LEADERSHIP ASSIGNMENT PART 2

EVIDENCE- BASED CARE SHEET

Authors Jennifer Kornusky, RN, MS

Cinahl Information Systems, Glendale, CA

Debra Balderrama, RN, MSCIS Clinical Informatics Services, Tujunga, CA

Reviewers Darlene Strayer, RN, MBA

Cinahl Information Systems, Glendale, CA

Sara Richards, MSN, RN Cinahl Information Systems, Glendale, CA

Nursing Executive Practice Council Glendale Adventist Medical Center,

Glendale, CA

Editor Diane Pravikoff, RN, PhD, FAAN

Cinahl Information Systems, Glendale, CA

September 7, 2018

Published by Cinahl Information Systems, a division of EBSCO Information Services. Copyright©2018, Cinahl Information Systems. All rights reserved. No part of this may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system, without permission in writing from the publisher. Cinahl Information Systems accepts no liability for advice or information given herein or errors/omissions in the text. It is merely intended as a general informational overview of the subject for the healthcare professional. Cinahl Information Systems, 1509 Wilson Terrace, Glendale, CA 91206

Adverse Healthcare Events: Prevention – Failure Modes and Effects Analysis (FMEA)

What We Know › According to The Joint Commission (TJC), the likelihood of adverse events occurring can

be reduced by participating in a proactive risk assessment process(6)

• Risk assessments should focus on processes that have the greatest risk for impacting patient safety

• TJC standards address the need for hospitals to regularly evaluate safety. These standards include having a process that focuses on and addresses safety, using data when making decisions regarding processes and their impact on performance, and implementing process changes as needed to promote improved performance(8)

• The World Health Organization (WHO) defines adverse healthcare events as “undesirable incidents” that result from the care provided by healthcare services that may or may not hurt the patient but extend the length of stay (LOS) in the hospital because of the adverse event that was not related to the patient’s initial admission diagnosis(9)

› Failure Modes and Effects Analysis (FMEA) is a team-based systematic and proactive approach for identifying the ways that a process or system can fail, why it might fail, the effects of failure, and how the process can be made safer(1,4,5,6)

• FMEA is also known as Failure Modes Effect and Criticality Analysis (FMECA) and Potential or Process Failure Modes and Effects Analysis (PFMEA)(10)

› FMEA is a widely used technique in health care for the proactive identification of possible failures in high-risk clinical processes and systems(2,4,6)

• High-risk clinical processes are those that involve multiple steps and for which process failure is likely to cause severe harm to patients(4,5,6)

– Examples of high-risk clinical processes in health care are medication use, operative procedures, blood transfusions, and emergency care/resuscitation(5)

– Failure in such processes can result in a sentinel event (i.e., severe temporary or permanent patient injury or death)(5,6,7)

› Definitions of key terms used in FMEA(1,6,10)

• Failure means any malfunction, error, or defect that results in a process not being performing as intended

• Failure mode means anything that could go wrong during the completion of a step in the process

• Effects analysis means studying the effects, results, or consequences of the failure mode › FMEA is used prospectively to identify potential failures in high-riskclinical systems and

to fix the potential failure before an adverse event can actually occur(1,4,5,6)

• The goal of using FMEA is to prevent patient harm(1,4,5,6)

• FMEA is performed before an adverse event occurs. It is preventive and poses the question, “What could go wrong?”(5)

• FMEA is not performed as a retrospective analysis after an adverse event occurs and does not pose the question, “What went wrong?”(5)

• FMEA does not focus on a specific event, but rather on a specific process › The FMEA technique was not initially developed for use in health care(4)

• FMEA was first used in the 1940s by the United States military(2)

• FMEA began to be used in the aerospace industry in the 1960s and its use expanded to other fields in the 1970s and 1980s, including nuclear power, aviation, chemical, and electronics fields(5,10)

• FMEA was introduced in health care in 2002 when TJC initiated the requirement that hospitals perform a proactive risk assessment on all high-risk processes at least once each year(1,2,5)

› There are several specialized types of FMEA that are specific to the purpose for performing the FMEA • In 2001, the US Department of Veterans Affairs (VA) National Center for Patient Safety developed a specialized tool for

health care called the Health Care-FMEA (HFMEA)(1,3)

– Although the first 3 steps in FMEA and HFMEA are the same, HFMEA includes additional steps that are not part of FMEA

– HFMEA includes a Hazard Scoring Matrix, which simplifies the scoring system – With the exception of the use of HFMEA in the VA, FMEA is more commonly taught and utilized in health care(4,6)

› A series of sequential steps are required to conduct an FMEA(1,3,4,5,6,10)

• Step 1: Select a high-risk clinical process to analyze with FMEA – For example, to identify where and how medication errors occur, the system for medication use and administration would

be analyzed • Step 2: Identify a multidisciplinary team of healthcare clinicians

– It is essential that all members of the team know and understand the process being analyzed. Clinicians who use the system are knowledgeable regarding its vulnerabilities and the points at which failure could occur(1,4,5,10)

– To review medication use, nurses, pharmacists, and physicians would be assigned to the team • Step 3: The team should identify and document all steps that are performed in the process of medication use and

administration – The first step would be the physician who is ordering/prescribing a medication

• Step 4: For each step, the team should list all potential failure modes – In the first step of the system for medication use, a potential failure mode would be that the physician writes an

incomplete order • Step 5: For each failure mode the team should identify possible causes

– Identified causes are the reasons why certain steps in the process could fail. The team should list all possible causes for failure(1,4,5)

– For example, possible causes for a physician to write an incomplete order are that the physician - is distracted - hand-writes the order and his/her writing is not legible - does not follow the facility’s established protocol for writing orders

• Step 6: For each failure mode that is identified, the team should identify the potential effects of failure – Potential effects of an incomplete order are that the patient could receive the

- wrong dosage of the medication - medication by the wrong route

• Step 7: For each failure mode that is identified, the team should assign a numeric value of 1–10 to represent the likelihood of occurrence, likelihood of detection, and severity of the failure (i.e., the severity of the effect on the patient if failure occurs)(1,4,5)

– The team determines the likelihood of occurrence and assigns a score of 1–10, with 1 meaning it is very unlikely to occur and 10 meaning it is very likely to occur

– The team determines the likelihood of detection before the failure occurs and assigns a score of 1–10, with 1 meaning it is very likely to be detected and 10 meaning it is very unlikely to be detected

– The team determines the severity of the failure and assigns a score of 1–10, with 1 meaning it is very unlikely that harm to the patient will occur and 10 meaning it is very likely that severe harm will occur - Assigning a severity score of 10 indicates that it is very likely the patient would die as a result of the failure

• Step 8: The team should calculate the risk priority number (RPN) for each failure mode(1,4,5)

– An RPN is calculated for each identified failure mode by multiplying the 3 scores for likelihood of occurrence, likelihood of detection, and severity assigned to each failure mode

– For example, if a failure mode was scored 3 for likelihood of occurrence, 5 for likelihood of detection, and 5 for severity, the failure mode would receive an overall RPN of 75 based on the calculation 3 x 5 x 5

• Step 9: The team should redesign the process or system to prevent, avoid, or mitigate the identified failure modes – Process/system redesign strategies focus on decreasing the frequency of occurrence, increasing detectability, and/or

reducing the severity of a failure mode(1,4,5)

– Strategies for decreasing the frequency of occurrence of a failure mode include implementing checklists, performing double-checks, establishing procedural redundancy, and eliminating causes

– Strategies for increasing the detectability of a failure mode include implementing automated warning systems, technologic alerts, and/or devices with alarms

– Strategies for reducing the severity of the effects of a failure mode include implementing methods that facilitate early identification of an adverse event such as increased monitoring of vital signs and developing rapid response teams

– Failure modes with a high RPN, especially those with high severity scores, should be prioritized(1,4,5)

• Step 10: The redesigned process/system should be implemented, tested, and serially evaluated(1,4,5,6)

What We Can Do › Learn about FMEA and participate in the multidisciplinary team performing FMEA in your facility so you can prevent

adverse healthcare events in your patient population › Collaborate with your colleagues to identify a high-risk clinical process and perform FMEA to reduce the incidence of

adverse events. Apply FMEA methodology to list the steps in the process/system; identify failure modes, causes, and effects; assign values for likelihood of occurrence and detection and for severity; and calculate RPN. Use the following template, as appropriate:(4)

.

Steps in Process

Failure Mode

Failure Causes

Failure Effects

Occurrence (1–10)

Detection (1–10)

Severity (1-10)

RPN

Actions Taken to Redesign Process

1 2

. › Consider performing FMEA on the use of restraints, chemotherapy administration, parenteral electrolyte use, admission/

discharge/transfer processes, and/or the patient identification process › After performing FMEA, redesign the analyzed process/system, implement the new process, test the new process, and

serially monitor and evaluate changes in the process

Coding Matrix References are rated using the following codes, listed in order of strength:

M Published meta-analysis

SR Published systematic or integrative literature review

RCT Published research (randomized controlled trial)

R Published research (not randomized controlled trial)

C Case histories, case studies

G Published guidelines

RV Published review of the literature

RU Published research utilization report

QI Published quality improvement report

L Legislation

PGR Published government report

PFR Published funded report

PP Policies, procedures, protocols

X Practice exemplars, stories, opinions

GI General or background information/texts/reports

U Unpublished research, reviews, poster presentations or other such materials

CP Conference proceedings, abstracts, presentation

References 1. Brook, O. R., Mendiratta-Lala, M., & Hallett, D. T. (2011). Application of Failure Mode and Effect Analysis in a radiology department. RadioGraphics, 31, 281-293. doi:10.1148/

rg.311105018 (QI)

2. California Hospital Patient Safety Organization (CHPSO). (2011). FMEA: Not just for compliance anymore. Patient Safety News. Retrieved August 23, 2018, from http://www.chpso.org/sites/main/files/file-attachments/201104_0.pdf (QI)

3. DeRosier, J., Stalhandske, E., Bagian, J. P., & Nudell, T. (2002). Using health care failure mode and effect analysis: The VA national center for patient safety's prospective risk analysis system. The Joint Commission Journal on Quality Improvement, 28(5), 248-267. (PGR)

4. Institute for Healthcare Improvement. (n.d.). Failure modes and effects analysis (FMEA). Retrieved August 23, 2018, from http://www.ihi.org/resources/pages/tools/ failuremodesandeffectsanalysistool.aspx (G)

5. Institute for Safe Medication Practices Canada. (n.d.). Failure modes and effects analysis workshop. Retrieved August 23, 2018, from https://www.ismp-canada.org/download/ISMP_Canada_FMEA_presentation.pdf (CP)

6. The Joint Commission. (2016). 2016 Comprehensive accreditation manual for hospitals: The Patient Safety Systems Chapter. Retrieved August 23, 2018, from https:// www.jointcommission.org/assets/1/18/PSC_for_Web.pdf (G)

7. The Joint Commission. (2016, January 1). Sentinel events (SE). In Comprehensive accreditation manual for hospitals (CAMH) (pp. 1-19). Oakbrook, IL: Joint Commission Resources, Inc. (G)

8. The Joint Commission. (2018). 2018 Comprehensive accreditation manual for hospitals. Oakbrook Terrace, IL: Joint Commission Resources. (G)

9. Serafim, C. T. R., Dell’Acqua, M. C. Q., Castro, M. C. N. E., Spiri, W. C., & Nunes, H. R. C. (2017). Severity and workload related to adverse events in the ICU. Revista Brasileira de Enfermagem, 70(5), 942-948. doi:10.1590/0034-7167-2016-0427 (R)

10. Tague, N. R. (2005). In Failure Mode Effects Analysis (FMEA). The Quality Toolbox <http://asq.org/quality-press/display-item/index.html?item=H1224> (2nd ed., pp. 236-240). : American Society of Quality, Quality Press, Milwaukee. (QI)