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Monday, February 12, 2018

Quality upside down and backwards

Warning:  This entry is deeply in the weeds.  If you are not a ISO-wonk or Qualitologist, this will drive you crazy.  For a quick read, jump down to the last two paragraphs.

The International Organization for Standardization (ISO) is a crafter of standards, but NOT creator of original thought.  Ideas exist, usually from other international organizations, but taken to their origins, from true original thinkers.  For example ISO/IEC 17025 first came to life as ILAC Guide 25, a document created so that international accreditors could have a single source against which to assess laboratories.  Similarly ISO9000 was derived from a combination of a British Standards Institute document and a UC Military Standard and another from the Canadian Standards Association, but ultimately they were derived from the teachings of Deming and Juran and Crosby.

The concepts of Plan-Do-Study-Act, Risk, Document Control, Corrective Actions all long proceeded their appearance in documents published by ISO.  Think of ISO as the iterator or popularizer or disseminators of ideas rather that a creator.

In my laboratory when we actively decided that this stuff called TQM or Quality was something that we should look at, we learned  about it through books (read Ray Bartlett’s classic Microbiology Laboratories: Quality, Cost and Clinical Relevance) and guidelines many from the organization then known as NCCLS (now CLSI). 
We had looked at the recommendations and guidelines on how to write an SOP or how to set up document control.   The nice part was that the books and guidelines that I learned from were written as books and guidelines whose primary task was to teach.  And importantly there was no pressure.  

I could take the information as given or fiddle with it or ignore it.  My laboratory, my choice.   

Today it doesn’t work like that.  Today laboratories generally don’t start from scratch.  They start from the perspective of what is written in ISO standards or from the expectations of an accreditation body.  And that is tough because ISO standards are not, were not and never will be designed as tools from which to learn.  They are designed as documents for rules setting. 

So here is my problem.  

For the last 17-18 years we have taken the view that the way developing laboratories need to learn about implementing Quality is NOT to start from the perspective of basic components, but rather to start from obeying the dicta of ISO.  And so far that idea is not working particularly well.  And further when we assess their progress we do it against an accreditation level standard.  

Recently I was in conversation with a person very involved in monitoring progress of laboratories in a developing country and was told that the laboratories were not doing particularly well by their measurements as assessors.  I knew what the problem was; it’s was not that they had no written SOPs, it was that their SOPs did not meet the requirements of ISO.  So what!!!

These laboratories are just learning about quality management and importantly, there were no small laboratories from developing or evolving countries that participated in any part of the ISO process.  They had no opportunity to object and make the point that the standard as written was not designed or intended for them.  This is really a round hole-square peg situation.  

We should be promoting them to learn and discover Quality in the same way as we did; start from having a purpose and finding a solution.  Allow them to play around with different versions of document management, or risk, or SOP production.  Allow them to discover and appreciate value and then refine.

 We should NOT be using ISO standards to promote quality in these laboratories.  
And ANY person who answers a question by saying “we do it this way because that is what is said in ISO15189” should be thanked for their service and shown the door.    

Tuesday, January 2, 2018

Fit for Process versus Fit for Purpose

Recently I have had the chance to work with a number of laboratories around the world that are relatively early on in their march to Quality Progress (by this I don’t mean subscribing to the ASQ magazine, but actually trying to making progress implementing Quality Management in their laboratories).  What I have seen is a lot of implementing new procedures which will be hopefully in time active and appropriate. But so far maybe not so much. 

What I see a lot of is laboratories deciding they want to get accredited tomorrow or they are told by their overseers that they have to implement a quality system NOW.  So they buy a book, or hire a consultant and they start by looking at the documents that they have to create: Organizational Chart, Quality Manual, Mission and Vision statements, Standard Operating Procedure forms, Document Control List, Corrective Action Form, Quality Indicator Forms, plus, plus.  

So the documents get created “by the book”, and get set up for use “by the book”.  I call this Fit-for-Process; documents that can be shown to an assessor so that they can get a checkmark in the appropriate box.  

What I also see with these documents is a ton of documentation that that looks pretty, but seems to exist solely for the purpose of being seen.  They are not designed so they can be used to actually make the quality process work better.  They become documents of busy work.  What they are NOT are documents Fit-for-Purpose.

They remind me of Billy Crystal’s character Fernando who would follow up his catch phrase in some generically hip pseudo-Spanish accent, “you look MARVELLOUS” followed by “It is better to look good than to feel good (and you know what I mean)”.  

The problem of course is that the documents get created in response to the question, “what do we need?” rather than “why do we need?”

What happens is inevitable; documents get created to record everything on every topic on every occasion.  And then fatigue sets in and they get filled in not with everything or on every occasion, but with less stuff and less often. And not far down the road, they just stop, and the complaints start; “this Quality stuff is a waste of time, and we are so busy and we don’t have the time to waste!”  

The problem was not that Quality takes too much time, it is that implementation was done in a hurry, to Fit-the-Process, to get that checkmark, to get that accreditation done and out of the way.  The purpose, if there was any, was solely about getting the certificate NOW.  
The reality is the Quality takes time, and grows with insight and with organizational culture.  And if it takes a year or so, then let that happen.  

Quality Management systems create a framework for planning and assessing risk and reducing the number of repeated errors.  When implemented Fit-for-Purpose, the process saves time rather than consumes time.  When implemented Fit-for-Purpose, the process reduces stress rather than driving the Qualitists crazy filling in the pretty documents with the excessive information.  When implemented Fit-for-Purpose, your next steps are refinements, not overhauls or do-overs.

So as you charge forward towards getting your stars or your certificate, let me ask you the obvious…”what’s your hurry?”

Upon reflection, when it comes to building your Quality system, Crosby was spot-on.  Do it Right the First Time (DIRFT).

Wednesday, November 29, 2017

Quality Progress Taking Hold in African Countries

I was looking at some earlier files and presentations, going back to 2004-2005.  The subject from this retrospective “look-back” was my involvement in laboratory quality in African countries.  My introduction was through a senior partner group participating in the US President’s Emergency Program for AIDS Relief (PEPFAR) program set up by George W. Bush.  To the credit of the people responsible, they were able to see that establishing a program of monitoring for AIDS diagnostics was going to require the establishment of Africa based laboratories capable of Quality and Competent practices.  

Back then there was lots of evidence that this was going to be a major barrier.  Laboratories were working with at best rudimentary equipment, usually with out-dated reagents.  Samples all too frequently were being delivered to the laboratory not in typical sample container tubes, but more likely in repurposed medication vials.  Additives like heparin were being added by hand and pipette with little sense of precision.  In microbiology, critical samples such as blood cultures were a travesty,  with reliability closer to 30-40%; huge false positive results from contamination and false negative results from faulty media and terrible technology.  
When I think back to those days, my amazement of what is happening today is triple underlined and reinforced in gold.  

This week we are finishing off a 21-week on-line course that was put on for 15 Quality Assurance Officers.  This group has the same level of knowledge and sophistication about laboratory quality as peers almost anywhere in the world, and truly better than most.  Our discussions about things Quality, like internal audit, quality indicators, document control, quality control, inventory management, Lean, 5S, Six-Sigma, SIPOC would parallel or surpass many laboratories in much wealthier laboratories.   

So how did the laboratories get from then to now?  With a lot of work both from without and within.

Importantly governments from around the world, and US in particular, have spent a ton of tax-payer supported money, supporting laboratories, equipment, PEPFAR partners, mentors, and education.
But all that and a another dollar and a half would still not buy a Starbucks coffee were it not for a massive effort from the Africa Society for Laboratory Medicine (ASLM).  It was ASLM who with the support of World Health AFRO who introduced two programs; Strengthening Laboratory Management Toward Accreditation (SLMTA) and Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA).  SLMTA is an education program to promote education and knowledge about laboratory quality and SLIPTA is a graduated check-list that allows laboratories work at their own pace towards preparation for international accreditation. 

SLMTA and SLIPTA were introduced and implemented into some 1000-plus laboratories in near 50 different countries.

I know these programs were effective in moving the progress towards success because we had introduced earlier progenitor programs under the PEPFAR banner.  SLMTA and SLIPTA differed from what we did because they were Africa created, Africa taught and mentored, and Africa monitored.  

[To be honest, I am not sure that I see international accreditation as an important goal for many laboratories anywhere in the world, much less in Africa.  Most laboratories don’t do enough international work that then need to achieve accreditation to keep them in the international flow.  I do see the international documents a worthy goal, and a standard that states, provinces and countries everywhere can and should adopt in lieu of home-brew accreditations. 
But while that is a side digression, let me just say the next step to African laboratory quality is going to have to require African countries stepping up to the plate and demanding laboratories meet certain accreditation expectations for the sake of patient safety.]

To be fair and honest, many (most) laboratories in Africa that I have seen would not be able to function providing services in most developed countries, but that is NOT the fault of the laboratories.  The single biggest problem is that equipment and reagent distributors do not serve the laboratory community in Africa in the same way as they do in Europe or North America.  Part of this is money, and part is passivity, but the reality is that African population is around 1.2 billion people, and there is every reason they should be able to expect and demand better service.

But getting back to my original commentary.  Over the last 15 years we have seen monumental progress in medical laboratory performance and quality in many African countries.  
I would like to delude that I had a tiny role to play in this, but that would be grandiose thinking.

 African physicians are now in a position that they can actually make clinical decisions based on laboratory test results.  That was not the case a mere 15 years ago.

There clearly is more work to be done, but I NEVER would have imagined that we would see the levels of success that we are seeing today. 

Wednesday, October 4, 2017

A successful Quality conference

The Department of Pathology and Laboratory Medicine’s  Program Office for Laboratory Quality Management hosted its 6th October Quality Conference at the Paetzold Education Centre at the Vancouver General Hospital  from  October 1-3, 2017.  

The theme of Laboratory Quality in Challenging Times seemed to be appropriate.  While the reality of medical laboratories for the past twenty-five plus years, seems that it is always challenging, we seem to be reaching a capstone point with shrinking resources, fewer (and aging) staff, increasing customer expectations and demands, new sources of competition, and disruptor technologies.  Laboratory life is becoming a perpetual "Advil" moment.  On a more positive note, we are seeing new and thriving signs of inspiration and initiative and innovation.  

Tomorrow may yet be a better day!

The conference was attended by around 80 participants including students from the university and provincial institute of technology.  While most attendees were from my home province, there were also laboratorians from across Canada and from the United States.  Its good to have a base, but I will continue to push for a broader audience.

 For a Canadian conference on Quality I was very satisfied with the audience size.  It created a great opportunity for both individual and group participation in a way that larger conferences can't offer.  One example:  After each themed section with two or three speakers, there was a round-table discussion in which the audience, speakers, and moderators could discuss, challenge and debate for 20-30 minutes.  It was an energizing participatory exercise that created as many sparks as the presentations themselves.  Tough to do that with an audience of 500 or more..

 A coterie of excellent speakers from our department, from across Canada and international spoke to the theme of Laboratory Quality in Challenging Times, touching on topics including Patient-Centred Care, Laboratory Leadership, Improvement, Evolution of International Standardization, “Take-Away Tools”, Quality Initiatives, and the Opportunities for Quality Specialists.  Speaking to the collaborative program between POLQM and the International Training and Education Center for Health (I-TECH), currently in conjunction with the  American International Health Alliance, and the Ministry of Health Zambia,  Dr. Lucy Perrone, University of Washington and Directory of   I-TECH Laboratory Strengthening Program spoke of the International Opportunities in Quality and Dr. Michael Noble spoke to training in Quality through the Program Office’s  on-line Continuing Professional Development course.  

We were not surprised, but were still pleased to see that the participants scored the conference for its content.  It was clear that we hit all the relevant key-points for a Quality conference. 


In the on-line satisfaction survey, responses were received from more than 50 percent of the participants.  Significantly and consistent with human-sized conferences the conferences was rated highly for networking opportunities.  

Overall, the conference was rated at an impressive average score of 86/100 (median score  89 and mode score 90).

Planning for our next October Quality Conference (2018) will be starting soon.  

For those interested the presentations are available at www.polqm.ca