Provider Healthcare Services
North Shore Hospital Campus
Shakespeare Road, Takapuna
Private Bag 93-503, Takapuna
Auckland 0740
Telephone: 09 489 0527
Facsimile: 09 486 8339
19 May 2020
Amy S Van Wey Lovatt
[FYI request #12531 email]
Dear Ms Van Wey Lovatt
Re: OIA request – Human tissue for diagnostic purposes
Thank you for your Official Information Act request received 23 March 2020 seeking a copy of
Waitematā DHB’s best practice protocol for the archiving, storage or biobanking of human tissue for
diagnostic purposes and other information about retention of tissue samples.
You requested the fol owing information:
I am writing to request a copy of your best practice protocol for the archiving, storage or
biobanking of human tissue for diagnostic purposes, whether they are formalin-fixed, paraffin-
embedded or pathology slides and the standards, legislation or scientific evidence which provides
the basis for our protocol.
Waitematā DHB’s Surgical Pathology department is IANZ accredited and follows the National
Pathology Accreditation Advisory Council (NPAAC) standards which state that blocks and slides must
be kept for a minimum of 10 years with the exception of paediatric samples, which must be kept for
25 years. Paediatric samples are managed by Auckland DHB.
Tissue banking samples are kept indefinitely with the consent of the patient (at time of surgery).
Patient specimens reported by the Surgical Pathology department are formalin-fixed, paraffin-
embedded tissue samples and cover filmed pathology slides.
Please see
Attachment 1 - Retention of laboratory records and samples policy.
Is your DHB protocol-based on a universal y adopted standard within New Zealand or has your
DHB determined its own policy?
Waitematā DHB’s policy aligns with the NPAAC standards, ‘Requirements for the retention of
laboratory records and diagnostic material (seventh edition 2018)’.
Explain the potential hazards of leaving formalin-fixed, paraffin-embedded or pathology slides in
an unsecure, non-temperature and non-humidity regulated environment for two months over a
New Zealand summer: say on an employee’s desk which is open to the public and in a repurposed
house adjacent to the hospital from mid-December to late February.
The surgical pathology department at Waitematā DHB is a secure facility which is accessible only via
electronic swipe card. The laboratory, pathologist offices and archival areas are not accessible to the
public at any time. The department operates according to the Privacy Act 1993 and local Waitematā
DHB policies to safeguard against loss, misuse, or disclosure of personal and health information.
On production of theare formalin-fixed, paraffin-embedded (FFPE) block, a pathology slide is
generated. The slide is transported from the laboratory to the pathologist office for microscopic
examination. These slides remain with the pathologist for the duration of the examination and often
for a period of time after the report has been released.
Understandably, complex cases can often require a long period of evaluation; and may be subjected
to ancillary testing and referrals to expert external consultants. Slides may also be retained for an
extended period by the pathologist in instances where the case is to be discussed at a
multidisciplinary meeting.
In the majority of cases, the blocks will remain in the laboratory area. However, there may be times
when pathologists also request the blocks to accompany the slides to external sites for further
opinion or as a result of a third party request. There is no adverse effect on the FFPE block if this
request is made.
On conclusion of the case, the slides and blocks are returned to the laboratory where they are
archived accordingly.
Both FFPE blocks and mounted slides are stored at ambient temperatures in a secure archival room.
There are no specific temperature requirements for the storage of such materials.
Provide the name of the independent agency or agencies which provides oversight for your
medical laboratory.
Waitematā DHB’s laboratory is IANZ (International Accreditation of New Zealand) accredited. All
laboratory staff members are governed by the New Zealand Medical Sciences Board and the
pathologists are all Fellows of the Royal College of Pathologists of Australasia (RCPA).
I trust that this information is helpful.
Waitematā DHB supports the open disclosure of information to assist community understanding of
how we are delivering publicly funded healthcare. This includes the proactive publication of
anonymised Official Information Act responses on our website from 10 working days after they have
been released.
If you consider there are good reasons why this response should not be made publicly available, we
wil be happy to consider your views.
Yours sincerely
Dr Debbie Holdsworth
Acting Director Hospital Services
Waitematā District Health Board
2
Attachment 1
SPU QM, Retention of laboratory records and samples 9808S
Supersedes 26 April 2018
Issued 08 April 2020
Retention of laboratory records and samples
The department is electronically secured with access available to authorised personnel only.
All records are secure, identifiable, and legible and stored in readily retrievable form. Electronic records may be stored in place of
hard copies.
All records containing patient information requiring disposal are to be placed in confidential rubbish.
Retention Times are based on the NPAAC 2018 Guidelines, and local policy.
Reference
General
Minimum Retention
Storage
Disposal
Time
NPAAC 2.1.2
Assessments
4 years
Quality Manager, Medialab,
Destroy
Systems, compliance,
IANZ
environment, quality
Both internal and external
NPAAC 2.1.2
Quality
4 years
Quality Manager, Medialab,
Destroy
MRM minutes, meeting
IANZ
minutes
Quality Improvement projects
Incident reports
NPAAC 2.1.4
Operating Procedures
Retain historical
Medialab,
versions
Network Folder
EQA assessment records
4 years
Quality Manager,
Destroy
Medialab
Local SPU Policy
Complaints and Actions
15 years
Unit Manager Office
Destroy
NPAAC 2.1.1
Personnel Records
Employment + 4 years
Personnel Files
Destroy
NPAAC 2.1.3
Equipment Maintenance
Life span of equipment
Network Equipment Folder
Archive
Records
+ 4 years
Local SPU Policy
Accession Log Books
Indefinite
Cut Up, Cytology
Local SPU Policy
Laboratory Workbooks
4 years
Cut Up
Page
1 of
3
Authority to Issue SPU Quality Manager
SPU QM, Retention of laboratory records and samples 9808S
Supersedes 26 April 2018
Issued 08 April 2020
Retention of laboratory records and samples
Reference
Specimen and Patient
Minimum Retention
Storage
Disposal
material
Time
NPAAC 2.1.5
Laboratory Request Forms
4 years
SPU Records Room
Destroy
NPAAC 2.2.3
and digital images of
specimens
NPAAC 2.2.1
Reports, copy of original,
10 years
1984-95; SPU Records Room
Local SPU Policy
or ability to reprint an
7 years from the age
1995-1999 APS
original report
of majority for minors
27 10 1999-Present DAP
NPAAC 2.2.4
Paraffin blocks
10 years
Retained indefinitely
Local SPU Policy
7 years from the age
of majority for minors
NSH blocks1984-2017; Crown
Storage
2017-Present;
SPU Storage Room
Medlab blocks 1995-1999; APS
NPAAC 2.2.2
Histology Slides; sections
10 years
Slides prior to 2002; Destroyed
Discard
of fixed tissue preserved in
2003-2017; Crown Storage
mounting medium
2018-Present; SPU Storage
Rooms
NPAAC 2.2.5
Frozen Section Slides
10 years
Slides prior to 2002; Destroyed
Frozen section blocks
2003-2017; Crown Storage
processed to paraffin
2018-Present; SPU Storage
Residual tissue processed
Rooms
to paraffin
Blocks retained indefinitely
Page
2 of
3
Authority to Issue SPU Quality Manager
SPU QM, Retention of laboratory records and samples 9808S
Supersedes 26 April 2018
Issued 08 April 2020
Retention of laboratory records and samples
Reference
Specimen and Patient
Minimum Retention
Storage
Disposal
material
Time
NPAAC 2.2.7
Wet Specimens
1 month from date of
Stored for 8 weeks post reporting
Discard
issue of report
in specimen filing room
Wet specimens may be retained
for a longer time period at the
request of the reporting pathologist
depending on complexity and
reporting TAT.
NPAAC 2.2.7
Containers with no
1 month from date of
Stored for 4 weeks in dated bags
Discard
residual tissues
issue of report
NPAAC 2.2.2
Cytology Slides
10 years
1999-2009; Crown Storage
2010-Present; SPU storage room
NPAAC 2.1.7
Cytology Specimens
7 days from receipt or
Discard
2 days after final
Prep Room for 7 days
report (whichever is
longest)
Reference
Bio-banking
Retention Time
Storage
ARB
Samples of specimens
Indefinitely at -80oC
Retained indefinitely at the WDHB
MOH Guidelines for the
that have been consented
Bio bank space permitting before
use of Human Tissue for
for bio banking
transfer to
future unspecified
ARB Auckland Regional Bio bank
research purposes 2007
at Auckland University
Page
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3
Authority to Issue SPU Quality Manager