Doc. Control No.

:
DCN:LAB_GDN-
05242018-1
Revision Level
MEDIUM

RETENTION OF
LABORATORY RECORDS
AND DIAGNOSTIC
MATERIAL

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 Table 1 General minimum retention times†

Record/material Minimum retention time

1.1 Personnel records Period of employment + 3 years
1.2 All quality control and quality assurance records 3 years
1.3 Equipment maintenance Life of equipment + 3 years
1.4 Laboratory methods/procedures (manuals) 3 years1
1.5 Referring doctor’s request, Laboratory records such 3 years2
as records of analysis, calculations and observations
from which the result is derived
1.6 All Specimens, unless otherwise specified under the 7 days from date of receipt or until 2 days
separate disciplines given in the tables that follow after the date of the issued report
(whichever date is later), under
appropriate storage conditions and
reliable retrieval †

1.7 Copy of original report, or ability to reprint the 7 years for adults
information content of an original report 7 years from the age of majority for
minors3

Table 2 Minimum retention times for cytology

Record/material Minimum retention time

2.1 Exfoliative cytology and fine needle aspirations (FNAs) 10 years
including slides and cell blocks
2.2 Gynaecological (cervical) cytology slides 10 years
2.3 Specimens of sputum, urine and other body fluids See General 1.6
2.4 Specimens received in liquid-based fixative 1 month

Table 3 Minimum retention times for haematology

Please refer to Table 1 (General minimum retention times) for both record and material retention times, unless
otherwise specified below.
Record/material Minimum retention time
3.1 Blood films Clinically significant: 1 year
Not clinically significant: 1 month
3.2 Plasma for special haemostasis testing 3 months at -20oC or lower

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 3.3 Blood Specimens, other than 6.1–6.2 As for General 1.6 for purpose of
identification and traceability, noting
that repeat testing may not be
technically reliable after 2 days
3.4 Bone marrow — slides and reports 10 years

Table 4 Minimum retention times for immunohaematology (blood transfusion)

Please refer to Table 1 (General minimum retention times) for both record and material retention times, unless
otherwise specified below.
Record/material Minimum retention time
4.1 Laboratory records of blood products received and issued 20 years

Table 5 Minimum retention times for immunology

Please refer to Table 1 (General minimum retention times) for both record and material retention times, unless
otherwise specified below.
Record/material Minimum retention time
5.1 Serum, plasma, other body fluid and tissue Specimens See General 1.6
5.2 Frozen tissue blocks, including Specimens for 1 month at -70oC or lower
immunofluorescence studies
5.3 Immunofluorescence slides See General 1.6

Table 6 Minimum retention times for microbiology

Please refer to Table 1 (General minimum retention times) for both record and material retention times, unless
otherwise specified below.
Record/material Minimum retention times
6.1 Slides Wet preparations: discard
Immunofluorescence slides: 7 days
Gram stains: 2 weeks
Ziehl-Neelsen stains: 6 weeks
Other stained slides: 2 weeks
6.2 Isolates Clinically significant: 5 days
Not clinically significant: discard
6.3 Serum/plasma for infectious disease All sera (unless specified below): 4 months
serology Antenatal sera: 12 months
Syphilis (reactive): 12 months
6.4 Urine Specimen for microbiological 3 days from date of receipt: under refrigeration
examination

Table 7 Minimum retention times for clinical microscopy

Please refer to Table 1 (General minimum retention times) for both record and material retention times, unless
otherwise specified below.
Record/material Minimum retention time

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7.1 Serum, plasma, other body fluid and tissue Specimens See General 1.6

Table 8 Minimum retention times for chemical chemistry

Record/Material Minimum retention times

Request form accompanying
8.1 specimen
5.1.1 Routine test 1 month after issue of report /result
5.1.2 Special test 12 months after issue of report/result
8.2 Report duplicates
5.2.1 Neonatal screening and
inborn error 25 years
of metabolism
5.2.3 Drug of abuse testing
(confirmatory 7 years
or screening)
5.2.4 Therapeutic drug
monitoring 7 years
5.2.5 All other reports 7 years

8.3 Results 3 years

8.4 Samples
5.4.1 Serum, plasma, blood, frozen
urine 2 days after issue of report/ result
and other frozen body fluids
5.4.2 Other body fluids e.g. urine,
24 hours after test is done
cerebrospinal fluid, pleural
fluid

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 Table 9 Minimum retention times for histopathology
Please refer to Table 1 (General minimum retention times) for both record and material retention times, unless
otherwise specified below.
Record/material Minimum retention time
9.1 Slides:
Sections of fixed tissue preserved in mounting 10 years4
medium
Sections of unfixed tissue not in permanent See General 1.6
mounting medium (including
immunofluorescence slides)

9.2 Blocks of tissue embedded in paraffin wax or any 10 years††5

other permanent embedding medium

9.3 Specimens for intra-operative frozen section 10 years8

diagnosis:

(i) The original section(s) used for

diagnosis, preserved in permanent mounting
medium

(ii) Residual tissue from which the sections

in (i) were prepared, embedded in paraffin

(iii) All other blocks of paraffin-embedded

tissue from the same Specimen or Specimens
from which tissue has been selected for frozen
section examination
9.4 Frozen tissue blocks, including Specimen for
immunofluorescence studies
9.5 (i) Containers with no residual tissue
(ii) Unblocked tissue from Specimens removed at
surgery
(iii) Unblocked tissue from Specimens retained at
autopsy
9.6 Autopsy — registers, report duplicate, blocks and
slides, records of tissue and organ disposal
1 month at -70°C or lower
1 month
1 month from date of issue of Specimen report
3 months after autopsy unless a limitation is
imposed, such as the need to reunite retained
Specimens with the body before a funeral has
been stipulated by next-of-kin
10 years for autopsy other than forensic or other
medico-legal autopsy

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 9.7 Forensic and medico-legal In accordance with jurisdiction requirement or 20
years if not specified

TITLE RETENTION OF LABORATORY RECORDS AND DIAGNOSTIC MATERIAL

THE RETENTION OF LABORATORY RECORDS AND DIAGNOSTIC MATERIAL AIMS TO ENSURE THERE IS PHYSICAL AUDIT
TRAIL IN CASE OF INTEGRITY OR IDENTIFICATION OF THE SPECIMEN NEEDS TO BE ESTABLISHED AND TO MAINTAIN A
SCOPE NUMBER OF RECORDS WHICH SUBSTANTIATE THE VALIDITY OF TESTING DONE FOR THE PRODUCTION OF RESULTS FOR
PATIENT RECORDS.

Date Effective: _________________________

Prepared By: Reviewed by:

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 Nakahara Chuuya Yosano Akiko
Section Head department/ Quality control and Quality
assurance officer Head Department Pathologist
Received By: Approved By:

Osamu Dazai Edogawa Ranpo

Quality Assurance Officer Director / Head
Date Signed: ____06/27/19______ Date Signed: ____06/27/19______

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