November 2009
Feature Story

Mariann Stephens

M. Elizabeth H. Hammond, MD, chaired the CAP ad hoc committee that created the new CAP Pathology and Laboratory Quality Center, and she is emphatic that the Center is open to all. “This is everybody’s job, it’s everybody’s Center,” she says, and adds, “Anybody can apply and anybody can help.” She’s speaking of the evidence-based guidelines that will be written under the Center’s auspices and says, “We need ideas for guidelines, people to help write those guidelines, and people to step up and educate their peers about the documents that are developed.” The concept, she says, is to make the Center free of “political encumbrance.”

In this CAP TODAY interview, Dr. Hammond explains how the Center will work, why it’s needed, how pathologists can participate, and why, despite her not needing another cause in her life, she agreed to lead this one.

Dr. Hammond is an attending pathologist at Intermountain Healthcare, Salt Lake City, a professor of pathology and adjunct professor of internal medicine (cardiology) at the University of Utah School of Medicine, and a member of the CAP Board of Governors.

What prompted the College to found the Center?

The College has long recognized the need for best practices guidelines in all areas of pathology. We have been engaged for years in developing consensus-based and expert-based guidelines in clinical pathology, covering what should be done, how tests should be run, and how quality assurance should be engineered. In years past, anatomic pathology was thought to be a descriptive process, but we have come to realize that the principles used in the clinical laboratory are directly applicable to anatomic pathology. It’s just the sample type that is different.

The cancer protocols reflected a recognition that there was a right way to examine cancer specimens in order for the pathologist to describe a minimum number of important elements related to how the patient should be treated. That was the beginning of guidelines development in anatomic pathology; the cancer protocols showed it could be done.

As we moved into the new century, more and more drugs were being developed that required specific tests to predict whether they would work in a given patient. Two examples would be the HER2 guidelines released in 2007 and the ER/PR [estrogen receptor/ progesterone receptor] guidelines for predictive cancer testing that are nearly complete. Again, it was clear that pathologists needed to include a minimum amount of information in their reports and the College needed to develop guidelines to structure that reporting. It was while the cancer protocols and the HER2 and ER/PR guidelines were being developed that many realized it was critical for us to create this kind of guidance across all disciplines of pathology.

What will be the relationship between the Center and the protocols and the Cancer Committee that writes them?

The cancer protocols represent a large group of documents produced by the College that will now fall under the rubric of the Center. Everything the College produces to enable pathologists to do their work more accurately will be under the rubric of the Center. The Center will be the clearinghouse for all of those documents, making sure they conform to the standards and pro­cesses we develop.

However, there are no committees in the Center. When groups like the Cancer Committee derive documents, the Center is responsible for making sure those documents remain current. The Center will also promote the concept of guidelines and the use of those that we develop, but again, the Center itself has no committees. Instead, the Center appoints groups of people who are expected to develop guidelines. Guidelines that are continually changed, like the cancer protocols, involve a standing committee of the College like the Cancer Committee and its cancer protocol review panels. For short-term projects like the KRAS document, a temporary group will do the work.

For the most part, what the Center will do is find experts who will come together around a specific need to derive a document, and the Center will make sure the content is maintained.

So the Center will enable a durable, efficient process to generate and maintain evidence-based guidelines.

We can turn the crank faster if we have a process in place and don’t have to go through a series of approvals each time. Here is how it will work. Acting on suggestions from individuals and groups, we will identify areas most in need of guidelines. Center staff will look at the evidence and determine whether it is sufficient to support evidence-based guidelines, and, if so, we will appoint an ad hoc group to come up with a document. Part of what we will do in creating these ad hoc groups is look for other organizations to partner with us in the effort. The Center staff will provide the evidence to the ad hoc group, along with a template to follow in writing guidelines. It will be a highly standardized process.

We are also creating a Web site on which all these documents will live. There you will find a form that pathologists and organizations can fill out to say, ‘We propose a guideline document for this group of patients and these kinds of tests because there’s a critical need.’

It sounds as if the Center was in part a response to the accelerated introduction of new technologies and agents for treatment.

The Center was conceived of by the Board of Governors after we had done the cancer protocols and the ASCO/CAP HER2 guidelines, which took an inordinate amount of time and effort and were difficult because we didn’t have a good process in place. I wasn’t on the Board at the time so I wasn’t part of that discussion, but I think it became obvious that we couldn’t keep doing these one by one—it was too expensive and time-consuming and wasn’t meeting the need.

And the Center was also conceived as an agent of transformation.

Yes, the Center also has a larger purpose as one of the initiatives of the Transformation Program Office. The Center will give pathologists tools that will create actual opportunities to make a difference. The Board of Governors strongly believes that pathologists need to be in the middle of patient care teams, not off to the side. So how do you get them in the middle of those teams? By making them the holders of critical information that will make patient care better and patients safer because they will get the right treatment at the right time because their diagnosis will be more accurate. If the pathologist is the holder of those documents and the strategies that will help the patient, then they can gather all the parties together and say, ‘Here’s the evidence, here’s how we are going to do the test,’ and afterward, ‘Here’s what the test results meant.’ It will enable transformation of our specialty.

What is the Transformation Program Office?

It is a new entity that facilitates and integrates transformational activities, like the Center, across the College. A steering committee oversees the TPO. It’s composed of pathologists, CAP professional staff, and other stakeholders in the transformation, such as primary care physicians. It’s responsible for reviewing the various transformational activities, like the Center’s proposals, and deciding how to best allocate resources among these priorities.

How will they set priorities for the Center?

There are two important elements. No. 1, it has to be important to the patient. It has to affect his or her safety or test accuracy in some important way. No. 2, there has to be evidence that points to the right approach, because you can’t make guidelines if you don’t have any evidence of what should be done. So there has to be good evidence and a serious need. Then there are minor criteria, which are on the CAP Center Web site, available for all to look at and comment on.

The Center subcommittee of the TPO steering committee will review each idea according to the criteria and decide which guidelines we should do in the next year. The budget will allow us to do about six of these a year because we will be working with ad hoc teams that meet mostly on the telephone. Staff will do all the evidence gathering. The teams will create their documents within a formatted template. The process is organized to allow a smooth flow to ensure all criteria are met.

So the Transformation Program Office steering committee has an oversight role?

Right. Let’s say the steering committee Center subcommittee goes through its process and finds eight guidelines that need to be developed right now, but we have money for only six. They take their work back to the TPO steering committee, which will review what they’ve come up with and say, ‘Yes, you really do need eight this year; we’re going to have to take resources from some other initiative to do this’ or ‘No, this other area needs resources more; you can do only four this year.’ So the steering committee will be the resource that helps us find extra bodies if we need them or takes bodies away if we aren’t making progress. They will do resource allocation across the College to make sure we do something that matters. They will hold us accountable and give us resources.

How will team participants be selected?

The teams will involve anyone who has expertise in that topic. We will try in every case to involve other organizations with a critical need for the information. For HER2, we involved ASCO [American Society of Clinical Oncology]. ASCO will be one of our partners and there will be others. If we’re coming up with a blood banking standard, it might be the AABB or a group of surgeons who have a lot of need for blood utilization guidelines. It could be the American College of Obstetricians and Gynecologists or the American Academy of Pediatrics or the American College of Physicians. It could be any individual or group that wants or needs the guideline information badly and wants to work with us to develop those guidelines.

To increase our ability to put this out, we will troll around the literature to see who has produced an excellent guideline in an area of need. An example of that would be the clinical laboratory standards. The CLSI [Clinical and Laboratory Standards Institute] might develop a standard that we can endorse, or we might work together. There are all sorts of different ways we might try to do our work.

How will the Center foster transformational pathology?

Transformational pathologists take ownership of their role as members of the patient care treatment team. Evidence-based guidelines enable us to do our job in a way that is most clear and useful to the many physicians we collaborate with.

The template stipulates minimum required information; how you share that information will depend upon whom you’re speaking to. If you are dealing with someone who is unfamiliar with an area where your expertise is great, you need to give them more guidance about what may be the right treatment. You might say, ‘In this case, doctor, you should be considering trastuzumab because the HER2 test is positive.’ It’s logical.

The point of transformational pathology is to recognize that you are one of a group of critical individuals who have to come up with the patient treatment and you can’t abdicate that responsibility by saying, ‘All I’m doing is giving out test results.’ If all you’re doing is giving out a test result, you’re just being a technician who reacts and responds. If you’re going to be a doctor, you have to be involved in treating the patient and giving information that will make the treatment right. You don’t always have to be the person who defines the treatment type exactly, but you have to make sure the people listening understand which bucket the patient belongs in so the appropriate treatment can be given. Over time, the patients will be in smaller and smaller buckets and treatments will be more and more personalized. Who will define who sits in which bucket? We are going to define that because we do the tests.

When we get a KRAS test result, I might write, ‘A patient with this mutation will not respond to EGFR inhibitors.’ You have to put that in. Some people will say, ‘No, I will only say what the mutational status is.’ Well, they have to know what that mutation means.

When I was a resident at Massachusetts General, we were told that if we wrote a report that gave the physician no specific information that could then be used to treat the patient, then we didn’t deserve to call ourselves doctors. We were told to keep working on the case until we knew enough about it so that the person getting that report knew exactly what to do, because if the doctor didn’t know what to do on the basis of our report, we had basically accomplished nothing.

I know that some pathologists are reluctant to give a report that explains the meaning of test findings, but we explain the meaning of test findings all the time when we do a frozen section. We go in and say, ‘This patient has cancer,’ or ‘This patient has a benign lesion.’ That’s the same as defining treatment. When we tell them the diagnosis, the treatment choice is clear to the doctor you’re speaking to. Pathologists who are reluctant to explain what a test means are concerned that they would then be treating the patient, but you’re not treating the patient. You’re making sure the doctor who is treating the patient understands what the diagnostic information you are giving them means to the patient and means to the patient’s treatment. That’s the critical step that has been missing. You can’t just say, ‘This is what I found’ if you also know that if this is what was found, then this is what it means.

People are reluctant, in part, because they need evidence-based guidance that will indicate what information they have to put in that report. That is what our guidelines will provide. When they include that information, the report will provide explanation and meaning to guide the doctor in prescribing treatment. It’s a strategy that I think most pathologists will embrace to help our patients and their physicians. It will close the loop.

How would someone find out what is coming out of the Center and volunteer to be a part of it?

You can go to the Center Web site and volunteer to participate in an ad hoc group. You can fill out a request for a guideline that you don’t see. You can look at the guidelines we’ve produced, and you can review the evidence for the guidelines that are there. You can alert us to guidelines produced by other groups that should be endorsed or modified and endorsed.

Expert volunteers will be needed to review the evidence as members of ad hoc committees. We need pathologists to serve on those committees, and we are hoping that large numbers will go there and volunteer. As you can imagine, we can’t have the same people doing this every time. A larger number of us need to be involved in this process, not only in producing the guidelines but in the critical step that must take place after the documents are produced.

We have to make sure the guidelines are explained to everybody in a clear way, and that will be done through education initiatives. So not only will we need pathologists to serve on ad hoc committees, we will have to have them presenting the data to their own institutions, to their own pathology groups at national and regional meetings, and so on.

When I presented this to a meeting of the House of Delegates last year and we talked about the need for guidelines, it was exciting to me to see how many people came up afterward and volunteered to help. Twenty or 30 people gave me their names that day. I also came away with a list of things about which they want guidelines to be produced. Clearly, this is an unmet need.

Are there credentials requirements for volunteers?

Any pathologists who consider themselves expert in some part of pathology should consider volunteering. It doesn’t matter where they’re practicing, whether in a general hospital or an academic setting. If they’re really good at blood banking, if that’s where they do all their reading, and if they know the evidence about the use of blood, about how platelets interact with the immune system, if there’s one little thing they’re frustrated there is no guideline about, they should propose it and volunteer to help write it.

Another good example might be microbiology. Scientists in Denver have been studying the microbiology of indoor environments and found that a biofilm with high levels of Mycobacterium avium showed up in 20 percent of showerheads tested. It seems that this bacterium isn’t problematic in most environments but can be a danger to some people if it is aerosolized, and the biofilm in the showerheads aerosolizes in the shower. Preliminary findings suggest that plastic showerheads host more of the bacteria than metal ones and that some people might want to consider baths instead of showers. One of these researchers might want to produce a guideline on what we want to make sure people with compromised immune systems know about aerosolized Mycobacterium avium, why they should care, and what they can do about it.

Anybody who really reads the literature can volunteer; the only requirement is that you have read the literature well enough so you know about something that is important to patients and you know the literature about it. If those two things are true, then we want you. Most pathologists are in that category.

What types of topics do you envision for the first guidelines?

Right now, we have guidelines on HER2, KRAS, and ER/PR. There could be public health kinds of things, such as what constitutes making an environment safe. Maybe guidelines on proper handling of blood cultures. Certainly, we’ll be looking at which genetic test is better for this or that disease. With KRAS, we had a bunch of different tests out there; once we get to where we know the specific one, the College could write a guideline that explained why that test was better. For HPV testing, there are many types of tests available. Should we be writing guidelines for HPV testing? Should we revise the Pap test guidelines to take advantage of what we know about HPV and its role in cervical cancer?

In anatomic pathology, many guidelines are needed about how tissue is handled before testing. What fixatives are acceptable? How long should tissue be held from time of removal until fixation? There’s very little work on that; if there were work, we could do that guideline right now. We don’t have any data. You can only write guidelines where there is evidence; it’s not really safe to do guidelines without adequate evidence.

There are people who want to write consensus-based guidelines, but we have enough areas in need of guidelines where there’s evidence. I don’t want to start with consensus-based guidelines because experts may not be right; I want to stick with evidence-based for the first. Maybe we will get to a point where we might say, if you examine the evidence and the evidence is not persuasive, you could use expert opinion to decide which way to go. If there were two camps, you could use experts to help divine a consensus. But I would not use experts to tell you what to do without consulting the evidence.

As forward-thinking as it sounds, I get the idea that the Center is not an enterprise head of its time so much as a solution that captures the needs of its time.

It’s absolutely critical, and there’s no organization better positioned than the College to do it. I didn’t have any desire to take on another cause in my life, but when [immediate past president] Jared [Schwartz, MD, PhD] called and asked me to take over the ad hoc committee to create the Center, I couldn’t help but agree because it’s so critical. I believe in it very much. If we are going to do anything for patient care, we first need to create guidelines that will make the testing more accurate and more understandable to doctors so that patients will get the right treatment at the right time.