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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.

Friday, February 24, 2017

Quality Errors - When ISO gets it WRONG!

A ways back maybe 1978 (?) when I was training to be a medical specialist I was doing a research review of the records of patients with a particular infection.  This required going through medical records going back 10 years.  
I remember this even today because after reading one particularly horrific record, I realized it had been written by ME about 6 years previous.  My more experienced self was embarrassed by my younger self’s incompleteness and clinical illogic.  It was a painful lesson.

Today, I  had a similar (sort of) experience.

I was going through, once again, the standard ISO15189:2012 (medical laboratories – requirements for quality and competence) in preparation for an upcoming presentation.  I must have read this document maybe 100 times.  But maybe (by which I mean clearly) this time I was being more attentive. 
I was looking for what we wrote about Quality Indicators, a personal topic of interest  See: [ http://www.medicallaboratoryquality.com/2017/01/lamp-oil-and-quality-indicators.html ].  

Here is what ISO 15189 says within the definitions:
“3.19:  quality indicator -  measure of the degree to which a set of inherent characteristics fulfils requirements

NOTE 1 Measure can be expressed, for example, as % yield (% within specified requirements), % defects (% outside specified requirements), defects per million occasions (DPMO) or on the Six Sigma scale.

NOTE 2 Quality indicators can measure how well an organization meets the needs and requirements of users and the quality of all operational processes. 

EXAMPLE If the requirement is to receive all urine samples in the laboratory uncontaminated, the number of contaminated urine samples received as a % of all urine samples received (the inherent characteristic of the process) is a measure of the quality of the process. “

So what’s wrong with that you are probably saying.  Looks like reasonable stuff.  And it is, until you read the EXAMPLE.  

I was one of a very few microbiologists on the committee that wrote the standard.  I hope that I was not the person who contributed the example, because it is worse that terrible.  My more experienced self today would strenuously object to it being incorporated into the standard, because by its presence, gives license to laboratories to waste their time collecting useless information that sheds NO light on laboratories’ quality or competence.  

I feel some sense of responsibility for allowing the inclusion of a wrong and misleading example.

This is an “in the weeds” issue and one that may not be clear to folks who are not medical laboratorians, but the issue in NOT unique to medical laboratories.  There is  a general and guiding principle: there is no quality or indicator  value in collecting and monitoring information on activities that you do not and can not control.  

To address the aforementioned example, without getting too icky and biological, urine that is in your bladder is supposed to be sterile.  Having bacteria in urine in the bladder generally means the person has a urinary tract infection.

The problem is that when urine leaves the bladder on its way to the toilet or the specimen collection bottle, it can pick up bacteria inside or around the anatomic channel that goes from the bladder to the outside.  Those bacteria are considered contaminants.  Without going into detail, bacteria that are found in bladder urine and bacteria found as contaminants are often the same, so it may be difficult to look at a culture test result and sort if the bacteria came from the inside or outside.  There are washing and collecting techniques that can be used to reduce the amount of contamination that exiting urine may be exposed to.  

But  (and here is the point)  Laboratory workers do not collect urine samples; people go into a bathroom and “pee in private” and then leave the sample on a counter or in a refrigerator.  

We can explain and instruct to people about washing and how to collect the sample, but we don’t join them at the toilet (too gross!!).  The only ways we can control contamination are by explaining to people or putting explanatory pictures in the bathroom, to which people may or may not pay attention.  

So we can, as the example suggests count the “number of contaminated urine samples received as a % of all urine samples” but the number has no meaning and worse, we can do nothing to increase it or decrease it.  So while it may be an interesting number, it has nothing to do with quality or performance, and collecting the information is a waste-of-time.  There is nothing here that sheds any light on quality.  (no LAMP OIL here!!)

So here is a message to the current members of the ISO technical committee who will soon be reviewing and revising the standard:  KEEP the requirement for Quality Indicators, but KILL the example.