Week 6 Practice Problem Analysis and Presentation

nursing presentation and need the explanation and answer to help me learn.

Week 6
Practice Problem Analysis and Presentation
The purpose of this assignment is to critically evaluate a practice problem idea you identified. This assignment builds on the Week 4 assignment. Information used in the Week 4 assignment may be used as a basis for this assignment. The goal is to develop a deeper understanding of the identified practice problem idea, using two continuous quality improvement tools, specifically, a Failure Mode and Effects Analysis (FMEA) and an Ishikawa (fishbone) cause and effect diagram to analyze, improve, and mitigate related risks. This assignment will allow you to apply competencies through sequential development of workflow steps in relation to an identified practice problem idea and promotion of presentation skills. Assignment content supports professional formation, communication, and dissemination skills relevant to the DNP-prepared nurse.
This assignment has four components:
Identified practice problem idea in PICOT format
Failure Mode and Effects Analysis
Ishikawa (Fishbone) cause and effect diagram
Professional PowerPoint with speaker notes at the bottom of each slide to disseminate information
Follow these guidelines when completing each component of the assignment. Contact your course faculty if you have questions.
Consider the identified practice problem idea used in the Week 4 translation science project including PICOT, background, and significance. Incorporate course faculty feedback from the Week 4 assignment.
Review the examples of the failure mode and effects analysis and fishbone diagram in the Week 4 Explore section of the course called Evidence-Based Practice: Improving Outcomes.
Download the required documents inserted in the guidelines:
Link (PPT): PowerPoint TemplateLinks to an external site.
Link (Word doc): Failure Mode and Effects Analysis TemplateLinks to an external site.
Link (Word doc): Ishikawa Fishbone Template ALinks to an external site. (Word 2016 or higher)
Link (Word doc): Ishikawa Fishbone Template BLinks to an external site. (older version of Word)
Complete the failure mode and effects analysis and then the Ishikawa fishbone diagram. The Ishikawa fishbone diagram requires Word 2016 to download. If you do not have the Word 2016 version, you may update your current version of Word (click on the following link for instructions: Office 365Links to an external site.) or use the alternative version provided or create your own fishbone diagram as long as you are addressing the five areas:
Create the PowerPoint Presentation.
The assignment should include the following components. Use the templates provided for the assignment.
Introduction (1 slide)
Title of Practice Problem Analysis Presentation
Student Name
Assignment Title
Course Faculty Name
Practice Problem Identification (1-3 slides)
State identified practice problem as a PICOT question in question format.
Identify all PICOT components.
Describe the background and significance of the identified practice problem idea (cited).
Develop inclusion criteria for the population of interest.
Develop exclusion criteria for the population of interest.
Failure Mode and Effects Analysis (1-2 slides)
Identify three steps in the identified practice problem idea process with potential breakdown or process gaps.
Identify at least one potential error (failure mode) for each of the three process steps.
Identify at least one possible cause of failure (failure cause) for each of the three process steps.
Identify at least one adverse consequence (failure effect) for each of the three process steps.
Using a scale 1-10, rate likelihood of occurrence of failure for each process step.
Using a scale 1-10, rate likelihood of detection of failure for each process step.
Using a scale 1-10, rate likelihood of severity of harm if failure occurs for each process step.
Calculate the Risk Profile Number (Multiply likelihood of occurrence X likelihood of detection X likelihood of severity or harm).
Summarize FMEA analysis.
Note: The following article has scoring guidelines for FMEA ratings which may be helpful.
Warnick, R. E., Lusk, A. R., Thaman, J. J., Levick, E. H., & Seitz, A. D. (2020). Failure mode and effects analysis (FMEA) to enhance safety and efficiency of Gamma Knife Radiosurgery.Links to an external site. Journal of Radiosurgery and SBRT, 7, 115-125.
Ishikawa (Fishbone) Cause and Effect Diagram (1-2 slides)
Identify people involved in the identified practice problem idea.
Identify the environment in which the identified practice problem idea occurs.
Identify the materials used.
Identify the methods used.
Identify the equipment used.
Summarize cause and effect analysis.
Evidence-Based Intervention (1 -2 slides)
Identify the evidence-based intervention for your identified practice problem idea (listed in PICOT).
Identify barriers to overcome based upon what you learned from the FMEA and Fishbone Analyses.
Discuss feasibility of the evidence-based intervention.
Conclusion (1 slide)
Summarize the purpose and findings of the analysis.
Provide and justify the main conclusions.
Draw inferences from the quality improvement analysis.
References (1 slide)
Include in-text citations used in the presentation.
Provide complete matching references in correct APA format.
Include minimum of four scholarly sources.
Length: Maximum of 14 slides
Standard English usage and mechanics
APA format guidelines for in-text citation and references
Clear, succinct, and readable slides
Elaboration on the slide questions
Speaker notes section with legible comprehensive notes for each slide
The late assignment policy and the reuse repurpose policy (located in the student handbook) apply to this assignment.
This assignment enables the student to meet the following program competencies:
Applies organizational and system leadership skills to affect systemic changes in corporate culture and to promote continuous improvement in clinical outcomes. (PO 6)
Appraises current information systems and technologies to improve health care. (POs 6, 7)
This discussion enables the student to meet the following course outcomes:
Assess the impact of informatics and information technology on organizational systems, change, and improvement. (PCs 2, 4; PO 6)
Design programs that monitor and evaluate outcomes of care, care systems, and quality improvement. (PC 4; PO 7)
Appraise consumer health information sources for accuracy, timeliness, and appropriateness. (PC 4; PO 7)
Resolve ethical and legal issues related to the use of information, communication networks, and information and patient care technology. (PCs 2, 4; PO 6)
Requirements: 14 slide power point max. APA presentation.
Journal of Radiosurgery and SBRT Vol. 7 2020 115Jour. of Radiosurgery and SBRT, Vol. 7, pp. 115-125 © 2020 Old City Publishing, Inc.Reprints available directly from the publisher Published by license under the OCP Science imprint,Photocopying permitted by license only a member of the Old City Publishing Group.CliniCal investigationFailure mode and effects analysis (FMEA) to enhance the safety and efficiency of Gamma Knife radiosurgeryRonald E. Warnick, MD1,4, Amy R. Lusk, MSN4, John J. Thaman, MS2,4, Elizabeth H. Levick, MD3,4 and Andrew D. Seitz, BSN51Mayfield Clinic, Cincinnati, OH, USA2Medical Radiation Physics, Inc., Cincinnati, OH, USA3Oncology Hematology Care, Jewish Hospital–Mercy Health, Cincinnati, OH, USA4Gamma Knife Center, Jewish Hospital–Mercy Health, Cincinnati, OH, USA5Department of Quality, Jewish Hospital–Mercy Health, Cincinnati, OH, USA Correspondence to: Ronald E. Warnick, MD, Mayfield Clinic, 3825 Edwards Road, Suite 300, Cincinnati, OH 45209, USA. Email: nsgymd@mac.com(Received: January 13, 2020; Accepted: June 25, 2020)ABSTRACTThis risk analysis describes our Failure Mode and Effects Analysis (FMEA) for Gamma Knife stereotactic radiosurgery at our community hospital. During bi-monthly meetings over 5 months, our FMEA team mapped a detailed Gamma Knife process tree and identified potential failure modes, each were scored a Risk Priority Number (RPN) for severity, occurrence, detectability. In our process tree of 14 subprocesses and 177 steps, we identified 31 potential failure modes: 7 high scoring (RPN ≥150) and 3 modes (<150) selected by clinicians for mitigation strategies. Eighteen months later, rescoring of high-risk failure modes showed significant reduction in RPN scores, thus confirming the benefit of our FMEA mitigation strategies. Our study provides a roadmap to achieve high-quality Gamma Knife radiosurgery that can be utilized by new centers as a starting point for their quality management program. Five quality control documents were developed that can be customized by any Gamma Knife center.Keywords: FMEA, Gamma Knife, quality assurance, radiosurgery, risk analysisINTRODUCTIONGamma Knife radiosurgery utilizes a stereotactic head frame and highly collimated radiation beams to accu-rately treat intracranial diseases such as tumors, vascular malformations, and trigeminal neuralgia. This minimally invasive, multistep procedure involves a multidiscipli-nary team of physicians, nurses, and physicists. The high complexity of Gamma Knife radiosurgery requires strict attention to accuracy and safety throughout the process. A prospective risk analysis can identify high-risk process steps before failure occurs providing the opportunity to establish preventive measures. In stereotactic radiosurgery, early risk analysis focused on quality assurance of the treatment unit, stereotactic accessories, and imaging.1 We now have a greater understanding about the importance of process design, information flow, staff training, and documenta- 116 Journal of Radiosurgery and SBRT Vol. 7 2020tion in preventing an undetected error that could result in patient injury.Failure Mode and Effects Analysis (FMEA) is a well-recognized tool for conducting a system-atic, proactive analysis of a complex process in which harm may occur. Developed in 1949 by the United States Department of Defense, FMEA was subsequently utilized by many industries including aerospace, automotive, and healthcare.2 This type of analysis was also applied to modern radiation oncology for intensity modulated radiation (IMRT), stereotactic body radiation therapy, linear accelera-tor (LINAC) stereotactic radiosurgery, and Gamma Knife radiosurgery, mainly at academic medical centers.3-8 Nonetheless, the Nuclear Regulatory Com-mission recorded seven critical medical events over the past 5 years involving Gamma Knife radiosur-gery, thus pointing to the need for a more in-depth clinically-oriented analysis.9-16 Toward this aim, this study documents our imple-mentation of FMEA for Gamma Knife radiosurgery at a community hospital, including the creation of the multidisciplinary team, development of a process tree, and identification of critical failure modes (i.e., any event that could potentially lead to an undesired treatment outcome). We review the interventions implemented to address the riskiest of these poten-tial events and the reassessment 18 months later. The results provide a roadmap for clinicians launching a Gamma Knife radiosurgery program or existing cent-ers that wish to enhance their quality management program. METHODS AND MATERIALSRadiosurgery treatment processSince our radiosurgery team began using the Gamma Knife Perfexion® (Elekta Instrument AB, Stockholm, Sweden) in March 2013, we have treated 1,400 patients with brain tumors, vascular malfor-mations, and trigeminal neuralgia. At our center, the procedure begins with placement of a stereotactic headframe under conscious sedation by the neuro-surgeon. Diagonal pins are tightened in a sequential fashion using a torque wrench calibrated to 0.4 nM (3.5 in-lb). Patients then undergo magnetic resonance imaging (MRI) with a stereotactic localizer. Patients with skull base tumors (e.g., vestibular schwannoma) or trigeminal neuralgia also undergo computed tomography (CT) scans. Next, images are imported into the treatment planning workstation and defined in stereotactic space. With contouring of the skull, targets, and critical structures by the physicians, a treatment plan is generated and approved by the neu-rosurgeon, radiation oncologist, and medical physi-cist. After receiving intravenous steroids, the patient is positioned and secured onto the treatment table, and monitored throughout treatment delivery by the physicians and nurses. Lastly, the nurses remove the stereotactic frame and the patient receives discharge instructions. Overview of the FMEA processOur FMEA project was initiated in February 2017 after we had treated 610 patients. Our working group consisted of a neurosurgeon, radiation oncolo-gist, nurse, medical physicist, MRI technologist, and four hospital quality experts, one of whom was highly experienced in the FMEA process. The team met biweekly for a 5-month period and then again 18 months later to review the effectiveness of the qual-ity management program. Our analysis included crea-tion of a process tree, identification of possible failure modes, scoring of failure modes, and development of mitigation strategies.Development of a Gamma Knife process treeDuring the initial meeting, the working group reviewed the FMEA protocol, drafted an initial high-level process tree for Gamma Knife radiosurgery that began with the initial consult and ended 2 weeks after the procedure. During nine subsequent meetings, the team members further detailed each subprocess. Our resulting Gamma Knife process tree consisted of 14 subprocesses including: (S1) initial consult, (S2) scheduling of procedure, (S3) pre-procedure chart, (S4) patient registration, (S5) pre-frame tasks, (S6) frame placement, (S7) imaging, (S8) treatment plan-ning, (S9) physics quality assurance (QA), (S10) treatment delivery, (S11) frame removal, (S12) post-procedure chart, (S13) post-procedure call, and (S14) post-procedure visit (Table 1 and Supplement 1). Each subprocess was then subdivided into individual steps.Identification and scoring of possible failure modesWith identification of the individual steps of the process map, team members then identified and scored potential failure modes by consensus using a 10-point scale adapted from the Institute for Healthcare Improve-ment FMEA toolkit (Table 2).17 The Risk Priority Number (RPN) for each failure mode was calculated by multiplying the individual scores for severity (S), occurrence (O), and detectability (D) (i.e., 10 = highest severity, highest occurrence, lowest detectability). Miti- Journal of Radiosurgery and SBRT Vol. 7 2020 117gation strategies were developed for all failure modes with RPN scores ≥150 (similar to Younge et al.6) and for three additional failure modes <150 selected by the clinicians (Table 3).Creation of mitigation strategiesThe team’s strategies to increase the detectability of potential failure modes and reduce the likelihood of occurrence included various process controls, spe-cifically standardized forms, mandatory pauses, and time-out documents. Special emphasis was placed on redundant measures (e.g., multiple overlapping time-outs) that could reduce the possibility for a single unde-tected error resulting in harm to the patient.Implementation and follow-upNew process controls approved by the working group were immediately implemented. Therefore, some mitigation strategies were initiated early in the 5-month FMEA project whereas others were added later. Eight-een months after completing the FMEA project, the working group reconvened to re-score the RPN for each high-risk failure mode and assess the effectiveness of these new quality management tools.Table 1. Subprocesses, steps, and failure modes for Gamma Knife radiosurgerySubprocessDescriptionStepsFailure ModesS1Consult68S2Scheduling of procedure143S3Pre-procedure chart182S4Patient registration41S5Pre-frame tasks174S6Frame placement103S7Imaging83S8Treatment planning224S9Physics quality assurance (QA)321S10Treatment delivery201S11Frame removal81S12Post-procedure chart60S13Post-procedure call50S14Post-procedure visit70Within the 14 subprocesses before (blue), during (green), and after (gold) the procedure, our FMEA analysis identified 177 steps and 31 failure modes.Table 2. FMEA scoring guidelines adapted from the Institute for Healthcare Improvement FMEA toolkit17SEVERITY RATING1No effect on patient2Slight system problem – may annoy patient3Moderate system problem – may affect patient4Moderate system problem – may affect patient and delay or alter treatment5Major system problem – begins to affect patient adversely6Major system problem – additional effect on patient7Major system problem – begins to cause temporary harm to patient, additional monitoring and intervention required8Major system problem – moderate temporary harm to patient, aggressive monitoring and intervention required9Major injury, permanent harm, surgical intervention required10Terminal injury or deathOCCURRENCE RATING1Remote chance of occurring – no known occurrence2Remote chance – may occur, once a year3Low possibility of occurring 4Increasingly higher chance of occurring – several times a year5Moderate probability – monthly6Moderate probability – several times a month7High probability – occurs frequently, weekly8Occurs frequently – several times a week9Occurs very frequently – daily10Happens all the time – several times a dayDETECTION RATING1Error highly detectable – very obvious2Error highly detectable3High detectability – we will likely catch it4High detectability – we should detect5Moderate likelihood of detection – we might detect6Moderate detectability7Low-moderate detectability8Low likelihood of detection – we probably will not catch9Very low detectability10Detection not possible – we will never catch it 118 Journal of Radiosurgery and SBRT Vol. 7 2020Table 3. High-scoring and clinician-selected failure modes identified within subprocesses (S) before (blue) and during (green) the Gamma Knife procedure that were targeted for mitigation strategies. SFailure ModePotential Effect(s)Severity (S) × occurrence (O) × detectability (D) = Risk priority number (RPN)Mitigation StrategiesRPN ≥150S × O × DRPNPatient intake formPre-procedure checklistFrame placement time-outPhysics Check-listTreatment delivery time-outS1Incomplete documentation of prior head/neck radiationExcessive dose to critical structure9 × 4 × 5180✓✓S1Failure to review MRI in Gamma Plan (previously treated patients)Wrong target, over- or under-treatment9 × 5 × 8360✓✓S3Incomplete documentation of prior cranial surgeryPin penetration into brain9 × 3 × 8216✓✓S6Incomplete time-out procedureMissed critical step9 × 4 × 9324✓✓✓✓✓S7Inconsistant identifier information on DICOM imagesIncorrect MRI imported into patient’s plan9 × 10 × 4360✓S8Incorrect registration of DICOM imagesUnder-treatment of tumor or excessive dose to critical structure9 × 2 × 9162✓S10Failure to administer pre-procedural medicationsAdverse events (e.g., perilesional edema, seizures)8 × 5 × 7280✓Clinician-selected RPN < 150S2Failure to take appropriate outpatient medications Adverse events (e.g., perilesional edema, seizures)8 × 4 × 132✓✓S2Lack of recent glomerular filtration rate (GFR)Nephrogenic systemic sclerosis8 × 3 × 496✓✓S5Failure to confirm side of trigeminal neuralgiaTreatment of incorrect trigeminal nerve6 × 2 × 336✓✓ Journal of Radiosurgery and SBRT Vol. 7 2020 119RESULTSProcess treeOur FMEA identified a process tree with 14 subproc-esses (S1-S14) before, during, and after the Gamma Knife procedure (Figure 1 and Supplement 1). Sub-processes represented the pre-procedure period (n=3), day of procedure (n=9), and postoperative period (n=2). Each subprocess consisted of 4 to 32 steps, totaling 177 individual steps from consult to post-procedure visit (Table 1). Failure modesThirty-one potential failure modes were identified for the pre-procedure period (n=13), frame place-ment (n=8), imaging (n=3), treatment planning/qual-ity assurance (QA) (n=5), treatment delivery (n=1), frame removal (n=1), and post-procedure period (n=0) (Table 1 and Figure 1). The significant number of failure modes in the pre-procedure period reflected concerns that lack of a full clinical history (e.g., prior surgery or radiation) or inadequate preparation (e.g., failure to prescribe medications) could propagate the potential for patient injury throughout the procedure. Of 10 high-risk failure modes, 7 had RPN ≥150 related to preoperative preparation (n=3), frame placement (n=1), imaging (n=1), treatment planning (n=1), and treatment delivery (n=1) (Table 3 and Figure 1). Mean RPN score of these high-scoring failure modes was 269 (range 162-360). Three failure modes with RPN < 150 (mean 55, range 32-96) were selected for further study at the clini-cians’ discretion. Overall, two of the high-risk failure modes were specific to Gamma Knife (i.e., incomplete documentation of prior cranial surgery, inconsistent identi-fier information on DICOM images) whereas the remain-ing 8 high-risk failure modes were common to framed and frameless stereotactic radiosurgery (e.g., failure to admin-ister pre-procedural medications).Creation of mitigation strategiesAll 10 high-risk failure modes were addressed with mandatory pauses and overlapping time-out documents that achieved a level of redundancy. Supplement 2 con-tains the five quality control documents that were devel-oped or were revisions of existing documents: Patient Intake Form (at scheduling), Pre-Procedure Check-list (on arrival to hospital), Frame Placement Time-Out (just before frame placement), Physics Checklist (at completion of treatment planning), and Radiation Delivery Time-Out (just before treatment delivery). Table 3 illustrates the use of these documents to address each high-risk failure mode. Mitigation strategies were developed for each high-risk failure mode within subprocesses S1-S14 and for clinician-selected failure modes with <150 RPN.S1 Consult: Incomplete documentation of prior head/neck radiation (RPN 180). Knowledge of the timing, dose, and field of prior head/neck radiation is important S1CONSULT SUBPROCESS# OF STEPS# OF FAILUREMODES68RPN 180RPN 360Failure to review MRI in Gamma Plan (previously treated patients)RPN 96RPN 32RPN 216RPN 360RPN 16232114184321710822208657PRE-PROCEDUREDAY OF PROCEDUREPOST PROCEDURES2SCHEDULES3CHARTS4REGISTERS9QAS5PRE-FRAMES6FRAME ONS7IMAGINGS8 TX PLANS10 TX DELIVERYS11 FRAME OFFS12 CHARTS13POST CALLS14POST VISIT411RPN 32433RPN 3641RPN 280Failure to administer pre-procedural medicationsSYMBOL INDEXFailure modes selected for development of mitigation strategiesFailure modes not selected for development of mitigation strategies© Mayfield ClinicFigure 1. Infographic depicts our initial Gamma Knife process tree that consisted of 14 processes before, during, and after the procedure. Our FMEA team examined the 177-step process to reveal 31 potential failure modes, each of which scored a Risk Priority Number (RPN) based on severity, occurrence, and detectability. Mitigation strategies were developed for 7 high-scoring (RPN ≥150) failure modes (blue and green circles) and 3 clinician-selected failure modes (RPN <150); other failure modes were not considered high risk for mitigation (black circles). Two example RPNs of 360 and 280 are shown. (Figure with permission from Mayfield Clinic). 120 Journal of Radiosurgery and SBRT Vol. 7 2020during patient selection for radiosurgery and also for developing safe, effective treatment plans. This poten-tial failure was addressed in the Patient Intake Form and Pre-Procedure Checklist (“Has the patient ever received radiation to the head or neck? If so, are the radiation records available?”) (Supplement 2). Additionally, we required radiosurgery plans in DICOM format for all patients who previously underwent radiosurgery at out-side institutions. S1 Consult: Failure to review MRI in Gamma Plan (previously treated patient) (RPN 360). Determination of treatment response and tumor recurrence can be chal-lenging in patients with multiple brain metastases who have undergone multiple sessions of Gamma Knife radiosurgery. A risk exists for inadvertently retreating a tumor or failing to detect new lesions. Therefore, our center requires that all follow-up MRI scans be imported into Gamma Plan and then fused with prior treatment plans to assess tumor response and determine if the patient will undergo additional radiosurgery. Potential omission of this critical review was addressed in both the Patient Intake Form and Pre-Procedure Checklist (“Has the MRI been reviewed in Gamma Plan?”) (Sup-plement 2).S3 Preoperative chart: Incomplete documentation of prior cranial surgery (RPN 216). The neurosur-geon must be cognizant of the location and extent of any prior cranial surgery before placing the stereotactic frame to avoid pin penetration into the brain through a bony defect. The Patient Intake Form triggered request for information (“Previous craniotomy? If yes, “Is the operative report in the chart?”), and the Pre-Procedure Checklist queried the patient (“Has the patient ever had surgery on the head?”). Additionally, the neurosurgeon must mark the incision and bone flap of any prior cra-niotomy, a step that is confirmed by the Pre-Procedure Checklist (“Is the craniotomy site marked?”). If the neurosurgeon was uncertain of the proximity of the cra-niotomy, markers were placed at the proposed pin sites and the patient underwent a cone-beam CT scan before frame placement.S6 Frame placement: Incomplete time-out (RPN 324). During the FMEA process, the working group expressed concern that a critical step could be missed during completion of the five quality control docu-ments. This was resolved by developing templates in the electronic medical record (EMR) that required completion of all fields in each document before signa-ture was allowed into this record. Although this failure mode is listed under the frame placement subprocess, both the failure mode and mitigation strategy apply to all five documents.S7 Imaging: Inconsistent identifier information on DICOM images (RPN 360). The format of the patient’s name may differ; specifically, Gamma Plan has no field for middle name (or initial) whereas the DICOM for-mat usually includes a middle initial from the EMR. This discrepancy resulted in an error message for every DICOM import. Although the user could over-ride this, it raised the concern of alert fatigue wherein the user becomes desensitized to safety alerts and fails to respond appropriately to the warning (e.g., inadvert-ently override the warning and import another patient’s MRI scan). We resolved this discrepancy by adding the patient’s middle initial in the field for the first name in Gamma Plan, and confirmed patient identifiers on the MRI on the Physics Checklist (Supplement 2) (“Proper imaging studies requested and imported? Patient identi-fiers correct in Gamma Plan?”). S8 Treatment planning: incorrect registration of DICOM images (RPN 162). Imported MRI image sets must be registered in stereotactic space using the stere-otactic localizer fiducials. This process generates mean and maximum errors and provides a visual depiction of any magnetic distortion. However, a registration could be accepted that exceeds the tolerance (mean <0.6 mm), which would degrade the accuracy of the radiosurgery procedure. We safeguarded against this potential failure mode by requiring the user to enter the mean error of registration for each imaging sequence on the Physics Checklist. S10 Treatment delivery: Failure to administer pre-procedural medications (RPN 280). Dexamethasone 4 mg is administered intravenously immediately before treatment delivery, except for patients with trigemi-nal neuralgia. The morning of treatment, patients with supratentorial tumors also receive levetiracetam 500–1,000 mg orally. For tumors within the motor cortex, lorazepam 0.5–1 mg is given orally before the proce-dure. Failure to administer the appropriate pre-proce-dural medications could result in adverse events (e.g., perilesional edema and/or seizures). We addressed this potential failure mode with two questions on the Radiation Delivery Time-Out (Supplement 2) (“Has the patient received intravenous dexamethasone? Does the patient require Keppra or Ativan prior to treatment delivery?”).S2 Scheduling: Failure to prescribe appropriate outpatient medications (RPN 32). Outpatient medi-cations are at the discretion of the treating physician. At our center, dexamethasone 4 mg po bid is started 1 day before the procedure and levetiracetam 500 mg po bid 3 days before treatment. To ensure this, the Patient Intake Form prompts the nurse to request specific medication orders from the neurosurgeon or radiation oncologist when scheduling the procedure. Electronic prescriptions generated and documented in the chart are confirmed on the morning of the procedure in the Pre-Procedure Checklist (“List the procedure-specific medications taken by the patient this morning.”). Journal of Radiosurgery and SBRT Vol. 7 2020 121S2 Scheduling: Lack of recent glomerular filtration rate (RPN 96). The relationship between gadolinium-based contrast agents and nephrogenic systemic sclerosis was first described in 2006.18 Our radiology department uses the following guidelines based on glomerular filtra-tion rate (GFR): < 30 mL/min → no gadolinium, 30-59 mL/min → single-dose gadolinium, and ≥60 mL/min → double-dose gadolinium (for brain metastases). We require a GFR within 30 days of the procedure. To ensure against an omission, we developed a triple check: docu-mentation of this value on both the Patient Intake Form and Pre-Procedure Checklist (“What is the patient’s GFR?”), and the MRI technologist’s confirmation of the GFR and MRI order with their written guidelines.S6 Pre-procedure: Failure to confirm side of trigem-inal neuralgia (RPN 36). Confirmation of the side of pain is essential in patients with trigeminal neuralgia because there is usually no structural abnormality vis-ualized on the MRI scan. Bilateral trigeminal neural-gia, though rare, can be particularly confounding. The Nuclear Regulatory Commission reported a wrong-sided Gamma Knife radiosurgery procedure in 2014 for a patient with bilateral trigeminal neuralgia.9 For this reason, the neurosurgeon must review the clinic note and consent form on the morning of the procedure, query the patient regarding the side of pain, and affix a vitamin E capsule to the treatment side to ensure its visualization on the MRI scan as a final check during treatment planning. This check was addressed in both the Frame Placement Time-Out and Radiation Delivery Time-Out by two questions (“What side are we treat-ing? Is the side marked for laterality?)” (Supplement 2).Follow-up scoring of high-risk failure modesThe physicians and nurses of the original work-ing group reconvened 18 months after completing the FMEA to re-score the high-risk failure modes and assess the new quality control measures. For the seven failure modes with an initial RPN ≥150, the mean score decrease from 269 (range 162-360) to 47 (range 9-81) signified a positive result from the FMEA mitiga-tion strategies (Table 5). Scores for severity remained Table 4. Comparison of RPN scores based on severity (S), occurrence (O), and detectability (D) before and after FMEA process.SubprocessFailure ModeBefore FMEAAfter FMEARPN ≥150SODRPNSODRPNS1 ConsultIncomplete documentation of prior head/neck radiation94518093381S1 ConsultFailure to review MRI in Gamma Plan (previously treated patients)95836093381S3 Pre-procedure chartIncomplete documentation of prior cranial surgery93821692236S6 Frame placementIncomplete time-out procedure9493249119S7 ImagingInconsistant identifier information on DICOM images910436094272S8 Treatment planningIncorrect registration of DICOM images92916292236S10 Treatment deliveryFailure to administer pre-procedural medications85728081216Mean8.94.77.12698.92.32.147Clinician-selected RPN <150S2 SchedulingFailure to take appropriate outpatient medications 8413284132S2 SchedulingLack of recent glomerular filtration rate (GFR)834968118S5 Pre-frame tasksFailure to confirm side of trigeminal neuralgia623366116Mean7.332.7557.32115 122 Journal of Radiosurgery and SBRT Vol. 7 2020the same, frequency of occurrence decreased from mean (range) 4.7 (2-10) to 2.3 (1-4), and detectability decreased from mean (range) 7.1 (4-9) to 2.1 (1-3). Thus, strengthening our existing documentation and the introduction of new time-out procedures improved our ability to detect these potential failure modes, which resulted in lower detectability scores. This seems coun-terintuitive but is made clearer by examining the scor-ing of this parameter in Table 2 (i.e., low detectability score equates to a higher level of detectability).For the three clinician-selected failure modes, mean RPN decreased from 55 (range 32-96) to 15 (range 6-32), further confirming the benefit of our FMEA pro-cess (Table 4). Scores for severity scores remained the same, mean frequency of occurrence decreased from 3 (range 2-4) to 2 (range 1-4), and mean detectability decreased from 2.7 (range 1-4) to 1 (range 1-1). “Fail-ure to take appropriate outpatient medications” showed no change in RPN after the FMEA interventions. The working group discussed additional strategies and ulti-mately recommended calling the patient the day before the procedure to confirm their medications.DISCUSSIONOur Gamma Knife radiosurgery center conducted an FMEA with input from multiple disciplines to address this complex, multi-stage procedure with aim to reduce the risk of an undetected error that could result in patient death or injury. The Nuclear Regu-latory Commission requires Gamma Knife users to report critical medical events, such as, total delivered dose > 20% higher than prescription dose or any dose to the wrong patient.12 During the past 5 years, seven Gamma Knife misadventures reported to the Commis-sion included treatment of the wrong patient (1 event) or wrong side (2 events), stereotactic frame slippage (2 events), incorrect table docking of patient (1 event), and misalignment of treatment table (1 event).9-16 Therefore, the Gamma Knife community needs more robust quality management programs to minimize the occurrence of these events.Our center’s 5-month FMEA process achieved the goals of strengthening our Gamma Knife quality controls and cultivating a culture of excellence in our organiza-tion. Our Gamma Knife process tree, including 14 sub-processes and 177 individual steps, revealed 31 potential failure modes; 7 high-scoring failure modes (RPN ≥150) and 3 other clinician-selected modes (RPN <150) for problem-solving interventions. Other potential fail-ure modes not selected were deemed highly detectable because of existing quality controls developed during the initial 4 years of our Gamma Knife program. Notably, six potential failure modes chosen for mitigation strategies were in the preoperative period (e.g., office consultation, scheduling phone call, dis-cussion prior to frame placement). One failure mode (each) was related to frame placement, imaging, treat-ment planning, and treatment delivery. We believe that this reflects the evolution of our quality manage-ment program during the period from Gamma Knife installation to the FMEA project. At the launch of our center, we focused on optimizing frame place-ment, obtaining high-resolution and distortion-free MRI scans, optimizing Gamma Knife treatment plans, and confirming the mechanical precision of the treat-ment unit. Thereafter, our FMEA process focused on the potential for human failure and implementation of standardized procedures (mandatory pauses, time-out procedures) to reduce the likelihood of a mistake or error going undetected. Our 18-month follow-up eval-uation affirmed the value of these interventions: all high-scoring failure modes had become highly detect-able, and therefore, were unlikely to be propagated and result in patient harm.Previous FMEA studies in radiation oncologyThe seminal 2016 report by Huq et al. and the Task Group 100 (TG-100) of the American Association of Physicists in Medicine (AAPM) outlined the frame-work for using FMEA as the primary tool for quality management in radiation oncology.3 Their application for IMRT was comprehensively described including development of a process tree, identification and scor-ing of failure modes, fault tree analysis, and mitigation strategies. They also provided a practical guide to per-forming FMEA and introductory exercises for process mapping, FMEA, and quality management design.Among recent publications about FMEA for cra-nial stereotactic radiosurgery, Masini et al. identified two high-risk failure modes (RPN ≥125) (i.e., incor-rect collimator size, incorrect double-check of target coordinates) associated with framed LINAC radiosur-gery.5 The authors implemented corrective measures that increased the likelihood of their detection, and also commented on the overall increased awareness of quality and safety among the FMEA participants (halo effect).Younge et al. reported their experience with FMEA implementation before launching their frameless LINAC stereotactic radiosurgery program.6 Their five high-risk failure modes (RPN > 150) related to imaging (incorrect patient orientation during MRI), treatment planning (contours accidentally changed), and treat-ment delivery risks specific to frameless radiosurgery (inadequate mask immobilization, patient movement
Journal of Radiosurgery and SBRT Vol. 7 2020 123during treatment). Interestingly, team members selected their presumed high-risk failure modes before initiat-ing the FMEA project: only one item was borne out by the FMEA process (incorrect patient orientation during MRI). In the second FMEA publication on frameless LINAC radiosurgery, Manger et al. identified 10 high-risk failure modes (RPN ≥180) in the areas of imaging (n=1), treatment planning (n=5), and treatment deliv-ery (n=4).7 The preponderance of failure modes in the treatment planning and delivery may have reflected the composition of the FMEA team (four medical physi-cists, one physician). In the one previous publication on the use of FMEA for Gamma Knife radiosurgery, Xu et al. applied recommendations from the AAPM TG-100 report to framed radiosurgery with the Gamma Knife 4C and Perfexion® platforms.8 Their 2017 study identified 86 potential failure modes: 40 items spe-cific to Gamma Knife and 46 items common to all radiosurgery technologies. Notably, only one failure mode scored RPN >100 (frame adapter not properly attached, RPN 123). Several failures modes with the highest severity scores did not rise to the level of further analysis because occurrence and detect-ability scores were low as a result of previously implemented quality assurance procedures. These results are not unexpected when one considers the long history of the Pittsburgh Gamma Knife center (launched in 1987), its high patient volume (> 600 patients/year), and the senior author’s involvement in the AAPM Task Group 100. Our study differed from the 2017 Pittsburgh pub-lication8 in several important ways. First, our Gamma Knife program is based at a community (non-aca-demic) hospital and the FMEA project was initiated early in our clinical experience (after 4 years and 610 patients). Second, our multidisciplinary FMEA team included four hospital quality experts with expertise in FMEA. Third, our analysis focused on a single Gamma Knife platform (Perfexion®). These differ-ences may explain why we identified seven high-scoring failure modes (vs. Pittsburgh’s one) with the majority in the pre-procedure period (vs. none). Their single high-scoring failure mode (improper frame adapter attachment) did not reach an RPN ≥150 in our analysis because an Elekta field notice had raised our awareness of this pitfall (i.e., lowered the detectability score). Therefore, one should expect that each institu-tion’s FMEA output will uniquely reflect the technol-ogy platform, maturity of the radiosurgery program, composition of the FMEA team, and depth of existing quality management processes. We predict that our results and guidelines are more applicable to newly established Gamma Knife centers than the unique findings of the Pittsburgh group.FMEA roadmap for new Gamma Knife CentersNew Gamma Knife centers are provided consider-able manufacturer support during technology installation and launch of the clinical program. Physicians, nurse coordinators, and medical physicists must complete a Gamma Knife introductory course at an approved train-ing center. Elekta also provides on-site mentorship by an experienced Gamma Knife physician during the first week of treatment. The available policies and procedures focus primarily on image acquisition, treatment plan-ning, and quality control of the treatment unit and ste-reotactic accessories. However, less emphasis is placed on patient clinical care before and during the procedure. New centers are expected to develop their own quality management program at a point when they have limited experience with the Gamma Knife procedure.Our study provides a roadmap to achieve high-qual-ity Gamma Knife radiosurgery that can be applied by new centers as a starting point for their quality manage-ment program. We describe the methodology, high-risk failure modes, and mitigation strategies that can reduce the risk of an adverse event. A straightforward set of mandatory pauses and overlapping time-out documents provide a level of redundancy that reduces the likeli-hood of a mistake or error going undetected. These five quality control documents in Supplement 2 can be cus-tomized to the needs of each Gamma Knife center. Limitations of our studyOur FMEA working group’s scoring system adapted from the Institute for Healthcare Improvement FMEA toolkit differed from studies that used the scoring system recommended in the AAPM TG-100 report.3,17 The two systems differ in the descriptors used for rankings of sever-ity, occurrence, and detectability; this difference could result in RPN scores that are not directly comparable. Our strategy of generating an RPN score for each failure mode by consensus during our biweekly FMEA meetings was similar to that used by Manger et al.7 and Masini et al.5 but unlike that of Younge et al.6 and Xu et al.8 who relied on individual RPN scoring and averaging without group dis-cussion. It is possible that group scoring could be unduly influenced by one or more dominant voices.Ideally, an FMEA project produces mitigation strat-egies that would be implemented on a specific date to measure the incidence of adverse events before and after that date. In our study, if deemed important for patient safety, the recommended process controls were imple-mented immediately after the working group’s approval. Given that some mitigation strategies were initiated early during the 5-month project and others were added later, we cannot compare adverse events before and after their
124 Journal of Radiosurgery and SBRT Vol. 7 2020implementation. Instead, our working group reconvened 18 months after completing the FMEA project to re-score the RPN for high-risk failure modes and assess the benefit of the new quality management tools. Lastly, our FMEA analysis applies to the Gamma Knife Perfexion® and was performed at a commu-nity hospital after an initial 4-year clinical experience with 610 patients. We believe that the findings of our FMEA are generalizable to all Gamma Knife centers and the protocols in Supplement 2 can be easily modi-fied to suit the needs of an individual center. CONCLUSIONSWe applied FMEA to Gamma Knife Perfexion® stereotactic radiosurgery to identify high-risk failure modes and thereby develop effective mitigation strate-gies. The majority of high-risk failure modes related to preoperative patient care that may reflect our pre-existing quality processes focused on other steps in the procedure (e.g., imaging, treatment planning, treatment unit). Rescoring of these high-risk failure modes 18 months later showed significant reduction in risk scores thus confirming the value of FMEA. Our process tree (Supplement 1) and protocols (Supple-ment 2) can function as a roadmap for new Gamma Knife centers that wish to strengthen their quality management program.ACKNOWLEDGEMENTSThe authors thank medical illustrators Martha Headworth and Tonya Hines for infographic design and figures, and Mary Kemper for medical editing. The authors received no grant or other financial support for this work. The information pre-sented has not been previously presented or published.Supplementary information to this paper can be accessed from the electronic version. Authors’ disclosure of potential conflicts of interestThe authors have nothing to disclose.Author contributionsConception and design: Ronald E. Warnick, MD Data collection: Ronald E. Warnick, MD, Amy R. Lusk, MSN, John J. Thaman, MS, Elizabeth H. Levick, MD, Andrew D. Seitz, BSN Analysis and interpretation: Ronald E. Warnick, MD, Amy R. Lusk, MSN, John J. Thaman, MS, Elizabeth H. Levick, MD, Andrew D. Seitz, BSNManuscript writing: Ronald E. Warnick, MDFinal approval of manuscript: Ronald E. Warnick, MD, Amy R. Lusk, MSN, John J. Thaman, MS, Elizabeth H. Levick, MD, Andrew D. Seitz, BSNREFERENCES1. Seung SK, Larson DA, Galvin JM, Mehta MP, Potters L, Schultz CJ, Yajnik SV, Hartford AC, Rosenthal SA. American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) practice guideline for the performance of stereotactic radiosurgery (SRS). Am J Clin Oncol 2013;36(3):310-315.2. MIL-STD-1629A 1980. Procedures for performing a failure mode effect and criticality analysis. United States Department of Defense. This is an archived publication available at: https://www.weibull.com/mil_std/mil_std_1629a.pdf3. Huq MS, Fraass B, Dunscombe PB, Gibbons JP Jr, Ibbott GS, Mundt AJ, Mutic S, Palta JR, Rath F, Thomadsen BR, Williamson JF, Yorke ED. The report of the Task Group 100 of the AAPM: Application of risk analysis methods to radiation therapy quality management. Med Phys 2016;43(7):4209-4262.4. Veronese I, De Martin E, Martinotti AS, Fumagalli ML, Vite C, Redaelli I, Malatesta T, Mancosu P, Beltramo G, Fariselli L, Cantone MC. Multi-institutional application of failure mode and effects analysis (FMEA) to Cyberknife stereotactic body radiation therapy (SBRT). Radiat Oncol 2015;10:1-10.5. Masini L, Donis L, Loi G, Mones E, Molina E, Bolchini C, Krengli M. Application of failure mode and effects analysis to intracranial stereotactic radiation surgery by linear accelerator. Pract Radiat Oncol 2014;4:392-397.6. Younge KC, Wang Y, Thompson J, Giovinazzo J, Finlay M, Sankreacha R. Practical implementation of failure mode and effects analysis for safety and efficiency in stereotactic radiosurgery. Int J Radiat Oncol Biol Phys 2015;91(5):1003-1008.7. Manger RP, Paxton AB, Pawlicki T, Kim GY. Failure mode and effects analysis and fault tree analysis of surface image guided cranial radiosurgery. Med Phys 2015;42(5):2449-2461.8. Xu AY, Bhatnagar J, Bednarz G, Flickinger J, Arai Y, Vacsulka J, Feng W, Monaco E, Niranjan A, Lunsford LD, Huq MS. Failure modes and effects analysis (FMEA) for Gamma Knife radiosurgery. J Appl Clin Med Phys 2017;18(6):152-168.9. Event notification reports. United States Nuclear Regulatory Commission. https://www.nrc.gov/reading-rm/doc-collections/event-status/event/2014/20140417en.html (Event number 50011) 10. Event notification reports. United States Nuclear Regulatory Commission. https://www.nrc.gov/reading-rm/doc-collections/event-status/event/2015/20151013en.html (Event number 51442)
Journal of Radiosurgery and SBRT Vol. 7 2020 12511. Event notification reports. United States Nuclear Regulatory Commission. https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-3045.html (Event number 50868)12. Event notification reports. United States Nuclear Regulatory Commission. https://www.nrc.gov/reading-rm/doc-collections/event-status/event/2014/20140808en.html (Event number 50321)13. Event notification reports. United States Nuclear Regulatory Commission. https://www.nrc.gov/reading-rm/doc-collections/event-status/event/2016/20160216en.html (Event number 51713)14. Event notification reports. United States Nuclear Regulatory Commission. https://www.nrc.gov/reading-rm/doc-collections/event-status/event/2019/20190222en.html (Event number 53874)15. Event notification reports. United States Nuclear Regulatory Commission. https://www.nrc.gov/reading-rm/doc-collections/event-status/event/2016/20160224en.html (Event number 51735)16. Event notification reports. United States Nuclear Regulatory Commission. https://www.nrc.gov/reading-rm/doc-collections/event-status/event/2015/20150316en.html (Event number 52780)17. Institute for Healthcare Improvement. Failure modes and effects analysis tool. https://app.ihi.org/Workspace/tools/fmea/ accessed September 12, 2019.18. Grobner T. Gadolinium: A specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transplant 2006;21(4):1104-1108.
NR706: Week 6 | Practice Problem Analysis and Presentation— Failure Mode and Effects Analysis Template
Place the completed FMEA form on presentation slide and summarize FMEA findings in your presentation. (See assignment guidelines, rubric, and PowerPoint template.)
Occurrence Likelihood rate 1-10 (10 means most likely to occur)
Detection Likelihood rate 1-10 (10 means least likely to be detected)
Severity rate 1-10 (10 means most likely to cause severe harm)
To calculate Risk Profile Number: Multiply Occurrence Likelihood Times Detection Likelihood Times Severity Rate = Risk Profile Number
NR706: Week 6 | Practice Problem Analysis and Presentation—Fishbone Diagram Version A
Cause Effect

To develop your cause and effect diagram, do the following:
Identify practice problem idea you are trying to improve in the effect box.
In each category of causes—(a) people, (b) environment, (c) materials, (d) methods, and (e) equipment—input causes for the effect. (See example and rubric.)
NR706: Week 6 | Practice Problem Analysis and Presentation—Fishbone Diagram Version B
Often you will find the components arranged so they resemble the shape of a fish. See Week 4 Lesson: Evidence-Based Practice: Improving Outcomes for more details. Use the table below to enter your analysis if you do not have Word 2016 or higher to download the fishbone diagram.
Complete the word table below.
For this exercise, please identify the practice problem error you are trying to analyze along with the causes according to the five categories. Place the table on the PowerPoint slide and summarize your cause-and-effect analysis in the PowerPoint presentation. Please see rubric and guidelines.
Practice Problem: _____________________________________________________________________

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