Waived testing? Wave goodbye to that, says William A. Rock Jr., MD, medical director of the clinical laboratory, University Hospitals and Clinics, University of Mississippi Medical Center, Jackson, who did just that when he began putting together a point-of-care testing program for his institution a decade ago.
Today, he and three other colleagues run an extensive POCT program that involves 61 sites and more than 2,000 employees at three hospitals and a large outpatient clinic—all without relying on the waived tests that typically anchor POCT programs.
Waived tests are somewhat oddball actors in the highly ordered, detail-driven world of laboratory medicine. Though regulated, these tests fall short on full commitment, like the Sondheim character in “Company” who sings, “Marry me a little.” So simple are these tests, the FDA has cleared them for home use, and CLIA requires test users to follow only manufacturers’ instructions. No proficiency testing, no patient test management, no quality assurance, no quality control, and no personnel qualifications.
For Dr. Rock and his colleagues, it was also a no-go. At UMMC, they decided, the POCT program would be built to last. Any test supported in the POC program, even if CLIA has given it waived status, would have to meet CAP and Joint Commission guidelines, including:
- orientation competency
- annual competency
- quality control
- instrument maintenance
- proficiency testing
In other words, tests could no longer use their CLIA waived status to gain automatic entrance into the POC testing program. They were either in or out as full-fledged laboratory tests. Just as you can’t be a little bit pregnant, the middle ground disappeared.
At UMMC, “We don’t use the word ‘waived,’” Dr. Rock says. “We use ‘decentralized’ or ‘point-of-care testing.’” In case there’s any lingering confusion, he elaborates: “We don’t use the concept of waived testing. To us, there is no waived testing. We realize that CLIA has those regulations, but they’re not part of our thinking.” He stops just short of saying, “Waived testing is dead to us.”
Clearly, Dr. Rock, who is also professor of pathology, Department of Pathology, UMMC, wanted to raise the bar for POC tests. “We wanted to integrate point-of-care testing with all the same standards and all the same quality issues of any other laboratory test that the College is responsible for,” he says.
And then he and his colleagues took another flying leap—they handed off POC testing to the users.
Fortunately, nothing got broken in the landing. It was a calculated risk, and Dr. Rock says it’s produced an efficacious POC program.
Most of the time, Dr. Rock’s voice is a mellow drawl, and in a phone interview with CAP TODAY, he and one of his two POC coordinators, Nancy Prezas-Jones, BS, MT(ASCP), speak with the easy familiarity of longtime comrades, finishing each other’s sentences and polishing each other’s words. But occasionally he’ll deliver a series of unvarnished sentences that sound straight from New England. “We’re not running it. They’re running it,” he says. “We’re helping them do a better job.”
It all began at the rather urgent request of UMMC administrators, who, with an eye toward Joint Commission requirements, wanted to revamp the POC testing program at the institution. At the time, POCT followed the usual route, relying on the standards set for CLIA waived tests. The largest-volume POC test was blood glucoses. Here and there, other bedside tests were being done—urine pregnancy tests, heparin assays, blood gases—but none were considered part of a formal POC testing program.
Dr. Rock turned to the literature, unearthing two ideas that seemed to make or break POCT programs, both of which had underlying psychological dimensions.
One, the test had to be necessary. Otherwise, it might be considered superfluous or controversial, running the risk of being blocked by overworked and perhaps disgruntled staff.
POCT was unimpeachable, for example, when training patients with newly diagnosed diabetes how to do at-home glucose monitoring. This required in-house training by highly proficient operators, as well as accurate backup when patients visited the clinic for followup checkups, and no one could argue with the need for the test.
Two, there seemed to be plenty of pushback—to use a polite, consultant’s word—directed at the laboratories running POC programs.
This second point triggered a lightbulb moment for Dr. Rock, who decided the lab wouldn’t run it. The operators would. The lab would simply help them run it right.
Reagents and other testing items would come from each patient care area; they wouldn’t be considered lab supplies. Operators from each unit, rather than lab personnel, would perform the tests. The test results wouldn’t come from the lab; they would come from the folks manning the instruments.
All this is overseen by the POCT Section, which Dr. Rock and his colleagues established when they began overhauling POCT. Just like other laboratory sections—chemistry, toxicology—POCT is a division within the department, but it’s its own cost center. This, perhaps, gives point of care a bit of gravity throughout the vast UMMC system. They also created a point-of-care testing committee, which included another physician in addition to Dr. Rock; nurses who oversaw training and education at UMMC; and nurses with an obvious stake in point-of-care testing.
The newly formed section then posted the equivalent of a “Buses welcome” sign—any patient care unit that wanted to do point-of-care testing was encouraged to do so, with Dr. Rock and his colleagues giving their full support.
“Full” should not be confused with “blind,” however. Those who wanted to bring POCT onto their units had to follow a strict protocol (see chart, page 37). First, they had to sign a document—called a testing request form—that identified, among other things, who would be in charge of the program for that unit, the test(s) required, the number of personnel performing the test, the affected shift(s), the approximate test volume, and the reason for using a point-of-care test(s).
The POCT Section performs validation studies and linearity checks and writes the procedures. “It’s treated just like a regular test,” says Prezas-Jones. Training also falls to the POCT Section, which spells out what users will be required to do daily, weekly, and monthly. QC and competency training are part of each operator’s yearly evaluation. Making it so was an important step, says Dr. Rock, since early on in the program, compliance suffered. The move met no resistance, most likely because nursing services have supported the POCT Section from day one.
It also helps that many of the POCT instruments boast lockout features and connectivity. The POCT Section knows when someone has flunked QC or another protocol; moreover, it can put those failures into easily grasped financial terms. It’s a little like being bird-dogged by accountants. “We can report back to that unit, ‘You did 200 tests, but we weren’t able to bill because you didn’t follow the procedure, which cost us X number of dollars,’” Dr. Rock explains. For instruments that lack connectivity, the POCT Section has created worksheets that cover QC, maintenance, and the like; the worksheets are faxed to the section, where they’re reviewed and entered manually into the LIS.
As the program has grown, so have the demands for keeping everyone in the loop. Soon the POCT Section will be launching a Web site that will offer training and retraining modules. The POC manual—a thick binder containing All Things POC, from policies to procedures to protocols—will be made available on the site as well.
The manual itself is worth noting. It was launched, in part, because Dr. Rock is, as he puts it, “a policy guy.” Having all POCT-related information in one place makes sense for a large institution, where turnover can be high and policies plentiful.
The book also takes pains to distinguish POCT from the clinical laboratory’s offerings. Though there’s overlap between the two with some tests and procedures, the format describing those procedures is different. “It’s the same information, but organized differently, so they cannot be confused with anything that comes from the clinical lab,” Dr. Rock explains.
In its take-all-comers approach, the POCT Section is a little like home in the Robert Frost poem—they have to take you in. “We just don’t turn anybody down,” Dr. Rock says.
Occasionally, doing so would appear to be the more expedient action, particularly when a request for POCT doesn’t appear workable. One unit went through the formal application process and testing, after which—“Guess what? They ended up doing one test a month,” Dr. Rock says. “They decided they didn’t need it. But it was their decision. It wasn’t our decision.”
Dr. Rock points to UMMC’s anticoagulation clinic, which is run by PharmDs and overseen by a clinician. The clinic wanted to do whole blood point-of-care PTs with INRs. Twice the clinic has set up a comparison program, and twice its operators have watched the POC tests fall short of expectations.
There’s no trace of smugness in Dr. Rock’s voice as he talks about this. Indeed, he notes, his section plans to try again to validate the test. “Because for certain patients, point of care has real value,” he says, pointing to children and young adults who can’t spare high volumes of blood for traditional PTs with the INR.
And if it doesn’t work? Dr. Rock and his colleagues will persevere as long as the clinic wants. “We’re not going to tell them ‘no,’” Dr. Rock says. “We’re going to keep validating new instruments and reagents as they’re identified to find the system that works.”
The section makes it clear in its point-of-care agreement policy that each unit must implement and carry out the guidelines required by the CAP and Joint Commission, and that each must order its own POC supplies using its own departmental charge code. And while the POCT Section can (the policy states) coordinate or assist with CAP and Joint Commission guidelines, if the guidelines aren’t met, it will review the application for POCT. If deficiencies remain unresolved, the request must be denied. The policy concludes with an uncomplicated statement: “By signing this policy, you have agreed to be responsible for your patient treatment area’s Point of Care Testing.”
With those responsibilities spelled out, the POCT Section will move heaven and earth to help patient care units meet the stringent CAP requirements for non-waived tests. Like any other laboratory professional tackling POCT, Dr. Rock and his colleagues found themselves trying to convey a QC mindset to nurses and other non-lab staff who are “doing a million other things,” as Prezas-Jones puts it.
“My response to them is always, ‘Here’s the reg, let’s customize it to your area,’” says Prezas-Jones.
That attitude has gone a long way in helping the operators trust the POCT Section. “When we initially make contact, there’s a certain amount of natural resistance,” says Dr. Rock. Some may even harbor suspicions that the section is quietly trying to dissuade them from POCT—why else would Dr. Rock and his colleagues continually correct errors and insist on QC? But after repeated contacts, the section’s message sinks in: “We’re not here to make work for you. We’re here so that you can have a quality product every single time,” Dr. Rock says. “Then they see there’s no other motive, that we’re not trying to discourage them from doing point of care. We want them to do it right, to follow the regs so they can be confident in the results.”
Adds Prezas-Jones: “We want it to work.” She and her colleagues visit the 61 sites at least once a month. Early on, that was critical. “Now they feel comfortable calling us with issues or suggestions or problems,” she says. “They’re not afraid to call us, whereas initially we wouldn’t hear about it [a problem] until we did our rounds 30 days later.”
Their visibility shows the section does more than just talk a good game, says JoAnne Coleman, RN, MSN, assistant director, hospital education. When the POCT Section sees an issue, “instead of issuing a memo or pointing fingers, they go to the nurses and find out what’s happening.”
Just as gratifying, she says, is the way this support plays out at the POCT orientation sessions. Because of the steady stream of new hires at UMMC, blood glucose training is done weekly. The lab and the nursing instructor frequently teach the sessions together. “Then when the nurses are out on the unit, they see those same lab people making rounds and talking to them.”
At work here is the steady push-pull that defines the relationship between the POCT Section and the units it supports. Though each member of the section has 20-plus years of laboratory experience, they forsake a paternalistic approach—this is not Father Knows Best, but rather, Father Probably Knows Something but Wants You to Learn, Too.
“We’re making it easy for them to do it and do it well,” says Dr. Rock. “But it’s their program.”
Karen Titus is CAP TODAY contributing editor and co-managing editor.