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

Amy S Van Wey Lovatt made this Official Information request to Tairawhiti District Health Board

The request was successful.

From: Amy S Van Wey Lovatt

Dear DHB,

Request 1:
I am writing to request a copy of the your DHB's 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 your DHB's protocol.

Request 2:
Is your DHB protocol for the archiving, storage, or biobanking of human tissue for diagnostic purposes, whether they are formalin fixed, paraffin embedded or pathology slides, based on a universally adopted standard within NZ or has your DHB determined its own policy.

Request 3:
Please explain the potential hazards of leaving formalin fixed, paraffin embedded or pathology slides in an unsecure, non-temperature and non-humidity regulated environment for 2 months over a NZ summer: say a 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.

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

Thank you for your assistance in this matter. Please note, I have made this same request to every DHB in NZ in order to ascertain if there is a universal standard within NZ and also to determine if every DHB is familiar with the hazards associated with mishandling of pathology specimens.

Yours faithfully,

Amy S Van Wey Lovatt

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From: Emily Oakley
Tairawhiti District Health Board


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Kia ora Amy

 

Thank you for contacting Hauora Tairāwhiti. Your Official Information Act
request has been received.

Please note that many key staff involved with the sourcing and preparation
of material for your OIA request are also directly involved with the work
associated with COVID-19.

This may impact our ability to respond to certain OIA requests within
normal timeframes.

 

Ngā mihi

Emily

 

 

 
Emily Oakley
Communications Advisor
Phone: 06 869 0500 ext: 8115
[mobile number]
Address: 421 Ormond Road,
Gisborne, 4010
[1]www.hauoratairawhiti.org.nz
[2]Facebook.com/Hauora
Tairawhiti

 

 

 

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From: Emily Oakley
Tairawhiti District Health Board


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Attachment RESPONSE 12843 Policy re archiving storing and biobanking human tissue.pdf
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Kia ora Amy

 

Please find attached, a response to your OIA request regarding the
archiving, storing, and biobanking of human tissue for diagnostic
purposes.

 

Ngā mihi

 

Emily

 

 
Emily Oakley
Communications Advisor
Phone: 06 869 0500 ext: 8115
[mobile number]
Address: 421 Ormond Road,
Gisborne, 4010
[1]www.hauoratairawhiti.org.nz
[2]Facebook.com/Hauora
Tairawhiti

 

 

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From: Amy S Van Wey Lovatt

Dear Emily Oakley,

Thank you very much for responding to my OIA request. Given that your DHB contracts out their pathology services, I respectfully request that my OIA request be transferred to the appropriate agency, pursuant to section 14 of the OIA.

Yours sincerely,

Amy S Van Wey Lovatt

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From: Amy S Van Wey Lovatt

Dear Emily Oakley,

I have been reviewing the interpretation section of the OIA, which states:
(5) Any information held by an independent contractor engaged by any department or Minister of the Crown or organisation in his capacity as such contractor shall, for the purposes of this Act, be deemed to be held by the department or Minister of the Crown or organisation.

Thus, this means that even if TDHB contracts out their laboratory services, TDHB is still responsible for providing the information. I will be happy to provide another 5 working days to TDHB to provide a response to my OIA request to avoid any complaints to the Ombudsman.

Kindest regards,
Amy S Van Wey Lovatt

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From: Emily Oakley
Tairawhiti District Health Board

Kia ora

I am currently out of office.
If your enquiry is urgent, please contact Toni Lexmond (Communications
Manager) on 021 223 7094. Alternatively, I will respond to your email when
I return.

Ngā mihi
Emily

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From: Emily Oakley
Tairawhiti District Health Board

Good morning Amy

Thank you for your message. We are working on a response to your request which we will aim to provide by Friday 19 June.

Kind regards
Emily

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From: Amy S Van Wey Lovatt

Thank you Ms Oakley.

Yours sincerely,

Amy S Van Wey Lovatt

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From: Amy S Van Wey Lovatt

Thank you Ms Oakley.

Yours sincerely,

Amy S Van Wey Lovatt

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From: Emily Oakley
Tairawhiti District Health Board

Good afternoon Amy,

Just to let you know that we are still in the process of consulting with our independent contractor on this request and we will require an additional couple of working days in order to respond fully.
Please note that we will provide a response no later than Wednesday 24 June.

Kind regards
Emily

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From: Emily Oakley
Tairawhiti District Health Board

Good morning Amy

Please see below, a response to your questions.
To answer these queries, we have obtained information from our contracted agency MedLab Central.

You asked:

1.A copy of the your DHB's 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 your DHB's protocol.

2.Is your DHB protocol for the archiving, storage, or biobanking of human tissue for diagnostic purposes, whether they are formalin fixed, paraffin embedded or pathology slides, based on a universally adopted standard within NZ or has your DHB determined its own policy.

3.Please explain the potential hazards of leaving formalin fixed, paraffin embedded or pathology slides in an unsecure, non-temperature and non-humidity regulated environment for 2 months over a NZ summer: say a 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.

4.Please provide me with the name of the independent agency or agencies which provides oversight for your medical laboratory.

Hauora Tairâwhiti's response:

Hauora Tairâwhiti contracts it’s laboratory services to MedLab Central. The laboratory’s policies around storage of human tissue is based on the National Pathology Accreditation Advisory Council (NPAAC) guidelines. MedLab Central are also required to comply with ISO15189:2012 standards.

Medlab Central’s time of storage for human tissue is 10 years for histology and 14 years for cytology as described below:

• Histology - Slides: 10 years in laboratory and secure location
- Paraffin embedded tissue: 10 years in laboratory and secure location
• Autopsy – blocks and slides: 10 years (except forensic and other medico-legal autopsies)
• Cytology – Non-Gynae samples: 1 week in laboratory
- Slides 14 years in laboratory and secure location
- Gynae – LBC vials 1 month in processing laboratory
- Slides 14 years in laboratory and secure location

Medlab Central’s storage requirements are reflected in section 22 (referring to post-examination processes) of their Quality Manual. Please see the relevant extract below:

Sample Storage (5.7.2)

“Only specimens that are current, ie. are being worked on in present time, may be kept on the workbench. All specimens, when not being worked on, will be stored in an easily retrievable and identifiable manner. Specimens that have been tested will be kept from new specimens awaiting processing. The policy is to keep specimens stored until the work is complete.”

As current specimens only, are kept on the workbench, the issues described in question 3 do not arise.
International Accreditation New Zealand (IANZ) is the accrediting agency used to provide oversight to MedLab Central.

Kind regards
Emily

Emily Oakley | Communications Advisor

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From: Amy S Van Wey Lovatt

Dear Emily Oakley,

Thank you very much Ms Oakley for this information.

Yours sincerely,

Amy S Van Wey Lovatt

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Things to do with this request

Anyone:
Tairawhiti District Health Board only: