Sunday, January 27, 2013
Let me state from the get-go that in my opinion, the jump-start in medical laboratory Quality around the world in the last 10 years can be directly attributed to the International Organization for Standardization and its creation of its landmark standard ISO15189, requirements for quality and competence.
Many countries had dabbled with medical laboratory accreditation since the 1970’s most of their documents were created by cherry picking good ideas from a broad variety of processes, some from credible organizations, others developed from local opinion makers. Some countries, like the United States created federal legislation on minimum requirements, and others, like Australia adapted other documents, such as Guide 25 which became ISO17025. But the reality was that issues of Quality monitoring, and Quality improvement remained by and large a combination of minimal Quality Control and Lip Service.
With the increasing awareness of the dangers imposed by healthcare (IOM’s To Err is Human) and a voluntary standard ISO15189:2003 many medical laboratories around the world started to focus on implementing Quality Management Systems.
It has been an impressive change in mind-set. That is not to say that the task is done and now we can go on to the next thing. In my opinion medical laboratory Quality still has a long way to go.
Take for example the principle of Satisfaction. This is not a new concept. Japanese engineers, having benefited from giants like Deming and Juran and wrote early about customer expectations and “customer driven” Quality. Crosby reinforced and popularized the recognition of Quality as meeting requirements.
Business learned that waiting upon receipt of complaints was a poor way of assessing satisfaction; much more active approaches are needed to garner information. Many have taken to doing customer satisfaction surveys, often by internet. Unfortunately many are poorly designed and don’t create much useful information, but I have written about that before.
ISO15189:2012 talks about customers and complaints and suggestions, but the word “satisfaction” does not appear in the document. It does not suggest or imply that surveys can or should be done, which is interesting since the concept of surveys was included in the previous versions. There are so many steps along the way that can through simple and inexpensive measures improve service and efficiency from the specimen ordering form, through the process of sample collection, and transport to accessioning and on through reporting. They require some attention to detail, but they would reduce the risk of error that result in delayed results or worse.
Most docs and patients don’t bother to complain because it is not worth the bother. That is common everywhere. Many organizations have realized that most people do not complain, and that when one is received that represents perhaps 10 others that were felt but not entered. Actively pursuing information to learn how laboratory workers are functioning, through the eyes of the users is a valuable way to gather information. (Note: not the only way; direct observation through internal audit is also invaluable)
So entering into a third iteration of the document and stepping further back from actively pursuing information, in my opinion is a step backwards.
In Canada, where nearly all healthcare is public, the absence of an active process to define opinion is really lacking. One might interpret this as “who cares”. Government is very interested in reducing costs, and I suspect strongly believes that asking opinions of how to meet “customer driven” requirements would increase the costs, not lower them. But from Juran a long time ago it was clear that small improvements can result in substantial decreases in total costs associated with poor quality.
(As a side note, recently I was a customer of our health care system. Most of the experience was excellent, but there were also significant problems that could and should be addressed. If I want to bring these to people’s attention, I would be required to write a formal letter. I am not averse to writing, but I have to decide if it is worth the energy.)
The private sector of health care in Canada, the US, and the Caribbean are embracing 15189 more aggressively than the public sector; I suspect that is because they see the financial and business advantage that Quality and Satisfaction can bring. I trust that these organizations have the smarts to recognize that defining and meeting customer driven requirements is where Quality should begin, and not where it should end.
ISO15189:2012 is a valuable part of the Quality movement, but the crafters need to focus on gathering better information if they want laboratory Quality to get to the next step..
Tuesday, January 22, 2013
A common theme that comes up in this blog is Adult Education. As a central thought I have read and observed that adults are not sponges, open to learning about everything. Adults will learn what they want to learn provided that it is packaged in a way that they perceive suits their purpose and self-image. Adult learners, despite their motivation are very selfish.
There are so many choices these days; you can read a book or journal or go through an instruction manual or watch a video or attend a course or conference. And of course there is the hunt-and-peck or trial-and-error approach of trying to figure it out through the process of self-exploration.
I used to think that there were some natural divides that influenced how we try to learn. Stereotypically men would might think would tend more towards solitary learning and women would tend more towards group learning, but what study there is on the subject does not bear that out. Men and women use both forms of study, each for their own purposes, and each with their own degree of success.
There are many types of information that can be picked up by reading a manual or journals, but in my experience the opportunities for failure are much greater than success. If the writing is ambiguous or tedious, or if the conditions for reading are not perfect, or if you are distracted by multi-tasking or time urgency, the greatest probability is that the learning will be a struggle.
That is why I spend so much time on developing group opportunities for Continuing Education in Quality.
At the moment we are coming to the end of the first week in our on-line virtual classroom certificate course in Laboratory Quality Management, and it looks like this will be a successful year. There is a lot of dialogue and discussion going on.
Not everything is perfect; we are really struggling with a new on-line education platform that is not particularly intuitive or helpful. I understand the pressures on companies to demonstrate their commitment to innovation, but I am not impressed when “New and Improved” turns out to be “just New”. Grumble …grumble.
As I have mentioned before I am also working on a number of on-site Quality Education opportunities to supplement the course.
In April we will be hosting our 20th annual half-day Quality Seminar with the Canadian Association for Clinical Microbiology and Infectious Diseases (CACMID) and the Association of Medical Microbiology and Infectious Disease Canada (AMMI Canada) in Quebec City and in October we will host our POLQM Quality Conference in Vancouver (see below). Both these programs are coming along very well with strong subject content and high quality speakers.
There are some obvious differences between on-line and on-site learning for adults. On-line education, even in a group situation like our course, provides certain luxuries. You can enjoy the group discussion and group learning but at the same time you can participate when you want to; for me after midnight works well. You can have music or not, or sit in your underwear (provided that you don’t use Skype or You Tube!). You can get up and walk away and come back an hour later and nobody knows. You can even smoke.
On the other hand on-site learning provides a level of access and intimacy and connection that can never be truly paralleled by computer learning. You can ask questions directly and make new contacts and create new opportunities. As they say the real value of meetings is that you actually meet.
As a education developer, my personal experience is that putting on a course of a conference or a seminar by-and-large all consume the same amount of time and energy and effort and money. It is all in the preparation and detail. The process of lining up topics and speakers and developing content is always more than you expect. Regardless of format, each hour of content transfer takes about 10-12 hours of preparation time. If you think that you can do a credible job on less, you are probably wrong. And more importantly if you thing you can do it all by yourself, you are definitely wrong; Education is absolutely a team sport.
For the bottom line is that we get engaged in continuing education activities because we see it as interesting and worthwhile and a lot of work and a lot of fun. Making it all about Quality delivery makes it better.
It is a noble endeavor.
Thursday, January 17, 2013
There are a lot of things that I get to do that I really enjoy, albeit some more than others. I am not able to rank them one (1) to one hundred (100), but they certainly fit into a top, middle and bottle tiers. But clearly one of the biggies in the top tier is being involved in our Laboratory Quality Management course. This year, our 10th season, started today.
Each year starts off pretty much the same way; some folks come in within the first 30 minutes of access, others take longer, and some (grumble grumble) take a couple days. Most have little difficulty getting access, but every year there are a small number who have technical difficulties. This year is no different.
Over the years the course has become more democratic. People from many countries; mostly technologists, although the number of physicians is increasing a lot, and some scientists. Many have family commitments with spouses and children, and lots of mention about pets (This year we may even have a talking parrot The gender split is shifting as well. When we began, nearly all the participants were women; today it seems much closer to 60:40.
What the group does have in common is a wealth of experience with medical laboratories and a common desire to learn about Quality as a new opportunity and possibly and new career path.
I know that word clouds have become rather passé, but I still like them. They are a handy visual way of depicting common interests and common themes. One of the first tasks that we give our course participants is the writing of an introductory biography of a few 100 words to express where they are from and where they want to be in the future. It helps me and the others to get to know each other better.
I take the text from the introductions and combine them into s single text file and then pass them through a word cloud generator on the web. ( There are lots available; the ones that I tend to use frequently are Wordie, WordItOut, TagCrowd, or Tagul. All of them allow you to set certain parameters such as how many repetitions of a word are required to get it on the list, can commonly combined words be gathered together, how many words should be shown.
The following is a good example, or the introductory thoughts and presence of people taking our course. I suspect they are very representative of the group of people who are interested and engaged in laboratory quality management.
For me this works out really well. I enjoy being a part of the Quality arena. I enjoy mentoring new folks interested in becoming involved. And I get to play with toys like word clouds.
How fun it that!!
PS: This cloud does not represent the whole group. Some have not come on-line yet. But under the parameters used for the cloud, it would be unlikely to substantially change.
Thursday, January 10, 2013
Paul Borawski, the CEO of the American Society for Quality and the writer of the blog A View from the Q has written a very interesting entry on the Definition of Quality. It is worth a read [see: http://asq.org/blog/2013/01/how-do-you-define-quality/].
There are lots of definitions around that Paul was able to document in a Future of Quality report in 2011.
As I look at this list, I will tell you that in my opinion many, perhaps most, of the definitions presented are very unhelpful (The pursuit of perfect that never ends; Quality is conscience, Excellence, Quality is the degree of feeling happiness, Quality is the intangible that makes a better world tangible,.). These are phrases that contain nice but meaningless words.
Then there were a few suggestions that were equally unhelpful, but didn’t even bother to include some feel good intention (Quality is what the customer says it is, I know it when I experience it, My total experience of the provider.)
The problem with all these phrases is that none of them express any sense of objective measurability, and as such don’t provide any support for progress for the science or discipline of Qualitology [see: They do nothing to advance study or progress in Qualitology [ see: http://www.medicallaboratoryquality.com/2010/12/science-of-qualitology.html ].
In 1979, Phillip Crosby created a pretty good working (excellent) definition that has by-and-large stood the test of time. His Quality is the Conformance to Requirements has been reworked in a variety of ways, that all express the same concept (Quality is compliance to a specification, or Conformance to requirements, or Meeting customer requirements)
This has proven to be a helpful place to start. In my field, it starts to break down, for several reasons. First, it implies that there is a uniform customer or a common customer need. It assumes that organizations has the flexibility to provide a unique service for each customer. Second, it implies that customer requirements can always be met, and third it implies that we can capture and analyze the degree to which we have met the requirement (think customer satisfaction surveys). I don’t think any of those are generally true statements.
I am not suggesting that the Crosby definition is wrong, or that it should be discard, or even denigrated, but I think in some fields it needs to be adjusted to fit the circumstance better.
With that in mind let me suggest:
Quality is meeting the requirements and expectations in service or product that were committed to.
Hold me responsible to what I commit to do. If I do that then I can say I have Quality performance. If I miss due to over-commitment or under-performance I have detracted from my Quality.
If I told you that I would get your dry-cleaning done by 10:00 AM, then Quality service requires me to have the job done without fault or damage and ready to go by 10:00 AM. You can count on it.
And if I told you it would be ready at 10:00 AM and you come at 09:00 AM and are angry because it is not ready yet, that may be a disappointment, but is not a reflection on the Quality of my service.
If I told you that I would have that urine culture completed by Tuesday morning before 7:00 AM, that means that you can expect to have an accurate quality-controlled and quality-assured interpretable culture report with the appropriate antimicrobial susceptibility results on your computer screen for 07:00 hr rounds.
And if I told you that I would build a bridge for 3.3 Billion dollars that people can drive across safely, and what I provide within time, and under budget a bridge that nearly kills people in a predictable period of poor weather, that is called the Opposite of Quality.
The value of my extension to Crosby’s definition is that it is predicated on to what I made a commitment. If my commitment is not close to meeting customer needs then we have a second issue (more on this later), but I can and should be held to what I commit to do. If I have completed as committed then I can say I have performed a Quality task. If I get it done well, but late, I can measure the degree of lateness (in the laboratory we call that turn-around time) and I can define the amount of Quality lost. I can measure amount of conformance to commitment, and I can study the deviation and develop a specific strategy for improvement.
So in summary my definition for quality is tied to the customer need, but is further refined based on my ability to perform based upon what I promised; it is stateable, and it is measureable, and it is studyable. Mission accomplished.
Not bad, eh?
PS: The planning for the UBC POLQM Quality Conference (October 16-18, 2013) is coming along nicely. The themes of World Standards in Health and Improving medical laboratory services for better consumer care are coming together are established.
Sunday, January 6, 2013
Quality Moves On
Twenty thirteen (2013) begins as with every year; not a bang or a whimper. Just a turn of a page on a calendar. Only time will tell how things progress. But from my perspective, risk analysis points to more opportunities for upside than downside.
The international standard on Quality and Competence for Medical Laboratories (ISO 15189:2012) has been published. There is precious little new in the document, but it is more comprehensively written with more interpretive commentary. It should be easier to digest for first time readers, and this might have an impact on more uptake by laboratories seeing a value in voluntary supplementary accreditation. Fortunately for our Program Office Certificate Course in Laboratory Quality Management course, our text, the Canadian Standards Association 15189 Essentials is still relevant, but we will have to see if there is room or necessity for change for next year.
In the meantime there is increasing awareness of the role of Risk in the medical laboratory. At present we have the document ISO/TS 22367:2008 Medical laboratories -- Reduction of error through risk management and continual improvement. From my perspective, the time has come to strengthen the suite of documents that surrounds 15189 rather than spending more time making cosmetic changes to 15189. In my point of view laboratories need to have better documents to ground risk and safety and point of care. Some might argue that these are documents that have more value for developed countries, and I can sort of see that point of view. But on the other hand, se are seeing some really interesting change in developing laboratories that involve “technology hopscotch”. We are seeing huge change in laboratories directly linked to cell phone and smart phones. Who would have believed that rural laboratories could have direct to patient transmission of rapid information, or direct to wireless printing, and direct to distance continuing education? Time will tell where all this leads, but it certainly becomes a huge opportunity for risk and evolution. It is exciting.
In the meantime I will be tied up with a series of additional programs that carry huge opportunity. In February I likely will be in Tanzania, and in April will be hosting my 20th Quality Conference for Microbiology Quality. This conference has gone through huge change over time. I started as a joint meeting of Canadian proficiency testing programs sharing innovations and progress. In many respect I miss that meeting because if was the ultimate foundation for collaboration. Gradually the meeting changed with increasing more Quality oriented subjects than just proficiency testing. I will be very interested to see how the meeting evolves as it goes forward under someone else’s command.
Most importantly I am looking forward to the progress that we are having with resident training and PhD training and our October meeting.
The October meeting (see below) is coming along really well. This will be truly a national meeting with partners from the federal government and (hopefully) with a major provincial organization, and perhaps a supplemental workshop for a special certificate. What was planned as a relatively small meeting is growing very quickly. Our plan is to start our formal promotional program in a few weeks, but anyone interested in hearing more can send a request information through email@example.com