Whole-Slide Imaging & Validation SOP

Purpose

To outline the procedures for whole-slide imaging and validation to ensure accurate digital pathology results.

Scope

This SOP applies to all personnel involved in whole-slide imaging in the laboratory.

Responsibilities

• Technologist: Perform whole-slide imaging according to the SOP
• Quality Manager: Ensure compliance with the SOP and conduct periodic reviews
• Pathologist: Validate the images for diagnostic use

Materials & equipment

• Whole-slide scanner
• Computer with imaging software
• Calibration slides
• Storage media
• Quality control materials

Procedure

1. Prepare the whole-slide scanner according to the manufacturer's instructions.
2. Calibrate the scanner using calibration slides before imaging.
3. Load the slide onto the scanner stage and ensure proper alignment.
4. Select appropriate imaging parameters based on the specimen type.
5. Initiate the imaging process and monitor for any errors.
6. After imaging, save the digital slide in the designated storage media.
7. Perform a preliminary review of the image for quality assurance.
8. Document the imaging parameters and any issues encountered.
9. Validate the image by a qualified pathologist for diagnostic use.
10. Store the validated images in the laboratory's digital archive.

Records

• Imaging log
• Validation report
• Calibration records
• Quality control records

Safety

• Ensure all electrical equipment is properly grounded.
• Follow ergonomic practices while operating the scanner.