Central Carolina Perfusion 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

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

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

Needs Assessment Outcomes – The Envelope Please! Low Maintenance/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)

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

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”

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

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