Regulations/Legal

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October 2018
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FDA statement on access to opioids for patients with chronic, end-of-life pain

Editor's Note Food & Drug Administration (FDA) commissioner, Scott Gottlieb, MD, on July 9 issued a statement on balancing access to appropriate treatment for patients with chronic and end-of-life pain with the need to stem the misuse and abuse of opioids. As the FDA considers new steps to address the…

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By: Judy Mathias
July 12, 2018
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FDA requires new labeling for fluoroquinolone antibiotics

Editor's Note The Food & Drug Administration announced on July 10 that it was requiring labeling changes for fluoroquinolone antibiotics because they may cause significant decreases in blood sugar and mental health side effects. The labels will add that low blood sugar levels can lead to coma and make the…

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By: Judy Mathias
July 11, 2018
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Study: CMS policy on CLABSI, CAUTI has minimal effect on reimbursement

Editor's Note This study found that the Centers for Medicare & Medicaid Services (CMS) hospital-acquired conditions policy on central line-associated bloodstream infections (CLABSI) and catheter-associated urinary tract infections (CAUTI) had minimal financial effects on hospitals because billing codes for CLABSI and CAUTI were rarely used and there was a significant…

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By: Judy Mathias
July 9, 2018
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CMS extends deadline for new alternative bundled payment model

Editor's Note The Centers for Medicare & Medicaid Services (CMS) announced that it is extending the deadline for its new alternative bundled payment model from August 1 to August 8, the July 5 Modern Healthcare reports. CMS extended the deadline after receiving complaints from providers and hospitals that they weren’t…

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By: Judy Mathias
July 9, 2018
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FDA: US will no longer perform Zika tests on individual blood donations

Editor's Note The Food & Drug Administration (FDA) on July 6 announced that individual blood donations no longer need to be screened for Zika virus, “unless there is an increased risk of local mosquito-borne transmission of Zika virus in a specific geographic area that would trigger individual donation testing in…

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By: Judy Mathias
July 9, 2018
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Joint Commission: OSHA requires Form 300A data to be submitted electronically

Editor's Note The Joint Commission on June 27 announced that the Occupational Safety & Health Administration (OSHA) now requires employers (including many healthcare organizations) to report Form 300A data electronically because it no longer accepts paper submissions. Form 300A is a summary of serious work-related injuries and illnesses that occur…

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By: Judy Mathias
June 28, 2018
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Joint Commission releases prepublication revisions for pain assessment and management standards

Editor's Note The Joint Commission on June 25 released new and revised pain assessment and management standards that will be applicable to accredited critical access hospitals and ambulatory care and office-based surgery organizations, effective January 1, 2019. The standards are designed to strengthen an organization’s practices for pain assessment, treatment,…

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By: Judy Mathias
June 27, 2018
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Joint Commission issues Quick Safety on identifying human trafficking victims

Editor's Note The Joint Commission on June 20 announced “Quick Safety 42: Identifying human trafficking victims.” The Quick Safety focuses on: recognizing signs of human trafficking knowing when to involve law enforcement becoming familiar with community resources that can help the victims.

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By: Judy Mathias
June 25, 2018
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Joint Commission seeking comments on anticoagulation NPSG

Editor's Note The Joint Commission announced on June 20 that it is seeking comments on proposed changes to the National Patient Safety Goal (NPSG) 03.05.01 on reducing harm from anticoagulant therapy. Revised requirements, which will address the use of new direct oral anticoagulant medications, include: drug selection dosing and monitoring…

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By: Judy Mathias
June 22, 2018
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FDA letter updates risks of Type III endoleaks with aortic endovascular graft systems

Editor's Note In a June 19 letter to healthcare providers, the Food & Drug Administration (FDA) says it continues to evaluate information from several sources, including manufacturers, on the risks associated with Type III endoleaks with various endovascular graft systems used for treatment of abdominal aortic aneurysms (AAAs) and aorto-iliac…

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By: Judy Mathias
June 20, 2018
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