Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

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The Problem of Lack of Respect for Time-out Procedures and Protocols at St. Joseph Pain and Rehabilitation Center: Presenting the Existing Evidence for the Presence of the Problem and Making a Choice of Quality Improvement Model  Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

Quality healthcare is a major necessity in today’s healthcare landscape. The success of any healthcare setting depends on its ability to provide quality healthcare. That is care given to patients that is timely, safe, effective, efficient, equitable, patient-centered (Tzelepis et al., 2015). It is for this reason that quality improvement or QI has become an important pillar of the strategic objectives of many healthcare organizations. Many quality indicators exist and are used by organizations to monitor and improve the quality of care they offer. Regulatory bodies such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) also monitor these quality benchmarks for quality assurance and certification purposes.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room. It is a common feature to find several quality indicators being monitored on the dashboards of electronic health record (EHR) systems of many healthcare organizations. At the St. Joseph Pain and Rehabilitation Center, it has been found that surgical care given to patients is not safe, effective, efficient, and patient-centered. This is with regard to observing of the time-out protocols as required for safe surgical procedures. This is a quality improvement issue and practice problem that must be corrected immediately as it has led to an increase in the rate of wrong-site surgeries. Wrong-site surgeries are described as sentinel events by the JCAHO (The Joint Commission, 2021). The purpose of this paper is to restate the clinical problem, analyze and synthesize available scholarly evidence for the existence of the problem, and choose a quality improvement model to be used to address the clinical problem. Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

Quality Improvement Project

The quality improvement project aimed at addressing the time-out problem is about diagnosing the root cause of the non-adherence, retraining all the surgical staff using resource persons from JCAHO, and restructuring the supervisory management of the operating theaters and the surgical unit. After retraining and reskilling, nurse managers overseeing operations in the theaters and the surgical unit will need to properly perform their managerial duties of planning, organizing, directing, and controlling. In this case, supervision and monitoring as components of the function of ‘controlling’ must be done properly.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room. This will deter staff from taking costly shortcuts that negatively impact patient safety. The nurse managers will have both authority and responsibility to carry out this function and will be held responsible in case of non-compliance to time-out procedures. The key stakeholders at the facility to collaborate with on this are the nurses, the surgeons, and the management. Their buy-in has already been sought and they are ready to co-operate.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

Measurable Indicators

The Quality Improvement Committee at St. Joseph Pain and Rehabilitation Center has, through the tracking of quality metrics on the institution’s electronic health record (EHR) system dashboard, found a safety issue requiring addressing. The data they have shows that there has been a 20% increase in sentinel events in the surgical unit with regard to wrong-site operations in the last financial year. This resulted in several medical malpractice lawsuits for the Tort of Negligence. Three of these already resulted in settlements of remedies amounting to $1.8 million dollars in compensation. According to The Joint Commission, a sentinel event is a preventable patient safety incident that causes permanent disability, severe bodily harm, or death to a patient. According to Chung (2015), a total of 8,275 sentinel events were recorded by the JCAHO between 2003 and 2014. A whole 67% of these were however self-reported, meaning that the real magnitude of the problem could be astonishingly higher.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

Rationales and Patient Outcomes

The reason why this specific clinical problem was chosen is that the rates of wrong-site surgeries (WSS) as a quality indicator are not as regularly highlighted as other quality benchmarks such as fall rates, pressure ulcer rates, catheter-associated urinary tract infection (CAUTI) rates, central line-associated blood stream infection (CLABSI) rates, and ventilator-associated pneumonia or VAP rates amongst others. This does not mean however that WSS rates are less of a quality benchmark. I also chose the time-out problem because it results in sentinel events that pose a very serious threat to patient safety and organizational fiscal viability. This project will improve patient outcomes in that no patient will come out of the operating theater as a cadaver, with a permanent disability, or with severe bodily harm as a result of negligence.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room. The project will therefore foster the bioethical principle of nonmaleficence or primum non nocere in that the surgical patients will not be harmed by deliberate acts of omission. The project is about re-familiarising the surgical staff with the concept of “time-outs” and then enforcing the same to avoid WSS through close and proper supervision by mid-level management. The quality of care will improve tremendously as checks and balances created by time-outs will eradicate the possibility of WSS at the St. Joseph Pain and Rehabilitation Center.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

Literature Review

Purpose

The purpose or objective of the study by Rothman et al. (2016) was to come up with an evidence-based care redesign intervention that would minimize the rate of WSS. According to Jeanette and Elizabeth (2016), the implicit purpose of their article was to provide a background to the serious clinical problem of disregarding time-out procedures. They provide anecdotal snippets of real events that occurred in the past with regard to WSS. The purpose of their article and study lays the foundation for the purpose of the study by Rothman et al. (2016). The Agency for Healthcare Research and Quality (AHRQ, 2019) on its part presents an article whose purpose is to demonstrate the significant risk that wrong-site, wrong-patient, and wrong-procedure errors pose to patient safety.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room. This is congruent with the purposes of the literature from Rothman et al. (2016) and Jeanette and Elizabeth (2016). According to Mulloy and Hughes (n.d.), their implicit purpose was to prove that WSS are sentinel events caused by preventable human errors. Lastly but not least, Chung (2015) had as the purpose to provide real concrete data from the Joint Commission about reported sentinel events in the past. The purposes of both of these last two groups of authors are in line and agreement with the other three. There are no disagreements or inconsistencies in purpose among all the five groups of authors. Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

Methods

Rothman et al. (2016) used an interventional observational study to come up with an electronically mediated time-out care plan that would lower the rates of WSS. Jeanette and Elizabeth (2016), AHRQ (2019), and Mulloy and Hughes (n.d.) are expert opinions that typically would offer the least evidentiary value with regard to the levels of evidence (LOE) from scholarly literature. The three methods significantly differ from that by Rothman et al.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room. (2016) because the latter is a well-designed study methodology with a study sample, setting, interventions, and hypothesis/ research questions. The other difference also is that because of the method used by Rothman et al. (2016), the study gives a higher evidentiary value at level III. Lastly, Chung (2015) uses a retrospective method to present historical data about sentinel events. His method is closer to Rothman et al. (2016) in terms of giving better evidentiary value than it is to those of the other three groups of authors.

Findings

According to Rothman et al. (2016), it is possible to force staff to follow an electronically-mediated time-out protocol but it is not certain whether the approach can yield practical results. Jeanette and Elizabeth (2016), AHRQ (2019), and Mulloy and Hughes (n.d.) all agree that WSS as sentinel events are costly human errors that are preventable. The findings of these three groups of authors support those of Rothman et al. (2016) and Chung (2015), whose findings were that the number of sentinel events is unacceptably high.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

Quality Improvement Process

The QI process chosen for this project is that defined by the acronym FADE. The acronym stands for Focus, Analyze, Develop, and Execute (Spath, 2018). The process will involve data collection, assembly of resources, implementation, and evaluation of the outcomes.

Quality Improvement Tool

The quality improvement tool that will be used in this case will be the recommended time-out checklist given out by the JCAHO. This is the checklist that should be used by all organizations to ensure that WSS as sentinel events do not occur and breach patient safety.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

The Practice Problem of Non-Observance of Time-Out Procedures at the St. Joseph Pain and Rehabilitation center: Analysis of the Existing Evidence for the Problem and Choice of a Quality Improvement Model 

The concept of healthcare quality is a very important concept that determines the way care is viewed by stakeholders in terms of patient outcomes. Because of this, quality improvement (QI) is a very critical part of any strategies put forward by healthcare organizations. There are several quality indicators that organizations use to undertake QI initiatives enabling them to stay on course with expected quality standards. These are the same quality indicators that regulatory and supervisory organizations such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) use. Some of these quality benchmarks are patient readmission rates, patient fall rates, pressure ulcer rates, catheter-associated urinary tract infection (CAUTI) rates, and ventilator-associated pneumonia (VAP) in mechanically ventilated ICU patients amongst others. In this project undertaken at the St. Joseph Pain and Rehabilitation Center, the practice problem meriting quality improvement that was identified is that of non-respect for time-out procedures. This has led to medical errors of operations on the wrong site with life-long consequences for the patients (Pellegrini, 2017).Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room. This paper recaps on the problem, provides an analysis and synthesis of the available evidence for the existence of the problem, and proposes the QI model that will be used to correct the situation.

The Practice Problem of Non-Adherence to Time-Out Protocols in the Operating Room

There is a practice problem of surgeries conducted on the wrong patient and wrong site identified at the St. Joseph Pain and Rehabilitation Center. Data collected by the Quality Improvement Committee of the hospital shows that in the last financial year, there was a 20% increase in this problem. This resulted in especially three lawsuits for the tort of negligence (medical malpractice) that cost the organization over $1.8 million in compensation claims. It is a problem that has now reached unacceptable proportions and needs to be addressed as a matter of priority. The term ‘wrong-site surgery’ denotes any surgical procedure that has been done on the wrong patient, on the wrong side of the body, on the wrong part of the body, or at the wrong level of the correct part of the body.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room. According to statistics from the Joint Commission on Accreditation of Healthcare Organizations, cases of wrong-patient surgeries are not as common as surgeries conducted on the wrong side of the patient (such as the right kidney instead of the left) or the wrong level of the correctly identified site (Chung, 2015). However, their rates are still unacceptably high considering for example the Six Sigma mantra for quality control which is “zero defects”. The JCAHO considers the quality indicator of wrong-site surgery as a sentinel event. That is a patient safety occurrence that results in severe bodily harm, permanent disability, or death (The Joint Commission, 2021).Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

Data collection through interviews with the concerned nurses and surgeons reveal that the non-observance of the laid down time-out protocols may be due to two factors. These factors are burnout due to long working hours as well as staff shortage, and complacency due to laxity in supervision by nurse managers. In resolving this QI problem, attention will focus on these two areas in terms of allocation of nursing resources and training. The rationale for selecting this practice problem is that it is a neglected QI issue that is not regularly focused upon. It is also my view that it is a very costly medical error that is preventable and that results from direct omission and commission by the healthcare staff.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

Current Available Evidence Pointing to the Existence of the Problem of Non-Adherence to Time-Outs Leading to Wrong-Site Surgeries

In an interventional study, Rothman et al. (2016) recognize the presence of the QI issue of wrong-site surgery in clinical practice. They concur that this is the type of surgical procedure that is done on the wrong site or the wrong patient. However, they also make a very important inclusion – that it could also be the wrong operation conducted on the right patient. Most importantly, they state that the actual incidence of this quality indicator is about 1 in 5,000 cases (Rothman et al., 2016). They created large in-room LCD displays that showed to all the time-out procedure and checklist.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

Jeanette and Elizabeth (2016) also agree in their article that “time-outs” are meant to prevent harm to the patient and to protect the surgical team. They categorically state that when wrong surgery occurs, the impact to both the patient and the surgical team is devastating in terms of consequences. The patient is scarred both literally and psychologically for life while the reputation of the surgical team members is also dented. This observation by these authors is an indicator of and evidence that the practice problem chosen at St. Joseph Pain and Rehabilitation Center indeed exists.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

The Agency for Healthcare Research and Quality (AHRQ) is a body that is known to guide and facilitate quality improvement in healthcare organizations. In its publication on the Patient Safety Network, it tackles this time-out problem by writing about the practice issue of wrong-procedure, wrong-site, and wrong-patient surgical operations (AHRQ, 2019). They state in this piece of evidence from literature for the presence of this problem that operations on the wrong site or patient are referred to as never events. This is because they are errors that are not supposed to happen as they invariably point to a major safety concern in the organization.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

Mulloy and Hughes (n.d.) also provide evidence with literature in support of the presence of the chosen practice problem and its severity as a quality indicator. To begin with, they acknowledge the problem but state categorically that it is a preventable medical error that should not happen in the first place. They admit that wrong-site surgery (WSS) is a present and realistic threat to patient safety (Mulloy & Hughes, n.d.). Last but not least is evidence from Chung (2015). This author presents the evidence in support of the presence of this problem by showing statistics about sentinel events as collected by the JCAHO. For instance, between 2003 and 2014 or about 10 years there were a total of 8,275 sentinel events recorded by JCAHO. Of these, 5,563 were self reported while 2,712 were non-self reported (Chung, 2015). However, the fact that majority of these cases were self-reported indicates that these statistics might be an underestimation of the magnitude of the problem.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

The Quality Improvement Process for Addressing the QI Issue

Quality improvement (QI) is the process of systematically correcting clinical problems in healthcare that negatively impact the quality of care delivered as well as patient safety. In this case, the QI process will include:

• Collection of data and gathering of evidence for action
• Search for evidence-based interventions that can solve the problem
• Choice of evidence-based interventions to use
• Assembly of resources required for the QI initiative
• Implementation of the QI initiative
• Evaluation of the success or failure of the QI initiative.

The QI model that will be used to actualize the QI project will be FADE. This is an acronym that stands for Focus, Analyze, Develop, and Execute (Spath, 2018). The QI tool that will be used in the QI plan will be the time-out checklist proposed and recommended by the JCAHO.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.

Conclusion

Quality improvement is a major undertaking in any serious healthcare organization. It is initiated by data from dashboard metrics that track quality benchmarks such as the rate of wrong-site operations per 1,000 patient procedures. At the St. Joseph Pain and Rehabilitation Center, the problem of non-adherence to tine-out protocols by JCAHO has been identified. Evidence has been found to justify concentration on the problem, and a QI process and model have been chosen for taking care of the problem’s correction. What remains is its implementation.Analysis of the Existing Evidence for the Problem and Choice of  Quality Improvement in the Operation Room.