What is Safety & Compliance? Case Study of a Laboratory Accident Who Sets the Standards for Safety & Compliance Promoting a Culture of Safety Roles

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1 Department of Environmental Health & Safety EHS Director: Ethan Carter, PhD Website: Facebook: February 6, 2013

2 What is Safety & Compliance? Case Study of a Laboratory Accident Who Sets the Standards for Safety & Compliance Promoting a Culture of Safety Roles and Responsibilities

3 If you want to become a chemist, you have to ruin your health. Who does not ruin his health by his studies, nowadays will not get anywhere in Chemistry. -- August Kekulé

4 Acting in accordance with regulations Responsible Conduct of Research Good Laboratory Practices Standard and Special Microbiological Practices Written Standard Operating Procedures Research Norms & Values

5 Lack of knowledge that regulations exist Lack of written SOPs reliance on memory of verbal instructions Missing skill set to follow an established SOP Presumption the non-compliant action or activity increases efficiency Outright disregard Lack of mentoring or coaching underpin all of these

6 The UCLA laboratory fire of December ationid=90&f_categoryid=1

7 Joined UCLA in July of 2008 as the inaugural Donald J. and Jane M. Cram Chair in Organic Chemistry Dr. Harran was previously at University of Texas Southwestern Medical Center at Dallas In temporary labs while permanent labs were being finalized.

8 Spring 2008 B.S. Chemistry grad 23 years old Working in Harran lab for 2 months No prior pyrophoric experience

9 From EH&S Because Sangji, Chen and Ding had started in mid- October they had missed EH&S training for the fall. They were scheduled to be trained in January. From Dr. Harran we were in temporary laboratory space we had never gone over where the showers were, how to use them. UCLA had no records that Sangji was trained. Relied on safety training from past institutions for Sangji, Chen and Ding.

10 UCLA fined $31,875 OSH Act Civil Penalties Criminal Penalties Proposed Legislation to Increase Penalties State-specific Laws About Corporate Responsibility Prosecution of Dr. Harran

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15 Institutional committees Local, State, or Federal laws and regulations Adopted standards Funding agency s policies

16 1. Institutional Animal Care & Use Committee (IACUC) 2. Institutional Biosafety Committee (IBC) Use of recombinant DNA in bench, animal, plant or human subjects research Use of Select Agents pathogens or toxins in research 3. Committee on Ionizing Radiation (CIR) Use of ionizing radioactive materials 4. Radioactive Drug Research Committee (RDRC) Use of radioactive drugs in human subjects research 5. Colorado Multi Institute Review Board (COMIRB) Human subjects research review

17 Colorado Dept. of Public Health & Environment Biomedical / Regulated Medical Waste Management Chemical / Hazardous Materials Management in conjunction with EPA Radioactive Materials License agreement State with NRC Metropolitan Waste Water District Commission Regulates all discharges to the sanitary sewer systems through the City of Aurora and City of Denver systems. Compliance with federal Clean Water Act.

18 Biosafety Bible Guidance on best practices: standard & specialized microbiological practices Regulatory in nature, for some materials, specifically Select Agents & Toxins, enforcing federal law

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20 Health and Safety Regulations and Guidelines 29 CFR Part , Bloodborne Pathogens, Exposure Control & Needlestick Safety 29 CFR Part , Occupational Exposure to Hazardous Chemicals in Laboratories Biosafety in Microbiological and Biomedical Laboratories, CDC and NIH, HHS. (current edition)

21 Public Health Security and Bioterrorism Preparedness and Response Act (Select Agents) 42 CFR Part 73 (CDC) 9 CFR 121 & 7 CFR Part 331 (USDA) USA PATRIOT Act & Restricted Persons

22 NIH Guidelines for Research Involving Recombinant DNA Molecules, (including Human Gene Transfer Research) Institutional Biosafety Committee EPA Resource Conservation and Recovery Act (RCRA) and Clean Water Act.

23 Committees Occupational health Lab audit and compliance programs Training

24 Provides services to faculty and staff of the University of Colorado Denver Downtown Campus and Anschutz Medical Campus. Students requirements per their School or College are covered under their Student Health Insurance. Services: Medical Surveillance--Occupational Exposures Health Risk Assessment--Occupational Exposures Immunizations & Testing Animal Exposure Surveillance Respiratory Protection Risk Assessment

25 Your lab can be audited at any given time by any agency providing funding or regulatory oversight to the university. EHS will schedule an audit with you or conduct an unannounced inspection on an annual basis. It is up to you to ensure you are prepared.

26 Kids and pets are NOT allowed in the lab areas. Food and drinks are NOT allowed in the lab areas. Personal Protective Equipment (PPE) appropriate to the task.

27 On-line Training Courses thru SkillPort Laboratory Safety Bloodborne Pathogens/Exposure Control for Research Regulated Medical Waste Chemical Waste Management Radiation Safety (not yet on-line) Shipping of Biological Materials Laser Safety Respiratory Protection

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29 General overview of common laboratory hazards; Risk management; Hazards of chemicals and equipment; Protective equipment needed How to prepare for emergencies

30 For researchers working with human blood products, cell culture, rdna, infectious materials Complete within 10 days of hire Online refresher annually

31 New requirement from CDPHE Required of all people who generate regulated medical waste (human and cell culture work) Required every 3 years

32 Required per EPA and the Colorado Department of Public Health & Environment On-line module to complete within 30 days of being hired with on-the-job training component also required. No unsupervised lab work until initial training complete Online refresher annually.

33 Four modules for employees / 5 modules for P.I. Only need to attend a class room for Module 2. Other modules are self-study with exams. Can t get your badge until the first three modules are completed or a Worker in Training form is filed with EHS. Online refresher annually.

34 Biological/Regulated Medical Wastes for regulatory requirements for waste pickup Chemical & Hazardous Material Wastes Radioactive Wastes

35 Academic laboratories like all labs are concerned with meeting the fundamental safety goals of minimizing accidents and injuries. But academic settings have unique requirements and responsibilities: Forming the foundations of a lifelong attitude of safety consciousness, risk assessment, and prudent lab practice is an integral part of every stage of scientific education Teaching and academic institutions must accept this unique responsibility for attitude development Institutional resources must be made available to facilitate safety training and compliance

36 Advanced training in safety should be mandatory for students engaged in research. This training needs to be hands-on whenever possible Research often involves making new materials by new methods, which may pose unknown or unique hazards Faculty are expected to provide a safe environment for research via careful oversight of student s work Promoting safety extends beyond EHS and senior researchers it applies to all scientists and students

37 Make a lab safety topic an item at every lab meeting Periodically review the results of lab inspections with entire lab group Encourage students and lab employees to contact EHS if they have questions about safe handling or procedures Require that all accidents and incidents (even minor ones) are reported to EHS so the root cause can be identified Review new procedures with students and discuss all safety concerns Make sure all safety rules are followed by everyone Recognize and reward students and staff for attention to safety Taken from Prudent Practices in the Laboratory

38 Laboratories are inherently dangerous work places.

39 Failure to keep up with training and/or keep your lab safe can lead to regulatory actions against the entire university.

40 Violations can result in: loss of access to the labs fines from regulatory agencies, and injunctions against the university This would potentially affect your career, everyone on campus and our University reputation!

41 Take the required training, complete your OJT, have an active presence in lab meetings & contact EHS if you have questions or concerns. Remember, EH&S is here to help Compliance Specialists Alison Welch MS x Kara Franke, MPH x Main Desk x x4-0699