Multitasking in the Quality Arena

In 1977, on the television show M.A.S.H. a new character was introduced, an ill-place army surgeon named Charles Emerson Winchester lll.  Wanting to define the character as Bostonian, elitist, and arrogant, a brilliant (in my opinion) writer gave the character the line “I do one thing, I do it very well, and then I move on.”

 

Every time I make an error, or I see someone else around me trying to multitask and result in inconvenience, accident, or injury, my mind wanders back to “I do one thing…”  (Over the weekend I saw a young man riding his bicycle while talking on his cell phone, ride into the back of a parked car.)

Unfortunately “piling on” task over task has become for me a chronic and persistent bad habit, and I leave myself overly vulnerable to making too many distracted errors.  Over the last month we have held our CMPT Annual General Meeting, started our annual review of the POLQM Certificate Course in Laboratory Quality Management, attended the ISO Technical Committee 212 annual Plenary Meeting (this year in Toronto!!), attended the annual conference for the European Association for EQA providers, (EQALM), written a new manuscript, been a reviewer of 2 journals, signed a commitment for CMPT to seek accreditation to the ISO standard 17043:2010, and prepared a Competency Assessment for a laboratory physician renewing their licence.  I mention the list, not so much to impress, but to point out to myself that as continue along the path of excessive commitment, I create the increased opportunities for distracted error, the potential for dropping the ball or making errors that could have serious impact on my career and others in a major way is unacceptably high.  (Memo to self:  I need to focus one thing, to do it well, and then move on!!).

Knowing myself as I do, I know that I will never stop being a “piling-oner”,  it is therefore important to ensure that I incorporate some protections that should decrease my doing serious harm to the programs that are important. 

For me, the most significant protection is the implementation of standards and backing that up with external assessment, in this case meaning on-site accreditation visits.  In my opinion, our adding in the requirements for ISO/IEC17043 (Conformity assessment - General requirements for proficiency testing) is an important step forward in our path towards improved Quality.  Our strict adherence to ISO9001:2008 (Quality Management systems – Requirements) has bought our program to an extremely effective management level.  Adding to this the more vertical (drill down) requirements for proficiency testing programs will ensure that our skills remain focused and sharp, to the betterment of our program and by extension the betterment of the laboratories that we serve and for the patients that use their services. 

I am not sure that a non-academic program would see particular value in putting expectations on themselves to meet two international standards (one more horizontal in nature, and the other more vertical).  It might seem to be abusive and inappropriately expensive.  But for me, I see sufficient clear benefit.  I find that during assessments, the folks responsible for ISO9001 are excellent in understanding and reviewing our activities with respect to organizational management, risk, personnel, quality improvement, error detection, quality improvement, customer satisfaction, management review.  They have a strong sense of these topics and review them well both in context of the standard, also in context of common best practice.  On the other hand, the laboratory assessors focus very well on the finer aspects of Quality Control, and aspects critical to PT users, like committee structure, instruction information, cautionary information,  and statistical analysis. It creates a healthy blend of practical and pragmatic, of ying and yang, of masculine and feminine.

If we can continue to afford to run both accreditation (17043) and certification (9001) we will continue to do so. 

Learning about Risk and Prevention through Continual Improvement

Learning about Risk and Prevention through Continual Improvement

Yesterday we had our 12^th 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. 

 

 

Does Laboratory Accreditation Improve Patient Safety?

Does Laboratory Accreditation Improve Patient Safety?

Module 3 in our Certificate Course in Laboratory Quality Management is my favorite because it addresses the critically relevant issues of the modern medical laboratory including the Costs of Poor Quality and the Role of Quality Partners.  

For reasons unclear, many (most?) modern laboratorians have brainwashed themselves into disparaging all the groups that have been created to HELP laboratories meet customer requirements.  “We” are suspicious of accreditation bodies, and disparage proficiency testing programs.  “We” trivialize educators, and demean suppliers for being in it only for the money (as if making money is a bad thing!).  I am not sure why we do this.  It has been the order of the day ever since I got involved in laboratory medicine in the 1970s.  But through our course, the evidence for increasing awareness of the importance of Quality through  literature and conferences and activities is very present.  I think that we are recognizing our friends better but it has been a slow process. 

One of the questions that I pose to the group in Module 3 is “Does laboratory accreditation improve patient safety, and how can you prove it?”.

I will say that I come to this question with a point of view.  I wrote an opinion piece now a long time ago [see  Noble MA. Does external evaluation of laboratories improve patient safety? Clin Chem Lab Med. 2007;45(6):753-5] at which time I opined that it is impossible to demonstrate by evidence, but it would be a mistake to stop accreditation just because you can prove it helps patients.  I have also written in this on-line journal [see: http://www.medicallaboratoryquality.com/2013/03/making-your-quality-partner-your-enemy.html and http://www.medicallaboratoryquality.com/2013/03/quality-and-accreditation-partnership_18.html ] 

It is still a relevant question to ask, especially with this group of experienced laboratorians who are sufficiently committed to laboratory quality that they would put a lot of money out and spend a lot of time thinking about and discussing relevant Quality.  

Of note and interest, all participants who engaged in the conversation wanted to believe that accreditation would increase patient safety for all the same and reasonable reasons.

First and second, accreditation would increase the interest in maintaining standards, and accreditation would increase the strength of the Culture of Quality.  Some did a PubMed search and found Peter’s aspirational and speculative  “Impact of Laboratory Accreditation on Patient Care and the Health System” (Am J Clin Pathol 2010) which says but doesn’t demonstrate the relationship.  

One person, wrote that on balance accreditation had more advantages than disadvantages.  That is a great sentence.

One of the challenges to writing more definitive statements is that the value of accreditation is very difficult to prove by study.  We talked about studying laboratories before and after accreditation looking for parameters like turnaround, and error, and report quality, but that sort of study could take years, and even with that looking for those markers would not help.  We talked about going to a native jurisdiction where there is no accreditation and then preparing one group while leaving the other group alone.  Aside from the moral perspective, this approach would likely fail as well because the point of Quality is not so much to stop errors, but to pick them up faster, and that would be very difficult to demonstrate.

All this taken aside, the important first step is that we have a group of laboratorians who believe accreditation is a positive step forward, and to my way of thinking that is indeed the most important step forward.  In this group the scepticism about accreditation is replaced with confidence and trust.  That is brilliant and a huge step forward. 

Now if we can figure out how to block health authority and government and capitalist bean and profit counters who all want to throw out the baby with the bath water and actually kill medical laboratories with “redundancy is bad” insanity, we actually have laboratorians  who have insight and care.

But I have my doubts.

Laboratory Quality: words or rhetoric?

Laboratory Quality: words or rhetoric?

This month the Infectious Diseases Society of America published a new article (A Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2013 Recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM)) in the journal Clinical Infectious Diseases. It is an impressive document and for those interested in laboratory medicine, and clinical microbiology and laboratory diagnosis to assist infectious diseases, it is an impressive document.  It is about 100 pages long and includes 250 references, so it would be fair to call it comprehensive. 

It was an impressive task to compile all this information and put it together in a single comprehensive manuscript.  The authors should be congratulated. 

Unfortunately, despite all these positives and kudos, it not only misses the bull’s eye, in my opinion it by-and-large misses the whole target. 

The shame of the matter, is that the authors are all very well know and well respected microbiologists in the clinical laboratory community; and they know what the target is, or at least should be.  They say right up front “Physicians need confidence that the results provided by the microbiology laboratory are accurate, significant, and clinically relevant. Anything less is below the community standard of care.” And they are bang-on.  I agree entirely. 

So what is their plan to ensure that laboratory results meet those criteria; their answer is that “all microbiology specimens be properly selected, collected, and transported to optimize analysis and interpretation.”  The problem is that this is just far enough off to be misleading and misguided. 

Don’t get me wrong, I think that collection and transport of clinical samples is important, indeed very important.  And if you want a document to help with clinical sample collection and transport, you can consider this manuscript, or better, look at the Canadian Standards Association document “Z316.7-12 - Primary sample collection facilities and medical laboratories - Patient safety and quality of care - Requirements for collecting, transporting, and storing samples”, which I think is eminently readable and applicable. 

Where we diverge from the value of the IDSA article, is that even if the sample is collected and transported properly, that does not ensure that it will be processed properly or accurately, or that the results reported in the clinical report will be significant or  clinically relevant.

While it is true that many, indeed most REPORTED laboratory errors are derived from the pre-examination phase and it is also true that testing accuracy and significance are affected by specimen quality, it is also true that testing, interpretation are influenced largely by laboratorian practice and competency as is the ability to generate a clinically relevant report.  We know that from data generated from our proficiency testing program over the last 10 years. 

In the table below, you can see performance of advanced laboratories (Blue), intermediate (Red), small (Silver) and very small (Green).  

Creating a manuscript that says all the problems are caused by improper collection and transport is an easy out.  “It’s not my problem, it’s not my fault.  Those guys who collected the sample did it wrong.”  “And if they don’t understand my report structure or my report content or my report jargon, that’s their fault too. “  “The problem isn’t me.  I know what I’m doing.  It’s all those other guys (i.e. you!) who are the problem.” “Trust me, trust me.” 

It speaks to the mindset of the authors when the word “Accreditation” is found in a 100 page (about 10,000 word) document only once, and this is in a footnote.  The word “proficiency” is similarly found only once, and not in the context of proficiency testing.  And the word “competency” is not found at all, nor is the phrase “quality management”. 

If clinicians are going to have the confidence that laboratory results are accurate, clinically relevant, and significant we need to be able to document in a public fashion that we laboratorians take these issues seriously and that we undertake the necessary steps to ensure through qualified external assessment that our leadership and sample management and competence and knowledge and proficiency are active and intact.   

PS: The October in Vancouver Conference for Medical Laboratory Quality is coming along nicely.  Hotel space is filling up well.  I suspect we will have more registrations than rooms at the convention rate.

For additional information see:  http://polqm.ca/conference_2013/conference_2013/conference_home.html

Is Accreditation the only way?

Over my career I have had a bipolar relationship with medical laboratory accreditation bodies.  On the one side I see accreditation when it performs its functions as an external assessment body as an important and valued partner for laboratory Quality.  Being an outside set of eyes with both an understanding of Quality and laboratory practices and armed with an established standard such as ISO 15189:2012 or ISO/IEC17025:2005 or one of the related documents that has been adapted from the parent document and used on a local or regional basis, accreditation bodies can be powerful supporters of the laboratory Quality performance.

On the other side I have been particularly critical when accreditation bodies believe it is within their purview to write or cherry pick their own standards or when they allow for loose understanding and even looser interpretation by peer reviewers.  Any assessor who starts an accreditation observation with the phrase “Well in my laboratory we do it this way…” is a bad assessor should be terminated immediately.  I don’t care what someone does in their laboratory; I need to know if my laboratory is meeting the word and spirit of the established standard. 

And it irks me when folks who have never worked in a laboratory or have no recent understanding of laboratory activity believe they are appropriate persons to be take authority for creating standards. 

And I really fatigue of Accreditation Bodies that year over year a hundred percent success rate on laboratory accreditation.  While I don’t think it is nice that some laboratories are closed and people lose their jobs or hospitals or communities are inconvenienced, I find it far worse when weak laboratories are given admonitions, knowing full well that nothing is going to happen.  If a laboratory has a poor performance, it is far better than the inconvenient thing happen and the problems get addressed rather than wait for the horrific failure to occur. 

And what especially annoys me is the verbiage that says that Accreditation can assess the competence of a laboratory.  What total nonsense.  Accreditation visits are staged events, barely longer than a Broadway play.  The notion that a group of people can come into a laboratory on a given day and make anything other than superficial commentary on the activities of the people working on that day is a good example of a hallucinatory pipedream.

Recently I was in discussion with a person with responsibility and authority and commented that the olden days the technical requirements of a laboratory were both manual and working knowledge based.  Laboratory workers need a lot of hands-on skills and accurate recall of intricate data.  Today’s laboratory is different;  autoanalysers have taken over most of the manual and mental skills, leaving staff requiring a new skills focused mainly on computer and data handling.  In the olden days, laboratory workers needed to be able to manually maintain hardware and sometimes ripping it apart and then repairing it.  No longer.  Equipment these days needs service experts or more often, is just swapped out. 

Skill sets come in two categories, routine and crisis intervention.  Both work well the vast majority of time, with the rare and irregular slip and/or distraction that leads to error.  The reality is slips and distractions do not lend themselves to measurement for competence on a given day by a given group no matter how clever they are.  Most site visits will never occur on the day that an error happens.

What accreditation bodies look these days is evidence that Quality Control and the Quality System are intact and being followed faithfully The accreditation body is determining if the organization is meeting its laboratory-relevant Quality system in a manner than is likely to detect error early, remediate it and correct it before ensuing harm spreads beyond the confines of the laboratory.  Not to belabour the point, but we have groups that look at whether or not an organization’s Quality system is intact: we call them Certification Bodies.   

So while the accreditation bodies often view certification bodies as their inferior and evil twins, the reality is that by and large to two groups provide the same function.  And if that is the case, do we really need both?

From my personal perspective, I find that the Certification Body that visits CMPT on an annual basis, provides a demanding review of our Quality System and Quality Control.  They don’t have the time or experience or knowledge to sit and watch as we go through the tasks related to planning or creating or transporting our PT samples, no do they sit in as we go through the evaluation process.  They find and examine the secondary evidence that supports that we are doing our tasks well.  Our adoption and regular assessment to ISO 9001:2008 has made us very effective PT provider. 

At a certain point medical laboratories authorities may want to ask if assessment of Quality and Competence can only be done one way.