Sunday, May 27, 2012

The Canadian Standards Association: Impact versus Awareness

I am putting together a presentation for a meeting in Quebec City in June.  I was invited to talk about the impact of Canadian Standards Association (CSA) documents on Canadian healthcare.  As I am putting it together I recall a conversation that I had at another meeting about 10 years where a Canadian microbiologist spoke up asking why I would put in any time with the CSA because they did so little for healthcare other than to check that the electrical plugs on radios and equipment were OK.  I suspect that at that time vast majority of my colleagues probably thought this same way.  We will see if things have changed.    

To be fair to my colleagues, most of their time is spend being hands-on technical laboratorians and most of the documents that they look are written by the Clinical and Laboratory Standards Institute.  The CLSI is a developer of many documents of critical interest for the laboratory worker.  Many of their documents are used world wide.  CLSI documents fill a specific niche extremely well.  But if you think about spheres of influence as a form of Venn diagram, the areas where CLSI and CSA cross over is quite narrow, and there are many health related documents that are addressed by CSA that are not addressed by other organizations, including CLSI.

I have spent a lot of career time working around the CSA.  I helped develop and chair the technical committee to focus on medical laboratory Quality Systems, and with CSA support lead the Canadian delegation to the ISO.  Through that committee we participated in writing key documents for laboratory Quality (ISO 15189), laboratory safety (ISO 15190), and point-of-care (ISO 22870) all of which became national documents.  We have shared in developing documents on medical laboratory Risk Management, antimicrobial testing, and packaging labelling.  So from that point of view alone I could justify the time spent working with CSA was time well spent.

But it was when I moved up a step to being a part of the Strategic Steering Committee for Heath Care Technologies and Services that I truly appreciated how much CSA is a health standards body.  Today there are hundreds of healthcare related CSA documents that impact medical devices, facilities engineering, anaesthetic gases, peri-operative procedures, renal dialysis, blood transfusion, tissue transplantation, equipment cleaning and sterilization and infection control, radiology, ultra sound, dentistry, caring for disabilities and medication packaging.  There are essential standards that impact every aspect of the medical laboratory.  Indeed it is hard to think of any part of healthcare inside or outside of health care facilities that is not directly influenced by CSA standards.  

I wonder why after 50 years of engagement in healthcare, there continues to be this huge disconnect between impact and awareness.  

My guess is that there are a variety of reasons that come down to a few root causes.  First is that CSA works in the arena of documents creation, and to many in healthcare this is just plain BORING.  Additionally there are so many organizations that truly believe that document development is a “nickel-dime” process and that they can do it themselves.  And they can and do.  It is just that they do it very badly.  I sat on the standards and guidelines committee for a medical organization for a number of years.  The number of trash documents was tragic.   Recent experiences tell me that little has changed.  The consequence is that there is little regard or even awareness in document source or relevancy.  Just photocopy it and be done with it.
A contributing factor is that Quality issues have almost no play in any aspect of medical education at any level; it is for all intents absent from undergraduate and post graduate education.  The words like “standards development organizations” or “quality partners” or “accreditation” or “proficiency” never come up; ever.  Quality means newer or fancier, not better.  Certainly no one would ever discuss an essential quality partner like the CSA.  Healthcare professionals have little idea about what is a document and what is a standard until well into their career.  It is a stumbling-bumbling process. Perhaps the fact that there is a meeting for laboratorians and I have been invited to present on the topic is a key step forward.

But in the meantime, for us that are interested, the field remains wide open, filled with opportunity and promise.  And a real sense of accomplishment, knowing that we contribute to greater healthcare and society in truly essential ways that others can not understand.  

For those interested, I will post the presentation file after the meeting.

Also, you can visit the CSA on-line store catalogue at:  Click on the Publications link at the top.

Thursday, May 24, 2012

The Challenges of Quality oriented research

A few years ago I wrote a paper "Does external evaluation of laboratories improve patient safety" (Clinical Chemistry 2007).  The premise of the article was that literature and studies link positive correlations between awareness of standards and accreditation and performance on proficiency testing and on opinion/knowledge about quality issues, but there are none that demonstrate any of these important issues are definitively associated with improved or better laboratory performance.  

The answer about why this is the case is clear.  In the first place there are a huge numbers of variables that are known to have an impact on laboratory performance.  We have talked about many of them in MMLQR.  Factors such as busyness, noise, distraction, temperature, staff levels, stress levels, personnel personal issues, supervision, laboratory financial health, patient factors all play a role in generation of error and would not likely be evenly distributed.  Errors are usually not reported, and even at their worst happen uncommonly and irregularly, and that would mean that a study would have to occur for an extended period of time to generate enough information to draw a conclusion.  Put succinctly, to perform study on impact of accreditation, proficiency testing, and knowledge on laboratory performance would be near impossible.
That being said, it is important that I stress that in my paper I opined that while it may NOT be possible to prove that being accredited or doing well on proficiency testing was likely to result in improved performance, it would nonetheless be inappropriate and completely wrong to end Quality Assurance programs

On the other hand, it seems to me that there are certain sectors where a study could be developed, at least theoretically.  Take the construction industry.  In theory one could identify two groups of construction organizations, one group known to be certified to ISO 9001 and another group known to NOT be certified to ISO 9001.  Find them in a common geographic region, with relatively same types and numbers of employees, generally being involved in the same activities such as building homes or roads or bridges.  Put together a survey instrument to ask about opinions and knowledge and then talk to their customers about turnaround time, error, complaints, etc.  The study might take a couple years and a million dollars or so, but it is theoretically possible.  It would be reasonable to suggest that if Quality participation was seen to definitively improve construction performance, it would support the argument to maintain it in heath.

So I was really excited when I saw an article title in the January 2012 edition of ASQ Quality Management Journal entitled “The Effects of ISO Certification on Organization Workmanship Performance” by Jospeh Iwaro and Abrahams Mwasha, both from the University of West Indies in Trinidad and Tobago.  I was especially pleased to find in the abstract “It was found that ISO9001 certified organizations performed better in workmanship performance..."

Unfortunately, at least the way I read their article, as much as it has a lot of good information, I could not in the manuscript as published and printed the direct evidence to support better performance.  My interpretation of the study is that a survey was undertaken with a spectrum of people in the construction industry about their opinions on a number of factors that would be linked to better performance.  People working in ISO certified companies were significantly more likely to say as compared to people working in companies not ISO certified that they had seen or believed that workmanship performance was enhanced by improved communication, better documentation, better supervision, better work performance, and better management, but that is different from actually looking at the product of the performance, such as error free homes or bridges or roads.  I can understand why people in certified organizations would believe that ISO certification improves performance, even though there is good evidence that most certifications are ineffective (see Boiral and Amara, QMJ July 2009).

Assuming that I have read and understood this paper by Iwaro and Mwasha properly, it provides interesting information that is strongly supportive of Quality participation, even if it is not the definitive study.  But is is still much appreciated and is very much worth the read.

Here is what I believe:
1.    Research in the impacts of Quality participation is very difficult but is nonetheless very important.
2.    Doing direct impact studies may be impossible, but at a certain point a preponderance of support from indirect studies will “prove” the value of Quality participation.
3.    In the mean time, there is already enough information and evidence to support that standards development, quality management procedures, accreditation and/or certification oversight, and participation in external quality assessment help organizations improve.
4.    It is a bad and dangerous decision to consider it acceptable to avoid Quality participation as an approach to reducing expenses. 

Smart organizations understand the value of Quality participation, even if they can’t definitively prove its value.

Wednesday, May 16, 2012

Taking a Quality Ride

I spend a lot of time looking for new and interesting books to expand my Quality library.  There are tons of books available, but a lot of them have that “been-there and done-that” feel and content.  Every once in a while I find a pearl that makes it worthwhile for me to keep going.

This week I went to Amazon and found a 2006 little book (113 pages) entitled  Take a Quality Ride: The Realities of Implementing A Quality Management System written by Susan Marie Hinkle.  It is a real gem, and even though it is now 6 years old, I find that it still holds up as a must read.

Susan Hinkle is a Quality Professional with a lot of experience implementing and maintaining Quality systems in a variety of industries (not health care).  She has written this book, not to compete with Joseph Juran or Phillip Crosby or W. Edwards Deming, but to point out some valuable insights based on her experiences.  I like this approach, in large part because her experiences are a lot like mine, and I think really valuable for the organization that is thinking about implementing a program for the first time.  I suspect that there may also be some organizations that have tried to implement but failed, who might be interested in reading that they are not alone in their failure.  It might give them reason to try again, being more aware of the pitfalls that are very common.

She raises a number of key points such as the importance of doing Gap Analysis.   I used to see this all the time; organizations thinking that they can save some money by skipping a Gap Analysis before they get the certification body or accreditation body involved.  This is rarely a good idea, and defeats the notion of organizational learning through improvement of gaps and errors.  I have mentioned before the real value of bringing in an outside person to help with this step (the so-called External – Internal audit.   

Another point she makes is about the real power of the voluntary certification or accreditation.  Susan makes the point that given a choice the organization should find the best fit assessor (It is not necessarily wise to choose the lowest priced certification body or appraiser.  Remember the certification auditor or lead appraiser is there to find out what is working well and encourage you to get certified or rated, not to punish you for things you have not done, so it is in your own interest to find a competent certification body or appraiser.)  I suspect that these days she might extend this further to reinforce that this optimum assessor is the one that best fits your needs.  Just as the cheapest is often not the best choice, neither should the most expensive be the best option, and similarly a cautious look should be taken before on takes on a assessment just because it is from another country.  Often local is best because the assessors know the language and know local conditions.  The key issue is to actively decide on whom to use as the assessor.

I also like her point about those annoying experts who extend unsolicited advice or suggestions that are rarely useful. Expect the “experts” to come out of the woodwork, but do not let them get in the way of your implementation project or get you down.

One point were we might disagree is where Susan talks about thinking about Costs of Quality mainly in money terms.  This was really an older concept which ignores the impacts of consumption of time and effort and energy that not are the consequence of error but important causation or perpetuation factors (TEEM).  I suspect up reflection that she would consider this as a better scale for measuring costs.

So, from my perspective, Take a Quality Ride is still a fast easy read and a great book.  It is well worth the money you would pay for a paper copy (less than $20).  Buying an electronic copy is almost like getting it for free, but in this situation the old adage of “you get what you pay for” does NOT apply.

I am interested in others’ opinions (including Ms.Hinkle’s) on this or any other book gem out there.

Saturday, May 12, 2012

Convocation messages

I attended a medical school convocation ceremony this weekend with a about 300 young people transitioning from being medical students to medical graduates.  A lot of positive vibe going on with satisfied students and appropriately proud families and friends.  It was a re-enactment of a tradition that goes back for hundreds of years.  It reminded me of my own convocation ceremony and gave me opportunity to reflect upon how much I had learned in medical school and how little I knew and understood.

It is perhaps a reflection of my last 30 years, but as I heard the occasional presentation by the Associate Dean of the school, I actually listened to what he had to say.  I know that his goal was to be aspirational, but I wanted to give a commentary response.  Fortunately I had enough foresight to keep quiet.  Convocation presentations are not intended for discussion and debate. 
First, I could not agree more with his advisement to the class that society gives physicians the awesome authority by which with their signature on a piece of paper they can provide people with medications, can allow people to either remain off or return to work, and most importantly can spend very large sums of other people’s money (OPM). 

I have always been aware of the close connections between OPM and OPIUM.  Consuming both can provide a certain amount of pleasure and sense of power, but can become dangerously addictive and can lead to ruin.  Extensive over-ordering of tests can become a problematic habit and a danger to Quality. 

Somewhere along the way medical students should learn very early in their careers that ordering every test is a good defensive strategy to prevent being sued.  A better message is that inappropriately excessive tests costs the system a fortune, but does not provide more information; it indeed provides less.  Over-ordering tests leads to diagnostic confusion, false positives, and leads to more repeat tests and more supplemental testing.

Here’s a thought; if docs want to order tests for their own purpose, there should be an insurance code where the charge for the test is billed against the physician, not against the patient.  If you want it just because the information would be “nice to know”, then you should pay for it yourself.   

When students learn that over-ordering is both bad medical practice and poor patient care, and a tragic waste of other people’s money (OPM) they have learned a valuable lesson. 

Unfortunately in the same presentation, the Associate Dean commented that when students came to medical school they were both unknowledgeable (true) and ignorant (maybe a little strong!), but over their 4 years of education they learned not only how to perform medicine, but also how to speak medicine.  They learn the language of medicine that allows them to speak to other colleagues.  They had learned the “special words”.  I agree with him that that is what medical students learn, but I have to disagree with his intent because I understand the term “special words” to mean the same as “jargon”.  

As I have mentioned here before, I do not consider speaking and writing in jargon a good thing, I consider it a potentially dangerous crutch that needs selective use and containment.  We don’t go to school so that we can talk with other doctors.  We go to school that we can communicate and assist patients.  Patients need to understand what we are trying to say and saying it with “special words” does not help.  As pointed out before, today and even more tomorrow, our laboratory test reports and surgical reports, and medical notes are viewed as the proper property of our patients.  It is not the obligation of patients to learn how to understand our “special words”, it is our obligation to create information in a manner and text that people can understand without being trivial. 

Inevitably there will always be some words that need to be part of common dialectic; words like Calcium, and Haemoglobin, Thyroid hormone, and Staphylococcus.  But at the same time when we use these words we need to supplement them with text that allows people to understand our interpretation of results.  This will not be easy.  We have become very comfortable within our own jargon. 

We do spend some time learning how to speak to patients but is not a priority for students in the same way as jargon is.  But is something that our future students will have to learn.  It is a matter of communication and a matter of Quality care.

Tuesday, May 8, 2012

Quality and the Pre-examination delemma

In my last post I commented on our recent  Quality Seminar in which there were two papers on a new standard being developed to help laboratories improve their pre-examination procedures.   

The problems are well established.  The pre-examination phase of laboratory testing is a highly manual, person intensive group of procedures that address collecting, transport, accessioning and storing of patients’ samples.  The system is fraught with error, usually accounting for 70-80 percent of reported laboratory errors. If a laboratory wants to improve their overall performance and contribution to medical care they should focus on reducing their absolute numbers of laboratory error.
The new Canadian Standards Association standard (Z316.7 Primary sample collection facilities and medical laboratories – Requirements for requesting, collecting, transporting, and storing samples for patient safety and quality of care.) is going to be a valuable and informative guidance document.  

I suspect that most Canadian accreditation bodies will pick it up as a good accreditation document, and even if they don’t, laboratories will still find it an invaluable document to support their quality system.  It is broadly inclusive and rich with guidance.  If I have a criticism (and it is pretty minor), it is that some may find it almost too encyclopaedic.

On the other hand the informative annex designed for Microbiology is the opposite of encyclopaedic.  It is compact and more general than specific, but in an invaluable way.  Microbiology and tissue pathology are very different from Chemistry and Haematology because microbiology and pathology samples are rarely collected by laboratory trained and supervised personnel.  The annex makes it clear that that samples for each laboratory need to meet a specification  set (proper technique, correct container, accurate information, proper handling and transport) and if they are not met, the sample will likely be damaged and the quality of the sample impaired.  

The collector needs the information before collecting (afterwards is too late) and if they do not know the information for this specific laboratory (each laboratory is 
different) then check the correct manual or CONTACT  the laboratory BEFORE you collect the sample. 

Commonly microbiology samples are collected by nurses or physicians, and sometimes by the patient or their family.  The physicians and nurses that collect these samples are all professional, and caring, and knowledgeable in their field, but the reality is that few of them are informed about what to consider when collecting a sample for the laboratory.  Few actually look at a collection manual, and assume the way they learned it back in school is still the right way.  Some (not many) still work with“Just get it to the laboratory.  They’ll figure out what to do with it.” 

All too often we have not been clear enough about our message:  if you didn’t do it right, then you did it wrong and the laboratory can’t undo the damage.

The challenge to us is how to communicate the message.  We can write collection manuals, but when you consider how many pre-examination error occur, that does not appear to be particularly effective.  In some special facilities some of the information can be embedded in the laboratory information system, but again the information is usually seen after the collection when it is already in a wrong container, or in the refrigerator.  And none of this addresses the sample collection that goes on in all the family practice offices, and walk-in clinics, and homecare settings.  

The new standard makes it clear that as much as we have allowed the other people to collected our samples, we are responsible for the overall quality and we need to take more responsibility in ensuring that the pre-examination phase is done properly. 
All this brings us back to how we teach adult learners.  Adults learn what they understand is relevant to them.  They want it delivered clearly and concisely in a format that makes sense and in a manner that allows for communication and clarity.  

Experience tells us that writing memos or newsletters or posters are not sufficiently effective.  Holding workshops and seminars doesn’t seem to hold a lot of interest.  Non-motivated adults choose to not learn.  Positive motivation works better, but sometimes so does negative motivation.

If we are responsible for the creation of laboratory information, then at a certain point we may eventually have to become more aggressive in ensuring pre-examination requirements.   More hard lined.  Samples will not be accepted unless we can confirm they were collected in the proper fashion, and put in the appropriate containers and handled for transport in the appropriate fashion.  Fewer samples will be processed, but our confidence in the reliability of outcome for the ones that are will be higher.

In the coming era, soon if not now upon us, when reports go directly to patients with increasing expectation for accurate and meaningful results, then our choices are getting fewer.

So with apologies to Philip Crosby, welcome to the new version of DIRFT:  Do It Right Or Don’t Do It At All (DIRODDIAA).  

It would be enough to get Demining to roll over in his grave.   

Friday, May 4, 2012

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 19th 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