As a rule I
have stayed away from the getting engaged in the formal politics and laboratory
Quality, especially the politics outside of Canada. But a I find it difficult to leave this
alone, because it is an area about which I have some well thought out opinions.
This month the
US Department of Health and Human Services (HHS) proposed to improve access to laboratory
test results by bypassing laws in several states that require patients to get
the data from their physicians. Proposed
rules changes would over-ride the patient privacy provisions of CLIA 1988. and the HIPAA (Health Insurance Portability
and Accountability Act) 1996. If approved laboratories would be able to release
results to the treating provider, the referring laboratories, and “authorized
persons,” including the patient.
The proposed
lab regulations were part of a patient “empowerment” package with the intent to
lead to better health and healthcare.
At the moment
count me as “unconvinced”.
First I should
mention that I have discussed this change with a number of people. Many think the rule REQUIRES laboratories to
provide direct-to-patient (DTP) reporting.
I have interpreted the rule more as
being permissive rather than regulatory.
Laboratories have HHS permission to over-ride the state restrictions and
report directly to patients. The text
does not require them to do so. If I am
right, that should take a lot of pressure off the laboratories.
Regardless, in
North America the relationship between clinicians and laboratories has been a continuous
work-in-progress. Clinicians have not
always ordered the right test the right way.
Smart laboratorians have figured out the way to notify and make
suggestions for improvement. The other
ones just do the test “nilly-willy” with little interest in results
validity.
At the same
time laboratories have not always get the test right the first time or
developed processes for correcting reports after the fact. Sometimes reports get some names wrong or
send results to the wrong people.
Importantly,
because the conversation has always been between laboratories and clinicians the
two groups have developed a special language based on medical jargon. One needs to be “in” to understand what the
reports say.
With this new
rule, I suspect all that will have to change.
In my province, each year we have
about 5 thousand reported errors for about 5 million tests. If we take into consideration the error
results not reported, the error rate may be double. While most are inconsequential, almost all
have an amended report. By
extrapolation, in the US there are now around 1.5 billon tests done annually,
so you can estimate somewhere between 1.5 to 3 million amended reports
annually. Most of these will be inconsequential, but with DTP reporting many of
the amended reports will be going directly to patients.
This is likely to have impact on a
lot of patients. Since patients have a
lot more invested in their own health and confidentiality, I wonder how many
will get upset getting results that amend false positive and false negative
results. Will patients understand that
results of tests with a high degree of uncertainty can dance all over the place
and still be acceptable?
Will report jargon will be
confusing. Will they understand terms
like “Beta haemolytic streptococcus” or “Group A streptococcus” may be the same
or may be different? Will the understand
the significance of “many RBCs in urine” or the term “monoclonal peak”?
I wonder if patients who receive
reports amended reports or unclear reports will be accepting or will they
respond with anger. I worry that angry
patients sometimes react via lawyers and the media.
To avoid this laboratories are
going to have to make a lot to change quickly.
Error detection is going to have to be a lot sharper and the language of
reports is going to have to change. I worry
that smaller laboratories not in a financial position to make the necessary
changes will close shop, leading to another wave of laboratory closures and
buy-outs and consolidations.
I am not arguing that changes
should not need to be made. Indeed, they
should be made. We should be more
aggressive in reducing repetitive error.
We should be clearer in our language.
We should be regularly incorporating informative notes and cautionary
notes. But all this should be done based
on rock solid Quality principles like PDSA and process monitoring.
We will see what happens.