The accreditation of qualified endoscopy unit (AQEU) assessment program was initiated in 2012 by the Korean Society of Gastrointestinal Endoscopy (KSGE) to enhance high-quality gastrointestinal (GI) endoscopy services. Based on the experience gained from the previous program, KSGE has updated this program in 2019. Endoscopic units aim at providing high-quality diagnostic and therapeutic endoscopy services [1]. These units must be characterized by a comfortable and safe environment for patients and a productive and efficient environment for the staff. Quality assurance is a main concern in cases of endoscope malfunctions and inadequate repair [2]. Accurate and adequate endoscopic processes improve the quality and safety of endoscopic practices [3]. The measurement of endoscopic outcomes, such as safety and efficiency profiles, is mandatory to monitor and improve poor performance [3]. These facility/equipment, procedures, and outcome measures serve as endoscopic quality indicators. In 2019, KSGE updated the AQEU assessment items for these quality indicators to establish competence and help in defining areas of continuous quality improvement. The AQEU assessment items for the facility and equipment are divided into the following categories (Table 1): endoscopes/accessories, facilities/spaces, and emergency aid equipment/patient monitoring systems. The assessment items comprise of a total of 23 items, including 16 mandatory items that require 100% compliance and 7 recommended items. The quality improvement items for the process are designed to assess processes before, during, and after the GI endoscopic procedures, including processes of explaining the procedure to the patients and obtaining patient consent for endoscopic examination, endoscopic examination itself, tissue biopsy, and interpretation of test results. There are a total of 20 items for process assessment, including 19 mandatory items and 1 recommended item (Table 2). The assessment of performance indicators comprises 14 items, including 10 mandatory and 4 recommended items (Table 3). Here, we present the updated program guidelines with respect to the facilities, procedures, and performance of the accredited endoscopy unit.

Rationale: Regular care of the endoscopes and endoscope main body is mandatory for accurate endoscopic diagnosis. Regular care of the endoscopes and endoscope main body is required to extend the lifespan of the endoscopic equipment and to ensure accurate and safe endoscopic examinations while maintaining the resolution of endoscopy.

Rationale: Endoscopic accessories, which may be used to respond appropriately to complications that may occur during endoscopy, such as bleeding, must be available to ensure a timely response to emergency situations and should be used and managed properly to ensure patient safety.

Rationale: With respect to documentation for accessories used in endoscopic procedures, the amount used, remaining inventory, storage conditions, and expiration or usage dates should be recorded and maintained. The purpose of such practice is to generate an adequate level of inventory based on calculation of amount use over a set period of time and quality assurance for effective use of medical supplies and accessories.

Rationale: In particular, all patients undergoing colonoscopy must wear an examination gown. In such cases, separate changing rooms for male and female patients should be provided, where the patients could keep their clothes and personal belongings.

Rationale: Bowel preparation is required for colonoscopy [4]. Bathrooms must be available for bowel preparation, enema as rescue for inadequate bowel preparation, and post-procedural self-care.

Rationale: Prior to the endoscopic procedure, patients may feel tension, which may cause changes in their vital signs, such as blood pressure and heart rate. Accordingly, a comfortable waiting area is required for patients. Some endoscopic procedures may be longer, and thus, a bulletin board or monitor should be set up to provide updates on the progress of the endoscopic examination or procedure. It is recommended that educational materials and videos are available in the waiting area to minimize anxiety about the endoscopic examination and procedure.

Rationale: As patient education is essential for safe endoscopy, obtaining consent from patients using a form and explaining the procedure to the patients are becoming mandatory. Especially with the increase in the number of therapeutic endoscopic procedures, there is a higher number of cases wherein information must be provided to the patient and guardian before, during, and after the procedure. Therefore, it is absolutely necessary to maintain a patient consultation area inside the endoscopy unit.

Rationale: The saliva, blood, and feces of patients are collected in endoscopic examination rooms. In addition, various complications may occur inside this room due to different drugs used when endoscopy under sedation is performed. Therefore, it is necessary to have this area separated from other examination rooms, in order to prevent infection and to allow for provision of emergency care.

Rationale: Emergency situations may occur during endoscopy under sedation, and thus, sufficient space, equipment, and personnel are required to monitor and respond to such situations.

Rationale: Patients recover after an endoscopic procedure in the endoscopy recovery room. Due to the increase in the number of patients requiring endoscopy under sedation, the number of patients requiring an endoscopy recovery room is also increasing. In some cases, patients may pose a risk of infection to other patients; thus, recovery room beds must be separated by curtains or partitions. Moreover, some patients may present with incomplete recovery of cognitive functions after endoscopy under sedation; thus, it is absolutely necessary to provide partitions between beds for privacy.

Rationale: Different patients show various rates of recovery from sedation after an endoscopic procedure, and accordingly, the recovery room must include equipment for continuous patient monitoring until patients recover completely from sedation [5].

Rationale: During an endoscopic procedure, severe adverse events (AEs), such as respiratory distress, hypotension, and shock may occur; thus, emergency medical supplies and equipment must be available for potential emergency responses. When performing endoscopy, emergency medication, such as epinephrine, and emergency resuscitation equipment, including a cardiopulmonary function monitor, intubation instruments, and artificial respiratory equipment, must be available. In addition, it is also necessary to establish measures to cope with loss of cardiopulmonary function that may occur spontaneously during endoscopy under sedation. In addition to the oxygen-supply equipment, emergency resuscitation tools, such as laryngeal mask, intubation instruments, and heart defibrillator, along with emergency medication, such as epinephrine, flumazenil, and naloxone, must be available for use.

Rationale: A patient monitoring system must be available to monitor blood pressure, heart rate, and oxygen saturation, because hypotension, hypertension, arrhythmia, or myocardial infarction may occur during an endoscopic procedure. A patient monitoring system includes a blood pressure manometer, a pulse measuring device, a pulse oximeter, and an electrocardiogram (ECG) monitor [5]. The aim is to enable early detection of abnormal signs during an endoscopic examination. The pulse oximeter should be non-invasive, portable, and allow for continuous monitoring.

Rationale: With the increasing number of elderly patients and patients with cardiopulmonary diseases, there is an increased likelihood of oxygen desaturation during endoscopy. In response to this, it is necessary that each bed is equipped with oxygen-supply equipment to supply oxygen, when necessary. In particular, as the use of endoscopy under sedation and lengthy therapeutic endoscopy is increasing and as supplying oxygen to patients during endoscopy under sedation is recommended, it is mandatory that the oxygen-supply equipment should be available.

Rationale: It is absolutely necessary to have equipment capable of measuring or monitoring ECG during endoscopy as hypotension, hypertension, arrhythmia, or myocardial infarction may occur during the procedure. In particular, the rapid increase in the number of patients requiring therapeutic endoscopy procedures has led to lengthier endoscopy under sedation and thus, there has been an increase in the number of cases that require intensive monitoring. Patient monitoring equipment, including an ECG monitor in the endoscopy unit, will help to detect any abnormalities by measuring or monitoring ECG when cardiac anomalies are suspected during an endoscopic examination or when patient history indicates a need for intensive heart monitoring.

Rationale: A portable oxygen tank must be available to provide aid if hypoxia develops after an endoscopic procedure, while it is also needed during transfer to the intensive care unit or to another hospital for additional care after emergency resuscitation. However, there are no data regarding the accurate number of portable oxygen tanks that are required per endoscopic examination room, indicating the need for further discussions.

Rationale: Using a carbon dioxide insufflation system during colonoscopy can reduce post-procedure pain and cramps and increase the level of satisfaction for the procedure for both the patient and the physician, and thus, the availability of such of system is recommended [6,7].

Rationale: The saliva, blood, and feces of the patients are collected in an endoscopic examination room, hence there is a high likelihood of exposure to various drugs. Moreover, since patients with various infectious diseases, including tuberculosis, may be examined in the endoscopy unit, it is absolutely necessary to be prepared for such situations [8,9]. Therefore, a suitable ventilation system is recommended to minimize transmission of infection between patients and guarantee the safety of examination room employees [9].

Rationale: An endoscopy unit must be equipped with an endoscopy system, bed, and accessories to enable proper endoscopic procedures. Thus, a suitably sized examination room should be available. Currently, there are not enough data regarding the appropriate size of endoscopic examination rooms, but the American Society for Gastrointestinal Endoscopy suggests 180 ft² (16.72 m²) as an appropriate size for endoscopic examination rooms and 36 inches (0.91 m) as an appropriate door width [10]. A previous survey found that the average size of endoscopic examination rooms in hospitals in Korea was 14.1 m2.

Rationale: Submucosal injection solutions, sedatives, other drugs, and infusions may be used during the endoscopic procedures, and thus, should be stored accordingly. In particular, safe preparation of injection materials for parenteral administration or endoscopic injection is very important. Thus, it is necessary to have an independent preparation room inside the endoscopy unit for preparation and formulation of injections in aseptic conditions.

There are some prerequisites for safe drug administration. An independent preparation room is required, which must not be in direct contact with patients or with the examination room. All drugs must be labeled, and disposable medical supplies must be clearly marked. Disposable infusion sets must be used in patients using aseptic techniques. Moreover, a disposable vial is preferred over a multi-dose vial, and syringes should not be reused. Used syringe and needles should be capped properly and disposed appropriately. Tube lubricants used during endoscopy may be used multiple times, and proper infection control measures should be applied. If the tube is suspected to be infected, it should be discarded immediately [9]. Due to the lack of expert consensus on such space requirements or regulations in Korea, these are presented as recommended items.

Rationale: Patients should recover from pain or stress after an endoscopic procedure. Some patients may present with unstable vital signs or pain to sudden dizziness or fainting after a procedure. Therefore, it is necessary to provide patients with an area where they can recover until their blood pressure or heart rate stabilizes. Patients, who undergo endoscopy under sedation, may present with a sudden onset of symptoms, such as fainting while standing, despite intensive monitoring, and thus, an area where patients can recover while seated is also required.

Rationale: With the increased importance of quality assurance in endoscopy, the importance of appropriate education for employees and patients has increased as well [4]. Therefore, an adequately sized area for education is a mandatory requirement. However, as securing a necessary facility and space may require time and budget, this item is designated as a recommended item.

Rationale: Endoscopy units represent an area where physicians, nurses, nursing assistants, and other medical assistants work. Published data have indicated that increased fatigue in medical personnel from continuously performing endoscopic procedures can lead to a decline in the quality of endoscopy. In addition, musculoskeletal fatigue due to performing the endoscopic procedure, changing patient’s position, and moving around can also lead to a decline in the quality of care. In particular, therapeutic and emergency endoscopy present added pressure, and thus, an area for the medical staff to wait and rest is required. A changing room is also required to allow the medical staff to change their clothes. Due to lack of sufficient supporting evidence, this item is designated as a recommended item.

Rationale: A process for verifying the exact identity of examinee prior to endoscopic examination is required for accurate communication between the medical staff and to avoid confusion.

Rationale: Prior to endoscopic examination, information must be provided to the examinee regarding the reason for performing the endoscopic procedure and the details about the endoscopic procedure.

Rationale: The consent form must contain information about the type of the scheduled endoscopic procedure, pre-procedure precautions, the process involved in the endoscopic procedure, potential problems and complications (hypersensitivity, hypoxia, respiratory complications, stroke, myocardial infarction, bleeding, perforation, and others) that may occur during the procedure, and post-procedure precautions [12].

Rationale: The consent form must contain information about the type of scheduled endoscopic procedure, pre-procedure precautions, the process involved in the endoscopic procedure, potential problems and complications that may occur during the procedure (nausea/vomiting, abdominal discomfort/distention, hypothermia, fluid and electrolyte disturbance, nephrotoxicity, hypersensitivity, hypoxia, respiratory complications, stroke, myocardial infarction, bleeding, perforation, and others), and post-procedure precautions.

Rationale: The consent form must include the signature of the medical personnel and the examinee or the consent holder. If the form is signed by a consent holder, the reason for signing on behalf of the examinee and the date must be included. In principle, the consent form should be personally signed by the examinee. However, a guardian or legal representative may act as a consent holder on behalf of the patient under the following circumstances: the patient has physical or mental impairment that makes it difficult to make decisions on their own, the patient is a minor, explanation of the content of the consent form may significantly impact the mental well-being of the examinee, and the patient has provided a power of attorney to someone else. In such cases, the reason for designating a consent holder must be recorded in the consent form.

Rationale: The endoscopy under sedation consent form must include information about the sedative endoscopic procedure, the purpose and necessity of sedation, processes and methods of endoscopy under sedation, problems, complications, and sequelae associated with endoscopy under sedation, alternative treatment options other than endoscopy under sedation, and prognosis if left untreated.

Rationale: To maximize the efficacy of an endoscopic procedure and minimize complications, risk assessment based on detailed medical history and physical examination is needed, along with appropriate responses to identify risks. Prior to an endoscopic procedure, it is necessary to check the medical history that may affect the procedure; general conditions that may increase the risk of endoscopy-related complications; and medical history that may affect treatments prior to endoscopy, including history of neck surgery (including the pharyngolarynx), liver cirrhosis, heart failure, bleeding tendency disease, renal insufficiency, artificial valve/pacemaker, history of endocarditis, asthma, chronic obstructive pulmonary disease, hypertension, diabetes, cerebrovascular disease, glaucoma, prostate hypertrophy, and allergy. For examinees administered antiplatelet agents or anticoagulants, the risk of bleeding versus thrombosis and embolism should be considered to determine whether the medications should be discontinued; in addition, it should be checked whether insulin/oral hypoglycemic agent should be discontinued temporarily and determined whether antidepressants/sedatives are being administered.

Rationale: To increase the detection rate of adenoma or colorectal cancer, which is the primary goal of colonoscopic examinations, adequate bowel preparation is a key prerequisite that determines the efficacy and quality of the examination. The importance of proper dietary control and proper use of a bowel-cleansing agent must be explained to the patient prior to the procedure to ensure a high-quality colonoscopic examination without missing important lesions.

Rationale: Images acquired during an endoscopic examination are also considered to be treatment data, and thus, saving and keeping such data for a specific period of time would be considered a mandatory item. Endoscopic images saved in printed form are considered not acceptable.

Rationale: The standard imaging areas for upper GI endoscopic examination are: (1) the upper esophagus, (2) the gastroesophageal junction, (3) the cardia, (4) the upper part of the gastric lesser curvature side, (5) the gastric angle, (6) the antrum, (7) the duodenal bulb, and (8) the second portion of the duodenum. At least 8 images must be acquired, including all areas listed above [13]. Therefore, it is necessary to designate the standard imaging areas and the minimum number of images required.

Rationale: Because H. pylori has already been identified as a major cause of gastric or duodenal ulcer, its presence must be checked [14].

Rationale: Various colorectal diseases are prevalent in the right colon and the cecal intubation rate is a very important factor when assessing the quality of colonoscopy [15-17]. Therefore, it is absolutely necessary to ensure that colonoscopy included imaging of the cecal area.

Rationale: The standard imaging areas for colonoscopy include (1) the cecum, including the appendiceal opening; (2) the ileocecal valve; (3) the distal part of the ascending colon to the area directly superior to the hepatic flexure; (4) the proximal transverse colon directly inferior to the hepatic flexure (including the liver shadow); (5) the distal transverse colon directly superior to the splenic flexure; (6) the descending colon to the area direction inferior to the splenic flexure; (7) the middle segment of the sigmoid colon; and (8) the entire rectum up to 2 cm superior to the anal verge. At least 8 images must be acquired, including the maximum intubation site and all areas listed above. Basic images of different parts of the entire colon must be acquired during the colonoscopy, which would serve as evidence that the examination was performed adequately.

Rationale: During a colonoscopy, the withdrawal time must be sufficient to assure that important lesions were not overlooked. The average colonoscopy withdrawal time for assuring adequate level of quality is at least 6 minutes and improvement in detection rate or preventive effect can be achieved by meeting this requirement [18].

Rationale: Abnormal findings in an endoscopic examination include ulcers, cancer-suspicious lesions, adenoma, and dysplasia. When abnormal findings are observed in an endoscopic examination, tissue biopsy is absolutely necessary for a definitive diagnosis of the lesion [19]. In particular, the tissue biopsy should be performed on the most advanced part after thoroughly observing the lesion. Since the risk of complications, such as bleeding, is present, smooth manipulation of the endoscope should be encouraged.

Rationale: Endoscopic examination is a relatively safe procedure, but AEs may occur in rare cases. Awareness of the possibility of all AEs should be communicated as much as possible in an effort to prevent and respond to such AEs [20]. When AEs occur, appropriate response measures must be taken and records of such measures must be maintained.

Rationale: Sufficient information must be provided to the examinees to ensure that they understand why a H. pylori test was necessary during the endoscopic examination or why a tissue biopsy was performed for definitive diagnosis when an abnormal lesion was found. In addition, information must be provided regarding the exact amount of time required for pathological diagnosis and procedures for obtaining the test results when they become available.

Rationale: It is necessary to inform the examinee about delayed symptoms that may appear after an endoscopic procedure and how to respond to such complications to prevent serious complications before they actually occur [21]. For examinees who underwent an endoscopic procedure under sedation, the explanation should include recommendations not to operate a motor vehicle or make major decisions.

Rationale: Records about patients who underwent tissue biopsy are necessary for proper management of specimens [22].

Rationale: Any changes to a submitted endoscopic examination report should be made in accordance with the designated regulations and guidelines.

Rationale: An endoscopy report also serves as objective evidence for the quality of the procedure, including pre-treatment of the examination, diagnosis, and post-procedure safety assessment. Therefore, the items described above must be thoroughly checked and described in the report.

Rationale: Just as with upper GI endoscopy, the colonoscopy report serves as objective evidence, and thus, it must be drafted faithfully. For cecal intubation, the report must include images of the ileocecal valve or the whole cecum, including the appendiceal opening, and descriptions of the images. Moreover, the degree of bowel preparation must be scored and written in the report. Herein, withdrawal time is defined as the pure observation time, excluding time spent for polypectomy or tissue biopsy.

Rationale: Evaluation of the perianal area by visual inspection, palpation, and anal tone prior to inserting the endoscope can be very useful in assessing various anal diseases, including hemorrhoids, anal fissure, anal mass, and motor disorders such as fecal incontinence [23].

Rationale: Despite the fact that adequate bowel preparation is required for a thorough examination of lesions during colonoscopy, some researchers have reported up to 30% of cases with poor bowel preparation [24-26]. Various national and foreign guidelines recommend that the minimum rate of adequate bowel preparation should be maintained at ≥80% for cases involving colon without any surgical or anatomical abnormal findings [16,17,27].

Rationale: The endoscopist must objectively record information about all lesions found during the endoscopic procedure in the endoscopy report; objective information must include the number, location, gross morphology, and size of the lesions.

Rationale: If a therapeutic endoscopic procedure was performed on lesion(s) found during endoscopy, the endoscopist must describe the details of the procedural method used in the endoscopy report to allow such information to be used as objective evidence for follow-up examinations or re-treatment of the lesion(s).

Rationale: The endoscopist must verify the indications for performing the endoscopic procedure and approach the procedure considering the predicted lesions based on these indications. The records of the indications for the endoscopic procedure could be used as objective evidence for diagnosis and treatment by endoscopy and may be informative for determining the follow-up examination period.

Rationale: The endoscopist must objectively record, in the endoscopy report, the complications that occurred during an endoscopic procedure, to inform future treatments and to help to improve patient safety outcomes.

Rationale: In addition to facility, equipment, and competency of the endoscopist, all endoscopic procedures are directly affected by the time of day that the procedure is performed, procedure length, interval between procedures, and fatigue of the endoscopist [17,21]. Each institution must provide monthly statistics on diagnostic and therapeutic endoscopic procedures performed. The statistics must be used to check and record whether an appropriate number of procedures are being performed based on the number of endoscopists.

Rationale: The incidence of complications must be calculated and prevention of recurrence of such complications must be addressed.

Rationale: The endoscopist must objectively record, in the endoscopy report, information pertaining to disease and medication history of the examinee and this information could be used as objective evidence to determine treatment and prevention of complications associated with endoscopic procedures.

Rationale: Adenoma detection rate (ADR) is significantly negatively correlated with incidence of interval colorectal cancer and is known to be an important indicator, among various quality indicators, for colonoscopy [17,28]. The American Society for Gastrointestinal Endoscopy/American College of Gastroenterology Taskforce on Quality in Endoscopy determined that ADR is ≥25% and 15% in asymptomatic male and female patients, respectively [15].

Rationale: Early cancer detection is one of the most important reasons for performing upper GI endoscopy or colonoscopy. In particular, when gastric cancer is detected early, there is a higher probability of cure with a 5-year survival rate over 95%. Therefore, all endoscopic examination results for each month should be reviewed and monthly statistics on the detection of gastric and colorectal cancer should be calculated and recorded in an ongoing effort to identify the level of cancer detection and to improve cancer detection rate.

Rationale: Records serve as objective evidence for the quality of a procedure, including pre-treatment prior to the examination and safety assessment during and after the procedure; thus, records must be thoroughly completed.

This document provides updates on quality indicators, such as facility/equipment, process and outcome measures, in Korea. Some quality indicators show low level of evidence and were based on expert opinion. However, this updated guideline will be useful to establish competence and help to define areas of continuous quality improvement in Korean endoscopic practice. Future studies should be performed to address the lack of evidence to support our AQEU assessment items.