Anatomic Pathology's Quality Journey

ANTHONY M. MAGLIOCCO, M.D., FRCPC, FCAP: Thank you very much for that kind introduction, and thank you for inviting me to share my experiences with quality anatomic pathology. I think that this is a fascinating time for anatomic pathologists, and also a challenging time. So I’ll try to move through the presentation fairly quickly for you.

The objectives of today’s talk is to really review the challenges in anatomic pathology, to share with you the type of system that we’re implementing to Moffitt Cancer Center, and to really discuss how improved quality can contribute to better patient outcomes.

Now we live in changing times as practitioners in medicine, and we’re moving from a reimbursement model where we are paying for service to one where payers are now demanding quality that are the investments in the system actually paying off in improved outcomes for patients. In addition, with internet and broadly available information, the patients are becoming more empowered about what is happening to them.  And with the changes in reimbursement and insurance, patients are facing higher deductibles.

So they are also taking greater ownership in how they are selecting their treatments.  As information is coming out into the public domain, there is a reduced tolerance of error. In our society, error is not really expected.  And we will review what these changes mean for anatomic pathology.

Unfortunately, for anatomic pathology, not all news is good news. And one thing about pathologists that I think is that pathologists tend not to really market themselves very well. So often the type of marketing that they do get in the public eye is frequently negative where when problems affect patients, the patients sometimes go to the press, the press looks at investigations, and we see a number of studies now coming out where basically there is not good coverage of pathology mistakes, problems with pathology, and things encouraging patients to seek second opinions.

It’s also important to remember that today’s system is getting more complex, and pathologists don’t just make diagnoses. They actually make recommendations about therapy. The staging of a cancer can effect what type of this used, and the selection of biomarkers and the performance of those biomarkers in a path lab can also impact which treatment is used, whether something like Herceptin is indicated for a patient or not.

Now the other thing is that there is a lot of information for patients now for the internet.  And what patients face a diagnosis of cancer, frequently they will start browsing the web. There is one website called Cancer Points where they present information for the patients to help them understand what their options are, what are the implications of cancer and, so on. And on this website, they have highlighted a number of studies, including a study from Johns Hopkins and others that show that as much as 44% of the time, pathology reports may contain errors. This high rate of error refers to cases of prostate cancer with incorrect Gleason grading which may affect the treatment choice for a particular patient.

Now we also recognize that pathology is still practiced by pathologists, and pathologists have different training backgrounds, different abilities, different skills, and often they are still practicing in isolation, and in silos. And as this becomes apparent, again, the media is now identifying this that the quality of care that the patients are receiving at different centers are different.  In the top, this is a study from Canada where it was determined that estrogen receptor determination in a single lab was really incorrect for a period of over ten years.

     In another study, again, in Canada, in Newton, New Brunswick, it was discovered that a practitioner in New Brunswick may have been making errors for as long as 13 years. So these kinds of discoveries have certainly affected health systems in determining what is happening in pathology, is there a real problem in anatomic pathology, and how are we going to address that.

Now if we look at the other side in terms of litigation, where the litigation problems are arising, so we can break down the anatomic pathology process into three steps, basically pre-analytical, analytical, and post-analytical, most of the litigation is actually in the analytical area which is the active diagnosis. I sometimes think that in the pre-analytical, that frequently errors in pre-analytical may not actually be detected, and I’ll talk a little bit about that as we go through the talk.

Anatomic Pathology

So I believe that anatomic pathology has a great opportunity for improvement in quality. Now if we look at where anatomic pathology begins, this is an example of a gross room in a typical hospital. And we see that this is somewhat of a chaotic environment. The anatomic pathology lab looks quite different from a chemistry lab or a blood bank in that we are managing tissue, that the environment is a little bit more chaotic, and it’s not automated at this point in time.

The problem is that this brings up issues with potential identification of specimens or are the specimens identified correctly.

And as the process of managing these specimens occur in the labs, there are many steps where specimens are transferred. They go from containers to the examination, into cassettes, and there are opportunities for errors, and mix-ups to occur at every possible step. Going back also with material like this, it’s very important to maintain a clean environment, and also with instruments because material can get stuck on instruments, and be carried over from one case to the next causing biopsy mix-ups, and floaters that can confuse diagnosis.

This is another hand-off where material comes from for embedding, and then basically additional hand-offs where blocks are cut─

Material is floated in a water bath, and this is another area where potential problems do happen that there may be residual pieces of other specimens that can potentially get mixed onto a specimen as it gets mounted onto a slide. So that is the pre-analytical process, and I think that there are opportunities for improvement in pre-analytical pathology and anatomic pathology in terms of minimizing the opportunities for a mix-up of specimens and tracking specimens through that process.

Now the specimen finally makes it to your friendly neighborhood pathologist, and there is a smiling Dr. Kallele [phonetic], a friend of mine in Calgary, who is a great pathologist.  And, again, the pathologist’s office is not changed a lot over time in that they have complex filing systems, and that the real diagnosis rests on the pathologist. So the pathologist is very key to how a patient is diagnosed, and how a specimen is reported out. Now one thing about pathologists as it was noted, the pathologist is perhaps the most important physician that the patient never meets. 

So often, a patient is unaware of what the pathologist is going to receive, what is the training of the pathologist, what are the skills of the pathologist. And in a complex system like ours, really it’s incumbent upon us to ensure that all the patients receive the highest possible level of care. So that means we have to come up with a system where pathology knowledge is available, and shared and made available for really every patient that comes through the system.  Now the purpose of quality assurance in anatomic pathology, clearly the baseline is to comply with accreditation and certification. But I view this as really a baseline, and that should be a given. We want to make a system that goes beyond what the minimal expectations are to a total quality system where we really can minimize errors, and ensure safety and quality for all of our patients.

Quality in AP

And this isn't just to avoid litigation. It is really the right thing to do, and it will improve efficiency and quality.

Now if we look at interpretive diagnostic errors where interpretation comes in, there was a meta-analysis done by CAP that showed that there were a number of studies, so they actually reviewed 89 studies. And in those studies they found that the error rate of discrepancies was as high as 18% in surgical pathology. And major discrepancies in what they defined as a major discrepancy are discrepancies that would affect treatment. They reviewed 66 studies and 6.3% of them showed major discrepancies.

     Now if we look at breaking it down into whether cases were reviewed internally versus externally that it was determined that if you had an internal review, the discrepancy rate was only 1.3%, whereas if you had an external review the discrepancy rate was much higher at 7.4%. And that may not be too surprising, but we will walk through why that may be the case.

Now one thing that did affect us at Moffitt is that there was a publicity of the case where there was an error made in the diagnosis and that did trigger Moffitt to look at its processes.  Now just to give you a little bit of a background of the Moffitt Cancer Center, the Moffitt Cancer Center is located in Tampa, Florida.  It’s the largest cancer center there. It’s a comprehensive cancer center, and the NCI designation for comprehensive cancer centers is granted to centers that really focus on cancer care and have integrated programs of both treatment and research. I believe there are only 46 of them now in the United States.

Moffitt is a busy practice for a cancer center seeing over 17,000 new patients a year, and basically over 300,000 outpatient visits a year. The practice pattern of Moffitt is multidisciplinary, so it’s not organized into traditional departments except for pathology, radiation, oncology, and radiology.  The other teams are organized around tumor sites.

And the other thing that Moffitt runs is something called Total Cancer Care, which is a very deep research program to essentially try to enroll as many patients as possible with their permission to enable us to study how the patients are treated, the molecular aspects of their tumors, and outcome. And to-date about 80% of the patients agree to enroll in this program, and we currently have over 100,000 patients enrolled.

Now the value of this program is that it creates a rich research database for us to understand how treatment evolves over time, it enables us to look at these tumors to test new biomarkers to determine how they might impact─ how testing might affect the measurement, and to look at how the patients are treated and with outcomes, so there is a fairly rich resource here at Moffitt that allows us to do research in this particular area.

The other thing that Moffitt has moved towards is something called Pathways of Care. And this is where essentially Moffitt has created pathways to facilitate or to enable oncologists to understand what treatment options are available and to help them select the best ones. These pathways were written by Moffitt experts in each field.  They were written after extensive consultation with NCCN guidelines and a review of the literature, and a review of current practice. And these are living documents that are updated on a regular basis that enable us to try to standardize care.

On the Moffitt website, they are all available, so for each tumor site a number of pathways are available. And so, for example, under breast, there are pathways for treating invasive breast cancer and also for diagnostic evaluation. 

Now this is what the pathway looks like in the programming sense. It is displayed to the oncologist differently, but essentially what happens is that there are decision points identified for the patient. The oncologist is notified if there are clinical trials available. And one other aspect of this is actually the cost of the treatment that is also displayed to the oncologist so they might consider alternative treatments and really understand what the impact of a particular treatment has for a patient. There are also surveillance recommendations included in these pathways.

Now Moffitt also has a deep program in personalized medicine, and this personalized cancer medicine is integrating genomic testing, complex testing, and it centers around having a clinical genomics action committee, and the personalized medicine consultation service. Now these services are essential to ensure that the correct test is being used, and also that the results are available for the oncologist and the patient in an understandable form. Often we do find opportunities for off-label use and clinical trial use, and we have found that recommendations from these committees go a long way to helping insurers pay for those treatments as they do respect the recommendations of these multidisciplinary evaluations.

Now we will go over the review process that we currently have in anatomical pathology at Moffitt to share with you, so that perhaps you may use them in your own practice.  The first thing that happens is that all new pathologists go through a focus review. So when a pathologist comes on at Moffitt for a period of six months, they are guided by the more experienced pathologist, and their cases are reviewed to determine if there are any issues in their practice. 

     We have a policy of second expert review in all new Moffitt patients, so all patients that come from outside do have a review and a presentation at the multidisciplinary tumor board rounds which we feel is very valuable to ensure that the report is integrated and that the oncologist has the latest information available. We also have created policies regarding consultation, so that if there is a major error detected that there is a way to manage that error to report it back to the oncologist and the patient, and then also to the regulatory within the hospital.

     We mandate the use of synoptics because we feel that that ensures complete reporting, and also enables us to capture discreet elements for monitoring. The key point in any sort of quality program, you have to be able to measure your activities and ensure that you can measure improvement as you implement change. Another important aspect is the daily microscope rounds where cases, difficult cases, are shared amongst the pathologist.  And there is a process for formalized interdepartmental consultation, so that those are actually tracked and monitored. 

     Another important activity is a week or a monthly quality assurance meeting which is actually mandatory for all staff to attend.  And I will show you the aspects of that as we move through the presentation, but the data is shared with all the pathologists about their performance and about the performance of the entire department, so it is important that that information does get back.  We are continuously developing key performance indicators.  Now for a key performance indicator, it is important that the indicator is actually easy to collect, and that it is meaningful.

And I don't think that you need a lot of them, but you have to think carefully about what they might be.  They could be things like turnaround time, they could be things of a major change in diagnosis, lost specimens, etc.  Those are important to establish and to monitor.  We also have a special rounds called our morbidity rounds in pathology.  And this is where misses, near misses are brought for discussion, so that we can learn from errors that do occur in the department, so that we can try to avoid them in the future.  

Another thing that is important is the safety committee.  I’ll talk to you a bit about that again to emphasize that.  That is the committee that meets ad-hoc to review all incidences as part of the critical incident review.  And another thing that we are really investigating now is external proficiency testing reviews and the potential use of telepathology to really access experts beyond the walls at Moffitt to really ensure that our practice is integrated nationally and internationally.

The other mechanism that we do have to try to modify practice is quality incentives. And we can tie quality; quality is a component of the annual bonus program at Moffitt, usually a different quality indicator is selected each year and monitored for the faculty.

Now going through this in a little bit more focus.  We view pathology, we feel it’s essential for all new cancer patients.  We saw that there is a significant discordance rate in the community practice versus the centralized cancer lab practice.  This doesn’t mean that the community pathologists are poor practitioners by any means, it’s that the type of practice is different, and that the typical community practice may be as few as one to four pathologists, and it’s very hard for them to maintain expertise in a rapidly changing cancer world where there are new advances continuously.

In a practice like Moffitt, we do have 25 anatomic pathologists, and 13 hemato-pathologists all structured into a subspecialty practice enabling the teams to really focus on specific tumors of interest, and develop very deep expertise in those tumors.  In addition, the integration of the pathologists with the multidisciplinary team gives them significant clinical insight to understand how pathology impacts clinical decision-making. 

We recommend that expert review is performed before commencing definitive treatment, so that the patient is on the right treatment path right from the beginning.

Again, this is a subspecialty practice that enables a really deep understanding of each tumor site.  And there are also opportunities for academic development and training in this environment. 

Synoptic reporting is something that is becoming more mandated.  I think it has some positive, and negative aspects.  The positive aspects are that it does help the pathologist to ensure that reporting is complete, so that there are reminders; yes, I do need to report about this margin, I do need to measure this thing, the size of the tumor, I do need to report grade, and I do need to order certain biomarkers.  So it does ensure completeness.

But what it does not ensure is accuracy because essentially that relies on the pathologist’s interpretation.  When it’s reported back to the oncologist and the patient, it does give a very good illusion of accuracy because the report is, so detailed and has so many aspects to it.  But we should remember that completeness does not necessarily equate with accuracy, and we need to be certain that what is being reported in the synoptic is actually correct.

The daily microscope rounds are a great feature for a big department.  It enables the pathologist to meet with their colleagues to share difficult cases, and also to share cases across subspecialties because the pathologists do cover the frozen sections where multiple specimens are seen, so it enables them that even though they are focusing on one subspecialty, to maintain to see cases from different specialties as well.

It also allows the pathologist to calibrate their calls of atypia, etc, on cytology, and to share knowledge.  One problem I have noted with these rounds is that sometimes they are not well documented, and they may be rushed.  So if you are doing these rounds you have to think about that.  Are you actually making clinical decisions by showing one slide out of 30 to your colleagues?  Is the decision thoughtful, are you going to document in some way and include it in a report?  

So I would discourage using the multidisciplinary route to really make decisions, and if a critical decision is required, that a formal intradepartmental consultation is probably indicated so that it can be, so that the consultant has ample opportunity to really review it in depth and write a detailed report. 

Now tumor board activity is very busy at Moffitt.  We have 13 tumor boards a week, so there are two a day.  Pathologists are assigned to these, and they can review as many as 30 or 40 cases per tumor board.  So they are busy.  It does allow the pathologist to interact with the oncologist and enable them to understand how pathology diagnoses impacts treatment recommendations.

Some of the problems with tumor boards is it can be difficult getting outside materials, and the quality of the outside materials can be variable and can be difficult to read at times.

Our morbidity, and mortality committee meets as needed generally once a month, and reviews all the errors, near misses, and diagnostic challenges.  And it’s done generally in a blinded way, so to avoid putting significant embarrassment on pathologists and to enable an open discussion of issues so that we can really share our potential errors with each other, and try to learn from that, so that we don’t make them in the future.

We formed a safety committee two years ago.  We have picked general faculty, so these are members that are not holding any administrative positions.  They are practicing members.  If there are specific cases, sometimes they may call ad-hoc members.  They review critical safety events and they make recommendations.  It’s recorded, it’s a formal process, and they can meet on an ad-hoc basis.  And we have found this committee quite useful.  There are about eight members on it and they give great insights when errors occur and to process improvement.

An area of concern or an area of opportunity I think for pathologists is informatics.  And typical pathology systems are things like Cerner.  And I have discovered that these systems are really designed for billing and reporting.  They really lack the tools necessary for adequate quality assurance monitoring, and that is problematic.  It’s difficult getting key performance metrics out of these systems.

And we are really struggling with that.  Often we use a lot of human man-hours to search for data to be able to monitor our practice.  And I put this out as a challenge to the IT, and the information system providers to give us better quality assurance metrics.

So once a month we do review all of our cases.  We look at different types of errors that occur in terms of whether, for example, typos occur, if specimens are─ if reports showed an error, and so on, and we monitor this on a monthly basis.  So these are important metrics, SP or internal surgical cases, shows our caseloads, and essentially our potential error rates that we’re seeing internally.

The other thing is we monitor synoptic use, so these are each of our pathologists, to determine if the pathologists are using synoptics in a way that we mandate.  And if they are falling short, we can identify those pathologists, and determine why the synoptics are not being used and help them incorporate that into their practice.

We also have a significant, or we look carefully at case correlation.  And we look at two components internal correlation events looking at the basic discrepancies between each of our programs.  And we can see that there are a number of discrepant cases that do turn up.  Certain programs have very high rates of changes in diagnosis from the community practice.  We notice in neuro-path, as many as 45% of the cases are altered.  In other tumor sites, for example in GU, as many as 20% of the cases show alterations on review.

We also track occurrences that need scrutiny such as lost specimens, cancelled orders, and other problems, so reviewing these on a monthly basis helps our team understand how these errors occur and bring up systems to improve them.

Now what are the key challenges?  It’s great to put on an internal review program, but the challenges even in a big practice like ours is that we only have one to three experts in each subspecialty practice.  And it creates a challenge of reviewing your peer because you may be reviewing a case that actually came from your mentor, maybe a case from your friend, it may be a case from your rival, and this is a potential problem in that in human interaction, it’s difficult to really give a very critical review in those instances. 

And this can turn into rubber-stamping.  And this may explain why internal reviews turn up less errors than external reviews.  And I think that as a pathology practice evolves, we really need to look at systems where we can get broader external reviews, so that we can get unbiased reviews, blinded reviews from people that are at arm’s length from our own practice.  And, you know, certain opportunities are now rising to enable us to do that.

Other Quality Issues

Another just quick review of other aspects of quality in anatomic pathology is that anatomic pathology frequently provides important ancillary tests that guide treatment recommendations. 

These include molecular biomarkers.  The other thing about anatomic pathology is that tissue was never really designed to be really well analyzed for biomarkers as we saw the way that growth rooms were set up.

Now there is a program in Canada, the HER2 testing program, where essentially after the problems that I highlighted in Newfoundland and other provinces that Canadian pathologists came together to look at testing practices and to share specimens, so there is an interlab comparison testing program where tissue microarrays were sent across laboratories.  The way to read this data is that each column is the laboratory and each row is basically a case. 

So you can go across a row like, for example, in this row here, and we see that most of the labs have reported that that case is negative.  In this row here, all the labs have reported it as positive.  But we can see that in some cases, for example, in this lab that there is a serious discrepancy in that this lab tends to report cases as being negative that probably should be positive.  So doing interlab comparisons like this can help a laboratory identify a deficiency in their testing practice.

This has significance, major significance, in clinical management because the patient where a HER2 result is negative would not be given the opportunity to receive trastuzumab, a treatment that can dramatically improve outcome in HER2 positive cancers.

Likewise, ER and progesterone receptor also sent out for testing, and we see that it is still problematic that there are labs that show discordant results.  And this has implications for treatment and that these patients would receive alternate therapies depending on which lab they actually have the result done at.

This is an area for further investigation because we really don’t fully understand how immunohistochemistry runs, how stable it is, and we need to develop better quality practices.  Here is an example of an antibody that we are working up at Moffitt called pBAD.  And this is showing its performance on successive days.  So as we go forward, this shows the case performance.  And we discovered that this antibody is extremely unstable, its performance is uncertain, and so this enables you to really evaluate an antibody of how well it functions and whether it really should be incorporated into the clinical practice.

Other tools are now available.  There are different antibodies for different parts or different clones of antibody, and here is a protein called ERCC1.  This is involved in DNA repair, and there are two different clones to measure it.  And we discovered that these two clones actually give completely different results for the measurement of this particular protein.  It was later discovered that the 8F1 clone actually measures some other proteins as well explaining the discordance.  So not only are there different ways to measures antibodies or different proteins, there are different clones available and one should be cautious about that.

Here is an example from another study where we studied cases from different labs.  These are labs in British Columbia, Calgary, and Toronto, and we found that the amount of staining was quite different even when they were all stained in the central lab.  And we attribute this to basically problems with pre-analytical conditioning in Toronto that somehow antigens were being lost in this particular preparation.

This brings us to remind us how pre-analytical conditions affect tumors.  Basically a person in space is much like a tumor being removed from the body.  A tumor, when it is existing in the body is happy, it’s warm, it has a blood supply, but as soon as you start interfering with it, you cut off its blood supply, you cool it, you bring it into the atmosphere and expose it to oxygen, that tumor goes under extreme stress. 

And a number of changes start happening in the tumor.  There is cell activation, acidosis, nutrition depletion, etc., so there are a number of changes that do occur.  And this affects the performance of biomarkers, so that if you were to measure a biomarker times zero, you would get a different result than if you measured it at 20 minutes or at 70 minutes.  So this brings us to remind us that the pre-analytical conditions may dramatically affect the performance of certain tissue markers, for example, phosphor-markers. 

Other markers may be more stable, but we need to be cognizant of this as we implement new biomarker testing into the anatomic pathology lab.  And unfortunately, we don’t have a lot of really strict quality standards in how specimens are managed in the pre-analytical period, how much warm ischemia do they have, how much cold ischemia do they have, etc.

The other thing that we need to be aware about as we understand the biology of cancer is that as we look through the evolution of a tumor, it starts as a single clone.  But as it evolves, it starts developing more clones.  If we look at a different time point that the composition of a tumor changes.  And also after treatment point, you may lose clones and a new tumor may arise with different clones arising in it.  And this indicates that a testing at this point may not actually give you the information that you required to know how to treat a tumor, but it recurs. 

So, understanding the biology of cancer is important as we design biomarker testing for patients, and we have to think very carefully about when we do the biomarker testing, and what about issues of heterogeneity within the tumor, and what happens when a tumor recurs, what sort of testing do we need to do then?  

There are challenges; specimen mix-ups can occur and it can be undetected.  Sometimes you will need to detect it after an unfortunate accident has happened.  For example, a patient may have a prostate biopsy showing high grade prostate cancer.  They go for a total prostatectomy, and then the prostate shows no evidence of cancer at all, and then a DNA type shows that there was a specimen mix-up.  And it’s very difficult to detect these kinds of errors if they move through the system. 

Other problems are poor quality samples if they are being sent in, if they aren't fixed properly because I discussed pre-analytical variation can impact biomarkers.  Heterogeneity and sampling errors are another issue where we really are evaluating tumors correctly.  What happens if you get another tumor in the same patient, and this is often a big source of error because you may make the assumption if the patient has a melanoma that the recurrent tumor is most likely a melanoma, which it is, but this patient may be at risk of other tumors like sarcomas. 

And if you are thinking that this is definitely a melanoma and you have a mimic of it, you could run into a problem.  So you always have to think that even though a patient has a diagnosis of one type of tumor, they may actually get a second tumor.  And this isn't really that uncommon because often the patients that do get cancer are from cancer-family syndromes.  They may get multiple tumors and different types of tumors.

The other important aspect is when working in teams, we only have to work on building trust and teamwork.  And in doing activities such as quality assurance and reviews, then this can turn into an activity that generates significant conflict.  So you need to be aware of how to manage that, how to minimize it, and how to really build trust in your teams.

The other problem is that pathologists may have lack of expertise, and this is knowing what you don’t know, and this can be a significant problem if you believe you are practicing well, but have no way to calibrate that or really no outside view to show that the practice may be offline. 

Information systems are problematic in that they don’t give us the data we need.  There is an explosion of new testing that pathologists aren't really familiar with managing.  For example, genomic data, proteomic data, evolution of data, and these are important informatics challenges. 

Now we also see the issue of integrating tests, so a single specimen may go from multiple FISH tests, they may go for genetic tests.  They may actually be reviewed by a series of different external consultants as well as patients shop their specimen around.  So this creates a challenge for the pathologist in how to integrate all of this data, and it brings up the opportunity that perhaps pathologists need to do more. 

There is not just the report of the case, but there may be a comprehensive review of all the pathology in creating something like an integrated report where the pathologists provide a detailed medical consultation to their on-call GU colleagues that review everything that happened to the specimen, including external opinions and to try to synthesize all of that information for the patient and the medical oncologist, so that they can really make an accurate treatment or at least an absolutely informed treatment decision. 

The other problem is that often there are inadequate dollars to support quality.  It isn't directly funded by CMS and other agencies, but clearly we see the quality is essential to the practice of medicine and pathology, and is really integral to achieving improved patient outcomes.  As we move more towards a value-based model, I expect that quality will be built into that model, and perhaps there will be bonuses for providing a higher quality with a greater accuracy of diagnosis.

Finally, there is knowledge management in creating tools to manage the knowledge distributed amongst the entire pathology practice.  That means from a single pathologist practicing in remote areas, large practice groups, and if there is a way for us to use informatics to build an entire network of knowledge base that all pathologists can tap into, I think we will see more of that in the future.

So as we move forward, we will see new tools for total quality management, then informatics are really going to be key to this.  Perhaps digital pathology, being able to distribute specimens in real time to experts around the country and the world will help us.  We may see the evolution of artificial intelligence for image analysis and for complex data management from tools such as IBM Watson and similar.  This won't replace the pathologist, but the pathologists will be much like a pilot in a plane that is using an autopilot.  The pilot still needs to monitor all the various components.

And I think that pathologists will really move into this position of information and tissue management.  We need to think about how to integrate improved molecular diagnostics into our practice, and also how do we incentivize quality and value, and how do we measure it in an important way.  An important aspect of this is for the next generation of pathologists incorporating quality into the training program and giving them the tools to really practice in a highly efficient and quality way.

And really the way to do this is to develop access to the best in class experts and networks around the world, so that we can really share this knowledge and implement it for our patients.

So I think in summary, we are living in a dynamic time when the practice of anatomic pathology is changing from sole practitioners to large practice groups to networks.  And also in a time when there is greater scrutiny of the role of anatomic pathology and how it impacts patient care.  So I think as we go forward there will be greater scrutiny of pathologists, and it really is incumbent on anatomic pathologists to create better quality systems because if we don’t regulate ourselves, then external agencies will come in and regulate us.  And, clearly, that is not the way we really want to go.

The best way is to have a peer process to develop standards, and to share expertise among the whole pathology community.

So I would like to thank the entire Moffitt pathology team, and also give special thanks to Dr. Centeno, who I appointed as Vice-Chair of anatomic path and the leader of quality programs when I first came to Moffitt four years ago.  And she has a lot of credit to take for quality improvement exercises that we now have implemented at Moffitt.  So, thank you for giving me the opportunity to share our experiences at Moffitt.  I hope you found it helpful, and we can now take questions.

Questions

MS. SANCHEZ:  

So we will begin with the first question, Doctor, from Kevin.  I heard that some companies have modules that leverage the data and the LIS, and then prompt for additional QA data that may be needed to compare results to establish KPI’s.  Any thoughts on these types of technology? 

DR. MAGLIOCCO:  Yes, I think that there is a real opportunity in the marketplace, and certain companies, like Quality - - and others, have come up with third party applications that can plug into the major vendors like Cerner and others to help extract the data into a data warehouse that can then be analyzed for specific key performance indicators.  And I think developing quality dashboards for the quality managers of the practice is important because the other thing about quality is that I think it must be timely. 

There is no point determining that your estrogen receptor test is not working 12 months ago because that is going to put you in a very difficult position.  You need to know when it goes offline immediately, so that you can rectify it and really make that disclosure to the patients, so that there is minimal harm being done.  So that is one key aspect of quality.  It must the timely, it must be accurate, and it must really be monitored in the most critical aspects of your practice.

MS. SANCHEZ:  This is from Anna; do you also monitor the quality and errors that occur in a lab prior to diagnosis based on things like growing [phonetic], the histology, histo-chemistry, and immunochemistry, etc.?  If so, how and what do you monitor?  I think this needs a little bit more, I think.

DR. MAGLIOCCO:  No, for example, in the gross room, we have a program where we ask─ there are a random number of cases selected where a sheet is put on the case to allow the pathologist to actually critique the pathology assistant to determine what the quality was of their grossing, you know were there any errors in the grossing, was it actually a really excellent job that was done because I think it’s important for the technical staff in the lab that they receive not only negative feedback, but really as much positive feedback as possible as well in terms of they are really doing a good job with this, keep doing that, stop doing this other thing, and working with them when an error does occur, so you know does the error─

You know we assume that the system failed not the person, but really focus on ways to try to avoid that error occurring.  And we do that in all of our labs, in our molecular labs, in our immunohistochemistry labs, our chemistry labs, etc, so it’s an ongoing process to really manage that and we do have a policy.  If it’s a system issue, we all need to work together to get to the root cause and we need to have a system that really rewards not only problems, but also excellence.

MS. SANCHEZ:  This is from Jesus, he actually sent two questions.  I think they are sort of related, so I will start with the first one and then ask the second one because I think they are both related.  He is asking, do you see current technology tools anatomic pathology being designed around these thoughts and expectations such as current APLIS or EHR, data gathering and mining to facilitate true diagnostic medical review?

DR. MAGLIOCCO:  Personally, I haven’t seen good examples of that.  I have seen it in third parties, but I haven’t really seen it in the core applications.  The core applications, particularly in the anatomic pathology, often seem to be add-ons to the clinical lab modules.  And I find them personally lacking in their ability to do searches, to extract quality information, and to really report on key performance indicators across cases.  They are well designed for reporting individual cases and billing and such things, but when you are trying to monitor across a practice, even things like work load, I find them lacking.  But I think there is an opportunity there for the vendors to really improve their products.

MS. SANCHEZ:  Do you ─ at Moffitt, this is from a couple of people ─ does Moffitt use some sort of bar coding and tracking system to help with missed errors?

DR. MAGLIOCCO:  Yes, we do.

MS. SANCHEZ:  And if they do, how do you see this as an advantage, I think? 

DR. MAGLIOCCO:  Well, we used a bar system and we are currently using the Lab Advantage system from Ventana.  There are others available.  We actually just implemented this system this year.  We feel it’s an advantage and allows you to track specimens at multiple points as it moves through the lab.  So if a specimen is lost, you can backtrack and see where it was last tracked into the system. 

It also has built-in systems if you follow the process correctly where if you have to do the scan it won't let you put a specimen into the wrong cassette, etc.  So it does add safeguards in that.  It might add time, but it does give you increased quality monitoring.  It also lets you monitor the efficiency in the process at the different time points to see where the systems may be broken down.  It also lets you monitor the efficiency of different technologists, etc, as well through the system.  So I think these systems do bring value.

MS. SANCHEZ:  From Elizabeth, what are some quality monitors like regulatory agencies may require to be reviewed?  Is there a regulatory maybe from CAP or from the European regulatory agencies that require some very intensive QA monitoring?

DR. MAGLIOCCO:  Yes, typically they tend to review that to look at certain time indicators like how long is a frozen section turned over, lost specimen indicators, how many specimens are lost in the lab, specimens received in the lab with inadequate identification, so there is a list of key performance indicators that are on CAP checklists that you can review. 

But I think that those really set the minimum bar and labs really need to think about what their practice is in terms of it because if you just make a proficiency program, you may only receive two or three specimens a year to determine if your program is functioning or not, whereas if you are reporting out dozens of cases a day, you really need to have put in place a high quality monitoring system to ensure that your production is accurate and that your results aren't drifting and that you are calibrated with other labs that are reporting similar results. 

So I think what you see from CAP are really the minimal standards, and you have to start thinking about the whole quality cycle, how can I make my lab more effective and safer for patients and for staff because we don’t want to be making errors because that puts us in the limelight and that puts us at risk of our reputation for malpractice.  So it clearly is a central activity.

MS. SANCHEZ:  Marcus has two questions that are continuations of each.  What is the role of digital pathology, computer software programs, and the future of an anatomical pathology?  And he is asking for the anatomic scoring software.

DR. MAGLIOCCO:  Yes, so digital pathology can help in a number of ways.  One, is it being able to share specimens easily to experts in distant locations, so if you have a challenging case you can send it to five experts instantaneously to get their opinion.  It also has a role in education.  We can use those challenging cases to educate our fellows and other pathologists.  And then moving into analytics, analytical software hasn’t been used very much in pathology, but we are seeing an uptake in it for things like measuring estrogen receptor, progesterone receptor, P67 in tissue that software can do that much more effectively than pathologists can count what the percentage of intensity of staining is.

     As we move forward, we may see even more sophisticated software that may be able to just, for example, screen across state biopsy for suspicious areas based on things like fractal analysis or other imaging modalities, artificial intelligence, and perhaps highlight those areas and display them to a pathologist to say, look here, what do you think, do you agree that this is an area of cancer of concern through pattern matching and other algorithms?  So as I keep an eye on it, we are going to see all kinds of explosions of use of digital pathology for multiple purposes ranging from archiving, education, and actual analytics.

MS. SANCHEZ:  And we have time for one more question, Doctor, and thank you so much for all of those explanations.  Do you see the approach for your total care, cancer care, of the bio-depository’s are trending for not only in cancer, but for other diseases as well?

DR. MAGLIOCCO:  Yes, absolutely.  I think you are going to see this in diabetes, cardiovascular disease, genetic disorders, etc.  Certainly cancer is at the forefront of this because of the complexity of the cancer that really demand tissue biopsies and of information.  But I think the tools that are developed in the cancer world will have broad applications to screening and to other diseases as well, absolutely.

MS. SANCHEZ:  Thank you, I mean that was fantastic.  I appreciate your time and I appreciate all the participants that send questions as well.  Very well done.  And I will hand the presentation back over to Rick.  Thank you so much.

DR. MAGLIOCCO:  Thank you very much.

RICK:  Thank you very much, Yolanda, and thank you very much, Dr. Magliocco.  And we know that you’re a - - today so we appreciate your toughing through it, so thank you for the presentation and for your toughness.  Before we leave today, I would like to remind everyone that the upcoming Pathology Leader webinars for this year, the very next one coming up, is customizing the anatomic pathology, the LIS, to improve patient safety and workflow, and that will be held on February 24.  And the presenter will be Clifford Chapman from Strata Pathology Services in Lexington, Massachusetts.  We hope to see you there.

Today’s recording will be available at the Pathology Leader’s website.  Suzanne is putting a bunch of good information into the chat box right now, so you should copy and paste that so you can access the recording and other wonderful resources that are always available at Pathology Leaders.  Those of you who have attended today’s entire presentation are eligible for PACE [phonetic] credit or Florida credit if you're a Florida laboratorian, as well as a certificate of attendance.  And if you would like to receive credit, when you close the event window you will land on the evaluation.  Don’t close your browser because the evaluation will appear in your browser, so just close the webinar window when you are ready to leave.

For those of you who have joined as a group, you will be receiving, if you have logged in today, you will be receiving an email with a link to the evaluation.  Forward that to everyone who joined with you so that they can access the evaluation and get their credit as well.  The certificate of attendance will be sent by email within a few days after we receive your evaluation.  We will be emailing you with the link to your customized certificate, as Yolanda mentioned earlier.

Any questions that came up that did not get answered or questions that come up in the next few hours or so, be sure and send those to yolanda.sanchez@leicabiosystems.com.  So for all of us, for everyone at Leica Biosystems, I would like to thank everyone for coming.  There were great questions and a very engaged group that you are, thank you for that.  I also want to thank Dr. Magliocco for a wonderful presentation and a great moderating job by you, Yolanda, and thanks to all of our good friends at Leica Biosystems and thanks, everyone, for coming today. 

We look forward to seeing you again.  If any of your colleagues would like to see today’s webinar, it will be repeated in a couple of hours, so feel free to register at the Pathology Leader’s website to attend.  Otherwise, we thank you for coming and have a wonderful rest of your day.  Thanks, everyone, and bye-bye now.

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