| 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 year |
|
| |
| 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 |
|
|
| |
