Sync template from atomicqms-style deployment
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SOPs/Specimen-Handling/.gitkeep
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SOPs/Specimen-Handling/.gitkeep
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SOPs/Specimen-Handling/SOP-PATH-001-Specimen-Accessioning.md
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SOPs/Specimen-Handling/SOP-PATH-001-Specimen-Accessioning.md
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# Standard Operating Procedure: Pathology Specimen Accessioning
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| Document ID | SOP-PATH-001 |
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|-------------|-------------|
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| Title | Pathology Specimen Accessioning and Processing |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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| Department | Anatomic Pathology |
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---
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## 1. Purpose
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To establish standardized procedures for the receipt, accessioning, and initial processing of pathology specimens to ensure proper identification, optimal preservation, and regulatory compliance.
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## 2. Scope
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This procedure applies to all anatomic pathology specimens including:
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- Surgical pathology specimens
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- Cytology specimens
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- Skin biopsies
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- Bone marrow biopsies
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- Autopsy specimens
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## 3. Responsibilities
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### 3.1 Accessioning Staff
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- Receive and log specimens
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- Verify specimen-requisition match
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- Assign case numbers
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- Distribute to appropriate areas
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### 3.2 Histology Technician
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- Process tissue specimens
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- Embed and section specimens
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- Prepare slides for pathologist review
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### 3.3 Pathologist
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- Perform gross examination
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- Dictate gross description
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- Review slides and render diagnosis
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### 3.4 Laboratory Director
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- Ensure quality standards
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- Review policies and procedures
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- Oversee accreditation compliance
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## 4. Definitions
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| Term | Definition |
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|------|------------|
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| Accession | Process of receiving and logging specimens |
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| Fixation | Chemical preservation of tissue |
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| Grossing | Macroscopic examination and description |
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| Cassette | Container for tissue during processing |
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| Block | Paraffin-embedded tissue section |
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## 5. Equipment and Materials
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- Specimen containers (various sizes)
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- 10% neutral buffered formalin (NBF)
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- Requisition forms
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- Barcoded labels
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- Cassettes
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- Tissue processor
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- Embedding station
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- Microtome
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- Slides and coverslips
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## 6. Procedure
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### 6.1 Specimen Receipt
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#### 6.1.1 Verification at Receipt
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Upon receiving each specimen:
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- [ ] Container properly labeled with patient identifiers
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- [ ] Requisition form accompanies specimen
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- [ ] Container intact without leakage
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- [ ] Specimen in appropriate fixative (if applicable)
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- [ ] Time of collection documented
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#### 6.1.2 Label Verification
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**Minimum required on container:**
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| Element | Present |
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|---------|---------|
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| Patient name | ☐ |
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| Second identifier (MRN, DOB) | ☐ |
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| Specimen type/site | ☐ |
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| Date of collection | ☐ |
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| Collector identification | ☐ |
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**Requisition must include:**
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| Element | Present |
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|---------|---------|
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| Patient name and identifiers | ☐ |
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| Ordering physician | ☐ |
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| Specimen source/site | ☐ |
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| Clinical history | ☐ |
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| Date/time of collection | ☐ |
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| Date/time of receipt in lab | ☐ |
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#### 6.1.3 Discrepancy Handling
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If discrepancies exist:
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1. Do NOT accessioned until resolved
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2. Contact ordering physician/collector
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3. Document resolution in LIS
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4. Complete discrepancy log
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| Discrepancy Type | Required Action |
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|------------------|-----------------|
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| Name mismatch | Contact collector, do not process |
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| Missing information | Request completion before accessioning |
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| Damaged container | Document, assess specimen integrity |
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| No requisition | Hold specimen, request requisition |
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| Unlabeled specimen | Do not process until properly labeled |
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### 6.2 Accessioning
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#### 6.2.1 Case Number Assignment
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1. Log specimen into Laboratory Information System (LIS)
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2. System assigns unique accession number
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3. Format: [Year]-S[Sequential#] (e.g., 2024-S12345)
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4. Generate specimen labels
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#### 6.2.2 Labeling
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1. Apply barcoded labels to:
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- Specimen container
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- Cassettes
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- All associated paperwork
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2. Verify label matches requisition
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3. Apply orientation labels if applicable
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#### 6.2.3 Specimen Categorization
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| Category | Description | Priority |
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|----------|-------------|----------|
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| Routine | Standard turnaround | 2-3 days |
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| Rush | Expedited processing | 24-48 hours |
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| STAT | Emergency | Same day |
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| Intraoperative | Frozen section | Immediate |
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### 6.3 Fixation Assessment
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#### 6.3.1 Optimal Fixation Times
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| Specimen Type | Minimum | Optimal | Maximum |
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|---------------|---------|---------|---------|
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| Small biopsy (≤5mm) | 6 hours | 6-12 hours | 24 hours |
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| Medium tissue (5-15mm) | 12 hours | 12-24 hours | 48 hours |
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| Large specimen (>15mm) | 24 hours | 24-48 hours | 72 hours |
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#### 6.3.2 Fixative Requirements
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- Standard: 10% neutral buffered formalin (10:1 ratio)
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- Breast tissue for biomarkers: Cold ischemia <1 hour, fixed within 1 hour
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- Special fixatives per protocol (e.g., Bouin's, B5)
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Document:
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- Time of collection (if available)
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- Time of receipt in fixative
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- Time placed in processor
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### 6.4 Gross Examination (Grossing)
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#### 6.4.1 Pre-Grossing Preparation
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1. Verify specimen identity
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2. Review clinical history and prior pathology
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3. Gather appropriate supplies
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4. Photograph specimen (if indicated)
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#### 6.4.2 Gross Description Components
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**Standard elements:**
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- [ ] Specimen type and site
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- [ ] How received (container, fixative)
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- [ ] Dimensions (3 measurements)
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- [ ] Weight (if applicable)
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- [ ] External appearance
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- [ ] Cut surface appearance
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- [ ] Lesion description (size, location, margins)
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- [ ] Sections submitted summary
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**For resection specimens:**
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- [ ] Orientation (sutures, clips, inks)
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- [ ] Margin assessment
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- [ ] Lymph node identification
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- [ ] Relationship of lesion to margins
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#### 6.4.3 Inking Protocol
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| Color | Common Usage |
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|-------|--------------|
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| Black | Anterior/superficial |
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| Blue | Posterior/deep |
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| Green | Superior |
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| Orange | Inferior |
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| Red | Medial |
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| Yellow | Lateral |
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Document inking scheme in gross description.
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#### 6.4.4 Section Submission
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| Specimen Type | Standard Sections |
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|---------------|-------------------|
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| Small biopsy | Entire specimen |
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| Skin ellipse | 3mm cross-sections, all margins |
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| Breast lumpectomy | Lesion, margins (6 directions), representative |
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| Colon resection | Tumor (4 sections), margins, nodes, mucosa |
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### 6.5 Tissue Processing
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#### 6.5.1 Processing Steps
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1. Dehydration (graded alcohols)
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2. Clearing (xylene)
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3. Infiltration (paraffin)
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4. Total processing time: 8-14 hours
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#### 6.5.2 Processing Schedules
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| Schedule | Duration | Specimen Types |
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|----------|----------|----------------|
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| Routine overnight | 12-14 hours | Standard specimens |
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| Extended | 16-20 hours | Fatty tissue, large specimens |
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| Rapid | 2-4 hours | Urgent specimens |
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| Rush microwave | 1-2 hours | STAT specimens |
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### 6.6 Embedding
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1. Orient tissue in cassette per protocol
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2. Embed in paraffin at 60°C
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3. Cool on cold plate
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4. Verify block identity
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### 6.7 Microtomy
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1. Face block until full tissue visible
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2. Cut at specified thickness (typically 4-5 µm)
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3. Float sections on warm water bath
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4. Pick up on labeled slide
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5. Dry slides before staining
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### 6.8 Slide Preparation
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1. H&E staining (routine)
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2. Special stains per request/protocol
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3. Immunohistochemistry as ordered
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4. Coverslip slides
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5. Verify slide-block-patient match
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## 7. Quality Control
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### 7.1 Daily QC
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- [ ] Reagent checks
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- [ ] Processor function verification
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- [ ] Temperature monitoring
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- [ ] Staining controls
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### 7.2 Specimen Quality Metrics
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| Metric | Target |
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|--------|--------|
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| Specimen rejection rate | <2% |
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| Accessioning errors | <0.5% |
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| Lost specimens | 0 |
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| Turnaround time (routine) | ≤48 hours |
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| Block/slide discrepancies | <0.1% |
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## 8. Documentation
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- FRM-PATH-001 Specimen Receipt Log
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- FRM-PATH-002 Gross Description Template
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- FRM-PATH-003 Processing Log
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- Discrepancy reports
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- QC logs
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## 9. References
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- CAP Laboratory Accreditation Checklist
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- ASCO/CAP Guidelines for Biomarker Testing
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- CLIA regulations
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- Institutional policies
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---
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## Revision History
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| Rev | Date | Description | Author |
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||||
|-----|------|-------------|--------|
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||||
| 1.0 | [DATE] | Initial release | [AUTHOR] |
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