The nature of being human may be the clinical laboratory's Achilles heel when it comes to ensuring patient safety. No matter what technology assists in the steps from specimen collection to reporting, the accuracy of a result still relies at some point on the vigilance of an employee to adhere to the highest possible standards.
"You shoot for zero errors," said Tim Hamill, MD, director of Clinical Laboratories, professor and vice chair, Department of Laboratory Medicine and director, Clinical Laboratories at Parnassus and China Basin Laboratory Medicine, University of California San Francisco (UCSF). "And the more robust the process you can make, the smaller that number gets, but I haven't seen any process that's 100 percent simply because for any process you put out there, there's someone who will make a workaround and defeat what you're trying to do."
James S. Hernandez, MD, assistant professor of Laboratory Medicine and Pathology, division of Laboratory Medicine, College of Medicine, Mayo Clinic, Scottsdale, AZ, encourages his lab staff to broaden the idea of a lab from a "zone of control" where they focus solely on specimens in their care to a "zone of influence" where they consider the pre-analytical realm--in the emergency department (ED), operating room (OR), clinic, etc.--as well as the post-analytical process.
"We no longer think of ourselves as doing a task, and if it's out of sight, out of mind," Dr. Hernandez said. "We start to think of the entire system."
Additionally, Dr. Hernandez stresses the need for lab managers and administrators to create a culture in which it is safe for bench technologists, in particular, to raise concerns about problems they observe or are aware of in the lab.
He said the emphasis needs to move from blame for minor slips or lapses to problem solving (although reckless/dangerous mistakes may require more serious personnel repercussions).
"If a supervisor or manager says, 'Well, I've had no errors in my area for 4 years,' I would be suspicious because there's probably underreporting," Dr. Hernandez said. "We have to reverse this so people feel free to bring up all issues of concern."
From the moment of specimen collection, barcoding technology, wristbands and laboratory information system (LIS) interconnectivity help keep patients safe.
At UCSF, patients have a wristband bar coded with their medical record numbers that helps when, for example, a nurse is about to perform a glucose test. The nurse scans the patient's bar code to verify positive patient identification in the LIS so she can proceed with collection.
|PATIENT ID: Handheld scanners can help phlebotomists confirm patient identification to ensure blood samples come from the correct patient every time. ADVANCE photo
The technology also helps in phlebotomy at UCSF. A handheld electronic phlebotomy solution from Cardinal Health, Dublin, OH, called CareFusion interfaces with the LIS so the phlebotomist, after arriving in a patient room with a pre-entered LIS order, can match information between the patient's bar code and order in the handheld device before performing a draw. The device is attached to a printer so labels are printed bedside.
Though preprinting labels may seem more efficient for workflow, the practice is potentially dangerous, said Enrique Terrazas, MD, associate clinical professor, Laboratory Medicine, chief of laboratory information systems, Department of Pathology and Laboratory Medicine, UCSF.
A nurse who preprints labels may keep them in her pocket and mislabel a requisition. Loose labels at the bedside can cause confusion and errors if they are not removed before a new patient arrives.
Dr. Terrazas once had a supposedly correct OR specimen sent to the blood gas lab on a patient who had been discharged days earlier. Ramifications for mislabeling can be huge.
"If it's an OR case and [the patient] gets a low hemoglobin result, it may lead to an unnecessary transfusion," Dr. Terrazas said. "If it's a high glucose, it may result in administration of insulin to someone whose glucose value is normal, resulting in hypoglycemia. On the other hand, if the glucose value comes back normal, and for that patient it's actually high, it could lead to not giving the correct insulin dose at that time. For therapeutic drug monitoring, you could give a wrong dose to try to correct for a high or low value."
In addition to assisting the human element of patient identification verification, bar codes (of patient samples) are read by lab automation equipment to query the LIS and determine what test is needed. Further out, biometric retinal scanning for patient identification and radiofrequency identification for specimen tracking may also help make patients safer.
A variety of government agencies, national associations and non-profit organizations have taken up the issue of advancing patient safety. Everyone from the Joint Commission and College of American Pathologists to the National Institutes of Health and World Health Organization provide guidance on the issue.
Dr. Hernandez turns first to the Joint Commission Web site when an error is discovered. "We have to understand root cause analysis, and a lot of those sites talk about what those tools are and how to use the tools," he said.
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