Laboratory Quality: words or rhetoric?

Laboratory Quality: words or rhetoric?

This month the Infectious Diseases Society of America published a new article (A Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2013 Recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM)) in the journal Clinical Infectious Diseases. It is an impressive document and for those interested in laboratory medicine, and clinical microbiology and laboratory diagnosis to assist infectious diseases, it is an impressive document.  It is about 100 pages long and includes 250 references, so it would be fair to call it comprehensive. 

It was an impressive task to compile all this information and put it together in a single comprehensive manuscript.  The authors should be congratulated. 

Unfortunately, despite all these positives and kudos, it not only misses the bull’s eye, in my opinion it by-and-large misses the whole target. 

The shame of the matter, is that the authors are all very well know and well respected microbiologists in the clinical laboratory community; and they know what the target is, or at least should be.  They say right up front “Physicians need confidence that the results provided by the microbiology laboratory are accurate, significant, and clinically relevant. Anything less is below the community standard of care.” And they are bang-on.  I agree entirely. 

So what is their plan to ensure that laboratory results meet those criteria; their answer is that “all microbiology specimens be properly selected, collected, and transported to optimize analysis and interpretation.”  The problem is that this is just far enough off to be misleading and misguided. 

Don’t get me wrong, I think that collection and transport of clinical samples is important, indeed very important.  And if you want a document to help with clinical sample collection and transport, you can consider this manuscript, or better, look at the Canadian Standards Association document “Z316.7-12 - Primary sample collection facilities and medical laboratories - Patient safety and quality of care - Requirements for collecting, transporting, and storing samples”, which I think is eminently readable and applicable. 

Where we diverge from the value of the IDSA article, is that even if the sample is collected and transported properly, that does not ensure that it will be processed properly or accurately, or that the results reported in the clinical report will be significant or  clinically relevant.

While it is true that many, indeed most REPORTED laboratory errors are derived from the pre-examination phase and it is also true that testing accuracy and significance are affected by specimen quality, it is also true that testing, interpretation are influenced largely by laboratorian practice and competency as is the ability to generate a clinically relevant report.  We know that from data generated from our proficiency testing program over the last 10 years. 

In the table below, you can see performance of advanced laboratories (Blue), intermediate (Red), small (Silver) and very small (Green).  

Creating a manuscript that says all the problems are caused by improper collection and transport is an easy out.  “It’s not my problem, it’s not my fault.  Those guys who collected the sample did it wrong.”  “And if they don’t understand my report structure or my report content or my report jargon, that’s their fault too. “  “The problem isn’t me.  I know what I’m doing.  It’s all those other guys (i.e. you!) who are the problem.” “Trust me, trust me.” 

It speaks to the mindset of the authors when the word “Accreditation” is found in a 100 page (about 10,000 word) document only once, and this is in a footnote.  The word “proficiency” is similarly found only once, and not in the context of proficiency testing.  And the word “competency” is not found at all, nor is the phrase “quality management”. 

If clinicians are going to have the confidence that laboratory results are accurate, clinically relevant, and significant we need to be able to document in a public fashion that we laboratorians take these issues seriously and that we undertake the necessary steps to ensure through qualified external assessment that our leadership and sample management and competence and knowledge and proficiency are active and intact.   

PS: The October in Vancouver Conference for Medical Laboratory Quality is coming along nicely.  Hotel space is filling up well.  I suspect we will have more registrations than rooms at the convention rate.

For additional information see:  http://polqm.ca/conference_2013/conference_2013/conference_home.html

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