Complete Traceability Documentation of Flexible Endoscopes

In the past few years, there have been a significant number of patients affected with infections as a result of having gastrointestinal endoscopy procedures using unclean flexible endoscopes.  In particular, duodenoscopes used in endoscopic retrograde cholangiopancreatography have set off a rash of sometimes deadly infections.

These tragic patient safety occurrences have resulted in a critical focus by regulatory agencies on the processes used to clean and sterilize flexible endoscopes at hospitals and outpatient clinics.  It is now recommended that hospitals and health systems completely trace the use of each individual scope to each procedure, patient, provider and the related processes which were used to clean and sterilize each endoscope.

Complete traceability means scanning and documenting the instrument path from patient use through the phases of sterilization to the shelf. Additional documentation within the EHR during intra-procedure point-of-care should include minimum data required to verify the sterilization of the scope and associate with the patient and procedure in the event of recall or alerts.

In order to document the entire path of the instrument, we start with listing the scope as instrumentation within an Instrument Tracking System. From there, tracking should include where the scope was sterilized prior to the procedure, who participated in the sterilization process and what sterilization method was used. During the procedure, nursing documentation is critical as well as utilizing any endoscopy software documentation (i.e. pictures taken during procedure, physician notes, etc).

To track scope usage on each procedure, nursing procedural documentation must now accommodate all information on each scope. Since that can be an overwhelming amount of information, the minimum documentation requirements, as published by SGNA (The Society of Gastroenterology Nurses and Associates, Inc.) 2013, is shown below:

  • Scope utilized (drop down box with all available scopes)
    • Not applicable
    • Scope ID number

The above example is the minimum data requirements. However, in J2’s experience, to achieve complete traceability of endoscopes, it is crucial to establish a standard naming methodology across clinical Information systems, Instrument tracking systems and Materials Management systems. Naming standardization means that each individual scope’s name within your database follows the same pattern. For example, the name starts with the same noun, then should include the type, model/catalog number, serial number and descriptive details which make each scope distinctive.  This information should be captured in a data type that is reportable since free text fields do not provide information that is easily analyzed and is open to inconsistent formatting from the end user.

Documentation errors may also arise when information systems do not support the workflows of clinicians and vice versa. For example, a clinician may not be able to find needed information in a poorly configured EHR. On the flip side, workflows may not accommodate the capabilities of current information system technology. Workflows and technology should be reviewed and aligned.

Additional benefits from a standard naming methodology:

  • Provides staff from all departments (OR, Endoscopy Units, Sterile Processing, Materials Management) with a consistent method to easily find the scope item within the database to support efficient documentation workflow
  • Supports scanning technology
  • Facilitates vendor endoscope recalls and alerts which are typically based on the “Model” level
  • Facilitates regulatory documentation compliance standards to support usage tracking and sterilization tracking information flow and workflow

For more information on how to clean, disinfect and sterilize instruments beyond manufacturer’s instructions, The US Food and Drug Administration has issued additional guidance. AORN has also published 2016 Guidelines for Processing Flexible Endoscopes with Competency Statements/Performance Criteria.

Are you facing these challenges? Comment below or contact us with any questions.