Reshaping healthcare at the clinical laboratory level

CONTINUING EDUCATION

To earn CEUs, visit
mlo-online.com
and see this month’s test by clicking the CE menu item.

LEARNING OBJECTIVES

Upon completion of this article, the reader will be able to:

1. recognize implications of hematology automated measurements with patient accountability;
2. define the clinical parameters of RET-He, IPF and IG; and
3. recognize how use of the new parameters can facilitate LEAN operations.

Proposed new rules for accountable care organizations (ACOs) released by the U.S. Department of Health and Human Services (HHS) March 31, 2011,¹ are designed to help doctors, hospitals, and other healthcare providers better coordinate care for Medicare patients across care settings — including doctors’ offices, hospitals, and long-term care facilities. The Medicare Shared Savings Program will reward ACOs that lower healthcare costs while meeting performance standards on quality of care and putting patients first.

As ACOs continue to be noted in national dialogue as a model that may reshape healthcare by helping to improve quality of care, increase efficiency, and reduce overall healthcare spending, we might ask what clinical laboratory departments can do to create their own “accountable care” laboratory models, which, in turn, would contribute to the efficiency and productivity of their hospitals overall. To answer this question, clinical laboratory professionals will want to consider reshaping their laboratories with clinical, operational, and financial foci.

Clinical excellence

The spectrum of clinical excellence begins with the core technology and clinical utility of a laboratory’s instrumentation and ends with diagnosis, treatment, and improved quality of life for the patient. As such, reliable best-in-class automated hematology systems with advanced, clinically relevant parameters that can potentially impact treatment guidelines, care pathways, patient flow, and return on investment are essential. Clinical laboratories will want to ensure that these advanced, clinical parameters can be automatically measured in the course of routine hematology testing and require minimal additional capital, labor, or reagents.

Refinement of already-embedded technologies has presented hematology laboratories with three new clinical parameters: reticulocyte hemoglobin (RET-He), immature platelet fraction (IPF), and immature granulocytes (IG). All three are fully reportable and all have one thing in common: the ability to analyze cell precursors to provide physicians with more information to help drive treatment decisions and a positive patient outcome. These three parameters meet key test criteria: clinical relevance, reliability and speed, and affordability.

Reticulocyte hemoglobin (RET-He)

Whether automated or performed manually, the reticulocyte count has been a mainstay for studying anemias and anticipating recovery of the red-cell population. A closer look at the reticulocyte population, however, can provide more information than the reticulocyte count alone since red-cell production does not necessarily mean the iron carrying capacity of the red-cell population is certain. Nor do iron-store estimates provide an assessment of the availability of iron for introduction into developing erythrocytes. Significant, rapid increases in red-cell production can overwhelm available iron stores, resulting in a hypochromic anemia due to functional iron deficiency².

RET-He is a measure of the hemoglobin content of reticulocytes and is a direct assessment of the incorporation of iron into erythrocyte hemoglobin, reflecting recent functional availability of iron. A study performed at DaVita and published in the American Journal of Kidney Diseases³ demonstrated the clinical application of RET-He, by physicians, as an indicator for anemia treatment decisions in end-stage renal disease patients on hemodialysis. RET-He is now an established parameter in the National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines for assessing the initial iron status of hemodialysis patients with chronic kidney disease. It is also used to assess IV iron replacement in these patients versus measuring storage or transport proteins, serum iron, or using algorithms which incorporate indirect assumptions. RET-He is now a routinely reported parameter.

Immature platelet fraction (IPF)

Platelet counts have been a challenging parameter for hematology instruments, particularly for low platelet counts. Recently, clinicians have been looking at the IPF as an indicator of imminent platelet recovery and as an indirect means to better evaluate the need for platelet transfusion.

In 1992, Ault, et al,⁴ publishing in the American Journal of Clinical Pathology, coined the term “reticulated platelets” to describe platelets with elevated nucleic-acid content. This platelet population also is characterized as having larger, more physiologically active platelets and is analogous to the red-cell immature reticulocyte fraction. This immature population is now referred to as the immature platelet fraction (IPF) and can be measured automatically through routine hematology analyzers. IPF is now accepted as an indicator of the rate of thrombopoiesis and platelet-count recovery. It is also able to help determine the etiology of thrombocytopenia by differentiating increased platelet destruction versus increased platelet consumption. The IPF, along with other clinical signs and symptoms, may also have the potential to be used by the physician to limit platelet transfusions in the recovering patient.

Immature granulocytes (IG)

Manual counts in the hematology laboratory are becoming a thing of the past now that the abnormal white-cell differential is automated. Instruments are able to identify and provide an absolute count and percent of the IG population comprised of metamyelocytes, myelocytes, and promyelocytes. Analysis is based on their increased fluorescence emission due to higher levels of DNA and RNA versus mature neutrophils. The measurement is made in seconds and is reported automatically with the other CBC results. This ability allows for enumeration of a large number of neutrophils at various levels of maturity — certainly beyond that possible with a 100-cell manual differential — and is critical in neutropenic samples. Furthermore, this comprehensive reporting may help improve laboratory productivity by eliminating manual reviews on systems that rely on “flags” to indicate the need for a manual examination for immature granulocytes, some of which will be false-positives.

In a study by Briggs published in Laboratory Hematology of 210 patients known to have infection or inflammation, the IG counts were often positive (>2%) when other known markers of infection (CRP, ESR, CD64, and IL6) were negative.⁵
Now that the lab is able to report the IG population with a high degree of accuracy and precision, the clinical utility of the white-blood-cell (WBC) count and differential can significantly increase, giving physicians additional diagnostic parameters to consider when assessing inflammation and acute infection for timely intervention with appropriate therapeutics. It is evident that the clinical utility of automated hematology parameters is increasing and being efficiently generated.

Operational efficiency

From an operational perspective, efficiencies within high-volume testing departments such as hematology are highly measurable. Specific measurements that are taken within this department include turnaround times, staffing utilization, operational costs, workflow efficiency, and productivity. Quality is also tightly controlled and it is enhanced with the application of LEAN and Six-Sigma principles to further improve processes by reducing errors. Additionally, hematology laboratories depend on automation and standardization to maximize efficiencies.

With these kinds of metrics already in place, we might ask, “How much more operationally efficient can a hematology laboratory be?” An integrated hospital network (IHN) provides a good example. From New York to the state of Washington, IHNs are reshaping their testing environments to address forecasted medical technologist shortages. The American Society for Clinical Pathology’s 2011 Vacancy Survey of U.S. Clinical Laboratories⁶ surveyed 625 facilities. Of the eight laboratory disciplines studied, hematology ranked fourth with nearly 7% vacancy rates reported. Of those working in hematology laboratories, 14.4% are expected to retire within the next five years.

More efficient instrument systems that generate high quality, reproducible results from all laboratory sites across a system will help hematology laboratories shift personnel between laboratory venues without the need to cross train on different types of analyzers; withstand future medical technologists’ shortages by handling increased workloads without the addition of personnel; and keep up with workload demands and testing complexity that may accompany our country’s aging population.

Costs and labor pressures will continue to weigh heavily on IHN laboratories. In response, labs will seek automation to minimize “test-tube touch-points” and improve standardization within the laboratory and across the enterprise. These challenges can best be met through a laboratory strategy that focuses on sample- and data-process control.

Standardization is achieved by using instrumentation with similar technologies, while offering different levels of sample throughput. Labs, especially those in large integrated health networks, are looking for standardization and scalability across the enterprise. IHNs require instruments that produce the same quality results (using the same technologies, the same reagents, and the same software-management system) and have the ability to scale up and down, depending on the test volume at the individual lab location. Applied rules must be the same 24/7 and across all instrumentation. Samples need to be handled the same way, regardless of shift or day of the week.

IHN medical technologists review a variety of data to validate results: instrument flags, demographic data, and comparison with previous results without subjective results variations. The time-consuming process of validation of manual, paper-based result comparison and unnecessary rerun testing needs to be eliminated. An instrument solution should help address these labor intensive, error-prone processes and have the ability also to manage the tube from pre- through post-analytical phase.

Hematology laboratories can achieve dramatic results and raise process standardization by applying rules-based decision-making software within their testing environment. The rules engine should be robust and comprehensive and should be able to handle complex decisions such as evaluating whether a smear needs to be prepared based on the “presence” of an instrument flag and/or a combination of demographic indicators and whether a slide was “not” made previously within a laboratory’s defined time frame.

Multivariable rules can be used to autovalidate 70% to 80% of hematology results, releasing them to the chart without operator intervention allowing technologists to focus on the remaining 20% to 30% of variant results that require additional decision-making. Labs can achieve dramatic results when combining many variables to build their rules, which can be very specific and may be adapted as the laboratory changes.

At New York Hospital Queens (NYHQ), a part of the New York-Presbyterian Health Care System, more than 2.3 million tests are performed yearly. The hematology department processes over 1,000 samples per day including 1,600 hemoglobin A1cs (HbA1c) per month on a fully automated lavender-top track system. The “line” consists of two advanced technology hematology analyzers, a slide-maker stainer, a hemoglobin A1c instrument, a tube sorter/archiver, and decision-logic software. The laboratory also has an automated digital-imaging system to help improve efficiencies and achieve standardization with its smear-review process. This comprehensive automation solution achieves a higher level of efficiency, process standardization, and staff utilization analyzing >90% of tests from lavender-top tubes and 100% of pre- and post-analytical sample handling. The laboratory is now autoverifying 85% to 90% of both CBCs and HbA1c results. The entire line is managed by only two technologists during peak workloads. According to Alfonso Ziccardi, MT(ASCP), assistant laboratory operations manager at NYHQ, true laboratory standardization is achieved by applying the same decision-making rules across the system.

In conjunction with standardization of instruments, IHNs need to standardize review and management of quality-control (QC) practices and results. Middleware-managed QC software, using system-wide rules that consistently evaluate QC across all labs, shifts, and technologists, meets these needs. Standardized QC qualification enables the IHN to measure instrument precision across the same lot numbers and across all sites by instrument type. This information can provide the ability to quickly identify QC trends (proactively versus retrospectively) to minimize risk to patient reporting. An enterprise view of QC viewed both graphically and statistically in real time, provides one more tool to help improve medical outcomes.

On the West Coast, PeaceHealth Laboratories recently standardized hematology testing across all nine of their laboratory sites. PeaceHealth installed an automated hematology track system in its high-volume core lab and three same-technology analyzers from the same vendor to accommodate workload variations at its other sites. PeaceHealth, a not-for-profit IHN which services Alaska, Washington, and Oregon, consistently receives national recognition for innovations in patient-centered care, patient safety, healthcare technology, and cost efficiency.

One PeaceHealth hematology laboratory, Longview, under the direction of Jerry Pittman, MT(ASCP), has managed a 40% increase in volume — and the implementation of new clinical parameters — with no additional staff and no prolongation of turnaround times. Pittman believes that recent advances in automated differential analyzers that allow for quantitative IG reporting has resulted in the biggest net efficiency change in how his hematology laboratory functions. By using all of the information the instrument provides, not just quantitative cell counts, he has cut manual smear reviews virtually in half. With decision-making, rules-based efficiency, and a significant amount of validation data on file, this hematology laboratory is now reporting up to 4% IGs without operator review due to the confidence they have in its analyzer.

By standardizing instrument platforms, information integration, and advanced technologies, integrated health networks can achieve unexpected levels of optimization for laboratory operations that literally transform their productivity.

Reimbursement and survival

In October 2008, the Centers for Medicare and Medicaid Services introduced significant restructuring of the diagnostic-related groups (DRGs) to medical-severity diagnosis-related groups (MS-DRGs) used in the inpatient prospective payment system (IPPS). New present-on-admission (POA) rules require evidence-based patient diagnosis on admission. This will impact how hospitals code patients upon admission and, consequently, the way in which hospitals are reimbursed. This, along with an aging American population, increasingly complex cases and diminished human and financial resources, make accurate patient diagnosis and instrument capability critical elements to adequate reimbursement and hospital survival.

Anticipating this need at NYHQ, the hematology laboratory is now conducting a study of the IG parameter and its ability to correlate with a positive blood culture, so that if a person arrives in the emergency department with an infection, the lab will have another tool to use to identify on admission that the infection was pre-existing and does not constitute a hospital-acquired infection, or HAI, which has reimbursement issues.

The crucial question

As the nation’s leaders continue their endeavors to reshape healthcare via new models of efficiency such as ACOs, clinical-laboratory instrument manufacturers must ask the question: “How is the clinical laboratory going to evolve over the years to come, and what can we do to shape and support that development?” Will new cellular studies that are able to assess red cell, white cell, and platelet precursors, and provide quantitative assessments usher in an age of “predictive hematology” that could significantly impact therapeutic choices and lessen interventional studies, contributing to patient safety? Manufacturers will need to make significant technology changes that impact clinical outcomes and costs. As such, clinical laboratories will want to make purchasing decisions based on a total “solution” strategy rather than on technology and throughput alone.

More than ever before, healthcare providers must balance the need to provide quality patient care with the need to deliver that care as efficiently and cost effectively as possible. These needs are not going to change, so it is the instrument manufacturers’ responsibility to provide products and service that help meet these needs today and in the long-term. Clinical labs, in turn, can create accountable-care laboratory models that have the potential to reshape healthcare at the clinical-laboratory level. By thoroughly considering reliable automated hematology systems with advanced, clinically relevant parameters, clinical laboratories can potentially impact treatment guidelines, care pathways, patient flow, and return on investment.

Both from Sysmex America, Mundelein, IL, Nilam Patel, MT(ASCP)SH, is senior product manager of Automation Solutions, and Barbara Connell, MS, MT(ASCP)SH is senior manager, Scientific Marketing. Sysmex’s broad platform of hematology solutions provides a standardized yet scalable set of hematology analyzers and middleware-support software. Standardization offers consistent operation, control materials, and workflow for comparable results with easy access to complex data across multi-site, multi-LIS organizations.

References

1. Centers for Medicare and Medicaid Services (CMS), HHS; Medicare Program; Medicare Shared Savings Program: Accountable Care Organization; HHS Press Office.
2. Rutherford C, Schneider T, Dempsey K, et al. Efficacy of different dosing regimens for recombinant human erythropoietin in a simulated pre-surgical setting: the importance of iron availability in optimizing response. Am J Medicine. 1994;96:139-145.
3. Van Wyck DB, Alcorn H, Gupta R. Analytical and Biological Variation in Measures of Anemia and Iron Status in Patients Treated with Maintenance Hemodialysis. Am J Kidney Diseases. 2010.
4. Ault KA, Rinder HM, Mitchell J, et al. The significance of platelets with increased RNA Content (reticulated platelets). A measure of the rate of thrombopoiesis. Am J Clin Path. 1992;98:637-646.
5. Briggs C, et al. Evaluation of Immature Granulocyte Counts by the XE-IG Master: Upgraded Software for the XE-2100 Automated Hematology Analyzer. Lab Hematol. 2003;9:117-124.
6. American Society for Clinical Pathology (ASCP), 2011 Vacancy Survey of U.S. Clinical Laboratories. Survey. Accessed May 1, 2011.