Laboratory Management Expert Discusses Clerical Mistake in Cancer Test Results

This case involves a 70-year-old woman from Kansas who had routine visits with her internist to screen for cancer. She had a family history of a particular type of cancer, and standard blood work was ordered for cancer screening. However, there was a data entry error and the patient was incorrectly tagged as male, thus, suspicious test figures weren’t flagged. The patient had results that were out of normal range for several years before they were investigated. Later, she was diagnosed with advanced cancer, and shortly thereafter the gender discrepancy error was identified on her previous lab studies. It was alleged that the lab was negligent in its record keeping, and that it had deviated from widely accepted industry practices designed to prevent mistakes of this nature.

Question(s) For Expert Witness

1. Have you previously overseen policy / procedures to prevent against such errors from occurring?

2. Have you previously published or lectured on the subject of data quality preservation, ensuring accurate information is captured and conveyed to patients and providers?

Expert Witness Response E-034857

After review of the details regarding this case, it appears that the proximate cause for the apparent misdiagnosis was the initial erroneous data entry for the patient's gender. What is not presented here is if this patient has a first name which might lead to some ambiguity of their gender, and which might make it difficult for staff whom are not in direct contact (such as coder's, billers, etc) to have a degree of reasonable confusion and not be able to contribute to the resolution. However, good clinical practice requires all providers and clinical staff to review the patient record on each visit, to insure that the incorrect record has not been accessed and that the history, clinical impressions, and findings are accurate. That is why The Joint Commission and College of American Pathologists mandate the use of two-patient identifiers; to prevent errors in treating the wrong patient or, in this case, applying incorrect reference values to the correct patient.

While the initial data error might be understandable, the fact that it was not apparently noticed for several years is extremely troubling and a major contributing factor. I have over 34 years of experience in clinical laboratory leadership and management, which includes over 15 years of serving as a College of American Pathologists (CAP) laboratory accreditation program Inspector. Over 17 of those years were as a Laboratory Manager, where I focused on quality assurance and quality management activities. As a Laboratory Manager and Chief Medical Technologist, I have been directly responsible for the development, maintenance and review of policies and procedures involved in error prevention, identification and remediation. I am an active member of our facility Patient Safety, Provision of Care and Infection Control Functional Management Teams (all 3 of these are mandated by The Joint Commission for all accredited facilities) and as such actively deal with prospective and potential issues such as this. I have lectured on these subjects on many occasions, all over the world.