This newsletter applies to all QUAD A facilities that perform sterilization, regardless of the manner of sterilization. We are often posed with the question of specific information that needs to be captured in the sterilization log and for how long these records need to be retained. This article delves into the significance of sterilization logs, the necessary components that make them effective and compliant, and the importance of record retention.
In any medical setting, items and instruments like surgical tools and even linens can harbor bacteria and viruses if not properly sterilized. A sterilization log acts as a record-keeping mechanism and a quality control measure, detailing the sterilization processes utilized, the instruments treated, and the results achieved.
QUAD A Surgical, Procedural, International, and Dentistry standards manuals address sterilization in Section 7: Infection Control, specifically in Sub-Sections C: Instrument Processing and D: Sterilization. In the Rural Health Clinic (RHC) Standards manual, sterilization is cross-referenced to the Centers for Medicare and Medicaid Services State Operations Manual at Standard 14-C-5.
Creating and managing a sterilization log requires diligence. Per AORN: “Documentation of cycle information and monitoring results should be maintained in a log (electronic or manual) to provide tracking to the individual patient.” Many facilities opt for digital systems that automate aspects of tracking and reporting, reducing the risk of human error. However, smaller practices may continue to document using paper logs, both of which are acceptable. Regardless of the format, the information logged must remain accurate, complete, and up to date.
Each entry in the sterilization log must include:
Further, facilities must provide sterility assurance through weekly spore testing. Spore testing determines that spores, the most resistant organisms, have been killed during the sterilization process.
It is crucial that all entries are made promptly following sterilization, as delays may lead to discrepancies and complicate reviews or audits. The sterilization log is fundamentally a record-keeping tool, and it’s also essential for quality assurance and continuous improvement. Regular audits of the logs can help identify patterns or recurring issues that may require further investigation. Keep in mind that it is important to store sterilization records securely and back-up electronic records regularly.
Monitoring records, including sterilization, spore testing, or the equivalent, and other disinfection logs, must be stored for a minimum of three (3) years per QUAD A standards. Facilities will need to verify with the state if there are any record retention requirements. The stricter requirement between the state and QUAD A prevails.
Lastly, all personnel should understand each sterilization protocol for the facility’s equipment and the importance of an accurate sterilization log. Annual and as-needed refresher training can be beneficial to reinforce correct practices and update staff on any new regulations or techniques. Retention of this information should be placed in the personnel files for proof of ongoing training and education.
The importance of maintaining meticulous sterilization logs in surgical and medical settings cannot be overstated. Diligent record-keeping and compliance with sterilization protocols pave the road to improved patient safety and enhanced reputation. Together, we can improve patient safety!
We encourage your facility to reach out to our team at standards@quada.org with any standards-related questions.
Since 1980, QUAD A (a non-profit, physician-founded and led global accreditation organization) has worked with thousands of healthcare facilities to standardize and improve the quality of healthcare they provide – believing that patient safety should always come first.