Laboratory Quality and Risk and Prevention and Priorities

In the August 2010  issue of Quality Progress (ASQ) there is an article entitled "Two in One" on Risk Strategy.  It is written by Gene Razzetti a management consultant and military analyst.  It is an excellent article.  While he writes about some ISO documents on risk, he has left out a document that in my opinion should be part of the medical laboratory qualitologists personal library:

ISO/TS 22367:2008 Medical laboratories -- Reduction of error through risk management and continual improvement.

 As a Technical specification (TS) the document had the opportunity of rapid publication without requiring the high demands of consensus needed for a standard.  But it is valuable because it ties together four elements that the qualitologist works with all the time (Quality, Risk, Prevention, Priority).

Working through remedial action and corrective actions are relatively easy, defining problems before they exist and then fixing them (Preventive Action) is tough.  Sometimes opportunites come from employee comments, concerns and complaints.  A big opportunity is by looking at implementation of new equipment or new procedures before they get implemented using risk tools such as the Failure Mode Effects Analysis (FMEA).  Another tool is using a RISK - Occurrence grid where on looks at the likelihood of the bad thing occurring (Remote, Rare, Common, Frequent) and its effects (Trivial, Minor, Major, Critical).  By creating measurement values to each pairing (a remote occurrence but with critical impact or a common occurrence with minor impact) one can define risk and set priorities.

These are decisions that come up all the time, and having a working strategy is REALLY useful.

The article in QP is pretty good and easy to follow.
But for a little bit of money you can order a copy of 22367.
Either way you can't loose.

m
 

Quality's second home.

From my perspective, modern Quality was born and raised in the United States.  Shewhart, Deming, Juran, Crosby were all international in their scope and influence, but their home was the US.  The military standard MIL-Q-9858 created by the US army as a requirement for businesses working the the US military became the root and origins of ISO9000.  When Ohno needed to learn about quality for the Toyota Production System can to the US to look at Ford and Piggly Wiggly, and it was in the US that Bob Galvin created the Motorola Quality System.  So the argument, in my mind, about the original home of Quality being the US is indisputable.

But it was in Australia that Quality grew up.  Australia is the home of the secretariat for the International Laboratory Accreditation Cooperation (ILAC) and the home (until recently) of International Society for Quality in Health Care Inc ( ISQua) .  And Australia is the home of NATA, which in my personal estimation is the premier and most credible national accreditation body in the world.  
So it will be a real personal pleasure for me next week to be involved in a Quality Workshop being held in Melbourne (Advanced Laboratories 2010).


For folks interested, there will be comments about the workshop here and copies of my presentations available on www.POLQM.ca after the workshop.


So in the meantime: G'Day Mate,
More Later.
m


PS: Canada is rapidly becoming a major player in the international quality arena, as well. 

For Folks with an interest in Proficiency Testing

As mentioned before, it is annual report time for CMPT.  Our annual meeting is coming up soon.
One of the names that is used for proficiency testing is "Inter-Laboratory Comparison".  There are many reasons to get rid of this name and indeed the concept because it implies that the point of the exercise is to somehow do "better" than other laboratories.  All that does is foster being duplicitous (i.e. cheat), and to view PT as something other than a quality measuring tool.
But at the same time, there are some advantages of creating a consistent method of grading performance, so that laboratories can monitor their own progress and performance, and provincial or state authorities can measure group performance.  In our program we developed a measurement which we call “Percent Achievability” 
In our program, we have 4 classes of laboratories: (A) complex , (B) Intermediate, (C) small, (C1) pack-and-ship.  Each group gets a set of samples that matches its level of complexity.  (A) laboratories get more samples and more complex samples.  (C1) laboratories get fewer and limited. 
Each sample or subcomponent of a sample, is graded in the same manner.  (4) Full value (3) Acceptable – with minor error (1) Unacceptable – major error and (0) Unacceptable – potential negative impact on patient care.
To measure Percent Achievability” we would take the score that a laboratory achieved over a year, and divide that by the score they would have received if all their challenges had received Full value.  For example: if a laboratory did 10 tests and received 8 Full Value (4) and 2 Acceptable – minor (3), their score would be 38, and their %Achievability would be 38/40 (95%).
We have tracked this now for a decade and have seen that over the years category (A) laboratories have maintained a consistent % Achievability near 95%, while smaller laboratories have not maintained the same level of success.  (see graph). 
First of all, I believe this graph to be a reflection of reality, and I think we can account for how and why this has happened.  As laboratory consolidation has occurred larger laboratories have been able to retain their expertise and competency, while smaller laboratories have not.
So my question is …
Is this a phenomenon that you are seeing in your jurisdiction?

Clinically Relevant Reporting.

Over the last while we have seen a number of events occur that are linked to POST-EXAMINATION error. One of them was related to our proficiency testing program (see the sheet on CMPT, and visit http://www.cmpt.ca/).

The sample was send as a urine sample from an elder female resident of a nursing home and was found to contain a pure culture of a viridans Streptococcus species.  The committee deemed this as a good and common example of a urine culture containing bacteria that most likely represents urethral or vaginal flora. 
there was an expectation that the laboratories recognize this and incorporate of a cautionary or interpretive comment an assessable requirement. Further providing susceptiblity tests results was deemed as inappropriate.  In other words, the laboratory was expected guide the interpreation of this urine sample result as a probable non-pathogen.

We have received a number of letters about this, citing the absence of commentary on such notes in commonly available textbooks and guidelines. But I think this is one situation where the books and guidelines are behind clinical reality.

This links to another situation that is developing in another part of Canada, where a pathologist has run into difficulty because of the difficulty in reading an interpreting her reports. 

And this ties to some additional discussion that is occurring to replace the term "normal flora" with "normal biota".
The central theme to all these occurrences is the single most important role that a laboratorian has is to provide useful relevant information.  It  is not enough to bring on new and novel tests and it is not enough to produce a rapid, accurate result. If the recipient of the report can't interpret the result, if the recipient can put the report into any clinical context, then everything else is a total waste of time, and potentially dangerous.
I suspect that Microbiologists and Anatomic Pathologists have more to learn about this than our Chemist and Haematology colleagues. Most of our information is in words (as opposed to numbers), and using un-interpretable terms, or mis-interpretable terms or unintelligible terms (call that jargon) is a clear defect.

So we believe that oversight quality partner bodies (like Proficiency Testing) have an obligation to ensure that laboratories provide information that is used for a clinical context.
So I don’t apologies for the committee’s decision to require clinical laboratories to provide not only accurate information, but also to frame the information in clear language that provides clinically appropriate context.
Proficiency Testing is not just about doing a test, it is about providing relevant and understandable information and that involves the whole of the total testing cycle.
M

PS: more on this topic later.

Training for Laboratory Medicine residents

It used to be said that the greatest deficiency in medical school training was the absence of any office management economics for those going into family practice.  I think that probably was true.   Maybe it still is.

But a close second in the absence of any quality management training for residents soon to be in management positions in Pathology around the world.  

Lots of time spend on immunohistochemistry (oops!), lots on Metallo-beta-lactamases (say what?), but precious little on what makes a laboratory competent.  Oh sure, a few spaghetti diagrams, and maybe a discussion by the local guy who does accreditation visits ("I can smell a bad lab within 5 minutes of being there"), but the message is still the same; PT is a pain but accreditation requires it, and "clean up this mess.... accreditation is coming!"

Two years ago I pushed to get 4 sessions in during the resident's "academic half-day"   (no, I won't go there) and covered a bunch of topics like Standardization, International Standards, Quality Partners, Quality Assessment (PT, Accreditation, and Internal Audits), and the Quality Tool Box (mostly LEAN and Six Sigma) and some general stuff on Laboratory Error.  The electronic survey indicated virtually no knowledge prior to the course (<10%), with increase in both knowledge and interest (>75%) after.  The group thought the sessions were sufficiently useful that it should be repeated every 2 years. 
Well, that was a good start.

So now it is 2 years later, and the message will be the same, but the focus is going to be different.
But this time I am being given 5 sessions (about 5 hours)

I am preparing my slides now.  This is my current plan. 

1:What is Quality Management, and why do you need to know about it. (History and perspective)
2: Laboratory Error - What is it?; What are the consequences (including Costs of Poor Quality)?; How can you measure and track it?;
3: Accreditation and Proficiency Testing as tools to support Quality Management and reduce Laboratory Error
4:  Monitoring Quality - Internal Audits, Quality Indicators, Quality Control,
5: Tools that support the Quality - Lean, Measuring Risk, Investigating error - including root cause.

Will continue to monitor knowledge and interest. Makes for an easy presentation at the International Conference on Resident Education.

m

PS: Input is welcome.  Just hit the tiny "comments" under the post.

August is a Quiet month

In my world, the Romans got it wrong.  August is really the end of the year and September is the real beginning.  (I know that  probably doesn't work for folks in Australia).  In Canada, August is the time of lazy hazy summer.  It's when nothing else is happening.  So August is a good time to reflect back on what has worked and what needs changing and what new opportunities lie ahead.

You could call this "taking stock" or since we are a Quality oriented group here, "Management Review".

For me it is the best time of the year for creating my Annual Report for CMPT, and maybe for POLQM.  It is also the perfect time for putting my presentations together for the upcoming few months.  I have presentations in September, October, November (maybe), January and February.

This year we will be making some substantial changes to the UBC Certificate Course in Laboratory Quality Management with a number of new video clips for introduction (a "talking head") and scenarios for case discussions.  The scripts are being written now, for videography probably in December.  I think the clips will add an extra dimension to the course content.

I had a conversation about the course with a manager of the  UBC Centre for Learning, Teaching and Technology.  This is the group that works our course through Vista Blackboard.  But they are also a team of teaching academics and creative designers and seem to know a lot about on-line teaching.  I think there will lead to fruitful discussion and help keep the course in the front lines of Quality education. 
One concept talked about is consistent with current practice.  Information and notifications generated about the course will show up here.  Case discussions and education will occur within the course site, but case materials will be published at www.POLQM.ca, we can use the full concert of education and information tools at our disposal.

The same thing will happen with CMPT and proficiency testing education.

So for those who may be filling some quiet, lazy August moments visiting MMLQR, use the comment section to say hello.   And for everyone else, see y'all in September.
m

PS:  Will be doing a Quality workshop in Melbourne September 6-7.  Report from that meeting later.

Deja View all over again

Today I read in Dark Daily another sad Quality story.  I suspect it is a true story for a number of reasons; Robert Michel, the Editor of the Dark Report and related sources, including the Dark Daily has become an important source of medical laboratory information, both good and bad.

For those that don't read the Dark Daily regularly, I suggest that you give it a look.

But the story here is about a poor performance on HER2 breast tumor markers for drug resistance.  Of note, this is the same test that got the laboratory in Newfoundland in so much trouble.  HER2 test errors lead to wrong decisions about the requirements for surgery and drug therapy.
I suspect there is not a medical qualitologist  (see "Welcome to the new laboratory")  in North America  that doesn't know the story of Eastern Health and the Cameron Commission.  So why was this hospital ignoring history 3 years later? 

What makes this story tragic is that they had a major signal when thy failed an EQA sample (see Proficiency Testing - in all its guises), and elected to ignore it. 
What makes it irresponsible  is that the problem was detected by staff and ignored by Management.

There is a good part to this story, although the hospital may not exactly appreciate it.  Two accreditation bodies did their job properly  (see Quality Partners  -- sorry not posted yet, but soon!) and closed that section of the laboratory down.

So by the time we finish with all the mess that this laboratory will now have to endure, what will be the sum total of the costs of poor quality here, and how many ways do can we think that the money could have been better spent.

By the time the last dollar is spent, having a functional Medical Laboratory Quality Team and a real quality management system will look REALLY inexpensive.

m

Welcome to the new laboratory?

I was reflecting with my colleagues the other day about how much laboratories have changed (in Canada) over the last few decades.  There was a time not that long ago when a laboratory had a General Pathologist Medical Director and that was it as far as medical leadership was concerned.  Gradually the number of medical laboratorians increased with a focused haematopathologist, or two, a clinical chemist (or 2) and a medical microbiologist, and a number of anatomic pathologists who focused their career around an organ system.  The laboratory was discipline oriented, but with more depth of senior expertise.  This all made a lot of sense because there were few technical or interpretive links between what the disciplines did, or how they interpreted their information.   

Note: these musings are not intended to be pejorative or dismissive of laboratory technologist.  See the next, or near next, posting.

But then around 1990 or so, everything started to change, first with the development of common technologies like immunoassay systems for antigen detection, and hormone detection, and increasing analyzers and automation in both haematology and chemistry.  The notion of distinct disciplines was starting to fade.

Today while we still focus our training programs in an increasingly archaic discipline structure, the laboratory is not only become more homogenized from a laboratory testing perspective, new foci of attention are growing rapidly.  Today there are folks (like me) that focus most of their attention on the broader aspects of quality, and others whose time is almost exclusively in administration, and others who exclusively do infection control, and others whose area of interest is all about molecular diagnosis that crosses every cusp that used to exist.

So we have become more and more specialized in what we do, but very little in a way linked to our traditional base.  I suspect that this is a trend that is not going to go away, and that as the years go by our foci of attention will still be more specialized and more cross discipline than ever before.

From my self-absorbed perspective, this is a good trend.  Laboratories will improve with the dedicated attention of management review, quality mission, internal audits, meaningful accreditation preparation, quality culture development and of course monitoring of indicators including costs of quality.

 So does that mean the number of quality focused laboratorians will increase  (a qualitologist?). 

Maybe.   I hope so.

m

PS:  Training programs better start to wake up.  As Bob Dylan opined, "the times they ARE a-changing". 

POLQM

What's a blog for?


While I am pretty much a neophyte at this, it has become abundantly clear that blogging is a bit of a self-indulgent vehicle for folks that are driven by ideas and the desire to communicate. If you accept that as true, then I am pretty much the poster-child for the blog. But there is still a lot of value in creating and sharing and reading blogs, and that is the quality and relevance of the information.

Take for example, that through this blog, I can notify you that starting today we have opened up the registration period for the 2011 version of the UBC Certificate Course for Laboratory Quality Management.

The course will start in early January 2011, is fully on-line, runs for 20 weeks. Certification is by an objective scale from discussion, assignments, quizzes, and a final examination. The cost for the 20 weeks (and all the textbooks) is $1700 CAN.

Each year we limit the number of students to 25-30 so that everyone gets to know everyone, and that the discussion groups are manageable, and the group tends to fill in fairly quickly. We one year we asked to expand to accomodate a larger group from one country, but we found that it was more detrimental than positive.

At one time the course was intended only to develop a group of medical laboratory quality managers for Canadian laboratories, but over the last several years, the participants have expanded to being pretty much world-wide. It was a good thing that the structure that we set up from the beginning required on-line asynchronicity. To address the needs of Canadians we needed to accommodate 5 time zones. Now we are pretty much at 12 hour spread in both directions.

We find that there are some characteristics that are associated with successful (or by inverse unsuccessful) certification.

• Since the course is largely intended to provide a pool for medical laboratories, people with medical laboratory experience tend to do better. We require 5 years of work experience.

• People with strong English communication skills, in our case with reading and writing, tend to be able to participate better.

• People who are so busy at work or other activities that they can not put in the time to take a course tend to fall away.

• People who by their nature are passive and are uncomfortable with discussion tend to struggle.

So we provide a course for people who are interested in quality, motivated and capable to spend time reading and participating, and a reasonable cost. Folks seems to enjoy the course and give us excellent reviews each year. You can read their reviews at http://www.polqm.ca/

So, if you are interested in quality, and you see personal value in an established course that provides certification, I suggest that you contact us sooner rather than later. The course does tend to fill up fairly quickly.

Again, http://www.polqm.ca/
Comments are welcome.
m

. 

Culture of Quality - whatamess

Today I was going through a story feed "Clip and Copy Advisory" and came across a Canadian Broadcasting Corporation (CBC) story on the problems and challenges facing Newfoundland and Labrador's Eastern Health Authority (see http://www.cbc.ca/canada/newfoundland-labrador/story/2010/07/29/nl-lab-review-729.html )

Everyone in Canada knows of the unfortunate events that lead to the judicial inquiry by Justice Margret Cameron related to misdiagnosis of breast cancer.  Now there is a problem with measuring and monitoring cyclosporine levels.
I have used the first story many times as an example of out of control Costs of Poor Quality when you add in the MILLIONS associated with the inquiry.  And what is so sad is that they may have to go through this whole cycle again.

I will only focus on a few points, this time, but reserve the right to come back again (and maybe again and again).
From a Costs of Poor Quality perspective, if one looks only at the traditional In-put costs (Prevention and Appraisal) and Out-put costs (Internal and External Failure Costs), you will miss the costs associated with patient and community convenience and expenditure, and way undervalue the costs associated with laboratory error.  [This theme will come back.]

From a Culture of Quality perspective, it must be both painful and embarrassing to read in the public record about dysfunctional relationships among various members of the medical staff, and inappropriate relationships and responsibilities between managers and medical staff, and low morale, suspicion and distrust within the group, not days, or weeks, or months, but years after most of this came to light. 
The messages of Shewhart and Deming and Juran and Crosby were established decades before these problems manifested in such an public and ugly way.  The Eastern Health tragedy has is origins in a medical administration system that ignored all the principles for years as the problems festered and eventually exploded.  

You might be able to cut the physician administration some slack because the knowledge of quality management was not available in medical training at any level (and by-and-large is still not!).  But all those folks with law degrees and business degrees and MBAs have no excuse.  If pointing fingers is something that is going to be done, start there.

So the bigger issue now is whether the folks with lead responsibility will have the personal jam to get the quality management implementation ball rolling now.

m

PS:  This is not a Newfoundland and Labrador story.  Eastern Health is just the one that got caught THIS TIME.  Our history in Canada and the US  is loaded with these stories, and there are many sitting and waiting to come to light.