THE B12 BETRAYAL
How PATHOLOGY LABORATORIES are
allowing ERRORS IN PATHOLOGY, ARROGANCE, APATHY AND GREED to cause
MISDIAGNOSIS OF VITAMIN B12 DEFICIENCY
Vitamin B12 Deficiency Information
Vitamin B12 References and Links
Site, Personal and Contact Information
The B12 Investigation
Evidence
Right of Reply
Deceptive B12 Deficiency Tests
Pathology Laboratory Errors
Arrogance, Apathy and Greed
PATHOLOGY LABORATORY ERRORS
The B12 Betrayal Home
Introduction
The Pathology Betrayal Home
Introduction
Pathology Laboratory Errors
Series 1 to 3
2005 - 2007
Sullivan Nicolaides Pathology
Interpretation Errors
Erroneous Normal Levels
Immunoassays
Interferences

Index

This page contains the following sections:

You can go to a section by selecting the link.

Summary of Investigation

Can you trust your pathology lab results?

Errors in pathology can cause the misdiagnosis of disease, with the potential for unnecessary harm and suffering to thousands of Australian patients. This part of my web site is dedicated to exposing these errors in pathology.

I investigated the misdiagnosis of vitamin B12 deficiency, caused by errors in pathology.

My investigation found the following very serious pathology errors:

  • labs did not recommend the right tests
  • interpretation information was incorrect
  • results were not accurate

The errors were so significant that they have the potential to very seriously affect interpretation of the vitamin B12 status, leading to misdiagnosis.

What started as an investigation of my disease, became an investigation into the pathology laboratories.

In addition to discovering the pathology errors, what I encountered included:

  • "loss" of many blood samples; one lab "lost" 29 samples
  • deliberate destruction of blood samples, preventing further testing by other labs
  • refusal to release results because of fear of publication
  • denial of any fault by labs, and threat of legal action if I publish my findings

Everything on this page is covered in detail elsewhere on this site.

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Summary of Pathology Errors

These are my findings about pathology tests for vitamin B12:

  • labs did not recommend the right tests
  • interpretation information was incorrect
  • results were not accurate

Labs did not recommend the right tests

The labs recommend serum B12 only. According to findings of expert researchers, serum B12 is NOT a sensitive indicator of vitamin B12 deficiency.

According to the experts, the labs should recommend the following tests for metabolic markers of cellular deficiency:

  • methylmalonic acid
  • total homocysteine

The labs also fail to offer the new test for active B12, holotranscobalamin; see References BH1 to BH26.

Interpretation information was incorrect

Many of the labs cite incorrect interpretation information in their pathology reports, including:

  • very significantly low "normal" level for vitamin B12, of 100 pmol/L; experts recommend 200 pmol/L cutoff in absence of symptoms, or 295 pmol/L in presence of neurological symptoms
  • very significantly high cut-off for methylmalonic acid of 1.0 umol/L; experts recommend cut-offs of 0.35 to 0.45 umol/L.
  • very significantly high "normal" level for total homocysteine, of 15 umol/L or 20 umol/L; experts recommend 12.0 umol/L or lower

These errors in "normal" levels or cut-offs have the potential to very seriously affect interpretation of the results, leading to misdiagnosis.

Results were not accurate

Following extensive testing I found that the results, from five of the eight labs used, are not sufficiently accurate or precise for reliable diagnosis of vitamin B12 deficiency. The labs were frequently unable to meet the minimum standard of performance for these tests:

  • serum vitamin B12
  • methylmalonic acid
  • total homocysteine

The errors were so significant that they have the potential to very seriously affect interpretation of the vitamin B12 status, leading to misdiagnosis.

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Examples of What Researchers Found

Errors in Australian Pathology Labs

In 1996, Mounira Khoury, Leslie Burnett and Mark A Mackay  reported (MJA 1996; 165: 128-130):
Error rates in Australian pathology laboratories vary widely, but may be as high as 46% for all specimens in some laboratories.

 

In an editorial referring to the above article, in the same issue of MJA:
If these findings are extrapolated to all laboratory activity in Australia, errors must abound in alarming numbers.
Australian pathology laboratories have been slow to adopt total quality improvement processes.

You can view the complete article and editorial in reference AA01 and AA02.

Misdiagnosis of Vitamin B12 Deficiency

Oh and Brown, reference DA01:

This observation suggests that use of a low serum vitamin B12 level as the sole means of diagnosis may miss up to one half of patients with actual tissue B12 deficiency. Other studies have shown similar findings, with the rate of missed diagnosis ranging from 10 to 26 percent when diagnosis is based on low serum vitamin B12 levels alone.

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Examples of What I Found

Here are five examples of very significant errors in results produced by some laboratories. In each case, the same sample, or two identical samples, gave very different results; one result is well below the safe cut-off level; the other is well above it, giving a totally different interpretation. In addition to analytical errors, there were mistakes in sample documentation and incorrect dates in reports.

You may view a chart in a separate window by selecting the link shown with each example.

All data shown here is included in the file B12 Test Results, which is available in Evidence. The chart numbers for the hyperlinks shown here correspond to the chart numbers in the Excel file.

Scanned copies of the complete original pathology reports are also available in Evidence.

A detailed analysis of the results is given in Results under The B12 Investigation.

Example 1 - Mater Pathology Assay of Methylmalonic Acid for 30 December 2005

Chart C13

Example 2 - Mater Pathology Assay of Methylmalonic Acid for 9 October 2006

Chart D12 and Chart D13
Mater Sample A Mater Sample B
Sample A Sample B
Westmead Sample A Westmead Sample B
You will note that the date on the Westmead Sample A is incorrect; there was no sample taken on 10 Oct 2006; the date on the documentation supplied by Mater Pathology did not match the label on the sample:

Example 3 - Queensland Health Pathology Service Assay of Methylmalonic Acid for 9 Oct 2006

Chart D16
QHPS Result Westmead Result

Note the comment about the incorrect sample date, as per Example 1.

Example 4 - Sullivan Nicolaides Pathology Assay of Homocysteine for 20 Nov 2006

Chart E13
SNP Result Westmead Result

Example 5 - Pacific Laboratory Medicine Services Assay of Homocysteine for 15 November 2006

Chart E27
PaLMS Result Westmead Result

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Evidence

Facts

All of my claims of fact are supported by evidence that is available from Evidence.

Expert Opinion

Expert opinion evidence is provided as quotations from peer-reviewed articles in respected medical journals. All references are available by direct links from the References page.

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