Problems with laboratory test results - how to complain

[helvella]

In the past few weeks we have had several posts which have suggested that some laboratory test results have been inconsistent.

Some have suggested two laboratories are inconsistent with each other.

Others have suggested that one laboratory is inconsistent with itself. (Obviously, if it is inconsistent with itself, it would also be inconsistent with other laboratories.)

All UK testing laboratories must be registered with UKAS.

If a laboratory fails to meet the requirements of UKAS, their accreditation may be withdrawn. That would cause the laboratory to close down, at least temporarily.

UKAS, of course, has a complaints process. I hope that members who have had laboratory issues will consider putting in complaints. The page added below is where they describe the complaints processes.

Remember, you do not have to have proof. You simply need to have enough evidence for there to be reasonable suspicion of issues.

UKAS welcomes feedback from its customers, stakeholders and the end users of accredited services. If you have any suggestions as to how UKAS might improve its services, please get in touch.

Complaints

UKAS recognises that on occasion it may be necessary for our customers, or those using accredited services, to raise a complaint with us and the following details the process to be followed.

Consumers and users of accredited services

If you are complaining about a UKAS accredited body, please ensure you have complained to them first, and that you have allowed them the opportunity to investigate and respond before escalating your complaint to UKAS.

Information on raising a complaint about an accredited body can be found here. Please read this information prior to submitting your complaint.

Note: financial disputes, matters of contract and/or claims for monies/refunds fall outside the remit of UKAS to investigate.

UKAS accredited bodies

If you are a UKAS customer and wish to make a complaint please, we would encourage you in the first instance to discuss your concerns with your Assessment Manager, as it may be possible to resolve any concerns you have via that route. However, if this does not resolve the matter you can submit a complaint. Any complaint must be submitted in writing, and we ask that it includes copies of relevant communications where applicable.

Complaints will be logged and acknowledged within 5 working days of receipt and an investigating officer appointed to review and respond to the complaint. The investigating officer will normally be an individual who has not been involved directly in the activities to which the complaint relates.

Timescales for completing the investigation will be communicated via the acknowledgement as these may vary dependent on the extent, complexity and severity of the issues detailed in the complaint. We do, however, aim to resolve most complaints within 1 working month of receipt.

Submitting a complaint

Please submit your complaint in writing to [e-mail].

Or

FAO Process Improvement & Feedback Manager

UKAS

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[N3ess]

I observed on a german web forum that some TsH values seemed to be falsely elevated. Guessed that there is something wrong with some TsH assays.

[helvella Administrator Thyroid UK in reply to N3ess]

There are some well-known possible causes.

If the person has antibodies to TSH, they form macro-TSH (where an antibody attaches to a molecule of TSH). Macro-TSH looks like a greater quantity of TSH to at least some tests. (Some tests are immune to this issue.)

[N3ess in reply to helvella]

I know the macro-TsH thing. But it is seldom. And there were / are some (more) labs with increased free T4 (due to dosage increasement) and increased TsH. Is it the same pattern here?

[helvella Administrator Thyroid UK in reply to N3ess]

The fundamental problem is that there has been insufficient worldwide progress towards harmonisation of thyroid-related blood tests.

We should be seeing the same reference intervals being used by all labs. And be sure that the same sample, sent to multiple labs, will return the same result.

But we regularly see widely divergent results.

[N3ess]

The progress is insufficient but it is progressing. But did you see uncommon elevated TsH values, too? I‘m just wondering about some labs in our german forum. Perhaps it is a side effect of the TsH harmonization progress? (That some assays have changed there callibration process? I‘m just an interested amateur on these questions, but something looks strange at the moment.)

[helvella Administrator Thyroid UK in reply to N3ess]

Afraid the website that was set up for the UK harmonisation appears not to have had any updates for over ten years. Indeed, worse than that, the actual website has been abandoned, and the sole document is now on the ACB site.

acb.org.uk/static/eea82309-...

I suspect they didn't have funds, and the cost of harmonisation was too great. (Of course, the cost of NOT harmonising is far greater. But is an accounting externality, so doesn't get counted.)

[Puddleperson]

I've just done two finger prick blood samples, one Medichecks for iron panel test and one Blue Horizon thyroid Gold. I did them both at the same time and sent them off at the same time to the same lab. Medichecks found the sample to be damaged but was still able to measure some elements. Their measurement of CRP was 2.88 whilst the BH sample, apparently undamaged, measured 3.06. I guess that's not a huge discrepancy but I still wonder why? It was the same finger just minutes apart...