Cross Contamination
Cross-contamination from endoscopes to patients are a noted problem throughout endoscopy units across the country. The media has reported exposure to harmful bacteria and viruses following endoscopic procedures from inadequately cleaned scopes, the efficacy of high level disinfectants used in reprocessors and the design of the scopes. Legislatures are now questioning the types of infection control programs within endoscopy units and whether qualified personnel are being hired as endoscope technicians (Mathias, 2014). The problem of cross-contamination are not limited to one type of scope but includes colonoscopies, gastroscopes and duodenal scopes. The complex design of each scope has cause for concern in the formation of biofilm to harden
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in the channels of the scopes causing contamination after reprocessing is completed (Bourdon, 2014). A decrease in Medicare reimbursements has resulted in a reduction of workforce of registered nurses in the endoscopy suites and replacement with unlicensed personnel. The Society of Gastroenterology Nurses and Associates (SGNA) reports acquired infection from endoscopes are associated with a breach in the reprocessing steps from unlicensed and uncertified personnel (Mathias, 2014). Interviews of endoscopy technicians reported that often they did not realize until years later that endoscopes had different channels that required cleaning (Bourdon, 2015). Endoscopy technicians are not required to have a background as a certified nursing assistant or any other formal training.
Recent research has found an alarming number of endoscopes harboring harmful bacterial and viral microbes following recommended cleaning guidelines set forth by the American Society for Gastrointestinal Endoscopy and the Society for Healthcare Epidemiology of America using evidence-based practice for reprocessing endoscopes (American Society for Gastrointestinal Endoscopy [ASGE], 2011). Despite strict endoscope reprocessing guidelines, harmful bacteria, viable microbes and organic residue are found on endoscopes. The efficacy of high level disinfectants are also in question, “persistent contamination on colonoscopies and gastroscopes detected by biologic cultures and rapid indicators despite reprocessing performed in accordance with guidelines” (Ofstead, et al., 2015, p. 794).
The project setting is the endoscopy unit at a hospital located in Western North Carolina. The endoscopy unit serves local citizens and is a regional referral center for surrounding counties. The population of patients range from healthy screening colonoscopies to the diagnosis and treatment of a wide range of gastrointestinal disorders. Endoscopes are used to visualize the large intestine, esophagus, stomach and the first portion of the duodenum. Specialty endoscopes are used to visualize the common bile duct and pancreatic ducts. Endoscopic ultrasounds scopes enables the physician to visualize through the walls of the gastrointestinal tract with special concentrations of the esophagus, liver, pancreas, and rectum. The required use of endoscopes for all types of endoscopic procedures lead to an increase risk of cross-contamination to patients.
The scope of the problem has not been fully identified however, facilities across the country have reported that patients may have been exposed to harmful bacteria and microbes from endoscopic procedures. Cross-contamination from endoscopes is a patient safety issue and has been noted in 2015, as being in the top ten hazards in health technology (Bourdon, 2014). “Evidence shows that more health care-associated outbreaks have been linked to contaminated endoscopes than to any other medical device” (Bourdon, 2014, p. 7). Lack of information detailing the extent of the problem is partially due to the fact that endoscopy units are not required to routinely test endoscopes for contamination nor is it mandated that endoscopy technicians be certified and licensed. The Veterans Affairs (VA) and other facilities suggest that cross-contamination from endoscopes are concerning. The VA reported that as many as 10,000 Veterans may have been exposed to human immunodeficiency virus (HIV) and hepatitis over a five year timeframe from endoscopes that had not been properly cleaned ("Steps to help ensure proper reprocessing," 2010).
The consequences of not developing an intervention for the problem are the risk of harm to endoscopy patients following endoscopic procedures. Reports of contaminated scopes places fear in adults who need screening colonoscopies for the prevention of colon cancer. Since colon cancer is the third leading cause of cancer deaths in the country and is the only cancer that is preventable with early detection and removal of colon polyps, assurance of safe scopes are needed. If mandates are not issued by the legislatures on scope reprocessing and a thorough investigation as to why microbes and bacteria are viable following high level disinfectants facilities may choose to continue the same process which places patients at potential risk for cross contamination.
Validation of the Problem Ten patients in the endoscopy unit were exposed to hepatitis C during their endoscopic procedure. The staff had never been trained to flush an ancillary port on the top of the scope nor was informed that the port needed to connect to the reprocessor for high level disinfection washing and patients were harmed. The staff was not provided an orientation to central processing nor was there training from the scope company on the different types of scopes and special cleaning of each channel. The scope competency was vague and did not have step by step instructions on the process.
The reporting of this informal evidence suggest that unlicensed and uncertified staff has the potential to cause harm to patients. Recently, the infection control department randomly tested several scopes and reported microscopic microbes in the scope. This had led to further scope training. Staff are now trained in central processing and required to obtain certification. Data estimates that twenty million gastrointestinal procedures are performed each year in the United States. Strict endoscope reprocessing guidelines were set in 2003 but reports of cross-contamination from various types of endoscopes continues. Until recently endoscopy units were not required to track patient outcomes following procedures. A study that was released in 2011 from reviews of 265 scientific articles between 1966 and 1992 found transmission of pathogens from endoscopes. The article suggested cross-contamination was due to a failure to follow the cleaning and disinfectant process. Of the 28 cases reviewed it was estimated that over a million of patients had been exposed to some type of pathogen ("Mulitsociety guideline on reprocessing," 2011).
Articles from 2015, provide evidence that inadequate endoscope reprocessing has placed the concern for patient’s safety within the top ten issues (Bourdon, 2015). Thirty-nine, Illinois hospital patients, between January 2013 and December 2013, tested positive for Escherichia coli (E coli). Between 2012 and 2014, 35 patients were contaminated by Carbapenem-resistant Enterobacteriaceae (CRE) at Virginia Mason Medical Center in Seattle. California has also had reports of multiple outbreaks of CRE. The University of California, Los Angeles contacted 179 patients, from October 2014 to January 2015, of their potential exposure to CRE from scopes that had tested positive. Seven patients tested positive to CRE and two died from the bacteria. Within a month, Cedars-Sinai Medical Center reported four patients had become infected with CRE. Florida, Washington and Wisconsin also reported outbreaks of CRE ("Southern California CRE outbreaks," 2015). In 2011, 10 patients in Western North Carolina were exposed to hepatitis C from improper reprocessing of an endoscope.
Results from studies proves that scopes that had been properly cleaned still tested positive for viable microbes and bacteria. Researchers tested 15 endoscopes from 60 procedures and found that 64% contained viable microbes following high-level disinfection (Ofstead et al., 2015). The results of this study provides evidence that further investigation is warranted to protect patients from cross-contamination following endoscopic procedures.
Purpose Statement The purpose of this project is to prevent cross-contamination from endoscopes in an endoscopy unit using evidence-based practice.
Systematic Plan for Search of Relevant Evidence Literature resources within the past five years will be researched for interventions in preventing cross-contamination from endoscopes. The Rating System for the Hierarchy of Evidence using ProQuest Nursing and Allied Health Source. The Evidence of Hierarchy uses findings gained from rigorous research or the evidence of best practice. The seven levels of evidence that will be used to indicate whether an intervention will improve the problem. The higher the level provides confidence that the evidence is correct (Melnyk & Fineout-Overhold, 2010).
• Level 1: Evidence from systematic review or meta-analysis of all relevant randomized control trials (RCT’s) of multiple experimental studies.
• Level II: Evidence obtained from well-designed randomized control trials (RCT’s) from single experimental studies.
• Level III: Evidence obtained from well-designed controlled trials without randomization using single quasi-experimental studies.
• Level IV: Evidence from well-designed case-control and cohort studies using case or cohort quasi-experimental …show more content…
studies.
• Level V: Evidence from systematic reviews of qualitative studies and/or quantitative studies that do not meet Level I criteria using multiple studies from quantitative non-RCT or qualitative studies.
• Level VI: Evidence from single quantitative descriptive or qualitative studies using single study quantitative or descriptive qualitative studies.
• Level VII: Evidence from the opinion of authorities and/or reports of expert committees using non-research from expert opinion.
Literature resources will be searched for interventions that will aid in identification and prevention of cross-contamination from endoscopes. The order of research will begin at the highest level of evidence at Level I to the lowest level. The databases to complete the literature review will include research NCLive and Mountain Area Health Education Center (MAHEC) digital library with access to OVID Technologies, Inc., Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Cochrane database of systematic reviews. Literature reviews will be restricted to the English language.
Chapter 2: Interventions
Collection of Evidence Overview Online databases was used to locate data for interventions to prevent cross-contamination from endoscopes. The literature examined was Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medline, PubMed Medline, and OVID collection of Journals within OVID Technologies, Inc. Online journals searched included Gastroenterology Nursing, American Journal of Gastroenterology, American Operating Room Nurse (AORN) Journal, and Gastroenterology. Measures used for inclusion were English resources. Disciplines from any country was searched under the topic of gastroenterology, infection control, and nursing. Key terms searched were contamination from endoscope and associated infections from endoscopes. Ancillary terms searched were meta-analysis, systematic review, randomized controlled trial, quasi-experiment, cohort study, and research. Seven articles were located from the data search. The years of publication extended from 2005 to 2014. One article each resulted from 2005, 2006, 2010, 2011, 2012, 2013 and 2014. Five of the articles were from the United States, one from Korea, and one from China. Five of the articles were from the gastroenterology discipline, one from nursing discipline, and one from infection control discipline. There were three randomized control studies, one convenience non-randomized study, one observational prospective cohort study, one quantitative and qualitative assessment, and one opinion of authorities. The levels for the hierarch of evidence included three Level II, one Level III, one Level IV, one Level V, and one Level VII (Melnyk & Fineout-Overhold, 2010).
Analysis of Interventions and Sources Five interventions from the articles were located to prevent cross-contamination from endoscopes. The interventions included: 1) improve education in reprocessing guidelines and monitor endoscope technicians practice, 2) manual cleaning using an effective enzymatic detergent, 3) use of the highest efficacy of high-level disinfectants in automated reprocessors, 4) the use of rapid indicators after manual cleaning to detect organic residues, 5) swab culture monitoring of automated endoscope reprocessors after high-level disinfection. Five articles had one intervention and two articles provided two interventions. An examination of the intervention data are detailed from each article in this section. The number one intervention was to improve education in reprocessing guidelines and to monitor endoscope technicians practice. Two articles were located for intervention number one from Level IV and Level VII. A Level IV article by Ofstead et al. (2010) was investigated on the first intervention. The article was an observational prospective cohort study from the United States in the discipline of gastroenterology. The purpose of this “observational study was to evaluate the practices used to reprocess endoscopes, employee perceptions about reprocessing methods, and occupational health” (p. 305). The study was ran in the United States within two gastroenterology centers, two hospitals, and one ambulatory surgery center. Data was collected through interviews, surveys, and direct observations of trained endoscope technicians. There were four to thirteen persons studied from five multi-sites. Two interventions from the study included improved training and tedious monitoring of the technicians. Measurement was based on the twelve step endoscope reprocessing guidelines recommended by the Society of Gastroenterology of Nursing Association (SGNA). The results proved that only 1.4% compliance with manual reprocessing versus 75.4% compliance with automated reprocessing. The strength of the observational study proved that advanced training and the use of automated reprocessors decreased the risk of cross-contamination. Each site gave approval and the employees provided consent added strength to the study. The limitation of the study included “scheduled times for observation which had the potential to affect the employee behavior, potentially resulting in higher adherence levels than those that occur when employees are not being monitored” (p. 310). A limitation was noted by the authors from size and the fact that the employees studied volunteered. A Level VII opinion of authorities’ article by the Society of Gastroenterology Nurses and Associates (2013) from the United States in the discipline of nursing was examined. The purpose was to assess if “education in the diligence in application of all steps of reprocessing remains paramount in the safe delivery of endoscopic services” (pp. 293-294). The authors recommended an intervention of education with training and quality assurance to reduce biofilm on endoscopes. Each endoscope technician should complete annual competencies on reprocessing and infection control. Quality assurance monitoring by the supervisory staff on the adherence to the strict reprocessing protocol. The main strength of the article stressed that endoscopes reprocessed following strict guidelines set poses no risk of cross-contamination to a patient. The article did not list any limitations but supports additional investigation on infection control and endoscope reprocessing. Another con to the article was it was not based on evidence using a research method. Intervention number two was to assess effective enzymatic detergents used in manual cleaning of endoscopes. Two articles were found that deliberated on the intervention one Level II and one Level V. Allen (2006) was a Level II prospective, randomized controlled study from the United States in the gastroenterology discipline. The purpose of the study was “to evaluate the cleaning ability of these two agents combined with a standard disinfectant to achieve high-level disinfection for reprocessing gastroscopes” (p. 863). The design of the study used random assignment. The setting was not provided in the article. Five different endoscopes were randomly assigned in the non-foaming, triple enzymatic detergent or in the aqueous solution of 4% chlorhexidine gluconate. One hundred thirty samples were collected from each group. The samples revealed that 2% glutaraldehyde is an effective enzymatic detergent as 4% chlorhexidine. The results indicate that both are effective in the removal of biofilm from endoscopes before automated high-level disinfection. “The rate of bacterial contamination was 3.85% (10 of 260 samples). The difference in the positive culture rate between the two groups was not statistically significant with a positive culture rate of 4.62% (6 of 130) from the enzymatic detergent group versus 3.08% (4 of 130) from the chlorhexidine group (P=.747)” (p. 863). Strength of the article suggest that either solution was effective in the removal of biofilm from endoscopes and recommended a process to monitor the efficacy of the solution used. Limitations were not discussed in the article. Hutchinson & LeBlanc (2005) was a systematic review of quantitative and qualitative assessment from the United States in the gastroenterology discipline. The purpose of the review was to “look at the types of enzymatic detergents and the effect of cleaning conditions on the amount of ortho-phthalaldehyde (OPA) and the presence of stainable proteinaceous material recovered after high level disinfection of colonoscopies” (p. 373). The study was conducted in Presbyterian Hospital in Dallas using Pentax brand scopes. The quantitative study used twelve endoscopes and the qualitative study used five colonsocopes to determine the amount of residual OPA following manual cleaning. Interventions using different dilution rates were assessed to determine the best method for removal of biofilm from scopes. The data analysis showed that nonionic detergents were easily rinsed. Nonionic detergents should be correctly diluted and rinsed after cleaning. “No staining or proteinaceous material by OPA was observed after high-level disinfection of endoscopes that had been cleaned with properly diluted nonionic detergent and then rinsed with water” (p. 374). The strength of the systematic review on the proper dilution of OPA followed by a rinsing proved that enzymatic cleaners effectively removed biofilm from scopes. Limitations were not provided in the article. Intervention number three was to determine the highest efficacy of high-level disinfectants in automated reprocessors. Kim et al., (2011) was a Level II randomly assigned study from Korea in the gastroenterology discipline. The purpose of the study “aimed to compare the efficacy of the combination of polyhexamethylenebiguanide hydrochloride alkyldimethylbenzylammonium chloride (PHMB-DBAC) and orthophththaladehyde (OPA) used in automated endoscope reprocessors” (p. 109). The setting was in the endoscopy unit of the Korea University Anam Hospital. Eighty-six endoscopes were randomly appointed for reprocessing using either PHMB-DBAC or with OPA. Culture samples were obtained from the endoscope tip and working channels of the scopes. The samples were incubated and bacterial clusters were counted. Results from the culture proved reprocessing with PHMB-DBAC yielded 2.33% (1/43) positive culture results versus 4.65% (2/43). PHMB-DBAC was equivalent to OPA at (p=0.032; confidence interval, -0.042 to 0.042). The strength of the study proved the efficacy of PHMB-DBAC was equal to OPA and is beneficial in respect to time and side-effects. PHMB-DBAC is a suitable alternative to OPA. The study was limited to the efficacy of the disinfectant against bacterial and viral cultures were not obtained. Intervention number four used rapid indicators after manual cleaning to detect organic residues. Visrodi et al. (2014) was a Level III non-randomized convenience study from the United States from the infection control discipline. The purpose of the study was “to evaluate contamination of clinically used endoscopes, using visual inspection and rapid indicator tests before and after manual cleaning” (p. 988). The clinical study on the effectiveness of endoscope reprocessing was ran in an inpatient endoscopy unit at the Mayo Clinic in Rochester, Minnesota. The sampling type was convenience. The size examined 121 endoscope mechanisms and completed 249 rapid indicator tests on twelve scopes. Rapid indicators test pads identified protein, blood, and adenosine triphosphate (ATP) after manual cleaning. After manual cleaning there was no detectable remnants on the endoscopes. The rapid indicator test proved 82% of the endoscope mechanisms tested resulted in a least one positive test. The strength of the study reinforces the need for routine monitoring after manual cleaning to detect organic residues. The study was limited to one hospital and the study did not define if scope cleaning guidelines were followed. Intervention number five assessed swab culture monitoring of automated endoscope reprocessors after high-level disinfection. Lung-Sheng et al. (2012) was a Level II randomized controlled trial from China of the gastroenterology discipline. The purpose of the study was “to conduct a bacterial culture study for monitoring decontamination of automated endoscope reprocessors (AERs) after high-level disinfection (HLD)” (p. 1660). The setting was at Chang Gung Memorial Hospital endoscopy unit. A total of 420 swabs were collected and cultured for bacteria. The swab culture was an effective tool for monitoring the sanitization of AERs. The positive culture rate was 2% (6/300) following AER. Aerobic bacteria was assessed from 50% (3/6) and 50% (3/6) of fungal contamination. The strength of the study indicates that swab cultures are effective in the detection of incomplete decontamination following an AER cycle. Limitations to this study is this is the first documented study conducted on swab cultures following AER.
Synthesis of Evidence Five interventions from a review of literature were used to prevent cross-contamination from endoscopes. Education and monitoring of endoscope technicians was reported in two articles (Ofstead et al., 2010; Society of Gastroenterology Nurses and Associates, 2013). Manual cleaning using an effective enzymatic detergent was reported in two articles (Allen, 2006; Hutchisson & LeBlanc 2005). The use of the highest efficacy of high-level disinfectants in automated reprocessors was reported in one article (Kim et al., 2011). The use of rapid indicators after manual cleaning to detect organic residues was reported in one article (Visrodi et al., 2014). Swab culture monitoring of automated endoscope reprocessors after high-level disinfection was reported in one article (Lung-Sheng et al., 2012). The level and quality to improve education in reprocessing guidelines with monitoring of endoscope technicians is rated at acceptable credibility and fit.
The intervention has shown that enriched training programs with observation of the technician decreases the risk of cross-contamination from endoscopes. Staff should be open to putting into practice the knowledge gained on scope reprocessing. Monitoring of staff would increase the workload for the supervisor but is beneficial for patient safety. The level and quality of manual cleaning using an effective enzymatic detergent is rated at acceptable credibility and fit. The intervention has shown that 2% glutaraldehyde and 4% chlorhexidine are both effective in the breakdown of bioburden. The study reported that one agent was not statistically superior to the other. Both agents are effective in reducing bacteria from scopes. The level and quality of the use of the highest efficacy of high-level disinfectants in automated reprocessors was rated at acceptable credibility and fit. The intervention has shown that PHMB-DBAC provides the same efficacy as OPA. PHMB-DBAC is a superior product in reduction of contact time and side effects. Proposal to changing from OPA would entail a cost analysis of the
products. The level and quality of the use of rapid indicators after manual cleaning to detect organic residues was rated at acceptable credibility and fit. The intervention has shown that endoscopes often remain contaminated after manual cleaning is complete. The detection by the rapid indicators alerts the technician of remaining protein, blood and ATP. The implementation of this intervention is another safety measures to prevent cross-contamination. The level and quality of the use of swab culture monitoring of automated reprocessors after high-level disinfection was rated at acceptable credibility and fit. The intervention has shown useful in monitoring decontamination after the AER cycle. The intervention is beneficial in preventing infectious outbreaks from scopes that were not properly disinfected. The implementation of this intervention would require another step for the technician but would greatly improve patient safety.
Decision The interventions that will be used to prevent cross-contamination from endoscopes include improved education, monitoring of technicians, the use of rapid test pad indicators, and swab cultures following AER. Methods used will include education from scope and AER representatives. Education on proper steps for scope reprocessing, the use of rapid indicator test pads, and swab cultures following AER. The decision is considered to be relatively convincing. The decision was predominantly centered on research. The Levels for the articles found are comprised of Level II randomized, consecutive sampling; Level III non-random, convenience study; and Level IV observational study with one Level VII expert opinion.
in the channels of the scopes causing contamination after reprocessing is completed (Bourdon, 2014). A decrease in Medicare reimbursements has resulted in a reduction of workforce of registered nurses in the endoscopy suites and replacement with unlicensed personnel. The Society of Gastroenterology Nurses and Associates (SGNA) reports acquired infection from endoscopes are associated with a breach in the reprocessing steps from unlicensed and uncertified personnel (Mathias, 2014). Interviews of endoscopy technicians reported that often they did not realize until years later that endoscopes had different channels that required cleaning (Bourdon, 2015). Endoscopy technicians are not required to have a background as a certified nursing assistant or any other formal training.
Recent research has found an alarming number of endoscopes harboring harmful bacterial and viral microbes following recommended cleaning guidelines set forth by the American Society for Gastrointestinal Endoscopy and the Society for Healthcare Epidemiology of America using evidence-based practice for reprocessing endoscopes (American Society for Gastrointestinal Endoscopy [ASGE], 2011). Despite strict endoscope reprocessing guidelines, harmful bacteria, viable microbes and organic residue are found on endoscopes. The efficacy of high level disinfectants are also in question, “persistent contamination on colonoscopies and gastroscopes detected by biologic cultures and rapid indicators despite reprocessing performed in accordance with guidelines” (Ofstead, et al., 2015, p. 794).
The project setting is the endoscopy unit at a hospital located in Western North Carolina. The endoscopy unit serves local citizens and is a regional referral center for surrounding counties. The population of patients range from healthy screening colonoscopies to the diagnosis and treatment of a wide range of gastrointestinal disorders. Endoscopes are used to visualize the large intestine, esophagus, stomach and the first portion of the duodenum. Specialty endoscopes are used to visualize the common bile duct and pancreatic ducts. Endoscopic ultrasounds scopes enables the physician to visualize through the walls of the gastrointestinal tract with special concentrations of the esophagus, liver, pancreas, and rectum. The required use of endoscopes for all types of endoscopic procedures lead to an increase risk of cross-contamination to patients.
The scope of the problem has not been fully identified however, facilities across the country have reported that patients may have been exposed to harmful bacteria and microbes from endoscopic procedures. Cross-contamination from endoscopes is a patient safety issue and has been noted in 2015, as being in the top ten hazards in health technology (Bourdon, 2014). “Evidence shows that more health care-associated outbreaks have been linked to contaminated endoscopes than to any other medical device” (Bourdon, 2014, p. 7). Lack of information detailing the extent of the problem is partially due to the fact that endoscopy units are not required to routinely test endoscopes for contamination nor is it mandated that endoscopy technicians be certified and licensed. The Veterans Affairs (VA) and other facilities suggest that cross-contamination from endoscopes are concerning. The VA reported that as many as 10,000 Veterans may have been exposed to human immunodeficiency virus (HIV) and hepatitis over a five year timeframe from endoscopes that had not been properly cleaned ("Steps to help ensure proper reprocessing," 2010).
The consequences of not developing an intervention for the problem are the risk of harm to endoscopy patients following endoscopic procedures. Reports of contaminated scopes places fear in adults who need screening colonoscopies for the prevention of colon cancer. Since colon cancer is the third leading cause of cancer deaths in the country and is the only cancer that is preventable with early detection and removal of colon polyps, assurance of safe scopes are needed. If mandates are not issued by the legislatures on scope reprocessing and a thorough investigation as to why microbes and bacteria are viable following high level disinfectants facilities may choose to continue the same process which places patients at potential risk for cross contamination.
Validation of the Problem Ten patients in the endoscopy unit were exposed to hepatitis C during their endoscopic procedure. The staff had never been trained to flush an ancillary port on the top of the scope nor was informed that the port needed to connect to the reprocessor for high level disinfection washing and patients were harmed. The staff was not provided an orientation to central processing nor was there training from the scope company on the different types of scopes and special cleaning of each channel. The scope competency was vague and did not have step by step instructions on the process.
The reporting of this informal evidence suggest that unlicensed and uncertified staff has the potential to cause harm to patients. Recently, the infection control department randomly tested several scopes and reported microscopic microbes in the scope. This had led to further scope training. Staff are now trained in central processing and required to obtain certification. Data estimates that twenty million gastrointestinal procedures are performed each year in the United States. Strict endoscope reprocessing guidelines were set in 2003 but reports of cross-contamination from various types of endoscopes continues. Until recently endoscopy units were not required to track patient outcomes following procedures. A study that was released in 2011 from reviews of 265 scientific articles between 1966 and 1992 found transmission of pathogens from endoscopes. The article suggested cross-contamination was due to a failure to follow the cleaning and disinfectant process. Of the 28 cases reviewed it was estimated that over a million of patients had been exposed to some type of pathogen ("Mulitsociety guideline on reprocessing," 2011).
Articles from 2015, provide evidence that inadequate endoscope reprocessing has placed the concern for patient’s safety within the top ten issues (Bourdon, 2015). Thirty-nine, Illinois hospital patients, between January 2013 and December 2013, tested positive for Escherichia coli (E coli). Between 2012 and 2014, 35 patients were contaminated by Carbapenem-resistant Enterobacteriaceae (CRE) at Virginia Mason Medical Center in Seattle. California has also had reports of multiple outbreaks of CRE. The University of California, Los Angeles contacted 179 patients, from October 2014 to January 2015, of their potential exposure to CRE from scopes that had tested positive. Seven patients tested positive to CRE and two died from the bacteria. Within a month, Cedars-Sinai Medical Center reported four patients had become infected with CRE. Florida, Washington and Wisconsin also reported outbreaks of CRE ("Southern California CRE outbreaks," 2015). In 2011, 10 patients in Western North Carolina were exposed to hepatitis C from improper reprocessing of an endoscope.
Results from studies proves that scopes that had been properly cleaned still tested positive for viable microbes and bacteria. Researchers tested 15 endoscopes from 60 procedures and found that 64% contained viable microbes following high-level disinfection (Ofstead et al., 2015). The results of this study provides evidence that further investigation is warranted to protect patients from cross-contamination following endoscopic procedures.
Purpose Statement The purpose of this project is to prevent cross-contamination from endoscopes in an endoscopy unit using evidence-based practice.
Systematic Plan for Search of Relevant Evidence Literature resources within the past five years will be researched for interventions in preventing cross-contamination from endoscopes. The Rating System for the Hierarchy of Evidence using ProQuest Nursing and Allied Health Source. The Evidence of Hierarchy uses findings gained from rigorous research or the evidence of best practice. The seven levels of evidence that will be used to indicate whether an intervention will improve the problem. The higher the level provides confidence that the evidence is correct (Melnyk & Fineout-Overhold, 2010).
• Level 1: Evidence from systematic review or meta-analysis of all relevant randomized control trials (RCT’s) of multiple experimental studies.
• Level II: Evidence obtained from well-designed randomized control trials (RCT’s) from single experimental studies.
• Level III: Evidence obtained from well-designed controlled trials without randomization using single quasi-experimental studies.
• Level IV: Evidence from well-designed case-control and cohort studies using case or cohort quasi-experimental …show more content…
studies.
• Level V: Evidence from systematic reviews of qualitative studies and/or quantitative studies that do not meet Level I criteria using multiple studies from quantitative non-RCT or qualitative studies.
• Level VI: Evidence from single quantitative descriptive or qualitative studies using single study quantitative or descriptive qualitative studies.
• Level VII: Evidence from the opinion of authorities and/or reports of expert committees using non-research from expert opinion.
Literature resources will be searched for interventions that will aid in identification and prevention of cross-contamination from endoscopes. The order of research will begin at the highest level of evidence at Level I to the lowest level. The databases to complete the literature review will include research NCLive and Mountain Area Health Education Center (MAHEC) digital library with access to OVID Technologies, Inc., Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Cochrane database of systematic reviews. Literature reviews will be restricted to the English language.
Chapter 2: Interventions
Collection of Evidence Overview Online databases was used to locate data for interventions to prevent cross-contamination from endoscopes. The literature examined was Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medline, PubMed Medline, and OVID collection of Journals within OVID Technologies, Inc. Online journals searched included Gastroenterology Nursing, American Journal of Gastroenterology, American Operating Room Nurse (AORN) Journal, and Gastroenterology. Measures used for inclusion were English resources. Disciplines from any country was searched under the topic of gastroenterology, infection control, and nursing. Key terms searched were contamination from endoscope and associated infections from endoscopes. Ancillary terms searched were meta-analysis, systematic review, randomized controlled trial, quasi-experiment, cohort study, and research. Seven articles were located from the data search. The years of publication extended from 2005 to 2014. One article each resulted from 2005, 2006, 2010, 2011, 2012, 2013 and 2014. Five of the articles were from the United States, one from Korea, and one from China. Five of the articles were from the gastroenterology discipline, one from nursing discipline, and one from infection control discipline. There were three randomized control studies, one convenience non-randomized study, one observational prospective cohort study, one quantitative and qualitative assessment, and one opinion of authorities. The levels for the hierarch of evidence included three Level II, one Level III, one Level IV, one Level V, and one Level VII (Melnyk & Fineout-Overhold, 2010).
Analysis of Interventions and Sources Five interventions from the articles were located to prevent cross-contamination from endoscopes. The interventions included: 1) improve education in reprocessing guidelines and monitor endoscope technicians practice, 2) manual cleaning using an effective enzymatic detergent, 3) use of the highest efficacy of high-level disinfectants in automated reprocessors, 4) the use of rapid indicators after manual cleaning to detect organic residues, 5) swab culture monitoring of automated endoscope reprocessors after high-level disinfection. Five articles had one intervention and two articles provided two interventions. An examination of the intervention data are detailed from each article in this section. The number one intervention was to improve education in reprocessing guidelines and to monitor endoscope technicians practice. Two articles were located for intervention number one from Level IV and Level VII. A Level IV article by Ofstead et al. (2010) was investigated on the first intervention. The article was an observational prospective cohort study from the United States in the discipline of gastroenterology. The purpose of this “observational study was to evaluate the practices used to reprocess endoscopes, employee perceptions about reprocessing methods, and occupational health” (p. 305). The study was ran in the United States within two gastroenterology centers, two hospitals, and one ambulatory surgery center. Data was collected through interviews, surveys, and direct observations of trained endoscope technicians. There were four to thirteen persons studied from five multi-sites. Two interventions from the study included improved training and tedious monitoring of the technicians. Measurement was based on the twelve step endoscope reprocessing guidelines recommended by the Society of Gastroenterology of Nursing Association (SGNA). The results proved that only 1.4% compliance with manual reprocessing versus 75.4% compliance with automated reprocessing. The strength of the observational study proved that advanced training and the use of automated reprocessors decreased the risk of cross-contamination. Each site gave approval and the employees provided consent added strength to the study. The limitation of the study included “scheduled times for observation which had the potential to affect the employee behavior, potentially resulting in higher adherence levels than those that occur when employees are not being monitored” (p. 310). A limitation was noted by the authors from size and the fact that the employees studied volunteered. A Level VII opinion of authorities’ article by the Society of Gastroenterology Nurses and Associates (2013) from the United States in the discipline of nursing was examined. The purpose was to assess if “education in the diligence in application of all steps of reprocessing remains paramount in the safe delivery of endoscopic services” (pp. 293-294). The authors recommended an intervention of education with training and quality assurance to reduce biofilm on endoscopes. Each endoscope technician should complete annual competencies on reprocessing and infection control. Quality assurance monitoring by the supervisory staff on the adherence to the strict reprocessing protocol. The main strength of the article stressed that endoscopes reprocessed following strict guidelines set poses no risk of cross-contamination to a patient. The article did not list any limitations but supports additional investigation on infection control and endoscope reprocessing. Another con to the article was it was not based on evidence using a research method. Intervention number two was to assess effective enzymatic detergents used in manual cleaning of endoscopes. Two articles were found that deliberated on the intervention one Level II and one Level V. Allen (2006) was a Level II prospective, randomized controlled study from the United States in the gastroenterology discipline. The purpose of the study was “to evaluate the cleaning ability of these two agents combined with a standard disinfectant to achieve high-level disinfection for reprocessing gastroscopes” (p. 863). The design of the study used random assignment. The setting was not provided in the article. Five different endoscopes were randomly assigned in the non-foaming, triple enzymatic detergent or in the aqueous solution of 4% chlorhexidine gluconate. One hundred thirty samples were collected from each group. The samples revealed that 2% glutaraldehyde is an effective enzymatic detergent as 4% chlorhexidine. The results indicate that both are effective in the removal of biofilm from endoscopes before automated high-level disinfection. “The rate of bacterial contamination was 3.85% (10 of 260 samples). The difference in the positive culture rate between the two groups was not statistically significant with a positive culture rate of 4.62% (6 of 130) from the enzymatic detergent group versus 3.08% (4 of 130) from the chlorhexidine group (P=.747)” (p. 863). Strength of the article suggest that either solution was effective in the removal of biofilm from endoscopes and recommended a process to monitor the efficacy of the solution used. Limitations were not discussed in the article. Hutchinson & LeBlanc (2005) was a systematic review of quantitative and qualitative assessment from the United States in the gastroenterology discipline. The purpose of the review was to “look at the types of enzymatic detergents and the effect of cleaning conditions on the amount of ortho-phthalaldehyde (OPA) and the presence of stainable proteinaceous material recovered after high level disinfection of colonoscopies” (p. 373). The study was conducted in Presbyterian Hospital in Dallas using Pentax brand scopes. The quantitative study used twelve endoscopes and the qualitative study used five colonsocopes to determine the amount of residual OPA following manual cleaning. Interventions using different dilution rates were assessed to determine the best method for removal of biofilm from scopes. The data analysis showed that nonionic detergents were easily rinsed. Nonionic detergents should be correctly diluted and rinsed after cleaning. “No staining or proteinaceous material by OPA was observed after high-level disinfection of endoscopes that had been cleaned with properly diluted nonionic detergent and then rinsed with water” (p. 374). The strength of the systematic review on the proper dilution of OPA followed by a rinsing proved that enzymatic cleaners effectively removed biofilm from scopes. Limitations were not provided in the article. Intervention number three was to determine the highest efficacy of high-level disinfectants in automated reprocessors. Kim et al., (2011) was a Level II randomly assigned study from Korea in the gastroenterology discipline. The purpose of the study “aimed to compare the efficacy of the combination of polyhexamethylenebiguanide hydrochloride alkyldimethylbenzylammonium chloride (PHMB-DBAC) and orthophththaladehyde (OPA) used in automated endoscope reprocessors” (p. 109). The setting was in the endoscopy unit of the Korea University Anam Hospital. Eighty-six endoscopes were randomly appointed for reprocessing using either PHMB-DBAC or with OPA. Culture samples were obtained from the endoscope tip and working channels of the scopes. The samples were incubated and bacterial clusters were counted. Results from the culture proved reprocessing with PHMB-DBAC yielded 2.33% (1/43) positive culture results versus 4.65% (2/43). PHMB-DBAC was equivalent to OPA at (p=0.032; confidence interval, -0.042 to 0.042). The strength of the study proved the efficacy of PHMB-DBAC was equal to OPA and is beneficial in respect to time and side-effects. PHMB-DBAC is a suitable alternative to OPA. The study was limited to the efficacy of the disinfectant against bacterial and viral cultures were not obtained. Intervention number four used rapid indicators after manual cleaning to detect organic residues. Visrodi et al. (2014) was a Level III non-randomized convenience study from the United States from the infection control discipline. The purpose of the study was “to evaluate contamination of clinically used endoscopes, using visual inspection and rapid indicator tests before and after manual cleaning” (p. 988). The clinical study on the effectiveness of endoscope reprocessing was ran in an inpatient endoscopy unit at the Mayo Clinic in Rochester, Minnesota. The sampling type was convenience. The size examined 121 endoscope mechanisms and completed 249 rapid indicator tests on twelve scopes. Rapid indicators test pads identified protein, blood, and adenosine triphosphate (ATP) after manual cleaning. After manual cleaning there was no detectable remnants on the endoscopes. The rapid indicator test proved 82% of the endoscope mechanisms tested resulted in a least one positive test. The strength of the study reinforces the need for routine monitoring after manual cleaning to detect organic residues. The study was limited to one hospital and the study did not define if scope cleaning guidelines were followed. Intervention number five assessed swab culture monitoring of automated endoscope reprocessors after high-level disinfection. Lung-Sheng et al. (2012) was a Level II randomized controlled trial from China of the gastroenterology discipline. The purpose of the study was “to conduct a bacterial culture study for monitoring decontamination of automated endoscope reprocessors (AERs) after high-level disinfection (HLD)” (p. 1660). The setting was at Chang Gung Memorial Hospital endoscopy unit. A total of 420 swabs were collected and cultured for bacteria. The swab culture was an effective tool for monitoring the sanitization of AERs. The positive culture rate was 2% (6/300) following AER. Aerobic bacteria was assessed from 50% (3/6) and 50% (3/6) of fungal contamination. The strength of the study indicates that swab cultures are effective in the detection of incomplete decontamination following an AER cycle. Limitations to this study is this is the first documented study conducted on swab cultures following AER.
Synthesis of Evidence Five interventions from a review of literature were used to prevent cross-contamination from endoscopes. Education and monitoring of endoscope technicians was reported in two articles (Ofstead et al., 2010; Society of Gastroenterology Nurses and Associates, 2013). Manual cleaning using an effective enzymatic detergent was reported in two articles (Allen, 2006; Hutchisson & LeBlanc 2005). The use of the highest efficacy of high-level disinfectants in automated reprocessors was reported in one article (Kim et al., 2011). The use of rapid indicators after manual cleaning to detect organic residues was reported in one article (Visrodi et al., 2014). Swab culture monitoring of automated endoscope reprocessors after high-level disinfection was reported in one article (Lung-Sheng et al., 2012). The level and quality to improve education in reprocessing guidelines with monitoring of endoscope technicians is rated at acceptable credibility and fit.
The intervention has shown that enriched training programs with observation of the technician decreases the risk of cross-contamination from endoscopes. Staff should be open to putting into practice the knowledge gained on scope reprocessing. Monitoring of staff would increase the workload for the supervisor but is beneficial for patient safety. The level and quality of manual cleaning using an effective enzymatic detergent is rated at acceptable credibility and fit. The intervention has shown that 2% glutaraldehyde and 4% chlorhexidine are both effective in the breakdown of bioburden. The study reported that one agent was not statistically superior to the other. Both agents are effective in reducing bacteria from scopes. The level and quality of the use of the highest efficacy of high-level disinfectants in automated reprocessors was rated at acceptable credibility and fit. The intervention has shown that PHMB-DBAC provides the same efficacy as OPA. PHMB-DBAC is a superior product in reduction of contact time and side effects. Proposal to changing from OPA would entail a cost analysis of the
products. The level and quality of the use of rapid indicators after manual cleaning to detect organic residues was rated at acceptable credibility and fit. The intervention has shown that endoscopes often remain contaminated after manual cleaning is complete. The detection by the rapid indicators alerts the technician of remaining protein, blood and ATP. The implementation of this intervention is another safety measures to prevent cross-contamination. The level and quality of the use of swab culture monitoring of automated reprocessors after high-level disinfection was rated at acceptable credibility and fit. The intervention has shown useful in monitoring decontamination after the AER cycle. The intervention is beneficial in preventing infectious outbreaks from scopes that were not properly disinfected. The implementation of this intervention would require another step for the technician but would greatly improve patient safety.
Decision The interventions that will be used to prevent cross-contamination from endoscopes include improved education, monitoring of technicians, the use of rapid test pad indicators, and swab cultures following AER. Methods used will include education from scope and AER representatives. Education on proper steps for scope reprocessing, the use of rapid indicator test pads, and swab cultures following AER. The decision is considered to be relatively convincing. The decision was predominantly centered on research. The Levels for the articles found are comprised of Level II randomized, consecutive sampling; Level III non-random, convenience study; and Level IV observational study with one Level VII expert opinion.