Retention of Records
College of American Pathologists' Recommendations
Requirements for the retention of laboratory records and materials are specified in the Clinical
Laboratory Improvement Amendments of 1988 (CLIA '88) and in individual state regulations governing
the performance of laboratory testing. Pathologists should note that applicable state laws may
require longer time periods than those specified in the CLIA '88 regulations.
The following are the College of American Pathologists' recommendations for the minimum requirements
for the retention of records and materials. These recommendations meet or exceed CLIA '88 requirements.
Laboratories are advised to retain records and/or materials for longer than specified when appropriate
for patient care, education of quality improvement needs.
General Laboratory |
| Accession log records |
2 years |
| Maintenance/instrument maintenance |
2 years |
| Quality control records |
2 years |
|
Surgical Pathology (Including Bone Marrows) |
| Wet Tissue |
2 weeks after final report |
| Paraffin Blocks |
10 years |
| Slides |
10 years |
| Reports |
10 years |
|
Cytology |
| Slides (negative-unsatisfactory) |
5 years |
| Slides (suspicious-positive) |
5 years |
| Fine-needle aspiration slides |
10 years |
| Reports |
10 years |
|
Non-Forensic Autopsy Records |
| Wet tissue |
3 months after final report |
| Paraffin blocks |
10 years |
| Slides |
10 years |
| Reports |
10 years |
|
Forensic Autopsy Records |
| Wet stock tissue |
3 years |
| Wet tissue of whole organs |
3 months |
| Paraffin blocks |
20 years |
| Reports |
Indefinitely |
| Slides |
Indefinitely |
| Gross photographs/negatives |
Indefinitely |
| Accession log records |
Indefinitely |
| Serum/CSF/urine |
2 years |
| Whole blood |
6 months |
| Dried blood stain of frozen tissue for DNA |
Indefinitely |
| Frozen tissue for toxicology |
6 months |
|
Clinical Pathology Records |
| Patient test records |
2 years |
| Serum/CSF/body fluids (except urine) |
48 hours |
| Urine |
24 hours |
| Peripheral blood smears/body fluid smears |
7 days |
| Permanently stained slides-microbology (gram, trichrome, etc.) |
7 days |
|
Cytogenetic Records |
| Slides |
3 years |
| Wet tissue/tissue |
Until adequate metaphase cells obtained |
| Fixed cell pellet |
2 weeks after final report |
| Final reports |
20 years |
| Diagnostic images (digitized or negatives) |
20 years |
|
Blood Bank Records |
| Donor and recipient records |
Indefinite |
| Records of employee signatures, initials, and identification codes |
10 years |
| Quality control records |
5 years |
| Record of permanently deferred donors |
Indefinitely |
| Specimens from blood donor units and recipients |
7 days post-transfusion Indefinitely |
|
Return to Regulatory Issues
