Best Practices in Biomarker Testing Documentation

Beth Sandy

Eve, what do you think about discussing best practices in biomarker documentation?

Eve Segal

It’s an important topic. I don't know how your electronic medical records are, but we have a lot of fascinating places where these results may wind up within it. Sometimes they're on the Lab Results tab, sometimes they're in the Scanned Media tab. So our providers put in their note and then copy forward every note saying, "This is their mutation status," which is great because that's helps the entire medical team have a complete picture.

Beth Sandy

Biomarker documentation can definitely go wrong. Very recently, my organization created a tab labeled Precision Medicine. I know what that means but I don't know if everybody in my practice knows that this is where the molecular biomarker testing results live. Let’s say you work in urology. You might wonder, "What the heck is this Precision Medicine tab? I don't know what that is."

Prior to that tab, the results were going in our Lab tab. But if your Lab tab is anything like mine, it’s long and difficult to sift through. I’d put a filter on it for molecular and lab or pathology, but they wouldn't always show up there. Sometimes the biomarker test result, whether it was PD-L1 or let's say a KRAS, was being embedded in the patient's original surgery path report.

Eve Segal

That’s not good.

Beth Sandy

I didn't know that was happening, so I’d spend a lot of time searching for it. Just knowing where it was documented in the chart was challenging. My filter wouldn't catch that because sometimes it was an outside biomarker report that was manually scanned into the EMR. I recommend making your own separate tab for it and everybody involved in that process--the administrative assistant, the molecular path department, the pathology department--has to know to file it under that Precision Medicine tab. It takes a lot of communication. Everyone on the care team should be responsible for this.

Eve Segal

Absolutely. Every member of the care team should know where the results are, especially if they keep seeing “pending” in the notes.

Beth Sandy

I have a case study that shows what can go wrong with poor placement of documentation. I had an elderly patient who was a smoker with stage 4 non-small cell lung cancer with pending biomarker results. There was a lot of copying and pasting of notes, but his care team finally found that his liquid biopsy report came back without any mutations, so he was started on chemo and immunotherapy, which he responded to a little bit. We might assume an elderly person who smokes and has lung cancer probably doesn’t have a mutation. The patient was progressing on chemo and immunotherapy, and his care team thought he might need to be put on hospice. Many months after the patient started treatment, his doctor realized that the tissue biomarker test was still pending. So the care team searched for the results, finally finding them in the original surgery pathology report. The results went to a pulmonologist who had ordered it as part of a procedure, and he had never sent it to the treating physician. The patient had a KRAS G12C, which was actionable at the time in the second-line setting. With the copying and pasting forward of the notes, it was much easier for the team to gloss over the fact that the biomarker results were still pending.

Eve Segal

You touched on earlier that this is every member of the care team's responsibility. So even though our pharmacists aren't responsible for the initial documentation, we touch every chemo order that comes through, both oral and IV. And our pharmacist, as part of their documentation, will put what type of lung cancer this patient has too. This way if they are seeing that the patient has a targetable mutation, they can have conversations and work more dynamically with the team.

Beth Sandy

In the case that I just mentioned, thank goodness it was a mutation that was in the second-line setting anyway. But recurrence is another issue. Let's say we treated someone curatively, and then 2 years later, their lung cancer recurs. What do you do at that time? Let's say that patient had an EGFR mutation on their original path, but they weren't treated at the time because they were early stage. We know now with early stage, we give them adjuvant treatment, but back 2 years ago, we weren't doing that.

We often do a re-biopsy when it recurs years later since we don't know if this is a new lung cancer or if it's a recurrence of their old one. Even a recurrence of their old one could potentially have a different PD-L1 expression, a different mutation. Oftentimes, especially if the recurrence has been over a year or two, we would probably try to re-biopsy. If they're having progression or recurrence within 6 months, maybe within a year, it's likely harboring the same molecular profile that it did then. Each case is unique. Would your practice re-biopsy if it recurred years later?

Eve Segal

Yes, a re-biopsy can be very helpful. In terms of progression, those notes are so important because they orient every player on the team when they interact with that patient's chart. The notes are especially helpful for recurrence. Now that we have a lot more options in the adjuvant setting, we are running into scenarios where the patient progressed. They were treated with a checkpoint inhibitor before, but it's been a couple of years so the question is if we should retrial it. Getting those re-biopsy results helps inform those decisions.

Beth Sandy

Sometimes we can't even get the prior results.

Eve Segal

That's true.

Beth Sandy

There should always be a way to call the original company and get that testing report back, unless there was insufficient tissue. In a previous conversation we talked about trying a liquid biopsy if there was insufficient tissue. But you have to weigh the risk and benefit of going back in and doing a biopsy. Is it a difficult tumor to access within their lung? Are they at high risk for a complication? Do you want to put them at that risk? A lot goes into the decision of whether or not to re-biopsy.

Bone metastases are also difficult to determine what to do with; a lot of times we're not going to be able to read the DNA on that well because of the degrading process that goes on. Hopefully there's always a way to retrieve a prior result, which could mean multiple calls to the company or pathology lab where it was done. But if there truly was insufficient tissue, you need to make a decision about doing a liquid biopsy versus going back in and doing another tissue biopsy.

Eve Segal

Yes, I agree. There’s a place for liquid biopsies. There seems to be a lot more data being developed for liquid biopsies too, including really strong data for EGFR and ALK. Hopefully we’ll see more data in the future.

Beth Sandy

Today’s takeaway: Everyone on the care team needs to make it their responsibility to ensure that critical precision medicine results are documented in the proper spot in the EMR.