Laboratory Response Network Elizabeth A. Macias, Ph.D., D(ABMM)

1. Laboratory Response Network Elizabeth A. Macias, Ph.D., D(ABMM) Gatekeeper, Air Force LRN Laboratories Air Force Institute for Operational Health Epidemiological Surveillance Division (AFIOH/SDE) Brooks City-Base, TX

2. What is the Laboratory Response Network ?

3. Laboratory Response Network (LRN) • Established in 1999 by the Centers for Disease Control and Prevention (CDC) • Integrated network of laboratories – state and local public health, hospital, military, veterinary, and international • Respond quickly to biological and chemical terrorism, as well as emerging infectious diseases and other public health threats

4. LRN Structure

5. LRN Structure – Sentinel Laboratories If you perform routine diagnostic Microbiology cultures, then you are a Sentinel laboratory. Minimum requirements: - Follow BSL-2 guidelines - Plate cultures on blood and chocolate agar - Microscopy capability (Gram stains, wet mounts)

6. LRN Structure – Sentinel Laboratories • Perform testing on clinical specimens, not environmental samples • Presumptive testing - protocols on American Society for Microbiology (ASM) website http://www.asm.org/Policy/index.asp?bid=6342 • Recognize, rule-out, and refer to Reference or National laboratories for further testing

7. LRN Structure Basic Sentinel Clinical Laboratory Advanced Sentinel Clinical Laboratory

8. Basic Sentinel Clinical Laboratory • 1. Certified under CLIP/CLIA for the applicable subspecialty within the specialty of Microbiology • Inspected by CMS-approved accreditation organization (i.e., CAP) • Policies/procedures for referral of specimens to an Advanced Sentinel Lab • Policies/procedures for direct referral of suspicious specimens or isolates to the nearest LRN Reference Lab

9. Advanced Sentinel Clinical Laboratory • First three same as for Basic Sentinel Labs: • 1. Certified under CLIP/CLIA for the applicable subspecialty within the specialty of Microbiology • Inspected by CMS-approved accreditation organization (i.e., CAP) • Policies/procedures for direct referral of suspicious specimens or isolates to the nearest LRN Reference Lab

10. Advanced Sentinel Clinical Laboratory Additionally… 4. Have a Class II or higher certified Biological Safety Cabinet 5. Comply with BSL-2 practices AND 6. Policies for additional respiratory protection 7. Use LRN Sentinel Level Clinical Guidelines from the ASM Website

11. Advanced Sentinel Clinical Laboratory 8. Personnel trained and demonstrate competency in LRN Sentinel Level Clinical Microbiology Guidelines 9. Personnel trained and certified in Packing and Shipping of Infectious Substances Guidelines 10. Procedures to track and account for decontamination of laboratory biological waste

12. Advanced Sentinel Clinical Laboratory It is further highly recommended… 11. Microbiology laboratory operates under negative pressure (applies only to new construction or remodeling) 12. On-site terminal decontamination capability, e.g., autoclaving, for disposal of wastes categorized as BSL-3 or Select Agent

13. LRN Sentinel Labs

14. LRN Sentinel Labs

15. Laboratory Response Network (LRN) USAF LRN Policies

16. Laboratory Response Network (LRN) May 2001: HQ/USAF SG mandated all AF medical laboratories support homeland defense by participating in the LRN “In support of the national laboratory response network and homeland defense, all AF medical laboratories will participate, at a minimum, at Level A [New terminology = Sentinel]….”

17. Laboratory Response Network (LRN) • August 2007 - National Laboratory Response Network Policy Letter • Discusses Basic and Advanced Sentinel labs • “AFMS laboratories will have the CDC technical protocols, notification procedures, and procedures to properly ship clinical samples in place by 1 October 2007…”

18. Air Force Laboratory Response Network Sentinel Laboratories

19. USAF LRN Basic Sentinel Labs (CCLM Classification) Andersen Aviano Beale Bolling Brooks CB (Clinic) Buckley Cannon Charleston Columbus Croughton Edwards Eielson Ellsworth Geilenkirchen Goodfellow Grand Forks Hickam Holloman Hurlburt Field Incirlik Kirtland Kunsan Lajes Laughlin Los Angeles Maxwell McChord Misawa Peterson Pope Ramstein Randolph Schriever Clinic Upwood Vance Whiteman

20. USAF LRN Advanced Labs (CCLM Classification) Altus Andrews Barksdale Bitburg (Spangdahlem) Davis Monthan Dover Dyess Eglin Elmendorf Fairchild F.E. Warren Hanscom Hill Kadena Keesler Lakenheath Langley Little Rock Luke MacDill Malmstrom McConnell McGuire Minot Moody Mountain Home Nellis Offutt Osan Patrick Robins Scott Seymour Johnson Shaw Sheppard Tinker Travis Tyndall USAFA Vandenburg Wright-Patterson Yokota

21. State-Based Sentinel Lab Activities

22. State-Based Sentinel Lab Activities FY2006 Public Health Emergency Preparedness Cooperative Agreement managed by the CDC Each of the grantees (50 state PH labs plus PH labs in DC, NYC, LA County, and Chicago) must accomplish critical tasks in exchange for direct funding received through the cooperative agreement

23. State-Based Sentinel Lab Activities Most of their activities focus on the capabilities and capacity in their own lab A small percentage of these critical tasks and performance measures surround LRN sentinel lab activities, including the following…

24. State-Based Sentinel Lab Activities • Maintain a database of all sentinel (biological) labs in the jurisdiction using the CDC-endorsed definition that includes: • POC Information • Biosafety Level • Certification status • Capability to rule-out Category A and B bioterrorism agents • Contact information for the reference labs used by these sentinel labs

25. State-Based Sentinel Lab Activities • Test the ability of the sentinel laboratories to send specimens to a confirmatory LRN lab on nights, weekends, and holidays • Ensure all laboratory staff know how to contact the next level LRN lab • Have properly trained staff for packaging and shipping (i.e., current biosafety training and IATA certification)

26. State-Based Sentinel Lab Activities • Increase the exchange of laboratory testing orders and results • Timely reporting of results from LRN confirmatory lab back to the submitting sentinel lab and reporting to CDC as appropriate • Linkage of results to public health

27. Tri-Service LRN Initiative CDC/LRN DoD Gatekeeper COL Dan Harms US Army Bill Nauschuetz USAF Elizabeth Macias USN CDR Sharon West

28. Summary of LRN Benefits What does the LRN offer to the Department of Defense and to the Nation? • True Network • Standardized testing, procedures and reagents (no cost for oligo’s, Abs) • Proficiency testing • Administrative materials – Safety SOP, chain of custody forms, FBI contacts, vaccination information, etc.

29. Missions of LRN BW agents Non-BT Missions of LRN • SARS Testing • Vaccinia testing – for smallpox vaccination adverse effects • Monkeypox testing • Avian Influenza

30. Questions? Elizabeth A. Macias, Ph.D., D(ABMM) Laboratory Director Air Force Institute for Operational Health, Epidemiological Surveillance Division (AFIOH/SDE) 2730 Louis Bauer Drive Brooks City-Base, TX 78235-5132 COMM: 210.536.1271 DSN: 240.1271 Email: elizabeth.macias@brooks.af.mil