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    Biosafety Outreach for Sentinel Laboratories

    ​About Biosafety Outreach

    bio img.jpg

    The Maryland Department of Health Laboratories Administration serves as a reference laboratory for CDC’s Laboratory Response Network (LRN).  The mission of the LRN is defined on the CDC website as: “The LRN  is a national security asset that, with its partners, will develop, maintain and strengthen an integrated domestic and international network of laboratories to respond quickly to biological and chemical threats and other high priority public health emergencies needs through training, rapid testing, timely notification and secure messaging of laboratory results”

    The MDH Laboratories Administration, in its role as an Advanced Level Reference Laboratory, provides resources to the Sentinel Laboratories through their Biosafety Outreach Program and the Office of Laboratory Emergency Preparedness and Response (OLEPR). In an effort to better serve the Sentinel Laboratories in the State of Maryland in their biosafety needs, we have established this webpage with appropriate links, resources, and contact information for the Lab Administration. 

    Sentinel Laboratories are the foundation of the LRN and play an important role in early detection of biological agents by providing routine diagnostic services, rule-out, and referral steps in their identification process. 

    Recognize – Rule-Out – Refer Biological Select Agents

    As Sentinel Labs are the first line of defense in recognizing biological select agents, it is important that they have the required resources to follow LRN-established guidelines in what is called Recognize – Rule-Out – Refer. To test suspected biological select agents, the Sentinel Labs should follow Biothreat Agent Bench Cards for the Sentinel Laboratory, provided by the Association for Public Health Laboratories (APHL) and American Society of Microbiology (ASM).  APHL has also created a poster for these Biothreat Agents, which serves as a quick reference for laboratory staff.

    If a Sentinel Laboratory is unable to “rule-out” an isolate as a Select Agent, it must be “referred-in” to the MDH Laboratories Administration. The Isolate Submittal Policy: Clinical Isolates That Cannot Be Ruled-Out As Select Agents provides detailed instruction on isolate/specimen submission, packaging & shipping information, and contact details for the MDH Labs.

    Prior to shipping the isolate/specimen, the Sentinel Labs MUST CONSULT the MDH LABORATORIES ADMINISTRATION

    (Phone numbers are listed in the Isolate/Specimen Submittal Policy)

    Packaging and Shipping Isolates/Specimens

    For guidelines on packaging and shipping diagnostic and clinical specimens, infectious substances, and biological agents to the Reference Laboratory (MDH Laboratories Administration), please refer to the ASM Sentinel Laboratory Guidelines for Suspected Agents of Bioterrorism-Packaging and Shipping Diagnostic and Clinical Specimens located on the OLEPR webpage.

    MDH is developing an informational guide for the best practices for shipping of potentially hazardous materials, which will be added in the Resource section at a later date. Recommended training for laboratorians is available through the CDC Packaging and Shipping Division 6.2 Materials.

    Biosafety Outreach Program

    • Risk Assessment

    Biological agents pose significant risk of exposure to the laboratorian/staff person performing the test, or the environment, if not handled or manipulated appropriately. Risk assessments for pathogens tested, and the procedures used in the testing, is highly recommended by all involved (Sentinel Labs, Reference Labs and National Labs) in LRN testing. APHL also provides guidance for performing risk assessments.

    'MDH – Biosafety Risk Assessment SOP'​, used by the MDH Laboratories Administration, provides detailed information on the factors involved in risk assessment for biological agents and the process of addressing and mitigating risks associated with biological testing in Sentinel Labs.

    'Procedure specific Risk Assessment' is a sample risk assessment that can be used as a template. The sample risk-assessment is specific to the ELISA-EIA assay routinely performed at the MDH Laboratories Administration. Additional sample risk-assessments for other procedures can be requested from the MDH Laboratories Administration.

    • ​​Resources

               The Biosafety Outreach Program can provide additional on-site training to assist your facility in addressing biosafety needs. Topics for this training include:

      • ​       General Biosafety (MDH Biosafety Training​)
      •      Preparing Risk Assessments (links above)
      •         Hands-on Shipping demonstration  
                Web-based trainings recommended for Sentinel Labs:
                CDC Biothreat Preparedness Training for Sentinel Labs

    If you need additional information on specific topics related to Biosafety, please contact MDH Labs Biosafety Office.

    High-Consequence Pathogens (HCP) Information

    MDH Laboratories Administration has prepared important documents for high-consequence pathogens testing. It is highly recommended that Sentinel Laboratories review and follow the instructions provided for all questions related to HCP testing.

    Please see below additional resources and links, provided by the CDC, on emerging infectious disease pathogens including Ebola virus.

    Guidance for managing and testing routine clinical specimens when there is a concern about Ebola Virus Disease


                Ebola: Personnel Protective Equipment (PPE) Donning and Doffing Procedures (Guidance for Donning and Doffing Personal Protective Equipment (PPE) During Management of Patients with Ebola Virus Disease in U.S. Hospitals)


     Additional References

    Safety and Accuracy of Matrix-Assisted Laser Desortption Ionization-Time of Flight Mass Spectrometry for Identification of Highly Pathogenic Organisms

    Guidelines for Safe Work Practices in Human and Animal Medical Diagnostics Laboratories 

    Sentinel Level Clinical Laboratory Protocols For Suspected Biological Agents and Emerging Infectious Diseases

    Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition

                Federal Select Agent Program

    Contact Information

    Biosafety Office, MDH Labs Administration

    Ami Patel, PhD-Biosafety Officer

    Email: amia.patel@maryland.gov

    Phone: 443-681-3870


    Amy Armitage-Biosafety Specialist

    Email: amy.armitage@maryland.gov

    Phone: 443-681-5187