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Pressing questions in POC glucose testing

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Kevin B. O’Reilly

April 2015—Sometimes major changes to a health care organization’s point-of-care testing system come from powerful regulatory agencies in Washington, DC. Or they may arise when a child with diabetes objects to frequent venipuncture. In either kind of case, experts say, pathologists and laboratory professionals must form strong relationships with clinicians and build structural foundations to help them meet these and other demands.

Most pressing is the challenge emanating from the nation’s capital. After years of building concerns about the use of blood glucose monitoring systems among critically ill patients, in January 2014 the FDA issued draft guidance on point-of-care glucose meters that calls on device makers to submit data on how the meters perform in different patient populations.

“If you intend to make claims for use of your meter in populations that are particularly vulnerable to potential interferences, you should include patients in surgical and medical intensive care units,” the guidance said. “To collect performance data in such populations, each study should include at least 50 patient samples from the surgical ICU and 50 patient samples from the medical ICU.”

The draft guidance, available at http://j.mp/fdabgms, has drawn dozens of comments—mostly negative—from physician organizations and other stakeholders concerned about its potential impact. Among those objecting is the CAP.

In an April 16, 2014 letter, CAP president Gene N. Herbek, MD, wrote, “First, we believe that the term ‘critically ill’ is too vague and should be avoided. We think it is more appropriate, and more scientifically valid, to focus on the specific limitations cited by the manufacturers and the literature, as specific situations in which the meters should not be used for capillary samples, including, among others, severe hypotension, dehydration, shock, hyperglycemic-hyperosmolar state. We agree with, and strongly support, the specific exclusion of blood glucose monitoring devices, under any and all circumstances, for so-called tight glycemic control.”

“The second issue,” Dr. Herbek added, “is the implication of the FDA draft document on the manufacturers’ current intended use package inserts, in that it could result in the immediate removal of BGM devices from acute-care situations. Removing these devices from a variety of hospital settings … will compromise some types of care because of the time delays associated with getting results from the central laboratory.”

The FDA has not yet taken action to finalize or otherwise alter its draft guidance.

The agency did issue its first—and at this article’s deadline the only—nod to a glucose meter for use among critically ill patients in September 2014, giving the OK to Nova Biomedical’s StatStrip Glucose Hospital Meter System. The clearance is valid only when venous, arterial, and neonatal arterial and heelstick whole blood specimens are used.

In his letter, Dr. Herbek noted how the FDA’s proposed move to tighten requirements for glucose meters could potentially compromise care. The Centers for Medicare and Medicaid Services then appeared to put flesh on the bones of that worry in November 2014.

The agency’s Survey and Certification Group issued a memo to state survey directors warning that using a test outside the FDA’s approved or cleared “intended use, limitations or precautions, as indicated in the manufacturer’s instructions, is considered ‘off-label use.’” That applies, the CMS said, “whether the test is waived or non-waived and it means that the test is considered modified and therefore defaults to a high-complexity test under the Clinical Laboratory Improvement Amendments regulations. This will require all laboratories using the device for an ‘off-label use’ to meet all applicable CLIA high-complexity requirements.”

The agency also instructed surveyors to document off-label use when found, and to issue a written statement of deficiencies that would give cited hospitals no more than a year to come into compliance. That would entail establishing the performance characteristics and meeting the testing personnel requirements to continue using the glucose meter off label. Alternatively, health care organizations could switch to Nova’s glucose meter or another POC device FDA-approved for CLIA-waived or moderate-complexity testing in critical-care settings, such as Abbott’s i-STAT or Abaxis’ Piccolo Xpress panel tests. Laboratory professionals can search the FDA’s website for moderately complex testing options at http://j.mp/modcomplex.

Dr. Perry

For now, hospitals and labs may have room to breathe, says Deborah A. Perry, MD, chair of the CAP’s Point of Care Testing Committee. She is a pathologist at Methodist Hospital and Children’s Hospital and Medical Center in Omaha. As a result of pressure from stakeholders, including the CAP, the CMS in March temporarily withdrew its Survey and Certification memo and reissued it as a draft (http://j.mp/cmsbgm_memo), providing an opportunity for comment. The document clarifies that bedside glucose devices can be used, but they must be validated as a high-complexity test if used in situations not specified in the manufacturer’s package insert and thereby regarded as off-label testing.

“The CAP is reviewing the draft and will comment as it continues to work with members and other stakeholders on a rational solution,” Dr. Perry says.

The CMS proposal on glucose meters would pose a huge change to current practice, said Sharon M. Geaghan, MD, a member of the CAP’s POC Testing Committee, former director of point-of-care testing at Lucile Packard Children’s Hospital Stanford, and associate professor of pathology at Stanford University School of Medicine.

“For the vast majority of us, we’re on a sinking ship without these devices.… Institutions must either cease point-of-care glucose testing in critical care areas, according to the FDA and CMS, or demonstrate to inspectors a robust performance evaluation in the intended population,” she said at a CAP ’14 session, “How to Surf the Wave of Point-of-Care Testing Technologies: Strategies for Establishing and Maintaining a Robust Quality System.”

“This has really shaken us all in the industry—the vendors and health care professionals,” she added.

“However, the FDA’s oversight of off-label use is an important protection for patients,” she tells CAP TODAY.
Dr. Perry says the regulatory direction outlined in the November 2014 CMS memo directly affects the clinical laboratory in two ways.

“First, use of a blood glucose meter not according to manufacturer’s guidelines requires that the laboratory perform a validation study on non-waived blood glucose meters. And second, the test complexity changes and thereby who can perform the test changes accordingly,” Dr. Perry says.

“These regulations have led health care facilities to review their current bedside glucose meters, their corresponding package insert and limitations, their current facility use of blood glucose monitors, and revise practices accordingly,” she tells CAP TODAY. “One of the biggest challenges to many facilities has been defining the ‘critically ill’ population, with the second challenge having the appropriately trained personnel available to perform the blood glucose monitoring.”

Washington’s attempt to give health care organizations wiggle room in how they define what constitutes a critically ill patient for the purposes of glucose meter use is more of a headache than a help, says David S. Bosler, MD. He also is a member of the POC Testing Committee and is the former medical director of POC testing at Cleveland Clinic.

“What’s happened here is that by just saying ‘critically ill patients’ and not providing any definition of what’s included in that, the FDA and CMS have left open to interpretation how those patient populations will be defined in a health system,” he says. “It could be someone who presents to an emergency room. It could be someone who’s in a code situation who needs advanced care and life support, who’s found pulseless—or it could exclude those things.”

“The more important question is not how you define critically ill, but how you define critical illness for the implementation of glucose testing,” Dr. Bosler says. “Probably the best thing to do is to understand the limitations and define protocols for those limitations, rather than just broadly painting critically ill patients with a big fat brush.”
Dr. Bosler, who now heads Cleveland Clinic’s reference laboratory operations, says there is a danger in applying the critical illness tag too broadly in an effort to comply with Washington’s dictates.

“Lots of laboratories and clinical organizations believe that restricted access to use of glucose meters in these settings will harm patient care,” he says. “The risk is that restricting access does more harm than it does good … potentially delaying diagnosis of hypoglycemia in these patients.”

The FDA and the CMS are not the only ones looking at this thorny question of glucose meter use in critically ill patient populations. The International Federation of Clinical Chemistry and Laboratory Medicine has established a workgroup composed of experts in glucose POC testing and critical care, as well as representatives from POC glucose device makers. The chair of the workgroup, Cynthia Bowman, MD, previously served as chair of the CAP’s POC Testing Committee.

“We know there are a number of technical and operational issues that have been associated with glucose meters,” Dr. Bowman says. “And those issues are potentially more prominent with critical care patients. That’s the very group of patients where you want the most accurate results, and where inaccurate results may have serious consequences. One of our concerns is that, both within the laboratory community and the broader clinical community, there may not be a full appreciation of all the variables or potential errors associated with glucose meters, especially with patients who are in a dynamic clinical state. Some experts believe that glucose meters have too much potential variation and should never be used for these types of patients.”

The IFCC workgroup will advocate a single high performance standard for glucose meters, but address the different ways that users can meet that standard. Dr. Bowman adds that a complete understanding of the issue requires looking beyond the glucose meter itself.

“It’s not just the accuracy of the result, but it’s how the result is used,” she tells CAP TODAY. “So, what is your definition of tight glycemic control, or glycemic control? And, then, what type of insulin-dosing protocol do you use? Those variables may be outside the lab’s control, but they are equally important in terms of what happens to a patient. We need to appreciate that there are variables associated with blood glucose results, but there are also variables associated with how those results will be used.”

Dr. Bowman recently joined Baystate Health System as laboratory medical director at Baystate Wing Hospital in Palmer, Mass., and at Noble Hospital in Westfield, Mass. She says the Baystate point-of-care testing staff is engaging with critical-care sites to survey how critical-care patients are defined, and how glycemic and insulin protocols are being used.

“We have to be engaging in these conversations,” she says. “We need to understand how our clinical peers are using glucose meters, whether they understand the potential limitations in different situations, how frequently they are measuring glucose levels, what glucose targets they use, and how they respond to those targets. If we do not know all this information, we are not working with a complete picture in a coordinated situation.”

Dr. Perry has been involved in the effort at Methodist and Children’s hospitals to respond to the developing situation over blood glucose testing.

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