This document summarizes the laboratory achievements and goals of Dr. Lynn Averill and Immunolabs in 2008. It outlines licensure, certifications, personnel changes and promotions, new tests implemented, and goals for expanding testing capabilities and implementing a new laboratory information system. Key points include licensure in multiple states, increased IgE panel testing, hiring of new staff, and training on a new LIS from Orchard Harvest.

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