Sunday, April 27, 2014
Sometimes it is worthwhile to look back at what you have been toiling with to see if you are staying on or near the path that you envisioned, or if the forces of either stagnation or innovation have taken you off into another place. This is a good time for me to make that look back.
A long time ago, I had the opportunity to get involved in the world of Quality for medical laboratories. To be truthful, it was not my idea, but rather that of my mentor, John Angus Smith, but I take credit for recognizing an opportunity when it came along and taking to places that John, I don’t think envisioned.
The primary model was to create a local proficiency testing program for local laboratories because of total frustration with the choices, especially those from out-of-country that were available at the time. By housing the program inside the university it gave him access available space and to physicians in specialty training (residents) who could help with writing the educational critiques.
When I took over the program, identified as Clinical Microbiology Proficiency Testing (CMPT) as it still is, I quickly realized that being “inside the walls” of the university provided more than space and slaves, but also create an environment for research and development and education in a topic that was essentially beyond the scope and vision of most academics.
Over time the theme of university based proficiency testing expanded from solely providing local community service in medical laboratory quality assessment to national coverage and then to international. The technical focus certainly expanded through aggressive research and development into innovative approaches to simulated samples in both clinical and water samples. Perhaps more importantly, and consistent with our education foundation was the generation of better educational critiques and photographs and treatises and manuscripts, the impact of which has been greatly expanded through electronic access.
The next phase of theme development was the topic of my last entry [see: http://www.medicallaboratoryquality.com/2014/04/fishing-and-proficiency-testing.html ] where it became relevant to share our knowledge, not though manuscript but through hands-on real-time training, with the people and countries that would benefit by establishing their own independent programs that could network with us, or not, depending on their own needs and requirements. Several have seen value, and have returned for more time with us, others have chosen to work though co-venture studies.
The next step was probably our most adventurous, when we developed our sister program the UBC Program Office for Laboratory Quality Management (POLQM) because it expanded our them from strictly laboratory technical to laboratory management, and opened up a whole new set of opportunities including study of basic knowledge of laboratory quality management, provision of community services in quality management and education, and participation in the national and beyond dialogue in the themes critical to patient safety through better laboratories.
One does not have to look very far to see how much information most laboratorians don’t have in the domain of quality to understand how much enthusiasm there has been in with POLQM participants and at the same time how much push back there has been from some laboratorian luddites. But in the meantime we have still been able to develop a form of graduate program (PhD) and a visiting scientist program.
Over the past two months we have had the opportunity to work with a visiting scientist from China, a senior laboratory director, with an interest and passion in learning more about laboratory quality and laboratory safety. It has been a real pleasure and a huge success in having him here. During his short visit, we have participated in a national Quality Seminar, participated in a number of Laboratory Safety Audits, Created an international (three continent) on-line survey on the Quality aspects of blood culturing, and developed a manuscript soon ready for submission on barriers to success in laboratory improvements.
So as I stand back today and remember where we started and how we have progressed, I feel pretty pleased with where we are. Where we could have been complacent we have been activist; where we could have been staid we have been innovative. And where we have met roadblocks we have created go-arounds. I think my mentor would have been pleased.
PS: Anyone interested in hearing more about the visiting scientist program is welcome to contact.
Friday, April 18, 2014
Fishing and Proficiency Testing
In our UBC Certificate Course in Laboratory Quality Management we introduced a concept which we call Quality Partners. These are agencies and organizations whose primary purpose is to enhance the quality of medical laboratories. Without these partners, the likelihood of a medical laboratory developing any semblance of quality enhancement and error reduction for all intents and purposes, negligible. The primary Quality Partners are Accreditation, Proficiency Testing providers, Standards Development organizations, Education providers, Professional Organizations, and Suppliers. While I am biased, of this group, the only partner that has ever demonstrated the ability to actually reduce errors is the Proficiency Testing provider group.
When PT exists with good and competent programs, laboratories receive samples that closely resemble actual samples, with the singular but essential difference being that the sample has been pre-tested and stabilized so that the correct result is known by the provider. The challenge to the laboratory is to test the sample and come to the same value. If the laboratory can do that they are told they are proficient; if they cannot they are told they have opportunities for improvement to learn how and why they made mistakes, and to determine how they can avoid such errors going forward.
PT providers are a committed group of people, dedicated to the premise that helping laboratories overcome errors directly contributes to patient care and patient safety.
While my own personal focus in on water testing and patient care microbiology sample testing, most developed countries have PT providers not only for medical laboratory testing and water, they also test for food and engineering, and many many other types of laboratory tests.
Unfortunately, developing countries see the value of developed medical laboratory testing, and see the value of quality partners, but they do not have local access to PT. And that is a problem.
For many, the solution is to purchase PT samples from a larger country, who is always more than happy to provide them. That the samples were never designed to address the issues of developing countries and that to get the samples to the laboratories at considerable distance they have to compromise their quality by freeze-drying the samples is of little concern. When they write the informative sheets, they are written from the perspective of the large parent country and without any perspective for the developing region.
So the product they receive is costly, not designed for their purpose, not optimised for their purpose, and not assessed or graded for their purpose. That does not seem to be much of a deal, and from what I have seen, the success rates on the samples is rarely barely close to acceptable.
We have taken a different approach.
Rather than just shipping samples, we bring one (or preferably two) able persons to our centre and give them intensive training in producing samples and setting up a basic program that will allow them to start a program, select, produce, transport samples relevant to their setting, and show them how to grade them and produce a critique. As mentioned it is an intensive program. Some get the information they want in one session, others come back for a second session.
Over the duration of our program we have usually had one country participate each year. This year we will have had representatives from 3 countries. And we are getting contacts and expressions of interest for next year. So by an awareness scale we seem to be having success.
This summer we will be doing a survey to see if the countries that have visited us have implemented programs and if those programs are still in operation. (Satisfaction and Loyalty).
Without getting too sophomoric, the whole experience reminds me the proverb “Give a man a fish, and you feed him for a day; show him how to catch fish, and you feed him for a lifetime.” Contrary to popular myth, this is not biblical nor Greek or by Confucius in origin, although I can understand the foundation for the various myths.
The original version was “…give a man a fish he is hungry again in an hour; if you teach him to catch a fish you do him a good turn." This was written originally by a British author, Anne Isabella Ritchie and published within a story entitled Mrs. Dymond, in an American magazine Littell's Living Age printed in September 1885.
Personally I prefer the original version.
PS: If you want to know more contact us through www.cmpt.ca
Sunday, April 6, 2014
Saturday, April 5, 2014
Learning about Risk and Prevention through Continual Improvement
Yesterday we had our 12th external audit by our ISO certification body in 12 years. You would think that by this time we would have the process down pat. It should be a walk in the park. Well this is sort of true. In the early days we would look at audit day with a certain degree of anxiety and distress. These days those negative concerns are gone, and in fact we look forward to the exercise because we still find opportunities for learning and opportunities for improvement.
Some would say that now that ISO 17043 (Conformity assessment — General requirements for proficiency testing) exists there is no longer a place for assessment of proficiency testing programs to ISO 9001. I can see the argument since ’43 is more specific, but to my mind there is no document more specific and exacting to quality management than 9001. So while we will likely seek an external auditor that we have confidence can do a competent assessment to ’43, we will continue to stick with 9001. Indeed, to my way of thinking, I suspect that when the smoke clears, we will likely find a way to do both.
One thing that I appreciate about our current ISO 9001 assessment body (SAI Global) is that they provide us with a knowledgeable and experienced auditor with a lot of knowledge and skill in the laboratory area. Several of his clients are in the laboratory arena. He is knowledgeable about calibration and equipment and quality control, and our assessment covers these areas thoroughly. In addition to our regular close look at our quality system and management review and customer satisfaction plus plus, we also get a solid review of critical laboratory expectations. So in a sense we feel we currently are getting the best of both worlds right now.
So how did we do. We were found to have no non-conformities. We continue to meet all the requirements. But we are not perfect. Although we do two major internal audits each year, (one in February-March and one in July-August) and had the documentation available, when I wrote up my Management Review report, I forgot to add in an “Internal Audit” section. We probably could have gotten away with that except we publish the MR review in our Annual Report (available on-line at www.CMPT.ca) and so the absence of an IA section was pretty obvious. This was written as an “OFI-Opportunity For Improvement” rather than as a non-conformity. I could go back and edit the MR review, but we agreed that the more appropriate approach would be to include the section in our next MR in our next Annual Report.
The other thing that came up is a common problem, but I think we have found a good solution. Like most organizations we are weak when it comes to having a documented list of Preventive Actions in our report. It looks like we continue to be only re-active to problems rather than pro-active through prevention. But in fact that is not true. Our problem is one of recognition and value.
We make changes and improvements all the time. We changed our glass slide labels to a better material so that they would not fall off and not get covered with stain. We changed our packaging to reduce the risks of leakage to a level beyond requirements. We implemented our earthquake preparedness safety kit, and revised the labelling on some of our reagent bottles. There have been probably 15-20 of these types of changes going on over the last year or two, and while we have thought of them as products improvements and safety requirements (which they are) they are also true Preventive Actions because each of them reduces a Risk of inconvenience to ourselves or our customers.
So now as we continue along our path of innovation and continual improvement we can also look at ourselves from a Risk and Preventive Action perspective. And if that was all we learned from this year’s audit, it was well worth the cost.
As a PS note, some explanation may be necessary. If we are so satisfied with our current assessment process, why would be even be thinking about including additional assessments? The answer is that for some of our customers (clients) seeing the words “Accredited to ISO 17043” is becoming more important, and so I suspect our move to accommodate their concerns will come to fruition fairly quickly.
Thursday, April 3, 2014
Over the years I have organized 22 Quality Seminars for what used to be called the Conjoint Meeting, an annual event in Canada that has brought all the interests of microbiology, infectious diseases, and public health together for the last 80 years or so. Today it is called the AMMI Canada CACMID conference, named for the two principal host organizations.
The Quality Seminars have changed their name and purpose since their inception in 1992. At first it was an opportunity for laboratory accreditation bodies and proficiency testing bodies that got together and discuss common interests. When the accreditation bodies dropped out the proficiency testing groups continued on and we could chat about interesting PT issues. Over time the focus started to move again more in the direction of standards development, and then finally very much into the areas of individual interest, such as international activities, education, and finally a whole slew of Quality oriented topics, that impacted mainly microbiology laboratories, but eventually the broader topics or error and culture and continual improvement.
The Quality Seminar has always been seen as separate from the main meeting. At the beginning it was an event that people could attend on the day after the conference was over, especially if they had a late flight on the next day. Then it became one of the day-before events so that people would have something to do when they got to town a day early. Both of these times worked out well because it was not competing with the chaos of the full meeting, and gave us lots of time as opposed to being limited to a slot of 45 to 90 minutes. While others were being shoehorned in, we always had at least 4 hours to fill, enough for at least 4-5 speakers and discussion and coffee breaks.
The audience was always a select special group. Even in the arena of laboratory and clinical medicine, the audience for Quality issues has never been huge. But it was a faithful group and every year, pretty much we could fill a small or intermediate sized room for the whole session.
Of interest, as the conference expanded, other groups began to see the day-before block as a desirable time slot and we found ourselves competing with other groups during our afternoon block, probably to the disadvantage of both. The people having the competing time meeting locked up all access to the physicians-in-training (aka Residents), a group of people that prior to this change would benefit from being at the Quality Seminar and being exposed to a topic for which their routine training was (and still is) somewhere between inadequate and absent. And we would have enjoyed having the Residents with us, because it would have increased the group size and expanded the group discussion. But it just was not to be.
So now after 22 years, I think it is time for me to call it quits. I have kind of run the gambit of topics and I am not sure I see the value to me in continuing on. That does not mean that Quality Seminar will end, indeed I hope that is not the case; it just means that someone else will need to take on the responsibility to organize it and lead it and keep it afloat and move it towards its next iteration.
For those interested, the presentations from the meeting will be on-line at www.POLQM.ca under the title AMMI-Canada CACMID 2014.