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Reporting And Data

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Contaminated Drugs, Devices, or Biologics - Death/Serious Injury (Sentinel Event 2A)

Facility must report patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the healthcare setting, including contaminants in drugs, devices, or biologics regardless of the source of contamination and/or product. Intended to capture contaminations that can be seen with the naked eye or with use of detection […]

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Unsafe FDA-Regulated Medical Devices and Drugs

Facilities are required to report when it receives information that reasonably suggests that a medical device has (or may have) caused or contributed to a serious injury or death of a patient or employee of the facility. The FDA receives voluntary reports on other serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that […]

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DISCLAIMER
Although many of these requirements apply to individual medical professionals and other types of hospitals and health care facilities, the information is presented solely to support Critical Access Hospitals. The reporting requirements and legal mandates on this site are not an exhaustive list and Nevada Rural Hospital Partners, Inc. bears no responsibility or liability for any hospitals' or providers' failure to comply with Federal or State laws or regulations.