Feature Story

Cancer protocols: leaner, later, more lenient

Cancer Protocols Chart

June 2004
Anne Paxton

If there’s one message that the CAP and the American College of Surgeons want to convey to pathologists about the mandatory cancer reporting protocols, it is "Don’t Panic."

As of Jan. 1, 2004, pathologists at the 1,425 U.S. cancer treatment centers accredited by the ACS Commission on Cancer must include all of the "essential data elements" of the cancer reporting protocols that were developed by the CAP originally as guidelines. Since the CAP intended the 42 protocols to be recommendations, not requirements, concern has swirled around the Commission on Cancer’s adoption of the CAP protocols for its inspection process.

The good news is that the protocols have been streamlined, pathologists have much more latitude in complying with them, and cancer reports won’t be formally checked against the protocols until July 2005. For the next 12 months, all that is expected of cancer centers undergoing inspection is that they have a plan in place to implement the protocols.

The ACS Commission on Cancer, or CoC, has no interest in micromanaging pathologists’ reporting, says M. Asa Carter, ACS manager of approvals and standards. The main point of the protocols is to ensure that essential elements are included in the cancer reports with no room for interpretation—not to replace narrative with synopsis, to insist on a particular format, or to make any other judgments.

"It’s certainly not our role to set requirements for the quality of pathology reports," she says.

Since it was the CAP that prepared the reporting guidelines, there has been resistance to the ACS move to make them mandatory. When ACS first announced its plans, "we had quite a bit of communication and concern," Carter says. "But since we’ve issued some clarifications, it has quieted down."

The CAP and ACS have worked to continue easing fears that the protocols would constrict cancer reporting. "The CAP Cancer Committee members felt that, as originally written, the checklists were probably overly detailed," explains committee member James L. Connolly, MD, director of anatomic pathology at Beth Israel Deaconess Medical Center, Boston.

"So the whole committee went through the checklists item by item to decide what we thought should be mandatory—that is, essential—versus optional. That greatly streamlined the process and I think clarified the protocols."

At the most recent ACS CoC meeting, held in May, the commission further clarified that inspections are limited to cancer-directed surgical resection specimens only. Cytologic specimens, diagnostic biopsies, and palliative resection specimens are excluded.

Essential data elements do not include the asterisked, as-yet-to-be-validated elements listed in the protocols, or special studies performed on specimens unless specifically indicated as an essential element in the CAP protocol. Inspectors are instructed to check for the presence of all of the essential elements in 90 percent of the pathology reports reviewed.

The leading worry for many pathologists has been that the protocols would shoehorn cancer reporting into a cut-and-dried format, but the CAP and ACS say this is not the case.

"There’s no penalty for sticking with narrative reporting," promises Carolyn C. Compton, MD, PhD, chair of the CAP Cancer Committee and the CAP’s representative to the CoC. "The CoC is not going to give you demerits for this. We made certain the quality of the pathology reports is going to be judged on the basis of the elements within the report and not on the style of the report itself."

More specifically, the CoC says that, though the synoptic report is preferred, no compliance judgments are to be made about the style of the report (narrative versus synoptic), the order in which mandatory elements appear, and the location of the data elements in a narrative.

For example, the mandatory elements may be reported in either the macroscopic (gross) description, the microscopic description, the pathologic diagnosis, or the special studies section of the report.

Since each inspection cycle reviews the previous year’s records, surveyors won’t see 2004 records until the July 2005 cycle. At that time, they’ll randomly sample 25 medical records from the five major cancer sites seen by the cancer program the previous year, and review pathology reports in these records.

Chances are high that any individual cancer patient will be receiving treatment at an ACS-accredited institution, says Dr. Compton, who is chief of pathology at McGill University Health Care Hospitals, Montreal.

In fact, data from the approved centers goes into a central registry, the National Cancer Data Base, which registers about 70 to 75 percent of all cases in the United States. "So they’re very keen to have all pathology reports coming in in a uniform format." It isn’t only good cancer medicine that will be aided by the protocols, she points out, but also clinical trials in both the U.S. and Canada that are funded by the National Cancer Institute.

William P. Reed Jr., MD, chair of the Committee on Approvals of ACS’ CoC and chair of the surgery department at Winthrop-University Hospital, Mineola, NY, says ACS wanted to move to the CAP’s protocols to try to standardize descriptions of tumors. "All our programs are required to have TNM stage and group stage placed on all new cancer patients. It’s a required part of the medical record, and the surgeon frequently has to make the entry."

"Especially for GI tumors," he says, "where pathologists have given descriptive terms for the depth of invasion, there has been confusion on the part of the managing physician translating these terms into T2, T3, or T4 for staging. Asking the pathologist to specify the T level will make staging a lot easier and more precise for the managing physician."

Some pathologists have expressed fear that the synoptic report might be confusing to surgeons. "But the definite preference expressed by membership of ACS is to have elements expressed in a clear, concise manner where you can just look down and see what’s contained," Dr. Reed says.

The elements in the CAP’s cancer protocol make up one of the 36 standards compiled during an ACS survey, but they are the first protocols to be included as accreditation requirements. The ACS is also considering many other protocols, mostly treatment-related, maintained by the comprehensive cancer centers designated by the NCI.

"The only required ones we have right now are CAP’s," Carter says. "However, that doesn’t mean we’re going to stop there. This is just the first set to be mandated."

That puts the CAP on the leading edge of an inexorable trend, CAP Cancer Committee members suggest. "The whole world is screaming for synoptic reports," Dr. Compton says. While some pathologists, especially those trained in old-fashioned methods of narrative reporting, may be reluctant to change, they may not understand how important it is, she says.

"A synoptic report is easier to produce, it’s easier to read, it can be programmed into a computer format, and certainly it’s way, way more user-friendly. No registrar of tumors has time to cull out items from a lengthy narrative report. They just want to see the elements at a glance."

It’s also a two-way street, she says. "Certainly pathologists on the receiving end would rather see medical synopses in that kind of format rather than have to read through pages and pages of lengthy narrative."

Admittedly, the pressure to synopsize runs counter to the way many pathologists, including Dr. Compton, were trained. "When I was a resident at Harvard, there was no emphasis at all on uniformity or standardization."

"Quite the contrary," she says. "We were trained in a kind of literary license, and more than that, the style a pathologist used to sign reports was a sign of distinction. Of course that’s an antiquated notion and so contrary to good medicine, but it’s very difficult to give up."

She was converted after being embarrassed before clinicians on a few occasions. "From time to time, when a clinician called to ask what is the lymph node status on that cancer, I realized I had looked but forgotten to write it down. So I had to pull the case, write an addendum report, and call the clinicians back." The synoptic checklist is a reminder that precludes that kind of omission, she says.

"If you go down a checklist so that you’re sure every time you sign out a case you’ve got all the essential information, it’s a huge timesaver for pathologists, clinicians, and secretaries, all of whom have to field phone calls because information is missing, and pull the slides for the pathologist, who has to read them again and issue an amended report that has to be typed by someone."

Although some research has suggested that synoptic reporting may impair communication instead of easing it, Dr. Compton says she would be astounded if that were true. "Crisp, clear uniform language in a standardized form is usually well understood across the board by all clinicians."

She adds, "If there is an issue that is difficult or impossible to convey in a completely standardized format, you’re free to put as much text commentary at the end of the synoptic report as you want, if you feel you need to explain something further or qualify it. This doesn’t stop you at all from using text commentary."

She and other pathologists involved in developing the protocols downplay the chance of legal repercussions. "I think people are worried, if there is a standard of reporting set out, that any pathologist who fails to conform to it will be at risk medicolegally," Dr. Compton says. "But, in fact, what’s on those checklists are the elements that are part of good medicine anyway, and if they’re not on a narrative report, the pathologist will not be any more protected from medicolegal repercussions."

"In our minds," she says, "this was more of an insurance against malpractice liability. If you use these checklists, which are endorsed not only by CAP but also the ACS CoC, no malpractice lawyer in the world would accuse you of practicing below the standard of care."

The clinicians at Beth Israel Deaconess love synoptic reporting, Dr. Connolly says. "We’ve had it for years, and I’ve always felt it’s the best way to report cancer specimens. It conveys things much better and certainly is more complete. But it may be something for people to get used to. To meet the protocols, any form of reporting will work as long as the essential elements are present."

To clarify what would be permissible under the guidelines, he took a typical synoptic report on a breast cancer specimen and reformulated it as a narrative. (See page 64.) Both reports comply with the protocols, he says.

He himself uses a combination of narrative and synopsis in his reports. "For example, if I have a left breast biopsy and sentinel lymph node, my top-line diagnosis might be ’1. Left breast biopsy: Invasive lobular carcinoma, 2. Sentinel lymph node, no evidence of malignancy,’ then, ’See synoptic report.’ In the synoptic report, I’d have all the details of grading the information necessary for staging and all additional necessary information."

Mahul Amin, MD, vice chair of the CAP Cancer Committee and director of surgical pathology at Emory University Hospital, Atlanta, characterizes the protocols as a postanalytic phenomenon, not an analytic one. "All the protocols do is standardize the reporting, make it consistent, and reduce the time needed to read reports."

"The histologic type, the grade, the stage, or how much the cancer has extended into the wall of the organ, other parameters like vascular invasion, and finally the margins—these five things form the basis of all reporting of cancer in general. We’re saying, make an independent analysis of these five things first, and make sure you’re reporting all of them."

Dr. Amin thinks the length of each complete protocol has contributed to confusion about their use in ACS standards. "Pull up the long version of a protocol and it may be 18 pages long, with explanatory notes, and a lot of information about application of parameters in the checklist. The long versions have overwhelmed people so much they’re really not looking at the short versions," he says. He points to the more reader-friendly summarized version at the beginning, generally about five pages long, that contains all the essential data elements and is titled "Surgical Pathology Cancer Case Summary (Checklist)."

The checklist format is user-friendly and effective, in his view. "We all agree that every time we fly on an aircraft it is very important that the pilot goes through a checklist of the most essential features critical to a safe flight. Once they do, then it’s practically foolproof; it reminds them in a short period of time to do everything needed." Checklists serve a similar function for a pathologist, he says, ensuring that the surgical pathology report has all the essential information for diagnosis, prediction, prognosis, and subsequent management of the patient.

Another advantage of the checklist format, Dr. Amin contends, is that pathology residents, whose residency period has been reduced from five years to four, will be more focused on what things they need to know and diagnose for a given case. "So rather than trying to remember which is the essential one for a particular malignancy, they can actually focus their efforts on learning how to apply the checklist parameters rather than which parameters to include in their report. Thus, checklists actually help streamline the education process for them as well."

Moving to a mandatory reporting standard has not been without problems. Philip Branton, MD, vice chairman of pathology at Inova Fairfax Hospital, Falls Church, Va., who has been on the CAP Cancer Committee for five years, said that at an unannounced CoC inspection earlier this year, inspectors retrieved pathology reports from clinicians and commented on the quality of the surgical pathology reports.

Incorrectly, "they had developed the belief that the cancer reports should be in the exact order that the data elements are in the CAP cancer protocol handbook, so apparently they made some comments about our reports, that they were somewhat suboptimal."

"I objected strongly when I heard, because it says in numerous places that the role of cancer protocols is to ensure the information is in the pathology reports. We’re not trying to micromanage people’s cancer reports, and we don’t even insist they report the data elements in synoptic format."

The surgeon who runs Inova Fairfax’s cancer center was not disturbed about the comments. "But I was," Dr. Branton says, "not so much because of the quality of the reports, but because I think it reflected some poor training on the part of the inspector from ACS. I think he was a retired trauma or orthopedic surgeon and not a pathologist. But if it’s going to be a surgeon, it should be someone on active duty and who has some experience treating cancer."

On the other hand, Richard Savage, MD, a pathologist with Mercy Medical Center, Des Moines, Iowa, reported a positive experience with an inspector last November, just before the protocols became mandatory.

Mercy’s cancer treatment program was granted a three-year approval with no contingencies. "Beforehand, I pulled a number of reports of cases from the top 10 sites we had in terms of cancer and evaluated them to see if they were meeting the criteria on the checklist. That’s something I would recommend-to look over a sampling of reports and have them ready for inspection."

What about worries that pathologists might be tripped up by the CAP’s revisions to the protocols before they’ve had a chance to implement them? Carter assures pathologists that any revisions, as well as their effective dates, will be entirely up to the CAP.

"We feel it’s not something ACS should specify but the CAP should say when any new pieces should be implemented, what is a reasonable timeframe or should they be done immediately."

For the near term, the CAP and ACS committee members have tried to make the transition to mandatory protocols as painless as possible, though they make no secret of their preference for a checklist format. However, over the long term, Dr. Compton predicts, it won’t prove necessary to mandate use of checklists. She says, "I think people will voluntarily go over to synoptic reporting—because it’s just easier."

Anne Paxton is a writer in Seattle.