A POC blood glucose program turned upside down: How a 17-hospital system survived a rollout and new requirements

Part of their task entailed determining whether to require trainees to successfully perform a quality check on the device, an actual patient test, or both. “We felt as a team that we would be meeting requirements by just doing a quality check, and yes, that would make it easier to achieve compliance,” Schindler says. “But when you think about what’s the right thing to do, we really wanted to have a brand-new user show they can do both a quality check and a patient test, so that we’ve seen them use the machine in two modes and they’ve really gotten a handle on it.”

That said, it was decided to use only simulated fingersticks during training. “It was not always feasible to do training in a clinical area, so we came up with a mechanism with which we were all comfortable,” she says. “We have them take out the lancet, show us how they would use it, activate it into the air or into a piece of material, show us where on the finger they’re going to stick, wipe it with alcohol, let it dry. Just at the point where they’re going to take the blood, they use simulated blood.”

Barbara Callahan, too, was involved in the education and competency structure. She is senior administrative director for patient care services, nursing education, professional development, research, and nurse practitioners at Long Island Jewish Medical Center (LIJMC). “Initially, the vendors suggested point-of-care education on the clinical units, which we knew was not going to work because you don’t have the complete attention of the nursing staff.” The department of nursing education decided to use a two-tier education approach, with the first part consisting of completing an educational module and a quiz and a required score of 100 percent. Tier-one education has to be completed to participate in the second tier of education. “This tier encompassed attendance at a hands-on skills class facilitated by the Roche education team and coordinated by nursing education. We had a nurse educator participate in every class for education support and to validate the competency of every attendee,” Callahan says.

To educate more than 2,000 nursing employees at LIJMC, the classes had to be held several times a day over a two-and-a-half-week period as well as during the off shifts. While Callahan says the process worked well, she adds that in hindsight, it might have been better to use a single-tier approach, in which the module, the quiz, and the attainment of the skill set were all completed in one session, to avoid the educational challenges involved in making sure that all enrolled in a class had completed the module and received a perfect score on the quiz.

For many nights before her site rolled out the Inform II in early May, Cathy Drechsel, point-of-care supervisor for LIJMC, found herself lying awake, “having nightmares of what this was going to be like.” But when implementation got underway, she discovered that the most troublesome things were those she hadn’t dreamed of at all, such as how to recycle the five-foot mounds of discarded wires from the old meters (“People were taking pictures of them”) and how to rotate the new meters on their bases so they all stayed charged until implementation.

And then there’s the label issue. The Inform II features “such a tiny little bottle” of control solution, Drechsel says with exasperation. “It may seem silly, but you need to put on this tiny little bottle the open date and the expiration date so we meet regulatory requirements. Well, now we have to design a label that’s small enough to fit, that’s not going to cover the lot number or the manufacturer’s expiration date, and that’s not shiny, so when someone writes the open date, it’s not going to smear. The thing I lost no sleep over, that’s the hardest thing.”

At the same time, she benefited from the experiences of colleagues at sites that went live before hers. At one site, for example, “they realized they had a port speed issue when they went to plug all their bases in,” Drechsel says. “Nothing was downloading, and they realized that the port speed was set to a speed that didn’t work for the Inform II bases. So while that site’s point-of-care supervisor had a crazy time that day, she passed that information on to the rest of us, so I was able to get IT to re-set ours ahead of time.” It’s that kind of collaboration that leads her to conclude: “I can’t emphasize enough how all this is such a team effort. It really, really is.”

“I can’t even begin to explain how everyone chipped in here,” Dr. Laser agrees. That team spirit became especially crucial when a potentially catastrophic obstacle arose: At one point in the Inform II implementation, Roche announced a weeks-long manufacturing shortage. “They weren’t in short supply. There was no supply,” he says. “We had to delay our site conversions, and while this wouldn’t normally have been so challenging, the shortage occurred after March 31, when we were no longer able to purchase additional Inform I strips. We were very nervous we were going to run out of Inform I strips while the Inform II couldn’t be acquired.”

In the core lab, Frederick found herself hanging on to Inform I strips as if they were silk stockings in post-war London. “I became the hub of hoarding strips,” she says. “It was ridiculous. You have no idea where we had them hidden. As a site rolled out the Inform II, I said, ‘Give me all your leftover Inform I strips,’ and then we held on to everybody’s supplies so we could get everybody rolled out.”

In another effort to stave off the threat of a strip shortage, Inform II implementation at LIJMC was moved forward by one week. “It may not sound like much time, but that one week allowed us to save an additional 15,000 test strips to add to our stock­pile and cover us until the Inform II meters were available,” Dr. Laser says.

Meanwhile, he and the rest of the implementation team also had to design and carry out a systemwide validation plan for use of the Inform II in the critically ill. “Because everyone is in uncharted territory, our goal here was to make our validation plan bulletproof from a regulatory perspective,” Dr. Laser says. That’s why, despite the FDA and the NYSDOH statements that laboratories can use CLSI document POCT12-A3 for validation guidance, “we did take pieces from the [more stringent] FDA draft guidance.”

For example, whereas POCT12-A3 requires only 100 patient samples for validation, the FDA draft guidance requires 350. “Because we are a large health system, we will actually reach the numbers that were suggested by the FDA,” Dr. Laser says. “In fact, I think we’re going to end up with data from nearly 600 patients.”

They’re collecting additional variables, too, he says. “For example, we’re going to collect any hematocrit data from the past 24 hours, because we know hematocrit is one of the interfering substances or limitations to the assay. In the POCT12-A3 document, there’s really no mention of interfering substances. We’re also collecting all medications that the patient is on at the time of the testing.”

Another item of interest: “The POCT12-A3 document says, Perform a venous draw, and from that tube analyze the blood on both the glucometer and the lab analyzer. With this data you can then compare the results to see if they’re concordant,” he says. “Now that really isn’t such a great experiment for critically ill patients, because the concern is that the glucose level in the fingerstick may not represent the glucose level in a major vessel. Although it’s in neither the FDA nor the POCT12-A3 document, the New York State Health Department, appropriately so, has made it clear that they expect hospitals to compare the glucose fingerstick to a venous lab analyzer.” Venous blood to venous blood is not acceptable, he says. “Obviously, our current validation plan increases the variation in the system that we’re testing, and we’ll see if it actually meets the acceptability criteria.”

Donna Sidoti, point-of-care supervisor for North Shore–LIJ’s Huntington Hospital, goes into more detail. “Our validation study design uses the CLSI POCT12-A3 standard, which says that 95 percent of results must be plus or minus 12.5 percent for glucose results greater than or equal to 100 mg/dL, and plus or minus 12 percent for glucose less than 100 mg/dL. Additionally, 98 percent of the results must be plus or minus 20 percent for glucose results greater than or equal to 75 mg/dL, and plus or minus 15 mg/dL for glucoses less than 75 mg/dL.

“These are the strictest criteria set forth so far for glucose meters that we have ever encountered,” Sidoti continues. “Our data collection is ongoing, and we hope to finish it soon. We feel really confident that we will be able to show validity in what we have chosen to do, and also that we will be able to incite confidence in the user that we’re providing a really well-evaluated and accurate method for use with their patients.”

In May, North Shore–LIJ had the chance to obtain feedback on this validation plan when one of its hospitals had an unannounced NYSDOH inspection. “What we were told is that if we did not have the glucose meters validated for us in the critical-care units, we would receive a deficiency and have to submit a plan of corrective action,” says Thompson, the administrative director of near-patient testing. “This facility was going to be cited, but then we had a collaborative and collegial conversation with the inspectors and representation from the senior leadership at NYSDOH and told them about our plan for our validation study, and our preliminary data, and they accepted it. They were very impressed at the comprehensiveness of our plan.”

To Dr. Laser, the NYSDOH’s positive reaction was an affirmation of everything that North Shore–LIJ had worked so hard to accomplish with its rollout of the Inform II. “We were trying to make decisions on a system level as best we could, given the information that was available in the changing landscape,” he says. “We thought we were doing a good job, but we weren’t sure until we were inspected. It turned out we were.”

That’s not to say, of course, that the team wouldn’t do a few things differently, given the chance to go back and start over. “I do think there was a bit of a bump at the very beginning of the project,” says Dr. Smith, VP of nursing education. “There had been discussions at the laboratory level regarding the maltose interference issue and the need to do a meter conversion relatively quickly, but the communication at that point wasn’t shared with the nurse executive leadership group, and so plans were being put into place to operationalize this initiative without having all the stakeholders around the table. That was an early lesson. I think we probably lost a few months, but we learned quickly, we had a smooth rollout, and we’ve now developed these much stronger collaborative bonds.”

Dr. Smith isn’t the only one who sees a stronger bond between nursing and the laboratory since the project began. “This is only the beginning of the wonderful relationship” between the two disciplines at North Shore–LIJ, says Hannah Poczter, MPH (DLM), assistant vice president of laboratory services. “Laboratories many times are not recognized for all the work they are doing in patient care. By partnering with nursing, the perception of the laboratory has totally changed.”

Meanwhile, POC supervisor Sidoti would like to see bidirectional connectivity added to the point-of-care glucose testing process. “We need bidirectional connectivity to really serve our patient population well,” she says. “Right now, it’s all manual data entry into an electronic medical record. The technology is there for a bidirectional interface. We have the RALS data-management system, and we have wireless glucose meters.” Connectivity is to be the next phase of the project. “Wireless connectivity is great,” she says, “but we need the bi­directional interface to fully appreciate the technology available. So I would like to see more efforts to get that piece of it in place.”

For her part, Frederick can’t think of anything she would change in the rollout process (except, maybe, finding a few more deep, dark hiding places for all those test strips). “I think we had a good grip on the project from the very beginning,” she says with satisfaction. “The issues that came up were unforeseen. As with all large interdisciplinary projects, you have to prepare for the worst and adjust thoughtfully to all unexpected challenges.”

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Anne Ford is a writer in Evanston, Ill.