Grossing - New Initiative for a New Generation

Let's move now to our moderator for today, Yolanda Sanchez.

Yolanda received her BS in Medical Technology from the University of Florida, and her master's in Clinical Research Management from Arizona State University. Now the global clinical affairs manager for Leica Biosystems, Yolanda is a published co-author with several studies to her credit, including "The Effect of Decalcification Solutions on Kappa and Lambda In Situ Hybridization," and "Performance Comparison of Multiple IHC and ISH Antibodies with Immunocal, Formical 2000, and EDTA."

So it is a great pleasure to open up your mic, Yolanda, and welcome to you.

Thank you so much, Rick, for a great introduction. I appreciate it, and thank you all for participating today.

It is truly my pleasure to introduce our two speakers, Michelle Lemphere and Alma Cortinas.

And I'll start with Michelle. She is the senior histology technician at Children's Medical Center in Dallas, Texas, and is responsible for all aspects of routine histology, including maintenance, quality assurance, training, and procedure writing. Her education as a histology journeyman was through the Armed Forces Institute of Pathology in Washington, DC.

Michelle began her career in the Air Force and continues to achieve personal career growth through continuing educational forums.

Our second speaker today is Elma Cortinas. She is the laboratory manager for anatomical pathology at Children's Medical Center as well. Elma is currently pursuing her master's degree from Texas Tech University in Lubbock, Texas, and received her bachelor's degree in biology from Texas A&M University in College Station, Texas. As the laboratory manager, she is responsible for the Department of Anatomical Pathology and a staff of 13.
Other responsibilities include supervision of operations, development, validation, and implementation of new clinical testing based on patient and clinical needs while seeking out new technologies to maintain the laboratory’s cutting-edge expertise and development.

At this time, it is my pleasure to hand over the presentation to Elma.

Hi, good morning. Thank you, Yolanda. I appreciate that introduction.

Just to give you a little bit of my background, I have been in this field for 26 years as a manager. I have been a manager for over 10 now, and that has been here at Children's Medical Center.

Just to give you a little background about our institution, Children's Medical Center is a part of the Children's Health system, and it is a not-for-profit hospital system with two full-service hospitals licensed for 595 beds and four outpatient centers. It brings about $1.6 billion to the regional economy, and our campus takes up more than 2.2 million square feet and 193 acres.

We are the seventh-largest pediatric healthcare provider in the nation, and it's the only academic health facility in North Texas that is dedicated exclusively to the comprehensive care of children.

In recent years, our surgeons have performed over 27,000 operations, and we've had over 6,000 inpatient surgeries, and more than 20,000 outpatient surgeries.

Just to give you a little bit about the AP lab, our anatomic pathology lab, we conduct over 10,000 surgical cases a year, which amounts to about 30,000 blocks and 65,000 slides. This is all accomplished with about 5.5 histotechs and one senior tech.

We report to 10 surgical pathologists, one fellow, and two rotating residents.

Learning Objectives

So as we go on, part of our learning objectives today are to review a new process on grossing in the histology lab. We're also going to discuss a project charter and the importance of implementing a new project. I'll discuss what a project charter is in a little bit and describe tips and techniques associated with grossing non-complex specimens.

Background

So part of the background when we started this initiative was to look at where we were going with our future in healthcare in anatomic pathology. We realized that healthcare reimbursement was dwindling, largely due to the impact of the Affordable Care Act. There were rising costs of medical supplies and tests. We see that every day when ordering supplies, and tests are becoming more expensive each year.

We also wanted to reevaluate the value-added education in our residency program. Here at Children's Medical Center, we have rotating residents, with two residents rotating through every two months. There is a lot of training involved, and we want to ensure they are getting the most out of their education.

We also considered what we could do for our histotechs. Their jobs were becoming very routine and sometimes mundane, and we wanted to add value to their education. So one thing I want to also remind people here is that our techs were already doing some grossing of the small biopsy specimens, and those included GIs, kidney biopsies, heart biopsies, liver biopsies, et cetera.

Project Charter

So as we got started into this program, we wanted to look at a couple of ideas.

In the recent past, I took a project management class to gain a better understanding of how to proceed with a project. And the resource was available at our hospital, and so I was challenged with that opportunity. It wasn't necessary, but I really wanted to get a personal understanding of how this worked.

Also keep in mind that we also had no additional money to implement this program. We were going to try and accomplish this with current personnel and current resources that we had. It was not a budgeted initiative.

The idea of the project was to give us a basis of where to start. The project summary included, number one, what was our project goal? And our goal was to obtain uniform and consistent grossing of tissues, utilizing high-complexity testing personnel within our lab. How are we going to do this What were our objectives? We wanted to develop and maintain consistency in the description of surgical pathology tissues and the quality of block submission.

Our UT Southwestern Pathology Residency program had reached a point of diminishing resident population. The residents were now occupying rotations for diagnostic grossing in their first and second year of residency. This young, inexperienced level had lengthened our turnaround time of cases.

For residents, there was no longer a value added to the repetitive grossing of routine specimens. They needed experience in the more complex cases, not the routine mundane cases.

This project had the ability to grow staff by tapping into and developing their personal career growth and adding extensive value to their current position. We would ask histotechs if they were interested in grossing specimens, and it would be strictly voluntary. There would not be any monetary incentive, and it was strictly what we considered for professional growth and learning.

The last thing, who was going to be involved and what was the capacity?

We definitely had to have the buy-in of our medical director and a pathologist. Our program sponsor or our project sponsor was our medical director.

Project managers were myself and Michelle, and some of the stakeholders were one of our pathologists who is the resident program director, our compliance manager, our safety coordinator, our lab operations director, and our LIS director. There were quite a few people involved in this whole project, and we wanted to make sure that we had everybody's buy-in to be able to get through it.

Project Scope

The next thing was, what was our scope? What were some of the system or process changes that had to take place?

Well, we knew that in the residency program, the workflow of the AP staff and policy changes, it was going to change schedules for some of our AP staff. We needed to make sure that we could maintain a good workflow, but still be able to get involved in this initiative.

What were some of the boundaries of the project? Well, all our current tasks and responsibilities of the technical staff would continue to be accomplished, but it would add some responsibilities. So we assumed that the workflow would stay the same and the technical staff would be able to take on the project.

Some of the risks, what are the risks that are involved, and what were they, if we had them? I think one of the biggest things that we thought about was just the inability to train personnel due to staffing. And I say staffing because, as most of you know, you may have five or six people in a lab, but on any given day, likely someone is either out, leaving early, gets sick, or an emergency happens. You don't ever really count on your full team being there that day.

But it was also just due to the inability of AP staff to complete routine day-to-day responsibilities. Being that a coworker who was going to go with this initiative would be taken off the bench, we assumed they would be available the whole time. We knew that that would be one of the risks that would be taken.

And the other possible derailment would be to encounter a major grossing mistake made by the technical staff. If that were the case, we knew that that was it. It would not continue if there was a major mistake made.

Finally, what was the date of implementation, and who was the stakeholder to indicate if it was successful or not? Our medical director was going to be the major stakeholder of the project, and she would know if it was going to be successful or not. We worked on the project plan for approximately nine months before we went live.

Project Plan

Now, I realize that this is probably a very busy slide to see, but I wanted to give you an idea of our project plan. We kept a spreadsheet of the different things that we did.

I'm just going to point out some of the highlights of the project plan. One of them was to query HistoNet. Michelle took that as a task owner to query on HistoNet about grossing performed at other clinical institutions and gained a lot of information and resources from that.

Another thing was to obtain resources such as books, training manuals, and journals to aid in the training of the grossing techs. Another was to work with our medical director to provide the list of small grossing specimens that we would initially be working on.

We also had to investigate educational requirements of regulatory agencies to perform this new initiative. This was one of the most time-consuming efforts, and Michelle was heavily involved in gathering this information.

Then we had to determine the training program and timelines, working with quality and compliance managers. And finally, we had to develop standard operating procedures, determine competency assessment processes, and create drafts.

CAP Checklist

Thank you, Elma. So this is Michelle, and I'm going to go into some of the logistical and qualification aspects of this initiative, because one of the biggest questions is exactly who can gross tissue samples. When people ask that, they often think of CAP, since many hospitals are regulated by CAP and want to ensure compliance. I have included a copy of the CAP checklist requirements from when we did this initiative. While there have been updates, the core questions remain the same.

Although CAP is often the focus, CAP is actually the follower in this situation, with CLIA being the primary authority. A few years ago, CAP defined both “processing” and “grossing.” Processing involved moving specimens into cassettes, while grossing involved manipulation such as measuring or describing tissue.

CLIA clarified that any manipulation requires qualification as high-complexity testing personnel, leading CAP to update its requirements.
Keep in mind that the medical director of the lab is ultimately responsible for determining who is qualified to perform grossing.

Qualifications

Number one, do they meet CAP guidelines? But also, more importantly, do they meet CLIA guidelines? CLIA goes into a lot more depth than CAP does about what the actual qualification guidelines are. So if you're following CLIA, you're perfectly okay for following CAP.

When we first started this initiative, I went online. The internet is an excellent resource for finding material, and I came across this great presentation by a joint commission person by the name of Stacy Olea and she had summarized these CLIA and CAP guidelines really nicely, and so I've included them in this presentation.

Essentially, what it comes down to is if you have an associate's degree or higher in a laboratory science or a medical laboratory technology, then you qualify for high complexity testing. There are some exceptions to this rule and this is the part that most people are interested in.

CAP Minimum Education/Training Methods

We're going to break it down just a little bit with the CAP standard for minimum education and training methods. Keep in mind, we're going to go over CLIA also in a little bit because CLIA drills down a little bit further than CAP does.

I'm not going to read these word for word. I'm just going to kind of summarize them for you. Basically, these are the minimum things. If you have earned an associate's degree in a science-related field from an accredited institution, you're okay. The keyword here is accredited. You can't have gone to a non-accredited institution to get your degree and then think that you're qualified because you're not. 

You can also do education and training that is equivalent to the associate's degree. It includes at least 60 semester hours plus training. The 60 semester hours have to incorporate certain sciences and certain biology, chemistry, that kind of thing. And your training has to be from an accredited institution, the ABHES or the NAACLS or other organizations that are approved by HHS.

Or, and this is just for the training, or you can have at least three months of documented laboratory training in each of the specialties which you're trying to qualify for high complexity testing.

High Complexity - Personnel

This is a summary of that. It's education and training equivalent to an associate's degree. This is just summarizing it. Again, make sure that you have your documentation. Make sure that you have those college transcripts. Make sure that if you have training, you have that very well documented. And make sure that your medical director is buying out or signing off on that.

So what are the exceptions? CLIA defines what the exceptions are because there is still grandfathering. Although these individuals are becoming fewer and far between. They're pretty rare now because the grandfathering stopped in the mid 1990s. So prior to 1992, you could have qualified as a technologist under the laboratory regulations that were published in 1992.

Now, between 1992 and 1995, you could have gone the high school route. If you had your high school degree equivalent, which I think means you could have had a GED, but you also had to have one of the following: you should have graduated from an accredited training program, or you could have completed your medical laboratory training through the military services. So that's in conjunction with your high school diploma.

After 1997, employees could no longer use that route. So the grandfathering essentially stops in 1997. I'm not sure here where the gap is between 1995 and 1997, but 1997 is what we use as the guideline. I just recommend that you take a very hard look at the qualifications and make sure that everything that you have is really well documented.

CLIA Regulations

This is what the actual CLIA regulation states, and I include this in here because it's really hard to find when you're going through all of the CLIA regulations to drill down and pinpoint exactly what they are. What it says in CLIA is for histopathology, tissue examinations must be performed by an individual who meets the qualifications of 493.1449. I have included those here. 1449 standard talks about technical supervisor qualifications.

The first one, the route B, is basically if you're a doctor, you're qualified, and that makes sense. Most people understand that, but what are the other
technical supervisor qualifications? That goes on to the next part

This is where it talks about the technical supervisor who is meeting the requirements for grossing specimens, and if you look at part five, it stops at having earned a bachelor's degree, and that's right here. So then you ask yourself, "But wait a minute what about the associate's? I thought you said we could have an associate's." CLIA's clearly stating that you have to have a bachelor's degree. Well, it really takes a special kind of person to be able to interpret CLIA regulations. I have also included a CMS interpretive guideline.

CMS Interpretive Guidelines

Basically, what CMS is interpreting is that they're saying if you have a person who is overseeing and can delegate the authority to do grossing samples, the person who is overseeing and delegating is the person who must have the bachelor's degree or above, up to and including your pathologist. And they can delegate that down to somebody else who has high complexity testing qualification, which is where the associate's degree and the grandfathering come in.

This is all really confusing, and I would just suggest if you have any questions about it at all, that you contact CAP or you contact CLIA and find out exactly what their interpretation is, and then document that. We definitely talked to CAP, and we wrote that down. We wrote down the person's name that we spoke to. We even had them send it to us in an email so that we would have that documentation in case we ran into any issues during an
inspection. 

Now we've gotten the qualifications down. We realized our technicians were good to go. Children's no longer, since CAP changed their guidelines to require high complexity testing for the grossing, we no longer employ people who are not qualified for high complexity testing, regardless of their certification status.

Utilization of External Resources

Now we're ready to move on and get this program up and running. These are the steps. First, we needed to do some research. We had never had histotechs grossing before. We'd only had residents grossing, and clearly they were qualified, and they were being trained by the pathologist. We were implementing something new, and we were implementing it from ground zero.

These are just a list of some of the resources that we used. The HistoNet was a big thing. I was able to connect with several people who had histotechs currently grossing, and I got their guidelines. I got copies of their policies. I was able to incorporate that or use that as a guideline for my own policies. We also ordered some  published surgical pathology manuals.  This one here by Susan Lester, "The Manual of Surgical Pathology" is an excellent resource. Our residents use it. Our pathologists still use it. And we also made some calls to local hospitals where we know people and talked to them in great detail about their programs and how they were working things.

Logistical Considerations

Now we're going to get into some of the logistical considerations of what we were doing. First off, were our staffing levels adequate? We took a look at our staff, and we took a really good, long, hard look at our staff. We thought, okay, yep, they can do this. They're great.

We had to take a look at our space. Did we have sufficient physical space for training and grossing so that our current processes would not be impacted? We took a look around, and we were very fortunate that we had recently, a year before we implemented this project, moved into a new lab space. We actually still had our old lab space available to us. What you see here is some of our-flooding issues, collapsed ceiling issues, things like that. Those issues had actually been taken care of prior to us implementing this project. We looked around and thought, oh, yeah, we definitely have some good space we can use. And so that's what we did.

Did we have the appropriate equipment and supplies for an additional grossing station? What we had decided for the additional grossing station, we wanted to implement something that was used primarily for training. As a senior tech, I get a lot of interruptions. I get a lot of phone calls. I get a lot of people asking me questions. I get a lot of people coming up to me wanting me to solve problems and stuff like that.

We thought for training, and especially because this was so new to us, that we would do the training in a different area, something that was kind of unavailable or not right in the middle of everything. And that honestly worked out really great until we realized that I was still getting just as many interruptions. It just took people longer to get to me to interrupt.

Did we have adequate safety measures in place? Ventilation and safety is a huge thing here for us, and we want to make sure that we are not being exposed to any more than we need to be. We did have our air monitoring done at the grossing station that we were going to be using, and when those results came back in, we realized, okay, this is great. We can definitely use this space.

Last but not least, and this is probably the most important part of this entire project, was making sure that we would have a pathologist available to perform the training and the periodic competency evaluations, as well as being available when we had questions. Pathologists are busy people. They have their own workloads. They have tons of meetings that they go to, and especially being in an educational institution, they work very closely with the residents, with the fellows. They do teaching and a lot of stuff like that. It was really important to make sure that we had the understanding that somebody was going to be available to us when we had questions.

In the beginning, we had a lot of questions. I've been doing histology now for 24 years, and I hear grossing, gross descriptions every day of my life. But when I was the person actually doing them, I realized, wow, I had a lot of questions about it, about what things were and what things looked like and that kind of thing. It was important for us to have the pathologist available, and they were. We could pick up the phone anytime we had a question, and they would stop what they were doing and come over to help us out and look at what we were doing and answer any questions that we had.

Initial Specimen Sources