3/15/2017. Predict, Prevent and Prepare: Improving Laboratory Biosafety and Biosecurity Across the Nation. Disclosure Statement.

Transcription

1 Predict, Prevent and Prepare: Improving Laboratory Biosafety and Biosecurity Across the Nation Drew Fayram, MS, Safety Officer State Hygienic Laboratory at the University of Iowa Rolinda Eddings, MT(ASCP), Biosafety Officer Tennessee Department of Health, Division of Laboratory Services Disclosure Statement The speakers have no disclosures to make at this time. Objectives At the end of this session, attendees will be able to: Describe the collaborative approach to biosafety and biosecurity between public health and clinical laboratory science. Define and develop biosafety and biosecurity plans, and be better prepared to implement in your own laboratory. Perform a laboratory biosafety risk assessment. 1

2 Emerging and evolving laboratory risks EVD Outbreak Redefined normal risk for clinical and public health labs 2015-present Zika Virus Outbreak New pathogens emerge all the time 2016 Emergence of B. cereus Biovar anthracis Ongoing evolution of pathogenicity Must remain vigilant 2017 Yellow Fever Outbreak Brazil CDC Issued travel alert Feb. 1 Potential urban transmission National Lapses in Laboratory Safety National Lapses in Laboratory Safety 2

3 National Lapses in Laboratory Safety National Support for Biosafety & Biosecurity Epidemiology and Laboratory Capacity (ELC) Cooperative Agreement (CDC) 2015 Domestic Ebola Supplement 2016 Laboratory Biosafety Project Association of Public Health Laboratories This funding aims to strengthen biosafety and biosecurity programs at public health laboratories and to assist public health laboratories to enhance biosafety and biosecurity practices at clinical laboratories. (Strengthening Lab Biosafety & Biosecurity January 2017.) Biosafety & Biosecurity Outreach State Public Health Laboratories Biosafety professionals to perform outreach to clinical laboratories Perform site visits to help clinical labs with biosafety and biosecurity Provide tools, templates and resources Develop and deliver training in biosafety and biosecurity Risk Assessment Packaging and Shipping Infectious Substances 3

4 Not that type of risk assessment IQCP (CMS) and CLSI Risk management and risk assessment defined for purposes of quality control Ensures test results are accurate and reliable Laboratory Safety Risk Assessment Part of risk management program to reduce exposures to hazards in the laboratory Ensures safety of staff, families, and community Why Perform a Laboratory Safety Risk Assessment? Predict potential sources of laboratory acquired infections (LAIs) or other injuries Determine mitigation strategies to Prevent LAIs and injuries Identify and implement training to Prepare staff to work safely Protect the safety, health and well-being of: Staff Families General Public Goal - Proactive, rather than reactive! Balancing risk and work performance A major obstacle to safe work practices is the drive for increasing efficiency in the workplace Safe work practices Performance of work in an accurate and efficient manner. Safety must be considered more important than efficiency and mitigation strategies 4

5 Balancing risk and work performance Upper management support is essential for success in developing a culture of safety in the workplace Director approval of a written Biorisk Management Policy Biorisk laboratory biosafety and biosecurity See CEN Workshop Agreement- CWA Biosecurity Biosafety Biorisk Management Biorisk Management Policy Protecting staff, contractors, visitors, community and environment from biological agents and toxins that are stored within the facility Reducing the risk of unintentional release of, or exposure to biological agents or toxins Reducing the risk to an acceptable level by conducting risk assessments and implementing the required control measures Complying with all legal requirements applicable to handling the biological agents or toxins 5

6 Biorisk Management Policy Ensuring the need for effective biorisk management shall take precedence over all non-health and non-safety operational requirements Effectively informing all employees and communicating individual obligations with regard to biorisk Continually improving biorisk management performance Risk Assessment Process of identifying the hazards and evaluating the risks associated with biological agents and toxins Takes into account the adequacy of any existing controls Determines whether or not the risks are acceptable Risk Assessment is not a new concept We conduct risk assessments all the time 6

7 Risk Assessment Hazard Source, situation, or act with a potential for causing harm or injury Risk Combination of the probability of occurrence of harm and the severity of that harm A prediction Examples of hazards and risks Hazard Dirty sharps Hazardous chemicals Open flame Risk Needle stick and potential infection from exposure Chemical splashing or vapors may cause adverse affects Employee may be burned and fire may start Risk Assessment Work Plan Begin by selecting the most hazardous procedures, understanding that the process will take time to complete assessments for all SOPs. Identify hazards, risks and current controls. Determine the need for additional controls to make risk acceptable. ImpIement. Evaluate staff competency and utilization of safety equipment. Review assessment with staff and management. 7

8 When to Perform a Risk Assessment Must be repeated at defined intervals. Annually (at minimum) Anytime a new component is introduced Pathogen Test Instrument Staff Facility/work environment change After an accident or near miss Risk Assessment Team Knowledgeable assessor Practical experience Problem-solving skills Facility Regulations Hazards Safety Modes of Transmission Risk Assessment Process 1. Identify hazards What may happen? How may it happen? 2. Evaluate/assess risks How likely? How severe? 3. Identify controls to mitigate risk Reduce risk until it becomes acceptable 4. Implement controls mitigate the risk Add changes to written SOP Train staff and implement 5. Review effectiveness of controls and adjust 8

9 Tools for the job Develop a site-specific template Examples: Iowa Laboratory Risk Assessment Tool Provided to you today Tennessee Laboratory Risk Assessment Tool Provided to you today APHL Risk Assessment Best Practices and Examples Biosecurity/Pages/default.aspx Simple Example to Consider Gram staining a slide for bacterial identification from a CSF tube Step 1: Identify the hazards What could go wrong? What hazardous substances, items and procedures are involved? 9

10 Step 1: Identify the hazards How could it happen? How could exposures occur? Step 2: Evaluate/assess risks Likelihood What is the probability. that an exposure will occur based on work practices? that an infection will result based on characteristics of organism? Common lab activities create aerosols 10

11 Step 2: Evaluate/assess risks Consequences What is the severity if an exposure occurred? Important considerations: Organism risk group, route of transmission, infectious dose, type of infection, vaccination status of staff, available treatments, etc. How hazardous are chemicals being used? What type of injury could result? Risk Assessment Matrix Physical risks Chemical risks Biological risks Mitigation defined Actions and control measures that are put into place to reduce or eliminate the risks associated with biological agents and toxins 11

12 Step 3: Identify controls and mitigate risk Describe controls currently in place Acceptable? NO Additional controls to be implemented Step 3: Identify controls and mitigate risk Identify work practices and administrative controls Examples: CSF tubes shall not be uncapped outside BSC. Open flames will not be used to heat-fix slides. Slide warmer will be used inside BSC. Step 3: Identify controls and mitigate risk Identify PPE controls Last line of defense, do not over use PPE Only control that actually allows staff to come in contact with hazards Identify Engineering Controls Isolates the worker from the hazard 12

13 Step 4: Implementation Edit SOP, Communicate, and Train There WILL be resistance to change Discuss how risks can affect staff and their families Inform staff of the need for changes: Incidents/near misses Best practices Regulations Step 5: Review Effectiveness of Controls Listen to staff concerns Develop a formal process for modifying risk assessment based on staff experience Risk Assessment Hotwash Worksheet Staff fill this out any time they believe change is needed Step 6: Regular review Review at least annually, and when: New pathogen New instrument New test/method Staff turnover Substantial facility changes Accident/Incident/Near Miss Plan-Do-Check- Act indicates need for mitigation change The risk assessment document is just a piece of paper and does no good if filed away and forgotten. 13

14 Risk Assessment After Action Review or Hotwash Worksheet Staff fill this out any time they believe change is needed Risk Assessment Process Overview Describe work activities Identify Hazards Decide if risk is acceptable If No Revise or close project Determine Risks If Yes Prepare risk control action plan Implement control measures Review adequacy of plan Proceed with work and monitor controls Biorisk Management There is some risk in everything we do; we can reduce it but not eliminate it 14

15 Assistance? Network with your biosafety outreach professional through your State Public Health Lab APHL Biosafety webpage for tools and references Biosecurity/Pages/BB-Resources.aspx Canada Pathogen Safety Data Sheets and Risk Assessment Biosafety in Microbiological and Medical Laboratories National Leadership and Support Thank You Drew Fayram - Drew-Fayram@uiowa.edu Rolinda Eddings - Rolinda.Eddings@tn.gov 15