E R I K A B A R R E T TT E C H N I C I A N , B I O L O G I C A L S A F E T Y

O F F I C E O F R A D I AT I O N , C H E M I C A L & B I O L O G I C A L S A F E T Y

B A R R E T T E @ E M A I L . A R I Z O N A . E D U5 2 0 - 6 2 6 - 5 8 6 9

F R I D AY, O C T O B E R 3 R D , 2 0 1 4

Implementation of an Audit Program

Requirements for an Audit Program

Good laboratory practiceSeveral federal agencies require an audit program such

as: Occupational Safety & Health Administration National Institute of Health United States Department of Agriculture

Evaluation

Planning (determining

needs, meetings)

Development (creating manuals, developing guides)

Implementing (audits, visits)

Report & Analysis (data analysis,

drafting reports)

Audit Program Process

Process Acceptance

Obtain responsible individuals approval Integrate them in the

planning stages Request comments on

developed forms, documents and guidelines

Create a culture of collaboration

Getting everyone to buy-in to the program will increase safety culture

Senior Vice President for Research

ORCBS = Office of Radiation, Chemical & Biological Safety

ORCBS &Committees

PrincipalInvestigators

LaboratoryWorkers

Self-Assessment

Self-assessment guides for the researchers “Audit Check Guides”

• Rooms• Agent Inventory• Workers• Training Requirements• Storage• Work Practices• PPE

PPE = Personal Protective Equipment

Guidelines

Publish forms, guidelines and reference documents in an accessible space Tailor the documents to the community Establish the priority of development (i.e. audit program 2.0) Publish prior to beginning the audit program if possible

Implementing the Audit Program

Once you have developed the program Start with the highest risk

laboratories first (e.g. Biosafety Level 3)

Then move down the levelsMulti-auditor visits to

create continuityChange the auditor for

each lab each yearComplete follow-up

BSL3

BSL2

BSL1 & PlantBSL = Biological Safety Level

History of the ORCBS Biological Safety Program

Support staff of the Institutional Biosafety Committee was responsible for UA biological safety

The University of Arizona was inspected by the NIH in April 2011

The Radiation Control Office became ORCBSThe CDC inspected the Select Agent/Toxin Program in

November 2011Requirements of ORCBS after inspection

Develop a complete audit program Provide training to every laboratory worker Obtain knowledge of current research community

NIH = National Institutes of Health, CDC = Centers for Disease Control & Prevention

History of the ORCBS Chemical Safety Program

Risk Management was responsible for UA chemical safety

ORCBS started laboratory chemical safety in Fall 2011 Staffed the new program Evaluated and updated forms Created an inspection checklist “Compliance checks” for granting authorities

The scope of registered laboratories expanded Currently developing database for full program use

Registration of a Laboratory

ORCBS is notified of a research laboratoryORCBS communicates with the researchers

Protocol forms Invitations to training

Forms sent to committee and workers complete trainingInitial visit

Follow-upAnnual audit

Follow-up

Total Biological Safety Registrations: 273Total Chemical Safety Registrations: 186 (Expected 500+)

Annual Audit Program

Annual audit for all laboratories Follow-up with any corrective measures

Unannounced laboratory visit 6 months from annual audit Follow-up with any corrective measures

A summary report of every visit and a previous inspection history is provided to the Principal Investigator

Perceived Difficulties Real Difficulties

Obtaining acceptance of the audit program

ComplianceBuilding relationshipsTransfer of

responsibility to ORCBS

Differences in prior safety training

Departmental rules varyClarity of regulations

MSDSs and inventory requirements are up to the individual programs

Gaining compliance

Difficulties for Implementation of Audit Program

Successes for Implementing an Audit Program

Overall programs current to standardIncreased safety cultureDecrease in number of findings per audit

Mostly new findings with updates, not reoccurring problemsUtilization of proactive communicationCompliance increased

2011 2012 2013 20140

50

100

150

200

250

300

Type of Visits by Year for Biological Safety

Audit FU LV

2011 2012 2013 20140

50

100

150

200

250

300

Type of Visits per Year for Chemical Safety

Audit FU

Time Requirement

For a new laboratory from start to finish for the first year, our office spends 10 hours for biological safety 8 hours for chemical safety

For biological safety, this amounts to 300 Approvals: 3,000 hours / 3 years

About 16% of our time each year was dedicated to new approvals, 15% for established approvals

Top Findings of 2011

1. Micropipette Tips 2. Biohazard Labeling

(Rooms & Equipment)3. Centrifuge Cups

Biological Safety Chemical Safety

1. Standard Operating Procedures

2. Spill Kit3. Autoclave4. Centrifuge Cups5. Micropipette Tips

1. Laboratory-specific training

2. General safety training3. (Material) Safety Data

Sheets4. Inventory5. Secondary containment

for acids and bases

Top Findings of 2012

Biological Safety Chemical Safety

1. Standard Operating Procedures

2. Training3. Spill Kit4. Centrifuge Cups

1. Laboratory-specific training

2. General safety training3. (Material) Safety Data

Sheets4. Inventory5. Particularly hazardous

chemical storage

Top Findings of 2013

2012 2013 20140

500

1000

1500

2000

2500

3000

512325 227

1045

2225

2765

Findings per Year for Biological Safety 2012-Present with Trained Workers

Number of Findings Total People Trained

Updates to the Audit Program

When there is an update to regulations, the audit program should reflect the change Raise awareness Begin to recommend the update Add requirement Finalize expectations and evaluate effectiveness

“Sharp-like” micropipette tip rule (non-federal)The Globally Harmonized System Training (federal)

Sharp-like Micropipettes Case Study

The radioactive material program at the UA designated pipette tips of 1 mL or less as sharp-like

Biological safety adopted this requirementResearch

BMBL Surveyed other campuses IBC voted

Integrated the change into training and audit program

12%

3.5%

3%

GHS: Case Study

OSHA adopted the Globally Harmonized System in 2012

Required training for all laboratory workers by December 1st, 2013

ORCBS created a web-based 15 minute training and quiz for laboratory workers to take

Initial e-mail and 3 reminder e-mails

10/24 10/29 11/3 11/8 11/13 11/18 11/23 11/28 12/30

200

400

600

800

1000

1200

1400

1600

1800

2000

Total GHS Training Completions 10/24/2013 - 12/4/2013

Total Trained by 12/1/2013: 1840

The Future of ORCBS Program

Both programs expect to be inspected by an outside agency within the next year NIH for biosafety, OSHA for chemical safety Freezer inventory

Chemical safety plans to deploy the full program in 2015

Future Goals Updated database Going paperless iPad program

Questions?