Welcome to the world of DTP reporting

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.