Audits, Monitoring and Safety Committees

Transcription

1 Audits, Monitoring and Safety Committees Andrew Cannons, Ph.D. Laboratory Director FL Bureau of Public Health Laboratories-Tampa Outline Auditing The Biosafety Program Self Auditing, Internal Auditing, External Auditing Monitoring Staff and Equipment Reporting Incidents, Accidents, Near Misses Updating Your Biosafety Program Preparing for Novel Threats Safety Committees 1

2 Auditing Your Biosafety Program- Why? Need to Ensure the Program is Successful Need to Ensure the Program is Maintained, Improved Where Necessary Need to Ensure Staff Understand the Program and Show Compliance Auditing Your Biosafety Program- How? Pre Program Audit/Questionnaire Might be difficult if your program is already established Ongoing 2

3 Auditing Your Biosafety Program- Types? Internal Internal (PI, Safety Officer, Director) Self (Department Staff) External CLIA (not safety orientated) CAP CDC/APHIS (Select agent program) How to Monitor -Internal Auditing Use Checklists What To Monitor? How Detailed? Frequency of Audits Monthly, Yearly? How to Report Major Issues Minor Issues Recurring Issues Incident Reports Identify Issues Between Audits 3

4 How to Monitor -Internal Auditing APHL Biosafety Checklist Covers risk assessment, safety practices, PPE, lab practices, training, auditing Others Public Health Practice Asks about frequency of checks Checklist Should Also be Used to Ask Staff E.g. are they adequately trained? Comfortable in doing the work? Have all the safety controls in place (PPE, equipment, secondary barriers)? How to Monitor-Internal Auditing BSL3 Checklist Looks at Safety and Security Related Components Completed Each Month by PI All BSL3 Users Informed of Report Includes observations, deficiencies, timeline to rectify any deficiencies Recurring deficiencies addressed immediately 4

5 How to Monitor-Internal Auditing Incident Reports Documents All Incidents In BSL3 Labs Completed By Persons Involved/PI/RO Way to Identify: Corrective Action Recurring Issues Can Supplement CDC Form 3 Used to Update Biosafety, Incident Response, Security Manuals Addressing Recurring Themes Some Items on Your Audit Checklist Might Keep Repeating Need to Increase SOP Compliance? Some IRs Might Show Similar Trends Training Problem? Look at Your Training Program Do Not Use Punishment Reduce Reporting Behavioral Cues 5

6 Behavioral Cues How to Monitor-External Auditing External Audits, Surveys, Inspections Conducted By Agencies to Ensure Compliance Typically Compliance is Required For Continuation Audits Typically on a Defined Rotation (unless unannounced) Examples: CDC/APHIS Select Agent Program CLIA CAP NELAC Audits By Third Party Safety Agency Another Laboratory 6

7 How to Monitor-External Auditing College of American Pathologists Peer Based Inspection Model On-Site Inspection Every Two Years Some Safety Component Included How to Monitor-External Auditing CLIA Required for all entities that perform tests on... "materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings. Surveys conducted every two years Main emphasis on quality assessment rather than biosafety 7

8 How to Monitor-External Auditing CDC/APHIS Select Agent Program Federal Select Agent Program oversees the possession, use and transfer of biological select agents and toxins Enhances the nation s oversight of the safety and security of select agents CDC/APHIS Select Agent Program 8

9 Monitoring Staff and Equipment Performance Competency/Performance Evaluation of Staff Acknowledge the good, address the not so good (not punitively) Annual Biosafety Training and Evaluations Looking for understanding and compliance Annual Respiratory Protection Training and FIT Testing Drills and Exercises, With AAR Monitoring Staff and Equipment Performance, cont. Biosafety Equipment Must be Monitored Regularly for Efficacy PPE Respirators (e.g. filter use) Common Use Equipment Biological Safety Cabinets (air flow) Centrifuges BSL3 Labs Deficiencies Reported Immediately and Fixed 9

10 Reporting Incidents, Accidents, Near Misses All Incidents Involving Infectious Agents Should be Reported Via the Agency s Procedures Spill (minor, major) LAI Incident Report Should be Completed Workman s Compensation Possible Form 3 to Select Agent Program Reporting Incidents, Accidents, Near Misses, cont. Close Calls Are Wake Up Calls Keep a Log Book Where Staff Can Document Near Misses Use Information for Making Improvements to Your Biosafety Program 10

11 Updating Your Biosafety Program Use Audit Information/Reports Use Incident Reports, Near Miss Documentation Exercise Procedures, After Action Report Discuss Biosafety Issues at Safety Committee Meetings Training Attend National Training if Possible Webinars Update Plans Accordingly Preparing for Novel Threats Legionella pneumophila Norwalk virus MRSA Chikungunya MERS D68 Ebola Cryptosporidium HIV Campylobacter Toxic Shock Syndrome Helicobacter pylori E. coli O157 Prions VRE What is Next? Ehrlichia West Nile virus SARS Nipah virus Novel H1N1 11

12 Safety/Biosafety Committee Safety/Biosafety Committee Key to Maintaining Culture of Safety Commitment from Leadership Representation from Each Department Regular Meetings 12