Checklist changes put out fire (drills), for starters

More checklist requirement information online

Two 90-minute CAP online educational sessions will cover the checklist requirement changes.

On Aug. 20, Denise Driscoll, MS, MT(ASCP)SBB, will present “The Truth About Personnel Competency.” She is director of accreditation and regulatory affairs, CAP Laboratory Accreditation Program.

On Sept. 17, Gerald Hoeltge, MD, in his “Checklist Updates” webconference, will cover the changes that affect the laboratory as a whole, the changes in pre- and postanalytics, entirely new sections, and changes within selected specialties and to test method management. He will also share the most common deficiencies reported in 2013. Dr. Hoeltge is chair of the CAP Checklists Committee.

Both Web sessions will begin at noon CT and will be available online within four weeks after the live event. Registered participants will have unlimited access to the files for one year.

To enroll, call 800-323-4040 option 1 or go to www.capatholo.gy/ccms and click on Live Events.[/box]

In his view, that’s because of heightened concern at that time regarding false-positives—a concern that has now shifted to the matter of identifying every patient who might benefit from trastuzumab or other anti-HER2 treatments. “So the new edition has changed the criteria for immunohistochemistry back to greater than 10 percent of tumor cells,” he says.

As for in situ hybridization, the definition of a positive result has been changed from a HER2-to-CEP (chromosome enumeration probe) ratio of greater than 2.2 to a ratio of greater than or equal to 2. At the same time, “there is one other point that is new about scoring regarding in situ hybridization, and that is the issue of tumor heterogeneity,” says Dr. Sarewitz. “In a given tumor, the majority of the cells may be HER2 negative, but there may be clones within it that are HER2 positive. The new checklist item states that the slides need to be scanned at low power, and if you can find a subpopulation of tumor cells that represents at least 10 percent of the total tumor cells, and those cells are positive, you have to report the case as positive. The provision is, you need to be able to count at least 20 cells in this subpopulation; it can’t be a three-cell population or something similar.”

These scoring changes may cause concern, Dr. Sarewitz acknowledges, about whether patients whose results were declared negative in the past should be re-tested on the chance their results would be considered positive under the new requirement. “The answer is not simple, but it’s basically no,” he says. “First of all, the number of patients this affects is probably pretty small. I think pathologists should have a discussion with their oncologist colleagues about this, and if there are patients whom the oncologists feel might benefit from HER2 therapy, then the tests could be repeated or the scoring could be looked at again. But it shouldn’t be a huge issue.”

The new edition of the checklist also requires that if a previously diagnosed patient returns with a recurrence, either in the breast or in a metastatic site such as a lymph node, the recurrence or metastasis be tested for HER2. “However, if a patient presents with a mass in the breast and a metastasis, both don’t have to be tested at that time, just one,” Dr. Sarewitz emphasizes.

Finally, the issue of histologic discordance has been raised. “What this means is, if the appearance of the tumor under the microscope does not fit with the HER2 result, then consider repeating the HER2 test. For example, if it’s a very low-grade tumor that’s estrogen- and progesterone-receptor positive, well, those tumors generally are HER2 negative. If you got a HER2 positive result on that tumor, question that result. Conversely, if you have a very high-grade tumor that looks very aggressive under the microscope and is negative for estrogen and progesterone receptors, well, it might be HER2 negative, but if it is, question that. Also, if a core biopsy has an equivocal result by immunohistochemistry, and the laboratory then goes ahead to test it by in situ hybridization, and that’s also equivocal, then it’s recommended that the test be repeated on an excisional specimen.”

Another significant change to the anatomic pathology checklist: the addition of a portion on circulating tumor cell analysis. In previous editions, this section appeared in the immunology checklist. “We asked around and found that in most laboratories, this type of analy­sis is done in the anatomic pathology or molecular anatomic pathology area,” says Checklists Committee member Michael Henry, MD, director of cytopathology at the Mayo Clinic. “So we felt it needed to be taken out of the immunology checklist, and plus the existing requirements were not necessarily directly related to the performance of circulating tumor cell analysis.”

That’s changed now, with the introduction of a comprehensive set of requirements that cover circulating tumor cell testing.

“They start with validation and calibration, and they go through quality control and into specimen analysis, including rejection criteria,” Dr. Henry says. The new checklist requirements mandate that there are documented guidelines for differentiating circulating tumor cells from other nucleated circulating cells, and that all reports are reviewed and signed by the pathologist. “We had a discussion about this requirement,” he says, “and we decided that because circulating tumor cells require morphologic interpretation in order to be performed correctly, the pathologist should be involved.” In addition, if the preliminary morphologic observations are performed by non-pathologist personnel, the qualifications of those personnel must be assessed.

In developing these new requirements, Dr. Henry and his colleagues purposely kept them somewhat general. That’s because while to date only one platform has been approved by the FDA for circulating tumor cell analysis, other platforms may be approved in the future, and the Checklists Committee wanted to ensure that these requirements are likely to be appropriate for those platforms as well.

Dr. Henry was also involved with changes to the whole-slide imaging section of the laboratory general checklist. “We decided to put this in laboratory general because this particular set of requirements, and there are only two of them, is very generic,” he says. “What you use the images for is covered in other areas of the checklist. This part is very simple.” The first requirement calls for documentation that users of the imaging system have been trained. “And the other one says that if you’re using a whole-slide imaging system, you have to have validated that system under the direction of the laboratory director. There’s not a specific protocol that is required,” Dr. Henry says, “but in the note in that particular requirement, there are some guiding principles that should be used.”

As for the clinical biochemical genetics checklist, it now contains a section dedicated to hemoglobin separation and aimed at laboratories that perform newborn screening. “Commonly, the laboratories that perform hemoglobin separation perform it in a diagnostic application,” says Devin Oglesbee, PhD, a member of the CAP-ACMG Biochemical and Molecular Genetics Resource Committee. “Screening laboratories, unfortunately, don’t have the luxury of large amounts of sample. They’re using blood screening cards and dried-blood spots, and have methodologies that are designed essentially to perform screening functions—meaning they will detect clinically relevant hemoglobinopathies, but there may also be other types of hemoglobin proteins present that need to be resolved through additional analysis. And these laboratories often don’t have enough sample to perform the additional assays that are required.

“And so this part of the checklist,” he continues, “addresses that primary screen assay, making it more applicable to newborn screening. It also recommends specific follow-up tests that would essentially differentiate between sickle cell trait and other hemoglobin variants.” Dr. Oglesbee is co-director of Mayo Clinic’s biochemical genetics laboratory in the Division of Laboratory Genetics and assistant professor of laboratory medicine and pathology and medical genetics, Mayo College of Medicine.

Finally, checklist users will notice a new instruments and equipment section in the all common checklist, though the requirements in this section aren’t new at all: They’ve been taken from each of the discipline-specific checklists, grouped, and streamlined for the sake of consistency and simplicity. “Things like thermometers and instrument maintenance function checks—they’re used all across the laboratory,” says CAP checklist editor Lyn Wielgos, MT(ASCP). “This consolidation is helpful for laboratories, because it promotes standardization across their processes and reduces the burden of having to prepare for inspection using multiple different checklist requirements.”

“Having these requirements in the all common checklist will help laboratories identify systemic issues across their different laboratory sections,” she adds.

During the streamlining process, Wielgos and her colleagues discovered gaps and remedied them. “One example is that we did not have a requirement in all of the checklists that addressed performance verification before initial use or after a repair. Another example is that some of the requirements didn’t refer to setting tolerance limits for something like a function check and performing corrective action. We realized this was a good opportunity to make sure these requirements are applied across the board,” she says.

In addition, Wielgos took the opportunity to address some common queries: “We get a lot of questions from laboratories about standardized thermometers, noncertified thermometers, and the checks they need to have done. So the checklist requirements have been revised to go into a little more detail about what the expectations are once a standardized thermometer expires.”

On a related note, she’d like laboratories to know that if they find themselves receiving what seems like a superfluous number of all common checklists, there’s a remedy for that. “This is one of the complaints we receive periodically,” she says. “Sometimes when we investigate these concerns, we find out that the laboratory could reduce the number of all common checklists it’s receiving by making sure the information it has reported to the CAP on its application reflects the actual organization of its laboratory.” For example, if a laboratory has a core laboratory set up under the supervision of one manager, it should put that under one section or department for the CAP. “That way, it would have just one all common checklist for that grouping of tests. Historically, the laboratory setup has been more siloed, but that’s changed a lot over the years, and some laboratories haven’t updated their application section information to reflect that,” she says.

Dr. Sarewitz, too, has a checklist-related message for laboratories. “Let’s say that a laboratory’s inspection isn’t scheduled for an extended period of time, for another year or 18 months or whatever,” he says. “One question we get sometimes is: Can and should the laboratory reflect the new ASCO/CAP guidelines as reflected in the new edition of the checklist immediately?”

His answer: a resounding yes. “Adopt them as soon as possible,” he says. “It’s good practice. The concern is, ‘Well, the new checklist takes five or six months to get out there. If we get inspected with the old edition of the checklist, will we be cited?’ The answer is no, you should not be cited. And if you are, that citation will be removed during the inspection review process afterward. So that shouldn’t be a problem.”
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Anne Ford is a writer in Evanston, Ill.