Project #85923 - FMEA IMPROVEMENT PLAN (I NEED TO EDIT THIS)

Root Cause Analysis And Outcome

 

 

 

A root cause analysis (RCA) is the primary tool hospitals turn to when looking for the cause for errors in healthcare. Additionally, a root cause analysis is required to be performed by the Joint Commission on all sentinel events like this unfortunate case with Mr. B.  As defined by the Joint commission, “Root cause analysis is a process for identifying the factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event.  A root cause analysis focuses primarily on systems and process, not on individual performance.  The analysis progress from special cause in clinical process to common causes in organizational processes and systems and identifies potential improvements in these process or systems that would tend to decrease the likelihood of such events in the future or determines, after analysis, that no such improvement opportunities exist” (Jointcomission.org 2015).

 

The root case analysis is focused on system error, instead of the individual at fault. It may have seem, that the RN was at fault for not applying the monitoring blood pressure cuff.  Improvement of the system can greatly reduce overall system errors, and decrease potential for human error.

 

A plan of action is to develop a change theory to formulate an improvement plan, to prevent future occurrences similar to Mr. B's case. And discuss how the FMEA plan can improve quality patient care.

 

                                               

 

 

 

                                   

 

Root Cause Analysis

 

 

 

            In the case of Mr. B, a 67 – year old patient, we are investigating the events, involving his treatment in the emergency department.  Mr. B was brought to the hospital by his son, he was noticed to be in severe pain. Upon assessment by nurse J: Mr. B’s vital signs on arrival are blood pressure 120/80, heart rate 88 and regular, temperature 98.6, and respiratory rate 32, his weight was 175 lbs. No known allergies was reported, neither, any history of past falls. He appears to be in distress; his left leg is evidently shorter, with swelling in the mid calf, limited range of motions, chemosynthesis and excruciating pain.

 

This could possibly indicate hip displacement. Mr. B’s past medical history includes: impair glucose tolerance and prostate cancer. Mr. B’s resent visit to his primary provider indicated elevated cholesterol and lipids. His current medications are atorvastatin and Oxycontin for chronic back pain.

 

            The case continues with the ER doctor, (Dr. T) implementing treatment with pain medication. Nurse J proceeds with the order and administer diazepam 5mg IVP to Mr. B at 4.05pm. On further assessment, the medication failed to have any effect on the patient.

 

Dr. T instructs Nurse J. to administer hydromorphone 2mg IVP, it was administered at 4.15pm. Again, the pain medication did not have any effect on the patient. Five minutes after Dr. T, then instructs nurse J, to administer another 2mg of hydromorphone IVP and an additional 5mg of diazepam. Dr. T then manipulated the relocation and alignment of Mr. T’s hip. At 4.25pm the patient appeared sedated and reduction of his left hip was in place. Mr. B was placed on an automatic b/p cuff q 5 minutes monitoring. However, the patient was left without oxygen support.

 

            At 1443, Mr. B’s son comes out of the room to report that the monitor was

 

alarming. Nurse J finds Mr. B not breathing; no palpable pulse can be detected; a blood pressure reading of 58/30, and pulse oximetry reading 79%. The code blue team was called and resuscitative efforts were enforced. Mr. B was found having ventricular fibrillation. Mr. B was intubated, defibrillated, and stabilized with all life sustaining measures. After 30 minutes of intervention, a return of, a normal sinus rhythm and the blood pressure was recorded as 110/70.

 

            Upon the families, request Mr. B was transferred to a tertiary care facility for advanced care. After several days, the receiving hospital notified the rural hospital, that the EEG’S interpreted that he suffered brain death. The family decided to remove life-support and Mr. B died.

 

            The root cause analysis encountered in this case arises three questions; in order to identify underlying causes that contributed to the occurrence of this horrific event. Dr. T decided on moderate sedation, but what happened? What lend to this sudden radical change in this patient’s death?

 

            In my intensive care unit, there is a policy that requires continuously monitoring of the patient before, during, and after procedure. The policy specifies continuous monitoring of q 15minutes of blood pressure, ECG, and pulse oximetry, adequate oxygenation for supportive care.

 

            The causative factor 1: that is encountered, in this case is the nurse’s failure to provide continuous monitoring of the patient’s vital signs and thus providing supportive measures. Causative factor 2: was the drug of choice. Moderate sedation is used to alter the level of consciousness of the patient, this enables the patient to maintain independent airway. Dilaudid, aka hydromorphine was used causing depressed and shallow respirations; further more lending to respiratory distress in some patients. I believe this procedure caused respiratory distress in Mr. B.

 

            The emergency department has six rooms, with two nurses, (one RN and one LPN), one secretary and one ER MD. A licensed vocational nurse should not be working in this department. This is a unit that requires critical thinking, advanced skills and enables safety to each patient. Mr. B required moderate sedation; he needed one to one monitoring of both the RN and the MD. Instead Mr. B was left unattended. Both the RN and the LPN was also discharging patients, as well as receiving another critical patient. This indicates unsafe workload and a failure to accurately document an admission and assessment report.

 

            Causative factor 3: The staffing for the ED was insufficient to meet the rising acuity level. An RN and a LPN does not safely provide quality patient care. Furthermore, the RN should have attended the alarm; who however, was busy with an admission of another patient in respiratory distress.

 

            Another error that led to the death of Mr. B is negligence. Although the patient is unconscious and under the support of machines, he was left alone with his son. The hospital should have ensured that at least one nurse; especially nurse J was left to care for Mr. B. The ER MD failed to place the patient on a ventilator. It is usually of utmost importance, to place a patient with abnormal ABG results and apnea on a ventilator. In Mr. B’s case neither was initiated!

 

 

 

                                   

 

 Root cause analysis has revealed several points; this was not evident in in Mr. B’s case. The doctor’s method of action was not per hospital protocol; also the patient was not monitored during the recovery phase. The data provided showed no sedation level assessment. An LPN is not qualified to monitor a sedated sedation patient.  Under normal circumstances, RN J should have done a neuro assessment, and monitor the patient’s vital signs q 15mins. If this was done, the Nurse J would have noticed the drastic change in Mr. B’s level of consciousness and decline in respiratory distress.

 

The code blue team would have been initiated; with reversal agents and cardiac failure could have been adverted.  An outlier is noted in this case, the patient’s left leg has a bruise and the calf is swollen. If this was a true (DVT) deep venous thrombus, it could have been dislodged during manipulation of the hip, causing a large emboli.  The emboli could have blocked blood flow to the heart, leading to a (PEA) pulse-less electrical activity. It is evident that the staffing; was inadequate and is the most important root cause for this case.

 

RCA:

 

 1. Inadequate staffing, lack of communication and proper documentation

 

 2. Sedation protocol training

 

 3. Post sedation monitoring

 

 4. LPN monitoring post sedation patient

 

 

 

 

 

 

 

                                               

 

                                                B. Improvement plan

 

            Every six months, training should be enforced to improve the care that nurses provide on a day to day basis to patients. Special training should be in place for Rn's and MD to ensure sedation protocol is carried out. One of the most important goals for all health care providers is to ensure patient's safety and comfort. Treating pain and anxiety that accompany the chief complaints are critical to patient satisfaction and patient care. A code team should always be present in the Emergency room. Staffing issue needs to be address. Heavy work - load affects patient care and safety. Nursing work load also contributes to errors, high work load in the form of time pressure which may reduce the devoted nurse’s attention to critical changes as seen in Mr. B's case. The hospital should have 2 RN's available. Importantly hospital policies and procedures will enforce protocols regarding conscious sedation. Implementation of stricter protocols regarding conscious sedation: will be effective immediately, procedural guidelines will be conducted per protocol.

 

B1 Change Theory

 

Kurt Lewin’s change theory of nursing can be applied to this case study. Lewin’s theory has three main concepts, “unfreezing, change, and refreezing” (Nursing-theory.org, 2015). The following schematic visualizes how change theory is intended to work for the purpose of this paper (Image.slidesharecdn.com, 2015)

 

Lewin's process of change creates the perception that a change is needed when moving to wards a new level of behavior, this model serves as a modernized model for change.

 

Unfreezing: before a change can occur, it has to go through this stage. Many members may be come resistant to new change. The primary goal of unfreezing is to create an awareness of acceptance. Communication is imperative during the phase. Employees are encouraged of the importance of staying motivated and supporting change in an organizational system.

 

Change: this is the transition in which organization move into a new state of improvement. Individuals start to learn new behaviors and way of thinking. Employees are constantly reinforced of how beneficial the change will be to both patients and the health care workers.

 

Refreezing: this act solidifies the new state after the change is in place. This step is in place to ensure, that people do not fall back into old ways of thinking.

 

 

 

 

 

 

Initially the system is known as an “equilibrium”, in which everyone feels they are doing everything they can, and the system seems at its best.  Motivation is a keen target here. Something like this can inject motivation for staff enabling “unfreezing” of the system.  The diagram above can be broken down into individual parts. This indicates when components are needed or not needed or may be missing.  At this point a new system can be engineered and disseminated culminating with refreezing the system and ensuring that the new methods are in place. The root cause analysis directly points to inadequate staffing, as a main root cause to this event. 

 

Change theory directs staff to build relationships with all team members, thus, building trust and nonjudgmental attitudes.  This ensures that all parties work together to a find common solution.  Second would be the acquisition of data and how often the hospital is short staff.  With sufficient data, the multidisciplinary team and management should conduct a meeting.  The focus of the meeting is to select a solution and ensure that the event will not happen again.  When a goal is attained, then implementation and refreezing in the new system can occur. 

 

Many facilities with a 60 beds unit operate with a nursing supervisor who ensures safe workflow.  If the ER RN becomes overwhelmed, then the nursing charge nurse is available for additional help.  I believe this should be implemented into the change plan.  Another change action secures a minimum of two RN’s; and an LPN to fulfill needs when the ER becomes hectic. 

 

The ER Doctor and RN needs to collaborate as a team, and have a formalized plan of action on how to proceed and seek assistance when needed. Special training should be enforced to both the RN and the MD regarding sedation protocol.

 

 

 

C: FAILURE MODES AND EFFECT ANALYSIS

 

            Failure Mode Effect Analysis (FMEA) is a valuable tool in this quest to reduce and eliminate defects. FMEA uses systematic methods to evaluate a process for identifying where and how it might fail, and to gauge the potential impact of different types of failures. FMEA then acts to identify the parts of the process that are most in need of change. FMEA provides an in-depth investigation of the following:

 

  • Steps in the process
  • What could go wrong
  • Why might the failure happen
  • What would be the consequences of each failure                   
  •                                                             C 1:                                                                             Major deviations occurred during the course of Mr. B's emergency room visit. Failure to comply with hospital policies and procedures regarding conscious sedation, lack of knowledge regarding medication administration, and inadequate staffing ratios, Organizational Systems, Error and hazards that were contributing causative factors, by the individual health care team members. Recruit a multidisciplinary team. Creating a team of cross-functional experts with knowledge about the process, product or service and the customer’s needs. The pre-steps for FMEA ensure positive outcomes for the entire process and form a multidisciplinary team. It is imperative to identifying the root cause as a team, while comparing with other hospitals and further databases. This is an excellent means of testing if the change theory plan will work in the ER from this case study. The members of my FMEA and RCA team will be an interdisciplinary group of nurses that work in ER, Doctors in ER, hospital supervisors, staffing coordinator, RT, pharmacist, director of nursing, and medical director.  This group will provide a broad knowledge on the problem along with administrative power to enact change                                            

 

                                                            C2. PRESTEPS:

 

           

 

            Select a process to evaluate with the FMEA, in this case it is poor staffing and lack of educational support regarding sedation protocol and policies. The primary cause of failure in this scenario is the failure of the healthcare team members to follow the conscious sedation protocol: This report will focus on education of all staff members. The team will gather and evaluate all internal and external data, scope of practice and clinical practice guidelines as outlined by the Board of Registered Nursing. All current hospital policies and procedures as it relates to conscious sedation.

 

           

 

           

 

                        C3. Have the team together to list all of the steps in the process

 

 

 

The three steps of FMEA are severity, occurrence and detection. Severity is how bad the outcome is. Occurrence is likeliness that this will occur. Detection looks at how easy it is to visualize.  Each member of the team will “assign a numeric value (known as the Risk Priority Number, or RPN) for likelihood of occurrence, likelihood of detection, and severity” (App.ihi.org, 2015).  The formula is The Risk Priority Number, or RPN, is a numeric assessment of risk assigned to a process, or steps in a process, as part of Failure Modes and Effects Analysis (FMEA). The team assigns each failure mode a numerical value from 1 to 10. This numerical grading quantifies a likelihood that the failure will occur, likelihood that the failure will not be detected, and the amount of harm or damage the failure mode may cause to a person. (Institute for Healthcare Improvement 2004.)

 

            FMEA provides an effective approach for the healthcare industry, to ensure protection of the health and safety of patients and the healthcare practitioners. This approach has been adapted and designed to go well with the needs of the health care industry. This method is preferred because it offers solutions to the identified risk in order to eliminate them and the allowance of improvement for the process over time. It is useful in the control of the products designed for the patients to ensure maximum benefits as well as safety. It takes into consideration the culture of the health setting, ensuring that it promotes a culture of safety in the hospital system. Vulnerabilities in the patient care system are explored, and improvements made out of the results, such as the use of electronic patient records. This makes information more accessible and easy to store as compared to the manual filing system. In addition, this technique allows for patient and health care professional education on safety issues. It is also beneficial as it involves identification of potential failures before they occur, which could be devastating for a sensitive industry such as healthcare. Prioritizing these failure modes based on the severity of their effects ensures redesign of the processes to avoid possible priority failure modes, which are also detected and dealt with early (Joint Commission Resources Inc.,

 

2005). The result is the implementation of a new control process that aims at providing quality goods and services.

 

 

 

                        C4 Implementation And Intervention

 

 

 

            Individual Health Care members: Implementation of stricter protocols regarding conscious sedation: Effective immediately, procedural guidelines will be conducted per protocol.  Recommendations: Respiratory Therapist will be present during procedure, until patient meets discharge criteria. Within 10 days the conscious sedation protocol will be reviewed and evaluated by the committee, to ensure safe and best practices are being implemented. Within 30 days of this report, all staff including RN's, LVN's and MD's will be educated on the facility's conscious protocols. Updates and reviews of conscious sedation protocols will be reviewed by ED staff, every 90 days, and then every annually 6months. Yearly educational update will include: conscious sedation protocol, medication administration, and knowledge of the mechanism of action.

 

            Facility Factors: Identifying protocols for safe staffing ratios: Effective immediately, the nursing supervisor will be notified of any emergency rescue transport to the facility. Within 10 days of this report, safe nursing to patient ratios will be implemented. Within 30 days policy and implemented which assist in the determination of when to place ER on divergence. An understaffed department affects the capabilities of the emergency room to deliver safe and effective patient care.

 

            I believe the primary cause of failure in this scenario is the failure of the healthcare team members to follow the conscious sedation protocol: This report will focus on education of all staff members.

 

           

 

            D.  DISCUSS THE KEY ROLE NURSES WOULD PLAY IN IMPROVING     THE QUALITY OF CARE IN THIS SITUATION:

 

            A nurse, provide holistic care and ensures change in day-to-day work environment.  Nurses are the first person who identifies a crisis situation. Nurses should be continuously educated on best evidence.  They are encouraged to follow hospital protocol and thus maintain safer patient care.

 

            The team (RN and LVN) will gather and evaluate all internal and external data, scope of practice and clinical practice guidelines as outlined by the Board of Registered Nursing. All current hospital policies and procedures as it relates to conscious sedation are to safely be carried out by an RN and MD.

 

                                                Conclusion:

 

            My plan for this ER would ensure that two RNs are on duty and an LPN is made available as needed. A system should be in place to increase staffing in the ER. Conscious sedation training must be implemented for both doctors and nurses in the ER.  A protocol must be filled out with each procedure. This would all be FMEA tested and applied with change theory as the driver.

 

                                               

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Due By (Pacific Time) 10/15/2015 12:00 am
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