Hematology panel: bridging gaps, staffing, Lab 2.0

October 2019—Automation, the workforce shortage, manual review rates, and Laboratory 2.0 were some of what came up in CAP TODAY’s latest gathering of hematology experts for a roundtable on what’s new, pressing, and in play. CAP TODAY publisher Bob McGonnagle convened a panel in August consisting of Cordelia Sever, MD, of TriCore Reference Laboratories; Olga Pozdnyakova, MD, PhD, of Brigham and Women’s Hospital; Danette Godfrey and Simon Shorter of Sysmex; and Matt Rhyner, PhD, MBA, and Rachel Burnside, PhD, MBA, of Beckman Coulter. What they said follows.

Access the 2019 hematology analyzer interactive product guide here.

Danette, what are Sysmex’s latest initiatives and how have customers responded?

Danette Godfrey, director of IVD product marketing, Sysmex: We added a new module to our hematology automation lines to bring even greater differentiation than our existing platform. At the low end of the market we made substantial changes for the point-of-care market with scalable solutions in the area of the XW-100 and changes to the instrument and the markets we serve.

We’re pleased with what we’re hearing well into the launch of our XN-20, to deliver next level flagging, with the new white precursor channel based on similar technology that our customers have grown to love. Being able to offer more differentiation to precursor cells is certainly helping our markets, which find value in highly sensitive and specific flagging of abnormal white blood cells, automatic reflex testing, and the information technologists need to reduce manual slide review rates. At the low end of the market we see an expansion of the understanding of the positioning of the XW and the markets we serve there. We have made advances there in how we communicate this to our customers and to what extent our customers find value in the solution.

Matt, what, if anything, has changed in the last year from your perspective and from the perspective of Beckman Coulter?

Matt Rhyner, PhD, MBA, senior director of product management and global marketing for hematology, Beckman Coulter: We’ve had two FDA clearances this year—one for our low-volume analyzer, the DxH 520, and the other for our Early Sepsis Indicator. Both have really added clinical value. Early Sepsis Indicator has a tremendous amount of value, but when we have worked with customers, we have had to help them bridge their own gaps between emergency doctors as well as the laboratory, and that’s been an interesting journey.

Rachel Burnside, PhD, MBA, senior manager of global marketing for hematology, Beckman Coulter: It’s just an aspect of bringing on a new assay. People are interested in what the Early Sepsis Indicator brings to the table, but they need education on what it is, what it’s measuring, and how it can impact their workflow.

We’re also anticipating the imminent launch of the DxH 690T, which is a tabletop analyzer for mid-volume laboratories that will have, as does the DxH 900, the capability for Early Sepsis Indicator.

Dr. Pozdnyakova, is there anything you would like to raise at the outset?

Olga Pozdnyakova, MD, PhD, associate pathologist, Brigham and Women’s Hospital; associate professor, Harvard Medical School; and medical director, B&W Harbor Medical Physician Diagnostics Lab: I would like to comment on bridging gaps. We use Sysmex hematology analyzers in all labs across Partners. These are modern, sophisticated analyzers that allow us to measure a lot of clinical parameters and advanced clinical parameters. I would like to mention immature platelet fraction and immature reticulocyte fraction parameters, which we are currently validating and planning to report. However, there is a great need to educate our clinicians on what to do with these parameters. Due to a lack of familiarity with these new parameters, clinicians may not find them useful and will not order them, creating a big gap between advanced laboratory technologies and their implementation into clinical practice.

You have dozens if not hundreds of clinicians and other people within your system who need to understand new assays and need to know how to handle the information you provide. Are rules-based applications within instruments and IT systems helpful there? Do you need to do in-service and visits and newsletters? How do you communicate information about the new features and benefits you can provide out of hematology instrumentation?

Dr. Pozdnyakova (Brigham and Women’s): The rules we use are created mostly for our clinicians and sometimes with their help. This is one of the ways to accomplish that. We do have a general broadcast to communicate changes and new features, which I do not find helpful because we see several each day. I find the best way is face-to-face communication and doing in-service and going to physicians’ offices or to their departments and explaining why we do what we do and how new technologies and instruments’ features can help them provide even better patient care.

Dr. Sever, would you like to comment?

Cordelia Sever, MD, VP and director of clinical pathology, Pathology Associates of Albuquerque; co-medical director of the clinical laboratory, hematology, TriCore Reference Laboratories; and medical director of the laboratory, Presbyterian Hospital: I am observing two major trends in our system. One is the migration of testing to the point of care, especially for the emergency department. In our system, they are overtaxed. They have too many patients and need to get them through the door, and many new models are popping up now. In that scenario we need machines that are robust and can be operated as moderately complex instruments. It’s important to be able to hardwire lockouts and be able to interface with POC software that can manage a lot of the QC, and there are new solutions out there.

The other trend is what Dr. Pozdnyakova said: We are using more and more of the new parameters—­immature platelet fractions and ­reticulocytes—so we are getting more sophisticated. I agree with Dr. Pozdnyakova that sending out paper or email notifications is rather ineffective. It has to be targeted presentations to clinicians and customer broadcast in the outpatient area. It’s slowly getting traction. For example, we find the immature retic fraction very useful as a screen for iron deficiency. So we are using numerous things to decrease other testing and expedite diagnoses at the point of care.

Matt, this reminds me of comments you made in a similar roundtable discussion last year, which is that the market is tending to go in two directions—a barbell scenario—in which we’re seeing a lot of interest at the point of care, as Dr. Sever mentioned, and a lot of interest in huge efficiency in core labs. How is that trend developing?

Dr. Rhyner (Beckman Coulter): One thing that’s clear is that 10 years from now the market will be very different. There have been a lot of entrants on the low end of the market in terms of the physician office lab or POC space, as well as more and more acquisition of hospital labs by companies like Quest and LabCorp that are driving a different sort of pressure in those ultra-high-volume spaces.

The cost drivers are huge for both ends of the market and that’s probably what we’re seeing, as well as the lack of trained staff to operate these devices. There is enormous cost and efficiency pressure, and it’s pushing the market in those two directions. I’ve only seen that trend intensify in the past year.

Will that create a certain strain within the system, because we’re talking about the need for education at both ends of that spectrum? It often falls on a labor force that’s increasingly stressed and strained and sending out in many places. It’s a burden that seems to be landing on laboratory staff of all types.

Simon Shorter, senior director of IVD product marketing, Sysmex: We’d broadly agree with Matt about that sort of barbell direction, and cost and efficiency and the age of the workforce are always concerns. So one of the areas that Sysmex has been focusing on is how we can reduce the burden for laboratory scientists by way of a new product we’re launching called Beyond­Care Quality Monitor, where we perform calibration verification in a different way.

We used to go on site and perform calibration verification, and in the next version we did this remotely, where the customer would run the product but we do everything else. Now with this new product, we are capturing the data from daily QC runs conducted by the customer and effectively performing continuous calibration verification every day. That’s one example where we are trying to find technological solutions to this and trying to begin to enter this space of digital transformation.

The workforce shortage seems to be becoming more acute. Dr. Pozdnyakova, how do you see your labor situation, particularly in reference to the hematology section?

Dr. Pozdnyakova (Brigham and Women’s): I could not agree more. We are short-staffed and have a hard time retaining people. It’s a problem across the country. And it affects all areas of hematology labs, and manual review of smears in particular. The best way to approach the problem is to become more efficient. One of the efficiencies we see with hematology analyzers is a more accurate flagging leading to more accurate identifying of the smears that require manual review. Currently our manual review rate of the smears hovers around 15 to 18 percent, and I think that’s pretty much true for many large academic institutions of similar size.

We are a tertiary care center so we have a lot of sick people, and many with hematologic malignancies, and that also drives the increase in the manual review rate. If we rely on our hematology analyzers more, if we validate them and know they truly do not miss what we don’t want them to miss, and they flag what needs to be flagged and do a manual review on those smears, that would help us tremendously.

Another efficiency is the use of Cella­Vision. We’ve had it in the lab for a little under a year, and it’s been a great, positive change in the operation of the lab. It is a more efficient way of reviewing peripheral blood smears, and we have seen a tremendous improvement in the turnaround time of the smear review and in the quality of work and quality of life of the technologists in the hematology lab. Our labs work very closely with Dana-Farber hematologist-oncologists, and they also recognize the utility and benefits of using the Cella­Vision system and its positive impact on patient care.

The way to deal with the labor shortage is to be smart and creative in how to become more efficient with what we have.

Dr. Sever, you’re in a similar situation because you have one foot in Presbyterian Hospital but you’re the co-medical director of the clinical lab in hematology at TriCore Reference Laboratories, which also is serving an enormous group of clinicians and patients. What is your current rate of manual review? Dr. Pozdnyakova said her lab’s is 15 to 18 percent. Is that in sync with what you’re seeing in Albuquerque?

Dr. Sever (TriCore): We have actually pushed it down even lower. In our core lab it’s about 12 percent, and at our hospitals it’s around 15 percent, with a high concentration of abnormal smears. We have addressed some of this with delta checking and looking at counts horizontally and not repeating differentials with the certain flags. Our clinicians are very good too at not ordering too many differentials. We have a high monitoring mode for just CBC, so we have the same problem in keeping our technologists well trained. We have distilled it to the highly abnormal smears.

Interestingly, in our hospital situation, we decided it takes more time to QC the Cella­Vision and maintain it, and we still have to look at manual diffs, especially in oncology, where low counts don’t work with Cella­Vision. So we don’t have that system in our high-complexity oncology environment. But in the core lab it makes sense. We have a much higher number of near normal with just a little bit of left shift or not, and those are still running with the CellaVision. So it’s targeted to the populations, and that works for us.