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

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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]
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