1 INFECTION CONTROL IN THE CARDIAC CATHETERIZATION LABORATORY: RESEARCH STUDY By Hannah M. Kerby B.S. R.T(R)(ARRT) Juliana Kasper B.S. A thesis submitted to the School of Radiologic Sciences in collaboration with a research agenda team In partial fulfillment of the requirements for the degree of MASTER OF SCIENCE IN RADIOLOGIC SCIENCES (MSRS) WEBER STATE UNIVERSITY Ogden, Utah December 16, 2022 2 THE WEBER STATE UNIVERSITY GRADUATE SCHOOL SUPERVISORY COMMITTEE APPROVAL of a thesis submitted by Hannah M. Kerby B.S. R.T(R)(ARRT) Juliana Kasper B.S. This thesis has been read by each member of the following supervisory committee and by majority vote found to be satisfactory. ______________________________ Dr. Robert Walker, PhD Chair, School of Radiologic Sciences ______________________________ Dr. Laurie Coburn, EdD Director of MSRS RA ______________________________ Dr. Tanya Nolan, EdD Director of MSRS ______________________________________________________________________ Christopher Steelman, MS Director of MSRS Cardiac Specialist 3 THE WEBER STATE UNIVERSITY GRADUATE SCHOOL RESEARCH AGENDA STUDENT APPROVAL of a thesis submitted by Hannah M. Kerby B.S. R.T(R)(ARRT) Juliana Kasper, B.S. This thesis has been read by each member of the student research agenda committee and by majority vote found to be satisfactory. Date December 16, 2022 ____________________________________ Hannah M. Kerby B.S. R.T(R)(ARRT) December 16, 2022 ____________________________________ Juliana Kasper, B.S. 4 Abstract Cardiovascular catheterization laboratories are described as “clean” or “semi-sterile.” At this time, there is no set infection control standard made specifically for sterility in the cardiac catheterization laboratory. Surveys will be conducted utilizing social media to gain a wide variety of data on this topic across the country. The chosen research design for this research project is going to be a scoping review in combination with a qualitative survey-based research study to inform practice and influence policymaking in the healthcare community. The participants in this study included administration staff, RCIS staff, registered nurses, radiologic technologists, and interventional cardiologists trained in the cardiac catheterization lab. The results of this study showed there was not an absolute disparity in infection control adherence. Based on ANOVA statistical tests, the results showed respondents in the RCIS role have slightly higher adherence to infection control standards in comparison to RN’s, and RT’s. Furthermore, the Western United States had the highest adherence to infection control standards while the Northeast United States had the lowest adherence to infection control standards per this research study survey. It was also found based on the ANOVA statistical test that there was not a disparity in infection control and high case load. Based on the results of this study, there is no current need for a standardization of sterility procedure in the cardiac cath lab. It is recommended that this study be replicated on a larger scale to be more representative of the population and reduce bias. 5 Acknowledgements I would like to thank Professor Christopher Steelman for his guidance throughout this intimidating yet rewarding process. Thank you to Dr. Ward for her assistance in navigating the data analysis software for this research study. I want to extend my gratitude and love to my family; especially my mom and dad for reminding me that the stars are not the limit and encouraging me with unwavering support. To my dad who read countless drafts of my papers, to my mom who gave me endless words of inspiration and love, and to my sisters who would call when they knew I needed encouragement. I want to recognize and thank all of my coworkers at Intermountain Medical Center’s cath lab for supporting me throughout my schooling and contributing to this paper through their advice. I could not have completed this without any of you! -Hannah I would like to express my deepest appreciation to Professor Chris Steelman for creating such an amazing program and guiding us in both our academic and professional goals. This endeavor would not have been possible without Dr. Coburn and Dr. Ward for assisting us in the thesis writing process. Lastly, I would be remiss in not mentioning my family, especially my parents. Their belief in me has kept my spirits and motivation high during this process. I would also like to thank coworkers at St. Joseph Hospital for their wisdom and advice as I completed my preceptorship. This accomplishment would not have been possible without any one of them. Thank you. -Juliana 6 Table of Contents Chapter 1: Introduction 10 Background 10 Statement of the Problem 10 Purpose of the Study 11 Research Questions 12 Nature of the Study 13 Significance of the Study 14 Definition of Key Terms 14 Summary 15 Chapter 2: Literature Review 16 Documentation 16 Increasing Standards of Sterility 17 Staff Advocating for Higher Standards 18 Difficulty of Sterility 20 Cath Lab Culture 21 Infection Control Diction 23 Economic Burdens 24 Aseptic Training 25 Summary 26 Chapter 3: Research Method 28 Research Methods and Design(s) 29 Population 30 Sample 31 Materials/Instruments 32 Data Collection, Processing, and Analysis 34 Assumptions 35 Limitations 36 Delimitations 36 Ethical Assurances 37 Summary 37 Chapter 4: Findings 38 Results 38 Evaluation of Findings 40 Summary 43 Chapter 5: Implications, Recommendations, and Conclusions 43 Implications 44 7 Recommendations 46 Conclusions 46 References 47 8 List of Tables Table 1. Survey Instrument/Questionnaire………………………………………………..32 Table 2. Highest Level of Education Completed………………………………………....37 Table 3. Race/Ethnicity of Respondents…………………………………………………..38 Table 4. Role in the Cath Lab………………………………………………………………39 Table 5. Infection Control Compliance Scores…………………………………………..39 Table 6. Infection Control Compliance by Cath Lab Role……………………………..40 Table 7. ANOVA: Infection Control Compliance by Region…………………………..40 Table 8. ANOVA: Infection Control Compliance by Case Load………………………41 ‘ 9 List of Figures Figure 1. Case Loads per Week of Respondents…………………………………………….…….2 10 Chapter 1: Introduction Background Cardiovascular catheterization laboratories are described as “clean” or “semi-sterile.” There is currently no clear-cut explanation of the infection control standards across every cardiac catheterization laboratory. Every research article has a different definition of the sterility standards within a catheterization lab. Since there is no precise standard currently present to delineate what infection control practices should take place, adherence to these protocols in these labs can be difficult to measure. Most follow an OR-style infection control, and these practices prove to be followed by staff due to the invasive nature. 1 However, an article from 2013 poses a great argument for the article written in 2016 in which there is a disparity among infection control guidelines amongst cath labs across the country, and not necessarily everyone if following the OR standard guidelines (i.e., like the controversial use of caps/hair coverings in the cath lab and whether they are necessary or not). 2 As cardiac catheterization cases become more complex in healthcare, with more invasive procedures such as TAVRs occurring in these lab environments, a standard for infection control protocols is increasingly becoming more necessary. Recent research explores how cardiac cath labs have slowly transitioned out of OR-style sterility and into a laxer version of OR standardizations. With the increase in invasive procedures and implantable device procedures occurring in the cardiac catheterization laboratory, standardization amongst infection control practices is proving to be more important to keep infection rates low. Statement of the Problem Through colloquial discussion with colleagues in the cardiac catheterization community, there may be disparities in adherence to infection control standards in this area of the hospital.1 11 The presence of this disparity brought up the question: why is there not currently a set standard for sterility protocols? Through extensive research of current existing literature, there are studies done in surgical settings, nursing departments, radiology departments - but none currently in the cardiac catheterization lab. 4Many catheterization laboratories follow surgical sterile procedures, but this is not a national standard, and each hospital has different regulations. Because of the conflicting ideas on sterility regulations, not all cath lab personnel are trained in proper sterile technique. As a new generation of registered invasive cardiac specialists (RCIS) enter the field, there is a push for better training and a higher standard of adherence to sterile procedure.5 Furthermore, this is a problem that needs to be addressed and acknowledged because there are an increasing number of invasive procedures being scheduled to be performed in cath labs, and currently there is no set standard for patient and staff infection control. Furthermore, bacteremia after PCI is reported in 18% of cases immediately after procedure and 12% after 12hrs. In a study of over 4000 patients with PCI, 0.64% of patients had a bacterial infection and 0.24% had septic complications. 2 These infection rates can be decreased significantly if all catheterization labs followed a set of sterile procedure standards. Morbidity and mortality rates in the cardiac cath lab are less than 1% for most patients, and is increased for certain subsets of patients, particularly those with three-vessel calcified coronary disease.6 Purpose of the Study The purpose of this study is to acknowledge the current lack of direction cardiac catheterization laboratories are given regarding infection control, and to hopefully gain the attention of public health officials to officially set these protocols to standardize adherence across all cath labs. This research study is a quantitative study that will consist of survey questions answered by cardiac catheterization laboratory staff country-wide using snowball 12 sampling and social media outreach to determine and explore the current adherence to infection control standards in the cardiac cath lab. This staff pool will include laboratory administration staff, RCIS staff, RCES staff, registered nurses trained in the cath lab, radiologic technologists trained in the cath lab, and interventional cardiologists. Research Questions This research study aims to determine the answers to the following research questions regarding infection control adherence using an online survey instrument that will be answered by various cardiac catheterization laboratory staff. Q1. Are there differences in adherence to infection control guidelines in various cardiac catheterization laboratories because there is no current set standard for sterility or infection control in these labs? Q2. If a disparity to infection control adherence exists, who (what role; RN, RT, RCIS, etc.) is the disparity more prevalent amongst? Q3. Is there a disparity in infection control secular to a certain geographical location in the United States? Q4. Does the disparity to infection control adherence rise or fall depending on the caseload of the cath lab? Hypotheses H1. If administration staff, RCIS staff, registered nurses trained in the cath lab, radiologic technologists trained in the cath lab, and interventional cardiologists are surveyed about sterility adherence in the cardiac catheterization lab, then it will be found that the catheterization laboratories do not strictly adhere to surgical-level sterility procedures. H2. If administration staff, RCIS staff, registered nurses trained in the cath lab, radiologic technologists trained in the cath lab, and interventional cardiologists are surveyed about sterility adherence in the cardiac catheterization lab, then it will be found that the RCIS staff adhere to infection control practices more strictly. 13 H3 If administration staff, RCIS staff, registered nurses, radiologic technologists, and interventional cardiologists are surveyed, it will be found that there will be a higher disparity in rural areas of the United States. H4 If administration staff, RCIS staff, registered nurses, radiologic technologists, and interventional cardiologists are surveyed, it will be found that labs that do more cases will adhere less strictly to infection control practices. Nature of the Study The research method for this study encompasses the qualities of a quantitative study. An online survey instrument alongside informed consent documents will be distributed with the use of snowball sampling and social media outreach. This will aid in reaching a diverse population representative of the cardiac catheterization community. The survey instrument will be an online database questionnaire, where the data will be collected and obtained within the same data collection website. The questionnaire will aid in answering this study’s research questions as they are focused on the direct observations of the participants in their work environment in the cardiac catheterization laboratory. Data analysis will include correlation coefficients as well as ANOVA testing. ANOVA testing will be performed to determine the relationship between multiple variables in this research study. The use of these specific methods for data analysis will be beneficial in this research study to aid in finding the similarities and differences as well as the spread of responses to the survey questions. The Journal of Education and Practice performed a research study like this, in which they surveyed nurses regarding their knowledge surrounding 14 infection control. They utilized the same regression model this study plans to use and were able to analyze their data efficiently and clearly to determine results of the study.8 Significance of the Study This research study will provide acknowledgement to the fact that there is no current set-standard for infection control or sterility protocols in cardiac catheterization laboratories. This new information in combination with current literature may gain the attention of public health officials who might consider standardizing this aspect of cardistaed. If this study were not to be performed, there is a risk that infection rates in patients post-cardiac cath lab procedures may start to rise as the growing number of invasive procedures are being performed. Definition of Key Terms Infection Control. prevents or stops the spread of infections in healthcare settings.9 Infection Control Guidelines. a set of standard recommendations used to reduce the risk of transmission of infectious agents from body fluids or environmental surfaces that contain infectious agents.10 Cardiac Catheterization Laboratory. where tests and procedures including ablation, angiogram, angioplasty, and implantation of pacemakers / ICDs are conducted. 11 Invasive Procedures. A medical procedure that invades (enters) the body, usually by cutting or puncturing the skin or by inserting instruments into the body.12 Summary This quantitative research study aims to regain the acknowledgement from public health officials regarding the lack of infection control standards in cardiac catheterization laboratories. Surveys will be sent out to various cardiac catheterization laboratory staff regarding their 15 adherence and observation of adherence to infection control standards and data analysis will be conducted with the utilization of regression analysis and ANOVA testing. 16 Chapter 2: Literature Review As the field of cardiac catheterization continues to evolve, this is an important topic to discuss as procedures become more complex and require a hybrid OR team. The environments of the cardiac catheterization laboratory are different in how they require distinct levels of infection control. Due to the differing requirements of infection control, this research study aims to discover whether there is a disparity in the adherence to infection control guidelines in different cardiac catheterization laboratories across the United States. There is currently research that exists on the infection control adherence in these departments, however, there exists a gap in the literature in which discovers the adherence disparity (if one exists) and the 'why' behind the existence of the disparity. All cath lab personnel should be trained on proper sterile technique and adhere to a standard that is set nationally. At this time, there is no set infection control standard made specifically for the cardiac catheterization laboratory. Surveys will be conducted utilizing social media to gain a wide variety of data on this topic across the country. The data from the surveys will be used to create a quantitative analysis of how well cardiac catheterization labs adhere to these national standards. Institutional Review Board approval has been obtained from Weber State University to distribute surveys to cardiac cath lab personnel. Documentation This literature review was collected from the following databases: Google Scholar, PubMed, and OneSearch. Our search strategies included the use of keywords, controlled vocabulary words with synonyms, and Boolean operators. We also reviewed greay literature, 17 such as, Cath Lab Digest, because although it is not reviewed by academic standards it discusses current issues in the cath lab field that pertain to this research study. A higher standard of sterility is necessary as the interventional cardiovascular world continues to evolve, and the procedures become more complex. Procedures in interventional radiology and cardiology are becoming more complex, and hybrid procedures that take place in the operating room are becoming more common. There is a need for all cath lab personnel to be familiar with surgical-level sterility. Cases such as TAVRs (transcatheter aortic valve replacements) are routinely done at some hospitals requiring cath lab personnel to collaborate with surgical teams. Patient preparation is much more intense and crucial in these cases and many more precautions are taken. Some facilities have specific cardiac cath labs dedicated specifically for TAVR procedures to ensure the cleanliness of the room is upheld and to limit traffic through those labs. An article from 2012 published by the Journal of the American College of Cardiology discusses in-depth the evolving clinical practices in the cardiac catheterization lab. They discuss newer procedures, as well as the rise in PCI cases. However, sterilization practices were vague and did not provide enough detail to fully understand the standards necessary. This can be a great source to discuss the changes in the interventional cardiovascular field in the past few decades, but also acknowledges the need for standardization of clinical practices in the cath lab as more complex procedures are introduced.4 An article by SCAI experts from 2016 discusses the best practices of physicians, technologists, and nurses for all catheterization procedures in this article. The article stated that the use of the 3M Avagard is used for the first scrub of the day, as well as all subsequent scrubs. 18 It also states that it is not mandatory for hats and masks to be worn in every procedure.13 Among colloquial discussion, a full surgical scrub should be completed at least once during the day, and Avagard may be utilized, with proper technique, for all subsequent scrubs. Hat and masks are also commonly always worn in the procedural room. This article contradicts many of the infection control standards used in common practice in cath labs today, shows the importance of this research study and the need for a national standard for sterilization procedures in the cath lab. Interventional Radiology staff are advocating for higher standards of infection control in the cath lab. There is a recurring sighting of staff fighting for higher infection control standards in their interventional radiology labs (electrophysiology and coronary cath labs) throughout current literature. This theme signals that adherence to infection control is followed in these areas of the hospital since the staff is requesting higher standards be implemented due to the invasive nature of these labs. Especially in the unfortunate nature of the healthcare condition today, it may seem unorthodox for healthcare workers to be asking for more protocols and standards to be implemented, so the fact that this is occurring within interventional radiology expresses that there may be change that needs to be implemented in these departments. An article from Cath Lab Digest (2016) discusses the disparities across multiple cath labs and how surgeons and physicians (interventional cardiologists specifically) have differing opinions on proper attire and infection control practices inside the cath lab. Most follow an OR-style infection control, and these practices prove to be followed by staff due to the invasive 19 nature. This expresses how guidelines are more closely followed in the cath lab vs. the general department where there is not a physician advocating for higher standards of infection control.1 An article from 2020 regarding management of quality control in the cath lab discusses ways to measure quality assurance and control for various aspects of the cardiac cath lab in this article. The article discusses how these procedures can reduce morbidity and mortality. What is most important about what Henien and Abbott address and acknowledge is that quality assurance and control is paramount for positive patient outcomes. The lack of a quality assurance or control system for infection control in the cath lab signals that patient outcomes could improve with the inclusion of a set standard.14 A journal in perioperative nursing by T. Schmidt from 2011, expresses the strive for change in infection control practices in interventional radiology (this includes the cardiac cath lab) areas. What is interesting about this article is that it expresses that the staff nurses are fighting for stronger infection control practices and guidelines due to the transition to more invasive procedures occurring in these areas, and that general standard precautions are not sufficient for patient safety. If the nurses are fighting for stronger infection control practices, this signals for future adherence to the guidelines in the lab.5 Difficulty of sterility in the cardiac catheterization laboratory This theme is a great contradiction to the positive adherence of infection control in the cath lab. Something as specific as cotton fiber on clothing can contaminate a sterile field, making sterility an incredibly challenging task to follow and adhere to. This theme expresses that even with the best intentions from everyone on the interventional radiology team, optimal sterility may be nearly impossible due to factors as minute as cotton fiber on clothing. It readdresses the 20 idea that the standard of sterility may need to be evaluated and possibly changed to ensure optimal sterility practices. A study published by the Journal of the Society for Cardiac Angiography and Interventions from 2006 revisits the sterility guidelines for cardiac catheterization labs. The article is from 2006, so all the information might not be current. However, they have a survey that we could use as a guide in creating our survey. This article also breaks down the different subtopics in the cath lab that can cause issues with sterility.15 An article titled Cotton Fiber Contamination in the Sterile Field is a great refutation and contradiction to some of the previous claims in this literature review. This article discusses that something as specific as cotton fibers on surgical equipment can still contaminate the sterile environment and function as a vehicle for microorganism transmission onto the patient and cause infection. Something as specific as this can make infection control more difficult in the cath lab and keeping infection at a low may seem and be easier in the general radiology department where little invasive procedures are performed.16 A research study regarding the effectiveness of current protocols for disinfecting medical equipment from 2016 discusses the microorganisms left on equipment in the nuclear medicine portion of the radiology department. The study’s conclusion section discusses that the radiology department coordinators need to work to provide better personnel education on disinfection techniques for certain equipment that can harbor microorganisms more readily due to their design. This presents the idea of radiology department personnel having to manually disinfect their equipment, where cath lab equipment comes already sterile for them, they just must work to keep the equipment sterile; an interesting viewpoint to consider.17 21 Culture of speaking up when sterility is broken in the cath lab Multiple articles express the culture of cath labs and how they strive to make their staff comfortable in calling each other out if they see someone break sterility. The goal is to stay aseptic and sterile, and if sterility is broken, a comfortable environment should be present where one can simply re-gown and glove with fresh PPE, set a new table, open new equipment – if theirs has been contaminated. This theme is another nod to the positive adherence to guidelines. In other places in the hospital, one may turn a blind eye to protocols not being followed. However, in interventional radiology suites such as the cardiac catheterization lab, speaking up when protocol seems to have been broken is encouraged and not looked down upon. Employees reveal they do not feel a fear of retaliation if they speak up when they see sterility accidentally broken. This environment allows for infection control protocols and standards to be followed more closely in these departments and areas. Johnson, Miranda, and Osborn (2012) discuss designing a safer radiology department and speak on how infection control and hygienic practices can be measured. In the radiology department, methods such as hand hygiene must be measured and ensured by direct observation. Typically, a radiographer works alone on patients, it is not necessarily a multi-person job to take radiographs.18 In the cath lab, however, there is usually a team of 4 or more personnel that can hold each other accountable to infection control standards. This article can reveal information of why radiology departments may be lacking in adherence to infection control practices because facilities do not implement the resources to directly observe personnel adhering to hygienic policies. 22 A research study by Phelps and Reed (2016) introduces an important concept that exists in the cath lab. This study aimed to change the culture of hand hygiene compliance in a healthcare facility, where they asked people of multiple levels of authority to speak up when they see noncompliance to infection control. Doing this takes away the severity of perceived consequences when being called out for noncompliance, and the healthcare facility found amazing results and improvement in their infection control guideline adherence. In the cardiac cath lab, every role (circulator, monitor, scrub, cardiologist, etc.…) is encouraged to speak up if they see a break in sterility or infection prevention. People in the cath lab are commonly not afraid to call a coworker out to protect the patient. This culture is not present in the radiology department, which may explain the disparity in infection control guideline compliance.19 Pradhan along with numerous medical doctors discuss good clinical practices in the cath lab in this article. A major aspect of this article that relates to this research project is the fact that they mention the importance of cath lab personnel to speak up when they see something being done incorrectly or if the sterile field is broken. This is a common practice found in the cath lab, which can hint that infection control practices are adhered more closely in the cath lab.20 Diction when speaking of infection control in the cath lab “scrupulous use of masks and hats,” “meticulous hand washing,” etc.… When one reads articles about other areas in a hospital, they are loose in their terms when they discuss items such as hand hygiene and cleanliness. Articles discussing hygiene and cleanliness in the cath lab are very specific in their diction to express the utmost cleanest environment. The new generation of cath lab personnel is pushing towards a sterilization 23 standard, setting themselves apart from the rest of the hospital and other departments that may take infection control protocols more lightly or lackadaisical. An article from 2013 discusses infection control guidelines that need to be followed by cardiac cath personnel that are obtaining femoral access in a patient to prevent common infections. They discuss the ‘scrupulous’ use of mask, cap, gown, and electrical clippers throughout the procedure. This article poses a great argument for the article utilized below from 2016 in which there is a disparity among infection control guidelines amongst cath labs across the country (i.e., like the controversial use of caps/hair coverings in the cath lab and whether they are necessary or not). If there were standardized procedures, these guidelines would be adhered to more closely, therefore reducing infections.2 A research study article on the safety of implantation of CIED’s in the cath lab from 2013 was important to include in this literature review because of the diction utilized when speaking of the cath lab. When referring to infection control protocols and hygienic standards and duties, the article discusses how cath lab personnel should be “carefully” trained on aseptic techniques and operating room protocols to reduce infection rates. This diction is not used in general radiology departments, even though infection control is just as important in that setting. The approach to educating personnel (more specific education for cath lab personnel, less emphasis on infection control for the general radiology department) can be an important contribution to this research topic.3 An article regarding the readiness of the cath lab for epidemics is another example of the diction used in reference to the cardiac cath lab and infection control guidelines. They use terms such as “meticulous hand washing.” In using terms with this connotation, it holds the cath lab 24 personnel to a higher standard of infection prevention, therefore encouraging staff to adhere more closely to guidelines.21 Economic burden forcing single-use equipment to be used on multiple patients in the cardiac catheterization laboratory This theme in a couple of articles brings up an interesting and conflicting viewpoint in recent years, where supply or money is down, and single-use equipment must be re-used on another patient. This can be another area that proves to be difficult to maintain asepsis in the cath lab. The safety of reusing single-use equipment and procedure outcomes needs to be addressed alongside deeper analysis of the resterilization process post-procedure. This includes ensuring the department has standards in place to ensure utmost cleanliness of surgical instruments and supplies after they have been used on a patient and before they are used on another. A study performed by Habib (2019) looks at the effectiveness of resterilization of single-use materials/tools in the cath lab, as well as the cost effect points of this process. The study showed no bacterial growth in cultures from the disposable equipment that were sterilized with formaldehyde. Restoration of disposable of coronary angiography and angioplasty balloon catheters to the manufacturer’s original specifications results in a high-quality product that can be used alone or with adjunctive devices on all types of coronary angioplasty lesions.22 An article written in 2007 by F. Tessarolo et al., introduces a new variable of economic burden disparity between the cardiac cath lab and the general radiology department. There is more equipment used in the cardiac cath lab, and that equipment will add up to be more of an economic burden on the department in comparison to the general radiology department. Healthcare facilities work to decrease costs wherever possible, and this article discusses 25 reprocessing single-use catheters in the cath lab to cut down costs 40%. This raises a hygienic issue in the cath lab due to the single-use nature of the catheter and the fact that they are re-using it on different patients.23 Specific aseptic and sterility training Any other area in the hospital usually does not require specific training for cleanliness in their units. However, in the cath lab, everyone is, at the very least, briefed on how to maintain asepsis and sterility while in the lab, and what to do if sterility is broken. The level to which sterility is taught and enforced in the cardiac cath lab varies from hospital to hospital. There is a need for standardization of sterility across all cath labs. Buerke, Mellmann, Kipp, Heindel, and Webling (2012) bring up an important aspect pertaining to this research project, hygiene and infection control training and the disparities between radiology and the interventional radiology lab. Sterility is an important topic that is brought up in interventional labs, however, infection control may not be specifically addressed in radiology training experiences. This would be an interesting aspect to investigate, if radiology departments adhere less closely to hygiene requirements due to a lack of training or lack of focus during training.24 A research study performed by da Costa, Lima, Possobon, and Ambrosano from 2018 assesses the infection control practices in dentist students performing oral radiography (dental x-rays.) The research study found that many of the participants assumed that the disinfection and cleaning process of the radiography equipment was being conducted by the cleaning staff in between patients. This represents a clear miscommunication to staff and disparity in infection control training and quality control in radiology.7 26 Summary Based on research through a literature review, it has been found that in cardiac catheterization laboratories there is a need for a higher standard of sterility, as the interventional cardiovascular world continues to evolve, and the procedures become more complex. As a new generation of registered invasive cardiovascular specialists enter the field, the catheterization lab personnel are fighting for a higher standard of sterility. With these new standards comes a need for sterility training for all personnel, as well as a discussion of the difficulties and the culture of speaking up if sterility is broken. It is also important to note the economic burdens of this new sterility standard and how these vital details can be documented and maintained within the department. The gap in literature, found during the research throughout this literature review, is information regarding adherence to infection control practices in the cardiac catheterization laboratory. This research study aims to fill that gap in knowledge to hopefully add to the community and provide solutions to standardizations and education that go together with a higher expectancy of asepsis in this area of the hospital. Addressing the source of these themes, which is inherently adherence to infection control standards, can greatly assist healthcare professionals in improving this aspect of cleanliness which in-turn will reap a multitude of benefits such as a decrease in nosocomial infections post-cardiac catheterization. 27 Chapter 3: Research Method This research study aims to determine the answers to the following research questions using a survey that will be answered by various cardiac catheterization laboratory staff. Q1. Are there differences in adherence to infection control guidelines in various cardiac catheterization laboratories because there is no current set standard for sterility or infection control in these labs? Q2. If a disparity to infection control adherence exists, who (what role; RN, RT, RCIS, etc.) is the disparity more prevalent amongst? Q3. Is there a disparity in infection control secular to a certain geographical location in the United States? Q4. Does the disparity to infection control adherence rise or fall depending on the caseload of the cath lab? Hypotheses H1. If administration staff, RCIS staff, registered nurses trained in the cath lab, radiologic technologists trained in the cath lab, and interventional cardiologists are surveyed about sterility adherence in the cardiac catheterization lab, then it will be found that the catheterization laboratories do not strictly adhere to surgical-level sterility procedures. H2. If administration staff, RCIS staff, registered nurses trained in the cath lab, radiologic technologists trained in the cath lab, and interventional cardiologists are surveyed about sterility adherence in the cardiac catheterization lab, then it will be found that the RCIS staff adhere to infection control practices more strictly. H3 If administration staff, RCIS staff, registered nurses, radiologic technologists, and interventional cardiologists are surveyed, it will be found that there will be a higher disparity in rural areas of the United States. H4 If administration staff, RCIS staff, registered nurses, radiologic technologists, and interventional cardiologists are surveyed, it will be found that labs that do more cases will adhere less strictly to infection control practices. 28 Research Methods and Design The chosen research design for this research project is going to be a scoping review in combination with a qualitative survey-based research study to inform practice and influence policymaking in the healthcare community. A scoping review is an appropriate approach as a research design for this project because information regarding adherence to infection control in the cardiac catheterization laboratory is lacking in current healthcare literature. It would be beneficial to delineate the gaps and perform a research study alongside it to add this information to the community. Observational studies will take place using surveys for this study. This method was chosen over other methods such as, quasi-experimental, because this study is not an attempt to change current infection control practices at this time. The goal is to discover if there is a disparity in adherence and/or training on sterility and infection control practices specifically in the cardiac cath lab. This study will be used to gain the attention of healthcare policymakers to standardize sterility in the cardiac cath lab as invasive procedures continue to evolve. The design steps involve determining how the sample size will be chosen and how participants will be selected and involved. To do this, social media outreach will be utilized to gain a higher volume of responders, and snowball sampling methods that will originate in the communities of Salt Lake City, Utah and Denver, Colorado. Informed consent documents will be created to ensure the protection of the study and the participants. Qualtrics, an online survey tool, will be utilized for ease of use for the researchers and the participants. A survey will be created regarding the observation and practice of infection control adherence within the cardiac catheterization laboratory. Demographic information about the participants will be included in the survey responses to ensure the participants fall under the demographic umbrella this research 29 study is aiming for. Ideally 100+ responses will be collected through this online survey tool and responses will be obtained and remain on that tool for access. These responses will be input into a grid-like table where they will be compared using regression analysis data analysis methodology. This research design will accomplish the goals of this research study through the volume of responses by using both social media outreach and snowball sampling. Using an online survey tool makes the research study more accessible and simpler, therefore volunteers will be more willing to participate in the study. The use of an online survey allows a broader population to be reached, to make our sample a more accurate representation of cath labs in the United States. One of the main goals of this research study is to obtain information regarding the adherence of infection control training in the cath lab, and the survey instrument used will hopefully give results of a clear picture of this idea in the cath lab. There will always be limitations of validity and reliability due to responses, but these issues arise with every research study. Population The population will include administration staff, RCIS staff, registered nurses trained in the cath lab, radiologic technologists trained in the cath lab, and interventional cardiologists. This population has been specifically chosen because all members of the cardiac cath lab play a significant role in keeping the lab sterile. Staff members may have different training in sterility based on their role in the lab. It is important to hear from every role to bring attention to the need for sterility standards across all cath labs. The estimated sample size will be around 100 to 300 participants. The goal is to create a sample that accurately represents all members that work in the cardiac catheterization lab. Catheterization labs will be sampled across the United States to avoid bias. The survey may attract healthcare personnel involved in electrophysiology labs as 30 well as angiography suites, and the sample drawn from this population will exclude any personnel outside a coronary catheterization lab. This allows the research study to be more specific and to narrow down the sample chosen for the study. Sample This will be a qualitative study to determine adherence to infection control and sterility in the cardiac cath lab. Population characteristics will be cardiac catheterization laboratory personnel, as described above. It will include personnel working directly in the labs as well as administrative roles that work closely with lab personnel as well. The recruitment strategy will involve social media outreach as well as snowball sampling. The survey will be created using Qualtrics survey software. The surveys will be adapted from previous studies with a focus on infection control. Social media outreach will involve creating social media posts on group pages on platforms such as Facebook and Twitter that cater specifically to cardiac catheterization personnel. The survey instrument will be distributed on these platforms - the instrument will include responses to demographic questions which will determine participant eligibility to ensure they are cardiac cath lab personnel. Also, snowball sampling will be utilized, with participants originating in Salt Lake City, Utah and Denver, Colorado, and expanding across the country. These recruitment methods should give a wide sample of participants from multiple modes; social media and word of mouth, to avoid bias and paint a clear picture of habits in cath labs across a larger geographic area rather than the Western portion of the United States. The 31 minimum sample size will be 100 participants, but ideally 100-300 participants will be selected to participate in this research study. Materials/Instruments The survey/interview data will be originally collected on an online survey platform, Qualtrics. The participants will input their answers to the survey questions and those answers will be collected and input into a database on the researcher’s personal computers for data analysis. Because the same questions are being asked in each survey, the reliability of this study should be quite high. Because the survey/interview questions are regarding behavior of the participant themself and observed behavior, validity may pose a bit of a limitation if participants are not 100% honest in their answers of personal behavior in addition to observed behavior. The instruments that will be published will be the distribution of answers as well as the data analysis section after T-tests are performed on the data. Again, reliability should not pose a limitation for this research study, but validity may pose a limitation if participants are not fully transparent about their habits and observed habits in the cath lab. The survey design represents itself as statements in which participants select a statement such as very confident, fairly confident, and not confident - in which they feel they are least to most compliant with each statement. The survey statements were curated with the standard infection control practices that should be occurring before and after every patient to understand the compliance levels in the cath lab. The Likert-scale style of responses were chosen based on a similar study already performed. Utilizing a Likert scale provides the ability to score participants on their adherence to infection control, thus answering the research questions. The questions were created based on the compilation of standard practices performed in the principal 32 investigators’ catheterization laboratories, as well as operating room standards as published by the CDC. The survey instrument has been included below for reference. Table 1 Question Possible Responses What is your role in the cath lab? Free response On average, how many cases do you see per week? Free response I wipe down the procedure table before every patient. I am confident I am fairly confident I am not confident I wipe down the procedure table after every patient. I am confident I am fairly confident I am not confident I wipe down all monitoring devices after every patient (pulse oximeter, EKG leads, blood pressure cuff and cord, etc.…) I am confident I am fairly confident I am not confident I mop the floors after each procedure. I am confident I am fairly confident I am not confident I change the pillowcase after every patient. I am confident I am fairly confident I am not confident I wipe down the c-arm (imaging tube) after every patient. I am confident I am fairly confident I am not confident I change out and remove the trash bags from the room after every patient and replace the cans with fresh, empty bags. I am confident I am fairly confident I am not confident I gown and glove in a sterile fashion while setting up the sterile table. I am confident I am fairly confident I am not confident I was fully trained on sterile technique for dropping equipment onto the sterile table and field. I am confident I am fairly confident I am not confident I was fully trained on sterile technique for working in the sterile field. I am confident I am fairly confident I am not confident Is there a standard written practice regarding infection control in your lab? I am confident I am fairly confident I am not confident During all invasive procedures in the lab, do you routinely wear a cap or head covering? I am confident I am fairly confident I am not confident During all invasive procedures in the lab, do you routinely wear a facemask? I am confident I am fairly confident I am not confident Is air exchange rate in your cath lab satisfactory? I am confident I am fairly confident I am not confident 33 Data Collection, Processing, and Analysis Data will be collected through social media outreach to gain a high volume of responders, and snowball sampling methods that originate in the communities of Salt Lake City, Utah and Denver, Colorado. Informed consent documents will be created to ensure the protection of the study and the participants. Qualtrics will be utilized for ease of distribution for the researchers and the participants. A survey will be created regarding the observation and practice of infection control adherence within the cardiac catheterization laboratory. Demographic information about the participants will be included in the survey responses to ensure the participants fall under the demographic umbrella this research study is aiming for. Ideally 100+ responses will be collected through this online survey tool and responses will be obtained and remain on that tool for access. These responses will be input into a grid-like table and assigned a point system based on the responses. The hypotheses will be evaluated utilizing the same survey questionnaire results. ANOVA testing will be conducted to determine if there is any correlation between the variables and adherence to infection control. Assumptions We will assume the survey is dependable and will be delivered in the same exact way for each participant. Assumptions about the participants will be that they are current cath lab personnel, have foundational background knowledge to fully understand the survey questions, and the participants answer truthfully. Due to the anonymity of the survey responses, participant honesty should be present in these responses. There is still a chance that respondents may not be fully honest and transparent, but the initial assumption regarding this research study is that 34 participants will be fully transparent in their responses. The informed consent document will outline the steps taken to ensure their privacy and confidentiality of their personal information and responses. For example, first and last names will not be recorded in the survey. The respondent will be informed of their anonymity clearly in the informed consent document as an additional step taken to encourage their honesty in their responses to the survey questions. Due to the use of social media outreach and snowball sampling, there will be an adequate number of responses to the survey questions/statements. Limitations The limitations of this study are that the researchers are basing the research off the participant’s honesty and candor in their observations, as well as their own behavior and actions in the cardiac catheterization laboratory. Measures taken to mitigate these limitations involve the clauses included in the informed consent document that inform the participant of the steps taken to ensure confidentiality of their identity and anonymity of their responses. Furthermore, this study will also be limited by the reach of the survey. It is possible that the study will have more survey responses from the states of Colorado and Utah due to the workplaces of the researchers and the initial ‘snowball’ of the snowball sampling recruitment process. To reduce the likelihood of this occurring, the survey will also be distributed online on social media platforms to reach a wider span of cath lab personnel across the United States. Delimitations The scope of this study spans cardiac catheterization lab employees such as cath lab radiologic technologists, cath lab nurses, cardiologists, and RCIS staff as well as administration roles such as cath lab directors and supervisors. The delimitations of this study involve not including surgical staff, interventional radiology staff (peripheral angiography staff), 35 electrophysiology staff or hospital employees not currently working in cath labs to narrow the scope of the study. The staff must have worked in the cath lab or their administration role for at least three months to qualify to be part of the study to ensure adequate knowledge of their cath lab. Ideally, all data gathered from the survey responses will be utilized in the study. If it is found that a question has answers that are too variable amongst respondents, it may be dismissed from both the study results and data analysis portion of this research study. Ethical Assurances Prior to any data collection procedures, Weber State University Institutional Review Board approval was obtained. Participants will be provided with an informed consent document prior to participating in the study and their consent must be obtained prior to their participation. This research study is anonymous; therefore, the study instrument will not request any specific name information. Responses from the study instrument will be kept on a password protected device and raw data will not be shared with anyone outside of the principal investigators. Summary The chosen research design for this research project is a scoping review to inform practice and influence policymaking in the healthcare community. Social media outreach will be utilized to gain a higher volume of responders, and snowball sampling methods that originate in the communities of Salt Lake City, Utah and Denver, Colorado. The population will include administration staff, RCIS staff, registered nurses trained in the cath lab, radiologic technologists trained in the cath lab, and interventional cardiologists. Informed consent documents will be created to ensure the protection of the study and the participants. An online survey tool, Qualtrics, will be utilized for ease of use for the researchers and the participants. A survey will be created and distributed regarding the observation, practice, and level of infection control 36 adherence within the cardiac catheterization laboratory. Demographic information about the participants will be included in the survey responses to ensure the participants fall under the demographic umbrella this research study is aiming for. Ideally 100+ responses will be collected through this online survey tool and responses will be obtained and remain on that tool for access by the principal investigators. The same questions are being asked in each survey; therefore, the reliability of this study should be quite high. Because the survey/interview questions are regarding behavior of the participant themself and observed behavior, validity may pose a bit of a limitation if participants are not 100% honest in their answers. 37 Chapter 4: Findings The purpose of this research study was to discover whether there is a disparity in infection control practices in cath labs and if a disparity is present, discover who this disparity is amongst based on cath lab role, geographic location, and caseload. This chapter will present the research findings of the Qualtrics questionnaire as well as the results of the regression, coefficient, and ANOVA testing. Results At the conclusion of data collection, there were 156 participants that responded to the survey questionnaire. 24 responses were excluded due to a multitude of reasons: incomplete informed consent, located outside of the United States, and if they did not fit the inclusion criteria. The respondent population included 83% female while 15.9% were male. Most of the respondents had either a bachelor’s or associate degree. The youngest respondent was 22 years of age and the oldest was 69 years of age. Most respondents come from catheterization laboratories that perform more than 20 cases per week, and most respondents were registered nurses. Table 2 Highest Level of Education Completed Frequency Percent Valid Percent Cumulative Percent Valid 1 .8 .8 .8 High school graduate (high school diploma or equivalent including GED) 1 .8 .8 1.5 Some college but no degree 5 3.8 3.8 5.3 Master's degree 6 4.5 4.5 9.8 Associate degree in college (2-year) 45 34.1 34.1 43.9 Bachelor's degree in college (4-year) 74 56.1 56.1 100.0 Total 132 100.0 100.0 38 Table 3 Race/Ethnicity Frequency Percent Valid Percent Cumulative Percent Valid 1 .8 .8 .8 American Indian or Alaska Native 1 .8 .8 1.5 White,American Indian or Alaska Native 1 .8 .8 2.3 Black or African American 2 1.5 1.5 3.8 Other 5 3.8 3.8 7.6 White 122 92.4 92.4 100.0 Total 132 100.0 100.0 Figure 1 Case Load Per Week 39 Table 4 Role in the Cath Lab Frequency Percent Valid Percent Cumulative Percent Valid 1 .8 .8 .8 MD 1 .8 .8 1.5 RT 23 17.4 17.4 18.9 RCIS 49 37.1 37.1 56.1 RN 58 43.9 43.9 100.0 Total 132 100.0 100.0 Evaluation of Findings There were three questionnaire responses possible: I am confident, I am fairly confident, and I am not confident, in response to multiple statements regarding infection control. A response of ‘I am confident’ gained the respondent 2 points, a response of ‘I am fairly confident’ gained the respondent 1 point, and a response of ‘I am not confident’ gained the respondent 0 points. The questionnaire on infection control adherence allowed a maximum score of 28 which would represent upmost infection control adherence per the survey, and a score of 0 would represent failure to adhere to infection control standards per this survey. The study results revealed multiple scores of 28, the lowest score of 15, and a mean score of 23. These results do not represent an absolute disparity in infection control adherence in catheterization laboratories. Table 5 Infection Control Compliance Scores VAR00001 N Valid 131 Missing 0 Mean 23.7176 Std. Deviation 2.93854 Variance 8.635 Range 13.00 Minimum 15.00 Maximum 28.00 40 Research Question 2. If a disparity to infection control adherence exists, what cath lab role is the disparity more prevalent amongst? Respondents in the RCIS role have slightly higher adherence to infection control standards in comparison to RN’s. Radiologic technologists have the lowest adherence to infection control per this research study survey. Table 6 Infection Control Compliance by Cath Lab Role Parameter Posterior 95% Credible Interval Mode Mean Variance Lower Bound Upper Bound MD 26.000 26.000 8.677 20.217 31.783 RCIS 24.327 24.327 .177 23.500 25.153 RN 23.414 23.414 .150 22.654 24.173 RT 23.087 23.087 .377 21.881 24.293 a. Dependent Variable: Infection Control Compliance Score b. Model: Cath Lab Role c. Assume standard reference priors. Research Question 3. Is there a disparity in infection control secular to a certain geographical location in the United States? The Western United States had the highest adherence to infection control standards while the Northeast United States had the lowest adherence to infection control standards per this research study survey. Table 7 ANOVA : Infection Control Compliance Scores by Region Parameter Posterior 95% Credible Interval Mode Mean Variance Lower Bound Upper Bound Midwest US 23.971 23.971 .236 23.017 24.924 Northeast US 21.000 21.000 .802 19.241 22.759 Southern US 23.340 23.340 .151 22.576 24.104 Western US 24.871 24.871 .259 23.872 25.870 a. Dependent Variable: Infection Control Compliance Score b. Model: United States Region c. Assume standard reference priors. 41 Research Question 4. Does the disparity to infection control adherence rise or fall depending on the caseload of the cath lab? Per this research study, the disparity is not more prevalent depending on the caseload of the cath lab. Table 8 ANOVA: Infection Control Compliance by Case Load Parameter Posterior 95% Credible Interval Mode Mean Variance Lower Bound Upper Bound Less than 10 22.714 22.714 1.259 20.511 24.917 Less than 20 23.350 23.350 .441 22.047 24.653 More than 20 23.856 23.856 .085 23.284 24.427 a. Dependent Variable: Infection Control Compliance Score b. Model: Case Load c. Assume standard reference priors. The results obtained from this research study were unexpected given the current literature. The literature that was evaluated for this research study revealed a high possibility of infection control disparities due to the multitude of factors playing a role such as: difficulty maintaining asepsis, the lack of standardization for infection control protocols in the cath lab, and the hybrid environment of the cath lab. Possible explanations for the conflicting results of this research study are the limitations based on honesty of the respondents as well as the small sample size of 132 participants. Given the results of this specific study with the lack of a disparity to infection control adherence, it may not seem necessary to implement standardization of infection control protocols in the cath lab at this time. However, due to the limitations of the study, it is in this specific population that these results apply to. Summary The results of this research study were unexpected given the literature. A more apparent disparity was expected, however fair adherence to infection control is present amongst the 42 population obtained by this specific study. With the highest score being 28 and the lowest being 0, the mean score was 23, which is a fair adherence to infection control standards per this survey’s questionnaire. Per this study’s population, RCIS respondents were found to be more compliant, as well as respondents in the Western United States. This study found that case load does not have a correlation with a disparity in infection control adherence. 43 Chapter 5: Implications, Recommendations, and Conclusions Within the cardiac catheterization community, there may be disparities in adherence to infection control standards in this area of the hospital.1 The presence of this disparity brought up the question: why is there not currently a set standard for sterility protocols? Through extensive research of current existing literature, there are studies done in surgical settings, nursing departments, radiology departments - but none currently in the cardiac catheterization lab. 4 The purpose of this study is to acknowledge the current lack of direction cardiac catheterization laboratories are given regarding infection control, and to hopefully gain the attention of public health officials to officially set these protocols to standardize adherence across all cath labs. This research study is a quantitative study that will consist of survey questions answered by cardiac catheterization laboratory staff country-wide using snowball sampling and social media outreach to determine and explore the current adherence to infection control standards in the cardiac cath lab. Prior to any data collection procedures, Weber State University Institutional Review Board approval was obtained. Participants will be provided with an informed consent document prior to participating in the study and their consent must be obtained prior to their participation. This research study is anonymous; therefore, the study instrument will not request any specific name information. The limitations of this study are that the researchers are basing the research off the participant’s honesty and by the reach of the survey. The results of this study were unexpected due to the literature about the cardiac catheterization lab sterility practices. Based on these findings, there is no current need for reform of practice, however it would be interesting to see if the results change if the study were replicated in the future. 44 Implications Based on the results of this study, there is not a large disparity in infection control. The results showed that about 82% of infection control standards were adhered to by the staff surveyed. These results do not support our hypothesis. Although this number shows sterility is not perfect, this is a higher number than expected based on the literature. If specific guidelines for infection control were put in place, this number could be improved. However, with the percentage of adherence being so high, there may not be a need for standardization of infection control practices in the cardiac catheterization laboratories at this time. However, this study was performed on a small scale, which could have affected the results. It would be beneficial to replicate this study with a larger population to see if the results are consistent with this study. The results of this study showed that there is some disparity between the separate roles in the cardiac catheterization lab. The highest adherence to infection control was the doctors, then RCIS, then nurses, and the least adherence to infection control was RTs. Our hypothesis is supported by these results. This may be due to the training RCIS staff members receive directly for working in the cardiac catheterization lab. This disparity between the roles in the catheterization lab and their adherence to sterility practices may suggest a need for more training for nurses are RTs. Both of these roles come with experience in other areas of the hospital and may not have been trained in sterility before working the cardiac catheterization lab. Providing a training course/ infection control certification to all staff new to the cath lab may lower the disparity between roles. The study showed that the Western United States had the highest adherence to infection control, whereas the Eastern United States has the lowest adherence. This does not support our hypothesis stating that rural areas will have the least adherence to infection control in the cardiac 45 catheterization lab. These results may have to do with how busy the labs are. The east coast tends to have remarkably busy laboratories. These labs may struggle with keeping sterility standards high when in turn and burn laboratories. Furthermore, it is interesting that the highest and lowest adhering to infection control practices are very populated areas. The responses received seemed to be a good representation of most of the United States, however there were a larger number of responses from Utah and Colorado. This may have skewed the results to show that the west has a higher adherence to infection control standards. If this study were replicated in the future with a larger population the bias would be minimized. Per this research study, the disparity is not more prevalent depending on the caseload of the cath lab. This did not support our hypothesis. It was hypothesized that a higher case load would adhere less strictly to infection practices due to the literature on difficulty maintaining asepsis in the cardiac catheterization labs. However, the results not supporting this hypothesis may be due to the fact that since these labs do a higher number of cases, they have a highly trained staff that allows them to do so many cases. Labs that have less cases per week should, in theory, have a higher level of adherence to infection control standards due to having more time. However, since the results do not support this statement, infection control guidelines may benefit these slower laboratories. The data from this study may be skewed due to the fact that about 75% of responses were from laboratories that perform over 20 cases a week. If this study was completed on a larger scale with more representation of staff from labs, these results may be much different. Recommendations Standardization of infection control guidelines across all laboratories may help decrease the disparities across roles in the lab ang geological region. However, overall adherence to 46 infection control did not show a large disparity. There needs to be more research done performed this topic, perhaps with a larger sample size. This study should be replicated on a larger scale to reduce bias and ensure appropriate infection control practices. Conclusions There is not a large disparity in infection control adherence, meaning there may not be a large need for reform at this time. 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