Why selling hematology will help your customers deliver more value to their patients and help you grow your business

One Button Wonder

Why selling hematology will help your customers deliver more value to their patients and help you grow your business.

Your customers are getting the lab message. Slowly but surely as a result of your consulting and collaborative work with your key lab manufacturers, new labs are being established, and existing labs are growing their testing portfolio.

Where is the proof? From 2021 to 2022, the number of CLIA-waived labs, which is the sweet spot for point of care labs, grew from 211,227 to 246,258 – a growth of about 16.6%. In the POL market, over 4,500 new waived labs were established during that time. Considering this growth took place as the COVID pandemic gripped the U.S., the number of new waived labs is even more impressive. At the same time, moderate complexity labs grew slightly, to over 34,000. As a very positive side note, the number of CLIA moderate complexity lab numbers has been dropping the last few years, and the latest data represents a reversal. Today I estimate that there are about 13,000 hematology systems in place in the POL, leading to a lot of opportunity. Your efforts are making it happen. Yes, practice size and specialty dictate which waived tests are appropriate for the POL, but many tests make sense across the board

By Jim Poggi

for most POLs. Your well-equipped waived lab should be performing rapid tests for hCG, flu, strep, RSV and COVID at least, ideally on a reader system or even a molecular platform. Urinalysis and lipid tests help round out the urgently needed waived tests. Check the box if most of your customers are using these tests and give yourself a gold star if they are also doing cardiac rapids.

So where do we go from here? Good question. This column is all about the “one button wonder”: hematology. A few years ago, you might have responded, “Wait a minute, hematology is CLIA moderate and the number of those labs is dropping.” That concern is no longer valid since the number of CLIA moderate labs is on the rise again and there is a CLIA-waived possibility for the customers who desire that option. My goal is to convince you to go after selling hematology, helping your customers deliver more value to their patients and helping you grow your business.

If you believe my philosophical cornerstone that the reason to perform lab tests in the POL is “to provide tests needed to initiate or modify a patient treatment program,” hematology is a nearly flawless fit. There are several reasons.

When you compare the simplicity of hematology testing to other CLIA moderate tests, the ease and simplicity stands out.

Let’s consider them together. First, hematology is an excellent fit for the three cornerstones of value, clinical, workflow and economic.

Clinical value

There is almost no other test I can think of that provides the simplicity of pressing one button and getting the same result every time with the rich set of clinical data that hematology provides. And, there is no other test so valuable in nearly every clinical setting from routine physicals to emergency room visits, sepsis diagnosis and for oncology and rheumatology practices. A single CBC measures red cells, white cells and platelets and provides a differential count of white cells, either 3 part or 5 part. The information provided helps guide the diagnosis of anemia, bleeding disorders, acute internal injury, infection, and cancer (diagnosis AND treatment effectiveness). It is also critical to inform decisions to administer several therapeutic agents based on the absolute number of these cells and the distribution of the white cells in the differential count. There is also at least one hematology system that aids in diagnosis of sepsis by providing a measure of monocyte distribution width. Monocyte distribution width greater than 20 is associated with sepsis. A normal monocyte distribution width indicates a sixfold decrease in the likelihood the patient has sepsis. With sepsis on the rise, this alone is a big deal.

Workflow value

One button does the job, providing the same result every time. When you compare the simplicity of hematology testing to other CLIA moderate tests, the ease and simplicity stands out. The sample is whole blood for speed and ease of specimen handling and the analysis is quick and provides a standardized list of the same test parameters every time. Hematology tests are easy to perform and easy to train for even the novice laboratorian. Maintenance of the system typically takes more training time than teaching how to perform the test and troubleshoot results.

Economic value

I know what you are thinking already: PAMA has decreased reimbursement for CBC along with most laboratory tests. While this is true, as of 2022 clinical lab fee schedule, CPT code 85025, an automated CBC with differential still reimburses $7.77 per test, making it likely to provide revenue to the

practice, while still upholding both of the other elements of value. I will be reporting the changes in the clinical lab fee schedule due to PAMA early in 2023 and will update you then.

Even when you look at the initial investment and on going costs to incorporate hematology into the POL it makes economic sense. Depending upon customer preference for features and throughput, initial investment in a hematology system can be well under $18,000. And depending upon the number of tests performed annually, the combined cost of a CLIA license AND enrollment in proficiency testing can cost under $03 per test. Even with PAMA reducing reimbursement, hematology testing is a sound economic choice, adding economic value to workflow and clinical value.

Because the hematology system provides the same result each time and does not have a broad menu of tests like a chemistry system would, set up on LIS and EMR should be fast and simple. Be sure to confirm with your LIS and/or EMR suppliers to be on the safe side.

New testing set up

Finally for the labs just considering CLIA moderate testing for the first time, the question inevitably becomes how to overcome the hurdle rate of making this change and the investment that goes along with it. The needs are pretty straightforward: they will need to create a new CMS form 116, listing the new tests as well as expected volume and pay the biennial fee. The designated clinician needs to become a lab director. This requires a certification that they have passed one of the programs entitling them to be a lab director. Among the many choices, COLA offers an online program that is well regarded.

The lab will also need to enroll in a proficiency program, acquire the required lab accessories such as rockers (which YOU will provide) and set up their standing orders for reagents, calibrators and controls which you will also provide. There are several steps but, working hand in hand with your key lab manufacturer, the process is not especially difficult or complicated. It simply requires some dedicated time on your part, the active assistance of your key lab supplier and the assurance that the new lab is ready, willing and able to add this exciting addition to their laboratory. Done right, it checks all the boxes for customer value and creates a satisfied customer who has just entered the exciting and everexpanding world of CLIA moderate complexity testing. Urge them to press the button. You and they will be glad you did.

There is almost no other test I can think of that provides the simplicity of pressing one button and getting the same result every time with the rich set of clinical data that hematology provides.