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Tag Archives: CAP lab accreditation/checklists/protocols/guidelines —

Small groups, big answers in HER2 testing

July 2018—Take the new ASCO/CAP guideline for HER2 testing. Since the first groundbreaking joint guideline appeared 11 years ago, the authors have made a habit of addressing cases that flummox pathologists, medical oncologists, and patients. Now, in 2018, they have clarified the diagnostic approach to in situ hybridization groups two, three, and four, rare cases that nonetheless cause an outsized share of headaches and worries. It also clarifies language from the 2013 guideline that had sent some labs astray, and it addresses the use of multiple alternative chromosome 17 probe assays. The previous guidelines turned out to be tough acts to follow—a bit like following Sean Connery in the role of James Bond—even as the new one benefits from new data.

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Clearing the air for electronic cancer checklists

May 2018—Length, cost, variability in vendor support, and lack of consistency have cast a cloud for pathologist users over the CAP’s cancer protocols and the electronic version of those protocols, the electronic cancer checklists. Work is underway to improve the user experience (Nakhleh RE, et al. Arch Pathol Lab Med. 2017;141[9]:1153–1154). Behind that effort is the undeniable: “Structured discrete data, using a controlled vocabulary, can be captured, stored, and reviewed much more readily than data in other formats,” says Mary Edgerton, MD, PhD, vice chair of the CAP’s Pathology Electronic Reporting (PERT) Committee and associate professor of pathology, University of Texas MD Anderson Cancer Center.

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Lung guideline goals: more tests, treatment

March 2018—Among the many never-ending chores that humans undertake—paying bills, filing taxes, flossing—writing medical guidelines can seem like an especially perpetual task. Just ask the architects of an updated document on molecular testing for lung cancer, issued by the CAP, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology.

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New HPV guideline for head, neck cancers

February 2018—Like a pair of one-size-fits-all jeans, testing all head and neck carcinomas for human papillomavirus may have seemed like a good idea at one time. In many cases, in fact, HPV testing is just what treating clinicians and patients need. On the other hand, not every head and neck case requires it. Now, a newly published CAP guideline should help physicians figure out the right fit in multiple settings.

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PD-L1 guideline panels hustle to keep pace with drug advances

October 2017—The expert and advisory panels for the CAP/IASLC/AMP guideline on molecular testing for lung cancer biomarkers started updating the guideline in 2014, and an important but fairly routine revision process may have seemed to lie ahead. Something like sedately stepping onto a moving sidewalk. The key question at that point was quotidian: Have new data emerged to warrant changing the original recommendations?

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New requirement, updates in transfusion checklist

September 2017—Like an old friend with a new facelift, or a high-mileage car with a thorough tune-up, the 2017 edition of the CAP transfusion medicine checklist has undergone a significant number of small changes—none of which is startling in itself, but all of which combine to produce a fresh and streamlined effect. More than 90 of the checklist’s requirements have been revised, many in the name of alignment with FDA requirements.

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A slimmer molecular micro section among changes to checklists

August 2017—There was no trip to the spa. But some sections of the 2017 edition of the CAP Laboratory Accreditation Program checklist are looking trimmed and toned compared with last year’s checklists. A microbiology section that is shorter by eight pages, fewer Individualized Quality Control Plan reporting requirements, and a new section addressing chain of custody once again reflect the hard work of the Checklists Committee and scientific resource committees to achieve conciseness and clarity.

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Laboratory director duties clarified in 2017 checklist

August 2017—Quantum theory is often interpreted to mean an object can be in two places simultaneously. Unfortunately, quantum theory doesn’t apply to laboratory directors, at least not on a scheduling level. Like the rest of us, directors can be in only one place at a time, no matter how many laboratories they oversee. Now a change to the CAP Laboratory Accreditation Program’s checklists will clarify expectations for directors who are in charge of more than one laboratory. The 2017 edition of the checklists, released this month, has eliminated the specific requirements for laboratory directors who are not on site full time and has clarified responsibilities for all directors, on site or remote.

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