Compliance Inspection Programs How to get it funded! Eoin OGrady - - PowerPoint PPT Presentation

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Developing and Sustaining Compliance Inspection Programs How to get it funded! Eoin OGrady PhD CRSP Manager, Laboratory Safety and University Biosafety Officer Sep 18, 2019 Canadian Biosafety Symposium, Toronto Preparation for the new

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Developing and Sustaining Compliance Inspection Programs

How to get it funded!

Eoin O’Grady PhD CRSP Manager, Laboratory Safety and University Biosafety Officer

Sep 18, 2019 Canadian Biosafety Symposium, Toronto

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2012 Phase I, II Consultations 2013 Phase III Consultations 2014 Draft Regs & Stds 2014 0.25 FTE hired

Preparation for the new licencing regime…

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2015 saw lots of internal program changes…

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2015 saw lots of internal program changes…

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2015 saw lots of internal program changes…

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2015 saw lots of internal program changes…

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2015 saw lots of internal program changes…

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Dec 2015 Submitted Mar 2016 Needs Improvement Sep 2016 Non- compliance Oct 2016 Re- submitted

The licence application “needs improvement”...

“The University BSO has made a business case for additional personnel resources to be allocated to the Biosafety Program. That business case is under consideration at present. In the interim, a part-time Biosafety Program Advisor is hired to assist with compliance inspections.”

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UCalgary ranks 12th among U15 in terms of biosafety FTE

1 2 3 4 Calgary Dalhousie, Queens,… Western, Saskatchewan Simon Fraser Manitoba McGill UBC McMaster Toronto Alberta Total FTE U15 counterparts U15 X U15 Y U15 Z U15 …

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Inspections to cover diverse lab activities

Specific biohazards ? Biosafety labs (400) + Radioactive labs (50) Chemical labs (550)

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Purpose of biosafety compliance inspection program

Monitor compliance for specific biohazards
Improve compliance assurance
Improve and ensure consistency
Report on non-compliances

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Scope developed against criteria

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Let’s prioritize our biohazard risks

Specific Biohazard Types

1. HIV 2. Prion (CL2) 3. Aquatic pathogens (AQC2) 4. Sand fly (Arthropod) 5. Small Animal Containment (CL2-SA) 6. Small Animal-Prion Containment (CL2-SA-Prion) 7. Large Animal Containment (CL2-Ag)

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Adhere to annual inspection process

Notify Inspect Report Follow- up Close

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1 2 3 4 5 6 7 8 9 10 HMRB HRIC HSC BI KNB VSRS QB

# Laboratories Building

SA HIV Arthropod Prion SA-Prion Aquatic Ag

Variety and complexity of lab types across campuses

Foothills (15) Main (3) Spyhill (3)

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Floor plans help in understanding the facility

ffice

anteroom autoclave freezers work area

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Visuals help others unfamiliar with facility

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Visuals (Laboratory-specific)

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Central, staffed autoclave facilities are leaders…

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Laboratory-specific PPE keeps us safe (and it’s fun!)

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Common findings prompt further action

Fabric chairs
Open lab doors
Exposed wood
Housekeeping
Non-reproducible key to access labs
Training records
SOPs
Decontamination records

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Common Findings (Facilities-specific)

Eyewash, ceiling lights, floor/wall notches, sealant, fire extinguishers

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Sand fly facilities creates new challenges

Sand fly is “alien” – CFIA
Sand fly is a vector for Leishmania
Leishmania is a parasite – PHAC

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Sand fly facilities creates new challenges

Sand fly is “alien” – CFIA
Sand fly is a vector for Leishmania
Leishmania is a parasite – PHAC
What kind of SOP is needed for “Escaped sand flies”?!

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Sand fly facility has some performance problems

30 deficiencies in 2017 including:

Material to buy/install
SOPs
Medical surveillance
Training records

24% 0% 10% 6% 76% 100% 90% 94%

OCT-17 MAY-17 OCT-18 CURRENT

N. PETERS LAB

(SAND FLY, HRIC 4B37A)

Non-Compliances Compliances Oct 16

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Sand fly facility has some performance problems

30 deficiencies in 2017 including:

Material to buy/install
SOPs
Medical surveillance
Training records

13 deficiencies in 2018 including:

SOPs
Housekeeping
Training records

24% 0% 10% 6% 76% 100% 90% 94%

OCT-17 MAY-17 OCT-18 CURRENT

N. PETERS LAB

(SAND FLY, HRIC 4B37A)

Non-Compliances Compliances Oct 16

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Find deficiencies before the regulators – HIV (RG3)

7 deficiencies including:

Housekeeping
Minor SOP updates
Eyewash maintenance

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Find deficiencies before the regulators – HIV (RG3)

7 deficiencies including:

Housekeeping
Minor SOP updates
Eyewash maintenance

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Double the deficiencies vs other HIV (RG3) lab

15 deficiencies including:

Doors stoppers
Doors kept open
Training records
Decontamination records

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Prion facility has significant wear and tear

32 deficiencies including:

Sealant broken
Access control
Training records
HACF/Lab manual/SOPs update
Decontamination process

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Year-over-year improvements are realized

5 deficiencies including:

Housekeeping
Labelling for transport
Training
Gasket repair

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Year-over-year improvements are realized

Oct 2016 - the business case for a part-time, permanent position is endorsed by:

Director, EHS
AVP, Risk
AVP, Research
University Veterinarian
Chair, Biosafety Committee

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Year-over-year improvements are realized

Oct 2016 - the business case for a part-time, permanent position is endorsed by:

Director, EHS
AVP, Risk
AVP, Research
University Veterinarian
Chair, Biosafety Committee

Dec 2018, position is funded

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Purpose of biosafety compliance inspection program

Monitor compliance for specific biohazards
Improve compliance assurance
Improve and ensure consistency
Report on non-compliances

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Purpose of biosafety compliance inspection program

Monitor compliance for specific biohazards
Improve compliance assurance
Improve and ensure consistency
Report on non-compliances