Online Program

A Failure Mode and Effects Analysis (FMEA) from Operating Room Setup to Incision for Living Donor Liver Transplantation

Monday, November 2, 2015

Donna Woods, PhD, EdM, Center for Healthcare Studies, Northwestern University, Chicago, IL
Elizabeth Pomfret, MD, Lahey Clinic, Burlington, MA
Mary Ann Simpson, PhD, Lahey Clinic, Burlington, MA
James Guarrera, MD, Columbia University Medical System, New York, NY
Robert Fischer, MD, FACS, Virginia Commonwealth University Medical Center, Richmond, IL
Timothy Curtis, BSN, RN, CEN, Center for Healthcare Studies, Northwestern University, Chicago, IL
Amna Daud, MD, MPH, Center for Healthcare Studies, Northwestern University, Chicago, IL
Ella Reyes, Center for Healthcare Studies, Northwestern University, Chicago, IL
Erin Wymore, MS, Center for Healthcare Studies, Northwestern University, Chicago, IL
Daniela Ladner, MD, MPH, Center for Healthcare Studies, Northwestern University, Chicago, IL

Living donor liver transplantation (LDLT) is a life-saving procedure, which a healthy volunteer donates his/her liver. It is paramount that the donor experiences minimal harm from the procedure. Operating room (OR) setup prior to incision provides the foundation for an event-free LDLT with minimal patient harm. To assess critical patient risks in LDLT, a Failure Modes and Effects Analysis was conducted across 4 large transplant centers.


Focus groups and interviews were conducted with 40 clinicians (e.g., surgeons, anesthesiologists, nurses, technicians, and coordinators) involved with LDLTs. Process maps outlining each step of the preoperative setup process were developed through observations and clinician interviews. A list of potential failures, consequences, causes and safeguards related to each step was generated and scored by severity, occurrence and existing safeguards (1 lowest to 10 highest). Safety issues reported after 113 procedures through web-based clinician debriefings (2010-2013) were integrated. Then a risk priority number was calculated and reviewed by criticality.


A total of 105 potential failures were identified, 56 potentially leading to patient harm. Ten percent of these were of the highest severity (9-10).  Weak safeguards were in place for 20 (19%) of all failures, consisting of single or double human visual inspection (e.g. Counts, delivery of antibiotics, timeout). Only, 29% of all potential failures had a moderate to highly reliable safeguard in place (Table 1). Critical areas potentially leading to patient harm include: errors of communication at transition points, blood availability, DVT prophylaxis and OR interruptions and distractions.

Numerous, critical vulnerabilities potentially leading to patient harm were identified. To address the identified vulnerabilities and prospectively prevent patient harm, sustainable methods for mitigation and improvement must be developed including the redesign of systems and processes to provide more reliable safeguards. Application of a proactive, prospective approach to patient safety in living donor hepatectomy must be applied to identify vulnerabilities prior to harming patients.

Standardization and optimization of the preoperative OR set-up process has the potential to reduce the incidence and severity of medical errors. 

Description of Failure Count (% of total failures)
Total number of potential failures identified by clinicians 105
Failures with severity score 6 or above (effect is patient harm) 56 (53%)
Failures with severity score 9, 10 (highest patient harm) 10 (10%)
Failures with occurance score above 9 (more than 1/20) 8 (8%)
Failures with safeguard score of 6 or worse for its reliability to "catch" the failure 20 (19%)

Learning Areas:

Administer health education strategies, interventions and programs
Basic medical science applied in public health
Planning of health education strategies, interventions, and programs

Learning Objectives:
Describe a safety risk assessment method – the Failure Modes Effects Analysis. List the steps in the FMEA process. Explain what can be learned from application of the FMEA methods and what was learned in the presented investigation.

Keyword(s): Physicians, Quality Improvement

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have been the PI and Co-I of many federal and foundation funded investigations focused on the considerable public health problems of patient safety and healthcare quality.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.