Sample Webinar Slides

From ACUP Consultingwww.acupconsulting.com/webinars.htm

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Compliance Inspections

PAM, Mock-USDA and Medical Record Audits

Melissa Hunsley, PhD, CPIA

www.ACUPconsulting.com

• 1-hour webinar • 60 slides • $75 per institution

Today’s Webinar

Inspection basics Where & when to inspect Inspection criteria Preparing for a visit from the USDA

Notes on “Adequate Veterinary Care” Medical Records Audits Other records that should be inspected and maintained

IACUC records & details “written narrative” in the IACUC protocol

Tips for IACUCs Review & Final Recommendations

“Basic” areas to inspect:

Centralized housing Decentralized housing & satellites Procedure areas (in & out of facility) Surgery areas (in & out of facility) Imaging and irradiation facilities Behavioral testing areas Feed, bedding & equipment storage Cage wash

When preparing for:

IACUC, AAALAC (the Guide)“Basic” areas plus: Occupational health program for all animal users Protocols using biohazards reviewed by Biosafety Professionals

If job requires respirator: fit testing Pre-employment screening (if allowed)

Training records for staff & students

All vertebrate animal use areas laboratory-bred Mus mice, Rattus rats, and birds

Fish & amphibians

When preparing for: USDA (AWA, AWR)

“Basic” areas plus Detailed review of USDA-species animal medical records• Compare to approved protocols

Disposition records for dogs and cats Environmental enrichment plan for NHPs Exercise plan for dogs

NO cold-blooded vertebrates, laboratory-bred Mus mice or Rattus rats, or birds

Procedure Areas- General

Drugs, agents, medical materials are: not expired listed on protocol stored appropriately

• Controlled substances locked up

• All subs stored away from detergents or chemicals

No corrugated cardboard, unsealed wood or cloth chairs

Stored feed and water is covered and not expired

Carcasses stored appropriately (i.e. freezer)

Compressed gas tanks secured to wall

Medical Record Audits Must be complete

Medical Records Audits Treatment Sheets (or Post-Procedural Care sheets) Record of each analgesic dose listed in the protocol, even if it’s during non-working hours•“every 6 hours” means there should be a dose late at night or early in morning

Designing & Implementing a PAMProgram for Your Institution

• 1-hour webinar • 56 slides • $75 per institution

Financial Incentives NIH

Enforcing their Policy on Allowable Costs for Grant Activities Involving Animals when Terms and Conditions are not Upheld•Institutions may have to give back grant money for the times when the protocol was not followed!

USDA 2008 Farm Bill authorized USDA to increase the maximum financial penalty to $10,000 per citation

Blueprint for a PAM Program Goals Design Staff Tasks Formalizing Training Scheduling Implementing

Design How large is your animal program?

# of protocols # of USDA-covered species # of different use locations

How complex/invasive are the protocols? What is the technical level of the personnel? Highly trained technicians vs. novice grad students

What is your budget? Will staff be dedicated to PAM

Private vs. Public institutions Level of public scrutiny, sunshine laws

Examples Small private company, 1000 cages of mice, highly trained techs, mostly breeding & euthanasia protocols Don’t need dedicated PAM staff Vet tech or high level husbandry can do PAM

Large public university, 30K cages of mice, USDA species, students & postdocs, invasive protocols 2+ dedicated staff, sufficient authority & support

Vet tech or MS/PhD IACUC or Animal Resources staff

Protocol Audits: Method Read protocol thoroughly, paying attention to: Surgical procedures Drugs and other agents administered Monitoring parameters Experimental manipulations and adverse effects

Other painful procedures Unexpected outcomes Endpoints Euthanasia

Protocol Audits: Method Evaluation of training records Meeting with all personnel on protocol to ask and answer questions

Observation of procedures Inspection of surgery areas Inspection of procedure areas Inspection of animals in facility Evaluation of medical & surgical records•Compare what is documented with what is listed in protocol

Common Non-Compliances 2• Failure to euthanize animals when they reach endpoints specified in protocol– Exhibiting specific clinical signs– Tumor size– Lesion appearance

• Training– Knowledge of euthanasia techniques listed in protocol (e.g. cervical dislocation)

– Recognize pain or distress in their species

The Guide, 8th edition

Highlights, Key Points and Implications for Animal Care and Use Programs

Melissa S. Hunsley, PhD, CPIA

• 1-hour webinar • 69 slides+8 bonus • $75 per institution

Guide, 8th ed. Webinar now on Demand!

Watch our informative webinar that discusses highlights, key points and significant changes, along with implications for your animal care and use program, all organized by chapter and page number, at any time on your computer. For more information:www.acupconsulting.com/webinars.htmwww.shop.animalresearchconsulting.com

This Presentation

Focuses on the changes from the 1996 Guide

Key additions, deletions and changes Implications for animal research facilities

Musts are highlighted

Chapter # page #

Ch. 1 Key Concepts

Added definitions The Three Rs Humane care Engineering, performance & practice standards

Policies, principles, procedures (including SOPs)

Clarification of the words Must = “imperative” and “mandatory” Should = “a strong recommendation”

• Require justification for not following May = “a suggestion to be considered”Chapter 1 p 6-8

Ch. 2 Animal Care and Use Program

Definitions and responsibilities of attending veterinarian (AV), institutional official (IO) and Institutional Animal Care and Use Committee (IACUC)

AV responsibilities and authority are outlined The AV “should” oversee other aspects of the Program

Authority of the AV is defined more clearlyChapter 2

p 13-14

Occupational Health Managing Occupational Health Risks Risk management process should include Health and Safety Specialists•AAALAC expects periodic review of risk

BMBL should be consulted when biohazards are used

Chapter 2 p 18-19

Protocol Review Additions

“a clear and concise sequential description” of the animal procedures

The impact of the procedures on the animals’ well-being

Plan for the care of long-lived species after the study is completed

“Description and rationale for the anticipated or selected endpoints” (animal)

Use of hazardous materialsChapter 2 p 25-26

Major and Minor Procedures

“Whether a procedure is major or minor should be evaluated on a case-by-case basis by the IACUC and veterinarian” (p 30) Implication: Some “majors” may not be required to be major (craniotomy on mice?), but

Implication: Some “minors” probably should be considered major if considerably painful (extensive tissue dissection)

Definition of penetrating a body cavity is removed in this location, however, it is used on pg 117

Chapter 2 p 30

Pharmaceutical-Grade Substances

Should be used when available

When not available, their use should be justified in the protocol Implication: All protocols using MS-222 and Avertin should include a justification

Implication: Researchers should be trained on this requirement- many order their drugs/compounds from SigmaChapter 2 p 31

Genetically Modified Animals (GMAs)

“Carefully designed breeding strategies and accurate genotype assessment” can reduce unwanted animals

When new genotypes are generated, they should be carefully monitored. New phenotypes that “negatively affect well-being” should be reported to the IACUC.

Chapter 3 p 77

Surgery

Investigators must have surgical training, including asepsis, hemostasis, use of instruments, etc.

IACUC and AV responsible for verifying proper training Implication: personnel performing rodent surgery may need formal general surgery training from ACUP

Chapter 4 p 115-16

Key Points Summary

Recurrent themes Social housing is the default Rodents treated less like “exceptions” GMAs need increased monitoring Disaster plan should consider all animals (aquatic, irreplaceable) and potential situations

Definition of major/minor surgery debatable

Staff may need training on signs of animal well-being, reporting recurring problems

Investigators may need further training (asepsis, pharmaceutical-grade drugs, etc.)

Additional Slides

Bonus Material!