Tuesday, December 20, 2016

What Medical Laboratorians Need To Know About Laboratory Quality

What Medical Laboratorians Need To Know
About Laboratory Quality

Medical laboratorians have many laboratory quality responsibilities today.  Accreditation, Quality Indicators, Process Management, Error Awareness, Corrective Actions, Preventive Actions, Risk Management, and more. 
In the past most medical laboratorians learned these skills the hard way on their own.

There is a better way.
The UBC Certificate Course in Laboratory Quality Management,
regularly updated, now in its 15th years covers:

International standards for Quality and Success
History of Quality Management
Costs of Poor Quality
Quality Partners
Quality Culture
Root Cause Analysis
Modern Tools for Quality in the Medical Laboratory
Risk Management
Document Preparation and Management
Understanding and Working with Error
Quality Education and Leadership
Quality Indicators
Continual Improvement
Six Sigma and Lean
And more…

Multi-media 21-week course in VCOLE (Virtual Classroom On-Line Education) format, highly interactive with faculty and participants across Canada and around the world.  An ideal way to get yourself, your students and residents ready for laboratory quality management. 

Appropriate for technologists, administrators, Quality Team, physicians
in all laboratories including medical, research, public health

Accredited by UBC CPD (Continuing Professional Development)
Accredited by CSMLS for Continuing Education Credits
For More Information Visit
Next course starts January 11, 2017

Friday, December 9, 2016

A Continent of Quality Success

The following is an abbreviated history of events and not absolutely accurate, but is close enough to give a clear picture.  

About 2002 (or there abouts)  in response to the appalling epidemic of HIV/AIDS in developing regions, developed countries and regions poured money, medical support, effort and energy into regions around the world, including but not limited to Africa.  Bush 43, created the program President’s Emergency Plan For AIDS Relief (PEPFAR).

The weakness in ability to investigate and diagnose disease could not be addressed until the laboratories achieved a new appreciation and recognition of laboratory quality standards and practices.  It was fairly quickly appreciated that asking laboratories to jump to an internationally acceptable level of laboratory  quality in one go was both unfair and unrealistic, but could be attained through a series of progressive steps, until the level of sufficient  competence could be achieved.

Now, near 15 years later, the situation is not perfect, but the amount of progress is spectacular.  

This is in large part due to the tremendous efforts of laboratorians, educators, governments, and the massive generosity of the American taxpayer (who in my experience nearly always gets left out of the recognition). 

Five years ago, in order to coordinate efforts, a new organization the African Society for Laboratory Medicine (ASLM) was created.  One of the missions of the ASLM was to create a forum for discussion and debate and celebrate success, which lead to the development of the ASLM Conference.  

Over the last week, ASLM hosted its Third ASLM Conference.  This year it was held in Cape Town.

This year I decided to attend the conference for the first time, in large part because I had had the opportunity to work with PEPFAR in the early days and (along with others) developed an early program of stepwise progress through ISO 15189:2003 Particular Requirements for Quality and Competence.  

This program was created while working with the PEPFAR partner Clinical and Laboratory Standards Institute (CLSI) and took laboratories through 3 levels, the first being very basic steps of laboratory quality (a form of 5S, SOPs, Quality Manual, etc).  I was backed up by continuing education, mentorship and progressive assessment.  I could be wrong, but I think that our program was the actual model for what ASLM later developed and called its Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) programme.

Following those early days, I was able to offer more help through assisting countries develop or improve national EQA programs.  

But enough about me (for a moment).

This meeting from my perspective was a massive success.  Presentation after presentation showed how much progress is being made in countries all over the continent.  Where laboratories were once a shamble of erratic tests by technologists trying their best without any concepts of laboratory quality and competence has been replaced with focused interest, skill mentoring and cross mentoring.  Presentations highlighted progress and approaches to improvement that would leave many laboratories in developed regions awash with eye-blinking amazement.  Presentations were professional and tight even when English was not a first (or second) language.

Not everything was perfect, indeed some of the presentations were shoddy and indeed terrible.  Of interest, the two worst presentations were done by people representing large international universities.  Their studies were severely flawed, full of mistakes, and yet presented with what can only be described as intellectual fraud and arrogance.   I am sorely tempted to describe their truly tragic performances, but (a) they know their work was atrocious crap and (b) hopefully is not typical of what other more competent people do in their institutions.

But for the moment, more about me (I have to do something about this overactive ego).  

At the closing ceremonies, awards were handed out to individuals and organizations that deserved recognition.  One of the categories was laboratories that had progressed to the level that they achieved recognition at meeting the requirements of ISO 15189:2012 (or ISO 17043:2010 – Proficiency Testing) as assessed and measured by international accreditation bodies.  By my count there were 18 laboratories meeting that level, and of them, 6 (!!!) were laboratories that I had had a direct hand in assisting.  Five were in Tanzania and one was in South Africa.  I could not be more proud of their success.

Congratulations goes to all the laboratories, to ASLM, to SLIPTA, and to the organizers and participants in an incredible conference.  

I am looking forward to the next ASLM to be in Abuja Nigeria in December 2018.
If Quality is your thing, you might want to also plan to attend, if only to get inspired.

Save the Date
POLQM Quality Conference
Vancouver BC Canada
October 1-3, 2017

Thursday, December 1, 2016

A Great Quality Read

As we prepare for the 15th year of our Program Office for Laboratory Quality Management Certificate Course we have made our regular fine-tuning changes in order to ensure the course continues to be relevant and up to date. 
This year, in addition, we have made a major change; we have adopted Juran's Quality Handbook: The Complete Guide to Performance Excellence, Seventh Edition as our primary reference text.  

There are several reasons for this.  For one, it has just been published and became available in November 2016; it is as current as a textbook can be. 

More importantly it is an excellent read; well designed and laid out.  The text is straight forward and laid out in a well-organized style .  The content is presented in the style commonly referred to as “plain language” (hurray!).  It is both complete and sophisticated and appropriately nuanced.  

In my mind this new Quality Handbook has all the hallmarks of an excellent textbook.  

Granted I am a little further along in my knowledge and motivation on the topic of quality, but even I (with my mild dyslexia and a tendency to easy distraction) can get into reading full chapters at a single go.  If I can do this, I imagine that so will many (or most) of our course participants.

To give credit where credit is definitely due, Joseph A Defeo, the President and CEO of the Juran Institute, not only took on the role of Editor, he also wrote about half (?) of the chapters.  While taking nothing away from the other contributors, having done both writing and editing myself, I know this dual tasking was a major consumer of many, many hours.

My course audience is very focused in healthcare and medical laboratories.  While this book is intended for a more general audience, I find it covers all our key topics, including Culture for Excellence and Quality, Leadership, Costs of Quality and Poor Quality, Risk, Process monitoring, Process improvement, plus, plus, plus in a manner that we will be able to appreciate in the context of  laboratory setting, just as someone in retail, or manufacturing will appreciate in their context.

While the key medical laboratory quality standard ISO15189:2012 (medical laboratories – requirements for quality and competence) does not come up (not even once), the content is this book with respect to ISO 9001:2015 (Quality Management Systems – Requirements) is stunning in its completeness and thoroughness.  For my two cents, I have long advocated that while medical laboratories should  appropriately be formally accredited to ISO 15189 (or to the requirements of the College of American Pathologists and CLIA), I think that many (many all) laboratories would be strongly improved if they were to supplement their accreditation with voluntary certification to ISO 9001 [see:  http://www.medicallaboratoryquality.com/2014/09/is-public-sector-place-for-iso-9001.html ].

There are a few places where the book could be modified to make it a little more relevant to healthcare.  The list includes failure costs such as satisfying warranty claims, investigating complaints, offsetting customer dissatisfaction with a recovery strategy, collecting bad debts and correcting billing errors, which are all reasonable in a manufacturing or retail sector.  But the primary external failure cost in medical laboratories is the time spent in tracing back similarly wrong results, notification of physicians, recall of patients, and potential liability because of actions taken on faulty information.

This book is going to be a great enhancement for our course.  In addition to the fore mentioned there were several other important reasons that we decided to add it to our course library (The cost of the book is built into the course registration.  There is no separate or additional cost to the participants).  

First and foremost it has great content.
Second, all our participants will undoubtedly recognize it as an essential quality reference for years to come. 
Third, it is available both in hardcopy and as an e-book, which means that we can reduce our costs and time losses when shipping books around the world. Delivery of e-books is virtually instantaneous. 
Fourth (an important feature for those participants that are sometimes challenged by things technical, this e-book is very easy to set up on any device.  For eyes, much younger than mine, it will also load on a smart phone).

So for my vote, I give Juran's Quality Handbook: The Complete Guide to Performance Excellence, Seventh Edition a 5 star rating.

Well done.

For those interested,
the POLQM Certificate Course
begins January 11, 2017.
For more information visit ...
and click on the 
LQM2017 link