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.

Preparing our next generation of leaders

I am preparing a number of new presentations for our Resident and Graduate Student Quality Seminar Series and took the opportunity to re-read Deming’s Out of the Crisis, written in 1982 to expand on the 14 Principles.  In chapter 2 Principles for Transformation of Western Management he writes “Support of top management is not sufficient.  It is not enough that top management commit themselves for life to quality and productivity.  They must know what is is that they have committed to – that is, what they must do.  The obligations can not be delegated.  Support is not enough; action is required. “

This is a core message that I am going to convey.  

Medical laboratories provide a broad variety of services including creation and provision of a menu of diagnostic tests, creation of a method for ordering tests (I hate that term: more on this later) and then providing a process for collection and transport.  The samples get accessioned and tested and results get generated and reported.   

Along the way some quality processes take place, including quality control and proficiency testing and sometimes accreditation.  Some projects, like the application of “Lean”, or a Lean variant of time and motion get initiated and sometimes actually competed. But we all know that problems still continue.  Over the last very few years we have seen pathologists misinterpreting and misreporting findings, faulty HIV testing, faulty tissue diagnostic tests, and pathologists with a pathological ineptness in writing reports.  We also have well documented sample contaminations in chemistry and microbiology.

In some laboratories we are starting to do more.  Quality management is starting to manifest some continual improvement processes (which is good) and even some error investigation (which is better).

So far I have told you nothing that you don’t know and that you have not heard before. 

But here’s what our residents need to know and understand.  That when push comes to shove all the above mentioned errors have a single primary root cause and it has little to do with technologist training or standard operating procedures, or competency assessment.  Our primary root cause of laboratory error is the consistent and persisted absence of personal active engagement by our medical laboratory directors in Management Review and change.  

 Quality is not about hiring a Quality Head, however named, and then delegating authority.  Management Review is not about being handed a bunch of manuals and annually signing them off, or about asking the Quality Guy how we are doing.

Our next generation of medical laboratory directors need to know that quality management is as much a part of their job as is reading pathology slides or signing our reports or dealing with human resources and budgets.  And it is not about number of slides read per hour worked or number of INRs ordered per week.  And it barely is about some artificial and artefactual measure of turnaround.   

They need to know there is a quality expectation, a quality vision.  Keeping laboratory staff focused on what matters is a critical function of the laboratory director . They need to know that satisfaction is not about making complaints go away, but is about comprehensive communication with hospital staff and patients.   

They need to know that quality is a science of planning, execution, measurement and response.  And they need to it is their job to make these things happen.

So it should be an interesting seminar series.

m

PS: I have a plan to see if we can monitor our impact on three scales: immediate, intermediate and at five years.  

PPS:   We have made some important changes to the Quality Weekend Workshop.  Dr. Denise Dudzinski is a bioethicist who recently published an article in NEJM on Disclosure Dilemma – Large-Scale Adverse Events.  I am looking forward to her presentation.

PPPS: I would really appreciate it if you can go back to the previous entry and fill in the survey.

Big enough to fail?

WITH APOLOGIES, THIS IS ANOTHER RANT.  RECENT EVENTS TELL ME THAT SOME THINGS ARE VERY RESISTANT TO CHANGE, EVEN WHEN WE KNOW BETTER.  IT'S KIND OF LIKE SMOKING.

Question 1: How many laboratories in Canada (or indeed anywhere) have been closed down because they did not get a perfect score on their proficiency testing challenges? Answer: None.  Never.  Notta. Zip. Zero.

Question 2: How many laboratories have been allowed to remain open, but lost their ability to bill their provincial medical services program for services rendered because they did not get a perfect score on their proficiency testing challenges.  Answer: see above.

Question 3: How many laboratories in Canada “game” their proficiency challenges by holding the sample back until the right technologist is available, or do repeat testing, or do extended testing, or send the sample to a referral laboratory.  More than one, disturbingly a lot more than one. 

Not to belabor the issue, but what is the point of the exercise?  Are we really that insecure about our professional competence that we have to “cheat” when there is nothing on the table, nothing to gain.  No gold stars, no extra cookies, no scholarship, nothing.

What we do lose is the opportunity to check that our standard operating procedures are getting us to the right answer.  What we do lose is the opportunity to do a competency check on our operating systems.  What we do lose is all the extra time, effort, energy and money is doing the extra testing, and scheduling. Consider that  finding a single weakness through PT can save you poor quality costs equaling your laboratory's total PT costs for a whole year, or more.

There are solutions or work-arounds that can be put into place, but they are either expensive or inconvenient, or create increased, and from my perspective unacceptable risk.  

We have been toying with the possible linking proficiency testing turnaround times to clinical sample turnaround times.  If a sample should pass through the clinical laboratory in less than 24 hours, then that becomes the upper limit for the P.T. challenge.  If it should take five days, then the PT turnaround limit is five days.  It would not be particularly difficult to do, for programs with on-line entry of results.  For paper or fax entry it may be a little more difficult.   It would result in more paper work on both ends and that would result in some inconvenience and added cost.

Another solution would be to create a link between the P.T.  provider and the laboratory information systems, so that reports would be automatically generated and sent tot he provider.  This would take some initial set-up time and save time on the laboratory side, but would, in most P.T. programs, cause increased time requirements to transfer results to the data base for analysis  with an inevitable increase in cost.  Additionally, it is stunning how unstandardized our reports are.  But that is a topic for another time.

Or we could disguise the samples completely and have them submitted as clinical samples.  But that would cause all sorts of challenges with getting site specific requisitions from each laboratory and creating patient names with appropriate identification numbers.  And then we would have to sort through the problems created with billings.  (A number of years ago when I was a resident, a microbiologist in the hospital created a  throat swab with C. diphtheriae.  It was a brilliant idea except that the result got reported to public health and much chaos ensued).

Or we could just get rid of proficiency testing, but most laboratories would lose an essential quality assessment tool and a major source of continuing education.

There is, I think, a more reasonable solution.  Laboratory management including the quality manager decide that as of this day we do things differently.  No more overwork, no more processing by the QC technologist.  Routine processing only.  It's worth a try.
Yes?

m

PS:
The POLQM Weekend Workshop is coming together well.  For those interested in doing a poster or podium presentation, register early and send your abstract to ubcpolqm@gmail.com

www.POLQMWeekendWorkshop.ca

Heresy?

 American Society for Quality has a number of  journals, and some excellent, and others pretty good.  One of the latter category, at least in my opinion, is the Journal for Quality and Participation.  Without wanting to be harsh, I tend to find articles, while generally interesting,  tending to be more  opinion than fact.  (The irony of me, an opinion oriented blog writer making this distinction is not lost!).

Nonetheless there were three interesting articles in the October 2010 edition that I received today.  One was “Improving Project Performance with Three Essential Pieces of Information” by Portnoy, and another “Creating a Self-Confident Workforce” by Denton.   The last one is  "Training on Trial” by Kirkpatrick and Kirkpatrick.  

I don’t intend to go into any (the journal is available at www.asq.org/pub/jap) in detail other than to say that the first article made the point that when designing a project briefing (the deliverable) it is useful to make it brief and unambiguous.  The point was that the more the number of words and the more jargon included, the more variable is the document's interpretation.  The training article was making the point that training can have a lot of challenges demonstrating that it actually provides a service that will address significant business results.  And the third article made the point that workers are more self-confident with less stress when they are empowered to make certain decisions on their own.

I can support all those points.

Which brings me to the heresy. 

At a laboratory where I was working, I often found myself in conversations that suggested that some of the standard operating procedures (SOPs) were so detailed and so “precise” that in my opinion, they were largely unfollowable.  Even with an adjoining process map they were unfollowable.  They were better when pictures were added in,  but especially better when pictures were used in place of words.  In the process of trying to make SOPs that were all encompassing, I felt we were laying the foundations for error.

And so I started to think that maybe it is not so important to tell microbiology technologists how they have to hold and streak a petri dish, but to let that happen on its own.  And defining precise colony counting methods was so rigid that it likely wasn’t followed anyways.  And trying to define all the combinations and permutations of bacterial growth was confusing.  

Now there are many procedures involving many pieces of highly precise equipment that do need precise instruction (I understand that) but if we pollute those instructions that are challenging to follow, I think we run the risk of some documents  that need attention and clarity getting lost in the shuffle.  

So my point is that SOP writers and trainers and supervisors need to take a closer look at the procedures that they create to make sure that they actually are useful for training, and more importantly allow the business purpose of the procedures to come through.  Its not only about the value stream, but also creating documents that give technologists the professional autonomy.  Smaller and selective documents, it  seems to me, make the procedure and much of the decision making process both more efficient and more effective.

And how heretical is that?

m

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.

m