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‘We wanted to be the best we could possibly be’: CAP ISO 15189-accredited labs on the difference it makes

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Quality systems manager Ruan Varney knows exactly how it looks. “We started with 125 subclassification codes in the first year and consistently grew to over 300 in 2018. Each manager is equipped with a monthly summary chart of their most frequent deviations to engage their staff as well as their external supplier for improvement opportunities.” They recently began an improvement process with the emergency department in hopes of reducing the number of clinical blood samples submitted to the laboratory that are categorized as “quantity not sufficient” and “clotted” by sharing data from the deviation management system.

“The latest enhancement in the deviation management system is to be able to narrow down to the phlebotomist who drew that specimen to understand the underlying root causes for improvements. This is huge for us and very exciting,” Varney says, explaining that the hope is to expand the pilot to other areas of the hospital. “We monitor the ongoing progress of this pilot with a daily metric board shared with the ED. While reducing the risk to patients, we have also earned a higher level of respect from our customers.”

Dr. Zarbo points to document control as another example of an area in which 15189 has made a big difference. “The College required us to have document control, and that was usually a paper-based system,” he says. “But if you’re going to do things so that all your policies and procedures are standardized across all laboratories in a system of almost 1,000 people, you have to be electronic. We realized that unless we had an electronic document system we could not pursue ISO.”

Since implementing that electronic document control as part of the 15189 accreditation requirements, the laboratory now has more than 10,000 documents in its EDS. All of the laboratory manuals are kept on the lab’s intranet, so that any employee anywhere in the system can consult them or print them out at any time. “This is a direct result of our quest for ISO,” Dr. Zarbo says.

One undertaking that was completely new to the laboratory at the time it began the 15189 accreditation process was the internal audits requirement. “The goal is to find things that people who do the work take for granted and don’t see as deficiencies,” he explains. “So we do this auditor work throughout the year of all laboratories in the system. And what has been the outcome? Almost every single laboratory under our direction has had a 90 percent decrease in Laboratory Accreditation Program deficiencies since we began this process.”

Varney says the laboratory has also seen a vast improvement in turnaround times since becoming 15189 accredited. “Previously, a prostate resection, for example, would have taken up to seven days to result; now it takes two days from receipt in the laboratory,” she says. “We also receive breast biopsy specimens the same day or next morning from our affiliate hospitals. That very same day the breast specimens are accessioned and processed and glass slides are delivered to the pathologists.” The significantly shorter turnaround times are monitored at each stage with a daily metric board. “We know when it was packaged for delivery from the site, when it was taken off the delivery log, when it was grossed and delivered to the pathologist. We have our clinicians complimenting us: ‘I don’t know what you guys do, but it is amazing—we have our results, we can expedite the patient appointments, and get them to the clinic faster for their management.’”

‘Almost every single
laboratory under our
direction has had a
90 percent decrease in
Laboratory Accreditation
Program deficiencies
since we began this process.’ — Richard Zarbo, MD

There are improvements in clinical pathology as well. Before 15189, it wasn’t unusual for a critical value phone call to be made to a physician at 2 AM regarding a specimen from a patient who had been seen at 10 AM that day. “Because of multiple continuous process improvements, we now call the clinician within about four hours of specimen collection,” Varney says. “When the call is made earlier in the same day, the clinician has a chance to attend to the patient earlier rather than our waking up the clinician in the middle of the night and the patient being sent to the ER.”

The 15189 standard requires management review. “We actually had a number of consultants with us years ago,” Dr. Zarbo says. “Their advice was to focus on only a certain aspect of management and just do a deep dive on that. We thought: That’s not really good enough for us as a system laboratory, so we’re going to do our own reflective self-inspection of every single management system that we have and whether it delivers on the goal of quality and human engagement, year after year after year.” It’s this approach, he says, that has led to a 35 percent drop in the rate of most common deficiencies.

To those intimidated by the 15189 accreditation process, Dr. Zarbo says, “This is hard work. But eventually, when it becomes the only way you work, it’s no longer hard; it just becomes the manner in which you work.” And to those who don’t see why such a lengthy and rigorous accreditation is worth it, he quotes the late quality management expert W. Edwards Deming: “Learning is not compulsory, and neither is survival.”

“This is really a survival mode,” he argues. “There’s going to be a lot of change going forward in health care, and not everybody’s going to be on the playing field. There’s going to be a lot of consolidation going forward, so this [15189 accreditation] is also a survival strategy, frankly. This is a competitive business strategy.”

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