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Start off on the Right Foot: How to Plan and Maintain a Solid Training Program

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 McCarthy BA RLATG. Agenda . Stephen Rydberg- “Formulating the Plan” Rebecca Serriello- “New User Facility Orientation”

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Start off on the Right Foot: How to Plan and Maintain a Solid Training Program

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

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

  3. >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 Who we are-Genzyme

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

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

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

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

  8. 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.”

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

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

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

  12. 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

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

  14. What is our Direction?

  15. 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?

  16. 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?

  17. 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

  18. 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)

  19. 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 Integration

  20. 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

  21. 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

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

  23. Welcome to the facility!

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

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

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

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

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

  29. 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 Why Orientation?

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

  31. 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 DCM & Science Staff

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

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

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

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

  36. Orientation today… surgeon tomorrow

  37. On The Job Training Modules and Beyond Rebecca McCarthy Training Specialist Senior Genzyme LAWTE 2009

  38. 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

  39. 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

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

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

  42. OJTRodent Basic Injectable Administration IP Injections-Mouse

  43. OJTRodent Basic Injectable Administration IP Injections-Mouse

  44. OJTRodent Basic Injectable Administration IP Injections-Mouse

  45. 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 Step-by-Step Guide

  46. 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

  47. 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

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

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

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

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