Financial Disclosure Coagulation Automation in the Academic Laboratory There are no relevant financial or nonfinancial relationships to disclose. Presented by: Letycia Catalina Núñez Argote, MPH, MLS(ASCP) CM and Cherika Robertson, MLS(ASCP) CM University of Arkansas for Medical Sciences Learning Objectives Identify key testing differences between the existing semi-automated and the new fullyautomated coagulation systems. Discuss the value of different testing techniques based on student feedback and experience. Explain how automated coagulation in the academic setting has the potential to be a learning tool to better prepare students for their professional experience. Hemostasis and Coagulation Testing Maintain blood flow in the intact vessels in normal circulation Arrest blood loss from injury or trauma Problems with Coagulation Excess bleeding Excess clotting Coagulation testing in the Clinical laboratory Routine and Diagnostic Tests Mugan, K. (2002). Coagulation in the MLS Academic Curriculum BOC Included in Hematology (17-22%) Platelets and Hemostasis NAACLS guidelines [ ]the medical laboratory scientist will possess the entry level competencies necessary to perform the full range of clinical laboratory tests in areas [ ] Hematology/Hemostasis Coagulation in Accredited programs 228 MLS programs follow BOC format Teaching Laboratory Theory vs. Practice Is providing hands-on experience in Coagulation relevant in the Academic setting? 1
Before 2015 One 3 hour session per semester Tilt tube Fibrinometer Electra 750 2015 New equipment added Siemens CA-600 Coagulation Lab For this study Participants 21 MLS Students 2 different days Tests performed PT and PTT Principles Normal ranges (Rodak) PT/INR: 12.6-14.6 seconds / 0.93-1.13 PTT: 25-35 seconds Student Survey Variables considered Instruments Pre-analytical Phlebotomy Sample handling Analytical Testing Post-analytical Reporting results Electra-750 Semi-automated Photometric method utilizes the change in optical density of plasma to detect a clotting endpoint Cross-contamination prevented because nothing comes in contact with specimen On-Board heating block maintains samples, pipettes, tips, reagents at 37 Reagent reservoir with magnetic stirring and special pipettes that automatically start the clottiming circuitry when reagent is added to patient sample Siemens CA-600 Instruments Automated Photo-optical detection of clot by LED lamp source. Single heated probe dispensing mechanism. Manual placement of reagents. On-board reagent rack set at controlled temperatures. Maximum load: 10 sample tubes. Single reaction tubes. Built in touch screen. Automated probe rinse eliminates manual steps. Simultaneous analysis of results. Specific reagents- PT: Dade Innovin PTT: Dade Actin FSL Reagent QC comparison between methods Student samples PT Testing Results 9.8 16.5 16 Normal Abnormal Auto Semi-auto Auto Semi-auto Mean 12 16.67 50.5 84.56 σ 1.41 1.36 3.5 12.7 P 0.05 0.0003 10.6 10.8 Results for PT test in seconds 17 16 16 10.2 9.8 8.6 19 15.5 9.3 9.5 1 2 3 4 5 6 7 8 17 PT Automated PT Semi-automated 2
QC comparison between methods Student samples PTT Testing Results 26.7 24 Normal Abnormal Auto Semi-auto Auto Semi-auto Mean 28 28.6 53 69.6 σ 2.8 1.5 5.7 2.8 P 0.83 0.15 28.1 25 Results for PTT test in seconds 29.2 28.8 25.5 25 28.1 28.1 28 28.5 26 Student Survey Results 1 2 3 4 5 6 7 8 PTT Auto PTT manual 52% of participants responded to survey Including multiple instruments, such as the Electra 750 semiautomated, and the Sysmex automated instrument was helpful for students to learn basic concepts of coagulation testing in the academic lab. 91% of students agree by responding with a 6 or greater. Sysmex CA600 will better prepare students for an internship at a clinical site. All participants responded with a 6 or better. Sysmex CA600 at the academic lab teaches students about troubleshooting and sample flow. 91% of students responded with a 6 or better. 1 student did respond with a 3.* Sysmex CA600 at the academic lab teaches students skills that can be easily translated to the clinical setting. All participants agreed by responding with a 6 or better. Sysmex CA600 at the academic lab teaches students about the importance of quality control in the clinical lab. 91% of students responded with a 6 or better. Different instrumentation 3
Impact on Clinical Experience: The exposure to different instruments will help us be prepared to work with different kinds of machines in the field. Offered various methods of coagulation and showed evolution of technology: I liked learning about all the different instruments because it gave you a better sense of different ways to coagulation. What do you suggest should be improved in using different instruments in the academic lab? Opportunities for more than one chance to use instrument/more time with the instrument: Having more instructors to help run the instruments and explain how they work theoretically would be nice. Old vs. New Coagulation analyzer Technical aspect QC results Normal comparable between two methods Abnormal had systematic differences (error) Student samples PT results were very different between two methods PTT results comparable Student response Positive feedback from students Improvements Allow students more hands-on time with the CA 600: Students could run quality control on certain hematology lab meetings throughout the semester. Students could run their samples on each instrument. Limitations Financial Cost of reagents Time Curriculum changes to allow more hands-on experience Result variance Operator variability QC reagents Instrument malfunction 4
Future Uses of Instrumentation in Coagulation Teaching Labs Use Electra-700 as demo Principle Experience Siemens CA-600 Add Fibrinogen into curriculum. Have students perform quality control. Allow students to use instruments for senior projects or other research opportunities. Summary Being able to compare different testing methods prepares students for their future as laboratory professionals. Academic lab can provide valuable experience to students by including semi-automated and automated testing. Survey feedback shows that automated coagulation testing is useful in the academic setting References American Society for Clinical Pathology. (2014). ASCP Board of Certification Medical Laboratory Scientist, MLS(ASCP), International Medical Laboratory Scientist, MLS(ASCP i ) Examination Content Guideline & Outline. Obtained from http://www.ascp.org/pdf/bocpdfs/guidelines/examinationcontentguidelinemls.aspx Bonar, R., Favaloro, E. J., & Adcock, D.M. (2010). Quality in coagulation and haemostasis testing. Biochemia Medica: The Journal of Croatian Society of Medical Biochemistry and Laboratory Medicine, 20(2), 184-99. http://dx.doi.org/10.11613/bm.2010.023 Medical Laboratory Automation. (1990). Electra 750/750A Instruction Manual. Pleasantville, NY: Medical Laboratory Automation, Inc. Mugan, K. (2002, April 1). Cascading through coagulation testing standards. Advance Healthcare Network for Laboratory, 46-53. Obtained from http://laboratory- manager.advanceweb.com/article/cascading-through-coagulation-testing- Standards.aspx#AnchorComment National Accrediting Agency for Clinical Laboratory Sciences. NAACLS Standards for Accredited and Approved Programs. (2015). Obtained from http://www.naacls.org/docs/standards2012.pdf Rodak, B. F., Fritsma, G. A., & Keohane, E. M. (2012). Hematology: Clinical principles and applications (4th ed.). St. Louis, Mo.: Elsevier Saunders. Siemens Healthcare Diagnostics. (2012) Sysmex CA-600 series technical specifications sheet. Tarrytown, NY: Siemens Healthcare Diagnostics, Inc. 5