RRS_Series: Clinical Laboratory Records

Activity
IV.05. FINANCE, ADMINISTRATION AND INFRASTRUCTURE/Public Safety
Series Name
Clinical Laboratory Records
Series ID
405-20-905
Description

Document the activities of clinical laboratories including quality control records, test results, and other laboratory records. To comply with Oregon regulations, laboratory records, found in all media (paper, digital, or other), must include: 

  • Quality assurance records  
  • Proficiency testing records 
  • Equipment calibration records 
  • Test procedure records 
  • Records of each specimen examined, including: 
    • laboratory number or other identification of the specimen;
    • the name or other identifier of the person from whom the specimen was taken, if available;
    • the name of the physician or other authorized person or clinical laboratory submitting the specimen;
    • the date and time the specimen was collected or date and time it was received in the laboratory;
    • the type of test performed; the results of the tests in units of measurement where applicable;
    • the signature, initials, or identification of the examiner;
    • the date and time the test results were reported; and
    • other information as needed to aid in the interpretation of laboratory results;
  • Records of any reporting errors;
  • Employee competence assessments;

For clinical records created by University Health Services (UHS) or another health service provider, follow Series 304-10-105 et seq.  For audit logs and related security policies and procedures, follow Series 406-10-405, 

Retention and Disposal Instructions

(a.) 2 years for quality assurance records, including calibration records and proficiency testing records (minimum); 

(b.) 2 years from the discontinuation date for records of test procedures, purge; 

(c.) 5 years for immunohematology records, purge; 

(d.) 10 years for cytology and pathology records, purge; 

(e.) 2 years for all other specimen records, including test results, not included in (c.) and (d.), purge;

(f.) Accreditation records, including CLIA certificates, do not purge; 

(g.) 2 years for other laboratory records, unless governed by other state or federal law or retention schedule, purge.

Exception: In the event of a subpoena, audit, legal hold, public records or similar state or federal information request, halt until further instructed any scheduled disposal activities, including purging or transferring material to University Archives.