3 Topic Commentaries

Regulatory Oversight and Accreditation Discrepancies

• 

  Ashish K. Jha, MD, MPH

  Internal Medicine; Health Policy

  •

  Harvard T.H. Chan School of Public Health

  There appears to be a disconnect between what accreditation is meant to do versus what it might be doing.

  Source
• 

  Everett E. Vokes, MD, FASCO

  Medical Oncology (Head & Neck, Thoracic)

  •

  American Society of Clinical Oncology (ASCO)

  Our members are providers who care for millions of patients across the country. They expect and rely on accurate IVDs—including LDTs—to inform treatment decisions throughout the course of medical treatment. Without FDA’s active oversight of high-risk LDTs, the development and quality of these tests will continue to place patients’ survival and quality of life at risk. We also believe that the U.S. public health would benefit from a regulatory framework for LDTs to ensure patient safety.

  Source
• 

  Christine England, MBA

  Pathology Administration; Regulatory Compliance

  •

  Memorial Sloan Kettering Cancer Center

  We’re constantly under regulatory surveillance: every two years by the New York State Department of Health, every three years by The Joint Commission.

  Source