RECORD RETENTION IN THE LABORATORY

Effective Date: 
Tue, 05/01/2012
Reviewed: 
Tue, 01/10/2017
Policy: 

PURPOSE

The UCSC SHC laboratory which performs tests is required to establish and maintain a system that assures optimum integrity for identification of patient specimens throughout the testing process, as well as complete and accurate results, and an effective way to store and retrieve those results.  Refer to the UCSC SHC Records Retention Policy.

Procedure: 

PROCEDURE

According to CLIA regulations, all test requisitions, patient charts, test results with pertinent reference ranges, name of person performing tests, instrument printouts and all other test records must be kept for a minimum of two years. Any immunohematology records must be kept for a minimum of five years. Pathology (biopsy, cytology, etc) reports and logs must be maintained for a minimum of ten years, even if specimens are merely collected and referred for outside testing.

Following is a listing of all records to be retained in the laboratory and the time period they must be kept:

Accession records (computer printouts): 2 years

Chain of custody forms: 2 years

Test validation data: 2 years

Technical raw data (to include logs, analyzer printouts, standards, controls, worksheets, patient results from analyzer): 2 years

Quality control data: 2 years

Instrument service logs (done by manufacturer or service reps) life of the instrument Proficiency testing reports: 2 years

Temperature charts and other routine maintenance: 2 years

Clinical reports on patient chart: 5 years

Disk data information: 5 years

The year of disposal is determined as follows:  the time is computed from January 1st of the subsequent date of the material, i.e. records dated from 2007 with a storage life of two years will be kept until January of 2010.

Periodically, all material will be placed in storage boxes and labeled with the complete contents and the date the material should be disposed. Storage boxes will be kept in an adjacent laboratory storage area and monitored by the Laboratory Staff for disposal. If stored "off-site", they must be readily available for inspection; they should be brought onsite before a scheduled inspection.