No Path? No Problem? Perspectives from a Public Health Laboratory

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No Path? No Problem? Perspectives from a Public Health Laboratory Bonnie Rubin, CLS, MBA, MHA Associate Director State Hygienic Laboratory at The University of Iowa

Why Biosafety Staffing Is On Our Minds All public health laboratories have had someone performing biosafety tasks for their internal operations Ebola outbreak revealed gaps of knowledge, procedures and collaborative processes between PHLs, clinical labs and state s epidemiology In 2015, CDC released funding via the Domestic Ebola Supplement to Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) - Building and Strengthening Epidemiology, Laboratory and Health Information Systems Capacity in State and Local Health Departments

CDC ELC Ebola Supplement Statement of Contract Purpose Project/Contract period is March 31, 2015 March 30, 2018 To enhance laboratory practice for infectious diseases and strengthen the collaboration between epidemiology and laboratory practices To support one full-time position over the three-year project length.

Project B: Enhanced Laboratory Biosafety and Biosecurity Capacity Background: The events surrounding laboratory testing of patient specimens suspected of Ebola virus infection point to a lack of biosafety programs in most U.S. clinical laboratories. Purpose: To support public health departments and their clinical partners to assess, develop and implement measures to improve laboratory and biological safety practices for dealing with current and emerging infectious diseases.

Project B Strategies and Collaborations 1. Designate a laboratory biosafety officer within jurisdiction s public health laboratory Improve laboratory coordination and outreach with clinical laboratory partners Collaborate with CDC funded Public Health Preparedness (PHEP) and LRN and other non-cdc organizations such as APHL.

Examples of Current Public Health Laboratory Solutions for the Biosafety Tasks Biosafety Officer Biosafety/QA Officer Laboratory Safety Officer Manager, Biosafety & Biosecurity Training Coordinator Director of Laboratory Preparedness, Education and Safety Unit Biosafety Outreach Officer Biosafety Officer/Microbiologist Laboratory Preparedness and Response Program Manager

Lack of an Academic Track Leads to Variation Examples of Education and Experience Requirements APHL Position Description BS in Micro, Biology, CLS or health related field At least 2 yrs. experience in a laboratory Knowledge of BSL-2 and 3 operations and practices Strong verbal and written communication skills Ability to establish working relationships with diverse groups Must pass appropriate background checks

State Public Health Laboratory A Master s in Micro, Molecular Biology, Genetics, Virology, or lifescience based discipline 1-3 years relevant biosafety, preparedness or emergency response experience Knowledge and experience with emergency preparedness involving biohazard agents. Knowledge of use of protective equipment and safety protocols associated with handling of hazardous material Extensive and applicable lab experience in BLS-2 or higher environment Working experience performing risk assessments and implementing mitigation strategies Working experience establishing training programs and procedures Ability to effectively communicate Extensive ability to use computer programs include Microsoft Office Suite and other database tools Working knowledge of project management and demonstration of experience in leading teams

State Public Health Laboratory B Must have technical expertise and education background to direct all aspects of a comprehensive biosafety program for a PHL including 5 years of biosafety experience managing a comprehensive biosafety program. (MA/MS in relevant field (micro, bio, chem) counts for 2 yrs., PhD counts for 3 years) Must has professional certification or eligibility for certification (Cert. Safety Prof., Cert. Biosafety Prof., Cert. IH) Extensive knowledge of safely working with infectious and environmental pathogenic agents and toxins, including SAs Extensive knowledge of laboratory biosafety and regulatory requirements for safe handling of bio and chemical agents. Be familiar with review and analysis of exposure and incident reports related to biosafety Must have ability to keep up with current regulations and develop appropriate policies and procedures Extensive knowledge of microbiology lab tests and techniques Thorough knowledge of laboratory equipment and instrumentation Ability to read and comprehend technical materials. Demonstrated teaching skills Ability to effectively communicate Ability to collaborate with a diverse workforce Strong self motivation, proactive, ability to work as part of a management team

The best way to predict the future is to create it. Abraham Lincoln

Does A Future Need to be Created? Recent search of job opportunities on ABSA* website: 9 listings as of January 22, 2016 1 Registered or Certified Biosafety Professional Preferred 1 Certified Biosafety Professional Preferred Rest Not applicable *American Biological Safety Association

Fruit Basket Upset or A Defined Profession? Does the Practice of Biosafety need a Scope of Practice? Google Searches for Scope of Practice Biosafety: CDC Guidelines for Biosafety Laboratory Competency Industrial Hygienist: 2006 bulletin Pharmacists: Scope of Contemporary Pharmacy Practice: Roles, Responsibilities, and Functions of Pharmacists and Pharmacy Technicians Nurses: Scope of Practice American Nurses Association

APHL Biosafety Job Competencies Safety 25% Workforce Training 15% Security 15% Microbiology 15% Communication 10% Emergency Management & Response 10% Quality Management System 5% General Laboratory Practice 5%

For Those Already in Biosafety Related Positions Require ABSA certification? Require some other program s certificate completion? What about ongoing continuing education, credentialing or licensure? Internal vs. external

And what about our future workforce? What should the terminal degree be and include? Associate Bachelor s Master s (promote to current workforce?) 2+2 program 3+1 Internships

What would you attempt to do if you knew you would not fail? Robert Schuller

Coralville, Iowa Let s Discuss and Share! Ankeny, Iowa Lakeside Laboratory, Milford Iowa