Creating a Culture of Safety
Through Standardization
Clinical Trial Research Findings — JohnMark International
Counts
X-Ray Required
Reduced Stress
Procedure
Overview
For decades, adverse events (AE), Retained Foreign Objects (RFO), Never Events (NE), and Retained Surgical Items (RSI) have plagued patients, hospitals, and medical staff alike. Professional organizations such as JACHO, AORN, and AST have developed policies and procedures to prevent poor patient outcomes — yet the persistent problems continue. New innovative technologies and methods for standardizing intraoperative procedures show tremendous potential to vastly improve patient and surgical team safety while reducing stress and unnecessary costs. This clinical trial provides evidence of the effectiveness of a standardized mapped surgical back-table drape during the intraoperative process.
The Persistent Problem
According to the World Health Organization, patient safety is defined as the “prevention of errors and adverse events associated with patient care.” Despite decades of policy development by JACHO, AORN, AST, and WHO, adverse events remain a global challenge — rarely caused by a lack of technical skill, but by a lack of safety culture among caregivers.
The persistent problems in operating rooms include intraoperative time delays, missed sponge and needle counts, unplanned x-ray use, forced overtime, and surgeon frustration — all leading to poor patient outcomes. Standardization has emerged as the pivotal, yet largely unimplemented, solution.
Financial Impact of Retained Surgical Items
| Years | Closed Claims | Paid Claims | Avg. Payout | Largest Payout | Total Payout |
|---|---|---|---|---|---|
| 2002–2006 | 727 | 244 | $73,889 | $1.35 million | $18 million |
| 2007–2011 | 892 | 253 | $104,842 | $865,000 | $26.6 million |
Physician Indemnity Costs — Physician Insurance Association of America Data Sharing Project
| Years | Closed Claims | Avg. Legal Costs | Total Legal Costs |
|---|---|---|---|
| 2002–2006 | 727 | $17,805 | $12.9 million |
| 2007–2011 | 892 | $29,152 | $26 million |
Physician Legal Defense Costs — Physician Insurance Association of America Data Sharing Project
per RSI claim (2007–2011)
permanent major damage
over 4 years (RSI)
per retained item (at $2K/min)
Study Design
19 staff · 96 surveys
staff meeting
96 procedures
questionnaire
10 participants
Figure 1. JMI Mapped Back Table Drape — left & right side standardization
Questionnaire: 19 Items Covering
- Intraoperative surgical counting
- Adverse events encountered
- Benefits of the MBTD setup
- Relief/break period handoffs
- X-ray usage to resolve counts
Pre-JMI Baseline Findings
Phase 1 — Baseline · July–September 2022Data collected before introduction of the MBTD, revealing widespread inconsistency in counting procedures and significant operational risk.
Post-JMI Intervention Results
Phase 2 — Intervention · October–December 2022Dramatic improvements across all measured safety metrics following introduction of the JMI Mapped Back Table Drape.
Staff Interview Excerpts
Most nurses and technicians in the OR know the importance of surgical counting and how it is supposed to be done, however it is usually performed incorrectly with disregard to hospital policy or any counting standard.
We have so many new OR techs and I am fairly new myself that I can’t keep up with how each new tech is counting. Each surgical case is so different even if it’s the same procedure but a different tech.
The part I hate about my job as a relief scrub is I always have to adjust to someone else’s setup in the middle of a case where I can’t immediately find items on the back table, then I get yelled at by the surgeon. Very stressful and very unsatisfying.
Many near-misses occur, and they are not reported so long as the problem was resolved without any harm to the patient.
JMI Setup vs. Current Methodology
Standardization Is a Must
Retained surgical items remain a persistent phenomenon within the surgical arena. As this study has proven, and as echoed by JACHO, AORN, WHO, and AST — standardization is a must if we are to protect our patients from near-misses, retained foreign objects, unnecessarily prolonged surgeries, and unplanned intraoperative x-ray use.
Contributors
References
- Aouicha, W., et al. (2022). Patient safety culture as perceived by operating room professionals. BMC Health Services Research, 22(1), 799. doi:10.1186/s12913-022-08175-z
- Sentinel Event Data Summary. The Joint Commission. (2023). jointcommission.org
- Sloane, T. (2013). The high cost of inaction: Retained surgical sponges. Becker’s Hospital Review.
- Sentinel Event Alert, Issue 51. The Joint Commission. October 17, 2013.
- Rafter, N., et al. (2015). Adverse events in healthcare: Learning from mistakes. QJM, 108(4), 273–277.
- Kyle, E. (2023). Preventing unintentionally retained surgical items. AORN Journal, 117(3), 192–199.
- Saver, C. (2022). Retained surgical items: Overview of a persistent problem. AORN Journal, 116(2), 111–115.
- Goodwin, B. (2018). Retained surgical item lawsuits will cost you. Urology Times.