June 2008
Feature Story

Mariann Stephens

That some laboratory test results are considered critical is not new. What is new is that emphasis is being placed now on quality improvement initiatives related to those results, says Corinne R. Fantz, PhD, who will speak on defining and reporting critical laboratory values at next month’s AACC annual meeting.

The Joint Commission’s national patient safety goal that addresses how, and how quickly, laboratorians communicate critical test results has raised the profile of critical values reporting. “There’s increased pressure for the lab to be able to document how long it’s taking to get the results and to contact the right person, and the processes around how to get the information to the correct provider,” Dr. Fantz says. Director of the core lab at Emory Crawford Long Hospital and director of point-of-care testing for Emory Healthcare, Atlanta, Dr. Fantz will talk about how the lab culled its critical values list and how it approaches the reporting requirements.

She is one of hundreds of speakers who will take the stage at the July 27–31 annual meeting to talk about everything from IT, HBA1c, and hepatitis C to tumor markers and warfarin pharmacogenomic testing—and where 650 exhibitors (among them 50 first-timers) will fill the exhibit floor. Another speaker, Cynthia Bowman, MD, who chairs the CAP Point-of-Care Testing Committee, will join a panel on the most commonly cited deficiencies found in POC testing inspections.

“There is literature available that shows things do go wrong with these [POC] assays and devices, and we need to acknowledge that,” says Dr. Bowman, medical director of medical laboratories and acting chair of laboratory medicine, Long Island Jewish Medical Center, New Hyde Park, NY. All laboratory testing in any setting—waived or not—should meet the same high standards, Dr. Bowman says, and the best way to ensure that is to be part of the CAP Laboratory Accreditation Program.

Dr. Fantz will discuss the process by which laboratory critical values are set and the possibility that a too-conservative sieve can produce an overwhelming number of critical value calls. A CAP Q-Probes study of 121 institutions, the findings of which were released in December 2007, showed that two was the median percent of test results that met the criteria for “critical.” In 89 percent of the participating institutions, the medical staff approved the list of critical values, and in 86 percent the medical staff approved the time frame within which critical values were to be called. National standards have not been set, Dr. Fantz notes.

“There isn’t enough evidence-based medicine,” she says, “and while our medical practice committee recognizes and supports standard practices, this group of practitioners represents many different service disciplines across our system.” Consequently, it may be a challenge to get them to agree on what constitutes a critical laboratory result. “Why call a low white count to somebody in the cancer center who knows their patient is getting chemo?” Dr. Fantz says.

She surveyed academic medical centers on her own, “to get our hands around what’s out there,” she says. “Just people I knew.” She found out that her hospital was “ultraconservative” in assigning critical values. “We were pretty much in the 90th percentile of conservative values,” she says.

She and her group were able to return to the medical practice committee with evidence of what comparable institutions were doing and data to show how their critical values list compared with those of other large academic centers. “They went for it because we had some evidence,” she says. The three hospitals and two laboratories involved adopted a revised critical values list in June 2007. “We went from calling about 1,500 criticals a week to about 750,” Dr. Fantz says.

Trending patterns in critical values is an area of interest at Emory. “At discharge, a patient may not have a critical platelet count,” she explains. “Maybe it’s falling and trending that way, but it hasn’t reached a critical point. The clinician should probably know that the last platelet count at discharge is lower than the one before that, and the one before that. So maybe we could watch trending patterns rather than one point in time or one change from the previous value.”

The thinking at Emory, Dr. Fantz says, is that there must be a way that data signaling a trend could be integrated in the computer system and the electronic medical record, so that physicians would be alerted to worrisome lab values before patients are discharged. “We don’t want to discharge anybody who has a bad lab trend,” she says. “If you’re trending up, even if it’s not outside the range, you might want to be alerted to that on discharge. We would just flag it. Otherwise, if it’s not critical, you won’t be called, and that doesn’t mean there isn’t anything happening in the background.”

The alerts could be put in proactively, much like the pharmacy does with drug interactions, Dr. Fantz says, pointing to a pharmacy software package that tracks potentially ominous patterns. “If someone is receiving a particular drug, the software will track a particular analyte. If it’s changing, that patient may have an adverse reaction,” she says. “That change in the laboratory result would trigger an intervention, perhaps earlier than relying on somebody’s memory to say, ‘Oh, right, I should monitor amylase and watch for signs of pancreatitis if my patient is receiving Lasix.’”

At the AACC meeting next month, Dr. Fantz will talk about critical values in adult patient populations, on a panel to include Dennis Dietzen, PhD, of St. Louis (Mo.) Children’s Hospital, speaking on critical values in pediatric practice, and Alexis Carter, MD, of Emory, on how to improve the reporting and documentation of the values.

Dr. Bowman will be one of three speakers on a July 27 panel addressing the most common deficiencies cited on the CAP point-of-care checklist. James Nichols, PhD, of Baystate Health, Springfield, Mass., will talk about specific deficiencies, and Brad Karon, MD, PhD, of Mayo Clinic, will offer tips for inspectors.

Dr. Bowman’s committee has been working with the Laboratory Accreditation Program Checklists Committee to refine the POC checklist; changes took effect last fall. Stephen J. Sarewitz, MD, who chairs the CAP’s Checklists Committee, says the changes have been made to simplify the process and accommodate the needs of those performing tests with limited training in laboratory procedure.

“Our main focus has been to try to keep the rigor of the program and the essentials of the program intact and at the same time make it easier for the laboratory and inspectors to deal with the inspection process,” Dr. Sarewitz says. The Checklists Committee is looking at further revisions to that end, including a separate checklist for waived testing.

In her talk at the meeting, Dr. Bowman will discuss the organization and intent of the POC checklist, describing and explaining changes made in the waived testing questions to simplify the process. A certificate of waiver, in her view, does not dilute a professional’s standards.

“Waived testing is defined as so simple that you probably won’t make an error, or if you do, it probably won’t have clinical significance.” And that, she says, is an over-simplification.

“In any testing, there are factors or variables that can lead to error,” Dr. Bowman says, “especially if you think about the pre- and postanalytical steps. The College has always questioned that. Why do a test if it doesn’t matter whether it’s right or wrong?”