Quality and Risk revisited.

I read with interest an article in last month’s (September) edition of American Society for Quality (ASQ) Quality Progress which is about doing risk assessments throughout an organization.  (See Site Seeing by L.W. Yu, E. Urkin, S. Lum, R.S. Kennett, and R. Ben-Jacob.   www.quality progress.com).  In it, the many (!) authors make the point that companies need to keep their eye on RISK throughout the organization and that that is best done as part of risk-based audits.   Helpfully, they present a number of tools that can be used, especially an example of a probability of occurrence-severity grid which in my experience is very helpful for setting priorities.  Attack the issues that have the highest (occurrence X severity) product first, and address the lesser issues later. 

I agree with them.  In the medical laboratory we have an ISO document   ISO/TC 22367: 2008 Medical laboratories -- Reduction of error through risk management and continual improvement which gives the same message.    (Actually I agree with them so much that I wrote on the subject over a year ago – see MMLQR:  Medical Laboratory – Quality and Risk.  September 25, 2010).   

A few comments about measuring risk, especially for laboratories which do not follow or understand ISO standards, in particular ISO15189:2007. 

One of the expectations of Quality Systems as iterated in 15189 (and CLIA and CLSI GP26) is that the laboratory should demonstrate that it performs preventive actions.  Commonly this is an expectation that laboratorians struggle with because they don’t understand where or why they fit within the laboratory.

Risk analysis fits perfectly within the Quality Management systems as a direct approach to  Preventive Action.  Preventive actions are the process of looking at new equipment, new procedures, new policies, or the existing environment (think safety audits) to see if they have the potential to cause more harm than good, and then addressing the problems BEFORE they occur (ergo they are preventive).   

I think that the reason that these are so difficult for laboratorians is because thinking about problems before they occur seems like a lot of “blue-skying “ and a waste of time.  Well it is blue-skying, but with a safety mechanism built in.  If you dream up a potential problem that is either so implausible  (very low occurrence) or so inconsequential (very low severity) you don’t have to do anything about it.  But on the other hand if you discover only one thing that has a real potential impact on worker safety, or patient safety, or test performance, or quality control, or finances, or liability, then the risk-preventive action process has done you a real favour. 

So how often do you go through the exercise?  It depends.  How often do you do a safety audit?   When you are setting up your safety program you probably do them frequently.  Once the system has settled in, you probably do them less often; same with risk-prevention audits.  The only real problem is when you slow down to the point that you have essentially stopped. 

As a commitment, you can tie doing a risk-prevention audit to when you introduce a new piece of equipment, a new procedure, or a new policy, and again a few months later when it has settled in.     

In addition, this can be really valuable when you have made changes because of an imposed change in regulation or budget.  Not that I am a “I told you so” kind of guy, but recording and reporting potential risks in a constructive structure along with a resource strategy of how to prevent them, can be both helpful and powerful.

Risk-prevention audits don’t have to take a lot of time.    Often you can work through the whole process in a few hours.  But give yourself enough time to take the task seriously. 

You may be very glad you did. 

PS:  Some folks still write and sell software that includes the term CAPA which suggests that Corrective Actions and Preventive Actions are the same thing.  They are not the same thing and those software packages are a waste of electrons and machine language and money.

Consensus and Quality.

Somebody (?) once said that the path to success is to find the work you want to do and to do it with passion surrounded by others that feel the same way.  That’s how it seems to work out for me in medical laboratory quality.   

In my career I have migrated from providing care on the individual level, to caring at the institutional level, and then for the province and nation.  In Quality I find I have impact at the international level.  It is something like being a doctor without borders, but different. 

Perhaps the most eye opening aspect is the people that I have met and interacted with; people from government, public sector, private sector, engineering, and nursing, standards development and assessment bodies proficiency testing providers and academia.  Some are self-employed as specialists or consultants, other are generalists.  Some are full-time employees, while others are part-time employees, and these days, many are what we called retired from gainful employment, but still busily engaged in doing good things.   All of them have similar levels of interest and passion and share the common belief that they (and we) are individually and collectively  working to make healthcare better. 

What is important here is that with all this interest and passion and diversity of background comes a lot of differing opinion about what exactly makes for better healthcare.  Purse-string holders see it as doing better but for less.  Others agree, as long as their own special interests are funded to the level that they want.  And others still see it not a matter of money but more about what is “just and right”.  There is the “right” way (also called “my” way) and then there is everything else.  And what is really annoying about all this is that all these opinions in there own way are valid and all of them can lead to the best path to better care. 

Fortunately the crafters of Quality understood that true Quality has to accommodate to all reasonable paths.  In the end, there is almost always a route to common purpose and common goal.  It is called consensus. 

Consensus is not 51% support, or even “super-majority – 66%”, or indeed even 90%.  Consensus is the recognition that while everyone may not love the decision, at least there is no one who is so absolutely and totally opposed, that they feel beyond absolutely compromised.  The point of the challenge is to find that place where everyone can live and support and agree.  You may not be happy, but at least you are not going to have to resort to self-immolation.

As Mick Jagger said,  “You can't always get what you want, but if you try sometime you find, you get what you need”. 

This is not only the best route to Quality, it is the only route, and there is only one way to get there.    It takes lots of discussion, lots of input and a lot of free-flowing opinion.  And it takes knowing the difference between wanting and needing, and being prepared to argue for what they believe is right.

So for those that participate with me in the pursuit of Quality, let me give full warning.   I will say that by nature I tend to be a pretty assertive (some say feisty while others say aggressive) participant in Quality discussions.  It is part of the passion.   I know what I know and believe what I believe and I will argue my point to the limit.  When I concede it is because I have found the way to “get what I need”.  It is not my responsibility to watch out what you want, but it is my responsibility , to all my extent possible, to respect what you need.

It isn’t personal, it is just business.

M

PS:  For those interested, the POLQM Certificate Course in Laboratory Quality Management is filling in more quickly this year than in any previous year.  If you are interested, check out the information at www.POLQM.ca  

Following through

There are lots of organizations with good ideas and even more with good intentions.  But in my experience even with those that plan to follow through the reality is that all too frequently it doesn’t happen.  It’s not that they didn’t want to; it’s just the way it works out.

Most organizations have an executive that gets voted in for 1 or 2 years.  It is unusual for the executive to continue for a lot longer than that.  This high turnover rate unfortunately usually results in change in focus and priorities.  It is not so much that people are solely driven by their own personal interest.  Its more that circumstances change.  But the problem is that a lot of good ideas get started, but never completed, and with that a lot of opportunities for success come and go without progress.  Here today and gone tomorrow.   

So now it is my turn.  And I will see if I am any better at being able to keep things on track. 

I have recently become the chair of a strategic steering committee for a Canadian Quality oriented organization.  This organization is excellent in creating standards for national and international use.  But when it comes to internal discipline at the committee level they are a lot like lots of other well intentioned folks.  Projects begin and then then go away. 

This year along with the committee chair position I have inherited a SWOT analysis that was stared a year ago at our last in-face meeting.  Folks gathered together, then broke into work groups and set out to define what the committee’s and organizations strengths and weaknesses as perceived by the committee members.  In addition, the analysis looked forward towards the opportunities that could enhance activities and threats that could throw things off-the-rails. 

That was a good start, but unfortunately, consistent with common behaviour, here we are now, one year on, with no further activity.

Well I congratulate my predecessor for recognizing the strategic value of examining activity in an organized approach, and I support the use of SWOT analysis and a valuable Quality tool, but if there is no follow through then the process is barely an intellectual exercise.  Without some form of timely follow-through it is essentially an intellectual waste-of-time.  With being unduly derisive, somewhere on the list someone should have included “not following through” as a weakness, or more appropriately a threat.  To be fair, my predecessor had to step down prematurely, so it would be unfair to lay the inaction as her responsibility.

I am pretty comfortable with SWOT analyses, I did my first one for my proficiency testing program about 6 years ago, and I update it every two years.  I find it a very useful technique for prioritizing next steps.  It keeps me focused on where we are and where we want to be.  My only looming threat at CMPT is my inability to create a cohesive succession plan for me.  

You can see the results of my SWOT review in the Management Review section of the CMPT Annual Report at www.CMPT.ca

But I digress.

Back to the challenge at hand.  In preparation for our meeting tomorrow, we have sent out an electronic survey to all the committee members to rate the 16 Opportunities cited on scales 1-5 (lowest to highest) for choice, appropriateness, feasibility, and interest, and identified the top 6 that clearly stood out on all scales.  At our meeting we will now select the top 2 to take to senior management with the why and how to capitalize. 

In addition we will look at the 6 Threats and sort out the 2 that need addressing the most. 

Actively working through a process of identifying and clearing threats and optimizing on opportunities is one of my personal definitions of organizational progress.  Doing it over and over contributes to sustained progress and success.  I haven’t checked, but I hope that concept is captured in ISO9004:2009.

As with all organizations it is not within our purview to do our own analysis and then go and spend organizational money.  But it is certainly our responsibility to go through the discipline of the exercise and present the results in a definitive way to those that can make those important decisions.

So I congratulate our committee on starting a introspective look at ourselves.  I take it as my responsibility to move the process forward.  Once started, there is an obligation to work to a sound conclusion. 

I am interested in knowing if others have worked through the exercise and found value in SWOT analysis.

The Maturing of ISO 15189

I am just back from our ISO technical committee 212 meeting and another session working on the next iteration of ISO 15189 in Las Vegas.  It would be easy to go to comparing standards development  and rolling of dice, but I won’t bother.

This was perhaps one of the most significant ISO meetings that I have ever attended (and I have attended them all!).  It was much like being a proud parent.  I was there at the beginning with all the excitement and enthusiasm associated.  As the committee started to grow and we saw all the lurches and pitfalls and wondered if this thing is going to ever survive.  And now we are starting  to see the signs of beginning of growing up with some maturity.  And similar to the child analogy, this process has taken has taken near 17 years.

I5189 has had its struggles.  We have been working on this new iteration for  three years.  By now it should be a near finished document with a lot of support and consensus.  But instead we  had over 1000 comments and concerns raised very late in the game.  This could be well interpreted as someone has not been listening.

One always has a choice, bulldoze ahead, or pause and review.  And this time, for the first time, the approach was the latter.  Considering that this is a document about Quality and Competence, it is refreshing that the technical committee actually did an examination and Root Cause and identified the causes and proposed a solution. 

The findings were disappointing.  People not knowing or following ISO rules, focusing on votes rather than consensus, irregular participation of experts, and prematurely pushing on, when consolidation would have made more sense.  All the things that you would not want to see in the creation of a standard of significant international import.   So we turned over a new leaf and that is good.

One example, the best example.  Measurement Uncertainty.  It is a tragic story described by one as READY-SHOOT-AIM.  I saw it as an exercise in counter Quality.  Deming taught the world about PDSA.  Well we did something different.  We inserted MU into the document in 2003 when no one (and I mean NO ONE!) had a clue what it was about.  Then when we studied the impact and opinions of users, it was clear that folks were unsettled and divided and confused about MU.  We ignored the evidence and forged onward.  Kind of a NO_PLAN - DO – STUDY – NO_ACTION (NP D S NA) sort of cycle.  Not something that a group of Qualitologists should be doing. 

So this time we actually started to fix the MU problem.  Stricter definition, more guidance, and clearer message. 

It is OK to make some errors along the way even in the production of documents, but when you leave them and ignore them and don’t learn from through the exercise, then at some point it is reasonable for folks to wonder if you are really up to the task of developing quality standards. 

Well finally we have done the right and positive thing, we have actually acknowledged that moving forward is not an issue of guilt or embarrassment.  It is a step along continual improvement. 

With luck we will see this next iteration perhaps as ISO15189:2012.  It will be the third iteration and the first with significant change. 

Good standards have a lot in common with good wines; they take time to mature and they get better with age.  They distinguish themselves from the plonk-du-jour that collapse into vinegar… bad vinegar. 

We will see what happens.  This can still go off the rails.  A nutso relative can still cause problems, can take these first forward and maturing steps and dash them all.  I know it and I understand it and I (in quiet moments) worry about it. 

In that case the document will probably disappear.

But in the meantime we can celebrate our taking a good idea for a great international standard and making it better.

I am such a proud parent.   

No "I" in TEAM but there is in "ISO"

I am looking forward to our annual plenary meeting ISO Technical Committee 212.  This one is at the MGM Grand in sunny and warm Las Vegas.  A lot of discussion, and maybe some time for a show.  ISO meetings are an interesting experience.  They remind me of that there is no “I” in TEAM” but there is a big one in “ISO” and a small one in “Quality”.

ISO (aka the International Organization for Standardization) is a collective of individuals each representing their country, their region, their organization and themselves.  There is a large wack of egos (including mine) in the room each there addressing a series of personal agendas.  On the highest level, there is the Prime Directive to ensure that any standard that gets created meets the needs of  each individual country and region.  The whole point of ISO is to set rules that will create and foster the foundations for common trade, business alliances and product compatibility.  If a document is created with undue unfairness or bias then a country’s business and trade can be compromised. 

I often remember the conversation that I had with a long-time colleague who told me that his specific instruction from his country was to attend these particular meetings and ensure that no document would ever see the light of day unless it was fully compatible with his country’s specific health system needs.

Individuals are very much aware that they attend these meetings at the pleasure of their employers.  Time to attend and participate in meetings in nice hotels in nice places comes with certain expectations.  For manufacturers they want to see their products on the winning side.  For accreditation bodies, they need to see opportunities for documents that can be used to help laboratories in their specific region.  For consultants they need to see opportunities for doing their consulting thing and making money.  And for academics it is about the books and manuscripts and coursework edge.  And for “bloggers” it is a gold mine for shared opinion and experience. 

None of this is bad stuff.  We might as well put our money on the table and acknowledge our collective vested interests.  What happens is course is that all these interests intermingle as the standards development process moves forward.  A little bit of altruism and a large dose of collective, sometimes incompatible self-interest trying to find that place where everyone can live with the outcome. 

As complicated as it sounds, what is remarkable that when the smoke clears it usually works fairly well, baring the unintended consequences that can arise, but more on that another time.

I will tell you that there is one collective loser in the process.  Resources limited regions (RLRs) always get ignored or always get the short end of the stick.  Folks from RLRs rarely have the resources to attend meetings and participate in the discussion.  The interests of the RLRs get subsumed by the interests of the attenders.  So the documents usually are a collective of wealthy region assumptions and wealthy region practices.  Many of the requirements are so far outside of the reality of the RLRs that their opportunity to adopt these documents in a meaningful way is all uphill and near impossible.  Good for the 1 percent, but  rarely a successful strategy for the remaining 99.  This could be fixed if RLRs were represented and were in a position to stand up for their reality and circumstance.  But this will unfortunately take a long time and a massive amount of work to overcome. 

An organization like the Gates Foundation could make dramatic steps forward in RLR health by a judicious use of representation money and resources with a lot of strings attached.  Bill, if by chance you are out there reading this, give me a call J.

But there is another “i” that is important to consider.  Documents like ISO 15189 and 9001 and 9004 and even (shutter) 17025 can enhance operational quality for the medical laboratory.  There is an "i" in Quality and It is in every person’s best interest for quality processes to succeed. 

For the employee Quality programs enhances personal TEEM (time, effort, energy and money).  Structure reduces time to the detection of error and reduces the effort and energy for getting back on track.  Reduced error saves the budget, and reduces the risk of budget overruns thereby protecting positions.  In the private sector, Quality increases profit. 

For the patients, quality reduces error and distrust and frustration, and reduces the need for looking for compensation (as in reducing the risk of malpractice suits).  For the clinicians it speeds up the process to high value diagnostic information. 

None of this is bad, indeed self interest is a motivator to make ones life better, and if it helps others at the same time, that is OK.  Gordon Gecko (a character in the 1980`s movie Wall Street said “Greed is Good”.  Well, by the same spirit,  self interest in Quality is also all for the good”.

More on the ISO meeting coming up.    

Standards do make the world go round –WSD 14 Oct

This year’s World Standards Day on 14 October 2011 is themed ‘International Standards – creating confidence globally’.  The international community recognized WSD2011 with a poster contest which was won by Caterina Fiorani  apparently a young architect working in Rome who has been quoted as saying that the graphic displays two open hands which are composed from the world’s continents, and represents honesty, helpfulness, and  cooperation for a common purpose (See below).

I congratulate the artist for her excellent design that well warrants the award and recognition. 

Although Canada is a very active member in the international arena of standards development, and I am a very active member of the Canadian standards community, I find that there is near nothing of recognition of WSD in my country.  I know it is so, but I don’t know why. 

Now I know and understand that WSD is not quite on the same level as Canada Day or Christmas.  But it must rank somewhere above Ground Hog Day.  I don’t really expect it to be a national holiday, but it is an opportunity for standards development bodies to create some buzz and awareness about what we do, and why it is actually pretty important to Canadian society. 

Imagine a world without electrical standards, construction standards, nuclear standards, and no medical standards.  Imagine a world without a Canadian Standards Association.  Shoddy and dangerous construction with ladders and bracings built out of sticks and twine.  Totally unstable electricity and dangerous wiring. Two or more people to a hospital bed.  Hygiene by and large non-existent.  And nuclear melt downs from incompetent workmanship (No, this does not describe Fukushema). 

Without standards we would all be huddled in a corner like some Eastern ba***rd freezing in the dark (ask any Canadian over the age of 50 for the reference to this phrase!)  

Standards Council of Canada is recognizing WSD2011 in a very small way, with a breakfast meeting in Ottawa.  That may be good for folks in Ottawa, and maybe as far away as Montreal, but it does not work well for us folks in British Columbia.  For the briefest of moments I thought about attending, but 3000 Km (and back) is a pretty long hike for a networking coffee and muffin. 

Maybe for next year I will be able to convince them that networking in Canada is better achieved through having linked events held in Halifax, Montreal, Ottawa, Toronto, Winnipeg, Edmonton and Vancouver perhaps with a video-linked presentation.  Such is the reality of living in a country that spans about 5000 Km west to east. 

I would like to say that at least we are doing something out here to recognize Friday as a special event day, but alas, I have been pretty silent here too. In part my absence of activity was a matter of problematic timing.  My colleague who is a graphic artist was on world travel during the month prior to the competition, so we did not get a poster done in time.  Again, it would have been very appropriate for us to have our Quality Weekend Workshop not in June, but in October.  We could have done that, but there are already a wack of conferences being held around this time and getting folks to travel would have been a challenge.  We also could have held our CMPT Annual General Meeting a few weeks later, but timing was not going to work out for that either.  

Bottom line was it did not work out.  As they say “Woulda, Coulda, Shoulda; but I didn’t”.  But if we want to be a part of the process then we have to stake our claim. 

No more excuses for WSD2012.  Written in stone.

M

PS:

In the meantime, lots happening next week including our annual meeting of ISO Technical Committee 212.  Will give a summary of the meeting.

Improvement through Disaster.

I have always believed that Quality improves with the help of Quality Partners and the Partner with the greatest power is a motivated angry public.  

Today we heard the Quebec hospital (Honoré-Mercier hospital in St-Hyacinthe Québec) agreeing to the terms of a class action suit for harm (and deaths) resulting from an outbreak of in-hospital (nosocomial) diarrhoea caused by a bacterium (Clostridium difficile) that was likely spread from patient to patient by less than hygienic practices.   The amount that each of the aggrieved will receive is small in comparison to settlements in other countries, but the implications will none the less be significant.

The institution will hire more infection control practitioners and improve their cleaning services either through more cleaning staff or a more extensive outsourced contract.  We understand that this will not solve their problems (and I am sure they do as well), but it at least has the potential to reduce the number of outbreaks and hopefully create the conditions to stop them faster. 

For Patient Safety issues this is all for the good, recognizing of course that when the next outbreak happens you can “hear” the finger pointing.  (“You assured me that if I hired you more staff, this wouldn’t happen.  Well I did and here we are.  THIS IS YOUR FAULT.  Once we are out of this mess you caused you are so-out-of-here!”).  On the more positive side, hospitals have long been hotbeds for injury resulting from insufficient staffing and inattention to detail.  Falls, medication errors, microbial transmissions. 

There is nothing like a lot of negative publicity and class action suit to get improvements. 

So what does that mean for laboratory practice and laboratory Quality?  From the half-empty side, since it is a challenge for us to get the public enraged enough to a class action suit, it could mean that laboratory quality will wait a long time to build that level of attention.  From the more-than-half-empty side, since budgets are a zero sum game, if budgets get expanded on the one side, the money is going to have to come from somewhere, and traditionally the laboratory has been an easy target.  

The reality is that clinicians often “price-in” poor laboratory quality, or at least what they perceive as poor laboratory quality.  “That result makes NO SENSE.  I don’t understand.  I never trust that D**N lab anyways.  Let’s just repeat the test and see what happens.”  The patient has no power in the exchange.  The patient never sees the result, never has the opportunity to put it into context, and has no discussion.  If the question is asked, there is usually a diffuse response.  The fact that the test was collected incorrectly, or transported late, or was mislabelled never becomes part of the conversation. 

Many laboratorians and their administrators have loved this because it provides the laboratory with a lot of buffer.  It may put them in a dangerously low profile position, but at least the negatives on budget result in only a slow (and persistent) leak.

But things are about to change.  As mentioned previously, some “commercial” [I prefer the terms “community-based” or to a lesser extent “private”] laboratories can now present results directly to patients.  Already CMS in the US has made rule change proposals to allow or oblige laboratories in the United States to do the same, even when state regulations prohibit.

Sooner of later, the conditions that result in upset public are going to happen.  Wrong result to the wrong patient.  A critical False Positive (a suicide from a false positive HIV).  A critical False negative.  An uninterpretable report.  An inadvertent crosslink between files and passwords.  But this time the patient will receive the result directly.  You know I am right because these things happen all the time today.  There is no reason for them to suddenly stop.  The only difference is that at this point the patient will receive the report directly and get angry. 

No one thinks of angry customers or law suits as good things.  They are not good things.  They are the consequence of poor practices.  They represent inadequate care.  They represent (sometimes) the consequence of persistently shrinking budgets, too few technologists, and too many personnel who are undertrained. 

So I say thank you for engaging the public directly.  I say let’s embrace the risk.  The smart laboratorians will figure this out before hand and mitigate the risk through pre-emptive improvement.  The others will learn the hard way. 

Nobody says that good things can’t arise from the ashes of disaster. 

To my Canadian colleagues, I wish you a Happy Thanksgiving.

M

AGMs and ARs are critical to laboratory quality

Monday and Tuesday we held our Annual General Meeting for CMPT.  It is an interesting exercise that we have done for each of the last 15 years.  Our audience is usually limited to our partners including most of the accreditation bodies across Canada, and all our committee members. 

We often have special guests, but unfortunately we have never figured out a fair and reasonable way to invite representatives from participant laboratories.  That is a problem with programs that come across the full scope of Canada.

Monday is a public session with everyone together for full discussion and participation.  Tuesday is an in-camera session when we define our EQA challenges for the next 12 months.  

The AGM is an opportunity for us to present on the activities of CMPT including our management review, our Opportunities for Improvement (OFI), our organizational indicators, the status of our current research and development, and in particular our objectives for the next 12 months.  It becomes a valuable time for open questions and answers.  AGMs are a good time for challenging questions, and clarifying policy and planning.

It is my experience that AGMs and ARs are instruments of organizations and corporations, and university departments, but not of laboratories.    That’s too bad.  One can understand why.  Neither is mentioned either normatively or as a recommendation in any of the three ISO standards important for laboratory quality (ISO9001, ISO15189, or ISO/IEC17025).  They are not mentioned in standards guidance from WHO or Clinical and Laboratory Standards Institute (CLSI) or within Clinical Laboratory Improvement Amendments (CLIA).  Neither  are noted as expectations within the documents of any Accreditation Bodies.  So in the absence of direction or requirement or expectation, they just never get onto the radar screen for any but a select few.  A Google search finds a few laboratory-created annual reports, but not very many.

There are a lot of advantages to AGMs and ARs that would be usual for many laboratories.  They are both instruments that focus attention.  It is really easy to think about all the good things that happened during the last 12 months.  It is even easier to forget all the bad.  In the absence of a record and presentation it is really difficult to ensure an active program of continual improvement. 

Further, in the absence of a record, it is really easy to have goals that are more ethereal rather than concrete.  Knowing that 12 months from now you are going to stand in front of a crowd of interested folks and explain why all your plans and goals went by the wayside is a pretty good motivator for staying on track.  If your goals were good enough to define, they are good enough to try an meet.  (Parenthetically, in as much as I don’t like to migrate into politics too often, let me just say that in my opinion, a politician who tells us what they plan to do once elected and then after the election go and do it, is my kind of politicians. I call it commitment.)

Finally, creating reports and presentations is perhaps one of the most effective modes of direct communication.  I know of no program more effective for sorting through customer satisfaction that facing the group in a room once a year. 

All in all the exercise is fun and entertaining, and in my opinion, worth a try.

As mentioned, the CMPT annual report is available for public viewing at www.CMPT.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.