Start off on the Right Foot How to

Start off on the Right Foot: How to Plan and Maintain a Solid Training Program Stephen A. Rydberg BA RLATG Rebecca Serriello BS CVT RLATG Rebecca Mc. Carthy BA RLATG

Agenda • Stephen Rydberg- “Formulating the Plan” • Rebecca Serriello- “New User Facility Orientation” • Rebecca Mc. Carthy- “On The Job Training Modules and Beyond”

Who we are-Genzyme • >11, 000 employees worldwide • Helping patients in 100 countries • 17 manufacturing sites • 9 genetic testing lab sites • 19 major marketed products • 2008 revenue of $4. 6 billion • 85 locations in >40 countries • Henri Termeer: Chairman, CEO

Department of Comparative Medicine • Size – ~50 K sq ft. – ~40 K animals/year – 1200 studies/year • Staff – Approx 50 FTE’s • Work groups – Husbandry – Technical – Internal Programs • Training • Compliance

Who we are. . . and where we came from • Then (pre-2003) –Informal –Small staff • Now –Structured –Larger Staff

DCM – Training Program David Lee-Parritz DVM -Director DCM Lynette Trumbore -Associate Director Internal Programs Rebecca Serriello Stephen Rydberg Rebecca Mc. Carthy Orientation IACUC Safety Science Staff DCM Staff

Formulating the plan Stephen A. Rydberg BA, RLATG Training Specialist Principal Department of Comparative Medicine Genzyme

Why a training program? • The Guide tells us (pg 13. )…. ”AWRs and PHS Policy require institutions to ensure that people caring for or using animals are qualified to do so. ”

What are our needs? • Goals • Self-assessment • Direction • Planning • Integration • Implementation

Goals of a solid training program • Quality science • Animal health and welfare • Safety • Compliance

Self assessment- Who are we? • Academic – Multi-users with different needs • Post docs, grad students, internal staff • Higher turnover rates • De-centralized

Self assessment cont’d • Private Biotech – Similar focus users • Scientists, Internal staff • Lower turnover rates • More centralized • Contract Lab – Similar focus users • Internal staff • Highly centralized

Self assessment cont’d • How big are we? – Number of “noses” – Square footage-Multiple buildings – Staffing

What is our Direction?

Other things to consider • Compliance issues –Animals/people harmed –Are too many mistakes happening? –Is data being rejected by the FDA, journals, etc. ? –Group is getting too large –Are outside resources inadequate? –Does it take too long to get people trained?

Who will assist in the designs? • How can we involve our staff? –Canvas program members to see what works best? –Work from a “template”? • Previous institution – Familiarity – Comfort –Start from the bottom-up?

Planning • Organization –Who will be in charge? –What tasks will we train? –Who will staff this group? • How do we identify a qualified trainer? • Technical skill-AALAS certifications • Experience • Educational challenges – Manual vs. didactic training – Adult learners – ESL

Planning continued • How many staff do we really need? • Can we utilize training “assistance items” such as videos and online training? • Documentation –Paper records –Electronic capture (database)

Integration • Compliance married with training – IACUC and QA requirements – If it’s not going to be accepted…why do it? • Tracking training – Assigning “qualifications” • Based upon title • Based upon duties • Make training available – Training plans • Management involvement is key – Ensures staff is available, motivated and accountable • Maximizes trainer time – Ensures trainer is available, prepared and accountable • Training goals are clearly defined and attainable

Implementation • Communication and scheduling –Training database-automated reminders –Highly organized trainers –Centralized scheduler of trainers • Paper-trails/E-mail notices –Ease of access to scheduling –“Hard copy” that communication was sent –Ability to forward to another trainer for coverage

Don’t forget about the trainer! • LAWTE involvement • AALAS involvement (local branches as well) • Outside training –Presentation skills –Scientific/technical writing –Computer skills –May not be directly related to animal science • Allowing time to fit into their schedule –Trainer’s lament…”I’m too busy!” –Schedule yourself

New User Facility Orientation Rebecca Serriello, CVT, RLATG Training Specialist Senior Department of Comparative Medicine Genzyme

Welcome to the facility!

Orientation • Department of Comparative Medicine (DCM) • Science staff –Scientists –Research Associate/Assistant –Intern • Facilities Department & Contractors

Orientation Goals- Animal Welfare • Don’t hurt the animals • Maintain Biosecurity

Orientation Goals- Safety • Don’t hurt yourself • Protect the public

Orientation Goals- Good Science • Maintain equipment • Write it down when it happens

Orientation Goals- Company’s Resources • Protect your company’s interests • Protect your job

Why Orientation? • General principles of animal care, safety and science • Site specific features – How to get around – Where do I find things? – How to get help • Compliance- IACUC, QA, documentation • Unique needs of the individual

Animal Facility Orientation at Genzyme • Introduction • Reading materials – SOPs – Safety modules and documents – Facility manual • Facility Tour • Wrap up

Orientation DCM & Science Staff • SOPs – Large amount of information • Required – Access procedures & PPE – Labeling of Chemicals – Storage of test materials – IACUC – Veterinary care – Good documentation & use of data forms

Orientation for DCM & Science Staff • Facility Manual • Facility Usage Agreement – IACUC, HR & legal approved document

Facility Tour • Biosecurity • Chemical waste satellite area • PPE • Fire evacuation policy, muster area • Animal related risks

Contractors/Facilities Orientation • Facility access SOP • Document training • Facility tour • Importance of biosecurity • Educate

Next steps… • Document training • Identify further training • Communication – Security/Manager – Portal links – SOPs – Point of contact information – IACUC personnel amendment

Orientation today… surgeon tomorrow

On The Job Training Modules and Beyond Rebecca Mc. Carthy Training Specialist Senior Genzyme LAWTE 2009

Terminology • Qualifications=Curriculum • Components=Skills • OJT=Tool for trainers to train a skill –Skills –Didactic>SOP, video, AALAS manual, lectures • Module=Reference/Take home material • Proficiency

Curriculum • Group of SOPs and skills required to execute the requirements of a functional job description • Example: Rodent Technician I must be able to perform basic technical procedures on study – Curriculum=Rodent Substance Administration, Rodent Basic Blood Collection, Study Outline/Protocol Review, Rodent Handling and Restraint, Rodent Health Monitoring, Rodent Tissue Harvesting, Rodent Basic Urine Collection – 6 Skills=Drug Calculations, Rodent Basic Injectable Administration, Small Animal Scale Balancing – 7 SOPs=Research Facility Operations-Rodents, Procedure for Reporting Lab Animal Adverse Events, Administration of Substances within the Animal Research Facility

Skills/Techniques (Rodent Substance Administration) 1. Basic Injectable Administration (IP, SQ, IM) 2. Rodent Oral Dosing 3. Drug Calculations 4. Small Animal Scale Balancing/Leveling and Calibration

OJT • Didactic-SOPs, AALAS manual, video • Materials/Equipment to perform skill-Needles • Critical Points • Proficiency Criteria • Progress

OJT Rodent Basic Injectable Administration IP Injections-Mouse

OJT Rodent Basic Injectable Administration IP Injections-Mouse

OJT Rodent Basic Injectable Administration IP Injections-Mouse

Step-by-Step Guide • Accompanies OJT • Contains same information as OJT • Step-by-step guide on how to perform the skill/prerequisite skills • Remains with the trainee as reference guide

Proficiency • Demonstrates trainee can perform the skill –Reliably –Accurately –Efficiently • Criteria established by Trainers / Veterinarians / Scientist • One day to several weeks depending on task and previous experience

Proficiency (Sham) Tests • Skill specific • Demonstrates to scientist that test material is administered properly and produces a physiologic effect on the animal • Administration of a marker to animals by testers and control injector • Serum analyzed for a % level of marker in the animals blood

Expression Results of Competent Trainee Control Results No expression shown, failed sham test

Refresher Training • Incident/Accident • Failure to pass sham test • Skill not performed recently • Compliance Issue • SOP requires retraining

Mentors • Senior technicians • Role models –study management –technical ability –professionalism • Development opportunity • “Train the trainer” –presentation skills –use of training documentation

Continuing Education • Group training • Special topics – journal articles – outside consultant (rabbit epidurals) – anesthesia monitoring – pulse oximetry • Address issues – incidents/accidents – Compliance – Safety – animal welfare

The 3 R’s (Russell & Burch) • Refinement > train better, accommodate individuals different modes of learning • Replacement > video, e-learning • Reduction > use of fewer animals with the use of videos, e-learning, use the trainer more efficiently

WRAP-UP • How we plan • Examples/Tools • Follow-through

Follow-through • Move forward with a purpose…. . while allowing some flexibility –Consistency must be maintained • Buy-in –All in the same boat –Best results • Science • Animals

Follow-through cont’d • Eye on the prize! • Avoid pitfalls to the plan – Don’t play “favorites” • Credibility issues • Sending mixed messages –Confusion –Errors • Continued self evaluation – Internal reviews and audits – Include other groups – Ask for feedback

Questions?