Irving M. Pike

Quality Indicators for Colonoscopy

Colonoscopy is widely used for the diagnosis and treatment of colonic disorders. Properly performed, colonoscopy is generally safe, accurate, and well tolerated by most patients. Visualization of the mucosa of the entire large intestine and distal terminal ileum is usually possible at colonoscopy. In patients with chronic diarrhea, biopsy specimens can help diagnose the underlying condition. Polyps can be identified and removed during colonoscopy, thereby reducing the risk of colon cancer. Colonoscopy is the preferred method to evaluate the colon in most adult patients with bowel symptoms, iron deficiency anemia, abnormal radiographic studies of the colon, positive colorectal cancer screening tests, postpolypectomy and postcancer resection surveillance, surveillance in inflammatory bowel disease, and in those with suspected masses. The use of colonoscopy has become accepted as the most effective method of screening the colon for neoplasia in patients over the age of 50 years and in younger patients at increased risk (1). The effectiveness of colonoscopy in reducing colon cancer incidence depends on adequate visualization of the entire colon, diligence in examining the mucosa, and patient acceptance of the procedure. Preparation quality affects the ability to perform a complete examination, the duration the procedure, and the need to cancel or reschedule procedures (2, 3). Ineffective preparation is a major contributor to costs (4). Longer withdrawal times have been demonstrated to improve polyp detection rates, (5‐7) and conversely, rapid withdrawal may miss lesions and reduce the effectiveness of colon cancer prevention by colonoscopy. The miss rates of colonoscopy for large (≥1 cm) adenomas may be higher than previously thought (8, 9) Thus, careful examinations are necessary to optimize the effectiveness of recommended intervals between screening and surveillance examinations. Finally, technical expertise will help prevent complications that can offset any cost benefit ratio gained by removing neoplastic lesions. The following quality indicators have been selected to establish competence in performing colonoscopy and help define areas for continuous quality improvement. The levels of evidence supporting these quality indicators were graded according to Table 1. PREPROCEDURE The preprocedure period encompasses the time from first contact by the patient until administration of sedation or instrument insertion. The aspects of patient care addressed in prior documents apply here as well, including timely scheduling, patient preparation, identification, history and physical examination, appropriate choice of sedation and analgesia, evaluation of bleeding risk, etc. Because many examinations are currently being performed for colon cancer screening and are elective, care must be taken to be certain that all potential risks have been reduced to as low as practically achievable. The American Society for Gastrointestinal Endoscopy (ASGE) (10) and the U.S. Multi-Society Task Force on Colon Cancer have published appropriate indications for colonoscopy (11) (Tables 2 and 3).

A lexicon for endoscopic adverse events: report of an ASGE workshop

Patients and practitioners expect that their endoscopy procedures will go smoothly and according to plan. There are several reasons why they may be disappointed. The procedure may fail technically (eg, incomplete colonoscopy, failed biliary cannulation). It may seem to be successful technically but turn out to be clinically unhelpful (eg, a diagnosis missed, an unsuccessful treatment), or there may be an early relapse (eg, stent dysfunction). In addition, some patients and relatives may be disappointed by a lack of courtesy and poor communication, even when everything otherwise works well. The most feared negative outcome is when something ‘‘goes wrong’’ and the patient experiences a ‘‘complication.’’ This term has unfortunate medicolegal connotations and is perhaps better avoided. Describing these deviations from the plan as ‘‘unplanned events’’ fits nicely

Quality indicators for colonoscopy.

Colonoscopy is widely used for the diagnosis and treatment of colonic disorders. Properly performed, colonoscopy is generally safe, accurate, and well tolerated by most patients. Visualization of the mucosa of the entire large intestine and distal terminal ileum is usually possible at colonoscopy. In patients with chronic diarrhea, biopsy specimens can help diagnose the underlying condition. Polyps can be identified and removed during colonoscopy, thereby reducing the risk of colon cancer. Colonoscopy is the preferred method to evaluate the colon in most adult patients with bowel symptoms, iron deficiency anemia, abnormal radiographic studies of the colon, positive colorectal cancer screening tests, postpolypectomy and postcancer resection surveillance, surveillance in inflammatory bowel disease, and in those with suspected masses. The use of colonoscopy has become accepted as the most effective method of screening the colon for neoplasia in patients over the age of 50 years and in younger patients at increased risk (1). The effectiveness of colonoscopy in reducing colon cancer incidence depends on adequate visualization of the entire colon, diligence in examining the mucosa, and patient acceptance of the procedure. Preparation quality affects the ability to perform a complete examination, the duration the procedure, and the need to cancel or reschedule procedures (2, 3). Ineffective preparation is a major contributor to costs (4). Longer withdrawal times have been demonstrated to improve polyp detection rates, (5–7) and conversely, rapid withdrawal may miss lesions and reduce the effectiveness of colon cancer prevention by colonoscopy. The miss rates of colonoscopy for large (≥1 cm) adenomas may be higher than previously thought (8, 9) Thus, careful examinations are necessary to optimize the effectiveness of recommended intervals between screening and surveillance examinations. Finally, technical expertise will help prevent complications that can offset any cost benefit ratio gained by removing neoplastic lesions. The following quality indicators have been selected to establish competence in performing colonoscopy and help define areas for continuous quality improvement. The levels of evidence supporting these quality indicators were graded according to Table 1. PREPROCEDURE

Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011.

● The beneficial role of GI endoscopy for the prevention, diagnosis, and treatment of many digestive diseases and cancer is well established. Like many sophisticated medical devices, the endoscope is a complex, reusable instrument that requires reprocessing before being used on subsequent patients. The most commonly used methods for reprocessing endoscopes result in high-level disinfection. To date, all published occurrences of pathogen transmission related to GI endoscopy have been associated with failure to follow established cleaning and disinfection/ sterilization guidelines or use of defective equipment. Despite the strong published data regarding the safety of endoscope reprocessing, concern over the potential for pathogen transmission during endoscopy has raised questions about the best methods for disinfection or sterilization of these devices between patient uses. To this end, in 2003, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Healthcare Epidemiology of America collaborated with multiple physician and nursing organizations, infection prevention and control organizations, federal and state agencies, and industry leaders to develop evidence-based guidelines for reprocessing GI endoscopes.1,2 Since that ime, high-level disinfectants, automated reprocessing mahines, endoscopes and endoscopic accessories have all volved.3-6 However, the efficacy of decontamination and high-level disinfection is unchanged and the principles guiding both remain valid.7 Additional outbreaks of infection related to suboptimal infection prevention practices during endoscopy or lapses in endoscope reprocessing have been well publicized. A cluster of hepatitis C cases was attributed to grossly inappropriate intravenous medication and sedation practices.8 In numerous other instances, risk of infection transission has been linked to less willful, but incorrect, eprocessing as a result of unfamiliarity with endoscope hannels, accessories, and the specific steps required for eprocessing of attachments.9 Recent on-site ambulatory urgery center surveys confirm widespread gaps in infecion prevention practices.10 Given the ongoing occurrences of endoscopy-associated infections attributed to

Quality Indicators for Endoscopic Retrograde Cholangiopancreatography

Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most technically demanding and highestrisk procedures performed by gastrointestinal endoscopists. Hence, it requires significant focused training and experience to maximize success and safety (1, 2). ERCP has evolved from a purely diagnostic to a predominately therapeutic procedure (3). ERCP and ancillary interventions are effective in the nonsurgical management of a variety of pancreaticobiliary disorders, most commonly removal of bile duct stones and relief of malignant obstructive jaundice (4). The American Society for Gastrointestinal Endoscopy (ASGE) has published specific criteria for the training and granting of clinical privileges for ERCP (5, 6) The ASGE/American College of Gastroenterology task force has established the following indicators to aid in the recognition of ERCP examinations of high quality. The levels of evidence supporting these quality indicators were graded according to Table 1. Such indicators would permit the development of quality assurance programs and enable endoscopists who perform ERCP to share their personal quality measures with patients and other interested parties.

Quality Indicators for Gastrointestinal Endoscopic Procedures: An Introduction

The assurance that high-quality endoscopic procedures are performed has taken increased importance. A high-quality endoscopy ensures that the patient receives an indicated procedure, that correct and clinically relevant diagnoses are made (or excluded), that therapy is properly performed, and that all these are accomplished with minimum risk. The motivation for developing quality indicators for endoscopy begins with the desire to provide patients with the best possible care. These indicators may then be used in programs to improve the overall quality of endoscopic services. The American Society for Gastrointestinal Endoscopy (ASGE) and the American College of Gastroenterology (ACG), as leaders in promoting the highest quality patient care, formed a task force to identify end points that could be used to document high-quality endoscopic services. In most cases these end points will require validation before they can be generally adopted. The task force consisted of expert endoscopists selected by the board of directors of the ASGE and the ACG (Table 1). These documents were then reviewed and approved by the governing boards. The task force developed quality indicators for the 4 major endoscopic procedures: colonoscopy, esophagogastroduodenoscopy (EGD), endoscopic retrograde cholangiopancreatography (ERCP), and endoscopic ultrasonography (EUS). Wherever possible, these indicators were chosen because there were published supporting data. These studies were identified through a computerized search of Medline followed by review of the bibliographies of relevant articles. When such data were absent, indicators were chosen by expert consensus. Our goal was to create a comprehensive list of potential quality indicators, recognizing that only a small subset may ultimately be implemented. The resultant quality indicators were graded on the strength of the supporting evidence (Table 2) (1). For each endoscopic procedure, indicators were considered for 3 time periods: preprocedure, intraprocedure, and postprocedure. Preprocedure indicators include proper indication for the procedure, consent, antibiotic prophylaxis, etc. Intraprocedure indicators include completeness of the examination and completion of therapeutic procedures. Postprocedure indicators include follow-up of pathology and recognition and management of complications. Our aim was to create indicators that in most cases could be extracted from the endoscopy report or procedural documentation. Although the endoscopist’s goal may be to achieve 100% compliance with every indicator in every patient, it is recognized that this will not be practically achievable in all cases. In most cases, acceptable compliance levels are unknown and should be determined by prospective study. Underlying this discussion of quality indicators is the assumption that adequate training and credentialing has taken place before a practitioner begins the practice of endoscopy. The ASGE has guidelines specifically addressing standards for training, assessing competence, and granting privileges to perform endoscopy (2). It is the task force’s recommendation that these guidelines be adopted by facilities where endoscopic procedures are performed. Although each endoscopic procedure will have quality indicators specific to that procedure, there will be some common to all. This introduction will review the general principles and end points that are common to all endoscopic procedures. The following articles will focus on indicators unique to specific procedures.

Quality Indicators for ERCP

ERCP is one of the most technically demanding and high-risk procedures performed by GI endoscopists. It requires significant focused training and experience to maximize success and to minimize poor outcomes (1, 2). ERCP has evolved from a purely diagnostic to a predominately therapeutic procedure (3). ERCP and ancillary interventions are effective in the non-surgical management of a variety of pancreaticobiliary disorders, most commonly the removal of bile duct stones and relief of malignant obstructive jaundice (4). The American Society for Gastrointestinal Endoscopy (ASGE) has published specific criteria for training and granting of clinical privileges for ERCP, which detail the many skills that must be developed to perform this procedure in clinical practice with high quality (5, 6, 7).

Quality indicators for esophagogastroduodenoscopy

Esophagogastroduodenoscopy (EGD) is one of the most commonly performed endoscopic procedures. Properly performed, it provides valuable information in patients with upper gastrointestinal (GI) conditions. Additionally, therapeutic EGD forms the mainstay of treatment for upper GI bleeding and for dilation or stenting of benign and malignant strictures. In this article, the task force has identified a set of quality indicators that are particular to diagnostic EGD and to therapeutic maneuvers that may be carried out during this procedure. The levels of evidence supporting these quality indicators were graded according to Table 1.

Quality Indicators Common to All GI Endoscopic Procedures

Quality of care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge (1). The American Society for Gastrointestinal Endoscopy (ASGE), the American College of Gastroenterology (ACG), and the American Gastroenterological Association (AGA) have continually promoted the ideal that all patients have access to high-quality GI endoscopy services. A high-quality endoscopy is an examination in which patients receive an indicated procedure, correct and relevant diagnoses are recognized or excluded, any therapy provided is appropriate, and all steps that minimize risk have been taken.

Quality Indicators for EUS

EUS has become integral to the diagnosis and staging of GI and mediastinal mass lesions and conditions. EUS-guided FNA (EUS-FNA) allows the endoscopist to obtain tissue or fluid for cytologic and chemical analysis, adding to the procedures utility. Furthermore, the recent development of EUS-guided core biopsy techniques enables his-tologic sampling in selected cases and for obtaining tissue for molecular analysis in neoadjuvant and palliative settings. The clinical effectiveness of EUS and EUS-FNA depends on the judicious use of these techniques.