Failure Modes and Effects Analysis of bilateral same-day cataract surgery

Abstract

PURPOSE To systematically analyze potential process failures related to bilateral same-day cataract surgery toward the goal of improving patient safety. SETTING Twenty-one Kaiser Permanente surgery centers, Northern California, USA. DESIGN Retrospective cohort study. METHODS Quality experts performed a Failure Modes and Effects Analysis (FMEA) that included an evaluation of sterile processing, pharmaceuticals, perioperative clinic and surgical center visits, and biometry. Potential failures in human factors and communication (modes) were identified. Rates of endophthalmitis, toxic anterior segment syndrome (TASS), and unintended intraocular lens (IOL) implantation were assessed in eyes having bilateral same-day surgery from 2010 through 2014. RESULTS The study comprised 4754 eyes. The analysis identified 15 significant potential failure modes. These included lapses in instrument processing and compounding error of intracameral antibiotic that could lead to endophthalmitis or TASS and ambiguous documentation of IOL selection by surgeons, which could lead to unintended IOL implantation. Of the study sample, 1 eye developed endophthalmitis, 1 eye had unintended IOL implantation (rates, 2 per 10 000; 95% confidence intervals [CI] 0.1–12.0 per 10 000), and no eyes developed TASS (upper 95% CI, 8 per 10 000). Recommendations included improving oversight of cleaning and sterilization practices, separating lots of compounded drugs for each eye, and enhancing IOL verification procedures. CONCLUSIONS Potential failure modes and recommended actions in bilateral same-day cataract surgery were determined using a FMEA. These findings might help improve the reliability and safety of bilateral same-day cataract surgery based on current evidence and standards.

Patient Experience and Satisfaction With Immediate Sequential and Delayed Sequential Bilateral Cataract Surgery

“…28,29 Additional risk mitigation methods in the implementation of ISBCS have been reported as well. 15,16,29 Past studies of patient satisfaction following cataract surgery have focused on patientlevel correlates of satisfaction 30 congruence between preoperative expectations and outcomes 31 the role of the setting 32 , the roles of communication, friendliness, and preoperative, intraoperative, and postoperative care 33 the type of implanted lens. 34 These studies of patient satisfaction, however, were conducted in the setting of DSBCS.…”

“…Protocols used to develop the ISBCS program are based upon the general principles for ISBCS excellence and a failure modes and effects analysis conducted by our institution. 15,16 Prior to consultation with a surgeon, patients may attend a cataract class where the options of DSBCS and ISBCS are presented. Surgeons offer suitable patients a choice between the ISBCS and DSBCS formats and there is no financial disincentive to surgeons for performing ISBCS.…”

Immediate Sequential vs. Delayed Sequential Bilateral Cataract Surgery

“…The use of intracameral antibiotic together with clinical workflow changes to reduce infection and toxic anterior segment syndrome, such as performing inspections of the surgical venue and cleaning and sterilization processes, are important aspects of risk reduction. 15 Practice recommendations for ISBCS 16 merit further consideration given the publication of new studies and evidence. 15 …”

“…15 Practice recommendations for ISBCS 16 merit further consideration given the publication of new studies and evidence. 15 …”

Immediately sequential bilateral cataract surgery (ISBCS) adapted protocol during COVID-19

“…For instance, Kaiser Permanente Health Maintenance Organization, the largest Health Maintenance Organization in the United States, reported on 3,561 ISBCS procedures (7,122 eyes). [11][12][13] Vision Group Canada reports over 30,000 ISBCS procedures, including bilateral refractive lens exchange, over the past decade performed by 50 surgeons. Dr. Steve Arshinoff based in Toronto, Canada has completed over 12,000 ISBCS procedures over the past 25 years, and currently performs ISBCS on 80-90% of patients.…”