Standardized Safe Surgery Program Reduces Serious Events

Laurie Barclay, MD

December 30, 2014

An effectively implemented standardized safe surgery program significantly reduced rates of serious reportable events (SREs), according to findings of a retrospective cohort study published online October 4, 2014, and in the January 2015 issue of the Journal of the American College of Surgeons. Risk for SREs is particularly high in robotic cases.

"Patient safety in the perioperative period remains a challenge, and the demand for a process that reduces risk grows with greater awareness of this problem," write Terrence Loftus, MD, MBA, from the Division of Care Management, Banner Health, Phoenix, Arizona, and colleagues. "The World Health Organization's...Safe Surgery Saves Lives Program demonstrated a reduction in rates of death and complications in adult patients undergoing noncardiac surgery across a diverse group of hospitals based on their published guidelines of recommended practices supporting safe surgery. The National Quality Forum...has also continued to advance the drive to improve patient safety and reduce the incidence of [SREs] during the course of surgical procedures."

Starting in October 2008, the Centers for Medicare and Medicaid Services no longer reimburses hospitals for four types of SREs related to surgery: wrong surgery or invasive procedure performed on a patient, surgery or invasive procedure performed on the wrong body part, surgery or invasive procedure performed on the wrong patient, or foreign object unintentionally left in the patient after surgery.

To determine whether following safe surgery practices would lower SRE rates, the researchers compared these rates before and after implementing a standardized safe surgery program at their large healthcare system. This program emphasized a consistent message, engaged leadership, clearly articulated procedures, and expected performance standards for all personnel.

The researchers defined SREs as retained surgical item, wrong site, wrong patient, and/or wrong procedure. Observational audits confirmed 96% compliance rates with the new safe surgery program.

The program included involving all care providers (including the surgeon and anesthesiologist) in verifying patient identification and surgical site, marking the surgical site, enforcing a time-out before the procedure, visual cues reminding staff to conduct instrument and sponge counts, team debriefings after the procedure, and competence validation.

During the 4-year study period, the researchers evaluated 683,193 cases in the operating room and labor and delivery. After implementation of the new safe surgery program, the SRE rate decreased from 0.075/1000 cases to 0.037/1000 cases (52% reduction; P < .05). Mean time between SREs increased from 27.4 days before implementation to 60.6 days after implementation (P < .05).

Although the new safe surgery program reduced SREs equally in robotic and nonrobotic cases, there was still a significant difference in SRE rates between these two groups of cases (P < .05). SRE rates were sevenfold higher in robotic than in nonrobotic cases.

Limitations of this study include a retrospective design precluding determination of causality.

"Effectively implementing a safe surgery program, designed with an understanding of both work flow and human cognitive factors, across a large diverse health care system, can lead to a reduction in SREs in the [operating room and labor and delivery] areas," the study authors conclude. "This can lead to both a significant cost avoidance and overall improvement to the quality of care delivered. Further work will need to focus on high risk areas such as robotic-assisted surgery in order to meet the expectation for considering SREs as never events."

The Care Management Division of Banner Health and a grant from Cardinal Health Foundation funded and supported this project. The authors have disclosed no relevant financial relationships.

J Am Coll Surg. 2015;220:12-17. Full text

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