Home >> Tag Archives: CAP lab accreditation/checklists/protocols/guidelines

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

Cytopathology in focus: Protocol for reporting cervicovaginal cytology specimens

August 2022—The protocol for the reporting of cervicovaginal cytology, the first in a series of CAP cytopathology protocols, became available for use in a synoptic format on June 22. This protocol is a collaborative effort, based on input from past and present members of the CAP Cytopathology Committee and prepared in conjunction with the CAP Pathology Electronic Reporting Committee. It was presented via webinar to the CAP House of Delegates on March 31. A two-week open comment period followed; all comments were reviewed and appropriate changes were incorporated into the protocol.

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Cytopathology in focus: Know the accreditation requirements for telecytology

May 2022—The number of minimally invasive fine-needle aspirations requiring rapid on-site evaluation (ROSE) in the cytopathology laboratory has increased over the past decade. Laboratories have seen lower gynecologic volumes and an increase in both nongynecologic fine-needle aspiration biopsy and touch imprint samples. ROSE for patient care has proven value. Sample adequacy allows for a single visit and avoids having to make multiple attempts to provide material sufficient for all required testing, including flow cytometry, microbiology, cell block preparation for immunohistochemical and histochemical staining, and molecular testing.

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A preanalytics push in accreditation checklists

September 2021—Taking steps to protect the integrity of specimens is at the heart of new and revised requirements in this year’s edition of the accreditation program checklists, set for release Sept. 22. A CAP team made up of members of the Checklists, Personalized Health Care, and Cytopathology committees collaborated to incorporate into the checklists the evidence-based recommendations set forth in a 2019 article on preanalytics and precision pathology. Many of the new and revised requirements, which are in seven checklists, are aimed at improving the quality of tissue and blood specimens that may undergo molecular testing for patients with cancer. The aim of others is to improve the preanalytic quality of specimens used for all types of testing.

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pTX and pNX should not be used in tumor staging

June 2021—For the June 2021 release of updates for the CAP cancer protocols and the corresponding electronic cancer checklists used by electronic health record vendors, pTX and pNX will no longer be selectable options for use by pathologists when assigning pathologic staging based on definitive surgical resection (pTNM). This change is coming after extensive discussions with the American Joint Committee on Cancer (AJCC) and with its unanimous endorsement. Why are we making this change?

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From manual to staging system—AJCC’s new path

April 2021—In the continuum of cancer care, diagnostic specialties such as ours play critical roles. We touch virtually all aspects of cancer care through cancer diagnostics, the use of molecular studies in treatment and as predictive markers, and our key role in anatomic pathologic staging. The widespread use of the CAP cancer protocols has improved cancer reporting by standardizing format and terminology while also incorporating the concept of human factors engineering and standards for developing high-quality clinical practice guidelines.

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At POC and in lab, 2 new checks on SARS-CoV-2 testing

November 2020—The CAP released in September its proficiency testing program for SARS-CoV-2 antigen testing, with the first shipment to laboratories set for Nov. 30. It also introduced recently a Quality Cross Check program that makes it possible for labs performing nucleic acid amplification testing for SARS-CoV-2 to monitor performance across multiple instruments, in compliance with the CMS directive prohibiting proficiency testing on multiple instruments.

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Quantitative image analysis: In guideline, preliminary rules for pathology’s third revolution

April 2019—With the release in January of a new guideline for quantitative image analysis of HER2 immunohistochemistry for breast cancer, the CAP believes it is filling a gap and blazing a trail for the profession. In setting evidence-based standards, the guideline provides background and details about the quantitative image analysis (QIA) process and the data and metadata it generates. The guideline will help facilitate pathology’s increasing use of not only digital pathology but also artificial intelligence, says Marilyn Bui, MD, PhD, chair of the CAP expert panel for QIA of HER2 IHC. “This is not just another guideline. It is a milestone for pathologists.”

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New accreditation program checklist section: Imaging mass spec scores its own quality standards

October 2018—It happened for next-generation sequencing. It was an important step for in vivo microscopy. And now it’s taking place with imaging mass spectrometry. The milestone: development and adoption of a set of specialized checklist requirements for laboratories that want CAP accreditation. Imaging mass spectrometry, an adjunct methodology to help pathologists analyze areas of interest in tissue specimens, is, at this point, used in a small number of research laboratories in the U.S., says CAP Checklists Committee member Christopher M. Lehman, MD, clinical professor of pathology, University of Utah College of Medicine, and medical director of the University of Utah Hospital Laboratory.

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‘We wanted to be the best we could possibly be’: CAP ISO 15189-accredited labs on the difference it makes

September 2018—Ten years ago, Richard J. Zarbo, MD, was feeling pretty proud of his laboratory. As system chairman of pathology and laboratory medicine at Detroit-based Henry Ford Health System, over the previous few years he’d seen his team rigorously implement Lean practices, practices that had paid off in greater safety and efficiency. “Setting the bar higher was important because that’s the culture here,” he says. “This is what we do.”

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Transfusion medicine checklist: Record and other requirements updated in new release

August 2018—One new requirement and several modified requirements in the CAP transfusion medicine checklist are part of the new edition of CAP accreditation program checklists released this month. In work led by the CAP Council on Accreditation, the checklists are examined anew and revised yearly, where needed. In transfusion medicine, the changes this year center on computer crossmatches, record retention, forward/reverse typing, and ABO group and Rh(D) type verification.

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Cytology workload limits: For adequacy assessments, it’s time, not slides

August 2018—The CAP and the Centers for Medicare and Medicaid Services reached an understanding earlier this year on how adequacy assessments and rapid on-site evaluations in cytology can be accounted for without causing undue impact on workload limits. The agreement, communicated to state survey agency directors in a March 16 CMS memorandum, is reflected in the updated CAP accreditation program cytopathology checklist released this month.

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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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Acute leukemia workups, from top to bottom

May 2017—Plenty can happen in five years. Just ask Cubs fans who watched their team leap from a 101-loss season in 2012 to a 103-win season in 2016 and a World Series title as the cherry on top. Or ask Daniel Arber, MD, who co-chaired a hefty new guideline—a half decade in the making—on diagnostic workup of acute leukemia. At the start of the project, “I think everyone going into it realized it was going to be a time-consuming, long process. But I don’t think anyone realized how long,” says Dr. Arber, professor and chair of pathology, University of Chicago, and the CAP co-chair for the guideline group.

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Laboratory accreditation program 2016 checklists: Less legwork, more clarity seen in personnel changes

September 2016—For the CAP Laboratory Accreditation Program, inspection checklist requirements covering personnel are a perennial concern. They are the leading source of disparities between the findings of the program’s inspectors and inspection audits done by the Centers for Medicare and Medicaid Services. Personnel is also high on the list of questions asked of Laboratory Accreditation Program staff. “Personnel is a hot topic for the College,” says CAP Checklists Committee chair William W. West, MD.

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In situ hybridization: more harmony across checklists

August 2016—As the use of in situ hybridization (ISH) expands, laboratories employing this form of testing increasingly rely on the CAP Laboratory Accreditation Program checklist for guidance. That is one reason members from three CAP committees started meeting to revise the ISH checklist, says CAP Surgical Pathology Committee member Aleodor Andea, MD, MBA. Another reason: to harmonize and streamline the ISH checklist requirements across three different disciplines.

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No worries with new cancer biomarker templates

October 2013—For anyone worried about the new CAP reporting templates for cancer biomarkers, Patrick L. Fitzgibbons, MD, has an important message: Don’t panic. “These are nothing new,” says Dr. Fitzgibbons, a pathologist at St. Jude Medical Center, Fullerton, Calif., and chair of the CAP Cancer Biomarker Reporting Committee. “We’re not adding anything. The templates will look very familiar to users of the CAP cancer protocols. They shouldn’t be considered a significant burden.”

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Missing transcripts, diplomas snag labs

April 2013—The paperless office may be just around the corner, and virtual reality may lie ahead too. But for the time being, when it comes to demonstrating that personnel have the required educational qualification to perform nonwaived point-of-care testing, the Centers for Medicare and Medicaid Services and the CAP have a message for laboratory directors: Primary documents are king. For accreditation under CLIA, it’s not enough to know personnel are qualified because of their certificate or license; you have to prove it with copies of their transcripts and diplomas.

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