GEM Premier 7000 with iQM3, unveiled at the ADLM Annual Meeting, introduces hemolysis detection at point-of-care, detecting and flagging hemolysis in 45 seconds.

RT’s Three Key Takeaways:

  1. Introduction of Hemolysis Detection: The GEM Premier 7000 with iQM3 by Werfen is a point-of-care blood gas testing system that features hemolysis detection.
  2. FDA Clearance and Presentation: The system has received 510(k) clearance from the US Food and Drug Administration and was unveiled at the Association for Laboratory Medicine (ADLM) Annual Meeting.
  3. Impact on Patient Care: The detection of hemolysis at the point of care can improve patient management, reduce inappropriate treatments and delays, and decrease healthcare costs by ensuring more accurate potassium level readings and other critical measurements.

Werfen unveiled the GEM Premier 7000 with Intelligent Quality Management 3 (iQM3), the first point-of-care blood gas testing system to offer hemolysis detection, at the Association for Laboratory Medicine (ADLM) Annual Meeting.

The system has received 510(k) clearance from the US Food and Drug Administration. 

As the number one source of preanalytical error, hemolysis accounts for up to 70% of all such errors.1 Despite its prevalence throughout different areas of the hospital, hemolysis is not visible in whole blood and can go unrecognized. Hemolysis occurs when red blood cell membranes rupture, causing cellular contents to leak into the surrounding fluid, which can elevate potassium results up to 152%.2 

In samples impacted by hemolysis, low potassium levels can appear normal, and normal levels can appear high. Consequences of in vitro hemolysis can include inappropriate patient management, increased length of stay, and increased costs, among others.3-7

“While hemolysis in point-of-care testing has been widely recognized as a significant problem, and the potential value of its detection tremendous, most have viewed this as an unsolvable challenge—until now. We are exceptionally proud to have solved this challenge with the patented technology in our new GEM Premier 7000 with iQM3 system,” says Remo Tazzi, vice president of worldwide marketing and service at Werfen, in a release. “Feedback from our initial customers has been very positive, and we look forward to expanding placements of these new systems throughout the US and ultimately the world to enhance both patient care and efficiency.”

Prevalence of Hemolysis in Hospitals

In vitro hemolysis is prevalent throughout the hospital. In neonatal intensive care units, up to half of whole blood samples have been shown to be hemolyzed, while in emergency departments, approximately 20% can be hemolyzed.1,8–10 Undetected hemolysis can lead to inappropriate or delayed treatment, unnecessary redraws, increased staff time, and higher costs.3-7

The system’s hemolysis detection is based upon patented acoustofluidic technology for plasma separation, combined with photometric determination. In 45 seconds, the GEM Premier 7000 detects hemolysis, while delivering a complete menu of results.

Quality Management

iQM3, a real-time, automated, quality management system, continuously ensures sample quality across the most common preanalytical errors, including hemolysis, micro-clots, bubbles, and lipemia. It automatically checks sample integrity before, during, and after every analysis, and corrects and documents errors. This helps assure quality results and compliance, 24/7, and informs and expedites critical decision-making, according to a release from Werfen.

The all-in-one GEM PAK cartridge is designed to automate labor- and skill-intensive processes and offer a variety of menu and test-volume configurations, tailored to the clinical setting. GEMweb Plus 500 Custom Connectivity aims to simplify control and compliance, enabling management of all systems, operators, and data oversight. Its sample handling reports help identify operator competency gaps and training needs.

Clinicians Perspective on Hemolysis Detection

“Every day our clinicians make critical decisions based on potassium measurements. Knowing whether a blood sample is hemolyzed is crucial for interpretation of potassium results,” says Heather Stieglitz, PhD, DABCC, co-director of clinical chemistry and point-of-care testing at The Ohio State University Wexner Medical Center, Columbus, Ohio, in a release. “While we have had the capability to detect hemolysis in a central laboratory, it was missing at the point of care. The GEM Premier 7000 closes this gap, and we are confident that our potassium results will allow clinicians to make safe and rapid decisions for the care of our patients.”

The GEM Premier 7000 with iQM3 system is the latest innovation in Werfen’s line of GEM Premier blood gas testing systems. The most recent, previously introduced model is the GEM Premier 5000 with iQM2, which introduced IntraSpect, performing continuous quality checks during sampling, in addition to before and after every sample.     

The GEM Premier 7000 with iQM3 system is not Health Canada-licensed. It is not available in all countries. 

References

  1. Lippi G, Salvagno GL, Favaloro EJ, Guidi GC. Survey on the prevalence of hemolytic specimens in an academic hospital according to collection facility: opportunities for quality improvement. Clin Chem Lab Med. 2009;47(5):616–618. 
  2. Lippi G, Plebani M, Di Somma S, Cervellin G. Hemolyzed specimens: a major challenge for emergency departments and clinical laboratories. Crit Rev Clin Lab Sci. 2011;48(3):143–153. 
  3. O’Hara M, Wheatley EG, Kazmierczak SC. The impact of undetected in vitro hemolysis or sample contamination on patient care and outcomes in point-of-care testing: a retrospective study. J Appl Lab Med. 2020;5(2):332-341. 
  4. Phelan MP, Ramos C, Walker LE, et al. The hidden cost of hemolyzed blood samples in the emergency department. J Appl Lab Med. 2021;6(6):1607–1610. 
  5. Phelan MP, Hustey FM, Good DM, Reineks EZ. Seeing red: blood sample hemolysis is associated with prolonged emergency department throughput. J Appl Lab Med. 2020;5(4):732–737. 
  6. Wilson M, Adelman S, Maitre JB, et al. Accuracy of hemolyzed potassium levels in the emergency department. West J Emerg Med. 2020;21(6):272–275. 
  7. Milutinović D, Andrijević I, Ličina M, Andrijević L. Confidence level in venipuncture and knowledge on causes of in vitro hemolysis among healthcare professionals. Biochem Med. 2015;25(3):401–409. 
  8. Nichols JH, Apple FS. Prevalence of hemolyzed results in acute care settings. J Appl Lab Med. 2023;8:431-434.
  9. Tóth J, Oláh AV, Petercsák T, et al. Detection of haemolysis, a frequent preanalytical problem in the serum of newborns and adults. EJIFCC. 2020;31(1):6
  10. Khedr S, Blake V, Erdogan E. Neonatal unit hemolysis rates from an academic medical center: A quality improvement project. Arch Path Lab. 2016;140(6):502-503.

Photo caption: GEM Premier 7000 with Intelligent Quality Management 3

Photo credit: Werfen