Best Practice: Archiving, Storage, Biobanking of Human Tissue for Diagnostic Purposes

Amy S Van Wey Lovatt made this Official Information request to Bay of Plenty District Health Board

The request was successful.

From: Amy S Van Wey Lovatt

Dear Bay of Plenty District Health Board,

Request 1:
I am writing to request a copy of the BPDHB 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 the BPDHB protocol.

Request 2:
Is the BPDHB 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, is a standard which is universally adopted by all NZ DHB's and medical laboratories, or does each DHB or medical laboratory determine their own best practice?

Request 3:
Please explain the potential hazards of leaving formalin fixed, paraffin embedded or pathology slides in an unsecure, non-temperature regulated environment (say a on an employee's desk outside of the laboratory) for 2 months.

Request 4:
Please provide me with the name of the independent agency or agencies which provides oversight for medical laboratories in NZ.

Thank you for your assistance in this matter. Please note, this request is for my information and is not a reflection upon the practices at BPDHB but to ascertain if there is a universal standard within NZ. I will be making this same request to every DHB in NZ.

Kindest regards,

Amy S Van Wey Lovatt (A NZ Citizen)

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From: Debbie Brown
Bay of Plenty District Health Board


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On behalf of Debbie Brown, Senior Advisor, Governance & Quality- BOPDHB

 

We acknowledge receipt of your email and  will respond as soon as
possible.

 

Kind regards.

 

Maria Moller

PA to Senior Advisor Governance & Quality

 

Governance & Quality / CEO Office

Bay of Plenty District Health Board| Tauranga Hospital | Cameron Road |
Private Bag 12024 | Tauranga 3143 

T: 07 579 8545 | E: [1][email address] | W:
[2]www.bopdhb.govt.nz  

[3]CARE email signature 3

Notice of Legal Status and Confidential Information: This electronic mail
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privileged and CONFIDENTIAL. If you are not the intended recipient you are
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of the information is strictly prohibited and may be unlawful. If you have
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destroy the message.

 

 

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From: Maria Moller
Bay of Plenty District Health Board


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Attachment 6.3.9 P1.pdf
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Attachment CPM.S4.6.pdf
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Attachment Information for Patients requesting return of Body Parts or Tissue..pdf
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On behalf of Debbie Brown, Senior Advisor Governance and Quality
 
Dear Amy
 
In response to your request of 11 March 2020, we provide the following
information:

 

1.       I am writing to request a copy of the BPDHB best practice
protocol for the archiving, storage, or bio-banking 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 the BPDHB protocol.

 

Attached Protocols and Information:

a.         Bay of Plenty District Health Board  Body Parts And Tissues –
Standards To Be Met Policy 6.3.9 Protocol 1;

b.         Specimens – Collection And Handling In Operating Theatre
Protocol Cpm.S4.6;

c.          Information for patients requesting return of body parts of
tissue requiring histological examination.

 

References used in these policies include:

    AORN Perioperative Standards and Recommended Practices, edition used
was current March 2018;

    J.C. Alexander, Alexander's Care of the Patient in Surgery, 14th
edition, St Louis, 2010, Mosby Inc. Missouri;

    Report of a Ministerial Inquiry into the Management of Certain
Hazardous Substances in Workplaces, July 2003. Accessed Aug 2010.

 

2.       Is the BPDHB best practice protocol for the archiving, storage,
or bio-banking of human tissue for diagnostic purposes, whether they are
formalin fixed, paraffin embedded or pathology slides, is a standard which
is universally adopted by all NZ DHB's and medical laboratories, or does
each DHB or medical laboratory determine their own best practice?

 

There is a standard for laboratories to meet regarding the handling of
tissue sample.  New Zealand Medical testing laboratories are required to
comply with ISO 15189.2012 standards for clinical testing and the NPAAC
guidelines for the storage and retention of tissue samples for diagnostic
testing. These are international standards.

 

3.       Please explain the potential hazards of leaving formalin fixed,
paraffin embedded or pathology slides in an unsecure, non-temperature
regulated environment (say a on an employee's desk outside of the
laboratory) for 2 months.

 

In terms of tissue integrity Formalin-fixed paraffin-embedded tissue
(FFPET) are quite stable as long as they are not in direct heat above 30
degrees for any length of time. The paraffin melts at high temperature and
is not good for tissue or anyone’s desk.  The provider of BOPDHB’s
laboratory services are required to keep FFPET slides for a minimum of 10
years.

 

4.       Please provide me with the name of the independent agency or
agencies which provides oversight for medical laboratories in NZ.

 

The agency responsible for ensuring compliance for New Zealand entities is
IANZ.

 

Kind regards.

 

Maria Moller

PA to Senior Advisor Governance & Quality

 

Governance & Quality / CEO Office

Bay of Plenty District Health Board| Tauranga Hospital | Cameron Road |
Private Bag 12024 | Tauranga 3143 

T: 07 579 8545 | E: [1][email address] | W:
[2]www.bopdhb.govt.nz  

[3]CARE email signature 3

Notice of Legal Status and Confidential Information: This electronic mail
message and any accompanying attachments may contain information that is
privileged and CONFIDENTIAL. If you are not the intended recipient you are
advised that any use, review, dissemination, distribution or reproduction
of the information is strictly prohibited and may be unlawful. If you have
received this document in error, please notify the sender immediately and
destroy the message.

 

 

From: Maria Moller On Behalf Of Debbie Brown
Sent: Wednesday, 11 March 2020 3:12 PM
To: '[FOI #12428 email]'
Subject: Official Information request - Best Practice: Archiving, Storage,
Biobanking of Human Tissue for Diagnostic Purposes

 

On behalf of Debbie Brown, Senior Advisor, Governance & Quality- BOPDHB

 

We acknowledge receipt of your email and  will respond as soon as
possible.

 

Kind regards.

 

Maria Moller

PA to Senior Advisor Governance & Quality

 

Governance & Quality / CEO Office

Bay of Plenty District Health Board| Tauranga Hospital | Cameron Road |
Private Bag 12024 | Tauranga 3143 

T: 07 579 8545 | E: [4][email address] | W:
[5]www.bopdhb.govt.nz  

[6]CARE email signature 3

Notice of Legal Status and Confidential Information: This electronic mail
message and any accompanying attachments may contain information that is
privileged and CONFIDENTIAL. If you are not the intended recipient you are
advised that any use, review, dissemination, distribution or reproduction
of the information is strictly prohibited and may be unlawful. If you have
received this document in error, please notify the sender immediately and
destroy the message.

 

 

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From: Amy S Van Wey Lovatt

Dear Maria Moller,

Thank you very much for the considered and thorough response to my OIA. I can imagine that formalin or paraffin fixed tissue, left out over the summer on someone's desk (where there is no temperature control) would not be good for either the tissue or the desk.

Excellent! Thank you so much for willingly (and so excellently) adhering to principles of transparency as envisioned in the OIA.

Yours sincerely,

Amy S Van Wey Lovatt

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Things to do with this request

Anyone:
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