Accreditation documentation for medical laboratories

Amy S Van Wey Lovatt made this Official Information request to International Accreditation New Zealand

Response to this request is long overdue. By law International Accreditation New Zealand should have responded by now (details and exceptions). You can complain to the Ombudsman.

From: Amy S Van Wey Lovatt

Dear International Accreditation New Zealand,

According to the IANZ Chairman, IANZ is New Zealand’s national authority for the accreditation of laboratories, inspection bodies, and radiology practices. It accredits laboratories in all sectors, including medical testing…

I respectfully request the following documents:

(1) a complete list of all standards and copies of the standards that medical testing laboratories, in which excised human tissue is tested for diagnostic purposes, must comply with in order to become accredited by IANZ; and

(2) the checklist used by IANZ to ensure that all required documents have been submitted by a medical testing laboratory, in which excised human tissue is tested for diagnostic purposes, for accreditation by IANZ; and

(3) all documents submitted by Waikato DHB’s anatomical pathology laboratory (including, cytology, histology, microbiology and haematology) that demonstrate Waikato DHB’s medical laboratory had met the required standards for accreditation by IANZ.

Thank you for your assistance in this matter.

Kindest regards,

Amy S Van Wey Lovatt

Link to this

From: Phillip Barnes
International Accreditation New Zealand


Attachment image001.png
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Attachment AS LAB C7.2 Requirements for Minimising Errors in Medical Histology Laboratories.pdf
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Attachment AS LAB C7 Specific Criteria Medical Testing.pdf
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For the attention of Amy S Van Wey Lovatt

 

Dear Amy

 

Your request of the 28 January 2020 was as follows:

 

I respectfully request the following documents:

 

(1)          a complete list of all standards and copies of the standards
that medical testing laboratories, in which excised human tissue is tested
for diagnostic purposes, must comply with in order to become accredited by
IANZ; and

 

(2)          the checklist used by IANZ to ensure that all required
documents have been submitted by a medical testing laboratory, in which
excised human tissue is tested for diagnostic purposes, for accreditation
by IANZ; and

 

(3)          all documents submitted by Waikato DHB’s anatomical pathology
laboratory (including, cytology, histology, microbiology and haematology)
that demonstrate Waikato DHB’s medical laboratory had met the required
standards for accreditation by IANZ.

 

Thank you for your assistance in this matter.

 

Kindest regards,

 

Amy S Van Wey Lovatt

 

In response:

 

1.       We use an international standard – ISO 15189 and are forbidden by
copyright law from providing you with a copy of this standard – you may
obtain a copy from Standards New Zealand or ISO directly.  I have attached
the IANZ Specific Criteria for Medical Testing (which contains a
bibliography of other standards we may reference) and another IANZ
document - Requirements for Minimising Errors in Histology Laboratories.

 

2.       The primary checklist we use is based on the standard ISO 15189
and in many places contains verbatim lists of clauses from the standard. 
I am concerned at potential breaches of copyright in releasing this
information and am therefore not able to provide you with a copy. 
Completed checklists and notes from a laboratory assessment would breach
our commercial confidentiality agreement with clients as per 3. Below.

 

3.       We sign a confidentiality agreement with all client laboratories
and this prevents us from releasing the information you have requested. 
You should request this directly from the laboratories in question. 
Evidence of a laboratory’s accreditation status can be obtained from the
IANZ website.

 

 

Kind regards

 

Phil Barnes

General Manager – Accreditation Services

 

International Accreditation New Zealand

Private Bag 28908, Remuera, Auckland 1541

Level 1, 626 Great South Road

Ellerslie, Auckland 1051

New Zealand

[1][email address]

Direct Dial: (09) 580 6770

Mobile: (0278) 078 539

 

[2]cid:image001.png@01D00D55.6876ECF0

[3]http://www.ianz.govt.nz/

 

 

References

Visible links
1. mailto:[email address]
3. http://www.ianz.govt.nz/

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From: Amy S Van Wey Lovatt

Dear Phillip Barnes,

Thank you very much for your response to my request. In my request that I submitted, I requested the
"the checklist used by IANZ to ensure that all required documents have been submitted by a medical testing laboratory, in which excised human tissue is tested for diagnostic purposes, for accreditation by IANZ". I note that this has not been included in the information that you have provided.

Request 1:
Thus, I request again this aforementioned information, which is consistent with section 3.3 of the IANZ Impartiality Policy which states all accreditation bodies "Conform in full with the requirements of ISO/IEC 17011 Conformity assessment – Requirements for accreditation bodies accrediting conformity assessment bodies".

In your response to my request for a checklist, you mentioned being concerned that providing the IANZ checklist would be a breach of copyright laws. I fail to see how such a checklist would be a breach of copyright laws.

Request 2:
Please provide the legal basis for why the requested check-list would be a breach of copyright laws.

I note that IANZ has published the NZS/ISO 15189:2007 policy for Radiologists online [http://www.ianz.govt.nz/wp-content/uploa... and used to provide the Medical Laboratory equivalent to laboratories for free (according to the IANZ website).

Request 3:
I respectfully request a copy of the NZS/ISO 15189:2007 policy for Laboratories which is not the current standard and should be no more a breach of copyright than IANZ's online publication of NZS/ISO 15189:2007 policy for Radiologists.

I am quite confused and concerned about the "confidentiality agreement" you have mentioned in regards to submissions for accreditation through IANZ. According to the IANZ website, "An organisation that holds IANZ accreditation can have confidence in its processes and thereby provide assurance to its customers and clients."

According to section 1 of the IANZ Impartiality Policy [https://www.ianz.govt.nz/about/about-ian... "Accreditation is a third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks. In order for IANZ to maintain its third-party status as an accreditation body it needs to undertake its accreditation activities in an impartial and objective manner - to be independent; free from conflicts of interest, bias & prejudice; neutral, fair, balanced and even handed in all its accreditation activities."

The “reasonable suspicion” test has become the standard in many common law jurisdictions, including New Zealand, for apparent bias. The decisions by the Court of Appeal in Muir and Saxmere established the precedent that the test for apparent bias be what the “fair minded observer” would conclude, given the facts, or the public perception of impartial administration of justice. IANZ's refusal to be transparent with the accreditation process, as well as be transparent in the documents which have been used to demonstrate that a laboratory had indeed met the accreditation standards, appears to be consistent with NZ case law definition of "apparent bias" and thus inconsistent with the IANZ Impartiality policy.

Request 4:
I respectfully request (i) a copy of the non-disclosure agreement you had mentioned, (ii) the specific legislative instrument and section which permits non-compliance with my OIA request for the checklist used by IANZ to ensure a laboratory has met the accreditation process in a manner that is unbiased, fair and balanced (per the IANZ Impartiality Policy), (iii) the name, section number, and quotation from the ISO standard on which the non-disclosure agreement is based, and (iv) the specific legislative instrument and section which permits non-compliance with my OIA request for the documents from Waikato DHB which were used to demonstrate their compliance with IANZ standards and thus accreditation of their laboratory.

Request 5:
As an alternative to part (iv) of Request 4, I request the documents submitted to IANZ by Waikato DHB demonstrating that the DHB has met the IANZ accreditation standards.

Thank you very much for your assistance in providing the requested information. I look forward to receiving the information in a timely manner.

Kind regards,

Amy S Van Wey Lovatt

Link to this

From: Phillip Barnes
International Accreditation New Zealand

Dear Amy

Please accept our apologies for the delayed response to your request. All of our staff have been working from home since the COVID-19 Level 4 alert was issued and this is constraining our normal business processes. Our organisation is also heavily involved in assisting the national response to the crisis.

I will respond to your queries as time allows and as I can access documentation in the next few weeks. I can say that we have withheld information from other similar OIA requests citing Section 9 (2) ba of The Act (our lawyers may have cited other sub-sections as well but I do not have ready access to all files at present) and that the Ombudsman has upheld our claim for exemption on those previous occasions.

However, I will do my best to supply as much of the information that I can, as soon as I can.

Thank you for your patience in these difficult times.

Kind regards

Phil Barnes
Acting CEO & General Manager – Accreditation Services

International Accreditation New Zealand
Private Bag 28908, Remuera, Auckland 1541
Level 1, 626 Great South Road
Ellerslie, Auckland 1051
New Zealand
[email address]
Direct Dial: (09) 580 6770
Mobile: (0278) 078 539

http://www.ianz.govt.nz/

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From: Amy S Van Wey Lovatt

Dear Phillip Barnes,

This a gentle reminder that I still have not received the information I initially requested on 27 January 2020, 30 days before the first documented NZ COVID-19 case.

I would like to draw your attention to IANZ document titled: Specific criteria for accreditation Medical Testing 7. The first paragraph of the introduction (section 1) states:
"Specific Criteria either provide detail or extra information to the generally stated requirements of the IANZ General Criteria for Accreditation, which remains the governing document. A list of all published Specific Criteria is available on www.ianz.govt.nz/publications or from IANZ on request."

The first two paragraphs of section 2 (Scope) states:
"This document sets out the specific requirements a medical testing laboratory has to meet, in addition to the general requirements of NZS/ISO 15189, if it is to be accredited by IANZ. The principles embodied within these criteria should be applied equally, where relevant, to all types of medical testing laboratories. In addition to this document, there are other criteria documents applicable to medical testing laboratories working in specialised areas of testing, which have their own set of unique criteria."

I have requested the complete specific criteria (e.g., specific policies, documentation, etc) IANZ requires for the accreditation of medical laboratories.

I still request ALL accreditation documents submitted by Waikato DHB. If IANZ has consulted with the Ombudsman regarding my request, and the Ombudsman agrees that IANZ may not provide the requested information, then I request that you transfer my OIA to Waikato DHB, pursuant to section 14 of the OIA.

According to NZ/ISO 15189, clause 4.2.3 stipulates that the laboratory policies include “the laboratory’s commitment to good professional practice…” Clause 4.5.1 states: “The laboratory shall have an effective documented procedure for evaluating and selecting referral laboratories as well as consultants who are to provide second opinions for histopathology, cytology and related disciplines.” Clause 5.1.4 stipulates that the laboratory director is responsible for setting policy and ensuring that the staff are appropriately educated , that there is a “safe laboratory environment in compliance with good practice and applicable regulations” and is required to “address any complaint, request or suggestion from users of laboratory services”.

I note that Waikato DHB has stated in a recent OIA request that they do not have a policy for requests by third party providers for second opinions on pathology specimens. This response can be found here: https://fyi.org.nz/request/12399/respons...

The Royal College of Pathologists of Australasia is the body which sets the professional standards for pathologists, and they have a specific policy regarding such requests: Provision of second opinions with particular reference to morphological examination.

Request:
If Waikato DHB does not have a policy which is consistent with the professional standards, and has not adopted the RCPA professional standards as their policy, then is Waikato DHB compliant with the ISO standards? How have the met the requirements set out in 4.5.1, 4.2.3 and 5.1.4? [Please note that the response did not come from the laboratory director or an employee within the lab, which also seems to be inconsistent with clause 5.1.4.]

I trust that there will no longer be a delay in the release of the requested information and that this information will be provided within the next 5 working days.

Yours sincerely,

Amy S Van Wey Lovatt

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From: Phillip Barnes
International Accreditation New Zealand

Dear Amy

I have transferred your OIA request to Waikato DHB as per the email copied to you earlier.

All of the relevant IANZ published criteria are available from our web site. As an international accreditation body we reserve the right to invoke any national and international standards/guidelines/technical notes/regulations/draft documents that we deem to be relevant and/or useful for any particular assessment. Any such documents cited in any particular assessment should be listed, if relevant, in the report of that assessment. It is not reasonable, practical or even possible to send you copies of all potential sources of information which may be used in assessments.

Kind regards

Phil Barnes
Interim CEO & General Manager

International Accreditation New Zealand
Private Bag 28908, Remuera, Auckland 1541
Level 1, 626 Great South Road
Ellerslie, Auckland 1051
New Zealand
[email address]
Direct Dial: (09) 580 6770
Mobile: (0278) 078 539

http://www.ianz.govt.nz/

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From: Amy S Van Wey Lovatt

Dear Phillip Barnes,

Thank you for your response. I hereby request a copy of the assessment for Waikato DHB's accreditation.

Yours sincerely,

Amy S Van Wey Lovatt

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Things to do with this request

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