LabOratory: The Waived CBC: A Game Changer?

On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted market clearance for the first ever CLIA – waived hematology analyzer for complete blood count and three-part differential testing. This analyzer, the Sysmex XW-100, is for use in both traditional and non-traditional point of care patient settings, including physician offices, community health clinics, and other healthcare facilities, allowing a wide range of support staff to provide patients with blood test results in as few as three minutes.   While not intended to replace more complex laboratory hematology testing, this analyzer is the latest example of a trend to improve laboratory testing capabilities in the near-patient environment. The goal is to reduce the turn-around time for test results, thus improving the delivery of patient care.

 “A CBC is one of the most common physician-ordered tests used to evaluate a patient’s blood levels, determine if an infection is present and if immediate intervention is needed. However, in the current health care setting, non-hospitalized patients who require a CBC can experience at least a 24-hour wait for test results, if not longer, when the test is performed by an off-site laboratory,” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “This waiting period may be detrimental to the health of patients whose care depends on quick results to rule out conditions that may require immediate medical intervention. With the device cleared today, processing time may now be reduced by making testing available in these additional settings.”

In addition, 37% of patients said that not being able to get laboratory results during the same visit was the reason a health provider failed to meet their expectations. In the study, patients said they wanted to avoid travel to more than one location, and eliminate follow-up visits to discuss test results.   

The XW-100 Automated Hematology Analyzer is intended for use in patients 2 years of age and older who require a whole blood cell count and white blood cell differential. Test results can be used with other clinical and laboratory findings to provide early alerts of patients with serious conditions such as severe anemia and agranulocytosis, who require additional testing. However, it is not intended to diagnose or monitor patients with primary and/or secondary hematologic diseases, including oncology and critically ill patients. The analyzer provides a complete blood count and a 3-part differential; a 12 parameter blood component profile as part of an overall patient health assessment.

Some in the clinical laboratory profession have expressed concern that a waived CBC test now has received FDA clearance. In part, that’s because there are examples of waived tests where untrained operators performed tests that produced inaccurate results for reasons ranging from an analyzer out of control and use of outdated reagents, to failure to properly perform quality control. These experiences are why it is important for Sysmex to tell the story behind the FDA’s clearance of a waived CBC. “Test processes were stripped to the essentials during the design process to meet requirements for ease-of-use, and to reduce risk, user error, and erroneous test results” said Ralph Taylor, CEO of Sysmex America. Inc. 

 

The Sysmex XW-100 Analyzer

 

 

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The CBC and Three-Part Differential:  uses a 15 µL sample of venous blood to provide clinically useful results. 

Analyses include:

  • White Blood Cell Count (WBC)
  • Red Blood Cell Count (RBC)
  • Hemoglobin (HGB)
  • Hematocrit (HCT)
  • Mean Corpuscular Volume (MCV)
  • Platelet Count (PLT)
  • Neutrophil Count (NEUT#)
  • Lymphocyte Count (LYM#)
  • Other White Blood Cell Count (Other WBC#)
  • Neutrophil Percentage (NEUT%)
  • Lymphocyte Percentage (LYM%)
  • Other White Blood Cell Percentage (Other WBC%)
  • MCH (calculateda0
  • MCHC(calculated)
  • RDW-SD (calculated)
  • RDW-CV (calculated)
  • MPV (calculated)

 

 

Key Differences in the New Sysmex Compared to Moderately Complex Analyzers

 

  • Missing are comprehensive reporting, and integration with the LIS and/or EHR. “This was by design,” noted Taylor. The FDA clearance as a waived test allows operators in CLIA-waived facilities to operate the system. 

 

  • The Sysmex XW-100 has several innovative features. “This benchtop analyzer requires no additional training to set up upon arrival,” explained Taylor. “Operator training consists of a brief video outlining basic features. Everything else is handled through onscreen prompts that walk operators step-by-step through the initial data-entry processes and starting the CBC test. “When started, the analyzer connects to Sysmex to verify reagent authenticity and expiration dates, and check control values,” he continued. “The instrument also stays connected to Sysmex and rechecks these after every eight hours of laboratory use, and when reagents are changed” 

 

  • Unlike more complex hematology analyzers, this system does not report to Sysmex outside of routine data checks. It also does not transmit data locally within the healthcare setting. Instead, it produces paper printouts of CBC and three-part differential results, which the physician uses to support diagnosis and treatment decisions. In addition to the print-out, the XW-100 stores the results of the last 100 tests on a first-in/first-out basis. 

 

  • “Values outside of the normal ranges are flagged and reported. For results outside of critical ranges, the numerical results are not reported to the operator and follow-up steps are recommended instead, such as referring the specimen to a core laboratory for test completion,” noted Taylor. “This ensures that erroneous data is not used to support the diagnosis or treat conditions.” Should tests return abnormal results due to machine error, or if the operator cannot bring the analyzer within standard control ranges, the machine locks out all operators, blanks out all viewable test data, and reports to Sysmex. “What happens next is a unique feature of this system,” added Taylor. “Sysmex will deliver a replacement analyzer the next day. Physicians return the malfunctioning unit using the box in which their new unit was delivered. This reduces maintenance and training requirements, ensures proper operation of the analyzer, and minimizes downtime for the physician.”

 

A sign of the times, and the universal application of modern digital technology is that Sysmex has adopted the same replacement policy that consumers expect with their computers, printers, smart phones, and similar devices. Call the company, report the malfunction, and a replacement is immediately shipped with a return label so that the malfunctioning device can be sent back to the manufacturer. 

 

For moderately complex labs that may worry about demand for one of its highest-volume tests shifting to POL and CLIA-waived environments, and taking revenue streams with them, here are some additional considerations: 

Under Defined Conditions Blood Samples Will Still Be Referred To the Core Lab: 

 

“This analyzer is designed so that samples will still be referred to central labs for either repeat testing or more detailed hematology tests that will give a greater level of information back to clinicians,” stated Taylor. “Our goal with this analyzer is to deliver information within the POL environment that allows clinicians to respond quickly and rapidly to begin treatment. Meanwhile, central labs will continue to provide detailed information that will be used to further refine treatment”’ 

 

 

 

Conclusion

 

The Sysmex XW-100 hematology analyzer is the first waived CBC with 3-part differential, approved by the FDA.  It is an analyzer that enables on-site CBC testing at near patient sites, resulting in more rapid patient treatment at reduced cost, saving the patient time, and return visits.  It also enhances efforts to enact value-based medicine through improved efficiency and cost savings.  However, many operational restrictions have been built into this instrument in order to ensure that facility staff can operate it without sacrificing patient safety. It is also not intended for higher levels of patient test volume; nor to be used for automated transmission of test results remotely.

 

It is intended for use in patients 2 years of age and older who require a whole blood cell count and white blood cell differential However, it is not intended to diagnose or monitor patients with primary and/or secondary hematologic diseases, including oncology and critically ill patients. While many point of care sites may acquire this analyzer to enable them to provide improved patient care, especially if they do not presently have an analyzer that can provide differentials,   the built in restrictions will more likely limit its use in larger facilities to that of supplementing the more complex hematology instruments that have a  larger test menu,  rapid throughput, and greater IT capabilities.

 

Irwin Z. Rothenberg is a Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel, and allied health professionals.  CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at www.criedu.org or call 1-800-981-9883.

 


Irwin Z. Rothenberg, MBA, MS, M.T. (ASCP)

Technical Writer/ Quality Advisor, COLA Resources, Inc.