Mislabeled Diagnostic Specimens Put Lab Team at Risk: Patient Safety Impact Story

The Doctors Company is continually working to identify potential sources of risk and enhance patient safety. Our Patient Safety INSIGHT Services and extensive library of resources and tools take a data-driven approach to help you reduce adverse events while increasing patient safety and satisfaction. Here is one story of how our Patient Safety/Risk Management team reduced risk in a member practice.

The Challenge

A clinical laboratory team that provides diagnostic evaluation of specimens sent in from multiple practices noticed an increase in tissue specimens arriving mislabeled, prompting a Practice Risk INSIGHT review by The Doctors Company.

Past measures to mandate a labeling template for incoming specimens had encountered pushback from practices, so adoption was limited. The Practice Risk INSIGHT review discovered that, in the previous two years, there had been:

The Severity of the Problem

The vast majority of specimens are tissue biopsies obtained via surgical or invasive procedures and are difficult or impossible to replace. The potential for litigation arising from a delayed diagnosis or from not being able to replace a specimen is substantial.

One case highlighted the issues:

• Biopsy results on Patient A with symptoms of upper respiratory infection, dyspnea, and hemoptysis indicated invasive lung cancer.
• Staging surgery to determine the cancer’s progression included additional biopsies, removal of mediastinal lymph nodes and the sixth rib, plus a right lung resection.
• Shockingly, this surgery revealed aspergillus (a fungal infection) and clear lymph nodes: No evidence of lung cancer.
• Investigations found tissue samples had been mislabeled during the biopsy. Patient A’s label went onto Patient B’s tissue sample, resulting in Patient A’s biopsy tissue being lost.
• Unidentified Patient B actually had cancer and had to be traced, with a resulting delay in treatment. Patient A’s surgery and tissue removal had been unnecessarily extensive.
• Patient A now lives with debilitating dyspnea and pain, struggling to stand or perform any demanding household tasks or work outside the home, all due to a simple labeling error.

The Intervention and Commitment from Management

Plans to implement a pathology module for the lab team’s EMR system were dramatically accelerated. This would significantly reduce errors, if adopted for use by the medical practices. 

History showed that the practices regularly avoided using EMR modules, preferring faster (but error-prone) manual processing, which appeared to be the root cause of all mislabeling.

Lab leadership agreed with the crucial, business-defining proposal: No longer would ANY specimens be accepted outside of the new labeling workflow module.

The Drive for High Reliability

Recognizing that there is no acceptable error rate, the entire lab team committed to:

• Drive ongoing process improvements internally.
• Work with client practices to advance a collective culture of safety.

The lab team worked with all associated medical clinics, highlighting the mutual benefits of accurate identification and training the clinics in-person on the new labeling system.

Lab leadership conducted one-to-one communication at the highest level with any practices or clinics resistant to adopting the new process.

The Results

Ultimately, the results rewarded all these efforts. One year after the intervention and adoption of the new system, the lab team saw:

We’re Here to Help

Members of The Doctors Company can request a comprehensive risk assessment by our Patient Safety/Risk Management experts. We will partner with you to tailor a survey to your practice and provide a customized service plan. To request a survey, contact us at (800) 421-2368 or by email.