2016 APHL BIOSAFETY AND BIOSECURITY SURVEY

Transcription

1 2014 APHL All Hazards Laboratory Preparedness Survey 2016 APHL BIOSAFETY AND BIOSECURITY SURVEY February 2016

2 Introduction 2016 APHL Biosafety and Biosecurity Survey Welcome to the 2016 APHL Biosafety and Biosecurity Preparedness Survey APHL s Biosafety and Biosecurity Survey assesses the status of biosafety and biosecurity programs and needs in public health laboratories (PHLs). The audience for this survey is biosafety officials (BSOs) also referred to as biosafety officers in local, state and territorial public health laboratories. All responses should be from May 2015 to February The Survey includes the following sections: 1. Funding 2. Workforce 3. Risk Assessments 4. Outreach to Clinical Laboratories 5. Training Needs Please coordinate with your preparedness staff to complete all sections. Section 1: Funding 1. Did your laboratory receive funding via the U.S. Centers for Disease Control and Prevention (CDC) Epidemiology and Laboratory Capacity (ELC) for Infectious Diseases Ebola Supplemental in 2015? Yes No Don t Know 2. Are there any funding gaps for laboratory biosafety and biosecurity? Yes, please describe No Page 1

3 Section 2: Workforce 2016 APHL Biosafety and Biosecurity Survey 3. Does your lab have a full time designated Biosafety Official (BSO)? Yes (go to Q 3a) No (go to Q3c and skip to Q6) 3a. How long has the individual been in this role at your laboratory? < 1 year 1 to 3 years 3 to 5 years > 5 years 3b. Please provide the BSO Name (acting or permanent): Phone: Please provide the Biosafety Outreach Official Name (if applicable): Phone: 3c. Please indicate the reasons for not having a BSO? Please check all that apply. Delays in obtaining CDC ELC funds through state or other jurisdictions Delays due to jurisdiction s personnel recruitment process Delays due to challenges in finding qualified personnel Offers rejected due to non-competitive salaries Lack of long term funding for staff Other, please specify 4. What is the experience level of your BSO? Please check all that apply. Experienced Biosafety Professional (i.e. more than 5 years working as a BSO in a laboratory setting) Intermediate Biosafety Professional (1 to 5 years working as a BSO in a laboratory setting). Biosafety specific education only (no previous experience working in a laboratory) Experience working in a public health laboratory performing analytical work Experience working in a clinical laboratory Experience working in a research or academic laboratory Currently a Registered Biosafety Professional (RBP) Currently a Certified Biosafety Professional (CBSP) Other, please specify 5. Please check any trainings offered to your BSO? Please check all that apply. Institution specific, please specify External courses, please specify (e.g. American Biological Safety Association ABSA training course on biosafety) Conferences, please specify APHL Courses, please specify Other, please specify 6. Have you developed safety specific competencies for laboratory staff? Page 2

4 Yes No, please explain the reasons why you did not develop safety competencies 7. Please indicate whether you are aware of the following Competency Guidelines: -CDC. Competency Guidelines for Public Health Laboratory Professionals. MMWR 2015; 60 (suppl): CDC. Guidelines for Biosafety Laboratory Competency. MMWR 2011;60(Suppl):1-28 Not aware of the guidelines 8. From May 2015 to February 2016, please provide information on the types of training courses your laboratorians and BSO completed. Training Topics Total Number of Laboratorians Requiring Training Total Number of Laboratorians Completed (do not include BSO) Has BSO Completed? BSL-2 safe practices (fundamentals of biological materials safety practices, excluding bloodborne pathogen training) Biological Risk Assessment Personal Protective Equipment Biosafety Cabinets and other Engineering Controls Bloodborne Pathogens Spill Prevention, Control, and Countermeasure Sharps Hazard Safe Handling and Use of Cryogenic Liquids Chemical Hazards Decontamination Regulated Waste Management Emergency Management and Response Certification in packaging/shipping of IATA Division 6.2 infectious substances (Category A) Biosecurity Plan Select Agent Regulations Page 3

5 Training Topics Total Number of Laboratorians Requiring Training Total Number of Laboratorians Completed (do not include BSO) Has BSO Completed? BSL-3 safety practices 8a. Please indicate if there are any other types of training courses that your laboratorians or BSO have completed. Section 3: Risk Assessment 9. From May 2015 to February 2016, has your PHL performed any risk assessments? Yes (go to Q 9a) No 9 a. Did you identify any gaps? Yes, please specify No (go to Q 10) 9b. Have you taken steps to mitigate the gaps identified from the risk assessment? Yes, please describe the steps: No 10. Please indicate the frequency and reasons for completing risk assessments on the following lab sections. Please check all that apply. Laboratory Section Annually Quarterly Biannually Molecular Testing New agent Change in procedure Change in equipment Incident New staff None Bacteriology/Microbio logy Virology Parasitology Chemistry Laboratory Response Network for Biological Threats Preparedness (LRN- B) Laboratory Response Network for Chemical Threats Preparedness (LRN- C) Page 4

6 10a. If you completed risk assessments for other lab sections, please provide the reasons for the assessment. 11. Do you have a mechanism to share documentation for risk assessments and risk mitigation with laboratory personnel? Yes No Section 4: Outreach to Clinical Laboratories 12. How many sentinel clinical laboratories do you have within your jurisdiction? Number of sentinel clinical labs which meet the APHL-CDC-ASM Definition: Number of additional clinical labs (as described in the ELC Performance Measures Guidance) 13. What forms of communication do you use with the clinical laboratories? Please check all that apply. Phone Site Visits Meetings hosted by my PHL ListServ Newsletter Other, please specify 14. From May 2015 to February 2016, have you conducted any of the following with your clinical laboratories? Performed site visits- please list the number of clinical labs you visited: Performed risk assessments Provided risk assessment templates None of the above 15. From May 2015 to February 2016, please indicate who provided the following trainings to the clinical laboratories. Please check all that apply. Training topic provided by Packaging/Shipping of IATA Division 6.2 infectious substances (Category A) BSL-2 safe practices (fundamentals of biological materials safety practices, excluding bloodborne pathogen training) My PHL APHL CDC NLTN Other Did not provide training Page 5

7 Training topic provided by Biological Risk Assessment Personal Protective Equipment Biosafety Cabinets and other Engineering Controls Bloodborne Pathogens Spill Prevention, Control, and Countermeasure Sharps Hazard Safe Handling and Use of Cryogenic Liquids Chemical Hazard Decontamination Regulated Waste Management Emergency Management and Response Biosecurity Plan BSL-3 safety practices My PHL APHL CDC NLTN Other Did not provide training 15a. Please list any other training topics provided to clinical laboratories. 16. Have you conducted any biosafety and biosecurity drills or exercises with your sentinel clinical labs from May 2015 to February 2016? Yes, please briefly describe the drills or exercises No, please specify any barriers 17. Please list the top 3 challenges encountered with engaging your clinical labs and provide suggestions for solutions. Challenge/Barriers Solution(s) (e.g. lack of staff time to participate in (E.g. public health lab goes to the clinical training) lab and offers training onsite). Page 6

8 18. If you have a successful model for outreach to your sentinel clinical laboratories, please share a brief summary below. A successful model includes routine communications between the clinical and public health lab, participating in training and exercises, a newsletter or other resource such as a Listserv, and other examples demonstrating that the clinical lab is actively connected to the public health lab. An APHL staff member will contact you to follow up on the model described below. [Limit to 250 words] Page 7

9 Section 5: Training and Related Resource Needs 19. What types of biosafety and biosecurity training would you like APHL or other partners to develop? Training Course Topic Audience (please specify) 20. Beside trainings, what specific biosafety and/or biosecurity guidance documents/tools or other resources do you need? 2016 Biosafety and Biosecurity Survey Glossary Biosafety Official (BSO): Also referred to as a Biosafety Officer or Professional. The BSO within the public health laboratory will ensure adequate biosafety training and practices to avoid potential hazards associated with the handling of biological materials, the spread of multi-drug resistant pathogens and threats of emerging pathogens, and acts of biological terrorism. The person in this position develops and monitors adherence to laboratory biosafety programs, provides related workforce training for biosafety for the agency and sentinel clinical laboratories, assists public health and clinical laboratories with biosafety risk assessments and risk mitigation plans, and works cohesively with key system partners and public health officials to improve communications and emergency management and response practices. Efficient communication skills, knowledge of microbiology and general laboratory practices, and experience in laboratory safety, training and outreach, and quality management systems are necessary for this position. Biosafety Level 2 (BSL-2): A laboratory suitable for work involving agents that pose moderate hazards to personnel and the environment. Some characteristics of a BSL-2 include; 1) laboratory personnel have specific training in handling pathogenic agents and are supervised by scientists competent in handling infectious agents and associated procedures; 2) access to the laboratory is restricted when work is being conducted; and 3) all procedures in which infectious aerosols or splashes may be created are conducted in biological safety cabinet (BSC) or other physical containment equipment. Biosafety Level 3 (BSL-3): A laboratory suitable for work involving indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure. Laboratory personnel must receive specific training in handling pathogenic and potentially lethal agents, and must be supervised by scientists competent in handling infectious agents and associated procedures. Branch state public health laboratory: A laboratory that is part of a group of laboratories reporting to a central state laboratory. An example of a branch system is Florida. Drill: A coordinated, supervised activity usually employed to test a single specific operation or function within a single entity (e.g., a fire department conducts a decontamination drill). Risk assessment: 1) the process of identifying risks to organizational assets and operations; includes threat and vulnerability analysis and is the fundamental tool to help select the right risk mitigation measures to achieve an acceptable level safety and/or security; 2) the evaluation of the probability and consequences of exposure to a given hazard, with the intent to reduce the risk by establishing the appropriate mitigation measures to be used. Page 8

10 LRN Sentinel Clinical Laboratories: A laboratory that is certified to perform high complexity testing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) by the Centers for Medicare & Medicaid Services (CMS) for the applicable Microbiology specialty or the laboratory is a Department of Defense (DoD) Laboratory certified under the DoD Clinical Laboratory Improvement Program or the laboratory is a veterinary medical diagnostic laboratory that is fully accredited by the American Association of Veterinary Laboratory Diagnosticians (AAVLD). Laboratory in-house testing includes Gram stains and at least one of the following: lower respiratory tract, wound or blood cultures. (Source: ELC Sentinel Clinical Laboratory: In addition to the sentinel clinical laboratories meeting the LRN definition above, for the purposes of Ebola activities, sentinel clinical laboratories include all laboratories that test or refer specimens that may contain Ebola virus or other emerging, highly infectious disease pathogens. This definition includes laboratories in designated Ebola Treatment Centers, Ebola Assessment Hospitals, and frontline healthcare facilities such as acute care hospitals, critical access hospitals, and urgent care clinics that perform or send out infectious disease testing. (Source: Performance Measures Guidance for Domestic Ebola Supplement) Page 9