Anne Ford
November 2017—A new flow cytometry section in the anatomic pathology checklist and a section on immunochemistry in the cytopathology checklist are among the many changes found in the latest edition of the CAP Laboratory Accreditation Program checklists, released in August.
“I don’t believe there’s anything that checklist users will be startled by,” Checklists Committee member Michael Ross Henry, MD, director of cytopathology in the Department of Anatomic Pathology, Mayo Clinic, Rochester, Minn., says of the new sections.
Dr. Henry
The anatomic pathology checklist now features a section on flow cytometry data interpretation. It applies to laboratories that perform the interpretation component of flow cytometry data where the flow cytometry technical component is performed at a laboratory with a different CAP and/or CLIA number. The new section consists of checklist requirements on peer education programs, record retention, appropriate antibodies, gating procedures, and final reports. If the technical and interpretive components are performed in the same laboratory, with the same CAP and/or CLIA number, the laboratory will continue to be inspected with the flow cytometry checklist.
Why the new section? “What we’ve found is that in the past, laboratories that were doing flow cytometry interpretation did not declare that activity to the CAP, and consequently they did not receive the flow cytometry checklist, so the inspection team couldn’t inspect those areas when they went there,” says Richard M. Scanlan, MD, chair of the CAP Commission on Laboratory Accreditation and vice chair of laboratory medicine and director of the transfusion medicine service at Oregon Health and Science University. In addition, more and more pathology laboratories are offering this type of interpretive service, and the Commission on Laboratory Accreditation was concerned it could be overlooked during a CAP inspection.
“We felt that an entire flow cytometry checklist was overkill for these laboratories,” Dr. Scanlan says, “because much of it has to do with quality of the wet testing, and that’s not an issue in a flow interpretation-only laboratory. So we took questions we felt were appropriate and we added them to the CAP anatomic pathology checklist so they could be inspected.”
Dr. Scanlan
The change will help the CAP keep down the cost of accreditation inspections, he adds. “Another issue with flow cytometry is that you need a subspecialty inspector to do the inspecting. We felt that a regular anatomic pathologist could do the limited inspection of an interpretation-only laboratory,” he says. “That will save a considerable amount of expense.”
A section on immunochemistry has been added to the cytopathology checklist. This new section is aimed at laboratories that perform immunochemistry staining procedures within the cytology laboratory where an anatomic pathology checklist is not already in use for immunohistochemistry. (Cytology laboratories that perform histology processing of cell blocks and tissues must be inspected with the AP checklist.) It consists of checklist requirements on specimen modification, buffer pH, QC antibodies, endogenous biotin, control slide review, antibody validation, new reagent lot confirmation of acceptability, immunochemistry assay performance, and slide quality. Also included are requirements related to pipette accuracy, microwave usage, microwave monitoring, microwave container venting, and microwave venting. As with the new flow cytometry data interpretation section in the anatomic pathology checklist, the Commission on Laboratory Accreditation decided this section should be added to the cytopathology checklist out of concern that these services would be otherwise overlooked during a CAP inspection.
Dr. Henry explains: “This [new section] encompasses all immunostaining procedures, whether it’s done on tissue obtained through cytologic methods or whether it’s cytology smears or cytologic preparations. If you are doing immunochemistry testing in a cytology laboratory, you should have already been following the checklist requirements that pertain to immunochemistry testing anyway. So there’s nothing new in these checklist requirements that is not already covered in the regular immunochemistry section in the AP checklist.”
The new section, he adds, is “really for a limited number of cytology laboratories, the ones that would actually be performing this type of testing within the cytology laboratory itself. I don’t believe there are a large number of them.”
Still, he says, it’s important that these types of immunochemistry tests, when performed on cytology specimens, be validated properly and have the proper positive and negative controls.
“Those are things that are addressed within this particular checklist, and it recognizes that cytology specimens may be fixed differently than normal formalin and fixed paraffin-embedded tissues, and therefore they need to be validated separately because of that fixation,” he says. “And the laboratory may need, if possible, different controls, although we recognize that sometimes those controls may be difficult or impossible to have. So there are other mechanisms that are delineated within these checklists for those possibilities.”
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Anne Ford is a writer in Evanston, Ill. The CAP Council on Accreditation leads the work to reexamine and revise the checklists. For other revisions found in the 2017 edition, see the August, September, and October 2017 issues of CAP TODAY.