CERTAINLY HIPAA SEEMS TO BE GETTING LOTS OF ATTENTION by all categories of healthcare providers, including laboratories. But I think the movement to disclose medical errors may eventually prove to be the more serious issue for clinical laboratories and anatomic pathology groups.
Our members and clients know that just last month JCAHO began requiring hospitals to disclose to patients whenever their care did not measure up to standards. Recently, two hospitals disclosed such incidents. In Valhalla, New York, 996-bed Westchester Medical Center released a statement to the press on July 30 taking responsibility for an accident in the hospital which killed a six-year-old boy. Michael Colombini was undergoing an MRI. He was struck in the head by an steel oxygen canister which was pulled toward the 10-ton MRI when it was turned on to start the scan. The oxygen canister, about the size of a fire extinguisher, was not supposed to be in the MRI room.
The next day, on July 31, 172-bed St. Agnes Medical Center in Philadelphia issued a statement to the press acknowledging that laboratory tests supporting coagulation therapy had been miscalculated, leading to the wrong dosages of Coumadin, a blood-thinning drug. The hospital said 932 patients had been affected, and this problem may have contributed to the death of two elderly patients. (See this related article.)
All of us know about lab errors and the ever-present human element. Just a few years ago in Chicago, there was a case where a pathologist lost the specimen before it was evaluated, but concealed the fact and issued a diagnosis anyway. When the real facts were discovered, the referring hospital yanked its business relationship with the clinical lab and there was a major reorganization of the pathology group which had issued the diagnosis.
The movement to openly disclose medical errors is gaining political and cultural support. Labs and pathology groups have different exposure than other categories of providers. All laboratorians know the complexities of performing a lab test. Look at the variables that can affect a test result: specimen collection, transport, in-lab specimen handling and labeling, reagent lot variability, a particular test’s sensitivity and specificity, performance of the instrument, et al. Will the lay public understand all the subtleties of the lab testing process? Certainly not! I think that is why the movement to report medical errors may eventually have a far-reaching impact on the laboratory industry.