NATIONAL PATHOLOGY ACCREDITATION ADVISORY COUNCIL
REQUIREMENTS FOR THE
RETENTION OF LABORATORY
RECORDS AND DIAGNOSTIC
MATERIAL
(Seventh Edition 2018)
NPAAC Tier 3B Document

Print ISBN: 978-1-76007-342-8
Online ISBN: 978-1-76007-341-1
Publications approval number: 12115
Copyright
© 2018 Commonwealth of Australia as represented by the Department of Health
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(a)
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Apart from rights as permitted by the Copyright Act 1968 (Cth) or allowed by this copyright
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First published  1987
Second edition   1998
Third edition
2002
Fourth edition   2007
(formerly titled: Retention of Laboratory Records and Diagnostic
Material)
Fifth edition
2009
reprinted with amendments
Sixth edition
2013
reprinted and reformatted to be read in conjunction with the
Requirements for Medical Pathology Services
Seventh edition  2018
revised and reprinted
Australian Government Department of Health

ii
Requirements for the Retention of Laboratory Records and Diagnostic Material

The National Pathology Accreditation Advisory Council (NPAAC) was established in 1979
to consider and make recommendations to the Australian, state and territory governments on
matters related to the accreditation of pathology laboratories and the introduction and
maintenance of uniform standards of practice in pathology laboratories throughout Australia.
A function of NPAAC is to formulate Standards and initiate and promote education programs
about pathology tests.
Publications produced by NPAAC are issued as accreditation material to provide guidance to
laboratories and accrediting agencies about minimum Standards considered acceptable for
good laboratory practice.
Failure to meet these minimum Standards may pose a risk to public health and patient safety.
iv
Requirements for the Retention of Laboratory Records and Diagnostic Material

Scope
The Requirements for the Retention of Laboratory Records and Diagnostic Material (Seventh
Edition 2018) is a Tier 3B NPAAC document and must be read in conjunction with the Tier 2
document Requirements for Medical Pathology Services. The latter is the overarching
document broadly outlining standards for good medical pathology practice where the primary
consideration is patient welfare, and where the needs and expectations of patients, laboratory
staff and referrers (both for pathology requests and inter-laboratory referrals) are safely and
satisfactorily met in a timely manner.
Whilst there must be adherence to all the Requirements in the Tier 2 document, reference to
specific Standards in that document are provided for assistance under the headings in this
document.
The Requirements for the Retention of Laboratory Records and Diagnostic Material
represents the minimum standards for retention of laboratory records and materials. These
principles are important for medical pathology services. Individual laboratories may choose
to exceed these minimum requirements based on local circumstances and historical practice.
This document does not address tissue banking, biobanking or issues related to research
records and specimens in research laboratories.
Requirements for the Retention of Laboratory Records and Diagnostic Material
v

Abbreviations
Abbreviation
Description
AS
Australian Standard
ISO
International Organization for Standardization
NPAAC
National Pathology Accreditation Advisory Council
NATA
National Association of Testing Authorities, Australia
NIPT
Non-invasive Prenatal Testing
TGA
Therapeutic Goods Administration
vi
Requirements for the Retention of Laboratory Records and Diagnostic Material

Definitions
Term
Definition
Requirements for
means the overarching document broadly outlining standards for
Medical Pathology
good medical pathology practice where the primary consideration
Services (RMPS)
is patient welfare, and where the needs and expectations of
patients, laboratory staff and referrers (both for pathology
requests and inter-laboratory referrals) are safely and
satisfactorily met in a timely manner.

Requirements for the Retention of Laboratory Records and Diagnostic Material
vii

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viii
Requirements for the Retention of Laboratory Records and Diagnostic Material

Introduction
Pathology reports form part of the patient’s medical record, and may also be retained in, or
remain accessible from, the laboratory information system. In addition, laboratories are
required to maintain a number of records that substantiate the validity of testing done for the
production of results for patient records.
Retaining specimens has two primary purposes: to ensure there is a physical audit trail, in
case the integrity or identification of the specimen needs to be established; and to allow
additional testing to be done on the original specimen, if required. In some cases, the original
specimen may be consumed, exhausted or be otherwise unsuitable for any additional testing;
however, retention is still required for audit and traceability purposes.
If a specimen subject to retention requirements is requested by another laboratory (e.g. for a
second opinion or additional testing), both original and reference laboratories have an
obligation to track the location of the specimen and ensure its safe return to the source
laboratory.
The Requirements for the Retention of Laboratory Records and Diagnostic Material (Seventh
Edition 2018) outlines the minimum best practice standards for retention of laboratory
records and materials. These principles have been developed with a risk-based approach and
are important for medical pathology services to assure they provide high quality pathology
services.
The overarching priority in the development of NPAAC Standards is patient welfare.
However in relation to the issue of retention of specimens and laboratory records, a balance
needs to be achieved between the possible requirement to retrieve materials to inform health
decisions for a patient and/or their family (clinical utility), and issues related to prolonged
storage. Material with implications for the long-term health of an individual or their family
members (such as records relating to germline genetic testing) may be required to be stored
for longer.
Representation has been made to NPAAC by various advocacy groups that are particularly
concerned at the reduction in minimum storage times for histology blocks from adult patients
from 20 years to 10 years in the previous version of the Requirement for the Retention of
Laboratory Records and Diagnostic Material (Sixth Edition, 2013). The issue has been
considered by the Drafting Committee, with input sought from professional groups,
researchers and consumer representatives, and a decision has been made to not reverse the
previous reduction in minimum storage times for histology specimens from adults. The
reasoning behind this decision is as follows:
• This NPAAC Standard relates to minimum storage times for routine specimens;
individual laboratories may choose to exceed these storage times if the capacity to do so
and clinical justification exists. It should be noted that the Standard has not altered the
requirement to retain histology specimens from a paediatric patient at least until the age
of 25 (majority plus 7 years) or until the minimum period has elapsed (whichever is
greater), thus for practical reasons, laboratories may choose to retain all specimens as if
they were of paediatric origin.

Requirements for the Retention of Laboratory Records and Diagnostic Material
1

link to page 10 •  The Standard does not address issues relating to research laboratories or Tissue Banking,
which are covered by other documents.*1,2 Tissue specimens that may have been
sub-optimally fixed, processed or stored, and that lack detailed clinical and follow-up
information are of limited value as research material.3
•  Despite recent advances in the ability to extract meaningful genetic information from
archival tissue specimens through the use of using next generation sequencing
techniques, similar techniques have highlighted tumour heterogeneity and clonal
evolution during tumour progression. Testing of an archival specimen (although
theoretically possible) is not necessarily a reliable predictor of the therapeutic response of
disease recurrence, which in nearly all cases would be amenable to biopsy for accurate
biomarker assessment and individualised treatment planning. Therefore, assessment of
archival tumour material becomes largely a matter of academic interest rather than
clinical utility, and the value of comparing previous with current tumour samples in very
occasional cases must be weighed against the impost of retaining all adult histology
samples for prolonged periods.
•  Triage of cases for prolonged retention on the basis of diagnosis alone cannot be
justified; the requirement for review and retesting is not limited to tumour samples, and
indeed, in very antiquated samples, a request for retrieval is more likely to be related to
other indications such as identity/paternity testing.
Another issue that was raised with NPAAC relates to the retention of high resolution digital
images as an alternative to the retention of glass histology slides. The Drafting Committee
concluded that removing the requirement to retain glass slides for a minimum period of
10 years would be premature at this point, although the issue should remain under active
review in future versions of the Requirements. The reasons for this decision are as follows:
•  the NPAAC Requirements for Digital Pathology is currently under development
•  there are concerns about interoperability of different digital imaging software
platforms/formats, particularly in the long term
•  advances in sequencing technologies are such that molecular diagnostics can be
performed on tissue retrieved from glass slides which represent a “specimen of last
resort” when the block has cut out. Loss of this resource, as expanding numbers of tests
are required on increasingly smaller biopsies, may negatively affect patient care.
The Standards also address requirements for the retention of digital images or graphical
output integral to diagnosis. These include scatter plots used in flow cytometric analysis,
FISH images, histological images subject to image analysis and tiled annotated images from
semi-automated cervical cytology screening. The slightly longer retention time for the latter
relates to the 5 year screening interval for the new National Cervical Screening Program. It is
not intended that this requirement apply to the graphical output of routine haematology
autoanalysers.
These Requirements do not override the minimum retention periods mandated by commercial
contracts, agreements or jurisdictional requirements governing retention of records or
specimens. Laboratories should have well documented procedures for ensuring that the
longer period of retention is observed in such circumstances.

* Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 20131 & Therapeutic Goods Order No.
88 – Standards for donor selection, testing and minimising infectious disease transmission via therapeutic
goods that are human blood and blood components, human tissues and human cellular therapy products2
2
Requirements for the Retention of Laboratory Records and Diagnostic Material

In addition, these Requirements do not stipulate detailed requirements for disposal of
specimens, however this should be undertaken in accordance with relevant State and
Territory legislation.
Guidance is provided on returning specimens to patients upon request (Appendix A), which
once again must be undertaken in accordance with relevant State and Territory legislation,
particularly as it pertains to health and safety issues. A summary of current legislation
relevant to retention and disposal of laboratory specimens and records is provided in
Appendix C.
These Requirements are intended to serve as minimum Standards in the accreditation process
and have been developed with reference to current and proposed Australian regulations and
other standards from the International Organization for Standardization including:
AS ISO 15189 Medical laboratories – Requirements for quality and competence.
These Requirements should be read within the national pathology accreditation framework in
conjunction with the current versions of the following NPAAC documents:
All Tier 2 and Tier 3 Documents
Tier 4 Documents
•  Requirements for Laboratories Reporting Tests for the National Cervical Screening
Program
In each section of this document, points deemed important for practice are identified as
‘Standards’ or ‘Commentaries’.
•  A Standard is the minimum requirement for a procedure, method, staffing resource or
laboratory facility that is required before a laboratory can attain and maintain
accreditation – Standards are printed in bold type and prefaced with an ‘S’ (e.g. S2.2).
The word ‘must’ in each standard within this document indicates a mandatory
requirement for pathology practice.
•  A Commentary is provided to give clarification to the Standards as well as to provide
examples and guidance on interpretation. Commentaries are prefaced with a ‘C’
(e.g. C1.2) and are placed where they add the most value. Commentaries may be
normative or informative depending on both the content and the context of whether they
are associated with a Standard or not. Note that when comments are expanding on a
Standard or referring to other legislation, they assume the same status and importance as
the Standards to which they are attached. As a general rule, where a Commentary
contains the word ‘must’ then that Commentary is considered to be normative.
Please note that any appendices attached to this document may be either normative or
informative and should be considered to be an integral part of this document.
Please note that all NPAAC documents can be accessed at Department of Health.

Requirements for the Retention of Laboratory Records and Diagnostic Material
3

While this document is for use in the accreditation process, comments from users would be
appreciated and can be directed to:
NPAAC Secretariat
Phone:
(02) 6289 4017
Diagnostic Imaging and Pathology Branch
Fax:
(02) 6289 4028
Medical Benefits Division
Email:
[email address]
Department of Health
Website:
www.health.gov.au/npaac
GPO Box 9848 (MDP 951)
CANBERRA ACT 2601
4
Requirements for the Retention of Laboratory Records and Diagnostic Material

link to page 13 1. Conditions of Specimen Storage
(Refer to Standard 7 in Requirements for Medical Pathology Services)
S1.1  Specimens must be stored under appropriate storage conditions that permit
reliable retrieval.
S1.2  Laboratories must demonstrate storage conditions are fit for purpose and retain
supporting documentation, including records of storage temperatures.
C1.2(i)
Recommended general storage temperatures are as follows:
(a)
Refrigeration
2 to 8°C
(b)
Freezer
-20°C or lower
(c)
Deep freezer
-70°C or lower.
C1.2(ii)  Some types of refrigerators and freezers involve “freeze/thaw” cycles as
part of their auto-defrost features. Specimens stored in these types of
refrigerators/freezers should not be intended for later testing of analytes that
are degraded by such freeze/thaw cycles.
S1.3  Storage of blood and blood products must be in accordance with AS 3864
Medical Refrigeration Equipment - for the storage of blood and blood products. 4
S1.4  Specimen refrigerators and freezers must not be used for storage of food or
drink.
S1.5  Use of specimen refrigerators and freezers for storage of tissue specimens
intended for transplantation or use as a therapeutic device requires that the
laboratory must comply with the regulatory requirements of the TGA†5 and
other relevant regulatory codes.
† TGA Publications5
Requirements for the Retention of Laboratory Records and Diagnostic Material
5

link to page 14 link to page 14 link to page 14 2.  Minimum Retention Times
(Refer to Standard 8 in Requirements for Medical Pathology Services)
Discipline variations
While preparing this document, a common set of requirements for retention across all
disciplines was acknowledged as an ideal; however, there are valid practical reasons for some
discipline-to-discipline variations. Every effort has been made to minimise these and where
they exist, ensure consistency of approach to comparable situations in the different
disciplines.
The minimum duration of retention of records relating to laboratory equipment has been
adjusted in consideration of a number of issues, such as the recent changes to the NATA
surveillance cycle from 3 to 4 years and an additional margin for records relating to Quality
Assurance.
Table 1
General minimum retention times‡

Record/material
Minimum retention time
1.1
Personnel records
Period of employment + 4 years
1.2
All quality control, quality assurance and
4 years
quality management records
1.3
Equipment maintenance
Life of equipment + 4 years
1.4
Laboratory methods/procedures (manuals)
4 years§
1.5
Referring doctor’s request, laboratory records
4 years**
such as records of analysis, calculations and
observations from which the result is derived
1.6
Digital images or graphical output used in
4 years
diagnosis
1.7
All specimens, unless otherwise specified under
7 days from date of receipt or until
the separate disciplines given in Tables 2 to 11
2 days after the final report is issued
(whichever date is later)
1.8
Copy of original report, or ability to reprint the
7 years for adults
information content of an original report unless
a longer period is specified in Tables 2 to 11
7 years from the age of majority for
minors


§ The retention time of 4 years refers to the circumstance where a laboratory method/procedure/in-vitro diagnostic (IVD) device has been
superseded or replaced by a new and unrelated methodology. However, where a laboratory method/procedure/IVD has simply been
modified, the full history of all earlier versions/modifications of that particular IVD must continue to be retained.
** Storage of scanned facsimile images and associated records of these intermediary documents is a satisfactory alternative to retention of
the original document. For those areas where material is retained for longer than 4 years, the laboratory may wish to consider retaining the

associated records for a corresponding period. See also Appendix B for electronic storage requirements of pathology request forms.
Although there is no minimum retention time for paper request forms after validated scanning has been performed, it would be prudent to
retain them for as longs as is necessary to exclude the possibility of scanning failure.
6
Requirements for the Retention of Laboratory Records and Diagnostic Material

link to page 15 link to page 15 Table 2
Minimum retention times for Anatomical Pathology
Please refer to Table 1 (General minimum retention times) for both record and material
retention times, unless otherwise specified below in Table 2.

Record/material
Minimum retention time
2.1
Copy of original report, or ability to reprint
10 years or
the information content of an original report
7 years from the age of majority for minors
(whichever is the greater)
2.2
Slides:

(i)  Sections of fixed tissue preserved in
10 years
mounting medium
(ii)  Sections of fixed tissue assessed by
6 months
FISH (fluorescence in situ hybridization
(iii)  Sections of unstained, fixed tissue not in
1 month
permanent mounting medium (unstained
spares)
(iv)  Sections of unfixed tissue not in
See General 1.7 in Table 1
permanent mounting medium (including
immunofluorescence slides)
2.3
Digital images used for diagnostic analysis
see General 1.6 in Table 1
2.4
Blocks:
Tissue embedded in paraffin wax or any other  10 years††
permanent embedding medium, including for
ultrastructural study
2.5
Specimens for intra-operative frozen section
10 years††
diagnosis:
(i)  The original sections used for diagnosis,
preserved on slides in permanent
mounting medium
(ii)  Residual tissue from which the frozen
sections were prepared, embedded in
paraffin blocks
(iii)  All other blocks of paraffin-embedded
tissue from the same specimen/s from
which tissue has been selected for frozen
section examination
2.6
Frozen tissue blocks, including specimens for
1 month at -70°C or lower
immunofluorescence studies


†† Where the report or specimen relates to a pediatric patient, the retention period for anatomical pathology and cytology
specimens should be the greater of 10 years or 7 years from the age of majority.
Requirements for the Retention of Laboratory Records and Diagnostic Material
7

Record/material
Minimum retention time
2.7
(i)
Containers with no residual tissue
1 month from date of issue of report
(ii) Unblocked wet tissue from specimens
1 month from date of issue of report
removed at surgery
2.8
Non-coronial autopsy:
(i)
Registers, report duplicate, blocks and
10 years
slides, records of tissue and organ
disposal
(ii)
Unblocked tissue from histological
3 months from date of issue of report
samples retained at autopsy, or
unless a limitation is imposed, such as the
need to reunite retained specimens with the
(iii)
Organs retained at autopsy with
body before a funeral has been stipulated
consent
by next-of-kin
Table 3
Minimum retention times for Chemical Pathology
Please refer to Table 1 (General minimum retention times) for both record and material
retention times, unless otherwise specified in Table 3.
Record/material
Minimum retention time
3.1
Serum, plasma, other body fluid and tissue specimens
See General 1.7 in Table 1
8
Requirements for the Retention of Laboratory Records and Diagnostic Material

link to page 17 link to page 17 Table 4
Minimum retention times for Cytology
Please refer to Table 1 (General minimum retention times) for both record and material
retention times, unless otherwise specified below in Table 4.

Record/material
Minimum retention time
4.1
Copy of original report, or ability to reprint the
10 years or
information content of an original report
7 years from the age of
majority for minors
(whichever is the greater)
4.2
Exfoliative non-gynaecological cytology and fine
10 years‡‡
needle aspiration (FNA) slides and cell blocks
4.3
Gynaecological (cervical) cytology slides
10 years
4.4
Residual specimens of sputum, urine and other body
See General 1.7 in Table 1
fluids following preparation of cytology slides
4.5
Specimens received in liquid-based fixative
1 month§§
4.6
Digital images used for diagnostic analysis e.g. semi-
6 years
automated pap screening images

‡‡ Where the report or specimen relates to a pediatric patient, the retention period for anatomical pathology and
cytology specimens should be the greater of 10 years or 7 years from the age of majority.
§§ Unless otherwise stated in the Requirements for Laboratories Reporting Tests for the National Cervical
Screening Program (First Edition 2017)
Requirements for the Retention of Laboratory Records and Diagnostic Material
9

Table 5
Minimum retention times for Forensic Pathology
Please refer to Table 1 (General minimum retention times) for both record and material
retention times, unless otherwise specified below in Table 5.

Record / material
Minimum retention time
5.1
Forensic and medico-legal autopsy:
In accordance with jurisdictional
requirements or indefinitely if not
(i)
Registers, report duplicate,
specified
blocks and slides, records of
tissue and organ disposal, gross
photographs, or
(ii)
Unblocked tissue from
histological samples retained at
autopsy, or
(iii)
Organs retained at autopsy with
consent, or
(iv)
Body fluids and tissues for
toxicology, or
(v)
Representative tissue suitable
for DNA analysis
5.2
Clinical Forensic Medicine
Clinical Forensic Medicine materials
In accordance with jurisdictional
including, but not limited to: biological  requirements or indefinitely if not
samples for toxicology, body swabs
specified
and slides, foreign material and trace
evidence, biological evidence,
fingernails, representative/reference
DNA samples, clothing and
photographs
10
Requirements for the Retention of Laboratory Records and Diagnostic Material

link to page 19 Table 6
Minimum retention times for Genetics (including biochemical genetics,
cytogenetics, molecular genetics and newborn screening)
Please refer to Table 1 (General minimum retention times) for both record and material
retention times, unless otherwise specified below in Table 6.
Record/material
Minimum retention times
6.1
Copy of original report, or ability to reprint the
information content of an original report
(i)
Constitutional genetic testing
100 years (effectively indefinite)
(ii)
Somatic genetic testing
10 years***
6.2
Cytogenetics:
(i)
Analysis records/karyotypes/digital
4 years
images including FISH images
(ii)
Stained microscope slides in permanent
4 years
mounting medium
(iii) Fixed chromosome cell suspension or
6 months
FISH slides
(iv) Original specimens and containers
1 month from date of issue of report
6.3
Cytogenetics/biochemical genetics/molecular
genetics:
Tissue cultures/cell culture lines
(i)
Rare clinically significant variants
For indefinite cryopreservation
(ii)
Common clinically significant variants or
As for General 1.7 in Table 1
clinically non-significant
6.4
Biochemical genetics:
Specimens of plasma, serum and urine
(i)
Original container
7 days
(ii)
Analytic aliquot
3 months after date of issue of report
6.5
Neonatal screening (dried blood spot):
(i)
Specimen (Guthrie) cards
2 years
(ii)
Records
see Genetics 6.1 in Table 6
6.6
Molecular genetics:
3 months from date of issue of the
(i)
Nucleic acid extracts for somatic or
report for an individual, or from
constitutive testing
completion of a family study where
the proband’s sample is required as a
control, or from completion of testing;
whichever of the three periods is the
longest
(ii)
Nucleic acid extracts or frozen plasma for
12 months
NIPT
6.7
Bioinformatic genetic data:
(i) Read data (e.g. FASTQ) or aligned reads
4 years from date of issue of report
(e.g. BAM)
(ii) Variant call files
10 years
(iii) Microarray analysis files
4 years
*** Where the report relates to a pediatric patient, the retention period should be the greater of 10 years or 7 years
from the age of majority
Requirements for the Retention of Laboratory Records and Diagnostic Material
11

Table 7
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 in Table 7.

Record/material
Minimum retention time
7.1
Blood films
(i)  Clinically significant
1 year
(ii)  Not clinically significant
1 month
7.2
Plasma for special haemostasis testing
1 month at -20oC or lower
7.3
Blood specimens, other than 7.1–7.2
As for General 1.7 for purpose of
identification and traceability, noting
that repeat testing may not be
technically reliable after 2 days
7.4
Bone marrow, slides and reports
10 years for adults
7 years from the age of majority for
minors
7.5
Flow cytometry
(i)  Reports
10 years for adults
7 years from the age of majority for
minors
(ii)  Graphical outputs used in diagnosis
see General 1.6 in Table 1
such as gated dot plots and histograms

12
Requirements for the Retention of Laboratory Records and Diagnostic Material

link to page 21 link to page 21 Table 8
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 in Table 8.
Record/material
Minimum retention time
8.1
Laboratory records of blood products received and
20 years
issued†††
8.2
Laboratory records of all immunohaematology
20 years
testing†††
Table 9
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 in Table 9.
Record/material
Minimum retention time
9.1
Serum, plasma, other body fluid and tissue specimens See General 1.7
9.2
Frozen tissue blocks, including specimens for
1 month at -70oC or lower
immunofluorescence studies
9.3
Immunofluorescence slides
See General 1.7 in Table 1
9.4
Digital images used for diagnostic analysis
see General 1.6 in Table 1
††† Should be done in accordance with the Requirements for Transfusion Laboratory Practice
Requirements for the Retention of Laboratory Records and Diagnostic Material
13

link to page 22 link to page 22 link to page 22 Table 10  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 in Table 10.

Record/material
Minimum retention times
10.1
Slides
(i)  Wet preparations
Nil (discard)
(ii)  Immunofluorescence slides
7 days
(iii)  Gram stains
2 weeks
(iv)  Ziehl-Neelsen stains
6 weeks
(v)  Other stained slides
2 weeks
10.2
Isolates‡‡‡6
(i)  Clinically significant§§§
5 days
(ii)  Not clinically significant
Discard
10.3
Serum/plasma for infectious disease
serology
(i)  All sera unless specified
4 months
below
(ii)  Antenatal sera
12 months
(iii)  Reactive syphilis sera
12 months
(iv)  Source and recipient sera from  12 months
body fluid exposure (needle-
stick), where this has been
notified to the laboratory
10.4
Urine specimen for microbiological  3 days from date of issue of report, under
examination
refrigeration
10.5
(i) Nucleic acid for diagnostic
1 month from date of issue of report
microbiological examination –

extract or original specimen
(ii) Nucleic acid for screening
1 month from date of issue of report****
examination – extract or original

specimen

‡‡‡ Unless addressed by the Security Sensitive Biological Agent (SSBA) legislation.6
§§§ Clinically significant isolate is considered to be all blood culture and sterile site isolates, plus any cultured
isolate which is reported by the laboratory as a potential pathogen (in contrast to contaminants and commensal
flora).
**** Unless otherwise stated in the Requirements for Laboratories Reporting Tests for the National Cervical
Screening Program (First Edition 2017)
14
Requirements for the Retention of Laboratory Records and Diagnostic Material

Table 11  Minimum retention times for other material
Please refer to Table 1 (General minimum retention times) for both record and material
retention times, unless otherwise specified below in Table 11.

Record/material
Minimum retention times
11.1
Semen for fertility analysis
2-3 days from date of issue of report for
purpose of identification and traceability
noting that repeat testing may not be
technically reliable after 1 day.
11.2
Cell therapy – tissue transplantation  Refer to relevant TGA regulations and
NPAAC Requirements that may be
applicable.
11.3
Flow cytometry on non-
See General 1.6 in Table 1.
haematological samples (e.g. tissue,
cerebrospinal fluid) - graphical
outputs used in diagnosis, such as
gated dot plots and histograms of
other specimens

Requirements for the Retention of Laboratory Records and Diagnostic Material
15

3. Tracking of Referred and Received Specimens
(Refer to Standard 9 in Requirements for Medical Pathology Services)
S3.1  Laboratories must have policies and procedures in place regarding the tracking
of specimens which are referred into or out of the laboratory, for the purposes of
traceability.
S3.2  Laboratories that refer a specimen with prolonged retention requirements to a
second laboratory must document the release and return of the specimen.
C3.2(i)
This requirement relates specifically to stained histological, cytological and
bone marrow slides and/or blocks referred or requested for second opinion
or additional testing.
C3.2(ii)  Laboratories must not retain referred materials with prolonged retention
requirements without the consent of the original/referring pathologist.
C3.2(iii)  Laboratories that receive a referral specimen with prolonged retention
requirements must ensure its safe and prompt return to the original
laboratory at the completion of review or additional testing. This does not
apply to spare slides or recut slides upon which additional testing was
performed, which should normally be retained according to Guidelines
above in the laboratory performing the additional testing.
S3.3  Laboratories performing additional review or testing on any referral specimen
must provide a copy of any report to the original laboratory to ensure continuity
of the medical record.
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Requirements for the Retention of Laboratory Records and Diagnostic Material

4.   Disposal of Specimens and Records
(Refer to Standard 8 in Requirements for Medical Pathology Services)
S4.1  Laboratories must dispose of specimens and patient records in accordance with
relevant state/ territory legislative requirements (refer to Appendix C).
C4.1(i)
Documents with identifying patient details should be shredded or disposed
of in another secure manner.
C4.1(ii)  Any organs retained at autopsy with consent of next-of-kin, should be
disposed of as outlined in the National Code of Ethical Autopsy Practice7
unless otherwise stipulated by the next-of-kin.
S4.2  Laboratories must have a policy to address patient requests for returned
specimens, including instructions for the disposal of specimens (refer to
Appendix A).
Requirements for the Retention of Laboratory Records and Diagnostic Material
17

link to page 26 5. Impact of Amalgamation, Mergers or Change of
Ownership
(Refer to Standard 3 and Standard 4 in Requirements for Medical Pathology
Services)
S5.1   When pathology practices amalgamate or merge, the data from both systems
must be maintained with integrity, and information from both systems must
remain accessible. ††††
S5.2  Retention times for records and diagnostic materials outlined in this document
must be maintained regardless of changes in ownership or governance of the
laboratory.
C5.2
Retention times for records and diagnostic materials must be maintained
regardless of changes in the information technology systems that result
from such changes of ownership or governance.
†††† Standard 4 - Requirements for Medical Pathology Services (Second Edition 2018)
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Requirements for the Retention of Laboratory Records and Diagnostic Material

Appendix A   Returning a Specimen or Body Part to
a Patient (Informative)
(Refer to Standard 1 in Requirements for Medical Pathology Services)
Returning a specimen to a patient or next-of-kin
Although a pathology practice may own the container in which a patient’s specimen is held,
in most jurisdictions it does not legally own the specimen itself. However, the laboratory
must consider its duty of care to the patient before agreeing to release a specimen to the
patient or next-of-kin. This involves confirming the identity of the applicant and assessing the
reason for the applicant’s request for an early release or return of the specimen, and using this
information to judge whether the request is reasonable. The laboratory must be particularly
aware of the possibility of an unauthorised third party trying to obtain access to a patient’s
specimens (e.g. for paternity testing or other litigation). In rare cases, the laboratory may wish
to seek legal advice about an unusual request.
In some jurisdictions (e.g. New South Wales), where the application is made on behalf of an
Indigenous Australian, there is some legal extension of the concept of who can act as the
agent for the patient, or in the case of a deceased person, for the next-of-kin.
If the specimens are returned to the patient, then Retention times are not applicable.
It should be noted that microbiological isolates derived from patient specimens do not fall
under the Human Tissue Act 1983 and are not considered to be the property of the patient.
These guidelines do not relate to the return of a specimen, organ, body part or tissue
specimens removed in the context of coronial/forensic autopsy.
Returning a body part
A ‘body part’ may be a whole organ removed at autopsy or at surgery (e.g. kidney or uterus);
however, at present most requests are for the return of a ‘pre-viable fetus’ for burial or
cremation. A pre-viable fetus is a fetus that is too early in gestation for it to be classified as a
stillbirth for which a special type of cause of death medical certificate must be issued. Such
fetuses, under current definitions of a stillbirth, are of less than 20 weeks gestational age;
however, in practice, determining exact gestational age between ~18 and ~22 weeks is
difficult and generally done on the best available evidence from the features of the fetus and
any clinical information about the pregnancy.
Jurisdictional regulations may constrain ownership of human tissue to prevent trading in
tissues and organs for transplantation. Infectious agents may be transmitted by tissues
(especially if unfixed), so the laboratory must comply with relevant regulations, and must be
satisfied that the applicant will dispose of the fetus, organ or other body part lawfully and in a
way that meets community standards.
The laboratory must maintain appropriate records of the return or disposal to the applicant of
a fetus, organ or other body part, and must obtain a signed receipt from the applicant, which
notes the above undertaking to dispose of the tissue lawfully.
Advice can be sought from the state/territory Public Health Authority.
Requirements for the Retention of Laboratory Records and Diagnostic Material
19

link to page 28 Returning a processed specimen
The general principles outlined above for returning body parts also apply to returning
processed specimens such as histopathology blocks or slides. However, because such
specimens are processed tissues, the ‘ownership’ of the material is less clear. For this reason,
although a laboratory is free to follow the above guidelines relating to a body part, it may
prefer to be less flexible when responding to requests for returning processed specimens for
unspecified purposes.
If the request for returning the material is to obtain a second opinion for a patient’s care, the
laboratory will normally comply. The patient’s interests should be considered paramount, and
permission not unreasonably refused. The laboratory may, however, require that the patient’s
consent be provided in writing, that the specimen is sent directly to the person providing the
second opinion‡‡‡‡8 and that, unless specifically agreed otherwise, all of the material is
returned to the original laboratory after the second opinion has been provided, along with a
copy of the second opinion.
‡‡‡‡ RCPA Policy 2/1999: Provision of second opinions with particular reference to morphological examination
(revised November 2017). 11
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Requirements for the Retention of Laboratory Records and Diagnostic Material

Appendix B  Notice of Information Technology (IT)
Requirements under the Electronic
Transactions Act 1999 for scanning
and storage of referrals and requests
(Normative)
1. Authority
1.1 This Notice is made pursuant to sections 9, 10, 11 and 12 of the Electronic Transactions Act
1999.
2. Scope
2.1 This Notice specifies Medicare Australia’s information technology requirements (Medicare
Australia’s IT requirements) for electronic scanning and storage of certain referrals and
requests1.
3. Date of Effect
3.1 1 October 2009.
4. Replaces
4.1 This Notice replaces the Notice of Information Technology (IT) Standards under the
Electronic Transactions Act 1999 for Electronic and Paper:
Referrals to Consultant Physicians or specialists
Requests and Confirmations of Requests for Pathology Services to Approved Pathology
Practitioners
Requests for Diagnostic Imaging Services
which is repealed with effect from 30 September 2009.
5. Definitions
5.1 A  ‘request’ means any request for diagnostic imaging or pathology Medicare Benefits
Schedule items. Any reference to a ‘request’ for a Medical Pathology Service includes a
confirmation of that request.
1 The term ‘request’ includes ‘combined requests and assignments’.
5.2 A ‘referral’ means any referral for Medicare Benefits Schedule claimable items.
Requirements for the Retention of Laboratory Records and Diagnostic Material
21

6. Scanning of paper referrals or requests for electronic storage
6.1 Clause 6 applies where a referral or request is required to be given to, or can be requested by,
Medicare Australia and an image of a paper referral or request is scanned for electronic
storage.
6.2 The scanning and storage system must ensure that:
(a) the scanned image is unaltered and unalterable from the moment scanning is finished;
(b) the date and time the image was converted to digital form be recorded; and
(c) the image be retrievable in a legible form.
7. Storage of electronically transmitted referrals or requests
7.1 Clause 7 applies where a referral or request is required to be given to, or can be requested by,
Medicare Australia and the referral or request has been electronically transmitted and stored.
7.2 The storage system must ensure that:
(a) the stored electronic transmission is unaltered and unalterable;
(b) the date and time the electronic transmission was received be recorded; and
(c) the stored electronic transmission be retrievable in a legible form.

8. Security and access
8.1 A system that electronically stores referrals or requests, whether scanned or electronically
transmitted, must provide reasonable measures to prevent any loss, improper disclosure or
destruction of the stored information.
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Requirements for the Retention of Laboratory Records and Diagnostic Material

Appendix C  Legislation relating to the retention
and disposal of laboratory records and
diagnostic materials (Informative)
This table is a summary of various relevant legislation that may affect retention requirements.
The references in this table are extensive, but are not intended to be exhaustive. In all cases,
the relevant jurisdictional legislation takes precedence over these Requirements in terms of
mandating retention times different from those specified in these requirements. Readers are
encouraged to review the current regulations available from the Federal Register of
Legislation, noting that the legislation may be subject to amendment from time to time.
Jurisdiction
Legislation and Guidelines
New South Wales
Health Practitioner Regulation (NSW) Regulation 2016
Public Health Regulation 2012
State Records Act 1998
Health Care Records – Documentation and Management (Policy
Directive 2012), Document Number PD2012_069
Human Tissue Act 1983
Queensland
Queensland Health (Pathology Laboratory Records) Retention and
Disposal Schedule 2006
Coroner’s Act 2003
Transplantation and Anatomy Act 1979
Public Records Act 2002
Northern Territory
Northern Territory Governments Record Disposal Schedule, Medical
Pathology Services, Department of Health (2017/8)
Australian Capital
Health Records (Privacy and Access) Act 1997
Territory
Public Health Act 1997
Medical Treatment (Health Directions) Act 2006
Health Act 1933
Victoria
Health Services Act 1988
Public Records Act 1973
South Australia
Freedom of Information Act 1991
South Australian Health Commission Act 1976
State Records Act 1997
Transplantation and Anatomy Act 1983
Tasmania
Anatomy Examinations Act 2006
Health Act 1997
Human Tissue Act 1985
Public Health Act 1997
Western Australia
Patient Information Retention and Disposal Schedule version 4, 2014
State Records Act 2000
Requirements for the Retention of Laboratory Records and Diagnostic Material
23

References
1.  Federal Register of Legislation 2017, Therapeutic Goods (Manufacturing Principles)
Determination No.1 of 2013, Therapeutic Goods Administration, Canberra, viewed 17
January 2018, <https://www.legislation.gov.au/Details/F2017C00967>
2.  Federal Register of Legislation 2013, Therapeutic Goods Order No.88 – Standards
for donor selection, testing and minimizing infectious disease transmission via
therapeutic goods that are human blood and blood components, human tissue and
human cellular therapy products, Therapeutic Goods Administration, Canberra,
viewed 17 January 2018, <https://www.legislation.gov.au/Details/F2013L00854>
3.
Grizzle WE, Bell WC, Sexton KC 2010,  Issues in collecting, processing and storing
human tissues and associated information to support biomedical research, Cancer
Biomark 2010; 9(1-6): 531-549
4.
SAI Global 1997, Australian Standard AS 3864: Medical refrigeration equipment –
For the storage of blood and blood products, Standards Australia, Sydney
5.
Therapeutic Goods Administration 2017, Australian Regulatory Guidelines for
Biologicals (ARGB), Therapeutic Goods Administration, Canberra, viewed 17
January 2018, <https://www.tga.gov.au/publication/australian-regulatory-guidelines-
biologicals-argb>
6.
Department of Health 2016, Security Sensitive Biological Agents, Australian
Government, Canberra, viewed 17 January 2018, <http://www.health.gov.au/ssba>
7.
The Australian Health Ministers' Advisory Council, Subcommittee on Autopsy
Practice 2002, The National Code of Ethical Autopsy Practice, Australian
Government, Adelaide.
8.
Royal College of Pathologists of Australasia 2017, RCPA Policy 2/1999: Provision of
second opinion with particular reference to morphological examination (Revised
November 2017), Royal College of Pathologists of Australasia, Sydney
24
Requirements for the Retention of Laboratory Records and Diagnostic Material

Bibliography
Human Tissue Authority 2014, Code of practice 5 – Disposal of human tissue (Updated July
2014), Human Tissue Authority, London, viewed 17 January 2018,
<http://www4.shu.ac.uk/_assets/pdf/research/ethics/code_of_practice_5_-
_disposal_of_human_tissue.pdf>
The Royal College of Pathologists and the Institute of Biomedical Science (IBMS) 2015, The
Retention and Storage of Pathological Records and Specimens (5th Edition) April 2015, The
Royal College of Pathologists and IBMS, London, viewed 17 January 2018,
<https://www.rcpath.org/resourceLibrary/the-retention-and-storage-of-pathological-records-
and-specimens--5th-edition-.html>
The Royal College of Pathologists of Australasia 2014, Guideline - Provisions of Second
Opinion in Forensic Pathology – Information for Requesting Agent, 6/2014, The Royal
College of Pathologists of Australasia, Sydney, viewed 17 January 2018,
<https://www.rcpa.edu.au/getattachment/42838169-dd28-4b28-a8d3-
2a6684049d43/Provisions-of-Second-Opinions-in-Forensic-Path-(1).aspx>
Requirements for the Retention of Laboratory Records and Diagnostic Material
25

Acknowledgements
Associate Professor Adrienne Morey (Chair)
Associate Professor Bruce Bennetts
Professor Graeme Nimmo
Dr Scott Ragg
Associate Professor Bev Rowbotham
Dr Helen Wordsworth
Members of the National Pathology Accreditation Advisory Council (NPAAC)
Members of the NPAAC Document Review and Liaison Committee
26
Requirements for the Retention of Laboratory Records and Diagnostic Material

Further information
Other NPAAC documents are available from:
NPAAC Secretariat
Phone:
(02) 6289 4017
Diagnostic Imaging and Pathology Branch
Fax:
(02) 6289 4028
Medical Benefits Division
Email:
[email address]
Department of Health
Website: www.health.gov.au/npaac
GPO Box 9848 (MDP 951)
CANBERRA ACT 2601
Requirements for the Retention of Laboratory Records and Diagnostic Material
27

Document Outline