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Analyzing data in the laboratory is a meticulous process and involves carefully-trained professionals. Even so, errors can occur during sample handling, and litigation may follow, putting the lab professional and the lab manager in serious hot water.
Kathleen Sazama, MD, medical officer for LifeSouth Community Blood Centers, says that the most common lab error is failure to acquire and/or maintain positive patient identification. This part of the lab process can occur during the sample collection or at another point of the workflow that ends with a laboratory result. A pre-analytic error might be drawing a sample from the wrong patient; an analytical error could be testing the wrong sample.
Dr. Sazama notes if a patient hasn't been properly identified at the time the sample was obtained, the results should not be reported. These are samples such as blood, urine and tissue. Dr. Sazama adds the same problems could exist if the sample isn't identified at all.
Dr. Sazama points out that rarely are there performance mistakes in the lab, thanks to different safeguards that are in place such as proficiency testing, laboratory accreditation, mandatory continuing education, licensure and other such practices. She did advise, however, that there is always a chance that any lab can have a "miscreant" who will deliberately falsify testing information.
Legal Implications
Legal ramifications of different lab errors can run higher or lower depending on the consequences of the misidentification, according to Dr. Sazama. The patient can sometimes fail to receive the appropriate intervention or receive the wrong medication because of a mistake from the lab. In this type of unfortunate event, Dr. Sazama states, the lab staff may be held liable. Litigation can occur and individual lab technicians can be held liable for harm if the patient can show that the lab professional acted negligently.
In a piece for the American Society for Clinical Pathology (ASCP), Dr. Sazama notes that errors that that lead to adverse consequences for patients happen when a lab professional fails to adhere to "that which is acceptable." She advises that labs are more likely to be held liable for regulatory violations than for negligence such as medical malpractice or other legal reasons.
Further, Dr. Sazama states that it's not the fact that the errors will happen that dictate whether legal action will be taken. It is how the laboratory responds to these errors that can avoid a potential lawsuit. The lab should have and adhere "scrupulously" to rules that protect the patient, Dr. Sazama tells ADVANCE. Focused efforts to ensure that the right sample is taken from the right patient, appropriately labeled and timely delivered for analysis, will likely eliminate more than half of the errors occurring in laboratories.
On the Safe Side
The United States government has provided useful guidance and a recommendation for creating a compliance officer to ensure that CLIA and Medicare regulations are met. Dr. Sazama says there have been well-publicized instances in which the laboratory's practices have been demonstrated to violate CLIA regulations. Such cases have frequently arisen due to "whistleblower" suits, which typically occur when a laboratory deliberately or inadvertently puts in place practices that are medically unnecessary that result in excess payments from patients, insurers and/or practices that are specifically intended for financial gain rather than to support medical decision making.
Dr. Sazama also advises that the best defense against a lawsuit is demonstration of knowledge of the standards and regulations and compliance with them, as documented in routine reviews, audits, external assessments and regular reports. She explains that a human will err up to 1 in 350 times when performing the same task repeatedly. She also advised that it is not the fact that errors will happen that dictates whether legal action will take place; rather, it is how the lab responds to these errors that will influence both whether a suit will be filed and, in many instances, what the outcome will be.
Steve Eichmann is a freelance writer based in Glenn Mills, PA.
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