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Thursday, June 15, 2017

Implementing the Essentail Eight for quality success



In the last while I have had 3 sessions with different audiences, all interested (if not necessarily committed) to laboratory quality management.  As much as we have made huge progress, it seems to me that we still have a long way to go.
As a group, these laboratorians have reached the step of vocabulary recognition.  They know the terms “Quality Indicators” and “Gap Analysis” and ISO15189, but putting these into an operational context is still missing.  What stands out more than anything else is the understanding that when it comes to  Quality Management and improvement activities it is NOT a one-and-done process, and equally important, almost all are missing the driving force “if not you, who?”.  Interest without commitment does not make for quality improvement.

What laboratorians must grasp as critical understanding that if Quality is going to improve it will have to involve their own personal and ACTIVE engagement on a regular and on-going basis.

There is an appreciation that putting in Quality Indicators is a good thing to do, but what is missing is that while Quality Indicators can be a useful measurement tool to address point specific concerns, the average laboratory has dozens (if not hundreds) of point specific concerns.
 
There is a full array of Quality Tools that should (must) be used to get a good overall picture of how well (or unwell) the laboratory’s quality efforts are working.  I think of them as the Essential Eight, and I argue strongly that (a) every laboratorian needs to be aware of each of these techniques and (b) each laboratorian should get their hands dirty by participating in implementing each of these techniques early-on.   



And laboratories have to develop and hone their Quality routine so that their Essential Eight activity is both Early and Often.
 
A quick look at the Essential Eight might suggest they are  divided into 2 groups, those for which the laboratory is responsible, and the others which are effected by others.  But coming to that conclusion would be wrong.  

The laboratory  has to take an active position in rolling out Proficiency Testing (EQA), making sure that every person at one time or another is involved and the challenges are tested using the laboratory’s normal and standard procedures, and that the reported results reflect how the laboratory would normal report.  

 And if the laboratory takes on a passive role of awaiting to be contacted by an Accreditation Body to prepare for an upcoming external audit, it is almost a guaranteed outcome that the preparation will be at best superficial and transient.  Every laboratory should be actively filling the time between accreditation external audit visits by doing their own internal audits either as a full audit or as a series of mini targeted audits.  Either approach can be effective and depends upon the size of the laboratory and the degree of change and innovation that is going on in the laboratory.

And if you feel that doing your own internal audit creates a risk for personal bias, then consider inviting someone (either a consultant, or a colleague) to come in and do an audit for you.  We call that an external-internal audit.  

Of the remaining essentials, without doubt the single most important essential is the setting up of an active Opportunity for Improvement (OFI) list that is honest and open and complete.  If the laboratory is not prepared to record their errors and mistakes, there will NEVER be any recognition, NEVER be any examination, and NEVER be any corrective action.  We can say with ABSOLUTE CERTAINTY, that in the absence of an OFI list  the laboratory is doomed to repeated errors and never achieving any evidence for improvement.

Quality Control as a monitor for quality is a given.  If a laboratory is not doing quality control, then it is difficult to think of it as a laboratory, and will undoubtedly be closed down by accreditation or lawyers, whichever comes first.

I have mentioned before the importance of recognizing the importance of customer needs [see:  http://www.medicallaboratoryquality.com/2016/10/conference-report-laboratory-and.html  ].  Waiting for complaints to come in is the way we used to deal with customer service, but that was a long time ago.  Actively seeking customer input and opinion is the only way to know if your efforts to improve are being noted and serving customer needs.

Without expounding on the other activities, let me point out opportunities to improve are all over the spectrum, and if your laboratory is not looking everywhere, many problems will be missed, until it is too late.    

By using all of the power of the Essential Eight, you increase your likelihood of success.  Put another way, there is an association between implementing Quality Improvement and playing Golf.  In theory, one can play a round of golf only using a seven iron and if you are patient and lucky you might succeed.   
if you goal is to capture as many of your error opportunities  as possible you will be far more successful of you take advantage of all your 14 clubs (or in this case 8!), each in its own appropriate way and place.  


The more essential tools the we don't use, the more gaps are created,

And Quality Gaps are BAD THINGS.

Tuesday, May 16, 2017

The Quality Tree Reenvisioned.




A teaching exercise (and more)


So I was going through my regular update and revision exercise for my presentation files.  I find it I don’t do this regularly, they can get very stale, and I get bored talking and teaching about Quality.  I suspect that I am not alone.

Anyways the target audience this time is medical laboratory physician trainees.  I don’t think I am giving away any secrets when I say that this is always a tough audience.  Most of this group have a singular attitude about quality which is unfortunately “What????  DKDC!!!”  or, for those uninitiated, “Don’t Know and Don’t Care”.  

It is usually, almost always the case that Quality issues are never front-of-mind until they are in positions of responsibility and confronted with a problem, usually an unhappy doc or patient of staff member who has become entangled with an laboratory error, and find themselves trying to dig themselves out of a mess.  (It’s the same with safety)

Fortunately we are able to get enough face-time that they may have some idea about where to start.

So one of the concepts that I have worked with over the years is the Quality Tree.  Don’t think of Quality as a pyramid with Policy being at the tip-top and its effect trickling down; rather, invert that pyramid and put Policy at the bottom, as the foundation, with its impact shoring up the rest of the process.  From there it was an easy step to creating an analogy as a Quality Tree with the roots that give support and nourishment as Policy.











But recently as a result of our working on and achieving the recent certification of our laboratory’s quality system to ISO9001:2015 (YAY !!!), I realized that this was a good step in the right direction, but was still incomplete.

Organizational Quality does NOT start at the level of Policy making; it starts with asking the most basic of questions,” (1) who are we and (2) what are we doing, and (3) what do we want to be when we grow up?”  

Quality starts with Top Management envisioning the organization’s Mission and Vision and setting the organization’s Goals and Objectives. 
Once those are in place, then all the rest can and will logically and consistently  follow.  

For the purpose of this re-positioning of activities, I set up a set of definitions, that work and make sense.  Mission and Vision are general statements about who we are, what we are doing, and what we want to become.   
Goals and Objectives follow on from the Mission and Vision, and are very specific and focused on what we expect  to be doing now, and in the near and intermediate future.   

Mission and Vision and Goal and Objectives  are the real drivers of our Policies and our Quality System.  This is what really nourishes Quality.

Once those are in place we can create policies and processes that are consistent with our plan, and procedures that follow.  The fruits of our labour are not only our products and services, but our Quality message as well.  And we can then point to our need to disseminate that message, through a clear and distinct error-free and consistent documentation pathway.  









And Top Management is the gardener whose task it is to care for and nourish the Quality Tree and ensure that it remains healthy and vital and strong.  

I know this is sounding pretty “in the weed’ish” but in my mind it all becomes clear through my new Quality Tree picture.  



Quality is like every other subject that has both academic and practical applications.  I don’t think these applications can be easily separated.  If thinking people don’t understand the foundations, then applying the practical rules is done only by rote, and all too often gets screwed up.  And equally important, if the academic purists don’t appreciate that Quality is not theoretical, it has to be applicable in a way that makes sense.

So for me, the picture works.
If, upon consideration, it also works for you, use it. I put it out here in the spirit of open access.  

Or maybe I have too much time on my hands.

Our 2017 October Quality Conference is coming together nicely

Sunday October 1 – Tuesday October 3, 2017
All our subjects are in place
All our speakers are in place
Our venue is contracted 

More news to come.




Sunday, April 23, 2017

Trust me is not good enough



One of my passions over the last 35 years has been laboratory proficiency testing (PT aka External Quality Assessment or EQA).  

PT/EQA is a requirement for all laboratories that are accredited to CLIA requirements, mainly in the United States and ISO15189:2012 almost everywhere else.  This is because PT/EQA programs provide objective, measurable, and reportable information on the Quality, Competence and Performance of laboratories in all disciplines.  In this broader context PT/EQA addresses the need of laboratories including but cerrtainly not limited to water and food testing, ore sampling, cement composition and compression, and industrial dyes, and ship steel.  

That laboratory workers are required by regulation and standard is interesting.  I suspect they are the largest group of workers in the world of whom it is required to have regular quality assessment testing in order to demonstrate performance competence.  There are few other groups that are monitored in this way, such as airline pilots, police (gun practice), and I think, bus drivers.  It is interesting and I think significant that physicians, nurses, teachers, lawyers, judges, dentists, and car mechanics, and scientists have no such requirement.  Once they finish their final training examination, there are no more required objective measures unless they choose to take a new course, or do a refresher course.

ISO/IEC17043:2010 the Quality and competence standard for proficiency testing providers, it is interesting to me that there is the following: “The need for ongoing confidence in laboratory performance is not only essential for laboratories and their customers but also for other interested parties, such as regulators, laboratory accreditation bodies and other organizations that specify requirements for laboratories”.

So my point is that while PT/EQA may be performed by the laboratory, an essential reason that happens is so that their customers and interested parties can be confident they take Quality seriously.

A number of years ago during a laboratory conference I raised some questions about what laboratories do with our Annual Certificate of Participation from our CMPT proficiency testing (PT/EQA) program.  Without going into details, the collective opinion was that (a) the Certificates were important to the laboratories and (b) most laboratories (I was surprised about this!) posted their certificates, usually framed, usually in a common area within the laboratory confines, where technologists and pathologists and scientists could view the certificates.  A small number of laboratories posted the certificates in public areas, such as the Patient Waiting Room.  

While for the most part, these were results better than I expected, I also saw this as an example of opportunity lost, because most of the laboratories were missing the opportunity to promote their Quality monitoring to a critical audience.  While it is nice that laboratory staff can see the affirmation they need about their Quality focus, the public, in most facilities gets no exposure or awareness to the information.  

In the “olden days” laboratory competence and quality was self-assured on little information.  (Of course we are a quality laboratory. Our laboratory is run by the finest scientists.  They would never make a mistake.  TRUST me!, trust ME!).  Today we appreciate how empty and self-serving that was.   

In today’s reality “trust me” doesn’t cut it.  Put up or shut up.

Today, laboratory tests have become increasingly more sophisticated, and often critical decisions are made solely on the basis of test results.  Often there are no correlating physical signs to support or reject the test result, until it is too late.  (think antimicrobial resistance or tumor drug resistance).  

If the laboratory gets it wrong, there can be consequences that ripple through the patient, the physician, the community and the public.   

So Proficiency Testing Providers primary function is to DEMONSTRATE  or ASSURE the community and all interested parties that the laboratory can be trusted to be proficient and competent, not based on inappropriate trust, but on OBJECTIVE, MEASURABLE, REPORTABLE EVIDENCE.  

PT/EQA Providers should be much more active in advising / informing the public that they provide their services as a way to advise laboratories when their assays are not properly, as a way to protect the public.  I am not saying that PT/EQA providers can or should be public whistle-blowers or be in the business of pointing fingers at laboratories that are not fulfilling their professional duty, but the public does need to know that their confidence in the health care is supported by objective measurable evidence.

Laboratories are better off when they can say “of course we are a quality laboratory. Our laboratory is run by the finest scientists, all of whom are closely monitored for their performance and competency on a regular and repeated basis.  You can have confidence because we have confidence and we have the evidence to back that confidence up.”

And that brings be back to my story of several years ago, and let me suggest that laboratories these days could go a long way to better strengthen their trust and credibility, I understand that this is a very small part of the exercise, but instead of putting their Quality Assessment certificates where they can be seen only by laboratory staff, but rather where they can be seen by patients, physicians, and administration.

And PT/EQA providers need to make a much bigger issue of their role in protecting the integrity of the laboratory in specific and healthcare in general.  We need to remind ourselves up front that laboratories’ clients are our customers too.  Yes we are science guys, but we are also Public Guardians.

And perhaps the time is coming that physicians and nurses and lawyers and teachers and scientists need to step up to the plate of regular Quality Assessment for continual improvement.

It has to be better than TRUST me, Trust ME!!