March 2010 Clinical Laboratory News: Lessons from the POCT Front

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March 2010: Volume 36, Number 3

Lessons from the POCT Front
How Can Labs Improve Implementation, Tackle Compliance Challenges?
By Genna Rollins

For at least a decade, point-of-care testing (POCT) has been the darling of the medical diagnostics industry, with sustained growth in testing volume and continual technological breakthroughs. The trend shows no sign of abating, as drivers such as the need for hospitals and clinics to better manage capacity and improve care, coupled with further innovations, are making POCT ever more attractive. Yet hospitals and health systems continue to experience challenges in implementing and sustaining POCT programs, at times leaving both laboratorians and clinicians frustrated and wary about the process. The reasons for less-than-satisfactory outcomes are as varied as the programs themselves, but experts cite many factors that can make or break a POCT application.

Several POCT medical directors placed the success of their programs squarely on the backs of point-of-care coordinators (POCCs), who do everything from investigating requests for new services and overseeing POCT implementations to troubleshooting problems and ensuring compliance with regulatory and quality control requirements that end users may view as onerous. “The biggest thing is not software or one machine that can operate better than another. It’s having that person who can make it happen,” explained Kent Lewandrowski, MD, associate chief of pathology and director of clinical services for anatomic and clinical pathology at Massachusetts General Hospital in Boston. “The administrator for our point-of-care program is a very competent, plain-spoken, forceful individual who makes clear what people have to do. She’s very well-organized and respected.”

Investment, Administrative Support Critical

As important as POCCs are, not every institution gives them the tools they need to be successful. “I have talked with so many people, and the ones who are struggling often seem not to have enough financial or staff resources to run good programs,” observed Lou Ann Wyer, MS, MT(ASCP), clinical specialist for point-of-care testing and quality management at Sentara Healthcare in Norfolk, Va. “No point-of-care program can be run easily if it’s not given enough administrative support.” That sentiment was echoed by Deanna Bogner, MS, MT(ASCP), point-of-care testing coordinator for Christus Santa Rosa Health Care in San Antonio. “Many point-of-care coordinators are expected to run the program by themselves, because point-of-care testing is not something some organizations dedicate a lot of resources to until it’s a problem,” she said. Wyer and Bogner are veteran POCCs and both have been recognized by AACC’s Critical and Point of Care Testing Division as Point-of-Care Coordinator of the Year, Wyer in 2001 and Bogner in 2003.

Giving a program just enough to get by on can put POCCs in a tough spot, particularly when they’re new and learning the ropes, according to Bogner. “They’re usually plucked from the main lab and are good at project management in the sense of being told the tests they’ll be doing every day and in managing that process and their time accordingly,” she noted. “But with point of care, they’re placed in a complex process that interfaces across several different areas of the hospital, and they have no idea what to do first.” Appropriate guidance and resources enable them to make the leap out of the lab and become excellent stewards of POCT services. “Just because they’ve only been a bench tech doesn’t mean that’s all they can be,” she added.

Variations on a Theme: The Role of POCT

Institutional philosophies about the role of and oversight process for POCT also are crucial in the ultimate success of any rapid testing application, experts say. NACB Laboratory Management Practice Guidelines on evidence-based practice for POCT recommend using an interdisciplinary committee to manage POCT. However, organizations appear to have quite different approaches to POCT oversight, with some erring on the side of approving new POCT requests, and others having much more structured approaches that are anything but rubber-stamp approvals. The former is a set-up for failure, according to Brad Karon, MD, PhD, director of point-of-care testing at the Mayo Clinic. “When the process by which new tests get approved is vague or ill-defined, there can be a lot of political pressure put on the lab to support all these tests,” he explained. “It becomes a political issue with the end users wanting point-of-care tests because vendors told them how great they were and lab administrators fighting it because of cost or quality concerns.” Karon also is chair of AACC’s Critical and Point-of-Care Testing Division.

In Bogner’s discussions with colleagues across the country, this approach is surprisingly common, with predictable unsatisfactory outcomes. “A doctor goes to administration requesting a certain POC test. Administration goes to the lab director, who tells the point-of-care coordinator to do it. Later, the coordinator comes back and reports that it’s not working, the quality control isn’t being done, etcetera, and by then it’s a big mess because no one asked the tough questions,” she explained.

The bottom line is that a serious evaluation of all proposed POCT applications is crucial, whether it’s accomplished via a formal standing committee or an ad hoc group of key participants. For example, Mayo Clinic’s Priorities Lab Testing Committee reviews POCT requests and oversees existing services. Conversely, Massachusetts General Hospital relies more on lab POCT staff, including the POCCs, reviewing requests with clinical and administrative staff of the service in question. Both Karon and Lewandrowski believe their respective approaches are working well.

Regardless of how the POCT review and approval process is structured, labs should aim to discover the same basic information, in the context of the institution’s view of the role of POCT. At Mayo Clinic, POCT is used to “support rapid decision-making and situations where rapid results lead to either improved outcomes or a more efficient disposition of the patient,” Karon explained. “The key to me is, if all you’re going to do with the test is have the result faster and there’s very little chance that any outcome will change, then the request is unlikely to be approved.”

A prime example of Mayo Clinic’s philosophy in action was the recent approval of a POC lactate test in the emergency department and intensive care units. “It was part of an institutional improvement initiative to recognize sepsis faster. This includes a sepsis response team that intervenes when a patient is suspected of having sepsis, and along with the POC lactate, the team gathers a number of other clinical parameters,” said Karon. “This test was approved because we had external published data that showed this sort of approach worked in other institutions, and the protocol for it made clear that the result would be used in a process that allowed decisions to be made in real time.” 

AACC Resources for Point-of-Care Coordinators

Recognizing the essential role that point-of-care coordinators (POCCs) play in the success of point-of-care testing (POCT) services, AACC’s Critical and Point-of-Care Testing Division has developed numerous resources to support and enhance the skills of POCCs.

In 2002, the Division held the first POCC Forum at AACC’s annual meeting. Over the past 7 years, this popular event has been attended by hundreds of POCCs across the U.S. Each year experts address various topics of importance to POCC practice. Past themes have included POCT in the emergency department, patient safety, and POCT-related quality issues. Division members also are invited to participate in the Division’s online forum, where they can exchange ideas about current practice challenges with colleagues across the country.

Since 2000, the Division has also bestowed a Point of Care Coordinator of the Year award to recognize outstanding achievements in the POCT field. The honorees receive a $500 cash award and travel allowance to attend AACC’s annual meeting, where they are formally recognized.

The Division’s latest offering is the POC Specialist Certificate Program, an eight-part online course designed to prepare POCCs for their critical role in POCT and promote standardized best practices in near-patient testing. The program covers eight areas of POCC practice, including regulations, policies and procedures, connectivity and IT, quality management, administration, instrument selection and validation, education and training, and communication. POCCs who complete the eight modules and pass a multiple choice test are awarded certificates at the AACC annual meeting and also are recognized at regional POC meetings. More than 450 laboratorians have enrolled since the program’s inception in 2008.

In addition to the Division’s formal programs, the 2008 Point of Care Coordinator of the Year, Peggy Mann, MS, MT(ASCP), has established a POCC-to-POCC mentoring program. Mann, who is POC and reference lab coordinator for clinics at the University of Texas Medical Branch in Galveston, has many years’ experience in the field and wanted to help newcomers deal with some of the challenges presented by POCT. The initiative pairs experienced POCCs with newer POCCs to guide them in developing and improving their practice. POCCs interested in this program should contact Peggy Mann.

More information about the CPOCT Division’s activities are available online.

Looking at Central Lab Solutions

Holding the line on POCT implementations that have the potential to cause problems down the road boils down to an open, honest dialogue with the requesting department, according to experts. Several lab directors emphasized the necessity of determining whether the lab can address the end user’s request before implementing a POCT solution. “It’s mainly used to decrease turnaround time, and the usual reason people want point-of-care is when the central lab can’t provide results in a timely manner,” noted Fred Kiechle, MD, PhD, medical director for clinical pathology at Memorial Healthcare System in Hollywood, Fla. “A great example is glucose results for diabetics with ketoacidosis who are on insulin drips. If the nursing unit needs results within the hour to adjust the drip, but we provide the result within an hour-and-a-half, we’re not helping them. So my first question would be, why can’t the central lab solve this problem?”

Often this type of dialogue leaves all parties satisfied with a lab-based, rather than POCT solution. “There were certain technologies where we improved the turnaround time in the central lab to such an extent that the units didn’t want point-of-care because they didn’t want to have to maintain it. If you adopt a point-of-care mentality in the central lab, that may be all that’s needed,” explained Cynthia Bowman MD, medical director of clinical laboratories at Long Island Jewish Medical Center in New Hyde Park, NY. As an example, Bowman’s lab now performs fecal occult blood testing for the emergency department with a 30-minute turnaround time. “That was fine for them. It helps with their workflow and they don’t have to worry about quality control issues,” she added. The central lab also maintains a 5-minute turnaround time for blood gasses to meet ICU needs, and tightened serum creatinine turnarounds to screen patients for kidney injury prior to radiological interventions.

Understanding What’s Really Involved

Very often, the requesting department does not have a good sense of what taking on a POCT application will require, in terms of costs, regulations, training, and quality control concerns, according to experts. Exploring these issues upfront can forestall later problems that frustrate end users and can lead to failures, where either both parties agree a point-of-care application is not working or the lab is forced to pull the service. Bogner has experienced this first hand. During her first 2 years at Christus Santa Rosa Health Care, the number of POCT applications shrank. “We started to pull the manual things like fecal occult blood testing that are so difficult to keep track of. We looked at how many tests the users were performing and went back to the nurse managers. We told them, ‘You only did 10 of these. Do you really want to keep 35 nurses competent with them?’ The answer was no, and tests like that went back to the main lab,” she recalled.

End users particularly may not understand the strict quality control and competency standards they’ll be held to. This can become a factor in failed implementations when using sites finally realize what they have to do to offer a test. “I worry that we’ve sold waived tests as being so simple you can’t make a mistake. But many of these devices are deceptively simple and actually very sophisticated,” said Bowman. “For point-of-care testing to really mature, a number of things have to happen, and one of them is that things don’t get taken for granted.” To underscore that point, Bowman and her staff take pains to determine how well the site understands the nitty-gritty details of operating the POCT device and complying with regulatory and quality assurance requirements. Temperature controls and storage issues are only two examples of the exacting standards the using site must adhere to. “I hear stories from my peers that people measure temperatures but store something up high or under a window and the kit deteriorates. So we ask if they’ll be able to document that the kit was kept in proper conditions throughout the life of the instrument,” she explained.

Maintaining and substantiating competency with an instrument in sites with a high number of staff members—such as the emergency department—can be the sticking point that either closes down a POCT service or prevents its approval. This also is one reason why applications that don’t work in one setting can make perfect sense in another. For instance, there was a request at Massachusetts General Hospital to perform rapid HIV testing in labor and delivery as a way to deal with the relatively small number of women who present in labor without having had prenatal care. The goal then would be to initiate antiretroviral therapy for HIV-positive mothers to prevent maternal-fetal HIV transmission. However, given the low volume of testing and the considerable size of the labor and delivery staff, the request was denied. “We set that up in the central lab where competency could be maintained. Yes, it takes a little longer, but the result is still available within 15 minutes. If we had implemented it in labor and delivery, it likely would have been a fiasco,” explained Lewandrowski. On the other hand, this same application was approved for the hospital’s sexually transmitted diseases clinic. “There, it made sense. There’s a limited number of people performing the test and the volume is such that they would be able to maintain competency.”

To bring home the point about the using site’s responsibility in quality control, the University of Texas Medical Branch (UTMB) in Galveston requires top-level sign-off on any new requests for service. “We require not just the nursing supervisor, but also the medical director of the site to sign-off. His or her name may not be on the CLIA certificate, but we require it so the site will know that point-of-care testing is tied to the CLIA certificate,” explained Peggy Mann, MS, MT(ASCP), POC and reference lab coordinator for clinics. She was recognized in 2008 by AACC’s Critical and Point of Care Testing Division as Point of Care Coordinator of the Year.

In concert with the using site’s responsibility for quality control, labs need an effective means of monitoring compliance. In many cases this boils down to the POCCs’ visible presence on units and in clinics. “The old ‘sneakernet’ is still extremely important. People trying to manage from their connectivity are not going to know the programs. They have to be out and about,” said John Petersen, PhD, professor of pathology, director of point-of-care testing, and associate director of clinical chemistry at UTMB. Petersen also is treasurer of AACC’s Critical and Point of Care Testing Division.

Mayo Clinic’s Priorities Lab Testing Committee oversees compliance via monthly audit reports. The site’s compliance with performance criteria are highlighted as red, yellow, or green. Two or more quarters with multiple red indicators requires a meeting with the committee to discuss remediation plans. If the problem continues, the site faces removal of the point-of-care method in question, according to Karon. Long Island Jewish Medical Center recently implemented a rotating system of intensive review of individual sites. “It’s a constant revolving focus on different units, so it hopefully encourages them to constantly keep up with compliance,” Bowman indicated.

A major consideration for Bowman is the leadership and past reliability of a site in maintaining quality control, competency, and the like. “Are these people who have a mindset to collaborate or are they indifferent or even hostile to that? We’ll work much more readily with sites that have already shown they can perform, than those that have been difficult to work with or have no track record,” she commented.

Clearing IT Hurdles

Although the increased sophistication of POCT devices has facilitated new testing applications and vastly improved connectivity and data collection, IT remains a major stumbling block to successful POCT services. As an example, Massachusetts General Hospital recently implemented POCT blood gas measurements in its surgical suites. The instruments, which were specially wired for use in that setting, also had middleware that enabled a direct interface with the LIS and hospital electronic health record. However, in practice, the devices weren’t always docked immediately after being used, and the LIS recognized when the data was received, not when the test was performed. “We had to pull the plug because we didn’t have a way to solve that technical problem short of a very expensive IT project we didn’t have the time or resources to invest in,” said Lewandrowski. “We plan to revisit this.”

Those types of challenges have forced POCCs to become more conversant with IT issues and work closer than ever with IT staff. “Point-of-care coordinators understand now that they’ll have heavy involvement with IT and need to communicate clearly and closely with IT,” observed Wyer. At Sentara, the POCC-IT connection has matured to the point that a dedicated team of IT staff works with the POCCs, and each group has developed an appreciation for issues of importance to the other. “Our worlds have meshed a little. That’s why our relationship is so collaborative,” said Wyer.

Analytic issues also continue to be a factor in the successful deployment of POCT. A key area of concern involves diabetes management, because blood glucose testing accounts for the majority of the POCT market. Recently an analysis of eight HbA1c POC instruments found that six did not meet CV criteria within the relevant clinical range (Clin Chem 2010; 56:44–52). In addition, because of mounting concerns about the accuracy of blood glucose meters and their use in settings not approved as safe and effective, the FDA will hold a hearing this month on appropriate clinical and analytical requirements for the devices.

As manufacturers, users, labs, and regulators collaborate to address POCT analytical issues, labs have an important role in managing expectations and clarifying appropriate usage of POCT devices. “Sometimes we as laboratorians ask about accuracy and precision in point-of-care like we would in a lab setting, where you’d want the most accurate method,” said Karon. “You often have to accept decreased accuracy or precision of the point-of-care method in exchange for the ability to improve outcomes by changing the way you use the information.”

With the POCT market only expected to grow in coming years, solid lab-POCT site relationships will be essential to maintaining viable POCT services, according to Bowman. “In the lab, we’re really focused on the technical process, while the clinical setting is usually focused on the patient process and outcomes. We need to bring the two perspectives together and there needs to be an appreciation that all concerns are ‘our’ issues so that our clinical peers understand we are not being arbitrary and obstinate and we show our willingness to work with their realities.”

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