the error and prevented the event? The answer to all three questions is “Yes”, so these all contributed to the event. Now, before moving towards the analysis, many times people will look at these causal factors and automatically blame the nurse. That is the incor- rect approach! We need to first look at the actually causes (system-based) before we can simply say that someone “messed up” or “erred”. Based on the information we collected it certainly looks like there are system related issues that caused the nurse to make mistakes. Examining to Find “Why” the Event Happened Root Cause Analysis Now that we have identified the causal or contributing factors and confirmed their impact we can move into per- forming the Root Cause Analysis. Within our process the idea is to remove all causal or contributing factors to an event. By doing so we would remove the event itself from our system in the future. So in this example we would find the root causes of each causal/contributing factor. This methodology of focusing on the smaller issues that caused/ contributed to the event aids the investigator in staying focused. If we were to try to examine the entire event at one time, there is a significant chance we might miss something. But through focusing on one smaller issue at a time we can maintain strict focus and complete the analyses thoroughly. With our Root Cause Tree® and Dictionary we provide a tool that provides a consistent path (used the same way for each causal or contributing factor), that has strict definitions (contained in our Dictionary) for every step in the Root Cause Tree® process which provide standardization between investigators and investigations. Different people investigating the same incident with the same data independently can come to the same conclusions because of the “data” focus of the process and the removal of “opinion”. Below is a graphical example of the analysis of causal/contributing factor “Medication labels misidentified as the
  7. 7. Protection Through Prevention – A Study in Root Cause Analysis of Patient Safety Events 7 same patient and medication. Labels both read S. Smith, one had DOB Jun 18, 1954, one had DOB Jul 18, 1954, One Clonidine .1mg, one Klonipin 1mg” ……. Deciding the type of causal/contributing factor you have Deciding what systems had impact on this Human Performance Issue
  8. 8. Protection Through Prevention – A Study in Root Cause Analysis of Patient Safety Events 8 Determining What Root Causes Relate to the factor being analyzed As we analyze through the process we utilize strict definitions at every level allowing the investigator to remain ob- jective. If there is data on the SnapCharT® to support answering yes to a cause on the Root Cause Tree® you sim- ply select it or if you don’t have that data, you cross it off and move on to the next. This process helps you provide a defendable path for the analyses. Following this tool, we find the following root causes for the three factors: 1) Medication labels misidentified as the same patient and medication. Labels both read S. Smith, one had DOB Jun 18, 1954, one had DOB Jul 18, 1954, One Clonidine .1mg, one Klonipin 1mg a. Labels Need Improvement b. Policy for Labeling Medications is not strict enough 2) Nurse 1 retrieved the wrong medication. There was no second check of labels, this is common practice during high census and has become accepted by supervision. Also the assumption was made that multiple medications in same bin were extra doses (common). a. Policy Not Used – Enforcement Needs Improvement 3) Nurse did not complete the 5 rights, required by policy, also a common practice accepted by supervision with no observations provided by management to ensure use of policy. a. Policy Not Used – Enforcement Needs Improvement b. Infrequent Audits & Evaluations Now we have some specific system related items to work on fixing. Any one of which would keep this event from occurring in the future. Building Corrective and Preventative Measures to “Fix” the Root Causes Now that we have gathered our information, organized it, understand the causal/contributing factors and have identified the root causes we need to develop our corrective and preventative measures. Each root cause needs to be addressed by a change and improvement to our systems. From the analysis above, I will choose several root cause to provide an example of how we create corrective and
  9. 9. Protection Through Prevention – A Study in Root Cause Analysis of Patient Safety Events 9 preventative measures. There are two tools we can use, one called Corrective Action Helper® is built into our system and provides guidance on correcting and preventing every root cause identified on the Root Cause Tree®. This tool can be accessed and used as a “Starter” for the actions. The pictures shown come from the TapRooT® software which allows simple access to these tools and techniques. The root causes I want to use for this example are: 1) Medication labels misidentified as the same patient and medication. Labels both read S. Smith, one had DOB Jun 18, 1954, one had DOB Jul 18, 1954, One Clonidine .1mg, one Klonipin 1mg a. Labels Need Improvement b. Policy for Labeling Medications is not strict enough Many times the first gut reaction to these root causes is to propose the following action: 1) Relabel the medications 2) Retrain the nurse and others on the new labels 3) Re-emphasize why closely examining the labels is important and to be more careful What do you think of these actions? Do they truly change the system enough to make a difference? And do the actually address the problem? I think everyone knows the answer. I would also like to show one other deficiency in these “gut reactions”, anytime we see a “Re” corrective action it should tell you that you have done these actions before and that it is likely that they did not work as you had the same problem again. As we build corrective and preventative actions for these causes I want to consider creating SMARTER corrective actions: S – Specific M – Measureable A – Accountable R – Reasonable T- Timely E- Effective R – Reviewed for Unintended Consequences These simple criteria can get you away from the “gut reaction” type actions and also help you avoid the “Re” cor- rective actions. By making sure that the action you create meets these 7 criteria, you have a much better chance of preventing issues in the future. By using SMARTER how can we address these items. Here is an example of a SMARTER corrective action to address these two root causes. 1) Revise the current labeling policy to provide additional data on medications prior to leaving the Pharmacy. Change the Pharmacy label requirements to include the following no later than April 15, 2015: a. Patient Full Name: Last, First, Middle Initial (bold font as this is key indicator) b. Print the Patient full DOB directly under name: Full date Month day, 4-digit Year (bold font as this is key indi- cator) 2) XYZ Label application will need to be revised to add these new labeling standards and checked by PI and
  10. 10. Protection Through Prevention – A Study in Root Cause Analysis of Patient Safety Events 10 Quality for adherence to the new policy prior to April 15, 2015. 3) Communicate the labeling changes to all staff members through in-service meetings. All meetings to be held before April 15, 2015 4) Interim measure to include an alert to all physicians and staff regarding this incident to raise the level of awareness for this issue and implement a second check on all medications to be continued until the new labeling standard is implemented in Pharmacy and new labels appear in the system. The second check should be done by an independent party outside of the continuum of care. This multitier approach will meet all of the criteria above in SMARTER and will certainly have a much better chance of success. We would then address the other remaining root causes from the analysis provided to ensure success. CONCLUSION The RCA process used by your facilities has to have multiple levels of analysis to truly identify the causes of Patient Safety related incidents. From robust data gathering and organizational tools, consistent objective root cause anal- ysis tools, and SMARTER tools to help you build the most effective corrective actions that will address and prevent these problems in the future. These tools all working in harmony with your systems will create a much safer environ- ment for patient care. If you would like to learn more about our TapRooT® process, our training, additional tools and software please feel free to contact me. Thank you for taking time examine this issue and I hope that you have been able to learn some useful tools and tips to aid you in your RCA process. Edward Skompski VP, TapRooT® www.linkedin.com/in/edwardskompski www.taproot.com skompski@taproot.com (865) 696-0329

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