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What are the MQSA requirements for a medical audit …

    https://www.accessdata.fda.gov/cdrh_docs/presentations/pghs/What_are_the_MQSA_requirements_for_a_medical_audit_and_outcome_analysis_recordkeeping_system_.htm
    Each facility must have a system to track positive mammograms and a process to correlate the findings with biopsy results. Positive mammograms are those with final assessment categories of...

Frequently Asked Questions About MQSA | FDA

    https://www.fda.gov/radiation-emitting-products/consumer-information-mqsa/frequently-asked-questions-about-mqsa
    Medical Audit: Each facility must have a system for following up on mammograms that reveal problems, and for obtaining biopsy results. The standards also …

The Annual MQSA Inspection: What Facilities Can Do …

    https://www.fda.gov/radiation-emitting-products/mqsa-insights/annual-mqsa-inspection-what-facilities-can-do-help
    Medical Audit and Outcome Analysis Written documentation of analysis to include: All positive mammograms interpreted as “Suspicious” or “Highly suggestive of malignancy" …

Compliance Guidance: The Mammography Quality …

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-guidance-mammography-quality-standards-act-final-regulations-preparing-mqsa-inspections
    The MQSA required that to provide mammography services legally after October 1, 1994, all facilities, except facilities of the Department of Veterans Affairs, must be accredited by an …

Regulations (MQSA) | FDA - U.S. Food and Drug …

    https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-and-program/regulations-mqsa
    If facilities follow the guidance developed for a specific MQSA requirement, they will be considered to have met the requirement. However, as guidance is intended to guide, not …

II. THE BASIC CLINICALLY RELEVANT AUDIT - ACR

    https://www.acr.org/-/media/ACR/Files/RADS/BI-RADS/FUOM-Basic-Audit.pdf
    MQSA Final Rule also requires analysis of any known false-negative mammography examinations by attempting to obtain surgical and/or pathology results and by review of …

Mammography Quality Standards Act (MQSA) | FDA

    https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mammography-quality-standards-act-mqsa
    (ii) comply with the requirements described in paragraph (4); (iii) submit to the Secretary the name of any facility for which the accreditation body denies, suspends, or revokes …

Understanding the Mammography Audit | Radiology Key

    https://radiologykey.com/understanding-the-mammography-audit/
    The MQSA requires each mammography facility to meet certain quality standards, maintain certification and accreditation, and undergo regular inspections and surveys. As a part of the quality …

The mammography audit: a primer for the …

    https://pubmed.ncbi.nlm.nih.gov/7785586/
    As such, portions of the audit will become integral to the quality assurance activities of every mammography practice under the Mammography Quality Standards Act (MQSA) of …

2022 MQSA Mammography Inspection Checklist - NCDHHS

    https://radiation.ncdhhs.gov/Mammo/documents/InspChecklist.pdf
    Medical Physicist (to include those involved in off-site monitor services): Initial Qualifications: Copy of degree, 20 semester hrs in Physics, 20 contact hrs in …



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