CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
January 2023—Respiratory viruses were up in most states when Compass Group members met online Dec. 6 with CAP TODAY publisher Bob McGonnagle, and some were looking to centralize their now decentralized rapid molecular testing. At least one system had already done so.
In California, a new law requires fentanyl screening be included in drug screens in all general acute-care hospital lab settings. What lab leaders had to say about that and about digital pathology, remote sign-out, and the No Surprises Act.
Day
Clark Day, with respiratory virus rates so high, what’s going on at IU Health?
Clark Day, VP of system laboratory services, Indiana University Health: If you look at a three-month moving average, our total RSV, flu, and COVID is down versus the past two-year periods over September, October, and November. But flu is two-and-a-half times what it was this time last year, RSV is almost two times what it was this time last year, and COVID is down about 60 percent. So it is a shift from COVID to flu in particular.
To ensure we continue to offer the best care for our patients while balancing good financial stewardship, we are moving to test only symptomatic patients with local rapid PCR assays in our region facilities. We’ll make some exceptions for hospital settings in which double-occupancy rooms are the only boarding option or where patients are high risk or require time-sensitive treatment. All other routine PCR-based testing will be routed to our central pathology laboratory to be performed on our fully automated high-throughput platforms.
Is anyone else contemplating a similar move?
Jennifer Laudadio, MD, professor and chair, Department of Pathology, University of Arkansas for Medical Sciences College of Medicine: We’ve already centralized at UAMS. It was partly due to continued inability to get supplies for some of our regional campus sites. And we had to make a substantial commitment to one of the vendors in our central lab and wanted to be able to continue to fulfill that contract. With test volumes decreasing, we needed that centralized volume.
Dwayne Breining, has recentralizing molecular infectious testing been brought up within the Northwell system?
Dwayne Breining, MD, executive director, Northwell Health Laboratories, New York: We’re looking at it constantly but haven’t pulled the trigger because we’re fearing another wave. It’s crowded here and we’ve seen an uptick from around Thanksgiving of around 30 percent with COVID. In New York State the flu curve is vertical now, and we anticipate being in this for probably two months. We’re looking to continue doing a lot of testing and focusing on figuring out a way to decant our emergency rooms when they get overcrowded from people who need just testing. We have plans to do a pseudo-drive-through or a walkthrough—go around the corner if you need just a test and then wait for your results at home.
Carino
Winnie Carino at Scripps, what do you have to share from Southern California?
Winnie Carino, MA, CLS, MLS(ASCP), director of laboratory services, Scripps Health, San Diego: We’re seeing an increasing number of flu and COVID cases, also some RSV. We previously had RSV centralized in our core lab, but we’re decentralizing it again.
The state of California passed a law [Senate Bill 864] effective January 1 that for every drug screen we perform, we have to include fentanyl screening in all general acute-care hospital laboratory settings. Currently our rapid drug screen does not include fentanyl, so we’re running fentanyl on our chemistry analyzer. We added the screening test using a Sekisui reagent. It’s an FDA-approved third-party reagent and we ran it on our chemistry platform, the Vitros 5600, but you can use it on other platforms as well. Whenever the screening is positive, we reflex a confirmatory test by liquid chromatography-tandem mass spectrometry sent to a reference lab. Since we’re just a few miles from the southern border, our rate of positivity is high and there are a lot of overdoses in the area. I went as far as reaching out to the vendor of our MedTox screen test kit; they have the panel that includes fentanyl but it’s not FDA approved in the United States. The product is available in Canada but not here. I tried to follow up and escalate the urgency of getting the product approved in the United States but haven’t had any luck. Hard to believe with the fentanyl crisis in the United States nationwide that no one has come up with a rapid screen yet that includes fentanyl.
Dhobie Wong, do you have insight on this fentanyl requirement?
Dhobie Wong, MBA, MLS(ASCP), CLS, VP of laboratory services, Sutter Health, Sacramento, Calif.: Our approach is to add the fentanyl to our urine drug screen, which is run on our chemistry analyzers. We’re in the process of implementing that.
Do you have to do a lot of validation to put it on the urine drug screen?
Dhobie Wong (Sutter Health): Yes. It’s a work in progress, and there’s the information systems component, as with any new test implementation.
Dr. Datta
Milt Datta, what do you have to share on the issue of fentanyl?
Milton Datta, MD, chair of pathology, Abbott Northwestern Hospital, Allina Health, Minneapolis: Lauren Anthony [MD, system laboratory medical director], who is in our group, looked at fentanyl testing with Hennepin County Medical Center, which does our rapid toxicology screens. Because fentanyl is so potent, the testing cannot get a reliable and accurate read on it. There were no rapid tests available as of June, when we did our study.
We’re cautious from a legal side, in particular for maternal screening with fentanyl because of false-positive results with testing. There is a legal case in which a false-positive result led to a patient becoming upset regarding how she perceived the medical staff treated her. So we’re treading carefully with the fentanyl testing question.
Stan Schofield, would you like to comment on fentanyl?
Stan Schofield, president, NorDx, and senior VP, MaineHealth: We test for fentanyl, but we do it with mass spectrometry. There’s nothing else; there’s not a good immunoassay that we know of, though I haven’t shopped this in the past year. We do not screen for fentanyl on presurgical or emergency cases unless medically suspected or there’s a history, and it has to be a physician request. It’s not in our normal screening panel for toxicology primary drugs of abuse because it’s hard to do and it’s expensive using mass spec. Mass spec technology is easy—getting the sample, setting it up, doing a run. Having people at a dedicated machine is what’s expensive.
Dr. Breining
Dwayne, what are your strategies around fentanyl testing?
Dr. Breining (Northwell): It’s similar to what other people have reported. We looked for a point-of-care test option a few months ago and didn’t find anything. The potency of fentanyl is so high that the levels you have to detect are tiny. The reference toxicology labs we use seem to be doing a prescreen immunoassay. I don’t know what platform it is, and they’re probably doing 100 percent backup on liquid chromatography-mass spectrometry to get the detection levels. We’d love to implement fentanyl testing systemwide in all our rapid-response labs but we haven’t found an option yet. It’s clearly the right thing to do medically.
In New York, virtually weekly there’s a fatal overdose from someone who didn’t think they were taking fentanyl. It has become a major problem in the street drug world because the ready availability of cheap fentanyl has flooded the illicit market. It’s being used to enhance and cut every substance sold on the underground.
Frank Beylo, where is your laboratory on this? And to be clear, this requirement is in California but it may become national?
Frank Beylo, BS, MT(ASCP), director, operations and technology, Inova Health Systems, Falls Church, Va.: We’re working on validation of fentanyl with our Abbott Alinity series. Yes, I would assume it may become national.