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MS Hospital QAPI Standards

Jim Sheldon-Dean
Jim Sheldon-Dean
Course ID: 2
Oct 28, 2025 – Nov 8, 2025
GoTo
Los Angeles - California - USA
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Total: $119
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Quality Assessment and Performance Improvement (QAPI) Conditions of Participation deficiencies are the third most frequently cited of the 24 Conditions for Medicare-certified hospitals. CMS believes that a hospital with a well-designed and well-maintained QAPI program, fully engaged in hospital-wide continuous assessment and improvement efforts can significantly enhance its ability to provide high quality and safe care to its patients, reduce the incidence of medical errors and adverse events throughout the hospital.

  • Discuss that the governing body and hospital leadership are responsible for the QAPI program, its implementation and completion 
  • Recall key requirements for a QAPI program that will be reviewed and assessed during a survey.
  • Recall areas to be assessed during a survey and what surveyors will be reviewing
  • Recall that CMS surveyors will review policies in place and observe for implementation of such policies and procedures.
    • Resources available
    • 2019 changes – new tag numbers
    • Program design and scope
    • Responsibilities of governing body and leadership
    • Program activities
    • Data collection and analysis
    • Performance improvement director and staff
    • Risk management
    • Quality staff
    • Compliance officer
    • Chief nursing officer
    • Chief medical officer
    • Patient safety officer
    • Nurse educator
    • Staff nurses
    • Nurse managers
    • Leadership staff
    • Accreditation staff
    • Department directors
    • Infection preventionist.
DAY 1 (4:30 PM - 4:31 PM IST)
    • Detention
      • Options for a detained shipment
      • Negotiating with FDA and U.S. Customs
        • What to say
        • What not to say
        • When to give up
      • Release from Detention and Government Refusal Remedies
      • Reducing the risk of detention
    • FDA Warning Letters and Automatic Detention
    • Enforcement
      • U.S. Customs and FDA authority
      • Burden of proof
      • Assistant U.S. attorney
      • Government remedies
    • Special provisions
      • Counterfeit
      • Import for export
      • International trade shows
      • Investigational device
      • “Compassionate Use”
    • New and Special Issues for Imports and Exports in 2020.
      • EU Medical Device Regulation (MDR) program for imported products
      • Inspection of personal mail
      • Personal use exception
      • Trade shoes and promotional marketing
      • Compassionate use
DAY 2 (9:20 AM - 6:20 AM IST)
    • FDA’s legal requirements
      • Statutory authority
      • Regulations
    • Foreign manufacturers obligations
      • U.S. initial importers obligations
      • User Fees
      • How does FDA do its job
      • What is CPB and how do they do their job
    • Selecting foreign suppliers
      • Inspection history
      • Samples analyzed
      • Vendor Audit
    • Product Import Procedures
    • (Case Study)

      • Entry Process (U.S. Customs/FDA)
      • How to Pick the right Custom House Broker
      • Documentation
        • FDA Form 2877
        • CPB Form 3461
        • Medical Device Affirmations of Compliance (AofC)
        • Electronic Entry Filing
          • FDA’s PREDICT computer screening program
          • U.S. Customs Automated Commercial Environment (ACE) program
          • Product sampling / testing
          • Detention, block list, automatic detention
        • Quality standards
        • Country of origin
        • Product type
Jim Sheldon-Dean

Jim Sheldon-Dean is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a wide variety of healthcare entities.  He is a frequent speaker regarding HIPAA, including speaking engagements at numerous regional and national healthcare association conferences and conventions and the annual NIST/OCR HIPAA Security Conference. Sheldon-Dean has more than two decades of experience specializing in HIPAA compliance, four decades of experience in policy analysis and implementation, business process analysis, information systems, and software development, and eight years of experience doing hands-on medical work as a Vermont-certified volunteer emergency medical technician.  

Sheldon-Dean received his B.S. degree, summa cum laude, from the University of Vermont and his master’s degree from the Massachusetts Institute of Technology.

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