NSG468 Wk4 UOPX Root Cause Analysis
Root Cause Analysis Worksheet NSG/468 Version 1 1 The Case Study A previously healthy 50-year-old man was hospitalized while recovering from an uncomplicated spine surgery. Although he remained in moderate pain, clinicians planned to transition him from intravenous to oral opioids prior to discharge. The patient experienced nausea with pills but told the bedside nurse he had taken liquid opioids in the past without difficulty. The nurse informed the physician that the patient was having significant pain, and liquid opioids had been effective in the past. When the physician searched for liquid oxycodone in the computerized prescriber order entry (CPOE) system, multiple options appeared on the list—two formulations for tablets and two for liquid (the standard 5 mg per 5 mL concentration and a more concentrated 20 mg per mL
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formulation). At this hospital, the CPOE system listed each choice twice, one entry with the generic name and one entry with a brand name. In all, the physician saw eight different choices for oxycodone products. The physician chose the concentrated oxycodone liquid product, and ordered a 5-mg dose. All medication orders at the hospital had to be verified by a pharmacist. The pharmacist reviewing this order recognized that the higher concentration was atypical for inpatients but assumed it was chosen to limit the volume of fluid given to the patient. The pharmacist verified the order and, to minimize the risk of error, added a comment to both the electronic medication administration record (eMAR) and the patient-specific label that the volume to be given was 0.25 mL (5 mg). For added safety, the pharmacist personally retrieved, labeled, and delivered the drug and a calibrated syringe to the bedside nurse to clarify that this was a high concentration formulation for which the volume to administer was 0.25 mL (a smaller volume than would typically be Source: The Joint Commission ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE. Revised 3/22/13. Accessed 10/07/2015: http://www.jointcommission.org/framework_for_conducting_a_root_cause_analysis_and_action_plan/ Root Cause Analysis Worksheet NSG/468 Version 1 2 delivered). Shortly thereafter, the nurse went to the bedside to administer the drug to the patient for his ongoing pain. She gave the patient 2.5 mL (50 mg) of liquid oxycodone, a volume that she was more used to giving, and then left for her break. A covering nurse checked on the patient and found him unconscious—a code blue was called. The patient was given naloxone (an agent that reverses the effect of opioids), and he responded well. He was transferred to the intensive care unit for ongoing monitoring and a continuous infusion of naloxone to block the effect of the oxycodone. By the following morning, the patient had returned to his baseline with no apparent adverse effects. The Commentary Medication errors in the hospital are all too common. Although it may seem that the only error in this case was the nurse giving the wrong amount of medication to the patient, many latent errors contributed to harm reaching the patient. Medication errors are rarely caused by failure of a single element or the fault of a single practitioner.(1) For example, in a root cause analysis (RCA) of a fatal medication error in which a nurse administered the wrong medication by intravenous route, an external review found four main proximate causes and multiple performance-shaping factors that contributed to the event.(2) To prevent similar errors from occurring, the reviewers identified more than 15 suggested changes that spanned the medication use system at the hospital.(2) Because medication errors are often multifactorial, analysis of errors should always identify Source: The Joint Commission ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE. Revised 3/22/13. Accessed 10/07/2015: http://www.jointcommission.org/framework_for_conducting_a_root_cause_analysis_and_action_plan/ Root Cause Analysis Worksheet NSG/468 Version 1 weaknesses in the system and corrective plans should include risk reduction strategies that span multiple processes. Systems Approach to Medication Errors The goal of a system-based analysis of errors is to discover underlying system failures that are amenable to correction. In their landmark study using a systems analysis of adverse drug events, Leape and colleagues identified several domains where underlying problems occurred. These domains included lack of information about the patient, drug stocking and delivery problems, and inadequate standardization.(3) Similarly, the Institute for Safe Medication Practices (ISMP) has identified 10 key system elements that have the greatest influence on safe medication use (Table 1).(4) Although other categorizations also exist, this commentary will use ISMP’s model to analyze the case. Readers who also wish to analyze errors in this manner can use a worksheet available on ISMP’s Web site (http://www.ismp.org/tools/AssessERR.pdf). Developing Effective Risk Reduction Strategies Identifying errors in the system may indicate where changes need to be made. There are two objectives of safe system design: (i) to make it difficult for individuals to make mistakes and (ii) to permit the detection and correction of errors before harm occurs.(3) However, designing effective strategies to make the system safer is difficult. It is easy to implement low leverage strategies (“weak” interventions) as a quick fix for an error. For example, a simple response to this case would be to tell the nurse to read the medication label and electronic medication administration record (eMAR) more carefully, the pharmacist to give better instructions, and the physician to be more careful when using the CPOE system. Such strategies are unlikely to prevent an error from occurring again as they rely on humans to avoid mistakes. Instead, higher leverage strategies (“strong” interventions) that prevent human errors from propagating through the system should be implemented. Source: The Joint Commission ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE. Revised 3/22/13. Accessed 10/07/2015: http://www.jointcommission.org/framework_for_conducting_a_root_cause_analysis_and_action_plan/ 3 Root Cause Analysis Worksheet NSG/468 Version 1 In the rank order of error-reduction strategies (Table 2), high leverage strategies create lasting change in the system. Fail-safes, constraints, and forcing functions are types of strategies that improve the system with minimal reliance on human vigilance and memory. On the other hand, providing education and information and drafting rules and policies are easy to implement but often rely on human vigilance. These low leverage strategies are likely to only be effective if combined with interventions that target systems issues.(5,6) System-Based Analysis A robust system-based analysis of this error might discover failures that are amenable to higher leverage solutions to prevent future occurrence. Rigorous analysis of medications errors should use the ISMP model and examine the 10 key system elements (Table 1). Applying the framework in the analysis of this case reveals a substantial number of failures and areas for clear system improvement. Patient Information Both the pharmacist and the physician in this case were likely unaware of key patient information which may have contributed to the error. For example, the physician may not have known the patient’s opioid-use history, such as which liquid opioid he used in the past, and thus could not reorder that specific medication and dose. It appears the pharmacist was not directly aware of the patient’s opioid use in the past and assumed the patient was a candidate for concentrated oxycodone. To prevent similar gaps in the future, the institution should ensure that information about a patient’s diagnoses, allergies and adverse reactions to medications (including the inability to tolerate specific formulations of medications), and patient-monitoring information is readily available to all practitioners. Drug Information Source: The Joint Commission ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE. Revised 3/22/13. Accessed 10/07/2015: http://www.jointcommission.org/framework_for_conducting_a_root_cause_analysis_and_action_plan/ 4 Root Cause Analysis Worksheet NSG/468 Version 1 5 All three practitioners lacked pertinent drug information to make safe decisions. The physician was unaware that liquid oxycodone comes in two concentrations, the pharmacist did not know that the concentrated product was not appropriate for an opioid-naïve patient, and the nurse, who was unfamiliar with the concentrated formulation, did not realize that the volume to be administered was indeed much less than to what she was accustomed. Multiple steps can be taken to prevent these knowledge gaps in the future. Up-to-date drug information should be available to all practitioners, and practitioners should know how to use these references. High-alert medications, such as concentrated oxycodone, should have additional safeguards that guide practitioners to their appropriate use. For example, a pain order set, guideline, or protocol could be used to identify when a patient is ready for escalation to more potent pain medications. Finally, restrict prescribing of certain medications, especially those that are used rarely, to specialized practitioners who are familiar with their use (e.g., a pain specialist in this case). Communication of Drug Information Not only were there issues with knowledge about the drug, but the lack of clear communication of drug information also contributed to the error. The list of choices that resulted when oxycodone was searched in the CPOE system was confusing. Even though there were four distinct oxycodone products, eight were listed due to duplication. Furthermore, the concentrated liquid was not sufficiently distinct from the regular product on that list. Unfortunately, the pharmacist and prescriber did not communicate on the intended plan for the patient to clear up the confusion. In response, the institution should ensure that when new products are added to a hospital’s formulary and built into the CPOE system and all aspects of the user interface should be examined. If medications are restricted to certain patient populations, that restriction should be reflected in the CPOE system. For example, if concentrated oxycodone is restricted to ordering by pain specialists, this drug should not Source: The Joint Commission ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE. Revised 3/22/13. Accessed 10/07/2015: http://www.jointcommission.org/framework_for_conducting_a_root_cause_analysis_and_action_plan/ Root Cause Analysis Worksheet NSG/468 Version 1 be available on the list of medications available to general practitioners in the CPOE system. There should be clear lines of communication between all practitioners. If a pharmacist or nurse has concerns about the appropriateness of a medication order, he should feel comfortable and obligated to question the prescriber. Drug Standardization, Storage, and Distribution The manner in which the medications were stored and distributed contributed to the error in this case as well. For distribution, the pharmacist dispensed the entire bottle of oxycodone, and the nurse was required to measure out the patient-specific dose. Ideally, medications should be dispensed from the pharmacy in the most ready-to-use form, which minimizes manipulation by the nurse. Pharmacies should dispense liquid medications that come in bulk bottles in unit-dose cups or oral syringes for those with standardized dosages or in oral syringes with the patient-specific dose already drawn into the syringe for the nurse. Staff Competency and Education Knowledge gaps in the safe use of opioids may have also contributed to this error. It is not clear if the physician, pharmacist, and nurse had adequate training on the optimal use of opioids for acute pain. According to an opioid knowledge assessment conducted by the Pennsylvania Hospital Engagement Network Adverse Drug Event Collaboration, practitioners of all levels had a weak understanding of important aspects of safe opioid use. The study suggests that organizations educate and assess staff understanding regarding effects of opioids on sedation and respiratory depression, differences between opioid-naïve and opioid-tolerant patients, indications for long-acting opioids, equianalgesic dosing among opioids, and required monitoring.(7) Patient Education Although it is not discussed directly in the case, the patient may not have been aware of the medication he was taking. Furthermore, he may not have been able to request the same opioid he tolerated in the past because he Source: The Joint Commission ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE. Revised 3/22/13. Accessed 10/07/2015: http://www.jointcommission.org/framework_for_conducting_a_root_cause_analysis_and_action_plan/ 6 Root Cause Analysis Worksheet NSG/468 Version 1 7 did not know the name. To help them prevent errors, patients and families should be empowered to detect medication errors by encouraging them to ask questions about their medications and the purpose of their medications and by explaining the safeguards that are being used to ensure they are receiving the right medication and dose. Quality Processes and Risk Management Lastly, more robust quality control processes may reduce the likelihood of this type of error. For example, the nurse did not have another practitioner independently double-check the medication before administering it. Although they should not be the only safeguard and should be used judiciously, independent double checks (the procedure in which two clinicians independently check each component of prescribing, dispensing, and administering a medication) can detect up to 95% of errors.(8) While the case does not detail the hospital’s processes surrounding identifying, reporting, and analyzing medication errors, all organizations should actively cultivate a culture in which error reporting is encouraged and non-punitive and leads to meaningful change. Using errors and near misses to identify systems issues should be done in an interdisciplinary manner. Proactive risk assessment tools, such as failure mode and effects analysis (FMEA), will help institutions ensure that new medications, processes, and services are implemented safely. Conclusion This case highlights the different system weaknesses that together resulted in an error harming the patient. Although it would be easy to fault the individuals involved, the absence of prescribing criteria for and restriction of concentrated oxycodone, the lack of a standard dispensing practice that minimizes nursing manipulation, and the need for staff education and guidance on such high-alert medications, among other factors, contributed to this event. To ensure all gaps in the system are addressed, a rigorous analysis using a model, such as ISMP’s Key Source: The Joint Commission ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE. Revised 3/22/13. Accessed 10/07/2015: http://www.jointcommission.org/framework_for_conducting_a_root_cause_analysis_and_action_plan/ Root Cause Analysis Worksheet NSG/468 Version 1 8 Elements of the Medication-Use System that is used here, should be employed. Furthermore, when designing changes, hospitals should adopt high leverage risk reduction strategies as much as possible. For example, instead of telling the nurse to read the label more carefully next time, the manipulation of the medication can be taken out of the nurse’s responsibility. Although the patient did not experience any lasting adverse consequences in this case, adopting strategies that address system weaknesses will decrease the risk that an error of this type will reach another patient. Take-Home Points • Medication errors are multifactorial; they are rarely due to only one failure mode or individual. • When analyzing medication errors, employ a systems approach by identifying weaknesses throughout the medication use system. • When choosing risk reduction strategies to implement, focus on those that do not rely on human vigilance or memory. • Use proactive risk assessment tools whenever new medications, processes, and services are implemented to prevent errors. Part I University of Phoenix Material Medication Mishap Root Cause Analysis Worksheet Complete the table below to analyze the Week 4 case study. The analysis questions in the table have been adapted from The Joint Commission’s Source: The Joint Commission ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE. Revised 3/22/13. Accessed 10/07/2015: http://www.jointcommission.org/framework_for_conducting_a_root_cause_analysis_and_action_plan/ Root Cause Analysis Worksheet NSG/468 Version 1 Root Cause Analysis and Action Plan Framework you reviewed in this week’s learning activity. Analysis Questions Considerations Root Cause Analysis Findings Root Cause (Y/N) What was the intended process flow? List the relevant process steps as defined by the policy, procedure, protocol, or guidelines in effect at the time of the event. Were there any steps in the process that did not occur as intended? Explain in detail any deviation from the intended processes. What human factors were relevant to the outcome? Staff-related human performance factors such as fatigue, distraction, etc. How did the equipment performance affect the outcome? Consider all medical equipment and devices. What controllable environmental factors directly affected this outcome? Consider things such as overhead paging that cannot be heard or safety or security risks. What uncontrollable external factors influenced this outcome? Factors the organization cannot change Were there any other factors that directly influenced this outcome? Internal factors What are the other areas in the organization where this could happen? List where the potential exists for similar circumstances. Was the staff properly qualified and currently competent for their responsibilities at the time of the event? Evaluate processes in place to ensure staff is competent and qualified. N/A N/A How did actual staffing compare with ideal levels? Include ideal staffing ratios and actual staffing ratios along with unit census. N/A N/A What is the plan for dealing with staffing contingencies? What the organization does during a staffing crisis N/A N/A Source: The Joint Commission ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE. Revised 3/22/13. Accessed 10/07/2015: http://www.jointcommission.org/framework_for_conducting_a_root_cause_analysis_and_action_plan/ 9 Root Cause Analysis Worksheet NSG/468 Version 1 Analysis Questions Considerations Were such contingencies a factor in this event? If alternative staff used, verify competency and environmental familiarity. Did staff performance during the event meet expectations? To what extent did staff perform as expected within or outside of the processes? To what degree was all the necessary information available when needed? Accurate? Complete? Unambiguous? Patient assessments were complete, shared and accessed by members of the treatment team To what degree was the communication among participants adequate for this situation? Analysis of factors related to team communication and communication methods Was this the appropriate physical environment for the processes being carried out for this situation? Proactively manage the patient care environment. What systems are in place to identify environmental risks? Were environmental risk assessments in place? What emergency and failure-mode responses have been planned and tested? What safety evaluations and drills have been conducted? How does the organization’s culture support risk reduction? Does the overall culture encourage change, suggestions, and warnings from staff regarding risky situations or problematic areas? What are the barriers to communication of potential risk factors? Describe specific barriers to effective communication among caregivers. How is the prevention of adverse outcomes communicated as a high priority? Describe the organization’s adverse outcome procedures. How can orientation and in-service training be revised to reduce the risk of such events in the future? Describe how orientation and ongoing education needs of the staff are evaluated. Root Cause Analysis Findings Root Cause (Y/N) N/A N/A N/A N/A N/A N/A Source: The Joint Commission ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE. Revised 3/22/13. Accessed 10/07/2015: http://www.jointcommission.org/framework_for_conducting_a_root_cause_analysis_and_action_plan/ 10 Root Cause Analysis Worksheet NSG/468 Version 1 Analysis Questions Considerations Was available technology used as intended? Such as: CT scanning equipment, electronic charting, medication delivery system, tele-radiology services How might technology be introduced or redesigned to reduce risk in the future? Describe any future plans for implementation or redesign. Root Cause Analysis Findings Root Cause (Y/N) Part II Read the Multifactorial Medication Mishap case study and the commentary that follows. Complete the root cause analysis worksheet to analyze the case. Write a 525 word APA formatted, cite-reference summary in which you: • • • Explain why a root cause analysis was appropriate for this situation. Analyze the impact of using tools like RCA, FMEA, and PDSA on the quality and safety of patient care. Summary section: Explain what you have learned. Cite a minimum of two peer-reviewed or evidence-based sources published within the last five years to support your summary in an APAformatted reference page. Source: The Joint Commission ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE. Revised 3/22/13. Accessed 10/07/2015: http://www.jointcommission.org/framework_for_conducting_a_root_cause_analysis_and_action_plan/ 11
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