1. 1 POC Testing: Analyzer Developments & Targeted Survey Standards Michaela Cvitkovic, BS., MT(ASCP) Laboratory Compliance Manager SpecialtyCare, Inc.

2. 2 ANALYZER COMPARISONS & DEVELOPMENTS Bleeding Management: ROTEM delta & TEG 5000 New Developments Quality Control POC analyzer Blood Gases: epoc & iSTAT1

3. 3 CVOR POC Lab Deficiencies Competency Credentialing Q.C. Failures Temperature Controlled Spaces

4. 4 Top Deficiencies Cited by JCAHO and CAP

5. 5 COMPETENCY & the NEW employee Must complete an Initial Training, before patient testing Must complete semi-annually competency during the first year of duties, by 6 months Continue with current staff on an annual basis

6. 6 COMPETENCY New Equipment – non-waived testing Retain Original Training Documents!! Implementation of new methodologies must have documentation of Initial Training (i.e. iSTAT1 to Gem3500). Even if the analyzer is an upgrade must retain original training material (i.e. iSTAT 200 to iSTAT1 – Signature Plus to Elite). Save this documentation as long as the analyzer is available for patient testing.

7. 7 CREDENTIALS Testing Personnel Limitations Perfusion Certification is not a CLIA defined eligibility route – may be asked to produce H.S. Diploma Know who is permitted to be classified as Testing Personnel. For example, in CA – Perfusionists are exempt from the lab licensing for patient testing, but staff like Perfusion Assistants or Anesthesia Technicians, are not.

8. 8 QUALITY CONTROL Failures Two consecutive wet failures in a row will trigger a repeat of the 10 or 30 day EQC study – depending on the analyzer. If have a wet failure on an analyzer that uses EQC, carefully determine C.A. before proceeding. Do not continue to repeat wets until get one in-range!

9. 9 TEMERATURES Refrigerator & Room If supplies (cartridges, QC) are being stored in a small local (O.R.) Refrigerator, there must be indication of temperature monitoring. CAP requires daily. If Refrigerator is not hard wired to Engineering or continuously monitored in some manner, must be manual documentation. If have supplies kept at Room Temp, such as cartridges, should have a monitoring system also.

10. 10 TEMERATURE Documentation acceptable range - C or F must be consistent - tightest range in use, (iSTAT 18-30 RT while Gem Cart 15-25) area for corrective action daily temp in addition to Min/Max – Daily is specified in CAP Checklist standards! monthly review w/ date & initials explanation of date w/out temp recorded

11. 11 ANALYZER COMPARISON – POC Blood Gas

12. 12 Epocal epoc ® System distributed by Alere Host Reader Test Card

13. 13 Epocal epoc ® System – Single-use, self-calibrating, 95 mL WB sample – Blood gases, electrolytes, metabolites and hematocrit on a single cartridge Common features vs. comparable POC analyzer: – Data management

14. 14 epoc system up to 6-month Room Temp shelf-life from date of manufacture bar coded cards read on insertion Unique features vs. comparable POC analyzer:

15. 15 epoc vs. iSTAT1 Room Temp storage only Room Temp cart storage for 2 wks 1pt cal before sample added, 165 sec ( 2.75 min ) 1 pt cal w/ sample upon cart. insertion 35 secs sample only Separate ABG, Lytes, Metabolite & Hct QC vials 130-200 secs Cal & sample processing Available Eurotrol QC ABG, Lytes, Metabolites & Hct one vial

16. 16 epoc vs. iSTAT1 Notification of update via e-m and installation from EDM via WiFi Updates mailed 2x/yr self-installed epoc analyzer = Reader & Host - Multiple Readers w/ 1 Host Analyzer all inclusive

17. 17 epoc vs. iSTAT1 Cart read upon insertion; each individually bar coded Each cartridge pouch manually scanned BGEM: pH, pCO2, pO2, Na, K, iCa, Glucose, Lactate, Hct CG8+ (No Lactate) Reader = Lithium Ion rechargeable battery only Rechargeable or Disposable batteries Only cartridge is BGEM Multitude of cartridge configurations

18. 18 epoc vs. iSTAT1 Automated Internal QC ( iQC ) - No External Sim. Internal QC & also External Simulator Host display Windows-like Basic text display

19. 19 epoc Future Developments as related to CVOR: Coag: ACT, PT, aPTT Creation of single-vial QC to contain ABG, Lytes, Metabolites & Hct

20. 20 New development in QC ABG, Lytes, Metabolites & Hct in one vial Eurotrol QC one ampule all analytes

21. 21 Eurotrol QC Hyperbaric X-High 710 mmHg

22. 22 Eurotrol QC Hypoxic X-Low 15 mmHg Generic for all blood gas analyzers – one range fits all

23. 23 Eurotrol Hyper & Hypoxic HYPER - – published ranges for iSTAT – use on any ABG analyzer, but must establish In House ranges HYPO - – one published range for all analyzers

24. 24 ANALYZER COMPARISON – Bleeding Management

25. 25 ROTEM ® delta

26. 26 ROTEM ® delta System Thromboelastometry 1600 units in clinical use in 50 countries more than 500 publications

27. 27 ROTEM delta System Common feature vs. comparable analyzer is the analysis platform: Clot formation, strength & stability, and subsequent lysis.

28. 28 ROTEM ® vs. TEG 5000 ® GENERAL INFO –Incorporated in July 2008 –Primarily targeted researchers at the start –2-test approval 3/23/10, in-tem & hep-tem –Additional 3 tests approved 8/12/11 –April 2000 Haemoscope received the 510K –Purchased by Haemonetics 11/21/07 –5 tests with different activators

29. 29 ROTEM vs. TEG 5000 Classical or Original method: Thromboelastography – originally described by H. Hartert in 1948 & trademarked by Haemoscope. Principle: cuvette is rotated and as clot forms it links the pin & cup together; movement of the pin is converted to electrical signals Rotational Thromboelastometry trademarked by Rotem Principle: pin oscillates as the cup remains stationary & as clot forms rotation becomes restricted & clot firmness detected optically PRINCIPLE

30. 30 ROTEM delta & TEG 5000 PRINCIPLE via graphics Cup takes 10 seconds per rotation Electrical detection Pin makes 13 oscillations per minute Optical detection

31. 31 ROTEM vs. TEG 5000 Control unit integrated Control unit on separate PC Some leveling requiredNo leveling required (constant monitoring system) 4 channel instrument COMPONENTS 2 channel instrument Up to 8 channels can run on one PC Scan can be viewed remotely using Secure Viewer software Scan can be viewed remotely

32. 32 ROTEM vs. TEG 5000 Automated pipette Manual pipetting Temp can be adjusted for Hypothermia COMPONENTS Touch screen monitor N/A (unless computer is set up as such)

33. 33 ROTEM vs. TEG 5000 EQC Option 2 – Aqueous QCs once/week Aqueous QCs every 8 hours of patient testing QUALITY CONTROL ROTROL N and ROTROL P Continuously monitors: Phase Shift, Variance, Center, Amplitude, Temperature No continuous monitoring, however eTest verifies and/or maintains the electronic functioning of the analyzer Level I and II QC

34. 34 ROTEM vs. TEG 5000 Both have available Proficiency Testing with CAP & API TEG5000 also has PlateletMapping Proficiency Testing with CAP REGULATORY CMS reimbursement available

35. 35 ROTEM vs. TEG 5000 SAMPLE PREP Citrated samples – must sit for at least 15 min, but run within 2 hours Non-Citrated samples – must be run within 4-6 minutes Once draw into Citrated tube, sample can be run immediately, or up to 4 hrs later.

36. 36 ROTEM vs. TEG 5000 intrinsic pathway in citrated whole blood specimens TEST MENU the intrinsic pathway in the presence of unfractionated heparin, in citrated whole blood specimens (open heart) research and less clinical practicality - Kaolin activator, Citrated sample - Kaolin activated, non-Citrated - Kaolin activator, Citrated sample, in Blue Heparinase cup - Kaolin activated, non-Citrated s. in Blue Heparinase cup - Non-activated, Citrated sample - Non-activated, non-Citrated s. in-tem® hep-tem® NATEM®

37. 37 ROTEM vs. TEG 5000 hemostasis via the extrinsic pathway TEST MENU measuring fibrinogen contribution to the clot detects hyperfibrinolysis RapidTEG, (TEG-ACT) non-citrated or citrated Research protocols using Tissue Factor alone Functional Fibrinogen non-citrated or citrated LY30 and lysis parameters in all TEG assays ex-tem® fib-tem® ap-tem® Rotem tests approved 8/12/11

38. 38 ROTEM vs. TEG 5000 TEST MENU Platelet function PlateletMapping® Assay - Activator F - ADP (tests for GPIIb/IIIa receptors) clopidogrel, etc - Arachidonic Acid (test for aspirin and other NSAIDs) N/A No anticoagulant or activator (liver transplants) Native, non-activated non-anticoagulated or citrated N/A

39. 39 ROTEM vs. TEG 5000 ROTEM - Does offer on-line FUZE Training. Data Interpretation using PowerPoint Presentation. - Discuss temogram interpretations. DECISION TREE

40. 40 TEG 5000 - Scan

41. 41 ROTEM ® - Screenshot Clot Quality Lysis ML (%) A20 = Clot Firmness (mm) 20 minutes after CT

42. 42 ROTEM vs. TEG 5000 CT - Clot Time, (seconds) R = Reaction time, (minutes) Time to initial fibrin formation CFT – Clot Formation Time (seconds) K = Coagulation time, (minutes) Speed of fibrin build up α Angle – Alpha Angle, (°) a = alpha angle, (°) Speed of clot strengthening MCF – Maximum Clot Firmness, (mm) MA = maximum amplitude, (mm) Strength of clot A (x) – Amplitude at a time point (minutes) 10/15/20/25/30 mm No equivalent parameter SCAN PARAMETERS

43. 43 ANALYZER WITH PENDING FDA SUBMISSION & APPROVAL

44. 44 HELENA ABRAZO Must stress For Investigational Use Only at this time FDA Submission in Sept 2011 Tests to be submitted for FDA Approval: aPTT, PT & Celite ACT Watch for further developments Specific contents of this slide approved by Helena

45. 45 ~ THANK YOU ~ Eurotrol, Inc. 866-234-5754 www.eurotrol.com Epocal Inc 888-893-6225 www.epocal.com Rotem 919-941-7777 www.rotem.de Abbott / iSTAT 800-827-7828 www.abbottpointofcare.com Helena 888-893-6225 www.helenapoc.com Michaela.Cvitkovic@specialtycare.net