Hematology - The New Business Model for Expanded Hematology Paramters - Immature Granulocyte

Hematology - The New Business Model for Expanded Hematology Paramters - Immature Granulocyte

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Hematology

The New Business Model for Expanded Hematology Paramters - Immature Granulocyte (IG)

These are transformative times in the healthcare industry and especially for the clinical laboratory. Significant reimbursement cuts and payment reform linked to quality measures are driving a new approach to laboratory testing. Laboratorians faced with a changing business model and growing staff shortages are increasingly being asked to justify the value the laboratory provides.

Given that, by some estimates, the lab generates 70 percent of the data included in a patient’s medical record, it is reasonable to look to the laboratory to take a leadership role in identifying and implementing new testing systems and clinically valuable parameters to improve patient care while managing cost. This has led to what we call the “Value-Driven Laboratory” - a laboratory that meets market demands by providing more and new types of diagnostic information to support the delivery of high quality and cost-effective healthcare.

Automated IG Parameter Adds Value to the Routine CBC

Sysmex’s Advanced Clinical Parameters were developed when considering how expanding the routine Complete Blood Count (CBC) might affect patient care and the healthcare system’s business as a whole. Three parameters are currently available: Immature Granulocyte count (IG), Reticulocyte Hemoglobin Equivalent (RET-He) and Immature Platelet Fraction (IPF). These parameters are automated and reportable immature cell indices with clinical applications established in the literature.

This article focuses on Sysmex’s automated Immature Granulocyte parameter.

The presence of a “left shift” is characterized by the appearance of immature neutrophils in the blood, with or without neutrophilia. The ability of laboratorians to properly and consistently identify these immature cells is crucial to the quality and significance of the WBC differential results.

The Immature Granulocyte count, performed as part of a 6-part differential, provides relevant information to the clinician regarding immature white blood cell mobilization that can:

  • Be easily implemented by the clinical lab and performed at no additional operating cost
  • Reduce CBC review rates and accelerate turnaround times even with growing staff shortages
  • Become a routine, integral part of quality and cost initiatives in healthcare systems
  • Streamline workflow for increased efficiency in the hematology department


The Growing Operational Value of the Immature Granulocyte Parameter

In the discussion section of a seminal paper, Dr. P. Joanne Cornbleet brought attention to the fact that there is little clinical value in a band count.1 When flagging algorithms on an automated hematology analyzer identify immature granulocytes, the laboratory usually performs a confirmatory manual differential to enumerate the immature cells; however, the traditional 100-cell manual differential is neither an accurate nor a precise measure of the left shift. Factors that make the manual 100-cell differential a poor measure include:

  1. Large distribution errors for rare cell events, such as immature the reported results from the 100-cell differential would range from 1.6-11.3 percent at a 95% Confidence Interval. granulocytes, can result in a coefficient of variation (CV) of greater than 40 percent. (Table 1) Compare this to the notably low CV (near Adapted from Rumke' with permission. 7%) of the automated IG count.2
  2. Cell morphology is often distorted on a 2-dimensional slide, making accurate identification challenging.
  3. Band cells are especially difficult to classify and differentiate because there are multiple different definitions of the band neutrophil found in the literature.3


The Absolute Neutrophil Count (ANC) reported from automated hematology analyzers includes both mature neutrophils and bands. While this parameter is an important variable in the physician’s diagnostic toolbox, it is often necessary to seek out additional information from the WBC differential, or diff. Sysmex’s automated Immature Granulocyte (IG) count includes metamyelocytes, myelocytes, and promyelocytes-cells that are precursors to those represented in the ANC. The Sysmex IG count is fully automated, and a study by Fernandes and Hamaguchi4 demonstrates that the automated IG count on the Sysmex XE-2100™ is very precise and accurate. Table 2 shows that even in low white blood cell counts, the automated IG result yields lower CVs than those obtained by manual counting.

An additional study performed by MacQueen et al. in 2016 concluded that the information from automated differentials is not inferior to that from manual differentials, and furthermore, automated differentials have the advantages of a larger sample size, faster performance times, and are less expensive than the labor-intensive manual differential.5 Together, automated IG and ANC may offer a faster, more precise indicator of left shift than the manual differential.

If one looks at the expansion of the WBC diff to include IG as an automated, routinely measured parameter, laboratories of any size and test volume can benefit from a 6-part diff. Laboratory productivity can improve through reduced review rates and faster turnaround times.

Reference Ranges for IG

Reference ranges are essential for the correct interpretation of many laboratory tests and, in practice, may be as clinically valuable as the results themselves.6 When considering implementation of a clinical parameter, it is important to contemplate how the test will be used and in what patient population. Patients of various age groups or medical conditions may require individual normal ranges to be applied. A large study conducted by Roehrl et al.7 concluded that separate reference ranges should be applied to children(≤10 yrs.) versus adults(> 10 yrs.) because many small but clinically significant IG elevations in the younger group may be missed if one cutoff is used for the entire population. (See PDF)

The Value-Driven Laboratory: Supporting the Continuum of Care

The healthcare provider’s reliance on accurate testing occurs throughout the care continuum, potentially affecting both quality and cost of care. (Figure 1) In an article in Beckers Hospital Review, Ann Pumpian, CFO of Sharp Healthcare in San Diego says, “hospitals will need to look at the entire continuum of care, regardless if they join an ACO, if they plan to stay profitable:10 In this section, we will look at healthcare providers’ perceptions of the clinical laboratory and suggest how labs can begin to benchmark the return on investment of adopting the automated IG.

In a CAP Today article, Kirsten Alcorn, MD, former Medical Director of the Transfusion Services at MedStar Washington Hospital Center, shared the findings of a study she conducted to assess satisfaction scores specific to laboratory results. The survey questioned 3127 nurses across 75 institutions to evaluate their understanding of test accuracy and methods. Findings showed that test result accuracy received a score of 4.3 out of a possible 5.0, the highest ranking on the survey.11 However, those statistics only represent about 80 percent, a solid “B”. To Alcorn, that simply is not good enough.

Alcorn recognizes that while laboratories work hard to report accurate results, they should undertake an effort to correct misperceptions about accuracy by educating nurses and other allied health practitioners about what a lab test means - i.e., the efforts that go into making test results scientifically and medically valid, reliable, and accurate. Then each member of the clinical healthcare team would be likely to develop a greater level of trust in the results and value the laboratory more highly, creating an environment where the Value-Driven Laboratory can excel.

Benchmarking Your Progress

When considering the potential return on investment by adopting the automated IG, the following ten considerations can provide valuable benchmark information to judge your progress:

Identify how this test may be beneficial to your hospital and patients:
  1. When is it clinically important for physicians to identify a neutrophil response as early as possible?
  2. Which of our patient populations is at greatest risk for an elevated IG?
  3. How early in the disease process do our physicians want to see indicators of left shift in a patient?
  4. Which of our patient populations is at greatest risk for readmission?

Identify the lab tests that currently distinguish patients at risk for an elevated IG:

  1. How do our clinicians define "left shift"?
  2. Given that bands have been removed from laboratory resulting guidelines, how are we defining immature WBC forms?
  3. Given the imprecision of manual band counts, how comfortable are we with clinicians using bands to screen patients upon admission?


Identify potential improvements that the clinical laboratory can support:

  1. What analytical quality does the lab want to maintain within their institution?
  2. Does the clinical staff fully understand the significance of - and cells included in - the automated IG count?
  3. GHow does faster turnaround time for a standardized automated WBC differential impact clinical decisions and patient outcomes in comparison to manual counting?


Summary

Technology now exists that provides laboratories with a new norm in Hematology. Sysmex's Advanced Clinical Parameters have expanded the routine CBC, improving patient results and the healthcare system's business as a whole. The IG parameter--an automated, reportable immature cell index--can contribute to the quality of patient care, the management of cost of care and the value your lab provides to physicians and patients.

Resources

1Cornbleet P. J. (2002). Clinical Utility of the Band Count. Clinics in Laboratory Medicine. 22(1), 101-136 9 Yu, L., Jin, Y., Li, M., Chen, X., Zheng, X. (2015). Changes and reference intervals of immature granulocytes in the peripheral blood of women according to pregnancy trimester. Int J Clin Exp Med, 9(5), 8169-8175 2 Rumke CL. The statistically expected variability in differential leukocyte counting. In Koepke JA (ed.): Differential Leukocyte Counting. College of American Pathologists, Skokie, IL 1978, with permission, p. 39 3 http://www.clinlabnavigator.com/ immature- granulocytes.html 10 Herman. B., (2011, November 29). 10 Ways for Hospitals and Health Systems to Increase Profitability in 2012. Beckers Hospital Review. Retrieved from https:// www. beckershospitalreview.com/finance/10-ways-for- hospitals-and-health-systems-to-increase-profitabiIityin-2012.htmI 4 Fernandes, B. & Hamaguchi, Y. (2007). Automated Enumeration of Immature Granulocytes. Am J Clin Pathol, 28(3), 454-463 11 Bowers, J. (2012) In RN Q-Probes, no room for complacency. CAP Today. 5 MacQueen, B., Christensen, R., Yoder, B., Henry, E., Baer, V., Bennett, 5., et al. (2016). Comparing automated vs manual leukocyte differential counts for quantifying the ‘left shift’ in the blood of neonates. J Perinatal, 36(10):843-8 6 Jones, G., & Barker, A. (2008). Reference Intervals. Clin Biochem Rev, 29(Suppl 1), 593-597 7 Roehrl, M., Lantz, D., Sylvester, C., and Wang, J. (2011). Age-Dependent Reference Ranges for AutomatedAssessment of Immature Granulocytes and Clinical Significance in an Outpatient Setting. Arch Pathol Lab Med, 135(4), 471-477 8 Field, D., Taube, E., Heumann, 5. (2006). Performance evaluation of the immature granulocyte parameter on the Sysmex XE-2100 automated hematology analyzer. Lab Hematol, 12(1), 11-14

Disclaimer

The clinical applications or uses presented in these materials have not been approved or cleared by the FDA. Example(s), including case studies, may be provided for illustration purposes only. Prior to using these devices, please review the manufacturer's Instructions for Use. It is the healthcare provider's responsibility to determine applicability in routine clinical practice.

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