Office of Laboratory Science and Safety

Transcription

1 Office of Laboratory Science and Safety Segaran Pillai, Ph.D, SM AAM, SM ASCP Director, Office of Laboratory Science and Safety Office of the Commissioner Office of the Chief Scientist

2 Mission Statement The Office of Laboratory Science and Safety (OLSS) will provide executive leadership, oversight, coordination of laboratory policies and operation, implement best laboratory science and practices and a quality management program to ensure laboratory safety, security and surety across FDA 2

3 Major Functions Serve as the agency's senior laboratory scientific advisor and consultant to the FDA Commissioner. Provide executive leadership in the area of laboratory safety and start a laboratory quality management program for FDA. Provide scientific, technical and managerial expertise and leadership in the development, enhancement and implementation of laboratory safety and security programs. Provide oversight and monitoring for FDA s laboratory safety program, ensuring that all agency's laboratories are in compliance with federal, state, and local regulatory standards and requirements. Represent FDA on intra- and inter-agency committees, work groups and task forces for laboratory safety, security, and public health initiatives in support of established directives. 3

4 Key Focus Areas Laboratory Safety and Security Training and Certification Regulatory Compliance and Assurance Communication Culture of Safety Accidents, Incidents, Near Misses and LAI Reporting Applied Research Centralized Inventory Control and Management Coordination, Collaboration and Partnership 4

5 Laboratory Safety/Security Training and Certification Training: Web Based Training - FDA University Wet Lab Training Conducted by Laboratory Supervisor/PI Course Designed to be Module Based: For Example - Module 1 Rules Regulations & Guidelines Module 2 Risk Assessments Module 3 General Laboratory Safety Practices Module 4 BSL 1 Practice Module 5 BSL 2 Practice Module 6 BSL 3 Practice Module 7 Laboratory Animal Facilities Module 8 Laboratory BioSecurity Module 9 Safety Equipment Module 10 Recommended Work Practice Module 11 Decontamination Module Bio hazardous Waste Module 13 Biohazard Spill Cleanup Module 14 Shipping and Transport of Biological Materials Module 15 - Blood Borne Pathogen 5

6 Laboratory Safety/Security Training and Certification Questions for Discussion Does the areas identified accounts for a robust Laboratory Safety /Security Training program? What is missing and what else should be included? How often should we require the laboratory scientist to take the on-line web based training? What additional training should be provide to the laboratory scientist? 6

7 Reporting of Laboratory Accidents, Incidents Near Misses and Acquired Infections Many of the laboratory associated accidents, incidents and acquired infection are not reported or captured across the U.S. Reason: Being perceived as something negative. Scientists understand that practices should be refined as observations are made, hypotheses tested, findings published, and technical progress achieved. The same holds true for safety in the laboratory, which should evolve as experience is gained and as laboratory activities change. Lack of Reporting = Loss of opportunity to leverage Lessons Learned and to implement better and safer practices 7

8 Reporting of Laboratory Accidents, Incidents, Near Misses and Acquired Infections Questions for Discussion How do we encourage the laboratory scientist to share this information? What type of information should we capture? Employee Info; Supervisor s Info; Date of Report Filed; Date and Time of Incident; Location of Incident; Description; Type of injury; Diagnosis by OHMO: Hazards involved; How was the incident mitigated?; What were the associated impact? etc. 8

9 Applied Research and Development Decontamination: What are the best methods for decontamination and cleaning of spills etc.? In activation: For rapid detection and diagnostics test development and validation by leveraging commercial, private and academic institution. Sterilization: Evaluation of our current Sterilization Techniques based on what we have learned form recent events. 9

10 Applied Research and Development Question for Discussion What other areas should we explore? 10