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MGH Research Safety Committee Meeting #5 February 27, 2014 Harry W. Orf, PhD, Senior Vice President for Research Robert Castaldo, Safety Director Michael Fisher, Director, RSMG Mary Gervino, Director, MGH Research Compliance

MGH Research Safety Committee - Partners HealthCare · MGH Research Safety Committee Meeting #5 February 27, 2014 Harry W. Orf, PhD, ... Carol Leary Gail McHugh ; WH . Medicine ;

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MGH Research Safety Committee

Meeting #5

February 27, 2014

Harry W. Orf, PhD, Senior Vice President for Research

Robert Castaldo, Safety Director

Michael Fisher, Director, RSMG

Mary Gervino, Director, MGH Research Compliance

1. Incident Updates – Bob Castaldo 2. Presentation of Interactive Training Module – Carl Blesius 3. Organizational Structure Update – Harry Orf 4. Status and Updates from Task Forces Communications Task Force – Harry Orf Documentation/Policy Task Force – Bob Castaldo Chemical Hygiene Task Force – Bob Castaldo Lab Survey Task Force – Michael Fisher Training Task Force – Mary Gervino 5. Questions and Open Discussion

Agenda

Page 2

1. Incident Updates – Bob Castaldo 2. Presentation of Interactive Training Module – Carl Blesius 3. Organizational Structure Update – Harry Orf 4. Status and Updates from Task Forces Communications Task Force – Harry Orf Documentation/Policy Task Force – Bob Castaldo Chemical Hygiene Task Force – Bob Castaldo Lab Survey Task Force – Michael Fisher Training Task Force – Mary Gervino 5. Questions and Open Discussion

Agenda

Page 3

1. Incident Updates – Bob Castaldo 2. Presentation of Interactive Training Module – Carl Blesius 3. Organizational Structure Update – Harry Orf 4. Status and Updates from Task Forces Communications Task Force – Harry Orf Documentation/Policy Task Force – Bob Castaldo Chemical Hygiene Task Force – Bob Castaldo Lab Survey Task Force – Michael Fisher Training Task Force – Mary Gervino 5. Questions and Open Discussion

Agenda

Page 4

1. Incident Updates – Bob Castaldo 2. Presentation of Interactive Training Module – Carl Blesius 3. Organizational Structure Update – Harry Orf 4. Status and Updates from Task Forces Communications Task Force – Harry Orf Documentation/Policy Task Force – Bob Castaldo Chemical Hygiene Task Force – Bob Castaldo Lab Survey Task Force – Michael Fisher Training Task Force – Mary Gervino 5. Questions and Open Discussion

Agenda

Page 5

Organizational Structure

Page 6

MGH Safety Committee

Research Safety

Committee

Departmental Safety

Coordinators

Site Safety Coordinators

PI’s and Individual

Researchers

Unit Safety Coordinators

PI’s and Individual

Researchers

Lab Safety Coordinators

PI’s and Individual

Researchers

Support Department Staff

EH&S Radiation Safety

Biosafety Compliance

Research Management Animal Welfare

Occupational Health Police and Security Emergency Services

Research Space Management

Staff

Research Management

EH&S Department

Page 7

Organizational Structure

Department Unit Unit Location (Site)

Department Safety

Coordinator

Unit Safety Coordinator

Site Safety Coordinator

Lab Safety Coordinator

RSMG Analyst

Anesthesia Stuart Forman NH Cancer Center Research 149-6 Khaleda Haider Carolyn Gorka NH Cancer Center Research 149-07 Khaleda Haider Laura Libby NH Cancer Center Research 149-08 Khaleda Haider Carolyn Gorka NH Cancer Center Research Simches 4 Khaleda Haider Nicole Smith NH Cancer Center Research Jackson 9 Khaleda Haider Mary Lynch NH CCIB Chris Kelleher MC CCM Jason Fuller JK CHGR Vijaya Ramesh WH CRM David Machon NH CSB Peter Waterman WH Center for Wellman Labs Bobby Redmon MC CIMIT MF CTSA MF Dermatology John Dellorusso MC Emergency Service Blair Perry NH Medicine Cardiology MC Medicine CVRC MC Medicine CIID 149-6 (Mempel) Carol Leary E. Carrizosa WH Medicine CIID 149-6 (Elkhoury) Carol Leary Suzanne Hickman WH Medicine CIID 149-6 (Moon) Carol Leary James Moon) WH Medicine CIID 149-8 (Luster) Carol Leary Carol Leary WH Medicine CIID 149-8 (Means) Carol Leary Terry Means WH Medicine CIID 149-8 (Shreffler) Carol Leary Alex Ma WH Medicine CIID 149-8 (HMC) Carol Leary Vlad Vrbanac WH Medicine CIID 149-8 (Anthony) Carol Leary Robert Anthony WH Medicine CIID 149-8 (Hacohen) Carol Leary Alice Lan WH Medicine CIID 149-8 (Steere) Carol Leary Gail McHugh WH Medicine CIID 149-8 (Tager) Carol Leary Leaya George WH Medicine Diabetes Mary Larkin NH Medicine Diabetes Yen Yi NH Medicine Diabetes 149-3 Faustman NH

Page 8

Organizational Structure

Areas Not Yet Represented CIMIT Infectious Disease – 65 Landsdowne, 50 Staniford St.. 149-5 OB/GYN Renal Membrane Biology Lab for Lipid Metabolism and Technology – 149-4

1. Incident Updates – Bob Castaldo 2. Presentation of Interactive Training Module – Carl Blesius 3. Organizational Structure Update – Harry Orf 4. Status and Updates from Task Forces Communications Task Force – Harry Orf Documentation/Policy Task Force – Bob Castaldo Chemical Hygiene Task Force – Bob Castaldo Lab Survey Task Force – Michael Fisher Training Task Force – Mary Gervino 5. Questions and Open Discussion

Agenda

Page 9

MGH Research Safety Committee

Communications Task Force Update

Harry W. Orf, PhD, Senior Vice President for Research

Status and Updates from Task Forces

Action Items from 5th Meeting

Tracking Safety Training “Central” Database for all Research Personnel w/Reqd Training now under development (Research Personnel Database – RPD) Research personnel survey to review all personal data and ID training needs – top level questions completed, detailed ones under development (e.g., work with animals? which types….)

Purchase ID badge scanner for recording training attendance Will pilot with Rad Safety Training and at a Research Council meeting

Hazardous chemical purchases – notification system to forward SOP’s Electronic list of purchases generated weekly by Materials Management We will develop a process to notify PI’s and send information to a database to track who has hazardous materials and supply generic SOP’s to be customized

Met with Lab Survey Team Will develop portable survey tool and database Formalize documentation of issues, resolution, feedback

Communications Task Force Update

MGH Research Safety Committee

Safety Documentation Task Force Update

Robert Castaldo, Safety Director

Status and Updates from Task Forces

Section 1: Organization and Hazard Management Process Describes safety program organization, roles and responsibilities and safety management principles; directed primarily to management level staff

Policy Statement Research Safety Organization Hazard Management and Loss Control Process

Section 2: Safety for All Research Community Personnel Presents material everyone in the research community needs to know about safety in their workplace, regardless of their job role

Safety Training Requirements Fire and Life Safety in Research Facilities

Emergency Preparedness and Response

General Administrative Policies and Procedures

Safety (Incident) Reporting Occupational Health Services

Police and Security

Section 3: Safety for All Technical Laboratory Personnel Addresses general safety requirements applicable to all technical personnel working in labs

Chemicals Hazardous Waste Management

Electrical

Personal Protective Equipment

Safety and Emergency Equipment

Laboratory Signage

Lab Equipment

Section 4: Special Hazards Presents safety information for technical staff who also work with the following special types of hazards or situations

Animals Biosafety Radiation

Lasers Human Subject Research Safety

Section 5: Helpful Resources

Links Forms Templates

Research Safety Manual – Orientation Chart

MGH Research Safety Committee

Chemical Hygiene Task Force Update

Robert Castaldo, Safety Director

Status and Updates from Task Forces

Chemical Safety

Hazard Communication Information from: • inventory • labels • SDS • training - Health Stream modules

Chemical Hygiene Plan Organization level

1. Health Hazards 2. Physical Hazards

Safety Policies & Procedures re: acquisition through use and disposal • flammables • corrosives • reactives • toxics • compressed gases • cryogens • emergencies • spill management • waste disposal Chemical Hygiene Plan

Department-specific level

Tools and Resources • Hazardous chemicals definitions and standard safety requirements • SOP template

Tools and Resources

Two major concerns

Chemical Hygiene Task Force Update

Status and Updates from Task Forces

Status and Updates from Task Forces

Status and Updates from Task Forces

Status and Updates from Task Forces

Status and Updates from Task Forces

MGH Research Safety Committee

Lab Survey Task Force Update

Michael Fisher, Director, RSMG

Status and Updates from Task Forces

Laboratory Safety Surveys Update

• The Task Force’s charge is to develop and implement an ongoing laboratory safety surveillance process in collaboration with the various departments, laboratories, and principal investigators.

• The ultimate goal is to assist principal investigators in identifying and mitigating unsafe conditions in their laboratories.

Laboratory Safety Surveys Update

• Each laboratory at MGH will be surveyed annually.

• The survey team will consist of: – RSMG Operations Manager – Representatives from

• B&G • Environmental Services • Police and Security • Environmental Health and Safety

– Two lab managers at large – Lab manager from the laboratory being surveyed – Departmental Safety delegate

Laboratory Safety Surveys Update

• Pre survey worksheet

•For use by laboratory in preparation for survey visit

•Two weeks prior to visit

•Survey instrument

•Web based application for use by survey team

•Survey results

•Prepared by survey team within two weeks

•Distributed to departmental safety coordinator, principal investigator, and laboratory manager

•On line response detailing mitigation plan and completed items

•Follow-up approximately 3 months by RSMG representative

Laboratory Safety Surveys Update

Survey Schedules

Trend Reports

Survey Reports

iPhone, iPad, etc. for use by

survey team

Follow-up Reports

Pre-survey Work Sheet

CENTRAL DATABASE

APPLICATION

MGH Research Safety Committee

Safety Training Task Force Update

Mary Gervino, Director, Research Compliance

Rachel Ackman, Sr. Research Compliance Associate

Status and Updates from Task Forces

Training Templates

• Why – Ease transition to interactive format – Shape current content to be cohesive, straightforward,

to-the-point – Provide a standard for newly developed trainings

Template Outline

• Training Objectives • Policy Statement in laymen’s terms with link to

regulation • What does this mean for me? • How do I implement • Best Practices • Summary • Resources • Quiz

Training Objectives

• What do we intend to accomplish? – This training will show you how to… – This training will teach you about… – This training will provide…

Training Objectives

• Hypothetical: Controlled Substances Use in Nonhuman Research

• What do we intend to accomplish? – This training will explain how to comply with the law and

obtain the appropriate registrations (licenses), order controlled substances from established distributors, and maintain secure storage and accurate inventory of controlled substances.

Policy Statement in Laymen’s Terms

• Why is this training required? – You must do X because Y… – NIH/OSHA/etc requires X because Y… – Its important to learn X because Y…

• For additional information: – The MGH/Partners policy can be found here… – The Federal/State law or regulation can be found here…

Policy Statement in Laymen’s Terms

• Hypothetical: Controlled Substances Use in Nonhuman Research

• Why is this training required?

– State and federal law requires specific Research Registrations in order to purchase and use controlled substances for nonhuman research.

• For additional information: – The MGH policy can be found at

http://library.partners.org/MGH1/trove.asp?FI=Research+Compliance&DI=Non-Human+Research+Controlled+Substances+Policy+%26+Procedure&HU=EmptyURL

What does this mean for me?

• What do I have to do?

What does this mean for me?

• Hypothetical: Controlled Substances Use in Nonhuman Research

• What do I have to do? – Researchers must apply for the appropriate licenses,

ensure that all drugs are securely stored, and determine who in the lab should have access. Drugs can be ordered from McKesson Pharmaceutical, and veterinary drugs can be ordered through Patterson (Webster) or Butler-Schein.

How do I implement

• What are the steps to implement this training?

How do I implement

• Hypothetical: Controlled Substances Use in Nonhuman Research

• Step 1: confirm that your drug storage meets the legal requirements, which are x, y, and z

• Step 2: apply for your state and federal research registrations for controlled substances, if you do not already have them. – State application can be located

http://www.mass.gov/eohhs/docs/dph/quality/drugcontrol/app-researcher.pdf

– Federal application can be located https://www.deadiversion.usdoj.gov/webforms/jsp/regapps/common/newAppLogin.jsp

– If a state or federal agent would like to interview you or visit your lab, contact Research Compliance immediately

Best Practices

– Always do X – Never do Y – It’s a good idea to do Z

Best Practices

• Hypothetical: Controlled Substances Use in Nonhuman Research – Always maintain an accurate inventory of controlled substances in

your drug safe. – Never store items other than controlled substances and the inventory

log in your drug safe. – It’s a good idea to schedule a reminder to renew your license every

year.

Summary

• Recap highlights – Who – What – Why – When/where – How

Resources

• Who to contact • Where to go for more info (policy, other helpful websites)

Quiz

1. Incident Updates – Bob Castaldo 2. Presentation of Interactive Training Module – Carl Blesius 3. Organizational Structure Update – Harry Orf 4. Status and Updates from Task Forces Communications Task Force – Harry Orf Documentation/Policy Task Force – Bob Castaldo Chemical Hygiene Task Force – Bob Castaldo Lab Survey Task Force – Michael Fisher Training Task Force – Mary Gervino 5. Questions and Open Discussion

Agenda

Page 42

Page 43

Discussion!

Questions?