Point-of-Care Laboratory Management in the O.R. Setting: Our Opti CCA Experience

1. Point-of-Care Laboratory Management in the O.R. Setting: Our Opti CCA Experience Howard Coston, BS, CCP, LP Winston-Salem, NC Central Carolina Perfusion Associates, Inc. Winston-Salem, NC

2. Overview – A Historical Timeline • Cardiac Program History • Forsyth Medical Center – 850 beds, 2nd largest hospital in NC • Cardiac program initiated in 1987 • Current annual caseload ~ 700 procedures, all adult • 4 perfusionists staffing 3 operating rooms • “Point of Care” History • 1987 – 2001: Succession of large, table-top Ciba-Corning devices typical • for a standard lab, very heavy with no portability • - placed in the perfusion department work room, centrally located • between 3 O.R. rooms • - supervised & maintained by the respiratory department • - significant time required to maintain multiple electrodes required • to perform range of tests necessary for cardiac surgery arena • - complicated reagent and blood/waste product management • - necessitated dedicated personnel to perform tests

3. A New Day Dawns! “But soft, what light through yonder window breaks?” Romeo • 2000: New Point-of-Care coordinator from the main lab arrives! • Needs assessment review with Perfusion and POC coordinator • a) Low maintenance • b) Reliability of testing outcomes • c) Portability • d) Electronic controls • e) Storage of testing supplies • f) Data management • g) Customer and technical support • Ultimately chose to evaluate I-Stat, Gem & Opti

4. Needs Assessment Outcomes – The Envelope Please! • LowMaintenance/Supplies Storage/Portability • ▫ No reagents, single use cassettes that calibrate prior to use • ▫ Room temperature cassette storage – never refrigerated • ▫ Standing inventory orders, with flexibility for caseload variability • ▫ No waste fluids or blood to be disposed of • ▫ AC or battery operation • ▫ Small size (12 lbs) does not require dedicated space • ▫ Virtually no moving parts to fail • - approximately once a year replace aspiration pump • - occasionally requires fuse replacement • Note: both interventions managed by POC staff, does • not require biomed department assistance • ▫ Still have 4 original instruments with only minor repairs (7 • years as of 9/2008)

5. Needs Assessment Outcomes – The Envelope Please! • Testing Reliability/CAP Compliance/QC’s • ▫ Electronic controls for daily QC’s (3 levels every 8 hours) • ▫ Liquid QC’s performed monthly & with each cassette shipment • ▫ Validation studies correlate with main laboratory instruments • ▫ Automatic aspiration of sample • ▫ Co-oximeter technology for Hgb measurement, not calculation • ▫ Rare cassette failure (typically “dirty optics”) • ▫ CAP Proficiency Testing • - commercially available QC’s for Blood Gas/Electrolytes • - Hgb technology unique – no available commercial QC’s • “CAP: if no testing product available commercially , an • acceptable alternative must be developed” • - POC department developed in-house alternative

6. Needs Assessment Outcomes – The Envelope Please! • Data Management • ▫ Integrated printer – 1 copy each for anesthesia and perfusion • - thermal paper cannot be placed in the Medical Record • ▫ QC and patient testing information downloaded weekly to • main lab (network docking station in perfusion work room) 4. Customer & Technical Support ▫ FMC was early user for the O.R. setting ▫ Early challenges: - CAP proficiency survey deficiencies * Minimum 10 peer group participants for benchmarking * Non-comparable “other instrument” survey group * Extensive liaison work with CAP done by tech support - Proprietary Hgb measurement technology (QC dilemma) ▫POC manager characterized customer and technical support as “incredible”

7. The Point-of-Care Benefits • Significantly decreased maintenance requirements • Decreased perfusion personnel requirements • Rapid turn-around time for lab results (< 3 minutes) • Facilitation of tight glucose management • Simple management of 5,163 patient tests in 2007 • - 4,647 cardiac surgery tests (7.4 tests/procedure) • - 516 main O.R. tests • * managed by anesthesia tech staff

8. Thank You