Before and After: Activate your Quality Program (Before), Use Root Cause Analysis (After) for Better QAPI in Surgical Services

By Julie Vandenbark, MLS, BSN, RN

At first impression, the idea of using a surgical instrument to inspect surgical instruments might sound silly. After all, aren’t there better tools for maintaining endoscopes and lumened instruments than …  other scopes? Well, perhaps not. That’s at least according to a team of researchers who recently determined that borescopes are well-suited to visually inspect the tubes that transport liquids or gasses during a medical procedure.

Surgical settings strive to provide quality care but aren’t immune to adverse events with an associated risk of patient harm. Hospitals and ASCs know that QAPI is mandatory and comprehensive of all departments. Tracking, trending, measuring, monitoring – all familiar concepts. And yet, the Centers for Medicare and Medicaid released a quality and safety memo on March 9, 2023, noting that QAPI Conditions of Participation deficiencies are the third most cited of the 24 CoPs for Medicare participating hospitals.¹

Activate through Ownership

Regulatory agencies expect to see a well-designed and well-maintained quality program that addresses aspects of performance including processes of care, contracted services, and internal operations. 

While the organization’s governing body ultimately ensures that a data driven program is in place,² individuals and teams can – and should – be engaged in identifying meaningful measurement goals (benchmarks) for the work they do.   

Offer guidelines for consideration when determining quality indicators:

• What is the established benchmark? Is it based on nationally-recognized standards of practice, or on the organization’s own history of performance?
• What is the sustainability time frame? If the benchmark is met consistently, do you increase the level of challenge or add a new metric? 
• Who owns oversight of QAPI reporting? At the team/department level? At the organization level? 
• How do the selected quality indicators demonstrate improved health outcomes or a reduction in medical errors?

Building individual ownership of quality is the best way to avoid the need for improvement based on an adverse event.  

When an event occurs

In addition to activating your quality proactively, consider QAPI data in adverse event analysis. 

In the surgical setting, an adverse event, or worse, a “never event,” requires immediate investigation. Perhaps a piece of equipment failed, an incorrect dose of medication was given, or a wrong site procedure took place. Calling attention to the issue alone is not sufficient to drive sustainable improvement. Uncover the “why” and “how” by conducting a root cause analysis (RCA). 

RCA is your key to a dynamic and effective QAPI response to an event. Pinpoint the underlying factors or causes of the failure. Don’t hesitate to dig deep into “why.” Did someone miss scheduling preventive maintenance or performing a routine calibration? Did an employee miss an important step? Why? Lack of documentation? A communication error? Were instructions readily available? Is there a flaw in the training program? 

Next comes the “how.” How will you fix it? Your goal is to avoid recurrence, so that the correction sticks. Use your RCA to choose the best single action – such as creating work instructions for maintaining each piece of surgical equipment, or refreshing staff education. Select the fewest number of actions that will create improvement. Throwing the kitchen sink at the problem means you’ll never know what was really effective. 

Case Study:  A Double Never Event

The Agency for Healthcare Research and Quality (AHRQ) Patient Safety Network published a case study chronicling one procedure that encompassed two never events: wrong patient and wrong side. 

“A first-year orthopedic surgery resident was consulted to aspirate fluid from the left ankle of a patient in the intensive care unit. The resident, accompanied by a second resident, approached the wrong patient, obtained consent from the patient’s wife via telephone, and inserted the needle into the patient’s right ankle. At this point, a third resident entered the room and stated that it was the incorrect patient. The procedure was immediately terminated, and the needle was withdrawn. The patient and family were notified of the error.”³

The study lists contributing factors uncovered by the RCA:

• The patient was incapable of providing informed consent, so the patient’s wife consented to the procedure – but did so with an incorrect patient name. 
• When the nurse questioned the procedure, the residents did not fully address her concerns. 
• The time-out did not include verification of the patient and procedure location. 

RCA Takeaways

What do these factors reveal? Education and training are clearly needed regarding the components of the time-out process, specifically patient identification and team member agreement prior to proceeding. How will this be accomplished? Time-out drills? Exercises to enhance team collaboration and cohesion? Formal evaluation of competencies? Whatever action is taken, it must be documented and measurable.

Clearly you are not going to wait for another adverse event to evaluate the effectiveness of your choice, so developing and performing simulations may be a good way of assessing success in the short term. 

As a portion of the RCA, the organization should record the implemented actions or changes, such as documented staff education and training attendance, demonstration of new or revised policies and  procedures, evidence that equipment has been repaired or replaced, plus any new quality monitoring indicators and evidence of appropriate reporting. 

Then the organization needs to assess whether the implemented strategies and actions have resulted in improved outcomes that are sustained over time. So, we’re back to identifying and tracking those indicators. 

You’ve undoubtedly put a lot of time and effort into your QAPI Program, but don’t shy away from revision. Does your current practice live up to its full potential? Take steps to make quality assurance work for you. 

1. Centers for Medicare and Medicaid.  March 9, 2023.  QSO-23-09-Hospital.  Revision to State Operations Manual (SOM), Hospital Appendix A – Interpretive Guidelines for 42 CFR 482.21, Quality Assessment & Performance Improvement (QAPI) Program.  Retrieved April 3, 2024 from https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-states/revision-state-operations-manual-som-hospital-appendix-interpretive-guidelines-42-cfr-48221-quality
2. Accreditation Requirements for Acute Care Hospitals, Quality Assessment & Performance Improvement standards 12.00.03, 12.02.02, 12.02.03.
3. Alyssa Bellini, MD and Edgardo S Salcedo, MD, FACS, A Double “Never Event”:  Wrong Patient and Wrong Site.  September 27, 2023.  Retrieved March 26, 2024 from https://psnet.ahrq.gov/web-mm/double-never-event-wrong-patient-and-wrong-side