animal-facility/README.md

# Animal Research Facility Quality Management System

A comprehensive QMS template designed for animal research facilities, vivaria, and laboratory animal care programs supporting biomedical research.

## 🐭 Designed For

- **Academic Vivaria** - University and medical center animal facilities
- **Pharmaceutical Research** - Drug discovery and preclinical testing facilities
- **Contract Research Organizations (CROs)** - Animal study service providers
- **Biotechnology Companies** - Research and development animal programs
- **Government Research Facilities** - NIH, CDC, and agency research programs
- **Veterinary Schools** - Teaching and research animal programs
- **Breeding Colonies** - Specialized genetic model production facilities

## 📋 Regulatory Framework

This template supports compliance with:

- **PHS Policy** - Public Health Service Policy on Humane Care and Use of Laboratory Animals
- **USDA/AWA** - Animal Welfare Act and Regulations (9 CFR Parts 1-4)
- **AAALAC** - Association for Assessment and Accreditation of Laboratory Animal Care International
- **IACUC** - Institutional Animal Care and Use Committee requirements
- **Guide for the Care and Use of Laboratory Animals** (8th Edition)
- **AVMA Guidelines** - Euthanasia and veterinary care standards
- **OLAW** - Office of Laboratory Animal Welfare requirements
- **GLP** - Good Laboratory Practice for regulated studies (21 CFR Part 58)
- **OSHA** - Occupational safety for animal handlers
- **CDC/NIH BMBL** - Biosafety in Microbiological and Biomedical Laboratories

## Repository Structure

```
├── SOPs/
│   ├── Animal-Care/           # Daily care, feeding, environmental enrichment
│   ├── Veterinary-Services/   # Health monitoring, treatments, euthanasia
│   ├── Colony-Management/     # Breeding, genetics, census tracking
│   ├── Facility-Operations/   # Sanitation, cage wash, environmental controls
│   ├── Safety/                # Zoonosis, allergens, occupational health
│   └── General/               # Document control, training, CAPA
├── Forms/
│   ├── IACUC-Protocols/       # Protocol submission and amendment forms
│   ├── Health-Records/        # Veterinary treatment and observation logs
│   ├── Census-Tracking/       # Animal inventory and disposition records
│   ├── Environmental/         # Temperature, humidity, light cycle logs
│   ├── Training/              # Competency assessments, certifications
│   └── Incident-Reports/      # Adverse events, protocol deviations
├── Policies/                  # Institutional policies and IACUC guidelines
├── Work-Instructions/         # Step-by-step procedures
└── Templates/                 # Document templates
```

## Document Numbering Convention

- **POL-XXX**: Policies
- **SOP-AC-XXX**: Animal Care SOPs
- **SOP-VET-XXX**: Veterinary Services SOPs
- **SOP-COL-XXX**: Colony Management SOPs
- **SOP-FAC-XXX**: Facility Operations SOPs
- **SOP-SAF-XXX**: Safety SOPs
- **WI-XXX**: Work Instructions
- **FRM-XXX**: Forms and Records
- **PRO-XXX**: IACUC Protocol Templates

## 🤖 AI-Powered Assistance

This repository includes **AtomicAI**, your animal facility QMS assistant. Mention `@atomicai` in any issue or pull request to:

- Draft species-specific SOPs for animal care and handling
- Create IACUC protocol templates and amendments
- Generate veterinary treatment and monitoring procedures
- Develop environmental enrichment programs
- Create biosafety and occupational health procedures
- Review documents for regulatory compliance

### Example Prompts

- "@atomicai create an SOP for rodent health monitoring per the Guide"
- "@atomicai draft a post-operative care procedure for surgical models"
- "@atomicai write an environmental enrichment policy for NHPs"
- "@atomicai create an IACUC annual review checklist"
- "@atomicai develop a quarantine procedure for incoming animals"
- "@atomicai create a controlled substance log for veterinary use"

## Getting Started

1. **Review IACUC Requirements** - Align policies with your institutional IACUC
2. **Customize Species SOPs** - Adapt procedures for your animal models
3. **Set Up Health Monitoring** - Configure veterinary observation forms
4. **Establish Environmental Controls** - Implement monitoring logs
5. **Train Personnel** - Use competency assessment forms

## Key Documents to Create First

1. **Animal Health Monitoring SOP** - Foundation for veterinary oversight
2. **Euthanasia Policy** - AVMA-compliant methods by species
3. **Environmental Enrichment Program** - Species-specific enrichment plans
4. **IACUC Protocol Template** - Standardized protocol submission format
5. **Post-Procedure Monitoring Form** - Observation and scoring records
6. **Occupational Health Program** - Staff safety and zoonosis prevention
7. **Sanitation and Cage Wash SOP** - Facility hygiene procedures

## Special Considerations for Animal Research

### Species-Specific Requirements
- Housing density and cage dimensions
- Environmental parameters (temp, humidity, lighting)
- Dietary requirements and feeding schedules
- Social housing and compatibility
- Enrichment appropriate to natural behaviors

### Veterinary Care
- Regular health monitoring schedules
- Pain and distress assessment scales
- Anesthesia and analgesia protocols
- Humane endpoints and euthanasia criteria
- Emergency veterinary coverage

### Regulatory Compliance
- IACUC protocol approval and amendments
- Annual protocol reviews and renewals
- Semi-annual facility inspections
- USDA annual reports (covered species)
- Personnel training documentation

### Biosafety and Occupational Health
- Zoonotic disease prevention
- Allergen exposure monitoring
- Personal protective equipment
- Hazardous agent handling (if applicable)
- Medical surveillance program

---

*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*