Canad's best laboratory Quality Seminar series

Over the years I have organized 22 Quality Seminars for what used to be called the Conjoint Meeting, an annual event in Canada that has brought all the interests of microbiology, infectious diseases, and public health together for the last 80 years or so.  Today it is called the AMMI Canada CACMID conference, named for the two principal host organizations.

The Quality Seminars have changed their name and purpose since their inception in 1992.  At first it was an opportunity for laboratory accreditation bodies and proficiency testing bodies that got together and discuss common interests.  When the accreditation bodies dropped out the proficiency testing groups continued on and we could chat about interesting PT issues.  Over time the focus started to move again more in the direction of standards development, and then finally very much into the areas of individual interest, such as international activities, education, and finally a whole slew of Quality oriented topics, that impacted mainly microbiology laboratories, but eventually the broader topics or error and culture and continual improvement. 

The Quality Seminar has always been seen as separate from the main meeting.  At the beginning it was an event that people could attend on the day after the conference was over, especially if they had a late flight on the next day.  Then it became one of the day-before events so that people would have something to do when they got to town a day early.  Both of these times worked out well because it was not competing with the chaos of the full meeting, and gave us lots of time as opposed to being limited to a slot of 45 to 90 minutes.  While others were being shoehorned in, we always had at least 4 hours to fill, enough for at least 4-5 speakers and discussion and coffee breaks.

The audience was always a select special group.  Even in the arena of laboratory and clinical medicine, the audience for Quality issues has never been huge.  But it was a faithful group and every year, pretty much we could fill a small or intermediate sized room for the whole session. 

Of interest, as the conference expanded, other groups began to see the day-before block as a desirable time slot and we found ourselves competing with other groups during our afternoon block, probably to the disadvantage of both.  The people having the competing time meeting locked up all access to the physicians-in-training (aka Residents), a group of people that prior to this change would benefit from being at the Quality Seminar and being exposed to a topic for which their routine training was (and still is) somewhere between inadequate and absent.  And we would have enjoyed having the Residents with us, because it would have increased the group size and expanded the group discussion.  But it just was not to be.  

So now after 22 years, I think it is time for me to call it quits.  I have kind of run the gambit of topics and I am not sure I see the value to me in continuing on.  That does not mean that Quality Seminar will end, indeed I hope that is not the case; it just means that someone else will need to take on the responsibility to organize it and lead it and keep it afloat and move it towards its next iteration. 

For those interested, the presentations from the meeting will be on-line at www.POLQM.ca under the title AMMI-Canada CACMID 2014. 

Confidentiality and Laboratory Error

Reporting information to the WRONG person is an error that really annoys me.  Over my working years I have been involved in more than 60,000 wrong communications situations.  I see every one of these as a potential confidentiality breach.  To me it is a BIG DEAL,

I accept that Errors happen, and that many, indeed most are slips or simple mistakes, and that the preponderance of these slips are of little consequence.  Slips and simple mistakes are to a large extent, human foibles that cannot be eliminated but can be reduced, especially by having an active quality management system that includes elements of audit and risk assessment.  

I also acknowledge that I may be overly sensitive but being a recipient of errant reports puts me in the middle of a patient confidentiality breach which is beyond my control, and at the same time, puts a huge onus on me to fix someone else’s mistake.  It costs me time, effort, energy and money.  

Misdirected information,  in my opinion cannot be included within  the classification of slips and mistakes because the intrusion into confidentiality raises the consequences significantly.

Personally I thought I that I had finally solved my long-term problem because I I previously informed all key offices and organizations that I would not take any responsibility for misdirected information, and then changed my address when my programs were moved to a new location.  But I was wrong.  

I have three stories from the last little while, that stand out from the all the others.  They indicate how pervasive casualness of patient information has become in our culture.

First story.   I received a letter from a lawyer’s office requesting information on a patient.  This is not an unusual request, but became complicated because I was aware of the patient in question; not because I had a professional relationship with the person, but a social one.  I contacted the lawyer’s office by telephone giving them my name, their file number, the date of the letter and explained that they had unfortunately sent their letter to the wrong person.  I chose to not mention the additional complication of compromised identification.   What transpired was that the lawyer’s office somehow saw this was my fault and that I had an obligation to inform them in writing and return the misdirected letter back to their office.  Being polite was a bit of a challenge, but for some reason, I actually complied.  Stunningly, six weeks later, I got a “letter of second notice” from the same lawyer demanding my file information on the same patient.       

Second story.  I recently was in the hospital and was referred to a clinic for follow-up.   The day following discharge I received a telephone call from the clinic to set up my appointment.  Having set an agreed upon time, I said, that was great.  Please send me an email confirmation, to which I was informed that they do not send emails confirmations because of concerns about confidentiality breaks.  Good for them; clearly they have thought their way through some of the confidentiality issues.  OK, just send me a notice to my home address, which they could do.  The problem was that they had a wrong address.  Not only was it a wrong address, it was one that my wife recognized because it was the home address of a friend with whom I share a common first name with her husband.  “I think you are talking to the wrong Michael” I said.  “Which Michael do you think you are talking to?”  I inquired, and confirmed the mixup.  Unbeknownst to me, the husband had a similar problem and was referred to the same clinic.  Someone entering the data had integrated our two files.

Third story.  In today’s mail I received a letter from an insurance company marked “Personal and Confidential” send to my address, but not intended for me.    

So here is my point.  Where I live, attention and focus on confidentiality seems to get lip service at best.  Confidentiality breaches happen all the time and they never go away, and they are pervasive through all parts of our collective society.

I can account for some (many or even most) as the result of slips and distractions.  I suspect that many result from overworked people putting out volumes and volumes of communications.  

When some organizations try to fix the problem (like prohibiting email confirmations) often their solutions fai.  They don’t solve the problems; if anything they make situations worse.  

The tragedy is that misdirected information can be avoided with even really simple quality improvement solutions, like double checking before sending out confidential material and when there is a breach, receiving and recording notification of error and implementing remedial action.   If you can prevent and fix them all, then at least you can fix some today, and aim to prevent some others  tomorrow.

But the first step, it seems to me, is to first, to give a damn.

PS:

As an addendum, out Quality Conference is attracting attention from Canada, the US, the middle East and India.  We are pleased with the rate of registrations.  Those thinking about attending should consider registering soon. 

For more information, please visit:  http://polqm.ca/conference_2013/conference_2013/conference_home.html

PT Bonus Opportunities: would your laboratory benefit?

PT Bonus Opportunities: would your laboratory benefit?

Frequently we talk about the benefits of Proficiency Testing as a method for the detection of systemic error in laboratory testing, especially as part of the examination phase.  Once you accept that Proficiency Testing challenges have been thoroughly quality controlled and are highly reliable, then it becomes, as my old calculus professor used to say, intuitively obvious that the greatest probable cause of deviation between a clinical laboratory’s result and the PT program’s result is some form of problem within the clinical laboratory.  It likely is a slip or distraction by someone in the laboratory’s testing chain, but it may reflect a larger systemic error that is otherwise is being not recognized or is under-appreciated.  Discarding deviations in PT performance can be lost opportunities for improvement.

But recently we had two interesting results come to light that reinforce that systemic error in the testing pathway detectable with proficiency testing materials can come from all sorts of places. 

As per our normal routine, our PT coordinator was checking the laboratories that had not yet sent in their results 48 hours before the due date, and found one such laboratory and contacted them.  [As an aside we can provide that extra level of service because we are a small program.  Large programs with thousands of participants could never provide that extra assistance.]

The laboratory checked their records and came back on the phone and said that the problem was on our end, because the laboratory had never received our samples in the first place.  We were the problem.  So a check was made through the courier service and what was found was that the samples had been delivered on time as committed, and that the delivery way-bill had been signed off within the laboratory.  A call-back was made and sure enough, the box was sitting in the refrigerator where they had been placed, un-opened.

The story has two messages.  First, if this happened with our package, this could have been a one-off by someone who simply forgot (call that a human slip) or perhaps this happens more commonly than the laboratory is aware (call that a system error).  Second, our system informs the laboratory on the day the package goes out.  If there is going to be a problem it would be captured within 48 (max 72) hours.  If someone had called us and checked, the box would have been found immediately.  That this didn’t happen either means that a distraction resulted in the call not being made, or that the laboratory has an inventory-control problem which needs checking. 

Either way the point is that even without being tested, this PT shipment has resulted in detection of two problems (is it OK to call them errors?) that the laboratory now has the opportunity to check-out.  Either they were a chain of simple human foible, or they were a manifestation of failures in the delivery handling and monitoring procedures. 

A second story is similar, but starts not from us contacting the laboratory, but the laboratory contacting us with an apology for a 5 day delay in submitting results.  Apparently, there usually was a Quality technologist whose job it was to submit  PT challenges reports, but that person had recently retired and no one had yet been appointed and so the job was “slipping through the cracks”. 

We understand that people do retire; that is called “business as usual”.  But if the PT reports are not being submitted, are there other tasks that are not getting done.  If quality control testing is being delayed, and reagent defects are not being identified, then how many hours are going to be lost having to remediate erroneous test reports?  Or worse, what if quality control testing isn’t being done at all?

My point is that PT samples are more than just a material to challenge the examination phase of laboratory testing.  They are known and traceable and regularly received materials that can be used to monitor every aspect of the laboratory cycle.  Usually everything works as it should, and sometimes it does not.  It is when things do not go well that these “safe” opportunities arise for checking for system error. 

Opportunity accepted or opportunity ignored?

Quality and Error and Standardization of Laboratory Reports

Over the last while I have been reading about and hearing presentations on Electronic Health Records.  The concept is that EHRs while expensive, and difficult to establish, once established will revolutionize care.  Dependence on having access to every clinician’s records will become a non-issue.  Test results will be readily and rapidly available side-by-side by date, rather than being in a separate record for each laboratory.  Repeat testing will become a thing of the past.  

Well it turns out that maybe by taking it very slow, we have done the right thing.  It may be that EHRs are going to be our Ford Edsel.  A whole slew of challenges have appeared.  Getting agreement on common EHR language is slow and painful.  And even if we have common language, many laboratory results are highly analyzer specific and not comparable across platforms.  And now some economic cracks are appearing [see: http://www.darkdaily.com/healthcare-observers-disagree-on-cost-effectiveness-of-electronic-health-record-systems-1116#axzz2CnmDcvnZ ]. 

So time will tell us soon enough whether EHRs are actually going to happen.  

But in the meantime, we still have a big problem that needs to be solved, one way or another.   

Several years back, I was in conversation with a group of pathologists all with particular interest in one particular anatomic target.  The group saw great opportunity to band together to create an on-call network so that there would always be pathology support for surgeons but at the same time they would also be free to work on their own research activities on a set schedule.  Because they were working as a team, they collectively agreed that if a doc called, he would get the on-call pathologist rather than a specific one.  Since they all basically had similar knowledge in the specific target, they could say that everyone was receiving a standardized level of care.  All that made infinite sense.  

Unfortunately the system started to break down after barely a few months.  The problem was that when it came to writing reports, each had their own style.  Some would construct separate sections within the report, while others preferred a narrative style.  Some were brief and precise, others were more verbose.  Some were heavily jargon enriched while others preferred to use both the accepted jargon, but also explanatory comments.  When we tried to establish a code to standardize reporting, the push-back was huge.  “No one is going to tell me how I can or will practice my craft.”  End stop.

It’s interesting that we also see this same mind-set in medical microbiology.  As much as we have much commonality to microbiology test methods, there is no requirement that these “standard” test methods actually get used.  There is no requirement that all microbiology laboratories use uniform microbial nomenclature.  There is no requirement that all microbiology laboratories use a common set of interpretive or cautionary notes; where common concepts get reported, they are as often as not crafted with personalized verbiage.  

We microbiologists are a highly individualized and ornery group.  “My laboratory … My way”.  It’s not that we are resistant to change [for a read on Luddites see: http://www.medicallaboratoryquality.com/2011/11/innovation-and-medical-laboratory-part.html ], it’s more that we sometimes get more locked into our own subtleties than in adopting general principles.   

Example 1:

At CMPT, our proficiency testing program, we promote common concepts, such as requiring the reporting of “Methicillin Resistant Staphylococcus aureus (MRSA)” rather than “ Staphylococcus aureus ; R-Oxacillin”.  

Clinicians understand that MRSA is a signal that Infection Control needs to be contacted.  Laboratories that choose to not use that terminology put patients at risk.

Example 2:

I understand that the problem is not necessarily an ego issue.  Sometimes it is our technology.  A number of years back at CMPT we sent out a simulated urine culture with a heavy and pure coliform, suggestive and supportive of a urinary tract infection.  [see: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3327405/ ]  Unfortunately because of the limitations of the LIS systems available at the time the results came back in 14 different styles of units, and rarely with a confirmation comment (consistent with urinary tract infection).  When we send out reports as either 1X10^5 bacteria/mL or 1000X10^5 bacteria/L or 1X10^8 bacteria/L, we can not be particularly surprised when confusion sets in (Note:  all these values are the SAME!). 

What concerns me is that for us, microbiology is what we do and understand.  That is not the case for clinicians.  When we refuse to adopt even simple rules for standardizing the text of reports, then we increase the risk of people misinterpreting our reports, and open the gates to error.    And now that many patients can receive reports directly, without any health care intermediary, our level of hazard and risk grows substantially.  

So here’s the bottom line.  Waiting for EHRs to solve our reporting standardization problems is a time killer and potentially a patient killer.  Simple low tech solutions are available, and we avoid them at our peril.

The bright ugly shining light of discovery

One of Canada’s two national newspapers carried an interesting article today about a federal study that identified problems with transfusion medicine in Canada.  See National Post: “Errors, mislabelled samples pose ‘staggering’ cost to Canada’s blood banks” [http://news.nationalpost.com/2012/08/06/errors-mislabelled-samples-pose-staggering-cost-to-canadas-blood-banks/] .  

The studied identified collection errors, transport delay errors, and identification errors and others that collectively resulted in loss and destruction of units of blood, inconvenience to patients, and loss of money.  It was a small study, involving about 10 percent of facilities and still found over 6000 errors.

This is not really a surprise.  In our own studies, about 80 percent of reported laboratory errors occur in the pre-examination phase of sample testing, with the issues identified being the most common problems.  

But it is disappointing, and should be a national embarrassment.  

Our Canadian blood system was torn apart in 1996-7 as a result of pretty serious errors in judgement that resulted in a Royal Commission of Inquiry lead by Mr. Justice Horace Krever.  While Krever did not address issues of collection errors, the government was sufficiently motivated to seek the creation of a quality standard on blood services practices by the Canadian Standards Association which was published as “Z902:2004(?) Blood and blood components”.  Z902 was identified as a national standard.  It has recently been republished under its current iteration Z902:2010.  

Z902 had a Quality Management section within it, albeit not as complete or as rigorous as ISO 15189, but had sufficient clarity around issues of collection and labelling and transport and corrective action and internal audit that by now these practices should be routine practices and well established.  

Today’s report suggests that that is not necessarily be the case.  

My own speculation is that the problem is that in too many laboratories, the notion of Quality is still stuck in the 1980’s at the level of Quality Control within the 4 walls of the laboratory.  Laboratory personnel are very strong on control charts and SOPs, but still weak on internal audits, preventive action, and active continuous improvement strategies.  As much as we talk about a laboratory cycle and all the steps that occur before the sample gets to the laboratory window and all the steps that occur after, we still focus the majority of our time on technical procedures inside those secure walls that separate us from the outside world.   
And that is not a good thing. 

A bold statement? Perhaps.  But I have a lot of evidence to support my speculation.

In our proficiency testing program we have always taken the position that all errors are errors, including transcription errors.  This started when we worked in pencils and paper, and has continued on as we moved to internet based reporting forms.  Every send-out we have laboratories that fill in reports using the wrong identifiers and then complain when we grade them down.  But if laboratories will do tests and mix them up in proficiency testing where they know that the results are being scrutinized, then how do we know that they don’t do the same with clinical samples?  

I personally keep a watch of how many misdirected, mislabelled reports I receive from clinical laboratories.  I have talked about this before.  Over the years it is in the 10s of thousands, with no evidence that it will ever slow down or stop.  

We have made big strides on our internal Quality, but our communication with the outside world is probably as bad today as it ever was.

 If this was isolated to a few laboratories, we could focus on the problematic few and move on.  But this is not an isolated issue.  It is widespread and systemic.  It is nation-wide and international.  

So am I surprised? Not at all.  But I am encouraged.  

Here we are in Canada, 15 years “post-Krever”.  A study is performed by the Public Health Agency of Canada.  It is reported by the National Post newspaper.  Our public Quality Partners are doing their work, shining a very bright light on a very ugly problem.  

Let’s see what happens next.

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