In this investigation, Milwaukee Journal Sentinel reporter Ellen Gabler found that laboratories across the nation are not following basic policies and procedures designed to ensure the accuracy of tests results. A secretive system hides mistakes from the public and allows medical laboratories — some among the most well-respected in the nation — to cut costs at the expense of patients.
In the first piece, Gabler focused on clinical laboratories that do our medical tests in doctor’s offices and hospitals. She found that private accrediting organizations policing labs on behalf of the federal government fail to cite serious violations that put patients’ health and lives at risk. Last year, one of those main accreditors missed enough violations to require review by federal regulators. Doctors and patients might never realize there was a mistake with a test result. Even if they do, labs often fight in court to avoid responsibility — or settle the case with strict confidentiality agreements that hide the specifics of how people were harmed and who was responsible.
The accrediting organizations that inspect the majority of major laboratories are allowed to keep their inspection reports private. In fact, federal law requires it in most cases. Gabler found the accrediting groups were missing major violations. The Joint Commission — a nonprofit that has long touted itself as a quality leader with rigorous performance standards — had been quietly flagged by regulators in 2014 for missing too many serious problems that could harm patients. After filing more than three dozen open records requests for documents and data, and reviewing tens of thousands of pages of inspection and regulatory reports, Gabler was able to identify serious problems in labs throughout the country.
Gabler worked with lab and quality control experts to understand the dense inspection reports. She filed additional requests with state and federal regulators to review the limited records that exist on complaints, sanctions, state audits and proficiency testing.
She discovered that even when serious violations are identified, offending labs are rarely sanctioned except in the most extreme cases. In 2013, just 90 sanctions were issued — accounting for not even 1% of the 35,000 labs that do high-level lab testing in the United States. In a second major piece, Gabler revealed a growing category of medical tests that have known quality issues, yet are increasingly used in doctor’s offices, emergency rooms and retail clinics. The tests are considered so foolproof that anyone is allowed to do them. But studies have shown they are often done incorrectly, which can lead to serious consequences. These kinds of tests are known as “waived tests” because they are essentially waived from regulation.
The percentage of facilities dedicated to waived tests has gone from 20% in 1992 to more than 70% of the country’s 250,000 labs today. Medical facilities are increasingly using the tests because they are quick, convenient and inexpensive; the lack of oversight and ability to hire untrained workers adds to their appeal. By law, facilities licensed to do the tests cannot be routinely inspected by government regulators. A two-year license costs $150. The lab director and testing personnel don’t need any formal education or training. Anyone — from a nurse practitioner to a receptionist to a drug store clerk — can do the tests.