Presentation Friday for 2008-22
- 1. - CONFIDENTIAL - Laboratory Clinical Laboratory Director Lynn Averill, MD PhD
- 2. - CONFIDENTIAL - Laboratory Achievements 2008 State of Florida • Lynn E. Averill, MD PhD • American Board of Medical Laboratory Immunology Certification • 7/3/07 • Immunology/Serology Laboratory Director License • 7/13/07-8/31/08 • Medical Doctor License • 6/4/08-1/31/-10 State of Florida • Immunolabs • Clinical Laboratory Certification • 10/1/07-9/30/08
- 3. - CONFIDENTIAL - Laboratory Achievements 2008 Federal Center for Medicare and Medicaid • CLIA Certificate Licensure • 11/30/2007-11/29/09 State of California: Clinical Laboratory License • Clinical Laboratory Licensure Certificate • 10/01/07-9/30/08 New York State Department of Health • Clinical Laboratory Director License • Lynn Averill, MD PhD • 12/4/07-12/4/09
- 4. - CONFIDENTIAL - Laboratory Achievements 2008 New York State • Clinical Laboratory Licensure Application • Application submitted; • 2/2008 • NYS laboratory inspection • 6/12/08 • Addendum items working on • Immuno-1 Bloodprint IgG food allergy tests require Physician and research data supporting IgG food allergy testing • FDA approved tests –Total IgE, IgE food/mold and inhalant panels, Anti-gliadin, tTG, and H. pylori do not require support data
- 5. - CONFIDENTIAL - Laboratory Achievements 2008 Implementation of Immulite 2000 • Siemens’ Automated Instrumentation for IgE allergen testing-June 2007 • Food/Mold and Inhalant panels • 12 panels of 36- food/mold or inhalants • Increase in sales and production of IgE panels • 23% increase for 10-month time period • 6/1/07-3/31/08 vs 6/1/06-3/31/07 • Increased revenue for the lab • 24 hr turn around time for the Clients
- 6. - CONFIDENTIAL - 0 50 100 150 200 250 Jun July Aug Sept Oct Nov Dec Jan Febru March 2006- 2007 2007- 2008 Linear (2006- 2007) Increase in Total number of IgE Panels ordered June-March (2006-2007;2007-2008)
- 7. - CONFIDENTIAL - Laboratory Goals 2008 Total IgE Screening Test • In general, the total IgE level is higher with a corresponding increase in number of allergens a person is reactive to • The finding of an elevated Total IgE result may justify testing for allergen-specific IgE from select panel(s) • Selection of a Reflex Test- Allergen specific IgE panel(s) • The physician should be familiar with the patient’s clinical history prior to selecting a specific IgE food/mold and/ or environmental inhalant panel(s)
- 8. - CONFIDENTIAL - 0 5 10 15 20 25 30 Nov. 2007 Dec. 2007 Jan. 2008 Feb. 2008 Mar. 2008 Increase in Number of Total IgE Lab Orders 11/2007- 3/2008
- 9. - CONFIDENTIAL - Laboratory Goals 2008 Helicobacter pylori • A curved bacillus, colonizes the upper gastrointestinal tract • Causative agent for most cases of chronic gastritis, duodenitis, and ulcers • Associated with gastric carcinoma • H. pylori IgG assay is performed on Immunolite 2000 and has been available to ordering physicians as of Feb. 2008- • We have performed 9 patient tests since mid-Feb and continue to get increased numbers of orders from physicians • Antibiotic treatment results in elimination of H. pylori and a decrease of intestinal inflammation along with healing of mucosa • H. pylori detection and elimination in conjunction with Immunolabs Human Bloodprint IgG standard panel should improve and ameliorate patient symptoms
- 10. - CONFIDENTIAL - 0 1 2 3 4 5 6 7 Feb. 2008 Mar. 2008 Increase in numbers of H. pylori lab tests Feb. to Mar. 2008
- 11. - CONFIDENTIAL - 300 350 400 450 500 550 600 650 700 5-Jan 12-Jan 19-Jan 26-Jan 2-Feb 9-Feb 16-Feb 23-Feb 1-Mar 8-Mar 15-Mar 22-Mar 29-Mar 5-Apr Total Number Lab Tests Completed per Week Ending (2008)
- 12. - CONFIDENTIAL - 1.2 1.3 1.4 1.5 1.6 1.7 1.8 5-Jan 12-Jan 19-Jan 26-Jan 2-Feb 9-Feb 16-Feb 23-Feb 1-Mar 8-Mar 15-Mar 22-Mar 29-Mar 5-Apr Average Lab Tests Per Requisition at Week Ending (2008)
- 13. - CONFIDENTIAL - Laboratory Goals 2008 Orchard Harvest LIS System • Advantages over ImmLab system • Increased and more efficient capacity for data mining and reporting • Strengthen our quality control and proficiency test reports for CLIA and State inspection compliance • Security enabling HIPPA compliance • Improved Backup system for maintaining patient reports • Excellent statistical analysis programs for research and development
- 14. - CONFIDENTIAL - Orchard Harvest LIS for Lab First Things First Handbook • Dr. Averill relayed all data and information on lab test assays to Orchard Harvest to begin programming • Christian Honig has coordinated the IT department at Immunolabs with Orchard Harvest to initiate implementation of servers and hardware • MVI is coordinating with Orchard and Immunolabs to program data to patient reporting • Omar Rodriguez is in Indiana training with Orchard Harvest this week and will function as System LIS Administrator
- 15. - CONFIDENTIAL - Laboratory Goals 2008 Immuno 1 Bloodprint • IgG ELISA Food Sensitivity Assays • Standard 115 IgG Food panel • New Comprehensive 154 IgG Food Panel • Eliminate Mixes; test for individual foods in mix • Adding new foods • Integration of New Gen5 Software and Bar coding system to LIS Orchard Harvest will enable data analysis by linking files of two 96 well microtiter plates for reporting 154 foods for a single patient’s Comprehensive panel
- 16. - CONFIDENTIAL - Laboratory Goals 2008 •New Environmental IgE Panel • Chemicals, animal dander, insects • Both pediatric and adult population • Increase diversity of our IgE testing • Panel allergens have been programmed into Immulite and are ready for production as soon as Orchard Harvest LIS is operational
- 17. - CONFIDENTIAL - Laboratory Goals 2008 New Environmental IgE Panel Chemicals Insects Animal Dander • Cotton Yellow Jacket Cat Rat • Ficus spp Honey Bee Dog Goat • Flour dust Cockroach Chicken Rabbit • Wool Mite Canary Swine • Houst dust Horsefly Mouse Pigeon • Formaldehyde Mosquite Cow Parrot • Latex Moth Duck feather • Silk Guinea Pig • Tobacco Drugs Goose feather Penicillin Hamster • Ampicillin Horse dander Sheep
- 18. - CONFIDENTIAL - Laboratory Achievements 2008 Laboratory Personnel • Nasrullah Khan Supervisor II demonstrates continued excellence in ensuring quality control and reporting of laboratory data and should be promoted to Operations Manager • Muhammad Riaz passed Supervisor test and was promoted to Supervisor I in 2007 and is continuing to do an excellent job while attending to more responsibilities in lab management • Both Alireza Najar Ranjbar and Barbara Sudasassi were hired as new technologists last year and are doing an excellent job in maintaining high quality standards in Lab performance and are truly a valuable asset to the lab • Nicole Cleavaeo will be joining the lab on May 5th and has earned her Medical Technologist license from Kaiser University.
- 19. - CONFIDENTIAL - Laboratory Achievements 2008 Accessions • We have Sherri Wilhelm, Lorry Accius, and Omar Rodriguez; all doing exceptional jobs in data processing and reporting patient results • Omar has been promoted to System Administrator of the new LIS system as he is very adept with computer operations systems. He is training this week with Orchard Harvest in Indiana and when he returns will train others in lab • Kinga Miller has been hired to replace Omar Rodriguez in Accessions and data entry and is doing an excellent job