Aug 16, 2023 | Article

Ensuring Patient Safety: The Crucial Role of Documentation in the Sterile Processing Department

  1. Identify what areas you could focus on for a Joint Commission Survey.
  2. Learn key guidelines to get prepared for accreditation surveys.
  3. Understand how documentation can set you up for success.


If it’s not documented, it didn’t happen.


That’s one way to look at the importance of documentation for Sterile Processing Departments (SPD). When surveyors from regulatory bodies like The Joint Commission (TJC), state health departments, or Det Norske Veritas (DNV) come for an assessment, the first thing they’ll often ask for is your documentation.


Because SPD is subject to various legal and regulatory requirements, including those set forth by organizations like the Food and Drug Administration (FDA) and the Occupational Safety and Health Administration (OSHA), regular surveys from accrediting bodies will help ensure the organization complies with the government’s rulings. Documentation plays a crucial role in meeting these requirements, demonstrating adherence to guidelines, and facilitating compliance with standards.


Having robust documentation in place will ensure your team can demonstrate its ability to maintain accreditation. And by maintaining accurate and comprehensive records, the SPD can ensure the delivery of properly sterilized instruments and contribute to the overall quality of patient care.


While documenting the documentation might be a step too far, you do need to ensure all documentation is readily available and complete. When your team goes the extra mile to ensure you have documentation on all processes and can show you’ve completed each of the steps needed for sterilization, you can ensure you have a smooth survey process.


Let’s dive into some of the key areas TJC focuses on during an assessment and how your team can have all the relevant documentation ready when they arrive.


What Are the Important Things the Joint Commission Focuses on in a Survey?

Surveyors are there to see if your staff can demonstrate and speak to their work processes in accordance with the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of Perioperative Registered Nurses (AORN) standards.


There are four areas surveyors focus on during an assessment. TJC will look heavily at adherence to best practices in high-level disinfection, sterilization records, instrumentation, and staff education and competencies.


We’ll dive into each and why they matter for your department.


High-Level Disinfection

This is a hot topic because of all the recent breakthroughs in best practices and standards. The delivery of high-level disinfection (HLD) healthcare products for use in patient care depends not only on the efficacy of the HLD process itself but also on documentation and reporting practices that enable the traceability of each facility-high-level disinfected medical device to the patient on whom it was used.


Reports and documentation enable traceability, which is vital in the event of a product recall or patient safety investigation. By maintaining detailed records of all endoscopes and items processed, including their disinfection cycles, load contents, and expiration dates, SPD can quickly identify affected items and take appropriate actions to mitigate risks and ensure patient safety.


Sterilization Records

Have records that cover the following:

  • Items sterilized
  • Date
  • Time
  • Load number
  • Biological lot number
  • Control lot number
  • Sterilizer print out
  • Sterilization parameters
  • Technician Name


Having records is important. Make sure you can show that each step was followed correctly and that the date, time, and staff names are documented on each step.


Instrument Maintenance

This is an area that continues to get more focus all the time and an area where documentation will need to be readily available and detailed. TJC will also note what type of products or equipment is being used and follow up to see if staff members are using them in accordance with manufacturers' instructions for use (IFUs). There are plenty of places where sterilization departments can run into problems.


  • Are manufacturer instructions for use available to staff performing reprocessing, and has staff been trained on these instructions?
  • Are users removing soil and keeping instruments moist as indicated in each instrument’s instructions for use?
  • Is terminal cleaning completed as soon as possible after use? Or, are instruments sitting for extended periods before being cleaned?
  • Are cleaning chemicals being diluted appropriately? Are cleaning solutions maintained at the correct temperature?
  • Is the instrument inspection process before packaging occurring in a well-lit location with magnification?
  • Are staff performing the integrity testing of instruments?


Can your team answer those questions? Can you prove adherence to guidelines by documenting each of these areas?


Staff Education and Competencies

Sterilization is a critical step in killing germs, viruses, and microbes, and therefore new requirements are regularly added. During a survey, you have a chance to show surveyors that you hold your staff to a high standard and can demonstrate this by showing how each team member is completing new training on standards and manufacturer’s instructions for use as they’re being released.


For example, AAMI recently released new guidelines around drying endoscopes. Research showed that improperly dried endoscopes were hotbeds for bacteria growth. To prevent problems, new guidelines were added to ensure SPDs properly dry endoscopes before storing them.


Get Prepared for Accreditation Surveys


Now that you know what key areas The Joint Commission will focus on during a survey, let’s talk about some standards and guidelines you need to know about to enhance accreditation preparation.


First, have a well-defined process for the design and functionality of the flow of instrumentation through sterile processing. Surveyors will need to be able to identify a one-way flow from dirty to clean.


Some key guidelines to keep in mind:

  • Your department will need to maintain a minimum of a two-compartment sink, though three is best practice.
  • In the most recent update, they recommend having an automatic endoscope reprocessor (AER) included as part of your disinfection process.


Next, make sure you have complete documentation around staff training, education, and competencies. This is a big area for surveyors; they need to know your staff is qualified to perform tasks correctly and that they can get answers to questions.


Some key guidelines to keep in mind:

  • There need to be scope and instrument instructions for use (IFUs) readily available.
  • Demonstrate ongoing training opportunities.


Finally, be prepared to show how your team is managing risk. Document the following:

  • Risk assessment: Identification of a source of failure that has the likelihood of occurring and the preparation to manage that failure
  • Risk management: The management of the identified failure in the risk assessment
  • Risk communication: The facility recall process that includes active communication between sterile processing, OR, infection prevention, risk management, patients and other concerned parties


Show surveyors you have a quality improvement process in place for each risk identified. This needs to be customized to your specific facility and show the steps being taken throughout the process.


Enhancing Documentation for Survey Success: Leveraging CensiTrac in the Sterile Processing Department


When you have the tools and processes in place to document during your normal workflow, then preparing for a survey doesn’t need to be stressful. For example, having tools and software to scan and document each instrument at each stage of the sterilization process will help your team automatically create an auditing trail that will be readily available when needed. Software that tracks each technician and prompts sign-offs at each stage creates detailed electronic trails that make it easy for surveyors to track adherence to your department’s processes.


Robust documentation requirements can feel overwhelming when taken as a whole. But ensuring that your processes incorporate automatic documentation within current workflows will not only ensure compliance and improve efficiency but can also impress the surveyors when they do arrive.


Using a tool like CensiTrac will help your team create a robust and detailed documentation process. CensiTrac helps teams stay compliant with the latest standards and supports your custom workflows and processes.


Want to learn more? Talk with an expert today.


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