Maria Claudia Stefanoli, MD
Over the last four decades, GI endoscopy has become of paramount importance to diagnose, treat, and prevent diseases of the digestive tract. These procedures are invasive and have the potential to cause harm to the patient, so every time an endoscopy is indicated, the benefits obtained from it must outweigh the risks of the procedure. Because the quality of endoscopy can vary we must be sure we are providing the highest possible standard of care.
How can we measure quality?
The quality of health care can be measured by comparing the performance of an individual or a group of individuals, with an ideal or benchmark. Each parameter used for comparison is named a quality indicator. For example a high quality endoscopy is an examination in which the procedure is indicated, the correct diagnoses are made or excluded, the therapy provided is appropriate, and all the risks have been minimized. 1,19
As the demand for quality control in endoscopic procedures has grown all over the world, the creation of effective quality control guidelines has become a need. Moreover it is necessary to translate these guidelines into practical recommendations that can be implemented in the endoscopy units.
There are 3 categories of quality indicators:
This review will focus on item 2 above, the process measures of endoscopy. These quality indicators can also be divided into three time
periods: preprocedure, intraprocedure, and postprocedure. Preprocedure, is the period of time before sedation is started or the introduction of the endoscope. During this period there are common issues for all endoscopic procedures, which include: correct indication, informed consent, risk assessment, sedation plan, management of prophylactic antibiotics and of anti-thrombotic drugs.
2a. Indications for the Procedure
The indication, included in a published standard list of appropriate indications, must be documented (priority indicator). A quality improvement
goal is to minimize the number of endoscopies done without appropriate indications. For open access endoscopy, where non gastroenterologists
schedule patients for endoscopy, most studies have shown that the procedures are done for appropriate indications. 2, 3, 4
Two other quality improvement goals are to allow for feedback to referring physicians with regard to appropriateness of indication, and how information about the procedure will be provided to patients before the endoscopy.
2b. Informed Consent
Informed consent should be obtained and documented in every procedure, except in rare emergency cases or with non-competent patients. 5, 6
The consent should be obtained personally by the endoscopist and should specifically address and document the most common complications (bleeding, perforation, missed diagnosis, and sedation-related complications), facilitating a full discussion with the patient. 7 This is especially important if there is a subsequent medico-legal case. 8
When sedation is provided by an anesthetist, there should be a separate consent form, which should be obtained by that specialist.
2c. Pre Procedure Patient Evaluation
Pre-procedure history and physical examination should be done and documented. 9, 10 The history should focus on indications, as well as conditions that may affect the performance and safety of the procedure. This includes sedation-related issues (abnormalities of major organ systems, previous adverse events with sedation or anesthesia, medication allergies, current medications, potential medication interactions, smoking, alcohol or substance use or abuse). It should document the last oral intake.
The endoscopist or the anesthetist, will perform and document a risk assessment for sedation related adverse events, using the American Society of Anesthesiologists (ASA) score or the Mallampati Score (assesses the upper airway)11,12. This information will be useful for decision making with regard to proceeding or deferring the endoscopy as well as modifying the procedure sedation plan. The intended
level of sedation must be specified (no sedation, minimal, moderate, deep sedation, or general anesthesia) and it should be documented. The ASA recommends that, because sedation is a continuum, the endoscopist or anesthetist should be able to rescue patients whose level of sedation becomes deeper than initially intended. 13
2d. Antibiotics and Antithrombotic Medications
Prophylactic antibiotics for prevention of bacterial endocarditis are not indicated in the vast majority of endoscopic procedures, only being
administered for selected settings for which they are indicated (priority indicator).
Antithrombotic medication used by the patient should be recorded, and the plan for the management of the specific medication should be documented and communicated to the patient and health care team (priority indicator). This will vary with the patients underlying conditions, the procedure being performed, the risk of events and the medication(s) being used. Patients who are at high risk for thromboembolic events may require bridge therapy, or the endoscopy may need to be deferred. Such decisions may need consultation with a cardiologist or other physicians caring for the patient. After endoscopic therapy, the timing of resumption has to be individualized, depending on the type of endoscopic procedure and the risk of thromboembolism.
2e. Quality of the Procedure
Before administration of sedation or insertion of the endoscope, the endoscopy team pauses to verify that the correct patient will be undergoing
the correct procedure, and this should be recorded. A quality endoscopy procedure is one performed by an endoscopist who has met objective
measures for competency. Achieving the desired objectives and minimizing adverse events define the quality of an endoscopic procedure. The American Society for Gastrointestinal Endoscopy (ASGE) has published training and credentialing guidelines that establish basic principles of competency; these should be applied to the credentialing process wherever GI endoscopy is performed.
Several important themes in this regard deserve emphasis: 1) objective measures of performance and not simply the number of procedures
performed in training should be used to define competency, 2) measures of competence using well established benchmarks should be universal and not vary by specialty, 3) competency in one procedure should not necessarily imply competency in another, 4) competency in an endoscopic procedure should require that the endoscopist should be able to perform minimum therapeutic maneuvers specific to that procedure (e.g. polypectomy in colonoscopy and stent placement for distal biliary obstruction in ERCP). 14, 15
The intraprocedure period extends from the administration of sedation or insertion of the endoscope when no sedation is given, until the endoscope is removed. It includes all the technical aspects of the procedure, including completion of the examination and therapeutic maneuvers.
The post-procedure period extends from the time the endoscope is removed to subsequent follow-up. It includes providing instructions to
the patient, documentation of the procedure, recognition and documentation of adverse events, pathology follow-up, communication with referring physicians, and assessing patient satisfaction.
The procedure report should be accurate and succinct. 16 Standardization of the language and structure of endoscopic reports may improve communication between physicians. Electronic medical records and computerized endoscopic report generating systems may be of great help. Quality assessment and “pay for performance” programs that depend on the collection of reliable, reproducible data benefit from such standardization.
3a. Adverse events
Adverse events must be documented, and should be classified according to their timing, level of certainty of attribution to the endoscopic procedure, and degree of consequent disturbance to the patient.
To standardize data collection and reporting, an ASGE Task Force has proposed definitions and classification of endoscopy-related adverse events. 17 An adverse event is one that prevents completion of the planned procedure or results in admission to the hospital, prolongation of existing hospital stay, another procedure, or subsequent medical consultation. Based on timing they can be subdivided as preprocedure,
intraprocedure, postprocedure (up to 14 days), or late (any time after 14 days). A level of certainty of attribution to the endoscopic procedure
as definite, probable, possible or unlikely should be recorded. Severity of adverse events should be graded by the degree of consequent disturbance to the patient and any changes in the plan of care as mild, moderate, severe, or fatal.
3b. Post procedure follow up
One important point is that the results of the endoscopic procedure and follow-up recommendations, must be communicated to the referring
provider or primary care physician. This communication should be documented. It is the responsibility of the endoscopist to provide results, recommendations regarding therapy, further diagnostic testing and follow-up; the lack of communication may result in patient mis-management. The information related to histological reports, should be properly defined.
In conclusion, having a guideline does not result in improved health outcomes per se; in order to improve quality it is essential to implement
guidance and measure performance. Performing regular quality audits allows identification of potential under-performance, which provides
an opportunity for discussion and support for the endoscopist. These will all, result in better outcomes for our patients.
A quality control program should be implemented in gastrointestinal endoscopy units.