CAP checklist versione Aprile 2006

GEN.20377

Are laboratory records and materials retained for an appropriate time?

NOTE: The following records must be retained for at least 2 years: specimen
requisitions (including the patient chart or medical record only if used as
the requisition), patient test results and reports, instrument printouts,
accession records, quality control records, instrument maintenance records,
proficiency testing records, and quality management records. Specimens of
serum, heparinized plasma, EDTA plasma, whole blood, CSF, and body fluids
(except urine) should be retained for 48 hours. Urine specimens should be
retained for 24 hours. Blood films, permanently stained body fluid slides,
and microbiology slides should be retained for 7 days.

Laboratories may wish to retain instrument maintenance records for longer
than the 2-year requirement (e.g., for the life of the instrument), to
facilitate trouble-shooting.

Records of method performance specifications must be retained while the
method is in use, and for at least two years afterwards. For requirements on
retaining records of changes to software, the test library, and major
functions of laboratory information systems, please refer to the Hardware
and Software section of the Laboratory Computer Services section of this
checklist.

More stringent requirements for certain laboratory records (e.g., in
anatomic pathology, cytopathology, transfusion medicine) may be found in the
discipline-specific checklists.

For data transmitted by computer interface (on-line system), it is not
necessary to retain paper worksheets, print-outs, etc., so long as the
computer retains the data for at least two years. Manual entry of patient
result data requires that all worksheets, print-outs, etc. are retained by
the laboratory for at least two years.

In establishing retention requirements, care should be taken to comply with
state and federal regulations.

REFERENCES: 1) College of American Pathologists. Guidelines for the
retention of laboratory records and materials. Northfield, IL: CAP, current
edition; 2) Department of Health and Human Services, Centers for Medicare
and Medicaid Services. Clinical laboratory improvement amendments of 1988;
final rule. Fed Register. 2003(Jan 24): [42CFR493.1105].