A Report on our 19th CACMID Quality Seminar.

Over the years I have hosted about 30 seminars or seminar series or workshops, and I will admit that I have be pleased with how about 25 of them have gone.    

Yesterday I hosted my 19^th seminar with the Canadian Association for Clinical Microbiology and Infectious Diseases conference which is being held here is Vancouver, and in all due respect to all the other sessions, this one ranks NUMBER 1 in terms of Quality of Content, and overall Quality of Speakers.  It was the perfect blend of new information, controversy, and future visioning.   I have long since stopped worrying about numbers of attendees.  The people that came all enjoyed the discussion and information.

The themes covered included Pre-examination issues in laboratory testing, with some particular reference to Microbiology (it is a part of a microbiology conference), reported laboratory errors, with particular reference to breaches in confidentiality and a special focus on Post-examination reporting of laboratory reports.  

All the content was excellent and well delivered, but from my personal perspective, the number 1 presentation was the one by Krystyna Hommen on reporting of results directly to patients.  Ms. Hommen is the President and CEO of a company in this province that provides the electronic service that transmits over 8 million medical laboratory reports to hospitals, physicians and patients every year.  That, by my estimate, would likely make her company the largest purveyor of medical information in this province, but would likely rank her in the top 3 in Canada and I would guess the top 25 in North America.  

Starting in 2010 under a program called eHealth, her company started to provide information in a structure that allows patients to access their own medical laboratory information.  Now, barely 2 years later, the uptake of people participating is near 220,000.  What is stunning about that number is that the total population of British Columbia is about 4 million, of which about probably 2 million would be in the age range of 16-80.  That means that over 10 percent of people are taking advantage of the system.  Her experience is that the rate of new registrations is near 400 a day which means that by this time next year the people taking advantage of accessing their own information will be near 400,000.  Even at that rate, one can extrapolate that within 5 years near 100 percent of the adult population of this province will have direct access.  

To put that number in other perspective, BC has about 6000 physicians which means that today personal access overwhelms physician access by near 4:1.  By this time next year it will be much closer to 8:1.  

What is so important is that people don’t just gather their information; they go back again and again, studying their information.  They are becoming better self-informed.  As Ms. Hommen points to, as they review their results, they are becoming more engaged in their own health issues.  And they are picking up errors such as lost or missing information.  So it is fair to say that eHealth is contributing directly to laboratory quality improvement when the report these problems.  

It was interesting that the questions from the audience picked up many of the issues that I have mentioned previously on MMLQR.  How do people respond to corrected reports?  How do people protect their information from others, including those from previous personal relationships?  Who has access to information for children?  All these were addressed.

Ms. Hommen pointed out that while her company is a leader in this field, several other provinces are coming on board with similar services.  Likely by 2020 this will be the way in which laboratory information is transmitted.

This is truly the dawn of a new and exciting era of personal ownership and engagement in personal health.  If the laboratory wants to remain a healthy and relevant part of the equation, there is a lot of work to be done.  The format and structure of reported information has to improve.  The quality and reliability of the information will have to become much, much better.  The jargon will have to go and be replaced by new and better informative content.  And laboratories are going to have to learn to take a whole lot more responsibility of the quality of their samples, in particular the impacts of collection and transport errors.  

As pointed out before, in Canada the route to satisfaction for medical error is suit.  In Canada we talk about malpractice suing, but we don’t really do it all that much.   As people become more engaged, the level of interest in how errors affect health decisions will become greater and greater.  Our patients’ patience will meet its limits.  And as a fellow on the television (Kevin O’Leary) says, the result will be that folks will sue laboratories into the Stone Age.

For reference, the presentations are available at www.POLQM.ca

The Ins and Outs of Canadian Laboratory Quality

Ross Sutherland wrote a comment to a MMLQR blog post.  This was an introduction for me to a book that he has written False Postive: Provide Profit in Canada’s Medical Laboratories (Fernwood Publishing 2011).  I guess his personal word-of-mouth awareness campaign was successful, to the extent that I bought a copy of the book and had a chance to read it.

It is not a bad read.  Well researched and referenced and well written.  The thesis of the book is focussed largely on the commercial laboratories that provide service primarily within the community setting in nearly all provinces.  Since in my career I have worked in both public and private sectors, and have been a patient in both as well I feel entitled to my opinion which differs somewhat from Ross’s.  That is not particularly uncommon in Canada where there tends to be political overtones when it comes to points-of-view of the Canadian healthcare system.  I suspect that this contagion is about to spread to the United States as well.

But this is not about that politic.  It is about some comments that are made about Canadian laboratory quality, a topic about which I know a great deal.

Sutherland talks about the difficulty that we have in Canada finding out how well or unwell Canadian laboratories perform in Quality assessments.  I absolutely agree. 

If you want to know about roofers, or car dealers, you can go to the Canadian Better Business Bureau and follow a company’s track record.  If you want to know how well schools perform on certain provincial examinations, that information is published annually.  If you want to find out about a restaurant you can get all sorts of reviews.  But to find out how a laboratory performs is very difficult. 

What most Canadians may not be aware is that in most provinces (not all) laboratories are expected to be accredited every 3-4 years following in on-site inspection that is fairly encompassing.  And most provinces (not all) expect laboratories to participate in proficiency testing (EQA – external quality assessment).  What is very difficult, maybe impossible, to find out how well they performed on the assessments.  Part of the reason is that governments choose to not make this information available, which is strange, when one thinks about Canada’s long and recent history of questionable performance and provincial inquiries.

One can think of a number of reasons why provincial governments don’t post the information.  First is that they likely don’t want to get into that because they might have to do something about the poor performers.  Second it would probably set them into a political minefield with provincial medical associations and healthcare sector unions.  And third, why make waves when clearly the general public doesn’t seem to care enough to ask or demand. 

CMPT does not share the information because we have a contractual relationship with the medical laboratories that respects confidentiality.  We share their results with the accreditation bodies, only if the laboratories agree.  If the laboratories choose to not, then the accreditation bodies receive that information directly from the laboratory. 

On two occasions (September 2011 and October 2010) I have presented information about aggregate performance, and I have made our Annual Report available on our website (www.CMPT.ca).  But we can not and do not release any individual laboratory.

But I do take umbrage about one comment that Sutherland makes about laboratory quality assessment.  Reading from a government report written in 2003, he quotes the author who said that medical laboratory quality is only assessed on a technical level and does not address pre-examination or post-examination performance.  Not only was she wrong in 2003 when she wrote it, Sutherland was wrong in 2011 when he quoted it.  The word irresponsible comes to mind to describe both the writer and quoter.  It reinforces two points:  just because you are paid as a consultant, it doesn’t mean you know what you are writing about, and just because you read it in a book doesn’t make it true. 

Canadian accreditation looks thoroughly at all three phases of laboratory performance.   Canadian proficiency testing, in particular CMPT focuses at least as much attention what information is written in the report as how the information was derived.  And for the last 10 years we have monitored pre-examination decision making through paper challenges.   The information is again in our Annual Report.

So I expect a “mea culpa” from Ross.

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.

Better Reporting for Microbiology Samples

In clinical microbiology we have the same three-phase cycle as everyone else: the pre-examination phase, the examination phase and the post-examination phase. 

Microbiology samples have some unique characteristics that directly impact upon how we have to act in all three phases.  Because many (hopefully not all!) samples contain contamination from surface flora, they have to have a very brief interval before being processed in the laboratory.  Otherwise these contaminants overgrow and confuse the clinical interpretation of results.  At the other end of the cycle, because our results tend to be wordy and qualitative, often they need to be associated with interpretive or explanatory or cautionary text.  And that is sometimes a problem.  In 1996 we published an article about reporting variation.  Laboratories found 22 different ways to report the same quantity of bacteria in a urine sample.  You can call that a lack of standardization in reporting structure.

In a recent customer survey, CMPT asked the information that we provide around our samples.  Overall we found the responses quite elucidative and helpful.  Some examples: 

CMPT expectations for sample reporting, do not always agree with the policy and procedures of other institutions. It is sometimes difficult in knowing who is the best practice source.

and…

The critiques should stick to the facts. There are many gray areas in Microbiology; many split opinions with no right or wrong answer.. The critiques often have the habit of stating these “gray” areas as clear cut, with the author’s opinion being presented as the only correct interpretation. It does not broaden anyone’s knowledge, by failing to represent the true dilemmas we face with cultures, and that there are no right or wrong answers in some situations.

I highlight these two results to make a few points.  First, I understand the feeling of challenge about sorting out who is and who is not a practical source of information.  I also disagree that with some consideration that the answer is difficult.  Second, I agree that Microbiology opinion can suffer because of the “gray” areas. 

In the olden days (like in the ‘50s and ‘60s and ‘70s) laboratorians were very comfortable with these gray areas because it meant that any answer was an OK answer.  Laboratorians were free to report results any way that they saw fit.  As I was told by a group of colleagues, "No one can infringe on my right to practice medicine the way I see fit".  

The problem with that approach was that it was predicated on the notion that laboratories exist for the benefit of the laboratory and not for the clinician and not for the patient.  Today the rules have changed and we understand that laboratory reports exist to provide information for the users.  When patients are tested in multiple laboratories there is some obligation to at least ensure that the information that they receive has some level of consistency.   Using the notion of  “gray areas” as a justification for inconsistent  reporting structure is not appropriate;  something more definitive is expected. 

In the absence of legislation and regulation or some other legally binding notion, at least we should make our decisions based on consensus within our community.  It is called standardization.

And that is where PT/EQA committees can and do play an important role. 

Take CMPT for example.  Our committee is a group of 13 medical microbiologists, scientists, technologists, with both clinical and laboratory expertise.  The group comes from across Canada and representing university hospitals, community hospitals and community laboratories.  The group collectively perceives the wording of reports as important and spends considerable time coming to conclusions about mutually agreeable decisions about meaningful clinical reports.     

If ever there is a group ideally designed to come to consensus opinion about the optimal way to report clinical samples, it would be a group just like this.  CMPT is not the only PT/EQA program in Canada, nor is it the only one that has a committee that assesses reports and determines optimal reporting patterns.

So with respect to the two comments mentioned above, I have to respectfully disagree.  There are better reports and poorer reports and there are community based PT/EQA committees well positioned to help define the better way to report.

Don’t agree?  That’s OK.  Submit an appeal with justifications.  The committee also  has the obligation to provide a second look.

But we will continue in our obligation to provide what we see is an important contribution to reporting standardization. 

It is one of the things that we do.

Direct to Patient Reporting

On September 29, 2010 I wrote about a possible future solution to pre-examination phase error.  Today I am interested at the other end, all the problems associated with post-examination problems.  There are so many ways in which laboratories can and do mess up reporting.

We put out late reports, we lose reports, we send them out with the wrong patient name or wrong identifiers, we send the report to the right doctor with the write patient name on-time, but with the wrong information.  And we send out the right information on the right patient but to the wrong physician.  And we do it with incredible repetition and frequency.  It is disturbing how often an amended or corrected report has to go out. 

And the aforementioned doesn’t include how many confusing or ambiguous reports we send out because of our incorporated jargon and stultifying formats. 

Put them all together and the number of post-examination errors can usually run around 1-3 per thousand reports, assuming that we capture them all.  What is really scary is that in many situations, our saving grace is that most results are “normal” so that if we confuse one person’s “normal” result with another person’s normal result, we would never pick it up. 

But I saw an interesting development in an broadsheet that I get mailed to my home called “Canadian Healthcare Technology” – September 2010 (http://www.canhealth.com/).  They promote themselves as Canada’s magazine for managers and users of information systems in healthcare.  This edition has an interesting series of articles on Lean in healthcare.

More interesting, and more relevant to the topic of post-examination challenges is an article on page 8 about a system which allows patients to access their own laboratory results electronically and directly without going through a clinician or physician. 

Just reading the title made my quality antennae go up.  On the one hand I am kind of a “power-to-the-people” type guy and so the concept is pretty intriguing.  It goes to the question, whose urine is it anyways?  Who says we always need a doctor to read what is on the piece of paper, or the computer screen.

But on the other hand I am a clinician, physician, laboratorian, qualitologist, and my immediate second reaction was OMG!  Considering all the challenges we have with post-examination error at the best of time, and now we add on going direct to patient without an interpretive intermediary. And when the wrong person gets the wrong information on the wrong patient, we call that a breach of confidentiality.

It reminded me of another concept called Quality Partners, the groups with whom we routinely interact to ensure we get our quality right: standards development bodies, accreditation bodies, proficiency testing bodies, educators, professional organizations, equipment and reagents suppliers, and the Public.  We can probably continue to get along sending difficult to interpret results to the usually right and sometimes wrong physician, usually on-time, and sometimes not.  But I imagine that the public may see things a little differently.  As a student said, you can wake up the sleeping giant, but watch out.  You have no idea where and how things go from there.  (Not to overstate the obvious, but in this case, the sleeping giant is the collective general public which of course includes its media, legislation, regulation, and litigation constituents.

 I can see three outcomes; either this will fade away as a plan in which no one is interested, or it will force laboratories to re-look and re-consider their report writing policies and practices, or the litigators and regulators will have a field day.

So we will see.  Direct to patient reporting – the new normal, or the newly normal, or the beginning of a new “long and winding road that will lead to your door and never disappear”?

Who says that the road to quality improvement is always supposed to be easy.

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