Validating Chemical Testing Strips for Effectiveness

The proper use of chemicals in the cleaning and disinfection process is critical to ensuring devices are safe for use.  A part of this process may include using testing strips to determine whether the chemical being used is at the correct concentration to be effective.  Part of this query should include validation that the testing strip being used provides accurate information.  Our consultant teams have found opportunities where organizations are not following the chemical/testing strip instructions for use in validating testing strip accuracy.  Often, these opportunities are with high-level disinfection processes, but may also exist in dietary, laboratory, and other applications.  Several types of opportunities include:

• An organization’s dietary services were using testing strips to validate the concentration of detergent in their sinks during cleaning;  however, the testing strips had expired.  The log in use did not reflect that they were documenting the expiration date in the designated place.
• A separate organization’s dietary service was using testing strips to determine the proper concentration of detergent in their automatic washer;  however, the testing strip being used was not designed for the chemical being used.  The organization had been documenting that the strip was reading the appropriate concentration.
• An organization was using Rapicide PA as part of their processing of endoscopes;  however, they were not following the testing strip instructions for use to validate effectiveness.  The instructions for use provided directions for conducting testing or, as an alternative, for downloading the certificate of conformance for the lot number of the test strips.  There was no documentation in their logs of test strip validation.

Organizations should ensure that their testing strips used with chemicals have been validated, either through testing or by obtaining a certificate from the supplier or manufacturer, to confirm their appropriateness for use.  Refer to the testing strip instructions for use for guidance.  Ensure that testing documentation is maintained as proof of validation.  Download certificates of conformance as you open new test strips and maintain them in the testing log as proof of validation.

Please contact us for questions or more information at 704-573-4535 or info@courtemanche-assocs.com.

Courtemanche & Associates specializes in Healthcare Accreditation and Regulatory Compliance Consulting Services. With over 30 years of being in business and 100+ years of healthcare experience amongst our consulting team, we are ready to assist with your accreditation and regulatory compliance needs.