November 2023—In the 2023 edition of the CAP accreditation program checklists is new guidance on analytical measurement range verification and new and revised requirements for mass spectrometry.
Read More »Soon to be required: current susceptibility testing breakpoints
October 2023—A CAP accreditation program requirement that microbiology laboratories use current antimicrobial susceptibility testing breakpoints, which was added to the checklist in 2021, will go into effect Jan. 1, 2024.
Read More »New viscoelastic testing requirement in checklist
September 2023—A proficiency testing accreditation requirement in the new checklist edition was revised to add clarification, and a new requirement on viscoelastic testing will close an existing gap.
Read More »Few but notable— new accreditation checklist changes
August 2023—Climate control, calculation verification, block retention, and histocompatibility section director (technical supervisor) qualifications are among the areas in which laboratories can expect to see revisions in the new edition of the CAP laboratory accreditation checklists, to be released this month.
Read More »Checklists now made to fit for next-gen sequencing labs
October 2022—As the diagnostic uses for next-generation sequencing have grown, so too has the length of the NGS section of the CAP molecular pathology accreditation program checklist. Now, with the release of the new checklist edition this month, NGS laboratories will find the NGS section in their customized checklists leaner, more relevant, and easier to read.
Read More »Need a written policy or procedure? Look for icon
September 2022—A new icon in the accreditation checklist edition to be released next month will make it easier to know if a written policy or procedure is needed for compliance with a requirement, and easier to inspect and be inspected.
Read More »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.
Read More »For inspectors, a new and better training course
May 2022—Users of the CAP’s redesigned laboratory inspector training course, introduced last December, should find it to be more fun, less chore, and tailored to what they need to know, say those who developed the new course. And it’s open and accessible to all.
Read More »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.
Read More »Cytopathology in focus: Statistical reporting—benefits beyond the numbers
January 2022—The CAP has a robust Laboratory Accreditation Program with a commitment to continually improving the programs and providing appropriate resources needed for compliance. As a deemed status organization, validation surveys are performed annually through the Centers for Medicare and Medicaid Services and the feedback obtained provides direction for education.
Read More »MMR, MSI testing guideline nears finish line
December 2021—No single assay can capture all cancer patients with DNA mismatch repair deficiency, and in determining a patient’s eligibility for immune checkpoint inhibitor therapy, assays for MMR deficiency, microsatellite instability, and tumor mutation burden should not be considered interchangeable.
Read More »Latest checklist takes quality management to next level
November 2021—In the latest edition of the laboratory general checklist, released in September, the requirements of the CAP Accreditation Programs have been edited to be more aligned with CAP 15189 (ISO 15189) accreditation requirements.
Read More »AST and safety at core of microbiology checklist changes
October 2021—By Jan. 1, 2024, laboratories must use current breakpoints to interpret antimicrobial minimum inhibitory concentration and disk diffusion test results, according to a new requirement in the latest edition of the CAP Accreditation Programs microbiology checklist, released Sept. 22.
Read More »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.
Read More »Virtual, blended inspections a sign of the times
June 2021—As COVID-19 restrictions halted traditional laboratory inspections, virtual and blended inspections became the stand-ins, and early adopters say there’s much to like and hold on to post-pandemic.
Read More »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?
Read More »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.
Read More »Checklist, CLIA line up on COVID reporting
November 2020—It’s been well understood since the Ten Commandments that rules that appear simple in theory can be fiendishly complex or even impossible to execute. The pandemic is providing a perfect example of that in the laboratory world, but with added twists, at least for now.
Read More »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.
Read More »What’s new in latest transfusion medicine checklist
September 2020—Strong quality management, patient safety, and conformity with regulations are at the heart of the new and revised requirements in the 2020 CAP accreditation program transfusion medicine checklist, released in June.
Read More »In 2020 checklist, a ‘gentle push’ to next quality level
August 2020—For quality management in the laboratory, it’s not enough to have checks and balances. The checks and balances have to work to improve quality. That’s how Stephen J. Sarewitz, MD, vice chair of the CAP Checklists Committee, characterizes the changes to the quality management requirements in the 2020 laboratory general checklist, released in June.
Read More »New checklist hones lab’s verification and validation requirements
July 2020—If a manufacturer assists a laboratory in setting up a new FDA-approved or -cleared test, the lab must make sure that the personnel who will perform the test participate in the verification or validation study.
Read More »HIV, TB requirements in latest accreditation checklist edition
June 2020—Best practices for HIV primary diagnostic testing and rapid detection of Mycobacterium tuberculosis complex are clarified and codified in new checklist requirements in the 2020 Laboratory Accreditation Program checklist edition published June 4.
Read More »ER/PgR guideline hones approach to ER-low positives
April 2020—The CAP and the American Society of Clinical Oncology released two years ago a focused update of their clinical practice guideline for HER2 testing for breast cancer, following an update in 2013. Read more.
Read More »Reporting, other changes in requirements for histocompatibility labs
October 2019—Histocompatibility laboratories that provide services for cellular therapy transplant patients have one more inspection option to consider, thanks to a new edition of the CAP’s histocompatibility checklist released in September.
Read More »For accredited biobanks, a path to CLIA equivalence
October 2019—The requirement revisions in the new edition of the Biorepository Accreditation Program checklist, published last month, are aimed at accommodating a growing overlap between clinical diagnostic activity and biomedical research.
Read More »New requirements for molecular micro waived testing
September 2019—Four new checklist requirements for waived molecular-based microbiology tests have been added to the CAP point-of-care testing, limited service laboratory, and immunology accreditation program checklists, as part of the 2019 checklist edition released this month.
Read More »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.”
Read More »New requirements for use and storage of liquid nitrogen, dry ice
October 2018—Laboratory personnel safety is at the center of two new requirements and a revised requirement in the latest edition of the CAP accreditation program checklists, released in August.
Read More »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.
Read More »For autopsy service, new requirements in AP checklist plus nine new requirements for forensic autopsies
September 2018—Quality management, communication, and consent are among the issues addressed in new and revised requirements in the autopsy pathology section of the latest edition of the CAP accreditation program anatomic pathology checklist.
Read More »‘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.”
Read More »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.
Read More »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.
Read More »Molecular lung cancer testing: from guideline to practice
August 2018—Testing turnaround times can affect whether non-small cell lung cancer patients receive an EGFR or ALK tyrosine kinase inhibitor when indicated. At disease progression on an EGFR TKI, integrating circulating tumor DNA and tissue-based testing may lessen some of the limitations of each form of testing.
Read More »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.
Read More »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.
Read More »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.
Read More »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.
Read More »New sections added to AP, cytopathology checklists
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.
Read More »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?
Read More »NGS checklist takes in infectious disease testing
October 2017—The CAP issued its first accreditation checklist for next-generation sequencing in 2014, as NGS was becoming a tool used in a growing number of clinical laboratories. The list of requirements, which was a new section in the molecular pathology checklist, focused on constitutive (germline) testing and oncology testing.
Read More »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.
Read More »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.
Read More »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.
Read More »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.
Read More »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.
Read More »New tests, technologies at center of 2016 CAP checklist revamp
August 2016—Maybe laboratory accreditation checklists aren’t the first reading you reach for when you want to unwind. But for an intriguing window into laboratory medicine and how it’s changing, you might take a look at the revisions in the 2016 edition of the Laboratory Accreditation Program checklists, released in August.
Read More »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.
Read More »Carbapenem resistance: advice from the frontline
August 2015—The problem of carbapenem resistance first made its way to Detroit’s Henry Ford Hospital in 2007, when a multidrug-resistant organism appeared in a sputum sample from the intensive care unit. Within weeks, several other cases emerged.
Read More »QC for accreditation: CMS validation inspections
May 2015—Quality control is second nature and part of the air that laboratories breathe. So it’s no surprise that QC should be subject to quality checks of its own, as one of the pivotal checklist areas that CAP’s Laboratory Accreditation Program focuses on during inspections.
Read More »Checklist changes put out fire (drills), for starters
May 2014—Gerald Hoeltge, MD, chair of the CAP Checklists Committee, is pretty sure he knows exactly the way many laboratories will react to a particular change in the latest edition of the Laboratory Accreditation Program checklists, which launch this month.
Read More »No ifs, ands, or buts on IHC assay validation
March 2014—Like Gypsy Rose Lee, tests and their true nature reveal themselves bit by bit. For immunohistochemistry, this unhurried disclosure has meant evolving ideas of whether these tests must indeed be validated and, if so, then how, exactly. The discussion recently culminated in a new CAP guideline for laboratories.
Read More »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.”
Read More »For prenatal NGS labs, new accreditation requirements
September 2013—With the 2013 edition of the Laboratory Accreditation Program checklist, the College moves to a new level in its effort to ensure the highest-quality practices in clinical laboratories’ use of next-generation DNA sequencing.
Read More »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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