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!!

Saturday, April 8, 2017

Revising the Laboratory Path of Workflow

Revising the Laboratory Path of Workflow
The concept of a medical laboratory path by which samples are collected and transported and worked upon and information in the form of a report has been around for a long time.  My first recollection was John Meyer’s cartoon in Raymond C Bartlett’s brilliant book Medical Microbiology : quality cost and clinical relevance first published in 1974.  (With interest, MM:QCCR is still available for purchase on Amazon for $1836.24 CAD!)
Meyer’s is more entertaining, but this is my version.

More recently this has been condensed to a more simple and linear arrow with three phases depicted: pre-examination, examination, and post-examination.  The arrow can be made more useful when the three phases are understood to range in relative importance depending on context in which the POW is being considered.  From a Logistic perspective all phases are essentially equal, but in terms of Error Detection, the Examination phase is relatively the minor consideration, while in terms of Clinical Relevancy (recording and reporting of clinically relevant information) the Pre-examination is the least impacting phase. 

In my particular area of interest, Proficiency Testing (PT) or External Quality Assessment, the variable arrow model reminds us that if we look solely at the Examination phase for PT/EQA challenges we miss testing a lot of areas of considerable importance.

But even more importantly there are events that are important in the laboratory but not along any part of the circular or linear POW that are nonetheless important considerations for PT/EQA in the modern era.  

They may or may not directly contribute to the traditional view of generating patient information, but they are critically important.  These are the issues of Safety, and Ethics, Risk management and SOP development and enactment of human error.  

These are NOT part of the POW but the SURROUND the POW.  For the sake of keeping them connected to laboratory terminology, i have taken the concept of surrounding and created a NEW term the PERI-EXAMINATION practices.  So now we can think of PRE-Examination, Examination, POST-Examination and PERI-Examination.  

In a recent presentation I talked about this as a new approach to PT/EQA making the point that we now have the tools to examine all four phases of laboratory life.

Four Phase PT/EQA

I have mentioned our Paper Challenges before as a method of creating text based scenario to challenges laboratories on pre- and post- examination topics.  They are generally liked and effective.  Video Challenges extent this for PT EQA challenges by replacing the text challenge with short .wma files that are easily seen across our network. They depict aspect of laboratory process that may or may not result in immediate error, but increase Risk.  
 Video challenges greatly extend our ability to provide PT/EQA challenges far beyond the traditional walls.  And laboratory workers seem to really enjoy them.  

We have a solid and appropriate concept.  We have the mechanisms and the means to do this extended challenging,  We can successfully argue that the extended testing will provide better insight into laboratory collection, testing reporting and supporting phases.  

The argument is compelling.