Solution Testing Strip Concerns

Our consulting team has noticed this year that we are finding increasing issues with testing strips.  These strips are used to determine if chemicals reach an acceptable concentration to be effective.  Specific examples include:

  • An organization was using an ortho-phthalaldehyde solution to process contaminated endoscopes. A review of the test strips indicated the staff were using strips that had expired for almost 3 weeks from the manufacturer’s printed date on the container.  The staff had written a 90-day beyond-use date on the container after opening, which extended past the expiration date.  (beyond use dates cannot extend past expiration dates)  Several scopes had been processed since the testing strips had expired.
  • An organization had not entered the lot number of the testing strips into their scope processing log as required by the manufacturer. In the event that the manufacturer recalled the testing strips, there was no means to determine if any patients had potentially been placed at risk.
  • An organization’s dietary kitchen used quaternary test strips to test the concentration of sanitizer in the automatic dishwasher. However, the sanitizer had been changed by the supplier, which required a different type of testing strip.  It was unclear if the staff knew of the change, but they had been using the quaternary strips for 2 months and documenting color changes that could not be replicated by the survey team with the new solution.

These observations could place organizations in immediate jeopardy with a regulatory agency and compromise patient safety. Without accurate readings from testing strips, organizations cannot be sure if their cleaning/disinfection of devices and equipment has been properly performed to ensure patient safety.   Leaders are highly encouraged to review their use of test strip practices during rounding.  This must include a review of strips for expiration/beyond-use dates, documentation of lot numbers for recall (as applicable from federal/state law), and the use of proper strips.  Ensure staff have been trained on the use of test strips and the implications of potential patient harm.  Consider creating an easy to use, laminated poster for placement at the location where the strips are being used and inform staff the poster is there to help them perform their duties.

Please contact us for questions or more information at  704-573-4535 or

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.

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