Meeting Lab Requirements for Gross Tissue Examinations

Gross tissue examination is a critical component of anatomic pathology and plays a vital role in ensuring accurate diagnosis and high-quality patient care. Regulatory requirements, including those outlined under ACHC Clinical Laboratory Accreditation Standard 09.00.03 [CLIA §493.1461(e) and §493.1283(a)(4)], establish clear expectations for how laboratories must perform, supervise, document, and assess competency in gross tissue examinations.

This article provides a fresh overview of these requirements and explains how laboratories can maintain compliance throughout 2026 while ensuring consistency and accuracy.

Policies and procedures

Every laboratory performing gross tissue examinations must have written policies and procedures that clearly define how macroscopic tissue examinations are conducted. These procedures must address:

• Proper tissue dissection.
• Accurate and complete gross descriptions.
• Appropriate histologic sampling for various specimen types.

These policies and procedures promote consistency in handling similar tissues and support standardized diagnostic practices across the laboratory.

Qualified personnel

Gross tissue examinations may be performed or assisted by individuals other than a pathologist, under specific conditions. These individuals may include:

• Pathology residents.
• Qualified testing personnel.
• Dermatologists (specifically in Mohs surgery).

When non-pathologists assist in gross examinations, the laboratory must ensure that they:

• Meet ACHC and CLIA requirements for high-complexity testing.
• Have clearly defined duties and limitations.
• Work under an established level of supervision.

The laboratory director is ultimately responsible for approving and maintaining these protocols.

Supervision requirements

The pathology technical supervisor plays a central role in oversight. Although direct, onsite supervision is not always required, the technical supervisor is responsible for:

• The accuracy of gross examination findings.
• Reviewing gross descriptions performed in their absence.
• Signing the examination report.

Any physical examination or mechanical procedure performed by qualified testing personnel—such as dissection, inking, marking, weighing, or orienting tissue—must be reviewed within 24 hours by the technical supervisor.

All microscopic tissue examinations, however, must be performed exclusively by individuals qualified as technical supervisors.

Initial and ongoing competency assessments

Laboratories must evaluate and document the competency of non-pathologists who assist with gross tissue examinations:

• Semiannually during the first year the individual performs gross examinations on patient specimens.
• Annually thereafter.

Competency assessments must follow established testing personnel standards (referenced in ACHC Standard 02.02.04), although not all six competency elements may apply in every situation.

For Mohs surgery, dermatologists are qualified to perform gross examinations and evaluate non-pathologist personnel.

Specimen-specific protocols

Written protocols must clearly list:

• The specific specimen types that non-pathologists are permitted to gross.
• The extent of the non-pathologist's involvement in the examination.
• The nature and level of supervision required for each individual.

These protocols must comply with national, federal, state/provincial, and local regulations.

Gross tissue description requirements

Laboratories must have procedures in place for reporting gross tissue descriptions. At a minimum, gross descriptions must include:

• Type of specimen.
• Size and/or weight.
• Measurements.
• Extent of gross lesions.

When appropriate, descriptions should also document:

• Block and slide designations.
• Margins of resection.
• Depth of tumor invasion.
• Breast quadrants.
• Lymph node levels.

This level of detail supports accurate microscopic correlation and diagnostic interpretation.

Documentation and recordkeeping

The laboratory must maintain documentation identifying the individual who performed the grossing portion of the test. While the name or initials of the person who grossed the specimen do not need to appear in the final report, the information must be recorded somewhere in the test record.

The final report remains the responsibility of the technical supervisor, regardless of who performed the gross examination.

In Mohs procedures, the surgical test requisition may serve as the surgical report, fulfilling documentation requirements.

Key takeaways

Gross tissue examination is a regulated, collaborative process that requires clear protocols, qualified personnel, defined supervision, and thorough documentation. By adhering to regulatory requirements and ACHC Standards and maintaining detailed procedures and competency assessments, laboratories ensure diagnostic accuracy, compliance, and patient safety. Consistent application of these standards strengthens laboratory operations and supports high-quality pathology services.