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Special Section on Event Analysis and Risk Management

Health Care Failure Mode and Effect Analysis in the Operating Room Setting

Pirouzi, Maryam MSc; Gorji, Hassan A. PhD; Ravaghi, Hamid PhD; Afshari, Atefeh PhD

Author Information
doi: 10.1097/QMH.0000000000000248
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Operating rooms (ORs) and surgical settings are a potential source of sentinel adverse events due to the organizational, educational, environmental, and technological complexities of these health service delivery settings.1,2 Every year, approximately 313 million surgical procedures are performed worldwide, with an average of one in 25 people undergoing surgery every year.3 It has been estimated that 14.4% of these patients experience unnecessary and avoidable accidents.4 Given the 0.5% to 10% postsurgery mortality rate,5,6 on a global basis, it is estimated that more than 4 million people die within 30 days after surgery annually.7 Besides, studies indicate that approximately half of the postsurgery deaths and complications can be avoided if OR standards are correctly observed.3,4,8,9

In order for health care environments to be safe and secure for patients and staff, effective risk management systems should be designed and implemented to identify system defects. In this regard, the use of a comprehensive systematic approach has been emphasized to investigate errors and make appropriate decisions to prevent errors in health and treatment settings.2,10,11 Healthcare Failure Mode and Effects Analysis (HFMEA), introduced by the National Center for Patient Safety (NCPS), is a risk assessment tool that has been modified specifically for health systems.12,13 HFMEA is a highly structured and systematic technique which synthesizes 3 different risk assessment tools (FMEA, Hazard Analysis and Critical Control Point [HACCP], and root cause analysis) for identifying and preventing latent errors before they result in adverse events in medical treatment and health care systems.14 By utilizing HFMEA, it is possible to enhance processes and procedures to ensure relatively safe and desirable clinical outcomes.15–17 Furthermore, HFMEA is an effective methodology for enhancing the overall quality of care through improving processes/procedure workflows, patient flow/performance management, training, and communication within health care teams.18

Patient safety is the primary concern of health systems19 wherein the OR is classified as a high-risk area. The present study was conducted to determine the characteristics of errors in the most important processes in the OR of Semirom's Hospital utilizing HFMEA methodology.


In this study, as a combination (qualitative and quantitative research), failure modes and effects were identified and analyzed using HFMEA methodology. Ten of 21 key processes were selected in the OR setting at Semirom's Hospital, which is a general hospital with 96 active beds. This OR setting constitutes 3 specialized operating theatres for general surgery, orthopedic surgery, and opthalmalogic surgery, with an average of 185 surgical procedures performed per month. The Delphi technique20 was utilized to select these 10 key processes based on the level of importance and complexity. The following stages of this study were conducted in accordance with the 5 stages of HFMEA methodology developed by the US Department of Veterans Affairs' NCPS.13 After reaching a consensus on team comments all information was entered in HFMEA worksheets. It should be noted that the time taken to carry out this study was 60 hours. The stages of this research according to the 5 steps of HFMEA methodology as set by the NCPS13 are as follows:

  1. Identify important topics and processes: In the first step of this study, due to the impossibility of analyzing all operating procedures and achieving consensus within a given time, a 2-round Delphi technique was used to determine the most important processes. At first, all processes of the OR were listed by a Quality Improvement Officer (QIO) via interviewing OR staff including surgeons, anesthesiologists, OR technicians, and the head nurse. Subsequently, we asked 12 people (30% of OR staff) as the representatives of various groups involved with OR processes (3 surgeons, 2 anesthesiologists, 6 OR technicians, and the head nurse) to determine the level of importance and complexity of each process based on a 5-point scale (“very low” to “very high”). Preliminary results of the 10 most significant processes were returned to the OR members for verifying. The final report of selected processes was presented to the hospital patient safety committee for any modification in conjunction with previous OR sentinel events.
  2. Formation of HFMEA multiprofessional team: At this stage, an 8-member team was formed consisting of a general surgeon, an anesthesiologist, 4 OR technicians, a head nurse, and a health care management expert (as team adviser). Overall, a total of 15 sessions were held with an average attendance of 60% across the team members. Four meetings were held for mapping out processes with an attendance of 50%, 5 meetings for error analysis with an attendance of 80%, 3 meetings for decision tree analysis with an attendance of 70%, and 3 meetings for presenting solutions with an attendance of 60%.
  3. Mapping the selected processes: During the 3 sessions, the QIO (who was an expert in process mapping) mapped out the preliminary workflow of selected processes and subprocesses in the 3 subgroup meetings (including the head nurse, surgeons, and anesthesiologists) to save time of team members14 and completed them by observing processes. The final draft of flowcharts was verified by the HFMEA team at this stage.
  4. Error analysis: This phase consisted of 3 stages. The first stage was the identification of possible failure modes within each step of the chosen processes. Potential failure modes were identified by means of brainstorming of team members. The second stage involved determination of the severity and frequency of failure modes. We requested each team member to determine the probability and severity of each failure mode in the initial HFMEA worksheet. We calculated and recorded the sum of failure mode severity scores based on the opinions of team members (catastrophic rating 4, major rating 3, moderate rating 2, and minor rating 1) and calculated the sum of the failure mode probability scores based on the team member's opinions (frequent rating 4, occasional rating 3, uncommon rating 2, and remote rating 1). We presented the preliminary results of the hazard scores in 2 HFMEA meetings to reach a final consensus. In the third stage, failure modes with hazard scores above 8 were transferred to the decision tree. Deciding whether to continue the analysis was based on weakness, control measure, and detectability.
  5. Provide suggestions and solutions: During this stage, potential causes for each failure mode were selected and assessed on the basis of its overall contribution toward the failure in question. To determine suitable solutions, key causation factors along with their viable solutions were presented to the team members for analysis and selection. For each selected solution, an action plan was designed and submitted to management for financial viability assessment and approval.


The following 10 processes were selected among 21 known processes in the studied OR by means of the Delphi technique (Table 1).

  1. Patient admission in the OR
  2. Patient injection
  3. Performing the patient's intubation
  4. Extracting the trachea tube
  5. Comprehensive monitoring during the operative stage
  6. Care of the patient in the recovery room
  7. Counting gases, swabs, and needles
  8. Electrosurgery and related care
  9. Preparing the prep pack and drape pack
  10. Positioning the patient

Table 1. - The Result of Selecting OR Processes Based on Delphi Technique
Processes Importance Level Complexity Level Overall Points Follow-up Consensus Final Confirmation
Set up and control daily surgery list ... ... 4 5 3 ... 1 3 4 4 2.08
Transfer sets and packages from CSSD for surgery 1 1 6 1 1 ... ... 2 5 5 2.125
Control of consumable and surgical table accessories 3 2 4 2 1 1 2 4 4 1 3.083
Patient transfer from the ward to the OR 2 3 4 2 1 ... ... 6 3 3 2.75
Patient admission in the OR 6 4 2 ... ... 1 3 5 2 1 3.708
Opening the packs and sterile equipment ... ... 3 5 4 ... 1 3 5 3 2.41
Scrub process 2 4 5 ... 1 ... 1 5 3 3 2.75
Wearing gowns and gloves 1 1 3 4 3 ... ... 3 4 5 2.125
Positioning the patient 1 3 5 1 1 ... 4 5 2 1 2.958
Preparing the prep pack and drape pack 1 2 6 2 1 ... 3 6 2 1 2.958
Draping process ... 1 7 3 1 ... 1 6 3 2 2.583
Counting gases, swabs, needles 6 3 3 ... ... 1 4 5 1 ... 4.08
Electrosurgery and related care 3 4 5 ... ... 2 4 5 1 ... 3.375
Maintaining and sending samples ... 1 4 5 1 ... ... 4 7 1 2.25
Comprehensive monitoring during the operative stage 5 3 4 ... ... 5 3 4 ... ... 4.08
Care of the patient in the recovery room 6 3 3 ... ... 5 4 3 ... ... 4.208
Preparing surgical instruments for transferring to CSSD ... 1 4 5 1 ... ... 6 4 2 2.291
Autoclaving surgical instruments 1 ... 4 5 1 ... 1 5 3 3 2.333
Patient injection 4 6 2 ... ... 7 3 2 ... ... 4.08
Performing the patient's intubation 4 5 3 ... ... 6 4 2 ... ... 4.041
Extracting the trachea tube 2 3 5 2 ... 2 1 6 2 1 3.416
Abbreviations: CSSD, Central Sterile Services Department; H, high; L, low; M, moderate; OR, operating room; VH, very high; VL, very low.

Subsequently, these processes were mapped by contributions of HFMEA team members in 4 meetings (3 meetings for initial mapping processes and 1 meeting after observation of the processes for final affirmation of flowcharts). During the following stage, 113 steps were identified for 10 processes and 7 subprocesses across a period of 1 month. For each identified step, all potential failure modes were identified by means of brainstorming. In total, 187 failure modes were identified and scored according to the Hazard Decision Matrix (Table 2). On the basis of these scores, 36 potential failure modes were classified as high-risk failures (hazard score above 8). Each of the 36 high-risk failure modes was mapped to a decision tree in order to determine whether the failure mode warranted further assessment/action. “Positioning a patient for surgery,” “Counting surgical supplies,” and “Patient induction” had the highest percentage of high-risk failure modes by 57%, 36%, and 23%, respectively. Finally, for key failure modes, possible causes (Figure) along with remedial actions were proposed to mitigate their associated hazard scores. For instance, “Developing policy for the familiarization of new personnel,” “Designing a checklist for accurate gases counting,” “Participation in treatment process,” “Revision and reengineering of processes,” “Comprehensive presurgical posters,” “Preparation of all necessary equipment in difficult intubation,” “Continuous monitoring and control of the working stages,” “Improvement of team communication,” “Developing instruction for monthly checking of the OR equipment,” “Development of the evaluation criteria of staff performance,” and “Adapting workload with the staff” were proposed to improve the quality of OR processes. Table 3 presents a summary of HFMEA worksheets. It may be worth noting that there were 23 HFMEA worksheets that consist of complete analyses of all failure modes, possible causes of failures, and a full list of solutions for each cause.

Causes of identified errors in the prospective risk analysis.
Table 2. - Percentage of High-Risk Errors in Each Selected Process
Number Process Name Number of Subprocess Number of Listed Steps Number of Detected Failure Modes Number of High-Risk Errors Percentage of High-Risk Errors to the Total Errors of Each Process
1 Performing patient intubation 1 13 39 4 10
2 Patient admission in the operating room 1 14 36 8 22
3 Care of the patient in the recovery room 3 12 25 4 16
4 Electrosurgery and related care 1 13 18 3 17
5 Full monitoring and care during surgery 1 11 16 3 19
6 Counting surgical supplies such as gases, swaps, needles, and sponges ... 8 14 5 36
7 Patient induction ... 20 13 3 23
8 Preparing the prep pack and drape pack ... 8 11 1 9
9 Extract the tracheal tube ... 8 8 1 12
10 Positioning a patient for surgery ... 6 7 4 57

Table 3. - Summary of HFMEA Worksheets for Some High-Risk Failure Modes From Selected Operating Room Processes
HFMEA Worksheet
Process Potential Errors Possible Causes Scoring Decision Tree Analysis Corrective Actions
Severity Probability Hazard Score Weakness Control Measure Detectability Proceed?
Admission of the patient in the operating room Transferring the patient to the operating room without a stretcher or wheelchair -Carelessness
-Lack of enough staff in the work shift
2 4 8 Y N N Y Compilation of instructions
Failure to take the necessary measures before surgery by the staff -Carelessness
-Lack of enough experience
-Continuous displacement of the staff
3 3 9 Y N N Y -Comprehensive presurgical posters
-Developing a new policy for the familiarization of new personnel
Full monitoring and care during surgery Lack of attention to the patient's pulse, pressure -Pulse sound loss due to reduced attention to pulse changes
2 4 8 Y N N Y -Compilation of the protocol of the monthly visit of the operating room equipment
-Follow up on repairing the pulse oximetry device
Early disconnection of anesthetic drugs -Lack of work experience
-Rush in discharging the patient from the operating room
2 4 8 Y N N Y -Establishment of protocol for surgical plan
Performing patient intubation Absence of anesthesia machine check -Lack of enough experience
-Lack of regular medical equipment monitoring
3 3 9 Y N N Y -Comprehensive presurgical posters
-Inclusion of the machine check mark in the performance evaluation program
-Compilation of the monthly check of devices by the responsible officer
Positioning the patient Patient fall -Failure to use safety equipment
-Positioning the patient alone
3 3 9 Y N N Y -Purchase protective supplies
-Drafting the protocol for the participation of the available workers in the positioning
Performing patient intubation Hand washing less than the standard -Lack of work experience
-Heavy workload
2 4 8 Y N N Y -Training of operating room staff
Not checking the patient for difficult intubation -Carelessness
-Lack of work experience
-The problem is the anatomy of the patient's face
3 3 9 Y N N Y -Preparation of all necessary equipment in difficult intubation
Extract the tracheal tube Extract the trachea tube without regard to the patient's vital signs -Carelessness
-Lack of knowledge and technical skills
3 3 9 Y N N Y -Provide periodic training
-Poster compilation of vital actions during surgery
Counting gases, swabs, and needles Incorrect counting of supplies such gases and sponges -Carelessness
-Single counting by scrub
-Inappropriate scheduling of the operating room program
3 3 9 Y N N Y -Compile a checklist for accurate gas counting
-Protocols for counting by 2 people
Leaving forceps and needle gas in the patient's body Inaccuracy and negligence
-The wrong counting of gases and needles
-Lack of awareness of the importance of the subject
3 3 9 Y N N Y -Compile a checklist for accurate gas counting
Electro surgery and related care Lack of examination of the surface of the plate and skin of the patient in terms of burn, wound -Lack of awareness of the importance of the subject
-Lack of technical knowledge
3 3 9 Y N N Y -Design a poster of necessary measures before surgery
Not drying the place after the prep -Lack of awareness of the importance of the subject 3 3 9 Y N N Y -Design a poster of necessary measures before surgery
Abbreviation: HFMEA, Healthcare Failure Mode and Effect Analysis.


Quality and outcomes of OR services require a broad assessment approach to address the complicated nature of this environment because a wide range of factors contributes to delivering surgical services.11 The described approaches to risk assessment (prospective) have long been used in other industries. However, the application of these methods within the health care industry is still in its early stages.14 Therefore, applying industry standard best practices extrapolated from other industries is an effective step in the proper implementation of risk management in health care.21,22 By selecting different processes from the presurgery, surgery, and postsurgery stages, a more comprehensive picture of the failures became clear regardless of the complexity created by a diverse range of treatment-supportive and administrative activities. It should be acknowledged that few studies have been conducted on the basis of a comprehensive analysis of the preoperative, presurgery, and postsurgery processes. Many studies have analyzed a specific process within the OR using a retrospective or prospective risk analysis method. For instance, Nagpal et al23 analyzed the communication processes in the preoperative, operative, and postoperative phases, whereas Anderson et al4 assessed 5 high-risk processes in the surgery ward by using modified HFMEA.

Of the 187 error modes detected in this study, a total of 32% of the errors were related to the preoperative procedures, 52% were related to the surgical procedure, and 16% were related to the postoperative process. In a systematic study, Nagpal et al23 concluded that 50% of the probable errors in communication were related to preoperative and patient-prepared procedures, which are a natural consequence of the importance of the flow of communication and its role in preparing the patient before surgery. However, Gawande et al,24 by examining the events reported by surgeons in 3 training hospitals, concluded that two-thirds (51%) of the errors occurred during the operation. However, it should be considered that any study based on reports presented by surgeons is likely to emphasize the surgical procedures themselves as opposed to pre- and postoperative activities. Of all the identified potential errors, 19% required corrective action based on the results of the analysis. In the study by Nagpal et al,23 31% of the identified failure modes during the communication in the OR were classified as high-risk failures and for 11% of the failure modes, 18 corrective actions have been proposed. In addition, Anderson et al4 identified 26% of failure modes as hazardous without any control action.

Of the 75 potential errors, 68% were related to human errors, 23% were related to organizational errors, and 9% were related to medical equipment deficiency. It is important to note that Gawande and colleagues24 assessed the role of human errors as crucial. Among the solutions proposed here, some covered several failure modes. For example, designing comprehensive posters of preoperative and operational procedures covered a large number of existing organizational defects. In addition, Einav et al25 discovered that the use of comprehensive posters before and during surgery with relevant training significantly reduced adverse events in the OR. The effectiveness of other suggestions has also been confirmed to reduce medical errors in various studies.

Through this study, we attempted to demonstrate a more comprehensive picture of failure modes in the preoperative, operative, and postoperative processes. Furthermore, team members gained in-depth insight into processes that were not of specific relevance to them but which were nonetheless very important for patient outcomes. For instance, surgeons became more familiar with the steps of the admission process and this resulted in them providing suggestions for improving some of the processes during the risk assessment. Moreover, an action plan has been designed across all key failure modes identified by the HFMEA team members that will be implemented as the OR quality improvement annual plan, funded by executive managers. Finally, the results of this research can be helpful in terms of optimizing risk analysis across hospitals. An important feature of this research methodology is the identification of primary causes of failure modes through evaluation by decision trees. As a result, limited organizational resources can be deployed toward resolving the most relevant causes.


According to research findings, 187 potential failure modes were identified from 10 key processes within the OR, of which 36 errors emerged as unacceptable risks. “Developing policy for the familiarization of new personnel,” “Designing a checklist for accurate gases counting,” “Comprehensive presurgical posters,” “Preparation of all necessary equipment in difficult intubation,” “Improvement of team communication,” “Instruction for monthly checking of the OR equipment,” “Development of the evaluation criteria of staff performance,” and “Adapting workload with the staff” are examples of solutions proposed to improve the quality of OR processes. Finally, conducting such a risk analysis can be helpful in identifying, prioritizing, and reducing failure modes in the OR and changing organizational culture from reactive to preventive approaches.


Because of the limitations of HFMEA and this research, it should be considered that failures within each organization are based on the organization and the environmental conditions of the institution concerned. It is difficult to generalize these results and apply them to other institutions or even compare them. Moreover, determination of the potential failures and rating procedure is highly subjective and based on team members' interpretations, so some of the real failures still cannot be determined or correctly prioritized, and ratings can be varied even in the same project by different team members.26 In addition, it is difficult to show the effect and cost-effectiveness of HMFEA-derived interventions to mitigate high-risk failure.


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Healthcare Failure Mode and Effect Analysis; operating room unit; risk management

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