Safety Protocols: Surgical Safety Checklist In Operating Rooms

Evidence-Based Practice Proposal- Final Paper
Portia Stephens
Grand Canyon University: NUR 699
June 12,2019
Table of Contents
Evidence-Based Practice Proposal
Abstract …………………………………………………………………………………….. 4
Section A: Cleveland Clinic Culture ……………………………………………………... 5 Organizational Culture ………………………………………………………………. 5
Section B: Problem Description …………………………………………………………... 6
Stakeholders …………………………………………………………………………..7
PICOT ………………………………………………………………………………...7
Objectives/Purpose …………………………………………………….…………….. 7
Section C: Literature Support …………………………………………….………………. 9
Locating credible evidence …………………………………………………...……… 9
Appraise the evidence ……………………………….……………………………….. 9
First Study …………………………………………………………………… 9
Second Study ……………………...………………………………………… 10
Third Study ………………………………………………………………...…11
Section D: Solution Description …………………………………………………...……… 13
Organization Culture ………………………………………………………………… 13
Proposed Solution …………………………………………………………………….13
Expected Outcomes ……………………………………………………………..……14
Achieve Outcomes …………………………………………………………………... 15
Outcome Impact ………………...…………………………………………………… 15
Section E: Change Model …………………………………………………………………. 17
Evaluation of ARCC ………………………………………………………………… 17
Change Model Implementation …………………………………….……………..... 17
Evaluation …………………………………………………………..………………. 18
Section F: Implementation Plan ……………………………….………….……………... 20
Setting ………………………………………………………………..……………… 20
Methods and Instruments ……………………………………….….……………….. 20
Timeline ………………………………………………………………….………..... 21
Data Collection and Management ……………………………………..……………. 21
Budget/Proposed ……………………………………………………….………….... 22
Solution after Implementation ……………………………………….……………... 22
Section G: Evaluation of Process …………………………………………..…………….. 24
Rational for Methods ……………………………………………….………………. 24
Outcome Measures …………………………………………………..……………… 25
Validity, Reliability, Applicability ………………………………….…………….... 25
Strategies for Negative Outcome ………………………………….…………….….. 26
Implications ………………………………………………………….………………26
Conclusion ……………………………………………………………………….………… 27
References …………………………………………………………………….……………. 28
Appendix …………………………………………………………………………………… 32
Abstract
In the United States alone, the reported prevalence of wrong-site surgery, according to the World Health Organization (WHO), is over 2500 cases every year. The instances of wrong-site surgery can be reduced or prevented by increasing our efforts involving patient safety through the use of an intra-operative protocol. In this project, the WHO Surgical Safety Checklist can lead the way to foster a patient safety program based on the checklist's perceived benefits with regard to the prevention of wrong-site surgery. The purpose of this patient safety improvement program is to validate whether the use of written surgical checklist can prevent the possibility of occurrence of wrong site surgery at Cleveland Clinic that will be implemented for over a year. Another objective is to bring about a practice of positive change when we look at operative room safety culture. This project will educate the providers on patient safety and the need for an intra-operative protocol that can maintain the integrity of health care providers to their patients. This project was based from three wrong-site surgery studies where the researchers observed the occurrence rate of wrong-site surgery before and after the implementation of the WHO surgical safety checklist. Their studies implemented the WHO checklist in the three phases of surgery: before the induction of anesthesia, before skin incision, and after the surgery. All of the studies indicated a decrease of wrong-site surgery after the introduction of the WHO checklist. There was also an increase in effective communication among the members of the surgery team. This project has the potential for a positive change in patient safety protocols by introducing a surgical safety checklist in operating rooms, thereby reducing or preventing the occurrence of wrong-site surgery.
Section A: Organizations Cultural Readiness
The organizations culture and readiness scores reflect their willingness to integrate Evidence based practice. They are committed to the improvement administration of patient care and for the continued competencies and strong EBP knowledge skills of its nursing staff. With the goal of acquiring magnet status the institution is focused on nursing research and the implementation of EBP as its main focus. This is APN driven through shared governance committees and ongoing online surveys and questionnaires encouraging staff participation. There are no barriers to the advancement of EBP as there are numerous champions’ at all administrative and clinical level encouraging participation through mentorship, workshops, conferences, and mentorship. Time is allotted for educational improvement within the schedule in each department to ensure staff is adequately educated on the need for research and EBP. There were low scores for availability of a library or librarian as the organization has been undergoing construction and the library is out of use and not available or accessible so staff has to resort to a makeshift room for access to the computers or use their PC's for access. However this is being addressed and will become available in a few weeks.
Section B: Problem Description
When a patient presents to a surgical team they have entrusted their lives into the care of someone who they may have just met briefly or to someone more familiar for a surgical procedure. They expect that professional to be as perfect as the reviews seen online from previous patients with the expertise that makes their safety sure. In the Operating room there are numerous types of surgeries done daily and each patient are done carefully and safely to ensure the best results. However over the years there have been occasions where what the patient consented for was not the procedure carried out resulting in a catastrophic consequence such as loss of limb or organ, or even death. This then becomes a sentinel event and patient safety issue or a legal issue.
Wrong site surgery is an international issue and within the United States there are over 2500 cases reported yearly according to the World Health Organization (WHO). As a result the WHO developed a surgical checklist to minimize wrong site surgery occurrence and this was adapted in 2008. The Centers for Medicaid and Medicare have also implemented a non reimbursement policy to institutions where these incidents occur due to the increasing in numbers of wrong site surgeries (Colins et al., 2014). The Joint Commission has since revised in 2010 and included wrong site surgery as part of the National Patient Safety Goals where emphasis is placed on site verification, site marking and 'time-out'. All of this being done while the patient is awake and aware for verification with the entire team. A checklist is not only required for surgery but in all aspects of our lives a checklist is required to keep things organized and to eliminate them as completed as we go along.
Stakeholders
Cleveland Clinic strives on providing excellent care to their patients, caregivers, the environment, and to the community. The institution has a capacity of 230 beds and a nursing staff of over 800 with 15 operating rooms and more than 285 physicians in 55 specialties (Cleveland Clinic, 2019). With this capacity and service offered our nurses are qualified to integrate and implement EBP. The stakeholders would include change agents, EBP champions, nurses, scrub technicians, surgeons, anesthesiologists, physicians’ assistants, perioperative students, nurse educators, administrators and lastly the patient. The high priority stakeholders are directly involved in the surgical case for an average of 8 hours per day and with the use of the surgical checklist prior to surgery and the involvement of all the members of the surgical team achieving reduction in wrong site surgery can occur.
PICOT
In the surgical patients (P), how does the use of a written intra-operative checklist (I), compared with no checklist (C), affect wrong site surgery (O) over a year (T)
Purpose and objective
The purpose and objective of this paper is to validate whether the use of written surgical checklist with all the parameters for safety is adhered to, preventing wrong site surgery and if this is not done but repeated from memory does the possibility of an occurrence of wrong site surgery exist. The importance of providers having knowledge about evolving evidence for optimal patient outcome and safety influenced this project. The purpose of the project is to bring about a practice change, with this in mind we will look at operative room safety culture in 'time-outs', marking of and identifying the operative site during the phases of surgery. This project will educate providers on patient safety and the need for an intra-operative checklist to minimize or eliminate wrong site surgeries which not only affects the patients involved but also costly to the institution.
Section C: Literature Support
The implementation of a universal checklist gave rise to multiple studies to observe its effects on morbidity and mortality. In the review made by Fudickar, Hörle, Wiltfang, and Bein (2012), they analyzed the effects of the WHO safety checklist using the results of about 20 different studies that included a single prospective randomize trial. The researchers reviewed original publications from databases on the search term "Surgical Safety Checklist." Furthermore, the articles used in the study include the PubMed and Medline databases that were published before February 2012.
Locating credible evidence
In these studies, patients who had undergone an emergency surgical procedure before and after the implementation of the WHO checklist, complete with all three phases, were observed. The reduced instances of wrong-site surgery and an increased improvement of communication and awareness of patient safety within the OR setting was concluded using the comparative review of different studies. Among these studies, two presented a drastic decrease of perioperative mortality and morbidity, which shows the need for the effective implementation of the WHO checklist as part of all operating procedures. Also a more resent study was appraised to further investigate the effects of using the WHO checklist.
Appraised Evidence
First Study
In the study made by Haynes et al. (2009), the reduction of wrong site surgery using the checklist was observed from October 2007 to September 2008 from eight hospitals located in eight different cities, including: Toronto, Canada; New Delhi, India; Amman, Jordan; Auckland, New Zealand; Manila, Philippines; Ifakara, Tanzania; London, England; and Seattle, WA. The initial data were collected on clinical process and outcomes of 3733 patients, whom are undergoing non-cardiac surgery with ages of 16 yrs. and older, before the implementation of the WHO checklist. Afterwards, the data of 3955 patients, after the WHO checklist was introduced, were collected to be compared with the initial data. The study only included the morbidity and mortality during the 30 day observation period after the operation. There are about 3733 patients who were studied before the WHO checklist and about 3955 patients after the WHO checklist was implemented. The resulting observations revealed a significant reduction of mortality cases from 56 in 3733 cases (1.5%) to 32 in 3955 cases (0.8%) and significant reduction of morbidity cases from 411 in 3733 cases (11%) to 288 in 3955 cases (7%).
Second Study
In a complementary study made by Weiser et al. (2010), the evaluation of the checklist's effectiveness in reducing the rate of complications and deaths during emergency surgical procedures was observed. The study is in conjunction with the previous study as it was also observed in the same hospitals of the same eight countries of the previous study; however, this study focused only on urgent surgery operation, within 24 hrs of assessment, rather than scheduled surgery. The initial data was collect from 842 patients with ages 16 yrs. and older who underwent emergency surgical procedure before the implementation of the WHO checklist. Afterwards, the data of 908 patients, after the WHO checklist was introduced during emergency medical procedures was collected. The study also revealed a significant reduction of mortality cases from 31 in 842 cases (3.7%) to 13 in 908 (1.4%) and morbidity cases from 151 in 842 cases (18.4%) to 102 in 908 cases (11.7%). The positive effects to patient safety of the WHO checklist promote an increased reduction rate of wrong-site surgery.
The studies described satisfy the real life conditions where external validity is concerned. The sample population that was described by Haynes et al. (2009) and Weiser et al. (2010) are from a global setting that represents varying economic factors within the hospitals and their diverse patients; however, there occurred some selection bias involving the comparison data. Added by Haynes et al. (2009) and Weiser et al. (2010), only the data before the introduction of the checklist and the consecutive data after the introduction of the WHO checklist in the same operating rooms of the same hospitals were used. There were no random selection of patients and random selection of operating rooms that occurred in both studies. Additionally, the patient observation was only limited to the complications and deaths within the hospital setting where any complications and deaths after the discharge of the patient were not collected.
Third Study
In a more recent study by Gillespie et al. (2018), a retrospective study about the occurrences of wrong site surgery was investigated in a 750-bed university hospital in Queensland, Australia. The data collected are from incident reports of 27 months. The data from October 2014 to 2015 was used to observe the wrong site surgery incidents before the implementation of the checklist while the data from November 2015 to 2016 was used to observe incidents of wrong site surgery after the implementation of the checklist. The study design used a prospective longitudinal design over three points and a retrospective secondary analysis of clinical incident. According to the collected data, there were improvement in surgical procedures in team participation and item adherence. About 33,109 surgical procedures were performed. In the sign-out where the completion rates where increased from 79.3% to 94.5%. Based on the subsample of 64 cases reports taken before and after the implementation of the checklist shows clinical incidents occurred in 0.25% before implementation and 0.13% cases after the implementation, but the decrease indicate a non-significant marginal decrease. The data analysis was taken from a random sample with 20% in accuracy; however, the study made use of only one hospital in the sampling methodology of data collection throughout. Also, the self-reported errors and other errors were not taken with non-random sampling were excluded since only those collected using random sampling were taken into account in representing the incident rates of wrong site surgery within the population.
Approximately 90% of the physicians endorsed the WHO checklist due to the great reduction of wrong-site surgery; however, there are still some doubts in its implementation (Fudickar et al., 2012). Some common errors in the implementation, includes: teams that do not initiate the checklist, teams perform the checklist from memory, the lack of completeness or incorrectly performed and processing in the absence of other team members or incorrect timing. The failure to implement the checklist may lead to the creation of a false sense of security that may propose a dangerous effect. Also, the interruption of the workflow is frustrating (Fudickar et al., 2012), which can prolong an operation procedure and increase the operation cost (Haynes et al., 2009; Rothman et al., 2016).
Section D: Solution Description
Organization Culture
At Cleveland Clinic, the incidence of wrong site surgeries is less likely to occur as the organization implements strategies to prevent this occurrence and engages in ongoing education of the operating room staff and the use of a safety checklist in the operating room. Tom Miheljevic, the current CEO and President of the Cleveland Clinic Health System, in an online document refers to zero as our non-negotiable target for serious safety events in the hospital and outpatient environments (2018). This move for change has improved the culture of the organization globally where Zero is considered as something that should not occur and referred to as “Start Strong and Finish Strong”. This is combined with the Universal Protocol developed by the Joint Commission in 2004 with the idea of safety checklists, as proposed by Boston surgeon Atul Gawande in 2009 (as cited in Miheljevic, 2018). The launching of this process "start strong and finish strong" is bringing all our facilities closer to target zero every day (Miheljevic, 2018). According to Miheljevic (2018), every voice on the team is heard, caregivers, patients and family are equal partners, anyone can speak up, and anyone can stop the line with a concern.
Proposed Solution
Current research made by Geraghty et al. (2017), reported incidence of wrong-site surgery occurring in approximately 1 in every 100,000 surgical cases varying among different specialties. According to Geraghty et al. (2017), the data reported in the United Kingdom recorded about 124 cases of wrong-site surgery from April 2014 to March 2015, where this number of incidence is the highest number of documented cases in their country in a single year. In the United States, approximately 2,700 patients are harmed by wrong-site surgery each year (Collins et al., 2014). The use of a checklist greatly reduces the incidence of wrong-site surgery and is cost effective in the long-term both to the patient, the staff involved and the institution where the possibility of legal implications would exist.
Expected Outcomes
The occurrence of wrong-site surgery should be eradicated or avoided as these events cause great harm not only to the safety of the patients but also to the institutional integrity of health professionals around the world. To minimize the occurrence of these avoidable events, the proposed solution or intervention needed is the implementation of a surgical safety checklist that was developed by the World Health Organization (WHO). The checklist can be in a poster format posted in the operating room, which is very cost effective, or with an electronic scheduling system using monitors to easily encourage the compliance of the surgical team in implementing the checklist.
In a complementary study made by Weiser et al. (2010), the evaluation of the checklist's effectiveness in reducing the rate of complications and deaths during emergency surgical procedures was observed. This study focused only on urgent surgery operation, within 24 hrs of assessment, rather than scheduled surgery. The initial observation revealed a significant reduction of mortality cases from 31 in 842 cases (3.7%) to 13 in 908 (1.4%) and morbidity cases from 151 in 842 cases (18.4%) to 102 in 908 cases (11.7%). The positive effects to patient safety of the WHO checklist promote a reduction in wrong-site surgery.
In another study by Van Klei et al. (2011), the authors made a retrospective cohort study; which included 25,513 adult patients in the University Medical Center Utrecht, from January 1, 2007 to September 30, 2010 about the use of the WHO checklist. The patient's data were collected from the hospital's information system. The study revealed the implementation the checklist reduced the crude mortality rate of patients in the hospital due to wrong-site surgery errors from 3.12% to 2.85%.
Achieve Outcome
The method to achieve outcomes based on the WHO checklist is divided into three parts, Sign-in (before operation), Time-out (before skin incision), and Sign-out (After operation). This method can be used in all types of surgical procedures including urgent surgeries. First, the sign-in part includes the scheduling of perioperative briefing, assurance of the willingness of the surgical team to follow the checklist, and reading the checklist items under the sign-in phase. The sign-in checklist items includes the conformation of the patient’s identity, operation site, procedure and consent. Next, the time-out part includes the posting of the checklist, if not already posted, in the operating room followed by the reading of the checklist items under the time-out phase. The checklist items includes the oral confirmation of the name and the role of all team members of the operation team; the reiteration of the patient's identity, surgical site, and procedure; review of anticipated critical events; and, the confirmation of imaging results to the correct patient. The last phase, sign-out, includes reading the checklist items about the review of the surgeon, nurse, and anesthesia professional about the key concerns for the recovery and care of the patient.
Outcome Impact
All of the studies indicated a decrease of wrong-site surgery after the introduction of the WHO checklist. There was also an increase in effective communication among the members of the surgery team. This project has the potential for a positive change in patient safety protocols by introducing a surgical safety checklist in operating rooms, thereby reducing or preventing the occurrence of wrong-site surgery. Although the WHO checklist decreases e...