Sync template from atomicqms-style deployment
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README.md
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README.md
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# pathology
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# Pathology & Laboratory Medicine Quality Management System
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A comprehensive QMS template designed for anatomic pathology, clinical pathology, and laboratory medicine departments.
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A comprehensive QMS template designed for anatomic pathology, clinical pathology, and laboratory medicine departments.
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## 🔬 Designed For
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- **Anatomic Pathology** - Surgical pathology, cytopathology, autopsy
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- **Clinical Pathology** - Chemistry, hematology, microbiology, transfusion medicine
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- **Reference Laboratories** - Specialized testing services
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- **Molecular Pathology** - Genetic and molecular diagnostics
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- **Forensic Pathology** - Medical examiner and coroner services
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- **Dermatopathology** - Skin biopsy interpretation
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- **Neuropathology** - Brain and nervous system pathology
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## 📋 Regulatory Framework
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This template supports compliance with:
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- **CAP** - College of American Pathologists accreditation
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- **CLIA** - Clinical Laboratory Improvement Amendments
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- **The Joint Commission** - Hospital accreditation (laboratory chapter)
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- **FDA** - IVD and LDT regulations
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- **AABB** - Blood bank standards (if applicable)
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- **State Clinical Laboratory Licensing** - State-specific requirements
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- **OSHA** - Bloodborne pathogens, chemical safety
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- **HIPAA** - Patient information privacy
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- **ASCP** - Pathologist and technologist standards
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- **CAP Biorepository** - Tissue banking requirements (if applicable)
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## Repository Structure
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```
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├── SOPs/
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│ ├── Specimen-Handling/ # Accessioning, processing, storage
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│ ├── Histology/ # Tissue processing, embedding, sectioning, staining
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│ ├── Cytology/ # Cytology preparation and screening
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│ ├── Autopsy/ # Post-mortem examination procedures
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│ ├── Molecular/ # Molecular testing, NGS, PCR
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│ └── General/ # Document control, training, CAPA
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├── Forms/
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│ ├── Requisition-Forms/ # Specimen submission, clinical history
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│ ├── Grossing-Templates/ # Specimen dictation templates
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│ ├── QC-Records/ # Staining QC, reagent logs, instrument checks
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│ ├── Report-Templates/ # Synoptic and narrative report templates
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│ ├── Competency/ # Technologist and pathologist assessments
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│ └── Incident-Reports/ # Specimen quality, labeling errors
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├── Policies/ # Department policies
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├── Work-Instructions/ # Step-by-step procedures
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└── Templates/ # Document templates
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```
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## Document Numbering Convention
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- **POL-XXX**: Policies
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- **SOP-SP-XXX**: Specimen Handling SOPs
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- **SOP-HIS-XXX**: Histology SOPs
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- **SOP-CYT-XXX**: Cytology SOPs
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- **SOP-AUT-XXX**: Autopsy SOPs
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- **SOP-MOL-XXX**: Molecular SOPs
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- **WI-XXX**: Work Instructions
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- **FRM-XXX**: Forms and Records
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## 🤖 AI-Powered Assistance
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This repository includes **AtomicAI**, your pathology QMS assistant. Mention `@atomicai` in any issue or pull request to:
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- Draft specimen handling and processing SOPs
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- Create histology and staining procedures
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- Generate grossing templates for specimen types
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- Develop molecular testing protocols
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- Create quality control procedures
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- Review documents for CAP/CLIA compliance
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### Example Prompts
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- "@atomicai create an SOP for surgical specimen grossing and sampling"
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- "@atomicai draft a tissue processor validation procedure"
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- "@atomicai write an immunohistochemistry staining and QC protocol"
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- "@atomicai create a synoptic report template for breast cancer"
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- "@atomicai develop a frozen section procedure with turnaround time standards"
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- "@atomicai create a specimen labeling and identification policy"
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## Getting Started
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1. **Establish Specimen Policies** - Define accessioning and handling requirements
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2. **Standardize Processing** - Document histology and cytology procedures
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3. **Implement QC Programs** - Set up staining, reagent, and instrument QC
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4. **Define Reporting Standards** - Create synoptic and narrative templates
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5. **Train Staff** - Use competency assessment forms
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## Key Documents to Create First
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1. **Specimen Accessioning SOP** - Receiving, labeling, and logging specimens
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2. **Tissue Processing SOP** - Fixation, processing, embedding procedures
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3. **H&E Staining Protocol** - Routine hematoxylin and eosin procedure
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4. **Immunohistochemistry SOP** - IHC staining and controls
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5. **Frozen Section SOP** - Intraoperative consultation procedure
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6. **Grossing Manual** - Specimen-specific grossing guidelines
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7. **Critical Values Policy** - Urgent result communication
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## Special Considerations for Pathology
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### Specimen Integrity
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- Specimen identification and labeling
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- Fixation timing and adequacy
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- Cold ischemia documentation
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- Tissue banking considerations
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- Chain of custody (legal cases)
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### Quality Control
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- H&E and special stain QC
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- IHC positive and negative controls
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- Reagent expiration and storage
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- Instrument calibration and maintenance
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- Proficiency testing participation
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### Reporting
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- Turnaround time standards
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- Synoptic reporting (CAP protocols)
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- Critical/unexpected results
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- Amendment and addendum procedures
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- Second opinion and consultation
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### Safety
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- Formalin handling and exposure limits
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- Xylene substitutes and ventilation
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- Infectious specimen handling
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- Sharps safety (microtome blades)
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- Prion precautions (CJD)
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---
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*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*
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