Research & Development
Policy & Regulation
Trends & Finance
Accreditation: Page 2
Practices set for more flexibility in use of emergency COVID-19 loans
The Senate voted to pass the Paycheck Protection Program Flexibility Act (HR 7010) on June 3, following passage by the House of Representatives on May 28, and the bill now goes to President Donald Trump, who is expected to sign it.The CAP is pleased that the House passed the Paycheck Protection Program Flexibility Act of 2020, as it provides greater flexibility to pathology practices that received small business assistance loans: https://t.co/GLubpoBClF. pic.twitter.com/fyGYzVSxcW
June 3, 2020
FDA authorizes home COVID-19 nasal sample kit
This is currently the "only authorized COVID-19 at-home sample collection kit for use with multiple authorized COVID-19 diagnostic tests," the FDA said.
May 17, 2020
Pathology guideline standardizes warfarin genotype testing
The guideline was developed by the Association for Molecular Pathology (AMP) and the College of American Pathologists (CAP), with input from the Clinical Pharmacogenetics Implementation Consortium (CPIC). Recommendations were published by Dr. Karen Weck, director of the molecular genetics laboratory at the University of North Carolina, and colleagues online May 4 in the Journal of Molecular Diagnostics.
May 5, 2020
New coronavirus package funds testing, more small business payroll aid
The $484 billion package was passed by the U.S. House and Senate this week and signed into law by President Donald Trump on April 24.
April 23, 2020
FDA cuts back on U.S. inspections due to COVID-19
The FDA said it was making the move out of concern for the safety and well-being of its staff, as well as due to industry concerns about visitors to their facilities. The move applies to inspections that the agency conducts every few years based on a risk analysis, the FDA said.
March 18, 2020
CAP suspends facility accreditation inspections
The U.S. suspension was approved by the U.S. Centers for Medicare and Medicaid Services (CMS) and took effect March 17. It applies to all inspections aside from immediate jeopardy complaint visits and follow-ups, CAP explained to members.
March 17, 2020
Dr. Fauci invokes Yogi Berra to describe emerging infectious disease challenge
C2N Diagnostics launching next-generation blood test for Alzheimer's disease detection
Thermo Fisher Scientific introduces digital PCR liquid-biopsy assays for academic, clinical research
Thermo Fisher Scientific updates Applied Biosystems genetic analyzers to comply with IVDR
Aspira announces commercial launch of blood-based ovarian cancer risk assay
MDxHealth sees Medicare delay for prostate cancer risk test, reduces 2022 revenue guide
Good news for pathology in 2020 Medicare Physician Fee Schedule
The final rule, which was published on November 1, updates payment policies, payment rates, and other provisions for services based on comments from the public and interested organizations. It includes the following changes:
November 5, 2019
Diagnomics debuts cardiovascular health panel
The Gene Impetus - Cardiac Care report will tap into information on more than 110 genes underlying more than 30 cardiovascular conditions, such as cardiomyopathies, high cholesterol, and arrythmias, according to the company.
October 7, 2019
CAP unveils award winners at annual meeting
Wagar chairs the laboratory medicine department at the University of Texas MD Anderson Cancer Center in Houston. She has more than 25 years of experience in pathology and lab medicine, and she was recognized for her work performing lab inspections as part of CAP's accreditation program, involvement in education, and contributions to evidence-based guidelines. Wagar has also held posts on various CAP committees and councils.
September 22, 2019
AACC: How not to fail your lab inspection
More than 8,000 labs are accredited on a voluntary basis by the Northfield, IL-based College of American Pathologists (CAP) and must meet particular requirements for proficiency testing. In June, the organization published a list of 41 labs that had been continuously accredited since 1964. CAP may provide inspections instead of the U.S. Centers for Medicare and Medicaid Services (CMS), which has an oversight role for labs through CLIA.
August 7, 2019
Call for more vitamin D testing | What's in FDA's private safety database? | Putting lab guidelines to the test
Dear Lab Pulse Member,
July 1, 2019
CAP showcases labs accredited for over 50 years
CAP noted that the program helps labs comply with regulations from the U.S. Centers for Medicare and Medicaid Services (CMS), which has an oversight role through the Clinical Laboratory Improvement Amendments (CLIA) of 1988. Accreditation includes onsite checks by laboratory peer inspectors every two years and compliance with quality and procedural checklists that are regularly updated. Through CAP accreditation, labs may also show that they are keeping up to date with new technologies in the pathology field, such as information technology, artificial intelligence, and liquid biopsies.
June 23, 2019
Page 2 of 2