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

Anne Ford

July 2014—When Rosemary Frederick learned last year that her employer, North Shore-LIJ Health System of New York state, would be switching from the Roche Accu-Chek Inform I point-of-care glucose meter to the Inform II due to a maltose interference issue, she knew she and her colleagues were facing a heck of a lot of work.

“I want you to realize the enormousness of this project,” says Frederick, who is the point-of-care manager for the health system’s core laboratories. “It wasn’t one hospital and 1,500 people. We had to roll out over 1,000 meters, and we had to train over 13,000 people systemwide.”

No 17-hospital, 6,000-bed insti­tution switches devices like that without a headache, but what Frederick and her colleagues got instead felt like a months-long migraine. Instead of the laborious but relatively straightforward conversion it had expected, North Shore-LIJ found itself facing down a massive, many-headed hydra of a project, one whose nature seemed to morph moment by moment.

“This was an ever-changing landscape,” says Jordan Laser, MD. “There was never a day when we thought we had a good understand­ing as to what was expected of us.” Dr. Laser is the health system’s director of near-patient testing, associate medical director of Core Laboratories, medical director of pathology and laboratory medicine at Long Island Jewish Medical Campus, and senior director of cytogenetics and molecular pathology.

What brought about all this confusion? How did Frederick, Dr. Laser, and their team find their way through it? And what effect is it likely to have on patient care at North Shore–LIJ?

North Shore–LIJ had known for some time that it would eventually switch to the Inform II. But the situation began to intensify this year on Jan. 7, when the FDA issued a draft guidance document (“Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use”) announcing new, more restrictive requirements for point-of-care glucose meters. The document proposed specific language to describe clinical situations in which the meters’ performance may not be acceptable, as in: “…FDA recommends statements such as the following: Critically ill patients should not be tested with a glucose meter because results may be inaccurate.”

Dr. Laser didn’t panic. “We recognized it was draft guidance,” he says, “and we thought the document was not really applicable for hospitals and health systems. It sounded like a document that pertained to manufacturers getting FDA clearance on their product.”

Instead, the panic struck after the arrival of a double whammy just a few days later, on Jan. 13. Whammy No. 1: The New York State Department of Health issued a letter saying that because the manufacturers of point-of-care glucose meters have not validated these products on critically ill patients, their use in that patient population is considered off-label and therefore high-complexity under CLIA. “This really shook us,” Dr. Laser says. Among other things, it meant that only staff licensed by the NYS Department of Education would be allowed to perform this testing.

Whammy No. 2: That same day, Roche issued a letter of dis­continuation for the Inform I meter, saying that as of March 31, it would no longer supply test strips for the device. In other words, not only did North Shore-LIJ have to figure out how to implement the Inform II in a way that complied with the state health department’s announcement, but it had to do it fast. As Dr. Laser puts it: “Within two weeks, we went from blissfully using glucometers to ‘Wow. What are we going to do?’”

What they did was get organized. Dr. Laser and Elaine L. Smith, EdD, RN, vice president of system nursing education, assembled a leadership group made up of personnel from the nursing, laboratory, IT, materials management, and procurement departments and representatives from Roche. (Dr. Laser says of the latter: “They were at the table problem-solving and supporting us throughout this process.”)

“We realized this was an opportunity to standardize a process across the system,” Dr. Smith says. “Keeping that as our mindset, we created working groups that looked at developing a policy to guide the performance of the test, the competency issues, and the laboratory-specific components.” The leadership group communicated with all North Shore–LIJ sites that used glucose meters, making them aware of the new regulatory and supply-chain challenges.

The first question on everyone’s mind: Did the health system have enough Inform I strips on hand to tide it over until it could complete the conversion to Inform II? “We were originally scheduled to convert by the end of August,” Dr. Laser says. “But after the discontinuation letter from Roche, clearly that was not going to be an option. So we had to figure out how many Inform I strips we had, how many we would need, then reach out to all of the sites, and create a new schedule.” With so many sites to convert, that schedule was a multifaceted, ever-moving target. “We had many balls in the air, more than we normally would with such a project. Time was not on our side.”

Nor, at least at first, was the institutional grapevine. “You can imagine that in a system this size, we were hearing that some mis­information was out there at a local level,” Dr. Smith says. “People were getting conflicting answers. So Jordan [Dr. Laser] and I decided we needed to establish ourselves as the people from whom the most up-to-date information was coming, so we could standardize the accuracy of the information being provided.”

To that end, the two began sending out weekly updates on the project’s progress. “We presented it as a united front,” Dr. Laser says. “This weekly communication was always co-signed by me and Elaine Smith. It demonstrated that the laboratory and nursing were working together, and that it wasn’t an issue of ‘The lab is making us do this,’ or ‘Nursing is making us do this.’ We were doing this together.”

In February and March, two pieces of good news landed in their laps. First, the FDA and the NYSDOH said that for validation guidance for point-of-care glucose testing, laboratories could refer not to the FDA’s January draft document, but to the less stringent CLSI document “Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities,” or POCT12-A3.

Second, in a meeting hosted by the Greater New York Hospital Association, NYSDOH repre­sentatives announced it was up to each institution to define the term “critically ill” for itself. Dr. Laser calls the announcement “a huge win.”

“Our strategy was to define ‘critically ill’ geographically,” he says. “Clearly anything that had the word ‘critical’ in it was a pretty easy sell, so the ICU, the NICU, the PICU.” In those areas of any North Shore–LIJ site, use of the Inform II would be considered off-label.

But not in emergency departments. “We chose to consider that use on-label for two reasons,” Dr. Laser explains. “First, the majority of patients in an emergency department are not critically ill by any definition. Second, from a quality and operational standpoint, it would be difficult to have two parallel processes in a given unit. Imagine that if a patient is considered critically ill by some definition, the glucometer can be used only by a nurse, and if the patient in the bed next to them is not critically ill, nonlicensed personnel can perform it. To set up that process, bring it into operation, monitor it, track it, and enforce it, it would be extraordinarily challenging to provide a high-quality environment.”

On a side note, North Shore–LIJ administrative director of near-patient testing Jean Thompson found that the health system’s physicians firmly supported the use of glucose meters in critical-care units. “Our clinicians really felt that using these meters in these units was a standard of care, and that it would be very difficult to either use a different type of instrument or to have the laboratory perform testing for glucose as often as is required,” she says. “Sometimes with the glucose meters, they perform testing numerous times daily, especially prior to the patients’ meals.” For patients on insulin protocols, glucose testing may be performed hourly. “It would really cause a hardship for the laboratory,” Thompson says. “The clinicians strongly felt there really was no other option [than to use the handheld meters in these areas].”

As for overseeing the education and competency components of the Inform II rollout, that task fell to Frederick and to Jaclyn Schindler, the health system’s assistant director of corporate nursing education. The two had begun creating the necessary training materials in October 2013, long before the FDA and NYSDOH made their announcements.

“Everything was rolling out really nicely until the challenging regulation in January describing how the meters can be used,” Frederick says. “It wasn’t 100 percent ‘back to the drawing board,’ but we had to go back and look at our SOPs and competencies and quizzes and adapt them.” For one thing, she adds, “we had to specifically change the frequency of performing QC in all the different critical care areas.”
“It took over six months from beginning to end to really roll this out,” she continues. “Even as we went from one site to the next one, we continuously tried to improve the process.” Schindler says they took the opportunity to incorporate feedback from all users.

“When Rosemary and I en­countered rationales for policy and practice as being required by the lab, or standard for nursing, we focused on what would provide practical and safe care to the patient whether cared for by lab personnel or nursing personnel. In this way, we developed a collaborative relationship, understanding that our respective practices need not contradict or supersede each other.”