Anatomic Pathology - Surgical pathology, cytopathology, autopsy
Clinical Pathology - Chemistry, hematology, microbiology, transfusion medicine
Reference Laboratories - Specialized testing services
Molecular Pathology - Genetic and molecular diagnostics
Forensic Pathology - Medical examiner and coroner services
Dermatopathology - Skin biopsy interpretation
Neuropathology - Brain and nervous system pathology

📋 Regulatory Framework

This template supports compliance with:

CAP - College of American Pathologists accreditation
CLIA - Clinical Laboratory Improvement Amendments
The Joint Commission - Hospital accreditation (laboratory chapter)
FDA - IVD and LDT regulations
AABB - Blood bank standards (if applicable)
State Clinical Laboratory Licensing - State-specific requirements
OSHA - Bloodborne pathogens, chemical safety
HIPAA - Patient information privacy
ASCP - Pathologist and technologist standards
CAP Biorepository - Tissue banking requirements (if applicable)

Repository Structure

├── SOPs/
│   ├── Specimen-Handling/     # Accessioning, processing, storage
│   ├── Histology/             # Tissue processing, embedding, sectioning, staining
│   ├── Cytology/              # Cytology preparation and screening
│   ├── Autopsy/               # Post-mortem examination procedures
│   ├── Molecular/             # Molecular testing, NGS, PCR
│   └── General/               # Document control, training, CAPA
├── Forms/
│   ├── Requisition-Forms/     # Specimen submission, clinical history
│   ├── Grossing-Templates/    # Specimen dictation templates
│   ├── QC-Records/            # Staining QC, reagent logs, instrument checks
│   ├── Report-Templates/      # Synoptic and narrative report templates
│   ├── Competency/            # Technologist and pathologist assessments
│   └── Incident-Reports/      # Specimen quality, labeling errors
├── Policies/                  # Department policies
├── Work-Instructions/         # Step-by-step procedures
└── Templates/                 # Document templates

Document Numbering Convention

POL-XXX: Policies
SOP-SP-XXX: Specimen Handling SOPs
SOP-HIS-XXX: Histology SOPs
SOP-CYT-XXX: Cytology SOPs
SOP-AUT-XXX: Autopsy SOPs
SOP-MOL-XXX: Molecular SOPs
WI-XXX: Work Instructions
FRM-XXX: Forms and Records

🤖 AI-Powered Assistance

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

Draft specimen handling and processing SOPs
Create histology and staining procedures
Generate grossing templates for specimen types
Develop molecular testing protocols
Create quality control procedures
Review documents for CAP/CLIA compliance

Example Prompts

"@atomicai create an SOP for surgical specimen grossing and sampling"
"@atomicai draft a tissue processor validation procedure"
"@atomicai write an immunohistochemistry staining and QC protocol"
"@atomicai create a synoptic report template for breast cancer"
"@atomicai develop a frozen section procedure with turnaround time standards"
"@atomicai create a specimen labeling and identification policy"

Getting Started

Establish Specimen Policies - Define accessioning and handling requirements
Standardize Processing - Document histology and cytology procedures
Implement QC Programs - Set up staining, reagent, and instrument QC
Define Reporting Standards - Create synoptic and narrative templates
Train Staff - Use competency assessment forms

Key Documents to Create First

Specimen Accessioning SOP - Receiving, labeling, and logging specimens
Tissue Processing SOP - Fixation, processing, embedding procedures
H&E Staining Protocol - Routine hematoxylin and eosin procedure
Immunohistochemistry SOP - IHC staining and controls
Frozen Section SOP - Intraoperative consultation procedure
Grossing Manual - Specimen-specific grossing guidelines
Critical Values Policy - Urgent result communication

Special Considerations for Pathology

Specimen Integrity

Specimen identification and labeling
Fixation timing and adequacy
Cold ischemia documentation
Tissue banking considerations
Chain of custody (legal cases)

Quality Control

H&E and special stain QC
IHC positive and negative controls
Reagent expiration and storage
Instrument calibration and maintenance
Proficiency testing participation

Reporting

Turnaround time standards
Synoptic reporting (CAP protocols)
Critical/unexpected results
Amendment and addendum procedures
Second opinion and consultation

Safety

Formalin handling and exposure limits
Xylene substitutes and ventilation
Infectious specimen handling
Sharps safety (microtome blades)
Prion precautions (CJD)

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