Specimen labeling still a major risk for ID errors and huge liability

Technology, focus on human factors can help

Patient identification errors continue to plague the healthcare industry despite years of efforts to eradicate this potentially disastrous problem. Understanding why patients and specimens are misidentified is key to reducing or eliminating errors, and risk managers can make progress by focusing on the human behavioral components of healthcare work.

Specimen labeling is one of the biggest risks for misidentification, with errors leading to delayed or wrong diagnoses, missed or incorrect treatments, blood transfusion errors, and additional laboratory testing. Literature reviews have identified specimen labeling error rates of 0.1% to 6.5%.

Recognizing this risk, The Joint Commission has implemented two hospital National Patient Safety Goals (NPSGs) for 2011 related to patient identification: NPSG.01.01.01 is "Use at least two ways to identify patients. For example, use the patient's name and date of birth. This is done to make sure that each patient gets the correct medicine and treatment." NPSG.01.03.01 is "Make sure that the correct patient gets the correct blood when they get a blood transfusion." The College of American Pathologists also includes patient and sample identification as one of its five top patient safety goals.

Phlebotomy is one of the fields most focused on labeling errors, and many health care providers take a punitive approach to errors, says Fran Charney, RN, MSHA, CPHRM, CPHQ, CPSO, FASHRM, director of educational programs with the Pennsylvania Patient Safety Authority (PPSA) in Harrisburg, PA. Before joining the PPSA, Charney was a risk manager and patient safety officer.

"Many organizations talk about taking a systems approach, but when it comes to phlebotomy, they have a 'three strikes and you're out' approach," Charney says. "Then we ask if the problem went away when they fired that phlebotomist, and of course they say it didn't."

Charney encourages risk managers to look at specimen labeling errors as a system problem, treating them much like any adverse event and asking not just who made the error, but why that error was possible and how it could be prevented. "A lot of times we don't dig deep enough to see why the error occurred," she says. "We just say Sally the phlebotomist made a mistake and put that in her record. If she forgot to double check the ID because the phone was ringing off the hook, why was that? Because you were short staffed? And that was because you had a flu epidemic?"

Understanding human factors is a big part of reducing identification errors, says Megan Shetterly, RN, MS, patient safety liaison for the Northeast Region of the PPSA. When investigating an error, ask not only what happened and how, but why, she says. "We need to ask them why several times, to drill down and find out what led to this error, not the simple mechanics of how it happened," Shetterly says. "The nurse or phlebotomist might say she grabbed the wrong label, but you can't leave it at that. Why did she take the wrong label? What was going on, and what about your procedures made it possible for her to do that?"

Common causes are disruptions, interruptions, and increased work load, Shetterly says. The most often cited explanation is that the employee was not following procedures, but the next question must be why, she says. The answer also involves the workload. "They often say that to get the workload done, they don't have time to do the A, B, C, and D that are spelled out in the policies and procedures," Charney says. "So they decide C isn't really necessary, and they do a workaround. That sounds like an individual decision, but we put them in an unsafe place where that looks like the only way out."

Patients should be involved with confirming their identification as much as possible, Charney says. Too often, she says, the caregiver enters the room and asks "Are you Mr. John Smith?" or says "You're Mr. Smith, right?" and the patient nods or mumbles a response. That is not an acceptable interaction, Charney says. "A much better way is to say, 'Can you state your name for me?'" she says. "That is a very different question, and you get a much better response. Sometimes you can go on and ask the patient to spell the last name. That kind of active participation by the patient is crucial."

Bar coding technology can significantly reduce patient identification errors but it is not a panacea, Shetterly says. She notes that the Centers for Disease Control and Prevention has recognized bar coding as a best practice for specimen collection. "The technology is very good, but it's only as good as the person using it," Shetterly says. "You still have the human element, so errors can occur. We've seen people printing out labels ahead of time, for instance, which facilitates mixing up the labels."

Are you at risk for being sued?

The malpractice implications of a mislabeled specimen are significant, says Laura A. Dixon, JD, RN, CPHRM, director of the Department of Patient Safety for the Western Region of The Doctors Company, a malpractice insurer in Napa, CA.

A patient might receive care indicated for someone else, while the other patient does not receive needed treatment. "Some of these errors can have long term, lasting physical effects on the patient," Dixon says. "But in addition to the physical problems, the individual also may have emotional trauma. Of the claims we have from identification errors, the majority are about emotional trauma rather than physical injury."

The typical lawsuit involves a relatively young and healthy individual who underwent an unnecessary procedure and believed for some period that he had cancer or another serious illness, Dixon says. The potential liability will depend on how state law addresses claims of emotional distress, but the payout tends not to be in the millions of dollars, she says.

Delayed diagnosis is a bigger liability risk, Dixon says. A delayed diagnosis of cancer because of a specimen mixup, for instance, could result in a costly malpractice lawsuit, she says.

"Those cases tend to involve real injury and perhaps an impact on long term survivability, so they can be quite costly, both in terms of the payout and the cost to defend them," Dixon says.


Fran Charney, RN, MSHA, CPHRM, CPHQ, CPSO, FASHRM, Director of Educational Programs, Pennsylvania Patient Safety Authority, Harrisburg. Telephone: (717) 346-0469. E-mail: fcharney@state.pa.us.

Laura A. Dixon, JD, RN, CPHRM, Director, Department of Patient Safety, Western Region, The Doctors Company, Napa, CA. Telephone: (800) 421-2368. E-mail: info@thedoctors.com.

Megan Shetterly, RN, MS, Patient Safety Liaison, Northeast Region, Pennsylvania Patient Safety Authority, Harrisburg, PA. Telephone: (717) 346-0469. E-mail: mshetterly@state.pa.us.