pathology/SOPs/Specimen-Handling/SOP-PATH-001-Specimen-Accessioning.md

# Standard Operating Procedure: Pathology Specimen Accessioning

| Document ID | SOP-PATH-001 |
|-------------|-------------|
| Title | Pathology Specimen Accessioning and Processing |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Anatomic Pathology |

---

## 1. Purpose

To establish standardized procedures for the receipt, accessioning, and initial processing of pathology specimens to ensure proper identification, optimal preservation, and regulatory compliance.

## 2. Scope

This procedure applies to all anatomic pathology specimens including:
- Surgical pathology specimens
- Cytology specimens
- Skin biopsies
- Bone marrow biopsies
- Autopsy specimens

## 3. Responsibilities

### 3.1 Accessioning Staff
- Receive and log specimens
- Verify specimen-requisition match
- Assign case numbers
- Distribute to appropriate areas

### 3.2 Histology Technician
- Process tissue specimens
- Embed and section specimens
- Prepare slides for pathologist review

### 3.3 Pathologist
- Perform gross examination
- Dictate gross description
- Review slides and render diagnosis

### 3.4 Laboratory Director
- Ensure quality standards
- Review policies and procedures
- Oversee accreditation compliance

## 4. Definitions

| Term | Definition |
|------|------------|
| Accession | Process of receiving and logging specimens |
| Fixation | Chemical preservation of tissue |
| Grossing | Macroscopic examination and description |
| Cassette | Container for tissue during processing |
| Block | Paraffin-embedded tissue section |

## 5. Equipment and Materials

- Specimen containers (various sizes)
- 10% neutral buffered formalin (NBF)
- Requisition forms
- Barcoded labels
- Cassettes
- Tissue processor
- Embedding station
- Microtome
- Slides and coverslips

## 6. Procedure

### 6.1 Specimen Receipt

#### 6.1.1 Verification at Receipt
Upon receiving each specimen:
- [ ] Container properly labeled with patient identifiers
- [ ] Requisition form accompanies specimen
- [ ] Container intact without leakage
- [ ] Specimen in appropriate fixative (if applicable)
- [ ] Time of collection documented

#### 6.1.2 Label Verification

**Minimum required on container:**
| Element | Present |
|---------|---------|
| Patient name | ☐ |
| Second identifier (MRN, DOB) | ☐ |
| Specimen type/site | ☐ |
| Date of collection | ☐ |
| Collector identification | ☐ |

**Requisition must include:**
| Element | Present |
|---------|---------|
| Patient name and identifiers | ☐ |
| Ordering physician | ☐ |
| Specimen source/site | ☐ |
| Clinical history | ☐ |
| Date/time of collection | ☐ |
| Date/time of receipt in lab | ☐ |

#### 6.1.3 Discrepancy Handling

If discrepancies exist:
1. Do NOT accessioned until resolved
2. Contact ordering physician/collector
3. Document resolution in LIS
4. Complete discrepancy log

| Discrepancy Type | Required Action |
|------------------|-----------------|
| Name mismatch | Contact collector, do not process |
| Missing information | Request completion before accessioning |
| Damaged container | Document, assess specimen integrity |
| No requisition | Hold specimen, request requisition |
| Unlabeled specimen | Do not process until properly labeled |

### 6.2 Accessioning

#### 6.2.1 Case Number Assignment
1. Log specimen into Laboratory Information System (LIS)
2. System assigns unique accession number
3. Format: [Year]-S[Sequential#] (e.g., 2024-S12345)
4. Generate specimen labels

#### 6.2.2 Labeling
1. Apply barcoded labels to:
   - Specimen container
   - Cassettes
   - All associated paperwork
2. Verify label matches requisition
3. Apply orientation labels if applicable

#### 6.2.3 Specimen Categorization

| Category | Description | Priority |
|----------|-------------|----------|
| Routine | Standard turnaround | 2-3 days |
| Rush | Expedited processing | 24-48 hours |
| STAT | Emergency | Same day |
| Intraoperative | Frozen section | Immediate |

### 6.3 Fixation Assessment

#### 6.3.1 Optimal Fixation Times

| Specimen Type | Minimum | Optimal | Maximum |
|---------------|---------|---------|---------|
| Small biopsy (≤5mm) | 6 hours | 6-12 hours | 24 hours |
| Medium tissue (5-15mm) | 12 hours | 12-24 hours | 48 hours |
| Large specimen (>15mm) | 24 hours | 24-48 hours | 72 hours |

#### 6.3.2 Fixative Requirements
- Standard: 10% neutral buffered formalin (10:1 ratio)
- Breast tissue for biomarkers: Cold ischemia <1 hour, fixed within 1 hour
- Special fixatives per protocol (e.g., Bouin's, B5)

Document:
- Time of collection (if available)
- Time of receipt in fixative
- Time placed in processor

### 6.4 Gross Examination (Grossing)

#### 6.4.1 Pre-Grossing Preparation
1. Verify specimen identity
2. Review clinical history and prior pathology
3. Gather appropriate supplies
4. Photograph specimen (if indicated)

#### 6.4.2 Gross Description Components

**Standard elements:**
- [ ] Specimen type and site
- [ ] How received (container, fixative)
- [ ] Dimensions (3 measurements)
- [ ] Weight (if applicable)
- [ ] External appearance
- [ ] Cut surface appearance
- [ ] Lesion description (size, location, margins)
- [ ] Sections submitted summary

**For resection specimens:**
- [ ] Orientation (sutures, clips, inks)
- [ ] Margin assessment
- [ ] Lymph node identification
- [ ] Relationship of lesion to margins

#### 6.4.3 Inking Protocol

| Color | Common Usage |
|-------|--------------|
| Black | Anterior/superficial |
| Blue | Posterior/deep |
| Green | Superior |
| Orange | Inferior |
| Red | Medial |
| Yellow | Lateral |

Document inking scheme in gross description.

#### 6.4.4 Section Submission

| Specimen Type | Standard Sections |
|---------------|-------------------|
| Small biopsy | Entire specimen |
| Skin ellipse | 3mm cross-sections, all margins |
| Breast lumpectomy | Lesion, margins (6 directions), representative |
| Colon resection | Tumor (4 sections), margins, nodes, mucosa |

### 6.5 Tissue Processing

#### 6.5.1 Processing Steps
1. Dehydration (graded alcohols)
2. Clearing (xylene)
3. Infiltration (paraffin)
4. Total processing time: 8-14 hours

#### 6.5.2 Processing Schedules

| Schedule | Duration | Specimen Types |
|----------|----------|----------------|
| Routine overnight | 12-14 hours | Standard specimens |
| Extended | 16-20 hours | Fatty tissue, large specimens |
| Rapid | 2-4 hours | Urgent specimens |
| Rush microwave | 1-2 hours | STAT specimens |

### 6.6 Embedding

1. Orient tissue in cassette per protocol
2. Embed in paraffin at 60°C
3. Cool on cold plate
4. Verify block identity

### 6.7 Microtomy

1. Face block until full tissue visible
2. Cut at specified thickness (typically 4-5 µm)
3. Float sections on warm water bath
4. Pick up on labeled slide
5. Dry slides before staining

### 6.8 Slide Preparation

1. H&E staining (routine)
2. Special stains per request/protocol
3. Immunohistochemistry as ordered
4. Coverslip slides
5. Verify slide-block-patient match

## 7. Quality Control

### 7.1 Daily QC
- [ ] Reagent checks
- [ ] Processor function verification
- [ ] Temperature monitoring
- [ ] Staining controls

### 7.2 Specimen Quality Metrics

| Metric | Target |
|--------|--------|
| Specimen rejection rate | <2% |
| Accessioning errors | <0.5% |
| Lost specimens | 0 |
| Turnaround time (routine) | ≤48 hours |
| Block/slide discrepancies | <0.1% |

## 8. Documentation

- FRM-PATH-001 Specimen Receipt Log
- FRM-PATH-002 Gross Description Template
- FRM-PATH-003 Processing Log
- Discrepancy reports
- QC logs

## 9. References

- CAP Laboratory Accreditation Checklist
- ASCO/CAP Guidelines for Biomarker Testing
- CLIA regulations
- Institutional policies

---

## Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |