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  Retention of Laboratory Records
  and Materials

 

 

  The College of American Pathologists makes the following recommendations for the minimum requirements for the retention of laboratory records and materials. They meet or exceed the regulatory requirements specified in the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88). It may be appropriate for laboratories to retain records and/or materials for a longer period of time when required for patient care, education, quality improvement, or other needs. Some state regulations as well as other federal mandates may require retention of records and/or materials for a longer time period than that specified in the CLIA 88 regulations; therefore any applicable state or federal laws should be reviewed carefully when individual laboratories develop their record retention policies.

 
Material/Record Period of Retention
General Laboratory
Accession log 2 years
Maintenance/instrument maintenance records 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
Wet tissue 3 months after final
Paraffin blocks 10 years
Slides 10 years
Reports 10 years
 
Forensic Autopsy
Wet stock tissue 1 year
Paraffin blocks Indefinitely
Reports Indefinitely
Slides Indefinitely
Gross photographs/negatives Indefinitely
Accession log Indefinitely
Body fluids and tissues for toxicology 1 year
Representative tissue suitable for DNA Analysis Indefinitely
 
Clinical Pathology
Patient test records 2 years
Serum/heparinized or EDTA plasma/CSF/Body fluids (except urine) 48 hours
Urine 24 hours*
*Exceptions may be made at the discretion of the laboratory director
Peripheral blood smears/body fluid smears 7 days
Permanently stained slides – microbiology (gram, trichrome, etc) 7 days
 
Cytogenetics
Permanently stained slides 3 years
Fluorchrome stained slides At the discretion of the laboratory director
Wet specimen/tissue Until adequate metaphase cells are obtained
Fixed cell pellet 2 weeks after final report
Final reports 20 years
Diagnostic images (digitized, prints or negatives) 20 years
 
Flow Cytometry
Gated dot plots and histograms 10 years
 
Blood Bank
Donor and recipient records 10 years
Patient records 10 years
Records of employee signatures, initials, and identification codes 10 years
Quality control records 5 years
Records of indefinitely deferred donors, permanently deferred donors, or donors placed under surveillance for the recipient’s protection (e.g., those donors that are hepatitis B core positive once, donors implicated in a hepatitis positive recipient) Indefinitely
Specimens from blood donors units
and recipients
7 days post-transfusion

Revision History

Adopted August 1995
Revised September 1995
Reaffirmed August 1998
Revised November 2000
Revised May 2001
Revised November 2001
Revised November 2004
Revised November 2005
Revised August 2007
Revised March 2010
Reaffirmed June 2013