Apr 8, 2021 | Article

Quality Audits

The Importance of Auditing your Sterilization Records

  1. Understand the importance of quality audits and how they contribute to protecting patients and staff
  2. Learn what you should be reviewing to validate a processed load has complete documentation
  3. Explain the quality improvement process

Healthcare organizations continually look for ways to minimize risk, keep patients safe, and comply with governing agencies. Performing quality audits (QA) on processed sterilizer load documentation is an effective way to ensure compliance. A quality audit should detect discrepancies, confirm compliance, and identify areas for improvement and educational opportunities.

IAHCSMM May/June 2020 edition of Process states, “INTEGRITY: THE CRITICAL PIECE TO QUALITY.” The article speaks about quality and how an error can spell big trouble for employee and patient safety. It can even mean the difference between life and death. Sterile processing staff members know they play a critical role in patient safety and strive to do what’s right. However, is anyone checking to make sure they are doing it correctly?

Quality Audit and why is it important to have a QA Tool

Quality Audit in sterile processing is a method of ensuring you are meeting requirements and industry standards. A QA process can assist the facility with compliance, protect staff and patients, and avoid unnecessary expenses.

QAs must be performed on a consistent basis. In sterile processing, they should be promptly completed for every processed load. Improving compliance requires education and training. If a discrepancy is discovered, the staff member who made the error can be educated and allowed to correct the mistake. “Learn from your mistakes,” is a lifelong mantra that applies to everything we do. In this case, if an error is unintentionally made, it can be used to train staff so they know the correct process for completing the task.

The word “audit” may make some people nervous. History has put the auditor on one side and the people or process being audited on the opposite side. This unfortunately has led to auditing being accusatorial when it shouldn’t be. If staff members are performing with integrity and in a conscientious manner, they are doing their best. So if an error occurs, it may be due to lack of education, rushing the process, or interruptions. Identifying the cause leads to developing quality initiatives for improvement.

Sterilization Records

There are requirements for documenting processed loads to meet compliance. What constitutes compliance is determined by the machine’s instructions for use (IFU) and requirements of governing agencies (e.g. AAMI Standards and the FDA).

The sterilization cycle should be determined based on the sterilizer capabilities and the instructions for use (IFU) of the items being sterilized. Having a sterilization monitoring device such as a biological or chemical integrator in every load is part of a good load release protocol. It allows for specific quality test results for staff to review prior to distributing a load for use. This is part of a QA audit. A Bowie-Dick test on steam sterilizers performing Pre-Vac loads should be performed every day that the machine is used.

When creating a sterilizer load, specific documentation for the load should include:

  • Date and time the load was created
  • Staff member creating the load
  • Load number
  • Specific contents in the load.

When documenting the contents of the load, identify specific items (e.g. Minor Basic #2, Minor Basic #5, Hand & Foot #1) to indicate the specific container sterilized. The same applies to peel packs and individually wrapped items.

After a sterilization load is completed and the items are cool enough to touch, sterilization parameters should be checked to ensure that the correct cycle was selected, and the parameters were met. If there is a discrepancy, follow the facility’s sterilization policy or standard operating procedure (SOP) for guidance. This may result in recalling the load and reprocessing/sterilizing it.

When documenting the processed sterilization load, the documentation should include specific information for that load:

  • Date and time of all documentation,
  • The staff member documenting the processed load,
  • The results of the load (e.g. Pass or Fail),
  • Cycle (e.g. temperature, exposure/sterilization time, dry time),
  • Process indicator (e.g. Bowie-Dick test, biological, chemical integrator)

If a Bowie-Dick test or biological was processed, the biological lot number and result must be documented. Similarly, if a chemical integrator was processed, those results also need to be documented. You are also required to verify that the cycle documented matches the cycle of the sterilizer printout tape, and the tape is legible.

Performing Quality Audits on Sterilization Records

A quality audit reviews the documented load information and validates that the correct process was followed. The facility’s sterilization policy or SOP should clearly state the process for creating and documenting a Bowie-Dick test load, an instrument load, and the process for a failed load.

Information on the specific reason for load failure should include the next steps for the operator to perform. These may include proper reprocessing of the contents of the load, documenting information, and who to notify.

Sterilization monitoring devices verify that the parameters of the sterilization cycle were met. When a monitoring device passes, the parameters were met, and the items are considered sterile and ready for use. However, if a human error prevents documentation of the load result and that biological, and/or chemical integrators passed, there is no verification that the items are sterile. The load is then typically recalled and reprocessed.

Performing quality audits on every load is a critical part of the sterilization process. If a processed load did not meet specifications the results may vary. A load can pass the cycle and chemical integrator portion, but the biological might have failed. When documenting a failed load, provide all the information pertinent to that load so that trends and patterns may be identified.

When a QA is performed, document that the QA was completed and by whom. This is “closing the loop” on a specific sterilization load. It is also the facility’s tool for quality performance and initiative in sterilization processing and documentation.

Quality Improvement and Compliance

A quality program consists of identifying is the process to be assessed, creating the policy or SOP, setting the standards, measuring the outcomes, reporting progress, identifying improvements, and developing the quality improvement process. Throughout the process, there is continual analysis to evaluate results, make necessary changes, and identify trends and patterns. The end goal is to minimize risk and improve quality in an efficient and cost-effective manner.

A QA program is only as good if it is consistently used. Enforcing compliance in sterile processing can prevent unintended consequences, identify adherence and non-adherence to policies, and provide sterilized items in a timely manner. Auditing compliance can spot, discourage, and prevent error so that patients and staff are safe, and the facility conforms to governing laws and regulations.

When a QA uncovers non-compliance, it is critical to identify the “who, what, where, and why”. When and why did this happen? Does it happen often? Is it the same person who is not complying? Or does the fault lie in the process, the environment, or the demand? Don’t just jump to conclusions and corrective action until you identify the root cause. This may be the environment, lack of education and experience, disruptions, the process itself, or the individual staff member’s commitment to sterile processing. When the root cause is identified it can then be addressed, analyzed, and corrected. Correcting patterns and trends requires consistent documentation of errors, corrections, interventions, and education.


A successful QA program means quality audits are performed on a routine basis against established performance based on policies and SOPs. That way, you know what you are auditing and how to perform the audit. Reporting should make it easy to measure your compliance and non-compliance.

Non-compliance should trigger a quality improvement process that is consistently adhered to and evaluated for effectiveness. If the quality improvement process is not producing positive outcomes, a new process may need to be developed to meet quality targets and measures.

Quality audits should ensure that the products processed and used on patients are safe. A common introspective question in sterile processing is, “Would you want this instrument used on you or a loved one?” The determining factor in answering “yes” is knowing that the instrument was correctly sterilized.

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