Description of Event: A patient presented to the Emergency Department with the complaints of hip and leg pain. The patient rated the pain 10/10 on the standard pain scale. His (L) leg appeared shortened with swelling, ecchymosis, and limited range of motion. The leg was stabilized and then he was further evaluated and discharged to a room in the nursing department.
The patient was also noted to have a history of impaired glucose tolerance and prostate cancer. The patient’s current medications were atorvastatin and oxycodone for chronic back pain. The patient was placed in a room and prepared for a procedure. The physician evaluated the patient and proceeded to order Valium, when unsuccessful hydromorphone was ordered. The patient had not achieved appropriate sedation for the procedure and additional medication was ordered.
The patient was not placed on a cardiac monitor and a baseline oxygen level was not obtained prior to the administration of sedatives. The patient was receiving “Conscious sedation” in order for the physician to perform a manipulative procedure. The patient eventually had a decrease in oxygen saturation and became hypotensive- an arrest occurred. The patient was resuscitated and then transferred to a tertiary center. The patient was found to have brain damage and after several days, the family removed the patient from the ventilator and the patient expired. [pic] [pic]
Conscious sedation training for all physicians in the ED Conscious sedation training for all Nursing Staff in the ED Competency completion regarding conscious sedation. Barriers: Unwillingness to accept change and alter staff levels in the ED Availability of nursing staff Lack of trained nursing staff Possible Questions from the Team? Should staffing consistent of (2) RN’s at all times in this ED setting? What training does the physician have in conscious sedation? Was the supervisor called for additional staffing to the area? What hospital policies, procedures, or guidance documents will be reviewed? Conscious sedation policy Staffing guidelines for the Emergency Department
Regulatory standards regarding the administration of Conscious Sedation Personnel records of staff involved to assess education and competency levels Team members should be assigned to be responsible for obtaining and reviewing required Documents. What is the final understanding of what happened? Causal statements: Statement #1 The policy and procedure for conscious sedation administration was not followed leading to inadequate monitoring of the patient receiving conscious sedation and subsequently harm to the patient eventually leading to the patient’s death. Does everyone on the team concur? Yes What individual is responsible? Team Does Management concur with this action and outcome measure? Yes Outcome Measure:
What will be measured, monitored, observed, or tested? Policy and Procedure compliance, competency, education, staffing compliment in the ED How many observation records, charts, chart entries, devices or tests will be conducted? Direct observation for period of (3) months for a goal of 100% compliance. 100% compliance with completion of education and monitoring of changes in the staffing compliment in the Emergency Department. How frequently will they be reviewed? d Period of at least (3) months How long will the measurement last? Ongoing in respect to staffing What level of compliance is expected? 100% compliance should be expected. Date measure tested? As determined by team
Are the test results satisfactory? Outcome should be reported to the PI/Quality Committee and the ED committee- eventually reporting to the governing body for review and discussion regarding the outcome and compliance. Lessons learned: |What needs to be shared? |Who needs to |How |Who is responsible? |When | | |Know? | | | | |Staffing changes in the ED|Unit Manager/Staff |Education of |Chief Nursing |By (Set date) | |/Communication concerns | |Staff.
Direct |Officer/Clinical Director| | | | |Observation | | | |Policy and Procedure on |Staff of the ED/Supervisor/ED|Education/Direct |Chief Nursing |By (Set date) | |Conscious Sedation |physician |Observation |Officer/Clinical | | | | | |Director/Unit Manager/ED | | | | | |Physician Director | | Pennsylvania Patient Safety Authority, 2010) Improvement Plan based on Lewin’s Change Theory: Change Theories can prove to serve as a useful foundation for nurses charged with informing stakeholders and overcoming resistance to new care delivery practices. The champions as well as the potential opponents to change must be identified. Delegation of responsibility for project related activities must occur. Someone must take on the role of the leader in order for change to be successful. Application of the Unfreezing stage: In respect to this event, the issue that needs to be corrected is the appropriate administration and monitoring of patients receiving Conscious Sedation.
Secondly, the appropriate staffing compliment needs to be in a Critical area such as the Emergency Department. The resistance to change will involve staff, education completion, and compliance with the facility Conscious Sedation policy and procedure. Application of the Moving Stage: The Unit Manager of the Emergency Department needs to embrace her role as a leader and institute change regarding appropriately trained staff within the Emergency Department. She will need to ensure that the appropriate education regarding “Conscious Sedation” takes place and that staff are competent to administer and perform. The ED Medical Director will have to do the same with the physicians.
The physicians must also review the policy and perform “ Conscious“Conscious Sedation “ according“according to the policy and procedure of the facility. Staffing will need to be monitored for compliance. Staff will need to be educated regarding when to call for assistance when working in the Emergency Department. Completion of education and annual competency will need to be documented. Formulation of a conscious sedation checklist to be used to ensure compliance with appropriate monitoring. Application of the Refreezing Stage: Observations during “ Conscious“Conscious sedation” will need to take place to ensure compliance with the policy and procedure of the facility.
Monitoring of staff education compliance and competency will need to take place by the Unit Manager to ensure compliance. The Unit Manager will need to assess staffing in the Emergency Department on a daily basis to ensure appropriate coverage. Customer satisfaction surveys and patient outcomes will need to be monitored to assess the results of this intervention. Failure Mode and Effects Analysis (FMEA) The FMEA is used to proactively identify and reduce risk points that may lead to patient safety issues during a process. Assessment of the systems in place enabling the facility to systematically identify risk points that increase the potential for patient safety issues to occur.
The FMEA is an effective technique for assessing processes prior to taking place to assure risk areas are assessed and addressed prior to an event. The use of the FMEA has been recommended by organizations such as the Joint Commission and other patient safety organizations(organizations JCAHO(JCAHO, 2009). TOPIC:Prevention of Patient Injuries/Death during the administration of ConsiousConscious Sedation Team Members: LeaderChief Nursing Officer RecorderAdministrative Secretary MemberQuality/Risk Manager MemberEmergency Department Medical Director MemberEmergency Department Unit Manager MemberNursing Shift Supervisor MemberNurse J MemberLPN on duty MemberDr. T Review the Process: Develop a flowchart of existing processes, listing all process steps.
This will assist in the next step of the FMEA process, when “Failure Modes” will be identified. [pic] #1 [pic] #2[pic] Brainstorm Potential Failure Modes, Causes, and Effects: Review what could go “wrong” at each step noted above. Evaluate the Risk of Failure, or Hazard Score The risk of failure and its effects are composed of three factors in an FMEA: Severity Probability of Occurrence Detection Capability Severity is the consequence of the failure should it occur The Probability of Occurrence is the likelihood of a failure mode occurring The Detection rating is our ability to catch the error before causing the patient harm Severity Rating Scale Rating |Description |Definition | |10 |Extremely dangerous |Failure could cause death and/or total system breakdown | |9 |Very dangerous |Failure could cause permanent injury and /or serious system disruption | |8 | | | |7 |Dangerous |Failure causes minor or moderate injury with a high degree of customer | | | |dissatisfaction and/or major system problems requiring repair | |6 |Moderate danger |Failure causes minor injury with some customer dissatisfaction and/or major | |5 | |system problems | |4 |Low to Moderate danger |Failure Causes minor injury or no injury but annoys customers and/or results | |3 | |in minor system problems that can be overcome with minor modifications to | | | |system or process | |2 |Slight danger |Failure causes no injury and customer is unaware of problem however the | | | |potential for minor injury exists, little or no effect on system. | |1 |No danger |Failure causes no injury and has no impact on system | (Goodman, S. L. , 1996) Occurrence Rating Scale |Rating |Description |Definition | |10 |Certain probability of occurrence |Failure occurs at least once a day; ailure occurs almost every time | |9 |Failure is almost inevitable |Failure occurs predicatably;or, failure occurs about once every 4 or 4 days | |8 |Very high probability of |Failure occurs frequently; or failure occurs about once per week | |7 |occurrence | | |6 |Moderately high probability of |Failure occurs about once per month | |5 |occurrence | | |4 |Moderate probability of occurrence|Failure occurs occasionally; or, failure once every (3) months. | |3 | | | |2 |Low probability of occurrence |Failure occurs rarely; or, failure occurs about once per year. |1 |Remote probability of occurrence |Failure almost never occurs; no one remembers last failure. | (Goodman, S. L. , 1996) Apply the refreezing stage: Detection Rating Scale |Rating |Description |Definition | |10 |No chance of detection |There is no known mechanism for detecting the failure | |9 |Very remote/Unreliable |The failure can be detected only with thorough inspection and this is not | |8 | |feasible or cannot be readily done. | |Remote |The error can be detected with manual inspection but no process is in place so| |6 | |that detection can be left to chance, | |7 | | | | |Moderate chance of detection |There is a process for double checks or inspection but is not automated and/ | |5 | |or is applied only to a sample and/or relies on vigilance. | |4 |High |There is 100% inspection or review of the process but it is not automated. | |3 | | | |2 |Very high |There is 100% inspection of the process and it is automated. |1 |Almost certain |There are automatic “shut offs” or constraints that prevent failure. | (Goodman, S. L. , 1996 Risk Priority Number The Risk Priority Number is equal to the Severity X Occurrence X Detectability The Risk Priority Number will be from 1 to 1000. Failure modes with RPN scores < = 100 are generally considered minor scores and might not be considered further by the team when and action plan is created. In this case: The Severity was rated a “10” (Highest Severity) Probability was rated a “7” (High) Detection was rated a “5” (Moderate) Therefore the RPN for this failure mode is 10x7x5 = 350 (High)
All RPN scores added together for all the failure modes is the total grand RPN score. This is the baseline for other comparisons. The total for this issue is 1, 250. Process scores can only be compared to themselves, not against other processes. Action Plan: • Review and Update Policy and Procedure on Conscious Sedation • Staff/Physician education on conscious sedation • Observation of compliance with policy and procedure on appropriate monitoring during the administration of conscious sedation. • Development of a Conscious Sedation checklist that includes all required monitoring elements. • Staff changes within the ED department to include (2) critical care trained RN’s. Staff education regarding communication with the supervisor when there is a need for additional staffing within the department. The RPN should be recalculated after implementation of the action plan to compare with the first FMEA analysis. All lessons learned should be reviewed and presented to the team. The team should be motivated throughout the process to ensure successful completion of the project. In conclusion, there were obvious areas that could be improved upon in this scenario. The patient’s death could have been prevented. The FMEA with RCA can be useful tools to evaluate any issues such as this and most importantly prevent repeat occurrences. References Goodman, S. L. (1996).
Design for Manufacturability at Midwest Industries, Harvard Business School, February 2, 1996, Lecture McDermott, Robin E. (1996). The Basics of FMEA, Productivity. Pennsylvania Patient Safety Authority, (2010). Retrieved from http://patient safety authority. org Wachter R. M. (2007). Understanding Patient Safety New York, NY: McGraw- Hill Professional ———————– Patient admitted to the ED Conscious sedation ordered Oxygen saturation /EKG not monitored Nurse left bedside Alarm not addressed/patient not reassessed Patient coded Patient transferred Patient expired Presentation Of patient requiring conscious sedation in the ED
ED RN administers conscious Sedation as ordered by the ED physician Patient monitored By BP monitor. No EKG monitor/ No Pulse Ox monitor No RN assigned to monitor patient post conscious sedation administration Supervisor not called for assistance from the ED staff Presentation Of patient requiring conscious sedation in the ED ED RN administers conscious Sedation as ordered by the ED physician No RN assigned to monitor patient post conscious sedation administrationNo detection of physiological changes. Supervisor not called for assistance from the ED staff Only (1) RN trained in conscious sedation in the ED Only (1) critical care trained RN in the ED.