Three at AACC: rapid STI testing, toxicology, biosafety

Understanding how to work through a false-negative screen is critical, Dr. Tacker says, as greater numbers of providers screen patients for prescription drug compliance. “False-negatives are a harder and newer kind of phenomenon that we get a lot of questions about because of the paranoia about overprescribing opioids.” If the patient for whom the lab and provider have a negative result is supposed to be taking a benzodiazepine, “are you going to accuse the patient of diversion or are you going to dig deeper?” Dr. Tacker says she urges digging deeper, “because a lot of patients are unintentionally noncompliant with prescriptions.” Some are simply afraid of the effects of opioids. “So there are nuances to work through in toxicology now that you did not hear as much about 10 or 20 years ago.”

Using nontraditional sources to find answers to some questions—those that are less straightforward—is becoming the norm, Dr. Heger says. Talking to a manufacturer, preferably someone in scientific affairs or R&D, can be a good source of information about a specific assay, he says, particularly for information that might have come online after the company’s initial FDA clearance.

Contacts at various reference labs, state regulatory agencies, or medical examiner offices can also reveal trends of new and emerging drugs and classes. “You’ve got to look outside the box,” he says.

Dr. Heger’s laboratory saves aliquots from each urine drug screen specimen for a minimum of three months. Providers aren’t necessarily able to follow up with the lab about a result right away, and when they do—especially if it is about a potential false-positive—it’s important to have the specimen on hand, he says.

Providers at Tufts Medical Center consult with pathologists and toxicologists before making a plan for definitive testing. That way, Dr. Heger explains, the toxicologists on staff are able to select the best test and the most suitable reference lab. “Depending on the clinical question, it might make sense to send it to one laboratory versus another, depending on the scope of testing, methodology, and price. We’ll ask the providers, ‘What is the question you’re trying to answer?’ From there we’ll start a dialogue.” When the results are back, he or a colleague sends the provider a customized response explaining what the result means. “And the clinicians love it,” despite it requiring more of their time on the front end.

“What we are trying to do,” Dr. Tacker says, “is hit on the gap between what the providers need and what lab professionals can provide and how we can fill it.”

Safety fatigue, a lack of regulatory “oomph,” and laboratory instruments that aren’t necessarily designed to be decontaminated are all hurdles clinical laboratories face in responding to biosafety risks, says Sheldon Campbell, MD, PhD, professor of laboratory medicine at Yale School of Medicine. The key to mitigating these risks, Dr. Campbell says, and what he and other speakers will address in “Biosafety Practices for Today and Beyond,” is for laboratories and for the laboratory community at large to develop the systemwide processes of quality laboratory safety practice.

Dr. Campbell will discuss instrument decontamination as a component of laboratory safety. While new disinfecting approaches—vaporized hydrogen peroxide is one example—emerged in the aftermath of the 2014 Ebola outbreak, “compatibility of different decontamination products and processes with all the complicated parts and materials in an instrument” remain ill-defined, says Dr. Campbell, who is also director of clinical laboratories, VA Connecticut Healthcare System.

One issue, he says, is that instrument manufacturers don’t often provide comprehensive documentation or instruction on decontamination. “There may be ways of decontaminating the sample-facing parts of the instrument, by running bleach through them, for example,” he says. “But instruments aren’t that simple. And when laboratories have done studies of contamination, you find nucleic acid from things like hepatitis C on the outside of the instrument.”

Though there are more disinfecting approaches today than in years past, “it’s still very much a work in progress,” Dr. Campbell says.

A good place for labs to start in performing safety risk assessments of laboratory hazards, instrument contamination, and exposure is with the Association of Public Health Laboratories website, which has a risk assessment best practices template. The Clinical and Laboratory Standards Institute is developing a document on decontamination procedures, to be released early next year.

Decontamination of point-of-care instruments could serve as a start for more comprehensive efforts, he says. “That’s a place where we can move forward and think about how we might do things in the central lab, because we do have the POC experience and it’s so enmeshed in the rest of the hospital’s infection control processes.”

More direction by way of CLIA or from regulatory agencies would help, he says. “We need to have some kind of incentive to more forward with this because it takes resources, and resources are hard to come by these days.”

Dr. Campbell will present several case scenarios, from the simple to the complicated. One example: A technologist who is testing a rack of serologies removes the rack from the instrument and then accidentally drops it back into the instrument. One of the samples is hepatitis B surface antigen positive. “So we’ll ask the audience: What’s your procedure? What’s necessary to decontaminate hepatitis B? Does it depend on where it spilled? What other protections are in place, and how can you minimize the subsequent risk of such events?”

Also presenting in the biosafety session will be Nancy Cornish, MD (recent history of biosafety and lessons learned), and Elizabeth Weirich (risk assessment and mitigation) of the CDC and Michael Pentella, PhD, of the University of Iowa (biosafety and quality management).

Charna Albert is CAP TODAY associate contributing editor.