Invitation to Participate with ISO

Greetings 

Those interested in medical laboratory Quality are aware that the cornerstone standard for Quality and Competency in the medical laboratory is ISO15189:2007 (now, but soon to be :2013).  In 2005, ISO published a document numbered ISO/TR22869 - Medical laboratories - Guidance on laboratory implementation of ISO 15189: 2003 that could assist some medical laboratories implement a Quality system.

This document is now outdated and  indeed should have been addressed at least 2 years ago.  

At this point the ISO Technical Committee has two opinions, one to terminate the document, the other to revise and refresh it.  Before a decision is made, they are interested in hearing the opinions of people who know something about medical laboratories and quality and the value of implementation guides.  

It is for this reason that I am posting a link to the survey that is being done for ISO TC 212.  Anyone interested in participation can go to:

http://www.surveymonkey.com/s/ISO22869

The survey has 9 questions, and should take less than 3 minutes to complete.

Thanks

Quick Quality

Question:  What do you think about "Quick Quality"?  Should we create the "Quality Olympics"; higher-faster-stronger?  Maybe we should require a new version of ISO standards every year.  How how about the 20 minute assessment?

I like to read Wikipedia.  I know that smart writers are not supposed to say that, because Wikipedia may be accessible and popular and quick and biased more towards opinions than irrefutable fact, but I like it for all those same reasons.  When I read through their articles I am not so sure of the verification of all the information, but it gives a sense of the scope of people’s thinking on a subject.

Take for example the word oxymoron.  It has nothing to do with stupid bovines (moronic oxen?)  

Wikipedia tells me that it is derived from an example of a Greek oxymoron basically interpreted as “sharply-dull”, and means a phrase of two juxtaposed that appear to constitute  an internal conflict, but which most commonly is seemingly accurate.  Examples include “bitter sweet” or “deafening silence”.  Relevant to this discussion, Wikipedia talks about “false oxymora” in which two words are put together in a way that expresses no inherent contradiction, but at the same time implies a condition that cannot occur.  This can be done for example as a way to express humor or an ideological conviction (“government worker”), or cynicism (“honest broker”).

It is within this context that I raise the term “Quick Quality”. 

From the discussion above, it seems to me that this is a phrase that the authors of the Wikipedia discussion would call a false oxymoron.  It may not be ideological and cynical; it is just a good example of alliterative and false language construct and a really bad idea.   

You can put the two words together but it generates a nonsense term.  Quick Quality may be something quickly but, for certain it does not derive from Quality, nor does it lead to Quality.  

You can look at the impact of Quickness at virtually every step along the way.

At the international and national standards development level quick decisions result in clauses like measurement uncertainty being put into standards like 17025 or 15189.  Here we are 10-15 years later and most of the laboratories of which I am aware (food and water laboratories) being accredited to the standards still don’t know or understand or support measurement uncertainty.  Clearly the inclusion of the clause was not given the time to be properly reflected upon.  Quick output of standards development inhibits the discussion and dialogue that is essential to ensure that the standards are actually recognizing and representing the key and core principles.  

It may be acceptable in consumer marketing to just get the thing out today.  Whatever is wrong, we can fix it with the next version.  That is not acceptable in standards development.

How about speeding up the implementation of Quality in the organization?  That seems like a good idea.  Why takes so long, we should be able to do it in 6 months, maybe less.  The implementation of Quality by management dictate is easy to say and easy to force.  But there is lots of experience and information on how not well that works out.  Quick in …Quick out.  

On a number of times I have referred to Boiral and Amara and their article on the high rate of certification failure  [see Boiral,O and Amara,N.  2009. Paradoxes of ISO 9000 Performance: A Configurational Approach.  QMJ VOL. 16, 36-60.]

Large internal barriers lead to failure, either as ineffective certification (when implementation never got started) or as ceremonial (when implementation occurred but actions were blocked).  I have seen both.

Those working in laboratories know and understand our accreditation cycle, fortunately now becoming a construct much in the past tense:

And wouldn't we all be happy if we could get those external assessments done in 20-30 minutes, maybe over coffee and lunch.  Quick and confident.  Right?

The reality is that Quality relies on the presence of leadership and planning and culture.  And it  takes time to be done right.  Rushing to get the quick Quality infusion gives the message that the organization is not really serious about this.  More likely this is more about a quarterly report or a requirement for an upcoming project or a decision to lead the charge to the next flavor-of-the-month.  Whatever it is, it is not about learning or improving or being engaged over the long haul.

So there may be areas where quick action is good action, but implementing Quick Quality is not one of them.

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.

Tangible Quality in Action

Manky Badger asks for some tangibles that will illustrate the notion of “Quality” in action. 

These tangibles are derived from knowledge, study and experience dating back through the past 70-80 years and adopted by many business sectors.  They exist today in a variety of sources, most commonly from the International Organization for Standardization. 
Whether a laboratory adopts them because they have to (mandatory accreditation or regulation) or because they see opportunity and advantage (voluntary adoption or voluntary accreditation) depends on the situation and circumstance. 
Some laboratories do both.
Many organizations in manufacturing and service sectors have demonstrated the tangible advantages to implementing Quality practices. 

Most locales that have created requirements for mandatory accreditation adapt these same tenets into their own language, regulation or legislation

An active Laboratory Quality program includes:

Management should manage:

Laboratory Management should show leadership in the laboratory by establishing policies that are important to laboratory testing, and then ensure that everyone in the laboratory knows what they are and why they are set as policy. 
Laboratory Management should then ensure that laboratory decisions are consistent with those policies.

Laboratory suitability:

Laboratories should be fit for working in.  They should be safe and secure and have enough resources to perform the tests that they laboratory is required to perform.

In-laboratory communications:

To reduce confusion that leads to error testing, ensure that your laboratory staff know to whom they report and who reports to them. 

Ensure that laboratory users know who is responsible for laboratory decisions.

Documents:

Laboratory documents should be written in a way that can be understood. 
When there are documents that are written as different versions, people working in the laboratory  should be able to know which is the most current and active version.  
When documents are stored, they should be stored safely and in an appropriate way so that they can be retrieved when needed.

Training and competency of laboratory staff:

Employees should know what tasks they have been hired to fulfill.  They should be trained to perform those tasks and their training confirmed.  They should be checked on some sort of regular basis to ensure they have continued competency doing those tasks, especially if they have been away, or ill, or the task has changed over time.

Laboratory personnel should have access to the information and resources they need to perform their tests and tasks both efficiently and effectively.  This means there should be some form of written instructions.

Equipment, materials and reagents should be  as well as equipment and reagents should be in a condition that assures they are working properly.   

Employees should have regular access to continuing education to ensure that their knowledge and skills meet current needs. 

Employees should be aware that working in a medical laboratory creates obligations with respect to error prevention, timely testing, error reporting, and patient confidentiality. 

Error Prevention:

Laboratories have an obligation to reduce the risk of error through the programs mentioned above and also monitoring for systemic error through active programs of quality control, quality assessment, and quality indicators.  Signals of problems are investigated to determine if errors have potentially been caused, and if so ensure they are addressed.

Pre-examination error:

The laboratory should have policies and procedures that prevent poor quality samples (wrong patient, wrong test request, wrong conditions, wrong timing) from being tested in order to reduce the risk of producing results that are clinically misleading.

Post-examination error:

The laboratory should ensure that the right person gets the right report on the right sample from the right patient in a clinically relevant time.

Addressing error:

Laboratories are complex environments and to some extent some error is inevitable.  That being said, laboratorians have an obligation to monitor for error, to detected it early, to remediate it rapidly, to investigation why the error occurred and to the extent possible correct the possible causes, reducing the risk of similar errors. 

Customer satisfaction:

Laboratorians should accept all complaints as cause for investigation and action.  Where problems have lead to the complaints these should be addressed and corrected.

If a laboratory is able to say with confidence that they are working within a system that enacts these tenets, then they are doing the things that will reduce the risk of producing error, increase the possibility of detecting error, and when error is found fix it and learn from it, thereby reducing the risk of repeating the same problem again

If they are in place, we call that having a Quality program. 

To get more tangible, Manky Badger may want to consider a course such as the UBC Certificate Course in Laboratory Quality Management (www.polqm.ca)

Embracing Quality

I was putting in time sitting on the airplane, reading their airline magazine and came across an interesting note ascribed to an hotelier Jaume Tapies.  “People only embrace what they help to create.  It’s important to share projects with those who are invested in them. “   This caught my eye for a number of reasons in part because I was just returning from a successful quality assessment project and second because I know that successful hoteliers understand the importance of customer satisfaction as part of the quality process.

The notion of people embracing what they create is a really important concept as we build laboratory quality systems.  Many laboratories create quality teams who create documents and quality system trees either on-paper or on-line that are consistent with one organization or another, without ever engaging the people who are going to be expected to use the system.  Then they spend their time “communicating the system” by talking at the staff or worse emailing the staff about how user friendly the system is.  “This is how to read our new SOP.  I know it seems long and looks complicated, but it has everything you will ever need.  Trust me.  Trust me.”

This is rarely a path to embracing and engaging in the quality system.

How often do you hear comments in your organization like “Oh that’s quality.  Talk to Pat.  She’s the quality person”, or “Talk to Shirley.  I know where the Quality stuff is, but I never actually use it”.  Even worse, “this stuff is a joke.  I do it because I have to, but what a waste .  I could be doing real things, important things”.

Laboratory quality teams need to keep a few concepts in mind.  Quality is based on a very few guiding principles.  How they get manifested is up to the organization.  The quality system does not exist to meet the expectations of qualitologists or ISO or accreditation bodies; it exists to help the staff prevent errors from occurring and when they do, to catch them early, and fix them and learn from them and move on.  Quality systems that capture the guiding principles and at the same time fit the needs of the staff are good systems; and more to the point, quality systems that don’t fit the needs of the people who are supposed to use it are bad systems. 

There is another concept to keep in mind.  Embracing quality is different than being engaged in quality.  Being engaged is doing the steps you have to do.  Embracing is understanding the concepts behind doing the steps you have to do.  For lots of situations if you can get folks engaged that is pretty good.  There are all sorts of ways to get staff engaged.  You can give them pizza prizes, you can give them little gold stars.  You can remind them about filling in the forms when they forget.

Getting folks engaged can be a lot of work, but will get things done. 
Getting folks engaged is a success.

But getting the message shared and having folks understand why it’s important and how it makes their lives easier and improves the outcome of their effort is always better.  Getting folks to embrace quality is an accomplishment.

So I am interested in receiving comments from folks who have ideas about the things that we can do to get laboratory staff to embrace quality.  Twitter length (140 characters) is good but not essential.

Human Factors and Safety and Quality (?)

In 1986 Briggs Phillips published a small, probably near forgotten, but important study in laboratory safety (see in Laboratory Safety: Principles and Practices.  ASM Press 1986).  The author was able to identify two groups of people: one group of 33 who had experienced at least one laboratory accident in the last 2 years, and another group of 33 who had been accident free during the same 2 years.   The two groups were matched by job classification.    

The two groups were interviewed and surveyed for additional information.   

While not matched for the following characteristics, all including age, years of education, years on the job, weight, height and gender and marriage status were identical.  In addition, wearing glasses, medication use, showed no differences.  Also of interest, accidents outside the laboratory, and driving records were also equal.  

The factors that had significant differences were (A) smoking  (B) the number of accidents and injuries and infections acquired in the 2 years prior to the current 2 years (C) personal attitude towards safety (D) opinions of the safety awareness of their supervisors and co-workers, and (E) importance of training and communication versus personal experience.  In all these, the accident involved were more likely smokers (remember this was 25 years ago), had a long history of accidents,  believed that technique was more important than attitude, but thought that personal experience was more important than training.   

The accident free group were significantly more critical of the supervisors and significantly more critical of their co-workers safety consciousness, and believed that safety attitude and awareness were more important than having techniques and equipment.  

[If you are safety aware you will avoid getting into the high risk behaviour of rushing or allowing distraction.  If you are not safety aware, you are more likely to assume that equipment will allow you to go faster and increase risk.]

The message of the study points to importance of attitude and awareness in the avoidance of having a laboratory accident or injury.  

So why am I bringing up 25 year old studies?  Two reasons.

First, a recent study in ASQ’s Quality Management Journal V18, N:1, 2011 on factors associated with continuous  improvement in patient safety  by E. Naveh et al came to a similar finding of the relative importance of opinions on attitude and priority.

Secondly, and more importantly, what made the first study possible was that records were maintained on who had been involved in a laboratory accident or injury.  In many laboratories today, we have virtually no records of Quality accidents, and where we do have records,  the names of the people are commonly deleted.  So in many (most?) laboratories if we wanted to study the human characteristics associated with increased error, it would be impossible because we have no place to even begin.

Deming wisely called to “Drive out Fear” and I agree with that.  He also said that most error was systemic, and I agree with that too.  But Quality in the medical laboratory is a new field, and it is important that we study why errors occur.  Confidentiality is important, and so if avoidance of a sense of retribution.  But let’s not “throw the baby out with the bathwater”.  Continuous improvement requires having data to study.

That’s why they call it PDSA.

Quality and Obama Care.

Welcome to 2011.  

I suspect that most folks missed an interesting story that was published on the Times wire in US newspapers just before Christmas.  The article described how new regulation set to take effect in January will direct a substantial portion of insurance premium dollars away from executive pay packages and overhead and instead will require increased support for medical care and health care quality improvement.  Apparently insurance companies now can retain 25 percent of premium revenue for non-medical costs, but under the new rules they will be able to retain only 15 percent.  

Well that sounds good, especially the part about increased spending on quality improvement. 

I suspect that the way this is will play out will be that insurance companies will not reduce the actual amount of money for salaries and bonuses, but rather will just increase the premiums.  If I do the arithmetic correctly, that will require an increase in premium rates by about 66%.  Again if my arithmetic is right, this will not go over very well.  A massive raise in health insurance rates may not be perceived as a totally positive step forward.  But we will leave that battle to someone else.  

But I think there is an important question here, and that is, is there is a way in which money collected through the private sector can be allocated to quality improvement with a reasonable expectation of success.  My guess is that this will be a major challenge.

Let’s see if we can break this down.
1: If money collected by individual insurers remains in the hands of the insurer to do good things, there is little  reason to believe that each insurance company would develop an effective distribution process to move funds into the appropriate sectors to improve clinical and laboratory care.  Further, development of distribution offices within each insurance company would require massive costs and result in huge redundancy.  As US insurers do not cross state borders, this would result in a huge amount of geographic mal-distribution of funds and resources.

2: If each insurer was required to transfer the funds to a central government office, it would likely be perceived as a new tax, and would probably get tied up in a series of court cases ending at the Supreme Court.  That would take years and cost a fortune resulting in quality improvement money mainly support legal staff.

3: If each insurer was required to pass funds to a private sector central Quality Improvement Office operated by the consortium of insurers, the costs of redundancy would go down, but process and distribution costs would go up.  In addition there would still need to be an active oversight agency to establish and monitor rules, and that too would create even more costs.

So while the idea sounds great, my cynical self sees more opportunities for failure than success.  It will be interesting to watch to see what happens.  But I am not holding my breath.

In the meantime, in Canada and other countries where this is a public health funding model, there is every reason that agencies be designed for Quality Initiative Allocations with independent oversight.  In Canada we would still end up with redundant spending because of our obsolete structure makes health a provincial responsibility with trivial federal funding support.

The reality is quality initiatives programs would create net savings not net losses, so there should still be an incentive to implement these agencies.  So far the answer is that they do not exist.

With so much to gain, one wonders why.

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