9 September 2019
Belinda Hodson
[FYI request #10839 email] Dear Ms Hodson
Official Information Act Request
Thank you for your request for information of 30 July 2019 for:
1. Changes/Updates to Reference Ranges for all Thyroid tests (TSH, Free T3,
RT3, thyroid anti-body etc.) recommended by Pathlab and approved by the
Waikato DHB for implementation by Pathlab; and implemented by Pathlab,
during the period 1st January 2010 to 20 July 2018; along with:
a) the rationale for these updates/changes and the citation list of the clinical
publications supporting these changes/updates (clinical research studies
and other clinical papers including guidelines referenced); plus
b) the associated ‘clinical updates’ for these changes/updates that have
been posted in the clinicians information area of Pathlab's website.
c) Copies of reports of these updates/changes provided to the Waikato
District Health Board by Pathlab or produced by the Waikato District
Health Board which monitors the impact of these updates/changes on
patient's health and well-being.
2. For the period 1 January 2010 to 20 July 2019 copies of all correspondence
associated with Waikato DHB and Pathlab approved updates./changes to
thyroid taking policy (the thyroid tests themselves and reference ranges )
with other NZ medical lab companies, the Royal Australasian College of
Physicians and the Ministry of Health.
I enclose the following information covered by your request.
1. Changes/Updates to Reference Ranges for all Thyroid tests (TSH, Free T3,
RT3, thyroid anti-body etc.) recommended by Pathlab and approved by the
Waikato DHB for implementation by Pathlab; and implemented by Pathlab,
during the period 1st January 2010 to 20 July 2018
Answer
Pathlab has been asked to provide this information which is attached. We can
confirm that the Waikato DHB Clinical Laboratory Group reviews and
approves all recommendation for any changes to tests. This group is clinically
led and has both hospital and Pathlab pathologists, secondary clinicians and
general practitioners as members they ensure that the best clinical care is not
impacted by any change to tests.
a) The rationale for these updates /changes and the citation list of the clinical
guidelines supporting these changes, clinical research studies and other
clinical papers including reference guidelines);
Answer
The rationale is summarised in the Pathlab response. See below for
information provided
b) The associated “clinical updates “ for these changes /updates that have been
posted in the clinicians information area of Pathlab website ; plus;
All relevant clinical updates are attached
c) Copies of reports of these updates provided to the Waikato DHB by Pathlab
or produced by the Waikato DHB which monitors the impact of these updates
/changes on patients health and well-being
Answer
All copies of clinical of updates are provided to Waikato DHB. Waikato DHB is
unaware of whether any monitoring has been undertaken of these updates/
changes on patient’s health or wellbeing. We have received no concerns
expressed directly from general practitioners or secondary clinicians on any
impacts on patient’s health.
2. For the period 1 January 2010 to 20 July 2019 copies of all correspondence
associated with Waikato DHB and Pathlab approved updates./changes to
thyroid taking policy (the thyroid tests themselves and reference ranges )
with other NZ medical lab companies, the Royal Australasian College of
Physicians and the Ministry of Health.
Answer
Thyroid Testing
A letter was received from TANZi (Thyroid Association of New Zealand)
regarding their objection to the restriction of thyroid testing recently approved
by the CLCGG citing negative impacts on patients in the Waikato and Bay of
Plenty. They alleged that Pathlab’s current policy on thyroid testing is based
on clinical evidence that is outdated and inaccurate and that they have an
over-reliance on TSH testing and an under-reliance on other thyroid blood
tests to accurately measure thyroid function and suggested that there was a
misunderstanding of the importance of these tests, particularly the Free T3
test. They submitted scientific articles in support of their position.
The hospital chemical pathologist advised the group that we are following
BPAC Guidelines. He reviewed all evidence submitted by TANZi and remains
unconvinced.
GPs used to order T3, T4, TSH – for unknown reasons, there is interference
between the tests and the follow-ups are extremely expensive and convoluted
with no outcome i.e. they are causing patients harm.
Pathlab Business Manager indicated that if Pathlab gets a request for a T3
test, a message goes back to the GP that if he/she really wants it done,
please phone. If it is not clinically indicated the patient has the option of
paying. One GP expressed concerns to Pathlab.
Attachments
19 March 2012: the Variation to Schedule Purchase Test is attached
4 December 2012: The PHO Performance Report on TSH tests is
attached
19 May 2017: Letters between TANZI, and the chemical pathologist
and Memorandum are attached
7 December 2017: Managing Demand for Tests. Investigating Thyroid
Function (pbac) previously available prior to 2010 was on the Agenda
for Community Laboratory Services Clinical Governance Group – the
relevant minute from that meeting is written in full below with the
only change being people’s names replaced by their actual roles to
protect privacy.
20 July 2019: Email request for information related to this OIA sent to
Pathlab
Information withheld
Some of the information you have requested has been withheld under Section
18(d) of the Official Information Act 1982 because the information requested is, or will
soon be, publicly available.
You have the right to request the Ombudsman investigate and review the decision to
withhold the information. The Ombudsman’s postal address is:
The Ombudsman
Office of the Ombudsmen
P O Box 10-152
WELLINGTON
Yours sincerely
Philip Grady
Interim Executive Director Strategy, Funding and Public Health